Nchi: Israeli
Lugha: Kiingereza
Chanzo: Ministry of Health
MICAFUNGIN AS SODIUM
ASTELLAS PHARMA INTERNATIONAL B.V., ISRAEL
J02AX05
POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
MICAFUNGIN AS SODIUM 100 MG
I.V
Required
ASTELLAS IRELAND CO. LTD, IRELAND
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.
2021-04-30
ראוד את 11458 :סקפ רפסמ ,ןיעה שאר 03-5366691 :ןופלט רפסמ 03-7501166 30.05.2018 ,ה/דבכנ ת/חקור ה/אפור ננוצרב אפורל ןולעב ןוכדע לע ךעידוהל ו MYCAMINE 50 MG POWDER FOR SOLUTION FOR INFUSION. MYCAMINE 100 MG POWDER FOR SOLUTION FOR INFUSION . : ליעפ רמוח MYCAMINE 50 MG: EACH VIAL CONTAINS 50 MG MICAFUNGIN (AS SODIUM). MYCAMINE 100 MG: EACH VIAL CONTAINS 100 MG MICAFUNGIN (AS SODIUM). אפורל ןולעב םינוכדע ןלהל ( ןמוסמ טסקט קורי ותועמשמ ןוכדע , )הרמחה ותועמשמ בוהצ ןמוסמ טסקט : […] 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with Mycamine should be initiated by a physician experienced in the management of fungal infections. Posology Specimens for fungal culture and other relevant laboratory studies (including histopathology) should be obtained prior to therapy to isolate and identify causative organism(s). Therapy may be instituted before the results of the cultures and other laboratory studies are known. However, once these results become available, antifungal therapy should be adjusted accordingly. depends on the body weight of the patient as given in the following tables: micafungin The dose regimen of […] should be administered for at least one week after resolution of clinical micafungin _ _ : Oesophageal candidiasis signs and symptoms. should be administered for at least one week after neutrophil micafungin infections: _Candida _ Prophylaxis of recovery. […] _Treatment duration_ _ _ Invasive candidiasis: The treatment duration of _Candida_ infection should be a minimum of 14 days. The antifungal treatment should continue for at least one week after two sequential negative blood cultures have been obtained and _AFTER_ resolution of clinical signs and symptoms of infection. should be administered for at least one week after neutrophil micafungin infections: _ida _ _Cand_ Prophylaxis of recovery. Experience with Mycamine in patients less than 2 years of Soma hati kamili
1 1. NAME OF THE MEDICINAL PRODUCT Mycamine 50 mg powder for concentrate for solution for infusion. Mycamine 100 mg powder for concentrate for solution for infusion. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Mycamine 50 mg: Each vial contains 50 mg micafungin (as sodium). After reconstitution each ml contains 10 mg micafungin (as sodium). Mycamine 100 mg: Each vial contains 100 mg micafungin (as sodium). After reconstitution each ml contains 20 mg micafungin (as sodium). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for concentrate for solution for infusion. White compact powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Mycamine is indicated for: 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 (see section 4.4). Mycamine should therefore only be used if other antifungals are not appropriate. CONSIDERATION SHOULD BE GIVEN TO OFFICIAL/NATIONAL GUIDANCE ON THE APPROPRIATE USE OF ANTIFUNGAL AGENTS. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with Mycamine should be initiated by a physician experienced in the management of fungal infections. 2 Posology Specimens for fungal culture and other relevant laboratory studies (including histopathology) should be obtained prior to therapy to isolate and identify causative organism(s). Therapy may be instituted before the results of the cultures and other laboratory studies are known. However, once these results become available, antifungal therapy should be ad Soma hati kamili