Irinotecan Hydrochloride - Efixano EN.pdf

Name of the product: EFIXANO 40

Active ingredient: Irinotecan hydrochloride 40 mg (as irinotecan hydrochloride trihydrate)

Dosage form: injection solution

Name of the product: EFIXANO 100

Active ingredient: Irinotecan hydrochloride 100 mg (as irinotecan hydrochloride trihydrate)

Dosage form: injection solution

Dispensing requirements: Rx only

Argentine Industry

Composition:

Each millilitre of solution contains irinotecan hydrochloride 20 mg (as irinotecan hydrochloride trihydrate), sorbitol, lactic acid and water for injection.

Indications:

EFIXANO is indicated for the treatment of patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following the initial 5-fluorouracil therapy.

Therapeutic action:

Antineoplastic.

Storage:

Keep at room temperature, between 15º and 30º C, in the marketed packing. Protect from light incidence. Do not freeze.

Marketed presentations:

EFIXANO 40 (irinotecan hydrochloride 40 mg/2 ml):

Packs containing 1 glass bottle.

EFIXANO 100 (irinotecan hydrochloride 100 mg/5 ml):

Packs containing 1 glass bottle.

Medicinal speciality authorised by the Ministry of Health.

Certificate Nº 48396

Laboratorio DOSA S.A.

Girardot 1369, (C1427AKC) Buenos Aires, Argentine

Pharmaceutical Director: María C. Terzo, Pharmacist