AZILECT TABLET 1MG

מדינה: סינגפור

שפה: אנגלית

מקור: HSA (Health Sciences Authority)

מרכיב פעיל:

RASAGILINE MESYLATE 1.56MG EQUIVALENT RASAGILINE

זמין מ:

LUNDBECK SINGAPORE PTE. LTD.

קוד ATC:

N04BD02

טופס פרצבטיות:

TABLET

הרכב:

RASAGILINE MESYLATE 1.56MG EQUIVALENT RASAGILINE 1 MG

מסלול נתינה (של תרופות):

ORAL

סוג מרשם:

Prescription Only

תוצרת:

Teva Pharmaceutical Industries, Ltd.

מצב אישור:

ACTIVE

תאריך אישור:

2017-07-07

מאפייני מוצר

AZILECT 1mg Tablets
rasagiline
1. NAME OF THE MEDICINAL PRODUCT
AZILECT 1 mg tablets
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 1 mg rasagiline (as mesilate).
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Tablet
White to off-white, round, flat, bevelled tablets, debossed with
“GIL” and “1” underneath on one side
and plain on the other side.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
AZILECT is indicated for the treatment of idiopathic Parkinson’s
disease (PD) as monotherapy
(without levodopa) or as adjunct therapy (with levodopa) in patients
with end of dose fluctuations.
4.2 Posology and method of administration
Posology
Rasagiline is administered orally, at a dose of 1 mg once daily with
or without levodopa.
It may be taken with or without food.
Elderly: No change in dose is required for elderly patients.
Paediatric population
:
AZILECT is not recommended for use in children and adolescents due to
lack
of data on safety and efficacy.
Patients with hepatic impairment: Rasagiline use in patients with
severe hepatic impairment is
contraindicated (see section 4.3). Rasagiline use in patients with
moderate hepatic impairment should
be avoided. Caution should be used when initiating treatment with
rasagiline in patients with mild
hepatic impairment. In case patients progress from mild to moderate
hepatic impairment rasagiline
should be stopped (see section 4.4).
Patients with renal impairment: No change in dose is required for
renal impairment.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients
(see section 6.1).
Concomitant treatment with other monoamine oxidase (MAO) inhibitors
(including medicinal and
natural products without prescription e.g. St. John's Wort) or
pethidine (see section 4.5). At least 14
days must elapse between discontinuation of rasagiline and initiation
of treatment with MAO
inhibitors or pethidine.
Rasagiline is contraindicated in patients with severe hepatic
impairment.
4.4 Special warning