Ireland - English - HPRA (Health Products Regulatory Authority)

koanaa healthcare limited - irinotecan hydrochloride trihydrate - concentrate for solution for infusion - 20 milligram(s)/millilitre - other antineoplastic agents; irinotecan

Ireland - English - HPRA (Health Products Regulatory Authority)

mcdermott laboratories ltd., t/a gerard laboratories - irinotecan hydrochloride trihydrate - concentrate for solution for infusion - 20 milligram(s)/millilitre - other antineoplastic agents; irinotecan

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

remedyrepack inc. - atazanavir sulfate (unii: 4mt4vie29p) (atazanavir - unii:qzu4h47a3s) - atazanavir 300 mg - reyataz ® (atazanavir) is indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection for patients 3 months and older weighing at least 5 kg. limitations of use: - reyataz is not recommended for use in pediatric patients below the age of 3 months due to the risk of kernicterus. - use of reyataz/ritonavir in treatment-experienced patients should be guided by the number of baseline primary protease inhibitor resistance substitutions [see microbiology (12.4)] . reyataz is contraindicated:reyataz is contraindicated: - in patients with previously demonstrated clinically significant hypersensitivity (eg, stevens-johnson syndrome, erythema multiforme, or toxic skin eruptions) to any of the components of reyataz capsules or reyataz oral powder [see warnings and precautions (5.2)] . - when coadministered with drugs that are highly dependent on cyp3a or ugt1a1 for clearance, and for which elevated plasma concentrations of the interacting drugs are associated with serious and/or lif

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

remedyrepack inc. - atazanavir sulfate (unii: 4mt4vie29p) (atazanavir - unii:qzu4h47a3s) - atazanavir 200 mg - reyataz ® (atazanavir) is indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection for patients 3 months and older weighing at least 5 kg. limitations of use: - reyataz is not recommended for use in pediatric patients below the age of 3 months due to the risk of kernicterus. - use of reyataz/ritonavir in treatment-experienced patients should be guided by the number of baseline primary protease inhibitor resistance substitutions [see microbiology (12.4)] . reyataz is contraindicated:reyataz is contraindicated: - in patients with previously demonstrated clinically significant hypersensitivity (eg, stevens-johnson syndrome, erythema multiforme, or toxic skin eruptions) to any of the components of reyataz capsules or reyataz oral powder [see warnings and precautions (5.2)] . - when coadministered with drugs that are highly dependent on cyp3a or ugt1a1 for clearance, and for which elevated plasma concentrations of the interacting drugs are associated with serious and/or lif

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

remedyrepack inc. - atazanavir sulfate (unii: 4mt4vie29p) (atazanavir - unii:qzu4h47a3s) - reyataz ® (atazanavir) is indicated in combination with other antiretroviral agents for the treatment of hiv-1 infection for patients 3 months and older weighing at least 5 kg. limitations of use: - reyataz is not recommended for use in pediatric patients below the age of 3 months due to the risk of kernicterus. - use of reyataz/ritonavir in treatment-experienced patients should be guided by the number of baseline primary protease inhibitor resistance substitutions [see microbiology (12.4)] . reyataz is contraindicated:reyataz is contraindicated: - in patients with previously demonstrated clinically significant hypersensitivity (eg, stevens-johnson syndrome, erythema multiforme, or toxic skin eruptions) to any of the components of reyataz capsules or reyataz oral powder [see warnings and precautions (5.2)] . - when coadministered with drugs that are highly dependent on cyp3a or ugt1a1 for clearance, and for which elevated plasma concentrations of the interacting drugs are associated with serious and/or lif

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

northstar rxllc - 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 irinot

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

bluepoint laboratories - irinotecan hydrochloride (unii: 042laq1iis) (irinotecan - unii:7673326042) - irinotecan hydrochloride 20 mg in 1 ml - • irinotecan hydrochloride injection, usp 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, usp is indicated for patients with metastatic carcinoma of the colon or rectum whose disease has recurred or progressed following initial fluorouracil-based therapy. 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 mg/kg/day to rats and rabbits during the period of organogenesis resulted in increased post-implantation loss and decreased

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

areva pharmaceuticals,inc. - irinotecan hydrochloride (unii: 042laq1iis) (irinotecan - unii:7673326042) - irinotecan hydrochloride 20 mg in 1 ml - • irinotecan hydrochloride injection, usp 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, usp 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 c max and auc about 3 and 0.5 times, respectively, the corresponding values in patie

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

hikma pharmaceuticals usa inc. - irinotecan hydrochloride (unii: 042laq1iis) (irinotecan - unii:7673326042) - irinotecan hydrochloride 20 mg in 1 ml - irinotecan hydrochloride injection, usp 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 injection 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 injection 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