Gilenya Capsule 0.5mg

Valsts: Singapūra

Valoda: angļu

Klimata pārmaiņas: HSA (Health Sciences Authority)

Aktīvā sastāvdaļa:

Fingolimod HCl 0.56 mg eqv Fingolimod

Pieejams no:

NOVARTIS (SINGAPORE) PTE LTD

ATĶ kods:

L04AA27

Deva:

0.5mg

Zāļu forma:

CAPSULE

Kompozīcija:

Fingolimod HCl 0.56 mg eqv Fingolimod 0.5mg

Ievadīšanas:

ORAL

Receptes veids:

Prescription Only

Ražojis:

Novartis Pharma Stein AG

Autorizācija statuss:

ACTIVE

Autorizācija datums:

2012-05-30

Lietošanas instrukcija

 
1 

1. 
NAME OF THE MEDICINAL PRODUCT 

GILENYA
TM
 0.5 mg hard capsules 

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Each capsule contains 0.5 mg fingolimod (as hydrochloride). 

For the full list of excipients, see section 6.1. 

3. 
PHARMACEUTICAL FORM 

Hard capsule 

Capsule of 16 mm with bright yellow opaque cap and white
opaque body; imprint with black ink, 
“FTY0.5 mg” on cap and two radial bands imprinted on the
body with yellow ink. 

4. 
CLINICAL PARTICULARS 

4.1 
THERAPEUTIC INDICATIONS 

Gilenya is indicated as monotherapy for the treatment of patients with the relapsing-remitting form of 
multiple  sclerosis  to  reduce  the  frequency  of  clinical  exacerbations  and  to  delay  the  progression  of 
physical disability. 

Gilenya  is  generally  recommended  in  MS  patients  who  have  had  an  inadequate  response  to,  or  are 
unable to tolerate, one or more therapies for multiple
sclerosis. 

_ _
4.2 
POSOLOGY AND METHOD OF ADMINISTRATION 

The treatment should be initiated and supervised by a physician
experienced in multiple sclerosis. 

Posology 
The recommended dose of Gilenya is one 0.5 mg capsule taken
orally once daily. Gilenya can be 
taken with or without food. 

If a dose is missed treatment should be continued with the
next dose as planned. 

For recommendations related to switching patients
from other disease modifying therapies to Gilenya 
(see section 4.4).   

Special populations 
_Elderly population_ 
Gilenya should be used with caution in patients aged 65 years and
over due to insufficient data on 
safety and efficacy (see section 5.2). 

2 
_Renal impairment _
Gilenya was not studied in patients with renal impairment in
the multiple sclerosis pivotal studies. 
Based on clinical pharmacology studies

Produkta apraksts

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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