GILENYA 0.5 MG

Country: Iżrael

Lingwa: Ingliż

Sors: Ministry of Health

Ingredjent attiv:

FINGOLIMOD AS HYDROCHLORIDE

Disponibbli minn:

NOVARTIS ISRAEL LTD

Kodiċi ATC:

L04AA27

Għamla farmaċewtika:

HARD CAPSULE

Kompożizzjoni:

FINGOLIMOD AS HYDROCHLORIDE 0.5 MG

Rotta amministrattiva:

PER OS

Tip ta 'preskrizzjoni:

Required

Manifatturat minn:

NOVARTIS PHARMA STEIN AG, SWITZERLAND

Grupp terapewtiku:

FINGOLIMOD

Żona terapewtika:

FINGOLIMOD

Indikazzjonijiet terapewtiċi:

Gilenya is indicated for the treatment of patients with relapsing forms of multiple sclerosis ( MS ) to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability.

Data ta 'l-awtorizzazzjoni:

2016-03-31

Fuljett ta 'informazzjoni

ةيئاودلا ةعرجلا لوانت لبق بلقلل
يئابرهكلا طيطختلا صحف
∙
ةيئاودلا ةعرجلا لوانت دعب ةعاس لك مدلا
طغضو ضبنلا صوحف
∙
ةيئاودلا ةعرجلا لوانت نم تاعاس 6 دعب
بلقلل يئابرهكلا طيطختلا صحف
∙
جلاعلا نع فقوتلا
.بيبطلا ةيصوت بسح جلاعلا ىلع ةبظاوملا
بجي
نسحت أرط ولو ىتح ،بيبطلا ةراشتسإ نودب
ءاودلاب جلاعلا نع فقوتلا زوجي لا
.ةيحصلا كتلاح ىلع
رظنأ ـ مقافتتو دوعت دق ددعتملا بلصتلا
ضارعأ نإف ،ءاودلا لوانت نع تفقوت اذإ
ةرقف يف »اينيليﭼ نع فقوتلا دعب
ددعتملا بلصتلا ضرم يف ديدش مقافت«
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.
ءاود ﺎهيف لوﺎﻨتت
ةرم لك يف
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عض وأ بيبطلا رشتسإ ،ءاودلا لﺎمعتسإ لوح
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مظن ؤطابت ىلإ يدؤت نأ اينيليﭼ ناكمإب
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Karatteristiċi tal-prodott

GIL API NOV23 V 10.1
Page 1 of 22
USPI Aug.2023, EU SmPC Dec.2022
PRESCRIBING INFORMATION
1
NAME OF THE MEDICINAL PRODUCT
Gilenya 0.5 mg
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
GILENYA is provided as 0.5 mg hard gelatin capsules for oral use.
Each 0.5 mg capsule contains 0.56 mg of fingolimod hydrochloride,
equivalent to 0.5 mg of fingolimod.
For the full list of excipients, see section 12.
3
PHARMACEUTICAL FORM
Hard capsule.
Hard capsules with a white opaque body and bright yellow opaque cap;
radial imprint in black ink
“FTY 0.5 mg”
on the cap and 2 radial bands imprinted on the capsule body with
yellow ink.
Fingolimod hydrochloride is a white to almost white crystalline
powder.
PATIENT/CAREGIVER GUIDE AND PREGNANCY REMINDER CARD
The marketing of Gilenya 0.5 mg is subject to a risk management plan
(RMP) including a 'Patient/Caregiver guide'
and a 'Pregnancy reminder card'.
These materials emphasize important safety information that the
patient should be aware of before and during
treatment.
Please explain to the patient the need to review these materials
before starting treatment.
PHYSICIAN'S CHECKLIST
This product is marketed with a 'physician's checklist' providing
important safety information.
Please ensure you are familiar with this material as it contains
important safety information.
4
THERAPEUTIC INDICATIONS
Gilenya is indicated for the treatment of patients with relapsing
forms of multiple sclerosis (MS) to reduce the frequency
of clinical exacerbations and to delay the accumulation of physical
disability.
5
DOSAGE AND ADMINISTRATION
GENERAL TARGET POPULATION
The recommended dose of Gilenya is one 0.5 mg capsule taken orally
once daily, which can be taken with or without
food.
If a dose is missed, treatment should be continued with the next dose
as planned.
Before initiating treatment with Gilenya, a recent complete blood
count (CBC) (i.e. within 6 months or after
discontinuation of prior therapy) should be available. Assessments of
CBC are also recommended periodically during
treatment, at month