Ireland - English - HPRA (Health Products Regulatory Authority)

fresenius kabi deutschland gmbh - irinotecan hydrochloride trihydrate - solution for infusion - 20 micromole(s) - other antineoplastic agents; irinotecan

Canada - English - Health Canada

teva canada limited - irinotecan hydrochloride - solution - 20mg - irinotecan hydrochloride 20mg - antineoplastic agents

Canada - English - Health Canada

telip, llc, a subsidiary of teligent, inc. - irinotecan hydrochloride (irinotecan hydrochloride trihydrate) - solution - 20mg - irinotecan hydrochloride (irinotecan hydrochloride trihydrate) 20mg - antineoplastic agents

Ireland - English - HPRA (Health Products Regulatory Authority)

teva b.v. - irinotecan hydrochloride trihydrate - concentrate for solution for infusion - 20 milligram(s)/millilitre - other antineoplastic agents; irinotecan

Ireland - English - HPRA (Health Products Regulatory Authority)

accord healthcare ireland ltd. - irinotecan hydrochloride trihydrate - concentrate for solution for infusion - 20 milligram(s)/millilitre - other antineoplastic agents; irinotecan

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

eugia us llc - irinotecan hydrochloride (unii: 042laq1iis) (irinotecan - unii:7673326042) - - irinotecan hydrochloride injection is indicated as a component of first-line therapy in combination with 5-fluorouracil (5-fu) and leucovorin (lv) for patients with metastatic carcinoma of the colon or rectum. - 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 adver

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

sandoz inc - irinotecan hydrochloride (unii: 042laq1iis) (irinotecan - unii:7673326042) - irinotecan hydrochloride 20 mg in 1 ml

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

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

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

areva pharmaceuticals, inc. - irinotecan hydrochloride (unii: 042laq1iis) (irinotecan - unii:7673326042) - - irinotecan hydrochloride injection is indicated as a component of first-line therapy in combination with 5­-fluorouracil (5-fu) and leucovorin (lv) for patients with metastatic carcinoma of the colon or rectum. - 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

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

armas pharmaceuticals inc. - irinotecan hydrochloride (unii: 042laq1iis) (irinotecan - unii:7673326042) - • 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. pregnancy category d [see warnings and precautions (5.9)] irinotecan hydrochloride can cause fetal harm when administered to a pregnant woman. radioactivity related to 14 c-irinotecan crosses the placenta of rats following intravenous administration of 10 mg/kg (which in separate studies produced an irinotecan cmax and auc about 3 and 0.5 times, respectively, the corresponding values in patients administered 125 mg/m2 ). intravenous administration of irinotecan 6 mg/kg/day to rats and rabbits during the period of organogenesis resulted in increased post-implantation loss and decreased numbers of live fetuses. in separate studies in rats, this dose produced an irinotecan cmax and auc of