Laboratorio DOSA S.A.

Name of the product: MELFALAN DOSA

Active ingredient: Melfalan 50 mg (as melfalan hydrochloride)

Dosage form: lyophilised injection

Name of the product: MELFALAN 2 DOSA

Active ingredient: Melfalan 2 mg

Dosage form: tablets

Name of the product: MELFALAN 5 DOSA

Active ingredient: Melfalan 5 mg

Dosage form: tablets

Dispensing requirements: Rx only

Argentine Industry

Composition:

MELFALAN DOSA:

Each glass bottle with lyophilised injection contains melfalan 50 mg (as melfalan hydrochloride), and povidone.

Each ampoule with dissolving solution contains sodium citrate, propylene glycol, ethanol 96 %, and water for injection.

MELFALAN 2 DOSA:

Each tablet contains melfalan 2 mg, lactose, corn starch, povidone, and magnesium stearate.

MELFALAN 5 DOSA:

Each tablet contains melfalan 5 mg, lactose, corn starch, povidone, and magnesium stearate.

Indications:

MELFALAN DOSA is indicated for the palliative treatment of the multiple myeloma and the ovarian adenocarcicoma non-resectable of epithelial origin.

Therapeutic action:

Antineoplastic.

Storage:

MELFALAN DOSA lyophilised injection: Keep at temperature between 15º and 30º C, in the marketed packing.

MELFALAN DOSA tablets: Keep at temperature between 2º and 8º C, in the marketed packing.

Marketed presentations:

MELFALAN DOSA lyophilised injection:

Packs containing 1 glass bottle with lyophilised injection + 1 glass bottle with dissolving solution.

Packs containing 100 glass bottles with lyophilised injection + 100 glass bottles with dissolving solution, for use in hospitals.

MELFALAN DOSA tablets:

Packs containing 25 and 50 tablets.

Packs containing 100 tablets, for use in hospitals.

Medicinal speciality authorised by the Ministry of Health.

Certificate Nº 51589

Laboratorio DOSA S.A.

Girardot 1369, (C1427AKC) Buenos Aires, Argentine

Pharmaceutical Director: María C. Terzo, Pharmacist