Země: Austrálie
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
doxorubicin hydrochloride, Quantity: 200 mg
Sandoz Pty Ltd
Doxorubicin hydrochloride
Injection
Excipient Ingredients: sodium chloride; dilute hydrochloric acid; water for injections
Intravenous, Intravesical
1 vial
(S4) Prescription Only Medicine
Doxorubicin has been successfully used to produce regression in neoplastic conditions, eg acute leukaemia, Wilms' tumour, neuroblastoma, soft tissue and bone sarcomas, breast carcinoma, lymphomas of both Hodgkin's and non-Hodgkin's type, bronchogenic (lung) carcinoma, thyroid carcinoma, hepatomas and ovarian carcinoma, etc. The main antitumour activities are listed in Table 1. Doxorubicin is also indicated in the primary management of nonmetastatic carcinoma of the bladder (Tis, T1, T2) by intravesical administration.
Visual Identification: Clear blood-red solution.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 1 Years; Container Temperature: Store at 2 to 8 degrees Celsius
Registered
2005-04-29
_Product Information _ _ _ _ _ _Page _1_ _ _Doxorubicin Ebewe injection _ 04/2014 _ _ _Sandoz Pty Ltd _ _ _ _ _ _Version 05 _ PRODUCT INFORMATION DOXORUBICIN EBEWE ® 10MG/5ML, 50MG/25ML, 100MG/50ML, 200MG/100ML INJECTION NAME OF THE MEDICINE Doxorubicin COMPOSITION Active. Doxorubicin hydrochloride. Inactive. Sodium chloride, dilute hydrochloric acid and water for injections. DESCRIPTION Doxorubicin hydrochloride: Molecular formula, C 27 H 29 NO 11 .HCl.; MW, 580.0 and CAS number, 25316-40-9. It is soluble in water and slightly soluble in methanol. Doxorubicin hydrochloride solution for injection is red in colour. Doxorubicin hydrochloride is a cytotoxic anthracycline antibiotic isolated from cultures of _Streptomyces peucetius _variant_ caesius_. The chemical structure of doxorubicin consists of a tetracyclic ring with the sugar daunosamine attached by a glycosidic linkage. Structurally, doxorubicin is related to daunomycin (daunorubicin) and differs only in hydroxyl group substitution (instead of hydrogen) at the alkyl side chain at position '9' of the 'A' ring. It is supplied in solution form containing sodium chloride. PHARMACOLOGY Though not completely elucidated, the mechanism of action of doxorubicin is related to its ability to bind to DNA and inhibit nucleic acid synthesis. Cell culture studies have demonstrated rapid cell penetration and perinucleolar chromatin binding, rapid inhibition of mitotic activity and nucleic acid synthesis, mutagenesis and chromosomal aberrations. _Product Information _ _ _ _ _ _Page _2_ _ _Doxorubicin Ebewe injection _ 04/2014 _ _ _Sandoz Pty Ltd _ _ _ _ _ _Version 05 _ Doxorubicin has immunosuppressive effects. It inhibits the titre of haemolytic and haemagglutinating antibodies in mice immunised with sheep red blood cells. Similar evidence in humans indicates that doxorubicin is a powerful but temporary immunosuppressant agent. Doxorubicin is a cell cycle, phase nonspecific cytotoxic medicine. The toxic effects of doxorubicin on the bone marrow appear to be related to its Přečtěte si celý dokument