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Name of the product: IDARRUBICINA 5 DOSA

Active ingredient: Idarubicin hydrochloride 5 mg

Dosage form: lyophilised injection

Name of the product: IDARRUBICINA 10 DOSA

Active ingredient: Idarubicin hydrochloride 10 mg

Dosage form: lyophilised injection

Dispensing requirements: Rx only

Argentine Industry

Composition:

IDARRUBICINA 5 DOSA:

Each glass bottle with liophilised injection contains idarubicin hydrochloride 5 mg and lactose.

Each ampoule with disolving solution contains water for injections.

IDARRUBICINA 10 DOSA:

Each glass bottle with liophilised injection contains idarubicin hydrochloride 10 mg and lactose.

Each ampoule with disolving solution contains water for injections.

Indications:

IDA in combination with other antileukaemic drugs is indicated for the treatment of acute myeloid leukaemia in adults. This includes the French-American-British classifications M1 through M7.

Therapeutic action:

Antibiotic, antineoplastic.

Storage:

Keep at temperature below 25º C, in the marketed packing.

Marketed presentations:

IDARRUBICINA 5 DOSA:

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

IDARRUBICINA 10 DOSA:

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

Medicinal speciality authorised by the Ministry of Health.

Certificate Nº 49174

Laboratorio DOSA S.A.

Girardot 1369, (C1427AKC) Buenos Aires, Argentine

Pharmaceutical Director: María C. Terzo, Pharmacist