Australie - anglais - Department of Health (Therapeutic Goods Administration)

astellas pharma australia pty ltd - micafungin sodium, quantity: 101.73 mg (equivalent: micafungin, qty 100 mg) - injection, powder for - excipient ingredients: citric acid; sodium hydroxide; lactose monohydrate - mycamine is indicated for: ? treatment of invasive candidiasis in children and adults ? treatment of oesophageal candidiasis in adults, adolescents greater than or equal to 16 years of age and the elderly patients for whom intravenous therapy is appropriate ? prophylaxis of candida infection in children and adult patients undergoing allogeneic haematopoietic stem cell transplantation or patients who are expected to have neutropenia (absolute neutrophil count < 500 cells/?l) for 10 or more days.

Australie - anglais - Department of Health (Therapeutic Goods Administration)

astellas pharma australia pty ltd - micafungin sodium, quantity: 50.86 mg (equivalent: micafungin, qty 50 mg) - injection, powder for - excipient ingredients: citric acid; sodium hydroxide; lactose monohydrate - mycamine is indicated for: ? treatment of invasive candidiasis in children and adults ? treatment of oesophageal candidiasis in adults, adolescents greater than or equal to 16 years of age and the elderly patients for whom intravenous therapy is appropriate ? prophylaxis of candida infection in children and adult patients undergoing allogeneic haematopoietic stem cell transplantation or patients who are expected to have neutropenia (absolute neutrophil count < 500 cells/?l) for 10 or more days.

États-Unis - anglais - NLM (National Library of Medicine)

baxter healthcare corporation - micafungin sodium (unii: is1up79r56) (micafungin - unii:r10h71bswg) - micafungin in sodium chloride injection is indicated for: limitations of use micafungin in sodium chloride injection is contraindicated in persons with known hypersensitivity to micafungin, any component of micafungin in sodium chloride 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 ris

Malte - anglais - Medicines Authority

viatris limited damastown industrial park, mulhuddart, dublin 15, dublin, ireland - powder for concentrate for solution for infusion - micafungin sodium 10 mg/ml - antimycotics for systemic use

Malte - anglais - Medicines Authority

viatris limited damastown industrial park, mulhuddart, dublin 15, dublin, ireland - powder for concentrate for solution for infusion - micafungin sodium 20 mg/ml - antimycotics for systemic use

Israël - anglais - 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.

Israël - anglais - Ministry of Health

astellas pharma international b.v., israel - micafungin as sodium - powder for concentrate for solution for infusion - micafungin as sodium 50 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.

États-Unis - anglais - NLM (National Library of Medicine)

zydus lifesciences limited - micafungin sodium (unii: is1up79r56) (micafungin - unii:r10h71bswg) -

États-Unis - anglais - NLM (National Library of Medicine)

astellas pharma us, inc. - micafungin sodium (unii: is1up79r56) (micafungin - unii:r10h71bswg) - micafungin sodium 10 mg in 1 ml - mycamine® 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 mycamine have not been established for the treatment of candidemia with meningoencephalitis and/or ocular dissemination in p

Royaume-Uni - anglais - MHRA (Medicines & Healthcare Products Regulatory Agency)

viatris uk healthcare ltd - micafungin sodium - powder for solution for infusion - 50mg