DIMETHYL FUMARATE TEVA 240 MG

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

DIMETHYL FUMARATE

متاح من:

TEVA ISRAEL LTD

ATC رمز:

L04AX07

الشكل الصيدلاني:

GASTRO RESISTANT HARD CAPSULE

تركيب:

DIMETHYL FUMARATE 240 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

TEVA PHARMACEUTICAL INDUSTRIES LTD, ISRAEL

المجال العلاجي:

DIMETHYL FUMARATE

الخصائص العلاجية:

Dimethyl Fumarate Teva is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis

تاريخ الترخيص:

2020-04-07

خصائص المنتج

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