Land: Singapore
Taal: Engels
Bron: HSA (Health Sciences Authority)
Pazopanib hydrochloride 433.4 mg eqv pazopanib
NOVARTIS (SINGAPORE) PTE LTD
L01XE11
400 mg
TABLET, FILM COATED
Pazopanib hydrochloride 433.4 mg eqv pazopanib 400 mg
ORAL
Prescription Only
Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations)
ACTIVE
2011-09-23
VOTRIENT TM PAZOPANIB HYDROCHLORIDE 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 first line treatment of advanced renal cell carcinoma (RCC) and for patients who have received prior cytokine therapy for advanced disease. Soft tissue sarcoma (STS) VOTRIENT is indicated for the treatment of adult patients with selective subtypes of Soft Tissue Sarcoma (STS) who have received prior chemotherapy for metastatic disease or who have progressed within 12 months after (neo) adjuvant therapy. Efficacy and safety has only been established in certain STS histological tumour subtypes (_see Clinical Studies_). DOSAGE AND ADMINISTRATION The recommended dose of VOTRIENT is 800 mg orally once daily. VOTRIENT should be taken without food (at least one hour before or two hours after a 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. Dose modifications Initial dose reduction should be from 800 mg to 400 mg daily. Subsequent 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. _ _ _C Lees het volledige document
Votrient Jun 2021.SIN Page 1 of 25 VOTRIENT Antineoplastic agents – Protein kinase inhibitor DESCRIPTION AND COMPOSITION PHARMACEUTICAL FORMS(S) Film-coated tablet 200mg Tablet: Modified capsule-shaped, pink; with GS JT debossed on one side. 400mg Tablet: Modified capsule-shaped, white; with GS UHL debossed on one side. ACTIVE SUBSTANCE(S) Each 200 mg tablet contains 216.7 mg of pazopanib hydrochloride, which is equivalent to 200 mg of pazopanib as free base. Each 400 mg tablet contains 433.4 mg of pazopanib hydrochloride, which is equivalent to 400 mg of pazopanib as free base. EXCIPIENTS Tablet core Magnesium stearate; microcrystalline cellulose; povidone (K30); sodium starch glycollate Tablet coating 200 mg (Opadry Pink): Hypromellose; Iron Oxide Red (E172); Macrogol / PEG 400; Polysorbate 80; Titanium dioxide (E171) 400 mg (Opadry White): Hypromellose; Macrogol / PEG 400; Polysorbate 80; Titanium dioxide (E171) CLINICAL INFORMATION INDICATIONS Renal cell carcinoma (RCC) VOTRIENT is indicated for the first line treatment of advanced renal cell carcinoma (RCC) and for patients who have received prior cytokine therapy for advanced disease. Soft tissue sarcoma (STS) VOTRIENT is indicated for the treatment of adult patients with selective subtypes of Soft Tissue Sarcoma (STS) who have received prior chemotherapy for metastatic disease or who have progressed within 12 months after (neo) adjuvant therapy. Efficacy and safety has only been established in certain STS histological tumour subtypes ( _see Clinical Studies_ ). Votrient Jun 2021.SIN Page 2 of 25 DOSAGE REGIMEN AND ADMINISTRATION DOSAGE REGIMEN GENERAL TARGET POPULATION The recommended dose of VOTRIENT is 800 mg orally once daily. (see Method of administration) DOSE MODIFICATIONS Initial dose reduction should be from 800 mg to 400 mg daily. Subsequent 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 daily dose of VOTRIE Lees het volledige document