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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