Ország: Izrael
Nyelv: angol
Forrás: Ministry of Health
DIMETHYL FUMARATE
TEVA ISRAEL LTD
L04AX07
GASTRO RESISTANT HARD CAPSULE
DIMETHYL FUMARATE 240 MG
PER OS
Required
TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL
DIMETHYL FUMARATE
Dimethyl Fumarate Teva is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis
2020-04-07
1 Dimethyl Fumarate Teva 120 & 240 mg SmpC Notification New 11_2023 1. NAME OF THE MEDICINAL PRODUCT Dimethyl fumarate Teva 120 mg gastro-resistant hard capsules Dimethyl fumarate Teva 240 mg gastro-resistant hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Dimethyl fumarate Teva 120mg capsule Each capsule contains 120 mg Dimethyl fumarate. Dimethyl fumarate Teva 240mg capsule Each capsule contains 240 mg Dimethyl fumarate For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Gastro-resistant hard capsule Dimethyl fumarate Teva 120 mg Gastro-resistant hard capsules with opaque white body and opaque light- blue cap, printed with ‘A188', containing white to off white tablets. Dimethyl fumarate Teva 240 mg Gastro-resistant hard capsules with opaque light- blue body and cap, printed with ‘A240', containing white to off white tablets. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Dimethyl fumarate Teva is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis. (see section 5.1 for important information on the populations for which efficacy has been established). 4.2 Posology and method of administration Treatment should be initiated under supervision of a physician experienced in the treatment of multiple sclerosis. Posology The starting dose is 120 mg twice a day. After 7 days, the dose should be increased to the recommended maintenance dose of 240 mg twice a day (see section 4.4). If a patient misses a dose, a double dose should not be taken. The patient may take the missed dose only if they leave 4 hours between doses. Otherwise, the patient should wait until the next scheduled dose. Temporary dose reduction to 120 mg twice a day may reduce the occurrence of flushing and gastrointestinal adverse reactions. Within 1 month, the recommended maintenance dose of 240 mg 2 Dimethyl Fumarate Teva 120 & 240 mg SmpC Notification New 11_2023 twice a day should be resumed. Dimethyl fumarate Teva should be taken with food (see section 5.2). For those patie Olvassa el a teljes dokumentumot