Negara: Indonesia
Bahasa: Bahasa Indonesia
Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
PRAMIPEXOLE
BOEHRINGER INGELHEIM INDONESIA - Indonesia
PRAMIPEXOLE
0,375 MG
TABLET PELEPASAN LAMBAT
DUS, 3 ALUBLISTER @ 10 TABLET PELEPASAN LAMBAT
BOEHRINGER INGELHEIM - West Germany
2015-11-17
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. � ; ����� � blets are indicated for the symptomatic treatme r t . � f � � io , � at �� - C- � e � _ t , I � - �� .. � � . � . � . � I ' Uf d� �fl;.: ............ . DOSAGE AND ADMINISTRATION ,L _.r_ _0_ _.��!_ _0_ _E' :.�.�._ _0_ _.: .. _ _�.�! _ _.. _ _� _ _.... ._ _(All dose information refers to pramipexole salt form) _ j : , , q, :� ll h ·.: ..... ••. •• • .... ..... . . . .. . I 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 Baca dokumen lengkapnya