Yhdysvallat - englanti - NLM (National Library of Medicine)

meitheal pharmaceuticals 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 marketi

Yhdysvallat - englanti - NLM (National Library of Medicine)

hikma pharmaceuticals usa inc. - micafungin (unii: r10h71bswg) (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   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

Malta - englanti - Medicines Authority

sandoz pharmaceuticals d.d. verovškova ulica 57, si-1000 ljubljana, slovenia - micafungin sodium - powder for concentrate for solution for infusion - micafungin sodium 50 mg - antimycotics for systemic use

Malta - englanti - Medicines Authority

sandoz pharmaceuticals d.d. verovškova ulica 57, si-1000 ljubljana, slovenia - micafungin sodium - powder for concentrate for solution for infusion - micafungin sodium 100 mg - antimycotics for systemic use

Kanada - englanti - Health Canada

juno pharmaceuticals corp. - micafungin (micafungin sodium) - powder for solution - 50mg - micafungin (micafungin sodium) 50mg

Kanada - englanti - Health Canada

accord healthcare inc - micafungin (micafungin sodium) - powder for solution - 50mg - micafungin (micafungin sodium) 50mg

Kanada - englanti - Health Canada

hikma canada limited - micafungin sodium - powder for solution - 100mg - micafungin sodium 100mg

Yhdysvallat - englanti - NLM (National Library of Medicine)

northstar rx 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 have not been established for the treatment of candidemia with meningoencephalitis and/or ocular dissemination in pediatric patients younger than

Yhdysvallat - englanti - NLM (National Library of Medicine)

zydus pharmaceuticals usa 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 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 have not been established for the treatment of candidemia with meningoencephalitis and/or ocular dissemination in pediatric patients younger than

Israel - englanti - Ministry of Health

astellas pharma international b.v., israel - micafungin as sodium - powder for concentrate for solution for infusion - micafungin as sodium 100 mg - micafungin - adults, adolescents ≥ 16 years of age and elderly:- treatment of invasive candidiasis.- treatment of oesophageal candidiasis in patients for whom intravenous therapy is appropriate.- prophylaxis of candida infection in patients undergoing allogeneic haematopoietic stem cell transplantation.children (including neonates) and adolescents < 16 years of age:- treatment of invasive candidiasis.- prophylaxis of candida infection in patients undergoing allogeneic haematopoietic stem cell transplantation.the decision to use mycamine should take into account a potential risk for the development of liver tumours. mycamine should therefore only be used if other antifungals are not appropriate.