FrancophonIA/ELRC3.0 huggingface dataset:
English: If you lose weight too quickly (more than 1.5 kg per week) talk to your doctor about it since this may cause problems such as gallstones.
Croatian: Ako prebrzo gubite na tjelesnoj težini (više od 1,5 kg na tjedan), porazgovarajte o tome sa svojim liječnikom jer to može uzrokovati probleme poput žučnih kamenaca.
English: It's normal if you see air bubbles in the liquid, and they will cause no harm.
Croatian: Normalno je da u tekućini vidite mjehuriće zraka i oni Vam neće naškoditi.
English: Connecting the parts
Croatian: Spajanje dijelova
English: Paediatric population Interaction studies with exenatide have only been performed in adults.
Croatian: Pedijatrijska populacija Ispitivanja interakcija s eksenatidom provedena su samo u odraslih.
English: What if the device malfunctions and I cannot unlock it?
Croatian: Što ako se brizgalica zaglavi i ne mogu je otključati?
English: There is a spare needle in case you need it.
Croatian: U setu se nalazi i rezervna igla, za slučaj da je zatrebate.
English: Test your blood glucose levels regularly, it is particularly important to do this if you are also using a sulphonylurea.
Croatian: Redovito kontrolirajte razine glukoze u krvi, što je posebno važno ako također uzimate sulfonilureju.
English: - How to inject this medicine.
Croatian: Kako injicirati ovaj lijek.
English: If you still cannot push the button in, this may mean that the needle is clogged.
Croatian: Ako ni tada ne možete pritisnuti gumb do kraja, to bi moglo značiti da je igla začepljena.
English: Hidden Needle
Croatian: Skrivena igla
English: The signs and symptoms of low blood sugar may include headache, drowsiness, weakness, dizziness, confusion, irritability, hunger, fast heartbeat, sweating, and feeling jittery.
Croatian: Znakovi i simptomi niskog šećera u krvi uključuju glavobolju, omamljenost, slabost, omaglicu, smetenost, razdražljivost, glad, ubrzani otkucaji srca, znojenje i osjećaj nervoze.
English: Your guide to the parts
Croatian: Vodič kroz dijelove
English: Be careful not to push in the plunger.
Croatian: Pazite da ne potisnete klip.
English: Ask your pharmacist how to safely throw it away.
Croatian: Pitajte svog ljekarnika kako ga zbrinuti na siguran način.
English: Caution should be exercised in patients with a history of pancreatitis.
Croatian: Potreban je oprez kod bolesnika koji imaju pankreatitis u povijesti bolesti.
English: • Attach the needle, see step 4a
Croatian: • pričvrstiti iglu, pogledajte korak 4a
English: When 1,000 mg paracetamol tablets were administered, either with or without a meal, following 14 weeks of prolonged-release exenatide therapy, no significant changes in paracetamol AUC were observed compared to the control period.
Croatian: Kada su tablete paracetamola od 1000 mg, uz obrok ili bez njega, primijenjene nakon 14-tjedne terapije eksenatidom s produljenim oslobađanjem, nisu opažene značajne promjene AUC-a paracetamola u usporedbi s kontrolnim razdobljem.
English: Use a new pen for each injection.
Croatian: Za svaku injekciju upotrijebite novu brizgalicu.
English: Figure 1: Time to First Adjudicated MACE (intent to treat patients)
Croatian: Slika 1: Vrijeme do prvog potvrđenog MACE događaja (bolesnici predviđeni za liječenje)
English: Some of these events occurred in patients experiencing events that may affect hydration, including nausea, vomiting, and/or diarrhoea and/or receiving medicinal products known to affect renal function/hydration status.
Croatian: Neki od tih događaja nastupili su u bolesnika koji su imali stanja koja mogu utjecati na hidrataciju, uključujući mučninu, povraćanje i/ili proljev i/ili primanje lijekova koji mogu utjecati na bubrežnu funkciju/stanje hidratacije.
English: Why do I need to hold the pen upright while removing the orange cap?
Croatian: Zašto moram držati brizgalicu uspravno dok skidam narančasti zatvarač?
English: The most frequently reported gastrointestinal adverse reaction was nausea.
Croatian: Najčešće prijavljena gastrointestinalna nuspojava bila je mučnina.
English: The two chambers are separated by a second chlorobutyl rubber piston.
Croatian: Dvije su komore odvojene još jednim klipom od klorobutilne gume.
English: Ask your pharmacist how to safely throw away the container with used pens and needles.
Croatian: Pitajte ljekarnika kako sigurno baciti spremnik s upotrijebljenim brizgalicama i iglama.
English: When used with insulin, prolonged-release exenatide and insulin must be administered as two separate injections.
Croatian: Kada se koristi s inzulinom, eksenatid s produljenim oslobađanjem i inzulin moraju biti primijenjeni kao dvije odvojene injekcije.
English: You must not save the mixed medicine to inject at a later time.
Croatian: Ne smijete čuvati pomiješani lijek da biste ga kasnije injicirali.
English: Administration of exenatide has been shown to reduce food intake, due to decreased appetite and increased satiety.
Croatian: Pokazano je da primjena eksenatida smanjuje unos hrane, zbog smanjena apetita i povećane sitosti.
English: The absolute change in 2-hour postprandial plasma glucose at Week 28 is modeled similarly using ANCOVA.
Croatian: Apsolutna promjena glukoze u plazmi 2 sata nakon obroka u 28. tjednu dobivena je na sličan način koristeći ANCOVA.
English: Patients should be informed of the characteristic symptom of acute pancreatitis: persistent, severe abdominal pain.
Croatian: Bolesnike treba upoznati s karakterističnim simptomom akutnog pankreatitisa: ustrajnom, jakom boli u abdomenu.
English: With your other hand, firmly hold the 2 grey squares on the white cap.
Croatian: Drugom rukom čvrsto uhvatite 2 siva kvadratića na bijelom zatvaraču.
English: It is an injectable medicine used to improve blood sugar control in adults with type 2 diabetes mellitus.
Croatian: To je lijek koji se primjenjuje injekcijom, a koristi se kako bi se poboljšala kontrola šećera u krvi u odraslih osoba sa šećernom bolešću tipa 2.
English: Patients with rapid weight loss should be monitored for signs and symptoms of cholelithiasis.
Croatian: Bolesnike koji brzo gube na tjelesnoj težini treba pratiti zbog znakova i simptoma kolelitijaze.
English: D. Compare both sides of the mixing window to the photos below,
Croatian: Usporedite obje strane prozorčića za miješanje s fotografijama u nastavku,
English: Animal studies with exenatide did not indicate harmful effects with respect to fertility; high doses of exenatide caused skeletal effects and reduced foetal and neonatal growth.
Croatian: Ispitivanja s eksenatidom provedena na životinjama nisu ukazala na štetne učinke s obzirom na plodnost; visoke doze eksenatida izazvale su učinke na skeletu i smanjile fetalni i neonatalni rast.
English: After removing the connector be careful not to push in the plunger.
Croatian: Nakon odvajanja priključka pazite da ne potisnete klip.
English: Rate based on completed long-term safety and efficacy studies (n = 526), unless other indicated.
Croatian: Stopa na temelju podataka iz dovršenih dugoročnih ispitivanja sigurnosti i djelotvornosti (n=526), osim ako nije drugačije navedeno.
English: The pooled clinical studies data set for Bydureon BCise comprises two phase 3 comparator-controlled studies of 6 to 12 months duration.
Croatian: Objedinjeni podaci iz kliničkih ispitivanja lijeka Bydureon BCise obuhvaćaju dva ispitivanja faze 3 kontrolirana usporednim lijekom, koja su trajala od 6 do 12 mjeseci.
English: In most patients who develop antibodies, antibody titres diminish over time.
Croatian: U većine bolesnika koji razviju protutijela, razina titra se tijekom vremena smanjuje.
English: One patient was reported with major hypoglycaemia since he had a low blood glucose value (2.2 mmol/l) and requested assistance with oral carbohydrate treatment which resolved the event.
Croatian: Prijavljen je jedan bolesnik s jakom hipoglikemijom, budući da je imao nisku vrijednost glukoze u krvi (2,2 mmol/l), što je zahtijevalo pomoć liječenjem peroralnim ugljikohidratima, čime je događaj razriješen.
English: You should use contraception if you could potentially become pregnant during treatment with this medicine.
Croatian: Tijekom liječenja ovim lijekom trebate koristiti kontracepciju ako postoji mogućnost da postanete trudni.
English: Then, take your thumb off the plunger.
Croatian: Tada maknite palac s klipa.
English: Prolonged-release exenatide must not be administered by intravenous or intramuscular injection.
Croatian: Eksenatid s produljenim oslobađanjem se ne smije primjenjivati intravenskom ili intramuskularnom injekcijom.
English: Frequencies reported in pooled data from the controlled periods of the two phase 3 clinical studies (n = 410).
Croatian: Učestalost prijavljena u objedinjenim podacima iz kontroliranih razdoblja dvaju kliničkih ispitivanja faze 3 (n=410).
English: The most common adverse events leading to withdrawal in either treatment group were nausea and vomiting.
Croatian: Najčešće nuspojave koje su dovele do prekida liječenja u obje liječene skupine bile su mučnina i povraćanje.
English: The “Instructions for the User”, provided in the carton, must be followed carefully.
Croatian: „Upute za korisnika“ koje su priložene u kutiji lijeka moraju se pažljivo slijediti.
English: Cardiovascular evaluation
Croatian: Kardiovaskularna ocjena
English: If you stop using this medicine this can affect your blood sugar levels.
Croatian: Prestanak primjene ovog lijeka može utjecati na razine šećera u krvi.
English: If you do not inject Bydureon immediately, the medicine will start to form small clumps in the syringe.
Croatian: Ako Bydureon ne injicirate odmah, počet će se stvarati male grudice lijeka u štrcaljki.
English: 1 single-dose kit contains:
Croatian: 1 jednodozni set sadrži:
English: Prolonged-release exenatide that has been frozen must not be used.
Croatian: Eksenatid s produljenim oslobađanjem koji je bio zamrznut ne smije se koristiti.
English: What should I do if I have trouble removing the needle cover?
Croatian: Što trebam učiniti ako imam poteškoća sa skidanjem poklopca s igle?
English: Consistent with the potentially immunogenic properties of protein and peptide pharmaceuticals, patients may develop antibodies to exenatide following treatment with prolonged-release exenatide.
Croatian: U skladu s potencijalnim imunogenim svojstvima proteinskih i peptidnih farmaceutskih lijekova, bolesnici mogu razviti protutijela na eksenatid nakon liječenja eksenatidom s produljenim oslobađanjem.
English: The mean age at study entry was 62 years (with 8.5% of the patients ≥75 years).
Croatian: Srednja vrijednost dobi pri uključivanju u ispitivanje iznosila je 62 godine (8,5% bolesnika bilo je u dobi od ≥ 75 godina).
English: You have diabetes because your body does not make enough insulin to control the level of sugar in your blood or your body is not able to use the insulin properly.
Croatian: Vaše tijelo ne stvara dovoljno inzulina za kontrolu šećera u krvi ili Vaše tijelo ne može iskoristiti inzulin na odgovarajući način.
English: In interaction studies of the effect of immediate-release exenatide on digoxin and lisinopril there were no clinical relevant effects on Cmax or AUC, however, a delay in tmax of about 2 h was observed.
Croatian: U ispitivanjima interakcija učinka eksenatida s trenutnim oslobađanjem na digoksin i lizinopril nije bilo klinički značajnih učinaka na Cmax ili AUC, no opažena je odgoda tmax od oko 2 sata.
English: Exenatide has been shown to bind to and activate the known human GLP-1 receptor in vitro, its mechanism of action mediated by cyclic AMP and/or other intracellular signalling pathways.
Croatian: Dokazano je da se eksenatid in vitro veže na poznati ljudski GLP-1 receptor i aktivira ga, uz mehanizam djelovanja posredovan cikličkim AMP-om i/ili drugim intracelularnim signalnim putevima.
English: Therefore, no dose adjustments for medicinal products sensitive to delayed gastric emptying are required.
Croatian: Stoga nije potrebna prilagodba doze lijekova osjetljivih na odgođeno pražnjenje želuca.
English: To prevent a clogged needle, always mix the medicine very well, and inject immediately after mixing.
Croatian: Kako biste spriječili začepljenje igle, uvijek vrlo dobro izmiješajte lijek i injicirajte ga odmah nakon miješanja.
English: Then choose a different injection site and finish taking the injection.
Croatian: Nakon toga izaberite drugo mjesto za injiciranje i dovršite primjenu injekcije.
English: This is what the syringe should now look like.
Croatian: Štrcaljka sada treba izgledati ovako.
English: Subsequently, exenatide concentrations of approximately 153-208 pg/ml were maintained, indicating that steady state was achieved.
Croatian: Nakon toga su se koncentracije eksenatida održavale na otprilike 153-208 pg/ml, što ukazuje na to da je postignuto stanje dinamičke ravnoteže.
English: DO NOT try to recap or reuse the needle.
Croatian: NEMOJTE pokušati vratiti zatvarač niti ponovno upotrijebiti iglu.
English: DO NOT use your pen or needle if any parts are broken or missing.
Croatian: Brizgalicu i iglu NE SMIJETE upotrijebiti ako im je bilo koji dio oštećen ili nedostaje.
English: Prolonged-release exenatide is not recommended in these patients.
Croatian: Eksenatid s produljenim oslobađanjem se ne preporučuje u tih bolesnika.
English: Examination of antibody-positive specimens revealed no significant cross-reactivity with similar endogenous peptides (glucagon or GLP-1).
Croatian: Pregledom uzoraka pozitivnih na protutijela nije utvrđena značajna unakrsna reaktivnost sa sličnim endogenim peptidima (glukagonom ili GLP-1).
English: It will be easier to mix the medicine if the pen is at room temperature.
Croatian: Lakše ćete pomiješati lijek ako je brizgalica ugrijana na sobnu temperaturu.
English: The mean apparent clearance of exenatide is 9 l/h.
Croatian: Prosječan prividni klirens eksenatida je 9 l/h.
English: If not mixed well, repeat Step 2 and check again.
Croatian: Ako lijek nije dobro promiješan, ponovite 2. korak i zatim ponovno pregledajte suspenziju.
English: It is important to stop pushing at this point, or you will waste your medicine and you will not get the correct dose.
Croatian: Važno je da u ovom trenutku prestanete potiskivati klip jer ćete inače izgubiti dio lijeka i nećete moći primijeniti točnu dozu.
English: If you use more of this medicine than you should, please consult your doctor first as you may need medical treatment.
Croatian: Ako primijenite više ovog lijeka nego što ste trebali, prvo se obratite svom liječniku jer će Vam možda trebati liječenje.
English: B. Check the expiration date (labelled EXP) printed on the pen label.
Croatian: Provjerite rok valjanosti (označen oznakom 'EXP') otisnut na naljepnici brizgalice.
English: This will allow enough time for all the medicine to go from the pen to under your skin.
Croatian: To je dovoljno vremena da sav lijek iz brizgalice uđe pod kožu.
English: Mean body weight (kg)
Croatian: Srednja vrijednost tjelesne težine (kg)
English: • is large enough to hold the entire pen,
Croatian: • koji je dovoljno velik da u njega stane cijela brizgalica
English: The reduction in Cmax is of limited clinical relevance and no adjustment of dosing of oral contraceptives is required.
Croatian: Smanjenje Cmax je ograničenog kliničkog značaja i nije potrebno prilagođavati doziranje oralnih kontraceptiva.
English: Prolonged-release exenatide has minor influence on the ability to drive and use machines.
Croatian: Eksenatid s produljenim oslobađanjem malo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: You will need a puncture-resistant container that is large enough to hold the entire pen.
Croatian: Trebat će Vam neprobojan spremnik koji je dovoljno velik da u njega stane cijela brizgalica.
English: The 28-week comparator-controlled period of the study was followed by a 24-week extension period during which all participating subjects received treatment with this medicinal product.
Croatian: Nakon 28-tjednog razdoblja ispitivanja kontroliranog usporednim lijekom uslijedio je 24-tjedni nastavak ispitivanja, u kojem su svi sudionici primali liječenje ovim lijekom.
English: Subsequently, exenatide concentrations of approximately 151-265 pg/ml were maintained indicating that steady state was achieved.
Croatian: Nakon toga su se koncentracije eksenatida održavale na otprilike 151-265 pg/ml, što ukazuje na to da je postignuto stanje dinamičke ravnoteže.
English: Overall, the percentage of antibody positive patients was consistent across clinical studies.
Croatian: Sveukupno gledajući, postotak bolesnika s pozitivnim protutijelima bio je konzistentan u svim kliničkim ispitivanjima.
English: • skin reactions at the injection site following injection of exenatide.
Croatian: • kožne reakcije na mjestu primjene injekcije nakon davanja injekcije eksenatida.
English: - If you have type 1 diabetes or diabetic ketoacidosis, as this medicine should not be used.
Croatian: - Ako imate šećernu bolest tipa 1 ili dijabetičku ketoacidozu, jer se ovaj lijek ne smije primjenjivati.
English: Minutes
Croatian: minuta
English: • Continue holding the pen upright to prevent the medicine from accidently leaking.
Croatian: • I dalje držite brizgalicu uspravno, da biste spriječili slučajno istjecanje lijeka.
English: You will need a puncture-resistant container that is large enough to hold the entire pen with a used needle attached.
Croatian: Trebat će Vam neprobojan spremnik koji je dovoljno velik za odlaganje cijele brizgalice s pričvršćenom upotrijebljenom iglom.
English: The mean BMI was 32.7 kg/m2 and the mean duration of diabetes was 13.1 years.
Croatian: Srednja vrijednost indeksa tjelesne mase (ITM) iznosila je 32,7 kg/m2, a srednja vrijednost trajanja šećerne bolesti 13,1 godinu.
English: Why should I inject my medicine right away after mixing it?
Croatian: Zašto moram injicirati lijek odmah nakon miješanja?
English: What should I do if the top of the plunger has been pushed past the black dashed Dose Line?
Croatian: Što trebam učiniti ako je gornji rub klipa potisnut preko crne isprekidane oznake doze?
English: • changes in INR (measurement of blood thinning) have been reported when used together with warfarin
Croatian: • promjene INR-a (mjerilo razrjeđivanja krvi) prijavljene kada je lijek primijenjen zajedno s varfarinom
English: While patients with high titre antibodies at the last visit had an attenuated HbA1c response, HbA1c reductions in these patients were clinically relevant (-0.6% to -0.7%).
Croatian: Iako su bolesnici s visokim titrom protutijela pri posljednjem posjetu imali smanjen odgovor HbA1c, sniženje vrijednosti HbA1c u tih bolesnika ipak je bilo klinički značajno (-0,6% do -0,7%)
English: Administration of a combination oral contraceptive (30 mcg ethinyl estradiol plus 150 mcg levonorgestrel) one hour before immediate-release exenatide did not alter the AUC, Cmax or Cmin of either ethinyl estradiol or levonorgestrel.
Croatian: Primjena kombiniranog oralnog kontraceptiva (30 μg etinilestradiola i 150 μg levonorgestrela) jedan sat prije primjene eksenatida s trenutnim oslobađanjem nije promijenio AUC, Cmax ili Cmin etinilestradiola ili levonorgestrela.
English: Shake vigorously like you would shake a bottle of oil-and-vinegar salad dressing.
Croatian: Snažno tresite kao što biste tresli mješavinu ulja i octa za preljev za salatu.
English: Patients who developed antibodies to exenatide tend to have more injection site reactions (for example: redness of skin and itching), but otherwise similar rates and types of adverse events as those with no antibodies to exenatide.
Croatian: Bolesnici koji su razvili protutijela na eksenatid češće su imali reakcije na mjestu injekcije (na primjer: crvenilo kože i svrbež), ali su inače imali slične stope i vrste nuspojava kao i oni bez protutijela na eksenatid.
English: These injection site reactions were generally mild and usually did not lead to discontinuation of study medication.
Croatian: Ove reakcije na mjestu injekcije uglavnom su bile blage i obično nisu vodile do prekida primjene ispitivanog lijeka.
English: The mean dose of insulin glargine at the beginning of treatment was 10.1 IU/day rising to 31.1 IU/day for insulin glargine-treated patients.
Croatian: Srednja vrijednost doze inzulina glargina na početku liječenja bila je 10,1 IU/dan, a povećala se na 31,1 IU/dan za bolesnike liječene inzulinom glarginom.
English: Stomach
Croatian: Trbuh
English: Medicines should not be disposed of via waste water or household waste.
Croatian: Lijekovi se ne smiju uklanjati putem otpadnih voda ili kućnog otpada.
English: Name and address of the manufacturers responsible for batch release AstraZeneca AB
Croatian: Naziv i adresa proizvođača odgovornih za puštanje serije lijeka u promet AstraZeneca AB
English: It is normal to see a few air bubbles in the mixture.
Croatian: Normalno je da vidite nekoliko mjehurića zraka u mješavini.
English: If not mixed well, continue to shake hard.
Croatian: Ako nije dobro promiješan, nastavite ga žustro tresti.
English: Effects of overdoses with exenatide (based on immediate-release exenatide clinical studies) included severe nausea, severe vomiting and rapidly declining blood glucose concentrations.
Croatian: Učinci predoziranja eksenatidom (na temelju kliničkih ispitivanja s eksenatidom s trenutnim oslobađanjem) uključuju tešku mučninu, teško povraćanje i brzo smanjivanje koncentracija glukoze u krvi.
English: Lower glucagon concentrations lead to decreased hepatic glucose output.
Croatian: Niže koncentracije glukagona dovode do smanjenja jetrene produkcije glukoze.
English: Unlike native GLP-1, prolongedrelease exenatide has a pharmacokinetic and pharmacodynamic profile in humans suitable for once weekly administration.
Croatian: Za razliku od nativnog GLP-1, eksenatid s produljenim oslobađanjem u ljudi posjeduje farmakokinetički i farmakodinamički profil prikladan za primjenu jednom tjedno.
English: • Keep the pen, and all medicines, out of the reach of children.
Croatian: • Čuvajte brizgalicu i sve druge lijekove izvan dohvata djece.
English: - If you have ever had inflammation of the pancreas (pancreatitis) (see section 4).
Croatian: - Ako ste ikada imali upalu gušterače (pankreatitis) (vidjeti dio 4).
English: Tap the vial several times against a hard surface to loosen the powder.
Croatian: Lagano kucnite bočicom nekoliko puta o tvrdu podlogu da rastresete prašak.
English: Exenatide Placebo
Croatian: Eksenatid Placebo
English: The powder in one chamber must be mixed with the solvent in the other chamber of the pre-filled pen.
Croatian: Prašak u jednoj komori mora se pomiješati s otapalom u drugoj komori napunjene brizgalice.
English: Most individual nodules did not interfere with study participation and resolved over time.
Croatian: Većina pojedinačnih čvorića nije ometala sudjelovanje u ispitivanju i s vremenom se povukla.
English: If you do not inject your medicine right away after mixing, the medicine may separate, and you will not get your full dose.
Croatian: Ako ne injicirate lijek odmah nakon miješanja, može doći do njegova razdvajanja, pa nećete primiti cijelu dozu.
English: All-cause mortality was the initial secondary endpoint assessed.
Croatian: Smrt zbog bilo kojeg uzroka bila je sekundarna mjera ishoda koja se prva ocjenjivala.
English: What should I do if I see air bubbles in the syringe?
Croatian: Što trebam učiniti ako vidim mjehuriće zraka u štrcaljki?
English: You may see air bubbles.
Croatian: Možda ćete vidjeti mjehuriće zraka.
English: The mean apparent volume of distribution of exenatide following subcutaneous administration of a single dose of exenatide is 28 l.
Croatian: Distribucija Prosječan prividni volumen distribucije eksenatida nakon supkutane primjene jedne doze je 28 l.
English: Common questions and answers.
Croatian: Česta pitanja i odgovori.
English: You should not use this medicine while breast-feeding.
Croatian: Ne smijete uzimati ovaj lijek tijekom dojenja.
English: Subsequent injections should use a different site of injection each week.
Croatian: Svakog tjedna narednu injekciju treba primijeniti na drugo mjesto.
English: Press the top of the vial firmly into the orange connector.
Croatian: Pritisnite vrh bočice čvrsto u narančasti priključak.
English: Do not touch the orange connector inside.
Croatian: Ne dotičite narančasti priključak koji se nalazi u omotu.