Страна: Австралия
Язык: английский
Источник: Department of Health (Therapeutic Goods Administration)
epirubicin hydrochloride, Quantity: 10 mg
Sandoz Pty Ltd
epirubicin hydrochloride
Injection, solution
Excipient Ingredients: water for injections; dilute hydrochloric acid; sodium chloride
Intravenous, Intravesical
1 vial x 5mL
(S4) Prescription Only Medicine
Epirubicin has produced responses in a wide spectrum of neoplastic diseases, and is indicated for the treatment of breast cancer, gastric cancer, ovarian cancer, small cell lung cancer, lymphoma (non-Hodgkin's lymphoma), advanced/ metastatic soft tissue sarcoma, and superficial bladder cancer (Tis, Ta). In bladder cancer, Epirubicin is also indicated in the prophylaxis of recurrence after transurethral resection of stage T1 papillary cancers and stage TA multifocal papillary cancers (grade 2 and 3).
Visual Identification: Clear, red solution, free of particles; Container Type: Vial; Container Life Time: 2 Years; Container Temperature: Store at 2 to 8 degrees Celsius
Licence status A
2007-01-10
_Product Information Page _ _EPIRUBICIN EBEWE 10mg/5mL, 50mg/25mL, 100mg/50mL, 200mg/100mL injection _ _05/2015 _ _ _ _Sandoz Pty Ltd _ _ _ _Version 10 _ _ _ _1 _ PRODUCT INFORMATION EPIRUBICIN EBEWE ® 10MG/5ML, 50MG/25ML, 100MG/50ML, 200MG/100ML INJECTION NAME OF THE MEDICINE _ _ Epirubicin hydrochloride CAS: 56390-09-1 Empirical formula: C 27 H 29 NO 11 .HCI Molecular Weight: 579.99 DESCRIPTION _ _ Epirubicin hydrochloride is a red-orange, almost odourless, hygroscopic powder, sparingly soluble in water and dilute alcohol. Structurally, epirubicin hydrochloride differs from doxorubicin hydrochloride only in the orientation of the hydroxyl group at the 4 position on the aminoglycoside ring. Composition Active: Epirubicin hydrochloride Inactive: Sodium chloride, water for injections, and dilute hydrochloric acid. _ _ _ _ _ _ _ _ PHARMACOLOGY The mechanism of action of epirubicin hydrochloride has not been fully elucidated but is probably related to its ability to bind DNA. Cell culture studies have shown cell penetration, localisation in the nucleus and inhibition of nucleic acid synthesis and mitosis. Epirubicin hydrochloride has proved to be active on the following experimental tumours: L 1210 ascites and P388 leukaemias, sarcoma SA 180 (solid and ascitic forms), melanoma B 16, mammary carcinoma, Lewis lung carcinoma and colon carcinoma 38. _Product Information Page _ _EPIRUBICIN EBEWE 10mg/5mL, 50mg/25mL, 100mg/50mL, 200mg/100mL injection _ _05/2015 _ _ _ _Sandoz Pty Ltd _ _ _ _Version 10 _ _ _ _2 _ The specificity of epirubicin hydrochloride toxicity appears to be related primarily to proliferative activity of normal tissue. Thus, bone marrow, gastrointestinal tract, lymphoid organs and the gonads are the main normal tissues damaged. Degenerative or functional alterations in liver and kidneys were also seen in animals dosed with epirubicin hydrochloride. Like most other anti-tumour and immunosuppressant agents, epirubicin hydrochloride, under experimental conditions, has mutagenic properties and is carcinoge Прочитать полный документ