FrancophonIA/ELRC3.0 huggingface dataset:
English: When it is used in combination with a sulphonylurea or insulin, patients should be advised to take precautions to avoid hypoglycaemia while driving and using machines (see section 4.4).
Croatian: Kada se primjenjuje u kombinaciji sa sulfonilurejom ili inzulinom, bolesnicima se mora savjetovati da poduzmu mjere opreza kako bi izbjegli hipoglikemiju za vrijeme vožnje ili rada sa strojevima (vidjeti dio 4.4).
English: The results showed that there was no increase in CV risk with dulaglutide compared with control therapies (HR: 0.57; CI: [0.30, 1.10]).
Croatian: Rezultati su pokazali da se kardiovaskularni rizik nije povećao uz primjenu dulaglutida u usporedbi s kontrolnim terapijama (HR: 0,57; CI: [0,30; 1,10]).
English: In the completed phase II and phase III initial registration studies, 4,006 patients were exposed to dulaglutide alone or in combination with other glucose lowering medicinal products.
Croatian: U završenim inicijalnim registracijskim ispitivanjima faze II i faze III, 4006 bolesnika bilo je izloženo dulaglutidu u monoterapiji ili u kombinaciji s drugim lijekovima za snižavanje razine glukoze.
English: Decreased appetite, dyspepsia, constipation, flatulence, abdominal distention, gastroesophageal reflux disease, eructation
Croatian: smanjen apetit, dispepsija, konstipacija, flatulencija, distenzija abdomena, gastroezofagealna refluksna bolest, eruktacija akutni pankreatitis
English: Pharmacotherapeutic group: Drugs used in diabetes, blood glucose lowering drugs, excl. insulins, ATC code: A10BJ05
Croatian: Farmakoterapijska skupina: Pripravci za liječenje šećerne bolesti, lijekovi za snižavanje glukoze u krvi, isključ. inzuline, ATK oznaka: A10BJ05
English: If you stop using Trulicity, your blood sugar levels can increase.
Croatian: Ako prestanete primjenjivati Trulicity, mogu Vam porasti razine šećera u krvi.
English: Dulaglutide should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
Croatian: Dulaglutid se ne smije primjenjivati u bolesnika sa šećernom bolešću tipa 1 niti za liječenje dijabetičke ketoacidoze.
English: After Week 1, patients were up-titrated to 1.2 mg/day and then at Week 2 to 1.8 mg/day.
Croatian: 1. tjedna bolesnicima je doza titrirana do 1,2 mg/dan, a zatim u 2. tjednu do 1,8 mg/dan.
English: Patients treated with dulaglutide should be advised of the potential risk of dehydration, particularly in relation to gastrointestinal side-effects and take precautions to avoid fluid depletion.
Croatian: Bolesnike koji se liječe dulaglutidom treba upozoriti na mogući rizik od dehidracije, osobito u slučaju gastrointestinalnih nuspojava, te im savjetovati da poduzmu odgovarajuće mjere opreza kako ne bi došlo do deplecije tekućine.
English: Consistent with the pharmacokinetic profile, dulaglutide has a pharmacodynamic profile suitable for once weekly administration (see section 5.2).
Croatian: Sukladno farmakokinetičkom profilu, i farmakodinamički profil dulaglutida prikladan je za primjenu jedanput na tjedan (vidjeti dio 5.2).
English: This clinical study did not include patients with end stage renal disease.
Croatian: U tom kliničkom ispitivanju nisu sudjelovali bolesnici u terminalnoj fazi bubrežne bolesti.
English: 78 weeks
Croatian: 78 tjedana
English: Type 2 Diabetes Mellitus
Croatian: Šećerna bolest tipa 2
English: Dulaglutide is a long-acting glucagon-like peptide 1 (GLP-1) receptor agonist.
Croatian: Dulaglutid je dugodjelujući agonist receptora glukagonu sličnog peptida 1 (engl. glucagon-like peptide 1, GLP-1).
English: Pharmacokinetic analyses have demonstrated a statistically significant inverse relationship between body weight or body mass index (BMI) and dulaglutide exposure, although there was no clinically relevant impact of weight or BMI on glycaemic control.
Croatian: Farmakokinetičke analize ukazale su na statistički značajan inverzan odnos između tjelesne težine ili indeksa tjelesne mase (ITM) i izloženosti dulaglutidu, iako ni tjelesna težina ni ITM nisu klinički značajno utjecali na kontrolu glikemije.
English: Figure 2: Forest plot of analyses of individual cardiovascular event types, all cause death, and consistency of effect across subgroups for the primary endpoint
Croatian: Slika 2: Grafikon raspona pouzdanosti za analize pojedinačnih vrsta kardiovaskularnih događaja, smrti zbog bilo kojeg uzroka te dosljednosti učinka u svim podskupinama za ocjenu primarne mjere ishoda
English: Place the clear base flat and firmly against your skin at the injection site.
Croatian: • Položite prozirnu bazu ravno i čvrsto na kožu na mjestu injiciranja.
English: Potentially immune-mediated injection site adverse events (e.g., rash, erythema) were reported in 0.7 % of patients and were usually mild.
Croatian: Potencijalno imunosno posredovani štetni događaji na mjestu injekcije (npr. osip, eritem) bili su prijavljeni u 0,7% bolesnika, a obično su bili blage.
English: • If you have vision problems, DO NOT use your syringe without help from a person trained to use the Trulicity syringe.
Croatian: • Ako imate problema s vidom, NE SMIJETE koristiti štrcaljku bez pomoći osobe koja je obučena za uporabu Trulicity štrcaljke.
English: If you want to do so, you can use the same area of your body each week.
Croatian: Ako je moguće, trebali biste ga primjenjivati istoga dana svaki tjedan.
English: The most frequently reported adverse reactions in clinical trials were gastrointestinal, including nausea, vomiting and diarrhoea.
Croatian: Najčešće prijavljene nuspojave u kliničkim ispitivanjima bile su gastrointestinalne nuspojave, uključujući mučninu, povraćanje i proljev.
English: They are most common when first starting dulaglutide but decrease over time in most patients.
Croatian: Najčešće su na početku liječenja dulaglutidom, ali se njihova učestalost u većine bolesnika s vremenom smanjuje.
English: The incidence of acute pancreatitis in Phase II and III clinical studies was 0.07% for dulaglutide compared to 0.14% for placebo and 0.19% for comparators with or without additional background antidiabetic therapy.
Croatian: Incidencija akutnog pankreatitisa u kliničkim ispitivanjima faze II i faze III iznosila je 0,07% za dulaglutid u usporedbi s 0,14% za placebo i 0,19% za usporedne lijekove, sa ili bez dodatne osnovne antidijabetičke terapije.
English: After coadministration with up to 3 mg of dulaglutide at steady state, there were no statistically significant differences on AUC(0-12), Cmax or tmax of paracetamol.
Croatian: Nakon istodobne primjene s najviše 3 mg dulaglutida u stanju dinamičke ravnoteže, nisu primijećene statistički značajne razlike u AUC(0-12), Cmax ni tmax paracetamola.
English: - Symptoms of low blood sugar may include headache, drowsiness, weakness, dizziness, feeling hungry, confusion, irritability, fast heartbeat and sweating.
Croatian: - simptomi niske razine šećera u krvi, koji mogu uključivati glavobolju, omamljenost, slabost, omaglicu, osjećaj gladi, smetenost, razdražljivost, ubrzane otkucaje srca i znojenje.
English: Coadministration of dulaglutide with an oral contraceptive (norgestimate 0.18 mg/ethinyl estradiol 0.025 mg) did not affect the overall exposure to norelgestromin and ethinyl estradiol.
Croatian: Istodobna primjena dulaglutida s oralnim kontraceptivom (norgestimat 0,18 mg/ etinilestradiol 0,025 mg) nije utjecala na ukupnu izloženost norelgestrominu i etinilestradiolu.
English: Reduction in body weight was observed in patients treated with dulaglutide irrespective of nausea, though the reduction was numerically larger in the group with nausea.
Croatian: Smanjenje tjelesne težine primijećeno je u bolesnika liječenih dulaglutidom neovisno o mučnini, ali je ono bilo brojčano veće u skupini koja je patila od mučnine.
English: The risk of hypoglycaemia may be lowered by a reduction in the dose of sulphonylurea or insulin (see sections 4.2 and 4.8).
Croatian: Rizik od hipoglikemije može se umanjiti smanjenjem doze sulfonilureje ili inzulina (vidjeti dijelove 4.2 i 4.8).
English: No cases of severe hypoglycaemia were observed for Trulicity or placebo.
Croatian: Nisu primijećeni slučajevi teške hipoglikemije ni uz Trulicity ni uz placebo.
English: The initial insulin glargine doses in patients with HbA1c <8.0% were reduced by 20%.
Croatian: Početne doze inzulina glargina u bolesnika kojima je HbA1c iznosio < 8,0% smanjene su za 20%.
English: • If you have vision problems, DO NOT use your pen without help from a person trained to use the Trulicity pen.
Croatian: • Ako imate problema s vidom, NE SMIJETE koristiti brizgalicu bez pomoći osobe koja je obučena za uporabu Trulicity brizgalice.
English: Dulaglutide is associated with mean increases from baseline in pancreatic enzymes (lipase and/or pancreatic amylase) of 11 % to 21 % (see section 4.4).
Croatian: Dulaglutid se povezuje sa srednjom vrijednosti povećanja razine gušteračnih enzima (lipaza i/ili gušteračna amilaza) od 11% do 21% u odnosu na početnu vrijednost (vidjeti dio 4.4).
English: For study results with respect to combinations, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1.
Croatian: Za rezultate ispitivanja koji se odnose na primjenu u kombinaciji s drugim lijekovima, učinke na regulaciju glikemije i kardiovaskularne događaje te ispitivane populacije vidjeti dijelove 4.4, 4.5 i 5.1.
English: Hypersensitivity Anaphylactic reaction#
Croatian: Poremećaji imunološkog sustava preosjetljivost anafilaktička reakcija#
English: When used with other medicines for diabetes, the recommended dose is 1.5 mg once a week.
Croatian: Kada se primjenjuje s drugim lijekovima za šećernu bolest, preporučena doza iznosi 1,5 mg jedanput na tjedan.
English: In-use: Trulicity may be stored unrefrigerated for up to 14 days at a temperature not above 30ºC.
Croatian: U uporabi: Trulicity se može čuvati izvan hladnjaka najviše 14 dana na temperaturi koja ne smije biti viša od 30ºC.
English: • Dispose of the syringe as directed.
Croatian: • Zbrinite štrcaljku sukladno uputama.
English: Changes in body weight with Trulicity 0.75 mg ranged from 0.86 kg to -2.63 kg.
Croatian: Promjene tjelesne težine uz Trulicity od 0,75 mg kretale su se u rasponu od 0,86 kg do -2,63 kg.
English: Dulaglutide exhibits several antihyperglycaemic actions of GLP-1.
Croatian: Dulaglutid iskazuje nekoliko antihiperglikemijskih učinaka karakterističnih za GLP-1.
English: The time of international normalised ratio response (tINRmax) was delayed by 6 hours, consistent with delays in tmax of approximately 4 and 6 hours for S- and R-warfarin, respectively.
Croatian: Vrijeme do postizanja odgovora internacionalnog normaliziranog omjera (tINRmax) bilo je produljeno za 6 sati, što je bilo u skladu s produljenjem tmax S-varfarina za približno 4 sata i R-varfarina za približno 6 sati.
English: To optimise the insulin glargine dose, both groups were titrated to a target fasting serum glucose of <5.6 mmol/L.
Croatian: Radi optimiziranja doze inzulina glargina, u obje se skupine provodila titracija do ciljne vrijednosti glukoze u serumu natašte od < 5,6 mmol/l.
English: In the absence of other signs and symptoms of acute pancreatitis, elevations in pancreatic enzymes alone are not predictive of acute pancreatitis (see section 4.8).
Croatian: Ako nisu prisutni drugi znakovi i simptomi akutnog pankreatitisa, povišene vrijednosti gušteračnih enzima nisu same po sebi pretkazatelj akutnog pankreatitisa (vidjeti dio 4.8).
English: It is important to continue to follow the advice on diet and exercise given to you by your doctor, pharmacist or nurse.
Croatian: Važno je da se nastavite pridržavati savjeta o dijeti i tjelovježbi koje su Vam dali Vaš liječnik,
English: The safety and efficacy of dulaglutide as add-on to a sulphonylurea was investigated in a placebo controlled study of 24 weeks duration.
Croatian: Sigurnost i djelotvornost dulaglutida kao dodatka sulfonilureji ocjenjivale su se u placebom kontroliranom ispitivanju u trajanju od 24 tjedna.
English: Trulicity can be taken out of the fridge for up to 14 days at a temperature not above 30ºC.
Croatian: Trulicity se izvan hladnjaka može čuvati najviše 14 dana na temperaturi koja ne smije biti veća od 30°C.
English: In general these reactions were mild or moderate in severity and transient in nature.
Croatian: Te su nuspojave u načelu bile blage ili umjerene težine te prolazne naravi.
English: The instructions for using the syringe, included with the package leaflet, must be followed carefully.
Croatian: Upute za uporabu brizgalice, koje su priložene uz uputu o lijeku, moraju se pažljivo slijediti.
English: In contrast to native GLP-1, dulaglutide is resistant to degradation by DPP-4, and has a large size that slows absorption and reduces renal clearance.
Croatian: Za razliku od nativnog GLP-1, dulaglutid je otporan na razgradnju enzimom DPP-4, a veća mu veličina usporava apsorpciju i smanjuje bubrežni klirens.
English: If you use Trulicity in combination with a sulphonylurea or insulin, low blood sugar (hypoglycaemia) may occur which may reduce your ability to concentrate.
Croatian: Ako primjenjujete Trulicity u kombinaciji sa sulfonilurejom ili inzulinom, može doći do pada razine šećera u krvi (hipoglikemije), što može smanjiti Vašu sposobnost koncentracije.
English: The directions regarding syringe handling and disposal are not intended to replace local or institutional policies.
Croatian: • Upute za rukovanje štrcaljkom i njezino zbrinjavanje ne predstavljaju zamjenu za lokalne propise ili propise pojedine ustanove.
English: In the presence of elevated glucose concentrations, dulaglutide increases intracellular cyclic AMP (cAMP) in pancreatic beta cells leading to insulin release.
Croatian: Kod povišenih koncentracija glukoze, dulaglutid povećava količinu unutarstaničnog cikličnog AMP-a (cAMP) u beta stanicama gušterače, što dovodi do otpuštanja inzulina.
English: The following adverse reactions have been identified based on evaluation of the full duration of the phase II and phase III clinical studies, the long-term cardiovascular outcome study and post-marketing reports.
Croatian: Sljedeće su nuspojave identificirane na temelju ocjene cjelokupnog trajanja kliničkih ispitivanja faze II i faze III, dugoročnog ispitivanja kardiovaskularnih ishoda te prijava nakon stavljanja lijeka u promet.
English: Cardiovascular Evaluation
Croatian: Kardiovaskularna procjena
English: In clinical studies, treatment with dulaglutide was associated with a 1.6 % incidence of treatment emergent dulaglutide anti-drug antibodies, indicating that the structural modifications in the GLP-1 and modified IgG4 parts of the dulaglutide molecule, together with high homology with native GLP-1 and native IgG4, minimise the risk of immune response against dulaglutide.
Croatian: U kliničkim je ispitivanjima liječenje dulaglutidom bilo povezano s 1,6%-tnom incidencijom protutijela na dulaglutid nastalih tijekom liječenja, što upućuje na to da strukturne modifikacije GLP-1 i modificirani dijelovi IgG4 molekule dulaglutida, u kombinaciji s visokom homolognošću s nativnim GLP-1 i nativnim IgG4, minimiziraju rizik od imunog odgovora protiv dulaglutida.
English: Patients discontinued their prestudy insulin regimen at randomisation.
Croatian: Bolesnici su pri randomizaciji prestali primjenjivati dotadašnji inzulinski režim.
English: Gently release the skin.
Croatian: Nježno pustite kožu.
English: Ask your doctor, pharmacist or nurse about how to dispose of medicines you no longer use.
Croatian: • Pitajte svoga liječnika, ljekarnika ili medicinsku sestru kako baciti lijekove koje više ne koristite.
English: Do not put the base cap back on - this could damage the needle.
Croatian: Zatvarač baze nemojte vraćati natrag na bazu - mogli biste oštetiti iglu.
English: Following a first dose of 1 and 3 mg dulaglutide, paracetamol Cmax was reduced by 36 % and 50 %, respectively, and the median tmax occurred later (3 and 4 hours, respectively).
Croatian: Nakon prve doze dulaglutida od 1 mg odnosno 3 mg, Cmax paracetamola smanjio se za 36% odnosno 50%, dok je medijan tmax nastupio kasnije (3 odnosno 4 sata).
English: - Inflamed pancreas (acute pancreatitis) which could cause severe pain in the stomach and back which does not go away.
Croatian: - upala gušterače (akutni pankreatitis), koja može uzrokovati jaku bol u trbuhu i leđima koja ne prolazi
English: Gently let go of the fold of skin.
Croatian: • Nježno pustite nabor kože.
English: These were typically mild or moderate in severity and were reported to peak during the first 2 weeks of treatment and rapidly declined over the next 4 weeks, after which the rate remained relatively constant.
Croatian: Navedeni su događaji obično bili blage do umjerene težine, a vrhunac prijava zabilježen je tijekom prva 2 tjedna liječenja, a zatim su tijekom naredna 4 tjedna naglo opadale, nakon čega je njihova stopa bila razmjerno konstantna.
English: Type 2 diabetes patients were randomly allocated to either Trulicity 1.5 mg (4,949) or placebo (4,952) both in addition to standards of care for type 2 diabetes (the 0.75 mg dose was not administered in this study).
Croatian: Bolesnici sa šećernom bolešću tipa 2 bili su nasumično raspoređeni za primanje lijeka Trulicity u dozi od 1,5 mg (4949) ili placeba (4952), oba kao dodatak standardnom liječenju za šećernu bolest tipa 2 (doza od 0,75 mg nije se primjenjivala u ovom ispitivanju).
English: No dosage adjustment is required in patients with mild, moderate or severe renal impairment (eGFR <90 to ≥15 mL/min/1.73m2).
Croatian: Nije potrebno prilagođavati dozu u bolesnika s blagim, umjerenim ili teškim oštećenjem bubrežne funkcije (eGFR < 90 i ≥ 15 ml/min/1,73 m2).
English: In all studies, dulaglutide produced clinically significant improvements in glycaemic control as measured by glycosylated haemoglobin A1c (HbA1c).
Croatian: svim je ispitivanjima dulaglutid doveo do klinički značajnih poboljšanja regulacije glikemije, koja su se mjerila razinom glikoziliranog hemoglobina A1c (HbA1c).
English: Treatment with dulaglutide provided reductions in systolic blood pressure (SBP) (-2.8 mmHg difference compared to placebo) at 16 weeks.
Croatian: Liječenje dulaglutidom dovelo je do smanjenja sistoličkog krvnog tlaka (SKT) (razlika od -2,8 mmHg u usporedbi s placebom) u 16. tjednu.
English: Exposures after subcutaneous administration of single dulaglutide (1.5 mg) doses in the abdomen, thigh, or upper arm were comparable.
Croatian: Razine izloženosti nakon supkutane primjene jedne doze dulaglutida (1,5 mg) u abdomen, bedro ili nadlakticu bile su usporedive.
English: INSERT 3.
Croatian: PRILOG III.
English: However, no trend in dulaglutide exposure was observed relative to the degree of hepatic impairment.
Croatian: Međutim, nije primijećen nikakav trend u izloženosti dulaglutidu koji bi bio povezan sa stupnjem oštećenja jetrene funkcije.
English: Statistically significant delays in lisinopril tmax of approximately 1 hour were observed on Days 3 and 24 of the study.
Croatian: Statistički značajna produljenja vremena do nastupa tmax lizinoprila od približno 1 sata primijećena su 3. i 24. dana ispitivanja.
English: Hypoglycaemia* (when used as monotherapy or in combination with metformin plus pioglitazone)
Croatian: hipoglikemija* (kada se primjenjuje u monoterapiji ili u kombinaciji s metforminom uz pioglitazon)
English: • Inject your dose using another syringe.
Croatian: • Injicirajte dozu koristeći drugu štrcaljku.
English: The other ingredients are sodium citrate (see section 2 under ‘Trulicity contains sodium citrate' for further information); citric acid, anhydrous; mannitol; polysorbate 80 and water for injections.
Croatian: Drugi sastojci su natrijev citrat (za dodatne informacije vidjeti dio 2 pod „Trulicity sadrži natrijev citrat“), bezvodna citratna kiselina, manitol, polisorbat 80 i voda za injekcije.
English: Treatment of rats throughout pregnancy and lactation produced memory deficits in female offspring at exposures that were 16-fold higher than those proposed clinically.
Croatian: Liječenje ženki štakora tijekom skotnosti i laktacije dovelo je do poteškoća s pamćenjem kod ženske mladunčadi pri razinama izloženosti koje su bile 16 puta veće od predložene kliničke izloženosti.
English: Glass syringe (type I) encased in a disposable pen.
Croatian: Staklena štrcaljka (staklo tipa I) uložena u brizgalicu za jednokratnu uporabu.
English: Studies characterising the pharmacokinetics of dulaglutide in paediatric patients have not been performed.
Croatian: Nisu provedena ispitivanja kojima bi se karakterizirala farmakokinetika dulaglutida u pedijatrijskih bolesnika.
English: For potentially vulnerable populations 0.75 mg once weekly can be considered as a starting dose.
Croatian: Za potencijalno osjetljive populacije može se razmotriti početna doza od 0,75 mg jedanput na tjedan.
English: In the clinical pharmacology studies described below, dulaglutide did not affect the absorption of the orally administered medications tested to any clinically relevant degree.
Croatian: U kliničkim farmakološkim ispitivanjima opisanima u nastavku dulaglutid nije u klinički značajnoj mjeri utjecao na apsorpciju ispitivanih peroralno primijenjenih lijekova.
English: During the fertility studies, a reduction in the number of corpora lutea and prolonged oestrous cycle were observed at dose levels that were associated with decreased food intake and body weight gain in maternal animals; however, no effects on indices of fertility and conception or embryonic development were observed.
Croatian: Tijekom istraživanja plodnosti primijećeno je smanjenje broja žutih tijela i produljenje estrusnog ciklusa pri dozama koje su se povezivale sa smanjenim unosom hrane i smanjenim prirastom tjelesne težine ženki s mladunčadi; međutim, nisu primijećeni učinci na indeks plodnosti i začeća niti na razvoj embrija.
English: In reproductive toxicology studies, skeletal effects and a reduction in foetal growth were observed in the rat and rabbit at exposures of dulaglutide 11- to 44-fold higher than those proposed clinically, but no foetal malformations were observed.
Croatian: U istraživanjima reproduktivne toksičnosti primijećeni su učinci na kostur i smanjen rast fetusa u štakora i kunića pri razinama izloženosti dulaglutidu 11 do 44 puta većima od predložene kliničke izloženosti, ali nisu primijećene malformacije ploda.
English: In a 2-year carcinogenicity study in rats, at ≥ 7 times the human clinical exposure following 1.5 mg dulaglutide per week, dulaglutide caused statistically significant, dose-related increases in the incidence of thyroid C-cell tumours (adenomas and carcinomas combined).
Croatian: U 2-godišnjem istraživanju kancerogenosti u štakora, uz izloženost ≥ 7 puta veću od kliničke izloženosti u ljudi nakon primjene doze od 1,5 mg dulaglutida na tjedan, dulaglutid je uzrokovao statistički značajna i s dozom povezana povećanja incidencije tumora C-stanica štitnjače (adenoma i karcinoma zajedno).
English: If the injection is given by someone else, they may inject in your upper arm.
Croatian: Ako Vam injekciju daje netko drugi, može injicirati lijek u nadlakticu.
English: • When refrigeration is not possible, you can keep your syringe at room temperature
Croatian: • Ako je ne možete odložiti u hladnjak, brizgalicu možete čuvati na sobnoj temperaturi (ispod
English: Treatment with dulaglutide resulted in significant reductions in mean post prandial glucose from baseline (changes from baseline to primary time point -1.95 mmol/L to -4.23 mmol/L).
Croatian: Liječenje dulaglutidom dovelo je do značajnih smanjenja srednje vrijednosti postprandijalne glukoze u odnosu na početne vrijednosti (promjena od početne vrijednosti do primarne vremenske točke: -1,95 mmol/l do -4,23 mmol/l).