Irinotecan hydrochloride Injection 100 mg in 5 mL (4)

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

irinotecan hydrochloride trihydrate, Quantity: 20 mg/mL

Available from:

Pfizer (Perth) Pty Ltd

Pharmaceutical form:

Injection, concentrated

Composition:

Excipient Ingredients: sorbitol; water for injections; lactic acid

Administration route:

Intravenous

Units in package:

1 X 5 mL

Prescription type:

(S1) This Schedule is intentionally blank

Therapeutic indications:

CANADA Irinotecan Hydrochloride Injection USP (irinotecan hydrochloride trihydrate) is indicated as a component of first-line therapy for patients with metastatic carcinoma of the colon or rectum. Irinotecan Hydrochloride Injection USP is also indicated as a single agent for the treatment of patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following 5-fluorouracil-based therapy. EGYPT CAMPTO is indicated as a component of first-line therapy for patients with metastatic carcinoma of the colon or rectum. CAMPTO is also indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial therapy.

Product summary:

Visual Identification: Clear, light yellow solution, free from visible particles.; Container Type: Vial; Container Material: PP; Container Life Time: 24 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Listed (Export Only)

Authorization date:

2019-09-03