IRINOTECAN INTAS irinotecan hydrochloride trihydrate 40 mg/2 mL concentrated injection vial

Active ingredient:

irinotecan hydrochloride trihydrate, Quantity: 40 mg

Available from:

Accord Healthcare Pty Ltd

INN (International Name):

irinotecan hydrochloride trihydrate

Pharmaceutical form:

Injection, concentrated

Composition:

Excipient Ingredients: water for injections; sodium hydroxide; hydrochloric acid; sorbitol; lactic acid

Administration route:

Intravenous Infusion

Units in package:

1 vial

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

Irinotecan hydrochloride is indicated as a component of first-line therapy for patients with metastatic carcinoma of the colon or rectum. Irinotecan hydrochloride 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: A pale yellow clear solution; Container Type: Vial; Container Material: Glass Type I Coloured; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Authorization status:

Licence status A

Authorization date:

2014-06-12