Nchi: Malesia
Lugha: Kiingereza
Chanzo: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ETOPOSIDE
MYLAN HEALTHCARE SDN. BHD.
ETOPOSIDE
1vial Vials
Mylan Laboratories Limited (OTL)
MYLAN ETOPOSIDE CONCENTRATE FOR SOLUTION FOR INJECTION 20MG/ML COMPOSITION Mylan Etoposide Concentrate for Solution for Injection 20 mg/mL - Each mL contains Etoposide 20 mg PRODUCT DESCRIPTION Mylan Etoposide Concentrate for Solution for Injection 20 mg/mL is nearly colourless to yellow liquid filled in type I flint vials with 20mm grey bromobutyl omniflex plus coated rubber closures with 20mm flip off aluminium seals. The reconstituted solution is a clear colourless liquid. PHARMACODYNAMICS Pharmacotherapeutic group: antineoplastic agent—podophyllotoxin derivatives ATC code: L01CB01 Etoposide is a semi-synthetic podophyllotoxin derivative. Its main effect seems to occur during the G 2 phase of the cell cycle. Two dose-dependent reactions occur: at high concentrations (> 10 µg/ml), lysis can be observed of the cells entering mitosis; at low concentrations (0.3–10 µg/ml), the cells are prevented from entering the prophase. The main macromolecular effect appears to be inhibition of DNA synthesis. PHARMACOKINETICS The concentration of etoposide in blood and organs is low with maximum values in the liver and the kidneys. Protein binding could be as high as 98%. On intravenous administration, the disposition of etoposide is best described as a biphasic process with an initial half-life of about 1.5 hours. After distribution, half-life is about 40 hours. The terminal half-life is 6-8 hours. Etoposide is cleared by both renal and nonrenal processes i.e. metabolism and biliary excretion. In patients with renal dysfunction plasma etoposide clearance is decreased. In adults, the total body clearance of etoposide is correlated with creatinine clearance, serum albumin concentration and nonrenal clearance. In children, elevated serum ALT levels are associated with reduced drug total body clearance. Prior use of cisplatin may result in a decrease of etoposide total body clearance. Following a single intravenous dose etoposide is excreted in the urine for about 63% and in the faeces for about 31% after 80 hours. INDICATI Soma hati kamili