Pays: Union européenne
Langue: anglais
Source: EMA (European Medicines Agency)
posaconazole
Merck Sharp and Dohme B.V
J02AC04
posaconazole
Antimycotics for systemic use
Candidiasis; Mycoses; Coccidioidomycosis; Aspergillosis
Noxafil gastro-resistant tablets are indicated for use in the treatment of the following fungal infections in adults (see sections 4.2 and 5.1):- Invasive aspergillosisNoxafil 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.Noxafil gastro-resistant tablets are 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 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 to the Summary of Product Characteristics of Noxafil oral suspension for use in oropharyngeal candidiasis. Noxafil concentrate for solution for infusion is indicated for use in the treatment of the following fungal infections in adults (see sections 4.2 and 5.1):- Invasive aspergillosisNoxafil concentrate for solution for infusion is indicated for use in the treatment of the following fungal infections in adult and paediatric patients from 2 years of age (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.Noxafil concentrate for solution for infusion is also indicated for prophylaxis of invasive fungal infections in the following adult and paediatric patients from 2 years of age (see sections 4.2 and 5.1):- Patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (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 (GVHD) and who are at high risk of developing invasive fungal infections.Please refer to the Summary of Product Characteristics of Noxafil oral suspension for use in oropharyngeal candidiasis. Noxafil gastro resistant powder and solvent for oral suspension is indicated for use in the treatment of the following fungal infections in paediatric patients from 2 years of age (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.Noxafil gastro-resistant powder and solvent for oral suspension is indicated for prophylaxis of invasive fungal infections in the following paediatric patients from 2 years of age:- Patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;- Haematopoietic 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 to the Summary of Product Characteristics of Noxafil concentrate for solution for infusion and the gastro-resistant tablets for use in primary treatment of invasive aspergillosis.Please refer to the Summary of Product Characteristics of Noxafil oral suspension for use in oropharyngeal candidiasis. 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.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:- Patients receiving remission-induction chemotherapy for acute myelogenous leukaemia (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.Please refer to the Summary of Product Characteristics of Noxafil concentrate for solution for infusion and the gastro-resistant tablets for use in primary treatment of invasive aspergillosis.
Revision: 37
Authorised
2005-10-25
1 ANNEX I SUMMARY OF PRO DUCT C HARACTERISTICS 2 1. NAM E OF THE MEDICINAL PROD UCT Noxafil 40 mg/mL oral suspension 2. QUALITATIVE AND QUANTITATIVE COMP OSITION Each mL of oral suspension contain s 40 mg of posaconazole. Excipients with known effect This medicinal p roduct contain s appr oximately 1.75 g of glucose per 5 mL of suspension. This medic inal product contains 10 mg of sodium benzoate (E211) per 5 mL of suspension. This medicinal product co nt ains up to 1.25 mg of benzyl alcohol per 5 m L of suspension. This med icinal product conta ins up to 24.75 mg of propylene glycol (E1520 ) per 5 mL of suspension. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral suspension Wh ite suspension 4. CLINICAL PARTICUL ARS 4.1 THERAPEUTIC INDICATIO NS Noxafil oral suspension is indicated fo r use in the treatment of the following fungal infections in adults (see section 5.1): - Invasive a spergillosis in patients with disease that is refractory to amphotericin B or itraconazol e or in patients who ar e intolerant of these medicinal produ cts; - Fusariosis in patients with disease tha t is refractory to am photer icin B or in patients who are int olerant of amphotericin B; - Chromoblastom yc osis and mycetoma in patients with di sease t hat is refractory to it raconazole or in patie nts who are int olerant of itraconazole; - Coccidioidomycosis in patients with dise ase th at is refractory to amphotericin B, itraconazole or fluconazole or in patien ts who are intolerant of these medicina l products; - Oropharyngeal ca nd idiasis: as fi rst-li ne therapy in p atients who have severe diseas e or are immunoco mpromised, in whom re sponse to topical therapy is expected t o be poor. Refractoriness is defined as pr og ression of infection or failure to im prove a fter a minimum of 7 days of prior thera peutic doses of effec tive an tifungal therapy . Noxafil oral suspension is also indicated for pr ophylaxis of invasive fungal infe ctions in the following patients: - Patients receiving remission - Lire le document complet
1 ANNEX I SUMMARY OF PRO DUCT C HARACTERISTICS 2 1. NAM E OF THE MEDICINAL PROD UCT Noxafil 40 mg/mL oral suspension 2. QUALITATIVE AND QUANTITATIVE COMP OSITION Each mL of oral suspension contain s 40 mg of posaconazole. Excipients with known effect This medicinal p roduct contain s appr oximately 1.75 g of glucose per 5 mL of suspension. This medic inal product contains 10 mg of sodium benzoate (E211) per 5 mL of suspension. This medicinal product co nt ains up to 1.25 mg of benzyl alcohol per 5 m L of suspension. This med icinal product conta ins up to 24.75 mg of propylene glycol (E1520 ) per 5 mL of suspension. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Oral suspension Wh ite suspension 4. CLINICAL PARTICUL ARS 4.1 THERAPEUTIC INDICATIO NS Noxafil oral suspension is indicated fo r use in the treatment of the following fungal infections in adults (see section 5.1): - Invasive a spergillosis in patients with disease that is refractory to amphotericin B or itraconazol e or in patients who ar e intolerant of these medicinal produ cts; - Fusariosis in patients with disease tha t is refractory to am photer icin B or in patients who are int olerant of amphotericin B; - Chromoblastom yc osis and mycetoma in patients with di sease t hat is refractory to it raconazole or in patie nts who are int olerant of itraconazole; - Coccidioidomycosis in patients with dise ase th at is refractory to amphotericin B, itraconazole or fluconazole or in patien ts who are intolerant of these medicina l products; - Oropharyngeal ca nd idiasis: as fi rst-li ne therapy in p atients who have severe diseas e or are immunoco mpromised, in whom re sponse to topical therapy is expected t o be poor. Refractoriness is defined as pr og ression of infection or failure to im prove a fter a minimum of 7 days of prior thera peutic doses of effec tive an tifungal therapy . Noxafil oral suspension is also indicated for pr ophylaxis of invasive fungal infe ctions in the following patients: - Patients receiving remission - Lire le document complet