GILENYA CAPSULE 0.25mg

Држава: Сингапур

Језик: Енглески

Извор: HSA (Health Sciences Authority)

Активни састојак:

Fingolimod HCl 0.28mg eqv Fingolimod

Доступно од:

NOVARTIS (SINGAPORE) PTE LTD

АТЦ код:

L04AA27

Фармацеутски облик:

CAPSULE

Састав:

Fingolimod HCl 0.28mg eqv Fingolimod 0.25mg

Пут администрације:

ORAL

Тип рецептора:

Prescription Only

Произведен од:

Novartis Pharma Stein AG

Статус ауторизације:

ACTIVE

Датум одобрења:

2019-08-05

Карактеристике производа

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1.
NAME OF THE MEDICINAL PRODUCT
GILENYA
®
0.25 mg hard capsules
GILENYA
®
0.5 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
0.25 mg hard capsules: Each capsule contains 0.25 mg fingolimod (as
hydrochloride).
0.5 mg hard capsules: Each capsule contains 0.5 mg fingolimod (as
hydrochloride).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule
0.5 mg capsule: White opaque (body) and bright yellow opaque (cap),
size 3; radial imprint with black
ink, “FTY 0.5 mg” on cap and two radial bands imprinted on the
body with yellow ink, containing white
to almost white powder.
0.25 mg capsule: Ivory opaque (body and cap), size 3, with black
radial imprint “FTY 0.25 mg” on cap
and black radial band on body containing white to almost white powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Gilenya is indicated as monotherapy for the treatment of adult
patients and paediatric patients of 10 years
of age and above with the relapsing-remitting form of multiple
sclerosis to reduce the frequency of clinical
exacerbations and to delay the progression of physical disability.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The treatment should be initiated and supervised by a physician
experienced in multiple sclerosis.
Posology
In adults, the recommended dose of Gilenya is one 0.5 mg capsule taken
orally once daily.
In paediatric patients (10 years of age and above), the recommended
dose is dependent on body weight:
_-_
_ _
_Paediatric patients with body weight ≤ 40 kg_
: one 0.25 mg capsule daily taken orally.
_-_
_ _
_Paediatric patients with body weight > 40 kg_
: one 0.5 mg capsule daily taken orally.
Paediatric patients who start on 0.25 mg capsules and subsequently
reach a stable body weight above
40 kg should be switched to 0.5 mg capsules.
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Gilenya can be taken with or without food. If a dose is missed
treatment should be continued with the
next dose as planned.
When switching from a 0.25 mg to a 0