Quốc gia: Armenia
Ngôn ngữ: Tiếng Anh
Nguồn: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
carbamazepine
Arpimed LLC
carbamazepine
200mg
tablets
Prescription
SUMMARY PRODUCT CHARACTERISTIC (SMPC) CARBAMAZEPINE 200 MG TABLETS 1. NAME OF THE MEDICAL PRODUCT – CARBAMAZEPINE 1.2. INTERNATIONAL NON-PROPERTY NAME – CARBAMAZEPINE 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 200 mg of carbamazepine For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet White or off white, round biconvex, scored on one side tablets, odorless. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Epilepsy - generalised tonic-clonic and partial seizures. Note: Carbamazepine is not usually effective in absences (petit mal) and myoclonic seizures. Moreover, anecdotal evidence suggests that seizure exacerbation may occur in patients with atypical absences. The paroxysmal pain of trigeminal neuralgia. For the prophylaxis of manic-depressive psychosis in patients unresponsive to lithium therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Carbamazepin is given orally, usually in two or three divided doses. Carbamazepine may be taken during, after or between meals, with a little liquid e.g. a glass of water. Before deciding to initiate treatment, patients of Han Chinese and Thai origin should whenever possible be screened for HLA-B*1502 as this allele strongly predicts the risk of severe carbamazepine-associated Stevens-Johnson syndrome (See information on genetic testings and cutaneous reactions in section 4.4). _ _ _Epilepsy_: The dose of carbamazepine should be adjusted to the needs of the individual patient to achieve adequate control of seizures. Determination of plasma levels may help in establishing the optimum dosage. In the treatment of epilepsy, the dose of carbamazepine usually requires total plasma-carbamazepine concentrations of about 4 to 12 micrograms/mL (17 to 50 micromoles/litre) (see warnings and precautions). _Adults:_ It is advised that with all formulations of Carbamazepine, a gradually increasing dosage scheme is used and this should be adjusted to suit the needs of the individual patient. Carbamazepine should be taken in a number of d Đọc toàn bộ tài liệu