Product Dossier
MEDITAB
Product Dossier for MEDITAB (irinotecan hydrochloride trihydrate, Cipla). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.
- Sponsor: Cipla
- Active ingredient: irinotecan hydrochloride trihydrate
- Therapeutic area: Oncology
- Related brand: ONIVYDE
- Related brand: EUG-IRINOTECAN
- Same area: TALZENNA
- Same area: ZARZIO
What it is
Meditab Irinotecan Injection contains irinotecan hydrochloride, supplied as 40 mg in a 2 mL injection and 100 mg in a 5 mL injection. It is a sterile, clear, colourless to pale yellow aqueous solution with pH 3.5. The product is intended for dilution with glucose 5% injection or 0.9% Sodium Chloride injection prior to infusion.
Approved indications
— First line therapy for patients with metastatic carcinoma of the colon or rectum. — Metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial therapy.
Dosing overview
Meditab Irinotecan Injection should be administered as an intravenous infusion over 90 minutes. It is recommended that patients receive premedication with antiemetic agents. When used in combination with 5-Fluorouracil and Leucovorin, Leucovorin should be administered immediately after Meditab Irinotecan, with 5-Fluorouracil to follow immediately after Leucovorin administration.
Key safety warnings
Prophylactic or therapeutic administration of atropine should be considered in patients experiencing cholinergic symptoms.
Regulatory history
Meditab Irinotecan Injection 40 mg / 2 mL (ARTG 167203) and 100 mg / 5 mL (ARTG 167202) were first listed on the Australian Register of Therapeutic Goods on 2010-10-28.