Země: Evropská unie
Jazyk: dánština
Zdroj: EMA (European Medicines Agency)
posaconazol
Merck Sharp and Dohme B.V
J02AC04
posaconazole
Antimykotika til systemisk brug
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. Uimodtagelighed over er defineret som progression af infektion eller manglende bedring efter minimum 7 dage før terapeutiske doser af effektiv svampedræbende terapi. 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. Uimodtagelighed over er defineret som progression af infektion eller manglende bedring efter minimum 7 dage før terapeutiske doser af effektiv svampedræbende terapi. 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. Uimodtagelighed over er defineret som progression af infektion eller manglende bedring efter minimum 7 dage før terapeutiske doser af effektiv svampedræbende terapi. 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):- Invasiv aspergillose hos patienter med sygdom, der er refraktære over for amphotericin B eller itraconazol eller patienter, der ikke tåler disse lægemidler;- Fusariosis hos patienter med sygdom, der er refraktære over for amphotericin B eller patienter, der er intolerante over for amphotericin B;- Chromoblastomycosis og mycetoma hos patienter med sygdom, der er refraktære over for itraconazol eller patienter, der er intolerante over for itraconazol;- Coccidioidomycosis hos patienter med sygdom, der er refraktære over for amphotericin B, itraconazol eller fluconazol eller patienter, der ikke tåler disse lægemidler.- Oropharyngeale candidiasis: som første linje behandling til patienter, som har svær sygdom eller er immunsvækkede, i, som reaktion på aktuelle behandling forventes at være fattig. Uimodtagelighed over er defineret som progression af infektion eller manglende bedring efter minimum 7 dage før terapeutiske doser af effektiv svampedræbende terapi. 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
autoriseret
2005-10-25
98 MÆRKNING, DER SKA L ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON – (MED BLUE BOX) 1. LÆ GEMIDLETS NAVN Noxafil 300 mg enteropulver o g solvens til oral suspension posaconazol 2. ANGIVELSE AF AKTIVT STOF/AKTIVE STO FFER Hver foliepose indeh older 300 mg posaconazol. Efter rekonstitution har den gastroresistente orale suspension en koncentration på ca. 30 mg pr. ml. 3. LISTE OVER HJÆLPESTOFFER Det rekonstituerede lægemiddel indeho lder methylparahydr oxybenzoat (E 218), propylparahydroxybenzoat, propylenglycol (E1520) og sorbitol opløsning (E 420). Se indlægssedlen for yderligere information. 4. LÆGEMIDDELFORM OG INDHOLD (PAKNIN GSSTØRRELSE) Enteropulver og solvens til oral suspension Denne pakning indeholder (pakning 1): 8 folieposer, to 3 ml og to 10 ml sprøjter med indhak i spidsen, to blandebægre, en flaske med solvens og en flaskeadapter ; og en pakning (pakning 2) med: yderligere seks 3 ml og seks 1 0 ml sprøjter med indhak i spidsen. 5. ANVEN DELSESMÅDE OG ADMINI STRATION SVEJ(E) Læs indlægssedlen inden brug. Oral anvendelse 6. SÆRLIG AD VARSEL OM , AT LÆGEMIDLET SKAL OPBEVA RES UTILGÆNGELI GT FOR BØRN Opbevares utilgængeligt for børn . 7. EVENTUELL E ANDRE SÆRLIGE ADVARSLER NOXAFIL ENTERO PULVER OG SOLVENS TIL ORA L SUSPENSION ER IK KE INDBYRDES OMBYTTELIG MED NOXAFIL ORAL SUSPENSION. 8. U DLØBSDATO EXP 99 9. SÆRLIGE OPBEVARINGSBETINGE LSER EFTER REKONSTITUTION: DEN GASTRORESISTENTE ORALE SUSPENSION SKAL ANVENDES INDEN F OR 30 MINUTTER . 10. EVENTUELLE SÆRLIGE FO RHO LDSREGLER VED BORTSKAFFELSE AF IKKE ANV ENDT LÆGEMIDD EL SAMT AF FALD HERAF 11. NAV N OG ADRE SS E PÅ INDEHAVEREN AF MARKED SFØRINGSTILL ADELSEN Merck Sharp & Dohme B.V. Waarderweg 39 2031 BN Haarlem Holland 12. MARKEDSFØRINGSTIL LADELSESNUMMER ( -NUMRE) EU/1/05/320/005 13. BATCHNUMMER Lot 14. GENEREL KLAS SIFIKATION FOR U DLEVERIN G 15. INSTRUKTIONER VEDRØRENDE ANVENDELSEN 16. INFORM ATION I BRAILLESKRIFT noxafil 300 mg pulver til oral suspension 17. EN TYDIG IDENT IFIKATOR – 2D- STREGKODE Der er anført en Přečtěte si celý dokument
1 BILAG I PRODUKTRESUM É 2 1. LÆGEMIDLETS NAVN Noxafil 40 mg/ml oral suspension 2. KVALITATIV OG KVANTITATIV SAMMENSÆTNING 1 ml oral suspension indeholder 40 mg posaconazol. Hjælpestoffer , som behandleren skal være opmærksom på Dette lægemiddel indeholder ca. 1,75 g glucose p r. 5 ml suspension. Dette lægemiddel indeholder 10 mg natriumbenzoat (E211) pr. 5 ml suspension. Dette lægemiddel indeholder op til 1,25 mg benzylalkohol pr. 5 ml suspension. Dette lægemiddel indeholder op til 24,75 mg propylenglycol (E1520) pr. 5 ml suspension. Alle hjæ lpestoffer er anført under pkt. 6.1. 3. LÆGEMIDDELFORM Oral suspension Hvid suspension 4. KLINISKE OPLYSNINGER 4.1 TERAPEUTISKE INDIKATIONER Noxafil oral suspension er indiceret til behan dling af følgende svampeinfe ktioner hos voksne (se pkt. 5.1): - Invasiv aspergillose hos patienter med sygdom, hvor behandling med amphotericin B eller itraconazol har været utilstrækkelig, eller hos patienter med intolerans over for disse lægemidler; - Fusari ose hos patienter med sygdom, hvor behandling med amphotericin B har været utilstrækkelig, eller hos patienter med intolerans over for amphotericin B; - Chromoblastomykose og mycetom a hos patienter med sygdom, hvor behandling med itraconazol har v æret utilst rækkelig, eller hos patienter med intolerans over for itraconazol; - Coccidioidomykose hos patienter med sygdom, hvor behandling med amphotericin B, itraconazol eller fluconazol har været utilstrækkelig, eller hos patienter med intolerans over for disse lægemidler; - Oropharyngeal candidiasis: som first - line behandling hos patienter, der har alvorlig sygdom eller har nedsat immunforsvar, hos hvem respons på lokal behandling forventes at være dårlig. Utilstrækkelig behandling defineres som progressio n af en inf ektion eller mangel på bedring efter mindst 7 dages terapeutiske doser af effektiv behandling med antimykotika. Noxafil oral suspension er også indiceret til forebyggelse af invasive svampeinfektioner hos følgende patienter: - Patienter Přečtěte si celý dokument