Irinotecan hydrochloride Injection 100 mg in 5 mL (10)

Country: Ավստրալիա

language: անգլերեն

source: Department of Health (Therapeutic Goods Administration)

active_ingredient:

irinotecan hydrochloride trihydrate, Quantity: 20 mg/mL

MAH:

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_indication:

Irinotecan is indicated for single-agent or combination treatment of patients with: ? Metastatic carcinoma of the colon or rectum that has recurred or progressed following 5-fluorouracil (5-FU)-based therapy ? Irinotecan in combination with cetuximab is indicated for the treatment of patients with epidermal growth receptor (EGFR)-expressing metastatic colorectal cancer after failure of irinotecan-including cytotoxic therapy. ? Previously untreated metastatic carcinoma of the colon or rectum ? Advanced cervical squamous cell carcinoma ? Irinotecan in combination with 5-FU, folinic acid (FA) and bevacizumab is indicated for first-line treatment of patients with metastatic carcinoma of the colon or rectum.

leaflet_short:

Visual Identification: Clear, light yellow solution, free from visible particles.; Container Type: Vial; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

authorization_status:

Listed (Export Only)

authorization_date:

2019-09-03