Malta - English - Medicines Authority

mylan ireland limited unit 35/36, grange parade, baldoyle industrial estate, dublin 13, ireland - irinotecan hydrochloride, trihydrate - concentrate for solution for infusion - irinotecan hydrochloride trihydrate 20 mg/ml - antineoplastic agents

United States - English - NLM (National Library of Medicine)

fresenius kabi usa, llc - irinotecan hydrochloride (unii: 042laq1iis) (irinotecan - unii:7673326042) - irinotecan hydrochloride 20 mg in 1 ml - irinotecan hydrochloride injection is indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy. irinotecan hydrochloride injection is contraindicated in patients with a known hypersensitivity to the drug or its excipients. risk summary based on findings from animal studies and its mechanism of action, irinotecan hydrochloride can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . available postmarketing and published data reporting the use of irinotecan hydrochloride in pregnant women, are insufficient and confounded by the concomitant use of other cytotoxic drugs, to evaluate for any drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes. in animal studies, intravenous administration of irinotecan to rats and rabbits during the period of organogenesis resulted in embryofetal mortality and teratogenicity in pregnant animals at e

New Zealand - English - Medsafe (Medicines Safety Authority)

novartis new zealand ltd - irinotecan hydrochloride trihydrate 20 mg/ml;   - solution for injection - 20 mg/ml - active: irinotecan hydrochloride trihydrate 20 mg/ml   excipient: lactic acid sodium hydroxide sorbitol water for injection - irinotecan ebewe is indicated for the first line treatment of patients with metastatic carcinoma of the colon or rectum, in combination with 5fu/leucovorin. irinotecan ebewe is also indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial therapy.

Ireland - English - HPRA (Health Products Regulatory Authority)

flynn pharma ltd - irinotecan hydrochloride trihydrate - concentrate for soln for inf - 20 micromol

Ireland - English - HPRA (Health Products Regulatory Authority)

actavis group hf - irinotecan hydrochloride trihydrate - concentrate for soln for inf - 20 mg/ml - other antineoplastic agents

Israel - English - Ministry of Health

abic marketing ltd, israel - irinotecan hydrochloride trihydrate - concentrate for solution for infusion - irinotecan hydrochloride trihydrate 20 mg/ml - irinotecan - * for the treatment of patients with metastatic colorectal cancer: - in combination with 5-fluorouracil and folinic acid in patients without prior chemotherapy for metastatic disease. - as a single agent in patients who have failed an established 5-fluorouracil containing treatment regimen. * for the treatment of patients with small cell lung cancer.* for the treatment of patients with gastric cancer.* irinotecan in combination with leucovorin, oxaliplatin and 5-fluorouracil, for the first-line treatment of patients with metastatic pancreatic adenocarcinoma.

Australia - English - Department of Health (Therapeutic Goods Administration)

hospira australia pty ltd - irinotecan hydrochloride trihydrate, quantity: 20 mg/ml - injection, solution - excipient ingredients: lactic acid; sorbitol; water for injections; sodium hydroxide; hydrochloric acid - irinotecan indicated for the treatment of advanced colorectal cancer. -in combination with 5-fluorouracil and folinic acid in patients without prior chemotherapy for advanced cancer -as a single agent in patients who have failed 5-fluorouracil containing treatment regimen.

Australia - English - Department of Health (Therapeutic Goods Administration)

medis pharma pty ltd - irinotecan hydrochloride trihydrate, quantity: 500 mg - injection, concentrated - excipient ingredients: sorbitol; lactic acid; sodium hydroxide; hydrochloric acid; water for injections - indicated as a component of first line therapy for patients with metastatic carcinoma of the colon or rectum. also indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial therapy

Canada - English - Health Canada

sandoz canada incorporated - irinotecan hydrochloride - solution - 20mg - irinotecan hydrochloride 20mg - antineoplastic agents

Australia - English - Department of Health (Therapeutic Goods Administration)

accord healthcare pty ltd - irinotecan hydrochloride trihydrate, quantity: 500 mg - injection, concentrated - excipient ingredients: sorbitol; hydrochloric acid; sodium hydroxide; water for injections; lactic acid - 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.