Страна: Ирландия
Язык: английский
Источник: HPRA (Health Products Regulatory Authority)
Micafungin
Pinewood Laboratories Ltd,
J02AX05
Micafungin
100 milligram(s)
Powder for concentrate for solution for infusion
micafungin
2021-03-19
1/6 PACKAGE LEAFLET: INFORMATION FOR THE USER MICAFUNGIN 50 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION MICAFUNGIN 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 or 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 is and what it is used for 2. What you need to know before you use Micafungin 3. How to use Micafungin 4. Possible side effects 5. How to store Micafungin 6. Contents of the pack and other information 1. WHAT MICAFUNGIN IS AND WHAT IT IS USED FOR Micafungin contains the active substance micafungin. Micafungin is called an antifungal medicine because it is used to treat infections caused by fungal cells. Micafungin is used to treat fungal infections caused by fungal or yeast cells called Candida. Micafungin 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 causes defects in the fungal cell wall, making the fungus unable to live and grow. Your doctor has prescribed Micafungin 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 appropriate. - To prevent infection with Candida in patients who are having a bone-marrow trans Прочитать полный документ
Health Products Regulatory Authority 19 March 2021 CRN00923C Page 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Micafungin 100 mg powder for concentrate for solution for infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 100 mg micafungin (as sodium). After reconstitution each ml concentrate for solution for infusion 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 to off‑white cake or powder. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Micafungin is indicated for: Adults, adolescent's ≥ 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/microL) 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/microL) for 10 or more days. The decision to use Micafungin should take into account a potential risk for the development of liver tumours (see section 4.4). Micafungin 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 Micafungin 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). Прочитать полный документ