Nchi: Malta
Lugha: Kiingereza
Chanzo: Medicines Authority
MICAFUNGIN SODIUM
Sandoz Pharmaceuticals d.d. Verovškova Ulica 57, SI-1000 Ljubljana, Slovenia
J02AX05
MICAFUNGIN SODIUM 100 mg
POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
MICAFUNGIN SODIUM 100 mg
POM
ANTIMYCOTICS FOR SYSTEMIC USE
Licence number in the source country: NOT APPLICAPABLE
Authorised
2020-08-13
PACKAGE LEAFLET: INFORMATION FOR THE USER Micafungin Sandoz 50 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION MICAFUNGIN SANDOZ 100 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION micafungin READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor, pharmacist. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Micafungin Sandoz is and what it is used for 2. What you need to know before you use Micafungin Sandoz 3. How to use Micafungin Sandoz 4. Possible side effects 5. How to store Micafungin Sandoz 6. Contents of the pack and other information 1. WHAT MICAFUNGIN SANDOZ IS AND WHAT IT IS USED FOR Micafungin Sandoz contains the active substance micafungin. Micafungin Sandoz is called an antifungal medicine because it is used to treat infections caused by fungal cells. Micafungin Sandoz is used to treat fungal infections caused by fungal or yeast cells called Candida. Micafungin Sandoz is effective in treating systemic infections (those that have penetrated within the body). It interferes with the production of a part of the fungal cell wall. An intact cell wall is necessary for the fungus to continue living and growing. Micafungin Sandoz causes defects in the fungal cell wall, making the fungus unable to live and grow. Your doctor has prescribed Micafungin Sandoz for you in the following circumstances when there are no other suitable antifungal treatments available (see section 2): • To treat adults, adolescents and children including neonates who have a serious fungal infection called invasive candidiasis (infection that has penetrated the body). • To treat adults and adolescents ≥ 16 years of age who have a fungal infection in the gullet (oesophagus) where treatment into a vein (intravenous) is approp Soma hati kamili
1 1. NAME OF THE MEDICINAL PRODUCT Micafungin Sandoz 50 mg powder for concentrate for solution for infusion Micafungin Sandoz 100 mg powder for concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Micafungin Sandoz 50 mg Each vial contains micafungin sodium equivalent to 50 mg micafungin. After reconstitution each ml contains micafungin sodium equivalent to 10 mg micafungin. Micafungin Sandoz 100 mg Each vial contains micafungin sodium equivalent to 100 mg micafungin. After reconstitution each ml contains micafungin sodium equivalent to 20 mg micafungin. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder for concentrate for solution for infusion Lyophilized white to off-white powder 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Micafungin Sandoz 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 or patients who are expected to have neutropenia (absolute neutrophil count < 500 cells / µl) for 10 or more days. 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 or patients who are expected to have neutropenia (absolute neutrophil count < 500 cells / µl) for 10 or more days. The decision to use Micafungin Sandoz should take into account a potential risk for the development of liver tumours (see section 4.4). Micafungin Sandoz 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. 2 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment with Micafungin Sandoz should be initiated by a physician experienced in the manageme Soma hati kamili