Страна: Сингапур
Язык: английский
Источник: HSA (Health Sciences Authority)
IDARUBICIN HCl
PFIZER PRIVATE LIMITED
L01DB06
5 mg/5 ml
INJECTION
IDARUBICIN HCl 5 mg/5 ml
INTRAVENOUS
Prescription Only
Bridgewest Perth Pharma Pty Ltd
ACTIVE
2003-10-29
ZAVEDOS ® TABLE OF CONTENT _Please click on either of the following links to access the required information: _ _ _ PRESCRIBING INFORMATION PATIENT INFORMATION LEAFLET Page 1 of 13 ZAVEDOS Idarubicin Hydrochloride Injection PRODUCT INFORMATION Zavedos (Idarubicin Hydrochloride), Solution for Injection (5 mg/5 mL & 10 mg/10 mL) NAME OF THE MEDICINE NON-PROPRIETARY NAME: Idarubicin Hydrochloride The structural formula of idarubicin hydrochloride is shown below: 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- -L-lyxo-hexopyranosyl)-5,12- naphthacenedione hydrochloride CAS REGISTRY NUMBER: 57852-57-0 DESCRIPTION Idarubicin hydrochloride is an odourless red-orange powder, slightly soluble in water, with a melting point of 173°C-174°C. The molecular formula is C 26 H 27 NO 9 ·HCl and the molecular weight is 533.95. Zavedos solution for injection consists of idarubicin hydrochloride as a red-orange, clear, mobile solution, free from particles. PHARMACOLOGY PHARMACODYNAMICS Zavedos is a semi synthetic antineoplastic anthracycline for intravenous use. Mechanism of action Page 2 of 13 Idarubicin 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. Pharmacodynamic effects Idarubicin has been shown to have a higher potency with respect to daunorubicin and to be an effective agent against murine leukaemia and lymphomas. Studies _in vitro_ on human and murine anthracycline-resistant cells have shown a lower degree of cross-resistance for idarubicin compared with doxorubicin and daunorubicin. Cardiotoxicity studies in animals have indicated that idarubicin has a better therapeutic index than daunorubicin and doxorubicin. The main metabolite, idarubicinol, has shown anti-tumour activities in experimental models both _in vi Прочитать полный документ
ZAVEDOS CS Idarubicin Hydrochloride Injection PRODUCT INFORMATION Zavedos CS (Idarubicin Hydrochloride), Solution for Injection (5 mg/5 mL & 10 mg/10 mL) NAME OF THE MEDICINE NON-PROPRIETARY NAME: Idarubicin Hydrochloride The structural formula of idarubicin hydrochloride is shown below: 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- -L-lyxo-hexopyranosyl)-5,12- naphthacenedione hydrochloride CAS REGISTRY NUMBER: 57852-57-0 DESCRIPTION Idarubicin hydrochloride is an odourless red-orange powder, slightly soluble in water, with a melting point of 173°C-174°C. The molecular formula is C 26 H 27 NO 9 ·HCl and the molecular weight is 533.95. Zavedos solution for injection consists of idarubicin hydrochloride as a red-orange, clear, mobile solution, free from particles. PHARMACOLOGY PHARMACODYNAMICS Zavedos is a semi synthetic antineoplastic anthracycline for intravenous use. Mechanism of action Idarubicin 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. Pharmacodynamic effects Idarubicin has been shown to have a higher potency with respect to daunorubicin and to be an effective agent against murine leukaemia and lymphomas. Studies _in vitro_ on human and murine anthracycline-resistant cells have shown a lower degree of cross-resistance for idarubicin compared with doxorubicin and daunorubicin. Cardiotoxicity studies in animals have indicated that idarubicin has a better therapeutic index than daunorubicin and doxorubicin. The main metabolite, idarubicinol, has shown anti-tumour activities in experimental models both _in vitro_ and _in vivo_ . In the rat, idarubicinol, administered at the same doses as the parent drug, is less cardiotoxic than idarubicin. PHARMACOKINETICS After intravenous administration of i Прочитать полный документ