Binocrit 유럽 연합 - 크로아티아어 - EMA (European Medicines Agency)

binocrit

sandoz gmbh - epoetin alfa - anemia; kidney failure, chronic - antianemijski pripravci - treatment of symptomatic anaemia associated with chronic renal failure (crf) in adult and paediatric patients: , treatment of anaemia associated with chronic renal failure in paediatric and adult patients on haemodialysis and adult patients on peritoneal dialysis;, treatment of severe anaemia of renal origin accompanied by clinical symptoms in adult patients with renal insufficiency not yet undergoing dialysis;, treatment of anaemia and reduction of transfusion requirements in adult patients receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma, and at risk of transfusion as assessed by the patient's general status (e. stanje kardiovaskularnog sustava, već postojeće anemije u početku kemoterapije).

Edistride 유럽 연합 - 크로아티아어 - EMA (European Medicines Agency)

edistride

astrazeneca ab - dapagliflozin propandiol monohidrat - diabetes mellitus, type 2; heart failure, systolic; heart failure; renal insufficiency, chronic - lijekovi koji se koriste u dijabetesu - type 2 diabetes mellitusedistride is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exerciseas monotherapy when metformin is considered inappropriate due to intolerance. osim drugih lijekova za liječenje šećerne bolesti tipa 2 . for study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4. 4, 4. 5 i 5. heart failureedistride is indicated in adults for the treatment of symptomatic chronic heart failure. chronic kidney diseaseedistride is indicated in adults for the treatment of chronic kidney disease.

Epoetin Alfa Hexal 유럽 연합 - 크로아티아어 - EMA (European Medicines Agency)

epoetin alfa hexal

hexal ag - epoetin alfa - anemia; kidney failure, chronic; cancer - antianemijski pripravci - treatment of symptomatic anaemia associated with chronic renal failure (crf) in adult and paediatric patients: , treatment of anaemia associated with chronic renal failure in paediatric and adult patients on haemodialysis and adult patients on peritoneal dialysis;, treatment of severe anaemia of renal origin accompanied by clinical symptoms in adult patients with renal insufficiency not yet undergoing dialysis. liječenje anemije i smanjenje potrebe transfuzije krvi kod odraslih pacijenata koji primaju kemoterapiju za uglednih tumora maligni limfom ili multiple myeloma, kao i na rizik трансфузии оцениваемым opće stanje pacijenta (e. stanje kardiovaskularnog sustava, već postojeće anemije u početku kemoterapije).

Forxiga 유럽 연합 - 크로아티아어 - EMA (European Medicines Agency)

forxiga

astrazeneca ab - dapagliflozin propandiol monohidrat - diabetes mellitus, type 2; heart failure, systolic; heart failure; renal insufficiency, chronic - lijekovi koji se koriste u dijabetesu - type 2 diabetes mellitusforxiga is indicated in adults and children aged 10 years and above for the treatment of insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exerciseas monotherapy when metformin is considered inappropriate due to intolerance. osim drugih lijekova za liječenje šećerne bolesti tipa 2 . for study results with respect to combination of therapies, effects on glycaemic control, cardiovascular and renal events, and the populations studied, see sections 4. 4, 4. 5 i 5. heart failureforxiga is indicated in adults for the treatment of symptomatic chronic heart failure. chronic kidney diseaseforxiga is indicated in adults for the treatment of chronic kidney disease.

Glivec 유럽 연합 - 크로아티아어 - EMA (European Medicines Agency)

glivec

novartis europharm limited - imatinib - precursor cell lymphoblastic leukemia-lymphoma; gastrointestinal stromal tumors; dermatofibrosarcoma; myelodysplastic-myeloproliferative diseases; leukemia, myelogenous, chronic, bcr-abl positive; hypereosinophilic syndrome - antineoplastična sredstva - glivec is indicated for the treatment of , adult and paediatric patients with newly diagnosed philadelphia-chromosome (bcr-abl)-positive (ph+) chronic myeloid leukaemia (cml) for whom bone-marrow transplantation is not considered as the first line of treatment;, adult and paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis;, adult and paediatric patients with newly diagnosed philadelphia-chromosome-positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy;, adult patients with relapsed or refractory ph+ all as monotherapy;, adult patients with myelodysplastic / myeloproliferative diseases (mds / mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements;, adult patients with advanced hypereosinophilic syndrome (hes) and / or chronic eosinophilic leukaemia (cel) with fip1l1-pdgfra rearrangement. učinak Гливека na ishod transplantacije koštane srži još nije određen. glivec is indicated for: , the treatment of adult patients with kit (cd 117)-positive unresectable and / or metastatic malignant gastrointestinal stromal tumours (gist);, the adjuvant treatment of adult patients who are at significant risk of relapse following resection of kit (cd117)-positive gist. pacijenti koji imaju niske ili vrlo nizak rizik recidiva ne bi trebali primati adjuvantne terapije; liječenje odraslih bolesnika s метастатической выбухающей dermatofibrosarcoma (dfsp) i odraslih pacijenata s relaps i / ili метастатической dfsp, koji nemaju pravo na operaciju. u odrasle osobe i pedijatrijska bolesnika, učinkovitosti glivec se temelji na zajedničkim гематологических i цитогенетических odgovora i preživljavanja bez progresije kod kml, na гематологический i цитогенетический odgovor cijene na ph+ all, mds / rafinerija, na гематологические indikatori odgovora u hes / cel i objektivnih odgovora kod odraslih pacijenata s неоперабельными i / ili метастатическими gist i dfsp i na безрецидивную stopa preživljavanja pri adjuvantne bit. iskustvo glivec u bolesnika s mds / rafinerija u svezi s pdgfr генных permutacija-vrlo ograničen (vidi odjeljak 5. osim po prvi put prijavljene kronične fazi kml, nema kontroliranih istraživanja pokazuju klinički učinak ili povećava stopu preživljavanja kod te bolesti.

Humira 유럽 연합 - 크로아티아어 - EMA (European Medicines Agency)

humira

abbvie deutschland gmbh co. kg - adalimumab - spondylitis, ankylosing; arthritis, juvenile rheumatoid; uveitis; colitis, ulcerative; psoriasis; arthritis, psoriatic; crohn disease; arthritis, rheumatoid - imunosupresivi - molimo pogledajte dokument s informacijama o proizvodu.

Imatinib Accord 유럽 연합 - 크로아티아어 - EMA (European Medicines Agency)

imatinib accord

accord healthcare s.l.u. - imatinib - precursor cell lymphoblastic leukemia-lymphoma; dermatofibrosarcoma; myelodysplastic-myeloproliferative diseases; leukemia, myelogenous, chronic, bcr-abl positive; hypereosinophilic syndrome - imatinib - imatinib accord is indicated for the treatment of- adult and paediatric patients with newly diagnosed philadelphia chromosome (bcr-abl) positive (ph+) chronic myeloid leukaemia (cml) for whom bone marrow transplantation is not considered as the first line of treatment. - adult and paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis. - adult and paediatric patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy. - adult patients with relapsed or refractory ph+ all as monotherapy. - adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements. - adult patients with advanced hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) with fip1l1-pdgfrα rearrangement. - adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. - the treatment of adult patients with kit (cd 117) positive unresectable and/or metastatic malignant gastrointestinal stromal tumours (gist). - the adjuvant treatment of adult patients who are at significant risk of relapse following resection of kit (cd117)-positive gist. patients who have a low or very low risk of recurrence should not receive adjuvant treatmentthe effect of imatinib on the outcome of bone marrow transplantation has not been determined. in adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in cml, on haematological and cytogenetic response rates in ph+ all, mds/mpd, on haematological response rates in hes/cel and on objective response rates in adult patients with unresectable and/or metastatic dfsp. the experience with imatinib in patients with mds/mpd associated with pdgfr gene re-arrangements is very limited (see section 5. osim po prvi put prijavljene kronične fazi kml, nema kontroliranih istraživanja pokazuju klinički učinak ili povećava stopu preživljavanja kod te bolesti. .

Imatinib Actavis 유럽 연합 - 크로아티아어 - EMA (European Medicines Agency)

imatinib actavis

actavis group ptc ehf - imatinib - leukemia, myelogenous, chronic, bcr-abl positive; precursor cell lymphoblastic leukemia-lymphoma; myelodysplastic-myeloproliferative diseases; hypereosinophilic syndrome; dermatofibrosarcoma - protein kinase inhibitors, antineoplastic agents - imatinib actavis is indicated for the treatment of: , paediatric patients with newly diagnosed philadelphia chromosome (bcr-abl) positive (ph+) chronic myeloid leukaemia (cml) for whom bone marrow transplantation is not considered as the first line of treatment;, paediatric patients with ph+ cml in chronic phase after failure of interferon-alpha therapy, or in accelerated phase or blast crisis;, adult patients with ph+ cml in blast crisis;, adult patients with newly diagnosed philadelphia chromosome positive acute lymphoblastic leukaemia (ph+ all) integrated with chemotherapy;, adult patients with relapsed or refractory ph+ all as monotherapy;, adult patients with myelodysplastic/myeloproliferative diseases (mds/mpd) associated with platelet-derived growth factor receptor (pdgfr) gene re-arrangements;, adult patients with advanced hypereosinophilic syndrome (hes) and/or chronic eosinophilic leukaemia (cel) with fip1l1-pdgfr rearrangement;, the treatment of adult patients with unresectable dermatofibrosarcoma protuberans (dfsp) and adult patients with recurrent and/or metastatic dfsp who are not eligible for surgery. učinak иматиниба na ishod transplantacije koštane srži nije određena. imatinib actavis is indicated for: , in adult and paediatric patients, the effectiveness of imatinib is based on overall haematological and cytogenetic response rates and progression-free survival in cml, on haematological and cytogenetic response rates in ph+ all, mds/mpd, on haematological response rates in hes/cel and on objective response rates in adult patients with unresectable and/or metastatic dfsp. iskustvo s иматинибом u bolesnika s mds/rafinerija u svezi s pdgfr генных permutacija-vrlo ograničen. nema kontroliranih istraživanja pokazuju kliničku korist ili povećanje preživljavanja za te bolesti.

Jardiance 유럽 연합 - 크로아티아어 - EMA (European Medicines Agency)

jardiance

boehringer ingelheim international gmbh - empagliflozin - diabetes mellitus, type 2; heart failure; renal insufficiency, chronic - lijekovi koji se koriste u dijabetesu - type 2 diabetes mellitusjardiance is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exerciseas monotherapy when metformin is considered in addition to other medicinal products for the treatment of diabetesfor study results with respect to combinations of therapies, effects on glycaemic control, and cardiovascular and renal events, and the populations studied, see sections 4. 4, 4. 5 i 5. of the annex. heart failurejardiance is indicated in adults for the treatment of symptomatic chronic heart failure.  chronic kidney diseasejardiance is indicated in adults for the treatment of chronic kidney disease.

Kineret 유럽 연합 - 크로아티아어 - EMA (European Medicines Agency)

kineret

swedish orphan biovitrum ab (publ) - anakinra - arthritis, rheumatoid; covid-19 virus infection - imunosupresivi - reumatoidni artritis (ra)kinneret prikazan kod odraslih za liječenje znakova i simptoma ra u kombinaciji s metotreksatom, sa neadekvatno odgovorom na metotreksat samo . covid-19kineret is indicated for the treatment of coronavirus disease 2019 (covid-19) in adult patients with pneumonia requiring supplemental oxygen (low- or high-flow oxygen) who are at risk of progressing to severe respiratory failure determined by plasma concentration of soluble urokinase plasminogen activator receptor (supar) ≥ 6 ng/ml. periodična groznica syndromeskineret je indiciran za liječenje sljedećih аутовоспалительные sindromi periodična bolest kod odraslih, mlade, djecu i dojenčad u dobi od 8 mjeseci i stariji s tjelesnu masu od 10 kg i gore:криопиринассоциированные periodične sindromi (caps)s kinneret indiciran za liječenje poklopaca, uključujući:za novorođenčad-početak Мультисистемное upalna bolest (НОМИД) / kronični инфантильный neurološki, kožni, zglobne sindrom (Синка)Макла-wells sindrom (mw)obiteljska холодовая Аутовоспалительные sindrom (fcas)obiteljska mediteranska groznica (ФМФ)kinneret indiciran za liječenje obiteljska mediteranska groznica (ФМФ). kinneret mora se dati u kombinaciji s drugim lijekovima, ako je potrebno. još diseasekineret navodi u odrasle, mlade, djecu i dojenčad u dobi od 8 mjeseci i stariji s tjelesnu masu od 10 kg i gore za liječenje bolesti Стилла-Шоффара, uključujući i sistem juvenilni idiopatski artritis (sjia) i odrasloj dobi bolest Стилла-Шоффара (aop), s aktivnim sistemske funkcije umjerena do visoka aktivnost bolesti, ili kod pacijenata s trajna aktivnost bolesti nakon liječenja nesteroidni protuupalni lijekovi (nsar) i glukokortikoidi. kinneret može se dati u monoterapiji ili u kombinaciji s drugim anti-upalne lijekove i заболевани-razrađen antirheumatic napitke (dmards).