Ülke: Endonezya
Dil: Endonezce
Kaynak: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
TENOFOVIR DISOPROXIL FUMARATE, LAMIVUDINE, DOLUTEGRAVIR SODIUM
SAMPHARINDO RETROVIRAL INDONESIA - Indonesia
TENOFOVIR DISOPROXIL FUMARATE, LAMIVUDINE, DOLUTEGRAVIR SODIUM
300 MG /300 MG /52.6 MG
TABLET SALUT SELAPUT
DUS, 1 BOTOL PLASTIK @ 30 TABLET SALUT SELAPUT
SAMPHARINDO RETROVIRAL INDONESIA - Indonesia
2021-10-21
TEMODAL Â COMPOSITION Each Temodal capsule contains 5 mg, 20 mg, 100 mg or 250 mg temozolomide. DESCRIPTION Temodal in an imidazotetrazene alkylating agent with antitumor activity. It undergoes rapid chemical conversion in the systemic circulation at physiologic pH to the active compound, MTIC (monomethyl triazeno imidazole carboxamide). The cytotoxicity of MTIC is thought to be due primarily to alkylation at the O 6 position of guanine with additional alkylation also occurring at the N 7 position. Cytotoxic lesions that develop subsequently are thought to involve aberrant repair of the methyl adduct. From preclinical safety data, Temozolomide knows as an embryotoxic, teratogenic and genotoxic alkylating agent. INDICATIONS TEMODAL Capsules are indicated in treatment of patients with reccurent malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma. DOSAGE AND ADMINISTRATION Adult patients : In patients previously untreated with chemotherapy, TEMODAL is administered orally at a dose of 200 mg/m 2 once daily for 5 days per 28-day cycle. For patients previously treated with chemotherapy, the initial dose is 150 mg/m 2 once daily, to be increased in the second cycle to the 20 mg/m 2 daily providing the absolute neutrophil count (ANC) is ³ 1.5 x 10 9 /L and the thrombocyte count is ³ 100 x 10 9 /L on Day 1 of the next cycle. Pediatric patients : In patients 3 years of age older, TEMODAL is administered orally at dose of 200 mg/m 2 once daily for 5 days per 28-day cycle. Pediatric previously treated with chemotherapy should receive an initial dose of 160 mg/m 2 once daily for 5 days, with excalation to200 mg/m 2 once daily at the next cycle if there is no hematologic toxicity. Use in patients with hepatic or renal dysfunction The pharmacokinetics of temozolomide were comparable in patients with normal hepatic function and in those with mild or moderate hepatic dysfunction. No data are available on the administration of Temodal in patients with severe hepatic dysfunction (Child’s Class III) or w Belgenin tamamını okuyun