natgillin/translations-raw huggingface dataset:
The safety and efficacy of Avastin in the treatment of recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer was studied in two phase III trials (AVF4095g and MO22224) with different patient populations and chemotherapy regimens.
Varnost in učinkovitost zdravila Avastin pri zdravljenju ponovitve epitelijskega raka jajčnikov, karcinoma jajcevodov ali primarnega peritonealnega karcinoma so proučevali v dveh preskušanjih faze III (AVF4095g in MO22224) pri različni populaciji bolnic in shemah kemoterapije.
The safety and efficacy of axitinib in children and adolescents < 18 years have not been established.
Varnost in učinkovitost aksitiniba pri otrocih in mladostnikih, mlajših od 18 let, nista bili dokazani.
The safety and efficacy of axitinib were evaluated in a randomised, open-label, multicenter Phase 3 study.
Varnost in učinkovitost aksitiniba so ocenjevali v randomizirani, odprti, multicentrični študiji faze 3.
The safety and efficacy of AZOPT in infants, children and adolescents aged 0 to 17 years has not been established and its use is not recommended in infants, children or adolescents
Varnost in učinkovitost zdravila AZOPT pri dojenčkih, otrocih in mladostnikih, starih 0 do 17 let, še nista bili dokazani in njegova uporaba pri dojenčkih, otrocih in mladostnikih ni priporočljiva.
The safety and efficacy of AZOPT in infants, children and adolescents aged 0 to 17 years has not been established.
Varnost in učinkovitost zdravila AZOPT pri dojenčkih, otrocih in mladostnikih, starih 0 do 17 let, še nista bili dokazani.
The safety and efficacy of belatacept as part of an immunosuppressive regimen following renal transplantation were assessed in two randomised, partially-blinded, multicenter, 3 year studies with the primary endpoint specified at Year 1.
Varnost in učinkovitost belatacepta v sklopu režima imunosupresivnega zdravljenja po presaditvi ledvice sta bili ovrednoteni z dvema randomiziranima, deloma slepima, multicentričnima 3-letnima študijama, s primarnim opazovanim dogodkom, določenim v prvem letu.
The safety and efficacy of Benlysta in children and adolescents (less than 18 years of age) has not been established.
Varnost in učinkovitost zdravila Benlysta pri otrocih in mladostnikih (mlajših od 18 let) nista ugotovljeni.
The safety and efficacy of Beromun in children under 18 years have not been established.
Varnost in učinkovitost zdravila Beromun pri otrocih, mlajših od 18 let, še nista bili dokazani.
The safety and efficacy of Biopoin in children and adolescents aged up to 17 years have not yet been established.
Varnost in učinkovitost zdravila Biopoin pri otrocih in mladostnikih, starih do 17 let, nista bili dokazani.
The safety and efficacy of BLINCYTO in paediatric patients have not yet been established.
Varnost in učinkovitost zdravila BLINCYTO pri pediatričnih bolnikih še nista dokazani.
The safety and efficacy of bosutinib in children less than 18 years of age have not been established.
Varnost in učinkovitost zdravila Bosulif pri otrocih, mlajših od 18 let, nista bili dokazani.
The safety and efficacy of brivaracetam in children aged less than 16 years have not yet been established.
Varnost in učinkovitost brivaracetama pri otrocih, mlajših od 16 let, nista bili dokazani.
The safety and efficacy of Budesonide/Formoterol Teva Pharma B.V. in children, 12 years and younger and adolescents, 13 to 17 years of age has not yet been established.
Varnost in učinkovitost zdravila Budezonid/formoterol Teva Pharma B.V. pri otrocih, starih 12 let in manj, ter pri mladostnikih, starih od 13 do 17 let, še nista bili dokazani.
The safety and efficacy of buprenorphine/naloxone in elderly patients over 65 years of age have not been established.
Varnost in učinkovitost buprenorfina/naloksona pri bolnikih, starejših od 65, let nista bili dokazani.
The safety and efficacy of caspofungin was evaluated in paediatric patients 3 months to 17 years of age in two prospective, multicenter clinical trials.
Varnost in učinkovitost kaspofungina so pri pediatričnih bolnikih, starih od 3 mesece do 17 let, ocenili v dveh prospektivnih, multicentričnih kliničnih preskušanjih.
The safety and efficacy of CE/bazedoxifene have not been evaluated in patients with hepatic impairment.
Varnosti in učinkovitosti CE/bazedoksifena pri bolnicah z okvaro jeter niso raziskovali.
The safety and efficacy of CELSENTRI in children younger than 18 years of age has not been established.
Varnost in učinkovitost zdravila CELSENTRI pri otrocih, mlajših od 18 let še nista bili dokazani.
The safety and efficacy of CHAMPIX in children or adolescents below 18 years have not yet been established.
Varnost in učinkovitost zdravila CHAMPIX pri otrocih in mladostnikih, starih manj kot 18 let, še nista bili dokazani.
The safety and efficacy of cholic acid in neonates less than one month of age has not been established.
Varnosti in učinkovitosti holne kisline niso ugotovili pri novorojenčkih, mlajših od enega meseca.
The safety and efficacy of CINQAERO in children and adolescents aged up to 17 years have not been established for the indication of CINQAERO.
Varnost in učinkovitost zdravila CINQAERO pri otrocih in mladostnikih, starih do 17 let, nista bili dokazani za indikacijo zdravila CINQAERO.
The safety and efficacy of Cinryze in children less than 12 years old has not yet been established.
Varnost in učinkovitost zdravila Cinryze pri otrocih, mlajših od 12 let, še nista bili dokazani.
The safety and efficacy of Circadin in children aged 0 to 18 years has not yet been established.
Varnost in učinkovitost zdravila Circadin pri otrocih starih 0 do 18 let še nista bili dokazani.
The safety and efficacy of clopidogrel have been evaluated in 5 double-blind studies involving over 88,000 patients: the CAPRIE study, a comparison of clopidogrel to ASA, and the CURE, CLARITY, COMMIT and ACTIVE-A studies comparing clopidogrel to placebo, both medicinal products given in combination with ASA and other standard therapy.
Varnost in učinkovitost klopidogrela so vrednotili v 5 dvojno slepih študijah, v katere je bilo vključenih več kot 88.000 bolnikov: študija CAPRIE je obsegala primerjavo klopidogrela in ASA, v študijah CURE, CLARITY, COMMIT in ACTIVE_A pa so primerjali klopidogrel s placebom; oboje pa so bolniki dobivali v kombinaciji z ASA in drugo standardno terapijo.
The safety and efficacy of clopidogrel in children and adolescents have not yet been established.
Varnost in učinkovitost klopidogrela pri otrocih in mladostnikih še nista ugotovljeni.
The safety and efficacy of Coagadex in children less than 12 years of age have not yet been established.
Varnost in učinkovitost zdravila Coagadex pri otrocih, mlajših od 12 let, še nista bili dokazani.
The safety and efficacy of cobicistat with atazanavir in HIV-1 infected patients were evaluated in the randomised, double-blind, active-controlled phase 3 study GS-US-216-0114 in HIV-1 infected patients with baseline estimated creatinine clearance above 70 ml/min who were treatment-naïve (n = 692).
Varnost in učinkovitost kobicistata z atazanavirjem pri bolnikih, okuženih s HIV-1, so ocenili v randomizirani, dvojno slepi, z zdravilno učinkovino kontrolirani študiji faze 3 GS-US-216-0114 pri predhodno nezdravljenih bolnikih, okuženih s HIV-1, z izhodiščnim ocenjenim očistkom kreatinina nad 70 ml/min (n = 692).
The safety and efficacy of Colobreathe in children under 6 years of age have not been established.
Varnost in učinkovitost zdravila Colobreathe pri otrocih, starih manj kot 6 let, še nista bili dokazani.
The safety and efficacy of combinations of CIALIS and other PDE5 inhibitors or other treatments for erectile dysfunction have not been studied.
Varnosti in učinkovitosti kombinacij zdravila CIALIS in drugih zaviralcev PDE5 ali drugih zdravljenj za erektilno disfunkcijo niso preučevali.
The safety and efficacy of combinations of Spedra and other PDE5 inhibitors or other treatments for erectile dysfunction have not been studied.
Varnost in učinkovitost zdravila Spedra v kombinaciji z drugimi zaviralci PDE5 ali drugimi zdravili za zdravljenje erektilne disfunkcije nista bili preučeni.
The safety and efficacy of combinations of tadalafil and other PDE5 inhibitors or other treatments for erectile dysfunction have not been studied.
Varnosti in učinkovitosti kombinacij tadalafila z drugimi inhibitorji PDE5 ali drugimi zdravili za erektilno disfunkcijo niso preučevali.
The safety and efficacy of combinations of tadalafil and other PDE5 inhibitors or other treatments for erectile dysfunction have not been studied.
Varnosti in učinkovitosti kombinacij zdravila Tadalafil Mylan in drugih zaviralcev PDE5 ali drugih zdravljenj za erektilno disfunkcijo niso preučevali.
The safety and efficacy of combinations of Vivanza film-coated tablets with vardenafil orodispersible tablets or other treatments for erectile dysfunction have not been studied.
Študij o varnosti in učinkovitosti zdravljenja z zdravilom Vivanza filmsko obložene tablete v kombinaciji z orodisperzibilnimi tabletami, ki vsebujejo vardenafil, ali z drugimi zdravili za erektilno disfunkcijo niso izvedli.
The safety and efficacy of combinations of Vivanza orodispersible tablets with Vivanza film-coated tablets or other treatments for erectile dysfunction have not been studied.
Študij o varnosti in učinkovitosti zdravljenja z zdravilom Vivanza orodisperzibilne tablete v kombinaciji z zdravilom Vivanza filmsko obložene tablete ali drugimi zdravili za erektilno disfunkcijo niso izvedli.
The safety and efficacy of Competact in children and adolescents under 18 years of age have not been established.
Varnost in učinkovitost zdravila Competact pri otrocih in mladostnikih, mlajših od 18 let, še nista bili dokazani.
The safety and efficacy of conversion from calcineurin inhibitors to Rapamune in maintenance renal transplant patients (6-120 months after transplantation) was assessed in a randomised, multicentre, controlled trial, stratified by calculated GFR at baseline (20-40 -mL/min vs above 40 mL/min).
Varnost in učinkovitost prehoda z zaviralcev kalcinevrina na zdravilo Rapamune pri bolnikih na vzdrževalnem zdravljenju po presaditvi ledvice (6-120 mesecev po presaditvi) so ocenjevali v randomizirani, multicentrični kontrolirani študiji, stratificirani glede na izračunano GFR v izhodišču (20-40 ml/min v primerjavi z več kot 40 ml/min).
The safety and efficacy of conversion from calcineurin inhibitors to Rapamune in maintenance renal transplant patients (6-120 months after transplantation) was assessed in a randomised, multicentre, controlled trial, stratified by calculated GFR at baseline (20-40 mL/min vs. above 40 mL/min).
Varnost in učinkovitost prehoda z zaviralcev kalcinevrina na zdravilo Rapamune pri bolnikih na vzdrževalnem zdravljenju po presaditvi ledvice (6-120 mesecev po presaditvi) so ocenjevali v randomizirani, multicentrični kontrolirani študiji, stratificirani glede na izračunano GFR v izhodišču (20-40 ml/min v primerjavi z več kot 40 ml/min).
The safety and efficacy of Cosentyx were assessed in 1,003 patients in two randomised, double-blind, placebo-controlled phase III studies in patients with active psoriatic arthritis (≥3 swollen and ≥3 tender joints) despite non-steroidal anti-inflammatory drug (NSAID), corticosteroid or disease-modifying anti-rheumatic drug (DMARD) therapy.
Varnost in učinkovitost zdravila Cosentyx so ocenjevali v dveh randomiziranih, dvojno slepih, s placebom kontroliranih študijah faze III pri 1.003 bolnikih z aktivnim psoriatičnim artritisom (z najmanj 3 oteklimi in najmanj 3 bolečimi sklepi) kljub zdravljenju z nesteroidnimi protivnetnimi zdravili, s kortikosteroidi ali z imunomodulirajočimi antirevmatičnimi zdravili (DMARDs).
The safety and efficacy of Cosentyx were assessed in four randomised, double-blind, placebo-controlled phase III studies in patients with moderate to severe plaque psoriasis who were candidates for phototherapy or systemic therapy [ERASURE, FIXTURE, FEATURE, JUNCTURE].
Varnost in učinkovitost zdravila Cosentyx so ocenjevali v štirih randomiziranih, dvojno slepih, s placebom kontroliranih študijah faze III pri bolnikih, ki so imeli zmerno do hudo psoriazo s plaki in so bili primerni za zdravljenje s fototerapijo ali sistemsko zdravljenje [študije ERASURE, FIXTURE, FEATURE in JUNCTURE].
The safety and efficacy of CRIXIVAN in children under the age of 4 years have not been established (see section 5.1 and 5.2).
Varnost in učinkovitost zdravila CRIXIVAN pri otrocih, mlajših od 4 let, nista bili dokazani (glejte poglavji 5.1 in 5.2).
The safety and efficacy of crizotinib in paediatric patients has not been established.
Varnost in učinkovitost krizotiniba pri pediatričnih bolnikih nista bili dokazani.
The safety and efficacy of Cubicin in children and adolescents aged below 18 years with right-sided infective endocarditis (RIE) due to Staphylococcus aureus or with Staphylococcus aureus bacteraemia (SAB) when associated with RIE or with cSSTI have not been established.
Varnost in učinkovitost zdravila Cubicin pri otrocih in mladostnikih, ki so stari do 18 let in imajo infekcijski endokarditis desne strani zaradi bakterije Staphylococcus aureus ali bakteriemijo z bakterijo Staphylococcus aureus v povezavi z infekcijskim endokarditisom desne strani ali z zapletenimi okužbami kože in mehkih tkiv, nista bili dokazani.
The safety and efficacy of dabrafenib have not yet been established in children and adolescents (<18 years).
Varnost in učinkovitost dabrafeniba pri otrocih in mladostnikih (< 18 let) še nista ugotovljeni.
The safety and efficacy of dabrafenib in non-Caucasian patients have not been established.
Varnost in učinkovitost dabrafeniba nista ugotovljeni pri bolnikih, ki niso belci.
The safety and efficacy of Dacogen in children aged < 18 years have not yet been established.
Varnost in učinkovitost zdravila Dacogen pri otrocih, starih < 18 let, nista bili dokazani.
The safety and efficacy of Daklinza in children and adolescents aged <18 years have not yet been established.
Varnost in učinkovitost zdravila Daklinza pri otrocih in mladostnikih, mlajših od 18 let, še nista bili dokazani.
The safety and efficacy of Daklinza in the treatment of HCV infection in patients who are co-infected with HBV have not been investigated.
Varnosti in učinkovitosti zdravila Daklinza pri zdravljenju okužbe s HCV pri bolnikih, ki so sočasno okuženi s HBV, niso raziskovali.
The safety and efficacy of daptomycin was evaluated in paediatric patients aged 1 to 17 years (Study DAP-PEDS-07-03) with cSSTI caused by Gram positive pathogens.
Varnost in učinkovitost daptomicina so ocenjevali pri pediatričnih bolnikih, ki so bili stari od 1 do 17 let in so imeli zapleteno okužbo kože in mehkih tkiv s katerim od po Gramu pozitivnih patogenov (študija DAP-PEDS-07-03).
The safety and efficacy of dasabuvir have not been established in patients with HCV/HBV co- infection.
Varnost in učinkovitost dasabuvirja pri bolnikih, sočasno okuženih s HCV in HBV, nista bili ugotovljeni.
The safety and efficacy of Defitelio in children aged less than 1 month has not yet been established.
Varnost in učinkovitost zdravila Defitelio pri otrocih, starih manj kot 1 mesec, nista še bili dokazani.
The safety and efficacy of denosumab have not been studied in patients with hepatic impairment (see section 5.2).
Varnost in učinkovitost denosumaba pri bolnikih z okvaro jeter nista raziskani (glejte poglavje 5.2).
The safety and efficacy of Descovy in children younger than 12 years of age, or weighing < 35 kg, have not yet been established.
Varnost in učinkovitost zdravila Descovy pri otrocih, mlajših od 12 let, ali s telesno maso < 35 kg, še nista bili dokazani.
The safety and efficacy of Desloratadine Actavis 5 mg film-coated tablets in children below the age of 12 years have not been established.
Varnost in učinkovitost zdravila Desloratadin Actavis 5 mg filmsko obložene tablete pri otrocih, mlajših od 12 let, nista bili dokazani.
The safety and efficacy of Dexdor in children aged 0 to 18 years have not been established.
Varnost in učinkovitost zdravila Dextor pri otrocih, starih 0 do 18 let nista bili dokazani.
The safety and efficacy of docetaxel in combination with prednisone or prednisolone in patients with hormone refractory metastatic prostate cancer were evaluated in a randomized multicenter phase III
Varnost in učinkovitost docetaksela v kombinaciji s prednizonom ali prednizolonom pri bolnikih z metastatskim hormonsko neodzivnim rakom prostate je bila ocenjena v randominizirani multicentrični študiji faze III.
The safety and efficacy of docetaxel in nasopharyngeal carcinoma in children aged 1 month to less than 18 years have not yet been established.
Varnost in učinkovitost zdravila Docetaksel Accord za zdravljenje nazofaringealnega karcinoma pri otrocih od 1 meseca do manj kot 18 let starosti nista ugotovljeni.
The safety and efficacy of docetaxel in the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN) was evaluated in a randomized, multicenter open-label, phase III study (TAX324).
Varnost in učinkovitost docetaksela za indukcijsko zdravljenje bolnikov z lokalno napredovalim skvamoznoceličnim karcinomom glave in vratu (SCCHN) so ocenili v randomiziranem multicentričnem odprtem preskušanju III. faze (TAX324).
The safety and efficacy of docetaxel in the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN) was evaluated in a randomized, multicenter open-label, phase III study (TAX324).
Varnost in učinkovitost docetaksela za indukcijsko zdravljenje bolnikov z lokalno napredovalim skvamoznoceličnim karcinomom glave in vratu (SCCHN) so ocenili v randomizirani multicentrični odprti študiji III. faze (TAX324).
The safety and efficacy of docetaxel in the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN) was evaluated in a randomized, multicenter open-label, phase III, study (TAX324).
Varnost in učinkovitost docetaksela za indukcijsko zdravljenje bolnikov z lokalno napredovalim skvamoznoceličnim karcinomom glave in vratu (SCCHN) so ocenili v randomiziranem multicentričnem odprtem preskušanju III. faze (TAX324).
The safety and efficacy of docetaxel in the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN) was evaluated in a randomized, multicenter open-label, phase III, study (TAX324).
Varnost in učinkovitost docetaksela za indukcijsko zdravljenje bolnikov z lokalno napredovalim skvamoznoceličnim karcinomom glave in vratu (SCCHN) so ocenili v randomizirani multicentrični odprti študiji III. faze (TAX324).
The safety and efficacy of docetaxel in the induction treatment of patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN) was evaluated in a randomized, multicenter open-label, phase III, study (TAX324).
Varnost in učinkovitost zdravila docetaksel za indukcijsko zdravljenje bolnikov s skvamoznoceličnim karcinomom glave in vratu (SCCHN) so ocenjevali v multicentrični odprti randomizirani študiji faze III (TAX323).
The safety and efficacy of docetaxel in the induction treatment of patients with squamous cell carcinoma of the head and neck (SCCHN) was evaluated in a phase III, multicenter, open-label, randomized study (TAX323).
Varnost in učinkovitost docetaksela za indukcijsko zdravljenje bolnikov s skvamoznoceličnim karcinomom glave in vratu (SCCHN) so ocenili v multicentričnem odprtem randomiziranemu preskušanju faze III (TAX323).
The safety and efficacy of docetaxel in the induction treatment of patients with squamous cell carcinoma of the head and neck (SCCHN) was evaluated in a phase III, multicenter, open-label, randomized study (TAX323).
Varnost in učinkovitost docetaksela za indukcijsko zdravljenje bolnikov s skvamoznoceličnim karcinomom glave in vratu (SCCHN) so ocenjevali v multicentrični odprti randomizirani študiji III. faze (TAX323).
The safety and efficacy of docetaxel in the induction treatment of patients with squamous cell carcinoma of the head and neck (SCCHN) was evaluated in a phase III, multicenter, open-label, randomized study (TAX323).
Varnost in učinkovitost docetaxel za indukcijsko zdravljenje bolnikov sskvamoznoceličnim karcinomom glave in vratu (SCCHN) so ocenjevali v multicentrični odprti randomizirani študiji faze III (TAX323).
The safety and efficacy of docetaxel in the induction treatment of patients with squamous cell carcinoma of the head and neck (SCCHN) was evaluated in a phase III, multicenter, open-label, randomized study (TAX323).
Varnost in učinkovitost zdravila docetaksel za indukcijsko zdravljenje bolnikov s skvamoznoceličnim karcinomom glave in vratu (SCCHN) so ocenjevali v multicentrični odprti randomizirani študiji
The safety and efficacy of docetaxel in the induction treatment of patients with squamous cell carcinoma of the head and neck (SCCHN) was evaluated in a phase III, multicenter, open-label, randomized study (TAX323).
Varnost in učinkovitost zdravila docetaksel za indukcijsko zdravljenje bolnikov s skvamoznoceličnim karcinomom glave in vratu (SCCHN) so ocenjevali v multicentrični odprti randomizirani študiji faze III (TAX323).
The safety and efficacy of docetaxel in the induction treatment of patients with squamous cell carcinoma of the head and neck (SCCHN) was evaluated in a phase III, multicenter, open-label, randomized study (TAX323).
Varnost in učinkovitost zdravila docetaksel za indukcijsko zdravljenje bolnikov s skvamoznoceličnim karcinomom glave in vratu (SCCHN) so ocenjevali v multicentrični odprti randomizirani študiji III. faze (TAX323).
The safety and efficacy of Docetaxel Winthrop in nasopharyngeal carcinoma in children aged 1 month to less than 18 years have not yet been established.
Varnost in učinkovitost zdravila Docetaxel Winthrop za zdravljenje nazofaringealnega karcinoma pri otrocih od 1 meseca do manj kot 18 let starosti nista ugotovljeni.
The safety and efficacy of dulaglutide was investigated in a placebo and active controlled (sitagliptin 100 mg daily) study of 104 weeks duration, all in combination with metformin.
Varnost in učinkovitost dulaglutida so preučevali tudi študiji, nadzorovani z aktivno primerjavo (liraglutid 1,8 mg na dan), ki je trajala 26 tednov, obakrat v kombinaciji z metforminom.
The safety and efficacy of dulaglutide were evaluated in eight randomised, controlled, phase III trials involving 5,770 patients with type 2 diabetes.
Varnost in učinkovitost zdravila dulaglutida sta bili ugotovljeni v osmih randomiziranih, nadziranih preskušanjih III. faze, ki so vključevala 5770 bolnikov s sladkorno boleznijo tipa 2.
The safety and efficacy of duloxetine for the treatment of diabetic peripheral neuropathic pain has not been studied.
Varnost in učinkovitost duloksetina za zdravljenje bolečine periferne diabetične nista bili dokazani.
The safety and efficacy of DuoResp Spiromax in children, 12 years and younger and adolescents, 13 to 17 years of age has not yet been established.
Varnost in učinkovitost zdravila DuoResp Spiromax pri otrocih, starih 12 let in manj, ter pri mladostnikih, starih od 13 do 17 let, še nista bili dokazani.
The safety and efficacy of DuoTrav in children and adolescents below the age of 18 years have not been established.
Varnosti in učinkovitosti zdravila DuoTrav pri otrocih in mladostnikih, mlajših od 18 let, še nista bili dokazani.
The safety and efficacy of ECALTA in children below 18 years have not been established.
Varnost in učinkovitost zdravila ECALTA pri otrocih, mlajših od 18 let, nista bili dokazani.
The safety and efficacy of Effentora in children aged 0 to 18 years have not been established.
Varnost in učinkovitost zdravila Effentora pri otrocih, starih 0 do 18 let, nista bili dokazani.
The safety and efficacy of Effentora in children aged 0 to18 years have not been established.
Varnost in učinkovitost zdravila Effentora pri otrocih, starih 0 do 18 let, nista bili dokazani.
The safety and efficacy of ELOCTA in previously untreated patients have not yet been established.
Varnost in učinkovitost zdravila ELOCTA pri predhodno nezdravljenih bolnikih še nista bili dokazani.