País: Australia
Idioma: inglés
Fuente: Department of Health (Therapeutic Goods Administration)
Idarubicin hydrochloride
Sandoz Pty Ltd
Medicine Registered
_Product information _ _ _ _ Page 1 _ _Idarubcin Ebewe 5mg/5mL, 10mg/10mL, 20mg/20mL solution for injection _ _10/2011 _ _Sandoz Pty Ltd _ _ Version 02 _ _PRODUCT INFORMATION _ IDARUBICIN EBEWE ® 5MG/5ML, 10MG/10ML, 20MG/20ML INJECTION NAME OF THE MEDICINE idarubicin hydrochloride _Chemical name: _(7_S_, 9_S_) -9-acetyl-7, 8, 9, 10-tetrahydro-6,7,9,11- tetrahydroxy-7-_O_- (2, 3, 6-trideoxy-3-amino-α-L-lyxo- hexopyranosyl)-5, 12-naphthacenedione hydrochloride _Molecular formula:_ C 26 H 27 NO 9 . HCI _Molecular weight:_ 533.95 _CAS No:_ 57852-57-0 DESCRIPTION Idarubicin Ebewe is a semi synthetic antineoplastic anthracycline for intravenous use. Idarubicin Ebewe solution for injection is a sterile, pyrogen free, clear, red to orange, mobile solution in vials for intravenous administration and consists of idarubicin hydrochloride. The excipients included are glycerol, dilute hydrochloric acid, sodium hydroxide and water for injections. PHARMACOLOGY Idarubicin hydrochloride is a cytotoxic agent. It is a DNA intercalating agent which reacts with topoisomerase II and has an inhibitory effect on nucleic acid synthesis. The compound has a high lipophilicity which results in an increased rate of cellular uptake compared with doxorubicin and daunorubicin. Idarubicin hydrochloride has been shown to have a higher potency with respect to daunorubicin and to be an effective agent against murine leukaemia and lymphomas _Product information _ _ _ _ Page 2 _ _Idarubcin Ebewe 5mg/5mL, 10mg/10mL, 20mg/20mL solution fo Leer el documento completo