Málta - angol - Medicines Authority

mylan s.a.s. 117 allee des parcs, 69800 saint priest, france - doxorubicin hydrochloride - concentrate for solution for infusion - doxorubicin hydrochloride 2 mg - antineoplastic agents

Kanada - angol - Health Canada

novopharm limited - doxorubicin hydrochloride - solution - 2mg - doxorubicin hydrochloride 2mg - antineoplastic agents

Kanada - angol - Health Canada

omega laboratories limited - doxorubicin hydrochloride - solution - 2mg - doxorubicin hydrochloride 2mg - antineoplastic agents

Kanada - angol - Health Canada

strides pharma canada inc - doxorubicin hydrochloride - solution - 2mg - doxorubicin hydrochloride 2mg - antineoplastic agents

Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

medis pharma pty ltd - doxorubicin hydrochloride, quantity: 50 mg - injection, powder for - excipient ingredients: methyl hydroxybenzoate; lactose - doxorubicin 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 types, bronchogenic (lung) carcinoma, thyroid carcinoma, hepatomas and ovarian carcinoma. doxorubicin is also indicated by intravesical administration in the primary management of nonmetastatic carcinoma of the bladder (tis, t1, t2).

Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

medis pharma pty ltd - doxorubicin hydrochloride, quantity: 10 mg - injection, powder for - excipient ingredients: lactose; methyl hydroxybenzoate - doxorubicin 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 types, bronchogenic (lung) carcinoma, thyroid carcinoma, hepatomas and ovarian carcinoma. doxorubicin is also indicated by intravesical administration in the primary management of nonmetastatic carcinoma of the bladder (tis, t1, t2).

Egyesült Államok - angol - NLM (National Library of Medicine)

janssen products, lp - doxorubicin hydrochloride (unii: 82f2g7bl4e) (doxorubicin - unii:80168379ag) - doxorubicin hydrochloride 2 mg in 1 ml - doxil is indicated for the treatment of patients with ovarian cancer whose disease has progressed or recurred after platinum-based chemotherapy. doxil is indicated for the treatment of aids-related kaposi's sarcoma in patients after failure of prior systemic chemotherapy or intolerance to such therapy. doxil, 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. doxil 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, doxil can cause fetal harm when administered to a pregnant woman; avoid the use of doxil during the 1st trimester. in animal reproduction studies, doxil was embryotoxic in rats and abortifacient in rabbits following intravenous administration during organogenesis at dos

Egyesült Államok - angol - NLM (National Library of Medicine)

hikma pharmaceuticals usa inc. - doxorubicin hydrochloride (unii: 82f2g7bl4e) (doxorubicin - unii:80168379ag) - doxorubicin hydrochloride 2 mg in 1 ml - adriamycin (doxorubicin hcl) for injection, usp 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 [see clinical studies (14.1)]. doxorubicin 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 doxorubicin 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 precautions (5.4)] severe hepatic impairment (defined as child pugh class c or serum bilirubin level greater than 5 mg/dl) [see warnings and precautions (5.5)] - severe hypersensitivity reaction to doxorubicin including anaphylaxis [see adverse reactions (6.2)] pregnancy category d risk summary doxorubicin can cause fetal harm when administered to a pregnant woman. doxorubicin was teratogenic and embryotoxic in rats and rabbits at doses approximately 0.07 times (based on body surface area) the recommended human dose of 60 mg/m2 . if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, apprise the patient of the potential hazard to a fetus. animal data doxorubicin was teratogenic and embryotoxic at doses of 0.8 mg/kg/day (about 0.07 times the recommended human dose based on body surface area) when administered during the period of organogenesis in rats. teratogenicity and embryotoxicity were also seen using discrete periods of treatment. the most susceptible was the 6- to 9-day gestation period at doses of 1.25 mg/kg/day and greater. characteristic malformations included esophageal and intestinal atresia, tracheo-esophageal fistula, hypoplasia of the urinary bladder, and cardiovascular anomalies. doxorubicin was embryotoxic (increase in embryofetal deaths) and abortifacient at 0.4 mg/kg/day (about 0.07 times the recommended human dose based on body surface area) in rabbits when administered during the period of organogenesis. doxorubicin has been detected in the milk of at least one lactating patient [see clinical pharmacology (12.3)] . because of the potential for serious adverse reactions in nursing infants from doxorubicin , a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. based on postmarketing reports, pediatric patients treated with doxorubicin are at risk for developing late cardiovascular dysfunction. risk factors include young age at treatment (especially < 5 years), high cumulative doses and receipt of combined modality therapy. long-term periodic cardiovascular monitoring is recommended for all pediatric patients who have received doxorubicin. doxorubicin, as a component of intensive chemotherapy regimens administered to pediatric patients, may contribute to prepubertal growth failure and may also contribute to gonadal impairment, which is usually temporary. there are no recommended dose adjustments based on age. doxorubicin clearance was increased in patients aged 2 years to 20 years as compared to adults, while doxorubicin clearance was similar in children less than 2 years as compared to adults [see clinical pharmacology (12.3)]. clinical experience in patients who were 65 years of age and older who received doxorubicin hcl-based chemotherapy regimens for metastatic breast cancer showed no overall differences in safety and effectiveness compared with younger patients. contraception females doxorubicin can cause fetal harm when administered during pregnancy. advise female patients of reproductive potential to use highly effective contraception during treatment with doxorubicin and for 6 months after treatment. advise patients to contact their healthcare provider if they become pregnant, or if pregnancy is suspected, while taking doxorubicin [see use in specific populations (8.1)] . males doxorubicin 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 [see nonclinical toxicology (13.1)] . infertility females in females of reproductive potential, doxorubicin may cause infertility and result in amenorrhea. premature menopause can occur. recovery of menses and ovulation is related to age at treatment [see nonclinical toxicology (13.1)] . males doxorubicin 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. the clearance of doxorubicin was reduced in patients with elevated serum bilirubin levels. reduce the dose of doxorubicin in patients with serum bilirubin levels greater than 1.2 mg/dl [see dosage and administration (2.2) and warnings and precautions (5.5)] . doxorubicin is contraindicated in patients with severe hepatic impairment (defined as child pugh class c or serum bilirubin levels greater than 5 mg/dl) [see contraindications (4)] .

Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

baxter healthcare pty ltd - doxorubicin hydrochloride, quantity: 2 mg/ml - injection, concentrated - excipient ingredients: hydrogenated soy phosphatidylcholine; histidine; hydrochloric acid; ammonium sulfate; cholesterol; water for injections; sodium hydroxide; sodium methoxy peg-40-carbonyl-distearoylphosphatidylethanolamine; sucrose - indications: for the treatment of: (1) advanced epithelial ovarian cancer in women who have failed a first-line platinum-based chemotherapy regimen. (2) aids-related kaposi's sarcoma (ks) in patients with low cd4 counts (<200 lymphocytes/cubic mm) and extensive mucocutaneous or visceral disease. 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). indications as at 29 february 2008: caelyx, as monotherapy, is indicated for the treatment of metastatic breast cancer. caelyx 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. caelyx 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). caelyx 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 who are unsuitable for bone marrow transplant.

Ausztrália - angol - Department of Health (Therapeutic Goods Administration)

baxter healthcare pty ltd - doxorubicin hydrochloride, quantity: 2 mg/ml - injection, concentrated - excipient ingredients: ammonium sulfate; histidine; water for injections; sodium hydroxide; cholesterol; sodium methoxy peg-40-carbonyl-distearoylphosphatidylethanolamine; sucrose; hydrogenated soy phosphatidylcholine; hydrochloric acid - for the treatment of aids-related kaposi's sarcoma (ks) in patients with low cd4 counts (<200 lymphocytes/mm) and extensive mucocutaneous or visceral disease. caelyx may be used for 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). indications as at 21 september 2001: for the treatment of: (1) advanced epithelial ovarian cancer in women who have failed a first-line platinum-based chemotherapy regimen. (2) aids-related kaposi's sarcoma (ks) in patients with low cd4 counts (<200 lymphocytes/cubic mm) and extensive mucocutaneous or visceral disease. 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). indications as at 29 february 2008: caelyx, as monotherapy, is indicated for the treatment of metastatic breast cancer. caelyx 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. caelyx 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). caelyx 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 who are unsuitable for bone marrow transplant.