natgillin/translations-raw huggingface dataset:
There is no experience in patients with congestive heart failure NYHA class III-IV and Xultophy is therefore not recommended in these patients.
Nema iskustva u bolesnika s kongestivnim srčanim zatajenjem NYHA stupnja III-IV pa se stoga primjena lijeka Xultophy ne preporučuje u tih bolesnika.
There is no experience in patients with congestive heart failure NYHA class III­IV and liraglutide is therefore not recommended in these patients.
Nema iskustva u bolesnika s kongestivnim srčanim zatajenjem NYHA stupnja III-IV pa se stoga primjena liraglutida ne preporučuje u ovih bolesnika.
There is no experience in surgery of paediatric patients.
Nema iskustva pri kirurškim zahvatima u pedijatrijskih bolesnika.
There is no experience in the subgroup of patients with both high body weight (>100 kg) and moderate renal impairment (creatinine clearance 30-50 ml/min).
Ne postoje iskustva primjene u podskupini bolesnika s tjelesnom težinom >100 kg i umjerenim oštećenjem bubrežne funkcije (klirens kreatinina 30 - 50 ml/min).
There is no experience in the treatment of
Nema iskustva s liječenjem
There is no experience in the use of mitotane in patients with hepatic impairment, so data are insufficient to give a dose recommendation in this group.
U bolesnika s oštećenjem jetre nema iskustva s uporabom mitotana te su podaci nedovoljni za davanje preporuke o doziranju u ovoj skupini.
There is no experience of concomitant administration of Lucentis and Visudyne.
Nema iskustava s istodobnom primjenom Lucentisa i Visudynea.
There is no experience of DuoTrav in inflammatory ocular conditions; nor in neovascular, angle-closure, narrow-angle or congenital glaucoma and only limited experience in thyroid eye disease, in open-angle glaucoma of pseudophakic patients and in pigmentary or pseudoexfoliative glaucoma.
Nema iskustava s DuoTrav kapima kod upalnih stanja oka; niti kod neovaskularnog glaukoma, glaukoma zatvorenog-uskog kuta ili kongenitalnog glaukoma, dok postoji samo ograničeno iskustvo kod tireoidne orbitopatije, kod glaukoma otvorenog kuta pseudofakičnih bolesnika i kod pigmentnog ili pseudoeksfolijativnog glaukoma.
There is no experience of initiating treatment with lumacaftor/ivacaftor in patients having a pulmonary exacerbation and this is not advisable.
Nema iskustva sa započinjanjem liječenja lumakaftorom/ivakaftorom u bolesnika s plućnom egzacerbacijom i ono se ne preporučuje.
There is no experience of the treatment of previously untreated patients with Nonafact.
Nema iskustva u liječenju lijekom Nonafact ranije neliječenih bolesnika.
There is no experience of the treatment of previously untreated patients with Nonafact.
Nema iskustva u liječenju lijekom Nonafact ranije neliječenih pacijenata.
There is no experience of the use of delamanid in patients receiving concomitant therapy against HIV (see section 4.5).
Nema iskustva o primjeni delamanida u bolesnika koji istodobno primaju terapiju protiv HIV-a (vidjeti dio 4.5).
There is no experience of the use of emtricitabine in patients who are failing their current regimen or who have failed multiple regimens.
Nema iskustva primjene emtricitabina u pacijenata u kojih trenutno liječenje nije uspješno ili u kojih više liječenja nije bilo uspješno.
There is no experience of the use of Emtriva in patients who are failing their current regimen or who have failed multiple regimens (see section 5.1).
Nema iskustva primjene Emtrive u pacijenata u kojih trenutno liječenje nije uspješno ili u kojih više liječenja nije bilo uspješno (vidjeti dio 5.1).
There is no experience of the use of Kalydeco in patients with severe hepatic impairment and therefore its use is not recommended unless the benefits outweigh the risks.
Nema iskustva s primjenom lijeka Kalydeco u bolesnika s teškim oštećenjem funkcije jetre te se stoga njegova primjena ne preporučuje osim ako je korist veća od rizika.
There is no experience of the use of NexoBrid on:
Ne postoji iskustvo s primjenom NexoBrida na:
There is no experience of travoprost in inflammatory ocular conditions; nor in neovascular, angle-closure, narrow-angle or congenital glaucoma and only limited experience in thyroid eye disease, in open-angle glaucoma of pseudophakic patients and in pigmentary or pseudoexfoliative glaucoma.
Nema iskustava s travoprostom kod upalnih stanja oka; niti kod neovaskularnog glaukoma, glaukoma zatvorenog kuta, glaukoma uskog kuta ili kongenitalnog glaukoma, dok postoji samo ograničeno iskustvo kod tireoidne orbitopatije, kod glaukoma otvorenog kuta pseudofakičnih bolesnika i kod pigmentnog ili pseudoeksfolijativnog glaukoma.
There is no experience of treating actinic keratosis lesions in patients with dark brown or black skin (skin sun sensitivity type V or VI according to Fitzpatrick).
Nema iskustava u liječenju lezija aktiničkih keratoza u bolesnika s tamnosmeđom ili crnom kožom (osjetljivost kože na sunce tipa V ili VI prema Fitzpatricku).
There is no experience of treating severe actinic keratoses or lesions which are pigmented or highly infiltrating.
Nema iskustava u liječenju teških aktiničkih keratoza ili pigmentiranih ili jako infiltrirajućih lezija.
There is no experience of using Eylea in pregnant women.
Nema iskustava s primjenom lijeka Eylea u trudnica.
There is no experience of using Lucentis in pregnant women; therefore the potential risks are unknown.
Ne postoje iskustva s primjenom Lucentisa u trudnica; stoga nisu poznati mogući rizici.
There is no experience of using Macugen in pregnant women.
Nema iskustva s primjenom lijeka Macugen u trudnica.
There is no experience on the use of Orgalutran in subjects with hepatic impairment, as they were excluded from clinical studies.
Nema iskustva s primjenom lijeka Orgalutran u osoba s oštećenjem funkcije jetre jer su bile izuzete iz kliničkih ispitivanja.
There is no experience on the use of Orgalutran in subjects with renal impairment, as they were excluded from clinical studies.
Nema iskustva s primjenom lijeka Orgalutran u osoba s oštećenjem funkcije bubrega jer su bile izuzete iz kliničkih ispitivanja.
There is no experience regarding the administration of PritorPlus in patients with recent kidney transplantation.
Ne postoji iskustvo glede primjene PritorPlusa kod bolesnika s nedavno presađenim bubregom.
There is no experience regarding the administration of Rasilez HCT in patients who have recently undergone kidney transplantation.
Ne postoji iskustvo vezano uz primjenu Rasilez HCT-a u bolesnika kojima je nedavno presađen bubreg.
There is no experience with administration of intravenous levetiracetam for a longer period than 4 days.
Nema iskustva s levetiracetamom primijenjenim intravenski u razdoblju duljem od 4 dana.
There is no experience with administration of intravenous levetiracetam for a longer period than 4 days.
Nema iskustva sa intravenskom primjenom levetiracetama za razdoblje duže od 4 dana.
There is no experience with administration of intravenous levetiracetam for longer period than 4 days.
Nema iskustva s intravenskom primjenom levetiracetama u razdoblju dužem od 4 dana.
There is no experience with atosiban treatment in patients with impaired function of the liver or kidneys.
Ne postoji iskustvo s atosibanom u liječenju bolesnica s oštećenom funkcijom jetre ili bubrega.
There is no experience with atosiban treatment in patients with impaired function of the liver or kidneys.
Nema iskustva s atosibanom u liječenju bolesnica s oštećenom funkcijom jetre ili bubrega.
There is no experience with ceftaroline in the treatment of CAP in the following patient groups: the immunocompromised, patients with severe sepsis/septic shock, severe underlying lung disease, those with PORT Risk Class V, and/or CAP requiring ventilation at presentation, CAP due to methicillin- resistant S. aureus or patients requiring intensive care.
Nema iskustva s primjenom ceftarolina u liječenju izvanbolnički stečene pneumonije u sljedećih skupina bolesnika: u imunokompromitiranih bolesnika, bolesnika s teškom sepsom/septičkim šokom, bolesnika s postojećom teškom bolešću pluća, bolesnika u klasi rizika V prema PORT bodovnom sustavu i/ili s izvanbolnički stečenom pneumonijom koja pri dolasku zahtijeva umjetnu ventilaciju, bolesnika s izvanbolnički stečenom pneumonijom čiji je uzročnik S. aureus rezistentan na meticilin te bolesnika kojima je potrebna intenzivna skrb.
There is no experience with dose reduction/increase or modification of the schedule in the treatment of extravasation.
Nema iskustava sa smanjenjem/povećanjem doze ili modifikacijom rasporeda liječenja ekstravazacije.
There is no experience with INTEGRILIN and low molecular weight heparins.
Nema iskustava s primjenom INTEGRILINA i heparina male molekulske težine.
There is no experience with Kepivance doses greater than 80 micrograms/kg/day administered intravenously in patients over 2 weeks (3 doses preceding and 3 doses following myeloablative therapy).
Nema iskustva u primjeni doza Kepivancea većih od 80 mikrograma/kg/dan primijenjenih intravenski u bolesnika u razdoblju od 2 tjedna (3 doze prije i 3 doze nakon mijeloablativnog liječenja).
There is no experience with Myocet in patients with a history of cardiovascular disease, e.g. myocardial infarction within 6 months prior to treatment.
Nema iskustva s Myocetom u bolesnika s anamnezom kardiovaskularne bolesti, primjerice infarkta miokarda unutar 6 mjeseci prije liječenja.
There is no experience with opicapone when used concomitantly with OATP1B1 substrates.
Nema iskustva s istodobnom primjenom opikapona i supstrata za OATP1B1.
There is no experience with overdose of asfotase alfa.
Nema iskustva s predoziranjem asfotazom alfa.
There is no experience with overdoses of Elaprase.
Nema iskustva s predoziranjem Elapraseom.
There is no experience with the use of forced diuresis, dialysis, hemoperfusion, or exchange transfusion in the management of combined use of bupropion and naltrexone overdoses.
Nema iskustva s primjenom prisilne diureze, dijalize, hemoperfuzije ili zamjenske transfuzije u liječenju predoziranja kombinirane uporabe bupropiona i naltreksona.
There is no experience with the use of Kentera in patients with hepatic impairment.
Nema iskustva s primjenom Kentere u bolesnika s jetrenim oštećenjem.
There is no experience with the use of Kentera in patients with renal impairment.
Nema iskustva s primjenom Kentere u bolesnika s bubrežnim oštećenjem.
There is no experience with the use of RoActemra with TNF antagonists or other biological treatments for RA patients.
Nema iskustva s primjenom lijeka RoActemra zajedno s antagonistima TNF-a ili drugim biološkim lijekovima za liječenje bolesnika s RA.
There is no experience with the use of RoActemra with TNF antagonists or other biological treatments for RA, sJIA or pJIA patients.
Nema iskustva s primjenom lijeka RoActemra zajedno s antagonistima TNF-a ili drugim biološkim lijekovima za liječenje bolesnika s RA, sJIA ili pJIA.
There is no experience with the use of Toujeo in children below the age of 2 years.
Nema iskustva s primjenom lijeka Toujeo u djece mlađe od 2 godine.
There is no experience with twice daily intravenous administration of brivaracetam for a period longer than 4 days.
Nema iskustva s intravenskom primjenom brivaracetama dvaput na dan tijekom razdoblja duljeg od 4 dana.
There is no experience with Xultophy in patients with inflammatory bowel disease and diabetic gastroparesis.
Nema iskustva s lijekom Xultophy u bolesnika s upalnom bolesti crijeva i dijabetičkom gastroparezom.
There is no gender difference in the pharmacokinetic properties of Ryzodeg.
Ne postoji razlika u farmakokinetičkim svojstvima lijeka Ryzodeg ovisno o spolu.
There is no gender difference in the pharmacokinetic properties of Tresiba.
Ne postoje razlike u farmakokinetičkim svojstvima lijeka Tresiba između spolova.
There is no indication for use of Bemfola during pregnancy.
Ne postoji indikacija za korištenje lijeka Bemfola tijekom trudnoće.
There is no information about the safety of Arzerra in pregnant women.
Ne postoje podaci o sigurnosti primjene lijeka Arzerra u trudnica.
There is no information available about interactions of Ceplene with food, drink and alcohol.
Nema dostupnih podataka o interakcijama Ceplenea s hranom, pićem i alkoholom.
There is no information available concerning the first and the third trimesters.
Nema dostupnih podataka koji se odnose na prvo i treće tromjesečje.
There is no information available concerning the first and the third trimesters.
Nema dostupnih podataka koji se odnose na prvoi treće tromjesečje.
There is no information available on clinical use of Episalvan for more than 4 weeks.
Nema dostupnih informacija o kliničkoj uporabi Episalvana dulje od 4 tjedna.
There is no information available on maternal-foetal transmission of hepatitis B virus in pregnant women receiving treatment with lamivudine.
Nema dostupnih podataka o prijenosu HVB-a s majke na dijete u trudnica koje su liječene lamivudinom.
There is no information available on use in children aged less than 3 years or aged from 10-17 years.
Ne postoje podaci o primjeni u djece mlađe od 3 godine ili u dobi od 10 do 17 godina.
There is no information for the use of CellCept in children with a heart transplant.
Nema podataka o primjeni lijeka CellCept kod djece s presađenim srcem.
There is no information for the use of CellCept in children with a heart transplant.
Nema podataka o primjeni lijeka CellCept u djece s presađenim srcem.
There is no information for the use of CellCept in children with a liver transplant.
Nema podataka o primjeni lijeka CellCept kod djece s presađenom jetrom.
There is no information for the use of CellCept in children with a liver transplant.
Nema podataka o primjeni lijeka CellCept u djece s presađenom jetrom.
There is no information for the use of Myclausen in children with a heart transplant.
Nema podataka o primjeni lijeka Myclausen kod djece s presađenim srcem.
There is no information for the use of Myclausen in children with a liver transplant.
Nema podataka o primjeni lijeka Myclausen kod djece s presađenom jetrom.
There is no information from the use of Xadago in pregnant women, but animal studies indicate harmful effects on the foetus following administration during pregnancy.
Nema informacija o uporabi lijeka Xadago u trudnica, ali ispitivanja na životinjama pokazala su štetne učinke na plod nakon primjene tijekom trudnoće.
There is no information on administration of Pandemrix with other vaccines.
Ne postoje podaci o primjeni Pandemrixa s drugim cjepivima.
There is no information on the effect of Mycamine on the ability to drive or use machines.
Nema podataka o utjecaju Mycaminea na sposobnost upravljanja vozilima i rada na strojevima.
There is no information on the effect on the transdermal patch of activities such as strenuous exercise or the use of sauna or whirlpools; therefore, you should avoid these activities while wearing SANCUSO.
Nema podataka o utjecaju aktivnosti poput intenzivnog vježbanja, korištenja saune ili masažnih bazena na transdermalni flaster; zato dok nosite flaster SANCUSO izbjegavajte te aktivnosti.
There is no information on the effects of rFIX on fertility.
Nema informacija o učinku faktora IX na plodnost.
There is no information on the precise food-effect when taken 1 hour after administration of cabozantinib.
Ne postoje podaci o preciznom učinku hrane uzete 1 sat nakon primjenekabozantiniba.
There is no information on the safety of aflibercept given at doses exceeding 7 mg/kg every 2 weeks or 9 mg/kg every 3 weeks.
Nema podataka o sigurnosti aflibercepta primijenjenog u dozama višima od 7 mg/kg svaka 2 tjedna ili 9 mg/kg svaka 3 tjedna.
There is no information on the use of Betaferon in children under 12 years of age.
Nema informacija o primjeni lijeka Betaferon u djece mlađe od 12 godina.
There is no information on the use of NexoBrid in patients with hepatic impairment.
Nema podataka o primjeni NexoBrida u bolesnika s oštećenjem funkcije jetre.
There is no information on the use of NexoBrid in patients with renal impairment.
Nema podataka o primjeni NexoBrida u bolesnika s oštećenjem funkcije bubrega.
There is no information on the use of Vargatef in pregnant women, but pre-clinical studies in animals have shown reproductive toxicity of this active substance (see section 5.3).
Nema podataka o primjeni Vargatefa u trudnica, ali pretklinička ispitivanja na životinjama pokazala su reproduktivnu toksičnost ove djelatne tvari (vidjeti dio 5.3).
There is no information to suggest that Cancidas affects your ability to drive or operate machinery.
Nema podataka koji ukazuju na to da Cancidas utječe na sposobnost upravljanja vozilima ili rada sa strojevima.
There is no known antidote for overdose of ONIVYDE.
Nema poznatog protuotrova za predoziranje lijekom ONIVYDE.
There is no known antidote to Ketoconazole HRA.
Ne postoji poznati antidot za Ketoconazole HRA.
There is no known cross-resistance between telavancin and other non-glycopeptide classes of antibiotics.
Nema poznate križne rezistencije između telavancina i drugih neglikopetidnih kategorija antibiotika.
There is no known interaction between Hycamtin and alcohol.
Nisu poznate interakcije između lijeka Hycamtin i alkohola.
There is no known specific antidote for [90Y]-radiolabelled Zevalin overdosage.
Ne postoji nijedan poznat specifični protulijek za predoziranje Zevalinom radioaktivno označenim izotopom [90Y].
There is no known specific antidote for bortezomib overdose.
Specifičan antidot kod predoziranja bortezomibom nije poznata.
There is no known specific antidote.
Nema specifičnog antidota.
There is no meaningful difference in the PK of apremilast between mild or moderate renal impaired subjects and matched healthy subjects (N=8 each).
U farmakokinetici apremilasta nema značajne razlike između ispitanika s blagim ili umjerenim oštećenjem funkcije bubrega i podudarnih zdravih ispitanika (N = 8 u svakoj od tih skupina).
There is no modification of the clearance after repeated administration.
Ponovljena primjena ovog lijeka ne uzrokuje promjene klirensa.
There is no need for contraceptive measures in women of childbearing potential treated with cholic acid or their partners.
Ne postoji potreba za mjerama kontracepcije u žena generativne dobi, a koje su liječene kolnom kiselinom, ili u njihovih partnera.
There is no need for dose adaptation in patients with a creatinine clearance >30 ml/min (as determined from serum creatinine using the Cockroft and Gault formula).
U bolesnika čiji je klirens kreatinina veći od 30 ml/min (utvrđen iz serumskog kreatinina pomoću Cockroftove i Gaultove formule) nije potrebna prilagodba doze.
There is no need to alter the dose in patients with mild or moderate kidney problems (patients with a creatinine clearance >30 ml/min).
Nema potrebe za izmjenom doze u bolesnika s blagim ili umjerenim problemima s bubrezima (bolesnici s klirensom kreatinina >30 ml/min).
There is no need to remove air bubbles before injection.
Nema potrebe za uklanjanjem mjehurića zraka prije injiciranja.
There is no need to replace the cap.
Vraćanje zatvarača nije potrebno.
There is no negative impact on the milk yield using the vaccine in lactating ewes and cows.
Primjena cjepiva ne utječe nepovoljno na mliječnost ovaca i krava tijekom laktacije.
There is no or only limited experience with the following treatments which may increase the risk of bleeding when used concomitantly with Pradaxa: anticoagulants such as unfractionated heparin (UFH), low molecular weight heparins (LMWH), and heparin derivatives (fondaparinux, desirudin), thrombolytic medicinal products, and vitamin K antagonists, rivaroxaban or other oral anticoagulants (see section 4.3), and platelet aggregation medicinal products such as GPIIb/IIIa receptor antagonists, ticlopidine, prasugrel, ticagrelor, dextran, and sulfinpyrazone (see section 4.4).
Ne postoji ili postoji samo ograničeno iskustvo sa sljedećim lijekovima koji mogu povećati rizik od krvarenja kada se primjenjuju istodobno s Pradaxom: antikoagulansi poput nefrakcioniranog heparina (UFH), niskomolekularni heparini (LMWH) i derivati heparina (fondaparinuks, desirudin), trombolitici, te antagonisti vitamina K, rivaroksaban, ili drugi oralni antikoagulansi (vidjeti dio 4.3), i lijekovi za agregaciju trombocita kao što su antagonisti GPIIb/IIIa receptora, tiklopidin, prasugrel, tikagrelor, dekstran i sulfinpirazon (vidjeti dio 4.4).
There is no or only limited experience with the following treatments which may increase the risk of bleeding when used concomitantly with Pradaxa: anticoagulants such as unfractionated heparin (UFH), low molecular weight heparins (LMWH), and heparin derivatives (fondaparinux, desirudin), thrombolytic medicinal products, and vitamin K antagonists, rivaroxaban or other oral anticoagulants (see section 4.3), and platelet aggregation medicinal products such as, GPIIb/IIIa receptor antagonists, ticlopidine, prasugrel, ticagrelor, dextran, and sulfinpyrazone (see section 4.4).
Ne postoji ili postoji samo ograničeno iskustvo sa sljedećim lijekovima koji mogu povećati rizik od krvarenja kada se primjenjuju istodobno s Pradaxom: antikoagulansi poput nefrakcioniranog heparina (UFH), niskomolekularni heparini (LMWH) i derivati heparina (fondaparinuks, desirudin), trombolitici, te antagonisti vitamina K, rivaroksaban, ili drugi oralni antikoagulansi (vidjeti dio 4.3), i lijekovi za agregaciju trombocita kao što su antagonisti GPIIb/IIIa receptora, tiklopidin, prasugrel, tikagrelor, dekstran i sulfinpirazon (vidjeti dio 4.4).
There is no or only limited experience with the following treatments which may increase the risk of bleeding when used concomitantly with Pradaxa: anticoagulants such as unfractionated heparin (UFH), low molecular weight heparins (LMWH), and heparin derivatives (fondaparinux, desirudin), thrombolytic medicinal products, and vitamin K antagonists, rivaroxaban or other oral anticoagulants (see section 4.3), and plateletet aggregation medicinal products such as GPIIb/IIIa receptor antagonists, ticlopidine, prasugrel, ticagrelor, dextran, and sulfinpyrazone (see section 4.4).
Ne postoji ili postoji samo ograničeno iskustvo sa sljedećim lijekovima koji mogu povećati rizik od krvarenja kada se primjenjuju istodobno s Pradaxom: antikoagulansi poput nefrakcioniranog heparina (UFH), niskomolekularni heparini (LMWH) i derivati heparina (fondaparinuks, desirudin), trombolitici, te antagonisti vitamina K, rivaroksaban, ili drugi oralni antikoagulansi (vidjeti 4.3), i lijekovi za agregaciju trombocita kao što su antagonisti GPIIb/IIIa receptora, tiklopidin, prasugrel, tikagrelor, dekstran i sulfinpirazon (vidjeti dio 4.4).
There is no other ingredient.
Nema pomoćnih tvari.
There is no paediatric experience for posaconazole concentrate for solution for infusion.
Nema iskustva s primjenom posakonazol koncentrata za otopinu za infuziju u pedijatrijskoj populaciji.
There is no paediatric experience for posaconazole tablets.
Nema iskustva s posakonazol tabletama u pedijatrijskoj populaciji.
There is no paediatric experience with posaconazole tablets.
Nema iskustva s tabletama posakonazola u pedijatrijskoj populaciji.
There is no parenteral formulation of ritonavir, therefore the extent of absorption and absolute bioavailability has not been determined.
Budući da nema ritonavira za parenteralnu primjenu, stupanj apsorpcije ni apsolutna bioraspoloživost nisu određeni.
There is no pharmacokinetic interaction with follitropin alfa when administered simultaneously.
Nema farmakokinetske interakcije s folitropinom alfa kada se daju istodobno.
There is no Phase 3 clinical experience in patients with co-administration of Sivextro with serotonergic agents such as selective serotonin re-uptake inhibitors [SSRI], serotonin norepinephrine reuptake inhibitors (SNRI), tricyclic antidepressants, MAO inhibitors, triptans, and other medications with potential adrenergic or serotonergic activity.
Nema iskustva iz kliničkih ispitivanja faze 3 u bolesnika s istodobnom primjenom lijeka Sivextro uz serotonergičke lijekove kao što su selektivni inhibitori ponovne pohrane serotonina [engl. selective serotonin re-uptake inhibitors, SSRI], inhibitori ponovne pohrane serotonina i noradrenalina (engl. serotonin norepinephrine reuptake inhibitors, SNRI), triciklički antidepresivi, inhibitori MAO, triptani i drugi lijekovi s potencijalnom adrenergičkom ili serotonergičkom aktivnošću.