Carboplatin DOSA.pdf

Name of the product: CARBOPLATINO DOSA 50 (*)

Active ingredient: Carboplatin 50 mg

Dosage form: lyophilised injection

Name of the product: CARBOPLATINO DOSA 150 (*)

Active ingredient: Carboplatin 150 mg

Dosage form: lyophilised injection

Name of the product: CARBOPLATINO DOSA 450 (*)

Active ingredient: Carboplatin 450 mg

Dosage form: lyophilised injection

Name of the product: CARBOPLATINO DOSA

Active ingredient: Carboplatin 150 mg

Dosage form: injection solution

Name of the product: CARBOPLATINO DOSA

Active ingredient: Carboplatin 600 mg

Dosage form: injection solution

Dispensing requirements: Rx only

Argentine Industry

Composition:

CARBOPLATINO DOSA 50:

Each glass bottle contains carboplatin 50 mg and mannitol.

CARBOPLATINO DOSA 150:

Each glass bottle contains carboplatin 150 mg and mannitol.

CARBOPLATINO DOSA 450:

Each glass bottle contains carboplatin 450 mg and mannitol.

CARBOPLATINO DOSA:

Each millilitre of solution contains carboplatin 10 mg and water for injection.

Indications:

CARBOPLATINO DOSA lyophilised powder for injection is indicated for the initial treatment of advanced ovarian carcinoma.

CARBOPLATINO DOSA injection solution is indicated for the palliative treatment of the recurrent ovarian carcinoma, including in patients who have previously received cisplatin therapy.

Therapeutic action:

Antineoplastic.

Storage:

Keep at room temperature between 15º and 30º C in the marketed packing. Protect from the light.

Marketed presentations:

CARBOPLATINO DOSA lyophilised injection:

Packs containing 1 and 25 glass bottles.

Packs containing 50 and 100 glass bottles, for use in hospitals.

CARBOPLATINO DOSA injection solution (carboplatin 150 mg/15 ml):

Packs containing 1 and 25 glass bottles.

Packs containing 50 and 100 glass bottles, for use in hospitals.

Medicinal speciality authorised by the Ministry of Health.

Certificate Nº 50899

Laboratorio DOSA S.A.

Girardot 1369, (C1427AKC) Buenos Aires, Argentine

Pharmaceutical Director: María C. Terzo, Pharmacist