Noxafil Europska Unija - hrvatski - EMA (European Medicines Agency)

noxafil

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.

Posaconazole Accord Europska Unija - hrvatski - EMA (European Medicines Agency)

posaconazole accord

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.

Cancidas (previously Caspofungin MSD) Europska Unija - hrvatski - EMA (European Medicines Agency)

cancidas (previously caspofungin msd)

merck sharp & dohme b.v. - caspofungin (as acetate) - candidiasis; aspergillosis - antimikotika za sustavnu uporabu - treatment of invasive candidiasis in adult or paediatric patients;treatment of invasive aspergillosis in adult or paediatric patients who are refractory to or intolerant of amphotericin b, lipid formulations of amphotericin b and / or itraconazole. refractoriness is defined as progression of infection or failure to improve after a minimum of seven days of prior therapeutic doses of effective antifungal therapy;empirical therapy for presumed fungal infections (such as candida or aspergillus) in febrile, neutropaenic adult or paediatric patients.

Alvanocyt 450 mg filmom obložene tablete Hrvatska - hrvatski - HALMED (Agencija za lijekove i medicinske proizvode)

alvanocyt 450 mg filmom obložene tablete

zentiva k.s., u kabelovny 130, dolni mecholupy, prag 10, Češka - valganciklovirklorid - filmom obložena tableta - 450 mg - urbroj: jedna filmom obložena tableta sadrži 496,3 mg valganciklovirklorida, što odgovara 450 mg valganciklovira (kao slobodne baze)

Triplixam 10 mg/2,5 mg/10 mg filmom obložene tablete Hrvatska - hrvatski - HALMED (Agencija za lijekove i medicinske proizvode)

triplixam 10 mg/2,5 mg/10 mg filmom obložene tablete

servier pharma d.o.o., ulica grge tuškana 37, zagreb, hrvatska - perindoprilarginin indapamid amlodipinbesilat - filmom obložena tableta - 10 mg + 2,5 mg + 10 mg - urbroj: jedna filmom obložena tableta sadrži 6,790 mg perindoprila što odgovara 10 mg perindoprilarginina, 2,5 mg indapamida i 13,870 mg amlodipinbesilata što odgovara 10 mg amlodipina

Triplixam 10 mg/2,5 mg/5 mg filmom obložene tablete Hrvatska - hrvatski - HALMED (Agencija za lijekove i medicinske proizvode)

triplixam 10 mg/2,5 mg/5 mg filmom obložene tablete

servier pharma d.o.o., ulica grge tuškana 37, zagreb, hrvatska - perindoprilarginin indapamid amlodipinbesilat - filmom obložena tableta - 10 mg + 2,5 mg + 5 mg - urbroj: jedna filmom obložena tableta sadrži 6,790 mg perindoprila što odgovara 10 mg perindoprilarginina, 2,5 mg indapamida i 6,935 mg amlodipinbesilata što odgovara 5 mg amlodipina

Triplixam 2,5 mg/ 0,625 mg/ 5 mg filmom obložene tablete Hrvatska - hrvatski - HALMED (Agencija za lijekove i medicinske proizvode)

triplixam 2,5 mg/ 0,625 mg/ 5 mg filmom obložene tablete

servier pharma d.o.o., tuškanova 37, zagreb - perindoprilum, indapamidum, amlodipinum - filmom obložena tableta - 2,5 mg + 0,625 mg + 5 mg - urbroj: jedna filmom obložena tableta sadrži 1,6975 mg perindoprila što odgovara 2,5 mg perindoprilarginina, 0,625 mg indapamida i 6,935 mg amlodipinbesilata što odgovara 5 mg amlodipina

Triplixam 5 mg/1,25 mg/10 mg filmom obložene tablete Hrvatska - hrvatski - HALMED (Agencija za lijekove i medicinske proizvode)

triplixam 5 mg/1,25 mg/10 mg filmom obložene tablete

servier pharma d.o.o., ulica grge tuškana 37, zagreb, hrvatska - perindoprilarginin indapamid amlodipinbesilat - filmom obložena tableta - 5 mg + 1,25 mg + 10 mg - urbroj: jedna filmom obložena tableta sadrži 3,395 mg perindoprila što odgovara 5 mg perindoprilarginina, 1,25 mg indapamida i 13,870 mg amlodipinbesilata što odgovara 10 mg amlodipina

Triplixam 5 mg/1,25 mg/5 mg filmom obložene tablete Hrvatska - hrvatski - HALMED (Agencija za lijekove i medicinske proizvode)

triplixam 5 mg/1,25 mg/5 mg filmom obložene tablete

servier pharma d.o.o., ulica grge tuškana 37, zagreb, hrvatska - perindoprilarginin indapamid amlodipinbesilat - filmom obložena tableta - 5 mg + 1,25 mg + 5 mg - urbroj: jedna filmom obložena tableta sadrži 3,395 mg perindoprila što odgovara 5 mg perindoprilarginina, 1,25 mg indapamida i 6,935 mg amlodipinbesilata što odgovara 5 mg amlodipina