natgillin/translations-raw huggingface dataset:
In Pom + LD-Dex treated patients neutropenia was infrequently serious (2.0% of patients), did not lead to treatment discontinuation, and was associated with treatment interruption in 21.0% of patients, and with dose reduction in 7.7% of patients.
U bolesnika liječenih kombinacijom Pom+LD- Dex neutropenija je rijetko bila ozbiljna (2,0 % bolesnika), nije dovela do prekida liječenja i bila je povezana s prekidima u liječenju u 21,0 % bolesnika te smanjenjem doze u 7,7 % bolesnika.
In Pom + LD-Dex treated patients neutropenia was infrequently serious (2.0% of patients), did not lead to treatment discontinuation, and was associated with treatment interruption in 21.0% of patients, and with dose reduction in 7.7% of patients.
U bolesnika liječenih s Pom + LD-Dex, neutropenija je rijetko bila ozbiljna (2,0% bolesnika), nije dovela do prestanka liječenja, a bila je povezana s prekidom liječenja u 21,0% bolesnika i sniženjem doze kod 7,7% bolesnika.
In Pom + LD-Dex treated patients pneumonia and upper respiratory tract infections were the most commonly reported infections (in 10.7% and 9.3% of patients, respectively);with 24.3% of reported infections being serious and fatal infections (Grade 5) occurring in 2.7% of treated patients.
U bolesnika liječenih Pom + LD-Dex, pneumonija i infekcije gornjih dišnih puteva bile su najčešće zabilježene infekcije (u 10,7% odnosno 9,3% bolesnika), s time da se od zabilježenih infekcija 24,3% odnosilo na ozbiljne i smrtonosne infekcije (5. stupnja) nastale u 2,7% liječenih bolesnika.
In Pom + LD-Dex treated patients, thrombocytopenia was serious in 1.7% of patients, led to dose reduction in 6.3% of patients, to dose interruption in 8% of patients and to treatment discontinuation in 0.7% of patients. (see sections 4.2 and 4.4)
U bolesnika liječenih Pom + LD-Dex trombocitopenija je bila ozbiljna u 1,7% bolesnika, dovela je do sniženja doze u 6,3% bolesnika, do prekida doziranja u 8% bolesnika te do prestanka liječenja u 0,7% bolesnika (vidjeti dijelove 4.2 i 4.4).
In PONV, the usual dose is one 40 mg capsule given to adults within the three hours before the patient is anaesthetised (‘put to sleep’).
Kod PONV-a uobičajena je doza jedna kapsula od 40 mg koja se odraslima daje tri sata prije anesteziranja („uspavljivanja”) bolesnika.
In pooled controlled studies using an every 2 week dosing interval, 796 of 3340 patients (23.8%) treated with Praluent had two consecutive values of LDL-C <25 mg/dL (<0.65 mmol/L), including 288 patients (8.6%) with two consecutive values <15 mg/dL (<0.39 mmol/L).
Prema objedinjenim podacima iz kontroliranih ispitivanja u kojima se koristio interval doziranja od svaka 2 tjedna, 796 od 3340 bolesnika (23,8%) liječenih lijekom Praluent imalo je dvije uzastopno izmjerene vrijednosti LDL-C od <25 mg/dl (<0,65 mmol/l), uključujući 288 bolesnika (8,6%) s dvije uzastopne vrijednosti od <15 mg/dl (<0,39 mmol/l).
In pooled data from the major efficacy trials, the proportion of patients experiencing successful penetration on vardenafil were as follows: psychogenic erectile dysfunction (77-87%), mixed erectile dysfunction (69-83%), organic erectile dysfunction (64-75%), elderly (52-75%), ischaemic heart disease (70-73%), hyperlipidemia (62-73%), chronic pulmonary disease (74-78%), depression (59-69%), and patients concomitantly treated with antihypertensives (62-73%).
U objedinjenim podacima iz velikih ispitivanja djelotvornosti, udio bolesnika koji su imali uspješnu penetraciju uz vardenafil bili su sljedeći: psihogena erektilna disfunkcija (77-87%), miješana erektilna disfunkcija (69-83%), organska erektilna disfunkcija (64-75%), stariji (52-75%), ishemijska bolest srca (70-73%), hiperlipidemija (62-73%), kronična bolest pluća (74-78%), depresija (59-69%) i bolesnici istodobno liječeni antihipertenzivima (62-73%).
In pooled data from the two vardenafil 10 mg orodispersible tablets trials, IIEF-EF domain scores were significantly higher with vardenafil 10 mg orodispersible tablet versus placebo.
U objedinjenim podacima iz dva ispitivanja vardenafil 10 mg raspadljivih tableta za usta, postignuti rezultati mjereni Internacionalnim indeksom erektilne funkcije (IIEF-EF) bili su značajno viši uz Vivanza 10 mg raspadljive tablete za usta nego uz placebo.
In pooled data from three trials, 39 patients with relapsed or chemoresistant, bulky disease (single lesion  10 cm in diameter), low grade or follicular B cell NHL received 375 mg/m2 of MabThera as intravenous infusion weekly for four doses.
U objedinjenim podacima iz tri ispitivanja 39 bolesnika s relapsirajućim ili kemorezistentnim proširenim ne-Hodgkinovim limfomom (promjer jedne lezije ≥ 10 cm) niskog stupnja malignosti ili folikularnim B-staničnim ne-Hodgkinovim limfomom je primilo lijek MabThera u dozi od 375 mg/m2 putem intravenske infuzije jedanput tjedno tijekom četiri tjedna.
In pooled data, mean eosinophil counts were 655 µL-1 (n=476) and 654 µL-1 (n=477) for the placebo and reslizumab treatment groups at baseline and were 514 µL-1 (n=405) and 61 µL-1 (n=407) at week 52.
U objedinjenim podacima, na početku je srednja vrijednost broja eozinofila bila 655 µl-1 (n=476) u skupini koja je primala placebo i 654 µl-1 (n=477) u terapijskoj skupini koja je primala reslizumab te 514 µl-1 (n=405) odnosno 61 µl-1 (n=407) u 52. tjednu.
In pooled pivotal phase 3 controlled clinical trials of alogliptin as add-on therapy to pioglitazone involving 3,504 patients, the observed adverse reactions are listed below (Table 2).
U tablici u nastavku (tablica 2) navedene su nuspojave opažene u analizi objedinjenih podataka iz pivotalnih kontroliranih ispitivanja faze 3 u kojima je alogliptin ispitan kao dodatna terapija pioglitazonu, a uključivala su 3504 bolesnika.
In pooled randomised placebo-controlled studies of post-menopausal osteoporotic patients, a significant increase in myocardial infarction has been observed in PROTELOS treated patients compared to placebo (see section 4.8).
Iz zbirnih podataka iz randomiziranih placebom kontroliranih ispitivanja bolesnika s osteoporozom u postmenopauzi primijećen je značajan porast infarkta miokarda kod bolesnika liječenih PROTELOS- om u usporedbi s placebom (vidjeti dio 4.8).
In poor metabolisers, active metabolite exposure was decreased by 63-71% compared to extensive metabolisers.
U sporih metabolizatora, izloženost aktivnom metabolitu bila je smanjena za 63- 71% u usporedbi s brzim metabolizatorima.
In population pharmacokinetic analysis, no clinically significant relationship was observed between erlotinib clearance and creatinine clearance, but there are no data available for patients with creatinine clearance <15 ml/min.
U farmakokinetičkoj populacijskoj analizi nije uočena klinički značajna povezanost između klirensa erlotiniba i klirensa kreatinina, ali nisu dostupni podaci za bolesnike s klirensom kreatinina <15 ml/min.
In post marketing experience these events have been reported in patients treated with memantine.
Ovi su događaji prijavljeni u postmarketinškom razdoblju kod bolesnika liječenih memantinom.
In post marketing experience these symptoms have also been observed in Parkinson's disease patients treated with AZILECT.
Ovi simptomi su opaženi i tijekom razdoblja nakon stavljanja lijeka u promet u bolesnika s Parkinsonovom bolešću liječenih AZlLECT-om.
In post marketing experience these symptoms have also been observed in Parkinson's disease patients treated with Rasagiline ratiopharm.
Ovi simptomi su opaženi i tijekom razdoblja nakon stavljanja lijeka u promet u bolesnika s Parkinsonovom bolešću liječenih Razagilin ratiopharmom.
In post marketing experience, a differentiation syndrome, like retinoic acid syndrome, has also been reported for the treatment of malignancies other than APL with TRISENOX.
Prema iskustvu nakon stavljanja lijeka u promet, za liječenje maligniteta različitih od APL s TRISENOXOM, zabilježen je i sindrom diferencijacije poput sindroma retinoične kiseline.
In post marketing experience, these symptoms have also been observed in Parkinson's disease patients treated with rasagiline.
U postmarketinškom iskustvu ovi su simptomi također opaženi u bolesnika s Parkinsonovom bolešću liječenih razagilinom.
In post marketing period, there was one case of elevated blood pressure in a patient using the ophthalmic vasoconstrictor tetrahydrozoline hydrochloride while taking rasagiline.
U postmarketinškom razdoblju bio je jedan slučaj povišenog krvnog tlaka u bolesnika koji je primijenjivao oftalmički vazokonstriktor tetrahidrozolinklorid tijekom uzimanja razagilina.
In post marketing very rare cases (<1/10,000) of hypersensitivity reactions occurred with palonosetron solution for injection for intravenous use.
Nakon stavljanja lijeka u promet, reakcije preosjetljivosti pojavile su se u vrlo rijetkim slučajevima (<1/10 000) primjene otopine palonosetrona za intravensku uporabu.
In post- marketing experience there have been cases of worsening or recurrence of atrial fibrillation after administration of Rapiscan.
Nakon stavljanja lijeka u promet bilo je slučajeva pogoršanja ili ponovne pojave fibrilacije atrija nakon primjene Rapiscana.
In post- marketing experience these events have been reported in patients treated with Axura.
Ovi su događaji prijavljeni u postmarketinškom razdoblju kod bolesnika liječenih Axurom.
In post- marketing experience these events have been reported in patients treated with Memantine Merz.
Ovi su događaji prijavljeni u postmarketinškom razdoblju kod bolesnika liječenih Memantine Merzm.
In post- marketing experience these events have been reported in patients treated with Memantine Merz.
Ovi su događaji prijavljeni u postmarketinškom razdoblju kod bolesnika liječenih Memantine Merzom.
In post- marketing experience these events have been reported in patients treated with memantine.
Ovi su događaji prijavljeni u postmarketinškom razdoblju kod bolesnika liječenih Memantin ratiopharmom.
In post- marketing experience these events have been reported in patients treated with memantine.
Ovi su događaji prijavljeni u postmarketinškom razdoblju kod bolesnika liječenih memantinom.
In post- marketing experience these reactions have been reported in patients treated with Ebixa.
Ove nuspojave su prijavljene u postmarketinškom razdoblju kod bolesnika liječenih Ebixom.
In post-hoc analyses of pooled data from 6 and 12 months clinical studies, Kaplan-Meier estimates of bone fracture and parathyroidectomy were lower in the cinacalcet group compared with the control group.
U post-hoc analizi skupnih rezultata iz 6-mjesečnih i 12-mjesečnih kliničkih studija, Kaplan-Meierovom metodom procijenjeno je manje koštanih prijeloma i paratireoidektomija u sinakalcet grupi u usporedbi s kontrolnom grupom.
In post-marketing data, 305 cases of dizziness were reported.
Tijekom postmarketinškog praćenja, prijavljeno je 305 slučajeva omaglice.
In post-marketing experience
U razdoblju nakon stavljanja lijeka u promet
In post-marketing experience isolated cases with international normalized ratio (INR) increases have been reported in patients concomitantly treated with warfarin.
U postmarketinškom iskustvu zabilježeni su izolirani slučajevi povišenja međunarodno ujednačenog omjera (INR-a) kod bolesnika koji su istodobno liječeni varfarinom.
In post-marketing experience of saxagliptin, there have been spontaneously reported adverse reactions of acute pancreatitis.
Nakon stavljanja saksagliptina u promet bile su spontano prijavljene nuspojave akutnog pankreatitisa.
In post-marketing experience these reactions have been reported in patients treated with memantine.
Te su nuspojave prijavljene u postmarketinškom razdoblju kod bolesnika liječenih memantinom.
In post-marketing experience very rare cases of atrial flutter with 1:1 atrioventricular conduction are observed.
Nakon stavljanja lijeka u promet uočeni su vrlo rijetki slučajevi undulacije atrija s atrioventrikularnim provođenjem 1:1.
In post-marketing experience with Ferriprox, neurological disorders (such as tremors, walking disorders, double vision, involuntary muscle contractions, problems with movement coordination) have been reported in children who had been voluntarily prescribed more than double the maximum recommended dose of 100 mg/kg/day for several years.
Nakon stavljanja Ferriproxa u promet prijavljeni su neurološki poremećaji (poput nevoljnog drhtanja, poremećaja hoda, dvoslika, nevoljnih mišićnih kontrakcija, problema s koordinacijom pokreta) u djece kojoj je dobrovoljno propisivano više od dvostruke najviše preporučene doze od 100 mg/kg/dan tijekom nekoliko godina.
In post-marketing experience, anaphylaxis (including anaphylactic shock and generalised rash) has been reported very rarely following administration of Samsca.
U post-marketinškim iskustvima, anafilaksija (uključujući anafilaktički šok i generalizirani osip) nakon primjene lijeka Samsca je opisivana vrlo rijetko.
In post-marketing experience, anaphylaxis (including anaphylactic shock and generalised rash) has been reported very rarely following administration of Samsca.
U postmarketinškim iskustvima, anafilaksija (uključujući anafilaktički šok i generalizirani osip) nakon primjene lijeka Samsca je opisivana vrlo rijetko.
In post-marketing experience, cases of anaphylactic-like reactions, including laryngeal/pharyngeal oedema and severe bronchospasm, and seizure have been associated with infliximab administration.
Nakon stavljanja lijeka u promet bilo je slučajeva reakcija nalik anafilaksiji, uključujući edem grkljana/ždrijela i teški bronhospazam te napadaje, koje su se povezivale s primjenom lijeka infliksimab.
In post-marketing experience, FVIII inhibitor development has been observed.
Nakon stavljanja lijeka u promet opažen je razvoj inhibitora faktora VIII.
In post-marketing experience, isolated cases with international normalized ratio (INR) increases have been reported in patients concomitantly treated with warfarin.
U postmarketinškom iskustvu zabilježeni su izolirani slučajevi povišenja međunarodno ujednačenog omjera (INR-a) kod bolesnika koji su istodobno liječeni varfarinom.
In post-marketing experience, renal dysfunction and cases of acute renal failure have been reported in patients at risk (see section 4.4).
Nakon stavljanja lijeka u promet u rizičnih bolesnika prijavljena je disfunkcija bubrega i slučajevi akutnog zatajenja bubrega (vidjeti dio 4.4).
In post-marketing experience, serious systemic hypersensitivity reactions (including anaphylactic reaction) have been reported following Simponi administration.
U razdoblju nakon stavljanja lijeka u promet prijavljene su ozbiljne sustavne alergijske reakcije (uključujući anafilaktičku reakciju) koje su uslijedile nakon primjene lijeka Simponi.
In post-marketing experience, severe and occasionally incapacitating bone, joint, and/or muscle pain have been reported in patients taking bisphosphonates.
U razdoblju nakon stavljanja lijeka u promet zabilježeni su jaki i ponekad onesposobljavajući bolovi u kostima, zglobovima i/ili mišićima u bolesnika koji su uzimali bisfosfonate.
In post-marketing experience, severe and occasionally incapacitating bone, joint, and/or muscle pain have been reported in patients taking bisphosphonates.
U razdoblju nakon stavljanja lijeka u promet, u bolesnika koji su uzimali bisfosfonate zabilježeni su jaki i ponekad onesposobljavajući bolovi u kostima, zglobovima i/ili mišićima.
In post-marketing experience, severe and occasionally incapacitating bone, joint, and/or muscle pain have been reported in patients taking zoledronic acid.
U razdoblju nakon stavljanja lijeka u promet prijavljeni su jaki i ponekad onesposobljavajući bolovi u kostima, zglobovima i/ili mišićima u bolesnika koji su uzimali zoledronatnu kiselinu .
In post-marketing experience, severe and occasionally incapacitating bone, joint, and/or muscle pain have been reported in patients taking zoledronic acid.
U razdoblju nakon stavljanja lijeka u promet, u bolesnika koji su uzimali zoledronatnu kiselinu prijavljeni su teški i ponekad onesposobljavajući bolovi u kostima, zglobovima i/ili mišićima.
In post-marketing experience, there have been no reports of inhibitory antibodies against NovoSeven or FVII in patients with haemophilia A or B. Development of inhibitory antibodies to NovoSeven has been reported in a post-marketing observational registry of patients with congenital FVII deficiency.
U iskustvima nakon stavljanja lijeka na tržište, nije bilo prijavljenih slučajeva stvaranja inhibitornih protutijela na NovoSeven ili FVII u bolesnika s hemofilijom A ili B. Razvoj inhibitornih protutijela na NovoSeven prijavljen je u postmarketinškom opservacijskom registru bolesnika s prirođenim nedostatkom FVII.
In post-marketing experience, there have been reports of hypersensitivity reactions (including anaphylaxis) which have occurred with one or more of the following: dyspnoea, chest discomfort, hypotension, angioedema, rash and urticaria.
U postmarketinškom razdoblju bilo je prijava reakcija preosjetljivosti (uključujući i anafilaksu) koje su se pojavile s jednim ili više događaja kako slijedi: dispneja, nelagoda u prsnom košu, hipotenzija, angioedem, osip i urtikarija.
In post-marketing safety surveillance, isolated, idiosyncratic cases of hypotension and/or worsening heart failure have been reported in patients with impaired cardiac function, in which a causal relationship to cinacalcet could not be completely excluded and may be mediated by reductions in serum calcium levels.
U postmarketinškom sigurnosnom ispitivanju opisani su izolirani, idiosinkratični slučajevi hipotenzije i/ili pogoršanje zatajenja srca, i to u bolesnika s oštećenom funkcijom srca kod kojih nije bilo moguće isključiti povezanost s terapijom sinakalcetom pa to može biti posljedica smanjenja vrijednosti serumskog kalcija.
In post-marketing spontaneous reporting, infections are the most common serious adverse event.
Nakon stavljanja lijeka u promet infekcije su bile najčešći spontano prijavljeni ozbiljni štetni događaj.
In post-marketing spontaneous reporting, infections are the most common serious adverse event.
Nakon stavljanja lijeka u promet infekcije su bile najčešći spontano prijavljeni ozbiljni štetni događaja.
In post-marketing spontaneous reports, there have been cases of medication error where the entire contents (up to 800 mcg) of the teriparatide pen have been administered as a single dose.
U spontanim prijavama nakon stavljanja lijeka u promet navode se slučajevi pogrešaka u primjeni lijeka, kada je cjelokupan sadržaj (do 800 mikrograma) brizgalice s teriparatidom primijenjen u jednoj dozi.
In post-marketing surveillance through the Antiretroviral Pregnancy Registry, established since January 1989, an increased risk of birth defects exposures with Kaletra has not been reported among over 1000 women exposed during the first trimester.
U praćenju nakon stavljanja lijeka u promet kroz Registar trudnoća izloženih antiretroviralnih lijekovima “Antiretroviral Pregnancy Registry” utemeljen u siječnju 1989. nije zabilježen povećan rizik od kongenitalnih oštećenja kod više od 1000 žena koje su bile izložene lijeku Kaletra tijekom prvog tromjesečja.
in post-menopausal women
kod žena u postmenopauzi
in post-menopausal women
u žena u postmenopauzi
In postmarketing experience, a case of fatal anaphylaxis following the first infusion of ORENCIA has been reported.
Nakon stavljanja lijeka u promet prijavljen je slučaj anafilaksije sa smrtnim ishodom nakon prve infuzije lijeka ORENCIA.
In postmarketing experience, third degree heart block and asystole have been reported within minutes of Rapiscan administration.
Nakon stavljanja Rapiscana na tržište prijavljena je pojava bloka trećeg stupnja i asistolije unutar nekoliko minuta od njegove primjene.
In postmarketing reports it is observed that IVIG high-dose indications in children, particularly Kawasaki disease, are associated with an increased reporting rate of haemolytic reactions compared to other IVIG indications in children.
U postmarketinškim izvješćima uočeno je da su indikacije koje zahtijevaju visoke doze i.v.Ig-om u djece, posebice kod Kawasakijeve bolesti, povezane s većom stopom prijavljenih hemolitičkih reakcija u usporedbi s drugim indikacijama za i.v.Ig-om u djece.
In postmarketing reports it is observed that the proportion of haemolysis cases to all case reports occurring in children is slightly higher than in adults.
U postmarketinškim izvješćima uočeno je da je udio slučajeva hemolize u odnosu na sve slučajeve koji se događaju kod djece blago povišen u odnosu na odrasle osobe.
in postmenopausal women,
u žena u poslijemenopauzi
In postmenopausal women, a significant reduction in the incidence of vertebral and non- vertebral fractures but not hip fractures has been demonstrated.
U postmenopauzalnih žena dokazano je značajno smanjenje incidencije vertebralnih i nevertebralnih prijeloma, no ne i prijeloma kuka.
In postmenopausal women, strontium ranelate reduces the risk of vertebral and hip fractures (see section 5.1).
Kod žena u poslijemenopauzi, stroncijev ranelat smanjuje rizik nastanka prijeloma kralježnice i kuka (vidjeti dio 5.1).
In pre- and post-natal rat studies, prolonged parturition was noted at 1,500 mg/kg/day: the safety margin between human exposure and the highest no-effect dose (500 mg/kg/day) in rats is 480-fold for oseltamivir and 44-fold for the active metabolite, respectively.
U pre- i postnatalnim ispitivanjima na štakorima uočen je produljeni porod pri dozama od 1500 mg/kg/dan: sigurnosna granica između ekspozicije u ljudi i najvećih doza koje nisu imale štetnih učinaka (500 mg/kg/dan) u štakora je 480 puta veća za oseltamivir, a 44 puta za aktivni metabolit.
In pre- and postnatal development studies in mice administered albiglutide during pregnancy or while nursing, reduced pre-weaning body weight of F1 offspring was observed at 1 mg/kg/day (at exposures below clinical exposure).
U ispitivanjima prenatalnog i postnatalnog razvoja u kojima su ženke miševa primale albiglutid tijekom skotnosti ili laktacije, primijećena je smanjena tjelesna težina mladunčadi prve filijalne generacije (F1) prije početka sisanja kod primjene doza od 1 mg/kg na dan (izloženost manja od kliničke izloženosti).
In pre-clinical studies no effect on fertility was observed in male and female rats (see section 5.3).
U pretkliničkim ispitivanjima nisu opaženi učinci na plodnost u ženki i mužjaka štakora (vidjeti dio 5.3).
In pre-clinical studies thiotepa, as most alkylating agents, has been shown to cause embryo foetal lethality and teratogenicity (see section 5.3).
U pretkliničkim studijama tiotepa, kao i većina alkilirajućih agensa, je uzrokovala smrtnost embrija i fetusa te je imala teratogeno djelovanje (vidjeti dio 5.3).
in pre-filled pen (SoloStar) cartridge (glass)
napunjenoj brizgalici (SoloStar) uložak (staklo) u
in pre-filled pen (SoloStar) cartridge (glass)
uložak (staklo) u napunjenoj brizgalici (SoloStar) uložak (staklo) u
In pre-haemodialysis and haemodialysis patients:
Kod bolesnika pred hemodijalizom i onih na hemodijalizi:
In pre-specified analyses of pooled phase 3 studies, treatment-emergent CV events confirmed by adjudication, consisting of coronary heart disease (CHD) death, myocardial infarction, ischemic stroke, unstable angina requiring hospitalisation, congestive heart failure hospitalisation, and revascularisation, were reported in 110 (3.5%) patients in the alirocumab group and 53 (3.0%) patients in the control group (placebo or active control) with HR=1.08 (95% CI, 0.78 to 1.50).
Prema unaprijed određenim analizama objedinjenih podataka iz ispitivanja faze 3, neovisno potvrđeni KV događaji koji su se javili tijekom liječenja, a uključivali su smrt zbog koronarne srčane bolesti, infarkt miokarda, ishemijski moždani udar, nestabilnu anginu koja je zahtijevala hospitalizaciju, hospitalizaciju uslijed kongestivnog zatajenja srca i revaskularizaciju, prijavljeni su u 110 (3,5%) bolesnika u skupini liječenoj alirokumabom te 53 (3,0%) bolesnika u kontrolnoj skupini (placebo ili aktivni kontrolni lijek), uz HR=1,08 (95% CI: 0,78 – 1,50).