Land: Europäische Union
Sprache: Englisch
Quelle: EMA (European Medicines Agency)
posaconazole
Schering-Plough Europe
J02AC04
posaconazole
Antimycotics for systemic use
Candidiasis; Mycoses; Coccidioidomycosis; Aspergillosis
Posaconazole SP is 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;- Oropharyngeal candidiasis: as first-line therapy in patients who have severe disease or are immunocompromised, in whom response to topical therapy is expected to be poor.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 SP 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 areat 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: 5
Withdrawn
2005-10-25
Medicinal product no longer authorised 25 B. PACKAGE LEAFLET Medicinal product no longer authorised 26 PACKAGE LEAFLET: INFORMATION FOR THE USER POSACONAZOLE SP 40 MG/ML ORAL SUSPENSION posaconazole READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. - If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What Posaconazole SP is and what it is used for 2. Before you take Posaconazole SP 3. How to take Posaconazole SP 4. Possible side effects 5. How to store Posaconazole SP 6. Further information 1. WHAT POSACONAZOLE SP IS AND WHAT IT IS USED FOR Posaconazole SP belongs to a group of medicines called triazole antifungal agents. These medicines are used to prevent and treat a wide variety of fungal infections. Posaconazole SP works by killing or stopping the growth of some types of fungi that can cause infections in humans. Posaconazole SP can be used to treat the following types of fungal infections in adults: - 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 due to fungi called _Coccidioides_ that have not improved during treatment with one or more of amphotericin B, itraconazole or fluconazole or when these medic Lesen Sie das vollständige Dokument
Medicinal product no longer authorised ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS _ _ Medicinal product no longer authorised 2 1. NAME OF THE MEDICINAL PRODUCT Posaconazole SP 40 mg/ml oral suspension 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _ _ Each ml of oral suspension contains 40 mg of posaconazole. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral suspension White suspension 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Posaconazole SP is 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; - Oropharyngeal candidiasis: as first-line therapy in patients who have severe disease or are immunocompromised, in whom response to topical therapy is expected to be poor. 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 SP 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 de Lesen Sie das vollständige Dokument