FrancophonIA/ELRC3.0 huggingface dataset:
English: What if I unlock the pen and press the green injection button before pulling off the base cap?
Croatian: Što ako otključam brizgalicu i pritisnem zeleni gumb za injiciranje prije nego što skinem zatvarač baze?
English: In addition, the dulaglutide molecule was engineered to prevent the Fcγ receptor-dependent immune response and to reduce its immunogenic potential.
Croatian: Osim toga, molekula dulaglutida oblikovana je tako da spriječi imuni odgovor ovisan o Fcγ receptoru i smanjuje njegov imunogeni potencijal.
English: SCAN THIS CODE TO LAUNCH www.trulicity.eu
Croatian: SKENIRAJTE OVAJ KOD DA BISTE OTVORILI STRANICU www.trulicity.eu
English: However, for patients receiving oral medicinal products requiring rapid gastrointestinal absorption or prolonged release formulations the potential for altered drug exposure should be considered.
Croatian: Međutim, u bolesnika koji uzimaju peroralne lijekove koji zahtijevaju brzu gastrointestinalnu apsorpciju ili formulacije s produljenim oslobađanjem treba uzeti u obzir mogućnost promijenjene izloženosti lijeku.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Trulicity in one or more subsets of the paediatric population for the treatment of type 2 diabetes mellitus (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove odgodila je obvezu podnošenja rezultata ispitivanja lijeka Trulicity u jednoj ili više podskupina pedijatrijske populacije za liječenje šećerne bolesti tipa 2 (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: Check with your doctor or pharmacist if you are not sure how to use this medicine.
Croatian: Provjerite s liječnikom ili ljekarnikom ako niste sigurni kako primjenjivati ovaj lijek.
English: Tell your doctor if you are pregnant, think you may be pregnant or are planning to have a baby, as Trulicity should not be used during pregnancy.
Croatian: mislite da biste mogli biti trudni ili planirate imati dijete, jer se Trulicity ne smije primjenjivati tijekom trudnoće.
English: This is not unusual and will not affect your dose.
Croatian: To nije neuobičajeno i neće utjecati na dozu.
English: If you use more Trulicity than you should talk to your doctor immediately.
Croatian: Ako primijenite više lijeka Trulicity nego što ste trebali, odmah razgovarajte sa svojim liječnikom.
English: If you use more Trulicity than you should
Croatian: Ako primijenite više lijeka Trulicity nego što ste trebali
English: What if the needle looks bent?
Croatian: Što ako igla izgleda savijeno?
English: Similar results for SBP and DBP were demonstrated at the final 26 week time point of the study.
Croatian: Slični rezultati za SKT i DKT primijećeni su i u završnoj vremenskoj točki u 26. tjednu ispitivanja.
English: Do not stop using Trulicity without talking with your doctor.
Croatian: Nemojte prestati primjenjivati Trulicity bez prethodnog razgovora s liječnikom.
English: Week 1 Week 2
Croatian: 1. tjedan 2. tjedan
English: In a 6-month carcinogenicity study in transgenic mice, there was no tumorigenic response.
Croatian: 6-mjesečnom istraživanju kancerogenosti na transgeničnim miševima nije primijećen tumorogeni odgovor.
English: There was no difference in diastolic blood pressure (DBP).
Croatian: Nije primijećena razlika u dijastoličkom krvnom tlaku (DKT).
English: Manufacturer Eli Lilly Italia S.p.A.,Via Gramsci 731/733, 50019, Sesto Fiorentino, Firenze (FI), Italy
Croatian: Eli Lilly Italia S.p.A.,Via Gramsci 731/733, 50019, Sesto Fiorentino, Firenca (FI), Italija
English: Your doctor, pharmacist or nurse can help you choose the injection site that is best for you.
Croatian: • Liječnik, ljekarnik ili medicinska sestra mogu Vam pomoći odabrati mjesto za injiciranje koje Vam najbolje odgovara.
English: Trulicity that has been frozen must not be used.
Croatian: Trulicity koji je bio zamrznut ne smije se primijeniti.
English: The GLP-1 analog portion of dulaglutide is approximately 90 % homologous to native human GLP-1 (7-37).
Croatian: Dio dulaglutida koji čini analog GLP-1 je približno 90% homologan nativnom humanom GLP-1 (7-37).
English: I don't know how to do a subcutaneous injection.
Croatian: Ne znam kako primijeniti potkožnu injekciju.
English: Your dose was delivered correctly if the grey part is visible (see step 3.)
Croatian: Doza je pravilno primijenjena ako je vidljiv sivi dio (pogledajte
English: Therefore, the use of dulaglutide is not recommended during pregnancy.
Croatian: Stoga, ne preporučuje se koristiti dulaglutid tijekom trudnoće.
English: Of these, 1,206 were ≥ 65 years of which 119 were ≥ 75 years.
Croatian: Među tim je ispitanicima njih 1206 bilo u dobi od ≥ 65 godina, a 119 od njih u dobi od ≥ 75 godina.
English: In certain situations, for example if you are 75 years or older, your doctor may recommend a starting dose of 0.75 mg once a week.
Croatian: U određenim situacijama, primjerice ako imate 75 ili više godina, liječnik će Vam možda preporučiti početnu dozu od 0,75 mg jedanput na tjedan.
English: Therefore, dulaglutide does have a high degree of protection against DPP-4 inactivation (see section 5.1, Mechanism of action).
Croatian: Stoga, dulaglutid doista ima visok stupanj zaštite od inaktivacije enzimom DPP-4 (vidjeti „Mehanizam djelovanja“ u dijelu 5.1).
English: Unlock by turning the lock ring.
Croatian: Otključajte okretanjem prstena za zaključavanje.
English: Type 2 diabetes is a condition in which your body does not make enough insulin, and the insulin that your body produces does not work as well as it should.
Croatian: Šećerna bolest tipa 2 je bolest kod koje tijelo ne proizvodi dovoljno inzulina, a inzulin koji tijelo proizvede ne djeluje onako kako bi trebao.
English: Trulicity was superior in preventing MACE compared to placebo (Figure 1).
Croatian: Trulicity je bio superioran placebu u prevenciji MACE događaja (Slika 1).
English: Do I need to hold the injection button down until the injection is complete?
Croatian: Moram li gumb za injiciranje držati pritisnutim do kraja injekcije?
English: Continue holding the clear base firmly against your skin until you hear a second click.
Croatian: Nastavite držati prozirnu bazu čvrsto priljubljenom uz kožu sve dok ne čujete još jedan klik.
English: Talk to your doctor, pharmacist or nurse about how to inject Trulicity correctly.
Croatian: Razgovarajte sa svojim liječnikom, ljekarnikom ili medicinskom sestrom o tome kako pravilno injicirati Trulicity.
English: These engineering features result in a soluble formulation and a prolonged half-life of 4.7 days, which makes it suitable for once-weekly subcutaneous administration.
Croatian: Te preinačene značajke rezultiraju topljivom formulacijom i produljenim poluvijekom od 4,7 dana, koji čine lijek pogodnim za supkutanu primjenu jedanput na tjedan.
English: The day of weekly administration can be changed if necessary, as long as the last dose was administered 3 or more days (72 hours) before.
Croatian: Ako je potrebno, dan tjedne primjene može se promijeniti, pod uvjetom da je posljednja doza primijenjena prije 3 ili više dana (72 sata).
English: the label to make sure you have the correct medicine and it has not expired.
Croatian: naljepnicu kako biste bili sigurni da imate pravi lijek i da mu nije istekao rok valjanosti.
English: Use a new pen for your injection.
Croatian: Upotrijebite novu brizgalicu za injekciju.
English: If pancreatitis is confirmed, dulaglutide should not be restarted.
Croatian: Ako se pankreatitis potvrdi, liječenje dulaglutidom ne smije se ponovno započeti.
English: Very common Common Uncommon
Croatian: Manje često Rijetko Nepoznato
English: • When you press the green injection button, the pen will automatically insert the needle into your skin, inject the medicine, and pull back (retract) the needle after the injection is complete.
Croatian: • Kada pritisnete zeleni gumb za injiciranje, brizgalica će automatski uvesti iglu u kožu, injicirati lijek i izvući iglu po završetku injekcije.
English: Injection site adverse events were reported in 1.9 % of patients receiving dulaglutide.
Croatian: Štetni događaji na mjestu injekcije bile su prijavljene u 1,9% bolesnika koji su primali dulaglutid.
English: In clinical pharmacology studies conducted in patients with type 2 diabetes mellitus up to 6 weeks, the majority of gastrointestinal events were reported during the first 2-3 days after the initial dose and declined with subsequent doses.
Croatian: U kliničkim farmakološkim ispitivanjima provedenima u bolesnika sa šećernom bolešću tipa 2 u trajanju do 6 tjedana, većina gastrointestinalnih događaja bila je prijavljena tijekom prva 2-3 dana nakon početne doze, a s daljnjim se dozama njihova učestalost smanjivala.
English: Do not use Trulicity - if you are allergic to dulaglutide or any of the other ingredients of this medicine (listed in section 6).
Croatian: - ako ste alergični na dulaglutid ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.)
English: The safety profile of Trulicity in patients with renal impairment was similar to that observed in other studies with Trulicity.
Croatian: Sigurnosni profil lijeka Trulicity u bolesnika s oštećenjem bubrežne funkcije bio je sličan onome opaženome u drugim ispitivanjima lijeka Trulicity.
English: AUCINR increased by 2 %, which is unlikely to be clinically significant, and there was no effect on maximum international normalised ratio response (INRmax).
Croatian: AUCINR povećao se za 2%, što vjerojatno nije klinički značajno, te nije bilo učinka na odgovor maksimalnog internacionalnog normaliziranog omjera (INRmax).
English: • For complete information about proper storage, read the Information for the patient.
Croatian: • Za cjelovite informacije o pravilnom čuvanju pročitajte Informaciju za bolesnike.
English: The increased exposure may enhance the effects of dulaglutide on blood glucose levels.
Croatian: Povećana izloženost može pojačati učinke dulaglutida na razine glukoze u krvi.
English: 1500-2000 mg/day (n=268)
Croatian: 1500-2000 mg/dan (n=268)
English: - you have type 1 diabetes (the type when your body does not produce any insulin) as this medicine may not be right for you.
Croatian: - ako imate šećernu bolest tipa 1 (tip kod kojega tijelo uopće ne proizvodi inzulin), jer ovaj lijek možda neće biti prikladan za Vas.
English: When your injection is complete, the plunger should be pushed fully into the syringe, with no more medicine left in it.
Croatian: Kada je injekcija završena, klip se cijelom duljinom mora nalaziti u štrcaljki te u njoj ne smije više biti lijeka.
English: Your doctor may want to lower the dose of these other medicines to prevent you from getting low blood sugar levels (hypoglycaemia).
Croatian: Vaš će liječnik možda htjeti smanjiti dozu tih drugih lijekova kako bi spriječio pojavu niske razine šećera u krvi (hipoglikemiju).
English: Following subcutaneous administration to patients with type 2 diabetes, dulaglutide reaches peak plasma concentrations in 48 hours.
Croatian: Nakon supkutane primjene u bolesnika sa šećernom bolešću tipa 2, dulaglutid postiže vršne koncentracije u plazmi za 48 sati.
English: The effect of dulaglutide on fertility in humans is unknown.
Croatian: Nije poznat učinak dulaglutida na plodnost u ljudi.
English: Inject your next dose on your regular scheduled day.
Croatian: Sljedeću dozu injicirajte prema uobičajenom rasporedu.
English: You can also change the day of the week on which you inject Trulicity if necessary, as long as it has been at least 3 days since your last dose of Trulicity.
Croatian: Ako je potrebno, možete promijeniti dan u tjednu kada primjenjujete Trulicity, pod uvjetom da je od primjene posljednje doze lijeka Trulicity prošlo najmanje 3 dana.
English: Dulaglutide significantly improved total treatment satisfaction compared to exenatide twice daily.
Croatian: Dulaglutid je značajno povećao cjelokupno zadovoljstvo liječenjem u usporedbi s eksenatidom dvaput na dan.
English: Frequencies for events have been calculated based on their incidence in the phase II and phase III registration studies.
Croatian: Učestalosti nuspojava izračunate su na temelju njihove incidencije u registracijskim ispitivanjima faze II i faze III.
English: Air bubbles are normal.
Croatian: Zračni mjehurići su normalna pojava.
English: The effect of dulaglutide on blood pressure as assessed by Ambulatory Blood Pressure Monitoring was evaluated in a study of 755 patients with type 2 diabetes.
Croatian: Učinak dulaglutida na krvni tlak ocijenjen kontinuiranim mjerenjem krvnog tlaka procijenjen je u ispitivanju sa 755 bolesnika sa šećernom bolešću tipa 2.
English: Nonmechanical intestinal obstruction
Croatian: Ne mehanička intestinalna opstrukcija
English: Trulicity contains an active substance called dulaglutide and is used to lower blood sugar (glucose) in adults with type 2 diabetes mellitus and can help prevent heart disease.
Croatian: Trulicity sadrži djelatnu tvar koja se zove dulaglutid, a koristi se za snižavanje razine šećera (glukoze) u krvi u odraslih osoba sa šećernom bolešću tipa 2 te može pomoći u sprječavanju srčane bolesti.
English: The improvement in fasting glucose was sustained through the longest study duration of 104 weeks.
Croatian: Poboljšanja razine glukoze natašte održala su se tijekom najduljeg ispitivanja u trajanju od 104 tjedna.
English: There were 3,114 (31.5 %) patients with established CV disease.
Croatian: U ispitivanju je sudjelovalo 3114 (31,5%) bolesnika s utvrđenom kardiovaskularnom bolešću.
English: In each case, patients can then resume their regular once weekly dosing schedule.
Croatian: U oba slučaja bolesnici nakon toga mogu nastaviti s uobičajenom primjenom lijeka jedanput na tjedan.
English: The adverse reactions are listed in Table 1 as MedDRA preferred term by system organ class and in order of decreasing incidence (very common: ≥ 1/10; common: ≥ 1/100 to < 1/10; uncommon:
Croatian: Nuspojave su navedene u Tablici 1 kao MedDRA preporučeni pojmovi prema klasifikaciji organskih sustava i u padajućem nizu prema ozbiljnosti (vrlo često: ≥ 1/10; često: ≥ 1/100 i < 1/10; manje često:
English: Check
Croatian: Provjerite
English: These changes are consistent with the gastric emptying delay of dulaglutide and within the pharmacokinetic variability of metformin and thus are not clinically relevant.
Croatian: Te promjene su u skladu s odgođenim pražnjenjem želuca koje uzrokuje dulaglutid i nalaze se unutar raspona farmakokinetičke varijabilnosti metformina pa stoga nisu klinički značajne.
English: - you have diabetic ketoacidosis (a complication of diabetes that occurs when the body is unable to break down glucose because there is not enough insulin).
Croatian: - ako imate dijabetičku ketoacidozu (komplikacija šećerne bolesti do koje dolazi kada tijelo ne može razgraditi glukozu jer nema dovoljno inzulina).
English: CHOOSE YOUR INJECTION SITE
Croatian: ODABERITE MJESTO ZA INJICIRANJE
English: Warnings and precautions Talk to your doctor, pharmacist or nurse before using Trulicity if:
Croatian: Upozorenja i mjere opreza Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primijenite Trulicity:
English: Dulaglutide has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis, and is therefore not recommended in these patients.
Croatian: Dulaglutid nije ispitivan u bolesnika s teškom bolešću probavnog sustava, uključujući tešku gastroparezu, pa se njegova primjena u tih bolesnika ne preporučuje.
English: Mark the day of the week you want to use your medicine to help you remember.
Croatian: Označite dan u tjednu kada želite primijeniti lijek kako biste se lakše sjetili primijeniti ga.
English: There is very limited experience in patients with end stage renal disease (<15 ml/min/1.73m2), therefore Trulicity cannot be recommended in this population (see sections 5.1 and 5.2).
Croatian: Iskustvo u bolesnika u terminalnoj fazi bubrežne bolesti (< 15 ml/min/1,73 m2) vrlo je ograničeno pa se primjena lijeka Trulicity u toj populaciji ne može preporučiti (vidjeti dijelove 5.1 i 5.2).
English: Effects of overdose with dulaglutide in clinical studies have included gastrointestinal disorders and hypoglycaemia.
Croatian: Učinci predoziranja dulaglutidom u kliničkim ispitivanjima uključivali su gastrointestinalne poremećaje i hipoglikemiju.
English: Native GLP-1 has a half-life of 1.5-2 minutes due to degradation by DPP-4 and renal clearance.
Croatian: Nativni GLP-1 ima poluvijek od 1,5-2 minute zbog razgradnje enzimom DPP-4 i bubrežnog klirensa.
English: The durability of effect on beta-cell function was maintained through the longest study duration of 104 weeks.
Croatian: Dugotrajni učinci na funkciju beta-stanica održali su se tijekom najduljeg ispitivanja u trajanju od 104 tjedna.
English: The safety and efficacy of dulaglutide were evaluated in nine randomised, controlled, phase III trials involving 6,193 patients with type 2 diabetes.
Croatian: Kontrola glikemije Sigurnost i djelotvornost dulaglutida ocijenjene su u devet randomiziranih, kontroliranih ispitivanja faze III u kojima su sudjelovala 6193 bolesnika sa šećernom bolešću tipa 2.
English: This leaflet was last revised in Month YYYY
Croatian: Ova uputa je zadnji puta revidirana u mjesec GGGG
English: Your doctor should tell you how to treat low blood sugar.
Croatian: Liječnik bi Vam morao reći kako liječiti nisku razinu šećera u krvi.
English: In the rat, there was no direct effect on mating or fertility following treatment with dulaglutide (see section 5.3).
Croatian: U štakora nije zabilježen izravan učinak na parenje ni plodnost nakon liječenja dulaglutidom (vidjeti dio 5.3).
English: The signs include rapid weight loss, feeling sick or being sick, a sweet smell to your breath, a sweet or metallic taste in your mouth, or a different odour to your urine or sweat.
Croatian: Znakovi uključuju nagli gubitak tjelesne težine, mučninu ili povraćanje, sladak miris daha, sladak ili metalan okus u ustima ili drugačiji miris mokraće ili znoja.
English: In the phase II and phase III clinical studies, systemic hypersensitivity events (e.g., urticaria, edema) were reported in 0.5 % of patients receiving dulaglutide.
Croatian: U kliničkim ispitivanjima faze II i faze III, događaji sistemske preosjetljivosti (npr. urtikarija, edem) bili su prijavljeni u 0,5% bolesnika koji su primali dulaglutid.
English: Dulaglutide is presumed to be degraded into its component amino acids by general protein catabolism pathways.
Croatian: Pretpostavlja se da se dulaglutid razgrađuje na sastavne aminokiseline općenitim putovima katabolizma proteina.
English: Patients receiving dulaglutide in combination with sulphonylurea or insulin may have an increased risk of hypoglycaemia.
Croatian: U bolesnika koji primaju dulaglutid u kombinaciji sa sulfonilurejom ili inzulinom može postojati povećan rizik od hipoglikemije.
English: For complete information about proper storage, read the Information for the patient.
Croatian: Za cjelovite informacije o pravilnom čuvanju pročitajte Informaciju za bolesnike.
English: Many of the reported adverse renal events occurred in patients who had experienced nausea, vomiting, diarrhoea, or dehydration.
Croatian: Mnogi od prijavljenih bubrežnih štetnih događaja nastupili su u bolesnika koji su imali mučninu, povraćanje, proljev ili dehidraciju.
English: When this happens, sugar (glucose) builds up in the blood.
Croatian: U tom slučaju dolazi do nakupljanja šećera (glukoze) u krvi.
English: What if there is a drop of liquid or blood on my skin after my injection?
Croatian: Što ako mi se nakon injekcije na koži nalazi kapljica tekućine ili krvi?
English: If you forget to inject a dose, and if there are at least 3 days before your next dose is due, then inject your dose as soon as possible.
Croatian: Ako zaboravite injicirati dozu, a do sljedeće je doze preostalo još najmanje 3 dana, injicirajte propuštenu dozu što je prije moguće.
English: When initiating treatment with Trulicity, you may in some cases experience loss of fluids/dehydration, e.g. in case of vomiting, nausea and/or diarrhoea which may lead to a decrease in kidney function.
Croatian: Na početku liječenja lijekom Trulicity u nekim slučajevima može doći do gubitka tekućine/dehidracije, npr. u slučaju povraćanja, mučnine i/ili proljeva, što može dovesti do smanjenja bubrežne funkcije.
English: Gender and race Gender and race had no clinically meaningful effect on the pharmacokinetics of dulaglutide.
Croatian: Spol i rasa nisu imali klinički značajnog učinka na farmakokinetiku dulaglutida.
English: Clinical studies with dulaglutide have indicated enhanced beta-cell function as measured by homeostasis model assessment (HOMA2-%B).
Croatian: Klinička ispitivanja dulaglutida ukazala su na poboljšanu funkciju beta-stanica, koja se mjeri procjenom modela homeostaze (HOMA2-%B).
English: METHOD AND ROUTE(S) OF ADMINISTRATION For single use only.
Croatian: NAČIN I PUT(EVI) PRIMJENE Samo za jednokratnu uporabu.
English: - you have ever had pancreatitis (inflammation of the pancreas) which causes severe pain in the stomach and back which does not go away.
Croatian: - ako ste ikada imali pankreatitis (upalu gušterače), koji uzrokuje jaku bol u trbuhu i leđima koja ne prolazi.
English: The majority of the effect on fasting blood glucose concentrations occurred by 2 weeks.
Croatian: Glavnina učinka na koncentracije glukoze u krvi natašte postignuta je do 2. tjedna.
English: The mean age was 66.2 years, the mean BMI was 32.3 kg/m², and 46.3 % of patients were female.
Croatian: Srednja vrijednost dobi iznosila je 66,2 godine, srednja vrijednost indeksa tjelesne mase (ITM) bila je 32,3 kg/m², a 46,3% bolesnika bilo je ženskog spola.
English: The Trulicity long-term cardiovascular outcome study was a placebo-controlled, double-blind clinical trial.
Croatian: Dugoročno ispitivanje kardiovaskularnih ishoda kod primjene lijeka Trulicity bilo je placebom kontrolirano, dvostruko slijepo kliničko ispitivanje.
English: In the absence of other signs and symptoms of acute pancreatitis, elevations in pancreatic enzymes alone are not predictive of acute pancreatitis.
Croatian: Ako nisu prisutni drugi znakovi i simptomi akutnog pankreatitisa, povišene vrijednosti gušteračnih enzima nisu same po sebi pretkazatelj akutnog pankreatitisa.
English: These changes were not clinically relevant; therefore no dose adjustment of lisinopril or metoprolol is necessary when administered with dulaglutide.
Croatian: Navedene promjene nisu bile klinički značajne i stoga nije potrebno prilagođavati dozu lizinoprila niti metoprolola kada se primjenjuju istodobno s dulaglutidom.
English: 3 INJECT
Croatian: 3 INJICIRAJTE
English: Prepare from the refrigerator.
Croatian: Pripremite se štrcaljku iz hladnjaka.
English: The molecule consists of 2 identical disulfide-linked chains, each containing a modified human GLP-1 analogue sequence covalently linked to a modified human immunoglobulin G4 (IgG4) heavy chain fragment (Fc) by a small peptide linker.
Croatian: Molekula se sastoji od dvaju identičnih lanaca povezanih disulfidnom vezom, a svaki od njih sadrži modificiran slijed analoga humanog GLP-1 koji je malenom peptidnom poveznicom kovalentno vezan s fragmentom teškog lanca (Fc) modificiranog humanog imunoglobulina G4 (IgG4).
English: Especially tell your doctor: - if you are using other medicines that lower the amount of sugar in your blood, such as insulin or a medicine containing sulphonylurea.
Croatian: Posebno je važno da obavijestite svog liječnika: - ako primjenjujete druge lijekove koji snižavaju razinu šećera u krvi, poput inzulina ili lijeka koji sadrži sulfonilureju.
English: - you are on dialysis as this medicine is not recommended.
Croatian: - ako ste na dijalizi, jer se ovaj lijek ne preporučuje bolesnicima na dijalizi.
English: Slowly push the plunger all the way in until all the medicine is injected.
Croatian: Polako pritisnite klip do kraja, sve dok ne injicirate sav lijek.
English: Combination therapy with metformin
Croatian: Kombinirana terapija s metforminom