TECFIDERA 120 MG

国: イスラエル

言語: 英語

ソース: Ministry of Health

有効成分:

DIMETHYL FUMARATE

から入手可能:

MEDISON PHARMA LTD

ATCコード:

N07XX09

医薬品形態:

GASTRO RESISTANT HARD CAPSULE

構図:

DIMETHYL FUMARATE 120 MG

投与経路:

PER OS

処方タイプ:

Required

製:

BIOGEN IDEC LTD, UK

治療領域:

DIMETYL FUMARATE

適応症:

Tecfidera is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis.

承認日:

2019-04-30

製品の特徴

1
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 capsule
Eachcapsule contains 120 mg dimethyl fumarate. Tecfidera 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
Tecfidera 120mg gastro-resistant hard capsules
Green and white gastro-resistant hard capsules, size 0, printed with
‘BG-12 120 mg’ containing
microtablets.
Tecfidera 240mg 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 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).
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
twice a day should be resumed.
2
Tecfidera should be taken with food (see section 5.2). For those
patients who may experience flushing
or gastrointestinal adverse reactions, taking Tecfidera with food may
improve tolerability (see
sections 4.4, 4.5 and 4.8).
_Special populations _
_Elderly _
Clinical studies of Tecfidera had limited exposure to patients aged 55
years and above, and did not
include sufficient numbers of patients aged 65 and over to determine
whether they respond differently
than younger patients (see section 5.2). Based on the