Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

mylan institutional llc - doxorubicin hydrochloride (unii: 82f2g7bl4e) (doxorubicin - unii:80168379ag) - doxorubicin hydrochloride 10 mg in 5 ml

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - 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) 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)] 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)] .

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

pfizer laboratories div pfizer inc. - doxorubicin hydrochloride (unii: 82f2g7bl4e) (doxorubicin - unii:80168379ag) - doxorubicin hydrochloride 2 mg in 1 ml

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

amneal-agila, llc - doxorubicin hydrochloride (unii: 82f2g7bl4e) (doxorubicin - unii:80168379ag) - doxorubicin hydrochloride 10 mg in 5 ml

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

pharmacia & upjohn company llc - epirubicin hydrochloride (unii: 22966tx7j5) (epirubicin - unii:3z8479zz5x) - epirubicin hydrochloride 2 mg in 1 ml - ellence 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)] . ellence is contraindicated in patients with: risk summary based on findings from animal studies and its mechanism of action, ellence can cause fetal harm when administered to a pregnant woman [see clinical pharmacology (12.1)] ; avoid the use of ellence during the 1st trimester. available human data do not establish the presence or absence of major birth defects and miscarriage related to the use of epirubicin during the 2nd and 3rd trimesters. there are reports of fetal and/or neonatal cardiotoxicity following in utero exposure to epirubicin (see clinical considerations) . in animal reproduction studies in pregnant rats, epirubicin was embryo-fetal lethal and caused structural abnormalities when administered during organogenesis at doses less than the maximum recommended human dose on a body surface area basis (see data) . advise pregnant women and females of reproductive potential of the potential risk to a fetus. the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. in the u.s. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. clinical considerations fetal/neonatal adverse reactions there have been rare reports of fetal and/or neonatal transient ventricular hypokinesia, transient elevation of cardiac enzymes, and a case of fetal demise from suspected anthracycline-induced cardiotoxicity following in utero exposure to epirubicin in 2nd and/or 3rd trimesters. cardiotoxicity is a known risk of anthracycline treatment in adults [see warnings and precautions (5.1)]. monitor the fetus and/or neonate for cardiotoxicity and perform testing consistent with community standards of care. data animal data intravenous administration of 0.8 mg/kg/day epirubicin(about 0.04 times the maximum recommended single human dose on a body surface area basis) to rats during days 5 to 15 of gestation resulted in embryofetal lethality (increased resorptions and post-implantation loss) and caused fetal growth retardation (decreased body weight).intravenous administration of 2 mg/kg/day epirubicin (about 0.1 times the maximum recommended single human dose on a body surface area basis) to rats on days 9 and 10 of gestation resulted in embryo-fetal lethality (increased late resorptions, post-implantation losses, and dead fetuses; and decreased live fetuses), retarded fetal growth (decreased body weight), and caused decreased placental weight and numerous external (anal atresia, misshapen tail, abnormal genital tubercle), visceral (primarily gastrointestinal, urinary, and cardiovascular systems), and skeletal (deformed long bones and girdles, rib abnormalities, irregular spinal ossification) malformations. administration of intravenous epirubicin to rabbits at doses up to 0.2 mg/kg/day (about 0.02 times the maximum recommended single human dose on a body surface area basis) during days 6 to 18 of gestation was not teratogenic, but a maternally toxic dose of 0.32 mg/kg/day increased abortions and delayed ossification. administration of a maternally toxic intravenous dose of 1 mg/kg/day epirubicin to rabbits (about 0.1 times the maximum recommended single human dose on a body surface area basis) on days 10 to 12 of gestation induced abortion, but no other signs of teratogenicity were observed. when doses up to 0.5 mg/kg/day epirubicin were administered to rat dams from day 17 of gestation to day 21 after delivery (about 0.025 times the maximum recommended single human dose on a body surface area basis), no permanent changes were observed in the development, functional activity, behavior, or reproductive performance of the offspring. risk summary there are no data on the presence of epirubicin in human milk, the effects on the breastfed child, or the effects on milk production. epirubicin is present in rat milk (see data) . when a drug is present in animal milk it is likely the drug will be present in human milk. because of the potential for serious adverse reactions in the breastfed child, advise lactating women not to breastfeed during treatment with ellence and for at least 7 days after the last dose. data animal data in a peri- and post-natal study, epirubicin was present in milk of rats treated with 0.5 mg/kg/day epirubicin (about 0.025 times the maximum recommended human dose on a body surface area basis). pregnancy testing verify the pregnancy status in female patients of reproductive potential prior to initiating ellence. contraception females ellence can cause fetal harm when administered to a pregnant woman [see use in specific populations (8.1)] . advise female patients of reproductive potential to use effective contraception during treatment and for 6 months after the last dose of ellence. males based on clinical findings and animal studies, ellence may cause 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 nonclinical toxicology (13.1)] . infertility females based on clinical findings and animal studies, ellence may impair female fertility 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 based on its mechanism of action and genotoxicity studies, advise male patients with female partners of reproductive potential to use effective contraception during treatment and for 3 months after the last dose of ellence. advise male patients with pregnant partners use condoms during treatment and for at least 7 days after the last dose of ellence [see clinical pharmacology (12.1) and nonclinical toxicology (13.1)]. safety and effectiveness of ellence have not been established in pediatric patients. pediatric patients may be at greater risk for anthracycline-induced acute manifestations of cardiotoxicity or late cardiovascular dysfunction. the pharmacokinetics of epirubicin in pediatric patients have not been evaluated. clinical experience in patients who were 65 years of age and older who received ellence chemotherapy regimens for primary breast cancer showed no overall differences in safety and effectiveness compared with younger patients. in elderly female patients, closely monitor for increased toxicity due to the risk of decreased clearance of epirubicin [see clinical pharmacology (12.3)]. epirubicin is eliminated by both hepatic metabolism and biliary excretion and clearance is reduced in patients with hepatic dysfunction. do not treat patients with severe hepatic impairment with ellence [see contraindications (4)] . reduce the starting dose for patients with less severe hepatic impairment [see dosage and administration (2.2) and clinical pharmacology (12.3)]. no significant alterations in the pharmacokinetics of epirubicin or its major metabolite, epirubicinol, have been observed in patients with serum creatinine <5 mg/dl. consider lower doses in patients with severe renal impairment (serum creatinine >5 mg/dl), as a reduction in plasma clearance was reported in these patients [see dosage and administration (2.3) and clinical pharmacology (12.3)]. patients on dialysis have not been studied.

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

alvogen inc. - doxorubicin hydrochloride (unii: 82f2g7bl4e) (doxorubicin - unii:80168379ag) - doxorubicin hydrochloride 2 mg in 1 ml

Իռլանդիա - անգլերեն - HPRA (Health Products Regulatory Authority)

accord healthcare ireland ltd. - epirubicin hydrochloride - solution for injection/infusion - 2 milligram(s)/millilitre - anthracyclines and related substances; epirubicin

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

hikma pharmaceuticals usa inc. - doxorubicin hydrochloride (unii: 82f2g7bl4e) (doxorubicin - unii:80168379ag) - doxorubicin hcl 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 - metastatic transitional cell bladder carcinoma - metastatic thyroid carcinoma - metastatic gastric carcinoma - metastatic bronchogenic 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 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)] .

Ամերիկայի Միացյալ Նահանգներ - անգլերեն - NLM (National Library of Medicine)

hikma pharmaceuticals usa inc. - doxorubicin hydrochloride (unii: 82f2g7bl4e) (doxorubicin - unii:80168379ag) - doxorubicin hcl 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 - metastatic transitional cell bladder carcinoma - metastatic thyroid carcinoma - metastatic gastric carcinoma - metastatic bronchogenic 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 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)] .

Հայաստան - անգլերեն - Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

accord healthcare polska sp. z o.o. - epirubicin (epirubicin hydrochloride) - solution for injection/infusion - 2mg/ml