Land: Singapur
Sprache: Englisch
Quelle: HSA (Health Sciences Authority)
Dimethyl fumarate
EISAI (SINGAPORE) PTE. LTD.
N07XX09
CAPSULE, ENTERIC COATED
Dimethyl fumarate 120.0mg
ORAL
Prescription Only
Corden Pharma Fribourg SA
ACTIVE
2016-07-26
DIN Pro-Regular, DIN Pro-Bold, DIN Pro-Italic 8.0 pt ART08490 01 English FPO STANDARD MOCK UP PAT INF INSERT X-LARGE TECFIDERA SGP N/A PKG00069-01 N/A XXXXXX Schawk-108385734/403211424 0020 08 Mar 2023 Black PMS 249 PMS 368 PMS 299 PHARMACODE NUMBER:FPO I_I_045_V2 W360 X H690, FOLDED: 100 X 45 TBC TBC TBC PROFILE PROFILE (NON PRINT) TBC ENGLISH 120 MG GASTRO-RESISTANT HARD CAPSULES 240 MG GASTRO-RESISTANT HARD CAPSULES DIMETHYL FUMARATE TECFIDERA GASTRO-RESISTANT HARD CAPSULES 1. NAME OF THE MEDICINAL PRODUCT Tecfidera 120 mg gastro-resistant hard capsules Tecfidera 240 mg gastro-resistant hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Tecfidera 120mg gastro-resistant hard capsules Each gastro-resistant hard capsule contains 120 mg dimethyl fumarate. Tecfidera 240mg gastro-resistant hard capsules Each gastro-resistant hard capsule contains 240 mg dimethyl fumarate For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Gastro-resistant hard capsule Tecfidera 120 mg gastro-resistant hard capsules Green and white gastro-resistant hard capsules, size 0, printed with ‘BG-12 120 mg’ containing microtablets. Tecfidera 240 mg gastro-resistant hard capsules Green gastro-resistant hard capsules, size 0, printed with ‘BG-12 240 mg’ containing microtablets. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS Tecfidera is indicated for the treatment of adult and paediatric patients aged 13 years and older with relapsing remitting multiple sclerosis (RRMS). 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. Tempora Lesen Sie das vollständige Dokument