দেশ: সিঙ্গাপুর
ভাষা: ইংরেজি
সূত্র: HSA (Health Sciences Authority)
Fingolimod HCl 0.56 mg eqv Fingolimod
NOVARTIS (SINGAPORE) PTE LTD
L04AA27
0.5mg
CAPSULE
Fingolimod HCl 0.56 mg eqv Fingolimod 0.5mg
ORAL
Prescription Only
Novartis Pharma Stein AG
ACTIVE
2012-05-30
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 সম্পূর্ণ নথি পড়ুন
Gilenya Dec 2020.SIN Page 1 of 30 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. Gilenya Dec 2020.SIN Page 2 of 30 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 সম্পূর্ণ নথি পড়ুন