Unjoni Ewropea - Kroat - EMA (European Medicines Agency)

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.

Unjoni Ewropea - Kroat - EMA (European Medicines Agency)

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. .

Unjoni Ewropea - Kroat - EMA (European Medicines Agency)

sanofi b.v. - sevelamer karbonat - hyperphosphatemia; renal dialysis - svi ostali terapeutski proizvodi - renvela je indicirana za kontrolu hiperfosfatemije kod odraslih osoba koje primaju hemodijalizu ili peritonealnu dijalizu. renvela također je prikazano za kontrolu hyperphosphataemia u odraslih bolesnika s kroničnom bolešću bubrega bez dijalizu s fosfora u serumu ≥ 1. 78 mmol/l. renvela treba koristiti u okviru nekoliko terapijskih pristupa koji se mogu uključiti dodataka kalcija, 1,25-дигидрокси vitamin d3 ili jedan od njegovih analoga za praćenje razvoja bolesti bubrega канальцах .

Unjoni Ewropea - Kroat - EMA (European Medicines Agency)

sanofi b.v. - sevelamer karbonat - hyperphosphatemia; renal dialysis - svi ostali terapeutski proizvodi - Севеламера kalcijev winthrop je dizajniran za kontrolu hyperphosphataemia kod odraslih pacijenata koji primaju гемодиализ ili перитонеальный dijaliza. Севеламера kalcijev winthrop također je prikazano za kontrolu hyperphosphataemia u odraslih bolesnika s kroničnom bolešću bubrega bez dijalizu s fosfora u serumu > 1. 78 mmol / l. Севеламера kalcijev winthrop treba koristiti u okviru nekoliko terapijskih pristupa koji se mogu uključiti dodataka kalcija, 1,25-дигидрокси-vitamin d3 ili jedan od njegovih analoga za praćenje razvoja bolesti bubrega канальцах .

Unjoni Ewropea - Kroat - EMA (European Medicines Agency)

sanofi b.v. - sevelamer - renal dialysis; hyperphosphatemia - svi ostali terapeutski proizvodi - renagel is indicated for the control of hyperphosphataemia in adult patients receiving  haemodialysis or peritoneal dialysis. renagel should be used within the context of a multiple therapeutic approach, which could include calcium supplements, 1,25 - dihydroxy vitamin d3 or one of its analogues to control the development of renal bone disease.

Unjoni Ewropea - Kroat - EMA (European Medicines Agency)

genzyme europe bv - sevelamer hidroklorid - hyperphosphatemia; renal dialysis - svi ostali terapeutski proizvodi - tasermititet je indiciran za kontrolu hiperfosfatemije u odraslih bolesnika koji primaju hemodijalizu ili peritonealnu dijalizu. sevelamer hidroklorida treba koristiti u kontekstu više terapijskih pristupa, koji mogu uključivati kalcij dodataka, 1,25 dihidroksi vitamina d3 ili jedan od svojih analoga kontrolirati razvoj bolesti bubrega kostiju.

Unjoni Ewropea - Kroat - EMA (European Medicines Agency)

abbvie deutschland gmbh co. kg - Омбитасвир, паритапревир, ritonavir - hepatitis c, kronični - antivirusni lijekovi za sustavnu uporabu - viekirax je indiciran u kombinaciji s drugim lijekovima za liječenje kroničnog hepatitisa c (chc) u odraslih. virus hepatitisa c (hcv) genotip određene aktivnosti .

Unjoni Ewropea - Kroat - EMA (European Medicines Agency)

cheplapharm arzneimittel gmbh - orlistat - gojaznost - pripravci protiv pretilosti, isključujući. prehrambeni proizvodi - xenical je indiciran u kombinaciji s blago hypocaloric dijeta za liječenje pretilih bolesnika s indeks tjelesne mase (bmi) veći ili jednak 30 kg/m2 ili bolesnika (bmi > 28 kg/m2) s čimbenicima rizika. liječenje орлистатом treba prestati kroz 12 tjedana, ako su pacijenti u stanju izgubiti najmanje 5% mase tijela, mjereno u početku terapije.

Unjoni Ewropea - Kroat - EMA (European Medicines Agency)

astellas pharma europe b.v. - enzalutamide - prostatske neoplazme - endokrinska terapija - xtandi is indicated for:the treatment of adult men with metastatic hormone-sensitive prostate cancer (mhspc) in combination with androgen deprivation therapy (see section 5. the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (crpc) (see section 5. the treatment of adult men with metastatic crpc who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5. the treatment of adult men with metastatic crpc whose disease has progressed on or after docetaxel therapy.

Unjoni Ewropea - Kroat - EMA (European Medicines Agency)

vifor fresenius medical care renal pharma france - kalcijevu otopinu - hiperkalijemija - lijekovi za liječenje hiperkalemiju i гиперфосфатемии - veltassa je indicirana za liječenje hiperkalemije kod odraslih osoba.