Fluradabine - Fluradosa EN.pdf

Name of the product: FLURADOSA

Active ingredient: Fludarabine phosphate 50 mg

Dosage form: lyophilised injection

Name of the product: FLURADOSA 10 (*)

Active ingredient: Fludarabine phosphate 10 mg

Dosage form: film-coated tablets

Dispensing requirements: Rx only

Argentine Industry

Composition:

FLURADOSA:

Each glass bottle contains fludarebine phosphate 50 mg, mannitol and sodium hydroxide.

FLURADOSA 10:

Each film-coated tablet contains fludarebine phosphate 10 mg, lactose monohydrate, microcrystalline cellulose, sodium croscarmellose, colloidal silicium dioxide, magnesium stearate, hydroxypropyl methylcellulose, polyethylene glycol 6000, and yellow titanium dioxide.

Indications:

FLURADOSA is indicated for the treatment of patients with B-cell chronic lymphocytic leukaemia who have not responded to or whose disease has progressed during the treatment with at least one standard alkylating-agent.

Therapeutic action:

Antineoplastic.

Storage:

Keep at temperature below 30º C, in the marketed packing. Protect from the light incidence.

Marketed presentations:

FLURADOSA:

Packs containing 5 glass bottles.

FLURADOSA 10:

Packs containing 15 and 200 film-coated tablets.

Packs containing 500 film-coated tablets, for use in hospitals.

Medicinal speciality authorised by the Ministry of Health.

Certificate Nº 50978

Laboratorio DOSA S.A.

Girardot 1369, (C1427AKC) Buenos Aires, Argentine

Pharmaceutical Director: María C. Terzo, Pharmacist