natgillin/translations-raw huggingface dataset:
There is limited information regarding the use of EDURANT in patients > 65 years of age.
O primjeni EDURANTA u bolesnika u dobi > 65 godina postoje ograničeni podaci.
There is limited information regarding the use of Eviplera in patients with mild or moderate hepatic impairment (Child-Pugh-Turcotte (CPT) Score A or B).
Postoje ograničene informacije o primjeni lijeka Eviplera u pacijenata s blagim ili umjerenim oštećenjem jetre (Child-Pugh-Turcotte (CPT) stadij A ili B).
There is limited information regarding the use of INTELENCE in patients > 65 years of age (see section 5.2), therefore caution should be used in this population.
Za primjenu INTELENCEa kod populacije bolesnika starijih od 65 godina potreban je oprez s obzirom na to da su dostupni ograničeni podaci (vidjeti dio 5.2).
There is limited information to recommend a starting dose for patients with platelet counts between 50,000/mm3 and <100,000/mm3.
Postoje ograničene informacije o preporučenoj početnoj dozi za bolesnike s brojem trombocita između 50 000/mm3 i <100 000/mm3.
There is limited safety experience of Simponi treatment in patients who have undergone surgical procedures, including arthroplasty.
Ograničena su iskustva o sigurnosti primjene lijeka Simponi u bolesnika podvrgnutih kirurškim postupcima, uključujući artroplastiku.
There is limited safety information available because of limited exposure due to recent and limited marketing of the product.
Dostupne su ograničene sigurnosne informacije zbog ograničene izloženosti koja je posljedica nedavnog i ograničenog stavljanja lijeka u promet.
There is limited therapeutic experience with INTEGRILIN in patients for whom thrombolytic therapy is generally indicated (e.g. acute transmural myocardial infarction with new pathological Q-waves or elevated ST-segments or left bundle branch block in the ECG).
Ograničeno je terapijsko iskustvo s INTEGRILINOM u bolesnika za koje je općenito indicirana trombolitička terapija (npr. akutni transmuralni infarkt miokarda s novim patološkim Q zupcima ili povišenim ST-segmentom ili kompletnim blokom lijeve grane u EKG-u).
There is little experience from re administration after more than 8 weeks since the previous dose.
Postoji malo podataka o ponovnoj primjeni lijeka Humira kad je prekid terapije trajao duže od 8 tjedana.
There is little experience in other types of surgery, for example gastrointestinal or urological surgery.
Nema puno iskustva s primjenom kod drugih vrsta operacija, na primjer gastrointestinalnih ili uroloških operacija.
There is little experience with cabozantinib in non-White patients.
Postoji malo iskustva s primjenom kabozantiniba u bolesnika drugih rasnih skupina osim bijelaca.
There is little or no accumulation of topotecan with repeated daily dosing and there is no evidence of a change in the PK after multiple doses.
Postoji malo ili ništa nakupljanja topotekana pri ponovljenom dnevnom doziranju i nema dokaza za promjene u farmakokinetici nakon multiplih doza.
There is little or no accumulation of topotecan with repeated daily dosing and there is no evidence of a change in the PK after multiple doses.
Postoji zanemarivo nakupljanje ili nema nakupljanja topotekana nakon primjene ponovljenih dnevih doza te nema dokaza o promjeni farmakokinetike nakon višestrukih doza.
There is little or no accumulation of topotecan with repeated daily dosing and there is no evidence of a change in the PK after multiple doses.
Pri ponovljenom svakodnevnom doziranju topotekan se malo ili uopće ne kumulira te nema dokaza o promjeni PK nakon višestrukih doza.
There is little or no accumulation of topotecan with repeated daily dosing and there is no evidence of a change in the PK after multiple doses.
Topotekan se akumulira u manjoj količini ili se uopće ne akumulira nakon ponovljenih dnevnih doza i nema dokaza o promjeni farmakokinetike nakon višestrukih doza.
There is little to no accumulation in AUC and Cmax and evidence of slight accumulation in C12 hr.
Kumulacija u AUC i Cmax je mala ili je nema, a opažena je neznatna kumulacija u C12h.
There is little to no experience with this medicine in patients with heart failure.
Malo je iskustva ili iskustva nema s primjenom ovog lijeka u bolesnika sa zatajenjem srca.
There is low entry of 6–mercaptopurine into the cerebrospinal fluid.
Prolazak 6–merkaptopurina u cerebrospinalni likvor je nizak.
There is more advice on reducing the risk of diarrhoea at the end of section 4.
Više informacija o načinima smanjivanja rizika za nastanak proljeva pogledajte na kraju dijela 4.
There is more information on how to use the pens in the “Instructions for Use”.
Dodatne informacije o uporabi brizgalica navode se u "Uputama za uporabu".
there is more than a thin layer of crystals at the bottom of the bottle, or
je na dnu boce uočljivo više od tankog sloja kristala, ili
There is neither evidence nor is it expected that Xofigo will affect the ability to drive or use machines.
Nije dokazano niti se očekuje da će Xofigo utjecati na sposobnost upravljanja vozilima i rada sa strojevima.
There is no accumulation of rivastigmine or the decarbamylated metabolite in patients with Alzheimer’s disease.
U bolesnika s Alzheimerovom bolešću nema nakupljanja rivastigmina ili dekarbamiliranog metabolita.
There is no additional benefit of the 184/22 micrograms dose compared to the 92/22 micrograms dose and there is a potential increased risk of systemic corticosteroid-related adverse reactions (see section 4.8).
Nema dodatnih korisnih učinaka kod primjene doze od 184/22 mikrograma u odnosu na dozu od 92/22 mikrograma, a postoji mogućnost povećanog rizika od nuspojava povezanih sa sistemskim kortikosteroidima (vidjeti dio 4.8).
There is no adequate data from the use of cysteamine in pregnant women.
Ne postoje odgovarajući podaci o primjeni cisteamina kod trudnica.
There is no animal or human data available concerning excretion of basiliximab into breast milk.
Nema podataka glede izlučivanja basiliksimaba u mlijeku životinja ili ljudi.
There is no antidote to Eliquis.
Ne postoji protulijek za Eliquis.
There is no basis for Myclausen dose adjustment following cardiac transplant rejection.
Ne postoji osnova za promjenu doze Myclausen nakon odbacivanja presađenog srca.
There is no basis for Mycophenolate mofetil Teva dose adjustment following cardiac transplant rejection.
Ne postoji osnova za promjenu terapijske doze Mikofenolat mofetila Teva nakon odbacivanja presađenog srca.
There is no clear evidence of saturation of metabolic clearance mechanisms at high doses of thiotepa.
Nema jasnog dokaza zasićenja mehanizama metaboličkog klirensa pri visokim dozama tiotepe.
There is no clinical data on the use of HBVAXPRO in pregnant women
Nema kliničkih podataka o primjeni cjepiva HBVAXPRO u trudnica.
There is no clinical data on the use of HBVAXPRO on breast-feeding women.
Nema kliničkih podataka o primjeni cjepiva HBVAXPRO u dojilja.
There is no clinical data to support dose adjustments in the elderly.
Nema kliničkih podataka koji govore u prilog potrebe prilagodbe doze kod starijih bolesnika.
There is no clinical efficacy and safety data in the clinical studies carried out with HEMANGIOL to recommend its initiation in children aged above 5 months.
Ne postoje podaci o kliničkoj djelotvornosti i sigurnosti u kliničkim studijama provedenim s HEMANGIOL-om kako bi se preporučilo započinjanje terapije HEMANGIOL-om kod djece starije od 5 mjeseci.
There is no clinical experience in patients with renal or hepatic insufficiency. (see section 5.2).
Nema kliničkih iskustava u bolesnika s bubrežnom ili jetrenom insuficijencijom (vidjeti dio 5.2).
There is no clinical experience in patients with severe hepatic impairment (Child-Pugh Class C) (see section 4.2).
Nema kliničkog iskustva o primjeni u bolesnika s teškim oštećenjem funkcije jetre (stupanj C prema Child- Pughovoj klasifikaciji) (vidjeti dio 4.2).
There is no clinical experience in patients with severe hepatic impairment (Child-Pugh Class C), therefore, Ongentys is not recommended in these patients (see section 5.2).
Nema kliničkog iskustva s primjenom u bolesnika s teškim oštećenjem jetre (stupanj C prema Child- Pughovoj klasifikaciji), stoga se Ongentys ne preporučuje u tih bolesnika (vidjeti dio 5.2).
There is no clinical experience in patients with severe hepatic impairment (Child-Pugh score > 9).
Nema kliničkog iskustva u bolesnika s teškim oštećenjem funkcije jetre (Child Pugh rezultat > 9).
There is no clinical experience in patients with severe hepatic impairment (Child-Pugh score 10), therefore its use is contraindicated in these patients (see sections 4.3 and 5.2).
Ne postoji kliničko iskustvo u bolesnika s teškim oštećenjem funkcije jetre (Child-Pugh rezultat 10) pa je stoga njegova primjena u ovih bolesnika kontraindicirana (vidjeti dijelove 4.3 i 5.2).
There is no clinical experience in the use of oritavancin to treat infections due to daptomycin-resistant or vancomycin-resistant S. aureus.
Nema kliničkog iskustva s primjenom oritavancina u liječenju infekcija prouzročenih bakterijom S. aureus otpornom na daptomicin ili na vankomicin.
There is no clinical experience of the use of emtricitabine in infants less than 4 months of age.
Ne postoje klinička iskustva s primjenom emtricitabina u dojenčadi mlaĎoj od 4 mjeseca.
There is no clinical experience with Actelsar HCT in patients with hepatic impairment.
Nema kliničkog iskustva s Actelsarom HCT kod bolesnika s oštećenjem jetre.
There is no clinical experience with Atripla in patients who are experiencing virological failure in a first-line antiretroviral treatment regimen or in combination with other antiretroviral agents.
Nema kliničkih iskustava s Atriplom u pacijenata s virološkim neuspjehom u primarnom režimu antiretrovirusnog liječenja ili u kombinaciji s drugim antiretrovirusnim lijekovima.
There is no clinical experience with direct-current cardioversion under two hours post-dose.
Nema kliničkog iskustva s kardioverzijom istosmjernom strujom manje od 2 sata nakon primjene doze.
There is no clinical experience with direct-current cardioversion under two hours postdose.
Nema kliničkog iskustva s kardioverzijom istosmjernom strujom manje od 2 sata nakon primjene doze.
There is no clinical experience with fosamprenavir in pregnant women.
Ne postoji kliničko iskustvo s fosamprenavirom kod trudnica.
There is no clinical experience with Kinzalkomb in patients with hepatic impairment.
Nema kliničkog iskustva s Kinzalkombom kod bolesnika s oštećenjem jetre.
There is no clinical experience with MicardisPlus in patients with hepatic impairment.
Nema kliničkog iskustva s MicardisPlusom kod bolesnika s oštećenjem jetre.
There is no clinical experience with overdose of mepolizumab.
Nema kliničkog iskustva s predoziranjem mepolizumabom.
There is no clinical experience with Ovitrelle in the treatment of other conditions (such as corpus luteum insufficiency or male conditions) therefore Ovitrelle is not indicated in these conditions.
Zasad ne postoji kliničko iskustvo s lijekom Ovitrelle u liječenju drugih stanja (kao što je manjak žutog tijela ili poremećaji kod muškaraca), stoga Ovitrelle obično nije indiciran za liječenje ovih stanja.
There is no clinical experience with PritorPlus in patients with hepatic impairment.
Nema kliničkog iskustva s PritorPlusom kod bolesnika s oštećenjem jetre.
There is no clinical experience with selexipag in patients with severe liver impairment (Child-Pugh class C), therefore Uptravi should not be administered in these patients.
Nema kliničkog iskustva s promjenom seleksipaga u bolesnika s teškim oštećenjem funkcije jetre (Child-Pugh stadij C), stoga se Uptravi ne treba primjenjivati u tih bolesnika.
There is no clinical experience with the use of 2.5 mg with ASA alone or with ASA plus clopidogrel or ticlopidine in these situations.
Nema kliničkog iskustva s primjenom 2,5 mg rivaroksabana samo s ASA-om ili s ASA-om uz klopidogrel ili tiklopidin u ovakvim situacijama.
There is no clinical experience with the use of macitentan in PAH patients with severe renal impairment.
Nema kliničkog iskustva s primjenom macitentana u bolesnika s PAH-om s teškim oštećenjem funkcije bubrega.
There is no clinical experience with use of Ryzodeg in pregnant women.
Nema kliničkog iskustva s primjenom lijeka Ryzodeg u trudnica.
There is no clinical experience with use of Toujeo in pregnant women.
Nema kliničkog iskustva s primjenom lijeka Toujeo u trudnica.
There is no clinical experience with use of Tresiba in pregnant women.
Nema kliničkog iskustva s primjenom lijeka Tresiba u trudnica.
There is no clinical experience with use of Xultophy during breast-feeding.
Nema kliničkog iskustva s primjenom lijeka Xultophy tijekom dojenja.
There is no clinical experience with use of Xultophy, insulin degludec or liraglutide in pregnant women.
Nema kliničkog iskustva s primjenom lijeka Xultophy, degludek inzulina ili liraglutida u trudnica.
There is no clinical experience with Xultophy in relation to fertility.
Nema kliničkog iskustva o utjecaju lijeka Xultophy na plodnost.
There is no clinical trial experience with Entyvio in patients previously treated with natalizumab.
Nema iskustva iz kliničkih ispitivanja s lijekom Entyvio u bolesnika prethodno liječenih natalizumabom.
There is no clinically relevant development of insulin antibodies after long-term treatment of Ryzodeg.
Nema klinički relevantnog razvoja inzulinskih protutijela nakon dugotrajnog liječenja lijekom Ryzodeg.
There is no clinically relevant difference in the pharmacodynamics of Tresiba between elderly and younger adult patients.
Nema klinički relevantne razlike u farmakodinamici lijeka Tresiba između starijih i mlađih odraslih bolesnika.
There is no combination of this capsule strength that can be used to achieve the target concentration; therefore, please use an alternative capsule strength.
Nije moguće postići ciljnu koncentraciju lijeka kombinacijom ove jačine kapsula; stoga treba upotrijebiti drugu jačinu kapsula.
There is no conclusive clinical evidence for intra-class differences in the magnitude of the pneumonia risk among inhaled corticosteroid products.
Nema kliničkog dokaza ne temelju kojeg se može se donijeti konačan zakjučak da se inhalacijski kortikosteroidni lijekovi unutar iste međusobno razlikuju po veličini rizika od pneumonije.
There is no consensus about the possible role of varicose veins and superficial thrombophlebitis in the onset or progression of venous thrombosis.
Nema konsenzusa o mogućoj ulozi varikoznih vena i superficijalnog tromboflebitisa u nastanku ili progresiji venske tromboze.
There is no data available for elderly patients.
Nema podataka koji se odnose na starije bolesnike.
There is no data available on male/female fertility.
Nema dostupnih podataka o plodnosti u muškaraca/žena.
There is no data available on male/female fertility.
Nisu dostupni podaci o plodnosti u mušakaraca/žena.
There is no data available on the concomitant use of Eylea with other anti-VEGF medicinal products (systemic or ocular).
Nema dostupnih podataka o istodobnoj primjeni lijeka Eylea s drugim anti-VEGF lijekovima (sistemskim ili okularnim).
There is no data from the use of IKERVIS in pregnant women.
Nema podataka o primjeni IKERVISA u trudnica.
There is no difference in dose between symptomatic and presymptomatic patients.
Nema razlike u doziranju simptomatskih i presimptomatskih bolesnicima.
There is no difference in response to irbesartan/hydrochlorothiazide, regardless of age or gender.
Ne postoji razlika u terapijskom odgovoru bolesnika na irbesartan/ hidroklorotiazid s obzirom na spol i dob.
There is no difference in the pharmacodynamic effect of Ryzodeg between elderly and younger patients.
Nema razlike u farmakodinamičkom učinku lijeka Ryzodeg između starijih osoba i mlađih bolesnika.
There is no difference in the pharmacokinetics of insulin degludec between healthy subjects and patients with renal impairment.
Ne postoje razlike u farmakokinetici degludek inzulina između zdravih ispitanika i bolesnika s oštećenjem bubrega.
There is no direct evidence for the role of IL-17A in the expression of CYP450 enzymes.
Nema izravnih dokaza o ulozi IL-17A u ekspresiji CYP450 enzima.
There is no equivalent dose of TREVICTA for the 25 mg dose of 1-monthly paliperidone palmitate injectable which was not studied.
Ne postoji ekvivalentna doza lijeka TREVICTA dozi od 25 mg paliperidonpalmitata u obliku 1- mjesečne injekcije, što nije ispitivano.
There is no evidence available on the effect of para-aminosalicylic acid on fertility.
Ne postoje dokazi o djelovanju paraaminosalicilatne kiseline na plodnost.
There is no evidence available on the effect of sodium phenylbutyrate on fertility.
Nema dostupnih podataka o učinku natrijevog fenilbutirata na plodnost.
There is no evidence currently available to indicate that dose should be adjusted in elderly patients.
Trenutno nema dostupnih dokaza koji bi ukazivali da se u starijih bolesnika mora prilagoditi doza.
There is no evidence currently available to indicate that dosing should be adjusted in older people.
Trenutno nema dostupnih dokaza da se u starijih osoba mora prilagoditi doza.
There is no evidence currently available to indicate that dosing should be adjusted in older people.
Trenutno nema dostupnih podataka koji bi pokazivali da je u starijih osoba potrebno prilagoditi dozu.
There is no evidence for any clinically relevant inter-ethnic differences between Asians and Caucasians in ibandronic acid disposition.
Nisu dokazane klinički značajne međuetničke razlike između azijata i bijelaca prilikom izloženosti ibandronatnoj kiselini.
There is no evidence for immunotoxic, dermal irritation, or phototoxic potential.
Nema dokaza za potencijalnu imunotoksičnost, dermalnu iritaciju ili fototoksičnost.
There is no evidence for special considerations when Strensiq is administered to elderly patients.
Nema dokaza da su potrebne posebne mjere opreza kada se Strensiq primjenjuje bolesnicima starije dobi.
There is no evidence from clinical studies that Tasmar adversely influences a patient’s ability to drive and use machines.
Nema dokaza iz kliničkih ispitivanja da Tasmar štetno utječe na bolesnikovu sposobnost upravljanja vozilima i rada sa strojevima.
There is no evidence from studies in rats and rabbits that filgrastim is teratogenic.
Filgrastim se nije pokazao teratogenim u štakora i kunića.
There is no evidence of an effect of Betaferon on the duration of relapses or on symptoms in between relapses, and no significant effect was seen on the progression of the disease in relapsing-remitting multiple sclerosis.
Nema dokaza učinka lijeka Betaferon na trajanje relapsa ili na simptome između relapsa te nije primjećen značajan učinak na progresiju bolesti u relapsno-remitirajućoj multiploj sklerozi.
There is no evidence of an effect of Betaferon on the duration of relapses or on symptoms in between relapses, and no significant effect was seen on the progression of the disease in relapsing-remitting multiple sclerosis.
Nema dokaza učinka lijeka Betaferona na trajanje relapsa ili na simptome između relapsa te nije primjećen značajan učinak na progresiju bolesti u relapsno-remitirajućoj multiploj sklerozi.
There is no evidence of flutemetamol (18F) binding to soluble forms of Abeta.
Nema dokaza o vezivanju flutemetamola (18F) za topljive oblike amiloida.
There is no evidence that Actelsar HCT would reduce or prevent diuretic-induced hyponatraemia.
Ne postoje dokazi da Actelsar HCT smanjuje ili sprječava hiponatremiju induciranu diureticima.
There is no evidence that alendronate is metabolised in animals or humans.
Nema dokaza da se alendronat metabolizira u životinja niti u ljudi.
There is no evidence that any of these agents counteracts the pharmacodynamic effects of tasonermin.
Ne postoje dokazi da neki od ovih lijekova umanjuju farmakodinamičke učinke tasonermina.
There is no evidence that enfuvirtide may alter the patient’s ability to drive and use machines, however, the adverse event profile of enfuvirtide should be taken into account (see section 4.8).
Nema dokaza da enfuvirtid može promijeniti bolesnikovu sposobnost upravljanja vozilima i rada sa strojevima, ali treba uzeti u obzir njegov profil nuspojava (vidjeti dio 4.8).
There is no evidence that ibandronic acid is metabolised in animals or humans.
Nema dokaza da se ibandronatna kiselina metabolizira u životinja ili ljudi.
There is no evidence that INTELENCE may alter the patient’s ability to drive and operate machines, however, the adverse drug reaction profile should be taken into account.
Ne postoje dokazi o utjecaju INTELENCE-a na bolesnikove sposobnosti upravljanja vozilima i rada sa strojevima, međutim, u obzir treba uzeti profil nuspojava.
There is no evidence that Kinzalkomb would reduce or prevent diuretic-induced hyponatraemia.
Ne postoje dokazi da Kinzalkomb smanjuje ili sprječava hiponatremiju induciranu diureticima.
There is no evidence that MicardisPlus would reduce or prevent diuretic-induced hyponatraemia.
Ne postoje dokazi da MicardisPlus smanjuje ili sprječava hiponatremiju induciranu diureticima.
There is no evidence that patients with HIV infection treated with filgrastim show an increase in HIV replication.
Nema dokaza da se u bolesnika s HIV infekcijom koji primaju filgrastim, pojačava replikacija virusa HIV-a.
There is no evidence that PritorPlus would reduce or prevent diuretic-induced hyponatraemia.
Ne postoje dokazi da PritorPlus smanjuje ili sprječava hiponatremiju induciranu diureticima.
There is no evidence that Riluzole Zentiva exerts a therapeutic effect on motor function, lung function, fasciculations, muscle strength and motor symptoms.
Nema dokaza da Riluzole Zentiva ima terapijski učinak na motoričku funkciju, funkciju pluća, fascikulacije, mišićnu snagu i motoričke simptome.
There is no evidence that Tolucombi would reduce or prevent diuretic-induced hyponatraemia.
Ne postoje dokazi da Tolucombi smanjuje ili sprječava hiponatremiju induciranu diureticima.
There is no evidence to suggest that any extra precautions are needed.
Nema dokaza koji bi ukazivali na potrebu dodatnih mjera opreza
There is no evidence to suggest that any special precautions are needed when older people are treated – although experience with Soliris in this patient population is still limited.
Nema dokaza koji pokazuju da su potrebne ikakve posebne mjere opreza kad se liječe starije osobe, iako je iskustvo s lijekom Soliris u ove populacije bolesnika i dalje ograničeno.
There is no evidence to suggest that eptotermin alfa alters fertility.
Nema podataka koji bi pokazali da eptotermin alfa utječe na plodnost.
There is no evidence to suggest that there is an interaction between Ketoconazole HRA and other steroidogenesis inhibitors (ie metyrapone).
Nema dokaza koji bi ukazivali na interakcije između Ketoconazolea HRA i drugih inhibitora steroidogeneze (primjerice metirapona).
There is no evidencefor immunotoxic, dermal irritation, or phototoxic potential.
Nema dokaza za potencijalnu imunotoksičnost, dermatološku iritaciju ili fototoksičnost.
There is no experience from clinical trials with Voncento in previously untreated patients (PUPs).
Nema iskustva iz kliničkih ispitivanja s Voncentom u prethodno neliječenih bolesnika (PUPs).
There is no experience from controlled clinical trials with concomitant use of Samsca and other treatments for hyponatraemia such as hypertonic saline, oral sodium formulations, and medicinal products that increase serum sodium concentration.
Nema iskustva iz kontroliranih kliničkih ispitivanja s istovremenom primjenom Samsce i drugih načina liječenja hiponatremije kao što su hipertonična otopina natrijeva klorida, peroralne formulacije natrija, te lijekova koji povećavaju koncentraciju serumskog natrija.
There is no experience from controlled clinical trials with concomitant use of tolvaptan and hypertonic saline, oral sodium formulations, and medicinal products that increase serum sodium concentration.
Iz kontroliranih kliničkih ispitivanja nema iskustava s istovremenom primjenom tolvaptana i hipertonične otopine natrijeva klorida, oralne formulacije natrija i lijekova koji povećavaju serumsku koncentraciju natrija.
There is no experience in patients >65 years.
Nema iskustva u bolesnika >65 godina.