natgillin/translations-raw huggingface dataset:
The safety and efficacy of tenofovir disoproxil fumarate in HIV-1 infected children under 2 years of age have not been established.
Varnost in učinkovitost dizoproksiltenofovirijevega fumarata pri otrocih, okuženih s HIV-1, starih do 2 leti, še nista bili dokazani.
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.
Varnost in učinkovitost kombinacije zdravila Cotellic in vemurafeniba pri bolnikih z melanomom z mutacijo BRAF V600, ki je zaseval v možgane, ni bila ocenjena.
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.
Varnosti in učinkovitosti kombinacije dabrafeniba in trametiniba niso ocenili pri bolnikih z melanomom z mutacijo BRAF V600, ki je metastaziral v možgane.
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.
Varnosti in učinkovitosti kombinacije trametiniba in dabrafeniba niso ocenili pri bolnikih z melanomom z mutacijo BRAF V600, ki je metastaziral v možgane.
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).
Varnost in učinkovitost prilagajanja intervalov odmerjanja nista bili ovrednoteni v kontroliranih kliničnih študijah, priporočila temeljijo na farmakokinetskih študijah in rezultatih analiz modelov (glejte poglavji 4.4 in 5.2).
The safety and efficacy of the dose interval adjustment have not been evaluated in controlled clinical trials and the recommendation is mainly based on pharmacokinetic modelling data.
Varnost in učinkovitost prilagajanja intervalov odmerjanja nista bili ovrednoteni v kontroliranih kliničnih študijah, priporočila temeljijo predvsem na podatkih farmakokinetskih modelov.
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.
Varnost in učinkovitost teh prilagoditev intervala odmerjanja na vsakih 72 ali 96 ur pri bolnikih z očistkom kreatinina < 30 ml/min še nista bili klinično ovrednoteni.
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.
Varnost in učinkovitost priporočenega odmerka trametiniba (2 mg enkrat na dan) v kombinaciji z dabrafenibom (150 mg dvakrat na dan) za zdravljenje odraslih bolnikov z inoperabilnim ali metastatskim melanomom z mutacijo BRAF V600 so proučevali v dveh študijah faze III in eni potrditveni študiji faze I/II.
The safety and efficacy of this medicinal product has not been established in patients with moderate or severe hepatic impairment.
Varnost in učinkovitost tega zdravila nista ugotovljeni pri bolnikih z zmerno ali hudo okvaro jeter.
The safety and efficacy of this product have not been established in patients below the age of 18 years.
Varnost in učinkovitost tega zdravila nista bili ugotovljeni pri bolnikih, ki so mlajši od 18 let.
The safety and efficacy of this product have not been established in patients below the age of 18 years.
Varnost in učinkovitost tega zdravila pri otrocih, mlajših od 18 let, nista bili ugotovljeni.
The safety and efficacy of this product have not been established in predialysis patients.
Varnosti in učinkovitosti tega zdravila pri bolnikih z ledvično okvaro, ki niso na dializi niso ugotavljali.
The safety and efficacy of this product have not been established in predialysis patients.
Varnosti in učinkovitosti tega zdravila pri bolnikih z ledvično okvaro, ki niso na dializi, niso ugotavljali.
The safety and efficacy of Thymanax in children from 2 years onwards for treatment of major depressive episodes have not yet been established.
Varnost in učinkovitost zdravila Thymanax pri otrocih, starejših od 2 let, pri zdravljenju velikih depresivnih epizod še nista bili dokazani.
The safety and efficacy of Tivicay in children aged less than 12 years or weighing less than 40 kg has not yet been established.
Varnost in učinkovitost zdravila Tivicay pri otrocih, mlajših od 12 let ali s telesno maso pod 40 kg, še nista bili dokazani.
The safety and efficacy of TMZ in children under the age of 3 years have not been established.
Varnost in učinkovitost TMZ pri otrocih, mlajših od 3 let nista bili dokazani.
The safety and efficacy of TMZ in children under the age of 3 years have not been established.
Varnost in učinkovitost TMZ pri otrocih, mlajših od 3 let, nista bila dokazana.
The safety and efficacy of TOBI Podhaler in children aged under 6 years have not been established.
Varnost in učinkovitost zdravila TOBI Podhaler pri otrocih, starih do 6 let, nista bili dokazani.
The safety and efficacy of Torisel in the treatment of advanced renal cell carcinoma were studied in the following two randomised clinical trials:
Varnost in učinkovitost zdravila Torisel v zdravljenju napredovalega karcinoma ledvičnih celic (RCC) so proučevali v naslednjih dveh randomiziranih kliničnih preskušanjih:
The safety and efficacy of Toujeo have not been established.
Varnost in učinkovitost zdravila Toujeo nista raziskani.
The safety and efficacy of Toujeo in children and adolescents below 18 years of age have not been established.
Varnost in učinkovitost zdravila Toujeo pri otrocih in mladostnikih, mlajših od 18 let, nista bili ugotovljeni.
The safety and efficacy of trametinib has not been established in children and adolescents (<18 years).
Varnost in učinkovitost trametiniba pri otrocih in mladostnikih (< 18 let) nista ugotovljeni.
The safety and efficacy of trametinib have not been evaluated in patients whose melanoma tested negative for the BRAF V600 mutation.
Varnost in učinkovitost trametiniba nista ocenjeni pri bolnikih, ki so imeli negativen izvid testiranja melanoma za mutacijo BRAF V600.
The safety and efficacy of Translarna in children aged 6 months to 5 years have not yet been established.
Varnost in učinkovitost zdravila Translarna pri otrocih, starih od 6 mesecev do 5 let, še nista bili dokazani.
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.
Varnost in učinkovitost zdravila Translarna so ocenjevali v randomizirani dvojno slepi s placebom kontrolirani multicentrični študiji o Duchennovi mišični distrofiji zaradi nesmiselne mutacije (nmDMD), v kateri je sodelovalo 174 moških bolnikov, starih od 5 do 20 let.
The safety and efficacy of travoprost in children and adolescents below the age of 18 years has not been established.
Varnosti in učinkovitosti travoprosta pri otrocih in mladostnikih, mlajših od 18 let, še nista bili dokazani.
The safety and efficacy of TRISENOX in children aged up to 17 years has not been established.
Varnost in učinkovitost zdravila TRISENOX pri otrocih, mlajših od 17 let, nista bili dokazani.
The safety and efficacy of Trudexa were assessed in over 1400 patients with moderately to severely active Crohn’s disease (Crohn’s Disease Activity Index (CDAI)  220 and  450) in randomised, double-blind, placebo-controlled studies.
Varnost in učinkovitost Trudexe so ocenili pri več kot 1400 bolnikih z zmerno do hudo, aktivno Crohnovo boleznijo (indeks aktivnosti Crohnove bolezni [CDAI]  220 in  450) v randomiziranih, dvojno slepih, s placebom kontroliranih študijah.
The safety and efficacy of Truvada for PrEP in patients with HBV or HCV infection has not been established.
Varnost in učinkovitost zdravila Truvada za zaščito pred izpostavitvijo pri bolnikih z okužbo z virusom HBV ali HCV nista bili ugotovljeni.
The safety and efficacy of Truvada in children under the age of 18 years have not been established.
Varnost in učinkovitost zdravila Truvada pri otrocih starih pod 18 let nista bili dokazani.
The safety and efficacy of Tyverb in children below the age of 18 years have not yet been established.
Varnost in učinkovitost zdravila Tyverb pri otrocih, mlajših od 18 let, še nista ugotovljeni.
The safety and efficacy of ustekinumab was assessed in 927 patients in two randomised, double-blind, placebo-controlled studies in patients with active PsA (≥ 5 swollen joints and ≥ 5 tender joints) despite non-steroidal anti-inflammatory (NSAID) or disease modifying antirheumatic (DMARD) therapy.
Varnost in učinkovitost ustekinumaba so ocenjevali pri 927 bolnikih z aktivnim PsA (≥ 5 oteklih sklepov in ≥ 5 občutljivih sklepov) v dveh randomiziranih, dvojno slepih, s placebom nadzorovanih preskušanjih, ki so prejemali tudi nesteroidna protivnetna (NSAID) ali protirevmatična (DMARD) zdravila.
The safety and efficacy of ustekinumab was assessed in three randomized, double-blind, placebo- controlled, multicenter studies in adult patients with moderately to severely active Crohn’s disease (Crohn’s Disease Activity Index [CDAI] score of ≥ 220 and ≤ 450).
Varnost in učinkovitost ustekinumaba so ocenili pri 1.996 bolnikih v dveh randomiziranih, dvojno slepih in s placebom nadzorovanih študijah pri bolnikih z zmerno do hudo psoriazo s plaki, ki so bili kandidati za fototerapijo ali sistemsko terapijo.
The safety and efficacy of Valdoxan in children from 2 years onwards for treatment of major depressive episodes have not yet been established.
Varnost in učinkovitost zdravila Valdoxan pri otrocih, starejših od 2 let, pri zdravljenju velikih depresivnih epizod še nista bili dokazani.
The safety and efficacy of vedolizumab in children aged 0 to 17 years old have not been established.
Varnost in učinkovitost vedolizumaba pri otrocih, starih od 0 do 17 let, nista bili dokazani.
The safety and efficacy of Velphoro in children below the age of 18 years has not yet been established.
Varnost in učinkovitost zdravila Velphoro pri otrocih, starih manj kot 18 let, še nista bili dokazani.
The safety and efficacy of vemurafenib has not been yet established in children and adolescents (<18 years).
Varnost in učinkovitost vemurafeniba pri otrocih in mladostnikih, mlajših od 18 let, še nista bili dokazani.
The safety and efficacy of Ventavis in children aged under 18 years have not been established.
Varnost in učinkovitost zdravila Ventavis pri otrocih, mlajših od 18 let, nista bili dokazani.
The safety and efficacy of Victoza in children and adolescents below age 18 have not been established (see section 5.1).
Varnost in učinkovitost zdravila Victoza pri otrocih in mladostnikih, mlajših od 18 let, nista bili dokazani (glejte poglavje 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.
Varnost in učinkovitost zdravila Victrelis samega ali v kombinaciji s peginterferonom alfa in ribavirinom za zdravljenje kroničnega hepatitisa C genotipa 1 pri bolnikih, ki imajo sočasno okužbo z virusom hepatitisa B (HBV) in HCV, nista bili raziskani.
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.
Varnost in učinkovitost zdravila Victrelis samega ali v kombinaciji s peginterferonom alfa in ribavirinom za zdravljenje kroničnega hepatitisa C drugih genotipov kot genotipa 1 nista bili ugotovljeni.
The safety and efficacy of Vipdomet in children and adolescents < 18 years old have not been established.
Varnost in učinkovitost zdravila Vipdomet pri otrocih in mladostnikih, mlajših od 18 let, nista bili dokazani.
The safety and efficacy of Viramune has not been established in patients with significant underlying liver disorders.
Varnost in učinkovitost zdravila Viramune še nista raziskani pri bolnikih s hujšimi jetrnimi motnjami.
The safety and efficacy of Voncento in children < 12 years with haemophilia A have not been established.
Varnost in učinkovitost zdravila Voncento pri otrocih < 12 let s hemofilijo A še nista bili dokazani.
The safety and efficacy of Voncento in previously untreated patients have not yet been established.
Varnost in učinkovitost zdravila Voncento pri predhodno nezdravljenih bolnikih še nista bili dokazani.
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.
Odmerjanje za zdravljenje skeletno dozorelih mladostnikov z gigantocelularnim kostnim tumorjem, ki ni operabilen, ali pri katerem bi kirurška odstranitev verjetno povzročila hudo obolevnost, je enako kot za odrasle.
The safety and efficacy of XGEVA was studied in two Phase II open-label, single arm trials (studies 4 and 5) that enrolled 529 patients with giant cell tumour of bone that was either unresectable or for which surgery would be associated with severe morbidity.
Varnost in učinkovitost zdravila XGEVA so raziskali v dveh odprtih preskušanjih II. faze z eno samo skupino (študiji 4 in 5), ki sta zajeli 529 bolnikov z gigantocelularnim kostnim tumorjem, ki je bil inoperabilen, ali je bil takšen, da bi kirurški poseg spremljala huda obolevnost.
The safety and efficacy of Xofigo in children and adolescents below 18 years of age have not been studied.
Varnosti in učinkovitosti zdravila Xofigo pri otrocih in mladostnikih, mlajših od 18 let, niso preučevali.
The safety and efficacy of Xydalba in children aged from birth to < 18 years have not yet been established.
Varnost in učinkovitost zdravila Xydalba pri otrocih od rojstva do <18 let še nista ugotovljeni.
The safety and efficacy of YERVOY in children and adolescents below 18 years of age have not been established.
Varnost in učinkovitost zdravila YERVOY pri otrocih in mladostnikih, mlajših od 18 let, nista bili dokazani.
The safety and efficacy of ZEPATIER have not been studied in HCV/HBV co-infected patients.
Varnost in učinkovitost zdravila ZEPATIER nista raziskani pri bolnikih, sočasno okuženih s HCV/HBV.
The safety and efficacy of Zinforo in children aged birth to < 2 months have not been established.
Varnost in učinkovitost zdravila Zinforo pri otrocih od rojstva do < 2 mesecev nista ugotovljeni.
The safety and efficacy of Zinforo in children below the age of 2 months have not yet been established.
Varnost in učinkovitost zdravila Zinforo pri otrocih, mlajših od 2 mesecev, še nista ugotovljeni.
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).
Varnost in imunogenost, opažena pri subkutano danem tocilizumabu, je bila skladna z znanim varnostnim profilom intravensko danega tocilizumaba, novih ali nepričakovanih neželenih učinkov niso opazili (glejte preglednico 1).
The safety and immunogenicity of IXIARO were evaluated in a randomized, controlled, open-label clinical trial conducted in the Philippines, where JEV is endemic.
Varnost in imunogenost cepiva IXIARO so ocenili v randomiziranem, nadzorovanem, odprtem kliničnem preskušanju na Filipinih, kjer je virus japonskega encefalitisa endemičen.
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.
Varnost in imunogenost cepiva Nimenrix so ocenili med zaporedno ali sočasno uporabo cepiva DTaP- HBV-IPV/Hib v drugem letu življenja.
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.
Varnost in imunogenost cepiva Nimenrix so ocenili med zaporedno ali sočasno uporabo cepiva DTaP- HBV-IPV/Hib v drugem letu življenja.
The safety and pharmacokinetics of eluxadoline in patients with renal impairment have not yet been established.
Varnost in farmakokinetika eluksadolina pri bolnikih z okvaro ledvic še nista dokazani.
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.
Varnost in farmakokinetika pazopaniba pri bolnikih z zmernim do hudim srčnim popuščanjem in bolnikih z LVEF, nižjim od normalnega, nista raziskani.
The safety and the efficacy of ADENURIC in children aged below the age of 18 years have not been established.
Varnost in učinkovitost zdravila ADENURIC pri otrocih, starih do 18 let, še nista bili dokazani.
The safety and the efficacy of JEVTANA in children and adolescents below 18 years of age have not been established.
Varnost in učinkovitost zdravila JEVTANA pri otrocih in mladostnikih do 18 let nista ugotovljeni.
The safety and the efficacy of the vaccine has not been established in breeding males.
Varnost in učinkovitost cepiva nista bili ugotovljeni pri plemenjakih.
The safety and the efficacy of the vaccine have not been established during lactation.
Varnosti in učinkovitosti cepiva v obdobju laktacije niso ugotavljali.
The safety and the efficacy of the vaccine have not been established in breeding males.
Varnosti in učinkovitosti cepiva pri plemenskih samcih niso ugotavljali.
The safety and the efficacy of the vaccine have not been established in lactating animals.
Varnosti in učinkovitosti cepiva v obdobju laktacije niso ugotavljali.
The safety and timing of vaccination should be discussed with the infant’s physician (see section 4.6).
O varnosti in časovni shemi cepljenja se je treba pogovoriti z dojenčkovim zdravnikom (glejte poglavje 4.6).
The safety and tolerability of naltrexone / bupropion should be assessed at regular intervals.
Varnost in prenašanje naltreksona/bupropiona je treba ocenjevati v rednih časovnih presledkih.
The safety and tolerability of Twynsta has been evaluated in five controlled clinical studies with over 3,500 patients, over 2,500 of whom received telmisartan in combination with amlodipine.
Varnost in prenašanje zdravila Twynsta so ocenili v petih nadzorovanih kliničnih študijah pri več kot 3500 bolnikih, od katerih jih je več kot 2500 jemalo telmisartan v kombinaciji z 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).
Ocena varnosti pri otrocih in mladostnikih temelji na analizi podatkov po 48 tednih preskušanja PIANO (preskušanje II. faze z eno skupino bolnikov) v katerem je 101 s HIV-1 okužen pediatrični bolnik, ki se je že zdravil s protiretrovirusnimi zdravili, stari 6 let do manj kot 18 let in s telesno maso najmanj 16 kg, prejemal zdravilo INTELENCE v kombinaciji z drugimi protiretrovirusnimi zdravili (glejte poglavje 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.
Ocena varnosti pri otrocih temelji na podatkih o varnosti iz 2 preskušanj, v katerih je zdravilo Zinforo prejemalo 227 pediatričnih bolnikov, starih od 2. meseca do 17 let, ki so imeli zapletene okužbe kože in mehkih tkiv oziroma zunajbolnišnično pljučnico.
The safety assessment in paediatric patients is based on the 48-week analysis of safety data from three Phase II trials.
Ocena varnosti pri pediatričnih bolnikih temelji na analizi podatkov o varnosti zdravila po 48 tednih iz treh preskušanj faze II.
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).
Ocena varnosti temelji na 48 tedenski analizi v odprti študiji faze 2 z eno preiskovano skupino, TMC278-C213, v kateri je 36 s HIV-1 okuženih mladostnikov, ki še niso prejemali protiretrovirusnih zdravil in s telesno maso najmanj 32 kg, prejemalo rilpivirin (25 mg enkrat na dan) v kombinaciji z drugimi protiretrovirusnimi zdravili (glejte poglavje 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.
Ocena varnosti rilpivirina temelji na podatkih iz 48. tedna ene odprte študije (TMC278-C213) z enim krakom pri 36 pediatričnih bolnikih, starih od 12 do < 18 let, s telesno maso vsaj 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.
Ocena varnosti zdravila temelji na podatkih skupno 855 bolnikov (z mielofibrozo ali pravo policitemijo), ki so prejemali zdravilo Jakavi v študijah faze 2 in 3.
The Safety Checklist should highlight the following:
V varnostnem kontrolnem seznamu mora biti izpostavljeno naslednje:
The safety data described below summarise all procedure and adverse reactions in the 295 patients in the 0.3 mg treatment group.
V nadaljevanju opisani podatki o varnosti povzemajo vse neželene učinke, potencialno povezane s postopkom injiciranja in z zdravilom, pri 295 bolnikih v skupini, ki je dobivala odmerek 0,3 mg.
The safety data for the administration of daptomycin via 2-minute intravenous injection are derived from two pharmacokinetic studies in healthy volunteers.
Podatki o varnosti vnašanja daptomicina z 2-minutno intravensko injekcijo izhajajo iz dveh farmakokinetičnih študij z zdravimi prostovoljci.
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).
Varnostni podatki pri bolnikih, zdravljenih z lumakaftorjem/ivakaftorjem dodatnih 24 tednov v dolgoročni obnovitveni študiji varnosti in učinkovitosti (preskušanje 3), so bili podobni kot v 24-tedenskih, s placebom kontroliranih študijah (glejte poglavje 5.1).
The safety data include all patient visits up to the time of the last patient’s completion of study week 144.
Podatki o varnosti zajemajo vse kontrolne obiske do trenutka, ko je zadnji bolnik končal 144 teden študije.
The safety data of elotuzumab have been assessed from a total of 554 patients with multiple myeloma treated with elotuzumab in combination with lenalidomide and dexamethasone (451 patients) or bortezomib and dexamethasone (103 patients) pooled across 6 clinical trials.
Varnost elotuzumaba so ovrednotili na osnovi združenih podatkov iz 6 kliničnih preskušanj pri skupno 554 bolnikih z multiplim mielomom, ki so se zdravili z elotuzumabom v kombinaciji z lenalidomidom in deksametazonom (451 bolnikov) ali bortezomibom in deksametazonom (103 bolniki).
The safety data of TAGRISSO reflects exposure from 411 previously treated T790M mutation- positive NSCLC patients who received a dose of 80 mg daily.
Podatki o varnosti zdravila TAGRISSO temeljijo na izpostavljenosti 411 predhodno zdravljenih bolnikov, ki so imeli NSCLC, pozitiven za mutacijo T790M in so prejemali odmerek 80 mg na dan.
The safety data provided in the following are based on the two Phase III, randomised, double-blind, placebo- controlled studies in 1,061 patients comparing treatment with nintedanib 150 mg twice daily to placebo for 52 weeks (INPULSIS-1 and INPULSIS-2).
Podatki o varnosti v nadaljevanju temeljijo na dveh randomiziranih, dvojno slepih, s placebom nadzorovanih študijah faze III, s 1.061 bolniki, v katerih so primerjali 52-tedensko zdravljenje z nintedanibom 150 mg dvakrat na dan s placebom (INPULSIS-1 in INPULSIS-2).