Država: Indonezija
Jezik: indonezijski
Izvor: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
TEMOZOLOMIDE
ORGANON PHARMA INDONESIA TBK - Indonesia
TEMOZOLOMIDE
20 MG
KAPSUL
DUS, 5 SACHET @ 1 KAPSUL
ORION CORPORATION - Finland
2021-08-18
TEMODAL Capsules Temozolomide COMPOSITION Each TEMODAL capsule contains 20 mg or 100 mg temozolomide. DESCRIPTION Temozolomide is an imidazotetrazine 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 occuring 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 known as embryotoxic, teratogenic and genotoxic alkylating agent. Preclinical safety data Single-cycle (5-day dosing, 23 days non-treatment), three- and six-cycle toxicity studies were conducted in rats and dogs. The primary targets of toxicity included the bone marrow, lymphoreticular system, testes, the gastrointestinal tract and, at higher doses, which were lethal to 60 % to 100 % of rats and dogs tested, degeneration of the retina occurred. Most of the toxicity showed evidence of reversibility, except for adverse events on the male reproductive system and retinal degeneration. However, because the doses implicated in retinal degeneration were in the lethal dose range, and no comparable effect has been observed in clinical studies, this finding was not considered to have clinical relevance. Temozolomide is an embryotoxic, teratogenic and genotoxic alkylating agent. Temozolomide is more toxic to the rat and dog than to humans, and the clinical dose approximates the minimum lethal dose in rats and dogs. Dose-related reductions in leucocytes and platelets appear to be sensitive indicators of toxicity. A variety of neoplasms, including mammary carcinomas, keratocanthoma of the skin and basal cell adenoma were observed in the six-cycle rat study while no tumors or pre-neoplastic changes were evident in dog studies. Rats appears to be particularly sensitive to Pročitajte cijeli dokument