Država: Izrael
Jezik: engleski
Izvor: Ministry of Health
MICAFUNGIN AS SODIUM
ASTELLAS PHARMA INTERNATIONAL B.V., ISRAEL
J02AX05
POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
MICAFUNGIN AS SODIUM 50 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 21.08.2019 ,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 : […] 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE HEPATIC EFFECTS: THE DEVELOPMENT OF FOCI OF ALTERED HEPATOCYTES (FAH) AND HEPATOCELLULAR TUMOURS AFTER A TREATMENT PERIOD OF 3 MONTHS OR LONGER WERE OBSERVED IN RATS. THE ASSUMED THRESHOLD FOR TUMOUR DEVELOPMENT IN RATS IS APPROXIMATELY IN THE RANGE OF CLINICAL EXPOSURE. THE CLINICAL RELEVANCE OF THIS FINDING IS NOT KNOWN. LIVER FUNCTION SHOULD BE CAREFULLY MONITORED DURING MICAFUNGIN TREATMENT. TO MINIMISE THE RISK OF ADAPTIVE REGENERATION AND POTENTIALLY SUBSEQUENT LIVER TUMOUR FORMATION, EARLY DISCONTINUATION IN THE PRESENCE OF SIGNIFICANT AND PERSISTENT ELEVATION OF ALT/AST IS RECOMMENDED. MICAFUNGIN TREATMENT SHOULD BE CONDUCTED ON A CAREFUL RISK/BENEFIT BASIS, PARTICULARLY IN PATIENTS HAVING SEVERE LIVER FUNCTION IMPAIRMENT OR CHRONIC LIVER DISEASES KNOWN TO REPRESENT PRENEOPLASTIC CONDITIONS, SUCH AS ADVANCED LIVER FIBROSIS, CIRRHOSIS, VIRAL HEPATITIS, NEONATAL LIVER DISEASE OR CONGENITAL ENZYME DEFECTS, OR RECEIVING A CONCOMITANT THERAPY INCLUDING HEPATOTOXIC AND/OR GENOTOXIC PROPERTIES. […] 4.6 FERTILITY, PREGNANCY AND LACTATION […] 4.8 UNDESIRABLE EFFECTS […] SYSTEM ORGAN ACLASS COMMON ≥ 1/100 to < 1/10 UNCOMMON ≥ 1/1,000 to < 1/100 RARE ≥ 1/10,000 to < 1/1,000 NOT KNOWN (frequency cannot be estimated from available data) Immune system disorders anaphylactic / anaphylactoid reaction (see section 4.4), hypersensitivity anaphy Pročitajte cijeli dokument
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 Pročitajte cijeli dokument