Metotrexato DOSA

Name of the product: METOTREXATO DOSA 5 (*)

Active ingredient: Methotrexate 5 mg (as methotrexate sodium)

Dosage form: lyophilised injection

Name of the product: METOTREXATO DOSA 50

Active ingredient: Methotrexate 50 mg (as methotrexate sodium)

Dosage form: lyophilised injection

Name of the product: METOTREXATO DOSA 500

Active ingredient: Methotrexate 500 mg (as methotrexate sodium)

Dosage form: lyophilised injection

Name of the product: METOTREXATO DOSA 50 (*)

Active ingredient: Methotrexate 50 mg (as methotrexate sodium)

Dosage form: injection solution

Name of the product: METOTREXATO DOSA 250 (*)

Active ingredient: Methotrexate 250 mg (as methotrexate sodium)

Dosage form: injection solution

Name of the product: METOTREXATO DOSA 500 (*)

Active ingredient: Methotrexate 500 mg (as methotrexate sodium)

Dosage form: injection solution

Name of the product: METOTREXATO DOSA 2.5 (*)

Active ingredient: Methotrexate 2.5 mg

Dosage form: film-coated tablets

Dispensing requirements: Rx only

Argentine Industry

Composition:

METOTREXATO DOSA 5 lyophilised injection:

Each glass bottle contains methotrexate 5 mg (as methrotexate sodium), and mannitol.

METOTREXATO DOSA 50:

Each glass bottle contains methotrexate 50 mg (as methrotexate sodium), and mannitol.

METOTREXATO DOSA 500:

Each glass bottle contains methotrexate 500 mg (as methotrexate sodium), and mannitol.

METOTREXATO DOSA injection solution:

Each millilitre contains methotrexate 25 mg (as methotrexate sodium), bencilic alcohol, sodium chloride, sodium hydroxide, and water for injection.

METOTREXATO DOSA 2.5 film-coated tablets:

Each film-coated tablet contains methotrexate 2.5 mg, lactose, Aerosil, corn starch, avicel PH101, yellow lake, and magnesium stearate.

Indications:

METOTREXATO DOSA is indicated for the initial or adjutant treatment of breast and ovarian carcinoma; head epithelioma; small-cell bronchial carcinoma; treatment of acute lymphoblastic leukaemias; at high doses, acute lymphoblastic leukaemias in infant patients (consolidation and prophylactic treatment of CNS); malignant non-Hodgking's lymphomas; and osteosarcomas.

Therapeutic action:

Antineoplastic.

Storage:

Keep at temperature between 15º and 30º C, in the marketed packing.

Marketed presentations:

METOTREXATO DOSA 5 lyophilised injection:

Packs containing 1 and 10 glass bottles.

Packs containing 25 and 50 glass bottles, for use in hospitals.

METOTREXATO DOSA 50 lyophilised injection:

Packs containing 1 and 10 glass bottles.

Packs containing 25 and 50 glass bottles, for use in hospitals.

METOTREXATO DOSA 500 lyophilised injection:

Packs containing 1 and 10 glass bottles.

Packs containing 25 and 50 glass bottles, for use in hospitals.

METOTREXATO DOSA 50 injection solution (methotrexate 50 mg/2 ml):

Packs containing 1 glass bottle.

METOTREXATO DOSA 250 injection solution (methotrexate 250 mg/10 ml):

Packs containing 1 glass bottle.

METOTREXATO DOSA 500 injection solution (methotrexate 500 mg/25 ml):

Packs containing 1 glass bottle.

METOTREXATO DOSA 2.5 film-coated tablets:

Packs containing 50 and 100 film-coated tablets.

Packs containing 500 and 1000 film-coated tablets, for use in hospitals.

Medicinal speciality authorised by the Ministry of Health.

Certificate Nº 41489

Laboratorio DOSA S.A.

Girardot 1369, (C1427AKC) Buenos Aires, Argentine

Pharmaceutical Director: María C. Terzo, Pharmacist