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

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)

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)

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

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

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

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)

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

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

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

pfizer australia pty ltd - doxorubicin hydrochloride, quantity: 2 mg/ml - injection, solution - excipient ingredients: hydrochloric acid; water for injections; sodium chloride - adriamycin has been used successfully to produce regression in neoplastic conditions such as: acute leukaemia, wilms' tumour, neuroblastoma, soft tissue and bone sarcomas, breast carcinoma, lymphomas of both hodgkin's and non-hodgkin's type, bronchogenic (lung) carcinoma, thyroid carcinoma, hepatomas, ovarian carcinoma, etc. the main antitumour activities are listed in table 1 of the product information. adriamycin is also indicated by intravesical administration in the primary management of non-metastatic carcinoma of the bladder. (tis, t1, t2).

New Zealand - English - Medsafe (Medicines Safety Authority)

sandoz new zealand limited - epirubicin hydrochloride 2 mg/ml;   - solution for injection - 2 mg/ml - active: epirubicin hydrochloride 2 mg/ml   excipient: hydrochloric acid sodium chloride water for injection - epirubicin hydrochloride has produced responses in a wide spectrum of neoplastic diseases, and is indicated for the treatment of breast cancer, gastric cancer, ovarian cancer, small cell lung cancer, lymphoma (non-hodgkin's lymphoma), advanced/ metastatic soft tissue sarcoma, and superficial bladder cancer (tis, ta). in bladder cancer, epirubicin hydrochloride is also indicated in the prophylaxis of recurrence after transurethral resection of stage t1 papillary cancers and stage ta multifocal papillary cancers (grade 2 and 3).

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

pfizer australia pty ltd - doxorubicin hydrochloride, quantity: 2 mg/ml - injection, solution - excipient ingredients: hydrochloric acid; water for injections; sodium chloride - adriamycin has been used successfully to produce regression in neoplastic conditions such as: acute leukaemia, wilms' tumour, neuroblastoma, soft tissue and bone sarcomas, breast carcinoma, lymphomas of both hodgkin's and non-hodgkin's type, bronchogenic (lung) carcinoma, thyroid carcinoma, hepatomas, ovarian carcinoma, etc. the main antitumour activities are listed in table 1 of the product information. adriamycin is also indicated by intravesical administration in the primary management of non-metastatic carcinoma of the bladder. (tis, t1, t2).