Country: Israel
Language: English
Source: Ministry of Health
POSACONAZOLE
MERCK SHARP & DOHME ISRAEL LTD
J02AC04
SUSPENSION
POSACONAZOLE 40 MG/ML
PER OS
Required
MERCK SHARP & DOHME CORP., USA
POSACONAZOLE
POSACONAZOLE
Noxafil is 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 - 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
2013-07-17
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 This medicine is marketed upon physician’s prescription only NOXAFIL ® SUSPENSION 40 MG/ML ORAL SUSPENSION Each mL of suspension contains: Posaconazole 40 mg For a list of inactive ingredients please refer to section 6. See also section 2.7 “Important information about some of the ingredients of the medicine”. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. This leaflet contains consice 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 suspension 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; - Infections 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 _that are resistant to treatment with amphotericin B, itraconazole or fluconazole or when the patient cannot receive these medicines; - Infections in the mouth or throat area (known as “thrush”) caused by fungi called _Candida_, which were not previously treated. - Fungal infection called Zygomycosis, in patients intolerant of or with Read the complete document
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Noxafil ® 40 mg/mL oral suspension 2. QUALITATIVE AND QUANTITATIVE COMPOSITION _ _ Each mL of oral suspension contains 40 mg of posaconazole. Excipients with known effect This medicinal product contains approximately 1.75 g of glucose per 5 mL of suspension. This medicinal product contains 10 mg of sodium benzoate per 5 mL of suspension. This medicinal product contains up to 1.25 mg of benzyl alcohol per 5 mL of suspension. This medicinal product contains up to 24.75 mg of propylene glycol per 5 mL of suspension. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral suspension White suspension 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Noxafil oral suspension 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. - 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 oral suspension is also indicated for prophylaxis of invasive fungal infections in the following patients: 2 - Read the complete document