Epirubicin Hydrochloride DOSA.pdf

Name of the product: EPIRRUBICINA 10 DOSA / EPIRRUBICINA 50 DOSA
Active ingredient: Epirubicin hydrochloride 10 mg / 50 mg
Dosage form: lyophilised injection

Dispensing requirements: Rx only
Argentine Industry

Composition:

EPIRRUBICINA 10 DOSA:
Each glass bottle with lyophilised injection contains epirubicin hydrocloride 10 mg, lactose monohydrate and methylparaben.
Each glass bottle with dissolving solution contains water for injection.

EPIRRUBICINA 50 DOSA:
Each glass bottle with lyophilised injection contains epirubicin hydrocloride 50 mg, lactose monohydrate and methylparaben.
Each glass bottle with dissolving solution contains water for injection.

Indications:

EPIRRUBICINA DOSA is indicated for the initial treatment of mammalian carcinoma; ovarian cancer; malignant non-Hodgkin lymphoma; Hodgkin disease; microcellular lung cancer; soft tissue sarcoma; cancer of the oesophagus, stomach, and pancreas; hepatocellular cancer; and epidermoidal cancer of the larynx area.

Therapeutic action:

Antineoplastic.

Storage:

Keep at temperature below 25º C in the marketed packing. Protect from the light and heat.

Marketed presentations:

EPIRRUBICINA 10 DOSA:
Packs containing 1 glass bottle with lyophilised injection + 1 glass bottle with dissolving solution.
Packs containing 50 glass bottles with lyophilised injection + 50 glass bottles with dissolving solution, for use in hospitals.

EPIRRUBICINA 50 DOSA:
Packs containing 1 glass bottle with lyophilised injection + 1 glass bottle with dissolving solution.
Packs containing 50 glass bottles with lyophilised injection + 50 glass bottles with dissolving solution, for use in hospitals.

Medicinal speciality authorised by the Ministry of Health.

Certificate Nº 50739

Laboratorio DOSA S.A.
Girardot 1369, (C1427AKC) Buenos Aires, Argentine
Pharmaceutical Director: María C. Terzo, Pharmacist