Negara: Australia
Bahasa: Inggris
Sumber: Department of Health (Therapeutic Goods Administration)
idarubicin hydrochloride, Quantity: 1 mg/mL
Sandoz Pty Ltd
idarubicin hydrochloride
Injection, concentrated
Excipient Ingredients: glycerol; water for injections; sodium hydroxide; dilute hydrochloric acid
Intravenous
5mg/5mL in a 5mL vial x 1, 5mg/5mL in a 5mL vial x 5
(S4) Prescription Only Medicine
Idarubicin Ebewe is indicated for use in acute myelogenous leukaemia (AML) in adults for remission induction in untreated patients or for remission induction in relapsed or refractory patients. Idarubicin Ebewe may be used in combination chemotherapy regimens involving other cytotoxic agents.
Visual Identification: Idarubicin Ebewe is a clear, red-orange solution supplied in a clear glass vial with a fluoropolymer coated halobutyl rubber stopper.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store at 2 to 8 degrees Celsius
Licence status A
2010-10-21
_Product information _ _ _ _ Page 1 _ _Idarubcin Ebewe 5mg/5mL, 10mg/10mL, 20mg/20mL solution for injection _ _03/2016 _ _Sandoz Pty Ltd _ _ _ _ _ _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 for injection _ _03/2016 _ _Sandoz Pty Ltd _ _ _ _ _ both by intravenous and oral routes. Studies in vitro on human and murine anthracycline-resistant cells have shown a lower degree of cross-resistance for idarubicin hydrochloride compared with doxorubicin and daunorubicin. Cardiotoxicity studies in animals have indicated that idarubicin hydrochloride has a better therapeutic index than daunorubicin and doxorubicin. The main metabolite idarubicinol, has shown antitumour activities in experimental models both _in vitro_ and _ Baca dokumen lengkapnya