Country: Kesatuan Eropah
Bahasa: Iceland
Sumber: EMA (European Medicines Agency)
posakónazól
Merck Sharp and Dohme B.V
J02AC04
posaconazole
Sveppalyf fyrir almenn nota
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. Svara ekki meðferð er skilgreint eins og framgangi sýkingu eða bilun til að bæta eftir að minnsta kosti 7 daga áður en lækninga skammta af árangri mikla meðferð. 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. Svara ekki meðferð er skilgreint eins og framgangi sýkingu eða bilun til að bæta eftir að minnsta kosti 7 daga áður en lækninga skammta af árangri mikla meðferð. 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. Svara ekki meðferð er skilgreint eins og framgangi sýkingu eða bilun til að bæta eftir að minnsta kosti 7 daga áður en lækninga skammta af árangri mikla meðferð. 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. Svara ekki meðferð er skilgreint eins og framgangi sýkingu eða bilun til að bæta eftir að minnsta kosti 7 daga áður en lækninga skammta af árangri mikla meðferð. 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
Leyfilegt
2005-10-25
98 UPPLÝSINGAR SEM EIGA AÐ KOMA F RAM Á YTRI UMBÚÐUM INNRI ASKJA – PAKKNING 1 (AF 2) ( ÁN BLUE BOX ) NOXAFIL 300 MG MAGASÝRUÞOLIÐ MIXTÚRUDUFT OG LEYSIR, DREIFA 1. HEITI LYFS Noxafil 300 mg magasýruþolið mixtúruduft og leysir, dreifa posakónazól PAKKNING 1 (AF 2) 2. VIRK(T) EFNI Hver skammta poki inniheldur 300 mg af posakónazóli. Eftir blöndun er st yrkur magsýruþol innar mixtúru, dreifu um það bil 30 mg í ml. 3. HJÁLPAREFNI Blandað lyfið i nniheldur metýlparah ýdroxýbenzó at (E218) , própýlparahýdroxýbenzóa t, própýlenglýkól (E1520) og so rbítóllausn (E420). Sjá frekari upplý singar í fylgiseðli. 4. LYFJA FORM OG INNIH ALD Magasýruþolið mixtúruduft og leysir, dreifa Þessi pakkning inniheldur: 8 skammtapoka, tvær 3 ml og tvær 10 ml sprautur með tenntum enda , tvo blöndunarbikara, eitt glas með leysi og eitt milli stykki fyrir glas. 5. AÐFERÐ VIÐ LYFJ AGJÖF OG ÍKOMULEIÐ(IR) Lesið f ylgiseðilinn fyrir notkun. Til inntöku 6. SÉRSTÖK VA RNAÐARORÐ UM AÐ L YFIÐ SKUL I GEYM T ÞAR SEM B ÖRN HV ORKI NÁ TIL NÉ SJÁ Geymið þar sem börn hvorki ná ti l né sjá. 7. ÖNNUR SÉRSTÖ K VARNAÐARO RÐ, EF MEÐ ÞARF NOXAFIL M AGSÝRUÞOLIÐ MIXTÚRU DUFT OG LEYSI , DREIFU MÁ EKKI NOTA Í STAÐINN FYRIR MIXTÚRU, DREIFU OG ÖFUGT. 8. FYRNINGARD AGSETNIN G EXP 99 9. SÉRSTÖK GEYMSLUSKIL YRÐI EFTIR BLÖNDUN VERÐUR AÐ NOTA MAGASÝRUÞOL NA MIXTÚRU, DREIFU INNAN 30 MÍNÚTNA. 10. SÉRSTAKAR VARÚÐ ARRÁÐSTAFAN IR VIÐ F ÖRGUN LYFJALEI FA EÐA ÚRGANGS VEGNA LYFSINS ÞAR SEM VIÐ Á 11. NAFN OG HEI MILISFANG M ARKAÐS LEYFISHA FA Merck Sharp & Dohme B.V . Waarderweg 3 9 20 31 BN Haarlem Holland 12. MARKAÐSLEYFISNÚMER EU/1/05/320/005 13. LOTUNÚMER Lot 14. AFGREIÐSL UTILHÖGUN 15. NOTKUNARLEIÐBEININGAR 16. UPPL ÝSINGAR MEÐ B LINDRALETRI noxafil 300 mg mixtúruduft, dreifa 17. EIN KVÆMT AUÐKENNI – TVÍVÍTT STRIKAMERKI 18. EINKV ÆMT AUÐKENNI – UPPLÝSING AR SEM FÓLK GETUR LESIÐ PC SN NN 100 LÁGMARKS UPPLÝS INGA R SEM SKULU KOMA FR Baca dokumen lengkap
1 VIÐAUKI I SAMANTEKT Á EIGINLEIKUM LYFS 2 1. HEITI LYFS Noxafil 40 mg/ml mixtúra, dreifa 2. INNIHALDSLÝSING Hver ml af mixtúru, dreifu inniheldur 40 mg af posakónazóli. Hjálparefni með þekkta verkun Lyfið inniheldur u.þ.b . 1,75 g af glúkósa í hverjum 5 ml af dreifu. Lyfið inniheldur 10 mg af natríumbensóati (E211) í hverjum 5 ml af dreifu. Lyfið inniheldur allt að 1,25 mg af bensýlalkóhóli í hverjum 5 ml af dreifu. Lyfið inniheldur allt að 24,75 mg af própýlengýkól i (E1520) í hverjum 5 ml af dreifu. Sjá lista yfir öll hjálparefni í kafla 6.1. 3. LYFJAFORM Mixtúra, dreifa Hvít dreifa 4. KLÍNÍSKAR UPPLÝSINGAR 4.1 ÁBENDINGAR Noxafil mixtúra, dreifa er ætluð til meðferðar við eftirfarandi sveppasýkingum hjá fullorðnum (sjá kafla 5.1): - Ífarandi aspergillosis hjá sjúklingum með sjúkdóm sem svarar ekki amfótericíni B eða ítrakónazóli eða hjá sjúklingum sem þola þessi lyf ekki; - Fusariosis hjá sjúklingum með sjúkdóm sem svarar ekki amfótericíni B eða h já sjúklingum s em þola e kki amfótericín B; - Chromoblastomycosis og mycetoma hjá sjúklingum með sjúkdóm sem svarar ekki ítrakónazóli eða hjá sjúklingum sem þola ekki ítrakónazól; - Coccidioidomycosis hjá sjúklingum með sjúkdóm sem svarar ekki amfótericín i B, ítrakónazó li eða fl úkónazóli eða hjá sjúklingum sem þola ekki þessi lyf; - Hvítsveppasýking í munni og koki: sem fyrsti valkostur hjá sjúklingum með alvarlegan sjúkdóm eða sem eru ónæmisskertir, þegar gert er ráð fyrir lítilli svörun við útvortis meðf erð. Skilgreiningin á þ ví að svara ekki meðferð er versnun á sýkingu eða engin batamerki eftir að minnsta 7 daga fyrri meðferðarskammta af virku sveppalyfi. Noxafil mixtúra, dreifa er einnig ætl u ð sem fyrirbyggjandi meðferð við ífarandi sveppasýkingum hj á eftirtöldum s júklingum: - Sjúklingum sem fá lyfjameðferð við bráðu mergfrumu hvítblæði eða merg rangvaxtarheilkenni (myelodysplastic syn Baca dokumen lengkap