Canada - English - Health Canada

juno pharmaceuticals corp. - micafungin (micafungin sodium) - powder for solution - 100mg - micafungin (micafungin sodium) 100mg

Canada - English - Health Canada

accord healthcare inc - micafungin (micafungin sodium) - powder for solution - 100mg - micafungin (micafungin sodium) 100mg

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

xellia pharmaceuticals usa llc - micafungin sodium (unii: is1up79r56) (micafungin - unii:r10h71bswg) - micafungin for injection is indicated for: - treatment of candidemia, acute disseminated candidiasis, candida peritonitis and abscesses in adult and pediatric patients 4 months of age and older [see clinical studies (14.1) and use in specific populations (8.4)]. - treatment of esophageal candidiasis in adult and pediatric patients 4 months of age and older [see clinical studies (14.2)]. - prophylaxis of candida infections in adult and pediatric patients 4 months of age and older undergoing hematopoietic stem cell transplantation [see clinical studies (14.3)]. limitations of use - micafungin for injection has not been adequately studied in patients with endocarditis, osteomyelitis and meningoencephalitis due to candida. - the efficacy of micafungin for injection against infections caused by fungi other than candida has not been established. additional pediatric use information is approved for astellas pharma us, inc.`s mycamine ® (micafungin for injection). however, due to astellas pharma us, inc.`s marketing exclusivity rights, this drug product is not labeled with that information. micafungin for injection is contraindicated in persons with known hypersensitivity to micafungin, any component of micafungin for injection, or other echinocandins. risk summary based on findings from animal studies, micafungin for injection may cause fetal harm when administered to a pregnant woman (see data) . there is insufficient human data on the use of micafungin for injection in pregnant women to inform a drug-associated risk of adverse developmental outcomes. in animal reproduction studies, intravenous administration of micafungin sodium to pregnant rabbits during organogenesis at doses four times the maximum recommended human dose resulted in visceral abnormalities and increased abortion (see data) . advise pregnant women of the risk to the fetus. the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. 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. data animal data in an embryo-fetal toxicity study in pregnant rabbits, intravenous administration of micafungin sodium during organogenesis (days 6 to 18 of gestation) resulted in fetal visceral abnormalities and abortion at 32 mg/kg, a dose equivalent to four times the recommended human dose based on body surface area comparisons. visceral abnormalities included abnormal lobation of the lung, levocardia, retrocaval ureter, anomalous right subclavian artery, and dilatation of the ureter. risk summary there are no data on the presence of micafungin in human milk, the effects on the breast-fed infant or the effects on milk production. micafungin was present in the milk of lactating rats following intravenous administration. when a drug is present in animal milk, it is likely that the drug will be present in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for micafungin for injection, and any potential adverse effects on the breast-fed child from micafungin for injection, or from the underlying maternal condition. pediatric patients 4 months of age and older the safety and effectiveness of micafungin for injection for the treatment of esophageal candidiasis, candidemia, acute disseminated candidiasis, candida peritonitis and abscesses, esophageal candidiasis, and for prophylaxis of candida infections in patients undergoing hsct have been established in pediatric patients 4 months of age and older. use of micafungin for injection for these indications and in this age group is supported by evidence from adequate and well-controlled studies in adult and pediatric patients with additional pharmacokinetic and safety data in pediatric patients 4 months of age and older [see indications and usage (1), adverse reactions (6.1), clinical pharmacology (12.3), and clinical studies (14)]. pediatric patients younger than 4 months of age treatment of candidemia, acute disseminated candidiasis, candida peritonitis and abscesses with meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age the safety and effectiveness of micafungin for injection have not been established for the treatment of candidemia with meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age. in a rabbit model of hematogenous candida meningoencephalitis (hcme) with candida albicans (minimum inhibitory concentration of 0.125 mcg/ml), a decrease in mean fungal burden in central nervous system (cns) compartments assessed as the average of combined fungal burden in the cerebrum, cerebellum, and spinal cord relative to untreated controls, was observed with increasing micafungin dosages administered once daily for 7 days. in this rabbit model, micafungin concentrations could not be reliably detected in cerebrospinal fluid (csf). due to limitations of the study design, the clinical significance of a decreased cns fungal burden in the rabbit hcme model is uncertain. treatment of esophageal candidiasis and prophylaxis of candida infections in patients undergoing hematopoietic stem cell transplantation in pediatric patients younger than 4 months of age the safety and effectiveness of mycamine in pediatric patients younger than 4 months of age have not been established for the: - treatment of esophageal candidiasis - prophylaxis of candida infections in patients undergoing hematopoietic stem cell transplantation additional pediatric use information is approved for astellas pharma us, inc.`s mycamine ® (micafungin for injection). however, due to astellas pharma us, inc.`s marketing exclusivity rights, this drug product is not labeled with that information. a total of 418 subjects in clinical studies of micafungin for injection were 65 years of age and older, and 124 subjects were 75 years of age and older. no overall differences in safety and effectiveness were observed between these subjects and younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. the exposure and disposition of a 50 mg micafungin for injection dose administered as a single 1-hour infusion to 10 healthy subjects aged 66 to 78 years were not significantly different from those in 10 healthy subjects aged 20 to 24 years. no dose adjustment is necessary for the elderly. micafungin for injection does not require dose adjustment in patients with renal impairment. supplementary dosing should not be required following hemodialysis [see clinical pharmacology (12.3)] . dose adjustment of micafungin for injection is not required in patients with mild, moderate, or severe hepatic impairment [see clinical pharmacology (12.3)] . no dose adjustment of micafungin for injection is required based on gender or race. after 14 daily doses of 150 mg to healthy subjects, micafungin auc in women was greater by approximately 23% compared with men, due to smaller body weight. no notable differences among white, black, and hispanic subjects were seen. the micafungin auc was greater by 19% in japanese subjects compared to blacks, due to smaller body weight. there has been no evidence of either psychological or physical dependence or withdrawal or rebound effects with micafungin for injection.

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

civica, inc. - micafungin sodium (unii: is1up79r56) (micafungin - unii:r10h71bswg) - micafungin for injection is indicated for: - treatment of candidemia, acute disseminated candidiasis, candida peritonitis and abscesses in adult and pediatric patients 4 months of age and older [see clinical studies (14.1) and use in specific populations (8.4)]. - treatment of esophageal candidiasis in adult and pediatric patients 4 months of age and older [see clinical studies (14.2)]. - prophylaxis of candida infections in adult and pediatric patients 4 months of age and older undergoing hematopoietic stem cell transplantation [see clinical studies (14.3)]. limitations of use - micafungin for injection has not been adequately studied in patients with endocarditis, osteomyelitis and meningoencephalitis due to candida . - the efficacy of micafungin for injection against infections caused by fungi other than candida has not been established. additional pediatric use information is approved for astellas pharma us, inc.`s mycamine® (micafungin for injection). however, due to astellas pharma us, inc.`s marketing exclusivity rights, this drug product is not labeled with that information. micafungin for injection is contraindicated in persons with known hypersensitivity to micafungin, any component of micafungin for injection, or other echinocandins. risk summary based on findings from animal studies, micafungin for injection may cause fetal harm when administered to a pregnant woman (see data). there is insufficient human data on the use of micafungin for injection in pregnant women to inform a drug-associated risk of adverse developmental outcomes. in animal reproduction studies, intravenous administration of micafungin sodium to pregnant rabbits during organogenesis at doses four times the maximum recommended human dose resulted in visceral abnormalities and increased abortion (see data) . advise pregnant women of the risk to the fetus. the estimated background risk of major birth defects and miscarriage for the indicated populations is unknown. all pregnancies have a background risk of birth defect, loss, or other adverse outcomes. 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. data animal data in an embryo-fetal toxicity study in pregnant rabbits, intravenous administration of micafungin sodium during organogenesis (days 6 to 18 of gestation) resulted in fetal visceral abnormalities and abortion at 32 mg/kg, a dose equivalent to four times the recommended human dose based on body surface area comparisons. visceral abnormalities included abnormal lobation of the lung, levocardia, retrocaval ureter, anomalous right subclavian artery, and dilatation of the ureter. risk summary there are no data on the presence of micafungin in human milk, the effects on the breast-fed infant or the effects on milk production. micafungin was present in the milk of lactating rats following intravenous administration. when a drug is present in animal milk, it is likely that the drug will be present in human milk. the developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for micafungin for injection, and any potential adverse effects on the breast-fed child from micafungin for injection, or from the underlying maternal condition. pediatric patients 4 months of age and older the safety and effectiveness of micafungin for injection for the treatment of esophageal candidiasis, candidemia, acute disseminated candidiasis, candida peritonitis and abscesses, esophageal candidiasis, and for prophylaxis of candida infections in patients undergoing hsct have been established in pediatric patients 4 months of age and older. use of micafungin for injection for these indications and in this age group is supported by evidence from adequate and well-controlled studies in adult and pediatric patients with additional pharmacokinetic and safety data in pediatric patients 4 months of age and older [see indications and usage (1), adverse reactions (6.1), clinical pharmacology (12.3), and clinical studies (14)] . pediatric patients younger than 4 months of age treatment of candidemia, acute disseminated candidiasis, candida peritonitis and abscesses with meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age the safety and effectiveness of micafungin for injection have not been established for the treatment of candidemia with meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age. in a rabbit model of hematogenous candida meningoencephalitis (hcme) with candida albicans (minimum inhibitory concentration of 0.125 mcg/ml), a decrease in mean fungal burden in central nervous system (cns) compartments assessed as the average of combined fungal burden in the cerebrum, cerebellum, and spinal cord relative to untreated controls, was observed with increasing micafungin dosages administered once daily for 7 days. in this rabbit model, micafungin concentrations could not be reliably detected in cerebrospinal fluid (csf). due to limitations of the study design, the clinical significance of a decreased cns fungal burden in the rabbit hcme model is uncertain. treatment of esophageal candidiasis and prophylaxis of candida infections in patients undergoing hematopoietic stem cell transplantation in pediatric patients younger than 4 months of age the safety and effectiveness of micafungin for injection in pediatric patients younger than 4 months of age have not been established for the: - treatment of esophageal candidiasis - prophylaxis of candida infections in patients undergoing hematopoietic stem cell transplantation additional pediatric use information is approved for astellas pharma us, inc.`s mycamine® (micafungin for injection). however, due to astellas pharma us, inc.`s marketing exclusivity rights, this drug product is not labeled with that information. a total of 418 subjects in clinical studies of micafungin for injection were 65 years of age and older, and 124 subjects were 75 years of age and older. no overall differences in safety and effectiveness were observed between these subjects and younger subjects. other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. the exposure and disposition of a 50 mg micafungin for injection dose administered as a single 1-hour infusion to 10 healthy subjects aged 66 to 78 years were not significantly different from those in 10 healthy subjects aged 20 to 24 years. no dose adjustment is necessary for the elderly. micafungin for injection does not require dose adjustment in patients with renal impairment. supplementary dosing should not be required following hemodialysis [see clinical pharmacology (12.3)] . dose adjustment of micafungin for injection is not required in patients with mild, moderate, or severe hepatic impairment [see clinical pharmacology (12.3)] . no dose adjustment of micafungin for injection is required based on gender or race. after 14 daily doses of 150 mg to healthy subjects, micafungin auc in women was greater by approximately 23% compared with men, due to smaller body weight. no notable differences among white, black, and hispanic subjects were seen. the micafungin auc was greater by 19% in japanese subjects compared to blacks, due to smaller body weight. there has been no evidence of either psychological or physical dependence or withdrawal or rebound effects with micafungin for injection.

Ireland - English - HPRA (Health Products Regulatory Authority)

pinewood laboratories ltd, - micafungin - powder for concentrate for solution for infusion - 100 milligram(s) - micafungin

Malta - English - Medicines Authority

mylan ireland limited unit 35/36, grange parade, baldoyle industrial estate, dublin 13, ireland - micafungin sodium - powder for concentrate for solution for infusion - micafungin sodium 20 mg/ml - antimycotics for systemic use

New Zealand - English - Medsafe (Medicines Safety Authority)

seqirus (nz) ltd - micafungin 100mg - powder for injection - 100 mg - active: micafungin 100mg excipient: citric acid lactose nitrogen sodium hydroxide - treatment of invasive candidiasis in children & adults treatment of oesophageal candidiasis in adults, adolescents nlt 16 yrs of age, and elderly patients for whom intravenous therapy is appropriate prophylaxis of candida infection in children and adult patients undergoing allogenic haematopoietic stem cell transplantation or patients who are expected to have neutropenia (absolute neutrophil count below 500 cells per microliter) for 10 or more days

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

fresenius kabi usa, llc - micafungin sodium (unii: is1up79r56) (micafungin - unii:r10h71bswg) - micafungin for injection is indicated for: - treatment of candidemia, acute disseminated candidiasis, candida peritonitis and abscesses in adult and pediatric patients 4 months of age and older [see clinical studies (14.1) and use in specific populations (8.4)]. - treatment of candidemia, acute disseminated candidiasis, candida peritonitis and abscesses without meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age [see use in specific populations (8.4)] . - treatment of esophageal candidiasis in adult and pediatric patients 4 months of age and older [see clinical studies (14.2)]. - prophylaxis of candida infections in adult and pediatric patients 4 months of age and older undergoing hematopoietic stem cell transplantation [see clinical studies (14.3)]. limitations of use - the safety and effectiveness of micafungin for injection have not been established for the treatment of candidemia with meningoencephalitis and/or ocular dissemination in pediatri

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

fresenius kabi usa, llc - micafungin sodium (unii: is1up79r56) (micafungin - unii:r10h71bswg) - micafungin for injection is indicated for: - treatment of candidemia, acute disseminated candidiasis, candida peritonitis and abscesses in adult and pediatric patients 4 months of age and older [see clinical studies (14.1) and use in specific populations (8.4)]. - treatment of candidemia, acute disseminated candidiasis, candida peritonitis and abscesses without meningoencephalitis and/or ocular dissemination in pediatric patients younger than 4 months of age [see use in specific populations (8.4)] . - treatment of esophageal candidiasis in adult and pediatric patients 4 months of age and older [see clinical studies (14.2)]. - prophylaxis of candida infections in adult and pediatric patients 4 months of age and older undergoing hematopoietic stem cell transplantation [see clinical studies (14.3)]. limitations of use - the safety and effectiveness of micafungin for injection have not been established for the treatment of candidemia with meningoencephalitis and/or ocular dissemination in pediatri

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

sagent pharmaceuticals - micafungin sodium (unii: is1up79r56) (micafungin - unii:r10h71bswg) - micafungin for injection is indicated for: - treatment of candidemia, acute disseminated candidiasis, candida peritonitis and abscesses in adult and pediatric patients 4 months of age and older [see clinical studies (14.1) and use in specific populations (8.4)]. - treatment of esophageal candidiasis in adult and pediatric patients 4 months of age and older [see clinical studies (14.2)]. - prophylaxis of candida infections in adult and pediatric patients 4 months of age and older undergoing hematopoietic stem cell transplantation [see clinical studies (14.3)]. limitations of use - micafungin for injection has not been adequately studied in patients with endocarditis, osteomyelitis and meningoencephalitis due to candida . - the efficacy of micafungin for injection against infections caused by fungi other than candida has not been established. additional pediatric use information is approved for astellas pharma us, inc.'s mycamine ® (micafungin for injection). however, due to astellas pharma us, inc.'s mark