크로아티아 - 크로아티아어 - HALMED (Agencija za lijekove i medicinske proizvode)

csl behring gmbh, emil-von-behring-str. 76, marburg, njemačka - inhibitor c1-esteraze, ljudski - prašak i otapalo za otopinu za injekciju - urbroj: jedna bočica sadrži 3000 iu inhibitora c1-esteraze, ljudskog; nakon rekonstitucije s 5,6 ml otapala vode za injekciju sadrži 500 iu/ml inhibitora c1-esteraze.

크로아티아 - 크로아티아어 - HALMED (Agencija za lijekove i medicinske proizvode)

apta medica internacional d.o.o., likozarjeva ulica 6, ljubljana, slovenija - teikoplanin - prašak i otapalo za otopinu za injekciju / infuziju - urbroj: jedna bočica sadrži 200 mg teikoplanina

크로아티아 - 크로아티아어 - HALMED (Agencija za lijekove i medicinske proizvode)

apta medica internacional d.o.o., likozarjeva ulica 6, ljubljana, slovenija - teikoplanin - prašak i otapalo za otopinu za injekciju / infuziju - urbroj: jedna bočica sadrži 400 mg teikoplanina

크로아티아 - 크로아티아어 - HALMED (Agencija za lijekove i medicinske proizvode)

csl behring gmbh, emil-von-behring-str. 76, marburg, njemačka - inhibitor c1-esteraze, ljudski - prašak i otapalo za otopinu za injekciju - urbroj: jedna bočica sadrži 1500 iu ljudskog inhibitora c1-esteraze; nakon rekonstitucije s 3 ml otapala vode za injekciju sadrži 500 iu/ml ljudskog inhibitora c1-esteraze.

크로아티아 - 크로아티아어 - HALMED (Agencija za lijekove i medicinske proizvode)

csl behring gmbh, emil-von-behring-str. 76, marburg, njemačka - inhibitor c1-esteraze, ljudski - prašak i otapalo za otopinu za injekciju / infuziju - urbroj: jedna bočica sadrži 500 iu ljudskog inhibitora c1-esteraze; nakon rekonstitucije s 10 ml otapala vode za injekciju sadrži 50 iu/ml ljudskog inhibitora c1-esteraze.

크로아티아 - 크로아티아어 - HALMED (Agencija za lijekove i medicinske proizvode)

octapharma (ip) sprl, allee de la recherche 65, anderlecht, belgija - адррес proteini ljudske plazme koji djeluju protiv inhibitora koagulacijskog faktora viii u - otopina za infuziju - 45-70 mg/ml - urbroj: 1 ml otopine za infuziju sadrži 45-70 mg proteina ljudske plazme

크로아티아 - 크로아티아어 - HALMED (Agencija za lijekove i medicinske proizvode)

octapharma (ip) sprl, allee de la recherche 65, anderlecht, belgija - ljudska plazma - prašak i otapalo za otopinu za infuziju - urbroj: jedna bočica s praškom sadrži 9 - 14 g proteina ljudske plazme specifičnih za krvne grupe ab0. nakon rekonstitucije sa 190 ml otapala, otopina sadrži 45-70 mg/ml proteina ljudske plazme specifičnih za krvne grupe ab0

몬테네그로 - 크로아티아어 - CInMED-Institut za ljekove i medicinska sredstva Crne Gore

"medica" d.o.o. za proizvodnju, trgovinu na veliko i malo, export-import, podgorica - proteini plazme, humani - rastvor za infuziju - 45-70mg/ml

유럽 연합 - 크로아티아어 - 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.

유럽 연합 - 크로아티아어 - EMA (European Medicines Agency)

celltrion healthcare hungary kft. - rituksimab - lymphoma, non-hodgkin; microscopic polyangiitis; leukemia, lymphocytic, chronic, b-cell; wegener granulomatosis - antineoplastična sredstva - rituzena navodi u odraslih prema sljedećim kriterijima:неходжкинские limfoma (nhl)rituzena indiciran za liječenje nisu prethodno tretirani za liječenje bolesnika sa iii faze i. фолликулярная limfom u kombinaciji s kemoterapijom. rituzena monoterapija namijenjen je za liječenje bolesnika sa iii fazi u iv folikularni limfoma, koji su Хемо-aksijalni ili drugi ili naknadne recidiva nakon kemoterapije. rituzena indiciran za liječenje bolesnika s cd20 pozitivne difuzno крупноклеточной b u staničnim ne-ходжкинских лимфом u kombinaciji sa chop (ciklofosfamid, doksorubicin, vinkristin, prednizon) kemoterapija. kronične limfocitne leukemije (ХЛЛ)rituzena u kombinaciji s kemoterapijom što je prikazano za obradu bolesnika prethodno liječenih liječenje i relapsed/тугоплавким ХЛЛ. postoje samo ograničeni podaci o učinkovitosti i sigurnosti bolesnika prethodno liječenih monoklonsko antitijelo, uključujući rituzenaor bolesnika, vatrostalne standardnim tretmanima na prethodnu rituzena plus kemoterapija. Гранулематоз s полиангиитом i mikroskopskoj polyangiitisrituzena, u kombinaciji s s glukokortikoidi propisan za indukciju remisije kod odraslih pacijenata s teškim aktivnim гранулематоз s полиангиитом (wegener) (hpa) i микроскопическим полиангиитом (mpa).