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

sun pharma anz pty ltd - doxorubicin hydrochloride, quantity: 2 mg/ml - injection - excipient ingredients: hydrochloric acid; sodium hydroxide; sucrose; histidine; cholesterol; sodium methoxy peg-40-carbonyl-distearoylphosphatidylethanolamine; hydrogenated soy phosphatidylcholine; ammonium sulfate; ethanol; water for injections - liposomal doxorubicin sun, as monotherapy, is indicated for the treatment of metastatic breast cancer.,liposomal doxorubicin sun is also indicated for the treatment of:,? advanced epithelial ovarian cancer in women who have failed a first-line platinum-based chemotherapy regimen.,? aids-related kaposi's sarcoma (ks) in patients with low cd4 counts (<200 lymphocytes/mm3) and extensive mucocutaneous or visceral disease.,liposomal doxorubicin sun may be used as first-line systemic chemotherapy, or as second line chemotherapy in aids-ks patients with disease that has progressed with, or in patients intolerant to, prior combination systemic chemotherapy comprising at least two of the following agents: a vinca alkaloid, bleomycin and doxorubicin (or other anthracycline).,liposomal doxorubicin sun is also indicated, in combination with bortezomib, for the treatment of progressive multiple myeloma in patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplant.

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

sun pharma anz pty ltd - doxorubicin hydrochloride, quantity: 2 mg/ml - injection - excipient ingredients: water for injections; cholesterol; ethanol; hydrogenated soy phosphatidylcholine; ammonium sulfate; sodium methoxy peg-40-carbonyl-distearoylphosphatidylethanolamine; histidine; hydrochloric acid; sodium hydroxide; sucrose - liposomal doxorubicin sun, as monotherapy, is indicated for the treatment of metastatic breast cancer.,liposomal doxorubicin sun is also indicated for the treatment of:,? advanced epithelial ovarian cancer in women who have failed a first-line platinum-based chemotherapy regimen.,? aids-related kaposi's sarcoma (ks) in patients with low cd4 counts (<200 lymphocytes/mm3) and extensive mucocutaneous or visceral disease.,liposomal doxorubicin sun may be used as first-line systemic chemotherapy, or as second line chemotherapy in aids-ks patients with disease that has progressed with, or in patients intolerant to, prior combination systemic chemotherapy comprising at least two of the following agents: a vinca alkaloid, bleomycin and doxorubicin (or other anthracycline). liposomal doxorubicin sun is also indicated, in combination with bortezomib, for the treatment of progressive multiple myeloma in patients who have received at least one prior therapy and who have already undergone or are unsuitable for bone marrow transplant.

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

sandoz pty ltd - doxorubicin hydrochloride, quantity: 200 mg - injection - excipient ingredients: sodium chloride; dilute hydrochloric acid; water for injections - doxorubicin has been successfully used to produce regression in neoplastic conditions, eg 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 and ovarian carcinoma, etc. the main antitumour activities are listed in table 1. doxorubicin is also indicated in the primary management of nonmetastatic carcinoma of the bladder (tis, t1, t2) by intravesical administration.

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

sandoz pty ltd - doxorubicin hydrochloride, quantity: 100 mg - injection - excipient ingredients: water for injections; dilute hydrochloric acid; sodium chloride - doxorubicin has been successfully used to produce regression in neoplastic conditions, eg 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 and ovarian carcinoma, etc. the main antitumour activities are listed in table 1. doxorubicin is also indicated in the primary management of nonmetastatic carcinoma of the bladder (tis, t1, t2) by intravesical administration.

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

sandoz pty ltd - doxorubicin hydrochloride, quantity: 50 mg - injection - excipient ingredients: water for injections; dilute hydrochloric acid; sodium chloride - doxorubicin has been successfully used to produce regression in neoplastic conditions, eg 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 and ovarian carcinoma, etc. the main antitumour activities are listed in table 1. doxorubicin is also indicated in the primary management of nonmetastatic carcinoma of the bladder (tis, t1, t2) by intravesical administration.

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

sandoz pty ltd - doxorubicin hydrochloride, quantity: 10 mg - injection - excipient ingredients: sodium chloride; dilute hydrochloric acid; water for injections - doxorubicin has been successfully used to produce regression in neoplastic conditions, eg 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 and ovarian carcinoma, etc. the main antitumour activities are listed in table 1. doxorubicin is also indicated in the primary management of nonmetastatic carcinoma of the bladder (tis, t1, t2) by intravesical administration.

USA - engelsk - NLM (National Library of Medicine)

zydus pharmaceuticals usa inc. - doxorubicin hydrochloride (unii: 82f2g7bl4e) (doxorubicin - unii:80168379ag) - doxorubicin hydrochloride liposomal infusion is indicated for the treatment of patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy. doxorubicin hydrochloride liposomal infusion is indicated for the treatment of aids-related kaposi's sarcoma in patients after failure of prior systemic chemotherapy or intolerance to such therapy. doxorubicin hydrochloride liposomal infusion, in combination with bortezomib, is indicated for the treatment of patients with multiple myeloma who have not previously received bortezomib and have received at least one prior therapy. doxorubicin hydrochloride liposomal infusion is contraindicated in patients who have a history of severe hypersensitivity reactions, including anaphylaxis, to doxorubicin hydrochloride [see warnings and precautions (5.2)]. risk summary based on findings in animals and its mechanism of action, doxorubicin hydrochloride liposomal infusion can cause fetal harm when administered to a pregnant woman; avoid the use of doxorubicin hydrochloride liposomal infusion during the 1st trimester. in animal reproduction studies, doxorubicin hydrochloride liposomal infusion was embryotoxic in rats and abortifacient in rabbits following intravenous administration during organogenesis at doses approximately 0.12 times the recommended clinical dose (see data) . available human data do not establish the presence or absence of major birth defects and miscarriage related to the use of doxorubicin hydrochloride during the 2nd and 3rd trimesters. advise pregnant women of the potential risk to a fetus. the background risk of major birth defects and miscarriage for the indicated populations are unknown. however, the background risk in the u.s. general population of major birth defects is 2-4% and of miscarriage is 15-20% of clinically recognized pregnancies. data animal data doxorubicin hydrochloride liposomal infusion was embryotoxic at doses of 1 mg/kg/day in rats and was embryotoxic and abortifacient at 0.5 mg/kg/day in rabbits (both doses are about 0.12 times the recommended dose of 50 mg/m2 human dose on a mg/m2 basis). embryotoxicity was characterized by increased embryo-fetal deaths and reduced live litter sizes. risk summary it is not known whether doxorubicin hydrochloride liposomal infusion is present in human milk. because many drugs, including anthracyclines, are excreted in human milk and because of the potential for serious adverse reactions in breastfed infants from doxorubicin hydrochloride liposomal infusion, discontinue breastfeeding during treatment with doxorubicin hydrochloride liposomal infusion. pregnancy testing verify the pregnancy status of females of reproductive potential prior to initiating doxorubicin hydrochloride liposomal infusion. contraception females doxorubicin hydrochloride liposomal infusion 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 and for 6 months after treatment with doxorubicin hydrochloride liposomal infusion. males doxorubicin hydrochloride liposomal infusion may damage spermatozoa and testicular tissue, resulting in possible genetic fetal abnormalities. males with female sexual partners of reproductive potential should use effective contraception during and for 6 months after treatment with doxorubicin hydrochloride liposomal infusion [see non-clinical toxicology (13.1)]. infertility females in females of reproductive potential, doxorubicin hydrochloride liposomal infusion may cause infertility and result in amenorrhea. premature menopause can occur with doxorubicin hydrochloride. recovery of menses and ovulation is related to age at treatment. males doxorubicin hydrochloride liposomal infusion may result in oligospermia, azoospermia, and permanent loss of fertility. sperm counts have been reported to return to normal levels in some men. this may occur several years after the end of therapy [see non-clinical toxicology (13.1)] . the safety and effectiveness of doxorubicin hydrochloride liposomal infusion in pediatric patients have not been established. clinical studies of doxorubicin hydrochloride liposomal infusion conducted in patients with either epithelial ovarian cancer (trial 4) or with aids-related kaposi's sarcoma (trial 5) did not contain sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger subjects. in trial 6, of 318 patients treated with doxorubicin hydrochloride liposomal infusion in combination with bortezomib for multiple myeloma, 37% were 65 years of age or older and 8% were 75 years of age or older. no overall differences in safety or efficacy were observed between these patients and younger patients. the pharmacokinetics of doxorubicin hydrochloride liposomal infusion has not been adequately evaluated in patients with hepatic impairment. doxorubicin is eliminated in large part by the liver. reduce doxorubicin hydrochloride liposomal infusion for serum bilirubin of 1.2 mg/dl or higher.

USA - engelsk - NLM (National Library of Medicine)

northstar rxllc - doxorubicin hydrochloride (unii: 82f2g7bl4e) (doxorubicin - unii:80168379ag) - doxorubicin hydrochloride injection is indicated as a component of multi-agent adjuvant chemotherapy for treatment of women with axillary lymph node involvement following resection of primary breast cancer. doxorubicin hydrochloride injection is indicated for the treatment of - acute lymphoblastic leukemia - acute myeloblastic leukemia - hodgkin lymphoma - non-hodgkin lymphoma (nhl) - metastatic breast cancer - metastatic wilms’ tumor - metastatic neuroblastoma - metastatic soft tissue sarcoma - metastatic bone sarcoma - metastatic ovarian carcinoma - metastatic transitional cell bladder carcinoma - metastatic thyroid carcinoma - metastatic gastric carcinoma - metastatic bronchogenic carcinoma doxorubicin hydrochloride injection is contraindicated in patients with: - severe myocardial insufficiency [see warnings and precautions (5.1)] - recent (occurring within the past 4 to 6 weeks) myocardial infarction [see warnings and precautions (5.1)] - severe persistent drug-induced myelosuppression [see warnings and

USA - engelsk - NLM (National Library of Medicine)

bluepoint laboratories - doxorubicin hydrochloride (unii: 82f2g7bl4e) (doxorubicin - unii:80168379ag) - doxorubicin hydrochloride liposome injection is indicated for the treatment of patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy. doxorubicin hydrochloride liposome injection is indicated for the treatment of aids-related kaposi's sarcoma in patients after failure of prior systemic chemotherapy or intolerance to such therapy. doxorubicin hydrochloride liposome injection, in combination with bortezomib, is indicated for the treatment of patients with multiple myeloma who have not previously received bortezomib and have received at least one prior therapy. doxorubicin hydrochloride liposome injection is contraindicated in patients who have a history of severe hypersensitivity reactions, including anaphylaxis, to doxorubicin hydrochloride [see warnings and precautions ( 5.2)]. risk summary based on findings in animals and its mechanism of action, doxorubicin hydrochloride liposome injection can cause fetal harm when ad

USA - engelsk - NLM (National Library of Medicine)

padagis us llc - doxorubicin hydrochloride (unii: 82f2g7bl4e) (doxorubicin - unii:80168379ag) - doxorubicin hydrochloride liposome injection is indicated for the treatment of patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy. doxorubicin hydrochloride liposome injection is indicated for the treatment of aids-related kaposi's sarcoma in patients after failure of prior systemic chemotherapy or intolerance to such therapy. doxorubicin hydrochloride liposome injection, in combination with bortezomib, is indicated for the treatment of patients with multiple myeloma who have not previously received bortezomib and have received at least one prior therapy. doxorubicin hydrochloride liposome injection is contraindicated in patients who have a history of severe hypersensitivity reactions, including anaphylaxis, to doxorubicin hydrochloride [see warnings and precautions (5.2)]. risk summary based on findings in animals and its mechanism of action, doxorubicin hydrochloride liposome injection can cause fetal harm when administered to a pregnant woman; avoid the