Ucedane
1 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 



2 
 

1. NAME OF THE MEDICINAL PRODUCT 
 
Ucedane 200 mg dispersible tablets 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each tablet contains 200 mg of carglumic acid. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Dispersible tablet. 
The tablets are rod-shaped, white and biconvex with three score lines on both sides and engraving 
“L/L/L/L” on one side. 
The tablet can be divided into four equal doses. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Ucedane is indicated in treatment of hyperammonaemia due to N-acetylglutamate synthase primary 
deficiency. 
 
4.2 Posology and method of administration 
 
Ucedane treatment should be initiated under the supervision of a physician experienced in the 
treatment of metabolic disorders. 
 
Posology 
 
Based on clinical experience, the treatment may be started as early as the first day of life. The initial 
daily dose should be 100 mg/kg, up to 250 mg/kg if necessary. 
It should then be adjusted individually in order to maintain normal ammonia plasma levels (see 
section 4.4). 
In the long term, it may not be necessary to increase the dose according to body weight as long 
as adequate metabolic control is achieved; daily doses range from 10 mg/kg to 100 mg/kg. 
 
Carglumic acid responsiveness test 
It is recommended to test individual responsiveness to carglumic acid before initiating any long 
term treatment. As examples: 
- In a comatose child, start with a dose of 100 to 250 mg/kg/day and measure ammonia plasma 

concentration at least before each administration; it should normalise within a few hours 
after starting Ucedane. 

- In a patient with moderate hyperammonaemia, administer a test dose of 100 to 
200 mg/kg/day for 3 days with a constant protein intake and perform repeated 
determinations of ammonia plasma concentration (before and 1 hour after a meal); adjust 
the dose in order to maintain normal ammonia plasma levels. 

 
Method of administration 
 
This medicine is for oral use ONLY (ingestion or via nasogastric tube using a syringe, if necessary). 
 



3 
 

Based on pharmacokinetic data and clinical experience, it is recommended to divide the total daily 
dose into two to four intakes to be given before meals or feedings. The breaking of the tablets in 
halves allows most of the required posology adjustments. Occasionally, the use of quarter tablets may 
also be useful to adjust the posology prescribed by the physician.  
 
The tablets must be dispersed in a minimum of 5-10 mL of water and ingested immediately or 
administered by fast push through a syringe via a nasogastric tube. 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
Breast-feeding during the use of carglumic acid is contraindicated (see sections 4.6 and 5.3). 
 
4.4 Special warnings and precautions for use 
 
Therapeutic monitoring 
Plasma levels of ammonia and amino acids should be maintained within normal limits. 
As very few data on the safety of carglumic acid are available, systematic surveillance of liver, 
renal, cardiac functions and haematological parameters is recommended. 
 
Nutritional management 
Protein restriction and arginine supplementation may be indicated in case of low protein 
tolerance. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
No specific interaction studies have been performed. 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
For carglumic acid no clinical data on exposed pregnancies are available. 
Animal studies have revealed minimal developmental toxicity (see section 5.3). Caution should 
be exercised when prescribing to pregnant women. 
 
Breast-feeding 
Although it is not known whether carglumic acid is secreted into human milk, it has been 
shown to be present in the milk of lactating rats (see section 5.3). Therefore, breast-feeding during 
the use of carglumic acid is contraindicated (see section 4.3). 
 
4.7 Effects on ability to drive and use machines 
 
No studies on the effects on the ability to drive and use machines have been performed. 
 
4.8 Undesirable effects 
 
Reported adverse reactions are listed below, by system organ class and by frequency. Frequencies 
are defined as: very common (≥1/10), common (≥1/100 to <1/10) and uncommon (≥1/1,000 to 
<1/100) 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, undesirable effects are presented in order of decreasing 
seriousness. 
 

System Organ Class Frequency Adverse reaction 



4 
 

Cardiac disorders Uncommon bradycardia 

Gastrointestinal disorders Uncommon diarrhea, vomiting 

Skin and subcutaneous tissue 
disorders 

Common increased sweating 

Not known rash 

General disorders and 
Administration site conditions Uncommon pyrexia 

Investigations Uncommon increased transaminases 
 
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 
 
In one patient treated with carglumic acid, where the dose was increased up to 750 mg/kg/day, 
symptoms of intoxication occurred which can be characterised as a sympathomimetic reaction: 
tachycardia, profuse sweating, increased bronchial secretion, increased body temperature and 
restlessness. These symptoms resolved once the dose was reduced. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1  Pharmacodynamic properties 
 
Pharmacotherapeutic group: Amino acids and derivatives; ATC code: A16AA05. 
 
Mechanism of action 
Carglumic acid is a structural analogue of N-acetylglutamate, which is the naturally occurring 
activator of carbamoyl phosphate synthetase, the first enzyme of the urea cycle. 
Carglumic acid has been shown in vitro to activate liver carbamoyl phosphate synthetase. 
Despite a lower affinity of carbamoyl phosphate synthetase for carglumic acid than for N-
acetylglutamate, carglumic acid has been shown in vivo to stimulate carbamoyl phosphate 
synthetase and to be much more effective than N-acetylglutamate in protecting against ammonia 
intoxication in rats. This could be explained by the following observations: 
i) The mitochondrial membrane is more readily permeable for carglumic acid than for N-
acetylglutamate 
ii) Carglumic acid is more resistant than N-acetylglutamate to hydrolysis by aminoacylase present 
in the cytosol. 
 
Pharmacodynamic effects 
Other studies have been conducted in rats under different experimental conditions leading to 
increased ammonia availability (starvation, protein-free or high-protein diet). Carglumic acid was 
shown to decrease blood ammonia levels and increase urea levels in blood and urine, whereas 
the liver content of carbamoyl phosphate synthetase activators was significantly increased. 
 
Clinical efficacy and safety 
In patients with N-acetylglutamate synthase deficiency, carglumic acid was shown to induce a rapid 
normalisation of plasma ammonia levels, usually within 24 hours. When the treatment was 



5 
 

instituted before any permanent brain damage, patients exhibited normal growth and 
psychomotor development. 
 
5.2 Pharmacokinetic properties 
 
The pharmacokinetics of carglumic acid has been studied in healthy male volunteers using both 
radiolabelled and unlabelled product. 
 
Absorption 
After a single oral dose of 100 mg/kg body weight, approximately 30% of carglumic acid is 
estimated to be absorbed. At that dose-level, in 12 volunteers given carglumic acid tablets, plasma 
concentration peaked at 2.6 μg/mL (median; range 1.8-4.8) after 3 hours (median; range 2-4). 
 
Distribution 
The plasma elimination curve of carglumic acid is biphasic with a rapid phase over the first 
12 hours after administration followed by a slow phase (terminal half-life up to 28 hours). 
Diffusion into erythrocytes is non-existent. Protein binding has not been determined. 
 
Metabolism 
A proportion of carglumic acid is metabolised. It is suggested that depending on its activity, the 
intestinal bacterial flora may contribute to the initiation of the degradation process, thus leading 
to a variable extent of metabolism of the molecule. One metabolite that has been identified in the 
faeces is glutamic acid. Metabolites are detectable in plasma with a peak at 36-48 hours and a 
very slow decline (half-life around 100 hours). 
The end product of carglumic acid metabolism is carbon dioxide, which is eliminated through the 
lungs. 
 
Elimination 
After a single oral dose of 100 mg/kg body weight, 9% of the dose is excreted unchanged in the 
urine and up to 60% in the faeces. 
 
Plasma levels of carglumic acid were measured in patients of all age categories, from newborn 
infants to adolescents, treated with various daily doses (7–122 mg/kg/day). Their range was 
consistent with those measured in healthy adults, even in newborn infants. Whatever the daily 
dose, they were slowly declining over 15 hours to levels around 100 ng/mL. 
 
5.3 Preclinical safety data 
 
Safety pharmacology studies have shown that carglumic acid administered orally at doses of 
250, 500, 1000 mg/kg had no statistically significant effect on respiration, central nervous 
system and cardiovascular system. 

Carglumic acid showed no significant mutagenic activity in a battery of genotoxicity tests 
performed in vitro (Ames test, human lymphocyte metaphase analysis) and in vivo 
(micronucleus test in rat). 

Single doses of carglumic acid up to 2800 mg/kg orally and 239 mg/kg intravenously did not 
induce any mortality or abnormal clinical signs in adult rats. In newborn rats receiving daily 
carglumic acid by oral gavage for 18 days as well as in young rats receiving daily carglumic acid 
for 26 weeks, the No Observed Effect Level (NOEL) was established at 500 mg/kg/day and the 
No Observed Adverse Effect Level (NOAEL) was established at 1000 mg/kg/day. 

No adverse effects have been observed on male or female fertility. In rats and rabbits no 
evidence has been seen of embryotoxicity, foetotoxicity or teratogenicity up to maternotoxic doses 
leading to fifty times exposure as compared to humans in rats and seven times in rabbits. 
Carglumic acid is secreted in the milk of lactating rats and although developmental parameters 
were unaffected, there were some effects on body weight / body weight gain of pups breast-fed 
by dams treated with 500 mg/kg/day and a higher mortality of pups from dams treated with 



6 
 

2000 mg/kg/day, a dose that caused maternotoxicity. The maternal systemic exposures after 500 
and 2000 mg/kg/day were twenty five times and seventy times the expected human exposure. 

No carcinogenicity study has been conducted with carglumic acid. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
microcrystalline cellulose,  
mannitol,  
colloidal anhydrous silica,  
sodium stearyl fumarate,  
crospovidone type B,  
copovidone K 28. 
 
6.2 Incompatibilities 
 
Not applicable. 
 
6.3 Shelf life 
 
36 months. 
 
6.4 Special precautions for storage 
 
Not applicable. 
 
6.5 Nature and contents of container 
 
Blister (ALU/ALU) packed in cartons. 
 
Pack size of 12 or 60 dispersible tablets.  
 
6.6 Special precautions for disposal  
 
No special requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Eurocept International BV 
Trapgans 5 
1244 RL Ankeveen 
The Netherlands 
 
 
8. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/17/1202/001 
EU/1/17/1202/002 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 23 June 2017 



7 
 

 
 
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. 



8 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 

A. 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 

 



9 
 

A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
 

Name and address of the manufacturer(s) responsible for batch release 
 
Lucane Pharma 
172 rue de Charonne  
75011 Paris 
France 
 
Eurocept International BV 
Trapgans 5 
1244 RL Ankeveen 
The Netherlands 
 
 
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). 
 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION  
 
• Periodic safety update reports  
 
The requirements for submission of periodic safety update reports 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 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.  



10 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 



11 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 



12 
 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON X 12 TABLETS 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Ucedane 200 mg dispersible tablets  
carglumic acid 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 200 mg of carglumic acid. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
12 dispersible tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use only. 
 
 
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 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
 



13 
 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Eurocept International BV (Lucane Pharma) 
Trapgans 5 
1244 RL Ankeveen 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/17/1202/002 
 
 
13. BATCH NUMBER 
 
Batch  
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Ucedane 200 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC:  
SN:  
NN:  
 
 



14 
 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON X 60 TABLETS 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Ucedane 200 mg dispersible tablets  
carglumic acid 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Each tablet contains 200 mg of carglumic acid. 
 
 
3. LIST OF EXCIPIENTS 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
60 dispersible tablets 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Read the package leaflet before use. 
Oral use only. 
 
 
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 
 
 
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 
 



15 
 

Eurocept International BV (Lucane Pharma) 
Trapgans 5 
1244 RL Ankeveen 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/17/1202/001 
 
 
13. BATCH NUMBER 
 
Batch  
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Ucedane 200 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC:  
SN:  
NN:  
 



16 
 

 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 
 
BLISTER 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Ucedane 200 mg dispersible tablets  
carglumic acid 
 
 
2. NAME OF THE MARKETING AUTHORISATION HOLDER 
 
Eurocept International BV (Lucane Pharma) 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Batch 
 
 
5. OTHER 
 
 



17 
 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 



18 
 

Package leaflet: Information for the user 
 

Ucedane 200 mg dispersible tablets  
Carglumic acid 

 
Read all of this leaflet carefully before you start taking 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, or pharmacist. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm 

them, even if their signs of illness are the same as yours. 
- 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 Ucedane is and what it is used for  
2. What you need to know before you take Ucedane 
3. How to take Ucedane  
4. Possible side effects  
5. How to store Ucedane  
6. Contents of the pack and other information 
 
 
1. What Ucedane is and what it is used for 
 
Ucedane can help eliminating excessive ammonia plasma levels (elevated ammonia level in 
the blood). Ammonia is especially toxic for the brain and leads, in severe cases, to reduced 
levels of consciousness and to coma. 
Hyperammonaemia may be due to the lack of a specific liver enzyme N- acetylglutamate 
synthase. Patients with this rare disorder are not able to eliminate nitrogen waste, which 
builds up after eating protein.  
This disorder persists during the entire life of the affected patient and therefore the need for this 
treatment is lifelong. 
 
 
2. What you need to know before you take Ucedane  
 
Do not take Ucedane: 
- if you are allergic to carglumic acid or any of the other ingredients of this medicine (listed in 

section 6); 
- during breast-feeding. 
 
Warnings and precautions 
Talk to your doctor or pharmacist before taking Ucedane. 
 
Ucedane treatment should be initiated under the supervision of a physician experienced in the 
treatment of metabolic disorders. 
 
Your doctor will evaluate your individual responsiveness to carglumic acid before initiating any long 
term treatment. 
The dose should be individually adjusted in order to maintain normal ammonia plasma levels. 
 
Your doctor may prescribe supplemental arginine or restrict your protein intake. 
 
In order to follow-up your condition and your treatment, your doctor may examine your liver, your 



19 
 

kidneys, your heart and your blood on a regular basis. 
 
Other medicines and Ucedane 
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. 
 
Ucedane with food and drink 
Ucedane must be taken orally before meals or feedings. 
The tablets must be dispersed in a minimum of 5 to 10 mL of water and taken immediately.  
 
Pregnancy and breast-feeding 
The effects of Ucedane on pregnancy and the unborn child are not known. Consult your doctor for 
advice if you are pregnant or planning to become pregnant. 
The excretion of carglumic acid into breast milk has not been studied in women. Nevertheless, as 
carglumic acid has been shown to be present in the milk of lactating rats with potential toxic effects 
for their fed pups, you must not breast-feed your baby if you are taking Ucedane. 
 
Driving and using machines 
Effects on the ability to drive and use machines are not known. 
 
 
3. How to take Ucedane 
 
Always take this medicine exactly as your doctor has told you. Check with your doctor or 
pharmacist if you are not sure. 
 
The initial daily dose is usually 100 mg per kilogram of body weight, up to a maximum of 250 mg 
per kilogram of body weight (for example, if you weight 10 kg, you should take 1 g per day, or 5 
tablets of 200 mg). In the long term, the daily dose usually ranges from 10 mg to 100 mg per 
kilogram of body weight.  
 
Your doctor will determine the dose suitable to you in order to maintain normal ammonia levels in 
your blood. 
 
Ucedane should ONLY be administered by mouth or via a feeding tube into the stomach (using a 
syringe, if necessary). 
 
When the patient is in hyperammonaemic coma, Ucedane is administered by fast push through a 
syringe via the tube set up and used to feed you. 
 
If you take more Ucedane than you should 
Ask your doctor or pharmacist for advice. 
 
If you forget to take Ucedane 
Do not take a double dose to make up for forgotten individual doses. 
 
If you stop taking Ucedane 
Do not stop Ucedane without informing your doctor.  
 
If you have any further questions on the use of this medicine, ask your doctor, or pharmacist. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
  Common side effects (may affect up to 1 in 10 people):  



20 
 

• increased sweating 
 
Uncommon side effects (may affect up to 1 in 100 people):  
• bradycardia (decreased frequency of the heart),  
• diarrhoea,  
• fever,  
• increased transaminases (liver enzymes),  
• vomiting 
 
Not known side effects (frequency cannot be estimated from the available data) 
• rash 
 
Reporting of side effects 
If you get any 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 Ucedane 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the blister and carton. The expiry 
date refers to the last day of that month. 
 
This medicine does not require any special storage conditions.  

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how 
to throw away medicines you no longer use. These measures will help protect the environment. 
 
 
6. Contents of the pack and other information  
 
What Ucedane contains 
- The active substance is carglumic acid.  
- The other ingredients are microcrystalline cellulose, colloidal anhydrous silica, 

sodium stearyl fumarate, mannitol, copovidone K28, crospovidone type B. 
 
What Ucedane looks like and contents of the pack 
Ucedane dispersible tablets are rod-shaped, white, and biconvex with three score lines on both sides 
and engraving “L/L/L/L” on one side. 
The tablet can be divided into four equal doses. 
The tablets are presented in Aluminium/aluminium blister packed in cartons. 
Pack size of 12 or 60 tablets. 
 
Marketing Authorisation Holder  
Eurocept International BV 
Trapgans 5 
1244 RL Ankeveen 
The Netherlands 
 
Manufacturer 
Lucane Pharma 
172 rue de Charonne 



21 
 

75011 Paris 
France 
 
Eurocept International BV 
Trapgans 5 
1244 RL Ankeveen 
The Netherlands 
 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
 

België/Belgique/Belgien 
Lucane Pharma 
Tél/Tel: + 33 153 868 750 
info@lucanepharma.com 
 

Lietuva  
FrostPharma AB 
Tel: +46 775 86 80 02 
info@frostpharma.com 
 

България 
Lucane Pharma 
Teл.: + 33 153 868 750 
info@lucanepharma.com 
 

Luxembourg/Luxemburg 
Lucane Pharma 
Tél/Tel: + 33 153 868 750 
info@lucanepharma.com 

Česká republika 
Lucane Pharma 
Tél/Tel: + 33 153 868 750 
info@lucanepharma.com 
 

Magyarország 
Lucane Pharma 
Tel: + 33 153 868 750 
info@lucanepharma.com 

Danmark 
FrostPharma AB 
Tlf: +45 808 20 101 
info@frostpharma.com 
 

Malta 
Lucane Pharma 
Tel: + 33 153 868 750 
info@lucanepharma.com 

Deutschland 
Lucane Pharma 
Tel: + 33 153 868 750 
info@lucanepharma.com 
 

Nederland 
Eurocept International BV 
Tel: +31 35 528 39 57 
info@eurocept.nl 

Eesti 
FrostPharma AB 
Tel: +46 775 86 80 02 
info@frostpharma.com 
 

Norge 
FrostPharma AB 
Tlf: +47 815 03 175 
info@frostpharma.com 

Ελλάδα 
Lucane Pharma 
Τηλ: + 33 153 868 750 
info@lucanepharma.com 
 

Österreich 
Lucane Pharma 
Tel: + 33 153 868 750 
info@lucanepharma.com 

España 
Lucane Pharma 
Tel: + 33 153 868 750 
info@lucanepharma.com 
 

Polska 
Lucane Pharma 
Tel: + 33 153 868 750 
info@lucanepharma.com 

France 
Lucane Pharma 
Tél: + 33 153 868 750 

Portugal 
Lucane Pharma 
Tel: + 33 153 868 750 



22 
 

info@lucanepharma.com 
 

info@lucanepharma.com 

Hrvatska 
Lucane Pharma 
Tel: + 33 153 868 750 
info@lucanepharma.com 
 

România 
Lucane Pharma 
Tel: + 33 153 868 750 
info@lucanepharma.com 
 

Ireland 
Lucane Pharma 
Tel: + 33 153 868 750 
info@lucanepharma.com 
 

Slovenija 
Lucane Pharma 
Tel: + 33 153 868 750 
info@lucanepharma.com 

Ísland 
Lucane Pharma 
Sími: + 33 153 868 750 
info@lucanepharma.com 
 

Slovenská republika 
Lucane Pharma 
Tel: + 33 153 868 750 
info@lucanepharma.com 

Italia 
Lucane Pharma 
Tel: + 33 153 868 750 
info@lucanepharma.com 

Suomi/Finland 
FrostPharma AB 
Puh/Tel: +35 875 32 51 209 
info@frostpharma.com 
 

Κύπρος 
Lucane Pharma 
Τηλ: + 33 153 868 750 
info@lucanepharma.com 
 

Sverige 
FrostPharma AB  
Tel: +46 775 86 80 02 
info@medicalneed.com 

Latvija 
FrostPharma AB 
Tel: +46 775 86 80 02 
info@frostpharma.com 

United Kingdom 
Lucane Pharma 
Tel: + 33 153 868 750 
info@lucanepharma.com 
 

  
 

 
This leaflet was last revised in {MM/YYYY} 
 
Other sources of information 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu.   


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER 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 ucedane is and what it is used for', 'Section_Content': 'ucedane can help eliminating excessive ammonia plasma levels (elevated ammonia level in the blood). ammonia is especially toxic for the brain and leads, in severe cases, to reduced levels of consciousness and to coma. hyperammonaemia may be due to the lack of a specific liver enzyme n- acetylglutamate synthase. patients with this rare disorder are not able to eliminate nitrogen waste, which builds up after eating protein. this disorder persists during the entire life of the affected patient and therefore the need for this treatment is lifelong.', 'Entity_Recognition': [{'Text': 'ucedane', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'ucedane', 'Type': 'TREATMENT', 'BeginOffset': 0, 'EndOffset': 7}, {'Text': 'excessive ammonia plasma levels', 'Type': 'PROBLEM', 'BeginOffset': 29, 'EndOffset': 60}, {'Text': 'elevated ammonia level in the blood', 'Type': 'PROBLEM', 'BeginOffset': 62, 'EndOffset': 97}, {'Text': 'ammonia', 'Type': 'TEST', 'BeginOffset': 100, 'EndOffset': 107}, {'Id': 0, 'BeginOffset': 136, 'EndOffset': 141, 'Score': 0.8873700499534607, 'Text': 'brain', 'Category': 'ANATOMY', 'Type': 'SYSTEM_ORGAN_SITE', 'Traits': []}, {'Text': 'reduced levels of consciousness', 'Type': 'PROBLEM', 'BeginOffset': 173, 'EndOffset': 204}, {'Id': 3, 'BeginOffset': 212, 'EndOffset': 216, 'Score': 0.6741031408309937, 'Text': 'coma', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'DIAGNOSIS', 'Score': 0.6363357901573181}]}, {'Id': 4, 'BeginOffset': 218, 'EndOffset': 233, 'Score': 0.9831830263137817, 'Text': 'hyperammonaemia', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'DIAGNOSIS', 'Score': 0.8923979997634888}]}, {'Id': 5, 'BeginOffset': 271, 'EndOffset': 311, 'Score': 0.3594132959842682, 'Text': 'liver enzyme n- acetylglutamate synthase', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'DIAGNOSIS', 'Score': 0.745348334312439}]}, {'Text': 'this rare disorder', 'Type': 'PROBLEM', 'BeginOffset': 327, 'EndOffset': 345}, {'Text': 'nitrogen waste', 'Type': 'TREATMENT', 'BeginOffset': 372, 'EndOffset': 386}, {'Text': 'this disorder', 'Type': 'PROBLEM', 'BeginOffset': 426, 'EndOffset': 439}, {'Text': 'this treatment', 'Type': 'TREATMENT', 'BeginOffset': 523, 'EndOffset': 537}]}
{'Title': '2. what you need to know before you take ucedane', 'Section_Content': 'do not take ucedane: - if you are allergic to carglumic acid or any of the other ingredients of this medicine (listed in section 6); - during breast-feeding. warnings and precautions talk to your doctor or pharmacist before taking ucedane. ucedane treatment should be initiated under the supervision of a physician experienced in the treatment of metabolic disorders. your doctor will evaluate your individual responsiveness to carglumic acid before initiating any long term treatment. the dose should be individually adjusted in order to maintain normal ammonia plasma levels. your doctor may prescribe supplemental arginine or restrict your protein intake. in order to follow-up your condition and your treatment, your doctor may examine your liver, your 19 kidneys, your heart and your blood on a regular basis. other medicines and ucedane tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. ucedane with food and drink ucedane must be taken orally before meals or feedings. the tablets must be dispersed in a minimum of 5 to 10 ml of water and taken immediately. pregnancy and breast-feeding the effects of ucedane on pregnancy and the unborn child are not known. consult your doctor for advice if you are pregnant or planning to become pregnant. the excretion of carglumic acid into breast milk has not been studied in women. nevertheless, as carglumic acid has been shown to be present in the milk of lactating rats with potential toxic effects for their fed pups, you must not breast-feed your baby if you are taking ucedane. driving and using machines effects on the ability to drive and use machines are not known.', 'Entity_Recognition': [{'Text': 'ucedane', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'allergic', 'Type': 'PROBLEM', 'BeginOffset': 34, 'EndOffset': 42}, {'Id': 4, 'BeginOffset': 46, 'EndOffset': 60, 'Score': 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'DX_NAME', 'Traits': [{'Name': 'DIAGNOSIS', 'Score': 0.9502987265586853}]}, {'Text': 'the excretion of carglumic acid into breast milk', 'Type': 'TREATMENT', 'BeginOffset': 1301, 'EndOffset': 1349}, {'Id': 7, 'BeginOffset': 1398, 'EndOffset': 1412, 'Score': 0.5624650120735168, 'Text': 'carglumic acid', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Id': 13, 'BeginOffset': 1487, 'EndOffset': 1500, 'Score': 0.8025045990943909, 'Text': 'toxic effects', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'DIAGNOSIS', 'Score': 0.8099636435508728}]}]}
{'Title': '3. how to take ucedane', 'Section_Content': 'always take this medicine exactly as your doctor has told you. check with your doctor or pharmacist if you are not sure. the initial daily dose is usually 100 mg per kilogram of body weight, up to a maximum of 250 mg per kilogram of body weight (for example, if you weight 10 kg, you should take 1 g per day, or 5 tablets of 200 mg). in the long term, the daily dose usually ranges from 10 mg to 100 mg per kilogram of body weight. your doctor will determine the dose suitable to you in order to maintain normal ammonia levels in your blood. ucedane should only be administered by mouth or via a feeding tube into the stomach (using a syringe, if necessary). when the patient is in hyperammonaemic coma, ucedane is administered by fast push through a syringe via the tube set up and used to feed you. if you take more ucedane than you should ask your doctor or pharmacist for advice. if you forget to take ucedane do not take a double dose to make up for forgotten individual doses. if you stop taking ucedane do not stop ucedane without informing your doctor. if you have any further questions on the use of this medicine, ask your doctor, or pharmacist.', 'Entity_Recognition': [{'Text': 'ucedane', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'this medicine', 'Type': 'TREATMENT', 'BeginOffset': 12, 'EndOffset': 25}, {'Text': '100', 'Type': 'NUMBER', 'BeginOffset': 155, 'EndOffset': 158}, {'Id': 2, 'BeginOffset': 166, 'EndOffset': 174, 'Score': 0.31991931796073914, 'Text': 'kilogram', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': [], 'Attributes': [{'Type': 'DOSAGE', 'Score': 0.6750446557998657, 'RelationshipScore': 0.8201901316642761, 'RelationshipType': 'DOSAGE', 'Id': 1, 'BeginOffset': 155, 'EndOffset': 161, 'Text': '100 mg', 'Category': 'MEDICATION', 'Traits': []}, {'Type': 'DOSAGE', 'Score': 0.9662339091300964, 'RelationshipScore': 0.999413251876831, 'RelationshipType': 'DOSAGE', 'Id': 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'MEDICATION', 'Traits': []}, {'Type': 'FREQUENCY', 'Score': 0.9671245217323303, 'RelationshipScore': 0.9956206679344177, 'RelationshipType': 'FREQUENCY', 'Id': 6, 'BeginOffset': 300, 'EndOffset': 307, 'Text': 'per day', 'Category': 'MEDICATION', 'Traits': []}, {'Type': 'DOSAGE', 'Score': 0.8036664724349976, 'RelationshipScore': 0.8580015301704407, 'RelationshipType': 'DOSAGE', 'Id': 7, 'BeginOffset': 312, 'EndOffset': 321, 'Text': '5 tablets', 'Category': 'MEDICATION', 'Traits': []}, {'Type': 'STRENGTH', 'Score': 0.5387255549430847, 'RelationshipScore': 0.7232103943824768, 'RelationshipType': 'STRENGTH', 'Id': 8, 'BeginOffset': 325, 'EndOffset': 331, 'Text': '200 mg', 'Category': 'MEDICATION', 'Traits': []}]}, {'Text': '10', 'Type': 'NUMBER', 'BeginOffset': 273, 'EndOffset': 275}, {'Text': '1', 'Type': 'NUMBER', 'BeginOffset': 296, 'EndOffset': 297}, {'Text': '5', 'Type': 'NUMBER', 'BeginOffset': 312, 'EndOffset': 313}, {'Text': '200', 'Type': 'NUMBER', 'BeginOffset': 325, 'EndOffset': 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{'Title': '4. possible side effects', 'Section_Content': 'like all medicines, this medicine can cause side effects, although not everybody gets them. common side effects (may affect up to 1 in 10 people): 20 increased sweating uncommon side effects (may affect up to 1 in 100 people): bradycardia (decreased frequency of the heart), diarrhoea, fever, increased transaminases (liver enzymes), vomiting not known side effects (frequency cannot be estimated from the available data) rash reporting of side effects if you get any 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': 'ucedane', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Text': 'all medicines', 'Type': 'TREATMENT', 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'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.5619540810585022}]}, {'Text': 'decreased frequency of the heart)', 'Type': 'PROBLEM', 'BeginOffset': 240, 'EndOffset': 273}, {'Id': 9, 'BeginOffset': 275, 'EndOffset': 284, 'Score': 0.9728965759277344, 'Text': 'diarrhoea', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.7767616510391235}]}, {'Id': 10, 'BeginOffset': 286, 'EndOffset': 291, 'Score': 0.9922837615013123, 'Text': 'fever', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.8073481321334839}]}, {'Id': 11, 'BeginOffset': 293, 'EndOffset': 316, 'Score': 0.724295437335968, 'Text': 'increased transaminases', 'Category': 'MEDICAL_CONDITION', 'Type': 'DX_NAME', 'Traits': [{'Name': 'SYMPTOM', 'Score': 0.646197497844696}]}, {'Id': 12, 'BeginOffset': 318, 'EndOffset': 331, 'Score': 0.5996149182319641, 'Text': 'liver enzymes', 'Category': 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{'Title': '5. how to store ucedane', 'Section_Content': 'keep this medicine out of the sight and reach of children. do not use this medicine after the expiry date which is stated on the blister and carton. the expiry date refers to the last day of that month. this medicine does not require any special storage conditions. do not throw away any medicines via wastewater or household waste. ask your pharmacist how to throw away medicines you no longer use. these measures will help protect the environment.', 'Entity_Recognition': None}
{'Title': '6. contents of the pack and other information', 'Section_Content': 'what ucedane contains - the active substance is carglumic acid. - the other ingredients are microcrystalline cellulose, colloidal anhydrous silica, sodium stearyl fumarate, mannitol, copovidone k28, crospovidone type b. what ucedane looks like and contents of the pack ucedane dispersible tablets are rod-shaped, white, and biconvex with three score lines on both sides and engraving "l/l/l/l" on one side. the tablet can be divided into four equal doses. the tablets are presented in aluminium/aluminium blister packed in cartons. pack size of 12 or 60 tablets.', 'Entity_Recognition': [{'Text': 'ucedane', 'Type': 'PRODUCT_NAME', 'BeginOffset': 0, 'EndOffset': 0}, {'Id': 6, 'BeginOffset': 48, 'EndOffset': 62, 'Score': 0.9911680221557617, 'Text': 'carglumic acid', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': [{'Name': 'NEGATION', 'Score': 0.44372060894966125}]}, {'Id': 7, 'BeginOffset': 92, 'EndOffset': 118, 'Score': 0.9910019040107727, 'Text': 'microcrystalline cellulose', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Id': 8, 'BeginOffset': 120, 'EndOffset': 146, 'Score': 0.9815946817398071, 'Text': 'colloidal anhydrous silica', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Id': 9, 'BeginOffset': 148, 'EndOffset': 171, 'Score': 0.9979479908943176, 'Text': 'sodium stearyl fumarate', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Id': 10, 'BeginOffset': 173, 'EndOffset': 181, 'Score': 0.9264935851097107, 'Text': 'mannitol', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Text': 'copovidone k28', 'Type': 'TREATMENT', 'BeginOffset': 183, 'EndOffset': 197}, {'Id': 12, 'BeginOffset': 199, 'EndOffset': 211, 'Score': 0.996109664440155, 'Text': 'crospovidone', 'Category': 'MEDICATION', 'Type': 'GENERIC_NAME', 'Traits': []}, {'Text': 'the pack ucedane dispersible tablets', 'Type': 'TREATMENT', 'BeginOffset': 260, 'EndOffset': 296}, {'Id': 13, 'BeginOffset': 324, 'EndOffset': 332, 'Score': 0.4480295479297638, 'Text': 'biconvex', 'Category': 'MEDICATION', 'Type': 'BRAND_NAME', 'Traits': []}, {'Id': 1, 'BeginOffset': 364, 'EndOffset': 369, 'Score': 0.8741389513015747, 'Text': 'sides', 'Category': 'ANATOMY', 'Type': 'SYSTEM_ORGAN_SITE', 'Traits': []}, {'Text': 'the tablet', 'Type': 'TREATMENT', 'BeginOffset': 407, 'EndOffset': 417}, {'Text': 'the tablets', 'Type': 'TREATMENT', 'BeginOffset': 456, 'EndOffset': 467}, {'Text': 'aluminium/aluminium blister', 'Type': 'TREATMENT', 'BeginOffset': 485, 'EndOffset': 512}, {'Text': '12', 'Type': 'NUMBER', 'BeginOffset': 545, 'EndOffset': 547}, {'Text': '60', 'Type': 'NUMBER', 'BeginOffset': 551, 'EndOffset': 553}]}