natgillin/translations-raw huggingface dataset:
The risk of these rare events may be higher with post- operative use of indwelling epidural catheters or the concomitant use of other medicinal products affecting haemostasis.
Rizik od nastupa tih rijetkih događaja može se povećati postoperativnom uporabom trajnih epiduralnih katetera ili istodobnom primjenom drugih lijekova koji utječu na hemostazu.
The risk of thrombocytopenia due to the use of heparin may persist for several years.
Rizik od trombocitopenije uzrokovane primjenom heparina može potrajati nekoliko godina.
The risk of torsade de pointes is related to the extent of QT prolongation, concomitant administration of QT prolonging medicinal products, a history of torsade de pointes, preexisting QT interval prolongation, congestive heart failure, administration of potassium-wasting diuretics, or other conditions that result in hypokalaemia or hypomagnesaemia.
Rizik od torsade de pointes povezan je sa stupnjem produljenja QT intervala, istodobnom primjenom lijekovakoji produljuju QT interval , anamnezom torsade de pointes, postojećim prethodnim produljenjem QT intervala, kongestivnim zatajenjem srca, primjenom diuretika koji troše kalij ili druga stanja koja rezultiraju hipokalemijom ili hipomagnezijemijom.
The risk of torsades may be increased in patients with electrolyte imbalance (see section 4.8).
Rizik od nastupa torsades de pointes može biti povećan u bolesnika s neravnotežom elektrolita (vidjeti dio 4.8).
The risk of using duloxetine in combination with other CNS-active medicinal products has not been systematically evaluated, except in the cases described in this section.
Rizici pri uzimanju duloksetina u kombinaciji s drugim lijekovima koji djeluju na SŽS nisu sustavno ocijenjeni, osim u slučajevima opisanima u ovom dijelu.
The risk of venous thromboembolism continues for 4−6 weeks after discontinuing combined oral contraception.
Rizik od venske tromboembolije nastavlja se još 4 do 6 tjedana nakon prekida liječenja kombiniranim oralnim kontraceptivima.
The risk of venous thromboembolism continues for 4−6 weeks after discontinuing combined oral contraception.
Rizik od venske tromboembolije postoji narednih 4-6 tjedana nakon prekida uzimanja kombiniranih oralnih kontraceptiva.
The risk of virological failure with Kivexa might be higher than with other therapeutic options (see section 5.1).
Rizik od izostanka virološkog odgovora može biti viši u liječenju lijekom Kivexa nego u drugim opcijama liječenja (vidjeti dio 5.1).
The risk of VTE (deep vein thrombosis and pulmonary embolism) is increased with other selective oestrogen receptor modulators (SERMs).
Rizik za pojavu VTE (tromboze dubokih vena i plućne embolije) povećan je tijekom primjene drugih selektivnih modulatora estrogenskih receptora (engl. selective oestrogen receptor modulator - SERM).
The risk of withdrawal symptoms seen with SSRI’s and SNRI’s may be dependent on several factors including the duration and dose of therapy and the rate of dose reduction.
Rizik od pojave simptoma koji se javljaju pri prekidu liječenja viđenih kod primjene SSRI-a i SNRI-ja može ovisiti o nekoliko faktora, uključujući trajanje i dozu terapije i brzinu smanjivanja doze.
The risk of withdrawal symptoms seen with SSRI’s and SNRI’s may be dependent on several factors including the duration and dose of therapy and the rate of dose reduction.
Rizik od pojave simptoma ustezanja uočenih kod primjene SSRI-ja i SNRI-ja može ovisiti o nekoliko čimbenika, uključujući trajanje liječenja, terapijsku dozu i brzinu smanjivanja doze.
The risk of you having bone problems is higher if you:
Vjerojatnost da ćete imati tegoba s kostima veća je ako:
The risk on virus shedding vertical viral transmission is theoretically negligible however not excluded.
Rizik izlučivanja virusa i vertikalnog prijenosa virusa je teoretski zanemariv, no ipak se ne isključuje.
The risk reduction of progression was 32.1% and was associated with a significantly longer TTP (p = 0.0004) in favor of the TCF arm.
Rizik smanjenja progresije bio je 32,1% i bio je udružen sa značajnim produljenjem TTP (p=0,0004) u korist TCF skupine.
The risk reduction of progression was 32.1% and was associated with a significantly longer TTP (p=0.0004) in favour of the TCF arm.
Rizik smanjenja progresije bio je 32,1% i bio je udružen sa značajnim produljenjem TTP (p=0,0004) u korist TCF skupine.
The risk requires assessment on a case-by-case basis (see section 4.2).
Rizik treba procjenjivati od slučaja do slučaja (vidjeti dio 4.2).
The risk requires assessment on a case-by-case basis (see section 4.4).
Rizik se procjenjuje za svakog bolesnika pojedinačno (vidjeti dio 4.4).
The risk to the unborn child is unknown.
Rizik za nerođeno dijete nije poznat.
the risk, co-administration of
delamanida i ritonavira smatra
the risk, co-administration of
nadmašuje rizik, bedakilin se
The risk-benefit balance should be considered in patients at risk of thromboembolic events (TEEs) of any aetiology.
Treba razmotriti omjer rizika i koristi kod bolesnika koji imaju povećani rizik za tromboembolijske događaje bilo koje etiologije.
The risk-benefit for the treatment of thrombocytopenia outside of the registered indication has not been established.
Nije utvrđen omjer rizika i koristi za liječenje trombocitopenije izvan odobrene indikacije.
The risk-benefit of Revolade in paediatric HCV-associated thrombocytopenia and SAA has not been established.
Nije utvrđen omjer rizika i koristi lijeka Revolade u pedijatrijske s HCV-om povezane trombocitopenije i teške aplastične anemije.
The risk-to-benefit ratio should be carefully evaluated before considering vaccination with ProQuad in such cases (see section 4.8).
U takvim slučajevima, prije razmatranja cijepljenja cjepivom ProQuad treba pažljivo procijeniti omjer rizika i koristi (vidjeti dio 4.8).
The risk/benefit ratio of mycophenolate mofetil in combination with tacrolimus or sirolimus has not been established (see also section 4.5).
Omjer rizika i koristi primjene mofetilmikofenolata u kombinaciji s takrolimusom ili sirolimusom nije ustanovljen (vidjeti i dio 4.5).
The risk/benefit-ratio of mycophenolate mofetil in combination with tacrolimus or sirolimus has not been established (see also section 4.5).
Omjer rizika i koristi primjene mofetilmikofenolata u kombinaciji s takrolimusom ili sirolimusom nije ustanovljena (vidjeti i dio 4.5).
The risks and benefits of Imlygic should be considered before initiating treatment in patients who have underlying autoimmune disease or before continuing treatment in patients who develop immune- mediated events.
Potrebno je razmotriti rizike i koristi lijeka Imlygic prije početka liječenja u bolesnika koji imaju podležeću autoimunu bolest ili prije nastavka liječenja u bolesnika u kojih su se razvili imunološki posredovani događaji.
The risks and benefits of pazopanib should be considered before beginning therapy in patients who have pre-existing cardiac dysfunction.
Potrebno je razmotriti rizike i dobrobit primjene pazopaniba prije započinjanja terapije u bolesnika koji imaju već postojeću disfunkciju srca.
The risks and benefits of vaccinating patients during therapy with ofatumumab should be considered.
Treba razmotriti rizike i koristi cijepljenja bolesnika tijekom terapije ofatumumabom.
The risks asociated with the surgical procedures and MACI
rizike povezane s kirurškim zahvatima i implantatom MACI
The risks associated with incorrect storage and mishandling
Rizik povezan s nepravilnim čuvanjem i rukovanjem
The risks of developing hypocalcaemia and accompanying parathyroid hormone elevations increase with increasing degree of renal impairment.
Rizik razvijanja hipokalcijemije, te pratećeg porasta paratireoidnog hormona povećava se s povećanjem stupnja oštećenja bubrega.
the risks of ectopic bone formation
rizicima od ektopičnog stvaranja kosti
The risks of off-label use within FXIII congenital deficiency
Rizik vezan za primjenu u neodobrenoj indikaciji kod prirođenog nedostatka FXIII
The risks of stopping Soliris include an increase in the destruction of your red blood cells, which may cause:
Rizici prekida primanja lijeka Soliris uključuju povećano razaranje crvenih krvnih stanica, što može prouzročiti:
The risks of stopping Soliris include an increase in the inflammation of your platelets, which may cause:
Rizici prekida primanja lijeka Soliris uključuju povećanu upalu krvnih pločica, što može prouzročiti:
the risks of treatment with eculizumab
rizike liječenja ekulizumabom
The rivaroxaban clinical program was designed to demonstrate the efficacy of Xarelto for the prevention of cardiovascular (CV) death, MI or stroke in subjects with a recent ACS (ST-elevation myocardial infarction [STEMI], non- ST-elevation myocardial infarction [NSTEMI] or unstable angina [UA]).
Klinički program za rivaroksaban osmišljen je da bi se pokazala djelotvornost lijeka Xarelto u sprječavanju kardiovaskularne (KV) smrti, infarkta miokarda ili moždanog udara u ispitanika s nedavnim akutnim koronarnim sindromom (infarkt miokarda s povišenjem ST spojnice [STEMI], infarkt miokarda bez povišenja ST-spojnice [NSTEMI] ili nestabilnom anginom pektoris.
The rivaroxaban clinical programme was designed to demonstrate the efficacy of rivaroxaban for the prevention of VTE, i.e. proximal and distal deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients undergoing major orthopaedic surgery of the lower limbs.
Program kliničke primjene rivaroksabana bio je osmišljen tako da se pokaže djelotvornost rivaroksabana u prevenciji VTE-a, tj. proksimalne i distalne duboke venske tromboze (DVT) i u prevenciji plućne embolije (PE) u bolesnika podvrgnutih velikim ortopedskim kirurškim zahvatima na donjim udovima.
The role and use of patient alert card.
Uloga i primjena Kartice s upozorenjima za bolesnika.
The role and use of patient alert card.
Uloga i uporaba kartice s upozorenjima za bolesnike.
The role and use of the Patient Alert Card
Ulogu i korištenje Kartice s upozorenjima za bolesnika
The role and use of the Patient Alert Card.
Ulogu i korištenje Kartice s upozorenjima za bolesnika.
The role and use of the Prescriber Checklist sticker included in the product package to document the established pregnancy status prior to dosing.
uloga i upotreba naljepnice s kontrolnim popisom za osobu koja propisuje lijek u pakiranju lijeka služi za dokumentiranje utvrđivanja trudnoće prije propisivanja doze.
The role of Ceplene is to protect lymphocytes, in particular NK cells and T cells, which are responsible for the immune- mediated destruction of residual leukaemic cells.
Uloga Ceplenea je zaštititi limfocite, osobito NK stanice i T stanice, koje su odgovorne za imunološki posredovano uništavanje rezidualnih stanica leukemije.
The role of the patient card in ensuring that patients are aware of the product they are taking and the recommendations for safe and effective use in particular once daily dose and the importance of avoiding switching between other tacrolimus containing products except under the advice and supervision of your doctor
Uloga kartice za bolesnika kako bi se osiguralo da su bolesnici upoznati s lijekom kojega uzimaju i preporukama za sigurnu i djelotvornu primjenu jedne doze dnevno, te važnost da se izbjegne prebacivanje između lijekova koji sadrže takrolimus osim ako je to u skladu sa savjetima i pod nadzorom vašeg liječnika
The RSV hospitalisation rate observed in patients enrolled with a diagnosis of CLDP was 28/723 (3.9%) and in patients enrolled with a diagnosis of prematurity without CLDP was 34/2583 (1.3%).
Stopa hospitalizacije zbog RSV-a kod bolesnika koji su imali dijagnozu CLDP- a prilikom ulaska u studiju bila je 28/723 (3,9%), a kod nedonoščadi bez CLDP-a prilikom ulaska u studiju bila je 34/2583 (1,3%).
The rubber stopper and surrounding surface of the vial containing Xiapex and the vial containing the solvent for reconstitution should be swabbed with sterile alcohol (no other antiseptics must be used).
Gumeni čep i okolnu površinu bočice koja sadrži Xiapex i bočice koja sadrži otapalo za rekonstituciju treba obrisati sterilnim alkoholom (ne smije se uporabiti neki drugi antiseptik).
The rubber top should be cleaned and a new syringe with needle inserted into the vial .
Gumeni čep treba obrisati i u bočicu umetnuti novu štrcaljku s iglom.
The rules for stopping when target liver iron concentration and serum ferritin are reached
pravila za prekid liječenja kada se postignu ciljane koncentracije željeza u jetri i serumskog feritina
The S- COMT activity inhibition was significantly increased in elderly subjects.
Inhibicija aktivnosti S-COMT bila je značajno povećana u starijih ispitanika.
The sachet is constructed from a multi-layer foil based laminate pouch material (polymethacrylate/acrylonitrile copolymer/adhesive/aluminum/low density polyethylene/paper).
Vrećica je izrađena od laminiranog materijala za vrećice koji se sastoji od višeslojne folije (polimetakrilat/kopolimer akrilonitrila/adheziv/aluminij/polietilen niske gustoće/papir).
The sachet is constructed from a multi-layer foil based laminated pouch material.
Vrećica je izrađena od laminiranog materijala za vrećice koji se sastoji od višeslojne folije.
The sachets should only be opened immediateley prior to use.
Vrećice treba otvarati samo neposredno prije upotrebe.
The sachets should only be opened immediately prior to use.
Vrećice otvarati neposredno prije primjene.
The sachets should only be opened immediately prior to use.
Vrećicu bi trebalo otvarati neposredno prije primjene.
The safe use of CELSENTRI in pregnancy has not been proven.
Sigurnost primjene lijeka CELSENTRI u trudnoći nije dokazana.
The safe use of Kalydeco during breast- feeding has not been established.
Sigurna primjena lijeka Kalydeco tijekom dojenja nije ustanovljena.
The safe use of Kalydeco during breast-feeding has not been established.
Sigurna primjena lijeka Kalydeco tijekom dojenja nije ustanovljena.
The safe use of pazopanib during lactation has not been established.
Nije utvrđena sigurna primjena pazopaniba tijekom dojenja.
The safe use of Zalmoxis has not been demonstrated during pregnancy and breast-feeding.
Sigurna primjena Zalmoxisa za vrijeme trudnoće i dojenja nije dokazana.
The safety after repeated implantations with Suprelorin in ferrets has not been investigated.
Neškodljivost Suprelorina nakon ponovljene implantacije nije dokazana u afričkih tvorova.
The safety analyses were done considering the clinical study 1 [CCG-1962] and study 2 [AALL07P4] adverse drug reactions (see section 5.1).
Analize sigurnosti provedene su uzimajući u obzir nuspojave iz kliničkog ispitivanja 1 [CCG-1962] i ispitivanja 2 [AALL07P4] (vidjeti dio 5.1).
The safety and antibody persistence data up to year 5 and the data on co-administration of MenACWY-TT with Prevenar 13 will be provided in sequential study reports at 1, 3 and 5 years after vaccination.
Podaci o sigurnosti i postojanosti protutijela do 5 godina i podaci o istovremenoj primjeni MenACWY-TT s Prevenarom 13 bit će dostupni u serijskim izvješćima o ispitivanju 1, 3 i 5 godina nakon cijepljenja.
The safety and appropriate dose of Sovaldi have not been established in patients with severe renal impairment (estimated glomerular filtration rate [eGFR] <30 mL/min/1.73 m2) or end stage renal disease (ESRD) requiring haemodialysis (see section 5.2).
Sigurnost i odgovarajuća doza Sovaldija nisu ustanovljene u bolesnika s teškim oštećenjem bubrega (procjena brzine glomerularne filtracije [eGFR] < 30 ml/min/1,73 m2) ili završnim stadijem bolesti bubrega koje zahtijeva hemodijalizu (vidjeti dio 5.2).
The safety and effectiveness of once every three weeks dosing of Aranesp therapy in reducing the requirement for red blood cell transfusions in patients undergoing chemotherapy was assessed in a randomised, double-blind, multinational study.
Sigurnost i učinkovitost terapije jednom dozom Aranespa svaka tri tjedna u smanjivanju potrebe za transfuzijom crvenih krvnih stanica u bolesnika na kemoterapiji utvrđena je u randomiziranoj, dvostruko slijepoj, multinacionalnoj studiji.
The safety and effectiveness of Plegridy in this age group are not known.
Sigurnost i djelotvornost Plegridyja u ovoj dobnoj skupini nisu poznati.
The safety and effectiveness of SonoVue in patients under 18 years old has not been established and the product should not be used in these patients.
Sigurnost i učinkovitost lijeka SonoVue kod bolesnika mlađih od 18 godina nisu ustanovljene te se lijek ne smije koristiti kod takvih bolesnika.
The safety and effectiveness of Tecfidera in this age group are not known.
Sigurnost i učinkovitost Tecfidere u ovoj dobnoj skupini nisu poznati.
The safety and effectiveness of Zinbryta in this age group are not known.
Sigurnost i djelotvornost Zinbryte u toj dobnoj skupini nije poznata.
The safety and efficacy are not yet known in this age group.
Sigurnost i djelotvornost još nisu poznati za tu dobnu skupinu.
The safety and efficacy have not been studied in patients with hepatic impairment.
Sigurnost i djelotvornost u bolesnika s oštećenjem funkcije jetre nisu ispitane.
The safety and efficacy have not been studied in patients with renal impairment.
Sigurnost i djelotvornost u bolesnika s oštećenjem funkcije bubrega nisu ispitane.
The safety and efficacy in children (below the age of 18 years) has not been studied.
Sigurnost i djelotvornost u djece (mlađe od 18 godina) nisu ispitivane.
The safety and efficacy in children (below the age of 18 years) has not been studied.
Sigurnost primjene i djelotvornost u djece (mlađe od 18 godina) nije ispitivana.
The safety and efficacy in children (including neonates) less than 4 months of age of doses of 4 and 10 mg/kg for the treatment of invasive candidiasis with CNS involvement has not been adequately established in controlled clinical studies.
Sigurnost i djelotvornost u djece (uključujući novorođenčad) mlađe od 4 mjeseca u dozama od 4 i 10 mg/kg za liječenje invazivne kandidijaze koja uključuje SŽS nije bila adekvatno ustanovljena u kontroliranim kliničkim ispitivanjima.
The safety and efficacy in children and adolescents below 18 years of age have not been established as there is no relevant use in the paediatric population for the indication of metastatic breast cancer (MBC).
Sigurnost i djelotvornost u djece i adolescenata mlađih od 18 godina nisu ustanovljene jer nije opravdana primjena lijeka u pedijatrijskoj populaciji za indikaciju metastatskog raka dojke.
The safety and efficacy in children have not been established.
Sigurnost primjene i djelotvornost u djece nisu ustanovljene.
The safety and efficacy in neonates and patients with autoimmune neutropenia have not been established.
Sigurnost i djelotvornost u novorođenčadi i bolesnika s autoimuniom neutropenijom nisu ustanovljene.
The safety and efficacy of 1.5 mg has not been studied (see section 4.4.)
Sigurnost i djelotvornost primjene doze od 1,5 mg nije bila proučavana (vidjeti dio 4.4).
The safety and efficacy of 1.5 mg has not been studied (see section 4.4.)
Sigurnost i učinkovitost primjene doze od 1,5 mg nije bila proučavana (vidjeti dio 4.4).
The safety and efficacy of 80 mg once-daily TAGRISSO was explored in an expansion cohort of 63 previously-treated patients with centrally confirmed T790M positive NSCLC.
Sigurnost i djelotvornost lijeka TAGRISSO u dozi od 80 mg jedanput dnevno ispitana je u ekspanzijskoj kohorti od 63 prethodno liječena bolesnika sa središnje potvrđenim NSCLC-om s pozitivnom T790M mutacijom.
The safety and efficacy of abatacept were assessed in a three-part study.
Sigurnost i djelotvornost abatacepta ispitane su u trodijelnom ispitivanju.
The safety and efficacy of ABILIFY solution for injection in children and adolescents aged 0-17 years have not been established.
Sigurnost i djelotvornost lijeka ABILIFY otopina za injekciju u djece i adolescenata u dobi od 0 do 17 godina nisu ustanovljene.
The safety and efficacy of Aclasta in children and adolescents below 18 years of age have not been established.
Sigurnost i djelotvornost Aclaste u djece i adolescenata ispod 18 godina starosti nije još utvrđena.
The safety and efficacy of Actelsar HCT in children and adolescents aged below 18 have not been established.
Nisu utvrđeni sigurnost i djelotvornost Actelsara HCT kod djece i adolescenata do 18 godina starosti.
The safety and efficacy of Actos in children and adolescents under 18 years of age have not been established.
Sigurnost i djelotvornost lijeka Actos u djece i adolescenata mlađih od 18 godina nije ustanovljena.
The safety and efficacy of ADCIRCA in individuals below 18 years of age has not yet been established.
Sigurnost i djelotvornost lijeka ADCIRCA u osoba mlađih od 18 godina još nisu ustanovljene.
The safety and efficacy of Aerivio Spiromax in this young population have not been established.
Sigurnost i djelotvornost Airexar Spiromaxa u ove mlade populacije nisu ustanovljene.
The safety and efficacy of AFLUNOV in subjects under 18 years of age have not yet been established.
Sigurnost i djelotvornost cjepiva AFLUNOV u ispitanika mlađih od 18 godina nisu još ustanovljene.
The safety and efficacy of Akynzeo in the paediatric population have not been established.
Sigurnost i djelotvornost Akynzea u pedijatrijskoj populaciji nisu ustanovljene.
The safety and efficacy of alogliptin when used as triple therapy with metformin and a sulphonylurea have not been fully established.
Sigurnost i djelotvornost alogliptina nisu u potpunosti ustanovljene kada se primjenjuje kao trojna terapija s metforminom i sulfonilurejom.
The safety and efficacy of Aloxi in children have not been established.
Sigurnost primjene i djelotvornost Aloxija u djece nije ustanovljena.
The safety and efficacy of ALPROLIX in previously untreated patients have not yet been established.
Sigurnost i djelotvornost lijeka ALPROLIX u bolesnika koji prethodno nisu bili liječeni nisu još ustanovljene.
The safety and efficacy of anagrelide as a platelet lowering agent have been evaluated in four open- label, non-controlled clinical trials (study numbers 700-012, 700-014, 700-999 and 13970-301) including more than 4000 patients with myeloproliferative disorders (MPDs).
Sigurnost i djelotvornost anagrelida kao sredstva za smanjenje broja trombocita procijenjene su u četiri otvorena nekontrolirana klinička ispitivanja (ispitivanja broj 700-012, 700-014, 700-999 i 13970-301) koja su uključila više od 4000 bolesnika s mijeloproliferativnim poremećajima.
The safety and efficacy of anagrelide in children has not been established.
Sigurnost i djelotvornost anagrelida u djece nije ustanovljena.
The safety and efficacy of anakinra in combination with methotrexate have been demonstrated in 1790 RA patients  18 years of age with varying degrees of disease severity.
Sigurnost i djelotvornost anakinre u kombinaciji s metotreksatom dokazana je u 1790 bolesnika s RA u dobi 18 godina s različitim stupnjevima težine bolesti.
The safety and efficacy of anidulafungin were evaluated in a pivotal Phase 3, randomised, double- blind, multicentre, multinational study of primarily non-neutropenic patients with candidaemia and a limited number of patients with deep tissue Candida infections or with abscess-forming disease.
Sigurnost primjene i djelotvornost anidulafungina procijenjena je u velikom randomiziranom, dvostruko slijepom, multicentričnom, multinacionalnom ispitivanju faze III i to prvenstveno na bolesnicima s kandidemijom bez neutropenije i na ograničenom broju bolesnika s infekcijom dubokih tkiva izazvanom Candidom ili apscedirajućim oblikom bolesti.
The safety and efficacy of apremilast were evaluated in 3 multi-center, randomized, double-blind, placebo- controlled studies (Studies PALACE 1, PALACE 2, and PALACE 3) of similar design in adult patients with active PsA (≥ 3 swollen joints and ≥ 3 tender joints) despite prior treatment with small molecule or biologic DMARDs.
Sigurnost i djelotvornost apremilasta procijenjene su u 3 multicentrična, randomizirana, dvostruko slijepa, placebom kontrolirana ispitivanja (ispitivanja PALACE 1, PALACE 2 i PALACE 3) sličnog dizajna u odraslih bolesnika s aktivnim psorijatičnim artritisom (≥ 3 otečena zgloba i ≥ 3 bolna zgloba) unatoč prethodnom liječenju malomolekulskim ili biološkim DMARD lijekovima.