natgillin/translations-raw huggingface dataset:
The safety and efficacy of Inflectra have not been studied in children with ulcerative colitis below the age of 6 years.
Varnost in učinkovitost zdravila Inflectra pri otrocih z ulceroznim kolitisom, mlajših od 6 let, niso preučevali.
The safety and efficacy of Inflectra in children and adolescents younger than 18 years in the indication juvenile rheumatoid arthritis have not been established.
Varnost in učinkovitost zdravila Inflectra pri otrocih in mladostnikih, mlajših od 18 let, za indikacijo juvenilni revmatoidni artritis nista bili dokazani.
The safety and efficacy of Inflectra in children and adolescents younger than 18 years in the indication psoriasis have not been established.
Varnost in učinkovitost zdravila Inflectra pri otrocih in mladostnikih, mlajših od 18 let, za indikacijo psoriaza nista bili dokazani.
The safety and efficacy of Inflectra in children and adolescents younger than 18 years in the indications juvenile idiopathic arthritis, psoriatic arthritis and ankylosing spondylitis have not been established.
Varnost in učinkovitost zdravila Inflectra pri otrocih in mladostnikih, mlajših od 18 let, za indikacije juvenilni idiopatski artritis, psoriatični artritis in ankilozirajoči spondilitis nista bili dokazani.
The safety and efficacy of infliximab have not been studied in children with Crohn’s disease below the age of 6 years.
Varnost in učinkovitost infliksimaba pri otrocih s Crohnovo boleznijo, mlajših od 6 let, nista bili dokazani.
The safety and efficacy of infliximab in children and adolescents younger than 18 years in the indication juvenile rheumatoid arthritis have not been established.
Varnost in učinkovitost infliksimaba pri otrocih in mladostnikih, mlajših od 18 let, za indikacijo juvenilni revmatoidni artritis nista bili dokazani.
The safety and efficacy of infliximab in children and adolescents younger than 18 years in the indication psoriasis have not been established.
Varnost in učinkovitost infliksimaba pri otrocih in mladostnikih, mlajših od 18 let, za indikacijo psoriaza nista bili dokazani.
The safety and efficacy of infliximab in children and adolescents younger than 18 years in the indications juvenile idiopathic arthritis, psoriatic arthritis and ankylosing spondylitis have not been established.
Varnost in učinkovitost infliksimaba pri otrocih in mladostnikih, mlajših od 18 let, za indikacije juvenilni idiopatski artritis, psoriatični artritis in ankilozirajoči spondilitis nista bili dokazani.
The safety and efficacy of infliximab were assessed in a multicenter, randomised, open-label, parallel-group clinical study (C0168T72) in 60 paediatric patients aged 6 through 17 years (median age 14.5 years) with moderately to severely active ulcerative colitis (Mayo score of 6 to 12; endoscopic subscore ≥ 2) with an inadequate response to conventional therapies.
Varnost in učinkovitost infliksimaba so ocenili v multicentrični, randomizirani, odprti klinični študiji vzporednih skupin (C0168T72) pri 60 pediatričnih bolnikih, starih od 6 do 17 let (mediana starost 14,5 let) z zmerno do močno aktivnim ulceroznim kolitisom (ocena Mayo od 6 do 12; delna endoskopska ocena ≥ 2), ki so se nezadostno odzvali na običajno zdravljenje.
The safety and efficacy of infliximab were assessed in a multicentre, randomised, open-label, parallel-group clinical study (C0168T72) in 60 paediatric patients aged 6 through 17 years (median age 14.5 years) with moderately to severely active ulcerative colitis (Mayo score of 6 to 12; endoscopic subscore ≥ 2) with an inadequate response to conventional therapies.
Varnost in učinkovitost infliksimaba so ocenili v multicentrični, randomizirani, odprti klinični študiji vzporednih skupin (C0168T72) pri 60 pediatričnih bolnikih, starih od 6 do 17 let (mediana starost 14,5 let) z zmerno do močno aktivnim ulceroznim kolitisom (ocena Mayo od 6 do 12; delna endoskopska ocena ≥ 2), ki so se nezadostno odzvali na običajno zdravljenje.
The safety and efficacy of INTELENCE in children less than 6 years of age or weighing less than 16 kg have not yet been established (see section 5.2).
Varnost in učinkovitost zdravila INTELENCE pri otrocih, starih manj kot 6 let ali s telesno maso manjšo od 16 kg, še nista ugotovljeni (glejte poglavje 5.2).
The safety and efficacy of intravenous temsirolimus for the treatment of relapsed and/or refractory mantle cell lymphoma were studied in the following Phase 3 clinical study.
Varnost in učinkovitost intravenskega temsirolimusa za zdravljenje recidivnega in/ali proti zdravljenju odpornega limfoma plaščnih celic so proučevali v naslednji klinični študiji 3. faze.
The safety and efficacy of IONSYS in children and adolescents younger than 18 years of age has not been established.
Varnost in učinkovitost zdravila IONSYS pri otrocih in mladostnikih, starih manj kot 18 let, nista dokazani.
The safety and efficacy of isavuconazole for the treatment of patients with invasive aspergillosis was evaluated in a double-blind, active-controlled clinical study in 516 patients with invasive fungal disease caused by Aspergillus species or other filamentous fungi.
Varnost in učinkovitost izavukonazola za zdravljenje bolnikov z invazivno aspergilozo so ocenili v dvojno slepi, z zdravilo učinkovino nadzorovani klinični študiji pri 516 bolnikih z invazivno glivično boleznijo zaradi gliv rodu Aspergillus ali drugih nitastih gliv.
The safety and efficacy of IVEMEND in children and adolescents below 18 years of age has not yet been established.
Varnost in učinkovitost zdravila IVEMEND pri otrocih in mladostnikih, starih manj kot 18 let, nista bili dokazani.
The safety and efficacy of Jakavi in children aged up to 18 years have not been established.
Varnost in učinkovitost zdravila Jakavi pri otrocih, starih do 18 let, nista bili dokazani.
The safety and efficacy of Jinarc in CKD stage 5 have not been adequately explored and therefore tolvaptan treatment should be discontinued if renal insufficiency progresses to CKD stage 5.
Varnosti in učinkovitosti zdravila Jinarc pri 5. stopnji kronične ledvične bolezni nista bili ustrezno raziskani, zato je treba zdravljenje s tolvaptanom prekiniti, če ledvična insuficienca napreduje do stopnje kronične ledvične bolezni.
The safety and efficacy of Kaletra in children aged less than 2 years have not been established.
Varnost in učinkovitost uporabe zdravila Kaletra pri otrocih, mlajših od 2 let še ni bila ugotovljena.
The safety and efficacy of Kalydeco in children aged less than 2 years with a gating (class III) mutation have not been established.
Varnost in učinkovitost zdravila Kalydeco pri otrocih, mlajših od 2 let, z eno od mutacij spreminjanja prehodnosti kanalčkov celične membrane (skupina III), nista bili dokazani.
The safety and efficacy of Keppra concentrate for solution for infusion in infants and children less than 4 years have not been established.
Varnost in učinkovitost zdravila Keppra, koncentrata za raztopino za infundiranje, pri dojenčkih in pri otrocih, mlajših od 4 let nista bili dokazani.
The safety and efficacy of Kineret in patients with chronic infections have not been evaluated.
Varnosti in učinkovitosti zdravila Kineret pri bolnikih s kroničnimi okužbami niso ovrednotili.
The safety and efficacy of Kivexa in children weighing less than 25 kg has not been established.
Varnost in učinkovitost zdravila Kivexa pri otrocih, ki tehtajo manj kot 25 kg, še nista bili dokazani.
The safety and efficacy of Kovaltry in previously untreated patients have not yet been established.
Varnosti in učinkovitost zdravila Kovaltry pri predhodno nezdravljenih bolnikih nista bili dokazani.
The safety and efficacy of lacosamide in children aged below 16 years have not yet been established.
Varnost in učinkovitost lakozamida pri otrocih, mlajših od 16 let, še nista bili dokazani.
The safety and efficacy of Lamivudine Teva in infants, children and adolescents aged below 18 years have not been established.
Varnost in učinkovitost zdravila Lamivudin Teva pri otrocih in mladostnikih starih manj kot 18 let ni bila dokazana.
The safety and efficacy of LEMTRADA were evaluated in 3 randomised, rater-blinded, active-comparator clinical trials in patients with RRMS.
Varnost in učinkovitost zdravila LEMTRADA so ocenjevali v 3 randomiziranih, za ocenjevalce zaslepljenih kliničnih preskušanjih z aktivno primerjavo pri bolnikih z RRMS.
The safety and efficacy of lenvatinib in children aged 2 to <18 years have not yet been established (see section 5.1).
Varnost in učinkovitost lenvatiniba pri otrocih, starih od 2 do <18 let, še nista bili dokazani (glejte poglavje 5.1).
The safety and efficacy of Levemir in children below 1 year of age have not been established.
Varnost in učinkovitost uporabe zdravila Levemir pri otrocih, mlajših od 1 leta, ni dokazana.
The safety and efficacy of Levemir in children below 1year of age have not been established.
Varnost in učinkovitost uporabe zdravila Levemir pri otrocih, mlajših od 1 leta, ni dokazana.
The safety and efficacy of levetiracetam concentrate for solution for infusion in infants and children less than 4 years have not been established.
Varnost in učinkovitost levetiracetama v obliki koncentrata za raztopino za infundiranje pri dojenčkih in pri otrocih, mlajših od 4 let, nista bili dokazani.
The safety and efficacy of Levetiracetam SUN concentrate for solution for infusion in infants and children less than 4 years have not been established.
Varnost in učinkovitost zdravila Levetiracetam SUN, koncentrata za raztopino za infundiranje, pri dojenčkih in pri otrocih, mlajših od 4 let nista bili dokazani.
The safety and efficacy of linaclotide in children aged 0 to18 years have not yet been established.
Varnost in učinkovitost linaklotida pri otrocih, starih od 0 do 18 let, nista bili dokazani.
The safety and efficacy of lixisenatide in children and adolescents less than 18 years of age have not yet been established.
Pri otrocih in mladostnikih, mlajših od 18 let, varnost in učinkovitost zdravila Lyxumia še nista ugotovljeni.
The safety and efficacy of Lojuxta in children < 18 years have not been established and the use of this medicinal product in children is therefore not recommended.
Varnost in učinkovitost zdravila Lojuxta pri otrocih, starih do 18 let, nista bili dokazani, zato uporaba tega zdravila pri otrocih ni priporočljiva.
The safety and efficacy of Lojuxta in children <18 years have not been established and the use of this medicinal product in children is therefore not recommended.
Varnost in učinkovitost zdravila Lojuxta pri otrocih, starih do 18 let, nista bili dokazani, zato uporaba tega zdravila pri otrocih ni priporočljiva.
The safety and efficacy of long-term (104 weeks) Sebivo treatment were evaluated in two active- controlled clinical studies that included 1,699 patients with chronic hepatitis B (NV-02B-007 (GLOBE) and NV-02B-015).
Varnost in učinkovitost dolgotrajnega zdravljenja (104 tedne) z zdravilom Sebivo so ocenjevali v dveh kontroliranih kliničnih študijah, v katere so vključili 1.699 bolnikov s kroničnim hepatitisom B (v študijah NV-02B-007 (GLOBE) in NV-02B-015).
The safety and efficacy of Lonquex in children and adolescents aged up to 17 years have not yet been established.
Varnost in učinkovitost zdravila Lonquex pri otrocih in mladostnikih, starih do 17 let, še nista bili dokazani.
The safety and efficacy of lumacaftor/ivacaftor in patients age 65 years or older have not been evaluated.
Varnosti in učinkovitosti lumakaftorja/ivakaftorja pri bolnikih, starih 65 let ali več, niso ocenjevali.
The safety and efficacy of LUMIGAN in children aged 0 to 18 years has not been established.
Varnost in učinkovitost zdravila LUMIGAN pri otrocih, starih od 0 do 18 let, nista bili dokazani.
The safety and efficacy of LUMIGAN in children aged 0 to 18 years has not yet been established.
Varnost in učinkovitost zdravila LUMIGAN pri otrocih, starih od 0 do 18 let, še nista bili dokazani.
The safety and efficacy of MabCampath in children aged less than 17 years of age have not been established.
Varnost in učinkovitost zdravila MabCampath pri otrocih, mlajših od 17 let, še nista bili dokazani.
The safety and efficacy of MabThera in children below 18 years has not been established.
Varnost in učinkovitost zdravila MabThera pri otrocih do 18 leta starosti nista dokazani.
The safety and efficacy of MabThera in children below 18 years has not been established.
Varnost in učinkovitost zdravila MabThera pri otrocih do 18. leta starosti nista dokazani.
The safety and efficacy of macitentan in children have not yet been established.
Varnost in učinkovitost macitentana pri otrocih še nista bili dokazani.
The safety and efficacy of Matever concentrate for solution for infusion in infants and children less than 4 years have not been established.
Varnost in učinkovitost zdravila Matever, koncentrata za raztopino za infundiranje, pri dojenčkih in pri otrocih, mlajših od 4 let nista bili dokazani.
The safety and efficacy of Matever in children below and adolescents 16 years as monotherapy treatment have not been established.
Pri samostojnem zdravljenju pri otrocih in mladostnikih, mlajših od 16 let, varnost in učinkovitost levetiracetama nista bili dokazani.
The safety and efficacy of Menveo in children under 2 years of age has not yet been established.
Varnost in učinkovitost cepiva Menveo pri otrocih, starih do 2 let, še nista bili dokazani.
The safety and efficacy of Metalyse in children (below 18 years) have not been established.
Varnost in učinkovitost zdravila Metalyse pri otrocih (do 18 leta starosti), nista bili dokazani.
The safety and efficacy of midazolam in children aged 0 to 3 months has not been established.
Varnost in učinkovitost midazolama pri otrocih, starih 0 do 3 mesece, nista dokazani.
The safety and efficacy of Mimpara in the paediatric population have not been established.
Varnost in učinkovitost zdravila Mimpara v pediatrični populaciji nista ugotovljeni.
The safety and efficacy of MIRCERA therapy in other indications, including anaemia in patients with cancer, has not been established.
Varnosti in učinkovitosti zdravljenja z zdravilom MIRCERA niso raziskali pri drugih indikacijah, vključno z anemijo pri bolnikih z rakom.
The safety and efficacy of Mozobil in children less than 18 years have not yet been established.
Varnost in učinkovitost zdravila Mozobil pri otrocih, mlajših od 18 let, še nista bili dokazani.
The safety and efficacy of multiple doses of Humira were assessed in adult patients with moderately to severely active ulcerative colitis (Mayo score 6 to 12 with endoscopy subscore of 2 to 3) in randomised, double-blind, placebo-controlled studies.
Varnost in učinkovitost večkratnih odmerkov zdravila Humira so ocenili pri odraslih z zmernim do zelo aktivnim ulceroznim kolitisom (ocena Mayo od 6 do 12 z endoskopsko podoceno 2 do 3) v randomiziranih, dvojno slepih, s placebom kontroliranih študijah.
The safety and efficacy of Myocet in children aged up to 17 years has not been established.
Varnost in učinkovitost zdravila Myocet pri otrocih, starih do 17 let, še nista bili dokazani.
The safety and efficacy of Myozyme was assessed in a randomized, double-blind, placebo-controlled study in 90 patients with late-onset Pompe disease who ranged in age from 10 to 70 years at initiation of treatment and were all naive to enzyme replacement therapy.
Varnost in učinkovitost zdravila Myozyme so ocenili v dvojno slepi klinični študiji, kontrolirani s placebom, z naključno razporeditvijo pri 90 bolnikih s poznim nastopom Pompejeve bolezni, ki so bili stari od 10 do 70 let ob začetku zdravljenja ter predhodno niso prejemali nadomestnega encimskega zdravljenja.
The safety and efficacy of naloxegol in children <18 years of age has not yet been established.
Varnost in učinkovitost naloksegola pri otrocih, mlajših od 18 let, še nista ugotovljeni.
The safety and efficacy of naltrexone / bupropion in children and adolescents below 18 have not yet been established.
Varnost in učinkovitost naltreksona/bupropiona pri otrocih in mladostnikih, mlajših od 18 let, še nista bili dokazani.
The safety and efficacy of Neulasta have not been evaluated in patients receiving chemotherapy associated with delayed myelosuppression e.g., nitrosoureas.
Pri bolnikih, ki dobivajo kemoterapijo, povezano z odloženo mielosupresijo, na primer nitrozouree, varnosti in učinkovitosti zdravila Neulasta niso ovrednotili.
The safety and efficacy of Neulasta have not been investigated in patients receiving high dose chemotherapy.
Varnosti in učinkovitosti zdravila Neulasta niso raziskovali pri bolnikih, ki prejemajo kemoterapijo v velikih odmerkih.
The safety and efficacy of Neulasta have not been investigated in patients with myelodysplastic syndrome, chronic myelogenous leukaemia, and in patients with secondary Acute Myeloid Leukaemia (AML); therefore, it should not be used in such patients.
Varnost in učinkovitost zdravila Neulasta nista raziskani pri bolnikih z mielodisplastičnim sindromom, s kronično mielogeno levkemijo in s sekundarno akutno mieloično levkemijo (AML), zato ga pri takšnih bolnikih ne smete uporabljati.
The safety and efficacy of Neupopeg administration in de novo AML patients aged  55 years with cytogenetics t(15;17) have not been established.
Varnost in učinkovitost Neupopega pri bolnikih z de novo AML, mlajših od 55 let in s citogenetiko t(15;17), nista ugotovljeni.
The safety and efficacy of NeuroBloc in children aged 0-18 years have not yet been established.
Varnost in učinkovitost zdravila NeuroBloc pri otrocih, starih 0-18 let, še nista dokazani.
The safety and efficacy of NEVANAC in children and adolescents have not been established.
Varnost in učinkovitost zdravila NEVANAC pri otrocih nista bili dokazani.
The safety and efficacy of Nimenrix in children under 12 months of age has not yet been established.
Varnost in učinkovitost cepiva Nimenrix pri otrocih, mlajših od 12 mesecev, še ni bila dokazana.
The safety and efficacy of nivolumab 3 mg/kg as a single agent for the treatment of advanced or metastatic squamous NSCLC were evaluated in a phase 3, randomised, open-label study (CA209017).
Varnost in učinkovitost nivolumaba v odmerku 3 mg/kg kot samostojnega zdravila za zdravljenje napredovalega ali metastatskega ploščatoceličnega NSCLC so vrednotili v randomizirani, odprti študiji 3. faze (CA209017).
The safety and efficacy of nivolumab in combination with ipilimumab or nivolumab vs. ipilimumab monotherapy for the treatment of advanced (unresectable or metastatic) melanoma were evaluated in a phase 3, randomised, double-blind study (CA209067).
Varnost in učinkovitost nivolumaba v kombinaciji z ipilimumabom ali nivolumaba v primerjavi z ipilimumabom v monoterapiji pri zdravljenju napredovalega (neoperabilnega ali metastatskega) melanoma so vrednotili v randomizirani, dvojno slepi študiji 3. faze (CA209067).
The safety and efficacy of Nonafact in children less than 6 years of age has not been established.
Varnost in učinkovitost zdravila Nonafact pri otrocih, mlajših od 6 let, ni bila dokazana.
The safety and efficacy of Norvir in childred aged below 2 years has not been established.
Varnost in učinkovitost zdravila Norvir nista ugotovljeni pri otrocih, mlajših od 2 let.
The safety and efficacy of Norvir in childred aged below 2 years has not been established.
Varnost in učinkovitost zdravila Norvir pri otrocih, mlajših od 2 let ni bila ugotovljena.
The safety and efficacy of Norvir in children aged below 2 years has not been established.
Varnost in učinkovitost zdravila Norvir nista ugotovljena pri otrocih, mlajših od 2 let.
The safety and efficacy of NovoEight in previously untreated patients have not yet been established.
Varnost in učinkovitost zdravila NovoEight pri predhodno nezdravljenih bolnikih še nista ugotovljeni.
The safety and efficacy of Nucala in children and adolescents under 18 years of age has not yet been established.
Varnost in učinkovitost zdravila Nucala pri otrocih in mladostnikih, mlajših od 18 let, še nista ugotovljeni.
The safety and efficacy of Nuwiq in previously untreated patients have not yet been established.
Varnost in učinkovitost zdravila Nuwiq pri predhodno nezdravljenih bolnikih še nista bili dokazani.
The safety and efficacy of OBIZUR for the treatment of serious bleeding episodes in subjects with acquired haemophilia with autoimmune inhibitory antibodies to human Factor VIII was investigated in a prospective, non-randomised, open-label trial of 28 subjects (18 Caucasian, 6 Black, and 4 Asian).
Varnost in učinkovitost zdravila OBIZUR za zdravljenje epizod hudih krvavitev pri preiskovancih s pridobljeno hemofilijo z avtoimunskimi inhibitornimi protitelesi proti humanemu faktorju VIII so raziskali v prospektivnem, nerandomiziranem, neslepem preskušanju pri 28 preiskovancih (18 belcih, 6 temnopoltih in 4 aziatih).
The safety and efficacy of Odefsey in children younger than 12 years of age, or weighing < 35 kg, have not yet been established.
Varnost in učinkovitost zdravila Odefsey pri otrocih, mlajših od 12 let, ali s telesno maso < 35 kg, še nista bili dokazani.
The safety and efficacy of Odefsey in patients co-infected with HIV-1 and HBV or HCV has not been established.
Varnost in učinkovitost zdravila Odefsey pri bolnikih s hkratno okužbo s HIV-1 in hepatitisom B (HBV) ali hepatitisom C (HCV) nista bili dokazani.
The safety and efficacy of OLYSIO for the treatment of HCV infection in patients co-infected with HBV have not been studied.
Varnosti in učinkovitosti zdravila OLYSIO pri zdravljenju okužbe s HCV pri bolnikih s sočasno okužbo s HBV niso preučevali.
The safety and efficacy of Oncaspar was evaluated in an open-label, multicenter, randomized, active-controlled study (Study 1).
Varnost in učinkovitost zdravila Oncaspar so ocenili v odprti, multicentrični, randomizirani, aktivno kontrolirani študiji (1. študija).
The safety and efficacy of ONIVYDE in children and adolescents aged ≤ 18 years have not yet been established.
Varnost in učinkovitost zdravila ONIVYDE pri otrocih in mladostnikih, starih ≤ 18 let, še nista bili dokazani.
The safety and efficacy of ONIVYDE were investigated in a multinational, randomized, open label, controlled clinical trial (NAPOLI–1) that tested two treatment regimens for patients with metastatic pancreatic adenocarcinoma who had documented disease progression after gemcitabine or gemcitabine-containing therapy.
Varnost in učinkovitost zdravila ONIVYDE so preučevali v večnacionalnem, randomiziranem, odprtem, nadzorovanem kliničnem preskušanju (NAPOLI–1), v katerem so preskušali dva režima zdravljenja za bolnike z metastatskim adenokarcinomom trebušne slinavke, ki so imeli dokumentirano napredovalo bolezen po zdravljenju z gemcitabinom ali zdravljenju, ki je vključevalo gemcitabin.
The safety and efficacy of OPATANOL in children aged under 3 years has not been established.
Varnost in učinkovitost zdravila OPATANOL pri otrocih, mlajših od 3 let, nista bili dokazani.
The safety and efficacy of OPTISON in children and adolescents below 18 years has not been established.
Varnost in učinkovitost kontrastnega sredstva OPTISON pri otrocih in mladostnikih, mlajših od 18 let, še nista bili proučeni.
The safety and efficacy of ORENCIA in children below 6 years of age have not been studied and therefore, ORENCIA is not recommended for use in children under six years old.
Varnosti in učinkovitosti zdravila ORENCIA pri otrocih, mlajših od 6 let, niso raziskovali, zato uporaba zdravila ORENCIA pri otrocih, mlajših od 6 let, ni priporočljiva.
The safety and efficacy of ORENCIA intravenous administration have been studied in children.
Pri otrocih so raziskovali varnost in učinkovitost zdravila ORENCIA za intravensko uporabo.
The safety and efficacy of ORENCIA subcutaneous administration in children below 18 years of age have not been established.
Varnost in učinkovitost zdravila ORENCIA za subkutano uporabo pri otrocih, mlajših od 18 let, nista bili dokazani.
The safety and efficacy of oritavancin in children and adolescents (<18 years) has not yet been established.
Varnost in učinkovitost oritavancina pri otrocih in mladostnikih (< 18 let) nista bili dokazani.
The safety and efficacy of Orkambi in children aged less than 12 years have not yet been established.
Varnost in učinkovitost zdravila Orkambi pri otrocih, mlajših od 12 let, še nista bili dokazani.