Nchi: Uingereza
Lugha: Kiingereza
Chanzo: MHRA (Medicines & Healthcare Products Regulatory Agency)
Micafungin sodium
Astellas Pharma Ltd
J02AX05
Micafungin sodium
100mg
Powder for solution for infusion
Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: 05020400; GTIN: 5013346011499
1 PACKAGE LEAFLET: INFORMATION FOR THE USER MYCAMINE 50 MG POWDER FOR SOLUTION FOR INFUSION MYCAMINE 100 MG POWDER 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 Mycamine is and what it is used for 2. What you need to know before you use Mycamine 3. How to use Mycamine 4. Possible side effects 5. How to store Mycamine 6. Contents of the pack and other information 1. WHAT MYCAMINE IS AND WHAT IT IS USED FOR Mycamine contains the active substance micafungin. Mycamine is called an antifungal medicine because it is used to treat infections caused by fungal cells. Mycamine is used to treat fungal infections caused by fungal or yeast cells called Candida _._ Mycamine 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. Mycamine causes defects in the fungal cell wall, making the fungus unable to live and grow. Your doctor has prescribed Mycamine 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 transplant or who are expected to have a neutropenia (lo Soma hati kamili
OBJECT 1 MYCAMINE 50MG POWDER FOR SOLUTION FOR INFUSION Summary of Product Characteristics Updated 05-Mar-2018 | Astellas Pharma Ltd 1. Name of the medicinal product Mycamine 50 mg powder for solution for infusion Mycamine 100 mg powder 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 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 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 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. Posology Specimens for fungal culture and other relevant labo Soma hati kamili