natgillin/translations-raw huggingface dataset:
The safety and efficacy of Torisel in the treatment of advanced renal cell carcinoma were studied in the following two randomised clinical trials:
Djelotvornost i sigurnost Torisela u liječenju uznapredovalog karcinoma bubrežnih stanica bile su ispitane u sljedeća dva randomizirana klinička ispitivanja:
The safety and efficacy of Toujeo have not been established.
Sigurnost primjene i djelotvornost lijeka Toujeo nisu ustanovljene.
The safety and efficacy of Toujeo in children and adolescents below 18 years of age have not been established.
Sigurnost i djelotvornost lijeka Toujeo u djece i adolescenata mlađih od 18 godina nisu ustanovljene.
The safety and efficacy of trametinib has not been established in children and adolescents (<18 years).
Sigurnost i djelotvornost trametiniba u djece i adolescenata (< 18 godina) nisu ustanovljene.
The safety and efficacy of trametinib have not been evaluated in patients whose melanoma tested negative for the BRAF V600 mutation.
Sigurnost i djelotvornost trametiniba nisu ispitivane u bolesnika u kojih je nalaz testa pokazao da je melanom negativan na mutaciju BRAF V600.
The safety and efficacy of Translarna in children aged 6 months to 5 years have not yet been established.
Sigurnost i djelotvornost lijeka Translarna u djece u dobi od 6 mjeseci do 5 godina nisu još ustanovljene.
The safety and efficacy of Translarna were assessed in a randomized, double-blind, placebo- controlled, multicentre nonsense mutation Duchenne muscular dystrophy (nmDMD) study of 174 male patients ages 5 to 20 years.
Sigurnost i djelotvornost lijeka Translarna procijenjeni su u randomiziranom, dvostruko slijepom, placebom kontroliranom, multicentričnom ispitivanju Duchenneove mišićne distrofije s besmislenom mutacijom provedenom u 174 muških bolesnika u dobi od 5 do 20 godina.
The safety and efficacy of travoprost in children and adolescents below the age of 18 years has not been established.
Sigurnost i djelotvornost travoprosta u djece i adolescenata ispod 18 godina nije ustanovljena.
The safety and efficacy of TRISENOX in children aged up to 17 years has not been established.
Sigurnost i djelotvornost TRISENOXA u djece u dobi do 17 godina nije ustanovljena.
The safety and efficacy of Triumeq has not been established in patients with significant underlying liver disorders.
Sigurnost i djelotvornost lijeka Triumeq u bolesnika sa značajnim podležećim poremećajima jetre nisu ustanovljeni.
The safety and efficacy of Truvada for PrEP in patients with HBV or HCV infection has not been established.
Sigurnost i djelotvornost primjene Truvade za predekspozicijsku profilaksu u pacijenata s infekcijom HBV-om ili HCV-om nije ustanovljena.
The safety and efficacy of Truvada have not been established in patients with significant underlying liver disorders.
Sigurnost i djelotvornost primjene Truvade nisu ustanovljene u pacijenata sa značajnim podležećim poremećajima jetre.
The safety and efficacy of Truvada in children under the age of 18 years have not been established.
Sigurnost i djelotvornost primjene Truvade u djece mlađe od 18 godina nisu ustanovljene.
The safety and efficacy of Unituxin in children aged less than 12 months have not yet been established.
Sigurnost i djelotvornost Unituxina u djece mlađe od 12 mjeseci nije još ustanovljena.
The safety and efficacy of Valdoxan in children from 2 years onwards for treatment of major depressive episodes have not yet been established.
Sigurnost i djelotvornost lijeka Valdoxan za liječenje velikih depresivnih epizoda u djece od 2 godine i više još nije utvrđeno.
The safety and efficacy of VANTAVO in children less than 18 years of age have not been established.
Sigurnost i djelotvornost VANTAVO tableta u djece mlađe od 18 godina nisu ustanovljene.
The safety and efficacy of Vectibix have not been studied in patients with renal or hepatic impairment.
Sigurnost i djelotvornost lijeka Vectibix nije ispitivana kod bolesnika s bubrežnim ili jetrenim oštećenjem.
The safety and efficacy of VELCADE (injected intravenously) were evaluated in 2 studies at the recommended dose of 1.3 mg/m2: a Phase III randomised, comparative study (APEX), versus dexamethasone (Dex), of 669 patients with relapsed or refractory multiple myeloma who had received 1-3 prior lines of therapy, and a Phase II single-arm study of 202 patients with relapsed and refractory multiple myeloma, who had received at least 2 prior lines of treatment and who were progressing on their most recent treatment.
Sigurnost i djelotvornost primjene VELCADEa (primjenjenog intravenskom injekcijom) u preporučenoj dozi od 1,3 mg/m2 procjenjivale su se u 2 ispitivanja: randomiziranom, komparativnom ispitivanju faze III (APEX), u usporedbi s deksametazonom (Dex) u 669 bolesnika s relapsom ili refraktornim multiplim mijelomom koji su prethodno bili primili 1-3 linije terapije te ispitivanju faze II u jednoj skupini od 202 bolesnika s relapsom i refraktornim multiplim mijelomom, koji su prethodno primili najmanje 2 linije terapije i u kojih je bolest napredovala za vrijeme posljednje terapije.
The safety and efficacy of VELCADE in children below 18 years of age have not been established (see sections 5.1 and 5.2).
Sigurnost i djelotvornost VELCADEa u djece do 18 godina starosti nisu ustanovljene (vidjeti dijelove 5.1 i 5.2).
The safety and efficacy of Velphoro in children below the age of 18 years has not yet been established.
Sigurnost i djelotvornost lijeka Velphoro u djece mlađe od 18 godina još nije utvrđena.
The safety and efficacy of vemurafenib has not been yet established in children and adolescents (<18 years).
Sigurnost i djelotvornost vemurafeniba u djece i adolescenata (< 18 godina) nisu još ustanovljene.
The safety and efficacy of Ventavis in children aged under 18 years have not been established.
Sigurnost i djelotvornost lijeka Ventavis u djece ispod 18 godina nisu ustanovljeni.
The safety and efficacy of Ventavis in children aged under 18 years have not been established.
Sigurnost i djelotvornost lijeka Ventavis u djece mlađe od 18 godina nisu ustanovljeni.
The safety and efficacy of Ventavis in children aged up to 18 years have not been established.
Sigurnost i djelotvornost lijeka Ventavis u djece u dobi do 18 godina nisu još ustanovljene.
The safety and efficacy of Victoza in children and adolescents below age 18 have not been established (see section 5.1).
Sigurnost i djelotvornost lijeka Victoza u djece i adolescenata mlađih od 18 godina nisu još ustanovljene (vidjeti dio 5.1).
The safety and efficacy of Victrelis alone or in combination with peginterferon alfa and ribavirin for the treatment of chronic hepatitis C genotype 1 infection in patients co-infected with hepatitis B Virus (HBV) and HCV have not been studied.
Nisu ispitivane sigurnost primjene i djelotvornost lijeka Victrelis primijenjenog samostalno ili u kombinaciji s peginterferonom alfa i ribavirinom u liječenju kroničnog hepatitisa C genotipa 1 u bolesnika koji su istodobno zaraženi virusom hepatitisa B (HBV) i HCV-om.
The safety and efficacy of Victrelis alone or in combination with peginterferon alfa and ribavirin for the treatment of chronic hepatitis C genotypes other than genotype 1 have not been established.
Nisu ustanovljene sigurnost primjene i djelotvornost lijeka Victrelis primijenjenog samostalno ili u kombinaciji s peginterferonom alfa i ribavirinom u liječenju kroničnog hepatitisa C drugog genotipa osim genotipa 1.
The safety and efficacy of Victrelis in children aged below 18 years have not yet been established.
Još nisu ustanovljene sigurnost primjene i djelotvornost lijeka Victrelis u djece mlađe od 18 godina.
The safety and efficacy of Viekirax have not been established in patients with HCV/HBV co-infection.
Sigurnost i djelotvornost lijeka Viekirax u bolesnika s istodobnom infekcijom HCV-om i HBV-om nisu ustanovljene.
The safety and efficacy of Vimizim in patients older than 65 years has not been established, and no alternative dosage regimen can be recommended in these patients.
Sigurnost i djelotvornost lijeka Vimizim kod bolesnika starijih od 65 godina nisu ustanovljene i za njih ne postoje preporučeni alternativni režimi doziranja.
The safety and efficacy of Vipdomet in children and adolescents < 18 years old have not been established.
Sigurnost i djelotvornost lijeka Vipdomet u djece i adolescenata < 18 godina starosti nisu utvrđene.
The safety and efficacy of Viramune has not been established in patients with significant underlying liver disorders.
Sigurnost i djelotvornost lijeka nisu utvrđene u bolesnika s već značajnim podležećim poremećajima jetre.
The safety and efficacy of Viramune has not been established in patients with significant underlying liver disorders.
Sigurnost i djelotvornost Viramunea nisu utvrđene u bolesnika s već značajnim podležećim poremećajima jetre.
The safety and efficacy of Viramune prolonged-release tablets in children aged less than 3 years has not been established.
Sigurnost i djelotvornost Viramune tableta s produljenim oslobađanjem kod djece u dobi manje od 3 godine nisu utvrđene.
The safety and efficacy of Viramune prolonged-release tablets in children aged less than 3 years has not been established.
Sigurnost i djelotvornost Viramune tableta s produljenim oslobađanjem u djece u dobi manje od 3 godine nisu utvrđene.
The safety and efficacy of Visudyne in the paediatric population have not been established.
Sigurnost i djelotvornost Visudynea u djece nije još ustanovljena.
The safety and efficacy of Voncento in children < 12 years with haemophilia A have not been established.
Sigurnost i djelotvornost lijeka Voncento u djece u dobi < 12 godina s hemofilijom A još nije ustanovljena.
The safety and efficacy of Voncento in children < 12 years with haemophilia A have not been established.
Sigurnost i djelotvornost lijekaVoncento u djece u dobi < 12 godina s hemofilijom A nije utvrđena.
The safety and efficacy of Voncento in children < 12 years with haemophilia A have not been established.
Sigurnost lijeka Voncento u djece u dobi < 12 godina s hemofilijom A još nije ustanovljena.
The safety and efficacy of Voncento in previously untreated patients have not yet been established.
Sigurnost i djelotvornost lijeka Voncento u bolesnika koji nisu prethodno bili liječeni nije utvrđena.
The safety and efficacy of Voncento in previously untreated patients have not yet been established.
Sigurnost i djelotvornost lijekaVoncento u bolesnika koji nisu prethodno bili liječeni nije utvrđena.
The safety and efficacy of Voncento in previously untreated patients have not yet been established.
Sigurnost i djelotvornost Voncenta u bolesnika koji nisu prethodno bili liječeni nije utvrđena.
The safety and efficacy of Voncento in previously untreated patients have not yet been established.
Sigurnost i djelotvornost Voncento u bolesnika koji nisu prethodno bili liječeni nije utvrđena.
The safety and efficacy of Voncento in previously untreated patients have not yet been established.
Sigurnost i djelotvornost Voncento u prethodno neliječnih bolesnika još nije utvrđena.
The safety and efficacy of voriconazole use for longer than 180 days has not been adequately studied in clinical trials.
Sigurnost i učinkovitost primjene vorikonazola duže od 180 dana nisu prikladno ispitane u kliničkim ispitivanjima.
The safety and efficacy of Xarelto in children aged 0 to 18 years have not been established.
Sigurnost i djelotvornost lijeka Xarelto u djece od 0 do 18 godina nisu ustanovljene.
The safety and efficacy of XGEVA have not been established in paediatric patients (age < 18) other than skeletally mature adolescents with giant cell tumour of bone.
Liječenje koštano sazrelih adolescenata s gigantocelularnim tumorom kosti koji je neresektabilan ili gdje kirurška resekcija može rezultirati teškim morbiditetom: doziranje je isto kao u odraslih.
The safety and efficacy of Xofigo in children and adolescents below 18 years of age have not been studied.
Sigurnost i djelotvornost lijeka Xofigo u djece i adolescenata mlađih od 18 godina nisu ispitane.
The safety and efficacy of Xydalba in children aged from birth to < 18 years have not yet been established.
Sigurnost i djelotvornost lijeka Xydalba u djece u dobi od rođenja do < 18 godina još nije ustanovljena.
The safety and efficacy of YERVOY have not been studied in patients with renal impairment.
Sigurnost i djelotvornost primjene lijeka YERVOY nije se ispitivala u bolesnika s oštećenjem funkcije bubrega.
The safety and efficacy of YERVOY in children and adolescents below 18 years of age have not been established.
Sigurnost i djelotvornost primjene lijeka YERVOY u djece i adolescenata mlađih od 18 godina nisuustanovljene .
The safety and efficacy of Zeffix in infants, children and adolescents aged below 18 years have not been established.
Sigurnost i djelotvornost lijeka Zeffix u novorođenčadi, djece i adolescenata mlađih od 18 godina još nisu ustanovljene.
The safety and efficacy of ZEPATIER have not been studied in HCV/HBV co-infected patients.
Sigurnost i djelotvornost lijeka ZEPATIER nisu ispitivane u bolesnika s istodobnom infekcijom HCV-om i HBV-om.
The safety and efficacy of Zinforo in children aged birth to < 2 months have not been established.
Sigurnost i djelotvornost lijeka Zinforo u djece od rođenja do < 2 mjeseca nisu ustanovljene.
The safety and efficacy of Zinforo in children below the age of 2 months have not yet been established.
Sigurnost i djelotvornost lijeka Zinforo u djece mlađe od 2 mjeseca nisu još ustanovljene.
The safety and efficacy of zoledronic acid in children and adolescents below 18 years of age have not been established.
Nije utvrđena sigurnost i djelotvornost zoledronatne kiseline u djece i adolescenata ispod 18 godina.
The safety and efficacy of ZYPADHERA in children and adolescents below 18 years has not been established.
Sigurnost i djelotvornost lijeka ZYPADHERA u djece i adolescenata mlađih od 18 godina nisu ustanovljene.
The safety and efficacy profiles of the 50 mg once-weekly and 25 mg twice-weekly regimens were similar.
Profili sigurnosti primjene i djelotvornosti 50 mg jednom tjedno i 25 mg dva puta tjedno režima bili su slični.
The safety and efficacy profiles of the two Enbrel treatment regimens were comparable at week 8 in their effect on signs and symptoms of RA; data at week 16 did not show comparability (non-inferiority) between the two regimens.
Profili djelotvornosti i sigurnosti za dva režima liječenja Enbrelom bili su usporedivi nakon 8. tjedna u smislu njihovog učinka na znakove i simptome RA Podaci u 16. tjednu nisu bili usporedivi (ne-inferiornost) za dva režima.
The safety and efficacy profiles of the two etanercept treatment regimens were comparable at week 8 in their effect on signs and symptoms of RA; data at week 16 did not show comparability (non-inferiority) between the two regimens.
Profili djelotvornosti i sigurnosti za dva režima liječenja etanerceptom bili su usporedivi nakon 8. tjedna u smislu njihovog učinka na znakove i simptome RA; podaci u 16. tjednu nisu bili usporedivi (ne- inferiornost) za dva režima.
The safety and immunogenicity observed for tocilizumab administered subcutaneous was consistent with the known safety profile of intravenous tocilizumab and no new or unexpected adverse drug reactions were observed (see Table 1).
Sigurnost i imunogenost primijećene kod supkutano primijenjenog tocilizumaba bile su u skladu s poznatim sigurnosnim profilom tocilizumaba za intravensku primjenu te nisu primijećene nikakve nove niti neočekivane nuspojave na lijek (vidjeti Tablicu 1).
The safety and immunogenicity of Nimenrix was evaluated when sequentially administered or co- administered with a DTaP-HBV-IPV/Hib vaccine in the second year of life.
Sigurnost i imunogenost cjepiva Nimenrix je procjenjivana kad je primijenjen nakon ili istovremeno s cjepivom DTaP-HBV-IPV/Hib u drugoj godini života.
The safety and immunogenicity of Nimenrix was evaluated when sequentially administered or co-administered with a DTaP-HBV-IPV/Hib vaccine in the second year of life.
Sigurnost i imunogenost cjepiva Nimenrix je procjenjivana kad je primijenjen nakon ili istovremeno s cjepivom DTaP-HBV-IPV/Hib u drugoj godini života.
The safety and pharmacokinetics of eluxadoline in patients with renal impairment have not yet been established.
Sigurnost i farmakokinetika eluksadolina u bolesnika s oštećenjem funkcije bubrega nisu još ustanovljene.
The safety and pharmacokinetics of pazopanib in patients with moderate to severe heart failure or those with a below normal LVEF has not been studied.
Sigurnost i farmakokinetika pazopaniba u bolesnika s umjerenim do teškim zatajenjem srca ili u onih s ejekcijskom frakcijom lijeve klijetke (LVEF) ispod normale nisu ispitivani.
The safety and the efficacy of JEVTANA in children and adolescents below 18 years of age have not been established.
Sigurnost i djelotvornost lijeka JEVTANA u djece i adolescenata mlađih od 18 godina nisu još ustanovljene.
The safety and the efficacy of the vaccine have not been established during lactation.
Neškodljivost i djelotvornost cjepiva nisu utvrđeni tijekom laktacije.
The safety and the efficacy of the vaccine have not been established in breeding males.
Neškodljivost i djelotvornost cjepiva nisu utvrđeni kod rasplodnih mužjaka.
The safety and the efficacy of the vaccine have not been established in breeding males.
Neškodljivost i djelotvornost cjepiva nisu utvrđeni u rasplodnih mužjaka.
The safety and the efficacy of the vaccine have not been established in lactating animals.
Neškodljivost i djelotvornost cjepiva nisu utvrđeni u životinja u laktaciji.
The safety and timing of vaccination should be discussed with the infant’s physician (see section 4.6).
O sigurnosti i vremenu cijepljenja treba razgovarati s djetetovim liječnikom (vidjeti dio 4.6).
The safety and tolerability of naltrexone / bupropion should be assessed at regular intervals.
Sigurnost i podnošljivost naltrekson/bupropiona treba procijeniti u redovnim intervalima.
The safety and tolerability of Onduarp has been evaluated in five controlled clinical studies with over 3500 patients, over 2500 of whom received telmisartan in combination with amlodipine.
Sigurnost i podnošljivost Onduarpa su ocjenjivane u pet kontroliranih kliničkih studija na više od 3 500 bolesnika, od kojih je preko 2500 primalo telmisartan u kombinaciji s amlodipinom.
The safety assessment in children and adolescents is based on the week 48 analysis of the single-arm, Phase II PIANO trial in which 101 antiretroviral treatment-experienced HIV-1 infected paediatric patients, 6 years to less than 18 years of age and weighing at least 16 kg, received INTELENCE in combination with other antiretroviral agents (see section 5.1).
Procjena sigurnosti u djece i adolescenata temeljena je na nalazima analize u 48. tjednu ispitivanja PIANO faze II s jednom skupinom, u kojem je 101 pedijatrijski bolesnik zaražen HIVom-1, u dobi od 6 do manje od 18 godina i težine najmanje 16 kg, koji je prethodno liječen antiretrovirusnim lijekovima, primio INTELENCE u kombinaciji s drugim antiretrovirusnim lijekovima (vidjeti dio 5.1).
The safety assessment in children is based on the safety data from 2 trials in which 227 paediatric patients aged from 2 months to 17 years with cSSTI or CAP received Zinforo.
Ocjena sigurnosti primjene u djece temelji se na podacima o sigurnosti primjene iz 2 ispitivanja u kojima je lijek Zinforo primijenjen u 227 pedijatrijskih bolesnika u dobi od navršena 2 mjeseca do 17 godina, koji su imali komplicirane infekcije kože i mekog tkiva ili izvanbolnički stečenu pneumoniju.
The safety assessment is based on all data from 1,203 patients in the Phase III placebo-controlled trials DUET-1 and DUET-2 in antiretroviral treatment-experienced HIV-1 infected adult patients, 599 of whom received INTELENCE (200 mg b.i.d.) (see section 5.1).
Sigurnosni profil temelji se na ukupnim podacima dobivenim iz DUET-1 i DUET-2 placebo kontroliranih kliničkih ispitivanja Faze III koja su u tijeku kod 1203 odrasla bolesnika s HIV-1 infekcijom te su prethodno liječeni antiretrovirusnim lijekovima, od kojih je 599 dobivalo INTELENCE (200 mg b.i.d.) (vidjeti dio 5.1).
The safety assessment is based on the week 48 analysis of the single-arm, open-label, Phase 2 trial, TMC278-C213, in which 36 antiretroviral treatment-naïve HIV-1 infected adolescent patients weighing at least 32 kg received rilpivirine (25 mg once daily) in combination with other antiretroviral agents (see section 5.1).
Sigurnost je procijenjena na temelju analize u 48. tjednu otvorenog ispitivanja faze 2 s jednom skupinom ispitanika, TMC278-C213, u kojem je 36 adolescentnih bolesnika zaraženih virusom HIV-1 koji prethodno nisu bili liječeni anitretrovirusnim lijekovima, tjelesne težine od najmanje 32 kg, primilo rilpivirin (25 mg jedanput dnevno) u kombinaciji s drugim antiretrovirusnim lijekovima (vidjeti dio 5.1).
The safety assessment of rilpivirine is based on Week 48 data from one single-arm open-label study (TMC278-C213) in 36 paediatric patients 12 to < 18 years and weighing at least 32 kg.
Sigurnosno ocjenjivanje rilpivirina utemeljeno je na podacima 48. tjedna iz otvorenog ispitivanja s jednom skupinom (TMC278-C213) u 36 pedijatrijskih bolesnika u dobi od 12 do < 18 godina s tjelesnom težinom od najmanje 32 kg.
The safety assessment was based on a total of 855 patients (with MF or PV) receiving Jakavi in phase 2 and 3 studies.
Procjena sigurnosti temeljila se na ukupno 855 bolesnika (s MF-om ili PV-om) koji su primali Jakavi u ispitivanjima faze 2 i 3.
The safety checklist about Esbriet should contain the following key elements related to liver function and photosensitivity:
Kontrolni popis za provjeru sigurnosti primjene lijeka Esbriet mora sadržavati sljedeće ključne elemente koji se odnose na funkciju jetre i fotoosjetljivost:
The safety concerns in children.
Razlozi za zabrinutost u pogledu sigurnosti primjene u djece.
The safety concerns in children.
Razlozi za zabrinutost u pogledu sigurnosti u djece.
The safety data described below include all adverse reactions from the eight phase III studies in the indications wet AMD, CRVO, BRVO, DME and myopic CNV with a reasonable possibility of causality to the injection procedure or medicinal product.
Niže opisani podaci o sigurnosti primjene uključuju sve nuspojave iz osam ispitivanja faze III u indikacijama vlažnog AMD-a, CRVO, BRVO, DME-a i miopijskog CNV-a s razumnom mogućnošću da su uzročno-posljedično povezane s postupkom davanja injekcije ili lijekom.
The safety data described below reflect exposure in adults to ustekinumab in 12 phase 2 and phase 3 studies in 5,884 patients (4,135 with psoriasis and/or psoriatic arthritis and 1,749 with Crohn’s disease).
Niže opisani podaci o sigurnosti primjene odražavaju izloženost odraslih bolesnika ustekinumabu u 12 ispitivanja faze II i III u 5884 bolesnika (4135 s psorijazom i/ili psorijatičnim artritisom i 1749 s Crohnovom bolesti).
The safety data for the administration of daptomycin via 2-minute intravenous injection are derived from two pharmacokinetic studies in healthy volunteers.
Sigurnosni podaci o primjeni daptomicina putem 2-minutne intravenske injekcije su dobiveni iz dva farmakokinetička ispitivanja u zdravih dobrovoljaca.
The safety data from patients treated with lumacaftor/ivacaftor for an additional 24 weeks in the long-term safety and efficacy rollover study (Trial 3) were similar to the 24-week, placebo-controlled studies (see section 5.1).
Sigurnosni podaci dobiveni od bolesnika liječenih lumakaftorom/ivakaftorom dodatna 24 tjedna u dugotrajnom prijelaznom (engl. rollover) ispitivanju sigurnosti i djelotvornosti (ispitivanje 3) bili su slični onima dobivenim u placebom kontroliranim ispitivanjima u trajanju od 24 tjedna (vidjeti dio 5.1).
The safety data include all patient visits up to the time of the last patient’s completion of study week 144.
Podaci o sigurnosti uključuju sve posjete bolesnika do završetka 144 tjedna ispitivanja.
The safety data include all patient visits up to the time of the last patient’s completion of study week 144.
Podaci o sigurnosti uključuju sve posjete bolesnika do završetka 144 tjedna.