natgillin/translations-raw huggingface dataset:
The safety and efficacy of docetaxel in combination with prednisone or prednisolone in patients with hormone refractory metastatic prostate cancer were evaluated in a randomized multicenter Phase III study.
Sigurnost i djelotvornost docetaksela u kombinaciji s prednizonom ili prednizolonom ocjenjivali su se u bolesnika s metastatskim karcinomom prostate refraktornim na hormonsko liječenje u randomiziranoj multicentričnoj studiji faze III.
The safety and efficacy of docetaxel in combination with prednisone or prednisolone in patients with hormone refractory metastatic prostate cancer were evaluated in a randomized multicenter phase III study.
Sigurnost primjene i djelotvornost docetaksela u kombinaciji s prednizonom ili prednizolonom ocjenjivali su se u bolesnika s metastatskim karcinomom prostate refraktornim na hormonsko liječenje u fazi III randomizirane multicentrične studije .
The safety and efficacy of docetaxel in combination with prednisone or prednisolone in patients with hormone refractory metastatic prostate cancer were evaluated in a randomized multicenter phase III study.
Sigurnost primjene i djelotvornost docetaksela u kombinaciji s prednizonom ili prednizolonom ocjenjivali su se u bolesnika s metastatskim karcinomom prostate refraktornim na hormonsko liječenje u fazi III randomizirane multicentrične studije.
The safety and efficacy of docetaxel in combination with prednisone or prednisolone in patients with hormone refractory metastatic prostate cancer were evaluated in a randomized multicenter phase III study.
Sigurnost primjene i djelotvornost docetaksela u kombinaciji s prednizonom ili prednizolonom ocjenjivali su se u bolesnika s metastatskim karcinomom prostate refraktornim na hormonsko liječenje u randomiziranoj multicentričnoj studiji faze III.
The safety and efficacy of docetaxel in nasopharyngeal carcinoma in children aged 1 month to less than 18 years have not yet been established.
Sigurnost primjene i djelotvornost lijeka docetaksel u nazofaringealnom karcinomu u djece starosti od 1 mjeseca do 18 godina nije još ustanovljena.
The safety and efficacy of docetaxel in the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN) was evaluated in a randomized, multicenter open-label, phase III study (TAX324).
Sigurnost i djelotvornost docetaksela u indukcijskom liječenju bolesnika s lokalno uznapredovalim karcinomom skvamoznih stanica glave i vrata (SCCHN) bili su evaluirani u randomiziranom, multicentričnom, otvorenom ispitivanju faze III (TAX324).
The safety and efficacy of docetaxel in the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN) was evaluated in a randomized, multicenter open-label, phase III study (TAX324).
Sigurnost primjene i djelotvornost docetaksela u indukcijskom liječenju bolesnika s lokalno uznapredovalim karcinomom skvamoznih stanica glave i vrata (SCCHN) bili su evaluirani u randomiziranom, multicentričnom, otvorenom ispitivanju faze III (TAX324).
The safety and efficacy of docetaxel in the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN) was evaluated in a randomized, multicenter open-label, phase III, study (TAX324).
Sigurnost i djelotvornost docetaksela u indukcijskom liječenju bolesnika s lokalno uznapredovalim karcinomom skvamoznih stanica glave i vrata (SCCHN) bili su evaluirani u randomiziranom, multicentričnom, otvorenom ispitivanju faze III (TAX324).
The safety and efficacy of docetaxel in the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN) was evaluated in a randomized, multicenter open-label, phase III, study (TAX324).
Sigurnost primjene i djelotvornost docetaksela u indukcijskom liječenju bolesnika s lokalno uznapredovalim karcinomom skvamoznih stanica glave i vrata (SCCHN) bili su evaluirani u fazi III randomiziranog, multicentričnog, otvorenog ispitivanja (TAX324).
The safety and efficacy of docetaxel in the induction treatment of patients with squamous cell carcinoma of the head and neck (SCCHN) was evaluated in a phase III, multicenter, open-label, randomized study (TAX323).
Sigurnost i djelotvornost docetaksela u indukcijskom liječenju bolesnika s karcinomom skvamoznih stanica glave i vrata (SCCHN) procjenjivala se u fazi III multicentrične, randomizirane studije otvorenog tipa (TAX323).
The safety and efficacy of docetaxel in the induction treatment of patients with squamous cell carcinoma of the head and neck (SCCHN) was evaluated in a phase III, multicenter, open-label, randomized study (TAX323).
Sigurnost primjene i djelotvornost docetaksela u indukcijskom liječenju bolesnika s karcinomom skvamoznih stanica glave i vrata (SCCHN) procjenjivala se u fazi III multicentrične, randomizirane studije otvorenog tipa (TAX323).
The safety and efficacy of DOCETAXEL KABI in nasopharyngeal carcinoma in children aged 1 month to less than 18 years have not yet been established.
Sigurnost primjene i djelotvornost DOCETAXEL KABI u nazofaringealnom karcinomu u djece starosti od 1 mjeseca do 18 godina nije još ustanovljena.
The safety and efficacy of Docetaxel Winthrop in nasopharyngeal carcinoma in children aged 1 month to less than 18 years have not yet been established.
Sigurnost primjene i djelotvornost lijeka Docetaxel Winthrop u nazofaringealnom karcinomu u djece starosti od 1 mjeseca do 18 godina nije još ustanovljena.
The safety and efficacy of dulaglutide were evaluated in eight randomised, controlled, phase III trials involving 5,770 patients with type 2 diabetes.
Sigurnost i djelotvornost dulaglutida ocijenjene su u osam randomiziranih, kontroliranih ispitivanja faze III u kojima je sudjelovalo 5770 bolesnika sa šećernom bolešću tipa 2.
The safety and efficacy of DuoResp Spiromax in children, 12 years and younger and adolescents, 13 to 17 years of age has not yet been established.
Sigurnost i djelotvornost lijeka DuoResp Spiromax u djece stare 12 godina i mlađe, te u adolescenata, od 13 do 17 godina još nisu ustanovljene.
The safety and efficacy of DuoTrav in children and adolescents below the age of 18 years have not been established.
Sigurnost i djelotvornost primjene DuoTrav kapi u djece i adolescenata ispod 18 godina nije ustanovljena.
The safety and efficacy of Ebymect in children and adolescents aged 0 to < 18 years have not yet been established.
Sigurnost i djelotvornost lijeka Ebymect u djece i adolescenata od rođenja do < 18 godina još nisu ustanovljene.
The safety and efficacy of ECALTA in children below 18 years have not been established.
Sigurnost i djelotvornost lijeka ECALTA u djece u dobi ispod 18 godina nisu još ustanovljene.
The safety and efficacy of Effentora in children aged 0 to18 years have not been established.
Sigurnost i djelotvornost Effentore u djece u dobi od 0 do 18 godina nisu ustanovljene.
The safety and efficacy of Elaprase has been shown in three clinical studies: two randomised, placebo- controlled clinical studies (TKT008 and TKT024) in adults and children above the age of 5 years and one open-label, safety study (HGT-ELA-038) in children between the age of 16 months and 7.5 years.
Sigurnost i djelotvornost Elaprasea dokazana je u tri klinička ispitivanja: dva randomizirana, placebom kontrolirana klinička ispitivanja (TKT008 i TKT024) u odraslih i djece starije od 5 godina i jednom otvorenom ispitivanju sigurnosti (HGT-ELA-038) u djece u dobi između 16 mjeseci i 7,5 godina.
The safety and efficacy of ELOCTA in previously untreated patients have not yet been established.
Sigurnost i djelotvornost lijeka ELOCTA u bolesnika koji prethodno nisu bili liječeni nisu još ustanovljene.
The safety and efficacy of eltrombopag has not been established in children and adolescents (< 18 years) with chronic HCV related thrombocytopenia or SAA.
Sigurnost i djelotvornost eltrombopaga u djece i adolescenata (< 18 godina) s trombocitopenijom povezanom s kroničnim HCV-om ili teškom aplastičnom anemijom nisu ustanovljene.
The safety and efficacy of eltrombopag in paediatric subjects has been investigated in two studies.
Sigurnost i djelotvornost eltrombopaga u pedijatrijskih ispitanika bile su istraživane u dva ispitivanja.
The safety and efficacy of eltrombopag in paediatric subjects has been investigated two studies.
Sigurnost i djelotvornost eltrombopaga u pedijatrijskih ispitanika bile su istraživane u dva ispitivanja.
The safety and efficacy of EMEND 165 mg in children and adolescents below 18 years of age has not been established.
Sigurnost i djelotvornost primjene lijeka EMEND 165 mg u djece i adolescenata mlađih od 18 godina nije ustanovljena.
The safety and efficacy of empagliflozin in patients with type 1 diabetes have not been established and empagliflozin should not be used for treatment of patients with type 1 diabetes.
Sigurnost i djelotvornost empagliflozina u bolesnika sa šećernom bolešću tipa 1 nisi ustanovljene te se empagliflozin ne smije primjenjivati u liječenju bolesnika sa šećernom bolešću tipa 1.
The safety and efficacy of empagliflozin in patients with type 1 diabetes have not been established and empagliflozin should not be used for treatment of patients with type 1 diabetes.
Sigurnost i djelotvornost empagliflozina u bolesnika sa šećernom bolešću tipa 1 nisu ustanovljene te se empagliflozin ne smije primjenjivati u liječenju bolesnika sa šećernom bolešću tipa 1.
The safety and efficacy of emtricitabine/tenofovir disoproxil have not been established in patients with significant underlying liver disorders.
Sigurnost i djelotvornost primjene kombinacije emtricitabina/tenofovirdizoproksila nisu ustanovljene u bolesnika sa značajnim podležećim poremećajima jetrene funkcije.
The safety and efficacy of emtricitabine/tenofovir disoproxil in children under the age of 18 years have not been established.
Sigurnost i djelotvornost primjene emtricitabina/tenofovirdizoproksila u djece mlađe od 18 godina nisu ustanovljene.
The safety and efficacy of emtricitabine/tenofovir disoproxil in children under the age of 18 years have not yet been established (see section 5.2).
Sigurnost i djelotvornost emtricitabina/tenofovirdizoproksila u djece mlađe od 18 godina još nisu još ustanovljene (vidjeti dio 5.2).
The safety and efficacy of Enbrel in patients with chronic infections have not been evaluated.
Nije procijenjena djelotvornost i sigurnost primjene Enbrela u bolesnika s kroničnom infekcijom.
The safety and efficacy of Enbrel were assessed in a two-part study in 69 children with polyarticular- course juvenile idiopathic arthritis who had a variety of juvenile idiopathic arthritis onset types (polyarthritis, pauciarthritis, systemic onset) .
Sigurnost primjene i djelotvornost Enbrela procjenjivana je u ispitivanju u dva dijela, a sudjelovalo je 69-ero djece s poliartikularnim juvenilnim idiopatskim artritisom koja su imala različite pojavne oblike juvenilnog idiopatskog artritisa (poliartritis, pauciartritis, sisemski nastup bolesti).
The safety and efficacy of Enbrel were assessed in a two-part study in 69 children with polyarticular- course juvenile idiopathic arthritis who had a variety of juvenile idiopathic arthritis onset types (polyarthritis, pauciarthritis, systemic onset) .
Sigurnost primjene i djelotvornost Enbrela procjenjivana je u ispitivanju u dva dijela, a sudjelovalo je 69-ero djece s poliartikularnim juvenilnim idiopatskim artritisom koja su imala različite pojavne oblike juvenilnog idiopatskog artritisa (poliartritis, pauciartritis, sistemski nastup bolesti).
The safety and efficacy of Enbrel were assessed in a two-part study in 69 children with polyarticular- course juvenile idiopathic arthritis who had a variety of juvenile idiopathic arthritis onset types (polyarthritis, pauciarthritis, systemic onset).
Sigurnost primjene i djelotvornost Enbrela procjenjivana je u ispitivanju u dva dijela, a sudjelovalo je 69-ero djece s poliartikularnim juvenilnim idiopatskim artritisom koja su imala različite pojavne oblike juvenilnog idiopatskog artritisa (poliartritis, pauciartritis, sisemski nastup bolesti).
The safety and efficacy of Enbrel were assessed in a two-part study in 69 children with polyarticular- course juvenile idiopathic arthritis who had a variety of juvenile idiopathic arthritis onset types (polyarthritis, pauciarthritis, systemic onset).
Sigurnost primjene i djelotvornost Enbrela procjenjivana je u ispitivanju u dva dijela, a sudjelovalo je 69-ero djece s poliartikularnim juvenilnim idiopatskim artritisom koja su imala različite pojavne oblike juvenilnog idiopatskog artritisa (poliartritis, pauciartritis, sistemski nastup bolesti).
The safety and efficacy of enoxaparin sodium has not been established in children below the age of 12 years.
Sigurnost i djelotvornost enoksaparinnatrija nije utvrđena u djece mlađe od 12 godina.
The safety and efficacy of enoxaparin sodium in children below the age of 12 years has not been established.
Sigurnost i djelotvornost enoksaparinnatrija mlađe od 12 godina nisu još ustanovljene.
The safety and efficacy of enoxaparin sodium in children below the age of 12 years has not been established.
Sigurnost i djelotvornost enoksaparinnatrija u djece mlađe od 12 godina nisu još ustanovljene.
The safety and efficacy of entecavir were also evaluated in an active-controlled clinical trial of 191 HBV- infected patients with decompensated liver disease and in a clinical trial of 68 patients co-infected with HBV and HIV.
Sigurnost i djelotvornost entekavira provjerile su se i u aktivno kontroliranom kliničkom ispitivanju na 191 bolesniku inficiranom HBV-om s dekompenziranom bolešću jetre i u kliničkom ispitivanju sa 68 bolesnika istodobno inficiranih HBV-om i HIV-om.
The safety and efficacy of Envarsus in children below 18 years of age have not yet been established.
Sigurnost i djelotvornost primjene Envarsusa u djece mlađe od 18 godina još nije ustanovljena.
The safety and efficacy of Epclusa has not been assessed in patients with severe renal impairment (estimated glomerular filtration rate [eGFR] < 30 mL/min/1.73 m2) or end stage renal disease (ESRD) requiring haemodialysis (see section 5.2).
Sigurnost i djelotvornost lijeka Epclusa nije procijenjena u bolesnika s teškim oštećenjem bubrega (procijenjena brzina glomerularne filtracije [eGFR] < 30 ml/min/1,73 m2) ili završni stadij bolesti bubrega koji zahtijeva hemodijalizu (vidjeti dio 5.2).
The safety and efficacy of Eperzan in children and adolescents under 18 years have not been established (see section 5.2).
Sigurnost i djelotvornost lijeka Eperzan u djece i adolescenata mlađih od 18 godina nisu ustanovljene (vidjeti dio 5.2).
The safety and efficacy of epoetin alfa in paediatric patients receiving chemotherapy have not been established.
Sigurnost i djelotvornost epoetina alfa u pedijatrijskih bolesnika na kemoterapiji nisu ustanovljene.
The safety and efficacy of Erivedge in children and adolescents aged below 18 years have not been established..
Sigurnost i djelotvornost lijeka Erivedge u djece i adolescenata mlađih od 18 godina nisu ustanovljene.
The safety and efficacy of eslicarbazepine acetate in children and adolescents below 18 years has not yet been established.
Sigurnost i djelotvornost eslikarbazepinacetata u djece i adolescenata starosti do 18 godina nije još ustanovljena.
The safety and efficacy of Eviplera have not been established in patients with significant underlying liver disorders.
Nije utvrđena sigurnost i djelotvornost primjene lijeka Eviplera u pacijenata sa značajnim temeljnim poremećajima jetre.
The safety and efficacy of EXJADE in children from birth to 23 months of age have not been established.
Sigurnost i djelotvornost lijeka EXJADE u djece od rođenja do 23 mjeseca starosti nisu ustanovljene.
The safety and efficacy of Eylea therapy administered to both eyes concurrently have not been systematically studied (see section 5.1).
Sigurnost i djelotvornost primjene lijeka Eylea istodobno u oba oka nije sustavno ispitana (vidjeti dio 5.1).
The safety and efficacy of Eylea were assessed in a randomised, multi-centre, double-masked, active- controlled study in patients with macular oedema secondary to BRVO (VIBRANT) which included Hemi-Retinal Vein Occlusion.
Sigurnost i djelotvornost lijeka Eylea procijenjene su u randomiziranom, multicentričnom, dvostruko slijepom ispitivanju s aktivnom kontrolom u bolesnika s makularnim edemom kao posljedicom BRVO-a (VIBRANT), što je uključivalo hemi-retinalnu vensku okluziju.
The safety and efficacy of Eylea were assessed in a randomised, multi-centre, double-masked, sham- controlled study in treatment-naïve, Asian patients with myopic CNV.
Sigurnost i djelotvornost lijeka Eylea bile su procijenjene u randomiziranom, multicentričnom, dvostruko slijepom ispitivanju kontroliranom placebo postupkom u liječenju bolesnika azijatskog podrijetla s miopijskim CNV-om koji prethodno nisu bili liječeni.
The safety and efficacy of Eylea were assessed in two randomised, multi-centre, double-masked, sham-controlled studies in patients with macular oedema secondary to CRVO (COPERNICUS and GALILEO) with a total of 358 patients treated and evaluable for efficacy (217 with Eylea).
Sigurnost i djelotvornost lijeka Eylea bile su procijenjene u dva randomizirana, multicentrična, dvostruko slijepa, ispitivanja kontrolirana placebo postupkom u bolesnika s makularnim edemom kao posljedicom CRVO (COPERNICUS i GALILEO), s ukupno 358 liječenih bolesnika (217 lijekom Eylea) u kojih se mogla procijeniti djelotvornost.
the safety and efficacy of Eylea when administered to both eyes at the same time has not been studied and if used in this way may lead to an increased risk of experiencing side effects. injections with Eylea may cause an increase in eye pressure (intraocular pressure) in some patients within 60 minutes of the injection.
sigurnost i djelotvornost lijeka Eylea kad se primjenjuje u oba oka istovremeno nisu ispitane te, ako se primjenjuje na ovaj način, može doći do povišenog rizika od nastanka nuspojava. injekcija lijeka Eylea može uzrokovati povišenje očnog tlaka (intraokularni tlak) u nekih bolesnika unutar 60 minuta od primjene injekcije.
The safety and efficacy of Feraccru for the treatment of iron deficiency anaemia was studied in 128 patients (age range 18-76 years; 45 males and 83 females) with inactive to mildly active IBD (58 patients with Ulcerative Colitis [UC] and 70 patients with Crohn’s disease [CD]) and baseline Hb concentrations between 9.5 g/dL and 12 / 13 g/dL for females / males.
Sigurnost i djelotvornost Feraccrua u liječenju anemije zbog manjka željeza ispitani su na 128 bolesnika (u dobi od 18 do 76 godina; 45 osoba muškog spola i 83 osobe ženskog spola) koji boluju od neaktivnog do blago aktivnog IBD-a (58 bolesnika s ulceroznim kolitisom [UC] i 70 bolesnika s Kronovom bolešću [CD]) te početnih vrijednosti Hb koncentracija između 9,5 g/dL i 12 / 13 g/dL u žena / muškaraca.
The safety and efficacy of Fexeric in children and adolescents aged 0 to 18 years have not yet been established.
Sigurnost i djelotvornost Fexerica u djece i adolescenata u dobi od 0 do 18 godina nisu još ustanovljene.
The safety and efficacy of filgrastim administration in de novo AML patients aged < 55 years with good cytogenetics [t (8; 21), t (15; 17), and inv (16)] have not been established.
Sigurnost i djelotvornost primjene filgrastima u bolesnika s de novo AML u dobi < 55 godina s dobrim citogenetskim nalazom [t (8; 21), t (15; 17), i inv (16)] nisu ustanovljene.
The safety and efficacy of filgrastim administration in de novo AML patients aged < 55 years with good cytogenetics [t(8;21), t(15;17), and inv(16)] have not been established.
Sigurnost i djelotvornost primjene filgrastima u bolesnika s de novo AML u dobi od <55 godina s povoljnim citogenetskim nalazom [t(8;21), t(15;17), i inv(16)] nisu ustanovljene.
The safety and efficacy of filgrastim administration in patients with myelodysplastic syndrome or chronic myelogenous leukaemia have not been established.
Sigurnost i djelotvornost primjene filgrastima u bolesnika s mijelodisplastičnim sindromom ili kroničnom mijeloičnom leukemijom nisu ustanovljene.
The safety and efficacy of filgrastim administration in patients with myelodysplastic syndrome, or chronic myelogenous leukaemia have not been established.
Nije utvrđena sigurnost i djelotvornost primjene filgrastima u bolesnika s mijelodisplastičnim sindromom ili kroničnom mijeloičnom leukemijom.
The safety and efficacy of Firazyr in children aged 0-18 years has not been established.
Sigurnost i djelotvornost lijeka Firazyr kod djece u dobi od 0 do 18 godina nisu ustanovljene.
The safety and efficacy of FIRDAPSE in children aged 0 to 17 years has not been established.
Sigurnost i djelotvornost lijeka FIRDAPSE u djece u dobi od 0 do 17 godina nije još ustanovljena.
The safety and efficacy of fluticasone furoate/vilanterol in children under the age of 12 years has not yet been established.
Sigurnost i djelotvornost flutikazonfuroata/vilanterola u djece mlađe od 12 godina još nisu ustanovljene.
The safety and efficacy of FORSTEO in children and adolescents less than 18 years has not been established.
Sigurnost i djelotvornost lijeka FORSTEO u djece i adolescenata mlađih od 18 godina nisu ustanovljene.
The safety and efficacy of FOSAVANCE in children less than 18 years of age have not been established.
Sigurnost i djelotvornost FOSAVANCE tableta u djece mlađe od 18 godina nisu ustanovljene.
The safety and efficacy of Galafold in children aged 0 to 15 years has not yet been established.
Sigurnost i djelotvornost lijeka Galafold u djece u dobi od 0 do 15 godina nisu još ustanovljeni.
The safety and efficacy of Gardasil 9 in women 27 years of age and older have not been studied (see section 5.1).
Sigurnost i djelotvornost cjepiva Gardasil 9 u žena u dobi od 27 godina i starijih nisu ispitane (vidjeti dio 5.1).
The safety and efficacy of Gazyvaro has not been established in patients with severe renal impairment (CrCl < 30 mL/min).
Sigurnost i djelotvornost lijeka Gazyvaro u bolesnika s teškim oštećenjem funkcije bubrega (CrCl < 30 ml/min) nisu ustanovljene.
The safety and efficacy of Genvoya in children younger than 12 years of age, or weighing < 35 kg, have not yet been established.
Sigurnost i djelotvornost lijeka Genvoya u djece mlađe od 12 godina ili težine < 35 kg nisu još ustanovljene.
The safety and efficacy of Gilenya in children aged 0 to 18 years have not yet been established.
Sigurnost i djelotvornost Gilenye u djece u dobi 0 do 18 godine nije još ustanovljena.
The safety and efficacy of Glustin in children and adolescents under 18 years of age have not been established.
Sigurnost i djelotvornost lijeka Glustin u djece i adolescenata mlađih od 18 godina nije ustanovljena.
The safety and efficacy of GRANUPAS in neonates have not been established.
Sigurnost i djelotvornost lijeka GRANUPAS u nedonoščadi nije utvrđena.
The safety and efficacy of Grastofil are similar in adults and children receiving cytotoxic chemotherapy.
Sigurnost i djelotvornost Grastofila u djece koja primaju citotoksičnu kemoterapiju slične su onima u odraslih.
The safety and efficacy of Holoclar in children and adolescents aged 0 to 18 years has not yet been established.
Sigurnost i djelotvornost Holoclara u djece i adolescenata u dobi od 0 do 18 godina nije još ustanovljena.
The safety and efficacy of Humira in children aged 12-17 years have not yet been established for hidradenitis suppurativa.
Sigurnost i djelotvornost lijeka Humira u liječenju gnojnog hidradenitisa u djece u dobi od 12 do 17 godina nisu još ustanovljene.
The safety and efficacy of Humira in children aged 2-17 years have not yet been established.
Sigurnost i djelotvornost lijeka Humira u djece u dobi od 2 do 17 godina još nisu ustanovljene.
The safety and efficacy of Humira in children aged 4-17 years have not yet been established.
Sigurnost i djelotvornost lijeka Humira u djece u dobi od 4 do 17 godina nije ustanovljena.