natgillin/translations-raw huggingface dataset:
Although Focetria in multidose vials contains a preservative that inhibits microbial growth, minimisation of the risk of contamination of the multidose vial during withdrawal of each dose is the responsibility of the user.
Iako Focetria u višedoznim bočicama sadrži konzervans koji inhibira rast mikroorganizama, za smanjenje rizika od kontaminacije višedozne bočice tijekom izvlačenja svake doze odgovoran je korisnik.
Although Foclivia in multidose vials contains a preservative that inhibits microbial growth, minimisation of the risk of contamination of the multidose vial during withdrawal of each dose is the responsibility of the user.
Iako Foclivia u višedoznim bočicama sadrži konzervans koji sprječava rast mikroorganizama, za smanjenje rizika od kontaminacije višedoznog spremnika prilikom izvlačenja svake pojedine doze odgovoran je korisnik.
Although gout, arthralgia and nephrolithiasis were reported as ADRs, the relationship to elevations in uric acid due to Preotact administration has not been fully established.
Premda su giht, artralgija i nefrolitijaza prijavljeni kao nuspojave, nije dokazana povezanost između povećanja urične kiseline i uzimanja Preotacta.
Although greater sensitivity to develop adverse reactions in some older patients and Asian patients cannot be ruled out, overall, no major differences were observed in the safety and effectiveness of axitinib between patients who were ≥ 65 years of age and non-elderly, and between White patients and patients of other races.
Iako se ne može isključiti veća osjetljivost za razvoj neželjenih reakcija u nekih starijih bolesnika i bolesnika azijskog podrijetla, ukupno gledajući, nema velikih razlika u sigurnosti i djelotvornosti aksitiniba između bolesnika u dobi od ≥ 65 godina i mlađih, kao ni između bijelaca i bolesnika drugih rasa.
Although group B meningococcal disease is relatively uncommon in Europe, the CHMP noted that it is more common in certain regions of Europe.
Iako je meningokokna bolest grupe B relativno neuobičajena u Europi, CHMP je primijetio da je uobičajenija u određenim dijelovima Europe.
Although haematological toxicities of neutropenia, thrombocytopenia and anaemia occurred more frequently in HCV/HIV co-infected patients, the majority could be managed by dose modification and rarely required premature discontinuation of treatment (see section 4.4).
Premda su se hematološke toksičnosti poput neutropenije, trombocitopenije i anemije javljale češće u bolesnika s istodobnom infekcijom HCV-om i HIV-om, većina ih se mogla zbrinuti prilagodbom doze, a rijetko je trebalo ranije obustaviti liječenje (vidjeti dio 4.4).
Although haematological toxicities of neutropenia, thrombocytopenia and anaemia occurred more frequently in HIV-HCV patients, the majority could be managed by dose modification and the use of growth factors and infrequently required premature discontinuation of treatment.
Premda su se hematološke toksičnosti u vidu neutropenije, trombocitopenije i anemije češće pojavljivale u bolesnika koinficiranih HIV-om i HCV-om, većinom su se mogle korigirati smanjenjem doze i upotrebom faktora rasta, a u rjeđim slučajevima su zahtijevale prijevremeni prekid liječenja.
Although hidden from view the needle tip is now uncovered.
Iako nije izložen pogledu, vršak igle je sada otkriven.
Although hyperparathyroidism was not reported in CA209017, immune-related hyperparathyroidism might be considered especially if associated with hypophosphataemia (reported in 6 hypercalcemic patients in this study).
Iako u ispitivanju CA209017 nije prijavljena hiperparatireoza, može se razmotriti imunološki uzrokovana hiperparatireoza, osobito ako je povezana s hipofosfatemijom (koja je u ovom ispitivanju prijavljena u 6 bolesnika s hiperkalcijemijom).
Although in patients aged ≥ 75 years, both BzmbR-CAP and R-CHOP were less tolerated, the serious adverse event rate in the BzmbR-CAP groups was 68%, compared to 42% in the R-CHOP group.
Iako su bolesnici u dobi od ≥ 75 godina, podnosili lošije i BzmbR-CAP i R- CHOP, stopa ozbiljnih nuspojava u BzmbR-CAP skupini bila je 68 %, u usporedbi s 42 % u R-CHOP skupini.
Although in patients aged ≥ 75 years, both BzR-CAP and R-CHOP were less tolerated, the serious adverse event rate in the BzR-CAP groups was 68%, compared to 42% in the R- CHOP group.
Iako su bolesnici u dobi od ≥ 75 godina, podnosili lošije i BzR-CAP i R-CHOP, stopa ozbiljnih nuspojava u BzR-CAP skupini bila je 68%, u usporedbi s 42% u R-CHOP skupini.
Although in patients aged ≥ 75 years, both VcR-CAP and R-CHOP were less tolerated, the serious adverse event rate in the VcR-CAP groups was 68%, compared to 42% in the R- CHOP group.
Iako su bolesnici u dobi od ≥ 75 godina, podnosili lošije i VcR-CAP i R-CHOP, stopa ozbiljnih nuspojava u VcR-CAP skupini bila je 68%, u usporedbi s 42% u R-CHOP skupini.
Although in placebo-controlled pivotal phase III studies, JETREA has shown benefit in inducing closure of macular holes associated with vitreomacular traction, in some instances increased traction with subsequent progression or development of new macular hole has been observed.
Premda se u III. fazi placebom nadziranih pivotalnih ispitivanja JETREA pokazala korisnom u indukciji zatvaranja makularnih rupa povezanih s vitreomakularnom trakcijom, u nekim slučajevima je zamijećena pojačana trakcija, nakon koje je slijedila progresija ili razvoj nove makularne rupe.
Although in the majority of cases the information was too limited to allow a causality assessment, confounding factors such as pre-existing lupus, including potential incipient SLE, were present in many of the remaining cases and the pathogenesis of SLE/drug-induced lupus is still poorly understood and probably multifactorial, it does not appear unreasonable that Xolair, a drug that forms immune complexes with IgE with the potential to induce immune complex injury and for which events such as serum sickness have been rarely reported, could play a role in the pathogenesis of SLE/drug-induced lupus.
Iako su u većini slučajeva informacije bile preograničene da bi bilo moguće ocijeniti uzročnu povezanost, zbunjujući čimbenici kao što su već postojeći lupus, uključujući potencijalni početni SLE, bili su prisutni u mnogima od preostalih slučajeva, a patogeneza SLE-a/lijekom induciranog lupusa još uvijek se premalo razumije i vjerojatno je uzrokovana višestrukim čimbenicima, pa se ne čini nemogućim da bi Xolair, lijek koji stvara imunokomplekse s IgE-om s potencijalom za induciranje oštećenja tkiva uzrokovanog imunokompleksima i uz kojeg su rijetko zabilježeni događaji poput serumske bolesti, mogao igrati ulogu u patogenezi SLE-a/lijekom induciranog lupusa.
Although in vitro data suggest that efavirenz inhibits CYP2C9 and CYP2C19, there have been contradictory reports of both increased and decreased exposures to substrates of these enzymes when co-administered with efavirenz in vivo.
Iako podaci in vitro pokazuju da efavirenz inhibira CYP2C9 i CYP2C19, postoje kontradiktorna izvješća kako o povećanoj, tako i o smanjenoj izloženosti supstratima ovih enzima kad se primjenjuju istovremeno s efavirenzom in vivo.
Although it is not known if Imlygic could be transmitted through sexual contact, it is known that wild- type HSV-1 can be transmitted through sexual contact.
Iako nije poznato može li se Imlygic prenijeti seksualnim kontaktom, poznato je da se divlji tip virusa HSV-1 može prenijeti seksualnim kontaktom.
Although it is not known whether topotecan is excreted in human breast milk, breast-feeding should be discontinued at the start of therapy.
Iako nije poznato izlučuje li se topotekan u majčino mlijeko, tijekom liječenja topotekanom preporučuje se prekid dojenja.
Although it is thought that these reactions are mostly surgery-related, a potential influence of the expanded chondrocytes cannot be completely excluded.
Iako se smatra da su te reakcije uglavnom povezane s kirurškim postupkom, ipak se ne može u potpunosti isključiti utjecaj ekspandiranih hondrocita.
Although it was not possible to conduct a study directly comparing Defitelio with placebo (dummy treatment), the company had provided sufficient data to show that patients treated with the medicine had improved chances of survival.
Iako nije bilo moguće provesti ispitivanje koje bi izravno usporedilo Defitelio s placebom (liječenjem bez djelatne tvari), tvrtka je dostavila dovoljno podataka koji dokazuju da bolesnici liječeni ovim lijekom imaju povećane izglede za preživljenje.
Although kidney problems have not been observed with Descovy, there is a possibility that you may experience kidney problems when taking Descovy over a long period of time.
Iako uz Descovy nisu opaţene tegobe s bubrezima, postoji mogućnost da Vam se jave tegobe s bubrezima ako uzimate Descovy tijekom dugog vremenskog razdoblja.
Although limited by the low number of patients, efficacy analyses among these patients with V600K-positive tumours suggested similar treatment benefit of vemurafenib in terms of OS, PFS and confirmed best overall response.
Iako ograničene malim brojem bolesnika, analize djelotvornosti u tih bolesnika s tumorom s pozitivnom mutacijom V600K su ukazale na podjednaku korist od liječenja vemurafenibom po pitanju ukupnog preživljenja, preživljenja bez progresije bolesti i potvrđenog najboljeg ukupnog odgovora na liječenje.
Although limited by the small number of female subjects in study GS-US-183-0145, subgroup analysis by gender showed that the rates of virologic success in female subjects at weeks 48 and 96 (HIV-1 RNA < 50 copies/mL) were numerically lower in the elvitegravir treatment arm than in the raltegravir treatment arm.
Unatoč ograničenom broju ispitanica u ispitivanju GS-US-183-0145, analiza podskupine prema spolu pokazala je da su stope virološkog uspjeha u ispitanica u 48. i 96. tjednu (HIV-1 RNK < 50 kopija/ml) brojčano niže u skupini liječenja elvitegravirom od skupine liječenja raltegravirom.
Although limited, data indicated that shortening treatment to 24 weeks might be associated with a higher risk of relapse (see Table 15).
Podaci, premda ograničeni, pokazuju da skraćivanje trajanja liječenja na 24 tjedna može biti povezano s većim rizikom pojave relapsa (vidjeti tablicu 15).
Although limited, evidence from the clinical trials suggests that patients not responding to tocilizumab or anakinra, may respond to canakinumab.
Iako ograničeni, dokazi iz kliničkih ispitivanja upućuju na to da bi bolesnici koji nemaju odgovor na tocilizumab ili anakinru mogli imati odgovor na kanakinumab.
Although low in frequency in clinical trials, major or severe bleeding may occur and, regardless of location, may lead to disabling, life-threatening or even fatal outcomes.
Iako rijetko po učestalosti u kliničkim ispitivanjima, može doći do velikog ili teškog krvarenja, koje, bez obzira na mjesto, može biti onesposobljavajuće, opasno po život ili čak fatalno.
Although meals (low or high fat content) have been shown to reduce the absorption of Rasilez substantially, the efficacy of aliskiren was shown to be similar when taken either with a light meal or without a meal (see section 4.2).
Iako se pokazalo da obroci (s niskim ili visokim sadržajem masti) značajno smanjuju apsorpciju Rasileza, djelotvornost aliskirena se pokazala sličnom kad se uzima s laganim obrokom ili bez obroka (vidjeti dio 4.2).
Although more data are needed to determine the size of the benefit, the Agency’s Committee for Medicinal Products for Human Use (CHMP) decided that Zalmoxis’ benefits are greater than its risks and recommended that it be approved for use in the EU.
Iako je potrebno više podataka kako bi se odredio stupanj koristi, Odbor za lijekove za humanu uporabu (CHMP) pri Agenciji odlučio je da koristi od lijeka Zalmoxis nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za primjenu u Europskoj uniji.
Although most bleeding associated with the use of cangrelor occurs at the site of arterial puncture, haemorrhage can occur at any site.
Iako se većina krvarenja povezanih s primjenom kangrelora pojavljuje na mjestu punkcije arterije, krvarenje se može pojaviti na bilo kojem mjestu.
Although no clinically relevant effect on the cardiovascular system is usually seen after the administration of Hirobriz Breezhaler at the recommended doses, as with other beta2-adrenergic agonists, indacaterol should be used with caution in patients with cardiovascular disorders (coronary artery disease, acute myocardial infarction, cardiac arrhythmias, hypertension), in patients with convulsive disorders or thyrotoxicosis, and in patients who are unusually responsive to beta2- adrenergic agonists.
Iako nije bio zapažen klinički značajan učinak na kardiovaskularni sustav nakon primjene Hirobriz Breezhalera u preporučenim dozama, indakaterol treba, kao i druge beta2-adrenergičke agoniste, oprezno primjenjivati u bolesnika s kardiovaskularnim poremećajima (koronarna srčana bolest, akutni infarkt miokarda, srčane aritmije, hipertenzija), u bolesnika s konvulzivnim poremećajima ili tireotoksikozom te u bolesnika koji imaju neuobičajeni odgovor na beta2-adrenergičke agoniste.
Although no clinically relevant effect on the cardiovascular system is usually seen after the administration of Onbrez Breezhaler at the recommended doses, as with other beta2-adrenergic agonists, indacaterol should be used with caution in patients with cardiovascular disorders (coronary artery disease, acute myocardial infarction, cardiac arrhythmias, hypertension), in patients with convulsive disorders or thyrotoxicosis, and in patients who are unusually responsive to beta2- adrenergic agonists.
Iako nije bio zapažen klinički značajan učinak na kardiovaskularni sustav nakon primjene Onbrez Breezhalera u preporučenim dozama, indakaterol treba, kao i druge beta2-adrenergičke agoniste, oprezno primjenjivati u bolesnika s kardiovaskularnim poremećajima (koronarna srčana bolest, akutni infarkt miokarda, srčane aritmije, hipertenzija), u bolesnika s konvulzivnim poremećajima ili tireotoksikozom te u bolesnika koji imaju neuobičajeni odgovor na beta2-adrenergičke agoniste.
Although no data are available in dogs, studies with laboratory animals have shown effects on their fertility and foetal development.
Iako ne postoje podaci za pse, istraživanja na laboratorijskim životinjama pokazala su djelovanje na plodnost i fetalni razvoj.
Although no direct comparisons with Enzyme Replacement Therapy (ERT) have been performed in treatment-naive patients with type 1 Gaucher disease, there is no evidence of Zavesca having an efficacy or safety advantage over ERT.
Iako nije bilo neposredne usporedbe s enzimskim nadomjesnim liječenjem (Enzyme Replacement Therapy - ERT) u liječenju bolesnika s Gaucherovom bolesti tipa 1, nema dokaza da je Zavesca učinkovitija ili sigurnija od ERT.
Although no dose adjustments are recommended in patients with moderate renal impairment (creatinine clearance 30-50 mL/min) or mild renal impairment (creatinine clearance 50-80 mL/min), careful clinical monitoring is advised during the treatment with enoxaparin sodium.
Iako nije preporučeno prilagođavanje doze u bolesnika s umjerenim (klirens kreatinina 30-50 ml/min) ili blagim oštećenjem funkcije bubrega (klirens kreatinina 50-80 ml/min), preporučuje se pažljivi klinički nadzor tijekom liječenja enoksaparin-natrijem.
Although no dose adjustments are recommended in patients with moderate renal impairment (creatinine clearance 30-50 mL/min) or mild renal impairment (creatinine clearance 50-80 mL/min), it is advised that your doctor carefully monitors your treatment.
Iako nije preporučeno prilagođavanje doze u bolesnika s umjerenim (klirens kreatinina 30-50 ml/min) ili blagim oštećenjem funkcije bubrega (klirens kreatinina 50-80 ml/min), preporučuje se da liječnik pažljivo nadzire Vaše liječenje.
Although no dose adjustments is necessary in patients with moderate (creatinine clearance 30 to 50 mL/min) and mild (creatinine clearance 50 to 80 mL/min) renal impairment, careful clinical monitoring of these patients should be carried out during treatment with enoxaparin sodium (see also sections 4.2 and 5.2).
Iako prilagodba doze u bolesnika s umjerenim (klirens kreatinina 30 do 50 ml/min) i blagim (klirens kreatinina 50 do 80 ml/min) oštećenjem bubrega nije potrebna, potreban je pažljivi klinički nadzor ovih bolesnika tijekom liječenja enoksaparin-natrijem (vidjeti također dijelove 4.2 i 5.2).
Although no dose adjustments is necessary in patients with moderate (creatinine clearance 30 to 50 mL/min) and mild (creatinine clearance 50 to 80 mL/min) renal impairment, careful clinical monitoring of these patients should be carried out during treatment with enoxaparin sodium (see also sections 4.2 and 5.2).
Iako prilagodba doze u bolesnika s umjerenim (klirens kreatinina 30 do 50 ml/min) i blagim (klirens kreatinina 50 do 80 ml/min) oštećenjem bubrega nije potrebna, potreban je pažljivi klinički nadzor ovih bolesnika tijekom liječenja enoksaparin-natrijem (vidjeti također dio 4.2 i 5.2).
Although no dose adjustments is necessary in patients with moderate (creatinine clearance 30 to 50 mL/min) and mild (creatinine clearance 50 to 80 mL/min) renal impairment, careful clinical monitoring of these patients should be carried out during treatment with enoxaparin sodium (see also sections 4.2 and 5.2).
Iako prilagodba doze u bolesnika s umjerenim (klirens kreatinina 30 do 50 ml/min) i blagim (klirens kreatinina 50 do 80 ml/min) oštećenjem bubrega nije potrebna, potreban je pažljivi klinički nadzor ovih bolesnika tijekom liječenja enoksaparinnatrijem (vidjeti također dio 4.2 i 5.2).
Although no evidence of an increased incidence of adverse reactions have been observed in patients with renal or hepatic impairment receiving granisetron orally and intravenously, based on granisetron pharmacokinetics, a degree of caution must be exercised in this population.
Iako u bolesnika s oštećenjem funkcije bubrega ili jetre koji su peroralno i intravenski primali granisetron nije uočen porast učestalosti nuspojava, na temelju podataka o farmakokinetici granisetrona, potreban je oprez u ovoj populaciji bolesnika.
Although no evidence of an increased incidence of adverse reactions have been observed in patients with renal or hepatic impairment receiving granisetron orally and intravenously, based on granisetron pharmacokinetics, a degree of caution must be exercised in this population.
Iako u bolesnika s oštećenjem funkcije bubrega ili jetre, koji su peroralno i intravenski primali granisetron, nije uočen porast incidencije nuspojava, na temelju podataka o farmakokinetici granisetrona, nužan je oprez u ovoj populaciji bolesnika.
Although no formal in vivo drug interaction studies have been performed with Brimica Genuair, it has been used concomitantly with other COPD medicinal products including short-acting β2-adrenergic bronchodilators, methylxanthines, and oral and inhaled steroids without clinical evidence of drug interactions.
Iako formalna in vivo ispitivanja interakcija lijekova s Brimica Genuairom nisu provedena, on se koristio istodobno s drugim lijekovima za KOPB uključujući kratkodjelujuće β2 -adrenergičke bronhodilatatore, metilksantine, te oralne i inhalacijske steroide bez kliničkih dokaza o interakciji lijekova.
Although no formal in vivo drug interaction studies have been performed with Duaklir Genuair, it has been used concomitantly with other COPD medicinal products including short-acting β2-adrenergic bronchodilators, methylxanthines, and oral and inhaled steroids without clinical evidence of drug interactions.
Iako formalna in vivo ispitivanja interakcija lijekova s Duaklir Genuairom nisu provedena, on se koristio istodobno s drugim lijekovima za KOPB uključujući kratkodjelujuće β2 -adrenergičke bronhodilatatore, metilksantine, te oralne i inhalacijske steroide bez kliničkih dokaza o interakciji lijekova.
Although no formal in vivo drug interaction studies have been performed, inhaled umeclidinium/vilanterol has been used concomitantly with other COPD medicinal products including short acting sympathomimetic bronchodilators and inhaled corticosteroids without clinical evidence of drug interactions.
Iako nisu provedena formalna ispitivanja interakcija in vivo, pri istodobnoj primjeni inhalacijskog umeklidinija/vilanterola i drugih lijekova za KOPB, uključujući kratkodjelujuće simpatomimetičke bronhodilatatore i inhalacijske kortikosteroide, nije bilo kliničkih dokaza interakcija između spomenutih lijekova.
Although no new safety concerns have been identified, the MAH proposed two changes to the product information.
Iako nisu prepoznata nova sigurnosna pitanja, nositelj odobrenja (MAH) je predložio dvije izmjene informacija o lijeku.
Although no safety issues were observed in patients over 75 years, data are limited in this age subgroup.
Iako u bolesnika starijih od 75 godina nisu uočeni sigurnosni problemi, podaci su ograničeni u toj dobnoj podskupini.
Although no side effects have been confirmed in ferrets, similar side effects could occur rarely.
Iako u afričkih tvorova nisu potvrđene nuspojave, slične se nuspojave mogu rijetko pojaviti.
Although no significant QTc increases were seen in a thorough QT study in healthy volunteers, based on PK/PD modelling, eliglustat plasma concentrations 11-fold the predicted human Cmax are predicted to cause mild increases in the PR, QRS, and QTc intervals (see section 5.1, Electrocardiographic evaluation).
Iako nisu uočena značajna produljenja QTc-a tijekom temeljitog ispitivanja QT-a u zdravih dobrovoljaca, temeljem PK/PD modela , predviđa se da će koncentracije eliglustata u plazmi koje su 11 puta više od predviđenog Cmax za ljude uzrokovati blago produljenje PR, QRS i QTc intervala (vidjeti dio 5.1, Elektrokardiografska procjena).
Although no systemic immunosuppressive effect was noted in healthy subjects the effects on systemic immune system function in patients with Inflammatory Bowel Disease patients is not known.
Iako nije uočen sustavni imunosupresivni učinak u zdravih ispitanika, sistemski učinci na imunološki sustav bolesnika s upalnom bolešću crijeva nisu poznati.
Although not studied clinically, voriconazole is likely to increase the plasma concentrations of benzodiazepines that are
Iako ova interakcija nije klinički ispitana, vorikonazol će vjerojatno povisiti plazmatske koncentracije benzodiazepina koji se metaboliziraju putem CYP3A4 i time produljiti sedativni učinak.
Although not studied clinically, voriconazole is likely to increase the plasma concentrations of statins that are metabolised by CYP3A4 and could lead to rhabdomyolysis.
Iako ova interakcija nije klinički ispitana, vorikonazol će vjerojatno povisiti plazmatske koncentracije
Although not studied directly, the MOA for the worsening of diarrhea with the combination is postulated to be mediated by the impairment of intestinal function related to the MOAs for the individual agents – VEGF/VEGFR and c-KIT inhibition by lenvatinib coupled with mTOR/NHE3 inhibition by everolimus.
Iako nije izravno ispitan, pretpostavlja se da je mehanizam djelovanja kod pogoršanja proljeva uz kombinaciju lijekova posredovan oštećenjem funkcije crijeva povezanim s mehanizmom djelovanja svakog lijeka pojedinačno – lenvatinib inhibira VEGF/VEGFR i c-KIT u sprezi s everolimusom koji inhibira mTOR/NHE3.
Although not studied in specific interaction studies, Efient has been co-administered in the phase 3 clinical trial with low molecular weight heparin, bivalirudin, and GP IIb/IIIa inhibitors (no information available regarding the type of GP IIb/IIIa inhibitor used) without evidence of clinically significant adverse interactions.
Iako nisu provedena specifična ispitivanja interakcija, Efient se u fazi III kliničkog ispitivanja primjenjivao s heparinom male molekulske mase, bivalirudinom i inhibitorima GPIIb/IIIa (nema podataka o vrsti GPIIb/IIIa inhibitora) bez znakova klinički značajnih štetnih interakcija.