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

wockhardt bio pty ltd - irinotecan hydrochloride trihydrate, quantity: 20 mg/ml - injection, concentrated - excipient ingredients: hydrochloric acid; lactic acid; sorbitol; water for injections; sodium hydroxide - irinotecan injection is indicated as a component of first-line therapy for patients with metastatic carcinoma of the colon or rectum. irinotecan injection is also indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial therapy.

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

wockhardt bio pty ltd - irinotecan hydrochloride trihydrate, quantity: 20 mg/ml - injection, concentrated - excipient ingredients: water for injections; lactic acid; sodium hydroxide; sorbitol; hydrochloric acid - irinotecan injection is indicated as a component of first-line therapy for patients with metastatic carcinoma of the colon or rectum. irinotecan injection is also indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial therapy.

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

wockhardt bio pty ltd - irinotecan hydrochloride trihydrate, quantity: 20 mg/ml - injection, concentrated - excipient ingredients: hydrochloric acid; lactic acid; water for injections; sodium hydroxide; sorbitol - irinotecan injection is indicated as a component of first-line therapy for patients with metastatic carcinoma of the colon or rectum. irinotecan injection is also indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial therapy.

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

wockhardt bio pty ltd - irinotecan hydrochloride trihydrate, quantity: 20 mg/ml - injection, concentrated - excipient ingredients: water for injections; lactic acid; hydrochloric acid; sodium hydroxide; sorbitol - irinotecan injection is indicated as a component of first-line therapy for patients with metastatic carcinoma of the colon or rectum. irinotecan injection is also indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial therapy.

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

wockhardt bio pty ltd - irinotecan hydrochloride trihydrate, quantity: 20 mg/ml - injection, concentrated - excipient ingredients: water for injections; sodium hydroxide; hydrochloric acid; lactic acid; sorbitol - irinotecan injection is indicated as a component of first-line therapy for patients with metastatic carcinoma of the colon or rectum. irinotecan injection is also indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial therapy.

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.

New Zealand - English - Medsafe (Medicines Safety Authority)

pharmacy retailing (nz) ltd t/a healthcare logistics - irinotecan hydrochloride trihydrate 20 mg/ml ((equivalent to 17.33 mg irinotecan));   - solution for infusion - 20 mg/ml - active: irinotecan hydrochloride trihydrate 20 mg/ml ((equivalent to 17.33 mg irinotecan))   excipient: hydrochloric acid lactic acid sodium hydroxide sorbitol water for injection - irinotecan hydrochloride trihydrate injection is indicated as a component of first-line therapy for patients with metastatic carcinoma of the colon or rectum, in combination with 5fu/leucovorin. irinotecan hydrochloride trihydrate injection is also indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial therapy.

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.

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 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. pregnancy category d [see warnings and precautions (5.9) ] irinotecan hydrochloride injection 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

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

accord healthcare pty ltd - irinotecan hydrochloride trihydrate, quantity: 100 mg - injection, concentrated - excipient ingredients: hydrochloric acid; lactic acid; sodium hydroxide; water for injections; sorbitol - 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.