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sagent pharmaceuticals - epirubicin hydrochloride (unii: 22966tx7j5) (epirubicin - unii:3z8479zz5x) - epirubicin hydrochloride 2 mg in 1 ml - epirubicin hydrochloride injection is indicated as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer [see clinical studies (14.1)]. patients should not be treated with epirubicin hydrochloride injection if they have any of the following conditions: cardiomyopathy and/or heart failure, recent myocardial infarction or severe arrhythmias [see warnings and precautions (5.3)]. previous treatment with maximum cumulative dose of anthracyclines [see warnings and precautions (5)] . hypersensitivity to epirubicin hydrochloride injection, other anthracyclines, or anthracenediones [see adverse reactions (6.2)]. pregnancy category d. see ‘warnings and precautions' section. epirubicin hydrochloride injection can cause fetal harm when administered to a pregnant woman. administration of 0.8 mg/kg/day intravenously of epirubicin to rats (about 0.04 times the maximum recommended single human dose on a body surface area basis) during days 5

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fresenius kabi usa, llc - epirubicin hydrochloride (unii: 22966tx7j5) (epirubicin - unii:3z8479zz5x) - epirubicin hydrochloride 2 mg in 1 ml - epirubicin hydrochloride injection is indicated as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer [see clinical studies (14.1)]. patients should not be treated with epirubicin hydrochloride injection if they have any of the following conditions: cardiomyopathy and/or heart failure, recent myocardial infarction or severe arrhythmias [see warnings and precautions (5.3)] previous treatment with maximum cumulative dose of anthracyclines [see warnings and precautions (5)]. hypersensitivity to epirubicin hydrochloride injection, other anthracyclines, or anthracenediones [see adverse reactions (6.2)]. pregnancy category d. see ‘warnings and precautions’ section. epirubicin hydrochloride can cause fetal harm when administered to a pregnant woman. administration of 0.8 mg/kg/day intravenously of epirubicin to rats (about 0.04 times the maximum recommended single human dose on a body surface area basis) during days 5 to 1

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

impax generics - epirubicin hydrochloride (unii: 22966tx7j5) (epirubicin - unii:3z8479zz5x) - epirubicin hydrochloride 2 mg in 1 ml - epirubicin hydrochloride injection is indicated as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer [see clinical studies (14.1)]. patients should not be treated with epirubicin hydrochloride injection if they have any of the following conditions: cardiomyopathy and/or heart failure, recent myocardial infarction or severe arrhythmias [see warnings and precautions (5.3)] previous treatment with maximum cumulative dose of anthracyclines [see warnings and precautions (5)]. hypersensitivity to epirubicin hydrochloride injection, other anthracyclines, or anthracenediones [see adverse reactions (6.2)]. teratogenic effects pregnancy category d. see ‘warnings and precautions’ section. epirubicin hydrochloride injection can cause fetal harm when administered to a pregnant woman. administration of 0.8 mg/kg/day intravenously of epirubicin to rats (about 0.04 times the maximum recommended single human dose on a body surface area bas

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sandoz inc - epirubicin hydrochloride (unii: 22966tx7j5) (epirubicin - unii:3z8479zz5x) - epirubicin hydrochloride 2 mg in 1 ml - epirubicin hydrochloride injection is indicated as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer [see clinical studies (14.1) ]. patients should not be treated with epirubicin hydrochloride injection if they have any of the following conditions: cardiomyopathy and/or heart failure, recent myocardial infarction or severe arrhythmias [see warnings and precautions (5.3) ] previous treatment with maximum cumulative dose of anthracyclines [see warnings and precautions (5) ]. hypersensitivity to epirubicin hydrochloride injection, other anthracyclines, or anthracenediones [see adverse reactions (6.2) ]. pregnancy category d. see ‘warnings and precautions ’ section. epirubicin hydrochloride injection can cause fetal harm when administered to a pregnant woman. administration of 0.8 mg/kg/day intravenously of epirubicin to rats (about 0.04 times the maximum recommended single human dose on a body surface area basis) during

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hikma pharmaceuticals usa inc. - epirubicin hydrochloride (unii: 22966tx7j5) (epirubicin - unii:3z8479zz5x) - epirubicin hydrochloride 2 mg in 1 ml - epirubicin hydrochloride injection, usp is indicated as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer [see clinical studies (14.1 )]. patients should not be treated with epirubicin hydrochloride injection if they have any of the following conditions: • cardiomyopathy and/or heart failure, recent myocardial infarction or severe arrhythmias [see warnings and precautions (5.3 )]. • previous treatment with maximum cumulative dose of anthracyclines [see warnings and precautions (5)] .  • hypersensitivity to epirubicin hydrochloride, other anthracyclines, or anthracenediones [see adverse reactions (6.2)].  teratogenic effects: pregnancy category d. see ‘warnings and precautions’ section. epirubicin hydrochloride can cause fetal harm when administered to a pregnant woman. administration of 0.8 mg/kg/day intravenously of epirubicin to rats (about 0.04 times the maximum recommended single human dose on a body surface area basi

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

actavis pharma, inc. - epirubicin hydrochloride (unii: 22966tx7j5) (epirubicin - unii:3z8479zz5x) - epirubicin hydrochloride 2 mg in 1 ml - epirubicin hydrochloride injection is indicated as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer [see clinical studies (14.1)]. patients should not be treated with epirubicin hydrochloride injection if they have any of the following conditions: cardiomyopathy and/or heart failure, recent myocardial infarction or severe arrhythmias [see warnings and precautions (5.3)] previous treatment with maximum cumulative dose of anthracyclines [see warnings and precautions (5)]. hypersensitivity to epirubicin hydrochloride injection, other anthracyclines, or anthracenediones [see adverse reactions (6.2)]. teratogenic effects pregnancy category d. see ‘warnings and precautions’ section. epirubicin hydrochloride injection can cause fetal harm when administered to a pregnant woman. administration of 0.8 mg/kg/day intravenously of epirubicin to rats (about 0.04 times the maximum recommended single human dose on a body surface area bas

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

areva pharmaceuticals,inc. - epirubicin hydrochloride (unii: 22966tx7j5) (epirubicin - unii:3z8479zz5x) - epirubicin hydrochloride 2 mg in 1 ml - epirubicin hydrochloride injection is indicated as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer [ see clinical studies (14.1)] .   patients should not be treated with epirubicin hydrochloride injection if they have any of the following conditions: cardiomyopathy and/or heart failure, recent myocardial infarction or severe arrhythmias [see warnings and precautions (5.3)] .   previous treatment with maximum cumulative dose of anthracyclines [see warnings and precautions (5)] . hypersensitivity to epirubicin hydrochloride injection, other anthracyclines, or anthracenediones [see adverse reactions (6.2)] .   pregnancy category d. see ' warnings and precautions' section. epirubicin hydrochloride injection can cause fetal

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

generamedix, inc. - epirubicin hydrochloride (unii: 22966tx7j5) (epirubicin - unii:3z8479zz5x) - injection, solution - 2 mg in 1 ml - epirubicin hydrochloride injection is indicated as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer. patients should not be treated with epirubicin hydrochloride injection if they have any of the following conditions: baseline neutrophil count < 1500 cells/mm3 ; severe myocardial insufficiency, recent myocardial infarction, severe arrhythmias; previous treatment with anthracyclines up to the maximum cumulative dose; hypersensitivity to epirubicin, other anthracyclines, or anthracenediones; or severe hepatic dysfunction (see warnings and dosage and administration).

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

otn generics inc. - epirubicin hydrochloride (unii: 22966tx7j5) (epirubicin - unii:3z8479zz5x) - injection, solution - 2 mg in 1 ml - epirubicin injection is indicated as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer. patients should not be treated with epirubicin injection if they have any of the following conditions: baseline neutrophil count < 1500 cells/mm3 ; severe myocardial insufficiency, recent myocardial infarction, severe arrhythmias; previous treatment with anthracyclines up to the maximum cumulative dose; hypersensitivity to epirubicin, other anthracyclines, or anthracenediones; or severe hepatic dysfunction (see warnings and dosage and administration).

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

pharmacia & upjohn company llc - epirubicin hydrochloride (unii: 22966tx7j5) (epirubicin - unii:3z8479zz5x) - epirubicin hydrochloride 2 mg in 1 ml - ellence is indicated as a component of adjuvant therapy in patients with evidence of axillary node tumor involvement following resection of primary breast cancer [see clinical studies (14.1)] . ellence is contraindicated in patients with: risk summary based on findings from animal studies and its mechanism of action, ellence can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] ; avoid the use of ellence during the 1st trimester. available human data do not establish the presence or absence of major birth defects and miscarriage related to the use of epirubicin during the 2nd and 3rd trimesters. there are reports of fetal and/or neonatal cardiotoxicity following in utero exposure to epirubicin (see error! hyperlink reference not valid. ). in animal reproduction studies in pregnant rats, epirubicin was embryo-fetal lethal and caused structural abnormalities when administered during organogenesis at doses less than the maximum recommended human dose on a body surface