VeraSeal
1 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 



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This medicinal product is subject to additional monitoring. This will allow quick identification of 
new safety information. Healthcare professionals are asked to report any suspected adverse reactions. 
See section 4.8 for how to report adverse reactions. 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
VeraSeal solutions for sealant 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Component 1: 
Human fibrinogen 80 mg/ml 
 
Component 2: 
Human thrombin 500 IU/ml 
 
Produced from the plasma of human donors. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Solutions for sealant. 
 
Frozen solutions. After thawing, the solutions are clear or slightly opalescent and colourless or pale 
yellow. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Supportive treatment in adults where standard surgical techniques are insufficient: 
 
- for improvement of haemostasis. 
- as suture support: in vascular surgery. 
 
4.2 Posology and method of administration 
 
The use of VeraSeal is restricted to experienced surgeons who have been trained in the use of this 
medicinal product. 
 
Posology 
 
The volume of VeraSeal to be applied and the frequency of application should always be oriented 
towards the underlying clinical needs for the patient. 
 
The dose to be applied is governed by variables including, but not limited to, the type of surgical 
intervention, the size of the area and the mode of intended application, and the number of applications. 
 
Application of the product must be individualised by the treating physician. In clinical trials, the 
individual dosages have typically ranged from 0.3 to 12 ml. For other procedures, larger volumes may 
be required. 
 



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The initial volume of the product to be applied at a chosen anatomic site or target surface area should 
be sufficient to entirely cover the intended application area. The application can be repeated, if 
necessary. 
 
Paediatric population 
The safety and efficacy of VeraSeal in children aged 0 to 18 years has not yet been established. 
Currently available data are described in section 5.1, but no recommendation on a posology can be 
made. 
 
Method of administration  
 
For epilesional use. 
 
For instructions on preparation of the medicinal product before administration, see section 6.6. The 
product should only be administered according to the instructions and with the devices recommended 
for this product (see section 6.6.). 
 
Prior to applying VeraSeal, the surface area of the wound needs to be dried by standard techniques 
(e.g. intermittent application of compresses, swabs, use of suction devices). 
 
For spray application, see sections 4.4 and 6.6 for specific recommendations on the required distance 
from tissue per surgical procedure. 
 
4.3 Contraindications 
 
VeraSeal must not be applied intravascularly. 
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
 
VeraSeal must not be used for the treatment of severe or brisk arterial bleeding. 
 
4.4 Special warnings and precautions for use 
 
Precautions for use 
 
For epilesional use only. Do not apply intravascularly. 
 
Life threatening thromboembolic complications may occur if the preparation is unintentionally applied 
intravascularly (see section 4.8). 
 
VeraSeal spray application should only be used if it is possible to accurately judge the spray distance, 
especially during laparoscopy. Spray distance from tissue should be within the range recommended by 
the marketing authorisation holder of VeraSeal (see section 6.6). 
 
When using accessory tips, the instructions for use of the tips should be followed. 
 
Before administration of VeraSeal, care must be taken that the parts of the body outside the desired 
application area are sufficiently protected (covered) to prevent tissue adhesion at undesired sites. 
 
VeraSeal should be applied as a thin layer. Excessive clot thickness may negatively interfere with the 
product’s efficacy and the wound healing process. 
 
Adequate data are not available to support the use of this product in tissue gluing, neurosurgery, 
application through a flexible endoscope for treatment of bleeding or in gastrointestinal anastomoses. 
 



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Hypersensitivity reactions 
 
As with any protein product, allergic type hypersensitivity reactions are possible. Signs of 
hypersensitivity reactions include hives, generalised urticaria, tightness of the chest, wheezing, 
hypotension, and anaphylaxis. If these symptoms occur, the administration must be discontinued 
immediately. In case of shock, standard medical treatment for shock should be implemented.  
 
Transmissible agents 
 
Standard measures to prevent infections resulting from the use of medicinal products prepared from 
human blood or plasma include selection of donors, screening of individual donations and plasma 
pools for specific markers of infection and the inclusion of effective manufacturing steps for the 
inactivation /removal of viruses. Despite this, when medicinal products prepared from human blood or 
plasma are administered, the possibility of transmitting infective agents cannot be totally excluded. 
This also applies to unknown or emerging viruses and other pathogens. 
 
The measures taken are considered effective for enveloped viruses such as human immunodeficiency 
virus (HIV), hepatitis B virus and hepatitis C virus, and for the non-enveloped hepatitis A virus. The 
measures taken may be of limited value against non-enveloped viruses such as parvovirus B19. 
Parvovirus B19 infection may be serious for pregnant women (foetal infection) and for individuals 
with immunodeficiency or increased erythropoiesis (e.g. haemolytic anaemia). 
 
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 
 
No formal interaction studies have been performed. Similar to comparable products or thrombin 
solutions, the product may be denatured after exposure to solutions containing alcohol, iodine or heavy 
metals (e.g. antiseptic solutions). Such substances should be removed to the greatest possible extent 
before applying the product.  
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy and breast-feeding 
 
The safety of fibrin sealant/haemostatic products for use in human pregnancy or breast-feeding has not 
been established in controlled clinical trials. Experimental animal studies are insufficient to assess the 
safety with respect to reproduction, development of the embryo or foetus, the course of gestation and 
peri- and post-natal development. Therefore, the product should be administered to pregnant and 
breast-feeding women only if clearly needed. 
 
Fertility 
 
Fertility studies have not been conducted. 
 
4.7 Effects on ability to drive and use machines 
 
Not relevant. 
 



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4.8 Undesirable effects 
 
Summary of the safety profile 
 
Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the 
application site, bronchospasm, chills, flushing, generalised urticaria, headache, hives, hypotension, 
lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) may 
occur in rare cases in patients treated with fibrin sealant/haemostatic products. In isolated cases, these 
reactions have progressed to severe anaphylaxis. Such reactions may especially be seen, if the 
preparation is applied repeatedly, or administered to patients known to be hypersensitive to 
constituents of the product.  
 
Antibodies against components of fibrin sealant/haemostatic products may occur rarely.  
 
Inadvertent intravascular injection could lead to thromboembolic event and disseminated intravascular 
coagulation (DIC), and there is also a risk of anaphylactic reaction (see section 4.4).  
 
For safety information with respect to transmissible agents, see section 4.4. 
 
Tabulated list of adverse reactions 
 
The table presented below is according to the MedDRA system organ classification (SOC and 
Preferred Term Level). 
 
Frequencies have been evaluated according to the following convention:  

- 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)  
- not known (cannot be estimated from the available data). 

 
Within each frequency grouping, adverse reactions are presented in order of decreasing of seriousness. 
 
Frequency of Adverse Reactions (ADRs) in clinical studies with VeraSeal:  
 
MedDRA System Organ 
Class (SOC) Adverse reaction Frequency 

Infections and infestations Abdominal abscess, cellulitis, liver 
abscess, peritonitis, postoperative 
wound infection, wound infection 
incision site infection, post procedural 
infection. 

Uncommon 

Neoplasms benign, malignant 
and unspecified (including 
cysts and polyps) 

Plasma cell myeloma Uncommon 

Blood and lymphatic system 
disorders 

Anaemia, haemorrhagic anaemia, 
leukocytosis, leukopenia 

Uncommon 

Immune system disorders Hypersensitivity* Unknown 
Metabolism and nutrition 
disorders  

Hyperglycaemia, hyperkalaemia, 
hypocalcaemia, hypoglycaemia, 
hypokalaemia, hypomagnesemia, 
hyponatraemia, hypoproteinaemia 

Uncommon 

Psychiatric disorders Anxiety, insomnia Uncommon 
Nervous system disorders Headache, somnolence Uncommon 



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MedDRA System Organ 
Class (SOC) Adverse reaction Frequency 

Eye disorders Conjunctival irritation Uncommon 
Cardiac disorders Atrial fibrillation, ventricular 

tachycardia 
Uncommon 

Vascular disorders 
 

Deep vein thrombosis, hypertension, 
hypotension 

Uncommon 

Respiratory, thoracic and 
mediastinal disorders 

Pulmonary embolism, dyspnoea, 
hypoxia, pleural effusion, pleurisy, 
pulmonary oedema, rhonchi, wheezing 

Uncommon 

Gastrointestinal disorders Nausea  Common 
Constipation, flatulence, ileus, 
retroperitoneal haematoma, vomiting  

Uncommon 

Skin and subcutaneous tissue 
disorders 

Pruritus 
 

Common 

Ecchymosis, erythema Uncommon 
Musculoskeletal and 
connective tissue disorders 

Back pain, pain in extremity Uncommon 

Renal and urinary disorders Bladder spasm, dysuria, urinary 
retention 

Uncommon 

General disorders and 
administration site conditions 

Chills, hyperthermia, oedema 
peripheral, pain, pyrexia, vessel 
puncture site haematoma 

Uncommon 

Investigations Parvovirus B19 test positive, activated 
partial thromboplastin time prolonged, 
alanine aminotransferase increased, 
aspartate aminotransferase increased, 
blood bilirubin increase, blood glucose 
increase, international normalised ratio 
increased, prothrombin time prolonged, 
transaminases increased, urine output 
decreased 

Uncommon 
 
 
 
 
 
 
 
 

Drug specific antibody present* Unknown 
Injury, poisoning and 
procedural complications 

Procedural pain Common 

Abdominal wound dehiscence, post 
procedural bile leak, contusion, incision 
site erythema, incision site pain, post 
procedural haemorrhage, procedural 
hypotension, vascular graft 
complication, vascular graft thrombosis, 
wound secretion 

Uncommon 

*All these reactions are class effect. None were reported in clinical trials; thus it is not possible 
to establish frequencies. 

 
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


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4.9 Overdose 
 
In the event of overdose, patients must be closely monitored for signs or symptoms of adverse 
reactions and appropriate symptomatic treatment and supportive measures instituted. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: Antihaemorrhagics, local hemostatics, ATC code: B02BC 
 
Mechanism of action 
 
The fibrin adhesion system initiates the last phase of physiological blood coagulation. Conversion of 
fibrinogen into fibrin occurs by the splitting of fibrinogen into fibrin monomers and fibrinopeptides. 
The fibrin monomers aggregate and form a fibrin clot. Factor XIIIa, which is activated from 
factor XIII by thrombin, crosslinks fibrin. Calcium ions are required for both, the conversion of 
fibrinogen and the crosslinkage of fibrin.  
 
As wound healing progresses, increased fibrinolytic activity is induced by plasmin and decomposition 
of fibrin to fibrin degradation products is initiated. 
 
Clinical efficacy and safety 
 
Randomized, single-blind clinical studies with VeraSeal were conducted in subjects undergoing 
vascular, parenchymous tissue and soft tissue surgery demonstrating haemostasis, and suture support 
in vascular surgery. 
 
During the vascular surgery study 225 subjects were enrolled and underwent vascular surgical 
procedures utilizing polytetrafluoroethylene graft material on end-to-side arterial anastomosis or on 
upper extremity vascular access arterial anastomosis. The mean age of the study population and its 
standard deviation was 63.2 (9.5) years. The most frequent surgery types were femoral-popliteal 
bypass grafting, upper extremity vascular access for hemodialysis, and ilio-femoral bypass grafting. 
VeraSeal was shown to be superior to the control group (manual compression) in achieving hemostasis 
by 4 minutes. The rate of hemostasis at the target bleeding site by 4 minutes was 76.1% in the 
VeraSeal treatment group and was 22.8% in the control group.  
 
During parenchymous tissue surgery study 325 subjects were enrolled and underwent liver resections. 
The mean age of the study population and its standard deviation was 57.9 (14.5) years. VeraSeal was 
shown to be superior to the control group (oxidized regenerated cellulose) in achieving hemostasis by 
4 minutes. The rate of hemostasis at the target bleeding site by 4 minutes was 92.8% in the VeraSeal 
treatment group and was 80.5% in the control group.  
 
During soft tissue surgery study 327 subjects were enrolled and underwent pelvic and retroperitoneal 
surgical procedures, and abdominoplasties and mastopexies. The mean age of the study population and 
its standard deviation was 47.2 (18.4) years. The most frequent surgery types were simple or radical 
hysterectomies, abdominoplasties, and radical cystectomies. VeraSeal was shown to be non-inferior to 
the control group (oxidized regenerated cellulose) in achieving hemostasis by 4 minutes. The rate of 
hemostasis at the target bleeding site by 4 minutes was 82.8% in the VeraSeal treatment group and 
was 77.8% in the control group.  
 
Paediatric population 
 
Eleven paediatric subjects aged 16 years or younger were treated with VeraSeal in the described 
clinical studies.  
 



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The European Medicines Agency has deferred the obligation to submit the results of studies with 
VeraSeal in one or more subsets of the paediatric population for the treatment of haemorrhage 
resulting from a surgical procedure as per paediatric investigational plan (PIP) decision, for the 
granted indication (see section 4.2 for information on paediatric use). 
 
5.2 Pharmacokinetic properties 
 
VeraSeal is intended for epilesional use only. Intravascular administration is contraindicated. 
Consequently, intravascular pharmacokinetic studies were not performed in man.  
 
Fibrin sealant/haemostatic products are metabolised in the same way as endogenous fibrin by 
fibrinolysis and phagocytosis.  
 
5.3 Preclinical safety data 
 
Non-clinical data reveal no special hazard for humans based on conventional studies of safety 
pharmacology and acute toxicity. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Human fibrinogen syringe 
 
Sodium citrate dihydrated 
Sodium chloride 
Arginine 
Isoleucine 
Glutamic acid monosodium 
Water for injections 
 
Human thrombin syringe 
 
Calcium chloride 
Human albumin 
Sodium chloride 
Glycine 
Water for injections 
 
6.2 Incompatibilities 
 
This medicinal product must not be mixed with other medicinal products.  
 
6.3 Shelf life 
 
2 years.  
 
After thawing, it can be maintained not more than 48 hours at 2ºC - 8ºC or 24 hours at room 
temperature (20ºC - 25ºC) before use if it remains sealed in the original packaging. 
 
In use shelf life: Once the blister is opened, VeraSeal should be used immediately. 
 
6.4 Special precautions for storage 
 
Store and transport in a freezer (at - 18 ºC or colder). The cold storage chain (- 18 ºC or colder) must 
not be interrupted until use. Keep the sterilized blister in the outer carton to protect from light. 



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Once thawed, do not refreeze. For storage conditions after thawing the medicinal product and after 
first opening, see section 6.3. 
 
6.5 Nature and contents of container  
 
VeraSeal is supplied as a single-use kit containing two pre-filled syringes (glass type I) with rubber 
stoppers, each with a sterile frozen solution, assembled in a syringe holder. 
 
One Dual Applicator with two additional Airless Spray Tips is supplied with the product, for 
application by spraying or dripping. The Airless Spray Tips are radiopaque. See scheme below. 

 
 
 
VeraSeal is available in the following pack sizes:  
- VeraSeal 2 ml (containing 1 ml of human fibrinogen and 1 ml of human thrombin)  
- VeraSeal 4 ml (containing 2 ml of human fibrinogen and 2 ml of human thrombin) 
- VeraSeal 6 ml (containing 3 ml of human fibrinogen and 3 ml of human thrombin) 
- VeraSeal 10 ml (containing 5 ml of human fibrinogen and 5 ml of human thrombin) 
 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal and other handling 
 
The instructions for use are also described in the healthcare professionals’ package leaflet part. 
 
Remove carton from freezer, open it and take out the two blisters. 
 
Place the blister containing the Dual Applicator at room temperature until the fibrin sealant is ready to 
use. 
 
• Room temperature thawing (preferred method) 

 
Thaw blister with VeraSeal pre-filled syringes at room temperature using the following steps: 
 
1. Place the blister containing the syringe holder with pre-filled syringes on a surface at 

room temperature (20 ºC – 25 ºC) 
 for approximately 70 minutes for the 2 ml and the 4 ml package sizes   
 for approximately 90 minutes for the 6 ml and the 10 ml package sizes 

 



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After thawing, it is not necessary to warm the product for its use. 
 
After thawing the solutions must be clear to slightly opalescent and colourless to pale yellow. 
Solutions that are cloudy or have deposits should not be used. 
 
Post-Thawing Storage 
 
After thawing, the kit containing the VeraSeal syringe holder with pre-filled syringes and Dual 
Applicator can be stored before use for not more than 48 hours in the refrigerator at 2 – 8 ºC or 
24 hours at room temperature (20 - 25 °C) if it remains sealed in the original packaging. Once 
the blisters are opened, use VeraSeal immediately and discard any unused contents.  
 
Once thawed, do not refreeze. 
 
Transferring instructions  
 
1. After thawing, remove the blister from surface at room temperature or from the 

refrigerator at 2 °C - 8 °C. 
2. Open the blister and make the VeraSeal syringe holder with pre-filled syringes available 

to a second person for transfer to the sterile field. The outside of the blister should not 
come in contact with the sterile field. See Figure 1. 

 

 
Figure 1 

 
• Sterile Water Bath (Quick Thawing)  

 
Thaw VeraSeal pre-filled syringes inside the sterile field in a sterile thermostatic water bath at a 
temperature not higher than 37 ºC using the following steps:  
 
NOTE: Once the VeraSeal blisters are opened, use the product immediately. Use sterile 
technique to avoid the possibility of contamination due to improper handling, and follow the 
steps below accurately. Do not remove the syringe luer cap until thawing is complete and the 
Dual Applicator is ready to be attached. 

  
 1.  Open the blister and make the VeraSeal syringe holder with pre-filled syringes available 

to a second person for transfer to the sterile field. The outside of the blister should not 
come in contact with the sterile field. See Figure 1. 

 2.  Place the syringe holder with pre-filled syringes directly into the sterile water bath 
ensuring that it is completely immersed in the water. See Figure 2.   

 3.  At 37 ºC, the time needed is approximately 5 minutes for the 2 ml, 4 ml, 6 ml, and 10 ml 
package sizes, but must not be left at this temperature for longer than 10 minutes.   
The temperature of the water bath must not exceed 37 ºC. 

 4.  Dry the syringe holder with pre-filled syringes after thawing, using a sterile surgical 
gauze. 



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Figure 2 

 
After thawing, the solutions must be clear to slightly opalescent and colorless to pale yellow. Do 
not use solutions that are cloudy or have deposits. 
 
Use VeraSeal immediately and discard any unused contents.  
 

• Connection instructions 
 
1. Open the blister and make the VeraSeal Dual Applicator and two additional Airless Spray 

Tips available to a second person for transfer to the sterile field. The outside of the blister 
should not come in contact with the sterile field. 

2. Hold the VeraSeal syringe holder with syringe luer caps pointed upward. See Figure 3. 
 3. Unscrew and discard the syringe luer cap of both fibrinogen and thrombin syringes. See 

Figure 3.  

  
Figure 3 

 
4. Hold the syringe holder with the luers pointed upward. To remove air bubbles from 

syringes, strike gently the side of the syringe holder one or two times while keeping the 
syringe holder in an upright position and lightly depress the plunger to eject air. See 
Figure 4. 



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Figure 4 
 

 5. Attach the Dual Applicator. See Figure 5. 
 NOTE: Do not depress plunger during attachment or prior to intended use because the 

two biologic components will pre-mix in the Airless Spray Tip, forming a fibrin clot that 
prevents dispensing. See Figure 6.  
 

 
 Figure 5 
 



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 Figure 6 
 
6. Tighten luer locks and ensure the Dual Applicator is firmly attached. The device is now 

ready to use. 
 

• Administration 
 
Apply VeraSeal using the syringe holder and plunger supplied. 
 
Apply VeraSeal using the Dual Applicator provided with the product. Other CE-marked 
applicator tips (including open surgery and laparoscopic use devices) intended for specific use 
with VeraSeal may also be used. When using the provided Dual Applicator, follow the 
connection instructions described above. When using other applicator tips, follow the 
instructions for use that are provided with the applicator tips. 
 

 Application by spraying 
 
1. Grasp and bend the Dual Applicator to the desired position. Tip will retain its shape. 
2. Position the Airless Spray Tip at least 2 cm away from the target tissue. Apply firm even 

pressure to the plunger to spray the fibrin sealant. Increase distance accordingly to 
achieve desired coverage of the target area. 

3. If expression is stopped for any reason, change the Airless Spray Tip. To change the 
Airless Spray Tip, remove the device from the patient and unscrew the used Airless Spray 
Tip. See Figure 7. Place the used Airless Spray Tip away from the spare Airless Spray 
Tips. Wipe the end of the applicator using dry or moist sterile surgical gauze. Then, 
connect a new Airless Spray Tip provided in the package and ensure it is firmly 
connected before use.  
NOTE: Red indicator will not be visible if Airless Spray Tip is properly connected. See 
Figure 8. 
NOTE: Do not continue pushing the plunger in an attempt to clear the fibrin clot within 
the Airless Spray Tip; otherwise the applicator may become unusable. 
NOTE: Do not trim the Dual Applicator to avoid exposing internal wire. 



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Figure 7 

 
Figure 8 
 

 Application by dripping 
 

1. Remove the Airless Spray Tip portion of the spray and drip tip by unscrewing the Airless 
Spray Tip. See Figure 7.  

2. Grasp and bend the drip tip to the desired position. Tip will retain its shape. 
3. During dripping, keep the end of the drip tip as close to the tissue surface as possible 

without touching the tissue during application.  
4. Apply individual drops to the surface area to be treated. To prevent uncontrolled clotting, 

allow the drops to separate from each other and from the end of the drip tip.  
 NOTE: Do not reconnect a used drip tip after it has been removed from the adapter; 

otherwise a clot may form inside the drip tip and the applicator may become unusable. 
 

• Disposal 
 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 
 

 
7. MARKETING AUTHORISATION HOLDER 
 
Instituto Grifols, S.A. 
Can Guasc, 2 - Parets del Vallès 
E-08150 Barcelona - Spain 
 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/17/1239/001-004 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 10 November 2017 
 
 



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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. 
 

http://www.ema.europa.eu/


16 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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 
 



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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)  
 
Instituto Grifols, S.A. 
Polígono Levante 
c/Can Guasc 2 
Barcelona 
08150 Parets del Vallès 
SPAIN 
 
Name and address of the manufacturer(s) responsible for batch release 
 
Instituto Grifols, S.A. 
Polígono Levante 
c/Can Guasc 2 
Barcelona 
08150 Parets del Vallès 
SPAIN 
 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
 
Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product 
Characteristics, section 4.2). 
 
• 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: 



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• 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.  
 

• Additional risk minimisation measures  
 
None 

 
 



19 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 



20 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 



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PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON [2 ml, 4 ml, 6 ml and 10 ml] 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
VeraSeal solutions for sealant  
 
human fibrinogen / human thrombin 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Component 1: 1 ml of human fibrinogen (80 mg/ml) 
Component 2: 1 ml of human thrombin (500 IU/ml) 
 
Component 1: 2 ml of human fibrinogen (80 mg/ml) 
Component 2: 2 ml of human thrombin (500 IU/ml) 
 
Component 1: 3 ml of human fibrinogen (80 mg/ml) 
Component 2: 3 ml of human thrombin (500 IU/ml) 
 
Component 1: 5 ml of human fibrinogen (80 mg/ml) 
Component 2: 5 ml of human thrombin (500 IU/ml) 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: 
human fibrinogen – Sodium citrate dihydrated, sodium chloride, arginine, isoleucine, glutamic acid 
monosodium, water for injections. 
human thrombin – Calcium chloride, human albumin, sodium chloride, glycine, water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solutions for sealant 
 
2 ml  
4 ml 
6 ml 
10 ml 
 
Two pre-filled syringes assembled in a syringe holder. 
1 Dual Applicator with 2 additional Airless Spray Tips. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Epilesional use. 
 
 



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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 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a freezer (-18 ºC or colder).  
  
Thaw completely before use. Do not refreeze once thawed.  
 
 
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 
 
Instituto Grifols, S.A. 
Can Guasc, 2 - Parets del Vallès 
E-08150 Barcelona 
Spain 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/17/1239/001 2 ml 
EU/1/17/1239/002 4 ml 
EU/1/17/1239/003 6 ml  
EU/1/17/1239/004 10 ml 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 



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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  
 



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PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING 
 
BLISTER LABEL [2 ml, 4 ml, 6 ml and 10 ml] 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
VeraSeal solutions for sealant  
 
human fibrinogen / human thrombin 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Component 1: 1 ml of human fibrinogen (80 mg/ml) 
Component 2: 1 ml of human thrombin (500 IU/ml) 
 
Component 1: 2 ml of human fibrinogen (80 mg/ml) 
Component 2: 2 ml of human thrombin (500 IU/ml) 
 
Component 1: 3 ml of human fibrinogen (80 mg/ml) 
Component 2: 3 ml of human thrombin (500 IU/ml) 
 
Component 1: 5 ml of human fibrinogen (80 mg/ml) 
Component 2: 5 ml of human thrombin (500 IU/ml) 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solutions for sealant 
2 ml  
4 ml 
6 ml  
10 ml  
 
Two pre-filled syringes assembled in a syringe holder. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Epilesional use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 



25 

8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a freezer (-18 ºC or colder).  
  
Thaw completely before use. Do not refreeze once thawed.  
 
 
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 
 
Instituto Grifols, S.A. 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
 
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 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 



26 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
SYRINGE LABEL – HUMAN FIBRINOGEN (1 ml, 2 ml, 3 ml and 5 ml) 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
VeraSeal solutions for sealant 
Component 1: Fibrinogen 80 mg/ml 
Epilesional use. 
 
 
2. METHOD OF ADMINISTRATION 
 
Read the package leaflet before use. 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
1 ml 
2 ml 
3 ml 
5 ml 
 
 
6. OTHER 
 
 
 



27 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
SYRINGE LABEL – HUMAN THROMBIN (1 ml, 2 ml, 3 ml and 5 ml) 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
VeraSeal solutions for sealant 
Component 2: Thrombin 500 IU/ml 
Epilesional use. 
 
 
2. METHOD OF ADMINISTRATION 
 
Read the package leaflet before use. 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
1 ml 
2 ml 
3 ml 
5 ml 
 
 
6. OTHER 



28 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 



29 

Package leaflet: Information for the user 
 

VeraSeal solutions for sealant 
human fibrinogen/human thrombin 

 
This medicine is subject to additional monitoring. This will allow quick identification of new 

safety information. You can help by reporting any side effects you may get. See the end of section 4 
for how to report side effects. 
 
Read all of this leaflet carefully before you start using this medicine 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. 
- If you get any side effects, talk to your doctor. This includes any possible side effects not listed 

in this leaflet. See section 4. 
 
What is in this leaflet 
 
1. What VeraSeal is and what it is used for  
2. What you need to know before you are treated with VeraSeal  
3. How VeraSeal is used 
4. Possible side effects  
5. How VeraSeal is stored 
6. Contents of the pack and other information 
 
 
1. What VeraSeal is and what it is used for 
 
VeraSeal contains human fibrinogen and human thrombin, two proteins extracted from the blood that 
form a clot when they are mixed together. 
 
VeraSeal is used as a sealant during surgical operations in adults. It is applied to the surface of 
bleeding tissue to reduce bleeding during and after the operation when standard surgical techniques are 
not sufficient. 
 
 
2. What you need to know before you are treated with VeraSeal  
 
Your surgeon must not treat you with VeraSeal 
 
- if you are allergic to human fibrinogen or human thrombin or any of the other ingredients of this 

medicine (listed in section 6). 
 
VeraSeal must not be applied inside blood vessels. 
 
VeraSeal must not be used to treat severe or rapid bleeding from an artery. 
 
Warnings and precautions  
 
Allergic reactions are possible. Signs of such reactions include hives, rash, tightness of the chest, 
wheezing, drop in blood pressure (e.g. light-headedness, fainting, blurred vision), and anaphylaxis (a 
severe reaction with a rapid onset). If these symptoms occur during surgery, the use of the medicine 
should be stopped immediately. 
 
VeraSeal spray application should only be used if it is possible to accurately judge the spray distance. 
The spray device should not be used closer than the recommended distance.  



30 

Special safety warning 
 
For medicines such as VeraSeal that are made from human blood or plasma, certain measures are 
taken to prevent infections being passed on to patients. These include carefully selecting blood and 
plasma donors to make sure those at risk of carrying infections are excluded, and testing each donation 
and pooled plasma for signs of virus/infections. Manufacturers also include steps in the processing of 
the blood or plasma that can inactivate or remove viruses. Despite these measures, when medicines 
prepared from human blood or plasma are administered, the possibility of passing on infection cannot 
be totally excluded. This also applies to any unknown or emerging viruses or other types of infections.  
 
The measures taken are considered effective for enveloped viruses such as human immunodeficiency 
virus (HIV), hepatitis B virus and hepatitis C virus, and for the non-enveloped hepatitis A virus. The 
measures taken may be of limited value against non-enveloped viruses such as parvovirus B19. 
Parvovirus B19 infection may be serious for pregnant women (fetal infection) and for individuals 
whose immune system is depressed or who have some types of anaemia (e.g. sickle cell disease or 
haemolytic anaemia). 
 
It is strongly recommended that every time you are treated with VeraSeal, the name and batch number 
of the medicine are recorded in order to maintain a record of the batches used. 
 
Children and adolescents 
 
VeraSeal is not recommended for use in children and adolescents under 18 years of age. 
 
Other medicines and VeraSeal 
 
The product may be affected after contacting solutions containing alcohol, iodine or heavy metals (e.g. 
antiseptic solutions). 
 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines. 
 
Pregnancy and breast-feeding 
 
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 
your doctor for advice before being treated with this medicine. Your doctor will decide whether you 
should be treated with VeraSeal. 
 
 
3. How VeraSeal is used  
 
The use of VeraSeal is restricted to experienced surgeons who have been trained in the use of 
VeraSeal. 
 
The surgeon will apply VeraSeal to the surface of blood vessels or to the tissue surface of internal 
organs using an application device during the course of the operation. This device allows equal 
amounts of the two components of VeraSeal to be administered at the same time, and ensures that they 
mix evenly, which is important for the sealant to work at its best. 
 
The amount of VeraSeal that will be applied depends on a number of factors, including the type of 
surgery, the size of the area to be treated during your operation and the way VeraSeal is applied. The 
surgeon will decide how much is appropriate, and will apply just enough to form a thin, even layer. If 
it does not seem to be enough, a second layer can be applied. 
 
 



31 

4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them.  
 
VeraSeal contains the component of fibrin sealant. Fibrin sealants may, in rare cases (up to 1 in 
1,000 people), cause an allergic reaction. If you experience an allergic reaction you might have one or 
more of the following symptoms: swelling under skin (angioedema), skin rash, hives or wheals 
(nettle-rash), tightness of the chest, chills, flushing, headache, low blood pressure, lethargy, nausea, 
restlessness, heart rate increase, tingling, vomiting or wheezing. In isolated cases, these reactions may 
progress to a severe allergic reaction. Allergic reactions may especially be seen if the preparation is 
applied repeatedly, or administered to patients known to be allergic to constituents of the product. If 
you experience any of these symptoms after surgery, you should immediately consult your doctor or 
surgeon. 
 
There is also a theoretical possibility that your immune system will produce proteins to attack 
VeraSeal and, that these may interfere with your blood clotting. The frequency of this type of event is 
not known. 
 
If this product is accidentally placed inside a blood vessel, it can lead to blood clots, including 
disseminated intravascular coagulation (DIC) (when blood clots form throughout the blood vessels in 
the body). There is also a risk of a severe allergic reaction. 
 
Side effects which were reported during clinical trials with VeraSeal included:  
 
Most serious side effects 
 
Uncommon (may affect up to 1 in 100 people): 
 
- Abdominal abscess (swollen area in abdomen caused by infection) 
- Abdominal wound dehiscence (wound breakdown due to incomplete healing) 
- Leak of bile (a liquid produced by the liver) after the procedure  
- Cellulitis (infection of the skin) 
- Deep vein thrombosis (blood clots in the blood vessels) 
- Liver abscess (swollen area in the liver caused by infection) 
- Peritonitis (inflammation of the wall of the abdomen) 
- Positive parvovirus B19 test (laboratory result showing infection with the virus) 
- Postoperative wound infection 
- Pulmonary embolism (blood clots in blood vessels in the lungs) 
- Wound infection 
 
 
Other side effects  
 
Common (may affect up to 1 in 10 people):  
 
- Nausea  
- Pain caused by the surgery 
- Pruritus (itching) 
 
Uncommon (may affect up to 1 in 100 people):  
 
- Anaemia (insufficiency of red blood cells) 
- Anxiety 
- Atrial fibrillation (irregular heartbeat) 
- Back pain 
- Bladder spasm 
- Chills 



32 

- Conjunctival irritation (eye irritation) 
- Constipation  
- Contusion (bruise) 
- Decreased urine output (reduced urine production) 
- Dyspnoea (difficulty in breathing) 
- Dysuria (pain or difficulty in urination) 
- Ecchymosis (bruising) 
- Erythema (reddening of the skin) 
- Flatulence 
- Headache 
- High body temperature 
- High or low blood pressure 
- High or low levels of white cells in blood 
- High potassium levels in blood 
- Ileus (obstruction of the intestine) 
- Impaired coagulation of blood 
- Incision site erythema (reddening of the skin at the incision site) 
- Incision site infection 
- Increased blood bilirubin 
- Increased levels of liver enzymes 
- Increased or decreased glucose levels in blood  
- Insomnia 
- Low blood pressure due to the procedure 
- Low calcium levels in blood 
- Low magnesium levels in blood 
- Low oxygen in blood 
- Low potassium levels in blood 
- Low protein levels in blood 
- Low red blood cell levels caused by blood loss 
- Low sodium levels in blood 
- Oedema peripheral (accumulation of fluid) 
- Pain, not specified 
- Pain at the incision site 
- Pain in extremity 
- Plasma cell myeloma (cancer of blood cells) 
- Pleural effusion (abnormal amount of fluid around the lung) 
- Pleurisy (inflammation of lungs wall) 
- Post procedural haemorrhage (bleeding after the procedure) 
- Post procedural infection (infection after the procedure) 
- Pulmonary oedema (excess of watery fluid in lungs)  
- Retroperitoneal haematoma (accumulation of blood in the abdomen) 
- Rhonchi (rattling lung sounds) 
- Sleepiness 
- Urinary retention 
- Vascular graft complication (complication of vessel bypass) 
- Vascular graft thrombosis (blood clots in blood vessel bypass) 
- Ventricular tachycardia (rapid heartbeats) 
- Vessel puncture site haematoma (bruising at site of vessel puncture) 
- Vomiting 
- Wheezing 
- Wound secretion 
 
Reporting of side effects 
If you get any side effects, talk to your doctor or surgeon. 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. 

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


33 

 
 
5. How VeraSeal is stored 
 
VeraSeal must be kept out of the sight and reach of children. 
 
This medicine must not be used after the expiry date which is stated on the label and carton after EXP.  
 
It must be stored in a freezer at -18 ºC or colder. The cold storage chain must not be interrupted until 
use. Keep the sterilized blister in the outer carton in order to protect from light. Thaw completely 
before use. Do not refreeze once thawed. After thawing, it can be maintained not more than 48 hours 
at 2 ºC - 8 ºC or 24 hours at room temperature (20 ºC - 25 ºC) before use. 
 
Once the blister is opened, VeraSeal should be used immediately. 
 
It must not be used if the solutions are cloudy or have deposits. 
 
Discard if the package is damaged. 
 
 
6. Contents of the pack and other information 
 
What VeraSeal contains  
 
The active substances are: 
- Component 1: Human fibrinogen 
- Component 2: Human thrombin 
 
The other ingredients are: 
- Component 1: Sodium citrate dihydrated, sodium chloride, arginine, isoleucine, glutamic acid 

monosodium, water for injections. 
- Component 2: Calcium chloride, human albumin, sodium chloride, glycine, water for injections. 
 
What VeraSeal looks like and contents of the pack 
 
VeraSeal is presented as solutions for sealant. It is supplied as a single-use kit containing two 
pre-filled syringes assembled in a syringe holder. Frozen solutions. After thawing the solutions are 
clear or slightly opalescent and colourless or pale yellow. 
 
One Dual Applicator with two additional Airless Spray Tips is supplied with the product, for 
application by spraying or dripping. The Airless Spray Tips are radiopaque. See scheme below. 
 



34 

 
 
 
VeraSeal is available in the following pack sizes:  
- VeraSeal 2 ml (containing 1 ml of human fibrinogen and 1 ml of human thrombin)  
- VeraSeal 4 ml (containing 2 ml of human fibrinogen and 2 ml of human thrombin) 
- VeraSeal 6 ml (containing 3 ml of human fibrinogen and 3 ml of human thrombin) 
- VeraSeal 10 ml (containing 5 ml of human fibrinogen and 5 ml of human thrombin) 
 
Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder and Manufacturer 
 
Instituto Grifols, S.A. 
Can Guasc, 2 - Parets del Vallès 
E-08150 Barcelona - Spain 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
AT/BE/BG/CY/EE/EL/ES/HR/HU/IE/LV/ 
LT/LU/MT/NL/RO/SI/SK 
Instituto Grifols, S.A. 
Tel: +34 93 571 01 00 
 

CZ 
Grifols S.R.O. 
Tel: +4202 2223 1415 
 

DE 
Grifols Deutschland GmbH 
Tel: +49 69 660 593 100 
 

DK/FI/IS/NO/SE 
Grifols Nordic AB 
Tel: +46 8 441 89 50 

FR 
Grifols France 
Tél: +33 (0)1 53 53 08 70 
 

IT 
Grifols Italia S.p.A. 
Tel: +39 050 8755 113 

PL 
Grifols Polska Sp. z o. o. 
Tel: +48 22 378 85 60 
 

PT 
Grifols Portugal, Lda. 
Tel: +351 219 255 200 

UK 
Grifols UK Ltd. 
Tel: +44 845 2413090 

 



35 

 
 
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: 
 
Posology and method of administration 
 
The use of VeraSeal is restricted to experienced surgeons who have been trained in the use of this 
medicinal product. 
 
The volume of VeraSeal to be applied and the frequency of application should always be oriented 
towards the underlying clinical needs for the patient. 
 
The dose to be applied is governed by variables including, but not limited to, the type of surgical 
intervention, the size of the area and the mode of intended application, and the number of applications. 
 
Application of the product must be individualised by the treating physician. In clinical trials, the 
individual dosages have typically ranged from 0.3 to 12 ml. For other procedures, larger volumes may 
be required. 
 
The initial volume of the product to be applied at a chosen anatomic site or target surface area should 
be sufficient to entirely cover the intended application area. VeraSeal should be applied as a thin layer. 
The application can be repeated, if necessary. 
 
Incompatibilities 
 
This medicinal product must not be mixed with other medicinal products. 
 
Special precautions 
 
For epilesional use only. Do not apply intravascularly. 
Life threatening thromboembolic complications may occur if the preparation is unintentionally applied 
intravascularly. 
 
When using accessory tips, the instructions for use of the tips should be followed. 
 
Before administration of VeraSeal, care must be taken that the parts of the body outside the desired 
application area are sufficiently protected (covered) to prevent tissue adhesion at undesired sites. 
 
VeraSeal should be applied as a thin layer. Excessive clot thickness may negatively interfere with the 
product’s efficacy and the wound healing process. 
 
Instructions for use 
 
Read this leaflet before you open the package. Please see pictograms at the end of this leaflet. 
 

http://www.ema.europa.eu/


36 

Handling of VeraSeal 
 
VeraSeal comes ready to use in sterilized packages and must be handled using sterile technique in 
aseptic conditions. Discard damaged packages as re-sterilisation is not possible. 
 
Remove carton from freezer, open it and take out the two blisters. 
 
Place the blister containing the Dual Applicator at room temperature until the fibrin sealant is ready to 
use. 
 
• Room temperature thawing (preferred method) 

 
Thaw blister with VeraSeal pre-filled syringes at room temperature using the following steps: 
 
1. Place the blister containing the syringe holder with pre-filled syringes on a surface at 

room temperature (20 ºC – 25 ºC) 
 for approximately 70 minutes for the 2 ml and the 4 ml package sizes   
 for approximately 90 minutes for the 6 ml and the 10 ml package sizes 
 

After thawing, it is not necessary to warm the product for its use. 
 

After thawing the solutions must be clear to slightly opalescent and colourless to pale yellow. 
Solutions that are cloudy or have deposits should not be used. 
 
Post-Thawing Storage 
 
After thawing, the kit containing the VeraSeal syringe holder with pre-filled syringes and Dual 
Applicator can be stored before use for not more than 48 hours in the refrigerator at 2 – 8 ºC or 
24 hours at room temperature (20 - 25 °C) if it remains sealed in the original packaging. Once 
the blisters are opened, use VeraSeal immediately and discard any unused contents.  
 
Once thawed, do not refreeze. 
 
Transferring instructions 
 
1. After thawing, remove the blister from the surface at room temperature or from the 

refrigerator at 2 °C - 8 °C. 
2. Open the blister and make the VeraSeal syringe holder with pre-filled syringes available 

to a second person for transfer to the sterile field. The outside of the blister should not 
come in contact with the sterile field. See Figure 1. 

 
• Sterile Water Bath (Quick Thawing)  

 
Thaw VeraSeal pre-filled syringes inside the sterile field in a sterile thermostatic water bath at a 
temperature not higher than 37 ºC using the following steps:  
 
NOTE: Once the VeraSeal blisters are opened, use the product immediately. Use sterile 
technique to avoid the possibility of contamination due to improper handling, and follow the 
steps below accurately. Do not remove the syringe luer cap until thawing is complete and the 
Dual Applicator is ready to be attached.  
 

 1.  Open the blister and make the VeraSeal syringe holder with pre-filled syringes available 
to a second person for transfer to the sterile field. The outside of the blister should not 
come in contact with the sterile field. See Figure 1. 

 2.  Place the syringe holder with pre-filled syringes directly into the sterile water bath 
ensuring that it is completely immersed in the water. See Figure 2.   



37 

 3.  At 37 ºC, the time needed is approximately 5 minutes for the 2 ml, 4 ml, 6 ml, and 10 ml 
package sizes, but must not be left at this temperature for longer than 10 minutes.   
The temperature of the water bath must not exceed 37 ºC. 

 4.  Dry the syringe holder with pre-filled syringes after thawing, using a sterile surgical 
gauze. 

 
After thawing, the solutions must be clear to slightly opalescent and colorless to pale yellow. Do 
not use solutions that are cloudy or have deposits. 

 
Use VeraSeal immediately and discard any unused contents.  
 

• Connection instructions 
 
1. Open the blister and make the VeraSeal Dual Applicator and two additional Airless Spray 

Tips available to a second person for transfer to the sterile field. The outside of the blister 
should not come in contact with the sterile field. 

2. Hold the VeraSeal syringe holder with syringe luer caps pointed upward. See Figure 3. 
 3. Unscrew and discard the syringe luer cap of both fibrinogen and thrombin syringes. See 

Figure 3.  
4. Hold the syringe holder with the luers pointed upward. To remove air bubbles from 

syringes, strike gently the side of the syringe holder one or two times while keeping the 
syringe holder in an upright position and lightly depress the plunger to eject air. See 
Figure 4. 

5. Attach the Dual Applicator. See Figure 5. 
 NOTE: Do not depress plunger during attachment or prior to intended use because the 

two biologic components will pre-mix in the Airless Spray Tip, forming a fibrin clot that 
prevents dispensing. See Figure 6.  

6. Tighten luer locks and ensure the Dual Applicator is firmly attached. The device is now 
ready to use. 

 
• Administration 

 
Apply VeraSeal using the syringe holder and plunger supplied. 
 
Apply VeraSeal using the Dual Applicator provided with the product. Other CE-marked 
applicator tips (including open surgery and laparoscopic use devices) intended for specific use 
with VeraSeal may also be used. When using the provided Dual Applicator, follow the 
connection instructions described above. When using other applicator tips, follow the 
instructions for use that are provided with the applicator tips. 

 
 Application by spraying 

 
1. Grasp and bend the Dual Applicator to the desired position. Tip will retain its shape. 
2. Position the Airless Spray Tip at least 2 cm away from the target tissue. Apply firm even 

pressure to the plunger to spray the fibrin sealant. Increase distance accordingly to 
achieve desired coverage of the target area. 

3. If expression is stopped for any reason, change the Airless Spray Tip. To change the 
Airless Spray Tip, remove the device from the patient and unscrew the used Airless Spray 
Tip. See Figure 7. Place the used Airless Spray Tip away from the spare Airless Spray 
Tips. Wipe the end of the applicator using dry or moist sterile surgical gauze. Then, 
connect a new Airless Spray Tip provided in the package and ensure it is firmly 
connected before use.  
NOTE: Red indicator will not be visible if Airless Spray Tip is properly connected. See 
Figure 8. 
NOTE: Do not continue pushing the plunger in an attempt to clear the fibrin clot within 
the Airless Spray Tip; otherwise the applicator may become unusable. 



38 

NOTE: Do not trim the Dual Applicator to avoid exposing internal wire. 
 
 Application by dripping 
 

1. Remove the Airless Spray Tip portion of the spray and drip tip by unscrewing the Airless 
Spray Tip. See Figure 7.  

2. Grasp and bend the drip tip to the desired position. Tip will retain its shape. 
3. During dripping, keep the end of the drip tip as close to the tissue surface as possible 

without touching the tissue during application.  
4. Apply individual drops to the surface area to be treated. To prevent uncontrolled clotting, 

allow the drops to separate from each other and from the end of the drip tip.  
 NOTE: Do not reconnect a used drip tip after it has been removed from the adapter; 

otherwise a clot may form inside the drip tip and the applicator may become unusable. 
 
• Disposal 

 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 
 

 
 
 

 
Figure 1 

 
 

 
Figure 2 

 



39 

 
Figure 3 

 
 

 
 Figure 4 

 
 

 
 Figure 5 
 



40 

 
 Figure 6 
 

 

 
Figure 7 
 
 

 
Figure 8 

 


	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 veraseal is and what it is used for', 'Section_Content': 'veraseal contains human fibrinogen and human thrombin, two proteins extracted from the blood that form a clot when they are mixed together. veraseal is used as a sealant during surgical operations in adults. it is applied to the surface of bleeding tissue to reduce bleeding during and after the operation when standard surgical techniques are not sufficient.', 'Entity_Recognition': [{'Text': 'veraseal', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'veraseal', 'Type': 'TREATMENT', 'BeginOffset': 0, 'EndOffset': 8}, {'Id': 0, 'BeginOffset': 18, 'EndOffset': 34, 'Score': 0.6006589531898499, 'Text': 'human fibrinogen', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Id': 1, 'BeginOffset': 39, 'EndOffset': 53, 'Score': 0.9547887444496155, 'Text': 'human thrombin', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Text': 'two proteins', 'Type': 'PROBLEM', 'BeginOffset': 55, 'EndOffset': 67}, {'Text': 'a clot', 'Type': 'PROBLEM', 'BeginOffset': 103, 'EndOffset': 109}, {'Text': 'veraseal', 'Type': 'TREATMENT', 'BeginOffset': 140, 'EndOffset': 148}, {'Text': 'a sealant during surgical operations', 'Type': 'TREATMENT', 'BeginOffset': 160, 'EndOffset': 196}, {'Text': 'bleeding tissue', 'Type': 'PROBLEM', 'BeginOffset': 240, 'EndOffset': 255}, {'Id': 4, 'BeginOffset': 266, 'EndOffset': 274, 'Score': 0.8975319266319275, 'Text': 'bleeding', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': []}, {'Text': 'the operation', 'Type': 'TREATMENT', 'BeginOffset': 292, 'EndOffset': 305}, {'Text': 'standard surgical techniques', 'Type': 'TREATMENT', 'BeginOffset': 311, 'EndOffset': 339}]}
{'Title': '2. what you need to know before you are treated with veraseal', 'Section_Content': 'your surgeon must not treat you with veraseal - if you are allergic to human fibrinogen or human thrombin or any of the other ingredients of this medicine (listed in section 6). veraseal must not be applied inside blood vessels. veraseal must not be used to treat severe or rapid bleeding from an artery. warnings and precautions allergic reactions are possible. signs of such reactions include hives, rash, tightness of the chest, wheezing, drop in blood pressure (e.g. light-headedness, fainting, blurred vision), and anaphylaxis (a severe reaction with a rapid onset). if these symptoms occur during surgery, the use of the medicine should be stopped immediately. veraseal spray application should only be used if it is possible to accurately judge the spray distance. the spray device should not be used closer than the recommended distance. special safety warning for medicines such as veraseal that are made from human blood or plasma, certain measures are taken to prevent infections being passed on to patients. these include carefully selecting blood and plasma donors to make sure those at risk of carrying infections are excluded, and testing each donation and pooled plasma for signs of virus/infections. manufacturers also include steps in the processing of the blood or plasma that can inactivate or remove viruses. despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of passing on infection cannot be totally excluded. this also applies to any unknown or emerging viruses or other types of infections. the measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (hiv), hepatitis b virus and hepatitis c virus, and for the non-enveloped hepatitis a virus. the measures taken may be of limited value against non-enveloped viruses such as parvovirus b19. parvovirus b19 infection may be serious for pregnant women (fetal infection) and for individuals whose immune system is depressed or who have some types of anaemia (e.g. sickle cell disease or haemolytic anaemia). it is strongly recommended that every time you are treated with veraseal, the name and batch number of the medicine are recorded in order to maintain a record of the batches used. children and adolescents veraseal is not recommended for use in children and adolescents under 18 years of age. other medicines and veraseal the product may be affected after contacting solutions containing alcohol, iodine or heavy metals (e.g. antiseptic solutions). tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. pregnancy and breast-feeding if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before being treated with this medicine. your doctor will decide whether you should be treated with veraseal.', 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{'Title': '3. how veraseal is used', 'Section_Content': 'the use of veraseal is restricted to experienced surgeons who have been trained in the use of veraseal. the surgeon will apply veraseal to the surface of blood vessels or to the tissue surface of internal organs using an application device during the course of the operation. this device allows equal amounts of the two components of veraseal to be administered at the same time, and ensures that they mix evenly, which is important for the sealant to work at its best. the amount of veraseal that will be applied depends on a number of factors, including the type of surgery, the size of the area to be treated during your operation and the way veraseal is applied. the surgeon will decide how much is appropriate, and will apply just enough to form a thin, even layer. if it does not seem to be enough, a second layer can be applied.', 'Entity_Recognition': [{'Text': 'veraseal', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Id': 0, 'BeginOffset': 154, 'EndOffset': 167, 'Score': 0.6952092051506042, 'Text': 'blood vessels', 'Category': 'ANATOMY', 'Type': 'SYSTEM_ORGAN_SITE', 'Traits': []}, {'Id': 1, 'BeginOffset': 178, 'EndOffset': 184, 'Score': 0.4251849353313446, 'Text': 'tissue', 'Category': 'ANATOMY', 'Type': 'SYSTEM_ORGAN_SITE', 'Traits': []}, {'Id': 2, 'BeginOffset': 196, 'EndOffset': 211, 'Score': 0.4562456011772156, 'Text': 'internal organs', 'Category': 'ANATOMY', 'Type': 'SYSTEM_ORGAN_SITE', 'Traits': []}, {'Text': 'an application device', 'Type': 'TREATMENT', 'BeginOffset': 218, 'EndOffset': 239}, {'Text': 'the operation', 'Type': 'TREATMENT', 'BeginOffset': 261, 'EndOffset': 274}, {'Text': 'this device', 'Type': 'TREATMENT', 'BeginOffset': 276, 'EndOffset': 287}, {'Text': 'veraseal', 'Type': 'TREATMENT', 'BeginOffset': 334, 'EndOffset': 342}, {'Text': 'veraseal', 'Type': 'TREATMENT', 'BeginOffset': 484, 'EndOffset': 492}, {'Id': 4, 'BeginOffset': 568, 'EndOffset': 575, 'Score': 0.920628547668457, 'Text': 'surgery', 'Category': 'TEST_TREATMENT_PROCEDURE', 'Type': 'PROCEDURE_NAME', 'Traits': []}, {'Text': 'your operation', 'Type': 'TREATMENT', 'BeginOffset': 619, 'EndOffset': 633}, {'Text': 'the way veraseal', 'Type': 'TREATMENT', 'BeginOffset': 638, 'EndOffset': 654}, {'Text': 'a second layer', 'Type': 'TREATMENT', 'BeginOffset': 805, 'EndOffset': 819}]}
{'Title': '4. possible side effects', 'Section_Content': 'like all medicines, this medicine can cause side effects, although not everybody gets them. veraseal contains the component of fibrin sealant. fibrin sealants may, in rare cases (up to 1 in 1,000 people), cause an allergic reaction. if you experience an allergic reaction you might have one or more of the following symptoms: swelling under skin (angioedema), skin rash, hives or wheals (nettle-rash), tightness of the chest, chills, flushing, headache, low blood pressure, lethargy, nausea, restlessness, heart rate increase, tingling, vomiting or wheezing. in isolated cases, these reactions may progress to a severe allergic reaction. allergic reactions may especially be seen if the preparation is applied repeatedly, or administered to patients known to be allergic to constituents of the product. if you experience any of these symptoms after surgery, you should immediately consult your doctor or surgeon. there is also a theoretical possibility that your immune system will produce proteins to attack veraseal and, that these may interfere with your blood clotting. the frequency of this type of event is not known. if this product is accidentally placed inside a blood vessel, it can lead to blood clots, including disseminated intravascular coagulation (dic) (when blood clots form throughout the blood vessels in the body). there is also a risk of a severe allergic reaction. side effects which were reported during clinical trials with veraseal included: most serious side effects uncommon (may affect up to 1 in 100 people): - abdominal abscess (swollen area in abdomen caused by infection) - abdominal wound dehiscence (wound breakdown due to incomplete healing) - leak of bile (a liquid produced by the liver) after the procedure - cellulitis (infection of the skin) - deep vein thrombosis (blood clots in the blood vessels) - liver abscess (swollen area in the liver caused by infection) - peritonitis (inflammation of the wall of the abdomen) - positive parvovirus b19 test (laboratory result showing infection with the virus) - postoperative wound infection - pulmonary embolism (blood clots in blood vessels in the lungs) - wound infection other side effects common (may affect up to 1 in 10 people): - nausea - pain caused by the surgery - pruritus (itching) uncommon (may affect up to 1 in 100 people): - anaemia (insufficiency of red blood cells) - anxiety - atrial fibrillation (irregular heartbeat) - back pain - bladder spasm - chills 32 - conjunctival irritation (eye irritation) - constipation - contusion (bruise) - decreased urine output (reduced urine production) - dyspnoea (difficulty in breathing) - dysuria (pain or difficulty in urination) - ecchymosis (bruising) - erythema (reddening of the skin) - flatulence - headache - high body temperature - high or low blood pressure - high or low levels of white cells in blood - high potassium levels in blood - ileus (obstruction of the intestine) - impaired coagulation of blood - incision site erythema (reddening of the skin at the incision site) - incision site infection - increased blood bilirubin - increased levels of liver enzymes - increased or decreased glucose levels in blood - insomnia - low blood pressure due to the procedure - low calcium levels in blood - low magnesium levels in blood - low oxygen in blood - low potassium levels in blood - low protein levels in blood - low red blood cell levels caused by blood loss - low sodium levels in blood - oedema peripheral (accumulation of fluid) - pain, not specified - pain at the incision site - pain in extremity - plasma cell myeloma (cancer of blood cells) - pleural effusion (abnormal amount of fluid around the lung) - pleurisy (inflammation of lungs wall) - post procedural haemorrhage (bleeding after the procedure) - post procedural infection (infection after the procedure) - pulmonary oedema (excess of watery fluid in lungs) - retroperitoneal haematoma (accumulation of blood in the abdomen) - rhonchi (rattling lung sounds) - sleepiness - urinary retention - vascular graft complication (complication of vessel bypass) - vascular graft thrombosis (blood clots in blood vessel bypass) - ventricular tachycardia (rapid heartbeats) - vessel puncture site haematoma (bruising at site of vessel puncture) - vomiting - wheezing - wound secretion reporting of side effects if you get any side effects, talk to your doctor or surgeon. 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': 'veraseal', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'all medicines', 'Type': 'TREATMENT', 'BeginOffset': 5, 'EndOffset': 18}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 20, 'EndOffset': 33}, {'Id': 17, 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{'Title': '5. how veraseal is stored', 'Section_Content': 'veraseal must be kept out of the sight and reach of children. this medicine must not be used after the expiry date which is stated on the label and carton after exp. it must be stored in a freezer at -18 ºc or colder. the cold storage chain must not be interrupted until use. keep the sterilized blister in the outer carton in order to protect from light. thaw completely before use. do not refreeze once thawed. after thawing, it can be maintained not more than 48 hours at 2 ºc - 8 ºc or 24 hours at room temperature (20 ºc - 25 ºc) before use. once the blister is opened, veraseal should be used immediately. it must not be used if the solutions are cloudy or have deposits. discard if the package is damaged.', 'Entity_Recognition': [{'Text': 'veraseal', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'veraseal', 'Type': 'TREATMENT', 'BeginOffset': 0, 'EndOffset': 8}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 62, 'EndOffset': 75}, {'Text': '-18', 'Type': 'NUMBER', 'BeginOffset': 200, 'EndOffset': 203}, {'Text': 'the cold storage chain', 'Type': 'TREATMENT', 'BeginOffset': 218, 'EndOffset': 240}, {'Text': 'the sterilized blister in the outer carton', 'Type': 'TREATMENT', 'BeginOffset': 281, 'EndOffset': 323}, {'Text': '48', 'Type': 'NUMBER', 'BeginOffset': 463, 'EndOffset': 465}, {'Text': '2', 'Type': 'NUMBER', 'BeginOffset': 475, 'EndOffset': 476}, {'Text': '8', 'Type': 'NUMBER', 'BeginOffset': 482, 'EndOffset': 483}, {'Text': '24', 'Type': 'NUMBER', 'BeginOffset': 490, 'EndOffset': 492}, {'Text': '25', 'Type': 'NUMBER', 'BeginOffset': 528, 'EndOffset': 530}, {'Text': 'the blister', 'Type': 'PROBLEM', 'BeginOffset': 552, 'EndOffset': 563}, {'Text': 'veraseal', 'Type': 'TREATMENT', 'BeginOffset': 575, 'EndOffset': 583}, {'Text': 'cloudy', 'Type': 'PROBLEM', 'BeginOffset': 653, 'EndOffset': 659}, {'Text': 'deposits', 'Type': 'PROBLEM', 'BeginOffset': 668, 'EndOffset': 676}]}
{'Title': '6. contents of the pack and other information', 'Section_Content': 'what veraseal contains the active substances are: - component 1: human fibrinogen - component 2: human thrombin the other ingredients are: - component 1: sodium citrate dihydrated, sodium chloride, arginine, isoleucine, glutamic acid monosodium, water for injections. - component 2: calcium chloride, human albumin, sodium chloride, glycine, water for injections. what veraseal looks like and contents of the pack veraseal is presented as solutions for sealant. it is supplied as a single-use kit containing two pre-filled syringes assembled in a syringe holder. frozen solutions. after thawing the solutions are clear or slightly opalescent and colourless or pale yellow. one dual applicator with two additional airless spray tips is supplied with the product, for application by spraying or dripping. the airless spray tips are radiopaque. see scheme below. veraseal is available in the following pack sizes: - veraseal 2 ml (containing 1 ml of human fibrinogen and 1 ml of human thrombin) - veraseal 4 ml (containing 2 ml of human fibrinogen and 2 ml of human thrombin) - veraseal 6 ml (containing 3 ml of human fibrinogen and 3 ml of human thrombin) - veraseal 10 ml (containing 5 ml of human fibrinogen and 5 ml of human thrombin) not all pack sizes may be marketed.', 'Entity_Recognition': [{'Text': 'veraseal', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': '1', 'Type': 'NUMBER', 'BeginOffset': 62, 'EndOffset': 63}, {'Text': 'human fibrinogen', 'Type': 'TEST', 'BeginOffset': 65, 'EndOffset': 81}, {'Text': '2', 'Type': 'NUMBER', 'BeginOffset': 94, 'EndOffset': 95}, {'Id': 0, 'BeginOffset': 97, 'EndOffset': 111, 'Score': 0.4897136688232422, 'Text': 'human thrombin', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Text': '1', 'Type': 'NUMBER', 'BeginOffset': 151, 'EndOffset': 152}, {'Id': 1, 'BeginOffset': 154, 'EndOffset': 179, 'Score': 0.981395423412323, 'Text': 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