Cardalis 欧州連合 - クロアチア語 - EMA (European Medicines Agency)

cardalis

ceva santé animale - benazepril hydrochloride, spironolactone - kardiovaskularnog sustava - psi - za liječenje kongestivnog zatajenja srca uzrokovanog kroničnom degenerativnom bolesti pilula kod pasa (s prikladnom diuretskom podrškom).

Kinzalkomb 欧州連合 - クロアチア語 - EMA (European Medicines Agency)

kinzalkomb

bayer ag - telmisartan, hydrochlorothiazide - hipertenzija - sredstva koja djeluju na sustav renin-angiotenzina - liječenje esencijalne hipertenzije. kinzalkomb s fiksnom kombinacijom doze (40 mg телмисартана / 12. 5 mg hidroklorotiazid, 80 mg телмисартана / 12. 5 mg hidroklorotiazid) prikazan pacijentima, kod kojih je krvni pritisak nije dovoljno prati na телмисартан sami. kinzalkomb s fiksnom kombinacijom doza (80 mg телмисартан / hidroklorotiazid 25 mg) prikazan pacijentima, kod kojih je krvni pritisak nije dovoljno prati na kinzalkomb (80 mg телмисартана / 12. 5 mg hidroklorotiazid) ili bolesnika, koji su prethodno bili su uhvaćeni na телмисартана ili hidroklorotiazid odvojeno.

MicardisPlus 欧州連合 - クロアチア語 - EMA (European Medicines Agency)

micardisplus

boehringer ingelheim international gmbh - telmisartan, hydrochlorothiazide - hipertenzija - sredstva koja djeluju na sustav renin-angiotenzina - liječenje esencijalne hipertenzije. micardisplus s fiksnom kombinacijom doze (40 mg телмисартана / 12. 5 mg hidroklorotiazid, 80 mg телмисартана / 12. 5 mg hidroklorotiazid) prikazan pacijentima, kod kojih je krvni pritisak nije dovoljno prati na телмисартан sami. micardisplus s fiksnom kombinacijom doza (80 mg телмисартан / hidroklorotiazid 25 mg) prikazan pacijentima, kod kojih je krvni pritisak nije dovoljno prati na micardisplus (80 mg телмисартана / 12. 5 mg hidroklorotiazid) ili bolesnika, koji su prethodno bili su uhvaćeni na телмисартана ili hidroklorotiazid odvojeno.

Noxafil 欧州連合 - クロアチア語 - 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.

Taxespira (previously Docetaxel Hospira UK Limited ) 欧州連合 - クロアチア語 - EMA (European Medicines Agency)

taxespira (previously docetaxel hospira uk limited )

hospira uk limited - docetaxel trihidrat - stomach neoplasms; prostatic neoplasms; breast neoplasms; head and neck neoplasms; carcinoma, non-small-cell lung - antineoplastična sredstva - cancertaxespira dojke u kombinaciji s doksorubicin i ciklofosfamid je indiciran za adjuvantne terapije pacijenata s:aktivni čvor-pozitivan rak dojke;aktivni čvor-negativnim rakom dojke . za pacijente s операбельным čvor-negativnim rakom dojke, adjuvantne terapije trebalo bi biti ograničeno pravo bolesnika na primanje kemoterapije po međunarodnim kriterijima na primarne terapije ranog raka dojke . taxespira u kombinaciji s doksorubicin je namijenjen za liječenje bolesnika s lokalno-uobičajena ili metastatskih tumora dojke, prethodno liječenih цитотоксической terapija za ovo stanje. taxespira monoterapija namijenjen je za liječenje bolesnika s lokalno-uobičajena ili metastatskih tumora dojke neučinkovitosti terapije цитотоксической. prethodne kemoterapije moraju uključivati антрациклиновый ili алкилирующий agent. taxespira kombinaciji s трастузумабом namijenjen je za liječenje bolesnika s metastatskih tumora dojke, tumora koje express her2 i koji ranije nisu primali kemoterapiju o popularnog bolesti. taxespira u kombinaciji s капецитабином namijenjen je za liječenje bolesnika s lokalno-uobičajena ili metastatskih tumora dojke neučinkovitosti цитотоксической kemoterapije. prethodna terapija mora sadržavati антрациклиновый. Немелкоклеточный rak pluća taxespira indiciran za liječenje bolesnika s lokalno-uobičajena ili metastatskih немелкоклеточным od raka pluća nakon neefikasnosti prethodne kemoterapije. taxespira u kombinaciji s цисплатином namijenjen je za liječenje bolesnika s нерезектабельным, lokalno-uobičajena ili metastatskih немелкоклеточным raka pluća kod pacijenata koji nisu prethodno tretirani i kemoterapiju za ove uvjete. taxespira raka prostate u kombinaciji s преднизоном ili преднизолоном indiciran za liječenje bolesnika s hormonski uporan метастатического raka prostate . Аденокарцинома želuca taxespira u kombinaciji s цисплатином i 5-фторурацилом namijenjen je za liječenje bolesnika s метастатической аденокарциномой želuca, uključujući i gušterače adenokarcinom пищеводно-želučani tranzicije, koji nisu primili ranije kemoterapije za метастатической bolesti. rak glave i vrata taxespira u kombinaciji s цисплатином i 5-фторурацилом dizajniran za indukcijska terapija bolesnika s lokalno-najčešći плоскоклеточным raka glave i vrata.

Sivextro 欧州連合 - クロアチア語 - EMA (European Medicines Agency)

sivextro

merck sharp & dohme b.v. - tedizolid fosfata - soft tissue infections; skin diseases, bacterial - antibacterials for systemic use, , other antibacterials - sivextro is indicated for the treatment of acute bacterial skin and skin structure infections (absssi) in adults and adolescents 12 years of age and older.

Xoterna Breezhaler 欧州連合 - クロアチア語 - EMA (European Medicines Agency)

xoterna breezhaler

novartis europharm limited - indacaterol, bromid glycopyrronium - plućna bolest, kronična opstruktivna - adrenergics u kombinaciji s антихолинергическими on. trostruki kombinaciji s kortikosteroidima - xoterna breezhaler je indicirana kao liječenje bronhodilatatora za održavanje radi ublažavanja simptoma u odraslih bolesnika s kroničnom opstruktivnom plućnom bolesti (copd).

Vipdomet 欧州連合 - クロアチア語 - EMA (European Medicines Agency)

vipdomet

takeda pharma a/s - alogliptin benzoat, метформина hidroklorid - dijabetes mellitus, tip 2 - drugs used in diabetes, combinations of oral blood glucose lowering drugs - vipdomet is indicated in the treatment of adult patients aged 18 years and older with type-2 diabetes mellitus:as an adjunct to diet and exercise to improve glycaemic control in adult patients, inadequately controlled on their maximal tolerated dose of metformin alone, or those already being treated with the combination of alogliptin and metformin;in combination with pioglitazone (i. triple combination therapy) as an adjunct to diet and exercise in adult patients inadequately controlled on their maximal tolerated dose of metformin and pioglitazone;in combination with insulin (i. trostruka kombinirana terapija) kao dodatak prehrani i fizičke vježbe za poboljšanje glikemijski kontrole kod bolesnika, kada inzulina u stabilne doze i metformin sami ne pružaju adekvatnu glikemijski kontrole.

Ultibro Breezhaler 欧州連合 - クロアチア語 - EMA (European Medicines Agency)

ultibro breezhaler

novartis europharm limited - indacaterol, bromid glycopyrronium - plućna bolest, kronična opstruktivna - adrenergics u kombinaciji s антихолинергическими on. trostruki kombinacija sa kortikosteroidima, lijekovi za opstruktivne plućne bolesti dišnih putova, - ultibro breezhaler je indiciran kao liječenje bronhodilatatora za održavanje radi ublažavanja simptoma kod odraslih osoba s kroničnom opstruktivnom plućnom bolesti (copd).

Ulunar Breezhaler 欧州連合 - クロアチア語 - EMA (European Medicines Agency)

ulunar breezhaler

novartis europharm limited - bromid glycopyrronium, maleat indacaterol - plućna bolest, kronična opstruktivna - lijekovi za opstruktivne plućne bolesti dišnih putova, - ulunar breezhaler je indiciran kao bronhodilatacijska terapija održavanja za ublažavanje simptoma u odraslih bolesnika s kroničnom opstruktivnom plućnom bolesti (kopb).