País: Unió Europea
Idioma: eslovè
Font: EMA (European Medicines Agency)
posakonazol
Merck Sharp and Dohme B.V
J02AC04
posaconazole
Antimikotiki za sistemsko uporabo
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 in 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 in 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 je opredeljena kot napredovanje okužbe ali neuspeh za izboljšanje po najmanj 7 dni pred terapevtskih odmerkih učinkovito protiglivično zdravljenje. 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 in 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 in 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 in 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 je opredeljena kot napredovanje okužbe ali neuspeh za izboljšanje po najmanj 7 dni pred terapevtskih odmerkih učinkovito protiglivično zdravljenje. 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 in 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 in 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 je opredeljena kot napredovanje okužbe ali neuspeh za izboljšanje po najmanj 7 dni pred terapevtskih odmerkih učinkovito protiglivično zdravljenje. 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):- Invazivne aspergillosis pri bolnikih z boleznijo, ki je neodzivna, da amphotericin B ali itraconazole ali pri bolnikih, ki ne prenašajo teh zdravil;- Fusariosis pri bolnikih z boleznijo, ki je neodzivna, da amphotericin B ali pri bolnikih, ki so nestrpne amphotericin B;- Chromoblastomycosis in mycetoma pri bolnikih z boleznijo, ki je neodzivna, da itraconazole ali pri bolnikih, ki so nestrpne itraconazole;- Coccidioidomycosis pri bolnikih z boleznijo, ki je neodzivna, da amphotericin B, itraconazole ali fluconazole ali pri bolnikih, ki ne prenašajo teh zdravil;- Žrela kandidoza: kot prvo linijo zdravljenja pri bolnikih, ki imajo hude bolezni ali so immunocompromised, v kateri je odziv na aktualne terapija je pričakovati, da bo slaba. Refractoriness je opredeljena kot napredovanje okužbe ali neuspeh za izboljšanje po najmanj 7 dni pred terapevtskih odmerkih učinkovito protiglivično zdravljenje. 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
Pooblaščeni
2005-10-25
109 B. NAVODILO ZA UPORABO 110 NAVODILO ZA UPORABO NOXAFIL 40 MG/M L PERORALNA SUSPENZIJA posakonazol PRED začet KOM JEMANJA ZDRAVILA NAT ančno p REBERITE NAVODILO, KER VSEBUJE ZA VAS POMEMBNE PODATKE! - Navodilo shrani te. Morda ga boste želeli p onovno prebrati. - Č e imate dodatna vpr ašan ja, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro. - Zdravilo je bilo pr edpisano vam ose bno in ga ne smete dajati drugim. Njim bi lahko celo škodovalo, čepra v imajo znake bol ezni, podobne vašim . - Če opazite kateri koli n eželeni uč inek, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro. Posvetujte se t udi, če opazite katere koli neželene uč inke, ki niso navedeni v tem navodilu. G lejte poglavje 4. KAJ VSEBUJE NAVODILO 1. Kaj je zdravilo Noxafi l in za kaj ga uporabljamo 2. Kaj morate vedeti, prede n boste vzeli zdr avilo Noxafil 3. Kako jemati zdravilo Noxafil 4. M ožni neželeni učinki 5. Shranjevanje zdravila Noxafil 6. Vsebina pakiranja in dodatne informacije 1. KAJ JE ZDRAVILO NOXAFIL IN ZA KAJ GA UPORABLJAMO Zdravilo Noxafil vsebuje u činkovi no posakonazol. Ta u čin kovina spada v skup ino zdravil, imenovanih "antimikot iki" (protiglivn a zdravila). Uporablja se za pr epreč evanje in zdravljenje števi lnih razli čnih v rst gl ivnih okužb. To zdravilo deluje tako, da un ič i nekatere vrste gliv, ki lahko povz ročajo okužbe , ali ustavi njihovo rast. Zdravilo Noxafil se lahko uporablja pri odraslih bolnikih za zdravljenje naslednjih vrst glivni h okužb , kadar druga protiglivna zdravila niso bila učinkov ita ali so vam jih morali ukiniti: • ok užb, k i jih pov zročajo glive iz družine Aspergillus in ki se niso izbo ljšale m ed zdravljenjem s pr otiglivnima zdra viloma amfotericin B ali itrakonazol, ali če je bilo treba ti dve zdravili ukiniti; • o kužb, ki jih p o vzročajo gliv e iz družine Fusarium in ki se niso izbolj ša le med zdr avljenjem z amfotericinom B , ali če je bilo treba amfotericin B ukiniti; • okužb z glivami, ki p ovzročajo Llegiu el document complet
1 PRILOGA I POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA 2 1. IME ZDRAVILA Noxafil 40 mg/ml peroralna suspenzija 2. KAKOVOSTNA IN KOLIČINSKA SESTAVA En ml peroralne suspenzije vsebuje 40 mg posakonazola. Pomožn a(e) snov(i) z znanim uč inkom: To zdravilo vsebuje približno 1,75 g glukoze na 5 ml suspenzije. To zdravilo vsebuje 10 mg natrijevega benzoat a (E211) na 5 ml suspenzije. To zdravilo vsebuje do 1,25 mg benzilalkohola na 5 ml suspenzije. To zdravilo vsebuje do 24,75 mg propilenglikola (E1520) na 5 ml suspenzije. Za celoten seznam pomožnih snovi glejte poglavje 6.1. 3. FARMACEVTSKA OBLIKA p eroralna suspenzija b ela suspenzija 4. KLINIČNI PODATKI 4.1 TERAPEVTSKE INDIKACIJE Zdravilo Noxafil peroralna suspenzija je indicirano za zdravljenje naslednjih glivnih okužb pri odraslih (glejte poglavje 5.1): - invazivne aspergiloze pri bolnikih z okužbo, odporn o na amfotericin B ali itrakonazol, ter pri bolnikih, ki ne prenašajo teh zdravil , - fuza rioze pri bolnikih z okužbo, od porno na a mfotericin B, ter pri bolnikih, ki ne prenašajo amfotericina B , - kromoblastomikoze in micetoma pri bolnikih z okužbo, odporn o na itrakonazol , ter pri bolnikih, ki ne prenašajo itrakonazola , - kokcidioidomikoze pr i bolnikih z okužbo, odporn o na amfoteric in B, itrakonazol ali flukonazol , ter pri bolnikih, ki ne prenašajo teh zdravil , - orofaringealn e kandidoze : kot terapija prve izbire pri bolnikih s hudo okužbo ali pri tistih z imunsko pomanjkljivostjo , pri katerih pričakujemo, da bo odziv na to pikalno te rapijo slab. Odpornost na zdravilo je opredeljena kot napredovanje okužbe ali brez izboljšanja po najmanj 7-dnevnem predhodn em zdravljenju s terapevtskimi odmerki učinkovit ega antimikotičn ega zdravila. Zdravilo Noxafil peroralna suspenzija je indicirano tudi za profilakso invazivnih glivnih okužb pri : - bolnikih, ki prejemajo kemoterapijo za doseganje remisije akutne mieloične levkemije (AML) ali mielodisplastičnih sindromov (MDS) in pri katerih se zato pričakuje dolgotrajnejš a nevtropenija Llegiu el document complet