Europska Unija - hrvatski - EMA (European Medicines Agency)

merck sharp and dohme b.v - posakonazol - candidiasis; mycoses; coccidioidomycosis; aspergillosis - antimikotika za sustavnu uporabu - noxafil gastro-resistant tablets are indicated for use in the treatment of the following fungal infections in adults (see sections 4. 2 i 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 i 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. Огнеупорность definira kao progresiju infekcije ili nedostatak poboljšanja nakon što je minimum 7 dana do terapijske doze učinkovit antifungalna terapija. 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 i 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 i 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 i 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. Огнеупорность definira kao progresiju infekcije ili nedostatak poboljšanja nakon što je minimum 7 dana do terapijske doze učinkovit antifungalna terapija. 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 i 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 i 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. Огнеупорность definira kao progresiju infekcije ili nedostatak poboljšanja nakon što je minimum 7 dana do terapijske doze učinkovit antifungalna terapija. 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. Огнеупорность definira kao progresiju infekcije ili nedostatak poboljšanja nakon što je minimum 7 dana do terapijske doze učinkovit antifungalna terapija. 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.

Europska Unija - hrvatski - EMA (European Medicines Agency)

accord healthcare s.l.u. - posakonazol - mycosis - antimikotika za sustavnu uporabu - posaconazole accord is indicated for use in the treatment of the following fungal infections in adults:invasive aspergillosis;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. Огнеупорность definira kao progresiju infekcije ili nedostatak poboljšanja nakon što je minimum 7 dana do terapijske doze učinkovit antifungalna terapija. Позаконазол accord je također indiciran za prevenciju invazivnih gljivičnih infekcija kod sljedećih bolesnika: kod bolesnika remisije-indukcija kemoterapije akutni миелолейкозе (aml) ili миелодиспластические sindroma (mds) očekuje se da će rezultat dugotrajne нейтропенией i visokim rizikom za razvoj invazivnih gljivičnih infekcija;presađivanje гемопоэтических matičnih stanica (ТГСК) primatelja, koji se održavaju высокодозную иммуносупрессивную terapiju reakcija graft protiv domaćina i koji su s visokim rizikom za razvoj invazivnih gljivičnih infekcija.

Europska Unija - hrvatski - EMA (European Medicines Agency)

accord healthcare s.l.u. - posakonazol - mycosis - antimikotika za sustavnu uporabu - ahcl позаконазол suspenzija za oralnu upotrebu indiciran za primjenu za liječenje sljedećih gljivične infekcije kod odraslih:invazivna аспергиллез u bolesnika s bolešću, uporan do амфотерицину u ili итраконазолу, ili kod pacijenata s laktoza tih lijekova;фузариоз u bolesnika s bolešću, uporan do амфотерицину u ili kod bolesnika koji su netolerantni amfotericin b;chromoblastomycosis i мицетома u bolesnika s bolešću, рефрактерного na итраконазолу ili u bolesnika s laktoza итраконазола;Кокцидиомикоз u bolesnika s bolešću, uporan do амфотерицину u, itrakonazol ili flukonazol ili u bolesnika s laktoza tih lijekova. Орофарингеальный kandidijaza: kao prva linija terapije u bolesnika koji pate od teških bolesti ili oslabljen imunitet, u kojoj je odgovor na aktuelno terapija, kao što se očekuje, biti loša. Огнеупорность definira kao progresiju infekcije ili nedostatak poboljšanja nakon što je minimum 7 dana do terapijske doze učinkovit antifungalna terapija. Позаконазол ahcl oralnu suspenziju također je propisan za sprječavanje invazivnih gljivičnih infekcija kod sljedećih bolesnika:kod bolesnika remisije-indukcija kemoterapije akutni миелолейкозе (aml) ili миелодиспластические sindroma (mds) očekuje se da će rezultat dugotrajne нейтропенией i visokim rizikom za razvoj invazivnih gljivičnih infekcija;presađivanje гемопоэтических matičnih stanica (ТГСК) primatelja, koji se održavaju высокодозную иммуносупрессивную terapiju reakcija graft protiv domaćina i koji su s visokim rizikom za razvoj invazivnih gljivičnih infekcija.

Hrvatska - hrvatski - HALMED (Agencija za lijekove i medicinske proizvode)

abdi farma unipessoal ltd., quinta da fonte, rua dos malhoes, edificio d. pedro i, paco de arcos, portugal - posakonazol - želučanootporna tableta - 100 mg - urbroj: jedna želučanootporna tableta sadrži 100 mg posakonazola

Hrvatska - hrvatski - HALMED (Agencija za lijekove i medicinske proizvode)

zentiva k.s., u kabelovny 130, dolni mecholupy, prag 10, Češka - posakonazol - želučanootporna tableta - 100 mg - urbroj: svaka želučanootporna tableta sadrži 100 mg posakonazola

Hrvatska - hrvatski - HALMED (Agencija za lijekove i medicinske proizvode)

teva b.v., swensweg 5, haarlem, nizozemska - posakonazol - želučanootporna tableta - 100 mg - urbroj: svaka želučanootporna tableta sadrži 100 mg posakonazola

Hrvatska - hrvatski - HALMED (Agencija za lijekove i medicinske proizvode)

sandoz d.o.o., maksimirska 120, zagreb, hrvatska - posakonazol - želučanootporna tableta - 100 mg - urbroj: svaka želučanootporna tableta sadrži 100 mg posakonazola

Hrvatska - hrvatski - HALMED (Agencija za lijekove i medicinske proizvode)

mylan pharmaceuticals limited, damastown industrial park, mulhuddart, dublin, irska - posakonazol - želučanootporna tableta - 100 mg - urbroj: jedna želučanootporna tableta sadrži 100 mg posakonazola

Hrvatska - hrvatski - HALMED (Agencija za lijekove i medicinske proizvode)

stada d.o.o., hercegovačka 14, zagreb, hrvatska - posakonazol - želučanootporna tableta - 100 mg - urbroj: jedna želučanootporna tableta sadrži 100 mg posakonazola