FARMORUBICIN RD 50 INJECTION

Land: Südafrika

Sprache: Englisch

Quelle: South African Health Products Regulatory Authority (SAHPRA)

Verfügbar ab:

Pfizer Laboratories (Pty) Ltd

Dosierung:

See ingredients

Darreichungsform:

INJECTION

Zusammensetzung:

EACH VIAL CONTAINS EPIRUBICIN HYDROCHLORIDE 50 mg

Berechtigungsstatus:

Registered

Berechtigungsdatum:

1992-01-04

Fachinformation

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: