natgillin/translations-raw huggingface dataset:
Patients with body weight below 50 kg may experience more adverse reactions and may be more likely to discontinue due to adverse reactions (see section 4.2).
Bolesnici s tjelesnom težinom manjom od 50 kg mogu imati više nuspojava te je vjerojatnije da će prekinuti liječenje zbog nuspojava (vidjeti dio 4.2).
Patients with body weight below 50 kg: Particular caution should be exercised in titrating patients with body weight below 50 kg above the recommended effective dose of 9.5 mg/24 h (see section 4.4).
Bolesnici tjelesne težine ispod 50 kg: Valja biti posebno oprezan kod titriranja doze u bolesnika s tjelesnom težinom ispod 50 kg iznad preporučene djelotvorne doze od 9,5 mg/24 h (vidjeti dio 4.4).
Patients with body weight greater than or equal to 80 kg
Bolesnici s tjelesnom težinom od 80 kg ili većom
Patients with bodyweight greater than 100 kg
Bolesnici s tjelesnom težinom većom od 100 kg
Patients with bone marrow cancer (multiple myeloma) who have low immunoglobulin levels in the blood and develop recurrent infections, if no immune response is obtained after vaccination against certain bacteria (pneumococci).
bolesnici s rakom koštane srži (multipli mijelom) koji imaju niske razine imunoglobulina u krvi i razvijaju ponavljane infekcije, ako nema imunološkog odgovora nakon cijepljenja protiv određenih bakterija (pneumokoki).
Patients with both CIRS > 6 and CrCl < 70 mL/min are more at risk of infections, including severe infections (see section 4.8).
Rizik od infekcija, uključujući ozbiljne infekcije, veći je u bolesnika koji imaju CIRS rezultat > 6 i CrCl < 70 ml/min (vidjeti dio 4.8).
Patients with brain metastases (Results from the Phase II study (BREAK-MB)
Bolesnici s metastazama u mozgu (Rezultati iz ispitivanja faze II (BREAK-MB)
patients with bronchial asthma; in these patients it is especially the risk of bronchospasm which is increased patients with a history of reactions to contrast agents, including a previous history of reaction to iodine-based contrast agents
kod bolesnika s bronhijalnom astmom; kod tih bolesnika posebno je povećan rizik nastanka bronhospazma kod bolesnika s anamnezom reakcije preosjetljivosti na kontrastna sredstva, uključujući reakcije na jodna kontrastna sredstva.
Patients with cancer of the bone marrow (multiple myeloma) and lack of antibody production with recurrent infections who have failed to respond to a vaccine against certain bacteria (pneumococci).
Bolesnici s rakom koštane srži (multipli mijelom) i nedostatkom stvaranja antitijela s ponavljajućim infekcijama koji nisu imali odgovor na cjepivo protiv određene bakterije (pneumokok).
Patients with cancer-related pain
Bolesnici s boli uzrokovanom rakom
Patients with CAPS and Still’s disease (or their carers) may inject Ilaris once they have been trained if their doctor believes it is appropriate.
Nakon odgovarajuće obuke oboljeli od CAPS-a i Stillove bolesti (ili njihovi njegovatelji) mogu sami ubrizgati Ilaris ako njihov liječnik smatra da je to primjereno.
Patients with cardiac arrhythmias
u bolesnika sa srčanim aritmijama
Patients with cardiac disease or risk factors such as a baseline LVEF value of < 45% by multigated radionuclide (MUGA) scan, clinically significant cardiovascular abnormalities (equal to New York Heart Association [NYHA] grade 3 or 4), myocardial infarction within the last 6 months, severe arrhythmia, uncontrolled hypertension, uncontrolled angina, or prior cumulative doses of doxorubicin or equivalent exceeding 450 mg/m2 should receive careful risk versus benefit consideration before receiving treatment with Pixuvri.
Kod bolesnika sa srčanom bolešću ili s postojećim kardiološkim faktorom rizika, kao što je početna vrijednost LVEF < 45% utvrđena pomoću MUGA-snimanja radionuklidima (MUltiGAted radionuclide), klinički značajnim kardiovaskularnim poremećajem (stupnja 3 ili 4 prema New York Heart Association [NYHA]), infarktom miokarda u zadnjih 6 mjeseci, teškom aritmijom, nekontroliranom hipertenzijom, nekontroliranom anginom pektoris ili ranijom terapijom kumulativnim dozama doksorubicina ili njegovog ekvivalenta koja prelazi 450 mg/m2, potrebno je pažljivo procjeniti odnos rizika i korist od terapije prije samog započinjanja liječenja Pixuvriom.
Patients with cardiac disease, risk factors for cardiac failure or history of renal failure should be monitored carefully, and any patient with signs or symptoms consistent with cardiac failure or renal failure should be evaluated and treated.
Bolesnike sa srčanom bolešću, faktorom rizika za zatajenje srca ili ranijim zatajenjem bubregatreba pažljivo pratiti, a svakog bolesnika sa znakovima ili simptomima koji ukazuju na zatajenje rada srca ili bubrega treba pregledati i liječiti.
Patients with cardiovascular co-morbidities could be at increased risk of cardiovascular adverse events triggered by postural hypotension.
U bolesnika s popratnim kardiovaskularnim bolestima može postojati povećan rizik od kardiovaskularnih nuspojava izazvanih posturalnom hipotenzijom.
Patients with cardiovascular diseases (e.g. coronary heart disease, Prinzmetal's angina and cardiac failure) and hypotension therapy with beta-blockers should be critically assessed and therapy with other active substances should be considered.
Bolesnike koji primaju beta-blokatore za liječenje kardiovaskularnih bolesti (npr. koronarne bolesti srca, Prinzmetalove angine i srčanog zatajenja) te hipotenzije, potrebno je kritički procijeniti i razmotriti kod njih liječenje drugim djelatnim tvarima.
Patients with certain immune disorders.
Bolesnici s određenim poremećajima imunosnog sustava.
Patients with CF who have a gating (Class III) mutation in the CFTR gene
Bolesnici s cističnom fibrozom koji imaju mutaciju III. klase gena CFTR zbog koje dolazi do nepravilne regulacije kanala
Patients with CHC awaiting liver transplantation
Bolesnici s CHC-om koji čekaju transplantaciju jetre
Patients with chronic disease conditions 21 Days After
Pacijenti s kroničnim bolestima 21 dan kasnije
Patients with chronic hepatitis B or C and treated with antiretroviral therapy are at an increased risk for severe and potentially fatal hepatic adverse reactions.
Pacijenti s kroničnim hepatitisom B ili C liječeni antiretrovirusnim lijekovima imaju povećan rizik od teških i potencijalno smrtonosnih jetrenih nuspojava.
Patients with chronic hepatitis B or C and treated with combination antiretroviral therapy are at an increased risk of severe and potentially fatal hepatic adverse reactions.
Bolesnici s kroničnim hepatitisom B ili C koji su na kombiniranoj antiretrovirusnoj terapiji imaju povećani rizik od nastupa teških i potencijalno fatalnih nuspojava jetre.
Patients with chronic hepatitis B or C treated with antiretroviral therapy are at an increased risk for severe and potentially fatal hepatic adverse reactions.
Bolesnici s kroničnim hepatitisom B ili C liječeni antiretrovirusnom terapijom izloženi su povećanom riziku od teških i potencijalno po život opasnih jetrenih nuspojava.
Patients with chronic hepatitis B or C treated with antiretroviral therapy are at an increased risk for severe and potentially fatal hepatic adverse reactions.
Bolesnici s kroničnim hepatitisom B ili C liječeni antiretrovirusnom terapijom, izloţeni su povećanom riziku od teških i potencijalno ţivotno opasnih jetrenih nuspojava.
Patients with chronic hepatitis B or C treated with antiretroviral therapy are at an increased risk for severe and potentially fatal hepatic adverse reactions.
Pacijenata s kroničnim hepatitisom B ili C liječeni antiretrovirusnom terapijom, izloženi su povećanom riziku od teških i potencijalno smrtonosnih jetrenih nuspojava.
Patients with chronic hepatitis B or C treated with antiretroviral therapy are at an increased risk for severe and potentially fatal hepatic adverse reactions.
Pacijenti s kroničnim hepatitisom B ili C liječeni antiretrovirusnom terapijom, izloženi su povećanom riziku od teških i potencijalno smrtonosnih jetrenih nuspojava.
Patients with chronic hepatitis B or C treated with ART are at an increased risk for severe and potentially fatal hepatic adverse reactions.
Bolesnici s kroničnim hepatitisom B ili C koji se liječe ART-om izloženi su povećanom riziku za razvoj teških nuspojava povezanih s jetrom s potencijalno smrtnim ishodom.
Patients with chronic kidney disease are predisposed to developing metabolic acidosis.
Bolesnici s kroničnom bubrežnom bolešću imaju predispoziciju za razvoj metaboličke acidoze.
Patients with chronic liver disease or with HIV infection or hepatitis C carriers should not be precluded from vaccination against hepatitis B. The vaccine could be advised since HBV infection can be severe in these patients: the Hepatitis B vaccination should thus be considered on a case-by-case basis by the physician.
Bolesnike s kroničnom bolesti jetre ili sa HIV infekcijom kao ni nositelje hepatitisa C ne treba isključivati iz skupine za cijepljenje protiv hepatitis B. Cijepljenje se može preporučiti budući da HBV infekcija kod tih bolesnika može biti teška: liječnik stoga cijepljenje protiv hepatitisa B treba razmatrati individualno za svaki pojedini slučaj.
Patients with chronic renal failure, patients with creatinine clearance < 50 ml/minute and/or on haemodialysis.
Bolesnici s kroničnim zatajenjem bubrega, bolesnici s klirensom kreatinina <50 i/ili na hemodijalizi
Patients with chronic renal failure, patients with creatinine clearance < 50 ml/minute and/or on haemodialysis.
Bolesnici s kroničnim zatajenjem bubrega, bolesnici s klirensom kreatinina <50 ml/min i/ili na hemodijalizi.
Patients with chronic wide-angle glaucoma may be treated with Corbilta with caution, provided the intra-ocular pressure is well controlled and the patient is monitored carefully for changes in intra-ocular pressure.
Bolesnici s kroničnim glaukomom otvorenog kuta mogu se uz oprez liječiti Corbiltom pod uvjetom da je intraokularni tlak dobro kontroliran i da se bolesnike pažljivo prati zbog promjena intraokularnog tlaka.
Patients with chronic wide-angle glaucoma may be treated with Levodopa/Carbidopa/Entacapone Orion with caution, provided the intra-ocular pressure is well controlled and the patient is monitored carefully for changes in intra-ocular pressure.
Bolesnici s kroničnim glaukomom otvorenog kuta mogu se uz oprez liječiti Levodopa/Carbidopa/Entacapone Orionom pod uvjetom da je intraokularni tlak dobro kontroliran i da se bolesnike pažljivo prati zbog promjena intraokularnog tlaka.
Patients with chronic wide-angle glaucoma may be treated with Stalevo with caution, provided the intra-ocular pressure is well controlled and the patient is monitored carefully for changes in intra- ocular pressure.
Bolesnici s kroničnim glaukomom otvorenog kuta mogu se uz oprez liječiti Stalevom pod uvjetom da je intraokularni tlak dobro kontroliran i da se bolesnike pažljivo prati zbog promjena intraokularnog tlaka.
Patients with chronic wide-angle glaucoma may be treated with Stalevo with caution, provided the intra-ocular pressure is well controlled and the patient is monitored carefully for changes in intra-ocular pressure.
Bolesnici s kroničnim glaukomom otvorenog kuta mogu se uz oprez liječiti Stalevom pod uvjetom da je intraokularni tlak dobro kontroliran i da se bolesnike pažljivo prati zbog promjena intraokularnog tlaka.
Patients with cirrhosis
Bolesnici s cirozom
Patients with cirrhosis may be at a higher risk for hepatic decompensation following hepatitis exacerbation, and therefore should be monitored closely during therapy.
Pacijenti s cirozom mogu biti izloženi većem riziku od dekompenzacije jetre nakon egzacerbacije hepatitisa i stoga se moraju pomno pratiti tijekom terapije.
Patients with cirrhosis N = 103
Bolesnici s cirozom N = 103
Patients with CLcr  20 ml/min do not require a dose adjustment, see section 5.2.
Bolesnici s klirensom kreatinina  20 ml/min ne zahtijevaju prilagodbu doze, vidjeti dio 5.2.
Patients with CLcr  20 ml/min do not require a dose adjustment, see section 5.2. In paediatric patients with renal dysfunction who are undergoing dialysis it is recommended that following each dialysis treatment patients receive an additional dose of Viramune oral suspension or immediate-release tablets representing 50 % of the recommended daily dose of Viramune oral suspension or immediate-release tablets which would help offset the effects of dialysis on nevirapine clearance.
Bolesnici s klirensom kreatinina  20 ml/min ne zahtijevaju prilagodbu doze; vidjeti dio 5.2. Kod pedijatrijskih bolesnika s bubrežnom disfunkcijom koji su podvrgnuti dijalizi preporučuje se dodatna doza Viramune oralne suspenzije ili tableta s trenutnim oslobađanjem nakon svake dijalize, što čini 50 % preporučene dnevne doze Viramune oralne suspenzije ili tableta s trenutnim oslobađanjem koji mogu pomoći neutralizirati učinke dijalize na klirens nevirapina.
Patients with CLcr  20 ml/min do not require a dose adjustment, see section 5.2. In paediatric patients with renal dysfunction who are undergoing dialysis it is recommended that following each dialysis treatment patients receive an additional dose of Viramune oral suspension or immediate-release tablets representing 50% of the recommended daily dose of Viramune oral suspension or immediate-release tablets which would help offset the effects of dialysis on nevirapine clearance.
Bolesnici s klirensom kreatinina  20 ml/min ne zahtijevaju prilagodbu doze; vidjeti dio 5.2. Kod pedijatrijskih bolesnika s bubrežnom disfunkcijom koji su podvrgnuti dijalizi preporučuje se dodatna doza Viramune oralne suspenzije ili tableta s trenutnim oslobađanjem nakon svake dijalize, što čini 50 % preporučene dnevne doze Viramune oralne suspenzije ili tableta s trenutnim oslobađanjem koji mogu pomoći neutralizirati učinke dijalize na klirens nevirapina.
Patients with clinically important abnormalities in rhythm and conduction as measured by resting electrocardiogram (ECG) (e.g.
Bolesnici s klinički važnim abnormalnostima u ritmu i provodljivosti, mjereno pomoću elektrokardiograma (EKG) u mirovanju (npr.
Patients with clinically important disruptions to the blood-brain barrier (e.g. primary brain malignancies, CNS metastases or other inflammatory conditions, active multiple sclerosis, advanced Alzheimer’s disease etc.) were not included in clinical studies and may be at risk for naloxegol entry into the CNS.
Bolesnici s klinički značajnim oštećenjima krvno-moždane barijere (npr. primarnim zloćudnim bolestima mozga, metastazama u SŽS-u ili drugim upalnim stanjima, aktivnom multiplom sklerozom, uznapredovalom Alzheimerovom bolešću itd.) nisu bili uključeni u klinička ispitivanja, pa u njih može postojati rizik od ulaska naloksegola u SŽS.
Patients with clinically significant aortic and mitral valve disease
bolesnici s klinički značajnom bolešću aortnog i mitralnog zaliska
Patients with Clinically Significant Response (%)
Bolesnici s klinički značajnim odgovorom (%)
Patients with CLL who received at least one prior therapy
Bolesnici s KLL koji su prethodno primili najmanje jednu terapiju
Patients with CMV viraemia without associated clinical signs of CMV infection should be carefully monitored.
Potrebno je pažljivo nadzirati pacijente s CMV viremijom bez povezanih kliničkih znakova infekcije CMV-om.
Patients with compensated cirrhos is
Pacijenti s kompenziranom cirozom
Patients with compensated cirrhosis and/or prior treatment failure
Pacijenti s kompenziranom cirozom i/ili prethodno neuspješnimlječenjem
patients with complete absence of activity of the dihydropyrimidine dehydrogenase enzyme;
u bolesnika s potpunim izostankom aktivnosti enzima dihidropirimidin dehidrogenaze;
Patients with complicated skin and soft tissue infections should be treated for five to 14 days, whereas patients who have community-acquired pneumonia should be treated for five to seven days.
Bolesnici s kompliciranim infekcijama kože i mekog tkiva moraju se liječiti pet do 14 dana, a bolesnici s izvanbolnički stečenom pneumonijom moraju se liječiti pet do sedam dana.
Patients with concomitant administration of medicinal products that may increase the risk of bleeding (e.g. non-steroidal anti-inflammatory drugs (NSAIDs), oral anticoagulants and/or fibrinolytics) within 24 hours of ticagrelor dosing.
Bolesnici koji istodobno uzimaju lijekove koji mogu povećati rizik od krvarenja (npr. ne-steroidni protuupalni lijekovi (NSAID), oralni antikoagulansi i/ili fibrinolitici) unutar 24 sata od uzimanja tikagrelora.
Patients with concomitant diseases, or who use medicinal products which have a potential for undesirable effects on the kidney, should be reviewed regularly in line with good medical practice during treatment.
Bolesnike s pratećim bolestima ili one koji koriste lijekove koji mogu imati štetne učinke na bubrege, potrebno je tijekom liječenja redovito kontrolirati u skladu s načelima dobre kliničke prakse.
Patients with concomitant diseases, or who use medicinal products which have a potential for undesirable effects on the kidney, should be reviewed regularly in line with good medical practice during treatment.
Bolesnike s pratećim bolestima ili one koji koriste lijekove koji mogu imati štetne učinke na bubrege, potrebno je tijekom liječenja redovito kontrolirati u skladu s načelima dobre medicinske prakse.
Patients with concomitant treatment of pravastatin, rosuvastatin or fluvastatin should be carefully monitored for signs and symptoms of myopathy and rhabdomyolysis. (See sections 4.3 and 4.5).
Bolesnike koji istodobno uzimaju pravastatin, rosuvastatin ili fluvastatin treba pomno nadzirati zbog mogućih pojava znakova i simptoma miopatije i rabdomiolize. (Vidjeti dio 4.3 i 4.5).
Patients with congenital factor XIII A-subunit deficiency do not have enough of the factor XIII A-subunit, or it does not work correctly, which makes them prone to bleeding.
Bolesnici oboljeli od prirođenog nedostatka faktora XIII podjedinice A nemaju dovoljno faktora XIII podjedinice A ili isti ispravno ne radi, zbog čega su podložni krvarenju.
Patients with congenital or acquired QT prolongation
Bolesnici s uroĎenim ili stečenim produljenjem QT intervala
Patients with congestive heart failure (CHF) have been identified as a population at higher risk for hypotension. (See section 4.8.)
Utvrđeno je da su bolesnici s kongestivnim zatajenjem srca populacija s povećanim rizikom za razvoj hipotenzije. (Vidjeti dio 4.8)
Patients with congestive heart failure (NYHA grades 3 and 4) have not been studied and therefore treatment of these patients is not recommended.
Primjena Daxasa kod bolesnika s kongestivnim zatajenjem srca (NYHA stupnjevi 3 i 4) nije ispitana te se liječenje takvih bolesnika ne preporučuje.
Patients with contraindications to the use of vasopressor agents.
Bolesnici s kontraindikacijama za primjenu vazopresornih lijekova.
Patients with COPD and patients who are heavy smokers may have a higher risk of developing cancer with Flixabi treatment.
Bolesnici s KOPB-om i bolesnici koji su teški pušači mogu imati povećan rizik za razvoj raka pri liječenju lijekom Flixabi.
Patients with COPD and patients who are heavy smokers may have a higher risk of developing cancer with Inflectra treatment.
Bolesnici s KOPB-om i bolesnici koji su teški pušači mogu imati povećan rizik za razvoj raka pri liječenju lijekom Inflectra.
Patients with COPD and patients who are heavy smokers may have a higher risk of developing cancer with Remicade treatment.
Bolesnici s KOPB-om i bolesnici koji su teški pušači mogu imati povećan rizik za razvoj raka pri liječenju lijekom Remicade.
Patients with COPD and patients who are heavy smokers may have a higher risk of developing cancer with Remsima treatment.
Bolesnici s KOPB-om i bolesnici koji su teški pušači mogu imati povećan rizik za razvoj raka pri liječenju lijekom Remsima.
Patients with COPD, asthma or compromised respiratory function due to other conditions should be treated with caution.
Stoga je potreban oprez u bolesnika s KOBP-om, astmom ili kompromitiranom respiratornom funkcijom zbog drugog uzroka.
Patients with coronary atherosclerosis were included who required PCI for stable angina (58%), non-ST-segment elevation acute coronary syndrome (NSTE-ACS) (26%), or ST-elevation myocardial infraction (STEMI) (16%).
Uključeni su bolesnici s koronarnom aterosklerozom kojima je trebao PCI za stabilnu anginu (58%), akutni koronarni sindrom bez elevacije ST-segmenta (26%), ili infarkt miokarda sa ST- elevacijom (16%).
Patients with CrCL 30 to 50 mL/min received a lower dose of Zavicefta than is currently recommended for patients in this sub-group.
Bolesnici s CrCL od 30 do 50 ml/min primili su nižu dozu lijeka Zavicefta nego što je trenutno preporučeno za bolesnike u ovoj podskupini.
Patients with CrCl between 30 mL/min and 60 mL/min:
Bolesnici s CrCl između 30 i 60 ml/min:
Patients with creatinine clearance >60 ml/min have been included in efficacy/safety studies of topotecan.
Bolesnici s klirensom kreatinina većim od 60 ml/min uključeni su u ispitivanja djelotvornosti/sigurnosti topotekana.
Patients with CRF experienced greater risks for death and serious cardiovascular events when administered ESAs to target higher versus lower haemoglobin levels (13.5 g/dl (8.4 mmol/l) versus
Bolesnici s kroničnim zatajenjem bubrega imali su veći rizik od smrti i ozbiljnih kardiovaskularnih događaja kada je LSE primijenjen s višim ciljnim vrijednostima hemoglobina nasuprot nižim vrijednostima (13,5 g/dl (8,4 mmol/l) naspram 11,3 g/dl (7,1 mmol/l); 14 g/dl (8,7 mmol/l) naspram
Patients with Crohn’s disease, who have not shown a response may benefit from a dose of Entyvio at Week 10 (see section 4.4).
Bolesnici s Crohnovom bolešću kod kojih nije zabilježen odgovor mogu imati koristi od doze lijeka Entyvio u 10. tjednu (vidjeti dio 4.4).
Patients with CSU: The effects of demographic characteristics and other factors on omalizumab exposure were evaluated based on population pharmacokinetics.
Bolesnici s KSU-om: Učinci demografskih karakteristika i drugih čimbenika na izloženost omalizumabu bili su ocijenjeni na temelju populacijske farmakokinetike.
patients with current concomitant therapy with oral anticoagulants (e.g. warfarin sodium)
bolesnici s istodobnom terapijom oralnim antikoagulansima (npr. varfarinnatrij)
Patients with current severe depression and/or suicidal ideation (see sections 4.4 and 4.8).
Bolesnici koji trenutno boluju od teške depresije i/ili imaju suicidalne ideacije (vidjeti dijelove 4.4 i 4.8).
Patients with current severe depression and/or suicidal ideation (see sections 4.4 and 4.8).
Bolesnici koji trenutno boluju od teške depresije i/ili imaju suicidalne ideje (vidjeti dijelove 4.4 i 4.8).
Patients with current severe depression and/or suicidal ideation (see sections 4.4 and 4.8).
Bolesnici koji trenutno boluju od teških depresija i/ili imaju suicidalne ideje (vidjeti dijelove 4.4 i 4.8).
Patients with current severe depression and/or suicidal ideation (see sections 4.4 and 4.8).
Bolesnici s postojećom teškom depresijom i/ili mislima o samoubojstvu (vidjeti dijelove 4.4 i 4.8).
Patients with current severe depression and/or suicidal ideation (see sections 4.4 and 4.8).
Bolesnici s trenutnom teškom depresijom i/ili suicidalnim idejama (vidjeti dijelove 4.4 i 4.8).
Patients with cystinosis taking immediate-release cysteamine bitartrate may be transferred to a total daily dose of PROCYSBI equal to their previous total daily dose of immediate-release cysteamine bitartrate.
Bolesnici s cistinozom koji uzimaju cisteamin bitartrat s trenutačnim oslobađanjem mogu prijeći na ukupnu dnevnu dozu lijeka PROCYSBI koja odgovara njihovoj prethodnoj dnevnoj dozi cisteamin bitartrata s trenutačnim oslobađanjem.
Patients with decompensated liver disease (see sections 4.4, 4.5 and 4.8).
Bolesnici s dekompenziranom bolesti jetre (vidjeti dijelove 4.4, 4.5 i 4.8).