natgillin/translations-raw huggingface dataset:
The safety and efficacy of Humira was assessed in an open-label, multicenter study in 32 children (2 - < 4 years old or aged 4 and above weighing < 15 kg) with moderately to severely active polyarticular JIA.
Sigurnost i djelotvornost primjene lijeka Humira ocijenjena je u otvorenom, multicentričnom ispitivanju koje je uključivalo 32 djece (u dobi od 2 do manje od 4 godine ili u dobi od 4 godine i više i tjelesne težine manje od 15 kg) s umjerenim do teškim aktivnim poliartikularnim JIA.
The safety and efficacy of Humira was assessed in two studies (pJIA I and II) in children with active polyarticular or polyarticular course juvenile idiopathic arthritis, who had a variety of JIA onset types (most frequently rheumatoid-factor negative or positive polyarthritis and extended oligoarthritis).
Sigurnost i djelotvornost primjene lijeka Humira ocijenjena je u dvama ispitivanjima (pJIA I i II) u djece s aktivnim poliartikularnim ili poliartikularnim tijekom juvenilnog idiopatskog artritisa i raznim vrstama početka JIA (najčešće negativni reumatoidni faktor ili pozitivni poliartritis i prošireni oligoartritis).
The safety and efficacy of Humira were assessed in a multicenter, randomised, double-blind study in 46 paediatric patients (6 to 17 years old) with moderate enthesitis-related arthritis.
Sigurnost i djelotvornost primjene lijeka Humira ocijenjena je u multicentričnom, randomiziranom, dvostruko slijepom ispitivanju koje je uključivalo 46 pedijatrijskih bolesnika (u dobi od 6 do 17 godina) s umjerenim artritisom povezanim s entezitisom.
The safety and efficacy of Humira were assessed in adult patients with non-infectious intermediate, posterior, and panuveitis, excluding patients with isolated anterior uveitis, in two randomised, double- masked, placebo-controlled studies (UV I and II).
Sigurnost i djelotvornost lijeka Humira ocjenjivale su se u odraslih bolesnika s neinfektivnim intermedijarnim, posteriornim i panuveitisom, isključujući bolesnike s izoliranim anteriornim uveitisom, u dvama randomiziranim, dvostruko maskiranim, placebom kontroliranim ispitivanjima (UV I i II).
The safety and efficacy of Humira were assessed in randomised, double-blind, placebo-controlled studies and an open-label extension study in adult patients with moderate to severe hidradenitis suppurativa (HS) who were intolerant, had a contraindication or an inadequate response to at least a 3- month trial of systemic antibiotic therapy.
Sigurnost i djelotvornost lijeka Humira ocjenjivale su se u randomiziranim, dvostruko slijepim, placebom kontroliranim ispitivanjima i jednom otvorenom produžetku ispitivanja u odraslih bolesnika s umjerenim do teškim gnojnim hidradenitisom (Hidradenitis suppurativa, HS) koji nisu podnosili sistemske antibiotike, koji su imali kontraindikacije za njihovu primjenu ili nisu postigli zadovoljavajući odgovor na liječenje sistemskim antibioticima tijekom najmanje 3 mjeseca.
The safety and efficacy of Humira were studied in adult patients with chronic plaque psoriasis ( 10% BSA involvement and PASI  12 or  10) who were candidates for systemic therapy or phototherapy in randomised, double-blind studies.
Sigurnost i djelotvornost lijeka Humira ispitivala se u odraslih bolesnika s kroničnom plak psorijazom (zahvaćeno ≥ 10% površine tijela i PASI rezultat od  12 ili  10) koji su bili kandidati za sistemsku terapiju ili fototerapiju u randomiziranim, dvostruko slijepim ispitivanjima.
The safety and efficacy of Iasibon in children and adolescents below the age of 18 years have not been established.
Sigurnost i djelotvornost lijeka Iasibon u djece i adolescenata mlađih od 18 godina nije ustanovljena.
The safety and efficacy of Iasibonin children and adolescents below the age of 18 years have not been established.
Sigurnost i djelotvornost lijeka Iasibon u djece i adolescenata mlađih od 18 godina nije ustanovljena.
The safety and efficacy of Ibandronic Acid Teva in children and adolescents below the age of 18 years have not been established.
Sigurnost i djelotvornost ibandronatne kiseline u djece i adolescenata mlađih od 18 godina nije ustanovljena.
The safety and efficacy of idelalisib were assessed in a single-arm, multicentre clinical study (study 101-09) conducted in 125 subjects with indolent B-cell non-Hodgkin lymphoma (iNHL,
Sigurnost i djelotvornost idelalisiba procijenjena je multicentričnim kliničkim ispitivanjem na jednoj skupini (ispitivanje 101-09) provedenim na 125 ispitanika s indolentnim B-staničnim non
The safety and efficacy of IDELVION in previously untreated patients have not yet been established.
Sigurnost i djelotvornost lijeka IDELVION u prethodno neliječenih bolesnika još nisu ustanovljene.
The safety and efficacy of Ilaris in CAPS patients under 2 years of age have not been established.
Sigurnost i djelotvornost Ilarisa u bolesnika s CAPS-om mlađih od 2 godine nije ustanovljena.
The safety and efficacy of imatinib in children with MDS/MPD, DFSP and HES/CEL aged less than 18 years of age have not been established in clinical trials.
Sigurnost i djelotvornost imatiniba u djece s MDS/MPD-om, DFSP-om i HES/KEL-om mlađe od 18 godina nisu utvrđene u kliničkim ispitivanjima.
The safety and efficacy of imatinib in children with MDS/MPD, DFSP, GIST and HES/CEL aged less than 18 years of age have not been established in clinical trials.
Sigurnost i djelotvornost imatiniba u djece s MDS/MPD-om, DFSP-om, GIST-om i HES/KEL-om mlađe od 18 godina nisu utvrđene u kliničkim ispitivanjima.
The safety and efficacy of IMBRUVICA in children aged 0 to 18 years have not been established.
Sigurnost i djelotvornost lijeka IMBRUVICA u djece u dobi od 0 do 18 godina nisu ustanovljene.
The safety and efficacy of IMBRUVICA in patients previously treated for CLL were further evaluated in a randomised, multicenter, double-blinded phase 3 study of IMBRUVICA in combination with BR versus placebo + BR (Study CLL3001).
Sigurnost i djelotvornost lijeka IMBRUVICA u bolesnika u kojih je kronična limfocitna leukemija prethodno liječena bile su dalje procijenjene u randomiziranom, multicentričnom, dvostruko slijepom ispitivanju faze 3 lijeka IMBRUVICA u kombinaciji s bendamustinom i rituksimabom (BR) naspram placeba + BR (Ispitivanje CLL3001).
The safety and efficacy of IMBRUVICA were demonstrated in a randomised phase 3, open-label, multicenter study including 280 patients with MCL who received at least one prior therapy (Study MCL3001).
Sigurnost i djelotvornost lijeka IMBRUVICA bili su dokazani u randomiziranom, otvorenom, multicentričnom ispitivanju faze 3 koje je uključilo 280 bolesnika s MCL-om koji su prethodno primili barem jednu terapiju (Ispitivanje MCL3001).
The safety and efficacy of imiquimod in actinic keratosis in children and adolescents below the age of 18 years have not been established.
Sigurnost i djelotvornost imikvimoda kod aktinične keratoze u djece i adolescenata mlađih od 18 godina nisu još ustanovljene.
The safety and efficacy of Imlygic monotherapy compared with subcutaneously administered GM- CSF were evaluated in a phase 3, multinational, open-label, and randomised clinical study of patients with stage IIIB, IIIC, and IV melanoma that was not considered to be surgically resectable.
Sigurnost i djelotvornost monoterapije lijekom Imlygic u u usporedbi sa supkutano primijenjenim GM-CSF procijenjene su u multinacionalnom, otvorenom, randomiziranom kliničkom ispitivanju faze 3, u bolesnika s melanomom stadija IIIB, IIIC i IV koji se nije smatrao operabilnim.
The safety and efficacy of immunization with any vaccine, particularly live viral vaccines, following therapy with Zevalin have not been studied (see also section ‘Special warnings and precautions for use’).
Sigurnost i djelotvornost imunizacije nijednim cjepivom, osobito cjepivima sa živim virusima, nakon terapije Zevalinom nisu ispitane (vidjeti također dio "Posebna upozorenja i mjere opreza pri uporabi").
The safety and efficacy of IMVANEX in individuals below 18 years of age have not been established.
Sigurnost i djelotvornost cjepiva IMVANEX u osoba u dobi ispod 18 godina nisu ustanovljene.
The safety and efficacy of INCIVO in children aged < 18 years have not yet been established.
Sigurnost i djelotvornost lijeka INCIVO u djece u dobi < 18 godina nisu još ustanovljene.
The safety and efficacy of INCRELEX in children below age of 2 have not been established.
Sigurnost i djelotvornost INCRELEXA kod djece u dobi ispod 2 godine nisu još ustanovljene.
The safety and efficacy of InductOs have not been established in the following conditions: used with interbody fusion devices made from material other than titanium, PEEK or bone
Sigurnost i djelotvornost InductOsa nisu utvrđene u sljedećim uvjetima: uporaba s napravama za interkorporalnu fuziju napravljenima od materijala koji nije titanij, PEEK ili kost
The safety and efficacy of Inflectra have not been studied in children with Crohn’s disease below the age of 6 years.
Sigurnost i djelotvornost lijeka Inflectra nisu ispitivani u djece mlađe od 6 godina koja boluju od Crohnove bolesti.
The safety and efficacy of Inflectra have not been studied in children with ulcerative colitis below the age of 6 years.
Sigurnost i djelotvornost lijeka Inflectra nisu ispitivani u djece mlađe od 6 godina koja boluju od ulceroznog kolitisa.
The safety and efficacy of Inflectra in children and adolescents younger than 18 years in the indication juvenile rheumatoid arthritis have not been established.
Sigurnost i djelotvornost lijeka Inflectra nisu utvrđeni u djece i adolescenata mlađih od 18 godina koji boluju od juvenilnog reumatoidnog artritisa.
The safety and efficacy of Inflectra in children and adolescents younger than 18 years in the indication psoriasis have not been established.
Sigurnost i djelotvornost lijeka Inflectra nisu utvrđeni u djece i adolescenata mlađih od 18 godina koji boluju od psorijaze.
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.
Sigurnost i djelotvornost lijeka Inflectra 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 infliximab have not been studied in children with Crohn’s disease below the age of 6 years.
Sigurnost i djelotvornost infliksimaba nisu ispitivane u djece mlađe od 6 godina koja boluju od Crohnove bolesti.
The safety and efficacy of infliximab in children and adolescents younger than 18 years in the indication juvenile rheumatoid arthritis have not been established.
Sigurnost i djelotvornost infliksimaba u djece i adolescenata mlađih od 18 godina koji boluju od juvenilnog reumatoidnog artritisa nisu ustanovljene.
The safety and efficacy of infliximab in children and adolescents younger than 18 years in the indication psoriasis have not been established.
Sigurnost i djelotvornost infliksimaba u djece i adolescenata mlađih od 18 godina koji boluju od psorijaze nisu ustanovljene.
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.
Sigurnost i djelotvornost infliksimaba u djece i adolescenata mlađih od 18 godina koji boluju od juvenilnog idiopatskog artritisa, psorijatičnog artritisa i ankilozantnog spondilitisa nisu ustanovljene.
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.
Sigurnost primjene i djelotvornost infliksimaba ispitivane su u multicentričnom, randomiziranom otvorenom kliničkom ispitivanju s paralelnim skupinama (C0168T72), provedenom u 60 pedijatrijskih bolesnika u dobi od 6 do 17 godina (medijan dobi 14,5 godina) s umjerenim do teškim, aktivnim ulceroznim kolitisom (Mayo rezultat 6-12, endoskopski ≥ 2) koji nisu odgovorili na konvencionalnu terapiju na odgovarajući način.
The safety and efficacy of infliximab were assessed in two (ACT 1 and ACT 2) randomised, double-blind, placebo-controlled clinical studies in adult patients with moderately to severely active ulcerative colitis (Mayo score 6 to 12; Endoscopy subscore ≥2) with an inadequate response to conventional therapies [oral corticosteroids, aminosalicylates and/or immunomodulators (6-MP, AZA)].
Sigurnost i djelotvornost lijeka infliksimab ispitivane su u dva randomizirana, dvostruko slijepa, placebom kontrolirana klinička ispitivanja (ACT 1 i ACT 2) u odraslih bolesnika s umjerenim do teškim, aktivnim ulceroznim kolitisom (Mayo bodovi 6 do 12; endoskopski ≥ 2), koji nisu odgovorili na konvencionalno liječenje na odgovarajući način [peroralne kortikosteroide, aminosalicilate i/ili imunomodulatore (6-MP, AZA)].
The safety and efficacy of INOmax in premature infants less than 34 weeks of gestation has not yet been established.
Sigurnost i djelotvornost INOmax-a u nedonoščadi gestacijske dobi manje od 34 tjedana još nije ustanovljena.
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).
Sigurnost i djelotvornost INTELENCEa u djece mlađe od 6 godina ili težine manje od 16 kg nisu još ustanovljene (vidjeti dio 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.
Sigurnost i djelotvornost intravenskog temsirolimusa za liječenje relapsa i/ili refraktornog limfoma plaštenih stanica ispitane su u sljedećem kliničkom ispitivanju faze III.
The safety and efficacy of IRESSA in children and adolescents aged less than 18 years have not been established.
Još nisu ustanovljene sigurnost primjene i djelotvornost lijeka IRESSA u djece i adolescenata mlađih od 18 godina.
The safety and efficacy of ivabradine for the treatment of chronic heart failure in children aged below 18 years have not been established.
Sigurnost i djelotvornost ivabradina u liječenju kroničnog zatajenja srca u djece starosti do 18 godina nisu ustanovljene.
The safety and efficacy of ivabradine for the treatment of chronic heart failure in children aged below 18 years have not been established.
Sigurnost i djelotvornost ivabradina u liječenju kroničnog zatajenje srca u djece starosti do 18 godina nisu ustanovljene.
The safety and efficacy of IVEMEND in children and adolescents below 18 years of age has not yet been established.
Sigurnost primjene i djelotvornost lijeka IVEMEND u djece i adolescenata mlađih od 18 godina nisu još ustanovljene.
The safety and efficacy of Jakavi in children aged up to 18 years have not been established.
Sigurnost i djelotvornost Jakavija u djece u dobi do 18 godina nisu još ustanovljene.
The safety and efficacy of Jentadueto in children and adolescents aged 0 to 18 years have not been established.
Sigurnost i djelotvornost Jentadueta u djece i adolescenata, u dobi od 0 do 18 godina, nisu još ustanovljene.
The safety and efficacy of Kaletra in children aged less than 2 years have not been established.
Sigurnost i djelotvornost lijeka Kaletra u djece mlađe od dvije godine nisu još ustanovljene.
The safety and efficacy of Kalydeco in children aged less than 2 years have not been established.
Sigurnost i djelotvornost lijeka Kalydeco u djece mlađe od 2 godine nisu ustanovljene.
The safety and efficacy of Kalydeco in children aged less than 2 years with a gating (class III) mutation have not been established.
Sigurnost i djelotvornost lijeka Kalydeco u djece mlađe od 2 godine s mutacijom (III. klase) zbog koje dolazi do nepravilne regulacije kanala nisu ustanovljene.
The safety and efficacy of Keppra in children below and adolescents 16 years as monotherapy treatment have not been established.
Kod monoterapije u djece i adolescenata mlađih od 16 godina sigurnost i djelotvornost Keppre nije dokazana.
The safety and efficacy of Kineret in patients with chronic infections have not been evaluated.
Sigurnost i djelotvornost Kinereta u bolesnika s kroničnim infekcijama nije procjenjivana.
The safety and efficacy of Kinzalkomb in children and adolescents aged below 18 have not been established.
Nisu utvrđeni sigurnost i djelotvornost Kinzalkomba kod djece i adolescenata do 18 godina starosti.
The safety and efficacy of Kinzalmono in children and adolescents aged below 18 years have not been established.
Sigurnost i djelotvornost Kinzalmona nije utvrđena u djece i adolescenata mlađih od 18 godina.
The safety and efficacy of Kinzalmono in children and adolescents aged below 18 years have not been established.
Sigurnost i djelotvornost Kinzalmonoa u djece i adolescenata u dobi ispod 18 godina još uvijek nisu utvrđene.
The safety and efficacy of Kivexa in children weighing less than 25 kg has not been established.
Sigurnost i djelotvornost lijeka Kivexa u djece tjelesne težine manje od 25 kg nisu još ustanovljene.
The safety and efficacy of Kovaltry in previously untreated patients have not yet been established.
Sigurnost i djelotvornost lijeka Kovaltry u bolesnika koji prethodno nisu liječeni nisu još ustanovljene.
The safety and efficacy of lacosamide in children aged below 16 years have not yet been established.
Sigurnost i djelotvornost lakozamida u djece mlađe od 16 godina nije još utvrđena.
The safety and efficacy of lacosamide in children aged below 16 years have not yet been established.
Sigurnost i djelotvornost lakozamida u djece mlađe od 16 godina nijejoš utvrđena.
The safety and efficacy of Lamivudine Teva in infants, children and adolescents aged below 18 years have not been established.
Sigurnost i djelotvornost lijeka Lamivudin Teva u djece i adolescenata u dobi ispod 18 godina nije još ustanovljena.
The safety and efficacy of LEMTRADA were evaluated in 3 randomised, rater-blinded, active-comparator clinical trials in patients with RRMS.
Sigurnost i djelotvornost lijeka LEMTRADA ocijenjena je u tri randomizirana klinička ispitivanja s bolesnicima oboljelima od RRMS-a, u kojima ocjenjivači nisu znali koji bolesnik prima koji lijek i u kojima je primjenjivan aktivni usporedni lijek.
The safety and efficacy of lenalidomide was assessed in a Phase III multicenter, randomized double blind 3 arm study (MM-015) of patients who were 65 years or older and had a serum creatinine < 2.5 mg/dL.
Sigurnost i djelotvornost lenalidomida procijenjena je u multicentričnom, randomiziranom, dvostruko slijepom ispitivanju faze III (MM-015) na 3 skupine bolesnika u dobi od 65 godina ili starijih, koji su imali kreatinin u serumu < 2,5 mg/dL.
The safety and efficacy of Levemir in children below 1 year of age have not been established.
Sigurnost i djelotvornost lijeka Levemir u djece mlađe od 1 godine nisu utvrđeni.
The safety and efficacy of Levemir in children below 1year of age have not been established.
Sigurnost i djelotvornost lijeka Levemir u djece mlađe od 1 godine nisu utvrđeni.
The safety and efficacy of levetiracetam concentrate for solution for infusion in infants and children less than 4 years have not been established.
Sigurnost i djelotvornost levetiracetam koncentarata za otopinu za infuziju kod dojenčadi i djece mlađe od 4 godine nije još ustanovljena.
The safety and efficacy of Levetiracetam SUN concentrate for solution for infusion in infants and children less than 4 years have not been established.
Sigurnost i djelotvornost Levetiracetam SUN koncentrata za otopinu za infuziju u dojenčadi i djece mlađe od 4 godine nisu utvrđeni.
The safety and efficacy of linaclotide in children aged 0 to18 years have not yet been established.
Sigurnost i djelotvornost linaklotida u djece u dobi od 0 do 18 godina starosti nisu još ustanovljene.
The safety and efficacy of linagliptin in children and adolescents has not yet been established.
Sigurnost i djelotvornost linagliptina u djece i adolescenata nisu još ustanovljene.
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.
Sigurnost i djelotvornost Lojuxte u djece < 18 godina nije ustanovljena pa se stoga u djece ne preporučuje upotreba ovog lijeka.
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.
Sigurnost i djelotvornost Lojuxte u djece < 18 godina nije ustanovljena pa se stoga u djece ne preporučuje upotreba ovog lijeka.
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).
Sigurnost i djelotvornost dugotrajnog liječenja Sebivom (104 tjedna) ispitivani su u dva ispitivanja s aktivnom kontrolom koja su uključivala 1699 bolesnika s kroničnim hepatitisom B (NV-02B-007 GLOBE i NV-02B-015).
The safety and efficacy of lopinavir/ritonavir has not been established in patients with significant underlying liver disorders.
Sigurnost i djelotvornost lopinavira/ritonavira u bolesnika sa znatnim podležećim poremećajima funkcije jetre još nisu utvrđene.
The safety and efficacy of Lucentis in children and adolescents below 18 years of age have not been established.
Sigurnost i djelotvornost Lucentisa u djece i adolescenata u dobi ispod 18 godina starosti nisu ustanovljene.
The safety and efficacy of LUMIGAN in children aged 0 to 18 years has not yet been established.
Sigurnost i djelotvornost LUMIGAN-a u djece u dobi od 0 do 18 godina nije još ustanovljena.
The safety and efficacy of LUMIGAN in children aged 0 to less than 18 years has not been established.
Sigurnost i djelotvornost LUMIGAN-a u djece u dobi od 0 do 18 godina nije ustanovljena.
The safety and efficacy of Lynparza in children and adolescents has not been established.
Sigurnost i djelotvornost lijeka Lynparza kod djece i adolescenata nisu ustanovljene.
The safety and efficacy of Lyrica in children below the age of 12 years and in adolescents (12-17 years of age) have not been established.
Sigurnost i djelotvornost lijeka Lyrica u djece mlađe od 12 godina i adolescenata (12–17 godina) nisu ustanovljene.
The safety and efficacy of macitentan in children have not yet been established.
Sigurnost i djelotvornost macitentana u djece nisu još ustanovljene.
The safety and efficacy of Matever in children below and adolescents 16 years as monotherapy treatment have not been established.
Kod monoterapije u djece i adolescenata mlađih od 16 godina sigurnost i djelotvornost Matevera nije dokazana.
The safety and efficacy of Metalyse in children (below 18 years) have not been established.
Sigurnost i djelotvornost Metalysea kod djece (ispod 18 godina starosti) nisu utvrđeni.
The safety and efficacy of Micardis in children and adolescents aged below 18 years have not been established.
Sigurnost i djelotvornost Micardisa nije utvrđena u djece i adolescenata mlađih od 18 godina.
The safety and efficacy of Micardis in children and adolescents aged below 18 years have not been established.
Sigurnost i djelotvornost Micardisa u djece i adolescenata u dobi ispod 18 godina još uvijek nisu utvrđene.
The safety and efficacy of MicardisPlus in children and adolescents aged below 18 have not been established.
Nisu utvrđeni sigurnost i djelotvornost MicardisPlusa kod djece i adolescenata do 18 godina starosti.
The safety and efficacy of Mimpara in the paediatric population have not been established.
Sigurnost i djelotvornost Mimpare u pedijatrijskoj populaciji nisu ustanovljeni.
The safety and efficacy of mirabegron in children below 18 years of age have not yet been established.
Sigurnost i djelotvornost mirabegrona u djece mlaĎe od 18 godine nisu još ustanovljene.
The safety and efficacy of MIRCERA therapy in other indications, including anaemia in patients with cancer, has not been established.
Sigurnost i djelotvornost primjene lijeka MIRCERA u drugim indikacijama, uključujući anemiju u bolesnika sa zloćudnim bolestima, nije utvrđena.