FINCORD CAPSULES 0.5 MG

Kraj: Singapur

Język: angielski

Źródło: HSA (Health Sciences Authority)

Składnik aktywny:

Fingolimod hydrochloride eqv. Fingolimod

Dostępny od:

ACCORD HEALTHCARE PRIVATE LIMITED

Kod ATC:

L04AA27

Forma farmaceutyczna:

CAPSULE, GELATIN COATED

Skład:

Fingolimod hydrochloride eqv. Fingolimod 0.5 MG

Droga podania:

ORAL

Typ recepty:

Prescription Only

Wyprodukowano przez:

Intas Pharmaceuticals Limited

Status autoryzacji:

ACTIVE

Data autoryzacji:

2022-06-29

Charakterystyka produktu

PRESCRIBING INFORMATION
For the use of a registered medical practitioner or a hospital or a
laboratory only
FINCORD
FINGOLIMOD CAPSULES 0.5MG
1.
NAME OF THE MEDICINAL PRODUCT
FINCORD [Fingolimod Capsules 0.5mg]
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard gelatin capsule contains:
Fingolimod hydrochloride USP 0.56mg eq.to
Fingolimod 0.5mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard gelatin capsule
Bright yellow opaque/white opaque size “3” hard gelatin capsule
imprinted with “FO 0.5 mg”
on the cap and two radial bands on the capsule body with yellow ink
containing white to off
white powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Fincord 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 Fincord 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.
Fincord 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 0.5 mg daily dose, it is
recommended to repeat the
observation after first dose.
For recommendations related to switching patients from other disease
modifying therapies to
Fingolimod (see section 4.4).
Special populations
_Elderly populati