Malta - inglês - Malta Medicines Authority

accord healthcare limited - idarubicin hydrochloride - solution for injection - idarubicin hydrochloride 5 mg/ml - antineoplastic agents

Malta - inglês - Malta Medicines Authority

accord healthcare limited - idarubicin hydrochloride - solution for injection - idarubicin hydrochloride 1 mg/ml - antineoplastic agents

Estados Unidos - inglês - NLM (National Library of Medicine)

hikma pharmaceuticals usa inc. - doxorubicin hydrochloride (unii: 82f2g7bl4e) (doxorubicin - unii:80168379ag) - - cardiomyopathy: myocardial damage, including acute left ventricular failure can occur with doxorubicin. the risk of cardiomyopathy is proportional to the cumulative exposure with incidences from 1% to 20% for cumulative doses from 300 mg/m2 to 500 mg/m2 when doxorubicin is administered every 3 weeks. the risk of cardiomyopathy is further increased with concomitant cardiotoxic therapy. assess lvef before and regularly during and after treatment with doxorubicin [see warnings and precautions (5.1)]. - secondary malignancies: secondary acute myelogenous leukemia (aml) and myelodysplastic syndrome (mds) occur at a higher incidence in patients treated with anthracyclines, including doxorubicin [see warnings and precautions (5.2)]. extravasation and tissue necrosis: extravasation of doxorubicin can result in severe local tissue injury and necrosis requiring wide excision of the affected area and skin grafting.immediately terminate the drug, and apply ice to the affected area [see warnings and precautions (5.3)]. extravasation and tissue necrosis: extravasation of doxorubicin can result in severe local tissue injury and necrosis requiring wide excision of the affected area and skin grafting.immediately terminate the drug, and apply ice to the affected area [see warnings and precautions (5.3)]. - severe myelosuppression resulting in serious infection, septic shock, requirement for transfusions, hospitalization, and death may occur [see warnings and precautions (5.4)]. adriamycin (doxorubicin hcl) injection, usp and 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)] the following adverse reactions are discussed in more detail in other sections of the labeling. - cardiomyopathy and arrhythmias [see warnings and precautions (5.1)] - secondary malignancies [see warnings and precautions (5.2)] - extravasation and tissue necrosis [see warnings and precautions (5.3)] - severe myelosuppression [see warnings and precautions (5.4)] - tumor lysis syndrome [see warnings and precautions (5.6)] - radiation sensitization and radiation recall [see warnings and precautions (5.7)] 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 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)] .

Malta - inglês - Malta Medicines Authority

accord healthcare ireland ltd euro house, euro business park, little island cork, t45 k857, ireland - idarubicin hydrochloride - solution for injection - idarubicin hydrochloride 1 mg/ml - antineoplastic agents

Malta - inglês - Malta Medicines Authority

accord healthcare ireland ltd euro house, euro business park, little island cork, t45 k857, ireland - idarubicin hydrochloride - solution for injection - idarubicin hydrochloride 1 mg/ml - antineoplastic agents

Malta - inglês - Malta Medicines Authority

accord healthcare ireland ltd euro house, euro business park, little island cork, t45 k857, ireland - idarubicin hydrochloride - solution for injection - idarubicin hydrochloride 1 mg/ml - antineoplastic agents

Irlanda - inglês - HPRA (Health Products Regulatory Authority)

novartis pharmaceuticals uk ltd - dexrazoxane - pdr/conc/soln for infus - 500mg/vial milligram

Israel - inglês - Ministry of Health

abic marketing ltd, israel - doxorubicin hydrochloride - concentrate for solution for infusion - doxorubicin hydrochloride 2 mg/ml - doxorubicin - doxorubicin - to produce regression in disseminated neoplastic conditions such as: - acute lymphoblastic leukemia, - acute myeloblastic leukemia, - wilms' tumor neuroblastoma, - soft tissue and bone sarcomas, - breast carcinoma, - lymphomas of both hodgkin's and non-hodgkin's types, - bronchogenic carcinoma in which the small cell histologic type is the most responsive compared to other cell types, - gastric carcinoma.

Israel - inglês - Ministry of Health

pfizer pfe pharmaceuticals israel ltd - idarubicin hydrochloride - powder for concentrate for solution for infusion - idarubicin hydrochloride 10 mg/vial - idarubicin - idarubicin - antimitotic and cytotoxic agent. acute non-limphocytic leukemia (anll) in adults for remission induction in untreated patients or for remission induction in relapsed or refractory patients.acute limphocytic leukemia (all) as second line treatment in adults and children.

Irlanda - inglês - HPRA (Health Products Regulatory Authority)

accord healthcare limited - doxorubicin hydrochloride - concentrate for soln for inf - 2 mg/ml - doxorubicin