natgillin/translations-raw huggingface dataset:
The safety and efficacy of Remsima in children and adolescents younger than 18 years in the indication juvenile rheumatoid arthritis have not been established.
Sigurnost i djelotvornost lijeka Remsima nisu utvrđeni u djece i adolescenata mlađih od 18 godina koji boluju od juvenilnog reumatoidnog artritisa.
The safety and efficacy of Remsima in children and adolescents younger than 18 years in the indication psoriasis have not been established.
Sigurnost i djelotvornost lijeka Remsima nisu utvrđeni u djece i adolescenata mlađih od 18 godina koji boluju od psorijaze.
The safety and efficacy of Remsima in children and adolescents younger than 18 years in the indications juvenile idiopathic arthritis, psoriatic arthritis and ankylosing spondylitis have not been established.
Sigurnost i djelotvornost lijeka Remsima nisu utvrđeni u djece i adolescenata mlađih od 18 godina koji boluju od juvenilnog idiopatskog artritisa, psorijatičnog artritisa i ankilozantnog spondilitisa.
The safety and efficacy of Renvela have not been established in adult patients with chronic kidney disease not on dialysis with serum phosphorus < 1.78 mmol/l.
Nije ustanovljena sigurnost primjene i djelotvornost lijeka Renvela u odraslih bolesnika s kroničnom bubrežnom bolešću koji nisu na dijalizi, a koji imaju razinu fosfora u serumu < 1,78 mmol/l.
The safety and efficacy of Renvela have not been established in children below the age of 18 years.
Sigurnost i djelotvornost lijeka Renvela nije ustanovljena u djece mlađe od 18 godina.
The safety and efficacy of Renvela have not been established in patients with the following disorders:
Sigurnost i djelotvornost lijeka Renvela nije ustanovljena u bolesnika sa sljedećim poremećajima:
The safety and efficacy of Resolor for use in patients with severe and clinically unstable concomitant disease (e.g. cardiovascular or lung disease, neurological or psychiatric disorders, cancer or AIDS and other endocrine disorders) have not been established in controlled clinical trials.
Sigurnost i djelotvornost Resolora za primjenu u bolesnika s teškom i klinički nestabilnom popratnom bolešću (npr. kardiovaskularna ili plućna bolest, neurološki ili psihijatrijski poremećaji, rak ili SIDA i drugi endokrini poremećaji) nije ustanovljena u kontroliranim kliničkim ispitivanjima.
The safety and efficacy of Respreeza in elderly patients (65 years of age or older) have not been established in specific clinical trials.
Sigurnost i djelotvornost Respreeze u starijih bolesnika (u dobi od 65 godina i stariji) nisu ustanovljene posebnim kliničkim ispitivanjima.
The safety and efficacy of Respreeza was evaluated in a randomized, double-blind, placebo- controlled, multi-center study (RAPID) followed by a 2-year open-label extension study (RAPID extension study).
Sigurnost i djelotvornost Respreeze procijenjena je u randomiziranom, dvostruko slijepom, placebom kontroliranom, multicentričnom ispitivanju (RAPID) nakon kojeg je slijedio 2-godišnji otvoreni nastavak ispitivanja (nastavak RAPID ispitivanja).
The safety and efficacy of retigabine in children below 18 years of age has not yet been established (see section 5.2).
Sigurnost i djelotvornost retigabina u djece mlađe od 18 godina nisu još ustanovljene (vidjeti do 5.2).
The safety and efficacy of RoActemra in children below 2 years of age has not been established.
Sigurnost i djelotvornost lijeka RoActemra kod djece mlađe od 2 godine nisu ustanovljene.
The safety and efficacy of RoActemra in children below 2 years of age has not been established.
Sigurnost i djelotvornost lijeka RoActemra u djece mlađe od 2 godine nisu ustanovljene.
The safety and efficacy of RoActemra subcutaneous formulation in children from birth to less than 18 years have not been established.
Sigurnost i djelotvornost formulacije lijeka RoActemra za supkutanu primjenu u djece od rođenja do manje od 18 godina nisu ustanovljene.
The safety and efficacy of Romiplostim in children aged under 18 years has not yet been established.
Sigurnost i djelotvornost romiplostima u djece mlađe od 18 godina nisu još ustanovljene.
The safety and efficacy of romiplostim was evaluated in two placebo-controlled, double-blind studies in adults with ITP who had completed at least one treatment prior to study entry and are representative of the entire spectrum of such ITP patients.
Sigurnost i djelotvornost romiplostima ispitivana je u dva placebo kontrolirana, dvostruko slijepa ispitivanja na odraslim bolesnicima s ITP-om, kod kojih je provedena barem jedna linija liječenja prije uključenja u ispitivanje, a reprezentativni su za cijeli spektar sličnih bolesnika s ITP-om.
The safety and efficacy of RotaTeq in individuals from birth to 6 weeks of age have not been established.
Sigurnost i djelotvornost cjepiva RotaTeq u pojedinaca u dobi od rođenja do 6 tjedana nije utvrđena.
The safety and efficacy of Ruconest in children (age 0 to 12 years) have not yet been established.
Sigurnost i djelotvornost Ruconesta u djece (u dobi od 0 do 12 godina) nisu još ustanovljene.
The safety and efficacy of rufinamide of children aged 4 years and less have not yet been established.
Sigurnost i djelotvornost rufinamida u djece u dobi do 4 godine nisu još ustanovljene.
The safety and efficacy of safinamide in children and adolescents under 18 years of age have not been established.
Sigurnost i djelotvornost safinamida u djece i adolescenata ispod 18 godina starosti nisu još ustanovljene.
The safety and efficacy of Savene in children below the age of 18 years have not been established and no data are available.
Sigurnost i djelotvornost lijeka Savene u djece mlađe od 18 godina nisu ustanovljeni i nema dostupnih podataka.
The safety and efficacy of saxagliptin as triple oral therapy in combination with metformin and a thiazolidinedione has not been established.
Nisu ustanovljene sigurnost i djelotvornost saksagliptina u trojnoj peroralnoj terapiji u kombinaciji s metforminom i tiazolidindionom.
The safety and efficacy of Selincro in children and adolescents <18 years of age have not been established.
Sigurnost i djelotvornost Selincra u djece i adolescenata u dobi <18 godina nisu još ustanovljene.
The safety and efficacy of Sevelamer carbonate Zentiva have not been established in children below the age of 18 years.
Sigurnost i djelotvornost lijeka Sevelamer carbonate Zentiva nisu ustanovljene u djece mlađe od 18 godina.
The safety and efficacy of Sevelamer carbonate Zentiva have not been established in patients with the following disorders:
Sigurnost i djelotvornost lijeka Sevelamer carbonate Zentiva nisu ustanovljene u bolesnika sa sljedećim poremećajima:
The safety and efficacy of sildenafil when co-administered with other PDE5 inhibitor products, including Viagra, has not been studied in PAH patients and such concomitant use is not recommended (see section 4.5).
U bolesnika s PAH-om nije se ispitivala sigurnost i djelotvornost sildenafila primijenjenog istodobno s drugim PDE5 inhibitorima, uključujući i lijek Viagra, te se istovremena primjena ne preporučuje (vidjeti dio 4.5).
The safety and efficacy of sildenafil when co-administered with other PDE5 inhibitor products, including Viagra, has not been studied in PAH patients and such concomitant use is not recommended (see section 4.5).
U bolesnika s PAH-om nije se ispitivala sigurnost i djelotvornost sildenafila primjenjenog istodobno s drugim PDE5 inhibitorima, uključujući i lijek Viagra te se istovremena primjena ne preporučuje (vidjeti dio 4.5).
The safety and efficacy of siltuximab have not been established in paediatric patients.
Sigurnost i djelotvornost siltuksimaba nisu bile ustanovljene u pedijatrijskih bolesnika.
The safety and efficacy of SIMBRINZA in children and adolescents aged 2 to 17 years has not been established.
Sigurnost i djelotvornost SIMBRINZE u djece i adolescenata u dobi od 2 do 17 godina nisu ustanovljene.
The safety and efficacy of Simponi were evaluated in a multi-centre, randomised, double-blind, placebo-controlled study (GO-RAISE) in 356 adult patients with active ankylosing spondylitis (defined as a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥ 4 and a VAS for total back pain of ≥ 4, on a scale of 0 to 10 cm).
Djelotvornost lijeka Simponi ispitana je u dva randomizirana, dvostruko slijepa, placebom kontrolirana klinička ispitivanja u odraslih bolesnika.
The safety and efficacy of SIRTURO in children aged < 18 years have not yet been established.
Sigurnost i djelotvornost lijeka SIRTURO u djece u dobi < 18 godina nisu još ustanovljene.
The safety and efficacy of sodium oxybate for the treatment of narcolepsy symptoms was established in four multicentre, randomised, double-blind, placebo-controlled, parallel-group trials in patients with narcolepsy with cataplexy except for one trial where cataplexy was not required for enrolment.
Sigurnost i djelotvornost natrijeva oksibata u liječenju simptoma narkolepsije utvrđena je u četiri multicentrična, randomizirana, dvostruko slijepa, placebom kontrolirana ispitivanja s paralelnim skupinama u bolesnika s narkolepsijom s katapleksijom, osim jednog ispitivanja u kojem katapleksija nije bila uvjet za uključenje.
The safety and efficacy of Soliris have not been studied in patients with hepatic impairment.
Sigurnost i djelotvornost lijeka Soliris nisu ispitane u bolesnika s oštećenjem funkcije jetre.
The safety and efficacy of Soliris in PNH patients with haemolysis were assessed in a randomized, double-blind, placebo-controlled 26 week study (C04-001).
Sigurnost i djelotvornost primjene lijeka Soliris u bolesnika s PNH-om procijenjene su u randomiziranom, dvostruko slijepom, placebom kontroliranom ispitivanju u trajanju od 26 tjedana (C04-001).
The safety and efficacy of Sovaldi in children and adolescents aged <18 years have not yet been established.
Sigurnost i djelotvornost Sovaldija u djece i adolescenata u dobi < 18 godina nisu još ustanovljene.
The safety and efficacy of SPRYCEL in children and adolescents below 18 years of age have not yet been established.
Djelotvornost i sigurnost primjene SPRYCELA u djece i adolescenata mlađih od 18 godina nisu još ustanovljene.
The safety and efficacy of STELARA for the treatment of Crohn’s disease in children less than 18 years have not yet been established.
Sigurnost i djelotvornost STELARE u liječenju Crohnove bolesti u djece mlađe od 18 godina nisu još ustanovljene.
The safety and efficacy of STELARA in children with psoriasis less than 12 years of age or in children with psoriatic arthritis less than 18 years of age have not yet been established.
Sigurnost i djelotvornost primjene STELARE u djece s psorijazom mlađe od 12 godina ili u djece s psorijatičnim artritisom mlađe od 18 godina još nisu ustanovljene.
The safety and efficacy of STELARA in treatment of Crohn’s disease in children less than 18 years have not yet been established.
Sigurnost i djelotvornost STELARE u liječenju Crohnove bolesti u djece mlađe od 18 godina nisu još ustanovljene.
The safety and efficacy of Stivarga in children and adolescents in the indication of gastrointestinal stromal tumors (GIST) have not been established.
Sigurnost i djelotvornost Stivarge u djece i adolescenata u indikaciji gastrointestinalnih stromalnih tumora (GIST) nisu ustanovljene.
The safety and efficacy of Stribild have not been established in patients with significant underlying liver disorders.
Sigurnost i djelotvornost primjene Stribilda nije utvrđena u pacijenata s postojećim značajnim poremećajima jetre.
The safety and efficacy of Stribild in children aged 6 to less than 18 years have not yet been established.
Sigurnost i djelotvornost Stribilda u djece u dobi od 6 do manje od 18 godina nisu još ustanovljene.
The safety and efficacy of Strimvelis in children less than six months of age or over 6 years 1 month has not been established (see section 4.4).
Sigurnost i djelotvornost lijeka Strimvelis u djece mlađe od 6 mjeseci i one starije od 6 godina i 1 mjeseca nisu ustanovljene (vidjeti dio 4.4).
The safety and efficacy of SUTENT in patients below 18 years of age have not been established.
Sigurnost i djelotvornost lijeka SUTENT u bolesnika mlađih od 18 godina nisu ustanovljene.
The safety and efficacy of Sycrest was evaluated in 403 paediatric patients with bipolar I disorder who participated in a single, 3-week, placebo-controlled, double-blind trial, of whom 302 patients received Sycrest at fixed doses ranging from 2.5 mg to 10 mg twice daily.
Sigurnost primjene i djelotvornost lijeka Sycrest ocijenjena je u 403 pedijatrijska bolesnika s bipolarnim poremećajem tipa I koji su sudjelovali u jednom trotjednom, placebom kontroliranom, dvostruko slijepom ispitivanju i od kojih je njih 302 primalo Sycrest u fiksnoj dozi u rasponu od 2,5 mg do 10 mg dvaput na dan.
The safety and efficacy of Taltz in children and adolescents aged 6 to 18 years have not yet been established.
Sigurnost i djelotvornost lijeka Taltz u djece i adolescenata u dobi od 6 do 18 godina nisu još ustanovljene.
The safety and efficacy of Tasigna in children from birth to less than 18 years have not yet been established (see section 5.1).
Sigurnost i djelotvornost Tasigne u djece od rođenja do dobi mlađe od 18 godina nisu još ustanovljene (vidjeti dio 5.1).
The safety and efficacy of Taxespira in nasopharyngeal carcinoma in children aged 1 month to less than 18 years have not yet been established.
Sigurnost primjene i djelotvornost lijeka Taxespira u nazofaringealnom karcinomu u djece starosti od 1 mjeseca do 18 godina nije još ustanovljena.
The safety and efficacy of Tecfidera in children and adolescents aged 10 to 18 years have not been established.
Sigurnost i djelotvornost Tecfidere u djece i adolescenata u dobi od 10 do 18 godina nisu ustanovljene.
The safety and efficacy of tedizolid phosphate in patients with neutropenia (neutrophil counts
Sigurnost i djelotvornost tedizolidfosfata u bolesnika s neutropenijom (broj neutrofila
The safety and efficacy of tedizolid phosphate when administered for periods longer than 6 days have not been established in patients (see section 4.4).
Sigurnost i djelotvornost tedizolidfosfata kada se primjenjuje duže od 6 dana nisu ustanovljene u bolesnika (vidjeti dio 4.4).
The safety and efficacy of Telmisartan Teva in children and adolescents aged below 18 have not been established.
Sigurnost i djelotvornost Telmisartana Teva nije utvrđena u djece i adolescenata mlađih od 18 godina.
The safety and efficacy of Telmisartan Teva in children and adolescents aged below 18 years have not been established.
Sigurnost i djelotvornost Telmisartana Teva nije utvrđena u djece i adolescenata mlađih od 18 godina.
The safety and efficacy of Telmisartan Teva Pharma in children and adolescents aged below 18 have not been established.
Sigurnost i djelotvornost Telmisartana Teva Pharma u djece i adolescenata u dobi ispod 18 godina nisu ustanovljene.
The safety and efficacy of telmisartan/amlodipine in children aged below 18 years have not been established.
Sigurnost i djelotvornost kombinacije telmisartan/amlodipin u primjeni kod djece ispod 18 godina starosti nisu utvrđene.
The safety and efficacy of tenofovir disoproxil fumarate in children with chronic hepatitis B aged 2 to < 12 years or weighing < 35 kg have not been established.
Sigurnost i djelotvornost tenofovirdizoproksilfumarata u djece s kroničnim hepatitisom B u dobi od 2 do < 12 godina ili tjelesne težine < 35 kg nisu ustanovljene.
The safety and efficacy of tenofovir disoproxil fumarate in children with chronic hepatitis B aged 2 to < 12 years or weighing < 35 kg have not been established.
Sigurnost i djelotvornost tenofovirdizoproksilfumatara u djece s kroničnim hepatitisom B u dobi od 2 do < 12 godina ili tjelesne težine < 35 kg nisu ustanovljene.
The safety and efficacy of tenofovir disoproxil fumarate in children with chronic hepatitis B aged 2 to < 12 years or weighing < 35 kg have not been established.
Sigurnost i djelotvornost tenofovirdizoproksilfumatara u djece s kroničnim hepatitisom B u dobi od 2 do< 12 godina ili tjelesne težine ≥ 35 kg nisu ustanovljene.
The safety and efficacy of tenofovir disoproxil fumarate in HIV-1 infected children under 2 years of age have not been established.
Sigurnost i djelotvornost tenofovirdizoproksilfumarata u djece s infekcijom virusom HIV-1 mlađe od 2 godine nisu ustanovljene.
The safety and efficacy of tenofovir disoproxil fumarate in HIV-1 infected children under 2 years of age have not been established.
Sigurnost i djelotvornost tenofovirdizoproksilfumarata u djece zaražene virusom HIV-1 u dobi do 2 godine nisu ustanovljene.
The safety and efficacy of tenofovir disoproxil fumarate in HIV-1 infected children under 2 years of age have not been established.
Sigurnost i djelotvornost tenofovirdizoproksilfumatara u djece s infekcijom virusom HIV-1 mlađe od 2 godine nisu ustanovljene.
The safety and efficacy of Teysuno in children and adolescents under 18 years old have not been established.
Sigurnost i djelotvornost lijeka Teysuno u djece i adolescenata u dobi do 18 godina nisu još ustanovljene.
The safety and efficacy of the 5 mg saxagliptin/10 mg dapagliflozin fixed-dose combination was evaluated in three phase 3, randomised, double-blind, active/placebo-controlled clinical trials in 1169 adult subjects with type 2 diabetes mellitus.
Sigurnost i djelotvornost fiksne kombinacije 5 mg saksagliptina/10 mg dapagliflozina ocjenjivala se u tri randomizirana, dvostruko slijepa, aktivnim lijekom/placebom kontrolirana klinička ispitivanja faze 3, u kojima je sudjelovalo 1169 odraslih ispitanika sa šećernom bolešću tipa 2.
The safety and efficacy of the combination of Cotellic and vemurafenib have not been evaluated in patients with a BRAF V600 mutation-positive melanoma which has metastasised to the brain.
Sigurnost i djelotvornost kombinacije lijeka Cotellic i vemurafeniba nisu se ocjenjivale u bolesnika s melanomom pozitivnim na mutaciju BRAF V600 koji je metastazirao u mozak.
The safety and efficacy of the combination of dabrafenib and trametinib has not been evaluated in patients with a BRAF V600 mutation-positive melanoma which has metastasised to the brain.
Sigurnost i djelotvornost kombinacije dabrafeniba i trametiniba nisu bile ocjenjivane u bolesnika s melanomom s pozitivnom BRAF V600 mutacijom koji je metastazirao u mozak.
The safety and efficacy of the combination of trametinib and dabrafenib have not been evaluated in patients with a BRAF V600 mutation-positive melanoma which has metastasised to the brain.
Sigurnost i djelotvornost kombinacije trametiniba i dabrafeniba nisu bile ocjenjivane u bolesnika s melanomom s pozitivnom BRAF V600 mutacijom koji je metastazirao u mozak.
The safety and efficacy of the dose interval adjustment guidelines provided in section 4.2 are based on single dose pharmacokinetic data and modelling and have not been clinically evaluated.
Sigurnost i djelotvornost smjernica za prilagoĎavanje intervala doziranja navedenih u dijelu 4.2, temelje se na farmakokinetičkim podacima i modelima koji nisu klinički analizirani.
The safety and efficacy of the dose interval adjustment have not been evaluated in controlled clinical trials and the recommendation is based on pharmacokinetic studies and modelling results (see sections 4.4 and 5.2).
Sigurnost i djelotvornost prilagođavanja intervala doziranja nisu procijenjeni u kontroliranim kliničkim ispitivanjima, a preporuka se temelji na farmakokinetičkim ispitivanjima i rezultatima farmakokinetičkih modela (vidjeti dijelove 4.4 i 5.2).
The safety and efficacy of the dose interval adjustments to every 72 or 96 hours in patients with creatinine clearance < 30 ml/min have not been clinically evaluated.
Sigurnost i djelotvornost prilagodbi intervala doziranja na svaka 72 ili 96 sati u pacijenata s klirensom kreatinina < 30 ml/min nisu klinički analizirane.
The safety and efficacy of the recommended dose of trametinib (2 mg once daily) in combination with dabrafenib (150 mg twice daily) for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation was studied in two Phase III studies and one supportive Phase I/II study.
Sigurnost i djelotvornost preporučene doze trametiniba (2 mg jedanput na dan) u kombinaciji s dabrafenibom (150 mg dvaput na dan) za liječenje odraslih bolesnika s neoperabilnim ili metastatskim melanomom s BRAF V600 mutacijom proučavale su se u dva ispitivanja faze III i jednom potpornom ispitivanju faze I/II.
The safety and efficacy of the reduced doses provided in section 4.2 are based on single dose pharmacokinetic data and modelling and have not been clinically evaluated.
Sigurnost i djelotvornost smanjenih doza, navedenih u dijelu 4.2, temelje se na farmakokinetičkim podacima i modelima koji nisu klinički analizirani.
The safety and efficacy of the vaccine has not been established in breeding males.
Neškodljivost i djelotvornost cjepiva nije utvrđena u rasplodnih mužjaka.
The safety and efficacy of the veterinary medicinal product has not been established during lay.
Sigurnost i djelotvornost veterinarsko medicinskog proizvoda nisu utvrđene tijekom nesenja.
The safety and efficacy of this combination have been established only using ribavirin together with peginterferon alfa-2b or interferon alfa-2b solution for injection.
Sigurnost i djelotvornost kombinirane terapije utvrđena je samo za primjenu ribavirina zajedno s peginterferon alfa-2b ili interferon alfa-2b otopinom za injekcije.
The safety and efficacy of this medicinal product has not been established in patients with moderate or severe hepatic impairment.
Sigurnost i djelotvornost ovog lijeka nisu ustanovljene u bolesnika s umjerenim ili teškim oštećenjem funkcije jetre.
The safety and efficacy of this medicinal product in children and adolescents aged 0 to < 18 years have not yet been established.
Sigurnost i djelotvornost ovog lijeka kod djece i adolescenata u dobi od 0 do < 18 godina još nisu ustanovljene.
The safety and efficacy of this medicinal product in children and adolescents from birth to < 18 years of age have not been established.
Sigurnost i djelotvornost ovog lijeka Komboglyze u djece i adolescenata od rođenja do < 18 godina starosti nisu ustanovljene.
The safety and efficacy of this product have not been established in patients below the age of 18 years.
Sigurnost primjene i djelotvornost ovog lijeka nisu ustanovljene u bolesnika mlađih od 18 godina.
The safety and efficacy of this product have not been established in predialysis patients.
Sigurnost primjene i djelotvornost ovog lijeka nisu ustanovljene u bolesnika koji još nisu bili na dijalizi.
The safety and efficacy of Thymanax in children from 2 years onwards for treatment of major depressive episodes have not yet been established.
Sigurnost i djelotvornost lijeka Thymanax za liječenje velikih depresivnih epizoda u djece od 2 godine i više još nije utvrđeno.
The safety and efficacy of ticagrelor in children below the age of 18 years have not been established.
Nisu ustanovljene sigurnost primjene i djelotvornost tikagrelora kod djece mlađe od 18 godina.
The safety and efficacy of Tivicay in children aged less than 12 years or weighing less than 40 kg has not yet been established.
Sigurnost i djelotvornost lijeka Tivicay u djece mlađe od 12 godina ili tjelesne težine manje od 40 kg nisu još ustanovljene.
The safety and efficacy of TMZ in children under the age of 3 years have not been established.
Sigurnost i djelotvornost TMZ–a u djece mlađe od 3 godine nisu ustanovljene.
The safety and efficacy of TMZ in children under the age of 3 years have not been established.
Sigurnost i djelotvornost TMZ–a u djece mlađe od tri godine nisu ustanovljene.
The safety and efficacy of TMZ in children under the age of 3 years have not beenestablished.
Sigurnost i djelotvornost TMZ–a u djece mlađe od 3 godine nisu ustanovljene.
The safety and efficacy of Tolucombi in children and adolescents aged below 18 have not been established.
Nisu utvrđeni sigurnost i djelotvornost lijeka Tolucombi kod djece i adolescenata do 18 godina starosti.
The safety and efficacy of tolvaptan in children and adolescents under the age of 18 years have not yet been established.
Sigurnost i djelotvornost tolvaptana u djece i adolescenata mlađih od 18 godina još nije ustanovljena.