Valsts: Dienvidāfrikas Republika
Valoda: angļu
Klimata pārmaiņas: South African Health Products Regulatory Authority (SAHPRA)
Pfizer Laboratories (Pty) Ltd
See ingredients
INJECTION
EACH VIALCONTAINS EPIRUBICIN HYDROCHLORIDE 10 mg
Registered
1992-01-04
Page 1 of 16 SCHEDULING STATUS: S4 PROPRIETARY NAME (AND DOSAGE FORM): FARMORUBICIN ® CSV 10 mg/5 ml (injection) FARMORUBICIN ® CSV 20 mg/10 ml (injection) FARMORUBICIN ® CSV 50 mg/25 ml (injection) FARMORUBICIN ® CSV 200 mg/100 ml (injection) COMPOSITION: Each vial contains: FARMORUBICIN CSV 10 mg/5 ml: Epirubicin HCl 10 mg (2 mg/ml) FARMORUBICIN CSV 20 mg/10 ml: Epirubicin HCl 20 mg (2 mg/ml) FARMORUBICIN CSV 50 mg/25 ml: Epirubicin HCl 50 mg (2 mg/ml) FARMORUBICIN CSV 200 mg/100 ml: Epirubicin HCl 200 mg (2 mg/ml) Excipients: Sodium chloride, hydrochloric acid, water for injection PHARMACOLOGICAL CLASSIFICATION: A26 Cytostatic agents PHARMACOLOGICAL ACTION: Epirubicin is an anthracycline antibiotic with antineoplastic activity. This mechanism of action is related to its ability to bind to DNA. Cell culture studies have shown rapid cell penetration, localisation in the nucleus and inhibition of nucleic acid synthesis and mitosis. In patients with normal hepatic and renal function, plasma levels after I.V. injection of 75 - 90 mg/m² of the medicine follow a tri-exponential decreasing pattern with a very fast first phase and a slow terminal phase with a mean half-life of about 40 hours. Plasma levels of the component’s main metabolite, the 13-0H derivative, are constantly lower and virtually parallel to those of the unchanged medicine. Page 2 of 16 Epirubicin is eliminated mainly through the liver: high plasma clearance values (0,9 l/min) indicated that this slow elimination is due to extensive tissue distribution. The medicine does not cross the blood-brain barrier. INDICATIONS: FARMORUBICIN CSV is indicated for the treatment of the following: Breast cancer Gastric cancer Non small cell lung carcinoma Non-Hodgkin’s lymphoma Hodgkin’s lymphoma Ovarian cancer Colorectal cancer Soft tissue sarcomas Malignant melanoma CONTRA-INDICATIONS: Hypersensitivity to FARMORUBICIN CSV or any other component of the product, other anthracyclines or anthracenediones. Intravenous use: Izlasiet visu dokumentu