نيوزيلاندا - الإنجليزية - 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.

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

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

الولايات المتحدة - الإنجليزية - 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

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

merrimack pharmaceuticals - irinotecan hydrochloride (unii: 042laq1iis) (irinotecan - unii:7673326042) - irinotecan hydrochloride 4.3 mg in 1 ml - onivyde™   is indicated, in combination with fluorouracil and leucovorin, for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy. limitation of use: onivyde is not indicated as a single agent for the treatment of patients with metastatic adenocarcinoma of the pancreas [see clinical studies (14) ] . onivyde is contraindicated in patients who have experienced a severe hypersensitivity reaction to onivyde or irinotecan hcl. risk summary based on animal data with irinotecan hcl and the mechanism of action of onivyde, onivyde can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1) ]. there are no available data in pregnant women. embryotoxicity and teratogenicity were observed following treatment with irinotecan hcl, at doses resulting in irinotecan exposures lower than those achieved with onivyde 70 mg/m2 in humans, administered to pregnant rats and rabbits during organogenesis [see data ]. a

الولايات المتحدة - الإنجليزية - 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

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

qilu pharmaceutical co., ltd. - 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 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

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

northstar rx 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 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, miscarri

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

bluepoint laboratories - 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 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 de

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

apotex corp. - 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 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

الولايات المتحدة - الإنجليزية - NLM (National Library of Medicine)

ipsen biopharmaceuticals, inc. - irinotecan hydrochloride (unii: 042laq1iis) (irinotecan - unii:7673326042) - irinotecan hydrochloride 4.3 mg in 1 ml - - onivyde® is indicated, in combination with oxaliplatin, fluorouracil and leucovorin for the first-line treatment of adult patients with metastatic pancreatic adenocarcinoma. - onivyde® is indicated, in combination with fluorouracil and leucovorin, for the treatment of adult patients with metastatic pancreatic adenocarcinoma after disease progression following gemcitabine-based therapy. limitations of use: onivyde is not indicated as a single agent for the treatment of patients with metastatic pancreatic adenocarcinoma. [see clinical studies (14)] . onivyde is contraindicated in patients who have experienced a severe hypersensitivity reaction or anaphylaxis to onivyde or irinotecan hcl. [see warnings and precautions (5.4), adverse reactions (6.2)]. risk summary based on animal data with irinotecan hcl and the mechanism of action of onivyde, onivyde can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] . there are no available data in pregnant women. embryotoxicity and teratogenicity were observed following treatment with irinotecan hcl, at doses resulting in irinotecan exposures lower than those achieved with onivyde 70 mg/m2 in humans, administered to pregnant rats and rabbits during organogenesis [see data] . advise pregnant women of the potential risk to a fetus. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. data animal data no animal studies have been conducted to evaluate the effect of irinotecan liposome on reproduction and fetal development; however, studies have been conducted with irinotecan hcl. irinotecan crosses the placenta of rats following intravenous administration. intravenous administration of irinotecan at a dose of 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 resulted in an irinotecan exposure of approximately 0.002 times the exposure of irinotecan based on area under the curve (auc) in patients administered onivyde at the 70 mg/m2 dose. administration of irinotecan hcl resulted in structural abnormalities and growth delays in rats at doses greater than 1.2 mg/kg/day (approximately 0.0002 times the clinical exposure to irinotecan in onivyde based on auc). teratogenic effects included a variety of external, visceral, and skeletal abnormalities. irinotecan hcl administered to rat dams for the period following organogenesis through weaning at doses of 6 mg/kg/day caused decreased learning ability and decreased female body weights in the offspring. risk summary there is no information regarding the presence of irinotecan liposome, irinotecan, or sn-38 (an active metabolite of irinotecan) in human milk, or the effects on the breastfed infant or on milk production. irinotecan is present in rat milk [see data]. because of the potential for serious adverse reactions in breastfed infants from onivyde, advise a nursing woman not to breastfeed during treatment with onivyde and for one month after the last dose. data radioactivity appeared in rat milk within 5 minutes of intravenous administration of radiolabeled irinotecan hcl and was concentrated up to 65-fold at 4 hours after administration relative to plasma concentrations. contraception females onivyde can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)]. advise females of reproductive potential to use effective contraception during treatment with onivyde and for seven months after the last dose. males because of the potential for genotoxicity, advise males with female partners of reproductive potential to use condoms during treatment with onivyde and for four months after the last dose [see nonclinical toxicology (13.1)]. safety and effectiveness of onivyde have not been established in pediatric patients. of the 634 patients who received onivyde as a single agent, in combination with fu and leucovorin or in combination with oxaliplatin, fu and leucovorin in napoli-1 and napoli 3, 49% were ≥ 65 years old and 10% were ≥ 75 years old. no overall differences in safety and effectiveness were observed between these patients and younger patients.