Country: Малезија
Језик: Енглески
Извор: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
OXALIPLATIN
MYLAN HEALTHCARE SDN. BHD.
OXALIPLATIN
1vial Vials
Onco Therapies Limited
Not Applicable Прочитајте комплетан документ
FRONT SIDE PRODUCT DESCRIPTION Oliplat for Injection 50 mg is a white lyophilized powder or plug. After reconstitution with 5% w/v Dextrose injection, the reconstituted solution is a clear colorless solution. Oliplat for Injection 100 mg is a white lyophilized powder or plug. After reconstitution with 5% w/v Dextrose injection, the reconstituted solution is a clear colorless solution. COMPOSITION Each vial of Oliplat for Injection 50 mg contains sterile lyophilized powder of Oxaliplatin 50 mg. Each vial of Oliplat for Injection 100 mg contains sterile lyophilized powder of Oxaliplatin 100 mg. PHARMACOLOGY Oxaliplatin is an antineoplastic drug belonging to a new class of platinum- based compounds, in which the platinum atom is complexed with 1,2-diaminocyclohexane (DACH) and an oxalate group. Oxaliplatin is a single enantiomer. Oxaliplatin exhibits a wide spectrum of both _in vitro_ cytotoxicity and _in vivo_ antitumor activity in a variety of tumor models. Oxaliplatin also demonstrates in _in vitro_ and _in vivo_ activity in various cisplatin resistant models. A synergistic cytotoxic action has been observed in combination with 5-fluorouracil both _in vitro_ and _in vivo_. Studies on the mechanism of action of oxaliplatin, even if this one is not completely understood, support the concept that biotransformed, aquated products of oxaliplatin interact with DNA to form intra and interstrand crosslinks, resulting in disruption of DNA synthesis leading to cytotoxicity and antitumor effects. PHARMACOKINETICS The pharmacokinetics of platinum in plasma, ultrafiltered plasma and red blood cells following a 2-hr oxaliplatin infusion of 130 mg/m 2 every 3 weeks for 1-5 cycles, are as follows: C end (mcg/ ml) C max (mcg/ ml) T max (hr) AUC 0-48 (mcg/ ml.hr) AUC 0-∞ (mcg/ ml.hr) t 1/2 α (hr) t 1/2ß (hr) t 1/2 γ (hr) V ss (L) Cl (L/hr) Ultrafiltrated Plasma Mean SD 1.21 0.10 1.21 0.10 2 8.2 2.4 11.9 4.6 0.28 0.06 16.3 2.9 273 19 582 261 10.1 3.07 Mean AUC 0-48 , C end and C max values were calculated on Cycle 5 Mean AUC 0 Прочитајте комплетан документ