200 mg dispersible tablets
Carglumic acid
1. WHAT CARBAGLU IS AND WHAT IT IS USED FOR
Carbaglu can help eliminate greatly elevated ammonia levels in the plasma(increased levels of ammonia in the blood). Ammonia is particularly toxic to the brain and can, in severe cases, lead to decreased levels of consciousness and coma. High ammonia levels (hyperammonemia) may be due to
- deficiency of a specific liver enzyme, N-acetyl glutamate synthase. Patients with this rare disease are not able to eliminate nitrogen residues that are formed after consuming protein. The disease persists throughout the life of the affected patient and the need for this treatment is therefore lifelong.
- isovaleric acidemia, methylmalonic acidemia, and propionic acidemia. Patients suffering from any of these diseases need treatment during the hyperammonemia crisis.
2. BEFORE YOU TAKE CARBAGLU
Do not take Carbaglu:
You must not take Carbaglu if you are hypersensitive (allergic) to carglumic acid or any of the other ingredients of Carbaglu.
Do not use Carbaglu if you are breast-feeding.
Take special care with Carbaglu:
Carbaglu treatment should be initiated under the supervision of a physician experienced in the treatment of metabolic diseases.
Your doctor will evaluate how you respond to treatment with carglumic acid before starting any long-term treatment.
Dose one should be adjusted individually to maintain normal ammonia plasma levels.
Your doctor may prescribe arginine supplements or limit your protein intake.
To monitor your condition and treatment, your doctor may need to examine you regularly for liver, kidneys, heart, and blood.
Use of other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Use of Carbaglu with food and drink
Carbaglu should be taken by mouth before a meal or feeding.
The tablets should be dissolved in at least 5 to 10 ml of water and taken immediately. Suspension one has a slightly sour taste.
Pregnancy and breastfeeding
The effects of Carbaglu on pregnancy and the fetus are unknown. Ask your doctor if you are pregnant or planning to become pregnant.
The secretion of carglumic acid into breast milk has not been studied in women. However, as the presence of carglumic acid in the milk of lactating rats has been shown, with a risk of toxic effects on the fed pups, you should not breast-feed your baby if you are taking Carbaglu.
Driving and using machines
Effects on ability to drive and use machines are not known.
3. HOW TO TAKE CARBAGLA
Always take Carbaglu exactly as your doctor has told you. If you are not sure, talk to your doctor or pharmacist.
Usual dose:
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 weigh 10 kg, you should take 1 g per day or 5 tablets).
In the long term, the daily dose usually varies between 10 mg and 100 mg per kilogram body weight for patients who are deficient in N-acetyl glutamate synthase.
Your doctor will determine the appropriate dose for you to maintain normal levels of ammonia in your blood.
Carbaglu should ONLY be given by mouth or by gavage (with a syringe , if needed).
If the patient is in a hyperammonemia coma, Carbaglu is given by rapidly squeezing the dose one through a syringe through the tube inserted for nutrient delivery.
If you take more Carbaglu than you should
Consult your doctor or pharmacist.
If you forget to take Carbaglu
Do not take a double dose to make up for forgotten dose.
If you stop taking Carbaglu
Do not stop taking Carbaglu without informing your doctor.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Carbaglu can cause side effects, although not everybody gets them.
The following adverse reactions have been reported as follows: very common (affects at least 1 in 10 patients), common (affects at least 1 in 100 patients), uncommon (affects at least 1 in 1,000 patients), rare (affects at least 1 patient) of 10,000 patients), very rare (occurs in at least 1 in 100,000 patients) and has been reported (occurs in an unknown number of users).
- Common: increased sweating
- Uncommon: bradycardia (decreased heart rate), diarrhea, fever, increased transaminases, and vomiting
- Has been reported: rash
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.
5. HOW TO STORE CARBAGLU
Keep out of sight and reach of children.
Do not use this medicine after the expiry date which is stated on the tablet can.
Store in a refrigerator (2ºC-8ºC).
After opening the jar: Store in a cool place. Do not store above 30 ° C.
Close the package tightly. Moisture sensitive.
Write the date of opening on the tablet jar. Discard 3 months after opening the package.
6. FURTHER INFORMATION
Content declaration
- The active substance is carglumic acid. Each tablet contains 200 mg of carglumic acid.
- The other ingredients are microcrystalline cellulose, sodium lauryl sulfate, hypromellose, croscarmellose sodium, anhydrous colloidal silica, sodium stearyl fumarate.
What the medicine looks like and the contents of the pack
Carbaglu 200 mg tablet is an elongated tablet with four embossments on one side with three notches. Carbaglu is available in plastic packs of 5, 15, and 60 tablets that are closed with a childproof lid.
Marketing Authorisation Holder
Record Rare Diseases
Real Estate “Le Wilson”
70, Avenue du Général de Gaulle
F-92800 Puteaux
France
Tel: +33 1 4773 6458
Fax: +33 1 4900 1800
Manufacturer
Record Rare Diseases
Real Estate “Le Wilson”
70, Avenue du Général de Gaulle
F-92800 Puteaux
France
or
Record Rare Diseases
Eco River Parc
30, rue des Peupliers
F-92000 Nanterre
France
For any information about this medicinal product, please contact the local representative of the Marketing Authorization Holder.
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