Ország: Izrael
Nyelv: angol
Forrás: Ministry of Health
POSACONAZOLE
MERCK SHARP & DOHME (ISRAEL - 1996) COMPANY LTD, ISRAEL
J02AC04
GASTRO RESISTANT TABLETS
POSACONAZOLE 100 MG
PER OS
Required
MERCK SHARP & DOHME LLC, USA
POSACONAZOLE
Noxafil gastro-resistant tablets are indicated for use in the treatment of the following fungal infections in adults:- 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.- Zygomycosis in patients intolerant of or with disease that is refractory to alternative therapy.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.
2021-05-31
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS REGULATIONS (PREPARATIONS) 1986 This medicine is marketed upon physician’s prescription only NOXAFIL ® 100 MG GASTRO-RESISTANT TABLETS Each tablet contains: Posaconazole 100 mg For a list of inactive ingredients see section 6 " FURTHER INFORMATION ". See also section 2.6 “ Important information about some of the ingredients of the medicine” . READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. • This leaflet contains concise information about NOXAFIL . 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 medical condition seems similar to yours. • NOXAFIL tablets is intended for use in adults (18 years of age and older) . 1. WHAT NOXAFIL IS INTENDED FOR? NOXAFIL is used to prevent and treat different types of fungal infections. NOXAFIL is used to treat the following types of fungal infections in adults when other antifungal medicines have not worked or you have had to stop taking them: • infections caused by fungi of the _Aspergillus_ family and are resistant to treatment with amphotericin B or itraconazole or when the patient cannot receive these medicines ; • infections caused by fungi of the _Fusarium_ family and are resistant to treatment with amphotericin B or when the patient cannot receive this medicine ; • infect ions caused by fungi that cause the conditions known as “chromoblastomycosis” and “mycetoma” and are resistant to treatment with itraconazole or when the patient cannot receive this medicine ; • infections caused by a fungus called _Coccidioides_ and are resist ant to treatment with amphotericin B, itraconazole or fluconazole or when t he patient cannot receive these medicines . • f ungal infection called Zygomycosis, in patients intolerant of or with disease that is refractory to alternative therapy. This medicine c an also be used to prevent fungal infections in adult Olvassa el a teljes dokumentumot
1 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 in dicated 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 pr oducts; - 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. - Zygomycosis in patients intolerant of or with disease that is refractory to alternative therapy. 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 leukaemia (AML) or myelodysplastic syndromes (MDS) expected t o 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. Please refer Olvassa el a teljes dokumentumot