מדינה: אינדונזיה
שפה: אינדונזית
מקור: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE
BOEHRINGER INGELHEIM INDONESIA - Indonesia
PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE
0,375 Mg
TABLET PELEPASAN LAMBAT
DUS, 3 ALUBLISTER @ 10 TABLET PELEPASAN LAMBAT
ROTTENDORF PHARMA GMBH - Federal Republic of Germany
2021-08-04
PT. Boehringer Ingelheim Indonesia Medical and Regulatory Affairs SIFROL ER, Rottendorf SIFROL ® PRAMIPEXOLE COMPOSITION 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. Excipients**: hypromellose 2208, maize starch, carbomer 941, colloidal anhydrous silica, magnesium stearate INDICATION/USAGE SIFROL ® 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. SIFROL ® tablets are indicated for the symptomatic treatment of idiopathic Restless Legs Syndrome. DOSAGE AND ADMINISTRATION _(All dose information refers to pramipexole salt form) _ PARKINSON ’S DISEASE Dosage Initial treatment As shown below dosages should be increased gradually from a starting dose of 0.375 mg per day and then increased every 5 - 7 days. Providing patients do not experience intolerable side effects, the dosage should be titrated to achieve a maximal therapeutic effect. ASCENDING-DOSE SCHEDULE OF SIFROL ® _week _ _total daily _ _dose (mg) _ _tablets (mg) _ _Extended-release _ _tablets (mg) _ 1 0.375 3 x 0.125 _0.375 _ 2 0.75 3 x 0.25 _0.75 _ 3 1.50 3 x 0.5 _1.50 _ If a further dose increase is necessary the daily dose should be increased by 0.75 mg at weekly intervals up to a maximum dose of 4.5 mg per day. Patients already taking SIFROL ® tablets may be switched to SIFROL ® prolonged-release tablets overnight, at the same daily dose. Maintenance treatment: The individual dose should be in the range of 0.375 mg to a maximum of 4.5 mg per day. During dose escalation in pivotal studies both in early and advanced disease efficacy was observed starting at a daily dose of 1.5 mg. This does not preclude that in in קרא את המסמך השלם