Country: Եվրոպական Միություն
language: անգլերեն
source: EMA (European Medicines Agency)
posaconazole
Accord Healthcare S.L.U.
J02AC04
posaconazole
Antimycotics for systemic use
Mycoses
Posaconazole Accord is indicated for use in the treatment of the following fungal infections in adults:Invasive aspergillosis;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.Posaconazole Accord is 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.
Revision: 7
Authorised
2019-07-25
32 B. PACKAGE LEAFLET 33 PACKAGE LEAFLET: INFORMATION FOR THE USER POSACONAZOLE ACCORD 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 Posaconazole Accord is and what it is used for 2. What you need to know before you take Posaconazole Accord 3. How to take Posaconazole Accord 4. Possible side effects 5. How to store Posaconazole Accord 6. Contents of the pack and other information 1. WHAT POSACONAZOLE ACCORD IS AND WHAT IT IS USED FOR Posaconazole Accord 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. Posaconazole Accord can be used in adults to treat fungal infections caused by fungi of the _Aspergillus _ family. Posaconazole Accord can be used in adults and children from 2 years of age weighing more than 40 kg to treat the following types of fungal infections: - infections caused by fungi of the _Aspergillus_ family; that have not improved during treatment with the antifungal 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 read_full_document
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Posaconazole Accord 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 Yellow coated, capsule shaped tablet of approximate 17.5 mm length and 6.7 mm width, debossed with “100P” on one side and plain on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Posaconazole Accord is indicated for use in the treatment of the following fungal infections in adults (see sections 4.2 and 5.1): - Invasive aspergillosis Posaconazole Accord gastro-resistant tablets are indicated for use in the treatment of the following fungal infections in paediatric patients from 2 years of age weighing more than 40 kg and adults (see sections 4.2 and 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. Posaconazole Accord is also indicated for prophylaxis of invasive fungal infections in the following paediatric patients from 2 years of age weighing more than 40 kg and adults (see sections 4.2 and 5.1): - Patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (AML) or myelodysplastic syndromes (MDS) expected to result read_full_document