Země: Velká Británie
Jazyk: angličtina
Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)
Posaconazole
Merck Sharp & Dohme Ltd
J02AC04
Posaconazole
100mg
Gastro-resistant tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 05020100; GTIN: 5013945301045 5013945301052
PACKAGE LEAFLET: INFORMATION FOR THE USER NOXAFIL® 100 MG GASTRO-RESISTANT TABLETS posaconazole READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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, or nurse. - This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. - If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Noxafil is and what it is used for 2. What you need to know before you take Noxafil 3. How to take Noxafil 4. Possible side effects 5. How to store Noxafil 6. Contents of the pack and other information 1. WHAT NOXAFIL IS AND WHAT IT IS USED FOR Noxafil contains a medicine called posaconazole. This belongs to a group of medicines called “antifungals”. It is used to prevent and treat many different fungal infections. This medicine works by killing or stopping the growth of some types of fungi that can cause infections. Noxafil can be used in adults to treat the following types of fungal infections when other antifungal medicines have not worked or you have had to stop taking them: infections caused by fungi of the _Aspergillus_ family that have not improved during treatment with the anti-fungal medicines amphotericin B or itraconazole or when these medicines have had to be stopped; infections caused by fungi of the _Fusarium_ family that have not improved during treatment with amphotericin B or when amphotericin B has had to be stopped; infections caused by fungi that cause the conditions known as “chromoblastomycosis” and “mycetoma” that have not improved during treatment with itraconazole or when itraconazole has had to be stopped; infections caused by a fungus called _Coccidioides_ that have not improved durin Přečtěte si celý dokument
OBJECT 1 NOXAFIL 100 MG GASTRO-RESISTANT TABLETS Summary of Product Characteristics Updated 26-May-2017 | Merck Sharp & Dohme Limited 1. Name of the medicinal product Noxafil® 100 mg gastro-resistant tablets 2. Qualitative and quantitative composition Each gastro-resistant tablet contains 100 mg of posaconazole. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Gastro-resistant tablet (tablet) Yellow-coated, capsule-shaped tablet of 17.5 mm length debossed with “100” on one side. 4. Clinical particulars 4.1 Therapeutic indications Noxafil gastro-resistant tablets are indicated for use in the treatment of the following fungal infections in adults (see section 5.1): - Invasive aspergillosis in patients with disease that is refractory to amphotericin B or itraconazole or in patients who are intolerant of these medicinal products; - Fusariosis in patients with disease that is refractory to amphotericin B or in patients who are intolerant of amphotericin B; - Chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intolerant of itraconazole; - Coccidioidomycosis in patients with disease that is refractory to amphotericin B, itraconazole or fluconazole or in patients who are intolerant of these medicinal products. Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy_._ Noxafil gastro-resistant tablets are also indicated for prophylaxis of invasive fungal infections in the following patients: - Patients receiving remission-induction chemotherapy for acute myelogenous leukemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections; - Hematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections. Přečtěte si celý dokument