natgillin/translations-raw huggingface dataset:
There is insufficient experience of the use of topotecan in patients with severely impaired renal function (creatinine clearance < 20 ml/min) or severely impaired hepatic function (serum bilirubin ≥ 10 mg/dl) due to cirrhosis.
Nedovoljno je podataka o primjeni topotekana u bolesnika s teškim oštećenjem bubrežne funkcije (klirens kreatinina <20 ml/min) ili teškim oštećenjem jetrene funkcije zbog ciroze (vrijednost bilirubina u serumu 10 mg/dl ili više).
There is insufficient experience of the use of topotecan in patients with severely impaired renal function (creatinine clearance < 20 ml/min) or severely impaired hepatic function (serum bilirubin ≥ 10 mg/dl) due to cirrhosis.
Nedovoljno je podataka o primjeni topotekana u bolesnika s teškim oštećenjem bubrežne funkcije (klirens kreatinina <20 ml/min) ili teškim oštećenjem jetrene funkcije zbog ciroze (vrijednost bilirubina u serumu ≥ 10 mg/dl).
There is insufficient experience of the use of topotecan in patients with severely impaired renal function (creatinine clearance < 20 ml/min) or severely impaired hepatic function (serum bilirubin ≥ 10 mg/dl) due to cirrhosis.
Nedovoljno je podataka o primjeni topotekana u bolesnika s teškim oštećenjem bubrežne funkcije (klirens kreatinina <20 ml/min) ili teškim oštećenjem jetrene funkcije zbog ciroze (vrijednost bilirubina u serumu ≥10 mg/dl).
There is insufficient information on the effects of desloratadine and pseudoephedrine sulphate in newborns/infants..
Nema dovoljno podataka o učinku desloratadina i pseudoefedrinsulfata na novorođenčad/dojenčad.
There is insufficient information on the effects of elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate in newborns/infants.
Nema dovoljno podataka o učincima elvitegravira, kobicistata, emtricitabina i tenofovirdizoproksilfumarata u novorođenčadi/dojenčadi.
There is insufficient information on the effects of emtricitabine and tenofovir in newborns/infants.
Nema dovoljno podataka o učincima emtricitabina i tenofovira na novoroĎenčad/dojenčad.
There is insufficient information on the effects of emtricitabine in newborns/infants.
Nema dovoljno podataka o učinku emtricitabina na novoroĎenčad/dojenčad.
There is insufficient information on the effects of esomeprazole in newborns/infants.
Nema dovoljno podataka o učincima esomeprazola u novorođenčadi/dojenčadi.
There is insufficient information on the excretion of asfotase alfa in human milk.
Nema dovoljno podataka o izlučivanju asfotaze alfa u ljudsko mlijeko.
There is insufficient information on the excretion of certolizumab pegol in human or animal breast milk.
Nema dovoljno informacija o izlučivanju certolizumabpegola u majčino mlijeko u ljudi ili životinja.
There is insufficient information regarding the concomitant use of Simponi with other biological therapeutics used to treat the same conditions as Simponi.
Nema dovoljno podataka o istodobnoj primjeni lijeka Simponi s drugim biološkim lijekovima koji se primjenjuju za liječenje istih stanja kao i Simponi.
There is insufficient information to determine the safety and efficacy of bevacizumab in children with newly- diagnosed high-grade glioma.
Nema dovoljno informacija na temelju kojih bi se utvrdila sigurnost i djelotvornost bevacizumaba u djece s novodijagnosticiranim gliomom visokog stupnja malignosti.
There is insufficient information to recommend dosage adjustments in adolescents aged from 12 to < 18 years with bodyweight < 33 kg and in children aged from 2 to 12 years with ESRD.
Nema dovoljno podataka za preporuku prilagodbe doziranja u adolescenata u dobi od navršenih 12 do <18 godina čija je tjelesna težina <33 kg te u djece u dobi od navršene 2 do 12 godina koji imaju završnu fazu bubrežne bolesti.
There is limited clinical data (n = 2) on the use of SIRTURO in elderly patients.
Postoje ograničeni klinički podaci (n = 2) o primjeni lijeka SIRTURO u starijih bolesnika.
There is limited clinical data in patients aged 75 or over.
Klinički podaci o primjeni kod bolesnica u dobi od 75 ili više godina su ograničeni.
There is limited clinical data on the safety of CIALIS in patients with severe hepatic impairment (Child-Pugh Class C); if prescribed, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician.
Malobrojni su klinički podaci o sigurnosti primjene lijeka CIALIS u bolesnika s teškim oštećenjem jetrene funkcije (Child-Pugh stadij C).
There is limited clinical data on the safety of CIALIS in patients with severe hepatic insufficiency (Child- Pugh Class C).
Malobrojni su klinički podaci o sigurnosti primjene lijeka CIALIS u bolesnika s teškim oštećenjem jetrene funkcije (Child-Pugh stadij C).
There is limited clinical data on the safety of single-dose administration of CIALIS in patients with severe hepatic insufficiency (Child-Pugh Class C).
Postoje malobrojni klinički podaci o sigurnosti primjene jednokratne doze lijeka CIALIS u bolesnika s teškim oštećenjem jetrene funkcije (Child-Pugh stadij C).
There is limited clinical data on the safety of single-dose administration of tadalafil in patients with severe hepatic insufficiency (Child-Pugh Class C).
Postoje malobrojni klinički podaci o sigurnosti primjene jednokratne doze tadalafila u bolesnika s insuficijencijom jetre (Child-Pugh stadij C).
There is limited clinical data on the safety of tadalafil in patients with severe hepatic insufficiency (Child-Pugh Class C).
Malobrojni su klinički podaci o sigurnosti primjene tadalafila u bolesnika s teškim oštećenjem jetrene funkcije (Child-Pugh stadij C).
There is limited clinical experience in patients with moderate hepatic impairment (Child-Pugh Class B).
Klinička iskustva s primjenom u bolesnika s umjerenim oštećenjem funkcije jetre (stupanj B prema Child- Pughovoj klasifikaciji) su ograničena.
There is limited clinical experience of the use of busulfan as a component of a conditioning regimen prior to HSCT in children with Fanconi’s anaemia.
Postoji ograničeno kliničko iskustvo u primjeni busulfana kao komponente protokola kondicioniranja prije HSCT-a u djece s Fanconijevom anemijom.
There is limited clinical experience with Dynastat treatment beyond three days.
Kliničko iskustvo s liječenjem Dynastatom duljem od tri dana je ograničeno.
There is limited clinical experience with Dynastat treatment beyond three days.
Kliničko iskustvo u liječenju Dynastatom duljem od tri dana je ograničeno.
There is limited clinical experience with NovoMix 30 in children aged 6–9 years (see section 5.1).
Kliničko iskustvo s lijekom NovoMix 30 u djece u dobi 6–9 godina ograničeno je (vidjeti dio 5.1).
There is limited clinical experience with selexipag in patients over the age of 75 years, therefore Uptravi should be used with caution in this population (see section 4.2).
Kliničko iskustvo s primjenom seleksipaga u bolesnika starijih od 75 godina je ograničeno te se stoga Uptravi u ovoj populaciji treba koristiti oprezno (vidjeti dio 4.2).
There is limited clinical experience with the use of naloxegol in OIC patients with cancer-related pain.
Kliničko iskustvo s primjenom naloksegola kod bolesnika s konstipacijom uzrokovanom primjenom opioida i boli uzrokovanom rakom je ograničeno.
There is limited clinical study experience with the use of STAYVEER in patients with PAH associated with HIV infection, treated with antiretroviral medicinal products (see section 5.1).
Iskustvo iz kliničke studije s primjenom STAYVEERA u bolesnika s PAH-om povezanom s HIV- infekcijom koja je liječena antiretrovirusnim lijekovima ograničeno je (vidjeti dio 5.1).
There is limited clinical study experience with the use of Tracleer in patients with PAH associated with HIV infection, treated with antiretroviral medicinal products (see section 5.1).
Iskustvo iz kliničke studije s primjenom Tracleera u bolesnika s PAH-om povezanom s HIV- infekcijom koja je liječena antiretrovirusnim lijekovima ograničeno je (vidjeti dio 5.1).
There is limited clinical trial efficacy experience with the use of desloratadine in adolescents12 through 17 years of age (see sections 4.8 and 5.1).
Postoji ograničeno iskustvo iz kliničkih ispitivanja djelotvornosti primjene desloratadina u adolescenata u dobi od 12 do 17 godina (vidjeti dijelove 4.8 i 5.1).
There is limited data available for patients older than 65 years.
Dostupni podaci koji se odnose na bolesnike starije od 65 godina su ograničeni.
There is limited data available on patients of African origin.
Vrlo je malo podataka dostupno za bolesnike afričkog podrijetla.
There is limited data in patients between 75-84 years old (N=60).
Ograničeni su podaci u bolesnika između 75 i 84 godine starosti (N = 60).
There is limited data in patients previously treated with rituximab (38 patients in the Pixuvri arm and 39 patients in the comparator arm).
Podaci o bolesnicima ranije liječenim rituksimabom ograničeni su (38 bolesnika u skupini Pixuvria i 39 u skupini s usporednim lijekom).
There is limited data in patients with cardiac impairment.
Postoje ograničeni podaci o bolesnicima s oštećenjem funkcije srca.
There is limited data on the efficacy and safety of Fortacin in patients 65 years and over.
Podaci o djelotvornosti i sigurnosti Fortacin u pacijenata u dobi od 65 godina i više su ograničeni.
There is limited evidence on the management of overdose with Brimica Genuair.
Ograničeni su podaci o zbrinjavanju predoziranja Brimica Genuairom.
There is limited evidence on the management of overdose with Duaklir Genuair.
Ograničeni su podaci o zbrinjavanju predoziranja Duaklir Genuairom.
There is limited experience for the booster dose in the elderly population.
Postoji ograničeno iskustvo s booster dozom u starijoj populaciji.
There is limited experience in children and adolescents with Ph+ ALL and very limited experience in children and adolescents with MDS/MPD, DFSP, and HES/CEL.
Postoji ograničeno iskustvo kod djece i adolescenata s Ph+ ALL i vrlo ograničeno iskustvo kod djece i adolescenata s MDS/MPD-om, DFSP-om i HES/KEL-om.
There is limited experience in children and adolescents with Ph-positive ALL and very limited experience in children and adolescents with MDS/MPD, DFSP and HES/CEL.
Postoji ograničeno iskustvo kod djece i adolescenata s Ph- pozitivnim ALL-om te vrlo ograničeno iskustvo kod djece i adolescenata s MDS/MPD-om, DFSP-om i HES/KEL-om.
There is limited experience in children and adolescents with Ph-positive ALL.
Postoji ograničeno iskustvo u djece i adolescenata s Ph- pozitivnim ALL-om.
There is limited experience in children with Ph-positive ALL and very limited experience in children with MDS/MPD, DFSP and HES/CEL.
Postoji ograničeno iskustvo kod djece s Ph-pozitivnim ALL-om te vrlo ograničeno iskustvo kod djece s MDS/MPD-om, DFSP-om, i HES/KEL-om.
There is limited experience in clinical studies in patients with bacteraemia, peripheral vascular disease or neutropenia, in immunocompromised patients, in patients aged > 65 years and in infections due to S. pyogenes.
Postoji ograničeno iskustvo u kliničkim ispitivanjima u bolesnika s bakterijemijom, perifernom vaskularnom bolesti ili neutropenijom, u imunokompromitiranih bolesnika, u bolesnika u dobi >65 godina i kod infekcija izazvanih bakterijom S. pyogenes.
There is limited experience in paediatric patients, see section 4.8.
Iskustvo u pedijatrijskih bolesnika je ograničeno, vidjeti dio 4.8.
There is limited experience in paediatric patients.
Iskustvo u pedijatrijskih bolesnika je ograničeno.
There is limited experience in patients older than 75 years with DME.
Iskustvo u bolesnika s DME starijih od 75 godina je ograničeno.
There is limited experience in patients with a history or presence of clinically relevant central nervous system (CNS) pathology (e.g. epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, Parkinson’s disease, cerebellar disease, organic brain syndrome, psychosis) as they were excluded from clinical trials.
Iskustvo u bolesnika koji u anamnezi imaju ili trenutno boluju od klinički značajne bolesti središnjeg živčanog sustava (SŽS) (npr. epilepsija, napadaji, pareza, afazija, moždani udar, teške ozljede mozga, demencija, Parkinsonova bolest, cerebralna bolest, moždani sindrom organskog porijekla, psihoza) je ograničeno, jer su takvi bolesnici bili isključeni iz kliničkih ispitivanja.
There is limited experience in patients with congestive heart failure New York Heart Association (NYHA) class I-II and Xultophy should therefore be used with caution in these patients.
Iskustvo je ograničeno u bolesnika s kongestivnim srčanim zatajenjem stupnja I-II prema New York Heart Association (NYHA) te je stoga potreban oprez kod primjene lijeka Xultophy u tih bolesnika.
There is limited experience in patients with congestive heart failure New York Heart Association (NYHA) class I­II and liraglutide should therefore be used with caution.
Iskustvo je ograničeno u bolesnika s kongestivnim srčanim zatajenjem stupnja I-II prema New York Heart Association (NYHA) te je stoga potreban oprez kod primjene liraglutida.
There is limited experience in patients with congestive heart failure.
Iskustvo s primjenom lijeka u bolesnika s kongestivnim zatajenjem srca je ograničeno.
There is limited experience in patients ≥ 65 years.
Iskustvo u bolesnika u dobi ≥65 godina je ograničeno.
There is limited experience in patients ≥65 years.
Iskustvo u bolesnika u dobi ≥65 godina je ograničeno.
There is limited experience in the elderly
Postoji ograničeno iskustvo u starijih osoba
There is limited experience in the use of Glybera in elderly subjects.
Kod starijih osaba, iskustvo s primjenom Glybere je ograničeno.
There is limited experience in the use of Glybera in elderly subjects.
Kod starijih osoba, iskustvo s primjenom Glybere je ograničeno.
There is limited experience in the use of imiquimod cream in the treatment of men with foreskin- associated warts.
Iskustvo u primjeni imikvimod kreme u liječenju bradavica na prepuciju (kožici penisa) ograničeno je.
There is limited experience in treating elderly CAPS patients.
Iskustva u liječenju starijih osoba s CAPS-om su ograničena.
There is limited experience of albiglutide when combined with thiazolidinediones alone, sulphonylureas + thiazolidinediones, and metformin + sulphonylureas + thiazolidinediones.
Postoji ograničeno iskustvo s primjenom albiglutida u kombinaciji samo s tiazolidindionima, sulfonilurejama + tiazolidindionima te metforminom + sulfonilurejama + tiazolidindionima.
There is limited experience of overdosage with lamivudine/zidovudine.
Iskustvo s predoziranjem Lamivudinom/Zidovudinom Teva je ograničeno.
There is limited experience on the use of the product in sick and debilitated animals, thus the product should only be used based on a benefit-risk assessment for these animals.
Ograničena su iskustva s primjenom ovoga proizvoda na bolesnim ili vrlo mršavim životinjama, stoga se ova otopina smije primijeniti samo na osnovi procjene da je korist veća od mogućih štetnih učinaka.
There is limited experience on the use of the product in sick and debilitated animals, thus the product should only be used based on a benefit-risk assessment for these animals.
Ograničeno je iskustvo u primjeni proizvoda kod bolesnih i iznurenih životinja, stoga bi se proizvod trebao primjenjivati na temelju procjene koristi-rizika kod tih životinja.
There is limited experience on the use of the product in sick and debilitated animals, thus the product should only be used based on a benefit-risk assessment for these animals.
Ograničeno je iskustvo u primjeni proizvoda kod bolesnih i slabih životinja, stoga bi se proizvod trebao primjenjivati na temelju procjene koristi-rizika-koristi kod tih životinja.
There is limited experience on the use of the product in sick and debilitated animals, thus the product should only be used based on a benefit-risk assessment for these animals.
Oraničena su iskustva s upotrebom ovoga proizvoda na bolesnim ili vrlo mršavim životinjama, stoga se ova otopina smije primijeniti samo na osnovi procjene da je korist veća od mogućih štetnih učinaka.
There is limited experience on the use of the product in sick and debilitated animals, thus the product should only be used based on a benefit-risk assessment for these animals.
Postoji ograničeno iskustvo u primjeni proizvoda kod bolesnih i iznurenih životinja, stoga bi se kod takvih životinja proizvod trebao primjenjivati na temelju procjene koristi/rizika.
There is limited experience with abrupt discontinuation of STAYVEER in patients with pulmonary arterial hypertension.
Postoji ograničeno iskustvo s naglim prekidom primjene STAYVEERA u bolesnika s plućnom arterijskom hipertenzijom.
There is limited experience with abrupt discontinuation of Tracleer in patients with pulmonary arterial hypertension.
Postoji ograničeno iskustvo s naglim prekidom primjene Tracleera u bolesnika s plućnom arterijskom hipertenzijom.
There is limited experience with BLINCYTO in patients with an active uncontrolled infection.
Iskustvo s lijekom BLINCYTO u bolesnika s aktivnom nekontroliranom infekcijom je ograničeno.
There is limited experience with BRINAVESS in patients with pacemakers.
Iskustvo s primjenom lijeka BRINAVESS u bolesnika s ugrađenim elektrostimulatorom srca je ograničeno.
There is limited experience with hydrochlorothiazides during pregnancy, especially during the first trimester.
Postoji ograničeno iskustvo uz hidroklorotiazid tijekom trudnoće, posebice tijekom prvog tromjesečja.
There is limited experience with Lojuxta in patients aged 65 years or older.
Iskustva s Lojuxtom u bolesnika u dobi od 65 godina ili starijih su ograničena.
There is limited experience with NovoMix 30 in children aged 6–9 years.
Iskustvo s lijekom NovoMix 30 u djece u dobi od 6–9 godina ograničeno je.
There is limited experience with opicapone when used concomitantly with tricyclic antidepressants and noradrenaline re-uptake inhibitors (e.g. venlafaxine, maprotiline and desipramine).
Iskustva s opikaponom kada se on istodobno primjenjuje s tricikličkim antidepresivima i inhibitorima ponovne pohrane noradrenalina (npr. venlafaksinom, maprotilinom i dezipraminom) su ograničena.
There is limited experience with Pegasys in treating paediatric patients with HCV aged 3 to 5 years, or who have failed to be adequately treated previously.
Ograničeno je iskustvo s primjenom lijeka Pegasys u liječenju pedijatrijskih bolesnika zaraženih HCV-om u dobi od 3 do 5 godina ili onih koji ranije nisu odgovarajuće liječeni.
There is limited experience with prasugrel and no experience with ticagrelor in the vorapaxar Phase 3 studies.
Kliničko iskustvo s prasugrelom u ispitivanjima vorapaksara faze 3 je ograničeno, a iskustva s tikagrelorom nema.
There is limited experience with self-administration of Xolair.
Postoji ograničeno iskustvo u samoprimjeni Xolaira.
There is limited experience with severely debilitated dogs or dogs with seriously compromised kidney or liver function.
Postoji ograničeno iskustvo s jako iznurenim psima ili psima s ozbiljnijim oštećenjem bubrežne ili jetrene funkcije.
There is limited experience with single doses higher than 400 mg/m2 body surface area to date or weekly administrations of doses higher than 250 mg/m2 body surface area.
Iskustva s pojedinačnim dozama višim od 400 mg/m2 tjelesne površine ili tjedne primjene doza viših od 250 mg/m2 tjelesne površine su ograničena.
There is limited experience with tedizolid phosphate in the treatment of patients with concomitant acute bacterial skin and skin structure infections and secondary bacteremia and no experience in the treatment of ABSSSI with and severe sepsis or septic shock.
Iskustvo s tedizolidfosfatom u liječenju bolesnika s istodobnim akutnim bakterijskim infekcijama kože i kožnih struktura i sekundarne bakterijemije je ograničeno, a nema iskustva u liječenju akutnih bakterijskih infekcija kože i kožnih struktura s teškom sepsom ili septičkim šokom.
There is limited experience with the use of abatacept in combination with TNF-inhibitors (see section 5.1).
Ograničeno je iskustvo s primjenom abatacepta u kombinaciji s TNF-inhibitorima (vidjeti dio 5.1).
There is limited experience with the use of intravenous rhythm control antiarrhythmics (class I and class III) in the first 4 hours after BRINAVESS administration, therefore these agents must not be used within this period (see section 4.3).
Iskustvo s primjenom intravenskih antiaritmika za kontrolu srčanog ritma (skupine I i III) u prva 4 sata nakon primjene lijeka BRINAVESS je ograničeno; stoga se unutar ovog razdoblja ti lijekovi ne smiju primjenjivati (vidjeti dio 4.3).
There is limited experience with the use of SPRYCEL in this age group.
Iskustvo s primjenom SPRYCELA u ove dobne skupine je ograničeno.
There is limited experience with the use of vernakalant in patients with previously documented LVEF ≤ 35%, its use in these patients is not recommended.
Iskustvo s primjenom vernakalanta u bolesnika s prethodno dokumentiranom ejekcijskom frakcijom lijevog ventrikula (LVEF) ≤ 35% je ograničeno pa se njegova primjena u tih bolesnika ne preporučuje.
There is limited experience with the use of Zavesca in Niemann-Pick type C disease patients under the age of 4 years.
Postoji ograničeno iskustvo u primjeni Zavesce kod bolesnika s Niemann-Pickovom bolesti tipa C, mlađim od 4 godine.
There is limited experience with ticagrelor in patients with moderate hepatic impairment, therefore, caution is advised in these patients (see sections 4.2 and 5.2).
Iskustvo s tikagrelolom u bolesnika s umjerenim oštećenjem funkcije jetre je ograničeno, stoga se preporučuje oprez u ovih bolesnika (vidjeti dijelove 4.2 i 5.2).
There is limited experience with tranexamic acid and no experience with aminocaproic acid and aprotinin in individuals receiving rivaroxaban.
Iskustvo s primjenom aminokaproatne kiseline je ograničeno te nema iskustva s primjenom traneksamatne kiseline i aprotinina u bolesnika koji primaju rivaroksaban.
There is limited experience with tranexamic acid and no experience with aminocaproic acid and aprotinin in individuals receiving rivaroxaban.
Iskustvo s primjenom traneksamnatne kiseline je ograničeno te nema iskustva s primjenom aminokaproatne kiseline i aprotinina u bolesnika koji primaju rivaroksaban.
There is limited experience with treatment of patients with ischaemic CRVO and BRVO.
Iskustva u bolesnika s ishemijskim CRVO i BRVO su ograničena.
There is limited experience with use of abatacept in combination with TNF-inhibitors (see section 5.1).
Iskustvo s primjenom abatacepta u kombinaciji s TNF-inhibitorima je ograničeno (vidjeti dio 5.1).
There is limited experience with use of Nimenrix in pregnant women.
Podaci o primjeni cjepiva Nimenrix u trudnica su ograničeni.
There is limited experience with vortioxetine overdose.
Iskustvo s predoziranjem vortioksetinom je ograničeno.
There is limited information in patients over 3 years of age who have used Temodal.
Informacije o primjeni lijeka Temodal u djece starije od 3 godine su ograničene.
There is limited information on the optimal timing to switch from amiodarone to MULTAQ.
Podaci o optimalnom vremenu za prelazak s amiodarona na MULTAQ su ograničeni.
There is limited information on the use of AVONEX in pregnancy.
Podaci o primjeni AVONEXA za vrijeme trudnoće su ograničeni.
There is limited information on the use of Betaferon in pregnancy.
Podaci o primjeni lijeka Betaferon u trudnica su ograničeni.
There is limited information on the use of Extavia in pregnancy.
Postoje ograničene informacije o primjeni Extavije u trudnoći.
There is limited information on the use of Plegridy in pregnancy.
Podaci o primjeni Plegridyja u trudnoći su ograničeni.
There is limited information on the use of Rebif in pregnancy.
Podaci o primjeni Rebifa u trudnoći su ograničeni.
There is limited information on the use of rufinamide in older people.
Informacije o primjeni rufinamida u starijih bolesnika su ograničene.
There is limited information on the use of rufinamide inolder people.
Informacije o primjeni rufinamida u starijih bolesnika su ograničene.
There is limited information on the use of Xagrid in children and adolescents and therefore this medicine should be used with caution.
Budući da su podaci o primjeni Xagrida u djece i adolescenata ograničeni, ovaj lijek treba primjenjivati s oprezom.