Country: Unjoni Ewropea
Lingwa: Norveġiż
Sors: EMA (European Medicines Agency)
posakonazol
Merck Sharp and Dohme B.V
J02AC04
posaconazole
Antimykotika for systemisk bruk
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 og 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 og 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. Refraktivitet er definert som progresjon av infeksjon eller unnlatelse av å forbedre etter minimum 7 dager før terapeutiske doser av effektive soppdrepende behandling. 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 og 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 og 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 og 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. Refraktivitet er definert som progresjon av infeksjon eller unnlatelse av å forbedre etter minimum 7 dager før terapeutiske doser av effektive soppdrepende behandling. 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 og 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 og 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. Refraktivitet er definert som progresjon av infeksjon eller unnlatelse av å forbedre etter minimum 7 dager før terapeutiske doser av effektive soppdrepende behandling. 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. Refraktivitet er definert som progresjon av infeksjon eller unnlatelse av å forbedre etter minimum 7 dager før terapeutiske doser av effektive soppdrepende behandling. 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
autorisert
2005-10-25
90 OPPLYSNING ER SOM S KAL ANGIS PÅ Y TRE EMBALLASJE YTRE KARTONG 1. LEGEMIDLETS NAVN Noxafil 100 mg enterotabletter posakonazol 2. D EKLARASJON AV VIRKESTOFF(ER) Hver enterotablett inneholder 100 mg posakonazol. 3. LISTE OVE R HJELPESTOFFER 4. LEGEMIDDELFORM OG INN HOLD (PAKNINGSST ØRRELSE) 24 enterotabletter 96 enterotabletter 5. ADMI NISTRASJO NSMÅTE OG -VEI(ER) Les pakningsvedle gget før bruk. Oral bruk 6. ADVARSEL OM AT LEGEM IDLET SKAL OPPBEVARES UTILGJENGELIG FOR BARN Oppbevares utilgjengeli g for barn. 7. EVENTUELLE ANDRE SP ESIELLE ADVARSLER NOXAFIL MIKSTUR, SUSPENSJON OG TABLETTER SKAL IKKE BRUKES OM HVERANDRE. 8. UTLØPSDATO EXP 9. OPPBEVARINGSBETINGELSER 10. EVENTUELLE SPESIELLE FORHOLDSREGLER VED DESTRUKS JON AV UBRUKTE LEGEMIDLER ELLER AVFALL 91 11. NAVN OG ADRESS E PÅ INNEHAVEREN AV MARKEDSFØRINGSTILLATELSEN Merck Shar p & Dohme B.V. Waarderweg 39 2031 BN Haarlem Nederland 12. MARKEDSFØRINGSTILLATELSESNUMMER (NU MRE) EU/1/05/320/002 24 tabletter EU/1/05/320/003 96 tabletter 13. PRODUKSJONS NUMMER Lot 14. GENE RELL KLASSIFIKASJON FOR UTLEVERING 15. BRUKSANVI SNING 16. INFORMAS JON PÅ BLI NDESKRIFT noxafil tabletter 17. SIKKERHETSANORDNING (UNIK IDENTITET ) – TODIMENSJONAL STREKKODE Todi mensjonal st r ekkode, inkludert unik identitet 18. SIKKERHETSANORDNING ( UNIK IDENTITET) – I ET FORMAT LESBART FOR MENNESKE R PC SN NN 92 MINST EKRAV TIL OPPLYSNING ER SOM SKAL ANGIS PÅ BLISTER ELLER STRIP BLISTER 1. LEGEMIDLETS NAVN Noxafil 100 mg enterotabletter posakonazol 2. NAVN PÅ INNEHAVEREN AV M ARKEDSFØRINGSTILLAT ELSEN MSD 3. UTLØPSDATO EXP 4. PRODUKSJONSNU MMER Lot 5. ANNET 93 OPPLYSNINGER SO M SKAL ANGI S PÅ YTRE EMBALLASJE YTRE KARTONG 1. LEGEMIDLETS NAVN Noxafil 300 mg konsentrat til infusjonsvæske , oppløsning posakonazol 2. DE KLARASJON AV VIRKES TOFF(ER) Hvert hetteglass inneholder 300 mg posakonazol. Hver ml inneholder 18 mg posakonazol. 3. LI STE OVER HJELPESTOFFER Hjelpe stoffer: Betadex Sulfobutyl Ether Sodium (SBECD), d inatriumedet at, saltsyre og natriumhydroksid (til pH -j Aqra d-dokument sħiħ
1 VEDLEGG I PREPARATOMTALE 2 1. LEGEMIDLETS NAVN Noxafil 40 mg/ml mikstur, suspensjon 2. KVALITATIV OG KVANTITATIV SAMMENSETNING Hver ml mikstur, suspensjon inneholder 40 mg posakonazol. Hjelpestoffer med kjent effekt Dette legemidl et inneholder ca . 1,75 g glukose per 5 ml suspensjon. Dette legemidlet inneholder 10 mg natriumbenzoat ( E211) per 5 ml suspensjon . Dette legemidlet inneholder opptil 1,25 mg benzylalkohol per 5 ml suspensjon . Dette legemidlet inneholder opptil 24,75 mg p ropylenglykol (E1520) per 5 ml suspensjon . For fullstendig liste over hjelpestoffer , se pkt. 6.1. 3. LEGEMIDDELFORM Mikstur, suspensjon Hvit suspensjon 4. KLINISKE OPPLYSNINGER 4.1 INDIKASJONER Noxafil mikstur, suspensjon er indisert for behandlin g av følgende soppinfeksjoner hos voksne (se pkt. 5.1): - Invasiv aspergillose hos pasienter med sykdom som er motstandsdyktig mot amfotericin B eller itrakonazol, eller hos pasienter som ikke tolererer disse legemidlene; - Fusariose hos pasient er med sykdom s om er motstandsdyktig mot amfotericin B eller hos pasienter som ikke tolererer amfotericin B; - Kromoblastmykose og mycetom hos pasienter med sykdom som er motstandsdyktig mot itrakonazol eller hos pasienter som ikke tolererer itrakonazol; - Koksidioidomykose hos pasienter med sykdom som er motstandsdyktig mot amfotericin B, itrakonazol eller flukonazol eller hos pasienter som ikke tolererer disse legemidlene; - Orofaryngeal candidiasis : som førstelinjebehandling hos pasienter med alvorlig sykdom eller som er im munsupprimerte, og hvor responsen overfor topikal terapi forventes å være dårlig. Motstandsdyktighet er definert som progresjon av infeksjon eller mang el på bedring etter minimum 7 dager med terapeutiske doser av effektiv soppbehandling. Noxafil mikstur , suspensjon er også indisert som profylakse ved invasive soppinfeksjoner hos følgende pasienter: - Pasienter som får remisjons - induksjons kjemoterapi for akutt myelogen leukemi (AML) eller for myelodysplastisk syndrom (MDS) som forventes å resultere i ved v Aqra d-dokument sħiħ