Pheburane

Package leaflet: Information for the patient

PHEBURANE 483 mg/g granules

Sodium phenylbutyrate
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What PHEBURANE is and what it is used for
2. What you need to know before taking PHEBURANE
3. How to take PHEBURANE
4. Possible side effects
5. How to store PHEBURANE
6. Contents of the pack and other information

1. What PHEBURANE is and what it is used for

PHEBURANE contains the active substance sodium phenylbutyrate, which is used for the treatment of
patients of all ages affected by urea cycle disorders. This rare type of disorder is due to a deficiency of certain liver enzymes required to eliminate waste nitrogen in the form of ammonia.
Nitrogen is an element contained in proteins, which are an essential component of the food we eat. When the body metabolizes proteins after ingestion, waste nitrogen accumulates in the form of ammonia, since the body is unable to eliminate it. Ammonia is particularly toxic to the brain and, in severe cases, may lead to decreased levels of consciousness up to coma.
This medicine helps the body eliminate waste nitrogen by reducing the amount of ammonia present in the body. However, PHEBURANE must be taken together with a specially designed low-protein diet prescribed by your doctor and dietitian. You must carefully follow this diet.

2. What you need to know before taking PHEBURANE

Do not take PHEBURANE:

• if you are allergic to sodium phenylbutyrate or any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant;
• if you are breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before taking PHEBURANE:

• if you have congestive heart failure (a form of heart disease in which the heart is unable to pump sufficient blood through the body) or reduced kidney function;
• if you have impaired liver or kidney function, as PHEBURANE is eliminated from the body via the liver and kidneys.

PHEBURANE does not completely prevent the occurrence of acute episodes of elevated ammonia levels in the blood (hyperammonemia), a condition that generally constitutes a medical emergency. If this condition occurs, symptoms such as nausea, vomiting, and confusion develop, requiring immediate medical attention.
If you are undergoing laboratory tests, it is important that you inform your doctor that you are taking PHEBURANE, as sodium phenylbutyrate may interfere with certain laboratory test results (such as electrolyte or protein levels or liver function tests).
If in doubt, consult your doctor or pharmacist.
Other medicines and PHEBURANE
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
It is particularly important that you inform your doctor if you are taking medicines containing:

• valproate (an antiepileptic medicine),
• haloperidol (used in certain psychotic disorders),
• corticosteroids (medicines used to relieve inflamed areas of the body),
• probenecid (for the treatment of hyperuricemia, i.e. high levels of uric acid in the blood, associated with gout).

These medicines may alter the effect of PHEBURANE, and you may need to have blood tests more frequently. If you are unsure whether the medicines you are taking contain these substances, check with your doctor or pharmacist.
Pregnancy and breastfeeding
Do not use PHEBURANE if you are pregnant, as this medicine may harm the fetus.
If you are a woman of childbearing potential, you must use reliable contraceptive methods during treatment with PHEBURANE. Consult your doctor for further information.
Do not use PHEBURANE if you are breastfeeding, as this medicine may pass into breast milk and harm the newborn.
Driving and using machines
It is unlikely that PHEBURANE will affect your ability to drive or use machinery.
PHEBURANE contains sodium and sucrose.
This medicine contains 124 mg (5.4 mmol) of sodium (the main component of table salt) per gram of sodium phenylbutyrate. This corresponds to 6.2% of the maximum daily recommended sodium intake for an adult.
The maximum daily dose of this medicine contains 2.5 g of sodium for 20 g of sodium phenylbutyrate, equivalent to 125% of the maximum daily recommended sodium intake for an adult.
Consult your doctor or pharmacist if you require 3 or more grams per day for a prolonged period, especially if you have been advised to follow a low-salt (low-sodium) diet.
This medicine contains 768 mg of sucrose per gram of sodium phenylbutyrate. This should be taken into account if you have diabetes mellitus. If your doctor has informed you that you have reduced tolerance to certain sugars, consult your doctor before taking this medicine.

3. How to take PHEBURANE

Always take this medicine exactly as directed by your doctor. If you have any doubts,
consult your doctor or pharmacist.
Dosage
The daily dose of PHEBURANE will be calculated based on body weight or body surface area and adjusted according to protein tolerance and the diet you are following. Regular blood tests will therefore be necessary to determine the exact daily dose. Your doctor will tell you the daily amount of granules to take.
Method of administration
PHEBURANE must be taken by mouth. Since the medicine dissolves slowly, PHEBURANE must not be administered via gastrostomy (a tube from the abdomen into the stomach) or through a nasogastric tube (a tube from the nose into the stomach).
PHEBURANE must be taken with a low-protein diet.
PHEBURANE should be taken with every meal or feeding. For young children, the frequency may range from 4 to 6 times daily.
The doses of PHEBURANE prescribed by your doctor are expressed in grams of sodium phenylbutyrate. A calibrated measuring scoop is supplied with the medicine to administer up to 3 g of sodium phenylbutyrate at one time. Only use the provided measuring scoop to measure the dose of PHEBURANE. The measuring scoop must not be used for other medicines.
To measure the dose:

• The markings on the scoop indicate the amount of PHEBURANE in grams of sodium phenylbutyrate. Take the exact amount prescribed by your doctor.
• Pour the granules directly into the scoop as shown in the image (on the outer packaging and in this leaflet).
• Tap the scoop once gently on a table to level the surface of the granules, and continue filling the scoop if necessary.

The granules may be ingested directly with liquid foods (water, fruit juices, protein-free infant formulas) or sprinkled onto a spoonful of solid food (such as mashed potatoes or applesauce). If the medicine is added to food, it is important that it is consumed immediately. This way, the granules will not produce any taste.
You will need to take this medicine and follow a special diet for life.
If you take more PHEBURANE than you should
In patients who have taken very high doses of sodium phenylbutyrate, the following have been reported:

• drowsiness, fatigue, lightheadedness, and less commonly, confusion,
• headache,
• altered sense of taste,
• hearing loss,
• disorientation,
• memory problems,
• worsening of pre-existing neurological conditions.

If any of these symptoms occur, contact your doctor or the nearest hospital emergency department immediately for supportive treatment.
If you forget to take PHEBURANE
Take the missed dose as soon as possible with the next meal. Ensure that at least 3 hours pass between doses. Do not take a double dose to make up for a forgotten dose.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If you experience persistent vomiting, contact your doctor immediately.

Very common side effects (may affect more than 1 in 10 people):
irregular menstrual cycles and cessation of menstrual cycles in women of childbearing age. If you are sexually active and your period stops completely, do not immediately assume this is due to PHEBURANE. Discuss this with your doctor, as absence of menstruation could be caused by pregnancy (see the section above "Pregnancy and breast-feeding") or menopause.

Common side effects (may affect more than 1 in 100 people):
changes in blood cell counts (red blood cells, white blood cells and platelets), changes in blood bicarbonate levels, reduced appetite, depression, irritability, headache, fainting, fluid retention (swelling), altered taste, stomach discomfort, vomiting, nausea, constipation, unusual skin odour, skin rash, abnormal kidney function, weight gain, and abnormal laboratory test results.

Uncommon side effects (may affect more than 1 in 1,000 people):
reduction in red blood cells due to bone marrow damage, bruising, altered heart rate, rectal bleeding, inflammation of the stomach, gastric ulcer, inflammation of the pancreas.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system listed in Annex V.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store PHEBURANE

Keep this medicine out of the sight and reach of children.
Do not use PHEBURANE after the expiry date stated on the carton and label of the bottle after Exp. The expiry date refers to the last day of the month.
After first opening, PHEBURANE must be used within 45 days.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What PHEBURANE contains
The active substance is sodium phenylbutyrate.
Each gram of granules contains 483 mg of sodium phenylbutyrate.
The excipients are: sugar spheres (composed of sucrose and maize starch; see section 2, "PHEBURANE contains sucrose"), hypromellose, ethylcellulose N7, macrogol 1500, povidone K25.

Description of the appearance of PHEBURANE and package contents
PHEBURANE granules are white to off-white in colour.
The granules are packaged in a plastic bottle with a child-resistant cap and a desiccant.
Each bottle contains 174 g of granules.
Each carton contains 1 bottle.
A calibrated measuring scoop is supplied with the product.

Marketing Authorisation Holder and Manufacturer
Eurocept International BV
Trapgans 5
1244 RL Ankeveen
The Netherlands

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Lucane Pharma FrostPharma AB
Tél/Tel: +33 153 868 750 Tel: +46 824 36 60
[email protected] [email protected]

България Luxembourg/Luxemburg
Lucane Pharma Lucane Pharma
Teл.: +33 153 868 750 Tél/Tel: +33 153 868 750
[email protected] [email protected]

Česká republika Magyarország
Lucane Pharma Lucane Pharma
Tél/Tel: +33 153 868 750 Tel: +33 153 868 750
[email protected] [email protected]

Danmark Malta
FrostPharma AB Lucane Pharma
Tlf: +46 824 36 60 Tel: +33 153 868 750
[email protected] [email protected]

Deutschland Nederland
Lucane Pharma Eurocept International BV
Tel: +33 153 868 750 Tel: +31 35 528 39 57
[email protected] [email protected]

Eesti Norge
FrostPharma AB FrostPharma AB
Tel: +46 824 36 60 Tlf: +46 824 36 60
[email protected] [email protected]

Ελλάδα Österreich
Lucane Pharma Lucane Pharma
Τηλ: +33 153 868 750 Tel: +33 153 868 750
[email protected] [email protected]

España Polska
Lucane Pharma Lucane Pharma
Tel: +33 153 868 750 Tel: +33 153 868 750
[email protected] [email protected]

France Portugal
Lucane Pharma Lucane Pharma
Tél: +33 153 868 750 Tel: +33 153 868 750
[email protected] [email protected]

Hrvatska România
Lucane Pharma Lucane Pharma
Tel: +33 153 868 750 Tel: +33 153 868 750
[email protected] [email protected]

Ireland Slovenija
Lucane Pharma Lucane Pharma
Tel: +33 153 868 750 Tel: +33 153 868 750
[email protected] [email protected]

Ísland Slovenská republika
FrostPharma AB Lucane Pharma
Sími: +46 824 36 60 Tel: +33 153 868 750
[email protected] [email protected]

Italia Suomi/Finland
Lucane Pharma FrostPharma AB
Tel: +33 153 868 750 Puh/Tel: +46 824 36 60
[email protected] [email protected]

Κύπρος Sverige
Lucane Pharma FrostPharma AB
Τηλ: +33 153 868 750 Tel: +46 824 36 60
[email protected] [email protected]

Latvija
FrostPharma AB
Tel: +46 824 36 60
[email protected]

More detailed information on this medicinal product is available on the website of the European Medicines Agency, http://www.ema.europa.eu/.
In addition, links to other websites on rare diseases and their therapeutic treatments are provided.

Patient Information Leaflet

PHEBURANE 350 mg/ml oral solution

sodium phenylbutyrate
Please read this entire leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What PHEBURANE oral solution is and what it is used for
2. What you need to know before taking PHEBURANE
3. How to take PHEBURANE
4. Possible side effects
5. How to store PHEBURANE
6. Contents of the pack and other information

1. What PHEBURANE is and what it is used for

PHEBURANE contains the active substance sodium phenylbutyrate, which is used to treat
patients with urea cycle disorders. These rare disorders are caused by a deficiency of certain
liver enzymes needed to eliminate waste nitrogen in the form of ammonia.
Nitrogen is a component of proteins, which are an essential part of the food we eat.
When the body breaks down proteins after eating, waste nitrogen in the form of ammonia accumulates because the body cannot eliminate it. Ammonia is particularly
toxic to the brain and, in severe cases, may lead to reduced consciousness and coma.
PHEBURANE helps the body eliminate waste nitrogen, thereby reducing the amount of ammonia in the body. However, PHEBURANE oral solution must be taken together with a specially designed low-protein diet prescribed by your doctor and dietitian. You must strictly follow this diet.

2. What you need to know before taking PHEBURANE

Do not take PHEBURANE:

• if you are allergic to sodium phenylbutyrate or to any of the other ingredients of this medicine (listed in section 6);
• if you are pregnant;
• if you are breastfeeding.

Warnings and precautions
Talk to your doctor or pharmacist before taking PHEBURANE:

• if you have congestive heart failure (a type of heart disease in which the heart is unable to pump sufficient blood throughout the body) or reduced kidney function;
• if you have reduced liver or kidney function, as PHEBURANE oral solution is eliminated from the body through the liver and kidneys.

PHEBURANE does not prevent the occurrence of acute hyperammonemia (a condition characterized by excessive ammonia in the blood), which usually constitutes a medical emergency. If this condition occurs, symptoms such as nausea, vomiting, and confusion may develop, requiring immediate medical attention.
If you need to undergo laboratory tests, it is important that you inform your doctor that you are taking PHEBURANE oral solution, as sodium phenylbutyrate may interfere with the results of certain laboratory tests (such as blood electrolyte or protein levels, or liver function tests).
If in doubt, consult your doctor or pharmacist.

Other medicines and PHEBURANE
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
It is particularly important that you inform your doctor if you are taking medicines containing:

• valproate (an antiepileptic medicine);
• haloperidol (used for certain psychotic disorders);
• corticosteroids (medicines used to relieve inflammation in parts of the body);
• probenecid (used to treat hyperuricemia, i.e. high levels of uric acid in the blood, associated with gout).

These medicines may alter the effect of PHEBURANE, and you may need to have blood tests more frequently. If you are unsure whether the medicines you are taking contain these substances, check with your doctor or pharmacist.

Pregnancy and breastfeeding
Do not use PHEBURANE during pregnancy, as this medicine may harm the unborn baby.
If you are a woman of childbearing age, you must use reliable contraceptive methods during treatment with PHEBURANE. Consult your doctor for further advice.
Do not use PHEBURANE if you are breastfeeding, as this medicine may pass into breast milk and harm the newborn.

Driving and using machines
It is unlikely that PHEBURANE oral solution will affect your ability to drive or operate machinery.

PHEBURANE oral solution contains sodium
This medicine contains 124 mg (5.4 mmol) of sodium (the main component of table salt) per gram of sodium phenylbutyrate. This corresponds to 6.2% of the maximum daily recommended sodium intake for an adult.
The maximum daily dose of this medicine contains 2.5 g of sodium, equivalent to 125% of the maximum daily recommended sodium intake for an adult.
Consult your doctor or pharmacist if you need to take 3 or more grams per day for a prolonged period, especially if you have been advised to follow a low-salt (low-sodium) diet.

PHEBURANE oral solution contains aspartame
This medicine contains 5.7 mg of aspartame per gram of sodium phenylbutyrate dose. Aspartame is a source of phenylalanine. It could be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine accumulates due to the body's inability to eliminate it properly.

The blackcurrant flavour contains propylene glycol
The medicine contains 26.55 mg of propylene glycol per drop.
If the child is less than 4 weeks old, you should discuss administration of the medicine with your doctor or pharmacist beforehand, especially if the child is taking other medicines containing propylene glycol or alcohol.

3. How to take PHEBURANE oral solution

Take this medicine exactly as directed by your doctor. If you have any doubts,
consult your doctor or pharmacist.
Dosage
The daily dose of PHEBURANE oral solution will be calculated based on body weight or body surface area and adjusted according to your tolerance to protein and the diet you follow.
Regular blood tests will therefore be necessary to determine the correct daily dose. Your doctor will tell you how much liquid to take.
Method of administration
PHEBURANE oral solution must be taken with meals.
Use only the oral dosing syringe supplied with PHEBURANE oral solution to measure a dose of PHEBURANE oral solution. Do not use other devices/spoons/syringes for administration. The dosing syringe ranges from 0.5 g to 3 g in 0.25 g increments. The markings on the dosing syringe indicate grams of sodium phenylbutyrate. Follow the instructions below for administering PHEBURANE oral solution.
Oral administration

1. Open the PHEBURANE oral solution bottle by pressing down and turning the cap to the left.

2. Remove the CE-marked dosing syringe connected to the bottle adapter from the pouch.

3. Insert (push) the adapter into the neck of the bottle while the syringe is inside the adapter.

4. Turn the bottle upside down.

5. Draw from the bottle the amount of PHEBURANE oral solution required (equivalent to the number of grams of sodium phenylbutyrate prescribed by your doctor) using the dosing syringe.

6. Separate the dosing syringe containing PHEBURANE oral solution from the adapter and pour the amount of PHEBURANE oral solution from the dosing syringe into a glass containing at least 20 ml of water.

7. Close the PHEBURANE oral solution bottle without removing the adapter inserted in the neck of the bottle.

8. When using the flavoured pack, add one drop of your preferred flavour (black currant or lemon-mint) to the contents of the glass of water; gently mix and drink (if one drop of flavouring is not sufficient to provide adequate taste intensity, two drops may be used). When using the unflavoured pack, gently stir and drink.

9. After each administration, wash the syringe with cold or lukewarm water only.

PHEBURANE oral solution must be taken with a special low-protein diet.
PHEBURANE oral solution must be taken with every meal or feed. In young children, the frequency may range from 4 to 6 times daily.
PHEBURANE oral solution may also be administered via nasogastric or gastrostomy tubes. PHEBURANE oral solution can be administered through tubes with a diameter equal to or greater than 2 mm (7–8 French). Use the supplied oral dosing syringe to measure the dose and follow the instructions below:
Preparation for administration via nasogastric or gastrostomy tube

1. Follow steps 1 to 5 of the Oral administration method.
2. PHEBURANE oral solution is ready to use and does not need to be diluted.
3. Do not add flavouring if administering via nasogastric or gastrostomy tube.
4. Insert the tip of the syringe filled with the medicine into the end of the nasogastric or gastrostomy tube.
5. Use the plunger of the dosing syringe to administer the prescribed dose of PHEBURANE oral solution through the nasogastric or gastrostomy tube.
6. After each administration, flush the tube once with the appropriate volume of lukewarm water and allow it to drain. For adults, use 20 ml of lukewarm water. For children weighing less than 20 kg and infants, use 3 ml of water.

You will need to take this medicine and follow the prescribed diet for life.
If you take more PHEBURANE oral solution than you should
In patients who have taken very high doses of sodium phenylbutyrate, the following have been reported:

• drowsiness, fatigue, mild confusion, and less commonly, disorientation;
• headache;
• taste disturbance (dysgeusia);
• hearing loss;
• disorientation;
• memory disturbances;
• worsening of pre-existing neurological conditions.

If any of these symptoms occur, contact your doctor or the nearest hospital emergency department immediately for supportive treatment.
If you forget to take PHEBURANE oral solution
Take the missed dose as soon as possible with your next meal. Ensure that at least 3 hours pass between doses. Do not take a double dose to make up for a forgotten dose.
If you have any questions about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If you experience persistent vomiting, contact your doctor immediately.

Very common side effects (may affect more than 1 in 10 people):

• Irregular menstrual cycles and cessation of menstrual cycles in women of reproductive age.
  If you are sexually active and your periods stop completely, do not immediately assume this is due to PHEBURANE oral solution. Instead, discuss this with your doctor, as absence of menstruation could be caused by pregnancy (see section above "Pregnancy and breastfeeding") or menopause.

Common side effects (may affect more than 1 in 100 people):

• Changes in blood cell counts (red blood cells, white blood cells and platelets), changes in blood bicarbonate levels, reduced appetite, depression, irritability, headache, fainting, fluid retention (swelling), altered taste, stomach discomfort, vomiting, nausea, constipation, unusual skin odour, skin rash, abnormal kidney function, weight gain, and abnormal laboratory test results.

Uncommon side effects (may affect more than 1 in 1,000 people):

• Decrease in red blood cells due to bone marrow damage, bruising, altered heart rate, rectal bleeding, inflammation of the stomach, stomach ulcer, inflammation of the pancreas.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system indicated in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store PHEBURANE oral solution

Keep this medicine out of the sight and reach of children.
Do not use PHEBURANE oral solution after the expiry date which is stated on the carton and
on the label of the bottle after Exp. The expiry date refers to the last day of the month.
After first opening the PHEBURANE oral solution bottle, the medicine must be used within 4 weeks.
Dispose of the bottle even if it is not empty.
After first opening, the flavour bottle must be used within 4 weeks. Dispose of the bottle even if it is not empty.
This medicine does not require any special storage conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Pack contents and other information

Two types of packaging are available: one with flavourings and one without.

What PHEBURANE oral solution contains

• The active substance is sodium phenylbutyrate. Each ml of liquid contains 350 mg of sodium phenylbutyrate.
• The other components are: purified water, aspartame (E951), sucralose (E955), glycerol (E422), hydroxyethylcellulose (E1525) (See section 2 “PHEBURANE oral solution contains aspartame”). The pack with flavourings also contains Flavourings:
  • The blackcurrant flavour consists of blackcurrant and mint flavouring and contains propylene glycol (E1520).
  • The lemon-mint flavour consists of lemon and mint flavouring.

Description of the appearance of PHEBURANE oral solution and contents of the pack
PHEBURANE oral solution is a clear liquid, colourless to pale yellow.
Each pack contains:

• An amber glass bottle of 100 ml for the oral solution, closed with a child-resistant plastic cap;
• A dosing syringe from 0.5 g to 3 g with 0.25 g increments to measure the dose in grams of sodium phenylbutyrate;
• A bottle adapter.
  The pack with flavourings additionally contains:
• An amber glass bottle of 3 ml of lemon-mint flavouring,
• An amber glass bottle of 3 ml of blackcurrant flavouring.

Marketing Authorisation Holder and Manufacturer
Eurocept International BV
Trapgans 5
1244 RL Ankeveen
The Netherlands
For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien Lietuva
Lucane Pharma FrostPharma AB
(Eurocept International BV) Tel: +46 824 36 60
Tél/Tel: +31 35 528 39 57 [email protected]
[email protected]
България Luxembourg/Luxemburg
Lucane Pharma Lucane Pharma
(Eurocept International BV) (Eurocept International BV)
Teл.: +31 35 528 39 57 Tél/Tel: +31 35 528 39 57
[email protected] [email protected]
Česká republika Magyarország
Lucane Pharma Lucane Pharma
(Eurocept International BV) (Eurocept International BV)
Tél/Tel: +31 35 528 39 57 Tel: +31 35 528 39 57
[email protected] [email protected]
Danmark Malta
FrostPharma AB Lucane Pharma
Tlf: +46 824 36 60 (Eurocept International BV)
[email protected] Tel: +31 35 528 39 57
[email protected]
Deutschland Nederland
Lucane Pharma Lucane Pharma
(Eurocept International BV) (Eurocept International BV)
Tel: +31 35 528 39 57 Tel: +31 35 528 39 57
[email protected] [email protected]
Eesti Norge
FrostPharma AB FrostPharma AB
Tel: +46 824 36 60 Tlf: +46 824 36 60
[email protected] [email protected]
Ελλάδα Österreich
Lucane Pharma Lucane Pharma
(Eurocept International BV) (Eurocept International BV)
Τηλ: +31 35 528 39 57 Tel: +31 35 528 39 57
[email protected] [email protected]
España Polska
Lucane Pharma Lucane Pharma
(Eurocept International BV) (Eurocept International BV)
Tel: +31 35 528 39 57 Tel: +31 35 528 39 57
[email protected] [email protected]
France Portugal
Lucane Pharma Lucane Pharma
Tél: +33 153 868 750 (Eurocept International BV)
[email protected] Tel: +31 35 528 39 57
[email protected]
Hrvatska România
Lucane Pharma Lucane Pharma
(Eurocept International BV) (Eurocept International BV)
Tel: +31 35 528 39 57 Tel: +31 35 528 39 57
[email protected] [email protected]
Ireland Slovenija
Lucane Pharma Lucane Pharma
(Eurocept International BV) (Eurocept International BV)
Tel: +31 35 528 39 57 Tel: +31 35 528 39 57
[email protected] [email protected]
Ísland Slovenská republika
FrostPharma AB Lucane Pharma
Simi: +46 824 36 60 (Eurocept International BV)
[email protected] Tel: +31 35 528 39 57
[email protected]
Italia Suomi/Finland
Lucane Pharma FrostPharma AB
(Eurocept International BV) Pub/Tel: +46 824 36 60
Tel: +31 35 528 39 57 [email protected]
[email protected]
Κύπρος Sverige
Lucane Pharma FrostPharma AB
(Eurocept International BV) Tel: +46 824 36 60
Τηλ: +31 35 528 39 57 [email protected]
[email protected]
Latvija
FrostPharma AB
Tel: +46 824 36 60
[email protected]

More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/.
In addition, links to other websites on rare diseases and their therapeutic treatments are provided.