SIFROL ER

Maa: Indonesia

Kieli: indonesia

Lähde: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Aktiivinen ainesosa:

PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE

Saatavilla:

BOEHRINGER INGELHEIM INDONESIA - Indonesia

INN (Kansainvälinen yleisnimi):

PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE

Annos:

0.375 MG

Lääkemuoto:

TABLET PELEPASAN LAMBAT

Kpl paketissa:

DUS, 3 ALUBLISTER @ 10 TABLET PELEPASAN LAMBAT

Valmistaja:

BOEHRINGER INGELHEIM PHARMA GMBH & CO. KG., GERMANY - Federal Republic of Germany

Valtuutus päivämäärä:

2020-11-05

Valmisteyhteenveto

PT. BOEHRINGER LNGCLHCIM INDONESIA
DRUG REGULATORY AFFAIRS DEPT.
1.
BASIC
PRODUCT INFORMATION
No. 0186-16
25 July 2012
SIFROL
®
PRAMIPEXOLE
COMPOSITION
1 tablet contains
0.125, 0.25 mg
(S)-2-amino-4,5,6,
7-tetrahydro-6-propylamino-benzothiazole dihydrochloride
monohydrate equivalent to 0.088, 0.18 mg pramipexole base
Exciplents:
mannltol, maize starch, anhydrous colloidal silica, polyvidone,
magnesium stearate
1 extended-release tablet contains
0.375, 0.75 mg
(S)-2-amino-4,5,6,
7-tetrahydro-6-propylamino-benzothiazole dihydrochloride
monohydrate equivalent to 0.26, 0.52 mg pramipexole base
Exciplents .. :
hypromellose 2208, maize starch, carbomer 941, colloidal anhydrous
silica, magnesium stearate
INDICATION
SIFROL
G
tablets and extended-release tablets are indicated for the treatment
of the signs
and symptoms of idiopathic parkinson's disease when the effect of
levodopa wears off or
becomes inconsistent and fluctuations of the therapeutic effect occur
(end of dose "on
off" fluctuations). It may be used alone (without levodopa) or in
combination with
levodopa.
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blets are indicated for the symptomatic treatme
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DOSAGE AND ADMINISTRATION
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_(All dose information refers to pramipexole salt form) _
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PARKINSON 'S DISEASE
Tablets
The tablets should be taken orally, swallowed with water, and can be
taken either with or
without food.
The daily dosage is administered in equally divided doses 3x per day.
Remarks: Yellow (CCDS 0186·13), blue (CCDS 0186-14), green (CCDS
0186-15), orange (CCDS 0186-16)
SIFROL
I')
CCDS 0186-16_ Reg May 12