Rotarix
1 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 



  2 

 
1.  NAME OF THE MEDICINAL PRODUCT 
 
Rotarix powder and solvent for oral suspension 
Rotavirus vaccine, live 
 
 
2.  QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
After reconstitution, 1 dose (1 ml) contains: 
 
Human rotavirus RIX4414 strain (live, attenuated)* not less than 106.0 CCID50 
 
*Produced on Vero cells 
 
Excipients with known effect: 
This product contains sucrose 9 mg and sorbitol 13.5 mg (see section 4.4). 
  
For the full list of excipients, see section 6.1. 
 
 
3.  PHARMACEUTICAL FORM 
 
Powder and solvent for oral suspension. 
The powder is white. 
The solvent is a turbid liquid with a slow settling white deposit and a colourless supernatant. 
 
 
4.  CLINICAL PARTICULARS 
 
4.1  Therapeutic indications 
 
Rotarix is indicated for the active immunisation of infants aged 6 to 24 weeks for prevention of gastro-
enteritis due to rotavirus infection (see sections 4.2, 4.4 and 5.1). 
 
The use of Rotarix should be based on official recommendations. 
 
4.2  Posology and method of administration 
 
Posology 
 
The vaccination course consists of two doses. The first dose may be administered from the age of 6 
weeks. There should be an interval of at least 4 weeks between doses. The vaccination course should 
preferably be given before 16 weeks of age, but must be completed by the age of 24 weeks. 
 
Rotarix may be given with the same posology to preterm infants born after at least 27 weeks of 
gestational age (see sections 4.8 and 5.1). 
 
In clinical trials, spitting or regurgitation of the vaccine has rarely been observed and, under such 
circumstances, a replacement dose was not given. However, in the unlikely event that an infant spits 
out or regurgitates most of the vaccine dose, a single replacement dose may be given at the same 
vaccination visit. 
 
It is recommended that infants who receive a first dose of Rotarix complete the 2-dose regimen with 
Rotarix. There are no data on safety, immunogenicity or efficacy when Rotarix is administered for the 
first dose and another rotavirus vaccine is administered for the second dose or vice versa. 
 



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Paediatric population 
 
Rotarix should not be used in children over 24 weeks of age. 
 
Method of administration 
 
Rotarix is for oral use only. 
 
Rotarix should under no circumstances be injected. 

 
For instructions for the preparation or reconstitution of the medicinal product before administration, 
see section 6.6. 

 
4.3  Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
 
Hypersensitivity after previous administration of rotavirus vaccines. 
 
History of intussusception. 
 
Subjects with uncorrected congenital malformation of the gastrointestinal tract that would predispose 
for intussusception. 
 
Subjects with Severe Combined Immunodeficiency (SCID) disorder (see section 4.8). 
 
Administration of Rotarix should be postponed in subjects suffering from acute severe febrile 
illness. The presence of a minor infection is not a contra-indication for immunisation. 
 
The administration of Rotarix should be postponed in subjects suffering from diarrhoea or vomiting. 
 
4.4  Special warnings and precautions for use 
 
It is good clinical practice that vaccination should be preceded by a review of the medical history 
especially with regard to the contraindications and by a clinical examination. 
 
There are no data on the safety and efficacy of Rotarix in infants with gastrointestinal illnesses or 
growth retardation. Administration of Rotarix may be considered with caution in such infants when, in 
the opinion of the physician, withholding the vaccine entails a greater risk. 
 
As a precaution, healthcare professionals should follow-up on any symptoms indicative of 
intussusception (severe abdominal pain, persistent vomiting, bloody stools, abdominal bloating and/or 
high fever) since data from observational safety studies indicate an increased risk of intussusception, 
mostly within 7 days after rotavirus vaccination (see section 4.8). Parents/guardians should be advised 
to promptly report such symptoms to their healthcare provider. 
 
For subjects with a predisposition for intussusception, see section 4.3. 
 
Asymptomatic and mildly symptomatic HIV infections are not expected to affect the safety or efficacy 
of Rotarix. A clinical study in a limited number of asymptomatic or mildly symptomatic HIV positive 
infants showed no apparent safety problems (see section 4.8). 
Administration of Rotarix to infants who have known or suspected immunodeficiency, including in 
utero exposure to an immunosuppressive treatment, should be based on careful consideration of 
potential benefits and risks. 
 
Excretion of the vaccine virus in the stools is known to occur after vaccination with peak excretion 
around the 7th day. Viral antigen particles detected by ELISA were found in 50% of stools after the 



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first dose and 4% of stools after the second dose. When these stools were tested for the presence of 
live vaccine strain, only 17% were positive. 
 
Cases of transmission of this excreted vaccine virus to seronegative contacts of vaccinees have been 
observed without causing any clinical symptom. 
 
Rotarix should be administered with caution to individuals with immunodeficient close contacts, 
such as individuals with malignancies, or who are otherwise immunocompromised or individuals 
receiving immunosuppressive therapy. 
 
Contacts of recent vaccinees should observe personal hygiene (e.g. wash their hands after changing 
child’s nappies). 
 
The potential risk of apnoea and the need for respiratory monitoring for 48-72h should be considered 
when administering the primary immunisation series to very premature infants (born ≤ 28 weeks of 
gestation) and particularly for those with a previous history of respiratory immaturity. 
 
As the benefit of the vaccination is high in this group of infants, vaccination should not be withheld or 
delayed. 
 
A protective immune response may not be elicited in all vaccinees (see section 5.1). 
 
The extent of protection that Rotarix might provide against other rotavirus strains that have not been 
circulating in clinical trials is currently unknown. Clinical studies from which efficacy data were 
derived were conducted in Europe, Central and South America, Africa and Asia (see section 5.1). 
 
Rotarix does not protect against gastro-enteritis due to other pathogens than rotavirus. 
 
No data are available on the use of Rotarix for post-exposure prophylaxis. 
 
Rotarix should under no circumstances be injected. 
 
The vaccine contains sucrose and sorbitol as excipients. Patients with rare hereditary problems of 
fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not 
take this vaccine. 
 
Traceability 
 
In order to improve the traceability of biological medicinal products, the name and the batch number 
of the administered product should be clearly recorded. 
 
4.5  Interaction with other medicinal products and other forms of interaction 
 
Rotarix can be given concomitantly with any of the following monovalent or combination vaccines 
[including hexavalent vaccines (DTPa-HBV-IPV/Hib)]: diphtheria-tetanus-whole cell pertussis 
vaccine (DTPw), diphtheria-tetanus-acellular pertussis vaccine (DTPa), Haemophilus influenzae 
type b vaccine (Hib), inactivated polio vaccine (IPV), hepatitis B vaccine (HBV), pneumococcal 
conjugate vaccine and meningococcal serogroup C conjugate vaccine. Clinical studies demonstrated 
that the immune responses and the safety profiles of the administered vaccines were unaffected. 
 
Concomitant administration of Rotarix and oral polio vaccine (OPV) does not affect the immune 
response to the polio antigens. Although concomitant administration of OPV may slightly reduce the 
immune response to rotavirus vaccine, clinical protection against severe rotavirus gastro-enteritis was 
shown to be maintained in a clinical trial involving more than 4,200 subjects who received Rotarix 
concomitantly with OPV. 
 
There are no restrictions on the infant’s consumption of food or liquid, either before or after 



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vaccination. 
 
4.6  Fertility, pregnancy and lactation 
 
Rotarix is not intended for use in adults. There are no data on the use of Rotarix during pregnancy and 
lactation.  
 
Based on evidence generated in clinical trials, breast-feeding does not reduce the protection against 
rotavirus gastro-enteritis afforded by Rotarix. Therefore, breast-feeding may be continued during the 
vaccination schedule. 
 
4.7  Effects on ability to drive and use machines  
 
Not relevant. 
 
4.8 Undesirable effects 

 
Summary of the safety profile 

The safety profile presented below is based on data from clinical trials conducted with either the 
lyophilised or the liquid formulation of Rotarix. 
In a total of four clinical trials, approximately 3,800 doses of Rotarix liquid formulation were 
administered to approximately 1,900 infants. Those trials have shown that the safety profile of the 
liquid formulation is comparable to the lyophilised formulation. 
 
In a total of twenty-three clinical trials, approximately 106,000 doses of Rotarix (lyophilised or liquid 
formulation) were administered to approximately 51,000 infants.  
 
In three placebo-controlled clinical trials (Finland, India and Bangladesh), in which Rotarix was 
administered alone (administration of routine paediatric vaccines was staggered), the incidence and 
severity of the solicited events (collected 8 days post-vaccination), diarrhoea, vomiting, loss of 
appetite, fever, irritability and cough/runny nose were not significantly different in the group receiving 
Rotarix when compared to the group receiving placebo. No increase in the incidence or severity of 
these events was seen with the second dose. 
 
In a pooled analysis from seventeen placebo-controlled clinical trials (Europe, North America, Latin 
America, Asia, Africa) including trials in which Rotarix was co-administered with routine paediatric 
vaccines (see section 4.5), the following adverse reactions (collected 31 days post-vaccination) were 
considered as possibly related to vaccination. 
 
Tabulated list of adverse reactions 

Adverse reactions reported are listed according to the following frequency: 
 
Frequencies are reported as: 
Very common (≥1/10) 
Common (≥1/100 to <1/10) 
Uncommon (≥1/1,000 to <1/100) 
Rare (≥1/10,000 to <1/1,000) 
Very rare (<1/10,000) 
 
System Organ Class Frequency Adverse reactions 

Gastrointestinal disorders Common Diarrhoea 

 Uncommon  Abdominal pain, flatulence 

 Very rare Intussusception (see section 4.4) 



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 Not known* Haematochezia 

 Not known* Gastroenteritis with vaccine viral 
shedding in infants with Severe 
Combined Immunodeficiency 
(SCID) disorder 

Skin and subcutaneous tissue 
disorders 

Uncommon Dermatitis 

Very rare Urticaria 

General disorders and 
administration site conditions 

Common Irritability 

Respiratory, thoracic and 
mediastinal disorders 

Not known* Apnoea in very premature infants 
(≤ 28 weeks of gestation) (see 
section 4.4) 

* Because these events were reported spontaneously, it is not possible to reliably estimate their 
frequency. 
 
Description of selected adverse reactions 
 
Intussusception 
 
Data from observational safety studies performed in several countries indicate that rotavirus vaccines 
carry an increased risk of intussusception, mostly within 7 days of vaccination. Up to 6 additional 
cases per 100,000 infants have been observed in these countries against a background incidence of 25 
to 101 per 100,000 infants (less than one year of age) per year, respectively.  
There is limited evidence of a smaller increased risk following the second dose.  
It remains unclear whether rotavirus vaccines affect the overall incidence of intussusception based on 
longer periods of follow-up (see section 4.4). 
 
Other special populations  
 
Safety in preterm infants 
 
In a clinical study, 670 pre-term infants from 27 to 36 weeks of gestational age were administered 
Rotarix and 339 received placebo. The first dose was administered from 6 weeks after birth. Serious 
adverse events were observed in 5.1% of recipients of Rotarix as compared with 6.8% of placebo 
recipients. Similar rates of other adverse events were observed in Rotarix and placebo recipients. No 
cases of intussusception were reported. 
 
Safety in infants with human immunodeficiency (HIV) infection 
 
In a clinical study, 100 infants with HIV infection were administered Rotarix or placebo. The safety 
profile was similar between Rotarix and placebo recipients. 
 
Reporting of suspected adverse reactions 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 
4.9  Overdose 
 
Some cases of overdose have been reported. In general, the adverse event profile reported in these 
cases was similar to that observed after administration of the recommended dose of Rotarix. 
 
 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc
http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


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5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmaco-therapeutic group: rotavirus diarrhoea vaccines, ATC code: J07BH01 
 
Protective efficacy 
 
In clinical trials, efficacy was demonstrated against gastro-enteritis due to rotavirus of the most 
common genotypes G1P[8], G2P[4], G3P[8], G4P[8] and G9P[8]. In addition, efficacy against 
uncommon rotavirus genotypes G8P[4](severe gastro-enteritis) and G12P[6] (any gastro-enteritis) has 
been demonstrated. These strains are circulating worldwide. 
 
Clinical studies have been conducted in Europe, Latin America, Africa and Asia to evaluate the 
protective efficacy of Rotarix against any and severe rotavirus gastro-enteritis. 
 
Severity of gastro-enteritis was defined according to two different criteria: 
- the Vesikari 20-point scale, which evaluates the full clinical picture of rotavirus gastro-enteritis by 

taking into account the severity and duration of diarrhoea and vomiting, the severity of fever and 
dehydration as well as the need for treatment 

or 
- the clinical case definition based on World Health Organization (WHO) criteria 
 
Clinical protection was assessed in the ATP cohort for efficacy, which includes all subjects from the 
ATP cohort for safety who entered into the concerned efficacy follow-up period. 
 
Protective efficacy in Europe 
 
A clinical study performed in Europe evaluated Rotarix given according to different European 
schedules (2, 3 months; 2, 4 months; 3, 4 months; 3, 5 months) in 4,000 subjects.  
 
After two doses of Rotarix, the protective vaccine efficacy observed during the first and second year 
of life is presented in the following table: 
 

 1st year of life 
Rotarix N=2,572  
Placebo N=1,302  

2nd year of life 
Rotarix N=2,554  
Placebo N=1,294  

Vaccine efficacy (%) against any and severe rotavirus gastro-enteritis 
[95% CI] 

Genotype Any severity Severe† Any severity Severe† 
G1P[8] 95.6 

[87.9;98.8] 
96.4 

[85.7;99.6] 
82.7 

[67.8;91.3] 
96.5 

[86.2;99.6] 
G2P[4] 62.0* 

[<0.0;94.4] 
74.7* 

[<0.0;99.6] 
57.1 

[<0.0;82.6] 
89.9 

[9.4;99.8] 
G3P[8] 89.9 

[9.5;99.8] 
100 

[44.8;100] 
79.7 

[<0.0;98.1] 
83.1* 

[<0.0;99.7] 
G4P[8] 88.3 

[57.5;97.9] 
100 

[64.9;100] 
69.6* 

[<0.0;95.3] 
87.3 

[<0.0;99.7] 
G9P[8] 75.6 

[51.1;88.5] 
94.7 

[77.9;99.4] 
70.5 

[50.7;82.8] 
76.8 

[50.8;89.7] 
Strains with P[8] 

genotype 
88.2 

[80.8;93.0] 
96.5 

[90.6;99.1] 
75.7 

[65.0;83.4] 
87.5 

[77.8;93.4] 
Circulating 

rotavirus strains 
87.1 

[79.6;92.1] 
95.8 

[89.6;98.7] 
71.9 

[61.2;79.8] 
85.6 

[75.8;91.9] 
Vaccine efficacy (%) against rotavirus gastro-enteritis requiring medical 

attention 



  8 

[95% CI] 
Circulating 

rotavirus strains 
91.8 

[84;96.3] 
76.2 

[63.0;85.0] 
Vaccine efficacy (%) against hospitalisation due to rotavirus gastro-enteritis 

[95% CI] 
Circulating 

rotavirus strains 
100 

[81.8;100] 
92.2 

[65.6;99.1] 
† Severe gastro-enteritis was defined as a score ≥11 on the Vesikari scale 
* Not statistically significant (p ≥ 0.05). These data should be interpreted with caution 
 
Vaccine efficacy during the first year of life progressively increased with increasing disease severity, 
reaching 100% (95% CI: 84.7;100) for Vesikari scores ≥17. 
 
Protective efficacy in Latin America 
 
A clinical study performed in Latin America evaluated Rotarix in more than 20,000 subjects. Severity 
of gastro-enteritis (GE) was defined according to WHO criteria. The protective vaccine efficacy 
against severe rotavirus (RV) gastro-enteritis requiring hospitalisation and/or rehydration therapy in a 
medical facility and the genotype specific vaccine efficacy after two doses of Rotarix are presented in 
the table below:  
 
Genotype Severe rotavirus gastro-

enteritis† (1st year of life) 
Rotarix N=9,009  
Placebo N=8,858  

Severe rotavirus gastro-
enteritis† (2nd year of life) 

Rotarix N=7,175  
Placebo N=7,062  

 Efficacy (%) 
[95% CI ] 

Efficacy (%) 
[95% CI ] 

All RVGE 84.7 
[71.7;92.4] 

79.0 
[66.4;87.4] 

G1P[8] 91.8 
[74.1;98.4] 

72.4 
[34.5;89.9] 

G3P[8] 87.7 
[8.3;99.7] 

71.9* 
[<0.0;97.1] 

G4P[8] 50.8#* 
[<0.0;99.2] 

63.1 
[0.7;88.2] 

G9P[8] 90.6 
[61.7;98.9] 

87.7 
[72.9;95.3] 

Strains with P[8] 
genotype 

90.9 
[79.2;96.8] 

79.5 
[67.0;87.9] 

† Severe rotavirus gastro-enteritis was defined as an episode of diarrhoea with or without vomiting 
that required hospitalization and/or re-hydration therapy in a medical facility (WHO criteria) 
* Not statistically significant (p ≥ 0.05). These data should be interpreted with caution 
# The numbers of cases, on which the estimates of efficacy against G4P[8] were based, were very 
small (1 case in the Rotarix group and 2 cases in the placebo group) 
 
A pooled analysis of five efficacy studies*, showed a 71.4% (95% CI:20.1;91.1) efficacy against 
severe rotavirus gastro-enteritis (Vesikari score ≥11) caused by rotavirus G2P[4] genotype during the 
first year of life. 
* In these studies, the point estimates and confidence intervals were respectively: 100% (95% CI: -
1,858.0;100), 100% (95% CI: 21.1;100), 45.4% (95% CI: -81.5;86.6), 74.7 (95% CI :-386.2;99.6). No 
point estimate was available for the remaining study. 
 
Protective efficacy in Africa 
 
A clinical study performed in Africa (Rotarix: N = 2,974; placebo: N = 1,443) evaluated Rotarix given 
at approximately 10 and 14 weeks of age (2 doses) or 6, 10 and 14 weeks of age (3 doses). The 



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vaccine efficacy against severe rotavirus gastro-enteritis during the first year of life was 61.2% (95% 
CI: 44.0;73.2). The protective vaccine efficacy (pooled doses) observed against any and severe 
rotavirus gastro-enteritis is presented in the following table: 
 
Genotype Any rotavirus gastro-enteritis 

Rotarix N=2,974 
Placebo N=1,443 

Severe rotavirus gastro-enteritis† 
Rotarix N=2,974 
Placebo N=1,443 

 Efficacy (%) 
[95% CI] 

Efficacy (%) 
[95% CI] 

G1P[8] 68.3 
[53.6;78.5] 

56.6 
[11.8;78.8] 

G2P[4] 49.3 
[4.6;73.0] 

83.8 
[9.6;98.4] 

G3P[8] 43.4* 
[<0.0;83.7] 

51.5* 
[<0.0;96.5] 

G8P[4] 38.7* 
[<0.0;67.8] 

63.6 
[5.9;86.5] 

G9P[8] 41.8* 
[<0.0;72.3] 

56.9* 
[<0.0;85.5] 

G12P[6] 48.0 
[9.7;70.0] 

55.5* 
[<0.0;82.2] 

Strains with P[4] 
genotype 

39.3 
[7.7;59.9] 

70.9 
[37.5;87.0] 

Strains with P[6] 
genotype 

46.6 
[9.4;68.4] 

55.2* 
[<0.0;81.3] 

Strains with P[8] 
genotype 

61.0 
[47.3;71.2] 

59.1 
[32.8;75.3] 

† Severe gastro-enteritis was defined as a score ≥11 on the Vesikari scale 
* Not statistically significant (p ≥ 0.05). These data should be interpreted with caution 
 
Sustained efficacy up to 3 years of age in Asia 
 
A clinical study conducted in Asia (Hong Kong, Singapore and Taiwan) (Total vaccinated cohort : 
Rotarix: N = 5,359; placebo: N = 5,349) evaluated Rotarix given according to different schedules (2, 4 
months of age; 3, 4 months of age). 
 
During the first year, significantly fewer subjects in the Rotarix group reported severe rotavirus gastro-
enteritis caused by the circulating wild-type RV compared to the placebo group from 2 weeks after 
Dose 2 up to one year of age (0.0% versus 0.3%), with a vaccine efficacy of 100% (95% CI: 72.2; 
100). 

 
The protective vaccine efficacy after two doses of Rotarix observed against severe rotavirus gastro-
enteritis up to 2 years of age is presented in the following table: 
 

 Efficacy up to 2 years of age 
Rotarix N= 5,263 
Placebo N= 5,256 

Vaccine efficacy (%) against severe rotavirus gastro-enteritis [95% CI] 
Genotype Severe† 

G1P[8] 100 [80.8;100] 
G2P[4] 100* [<0.0;100] 
G3P[8] 94.5 [64.9;99.9] 
G9P[8] 91.7 [43.8;99.8] 
Strains with P[8] genotype 95.8 [83.8;99.5] 



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Circulating rotavirus strains 96.1 [85.1;99.5] 
Vaccine efficacy (%) against rotavirus gastro-enteritis requiring hospitalisation 
and/or rehydration therapy in a medical facility [95% CI] 
Circulating rotavirus strains 94.2  [82.2;98.8] 

† Severe gastro-enteritis was defined as a score ≥11 on the Vesikari scale 
* Not statistically significant (p ≥ 0.05). These data should be interpreted with caution 
 

During the third year of life, there were no cases of severe RV gastro-enteritis in the Rotarix group 
(N=4,222) versus 13 (0.3%) in the placebo group (N=4,185). Vaccine efficacy was 100% (95% CI: 
67.5; 100). The severe RV gastro-enteritis cases were due to RV strains G1P[8], G2P[4], G3P[8] and 
G9P[8]. The incidence of severe RV gastro-enteritis associated with the individual genotypes was too 
small to allow calculation of efficacy. The efficacy against severe RV gastro-enteritis requiring 
hospitalisation was 100% (95% CI: 72.4; 100). 

 
Immune response 
 
The immunologic mechanism by which Rotarix protects against rotavirus gastro-enteritis is not 
completely understood. A relationship between antibody responses to rotavirus vaccination and 
protection against rotavirus gastro-enteritis has not been established. 
 
The following table shows the percentage of subjects initially seronegative for rotavirus (IgA antibody 
titres < 20 U/ml) (by ELISA) with serum anti-rotavirus IgA antibody titres ≥ 20U/ml one to two 
months after the second dose of vaccine or placebo as observed in different studies. 
 
Schedule Studies 

conducted in 
Vaccine Placebo 

  N % ≥ 20U/ml 
[95% CI] 

N % ≥ 20U/ml 
[95% CI] 

2, 3 months France, 
Germany 

239 82.8 
[77.5;87.4] 

127 8.7 
[4.4;15.0] 

2, 4 months Spain 186 85.5 
[79.6;90.2] 

89 12.4 
[6.3;21.0] 

3, 5 months Finland, Italy 180 94.4 
[90.0;97.3] 

114 3.5 
[1.0;8.7] 

3, 4 months Czech 
Republic 

182 84.6 
[78.5;89.5] 

90 2.2 
[0.3;7.8] 

2, 3 to 4 
months 

Latin 
America; 11 
countries 

393 77.9% 
[73.8;81.6] 

341 15.1% 
[11.7;19.0] 

10, 14 weeks 
and 6, 10, 14 
weeks 
(Pooled) 

South Africa, 
Malawi 

221 58.4 
[51.6;64.9] 

111 22.5 
[15.1;31.4] 

 
Immune response in preterm infants 
 
In a clinical study conducted in preterm infants, born after at least 27 weeks of gestational age, the 
immunogenicity of Rotarix was assessed in a subset of 147 subjects and showed that Rotarix is 
immunogenic in this population; 85.7% (95% CI: 79.0;90.9) of subjects achieved serum anti-rotavirus 
IgA antibody titres ≥ 20U/ml (by ELISA) one month after the second dose of vaccine. 
 
Effectiveness 

In observational studies, vaccine effectiveness was demonstrated against severe gastro-enteritis 
leading to hospitalisation due to rotavirus of common genotypes G1P[8], G2P[4], G3P[8], G4P[8] and 



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G9P[8] as well as the less common rotavirus genotypes G9P[4] and G9P[6]. All of these strains are 
circulating worldwide. 
 
Effectiveness after 2 doses in preventing RVGE leading to hospitalization 



  12 

 
Countries 
Period 

Age range N (1) 
(cases/controls) 

Strains Effectiveness 
% [95% CI] 

High Income countries 
Belgium 
2008-2010(2) 
 

< 4 yrs  
3-11 m 

160/198 
 

All 90 [81;95] 
91 [75;97] 

< 4 yrs  41/53 G1P[8] 95 [78;99] 
< 4 yrs 

3-11 m 
80/103 G2P[4] 85 [64;94] 

83 [11;96] (3) 
< 4 yrs 12/13 G3P[8] 87* [<0;98](3) 
< 4 yrs 16/17 G4P[8] 90 [19;99] (3) 

Singapore  
2008-2010(2) 

< 5 yrs 136/272 All 84 [32;96] 
89/89 G1P[8] 91 [30;99] 

Taiwan  
2009-2011 

< 3 yrs 275/1,623(4) All 
G1P[8] 

92 [75;98] 
95 [69;100] 

US  
2010-2011 

< 2 yrs 85/1,062(5) All 
G1P[8] 
G2P[4] 

85 [73;92] 
88 [68;95] 
88 [68;95] 

8-11 m All 89 [48;98] 
US 
2009-2011 

< 5 yrs 74/255(4) G3P[8] 68 [34;85] 

Middle Income Countries 
Bolivia  
2010-2011 

< 3 yrs 
6-11 m 

300/974 All 77 [65;84](6) 
77 [51;89] 

< 3 yrs 
6-11 m 

G9P[8] 85 [69;93] 
90 [65;97] 

< 3 yrs G3P[8] 93 [70;98] 
G2P[4] 69 [14;89] 
G9P[6] 87 [19;98] 

Brazil  
2008-2011 

< 2 yrs 115/1,481 All 72 [44;85](6) 
G1P[8] 89 [78;95] 
G2P[4] 76 [64;84] 

Brazil  
2008-2009(2) 
 

< 3 yrs 
3-11 m 

249/249 (5) All 76 [58;86] 
96 [68;99] 

< 3 yrs 
3-11 m 

222/222 (5) G2P[4] 75 [57;86] 
95 [66;99] (3) 

El Salvador 
2007-2009 

< 2 yrs 
6-11 m 

251/770 (5) All 76 [64;84] (6) 
83 [68;91] 

Guatemala 
2012-2013 

< 4 yrs NA(7) All 63 [23;82] 

Mexico 
2010 

< 2 yrs 9/17(5) G9P[4] 94 [16;100] 

Low Income Countries 
Malawi 
2012-2014 

< 2 yrs 81/234(5) All 63 [23;83] 

m: months 
yrs: years 
* Not statistically significant (P ≥ 0.05). These data should be interpreted with caution. 
(1) The number of fully vaccinated (2 doses) and unvaccinated cases and controls is given. 
(2) GSK sponsored studies  
(3) Data from a post-hoc analysis 
(4) Vaccine effectiveness was calculated using rotavirus-negative hospital control participants (estimates from 

Taiwan were calculated using combined rotavirus-negative hospital control and non-diarrhoea hospital 
control participants). 

(5) Vaccine effectiveness was calculated using neighborhood controls. 



  13 

(6) In subjects who did not receive the full course of vaccination, the effectiveness after one dose ranged from 
51% (95% CI: 26;67, El Salvador) to 60% (95% CI: 37;75, Brazil). 

(7) NA: not available. Vaccine effectiveness estimate is based on 41 fully vaccinated cases and 175 fully 
vaccinated controls. 

 
Impact on mortality§ 

Impact studies with Rotarix conducted in Panama, Brazil and Mexico showed a decrease in all-cause 
diarrhoea mortality ranging from 17% to 73% in children less than 5 years of age, within 2 to 4 years 
after vaccine introduction. 
 
Impact on hospitalisation§ 

In a retrospective database study in Belgium conducted in children 5 years of age and younger, the 
direct and indirect impact of Rotarix vaccination on rotavirus-related hospitalisation ranged from 64% 
(95% CI: 49;76) to 80% (95% CI: 77;83) two years after vaccine introduction. Similar studies in 
Armenia, Australia, Brazil, Canada, El Salvador and Zambia showed a reduction of 45 to 93% 
between 2 and 4 years after vaccine introduction.  

In addition, nine impact studies on all-cause diarrhoea hospitalisation conducted in Africa and Latin 
America showed a reduction of 14% to 57% between 2 and 5 years after vaccine introduction. 

§NOTE : Impact studies are meant to establish a temporal relationship but not a causal relationship 
between the disease and vaccination. Natural fluctuations of the incidence of the disease may also 
influence the observed temporal effect. 
 
5.2  Pharmacokinetic properties 
 
Not applicable. 
 
5.3  Preclinical safety data 
 
Non-clinical data reveal no special hazard for humans based on conventional studies of repeated dose 
toxicity. 
 
 
6.  PHARMACEUTICAL PARTICULARS 
 
6.1  List of excipients 
 
Powder 
Sucrose 
Dextran 
Sorbitol 
Amino acids 
Dulbecco’s Modified Eagle Medium (DMEM) 
 
Solvent 
Calcium carbonate 
Xanthan gum 
Sterile water 
 
6.2  Incompatibilities 
 
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal 
products. 



  14 

 
6.3  Shelf life 
 
3 years. 
 
After reconstitution: 
After the reconstitution, the vaccine should be administered immediately. If not used immediately,  
in-use storage should not be longer than 24 hours and at a temperature between 2-25°C. 
 
6.4  Special precautions for storage 
 
Store in a refrigerator (2°C – 8°C). 
Do not freeze. 
 
Store in the original package, in order to protect from light. 
 
For storage conditions after reconstitution of the medicinal product, see section 6.3. 
 
6.5  Nature and contents of container 
 
1 dose of powder in a glass container (type I glass) with a stopper (rubber butyl)  
1 ml of solvent in an oral applicator (type I glass) with a plunger stopper and a protective tip cap 
(rubber butyl).  
Transfer adapter for reconstitution (1/dose) in the following pack sizes: 
• pack size of 1 glass container of powder plus 1 oral applicator of solvent 
• pack size of 5 glass containers of powder plus 5 oral applicators of solvent 
• pack size of 10 glass containers of powder plus 10 oral applicators of solvent 
• pack size of 25 glass containers of powder plus 25 oral applicators of solvent 
 
Not all pack sizes may be marketed. 
 
6.6  Special precautions for disposal and other handling 
 
Before reconstitution: 
A white deposit and clear supernatant is observed upon storage of the oral applicator containing the 
solvent. The solvent should be inspected visually for any foreign particulate matter and/or abnormal 
physical appearance prior to reconstitution. 
 
After reconstitution: 
The reconstituted vaccine is slightly more turbid than the solvent and is milky white in appearance. 
 
The reconstituted vaccine should also be inspected visually for any foreign particulate matter and/or 
abnormal physical appearance prior to administration. In the event of either being observed, discard 
the vaccine. 
 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 
 
Instructions for reconstitution and administration of the vaccine: 
 
 

 
 



  15 

 
 
 
 
 
 
 
If the reconstituted vaccine is to be stored temporarily before administration, replace the protective tip cap on 
the oral applicator. The oral applicator containing the reconstituted vaccine should be shaken gently again 
before oral administration. Do not inject. 

 
 
7. MARKETING AUTHORISATION HOLDER 
 
GlaxoSmithKline Biologicals s.a. 
Rue de l'Institut 89 
B-1330 Rixensart, Belgium 
 
 
8.  MARKETING AUTHORISATION NUMBER(S) 

1. Remove the plastic cover from the 
glass container containing the powder 

Transfer 
adapter 

Oral 
applicator 

Oral 
applicator 
Tip-Cap 

2. Connect the transfer adapter onto 
the glass container by pushing it 
downwards until the transfer adapter 
is properly and securely placed 

3. Shake the oral applicator 
containing the solvent vigorously. The 
shaken suspension will appear as a 
turbid liquid with a slow settling white 
deposit 

4. Remove the protective tip cap from 
the oral applicator 

5. Connect the oral applicator into the 
transfer adapter by pushing it firmly 
on this device 

6. Transfer the entire content of the 
oral applicator into the glass 
container containing the powder 

7. With the oral applicator still attached, 
shake the glass container and examine it 
for complete suspension of the powder. 
The reconstituted vaccine will appear more 
turbid than the solvent alone. This 
appearance is normal 

8. Withdraw the entire mixture back 
into the oral applicator 

9. Remove the oral applicator from 
the transfer adapter 

10. This vaccine is for oral 
administration only. The child 
should be seated in a reclining 
position. Administer the entire content 
of the oral applicator orally (by 
administering the entire content of the 
oral applicator on the inside of the 
cheek) 

Glass 
container 

11. Do not inject. 



 

16 
 

 
EU/1/05/330/001 
EU/1/05/330/002 
EU/1/05/330/003 
EU/1/05/330/004 
 
 
9.  DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 21 February 2006 
Date of latest renewal: 14 January 2016 
 
 
10.  DATE OF REVISION OF THE TEXT 
 
Detailed information on this medicinal product is available on the website of the European Medicines  
Agency http://www.ema.europa.eu. 



 

17 
 

 
1.  NAME OF THE MEDICINAL PRODUCT 
 
Rotarix oral suspension in pre-filled oral applicator 
Rotarix oral suspension in squeezable tube 
Rotarix oral suspension in multi-monodose (5 single dose) squeezable tube presentation connected by 
a bar 
Rotavirus vaccine, live 
 
 
2.  QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
1 dose (1.5 ml) contains: 
 
Human rotavirus RIX4414 strain (live, attenuated)* not less than 106.0 CCID50 
 
*Produced on Vero cells 
 
Excipient with known effect: 
This product contains sucrose 1,073 mg (see section 4.4). 
 
For the full list of excipients, see section 6.1. 
 
 
3.  PHARMACEUTICAL FORM 
 
Oral suspension. 
Rotarix is a clear and colourless liquid. 
 
 
4.  CLINICAL PARTICULARS 
 
4.1  Therapeutic indications 
 
Rotarix is indicated for the active immunisation of infants aged 6 to 24 weeks for prevention of gastro-
enteritis due to rotavirus infection (see sections 4.2, 4.4 and 5.1). 
 
The use of Rotarix should be based on official recommendations. 
 
4.2  Posology and method of administration 
 
Posology 
 
The vaccination course consists of two doses. The first dose may be administered from the age of 6 
weeks. There should be an interval of at least 4 weeks between doses. The vaccination course should 
preferably be given before 16 weeks of age, but must be completed by the age of 24 weeks. 
 
Rotarix may be given with the same posology to preterm infants born after at least 27 weeks of 
gestational age (see sections 4.8 and 5.1). 
 
In clinical trials, spitting or regurgitation of the vaccine has rarely been observed and, under such 
circumstances, a replacement dose was not given. However, in the unlikely event that an infant spits 
out or regurgitates most of the vaccine dose, a single replacement dose may be given at the same 
vaccination visit. 
 
It is recommended that infants who receive a first dose of Rotarix complete the 2-dose regimen with 
Rotarix. There are no data on safety, immunogenicity or efficacy when Rotarix is administered for the 



 

18 
 

first dose and another rotavirus vaccine is administered for the second dose or vice versa. 
 
Paediatric population 
 
Rotarix should not be used in children over 24 weeks of age.  
 
Method of administration 
 
Rotarix is for oral use only. 
 
Rotarix should under no circumstances be injected. 
 
For instructions for administration, see section 6.6. 
 
4.3  Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
 
Hypersensitivity after previous administration of rotavirus vaccines. 
 
History of intussusception. 
 
Subjects with uncorrected congenital malformation of the gastrointestinal tract that would predispose 
for intussusception. 
 
Subjects with Severe Combined Immunodeficiency (SCID) disorder (see section 4.8). 
 
Administration of Rotarix should be postponed in subjects suffering from acute severe febrile 
illness. The presence of a minor infection is not a contra-indication for immunisation. 
 
The administration of Rotarix should be postponed in subjects suffering from diarrhoea or vomiting. 
 
4.4  Special warnings and precautions for use 
 
It is good clinical practice that vaccination should be preceded by a review of the medical history 
especially with regard to the contraindications and by a clinical examination. 
 
There are no data on the safety and efficacy of Rotarix in infants with gastrointestinal illnesses or 
growth retardation. Administration of Rotarix may be considered with caution in such infants when, in 
the opinion of the physician, withholding the vaccine entails a greater risk. 
 
As a precaution, healthcare professionals should follow-up on any symptoms indicative of 
intussusception (severe abdominal pain, persistent vomiting, bloody stools, abdominal bloating and/or 
high fever) since data from observational safety studies indicate an increased risk of intussusception, 
mostly within 7 days after rotavirus vaccination (see section 4.8). Parents/guardians should be advised 
to promptly report such symptoms to their healthcare provider. 
 
For subjects with a predisposition for intussusception, see section 4.3. 
 
Asymptomatic and mildly symptomatic HIV infections are not expected to affect the safety or efficacy 
of Rotarix. A clinical study in a limited number of asymptomatic or mildly symptomatic HIV positive 
infants showed no apparent safety problems (see section 4.8). 
Administration of Rotarix to infants who have known or suspected immunodeficiency, including in 
utero exposure to an immunosuppressive treatment, should be based on careful consideration of 
potential benefits and risks. 
 



 

19 
 

Excretion of the vaccine virus in the stools is known to occur after vaccination with peak excretion 
around the 7th day. Viral antigen particles detected by ELISA were found in 50% of stools after the 
first dose of Rotarix lyophilised formulation and 4% of stools after the second dose. When these stools 
were tested for the presence of live vaccine strain, only 17% were positive. In two comparative 
controlled trials, vaccine shedding after vaccination with Rotarix liquid formulation was comparable 
to that observed after vaccination with Rotarix lyophilised formulation. 
 
Cases of transmission of this excreted vaccine virus to seronegative contacts of vaccinees have been 
observed without causing any clinical symptom. 
 
Rotarix should be administered with caution to individuals with immunodeficient close contacts, 
such as individuals with malignancies, or who are otherwise immunocompromised or individuals 
receiving immunosuppressive therapy. 
 
Contacts of recent vaccinees should observe personal hygiene (e.g. wash their hands after changing 
child’s nappies). 
 
The potential risk of apnoea and the need for respiratory monitoring for 48-72h should be considered 
when administering the primary immunisation series to very premature infants (born ≤ 28 weeks of 
gestation) and particularly for those with a previous history of respiratory immaturity. 
 
As the benefit of the vaccination is high in this group of infants, vaccination should not be withheld or 
delayed. 
 
A protective immune response may not be elicited in all vaccinees (see section 5.1). 
 
The extent of protection that Rotarix might provide against other rotavirus strains that have not been 
circulating in clinical trials is currently unknown.  Clinical studies from which efficacy data were 
derived were conducted in Europe, Central and South America, Africa and Asia (see section 5.1).  
 
Rotarix does not protect against gastro-enteritis due to other pathogens than rotavirus. 
 
No data are available on the use of Rotarix for post-exposure prophylaxis. 
 
Rotarix should under no circumstances be injected. 
 
The vaccine contains sucrose as an excipient. Patients with rare hereditary problems of fructose 
intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this 
vaccine. 
 
Traceability 
 
In order to improve the traceability of biological medicinal products, the name and the batch number 
of the administered product should be clearly recorded. 
 
4.5  Interaction with other medicinal products and other forms of interaction 
 
Rotarix can be given concomitantly with any of the following monovalent or combination vaccines 
[including hexavalent vaccines (DTPa-HBV-IPV/Hib)]: diphtheria-tetanus-whole cell pertussis 
vaccine (DTPw), diphtheria-tetanus-acellular pertussis vaccine (DTPa), Haemophilus influenzae 
type b vaccine (Hib), inactivated polio vaccine (IPV), hepatitis B vaccine (HBV), pneumococcal 
conjugate vaccine and meningococcal serogroup C conjugate vaccine. Clinical studies demonstrated 
that the immune responses and the safety profiles of the administered vaccines were unaffected. 
 
Concomitant administration of Rotarix and oral polio vaccine (OPV) does not affect the immune 
response to the polio antigens. Although concomitant administration of OPV may slightly reduce the 
immune response to rotavirus vaccine, clinical protection against severe rotavirus gastro-enteritis was 



 

20 
 

shown to be maintained in a clinical trial involving more than 4,200 subjects who received Rotarix 
concomitantly with OPV. 
 
There are no restrictions on the infant’s consumption of food or liquid, either before or after 
vaccination. 
 
4.6  Fertility, pregnancy and lactation 
 
Rotarix is not intended for use in adults. There are no data on the use of Rotarix during pregnancy and 
lactation. 
 
Based on evidence generated in clinical trials, breast-feeding does not reduce the protection against 
rotavirus gastro-enteritis afforded by Rotarix. Therefore, breast-feeding may be continued during the 
vaccination schedule. 
 
4.7  Effects on ability to drive and use machines  
 
Not relevant. 
 
4.8  Undesirable effects 
 
Summary of the safety profile 
 
The safety profile presented below is based on data from clinical trials conducted with either the 
lyophilised or the liquid formulation of Rotarix. 
In a total of four clinical trials, approximately 3,800 doses of Rotarix liquid formulation were 
administered to approximately 1,900 infants. Those trials have shown that the safety profile of the 
liquid formulation is comparable to the lyophilised formulation. 
 
In a total of twenty-three clinical trials, approximately 106,000 doses of Rotarix (lyophilised or liquid 
formulation) were administered to approximately 51,000 infants.  
 
In three placebo-controlled clinical trials (Finland, India and Bangladesh), in which Rotarix was 
administered alone (administration of routine paediatric vaccines was staggered), the incidence and 
severity of the solicited events (collected 8 days post-vaccination), diarrhoea, vomiting, loss of 
appetite, fever, irritability and cough/runny nose were not significantly different in the group 
receiving Rotarix when compared to the group receiving placebo. No increase in the incidence or 
severity of these events was seen with the second dose. 
 
In a pooled analysis from seventeen placebo-controlled clinical trials (Europe, North America, Latin 
America, Asia, Africa) including trials in which Rotarix was co-administered with routine paediatric 
vaccines (see section 4.5), the following adverse reactions (collected 31 days post-vaccination) were 
considered as possibly related to vaccination. 
 
Tabulated list of adverse reactions 

Adverse reactions reported are listed according to the following frequency: 
 
Frequencies are reported as: 
Very common (≥1/10) 
Common (≥1/100 to <1/10) 
Uncommon (≥1/1,000 to <1/100) 
Rare (≥1/10,000 to <1/1,000) 
Very rare (<1/10,000) 
 



 

21 
 

System Organ Class Frequency Adverse reactions 

Gastrointestinal disorders Common Diarrhoea 

 Uncommon  Abdominal pain, flatulence 

 Very rare Intussusception (see section 4.4) 

 Not known* Haematochezia 

 Not known* Gastroenteritis with vaccine viral 
shedding in infants with Severe 
Combined Immunodeficiency 
(SCID) disorder 

Skin and subcutaneous tissue 
disorders 

Uncommon Dermatitis 

Very rare Urticaria 

General disorders and 
administration site conditions 

Common Irritability 

Respiratory, thoracic and 
mediastinal disorders 

Not known* Apnoea in very premature infants 
(≤ 28 weeks of gestation) (see 
section 4.4) 

* Because these events were reported spontaneously, it is not possible to reliably estimate their 
frequency. 
 
Description of selected adverse reactions 
 
Intussusception 
 
Data from observational safety studies performed in several countries indicate that rotavirus vaccines 
carry an increased risk of intussusception, mostly within 7 days of vaccination. Up to 6 additional 
cases per 100,000 infants have been observed in these countries against a background incidence of 25 
to 101 per 100,000 infants (less than one year of age) per year, respectively. 
There is limited evidence of a smaller increased risk following the second dose.  
It remains unclear whether rotavirus vaccines affect the overall incidence of intussusception based on 
longer periods of follow-up (see section 4.4). 
 
Other special populations  
 
Safety in preterm infants 
 
In a clinical study, 670 pre-term infants from 27 to 36 weeks of gestational age were administered 
Rotarix lyophilised formulation and 339 received placebo. The first dose was administered from 6 
weeks after birth. Serious adverse events were observed in 5.1% of recipients of Rotarix as compared 
with 6.8% of placebo recipients. Similar rates of other adverse events were observed in Rotarix and 
placebo recipients. No cases of intussusception were reported. 
 
Safety in infants with human immunodeficiency (HIV) infection 
 
In a clinical study, 100 infants with HIV infection were administered Rotarix lyophilised formulation 
or placebo. The safety profile was similar between Rotarix and placebo recipients. 
 
Reporting of suspected adverse reactions 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc
http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


 

22 
 

4.9  Overdose 
 
Some cases of overdose have been reported. In general, the adverse event profile reported in these 
cases was similar to that observed after administration of the recommended dose of Rotarix. 
 
 
5.  PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmaco-therapeutic group: rotavirus diarrhoea vaccines, ATC code: J07BH01 
 
Protective efficacy of the lyophilised formulation 
 
In clinical trials, efficacy was demonstrated against gastro-enteritis due to rotavirus of the most 
common genotypes G1P[8], G2P[4], G3P[8], G4P[8] and G9P[8]. In addition, efficacy against 
uncommon rotavirus genotypes G8P[4](severe gastro-enteritis) and G12P[6] (any gastro-enteritis) has 
been demonstrated. These strains are circulating worldwide. 
 
Clinical studies have been conducted in Europe, Latin America, Africa and Asia to evaluate the 
protective efficacy of Rotarix against any and severe rotavirus gastro-enteritis. 
 
Severity of gastro-enteritis was defined according to two different criteria: 
- the Vesikari 20-point scale, which evaluates the full clinical picture of rotavirus gastro-enteritis by 

taking into account the severity and duration of diarrhoea and vomiting, the severity of fever and 
dehydration as well as the need for treatment 

or 
- the clinical case definition based on World Health Organization (WHO) criteria 
 
Clinical protection was assessed in the ATP cohort for efficacy, which includes all subjects from the 
ATP cohort for safety who entered into the concerned efficacy follow-up period. 
 
Protective efficacy in Europe 
 
A clinical study performed in Europe evaluated Rotarix given according to different European 
schedules (2, 3 months; 2, 4 months; 3, 4 months; 3, 5 months) in 4,000 subjects. 
 
After two doses of Rotarix, the protective vaccine efficacy observed during the first and second year 
of life is presented in the following table: 
 

 1st year of life 
Rotarix N=2,572  
Placebo N=1,302  

2nd year of life 
Rotarix N=2,554  
Placebo N=1,294  

Vaccine efficacy (%) against any and severe rotavirus gastro-enteritis 
[95% CI] 

Genotype Any severity Severe† Any severity Severe† 
G1P[8] 95.6 

[87.9;98.8] 
96.4 

[85.7;99.6] 
82.7 

[67.8;91.3] 
96.5 

[86.2;99.6] 
G2P[4] 62.0* 

[<0.0;94.4] 
74.7* 

[<0.0;99.6] 
57.1 

[<0.0;82.6] 
89.9 

[9.4;99.8] 
G3P[8] 89.9 

[9.5;99.8] 
100 

[44.8;100] 
79.7 

[<0.0;98.1] 
83.1* 

[<0.0;99.7] 
G4P[8] 88.3 

[57.5;97.9] 
100 

[64.9;100] 
69.6* 

[<0.0;95.3] 
87.3 

[<0.0;99.7] 
G9P[8] 75.6 

[51.1;88.5] 
94.7 

[77.9;99.4] 
70.5 

[50.7;82.8] 
76.8 

[50.8;89.7] 



 

23 
 

Strains with P[8] 
genotype 

88.2 
[80.8;93.0] 

96.5 
[90.6;99.1] 

75.7 
[65.0;83.4] 

87.5 
[77.8;93.4] 

Circulating 
rotavirus strains 

87.1 
[79.6;92.1] 

95.8 
[89.6;98.7] 

71.9 
[61.2;79.8] 

85.6 
[75.8;91.9] 

Vaccine efficacy (%) against rotavirus gastro-enteritis requiring medical 
attention 
[95% CI] 

Circulating 
rotavirus strains 

91.8 
[84;96.3] 

76.2 
[63.0;85.0] 

Vaccine efficacy (%) against hospitalisation due to rotavirus gastro-enteritis 
[95% CI] 

Circulating 
rotavirus strains 

100 
[81.8;100] 

92.2 
[65.6;99.1] 

† Severe gastro-enteritis was defined as a score ≥11 on the Vesikari scale 
* Not statistically significant (p ≥0.05). These data should be interpreted with caution 
 
Vaccine efficacy during the first year of life progressively increased with increasing disease severity, 
reaching 100% (95% CI: 84.7;100) for Vesikari scores ≥17. 
 
Protective efficacy in Latin America 
 
A clinical study performed in Latin America evaluated Rotarix in more than 20,000 subjects. Severity 
of gastro-enteritis (GE) was defined according to WHO criteria. The protective vaccine efficacy 
against severe rotavirus (RV) gastro-enteritis requiring hospitalisation and/or rehydration therapy in a 
medical facility and the genotype specific vaccine efficacy after two doses of Rotarix are presented in 
the table below: 
 
Genotype Severe rotavirus gastro-

enteritis† (1st year of life) 
Rotarix N=9,009  
Placebo N=8,858  

Severe rotavirus gastro-
enteritis† (2nd year of life) 

Rotarix N=7,175 
Placebo N=7,062  

 Efficacy (%) 
[95% CI ] 

Efficacy (%) 
[95% CI ] 

All RVGE 84.7 
[71.7;92.4] 

79.0 
[66.4;87.4] 

G1P[8] 91.8 
[74.1;98.4] 

72.4 
[34.5;89.9] 

G3P[8] 87.7 
[8.3;99.7] 

71.9* 
[<0.0;97.1] 

G4P[8] 50.8#* 
[<0.0;99.2] 

63.1 
[0.7;88.2] 

G9P[8] 90.6 
[61.7;98.9] 

87.7 
[72.9;95.3] 

Strains with P[8] 
genotype 

90.9 
[79.2;96.8] 

79.5 
[67.0;87.9] 

† Severe rotavirus gastro-enteritis was defined as an episode of diarrhoea with or without vomiting 
that required hospitalization and/or re-hydration therapy in a medical facility (WHO criteria)  
* Not statistically significant (p ≥ 0.05). These data should be interpreted with caution  
# The numbers of cases, on which the estimates of efficacy against G4P[8] were based, were very 
small (1 case in the Rotarix group and 2 cases in the placebo group) 
 
A pooled analysis of five efficacy studies*, showed a 71.4% (95% CI: 20.1;91.1) efficacy against 
severe rotavirus gastro-enteritis (Vesikari score ≥11) caused by rotavirus G2P[4] genotype during the 
first year of life. 



 

24 
 

* In these studies, the point estimates and confidence intervals were respectively: 100% (95% CI: -
1,858.0;100), 100% (95% CI: 21.1;100), 45.4% (95% CI: -81.5;86.6), 74.7 (95% CI :-386.2;99.6). No 
point estimate was available for the remaining study. 
 
Protective efficacy in Africa 
 
A clinical study performed in Africa (Rotarix: N = 2,974; placebo: N = 1,443) evaluated Rotarix given 
at approximately 10 and 14 weeks of age (2 doses) or 6, 10 and 14 weeks of age (3 doses). The 
vaccine efficacy against severe rotavirus gastro-enteritis during the first year of life was 61.2% (95% 
CI: 44.0;73.2). The protective vaccine efficacy (pooled doses) observed against any and severe 
rotavirus gastro-enteritis is presented in the following table: 
 
Genotype Any rotavirus gastro-enteritis 

Rotarix N=2,974 
Placebo N=1,443 

Severe rotavirus gastro-
enteritis† 

Rotarix N=2,974 
Placebo N=1,443 

 Efficacy (%) 
[95% CI] 

Efficacy (%) 
[95% CI] 

G1P[8] 68.3 
[53.6;78.5] 

56.6 
[11.8;78.8] 

G2P[4] 49.3 
[4.6;73.0] 

83.8 
[9.6;98.4] 

G3P[8] 43.4* 
[<0.0;83.7] 

51.5* 
[<0.0;96.5] 

G8P[4] 38.7* 
[<0.0;67.8] 

63.6 
[5.9;86.5] 

G9P[8] 41.8* 
[<0.0;72.3] 

56.9* 
[<0.0;85.5] 

G12P[6] 48.0 
[9.7;70.0] 

55.5* 
[<0.0; 82.2] 

Strains with P[4] 
genotype 

39.3 
[7.7;59.9] 

70.9 
[37.5;87.0] 

Strains with P[6] 
genotype 

46.6 
[9.4;68.4] 

55.2* 
[<0.0;81.3] 

Strains with P[8] 
genotype 

61.0 
[47.3;71.2] 

59.1 
[32.8;75.3] 

† Severe gastro-enteritis was defined as a score ≥11 on the Vesikari scale 
* Not statistically significant (p ≥ 0.05). These data should be interpreted with caution 
 
Sustained efficacy up to 3 years of age in Asia 
 
A clinical study conducted in Asia (Hong Kong, Singapore and Taiwan) (Total vaccinated cohort: 
Rotarix: N = 5,359; placebo: N = 5,349) evaluated Rotarix given according to different schedules (2, 4 
months of age; 3, 4 months of age). 
 
During the first year, significantly fewer subjects in the Rotarix group reported severe rotavirus gastro-
enteritis caused by the circulating wild-type RV compared to the placebo group from 2 weeks after 
Dose 2 up to one year of age (0.0% versus 0.3%), with a vaccine efficacy of 100% (95% CI: 72.2; 
100). 

 
The protective vaccine efficacy after two doses of Rotarix observed against severe rotavirus gastro-
enteritis up to 2 years of age is presented in the following table: 
 



 

25 
 

 Efficacy up to 2 years of age 
Rotarix N= 5,263 
Placebo N= 5,256 

Vaccine efficacy (%) against severe rotavirus gastro-enteritis [95% CI] 
Genotype Severe† 

G1P[8] 100 [80.8;100] 
G2P[4] 100* [<0.0;100] 
G3P[8] 94.5 [64.9;99.9] 
G9P[8] 91.7 [43.8;99.8] 
Strains with P[8] genotype 95.8 [83.8;99.5] 
Circulating rotavirus strains 96.1 [85.1;99.5] 
Vaccine efficacy (%) against rotavirus gastro-enteritis requiring hospitalisation 
and/or rehydration therapy in a medical facility [95% CI] 
Circulating rotavirus strains 94.2  [82.2;98.8] 

† Severe gastro-enteritis was defined as a score ≥11 on the Vesikari scale 
* Not statistically significant (p ≥ 0.05). These data should be interpreted with caution 
 
During the third year of life, there were no cases of severe RV gastro-enteritis in the Rotarix group 
(N=4,222) versus 13 (0.3%) in the placebo group (N=4,185). Vaccine efficacy was 100% (95% CI: 
67.5; 100). The severe RV gastro-enteritis cases were due to RV strains G1P[8], G2P[4], G3P[8] and 
G9P[8]. The incidence of severe RV gastro-enteritis associated with the individual genotypes was too 
small to allow calculation of efficacy. The efficacy against severe RV gastro-enteritis requiring 
hospitalisation was 100% (95% CI: 72.4; 100). 

 
Protective efficacy of the liquid formulation 
 
Since the immune response observed after 2 doses of Rotarix liquid formulation was comparable to 
the immune response observed after 2 doses of Rotarix lyophilised formulation, the levels of vaccine 
efficacy observed with the lyophilised formulation can be extrapolated to the liquid formulation. 
 
Immune response 
 
The immunologic mechanism by which Rotarix protects against rotavirus gastro-enteritis is not 
completely understood. A relationship between antibody responses to rotavirus vaccination and 
protection against rotavirus gastro-enteritis has not been established.  
 
The following table shows the percentage of subjects initially seronegative for rotavirus (IgA antibody 
titres < 20 U/ml) (by ELISA) with serum anti-rotavirus IgA antibody titres ≥20U/ml one to two 
months after the second dose of vaccine or placebo as observed in different studies with Rotarix 
lyophilised formulation. 
 
Schedule Studies 

conducted in 
Vaccine Placebo 

  N % ≥ 20U/ml 
[95% CI] 

N % ≥ 20U/ml 
[95% CI] 

2, 3 months France, 
Germany 

239 82.8 
[77.5;87.4] 

127 8.7 
[4.4;15.0] 

2, 4 months Spain 186 85.5 
[79.6;90.2] 

89 12.4 
[6.3;21.0] 

3, 5 months Finland, Italy 180 94.4 
[90.0;97.3] 

114 3.5 
[1.0;8.7] 

3, 4 months Czech 
Republic 

182 84.6 
[78.5;89.5] 

90 2.2 
[0.3;7.8] 

2, 3 to 4 
months 

Latin 
America; 11 

393 77.9% 
[73.8;81.6] 

341 15.1% 
[11.7;19.0] 



 

26 
 

countries 
10, 14 weeks 
and 6, 10, 14 
weeks 
(Pooled) 

South Africa, 
Malawi 

221 58.4 
[51.6;64.9] 

111 22.5 
[15.1;31.4] 

 
In three comparative controlled trials, the immune response elicited by Rotarix liquid formulation was 
comparable to the one elicited by Rotarix lyophilised formulation. 
 
Immune response in preterm infants 
 
In a clinical study conducted in preterm infants, born after at least 27 weeks of gestational age, the 
immunogenicity of Rotarix was assessed in a subset of 147 subjects and showed that Rotarix is 
immunogenic in this population; 85.7% (95% CI: 79.0;90.9) of subjects achieved serum anti-rotavirus 
IgA antibody titres ≥ 20U/ml (by ELISA) one month after the second dose of vaccine. 
 
Effectiveness 

In observational studies, vaccine effectiveness was demonstrated against severe gastro-enteritis 
leading to hospitalisation due to rotavirus of common genotypes G1P[8], G2P[4], G3P[8], G4P[8] and 
G9P[8] as well as the less common rotavirus genotypes G9P[4] and G9P[6]. All of these strains are 
circulating worldwide. 
 
 
Effectiveness after 2 doses in preventing RVGE leading to hospitalization 

 
Countries 
Period 

Age range N (1) 
(cases/controls) 

Strains Effectiveness 
% [95% CI] 

High Income countries 
Belgium 
2008-2010(2) 
 

< 4 yrs  
3-11 m 

160/198 All 90 [81;95] 
91 [75;97] 

< 4 yrs  41/53 G1P[8] 95 [78;99] 
< 4 yrs 

3-11 m 
80/103 G2P[4] 85 [64;94] 

83 [11;96] (3) 
< 4 yrs 12/13 G3P[8] 87* [<0;98](3) 
< 4 yrs 16/17 G4P[8] 90 [19;99] (3) 

Singapore  
2008-2010(2) 

< 5 yrs 136/272 All 84 [32;96] 
89/89 G1P[8] 91 [30;99] 

Taiwan  
2009-2011 

< 3 yrs 275/1,623(4) All 
G1P[8] 

92 [75;98] 
95 [69;100] 

US  
2010-2011 

< 2 yrs 85/1,062(5) All 
G1P[8] 
G2P[4] 

85 [73;92] 
88 [68;95] 
88 [68;95] 

8-11 m All 89 [48;98] 
US 
2009-2011 

< 5 yrs 74/255(4) G3P[8] 68 [34;85] 

Middle Income Countries 
Bolivia  
2010-2011 

< 3 yrs 
6-11 m 

300/974 All 77 [65;84](6) 
77 [51;89] 

< 3 yrs 
6-11 m 

G9P[8] 85 [69;93] 
90 [65;97] 

< 3 yrs G3P[8] 93 [70;98] 
G2P[4] 69 [14;89] 
G9P[6] 87 [19;98] 

Brazil  < 2 yrs 115/1,481 All 72 [44;85](6) 



 

27 
 

2008-2011 G1P[8] 89 [78;95] 
G2P[4] 76 [64;84] 

Brazil  
2008-2009(2) 
 

< 3 yrs 
3-11 m 

249/249 (5) All 76 [58;86] 
96 [68;99] 

< 3 yrs 
3-11 m 

222/222 (5) G2P[4] 75 [57;86] 
95 [66;99] (3) 

El Salvador 
2007-2009 

< 2 yrs 
6-11 m 

251/770 (5) All 76 [64;84](6) 
83 [68;91] 

Guatemala 
2012-2013 

< 4 yrs NA(7) All 63 [23;82] 

Mexico 
2010 

< 2 yrs 9/17(5) G9P[4] 94 [16;100] 

Low Income Countries 
Malawi 
2012-2014 

< 2 yrs 81/234(5) All 63 [23;83] 

m: months 
yrs: years 
* Not statistically significant (P ≥ 0.05). These data should be interpreted with caution. 
(1) The number of fully vaccinated (2 doses) and unvaccinated cases and controls is given. 
(2) GSK sponsored studies 
(3) Data from a post-hoc analysis 
(4) Vaccine effectiveness was calculated using rotavirus-negative hospital control participants (estimates from 

Taiwan were calculated using combined rotavirus-negative hospital control and non-diarrhoea hospital 
control participants). 

(5) Vaccine effectiveness was calculated using neighborhood controls. 
(6) In subjects who did not receive the full course of vaccination, the effectiveness after one dose ranged from 

51% (95% CI: 26;67, El Salvador) to 60% (95% CI: 37; 75, Brazil). 
(7) NA: Not available. Vaccine effectiveness estimate is based on 41 fully vaccinated cases and 175 fully 

vaccinated controls. 
 
Impact on mortality§ 

Impact studies with Rotarix conducted in Panama, Brazil and Mexico showed a decrease in all-cause 
diarrhoea mortality ranging from 17% to 73% in children less than 5 years of age, within 2 to 4 years 
after vaccine introduction. 

Impact on hospitalisation§ 

In a retrospective database study in Belgium conducted in children 5 years of age and younger, the 
direct and indirect impact of Rotarix vaccination on rotavirus-related hospitalisation ranged from 64% 
(95% CI: 49;76) to 80% (95% CI: 77;83) two years after vaccine introduction. Similar studies in 
Armenia, Australia, Brazil, Canada, El Salvador and Zambia showed a reduction of 45 to 93% 
between 2 and 4 years after vaccine introduction. 

In addition, nine impact studies on all-cause diarrhoea hospitalisation conducted in Africa and Latin 
America showed a reduction of 14% to 57% between 2 and 5 years after vaccine introduction. 

§NOTE: Impact studies are meant to establish a temporal relationship but not a causal relationship 
between the disease and vaccination. Natural fluctuations of the incidence of the disease may also 
influence the observed temporal effect. 
 
5.2  Pharmacokinetic properties 
 
Not applicable. 
 



 

28 
 

5.3  Preclinical safety data 
 
Non-clinical data reveal no special hazard for humans based on conventional studies of repeated dose 
toxicity. 
 
 
6.  PHARMACEUTICAL PARTICULARS 
 
6.1  List of excipients 
 
Sucrose 
Di-sodium Adipate 
Dulbecco’s Modified Eagle Medium (DMEM) 
Sterile water 
 
6.2  Incompatibilities 
 
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal 
products. 
 
6.3  Shelf life 
 

- Pre-filled oral applicator: 3 years  
- Squeezable tube fitted with a membrane and a tube cap: 3 years 
- Multi-monodose (5 single dose) squeezable tube presentation connected by a bar: 2 years 

 
The vaccine should be used immediately after opening. 
 
6.4  Special precautions for storage 
 
Store in a refrigerator (2°C – 8°C). 
Do not freeze. 
 
Store in the original package, in order to protect from light. 
 
6.5  Nature and contents of container 
 
Pre-filled oral applicator 
1.5 ml of oral suspension in a pre-filled oral applicator (type I glass) with a plunger stopper (rubber 
butyl) and a protective tip cap (rubber butyl), in pack sizes of 1, 5, 10 or 25. 
 
Squeezable tube 
1.5 ml of oral suspension in a squeezable tube (polyethylene) fitted with a membrane and a tube cap 
(polypropylene), in pack sizes of 1, 10 or 50. 
 
Multi-monodose (5-single dose) squeezable tube presentation connected by a bar 
1.5 ml of oral suspension in a squeezable tube (polyethylene) presented in a multi-monodose (5-single 
dose) squeezable tube presentation connected by a bar, in pack size of 50 tubes. 
 
Not all pack sizes may be marketed. 
 
6.6  Special precautions for disposal and other handling 
 
The vaccine is presented as a clear, colourless liquid, free of visible particles, for oral administration. 
 
The vaccine is ready to use (no reconstitution or dilution is required). 
The vaccine is to be administered orally without mixing with any other vaccines or solutions. 



 

29 
 

 
The vaccine should be inspected visually for any foreign particulate matter and/or abnormal physical 
appearance. In the event of either being observed, discard the vaccine. 
 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 
 
Instructions for administration of the vaccine in a pre-filled oral applicator: 
 

   
 
 
 
 
 
Discard the empty oral applicator and tip cap in approved biological waste containers according to 
local regulations. 
 
 
Instructions for administration of the vaccine in a squeezable tube: 
 
Please read the instructions for use all the way through before starting to give the vaccine. 
 
A  What you need to do before giving Rotarix 
• Check the expiry date. 
• Check the tube has not been damaged nor is already 

open. 
• Check the liquid is clear and colourless, without any 

particles in it.   
 
If you notice anything abnormal, do not use the vaccine.  
• This vaccine is given orally - straight from the tube. 
• It is ready to use - you do not need to mix it with 

anything. 
 
 

 

 
B  Get the tube ready 
1.  Pull off the cap  
• Keep the cap – you need this to pierce the membrane. 
• Hold the tube upright. 
 
2. Repeatedly flick the top of the tube until it is clear of 
any liquid 
• Clear any liquid from the thinnest section of the tube by 

flicking just below the membrane. 

 

1. Remove the protective tip cap from 
the oral applicator. 

2. This vaccine is for oral 
administration only. The child 
should be seated in a reclining 
position. Administer orally (i.e. into 
the child’s mouth, towards the inner 
cheek) the entire content of the oral 
applicator. 

3. Do not inject. 

Oral applicator 
Tip-Cap 



 

30 
 

 

 
3.  Position the cap to open the tube 
• Keep the tube held upright. 
• Hold the side of tube 
• There is a small spike inside the top of the cap - in the 

centre. 
• Turn the cap upside down (180°). 

 
 
 
 
 

 

 
4.  To open the tube 
• You do not need to twist. Press the cap down to 

pierce the membrane.  
• Then lift off the cap. 
 

 

 
C  Check the tube has opened correctly 
1.  Check the membrane has been pierced 
• There should be a hole at the top of the tube. 
 
2. What to do if the membrane has not been pierced 
• If the membrane has not been pierced return to section 

B and repeat steps 2, 3 and 4.  
 
 

 

 
D  Give the vaccine 
• Once the tube is open check the liquid is clear, without 

any particles in it. 
       If you notice anything abnormal, do not use the vaccine. 
• Give the vaccine straight away. 
 
1.  Position the child to give the vaccine 
• Seat the child leaning slightly backwards. 
 
2. Administer the vaccine 
• Squeeze the liquid gently into the side of the child’s 

mouth - towards the inside of their cheek. 
• You may need to squeeze the tube a few times to get all 

of the vaccine out - it is okay if a drop remains in the tip 
of the tube. 
 

 

 

Discard the empty tube and cap in approved biological waste containers according to local regulations. 
 
 



 

31 
 

Instructions for administration of the vaccine in a multi-monodose (5 single dose) squeezable tube 
presentation connected by a bar: 
 
Please read the instructions for use all the way through before starting to give the vaccine. 
 
• This vaccine is given orally straight from an individual tube.  
• One oral tube delivers one dose of vaccine. 
• This vaccine is ready to use - do not mix it with anything else. 
 
A.  What you need to do before giving Rotarix 

1.  Check the expiry date on the connecting bar. 
2.  Check the liquid in the oral tubes is clear, colourless and 

free from any particles.   
- Do not use any of the oral tubes on the 

connecting bar if you notice anything unusual. 

3.  Check that each individual oral tube is not damaged and 
is still sealed. 

- Do not use the affected oral tube if you notice 
anything unusual.  

 

 
 

 

 

B.  Get the oral tube ready 

1.  To separate one oral tube from the others starting at one 
end: 
a) Hold the tab of one of the end oral tubes to 

separate it from the others. 
b) With your other hand, hold the tab of the oral 

tube next to it. 
c) Pull the tab and tear it away from the oral tube 

next to it. 
 

 
 
2.  To open the separated oral tube:  

d) Keep the separated oral tube held upright. 
e) Hold the tab of the separated oral tube in one 

hand and the connecting bar in the other hand. Do 
not hold the body of the oral tube, you may squeeze 
out some of the vaccine. 

f) Twist the separated oral tube.  
g) Pull it from the connecting bar. 

 
 

 

 
 
 

 

 

Connecting 
bar 

Neck 

Body 

Tab 

Expiry date: MM-YYYY 

Monodose 
oral tube 

Expiry date: MM-YYYY 

Twist Pull 

Pull  



 

32 
 

C. Give the vaccine orally immediately after opening 

1.  To position the child to receive the vaccine:  
• Seat the child leaning slightly backwards. 

 
2.  To administer the vaccine orally: 

• Squeeze the liquid gently into the side of the 
child’s mouth, towards the inside of their cheek. 

• You may need to squeeze the oral tube a few 
times to get all of the vaccine out - it is okay if a 
drop stays in the oral tube. 
 

 

   
 
 

 
D. Store remaining doses in the fridge immediately 
 
Unused oral tubes that are still attached to the connecting bar  
must be put back in the fridge immediately after an  
oral tube has been used. This is so that the unused oral tubes can  
be used for the next vaccination. 
 
 
 
Discard the used oral tubes in approved biological waste  
containers according to local regulations. 

 
 
7. MARKETING AUTHORISATION HOLDER 
 
GlaxoSmithKline Biologicals s.a. 
Rue de l'Institut 89 
B-1330 Rixensart, Belgium 
 
 
8.  MARKETING AUTHORISATION NUMBER(S) 
 
Pre-filled oral applicator 
EU/1/05/330/005 
EU/1/05/330/006 
EU/1/05/330/007 
EU/1/05/330/008 
 
Squeezable tube 
EU/1/05/330/009 
EU/1/05/330/010 
EU/1/05/330/011 
 
Multi-monodose (5-single dose) squeezable tube presentation connected by a bar 
EU/1/05/330/012 
 
 
9.  DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 21 February 2006 
Date of latest renewal: 14 January 2016 
 
 

Oral 
administration 
only 

2°C to 8°C 

Put back in  
fridge immediately 



 

33 
 

10.  DATE OF REVISION OF THE TEXT 
 
Detailed information on this medicinal product is available on the website of the European Medicines  
Agency http://www.ema.europa.eu. 
 



 

34 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 

A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE 
SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE 
FOR BATCH RELEASE 

 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY 

AND USE 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 
 

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE 
SAFE AND EFFECTIVE USE OF THE MEDICINAL 
PRODUCT 

 
 

 



 

35 
 

 
A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND 

MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturer(s) of the biological active substance(s) 
 
GlaxoSmithKline Biologicals s.a. 
Parc de la Noire Epine 
Rue Fleming, 20 
1300 Wavre Belgium 
 
Name and address of the manufacturer(s) responsible for batch release 
 
GlaxoSmithKline Biologicals s.a. 
Rue de l’Institut 89 
1330 Rixensart 
Belgium 
 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
 
Medicinal product subject to medical prescription. 
 
Official batch release:  

In accordance with Article 114 of Directive 2001/83/EC, the official batch release will be undertaken 
by a state laboratory or a laboratory designated for that purpose. 
 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 
 
 
• Periodic safety update reports (PSURs) 
 
The requirements for submission of PSURs for this medicinal product are set out in the list of Union 
reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any 
subsequent updates published on the European medicines web-portal. 
 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 
• Risk management plan (RMP) 
 
The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities 
and interventions detailed in the agreed RMP presented in Module 1.8.2. of the marketing 
authorisation and any agreed subsequent updates of the RMP. 
 
 
An updated RMP should be submitted:  

• At the request of the European Medicines Agency; 
• Whenever the risk management system is modified, especially as the result of new information 

being received that may lead to a significant change to the benefit/risk profile or as the result 
of an important (pharmacovigilance or risk minimisation) milestone being reached. 

 
 



 

36 
 

 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 



 

37 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 



 

38 
 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
GLASS CONTAINER WITH ORAL APPLICATOR AND TRANSFER ADAPTER, PACK 
SIZE OF 1, 5, 10 OR 25 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Rotarix powder and solvent for oral suspension 
rotavirus vaccine, live 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
After reconstitution, 1 dose (1 ml) contains: 
 
Human rotavirus RIX4414 strain (live, attenuated)* not less than 106.0 CCID50 
 
*Produced on Vero cells 
 
 
3. LIST OF EXCIPIENTS 
 
Powder: sucrose, sorbitol 
See the package leaflet for further information 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Powder and solvent for oral suspension 
 
1 glass container: powder 
1 oral applicator: solvent 
1 transfer adapter 
1 dose (1 ml) 
 
5 glass containers: powder 
5 oral applicators: solvent 
5 transfer adapters 
5 x 1 dose (1 ml) 
 
10 glass containers: powder 
10 oral applicators: solvent 
10 transfer adapters 
10 x 1 dose (1 ml) 
 
25 glass containers: powder 
25 oral applicators: solvent 
25 transfer adapters 
25 x 1 dose (1 ml) 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use 
Do not inject! 



 

39 
 

Shake before use 
Read the package leaflet before use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
Read the leaflet for the shelf-life of the reconstituted medicine. 
EXP {MM/YYYY} 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator 
Do not freeze 
Store in the original package in order to protect from light 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
GlaxoSmithKline Biologicals s.a. 
Rue de l’Institut 89 
B-1330 Rixensart, Belgium 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/05/330/001 – pack of 1 (glass container + oral applicator + transfer adapter) 
EU/1/05/330/002 – pack of 5 (glass container + oral applicator + transfer adapter) 
EU/1/05/330/003 – pack of 10 (glass container + oral applicator + transfer adapter) 
EU/1/05/330/004 – pack of 25 (glass container + oral applicator + transfer adapter) 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 



 

40 
 

 
 
16. INFORMATION IN BRAILLE 
 
Justification for not including Braille accepted 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 
 
 



 

41 
 

 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS 
ORAL APPLICATOR WITH SOLVENT FOR RECONSTITUTION WITH POWDER 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
 
3. EXPIRY DATE 
 
 
4. BATCH NUMBER 
 
 
5. OTHER 
 

 



 

42 
 

 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
GLASS CONTAINER WITH POWDER TO BE RECONSTITUTED WITH SOLVENT 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Rotarix 
Powder for oral suspension 
rotavirus vaccine, live 
Oral use 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
1 dose 
 
 
6. OTHER 



 

43 
 

 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
ORAL APPLICATOR WITH SOLVENT FOR RECONSTITUTION WITH POWDER 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Solvent for Rotarix 
Oral use 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
1 dose (1 ml) 
 
 
6. OTHER 



 

44 
 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
PRE-FILLED ORAL APPLICATOR, PACK SIZE OF 1, 5, 10 OR 25 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Rotarix oral suspension in pre-filled oral applicator 
rotavirus vaccine, live 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
1 dose (1.5 ml) contains: 
 
Human rotavirus RIX4414 strain (live, attenuated) not less than 106.0 CCID50 
 
 
3. LIST OF EXCIPIENTS 
 
Sucrose 
 
See the package leaflet for further information 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Oral suspension in pre-filled oral applicator 
1 pre-filled oral applicator 
1 dose (1.5 ml) 
 
5 pre-filled oral applicators 
5 x 1 dose (1.5 ml) 
 
10 pre-filled oral applicators 
10 x 1 dose (1.5 ml) 
 
25 pre-filled oral applicators 
25 x 1 dose (1.5 ml) 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use 
Do not inject! 
Read the package leaflet before use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 



 

45 
 

 
Ready to use 
No reconstitution required 
 
 
8. EXPIRY DATE 
 
EXP {MM/YYYY} 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator 
Do not freeze 
Store in the original package in order to protect from light 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
GlaxoSmithKline Biologicals s.a. 
Rue de l’Institut 89 
B-1330 Rixensart, Belgium 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/05/330/005 – pack of 1 pre-filled oral applicator 
EU/1/05/330/006 – pack of 5 pre-filled oral applicators 
EU/1/05/330/007 – pack of 10 pre-filled oral applicators 
EU/1/05/330/008 – pack of 25 pre-filled oral applicators 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Justification for not including Braille accepted 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 



 

46 
 

2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 
 
 



 

47 
 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
TUBE, PACK SIZES OF 1, 10 OR 50 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Rotarix oral suspension 
rotavirus vaccine, live 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
1 dose (1.5 ml) contains: 
 
Human rotavirus RIX4414 strain (live, attenuated) not less than 106.0 CCID50 
 
 
3. LIST OF EXCIPIENTS 
 
Sucrose 
See the package leaflet for further information 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Oral suspension 
1 tube 
1 dose (1.5 ml) 
 
10 tubes 
10 x 1 dose (1.5 ml) 
 
50 tubes 
50 x 1 dose (1.5 ml) 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use 
Do not inject! 
Read the package leaflet before use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
 
 



 

48 
 

 
   Read the instructions before administration of the vaccine. 
 
 
 
 
 
   This vaccine is intended for oral administration only. 
 
 
 
 
 
8. EXPIRY DATE 
 
EXP {MM/YYYY} 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator 
Do not freeze 
Store in the original package in order to protect from light 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
GlaxoSmithKline Biologicals s.a. 
Rue de l’Institut 89 
B-1330 Rixensart, Belgium 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/05/330/009 – pack of 1 tube 
EU/1/05/330/010 – pack of 10 tubes 
EU/1/05/330/011 – pack of 50 tubes 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 



 

49 
 

16. INFORMATION IN BRAILLE 
 
Justification for not including Braille accepted 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 
 
 



 

50 
 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
MULTI-MONODOSE (5 SINGLE DOSE) SQUEEZABLE TUBE PRESENTATION 
CONNECTED BY A BAR, PACK SIZE OF 50 TUBES 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Rotarix oral suspension 
rotavirus vaccine, live 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
1 dose (1.5 ml) contains: 
 
Human rotavirus RIX4414 strain (live, attenuated) not less than 106.0 CCID50 
 
 
3. LIST OF EXCIPIENTS 
 
Sucrose 
See the package leaflet for further information 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Oral suspension 
 
50 tubes 
10 x 5 single dose tubes connected by a bar 
1 dose (1.5 ml) 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Oral use 
Do not inject! 
Read the package leaflet before use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
 
 
 
   Read the instructions before administration of the vaccine. 
 



 

51 
 

 
 
 
   This vaccine is intended for oral administration only. 
 
 
 
 
 
8. EXPIRY DATE 
 
EXP {MM/YYYY} 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. 
Do not freeze. 
Store in the original package in order to protect from light. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
Dispose of in accordance with local regulations. 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
GlaxoSmithKline Biologicals s.a. 
Rue de l’Institut 89 
B-1330 Rixensart, Belgium 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/05/330/012 – pack of 50 tubes 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Justification for not including Braille accepted 
 



 

52 
 

 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 
 
 



 

53 
 

 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS 
PRE-FILLED ORAL APPLICATOR  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
 
3. EXPIRY DATE 
 
 
4. BATCH NUMBER 
 
 
5. OTHER 
 

 



 

54 
 

 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
PRE-FILLED ORAL APPLICATOR 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Rotarix 
Oral suspension 
rotavirus vaccine, live 
Oral use 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
1 dose (1.5 ml) 
 
 
6. OTHER 



 

55 
 

 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
TUBE 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Rotarix 
Oral suspension 
rotavirus vaccine, live 
Oral use 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
1 dose (1.5 ml) 
 
 
6. OTHER 



 

56 
 

 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
MULTI-MONODOSE (5 SINGLE DOSE) SQUEEZABLE TUBE PRESENTATION 
CONNECTED BY A BAR 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Rotarix 
Oral suspension 
rotavirus vaccine, live 
Oral use 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
5 single dose tubes 
1 dose (1.5 ml) 
 
 
6. OTHER 



 

57 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 



 

58 
 

 
Package leaflet: Information for the user 

 
Rotarix powder and solvent for oral suspension 

rotavirus vaccine, live 
 
Read all of this leaflet carefully before your child receives this vaccine because it contains 
important information for you. 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor or pharmacist. 
- This vaccine has been prescribed for your child only. Do not pass it on to others. 
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
1. What Rotarix is and what it is used for 
2. What you need to know before your child receives Rotarix 
3. How Rotarix is given 
4. Possible side effects 
5. How to store Rotarix 
6. Contents of the pack and other information 
 
 
1. What Rotarix is and what it is used for 
 
Rotarix is a viral vaccine, containing live, attenuated human rotavirus, that helps to protect your child, 
from the age of 6 weeks, against gastro-enteritis (diarrhoea and vomiting) caused by rotavirus 
infection. 
 
How Rotarix works 
 
Rotavirus infection is the most common cause of severe diarrhoea in infants and young children. 
Rotavirus is easily spread from hand-to-mouth due to contact with stools from an infected person. 
Most children with rotavirus diarrhoea recover on their own. However, some children become very ill 
with severe vomiting, diarrhoea and life-threatening loss of fluids that requires hospitalisation. 
 
When a person is given the vaccine, the immune system (the body’s natural defences) will make 
antibodies against the most commonly occurring types of rotavirus. These antibodies protect against 
disease caused by these types of rotavirus. 
 
As with all vaccines, Rotarix may not completely protect all people who are vaccinated against the 
rotavirus infections it is intended to prevent. 
 
 
2. What you need to know before your child receives Rotarix 
 
Rotarix should not be given 
• if your child has previously had any allergic reaction to rotavirus vaccines or any of the other 

ingredients of this vaccine (listed in section 6). Signs of an allergic reaction may include itchy 
skin rash, shortness of breath and swelling of the face or tongue. 

• if your child has previously had intussusception (a bowel obstruction in which one segment of 
bowel becomes enfolded within another segment). 

• if your child was born with a malformation of the gut that could lead to intussusception. 
• if your child has a rare inherited illness which affects their immune system called Severe 

Combined Immunodeficiency (SCID). 



 

59 
 

• if your child has a severe infection with a high temperature. It might be necessary to postpone 
the vaccination until recovery. A minor infection such as a cold should not be a problem, but 
talk to your doctor first. 

• if your child has diarrhoea or is vomiting. It might be necessary to postpone the vaccination 
until recovery. 

 
Warnings and precautions 
Talk to your doctor/health care professional before your child receives Rotarix if: 
• he/she has a close contact such as a household member who has a weakened immune system, 

e.g., a person with cancer or who is taking medicines that may weaken the immune system. 
• he/she has any disorder of the gastrointestinal system. 
• he/she has not been gaining weight and growing as expected. 
• he/she has any disease or is taking any medicine which reduces his/her resistance to infection or 

if his/her mother has taken during pregnancy any medicine that may weaken the immune 
system. 

 
After your child has received Rotarix, contact a doctor/health care professional right away if your 
child experiences severe stomach pain, persistent vomiting, blood in stools, a swollen belly and/or 
high fever (see also section 4 “Possible side effects”). 
 
As always, please take care to wash your hands thoroughly after changing soiled nappies. 
 
Other medicines and Rotarix 
Tell your doctor if your child is taking, has recently taken or might take any other medicines or has 
recently received any other vaccine. 
 
Rotarix may be given at the same time your child receives other normally recommended vaccines, 
such as diphtheria, tetanus, pertussis (whooping cough), Haemophilus influenzae type b, oral or 
inactivated polio, hepatitis B vaccines as well as pneumococcal and meningococcal serogroup C 
conjugate vaccines. 
 
Rotarix with food and drink 
There are no restrictions on your child’s consumption of food or liquids, either before or after 
vaccination. 
 
Breast-feeding 
Based on evidence generated in clinical trials, breast-feeding does not reduce the protection against 
rotavirus gastro-enteritis afforded by Rotarix. Therefore, breast-feeding may be continued during the 
vaccination schedule. 
 
Rotarix contains sucrose and sorbitol 
If you have been told by your doctor that the child being vaccinated has an intolerance to some sugars, 
contact your doctor before receiving this vaccine. 
 
 
3. How Rotarix is given 
 
The doctor or nurse will administer the recommended dose of Rotarix to your child. The vaccine (1 ml 
liquid) will be given orally. Under no circumstance should this vaccine be administered by injection. 
 
Your child will receive two doses of the vaccine. Each dose will be given on a separate occasion with 
an interval of at least 4 weeks between the two doses. The first dose may be given from the age of 6 
weeks. The two doses of the vaccine must have been given by the age of 24 weeks, although they 
should preferably have been given before 16 weeks of age.  
 
Rotarix may be given according to the same vaccination course to infants who were born prematurely, 
provided that the pregnancy had lasted at least 27 weeks. 



 

60 
 

 
In case your child spits out or regurgitates most of the vaccine dose, a single replacement dose may be 
given at the same vaccination visit. 
 
When Rotarix is given to your child for the first dose, it is recommended that your child also receives 
Rotarix (and not another rotavirus vaccine) for the second dose.  
 
It is important that you follow the instructions of your doctor or nurse regarding return visits. If you 
forget to go back to your doctor at the scheduled time, ask your doctor for advice. 
 
 
4. Possible side effects 
 
Like all medicines, this vaccine can cause side effects, although not everybody gets them. 
 
The following side effects may happen with this vaccine: 
 
♦ Common (These may occur with up to 1 in 10 doses of the vaccine):  

• diarrhoea   
• irritability 

 
♦ Uncommon (These may occur with up to 1 in 100 doses of the vaccine): 

• abdominal pain (see also below for signs of very rare side effects of intussusception) 
• flatulence 
• inflammation of the skin 

 
Side effects that have been reported during marketed use of Rotarix include: 

• Very rare: hives (urticaria) 
• Very rare: intussusception (part of the intestine gets blocked or twisted).  The signs may 

include severe stomach pain, persistent vomiting, blood in stools, a swollen belly and/or high 
fever. Contact a doctor/health care professional right away if your child experiences 
one of these symptoms. 

• blood in stools 
• in babies born very prematurely (at or before 28 weeks of gestation) longer gaps than normal 

between breaths may occur for 2-3 days after vaccination. 
• children with a rare inherited illness called Severe Combined Immunodeficiency (SCID) 

may have an inflamed stomach or gut (gastroenteritis) and pass the vaccine virus in their 
stools. The signs of gastroenteritis may include feeling sick, being sick, stomach cramps or 
diarrhoea. 

 
Reporting of side effects 
If your child gets any of the side effects, talk to your doctor or pharmacist. This includes any possible 
side effects not listed in this leaflet. You can also report side effects directly via the national reporting 
system listed in Appendix V. By reporting side effects you can help provide more information on the 
safety of this medicine. 
 
 
5. How to store Rotarix 
 
Keep this vaccine out of the sight and reach of children. 
 
Do not use this vaccine after the expiry date which is stated on the carton. The expiry date refers to the 
last day of that month. 
 
Store in a refrigerator (2°C – 8°C). 
Do not freeze. 



 

61 
 

Store in the original package in order to protect from light. 
 
After reconstitution, the vaccine contained in the oral applicator should be administered promptly. If 
the reconstituted vaccine is not used within 24 hours, it should be discarded. 
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines your child no longer uses. These measures will help to protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Rotarix contains 
 
- The active substances are: 
 
 Human rotavirus RIX4414 strain (live, attenuated)*  not less than 106.0 CCID50 
  
 *Produced on Vero cells 
 
- The other ingredients in Rotarix are:  

Powder: dextran, sucrose, sorbitol (see also section 2, Rotarix contains sucrose and sorbitol), 
amino acids, Dulbecco’s Modified Eagle Medium (DMEM) 
Solvent: calcium carbonate, xanthan gum, sterile water 

 
What Rotarix looks like and contents of the pack 
 
Powder and solvent for oral suspension 
 
Rotarix is supplied as a whitish powder in a single dose glass container and a separate oral applicator 
of solvent which contains a slow settling white deposit and a colourless supernatant. There is also a 
transfer adapter which allows easy transfer of the solvent into the glass container containing the 
powder for mixing the different components of the vaccine. 
 
Both components must be mixed together before your child receives the vaccine. The mixed vaccine 
will appear more turbid than the solvent alone. 
 
Rotarix is available in a pack of 1, 5, 10 or 25. 
 
Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder and Manufacturer 
 
GlaxoSmithKline Biologicals s.a. 
Rue de l’Institut 89 
B-1330 Rixensart 
Belgium 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien 
GlaxoSmithKline Pharmaceuticals s.a./n.v. 
Tél/Tel: + 32 10 85 52 00 
 

Lietuva 
GlaxoSmithKline Lietuva UAB 
Tel. +370 5 264 90 00 
info.lt@gsk.com 
 

България 
ГлаксоСмитКлайн ЕООД 

Luxembourg/Luxemburg 
GlaxoSmithKline Pharmaceuticals s.a./n.v. 



 

62 
 

Тел. + 359 2 953 10 34 
 

Tél/Tel: + 32 10 85 52 00 

Česká republika 
GlaxoSmithKline s.r.o. 
Tel: + 420 2 22 00 11 11 
cz.info@gsk.com 
 

Magyarország 
GlaxoSmithKline Kft. 
Tel.: + 36-1-2255300 
 

Danmark 
GlaxoSmithKline Pharma A/S 
Tlf: + 45 36 35 91 00 
dk-info@gsk.com 
 

Malta 
GlaxoSmithKline (Malta) Ltd 
Tel: + 356 21 238131 
 

Deutschland 
GlaxoSmithKline GmbH & Co. KG 
Tel: + 49 (0)89 360448701 
produkt.info@gsk.com 
 

Nederland 
GlaxoSmithKline BV 
Tel: + 31 (0)30 69 38 100 
nlinfo@gsk.com 
 

Eesti 
GlaxoSmithKline Eesti OÜ  
Tel: +372 667 6900 
estonia@gsk.com 
 

Norge 
GlaxoSmithKline AS 
Tlf: + 47 22 70 20 00 
 

Ελλάδα 
GlaxoSmithKline A.E.B.E. 
Tηλ: + 30 210 68 82 100 
 

Österreich 
GlaxoSmithKline Pharma GmbH. 
Tel: + 43 (0)1 97075 0 
at.info@gsk.com  
 

España 
GlaxoSmithKline, S.A. 
Tel: + 34 900 202 700 
es-ci@gsk.com  
 

Polska 
GSK Services Sp. z o.o. 
Tel.: + 48 (22) 576 9000 
 

France 
Laboratoire GlaxoSmithKline 
Tél: + 33 (0) 1 39 17 84 44 
diam@gsk.com 
 
 
Hrvatska 
GlaxoSmithKline d.o.o. 
Tel.: + 385 (0)1 6051999 
 

Portugal 
Smith Kline & French Portuguesa, Produtos 
Farmacêuticos, Lda. 
Tel: + 351 21 412 95 00 
FI.PT@gsk.com 
 
România 
GlaxoSmithKline (GSK) SRL 
Tel: +40 (0)21 3028 208 
 

Ireland 
GlaxoSmithKline (Ireland) Ltd 
Tel: + 353 (0)1 495 5000 
 

Slovenija 
GlaxoSmithKline d.o.o. 
Tel: + 386 (0) 1 280 25 00 
medical.x.si@gsk.com 
 

Ísland 
Vistor hf 
Sími : +354 535 7000 
 

Slovenská republika 
GlaxoSmithKline Slovakia s.r.o. 
Tel: + 421 (0)2 48 26 11 11 
recepcia.sk@gsk.com 
 

Italia 
GlaxoSmithKline S.p.A. 
Tel:+ 39 (0)45 9218 111 
 

Suomi/Finland 
GlaxoSmithKline Oy 
Puh/Tel: + 358 10 30 30 30 
Finland.tuoteinfo@gsk.com  
 



 

63 
 

Κύπρος 
GlaxoSmithKline (Cyprus) Ltd 
Τηλ: + 357 22 39 70 00 
gskcyprus@gsk.com 
 

Sverige 
GlaxoSmithKline AB 
Tel: + 46 (0)8 638 93 00 
info.produkt@gsk.com 

Latvija 
GlaxoSmithKline Latvia SIA 
Tel: + 371 67312687 
lv-epasts@gsk.com 
 

United Kingdom 
GlaxoSmithKline UK 
Tel: + 44 (0)800 221 441 
customercontactuk@gsk.com 
 

This leaflet was last revised in. 
 
Other sources of information 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu. 
------------------------------------------------------------------------------------------------------------------------- 
The following information is intended for healthcare professionals only: 
 
Before reconstitution: 
A white deposit and clear supernatant is observed upon storage of the oral applicator containing the 
solvent.  
The solvent should be inspected visually for any foreign particulate matter and/or abnormal physical 
appearance prior to reconstitution.  
 
After reconstitution: 
The reconstituted vaccine is slightly more turbid than the solvent and is milky white in appearance. 
 
The reconstituted vaccine should also be inspected visually for any foreign particulate matter and/or 
abnormal physical appearance prior to administration. In the event of either being observed, discard 
the vaccine.  
Any unused vaccine or waste material should be disposed of in accordance with local requirements. 
 
Instructions for reconstitution and administration of the vaccine: 
 
 



 

64 
 

 
 

 
 
 
 
 
 
 
If the reconstituted vaccine is to be stored temporarily before administration, replace the protective tip cap on 
the oral applicator. The oral applicator containing the reconstituted vaccine should be shaken gently again 
before oral administration. Do not inject. 

1. Remove the plastic cover from the 
glass container containing the powder 

Transfer 
adapter 

Oral 
applicator 

Oral 
applicator 
Tip-Cap 

2. Connect the transfer adapter onto 
the glass container by pushing it 
downwards until the transfer adapter 
is properly and securely placed 

3. Shake the oral applicator 
containing the solvent vigorously. The 
shaken suspension will appear as a 
turbid liquid with a slow settling white 
deposit 

4. Remove the protective tip cap from 
the oral applicator 

5. Connect the oral applicator into the 
transfer adapter by pushing it firmly 
on this device 

6. Transfer the entire content of the 
oral applicator into the glass 
container containing the powder 

7. With the oral applicator still attached, 
shake the glass container and examine it 
for complete suspension of the powder. 
The reconstituted vaccine will appear more 
turbid than the solvent alone. This 
appearance is normal 

8. Withdraw the entire mixture back 
into the oral applicator 

9. Remove the oral applicator from 
the transfer adapter 

10. This vaccine is for oral 
administration only. The child 
should be seated in a reclining 
position. Administer the entire content 
of the oral applicator orally (by 
administering the entire content of the 
oral applicator on the inside of the 
cheek) 

Glass 
container 

11. Do not inject. 



 

65 
 

 
Package leaflet: Information for the user 

 
Rotarix oral suspension in pre-filled oral applicator 

rotavirus vaccine, live 
 
Read all of this leaflet carefully before your child receives this vaccine because it contains 
important information for you. 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor or pharmacist. 
- This vaccine has been prescribed for your child only. Do not pass it on to others. 
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
1. What Rotarix is and what it is used for 
2. What you need to know before your child receives Rotarix 
3. How Rotarix is given 
4. Possible side effects 
5. How to store Rotarix 
6. Contents of the pack and other information 
 
 
1. What Rotarix is and what it is used for 
 
Rotarix is a viral vaccine, containing live, attenuated human rotavirus, that helps to protect your child, 
from the age of 6 weeks, against gastro-enteritis (diarrhoea and vomiting) caused by rotavirus 
infection. 
 
How Rotarix works 
 
Rotavirus infection is the most common cause of severe diarrhoea in infants and young children. 
Rotavirus is easily spread from hand-to-mouth due to contact with stools from an infected person. 
Most children with rotavirus diarrhoea recover on their own. However, some children become very ill 
with severe vomiting, diarrhoea and life-threatening loss of fluids that requires hospitalisation.  
 
When a person is given the vaccine, the immune system (the body’s natural defences) will make 
antibodies against the most commonly occurring types of rotavirus. These antibodies protect against 
disease caused by these types of rotavirus. 
 
As with all vaccines, Rotarix may not completely protect all people who are vaccinated against the 
rotavirus infections it is intended to prevent. 
 
 
2. What you need to know before your child receives Rotarix 
 
Rotarix should not be given 
• if your child has previously had any allergic reaction to rotavirus vaccines or any of the other 

ingredients of this vaccine (listed in section 6). Signs of an allergic reaction may include itchy 
skin rash, shortness of breath and swelling of the face or tongue. 

• if your child has previously had intussusception (a bowel obstruction in which one segment of 
bowel becomes enfolded within another segment). 

• if your child was born with a malformation of the gut that could lead to intussusception. 
• if your child has a rare inherited illness which affects their immune system called Severe 

Combined Immunodeficiency (SCID). 



 

66 
 

• if your child has a severe infection with a high temperature. It might be necessary to postpone 
the vaccination until recovery. A minor infection such as a cold should not be a problem, but 
talk to your doctor first. 

• if your child has diarrhoea or is vomiting. It might be necessary to postpone the vaccination 
until recovery. 

 
Warnings and precautions 
Talk to your doctor/health care professional before your child receives Rotarix if: 
• he/she has a close contact such as a household member who has a weakened immune system, 

e.g., a person with cancer or who is taking medicines that may weaken the immune system. 
• he/she has any disorder of the gastrointestinal system. 
• he/she has not been gaining weight and growing as expected. 
• he/she has any disease or is taking any medicine which reduces his/her resistance to infection or 

if his/her mother has taken during pregnancy any medicine that may weaken the immune 
system. 

 
After your child has received Rotarix, contact a doctor/health care professional right away if your 
child experiences severe stomach pain, persistent vomiting, blood in stools, a swollen belly and/or 
high fever (see also section 4 “Possible side effects”). 
 
As always, please take care to wash your hands thoroughly after changing soiled nappies. 
 
Other medicines and Rotarix 
Tell your doctor if your child is taking, has recently taken or might take any other medicines or has 
recently received any other vaccine. 
 
Rotarix may be given at the same time your child receives other normally recommended vaccines, 
such as diphtheria, tetanus, pertussis (whooping cough), Haemophilus influenzae type b, oral or 
inactivated polio, hepatitis B vaccines as well as pneumococcal and meningococcal serogroup C 
conjugate vaccines. 
 
Rotarix with food and drink 
There are no restrictions on your child’s consumption of food or liquids, either before or after 
vaccination. 
 
Breast-feeding 
Based on evidence generated in clinical trials, breast-feeding does not reduce the protection against 
rotavirus gastro-enteritis afforded by Rotarix. Therefore, breast-feeding may be continued during the 
vaccination schedule. 
 
Rotarix contains sucrose 
If you have been told by your doctor that the child being vaccinated has an intolerance to some sugars, 
contact your doctor before receiving this vaccine. 
 
 
3. How Rotarix is given 
 
The doctor or nurse will administer the recommended dose of Rotarix to your child. The vaccine (1.5 
ml liquid) will be given orally. Under no circumstance should this vaccine be administered by 
injection. 
 
Your child will receive two doses of the vaccine. Each dose will be given on a separate occasion with 
an interval of at least 4 weeks between the two doses. The first dose may be given from the age of 6 
weeks. The two doses of the vaccine must have been given by the age of 24 weeks, although they 
should preferably have been given before 16 weeks of age.  
 



 

67 
 

Rotarix may be given according to the same vaccination course to infants who were born prematurely, 
provided that the pregnancy had lasted at least 27 weeks. 
 
In case your child spits out or regurgitates most of the vaccine dose, a single replacement dose may be 
given at the same vaccination visit. 
 
When Rotarix is given to your child for the first dose, it is recommended that your child also receives 
Rotarix (and not another rotavirus vaccine) for the second dose.  
 
It is important that you follow the instructions of your doctor or nurse regarding return visits. If you 
forget to go back to your doctor at the scheduled time, ask your doctor for advice. 
 
 
4. Possible side effects 
 
Like all medicines, this vaccine can cause side effects, although not everybody gets them. 
 
The following side effects may happen with this vaccine: 
 
♦ Common (These may occur with up to 1 in 10 doses of the vaccine):  

• diarrhoea   
• irritability 

 
♦ Uncommon (These may occur with up to 1 in 100 doses of the vaccine): 

• abdominal pain (see also below for signs of very rare side effects of intussusception) 
• flatulence 
• inflammation of the skin 

 
Side effects that have been reported during marketed use of Rotarix include: 

• Very rare: hives (urticaria) 
• Very rare: intussusception (part of the intestine gets blocked or twisted). The signs may 

include severe stomach pain, persistent vomiting, blood in stools, a swollen belly and/or high 
fever. Contact a doctor/health care professional right away if your child experiences 
one of these symptoms. 

• blood in stools 
• in babies born very prematurely (at or before 28 weeks of gestation) longer gaps than normal 

between breaths may occur for 2-3 days after vaccination. 
• children with a rare inherited illness called Severe Combined Immunodeficiency (SCID) 

may have an inflamed stomach or gut (gastroenteritis) and pass the vaccine virus in their 
stools. The signs of gastroenteritis may include feeling sick, being sick, stomach cramps or 
diarrhoea. 

 
Reporting of side effects 
If your child gets any of the side effects, talk to your doctor or pharmacist. This includes any possible 
side effects not listed in this leaflet. You can also report side effects directly via the national reporting 
system listed in Appendix V. By reporting side effects you can help provide more information on the 
safety of this medicine. 
 
 
5. How to store Rotarix 
 
Keep this vaccine out of the sight and reach of children. 
 
Do not use this vaccine after the expiry date which is stated on the carton. The expiry date refers to the 
last day of that month. 
 



 

68 
 

Store in a refrigerator (2°C – 8°C). 
Do not freeze. 
Store in the original package in order to protect from light. 
 
The vaccine should be used immediately after opening. 
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines your child no longer uses. These measures will help to protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Rotarix contains 
 
- The active substances are: 
 
 Human rotavirus RIX4414 strain (live, attenuated)*  not less than 106.0 CCID50 
  
 *Produced on Vero cells 
 

- The other ingredients in Rotarix are: sucrose (see also section 2, Rotarix contains sucrose), Di-
sodium Adipate, Dulbecco’s Modified Eagle Medium (DMEM), sterile water 

 
What Rotarix looks like and contents of the pack 
 
Oral suspension in pre-filled oral applicator. 
 
Rotarix is supplied as clear and colourless liquid in a single dose pre-filled oral applicator (1.5 ml). 
 
Rotarix is available in a pack of 1, 5, 10 or 25. 
 
Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder and Manufacturer 
 
GlaxoSmithKline Biologicals s.a. 
Rue de l’Institut 89 
B-1330 Rixensart 
Belgium 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien 
GlaxoSmithKline Pharmaceuticals s.a./n.v. 
Tél/Tel: + 32 10 85 52 00 
 

Lietuva 
GlaxoSmithKline Lietuva UAB 
Tel. +370 5 264 90 00 
info.lt@gsk.com 
 

България 
ГлаксоСмитКлайн ЕООД 
Тел. + 359 2 953 10 34 
 

Luxembourg/Luxemburg 
GlaxoSmithKline Pharmaceuticals s.a./n.v. 
Tél/Tel: + 32 10 85 52 00 

Česká republika 
GlaxoSmithKline s.r.o. 
Tel: + 420 2 22 00 11 11 
cz.info@gsk.com 
 

Magyarország 
GlaxoSmithKline Kft. 
Tel.: + 36-1-2255300 
 



 

69 
 

Danmark 
GlaxoSmithKline Pharma A/S 
Tlf: + 45 36 35 91 00 
dk-info@gsk.com 
 

Malta 
GlaxoSmithKline (Malta) Ltd 
Tel: + 356 21 238131 
 

Deutschland 
GlaxoSmithKline GmbH & Co. KG 
Tel: + 49 (0)89 360448701 
produkt.info@gsk.com 
 

Nederland 
GlaxoSmithKline BV 
Tel: + 31 (0)30 69 38 100 
nlinfo@gsk.com 
 

Eesti 
GlaxoSmithKline Eesti OÜ  
Tel: +372 667 6900 
estonia@gsk.com 
 

Norge 
GlaxoSmithKline AS 
Tlf: + 47 22 70 20 00 
 

Ελλάδα 
GlaxoSmithKline A.E.B.E. 
Tηλ: + 30 210 68 82 100 
 

Österreich 
GlaxoSmithKline Pharma GmbH. 
Tel: + 43 (0)1 97075 0 
at.info@gsk.com  
 

España 
GlaxoSmithKline, S.A. 
Tel: + 34 900 202 700 
es-ci@gsk.com  
 

Polska 
GSK Services Sp. z o.o. 
Tel.: + 48 (22) 576 9000 
 

France 
Laboratoire GlaxoSmithKline 
Tél: + 33 (0) 1 39 17 84 44 
diam@gsk.com 
 
 
Hrvatska 
GlaxoSmithKline d.o.o. 
Tel.: + 385 (0)1 6051999 
 

Portugal 
Smith Kline & French Portuguesa, Produtos 
Farmacêuticos, Lda. 
Tel: + 351 21 412 95 00 
FI.PT@gsk.com 
 
România 
GlaxoSmithKline (GSK) SRL 
Tel: +40 (0)21 3028 208 
 

Ireland 
GlaxoSmithKline (Ireland) Ltd 
Tel: + 353 (0)1 495 5000 
 

Slovenija 
GlaxoSmithKline d.o.o. 
Tel: + 386 (0) 1 280 25 00 
medical.x.si@gsk.com 
 

Ísland 
Vistor hf. 
Sími : +354 535 7000 
 

Slovenská republika 
GlaxoSmithKline Slovakia s.r.o. 
Tel: + 421 (0)2 48 26 11 11 
recepcia.sk@gsk.com 
 

Italia 
GlaxoSmithKline S.p.A. 
Tel:+ 39 (0)45 9218 111 
 

Suomi/Finland 
GlaxoSmithKline Oy 
Puh/Tel: + 358 10 30 30 30 
Finland.tuoteinfo@gsk.com  
 

Κύπρος 
GlaxoSmithKline (Cyprus) Ltd 
Τηλ: + 357 22 39 70 00 
gskcyprus@gsk.com 
 

Sverige 
GlaxoSmithKline AB 
Tel: + 46 (0)8 638 93 00 
info.produkt@gsk.com 

Latvija 
GlaxoSmithKline Latvia SIA 

United Kingdom 
GlaxoSmithKline UK 



 

70 
 

Tel: + 371 67312687 
lv-epasts@gsk.com 
 

Tel: + 44 (0)800 221 441 
customercontactuk@gsk.com 
 

This leaflet was last revised in. 
 
Other sources of information 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu. 
------------------------------------------------------------------------------------------------------------------------- 
The following information is intended for healthcare professionals only: 
 
The vaccine is presented as a clear, colourless liquid, free of visible particles, for oral administration. 
 
The vaccine is ready to use (no reconstitution or dilution is required). 
The vaccine is to be administered orally without mixing with any other vaccines or solutions. 
 
The vaccine should be inspected visually for any foreign particulate matter and/or abnormal physical 
appearance. In the event of either being observed, discard the vaccine. 
 
Any unused vaccine or waste material should be disposed of in accordance with local requirements. 
 
Instructions for administration of the vaccine: 
 

   
 
 
 
 
 
 
Discard the empty oral applicator and tip cap in approved biological waste containers according to 
local regulations. 

1. Remove the protective tip cap from 
the oral applicator. 

2. This vaccine is for oral 
administration only. The child 
should be seated in a reclining 
position. Administer orally (i.e. into 
the child’s mouth, towards the inner 
cheek) the entire content of the oral 
applicator. 

3. Do not inject. 

Oral applicator 
Tip-Cap 



 

71 
 

 
Package leaflet: Information for the user 

 
Rotarix oral suspension in squeezable tube 

rotavirus vaccine, live 
 
Read all of this leaflet carefully before your child receives this vaccine because it contains 
important information for you. 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor or pharmacist. 
- This vaccine has been prescribed for your child only. Do not pass it on to others. 
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
1. What Rotarix is and what it is used for 
2. What you need to know before your child receives Rotarix 
3. How Rotarix is given 
4. Possible side effects 
5. How to store Rotarix 
6. Contents of the pack and other information 
 
 
1. What Rotarix is and what it is used for 
 
Rotarix is a viral vaccine, containing live, attenuated human rotavirus, that helps to protect your child, 
from the age of 6 weeks, against gastro-enteritis (diarrhoea and vomiting) caused by rotavirus 
infection. 
 
How Rotarix works 
 
Rotavirus infection is the most common cause of severe diarrhoea in infants and young children. 
Rotavirus is easily spread from hand-to-mouth due to contact with stools from an infected person. 
Most children with rotavirus diarrhoea recover on their own. However, some children become very ill 
with severe vomiting, diarrhoea and life-threatening loss of fluids that requires hospitalisation.  
 
When a person is given the vaccine, the immune system (the body’s natural defences) will make 
antibodies against the most commonly occurring types of rotavirus. These antibodies protect against 
disease caused by these types of rotavirus. 
 
As with all vaccines, Rotarix may not completely protect all people who are vaccinated against the 
rotavirus infections it is intended to prevent. 
 
 
2. What you need to know before your child receives Rotarix 
 
Rotarix should not be given 
• if your child has previously had any allergic reaction to rotavirus vaccines or any of the other 

ingredients of this vaccine (listed in section 6). Signs of an allergic reaction may include itchy 
skin rash, shortness of breath and swelling of the face or tongue. 

• if your child has previously had intussusception (a bowel obstruction in which one segment of 
bowel becomes enfolded within another segment). 

• if your child was born with a malformation of the gut that could lead to intussusception. 
• if your child has a rare inherited illness which affects their immune system called Severe 

Combined Immunodeficiency (SCID). 



 

72 
 

• if your child has a severe infection with a high temperature. It might be necessary to postpone 
the vaccination until recovery. A minor infection such as a cold should not be a problem, but 
talk to your doctor first. 

• if your child has diarrhoea or is vomiting. It might be necessary to postpone the vaccination 
until recovery. 

 
Warnings and precautions 
Talk to your doctor/health care professional before your child receives Rotarix if: 
• he/she has a close contact such as a household member who has a weakened immune system, 

e.g., a person with cancer or who is taking medicines that may weaken the immune system. 
• he/she has any disorder of the gastrointestinal system. 
• he/she has not been gaining weight and growing as expected. 
• he/she has any disease or is taking any medicine which reduces his/her resistance to infection or 

if his/her mother has taken during pregnancy any medicine that may weaken the immune 
system. 

 
After your child has received Rotarix, contact a doctor/health care professional right away if your 
child experiences severe stomach pain, persistent vomiting, blood in stools, a swollen belly and/or 
high fever (see also section 4 “Possible side effects”). 
 
As always, please take care to wash your hands thoroughly after changing soiled nappies. 
 
Other medicines and Rotarix 
Tell your doctor if your child is taking, has recently taken or might take any other medicines or has 
recently received any other vaccine. 
 
Rotarix may be given at the same time your child receives other normally recommended vaccines, 
such as diphtheria, tetanus, pertussis (whooping cough), Haemophilus influenzae type b, oral or 
inactivated polio, hepatitis B vaccines as well as pneumococcal and meningococcal serogroup C 
conjugate vaccines. 
 
Rotarix with food and drink 
There are no restrictions on your child’s consumption of food or liquids, either before or after 
vaccination. 
 
Breast-feeding 
Based on evidence generated in clinical trials, breast-feeding does not reduce the protection against 
rotavirus gastro-enteritis afforded by Rotarix. Therefore, breast-feeding may be continued during the 
vaccination schedule. 
 
Rotarix contains sucrose 
If you have been told by your doctor that the child being vaccinated has an intolerance to some sugars, 
contact your doctor before receiving this vaccine. 
 
 
3. How Rotarix is given 
 
The doctor or nurse will administer the recommended dose of Rotarix to your child. The vaccine (1.5 
ml liquid) will be given orally. Under no circumstance should this vaccine be administered by 
injection. 
 
Your child will receive two doses of the vaccine. Each dose will be given on a separate occasion with 
an interval of at least 4 weeks between the two doses. The first dose may be given from the age of 6 
weeks. The two doses of the vaccine must have been given by the age of 24 weeks, although they 
should preferably have been given before 16 weeks of age.  
 



 

73 
 

Rotarix may be given according to the same vaccination course to infants who were born prematurely, 
provided that the pregnancy had lasted at least 27 weeks. 
 
In case your child spits out or regurgitates most of the vaccine dose, a single replacement dose may be 
given at the same vaccination visit. 
 
When Rotarix is given to your child for the first dose, it is recommended that your child also receives 
Rotarix (and not another rotavirus vaccine) for the second dose.  
 
It is important that you follow the instructions of your doctor or nurse regarding return visits. If you 
forget to go back to your doctor at the scheduled time, ask your doctor for advice. 
 
 
4. Possible side effects 
 
Like all medicines, this vaccine can cause side effects, although not everybody gets them. 
 
The following side effects may happen with this vaccine: 
 
♦ Common (These may occur with up to 1 in 10 doses of the vaccine):  

• diarrhoea   
• irritability 

 
♦ Uncommon (These may occur with up to 1 in 100 doses of the vaccine): 

• abdominal pain (see also below for signs of very rare side effects of intussusception) 
• flatulence 
• inflammation of the skin 

 
Side effects that have been reported during marketed use of Rotarix include: 

• Very rare: hives (urticaria) 
• Very rare: intussusception (part of the intestine gets blocked or twisted).  The signs may 

include severe stomach pain, persistent vomiting, blood in stools, a swollen belly and/or high 
fever. Contact a doctor/health care professional right away if your child experiences 
one of these symptoms. 

• blood in stools 
• in babies born very prematurely (at or before 28 weeks of gestation) longer gaps than normal 

between breaths may occur for 2-3 days after vaccination. 
• children with a rare inherited illness called Severe Combined Immunodeficiency (SCID) 

may have an inflamed stomach or gut (gastroenteritis) and pass the vaccine virus in their 
stools. The signs of gastroenteritis may include feeling sick, being sick, stomach cramps or 
diarrhoea. 

 
Reporting of side effects 
If your child gets any of the side effects, talk to your doctor or pharmacist. This includes any possible 
side effects not listed in this leaflet. You can also report side effects directly via the national reporting 
system listed in Appendix V. By reporting side effects you can help provide more information on the 
safety of this medicine. 
 
 
5. How to store Rotarix 
 
Keep this vaccine out of the sight and reach of children. 
 
Do not use this vaccine after the expiry date which is stated on the carton. The expiry date refers to the 
last day of that month. 
 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc
http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


 

74 
 

Store in a refrigerator (2°C – 8°C). 
Do not freeze. 
Store in the original package in order to protect from light. 
 
The vaccine should be used immediately after opening. 
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines your child no longer uses. These measures will help to protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Rotarix contains 
 
- The active substances are: 
 
 Human rotavirus RIX4414 strain (live, attenuated)*  not less than 106.0 CCID50 
  
 *Produced on Vero cells 
 

- The other ingredients in Rotarix are: sucrose (see also section 2, Rotarix contains sucrose), Di-
sodium Adipate, Dulbecco’s Modified Eagle Medium (DMEM), sterile water 

 
What Rotarix looks like and contents of the pack 
 
Oral suspension. 
 
Rotarix is supplied as clear and colourless liquid in a single dose squeezable tube (1.5 ml). 
 
Rotarix is available in a pack of 1, 10 or 50. 
 
Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder and Manufacturer 
 
GlaxoSmithKline Biologicals s.a. 
Rue de l’Institut 89 
B-1330 Rixensart 
Belgium 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien 
GlaxoSmithKline Pharmaceuticals s.a./n.v. 
Tél/Tel: + 32 10 85 52 00 
 

Lietuva 
GlaxoSmithKline Lietuva UAB 
Tel. +370 5 264 90 00 
info.lt@gsk.com 
 

България 
ГлаксоСмитКлайн ЕООД 
Тел. + 359 2 953 10 34 
 

Luxembourg/Luxemburg 
GlaxoSmithKline Pharmaceuticals s.a./n.v. 
Tél/Tel: + 32 10 85 52 00 

Česká republika 
GlaxoSmithKline s.r.o. 
Tel: + 420 2 22 00 11 11 
cz.info@gsk.com 
 

Magyarország 
GlaxoSmithKline Kft. 
Tel.: + 36-1-2255300 
 



 

75 
 

Danmark 
GlaxoSmithKline Pharma A/S 
Tlf: + 45 36 35 91 00 
dk-info@gsk.com 
 

Malta 
GlaxoSmithKline (Malta) Ltd 
Tel: + 356 21 238131 
 

Deutschland 
GlaxoSmithKline GmbH & Co. KG 
Tel: + 49 (0)89 360448701 
produkt.info@gsk.com 
 

Nederland 
GlaxoSmithKline BV 
Tel: + 31 (0)30 69 38 100 
nlinfo@gsk.com 
 

Eesti 
GlaxoSmithKline Eesti OÜ  
Tel: +372 667 6900 
estonia@gsk.com 
 

Norge 
GlaxoSmithKline AS 
Tlf: + 47 22 70 20 00 
 

Ελλάδα 
GlaxoSmithKline A.E.B.E. 
Tηλ: + 30 210 68 82 100 
 

Österreich 
GlaxoSmithKline Pharma GmbH. 
Tel: + 43 (0)1 97075 0 
at.info@gsk.com  
 

España 
GlaxoSmithKline, S.A. 
Tel: + 34 900 202 700 
es-ci@gsk.com  
 

Polska 
GSK Services Sp. z o.o. 
Tel.: + 48 (22) 576 9000 
 

France 
Laboratoire GlaxoSmithKline 
Tél: + 33 (0) 1 39 17 84 44 
diam@gsk.com 
 
 
Hrvatska 
GlaxoSmithKline d.o.o. 
Tel.: + 385 (0)1 6051999 
 

Portugal 
Smith Kline & French Portuguesa, Produtos 
Farmacêuticos, Lda. 
Tel: + 351 21 412 95 00 
FI.PT@gsk.com 
 
România 
GlaxoSmithKline (GSK) SRL 
Tel: +40 (0)21 3028 208 
 

Ireland 
GlaxoSmithKline (Ireland) Ltd 
Tel: + 353 (0)1 495 5000 
 

Slovenija 
GlaxoSmithKline d.o.o. 
Tel: + 386 (0) 1 280 25 00 
medical.x.si@gsk.com 
 

Ísland 
Vistor hf 
Sími : +354 535 7000 
 

Slovenská republika 
GlaxoSmithKline Slovakia s.r.o. 
Tel: + 421 (0)2 48 26 11 11 
recepcia.sk@gsk.com 
 

Italia 
GlaxoSmithKline S.p.A. 
Tel:+ 39 (0)45 9218 111 
 

Suomi/Finland 
GlaxoSmithKline Oy 
Puh/Tel: + 358 10 30 30 30 
Finland.tuoteinfo@gsk.com  
 

Κύπρος 
GlaxoSmithKline (Cyprus) Ltd 
Τηλ: + 357 22 39 70 00 
gskcyprus@gsk.com 
 

Sverige 
GlaxoSmithKline AB 
Tel: + 46 (0)8 638 93 00 
info.produkt@gsk.com 

Latvija 
GlaxoSmithKline Latvia SIA 

United Kingdom 
GlaxoSmithKline UK 



 

76 
 

Tel: + 371 67312687 
lv-epasts@gsk.com 
 

Tel: + 44 (0)800 221 441 
customercontactuk@gsk.com 
 

This leaflet was last revised in 
 
Other sources of information 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu. 
------------------------------------------------------------------------------------------------------------------------- 
The following information is intended for healthcare professionals only: 
 
The vaccine is presented as a clear, colourless liquid, free of visible particles, for oral administration. 
 
The vaccine is ready to use (no reconstitution or dilution is required).  
The vaccine is to be administered orally without mixing with any other vaccines or solutions. 
 
The vaccine should be inspected visually for any foreign particulate matter and/or abnormal physical 
appearance. In the event of either being observed, discard the vaccine. 
 
Any unused vaccine or waste material should be disposed of in accordance with local requirements. 
 
Instructions for administration of the vaccine: 
 
Please read the instructions for use all the way through before starting to give the vaccine. 
 
A  What you need to do before giving Rotarix 
• Check the expiry date. 
• Check the tube has not been damaged nor is already 

open. 
• Check the liquid is clear and colourless, without any 

particles in it.   
 
If you notice anything abnormal, do not use the vaccine.  
• This vaccine is given orally - straight from the tube. 
• It is ready to use - you do not need to mix it with 

anything. 

 

 
B  Get the tube ready 
1.  Pull off the cap  
• Keep the cap – you need this to pierce the membrane. 
• Hold the tube upright. 
 
2. Repeatedly flick the top of the tube until it is clear of 
any liquid 
• Clear any liquid from the thinnest section of the tube by 

flicking just below the membrane. 
 

 

 



 

77 
 

3.  Position the cap to open the tube 
• Keep the tube held upright. 
• Hold the side of tube 
• There is a small spike inside the top of the cap - in the 

centre. 
• Turn the cap upside down (180°). 

 
 
 
 
 

 

 
4.  To open the tube 
• You do not need to twist. Press the cap down to 

pierce the membrane.  
• Then lift off the cap. 
 

 

 
C  Check the tube has opened correctly 
1.  Check the membrane has been pierced 
• There should be a hole at the top of the tube. 
 
2. What to do if the membrane has not been pierced 
• If the membrane has not been pierced return to section 

B and repeat steps 2, 3 and 4.  
 
 

 

 
D  Give the vaccine 
• Once the tube is open check the liquid is clear, without 

any particles in it. 
       If you notice anything abnormal, do not use the vaccine. 
• Give the vaccine straight away. 
 
1.  Position the child to give the vaccine 
• Seat the child leaning slightly backwards. 
 
2. Administer the vaccine 
• Squeeze the liquid gently into the side of the child’s 

mouth - towards the inside of their cheek. 
• You may need to squeeze the tube a few times to get all 

of the vaccine out - it is okay if a drop remains in the tip 
of the tube. 
 

 

 

 
Discard the empty tube and cap in approved biological waste containers according to local regulations. 
 
 
 
 



 

78 
 

Package leaflet: Information for the user 
 

Rotarix oral suspension in multi-monodose (5 single dose) squeezable tube presentation 
connected by a bar 

rotavirus vaccine, live 
 
Read all of this leaflet carefully before your child receives this vaccine because it contains 
important information for you. 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor or pharmacist. 
- This vaccine has been prescribed for your child only. Do not pass it on to others. 
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
1. What Rotarix is and what it is used for 
2. What you need to know before your child receives Rotarix 
3. How Rotarix is given 
4. Possible side effects 
5. How to store Rotarix 
6. Contents of the pack and other information 
 
 
1. What Rotarix is and what it is used for 
 
Rotarix is a viral vaccine, containing live, attenuated human rotavirus, that helps to protect your child, 
from the age of 6 weeks, against gastro-enteritis (diarrhoea and vomiting) caused by rotavirus 
infection. 
 
How Rotarix works 
 
Rotavirus infection is the most common cause of severe diarrhoea in infants and young children. 
Rotavirus is easily spread from hand-to-mouth due to contact with stools from an infected person. 
Most children with rotavirus diarrhoea recover on their own. However, some children become very ill 
with severe vomiting, diarrhoea and life-threatening loss of fluids that requires hospitalisation.  
 
When a person is given the vaccine, the immune system (the body’s natural defences) will make 
antibodies against the most commonly occurring types of rotavirus. These antibodies protect against 
disease caused by these types of rotavirus. 
 
As with all vaccines, Rotarix may not completely protect all people who are vaccinated against the 
rotavirus infections it is intended to prevent. 
 
 
2. What you need to know before your child receives Rotarix 
 
Rotarix should not be given 
• if your child has previously had any allergic reaction to rotavirus vaccines or any of the other 

ingredients of this vaccine (listed in section 6). Signs of an allergic reaction may include itchy 
skin rash, shortness of breath and swelling of the face or tongue. 

• if your child has previously had intussusception (a bowel obstruction in which one segment of 
bowel becomes enfolded within another segment). 

• if your child was born with a malformation of the gut that could lead to intussusception. 
• if your child has a rare inherited illness which affects their immune system called Severe 

Combined Immunodeficiency (SCID). 



 

79 
 

• if your child has a severe infection with a high temperature. It might be necessary to postpone 
the vaccination until recovery. A minor infection such as a cold should not be a problem, but 
talk to your doctor first. 

• if your child has diarrhoea or is vomiting. It might be necessary to postpone the vaccination 
until recovery. 

 
Warnings and precautions 
Talk to your doctor/health care professional before your child receives Rotarix if: 
• he/she has a close contact such as a household member who has a weakened immune system, 

e.g., a person with cancer or who is taking medicines that may weaken the immune system. 
• he/she has any disorder of the gastrointestinal system. 
• he/she has not been gaining weight and growing as expected. 
• he/she has any disease or is taking any medicine which reduces his/her resistance to infection or 

if his/her mother has taken during pregnancy any medicine that may weaken the immune 
system. 

 
After your child has received Rotarix, contact a doctor/health care professional right away if your 
child experiences severe stomach pain, persistent vomiting, blood in stools, a swollen belly and/or 
high fever (see also section 4 “Possible side effects”). 
 
As always, please take care to wash your hands thoroughly after changing soiled nappies. 
 
Other medicines and Rotarix 
Tell your doctor if your child is taking, has recently taken or might take any other medicines or has 
recently received any other vaccine. 
 
Rotarix may be given at the same time your child receives other normally recommended vaccines, 
such as diphtheria, tetanus, pertussis (whooping cough), Haemophilus influenzae type b, oral or 
inactivated polio, hepatitis B vaccines as well as pneumococcal and meningococcal serogroup C 
conjugate vaccines. 
 
Rotarix with food and drink 
There are no restrictions on your child’s consumption of food or liquids, either before or after 
vaccination. 
 
Breast-feeding 
Based on evidence generated in clinical trials, breast-feeding does not reduce the protection against 
rotavirus gastro-enteritis afforded by Rotarix. Therefore, breast-feeding may be continued during the 
vaccination schedule. 
 
Rotarix contains sucrose 
If you have been told by your doctor that the child being vaccinated has an intolerance to some sugars, 
contact your doctor before receiving this vaccine. 
 
 
3. How Rotarix is given 
 
The doctor or nurse will administer the recommended dose of Rotarix to your child. The vaccine (1.5 
ml liquid) will be given orally. Under no circumstance should this vaccine be administered by 
injection. 
 
Your child will receive two doses of the vaccine. Each dose will be given on a separate occasion with 
an interval of at least 4 weeks between the two doses. The first dose may be given from the age of 6 
weeks. The two doses of the vaccine must have been given by the age of 24 weeks, although they 
should preferably have been given before 16 weeks of age.  
 



 

80 
 

Rotarix may be given according to the same vaccination course to infants who were born prematurely, 
provided that the pregnancy had lasted at least 27 weeks. 
 
In case your child spits out or regurgitates most of the vaccine dose, a single replacement dose may be 
given at the same vaccination visit. 
 
When Rotarix is given to your child for the first dose, it is recommended that your child also receives 
Rotarix (and not another rotavirus vaccine) for the second dose.  
 
It is important that you follow the instructions of your doctor or nurse regarding return visits. If you 
forget to go back to your doctor at the scheduled time, ask your doctor for advice. 
 
 
4. Possible side effects 
 
Like all medicines, this vaccine can cause side effects, although not everybody gets them. 
 
The following side effects may happen with this vaccine: 
 
♦ Common (These may occur with up to 1 in 10 doses of the vaccine):  

• diarrhoea   
• irritability 

 
♦ Uncommon (These may occur with up to 1 in 100 doses of the vaccine): 

• abdominal pain (see also below for signs of very rare side effects of intussusception) 
• flatulence 
• inflammation of the skin 

 
Side effects that have been reported during marketed use of Rotarix include: 

• Very rare: hives (urticaria) 
• Very rare: intussusception (part of the intestine gets blocked or twisted).  The signs may 

include severe stomach pain, persistent vomiting, blood in stools, a swollen belly and/or high 
fever. Contact a doctor/health care professional right away if your child experiences 
one of these symptoms. 

• blood in stools 
• in babies born very prematurely (at or before 28 weeks of gestation) longer gaps than normal 

between breaths may occur for 2-3 days after vaccination. 
• children with a rare inherited illness called Severe Combined Immunodeficiency (SCID) 

may have an inflamed stomach or gut (gastroenteritis) and pass the vaccine virus in their 
stools. The signs of gastroenteritis may include feeling sick, being sick, stomach cramps or 
diarrhoea. 

 
Reporting of side effects 
If your child gets any of the side effects, talk to your doctor or pharmacist. This includes any possible 
side effects not listed in this leaflet. You can also report side effects directly via the national reporting 
system listed in Appendix V. By reporting side effects you can help provide more information on the 
safety of this medicine. 
 
 
5. How to store Rotarix 
 
Keep this vaccine out of the sight and reach of children. 
 
Do not use this vaccine after the expiry date which is stated on the carton. The expiry date refers to the 
last day of that month. 
 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc
http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


 

81 
 

Store in a refrigerator (2°C – 8°C). 
Do not freeze. 
Store in the original package in order to protect from light. 
 
The vaccine should be used immediately after opening. 
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to 
throw away medicines your child no longer uses. These measures will help to protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Rotarix contains 
 
- The active substances are: 
 
 Human rotavirus RIX4414 strain (live, attenuated)*  not less than 106.0 CCID50 
  
 *Produced on Vero cells 
 

- The other ingredients in Rotarix are: sucrose (see also section 2, Rotarix contains sucrose), Di-
sodium Adipate, Dulbecco’s Modified Eagle Medium (DMEM), sterile water 

 
What Rotarix looks like and contents of the pack 
 
Oral suspension. 
 
Rotarix is supplied as clear and colourless liquid in 5 single dose squeezable tubes (5 x 1.5 ml) 
connected by a bar. 
 
Rotarix is available in a pack of 50 tubes. 
 
Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder and Manufacturer 
 
GlaxoSmithKline Biologicals s.a. 
Rue de l’Institut 89 
B-1330 Rixensart 
Belgium 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien 
GlaxoSmithKline Pharmaceuticals s.a./n.v. 
Tél/Tel: + 32 10 85 52 00 
 

Lietuva 
GlaxoSmithKline Lietuva UAB 
Tel. +370 5 264 90 00 
info.lt@gsk.com 
 

България 
ГлаксоСмитКлайн ЕООД 
Тел. + 359 2 953 10 34 
 

Luxembourg/Luxemburg 
GlaxoSmithKline Pharmaceuticals s.a./n.v. 
Tél/Tel: + 32 10 85 52 00 

Česká republika 
GlaxoSmithKline s.r.o. 
Tel: + 420 2 22 00 11 11 
cz.info@gsk.com 

Magyarország 
GlaxoSmithKline Kft. 
Tel.: + 36-1-2255300 
 



 

82 
 

 
Danmark 
GlaxoSmithKline Pharma A/S 
Tlf: + 45 36 35 91 00 
dk-info@gsk.com 
 

Malta 
GlaxoSmithKline (Malta) Ltd 
Tel: + 356 21 238131 
 

Deutschland 
GlaxoSmithKline GmbH & Co. KG 
Tel: + 49 (0)89 360448701 
produkt.info@gsk.com 
 

Nederland 
GlaxoSmithKline BV 
Tel: + 31 (0)30 69 38 100 
nlinfo@gsk.com 
 

Eesti 
GlaxoSmithKline Eesti OÜ  
Tel: +372 667 6900 
estonia@gsk.com 
 

Norge 
GlaxoSmithKline AS 
Tlf: + 47 22 70 20 00 
 
 

Ελλάδα 
GlaxoSmithKline A.E.B.E. 
Tηλ: + 30 210 68 82 100 
 

Österreich 
GlaxoSmithKline Pharma GmbH 
Tel: + 43 (0)1 97075 0 
at.info@gsk.com  
 

España 
GlaxoSmithKline, S.A. 
Tel: + 34 900 202 700 
es-ci@gsk.com  
 

Polska 
GSK Services Sp. z o.o. 
Tel.: + 48 (22) 576 9000 
 

France 
Laboratoire GlaxoSmithKline 
Tél: + 33 (0) 1 39 17 84 44 
diam@gsk.com 
 
 
Hrvatska 
GlaxoSmithKline d.o.o. 
Tel.: + 385 (0)1 6051999 
 

Portugal 
Smith Kline & French Portuguesa - Produtos 
Farmacêuticos, Lda. 
Tel: + 351 21 412 95 00 
FI.PT@gsk.com 
 
România 
GlaxoSmithKline (GSK) SRL 
Tel: +40 (0)21 3028 208 
 

Ireland 
GlaxoSmithKline (Ireland) Ltd 
Tel: + 353 (0)1 495 5000 
 

Slovenija 
GlaxoSmithKline d.o.o. 
Tel: + 386 (0) 1 280 25 00 
medical.x.si@gsk.com 
 

Ísland 
ςιστορ ηφ.  
Sími: +354 535 7000  
 

Slovenská republika 
GlaxoSmithKline Slovakia s.r.o. 
Tel.: + 421 (0)2 48 26 11 11 
recepcia.sk@gsk.com 
 

Italia 
GlaxoSmithKline S.p.A. 
Tel: + 39 (0)45 9218 111 
 

Suomi/Finland 
GlaxoSmithKline Oy 
Puh/Tel: + 358 10 30 30 30 
Finland.tuoteinfo@gsk.com  
 

Κύπρος 
GlaxoSmithKline (Cyprus) Ltd 
Τηλ: + 357 22 39 70 00 
gskcyprus@gsk.com 
 

Sverige 
GlaxoSmithKline AB 
Tel: + 46 (0)8 638 93 00 
info.produkt@gsk.com 

Latvija United Kingdom 



 

83 
 

GlaxoSmithKline Latvia SIA 
Tel: + 371 67312687 
lv-epasts@gsk.com 
 

GlaxoSmithKline UK 
Tel: +44 (0)800 221 441 
customercontactuk@gsk.com 
 

 
This leaflet was last revised in. 
 
Other sources of information 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu. 
------------------------------------------------------------------------------------------------------------------------- 
The following information is intended for healthcare professionals only: 
 
The vaccine is presented as a clear, colourless liquid, free of visible particles, for oral administration. 
 
The vaccine is ready to use (no reconstitution or dilution is required).  
The vaccine is to be administered orally without mixing with any other vaccines or solutions. 
 
The vaccine should be inspected visually for any foreign particulate matter and/or abnormal physical 
appearance. In the event of either being observed, discard the vaccine. 
 
Any unused vaccine or waste material should be disposed of in accordance with local requirements. 
 
Instructions for administration of the vaccine: 
 
Please read the instructions for use all the way through before starting to give the vaccine. 
 
• This vaccine is given orally straight from an individual tube.  
• One oral tube delivers one dose of vaccine. 
• This vaccine is ready to use - do not mix it with anything else. 
 
A.  What you need to do before giving Rotarix 

1.  Check the expiry date on the connecting bar. 
2. Check the liquid in the oral tubes is clear, colourless and 

free from any particles.   
- Do not use any of the oral tubes on the 

connecting bar if you notice anything unusual. 

3.  Check that each individual oral tube is not damaged and 
is still sealed. 

- Do not use the affected oral tube if you notice 
anything unusual.  

 
 

 
B.  Get the oral tube ready 

1.  To separate one oral tube from the others starting at one 
end: 
a) Hold the tab of one of the end oral tubes to 

separate it from the others. 
b) With your other hand, hold the tab of the oral 

tube next to it. 
c) Pull the tab and tear it away from the oral tube 

next to it. 
 

 

 

 
 
 

Connecting 
bar 

Neck 

Body 

Tab 

Expiry date: MM-YYYY 

Monodose 
oral tube 

Expiry date: MM-YYYY 

Pull  



 

84 
 

 
2.  To open the separated oral tube:  

d) Keep the separated oral tube held upright. 
e) Hold the tab of the separated oral tube in one 

hand and the connecting bar in the other hand. Do 
not hold the body of the oral tube, you may squeeze 
out some of the vaccine. 

f) Twist the separated oral tube.  
g) Pull it from the connecting bar. 

 
 

 

 
C. Give the vaccine orally immediately after opening 

1.  To position the child to receive the vaccine:  
• Seat the child leaning slightly backwards. 

 
2.  To administer the vaccine orally: 

• Squeeze the liquid gently into the side of the 
child’s mouth, towards the inside of their cheek. 

• You may need to squeeze the oral tube a few 
times to get all of the vaccine out - it is okay if a 
drop stays in the oral tube. 
 

 

   
 
 

 
 
D. Store remaining doses in the fridge immediately 
 
Unused oral tubes that are still attached to the connecting bar  
must be put back in the fridge immediately after an  
oral tube has been used. This is so that the unused oral tubes can  
be used for the next vaccination. 
 
 
 
Discard the used oral tubes in approved biological waste  
containers according to local regulations. 

 
 
 
 
 
 

Oral 
administration 
only 

2°C to 8°C 

Put back in  
fridge immediately 

Twist Pull 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET
{'Title': '1. what rotarix is and what it is used for', 'Section_Content': "rotarix is a viral vaccine, containing live, attenuated human rotavirus, that helps to protect your child, from the age of 6 weeks, against gastro-enteritis (diarrhoea and vomiting) caused by rotavirus infection. how rotarix works rotavirus infection is the most common cause of severe diarrhoea in infants and young children. rotavirus is easily spread from hand-to-mouth due to contact with stools from an infected person. most children with rotavirus diarrhoea recover on their own. however, some children become very ill with severe vomiting, diarrhoea and life-threatening loss of fluids that requires hospitalisation. when a person is given the vaccine, the immune system (the body's natural defences) will make antibodies against the most commonly occurring types of rotavirus. these antibodies protect against disease caused by these types of rotavirus. as with all vaccines, rotarix may not completely protect all people who are vaccinated against the rotavirus infections it is intended to prevent.", 'Entity_Recognition': [{'Text': 'rotarix', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Id': 2, 'BeginOffset': 0, 'EndOffset': 7, 'Score': 0.40597274899482727, 'Text': 'rotarix', 'Category': 'MEDICATION', 'Type': 'BRAND_NAME', 'Traits': []}, {'Text': 'a viral vaccine', 'Type': 'TREATMENT', 'BeginOffset': 11, 'EndOffset': 26}, {'Text': 'attenuated human rotavirus', 'Type': 'TREATMENT', 'BeginOffset': 45, 'EndOffset': 71}, {'Text': '6', 'Type': 'NUMBER', 'BeginOffset': 123, 'EndOffset': 124}, {'Text': 'gastro-enteritis', 'Type': 'PROBLEM', 'BeginOffset': 140, 'EndOffset': 156}, {'Id': 6, 'BeginOffset': 158, 'EndOffset': 167, 'Score': 0.9905953407287598, 'Text': 'diarrhoea', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'DIAGNOSIS', 'Score': 0.8132482767105103}]}, {'Id': 7, 'BeginOffset': 172, 'EndOffset': 180, 'Score': 0.9944766163825989, 'Text': 'vomiting', 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vomiting. it might be necessary to postpone the vaccination until recovery. warnings and precautions talk to your doctor/health care professional before your child receives rotarix if: he/she has a close contact such as a household member who has a weakened immune system, e.g., a person with cancer or who is taking medicines that may weaken the immune system. he/she has any disorder of the gastrointestinal system. he/she has not been gaining weight and growing as expected. he/she has any disease or is taking any medicine which reduces his/her resistance to infection or if his/her mother has taken during pregnancy any medicine that may weaken the immune system. after your child has received rotarix, contact a doctor/health care professional right away if your child experiences severe stomach pain, persistent vomiting, blood in stools, a swollen belly and/or high fever (see also section 4 "possible side effects"). as always, please take care to wash your hands thoroughly after changing soiled nappies. other medicines and rotarix tell your doctor if your child is taking, has recently taken or might take any other medicines or has recently received any other vaccine. rotarix may be given at the same time your child receives other normally recommended vaccines, such as diphtheria, tetanus, pertussis (whooping cough), haemophilus influenzae type b, oral or inactivated polio, hepatitis b vaccines as well as pneumococcal and meningococcal serogroup c conjugate vaccines. rotarix with food and drink there are no restrictions on your child\'s consumption of food or liquids, either before or after vaccination. breast-feeding based on evidence generated in clinical trials, breast-feeding does not reduce the protection against rotavirus gastro-enteritis afforded by rotarix. therefore, breast-feeding may be continued during the vaccination schedule. rotarix contains sucrose and sorbitol if you have been told by your doctor that the child being vaccinated has an intolerance to 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{'Title': '3. how rotarix is given', 'Section_Content': 'the doctor or nurse will administer the recommended dose of rotarix to your child. the vaccine (1 ml liquid) will be given orally. under no circumstance should this vaccine be administered by injection. your child will receive two doses of the vaccine. each dose will be given on a separate occasion with an interval of at least 4 weeks between the two doses. the first dose may be given from the age of 6 weeks. the two doses of the vaccine must have been given by the age of 24 weeks, although they should preferably have been given before 16 weeks of age. rotarix may be given according to the same vaccination course to infants who were born prematurely, provided that the pregnancy had lasted at least 27 weeks. in case your child spits out or regurgitates most of the vaccine dose, a single replacement dose may be given at the same vaccination visit. when rotarix is given to your child for the first dose, it is recommended that your child also receives rotarix (and not another rotavirus vaccine) for the second dose. it is important that you follow the instructions of your doctor or nurse regarding return visits. if you forget to go back to your doctor at the scheduled time, ask your doctor for advice.', 'Entity_Recognition': [{'Text': 'rotarix', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Id': 0, 'BeginOffset': 60, 'EndOffset': 67, 'Score': 0.9720866084098816, 'Text': 'rotarix', 'Category': 'MEDICATION', 'Type': 'BRAND_NAME', 'Traits': []}, {'Text': 'the vaccine (1 ml liquid)', 'Type': 'TREATMENT', 'BeginOffset': 83, 'EndOffset': 108}, {'Text': 'this vaccine', 'Type': 'TREATMENT', 'BeginOffset': 160, 'EndOffset': 172}, {'Id': 17, 'BeginOffset': 192, 'EndOffset': 201, 'Score': 0.1836784929037094, 'Text': 'injection', 'Category': 'TEST_TREATMENT_PROCEDURE', 'Type': 'PROCEDURE_NAME', 'Traits': []}, {'Text': 'the vaccine', 'Type': 'TREATMENT', 'BeginOffset': 240, 'EndOffset': 251}, {'Text': '4', 'Type': 'NUMBER', 'BeginOffset': 329, 'EndOffset': 330}, {'Text': '6', 'Type': 'NUMBER', 'BeginOffset': 404, 'EndOffset': 405}, {'Text': 'the vaccine', 'Type': 'TREATMENT', 'BeginOffset': 430, 'EndOffset': 441}, {'Id': 25, 'BeginOffset': 470, 'EndOffset': 479, 'Score': 0.40108031034469604, 'Text': 'age of 24', 'Category': 'TIME_EXPRESSION', 'Type': 'TIME_TO_TREATMENT_NAME', 'Traits': [], 'Attributes': [{'Type': 'TREATMENT_NAME', 'Score': 0.6349853873252869, 'RelationshipScore': 0.5119732618331909, 'RelationshipType': 'OVERLAP', 'Id': 19, 'BeginOffset': 434, 'EndOffset': 441, 'Text': 'vaccine', 'Category': 'TEST_TREATMENT_PROCEDURE', 'Traits': []}]}, {'Text': '16', 'Type': 'NUMBER', 'BeginOffset': 542, 'EndOffset': 544}, {'Id': 9, 'BeginOffset': 559, 'EndOffset': 566, 'Score': 0.926870584487915, 'Text': 'rotarix', 'Category': 'MEDICATION', 'Type': 'BRAND_NAME', 'Traits': []}, {'Id': 20, 'BeginOffset': 602, 'EndOffset': 613, 'Score': 0.5778111219406128, 'Text': 'vaccination', 'Category': 'TEST_TREATMENT_PROCEDURE', 'Type': 'TREATMENT_NAME', 'Traits': []}, {'Id': 13, 'BeginOffset': 677, 'EndOffset': 686, 'Score': 0.9444136619567871, 'Text': 'pregnancy', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'DIAGNOSIS', 'Score': 0.9249371886253357}]}, {'Id': 28, 'BeginOffset': 707, 'EndOffset': 715, 'Score': 0.9243522882461548, 'Text': '27 weeks', 'Category': 'TIME_EXPRESSION', 'Type': 'TIME_TO_DX_NAME', 'Traits': [], 'Attributes': [{'Type': 'DX_NAME', 'Score': 0.9444136619567871, 'RelationshipScore': 0.8999941349029541, 'RelationshipType': 'OVERLAP', 'Id': 13, 'BeginOffset': 677, 'EndOffset': 686, 'Text': 'pregnancy', 'Category': 'MEDICAL_CONDITION', 'Traits': [{'Name': 'DIAGNOSIS', 'Score': 0.9249371886253357}]}]}, {'Text': 'your child spits', 'Type': 'PROBLEM', 'BeginOffset': 725, 'EndOffset': 741}, {'Text': 'the vaccine dose', 'Type': 'TREATMENT', 'BeginOffset': 770, 'EndOffset': 786}, {'Text': 'a single replacement dose', 'Type': 'TREATMENT', 'BeginOffset': 788, 'EndOffset': 813}, {'Id': 21, 'BeginOffset': 839, 'EndOffset': 850, 'Score': 0.4682927131652832, 'Text': 'vaccination', 'Category': 'TEST_TREATMENT_PROCEDURE', 'Type': 'TREATMENT_NAME', 'Traits': []}, {'Id': 10, 'BeginOffset': 863, 'EndOffset': 870, 'Score': 0.9470767378807068, 'Text': 'rotarix', 'Category': 'MEDICATION', 'Type': 'BRAND_NAME', 'Traits': []}, {'Id': 11, 'BeginOffset': 962, 'EndOffset': 969, 'Score': 0.9667689800262451, 'Text': 'rotarix', 'Category': 'MEDICATION', 'Type': 'BRAND_NAME', 'Traits': []}, {'Text': 'another rotavirus vaccine', 'Type': 'TREATMENT', 'BeginOffset': 979, 'EndOffset': 1004}]}
{'Title': '4. possible side effects', 'Section_Content': 'like all medicines, this vaccine can cause side effects, although not everybody gets them. the following side effects may happen with this vaccine: common (these may occur with up to 1 in 10 doses of the vaccine): diarrhoea irritability uncommon (these may occur with up to 1 in 100 doses of the vaccine): abdominal pain (see also below for signs of very rare side effects of intussusception) flatulence inflammation of the skin side effects that have been reported during marketed use of rotarix include: very rare: hives (urticaria) very rare: intussusception (part of the intestine gets blocked or twisted). the signs may include severe stomach pain, persistent vomiting, blood in stools, a swollen belly and/or high fever. contact a doctor/health care professional right away if your child experiences one of these symptoms. blood in stools in babies born very prematurely (at or before 28 weeks of gestation) longer gaps than normal between breaths may occur for 2-3 days after vaccination. children with a rare inherited illness called severe combined immunodeficiency (scid) may have an inflamed stomach or gut (gastroenteritis) and pass the vaccine virus in their stools. the signs of gastroenteritis may include feeling sick, being sick, stomach cramps or diarrhoea. reporting of side effects if your child gets any of the side effects, talk to your doctor or pharmacist. this includes any possible side effects not listed in this leaflet. you can also report side effects directly via the national reporting system listed in appendix v. by reporting side effects you can help provide more information on the safety of this medicine.', 'Entity_Recognition': [{'Text': 'rotarix', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'all medicines', 'Type': 'TREATMENT', 'BeginOffset': 5, 'EndOffset': 18}, {'Text': 'this vaccine', 'Type': 'TREATMENT', 'BeginOffset': 20, 'EndOffset': 32}, {'Id': 8, 'BeginOffset': 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{'Title': '5. how to store rotarix', 'Section_Content': 'keep this vaccine out of the sight and reach of children. do not use this vaccine after the expiry date which is stated on the carton. the expiry date refers to the last day of that month. store in a refrigerator (2 8). do not freeze. store in the original package in order to protect from light. after reconstitution, the vaccine contained in the oral applicator should be administered promptly. if the reconstituted vaccine is not used within 24 hours, it should be discarded. do not throw away any medicines via wastewater or household waste. ask your pharmacist how to throw away medicines your child no longer uses. these measures will help to protect the environment.', 'Entity_Recognition': [{'Text': 'rotarix', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'this vaccine', 'Type': 'TREATMENT', 'BeginOffset': 5, 'EndOffset': 17}, {'Text': 'this vaccine', 'Type': 'TREATMENT', 'BeginOffset': 69, 'EndOffset': 81}, {'Text': 'reconstitution', 'Type': 'TREATMENT', 'BeginOffset': 303, 'EndOffset': 317}, {'Text': 'the vaccine', 'Type': 'TREATMENT', 'BeginOffset': 319, 'EndOffset': 330}, {'Text': 'the oral applicator', 'Type': 'TREATMENT', 'BeginOffset': 344, 'EndOffset': 363}, {'Text': 'the reconstituted vaccine', 'Type': 'TREATMENT', 'BeginOffset': 400, 'EndOffset': 425}, {'Id': 5, 'BeginOffset': 438, 'EndOffset': 453, 'Score': 0.5771782398223877, 'Text': 'within 24 hours', 'Category': 'TIME_EXPRESSION', 'Type': 'TIME_TO_TREATMENT_NAME', 'Traits': [], 'Attributes': [{'Type': 'TREATMENT_NAME', 'Score': 0.4930516183376312, 'RelationshipScore': 0.8103591799736023, 'RelationshipType': 'OVERLAP', 'Id': 3, 'BeginOffset': 418, 'EndOffset': 425, 'Text': 'vaccine', 'Category': 'TEST_TREATMENT_PROCEDURE', 'Traits': []}]}, {'Text': '24', 'Type': 'NUMBER', 'BeginOffset': 445, 'EndOffset': 447}, {'Text': 'these measures', 'Type': 'TREATMENT', 'BeginOffset': 621, 'EndOffset': 635}]}
{'Title': '6. contents of the pack and other information', 'Section_Content': "what rotarix contains - the active substances are: human rotavirus rix4414 strain (live, attenuated)* not less than 106.0 ccid50 *produced on vero cells - the other ingredients in rotarix are: powder: dextran, sucrose, sorbitol (see also section 2, rotarix contains sucrose and sorbitol), amino acids, dulbecco's modified eagle medium (dmem) solvent: calcium carbonate, xanthan gum, sterile water what rotarix looks like and contents of the pack powder and solvent for oral suspension rotarix is supplied as a whitish powder in a single dose glass container and a separate oral applicator of solvent which contains a slow settling white deposit and a colourless supernatant. there is also a transfer adapter which allows easy transfer of the solvent into the glass container containing the powder for mixing the different components of the vaccine. both components must be mixed together before your child receives the vaccine. the mixed vaccine will appear more turbid than the solvent alone. rotarix is available in a pack of 1, 5, 10 or 25. not all pack sizes may be marketed.", 'Entity_Recognition': [{'Text': 'rotarix', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'human rotavirus rix4414 strain', 'Type': 'PROBLEM', 'BeginOffset': 51, 'EndOffset': 81}, {'Text': '106.0', 'Type': 'NUMBER', 'BeginOffset': 116, 'EndOffset': 121}, {'Text': 'vero cells', 'Type': 'TREATMENT', 'BeginOffset': 142, 'EndOffset': 152}, {'Id': 0, 'BeginOffset': 180, 'EndOffset': 187, 'Score': 0.8643684983253479, 'Text': 'rotarix', 'Category': 'MEDICATION', 'Type': 'BRAND_NAME', 'Traits': [], 'Attributes': [{'Type': 'FORM', 'Score': 0.5641095042228699, 'RelationshipScore': 0.5063372850418091, 'RelationshipType': 'FORM', 'Id': 1, 'BeginOffset': 193, 'EndOffset': 199, 'Text': 'powder', 'Category': 'MEDICATION', 'Traits': []}]}, {'Id': 2, 'BeginOffset': 201, 'EndOffset': 208, 'Score': 0.5093938112258911, 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