ประเทศ: อิสราเอล
ภาษา: อังกฤษ
แหล่งที่มา: Ministry of Health
CARGLUMIC ACID
MEDISON PHARMA LTD
A16AA05
TABLETS DISPERSIBLE
CARGLUMIC ACID 200 MG
PER OS
Required
RECORDATI RARE DISEASES, FRANCE
CARGLUMIC ACID
CARGLUMIC ACID
Carbaglu is indicated in treatment of :- hyperammonaemia due to N - acetylglutamate synthase primary deficiency.- hyperammonaemia due to isovaleric acidaemia.- hyperammonaemia due to methymalonic acidaemia.- hyperammonaemia due to propionic acidaemia.
2017-03-23
1 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) 1986 This medicine is dispensed with a doctor’s prescription only CARBAGLU DISPERSIBLE TABLETS Each tablet contains: CARGLUMIC ACID 200 MG Inactive ingredients see section 6 (“Additional information”) in this leaflet. READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have any further questions, consult your doctor or pharmacist. This medicime has been prescribed to treat your illness. Do not pass it on to others. It may harm them, even if it seems to you that their illness is similar to yours. 1. WHAT IS THIS MEDICINE USED FOR? CARBAGLU can help eliminate excess ammonia from the blood. When ammonia accumulates in your blood it is toxic mainly to the brain. In severe cases, its accumulation may cause decreased level of consciousness and coma. CARBAGLU is used to treat hyperammonemia (a condition in which high levels of ammonia are found in the plasma), in patients with hyperammonemia caused by: lack of a liver enzyme called N-acetylglutamate synthase. Patients with this rare condition cannot eliminate nitrogen, a waste material which accumulates in their body as a result of eating protein. This medical condition persists throughout a patient's life, therefore the need for this treatment is lifelong. certain acidemia conditions (propionic acidemia, isovaleric acidemia, methylmalonic acidemia). Patients suffering from one of these conditions must be treated during the hyperammonemia stage of their illness. THERAPEUTIC GROUP: CPS (carbamoyl phosphate synthase) activator. 2. BEFORE USING THIS MEDICINE DO NOT USE THIS MEDICINE IF: You are sensitive (allergic) to the active ingrediant carglumic acid or to any of the other ingredients in this medicine. You are breastfeeding SPECIAL WARNINGS ABOUT USING THIS MEDICINE Your doctor will evaluate your individual response to carglumic acid before deciding on long-term treatment. อ่านเอกสารฉบับเต็ม
1 PHYSICIAN'S PRESCRIBING INFORMATION 1 NAME OF THE MEDICINAL PRODUCT Carbaglu 200 mg dispersible tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 2.1 GENERAL DESCRIPTION Each tablet contains 200 mg of carglumic acid. 2.2 QUALITATIVE AND QUANTITATIVE COMPOSITION For a full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Dispersible tablet The tablets are white and elongated with three score marks and engraved on one side. The tablet can be divided into equal halves. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Carbaglu is indicated in treatment of • hyperammonaemia due to N-acetylglutamate synthase primary deficiency. • hyperammonaemia due to isovaleric acidaemia. • hyperammonaemia due to methymalonic acidaemia. • hyperammonaemia due to propionic acidaemia. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Carbaglu treatment should be initiated under the supervision of a physician experienced in the treatment of metabolic disorders. Posology: • For N-acetylglutamate synthase deficiency: 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 Carbaglu. - In a patient with moderate hyperammonaemia, administer a test dose of 100 to 200 mg/kg/day 2 for 3 days with a constant protein intake and perform repeated determinations of ammonia plasma c อ่านเอกสารฉบับเต็ม