Ülke: Endonezya
Dil: Endonezce
Kaynak: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
PAZOPANIB
NOVARTIS INDONESIA - Indonesia
PAZOPANIB
400 MG
TABLET SALUT SELAPUT
DUS, BOTOL PLASTIK @ 30 TABLET SALUT SELAPUT
GLAXO OPERATIONS UK LTD - England
2016-03-30
_Page 1 of 20 _ VOTRIENT TM PAZOPANIB QUALITATIVE AND QUANTITATIVE COMPOSITION _200 MG TABLET _ The 200 mg tablets contain 217 mg of pazopanib hydrochloride, equivalent to 200 mg of pazopanib free base. Modified capsule-shaped, pink; with GS JT debossed on one side. _400 MG TABLET _ The 400 mg tablets contain 433 mg of pazopanib hydrochloride, equivalent to 400 mg of pazopanib free base. Modified capsule-shaped, white; with GS UHL debossed on one side. PHARMACEUTICAL FORM Film-coated tablets CLINICAL INFORMATION INDICATIONS _Renal cell carcinoma (RCC) _ Votrient is indicated for the treatment of patient with advanced Renal Cell Carcinoma (RCC). _Soft tissue sarcoma (STS) _ Votrient is indicated for the treatment of patients with Soft Tissue Sarcoma (STS) who have received prior chemotherapy. The Phase III trial population excluded patients with gastrointestinal stromal tumour (GIST) or adipocytic STS. DOSAGE AND ADMINISTRATION Votrient treatment should only be initiated by a physician experienced in the administration of anti-cancer agents. The recommended dose of Votrient for the treatment of RCC or STS is 800 mg orally once daily. Votrient should be taken without food (at least one hour before or 2 hours after meal) ( _see _ _Pharmacokinetics_ ). Votrient should be taken whole with water and must not be broken or crushed ( _see _ _Pharmacokinetics_ ). If a dose is missed, it should not be taken if it is less than 12 hours until the next dose. DISETUJUI OLEH BPOM: 09/07/2021 EREG100005VR12100107 EREG100005VR12100108 _Page 2 of 20 _ DOSE MODIFICATIONS_ _ Dose modification, either an increase or decrease in dose, should be in 200 mg increments in a stepwise fashion based on individual tolerability in order to manage adverse reactions. The dose of Votrient should not exceed 800 mg. RENAL IMPAIRMENT There is no experience of Votrient in patients with severe renal impairment or in patients undergoing peritoneal dialysis or haemodialysis; therefore, use of Votrient is not recommended in these patients. Renal impairmen Belgenin tamamını okuyun