FrancophonIA/ELRC3.0 huggingface dataset:
English: It is not known if this medicine may harm your unborn child, therefore you should not use it during pregnancy and for at least 3 months before a planned pregnancy.
Croatian: Nije poznato može li ovaj lijek naškoditi Vašem nerođenom djetetu, prema tome ga ne smijete uzimati tijekom trudnoće i najmanje 3 mjeseca prije planirane trudnoće.
English: Months from Randomization
Croatian: Mjeseci od randomizacije
English: To take the correct dose, read each section so that you do every step in order.
Croatian: Da biste primijenili točnu dozu, pročitajte svako poglavlje, kako biste sve korake napravili točnim redoslijedom.
English: 24-Week Study
Croatian: 24-tjedno ispitivanje
English: Do not skip steps.
Croatian: Nemojte preskakati korake.
English: Component of a multipack, can't be sold separately.
Croatian: Dio višestrukog pakiranja, ne prodavati odvojeno.
English: If the top of the plunger has been pushed past the line, you should continue from step 4d and take the injection.
Croatian: Ako je gornji rub klipa potisnut preko crte, trebate nastaviti s korakom 4d i primijeniti injekciju.
English: Gently clean the area with soap and water or an alcohol swab.
Croatian: Nježno očistite područje sapunom i vodom ili alkoholnim tupferom.
English: Once weekly
Croatian: Jednom tjedno
English: Bydureon only needs to be taken once a week.
Croatian: Bydureon treba primjenjivati samo jednom tjedno.
English: Never mix insulin and Bydureon together in the same injection.
Croatian: Nikada ne miješajte zajedno inzulin i Bydureon u istoj injekciji.
English: Air bubbles are not a problem with this type of injection.
Croatian: Mjehurići zraka ne predstavljaju problem kod ove vrste injekcije.
English: You may give both injections in the same body area (for example, your stomach area), but you should not give the injections next to each other.
Croatian: Možete primijeniti obje injekcije u isto područje na tijelu (na primjer, područje trbuha), ali ne smijete primijeniti injekcije jednu do druge.
English: Approximately 62% of the patients were male.
Croatian: Približno 62% bolesnika bilo je muškog spola.
English: Includes follow-up within seventy days of the last dose received and extension period.
Croatian: Uključuje praćenje unutar 70 dana od posljednje primijenjene doze i razdoblje nastavka ispitivanja.
English: Hypoglycaemia may reduce your ability to concentrate.
Croatian: Hipoglikemija može smanjiti sposobnost koncentracije.
English: p-values are all adjusted p-values for multiplicity.
Croatian: P-vrijednosti su sve p-vrijednosti prilagođene za multiplicitet.
English: These clumps could clog the needle when you take the injection (see question 7).
Croatian: Te bi grudice mogle začepiti iglu tijekom injiciranja (vidjeti pitanje 7).
English: Your step by step guide
Croatian: Vodič korak po korak
English: Gender, race and body weight Gender, race and body weight have no clinically relevant influence on exenatide pharmacokinetics.
Croatian: Spol, rasa i tjelesna težina Spol, rasa i tjelesna težina nemaju klinički značajnog utjecaja na farmakokinetiku eksenatida.
English: If you are not sure you have taken the full dose of Bydureon If you are not sure if you have taken all of your dose, do not inject another dose of this medicine, just take it next week as planned.
Croatian: Ako niste sigurni jeste li primijenili cijelu dozu lijeka Bydureon Ako niste sigurni jeste li primijenili cijelu dozu, nemojte injicirati dodatnu dozu ovog lijeka, već ju uzmite sljedeći tjedan kako je planirano.
English: A. Look in the window.
Croatian: Pogledajte kroz prozorčić.
English: At the end of this period the pens must be used or discarded.
Croatian: Na kraju tog razdoblja brizgalica se mora iskoristiti ili baciti.
English: 1a Take a single-dose kit from the refrigerator.
Croatian: 1a Izvadite jednodozni set iz hladnjaka.
English: Safety findings at 156 weeks were consistent with those reported at 26 weeks.
Croatian: Sigurnosni podaci nakon 156 tjedana su bili konzistentni s onima prijavljenima nakon 26 tjedana.
English: The plunger may feel like it is springing back a little.
Croatian: Možete osjetiti kako se klip malo vraća unatrag.
English: What Bydureon is and what it is used for
Croatian: Što je Bydureon i za što se koristi
English: Locked Position
Croatian: Zaključan položaj
English: DO NOT push the injection button yet.
Croatian: NEMOJTE još pritisnuti gumb za injiciranje.
English: The overall incidence of minor hypoglycaemia was 6.3%.
Croatian: Ukupna incidencija manjih epizoda hipoglikemije iznosila je 6,3%.
English: Do not take two doses of Bydureon within 3 days of each other.
Croatian: Nemojte primijeniti dvije doze lijeka Bydureon u razmaku manjem od 3 dana.
English: Patients were followed as in routine clinical practice for a median of 38.7 months with a median treatment duration of 27.8 months.
Croatian: Bolesnici su bili praćeni kao i u rutinskoj kliničkoj praksi tijekom medijana od 38,7 mjeseci, dok je medijan trajanja liječenja iznosio 27,8 mjeseci.
English: • Do not use the pen if any parts look to be broken or damaged.
Croatian: • Nemojte upotrijebiti brizgalicu ako bilo koji njezin dio izgleda slomljeno ili oštećeno.
English: • Remove the needle cover and give the injection, see steps 4e to 4g
Croatian: • skinuti poklopac s igle i dati injekciju, pogledajte korake 4e do 4g
English: Each single-dose kit has everything you need for your weekly dose of Bydureon.
Croatian: Svaki jednodozni set sadrži sve što trebate za svoju tjednu dozu lijeka Bydureon.
English: • Swelling of the face, tongue or throat (angioedema)
Croatian: • oticanje lica, jezika ili grla (angioedem)
English: • STOP taking this medicine and contact your doctor immediately if you experience severe and persistent stomach pain, with or without vomiting, because you could have an inflamed pancreas (pancreatitis).
Croatian: • PRESTANITE uzimati ovaj lijek i odmah se javite svom liječniku ako dobijete tešku i upornu bol u trbuhu, s povraćanjem ili bez njega, jer biste mogli imati upalu gušterače (pankreatitis).
English: The black dashed Dose Line shows the correct dose.
Croatian: Crna isprekidana oznaka doze pokazuje točnu dozu.
English: I am having trouble mixing my dose.
Croatian: Imam poteškoća s miješanjem doze.
English: To review how to:
Croatian: Da se podsjetite kako:
English: When I inject, what should I do if I cannot push the plunger all the way down?
Croatian: Kada injiciram, što trebam učiniti ako ne mogu potisnuti klip do kraja?
English: Patients may be treated to relieve symptoms, while continuing treatment.
Croatian: Bolesnici mogu biti liječeni ublažavanjem simptoma i istodobno nastaviti s liječenjem.
English: Your doctor should tell you how to treat low blood sugar.
Croatian: Liječnik će Vam reći kako liječiti niski šećer u krvi.
English: Number at Risk
Croatian: Broj bolesnika pod rizikom
English: These pharmacokinetic characteristics of exenatide are independent of the dose.
Croatian: Ova farmakokinetička svojstva eksenatida neovisna su o dozi.
English: These medical conditions can increase the risk of getting pancreatitis, or getting it again, whether or not you are taking this medicine.
Croatian: Ova medicinska stanja mogu povećati rizik da dobijete upalu gušterače, odnosno da ju ponovo dobijete, bez obzira uzimate li ovaj lijek ili ne.
English: Do not try to unlock with excessive force or tools.
Croatian: Nemojte pokušavati otključati brizgalicu uporabom prekomjerne sile ili alata.
English: • Tell your doctor if you have had pancreatitis, gallstones, alcoholism or very high triglycerides.
Croatian: • Obavijestite liječnika ako ste imali pankreatitis, žučne kamence, probleme s alkoholizmom ili vrlo visoke trigliceride.
English: C. Wash your hands.
Croatian: Operite ruke.
English: Why should I store my pen flat in the refrigerator?
Croatian: Zašto moram brizgalicu čuvati u vodoravnom položaju u hladnjaku?
English: The active substance in this medicine slows stomach emptying so food passes more slowly through your stomach.
Croatian: Djelatna tvar u ovom lijeku usporava pražnjenje želuca, pa hrana sporije prolazi kroz želudac.
English: What Bydureon looks like and contents of the pack
Croatian: Kako Bydureon izgleda i sadržaj pakiranja
English: This means the needle has become clogged.
Croatian: To znači da se igla začepila.
English: In the event of overdose, appropriate supportive treatment should be initiated according to the patient's clinical signs and symptoms.
Croatian: U slučaju predoziranja treba započeti odgovarajuće potporno liječenje u skladu s bolesnikovim kliničkim znakovima i simptomima.
English: Overall, 26.9% of patients did not have any prior CV event, 73.1% had at least one prior CV event.
Croatian: Ukupno 26,9% bolesnika nije prethodno imalo nijedan KV događaj, dok je njih 73,1% imalo najmanje jedan prethodni KV događaj.
English: • Bydureon BCise pen should not be used by people who are blind or cannot see well, unless another person who is trained to use this device can help.
Croatian: • Bydureon BCise brizgalicu ne smiju koristiti slijepe ili slabovidne osobe, osim ako nemaju pomoć druge osobe obučene za njezinu uporabu.
English: What should I do if I cannot push the injection button all the way in when trying to inject my dose?
Croatian: Što trebam učiniti ako ne mogu pritisnuti gumb za injiciranje do kraja kada pokušam injicirati dozu?
English: Data in elderly are limited, but suggest no marked changes in exenatide exposure with increased age up to about 75 years old.
Croatian: Podaci o starijim bolesnicima su ograničeni, ali ne ukazuju na izrazite promjene u izloženosti eksenatidu s povećanjem dobi do oko 75 godina.
English: Needle (monoject)
Croatian: Igla („monoject“)
English: All-cause death
Croatian: Smrt zbog bilo kojeg uzroka
English: This means the medicine is not mixed evenly.
Croatian: To znači da lijek nije jednoliko pomiješan.
English: If you forget to use Bydureon You might like to choose a day that you always plan to make your Bydureon injection.
Croatian: Ako ste zaboravili primijeniti Bydureon Možda ćete htjeti izabrati dan u tjednu na koji ćete uvijek planirati injekciju lijeka Bydureon.
English: Patients with an Event (%)
Croatian: Bolesnici s događajem (%)
English: If you see any clumps, keep tapping.
Croatian: Ako vidite bilo kakve grudice, nastavite lupkati.
English: White to off-white opaque suspension.
Croatian: Bijela do bjelkasta neprozirna suspenzija.
English: After you receive your injection, you will see an orange rod in the window.
Croatian: Nakon što primijenite injekciju, u prozorčiću ćete vidjeti narančasti klip.
English: The medicine is mixed well when the liquid looks cloudy from both sides of the window.
Croatian: Lijek je dobro pomiješan kada tekućina izgleda mutno kroz obje strane prozorčića.
English: Do not recycle the container with used pens.
Croatian: Nemojte reciklirati spremnik s upotrijebljenim brizgalicama.
English: Pancreatitis can be a serious, potentially life-threatening medical condition.
Croatian: Pankreatitis može biti ozbiljna bolest, koja može biti opasna po život.
English: Make a note that you have taken your Bydureon today and mark your calendar for when you are due for your next injection.
Croatian: Zabilježite da ste danas primijenili Bydureon i označite na kalendaru kada je vrijeme za sljedeću injekciju.
English: No clinically relevant effects on Cmax or AUC were observed.
Croatian: Nisu opaženi klinički značajni učinci na Cmax ili AUC.
English: • intestinal obstruction (blockage in intestine)
Croatian: • intestinalna opstrukcija (zastoj u crijevima)
English: The presence of antibodies (high or low titres) is not predictive of glycaemic control for an individual patient.
Croatian: Prisutnost protutijela (visokih ili niskih titara) nije pretkazatelj kontrole glikemije za pojedinog bolesnika.
English: With one hand, hold the plunger in place so it does not move.
Croatian: Jednom rukom držite klip na mjestu da se ne pomiče.
English: You will not need the cap and can throw it away.
Croatian: Zatvarač Vam više neće trebati te ga možete baciti.
English: To prevent losing medicine, do not push in the plunger while attaching the needle.
Croatian: Kako biste spriječili gubitak lijeka, nemojte potiskivati klip dok pričvršćujete iglu.
English: INSTRUCTIONS FOR THE USER
Croatian: UPUTE ZA KORISNIKA
English: The suspension should be visually inspected prior to use.
Croatian: Suspenzija se prije uporabe mora vizualno pregledati.
English: The medicine should look even throughout (see pictures in Figure G and Figure H, Step 2C).
Croatian: Lijek mora izgledati sasvim jednoliko (pogledajte Sliku G i Sliku H u koraku 2C).
English: If you have an injection site reaction (redness, rash, or itching) you may like to ask your doctor for something to help relieve any signs or symptoms.
Croatian: Ako imate reakciju na mjestu injekcije (crvenilo, osip ili svrbež), možete zamoliti liječnika da Vam propiše nešto za ublažavanje znakova ili simptoma.
English: If it's not mixed well, tap longer and more firmly.
Croatian: Ako nije dobro pomiješan, lupkajte dulje i snažnije.
English: Test your blood glucose levels regularly.
Croatian: Redovito provjeravajte razine glukoze u krvi.
English: • is properly labelled to warn of hazardous waste inside the container.
Croatian: • koji ima odgovarajuću oznaku s upozorenjem da se u spremniku nalazi opasan otpad.
English: Thereafter, patients can resume their usual once weekly dosing schedule.
Croatian: Nakon toga bolesnici mogu nastaviti liječenje prema uobičajenom rasporedu primjene jednom tjedno.
English: • Hives and difficulty with breathing
Croatian: • koprivnjača i teškoće pri disanju
English: Most individual nodules were asymptomatic, did not interfere with study participation and resolved over 4 to 8 weeks.
Croatian: Većina pojedinačnih čvorića bila je asimptomatska, nije ometala sudjelovanje u ispitivanju i povukla se kroz 4-8 tjedana.
English: Pioglitazone 45 mg
Croatian: Pioglitazon 45 mg
English: Look
Croatian: Pogledajte
English: Once absorbed into the circulation, exenatide is distributed and eliminated according to its known systemic pharmacokinetic properties (as described in this section).
Croatian: Jednom apsorbiran u krvotok, eksenatid se distribuira i eliminira prema svojim poznatim sustavnim farmakokinetičkim svojstvima (kako je opisano u ovom dijelu).
English: Common Uncommon Rare Very rare Not known
Croatian: Često Manje često Rijetko Vrlo rijetko
English: Prolonged-release exenatide should be administered once a week on the same day each week.
Croatian: Eksenatid s produljenim oslobađanjem treba primijeniti jednom tjedno, istoga dana svakoga tjedna.
English: Keep shaking until the liquid and powder are mixed well.
Croatian: Tresite sve dok se tekućina i prašak dobro ne izmiješaju.
English: Hold for 10 seconds to make sure you get the full dose.
Croatian: Držite ga tako 10 sekundi kako biste bili sigurni da ste primili cijelu dozu.
English: The effect on HbA1c remained clinically significant over 52 weeks but partially diminished over time in the group that had initially received Bydureon BCise.
Croatian: Učinak na HbA1c ostao je klinički značajan tijekom 52 tjedna, ali se s vremenom djelomično smanjio u skupini koja je otpočetka primala Bydureon BCise.
English: During these next steps, you will be mixing the medicine and filling the syringe.
Croatian: Tijekom sljedećih koraka, miješat ćete lijek i puniti štrcaljku.
English: Needles (2)
Croatian: Štrcaljka igle (2)
English: You can re-mix your medicine if your pen is in the locked position.
Croatian: Lijek možete ponovno promiješati ako je brizgalica u zaključanom položaju.
English: No predetermined dose adjustment is required; however, lipid profiles should be monitored as appropriate.
Croatian: Iako nije potrebna unaprijed utvrđena prilagodba doze, treba odgovarajuće kontrolirati lipidne profile.
English: • dehydration, sometimes with a decrease in kidney function
Croatian: • dehidracija, ponekad uz smanjenje bubrežne funkcije
English: Turn the knob from the Lock to the Unlock position until you hear a click.
Croatian: Okrenite kotačić iz zaključanog u otključani položaj, dok ne čujete klik.
English: Keep this flap open so you can refer to it as you go through the steps
Croatian: Držite ovaj poklopac otvorenim da se možete vratiti kako budete prolazili kroz pojedine korake.
English: Using too much of this medicine can cause nausea, vomiting, dizziness, or symptoms of low blood sugar (see section 4).
Croatian: Previše ovog lijeka može uzrokovati mučninu, povraćanje, omaglicu ili simptome niske razine šećera u krvi (vidjeti dio 4).
English: After I mix the medicine, how long can I wait before taking the injection?
Croatian: Nakon što pomiješam lijek, koliko dugo mogu čekati prije nego ga injiciram?
English: The 156-week results were consistent with those previously reported in the 26-week interim report.
Croatian: Rezultati 156-tjednog ispitivanja su bili konzistentni s onima prethodno prijavljenima u privremenom izvješću nakon 26 tjedana.
English: If you use more Bydureon than you should
Croatian: Ako primijenite više lijeka Bydureon nego što ste trebali
English: However, exenatide does not impair the normal glucagon response and other hormone responses to hypoglycaemia.
Croatian: Međutim, eksenatid ne utječe na normalan odgovor glukagona i drugih hormonskih odgovora na hipoglikemiju.
English: • Hypersensitivity (rashes, itching and rapid swelling of the tissues of the neck, face, mouth or throat)
Croatian: • preosjetljivost (osip, svrbež i naglo oticanje tkiva vrata, lica, usta ili grla)
English: Interaction with warfarin
Croatian: Interakcija s varfarinom
English: This medicine helps your body to increase the production of insulin when your blood sugar is high.
Croatian: Ovaj lijek pomaže Vašem tijelu da poveća stvaranje inzulina kada je šećer u krvi visok.
English: You may use a biohazard container, another hard plastic container, or a metal container.
Croatian: Možete upotrijebiti spremnik za opasan biološki otpad, neki drugi spremnik od tvrde plastike ili metalni spremnik.
English: The results of the primary composite and secondary cardiovascular endpoints are shown in Figure 2.
Croatian: Rezultati za primarnu kompozitnu mjeru ishoda i sekundarne kardiovaskularne mjere ishoda prikazani su na Slici 2.
English: Your doctor is now prescribing this medicine as an additional medicine to help control your blood sugar.
Croatian: Liječnik Vam je sada propisao ovaj lijek kao dodatni lijek za pomoć u kontroli šećera u krvi.
English: This medicine should be discontinued at least 3 months before a planned pregnancy.
Croatian: Primjenu ovog lijeka treba obustaviti najmanje 3 mjeseca prije planirane trudnoće.
English: It should be injected into the skin and not into a vein or into the muscle.
Croatian: Mora se injicirati pod kožu, a ne u venu ili u mišić.
English: • Remove the blue cap of the needle, see step 1d
Croatian: • skinuti plavi zatvarač sa igle, pogledajte korak 1d
English: You may see a few drops of liquid on the needle or in the cover.
Croatian: Možda ćete vidjeti nekoliko kapi tekućine na igli ili u zatvaraču.
English: Prolonged-release exenatide can be administered at any time of day, with or without meals.
Croatian: Eksenatid s produljenim oslobađanjem se može primijeniti u bilo koje doba dana, uz obrok ili bez njega.
English: Nonclinical studies have shown that exenatide is predominantly eliminated by glomerular filtration with subsequent proteolytic degradation.
Croatian: Neklinička ispitivanja pokazala su da se eksenatid uglavnom eliminira glomerularnom filtracijom s naknadnom proteolitičkom degradacijom.
English: • pain in the stomach area
Croatian: • bol u području trbuha
English: Areas on body for injection
Croatian: Područja na tijelu za injekciju
English: The patient does not need to save any part of the single-use kit.
Croatian: Bolesnik ne mora sačuvati niti jedan dio seta za jednokratnu uporabu.
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 kombinirane terapije, učinke na kontrolu glikemije i kardiovaskularne događaje te ispitivane populacije, vidjeti dijelove 4.4, 4.5 i 5.1.
English: If you feel you should stop using this medicine, please consult your doctor first.
Croatian: Ako smatrate da trebate prestati primjenjivati ovaj lijek, najprije se posavjetujte sa svojim liječnikom.
English: Detailed information on this medicine is available on the website of the European Medicines Agency http://www.ema.europa.eu/
Croatian: Detaljnije informacije o ovom lijeku dostupne su na internetskoj stranici Europske agencije za lijekove http://www.ema.europa.eu/.
English: Lift here for a closer look at the parts
Croatian: Podignite ovdje za detaljan pregled sastavnih dijelova
English: INSTRUCTIONS FOR THE USER Read these instructions carefully before use
Croatian: UPUTE ZA KORISNIKA Prije uporabe pažljivo pročitajte ove upute
English: Do not go to the next step unless your medicine is mixed well.
Croatian: Nemojte prijeći na sljedeći korak ako niste dobro promiješali lijek.
English: After the click, continue to hold the needle in your skin for 10 seconds.
Croatian: Nakon što čujete klik, zadržite iglu u koži još 10 sekundi.
English: Resolution of pancreatitis has been observed with supportive treatment, but very rare cases of necrotising or haemorrhagic pancreatitis and/or death have been reported.
Croatian: Opaženo je da uz potpornu terapiju dolazi do povlačenja pankreatitisa, ali su prijavljeni vrlo rijetki slučajevi nekrotizirajućeg ili hemoragičnog pankreatitisa i/ili smrti.
English: Additional reductions in postprandial concentrations were also observed.
Croatian: Opaženo je i dodatno smanjenje koncentracija nakon obroka.
English: Refer to the package leaflet (section 3) on what to do if you are not sure if you have received a complete dose.
Croatian: Pogledajte u uputi o lijeku (dio 3) što učiniti ako niste sigurni da ste primili čitavu dozu.
English: Hospitalisation for ACS
Croatian: Hospitalizacija zbog AKS-a
English: Bydureon BCise pen can be kept at room temperature for up to 4 weeks.
Croatian: Bydureon BCise brizgalica može se čuvati na sobnoj temperaturi do 4 tjedna.
English: Choice of other medicinal products and dose selection should be considered accordingly, as adverse reactions may continue and efficacy may, at least partly, persist until exenatide levels decline.
Croatian: O tome treba voditi računa prilikom odabira drugog lijeka i izbora doze, s obzirom da se nuspojave mogu nastaviti, a djelotvornost, barem djelomično, i dalje održavati dok se ne snize razine eksenatida.
English: HR (active/placebo) and CI are based on Cox proportional hazards regression model, stratified by prior CV event, with treatment group only as explanatory variable.
Croatian: HR (aktivni lijek/placebo) i CI temelje se na Coxovom regresijskom modelu proporcionalnih hazarda, stratificiranom prema prethodnom KV događaju i uz liječenu skupinu kao jedinu objasnidbenu varijablu.
English: • Store in packaging provided to protect from light until you are ready to prepare and use your dose.
Croatian: • Čuvajte je u originalnom pakiranju, kako biste ju zaštitili od svjetlosti dok ne budete spremni pripremiti i primijeniti dozu.
English: What Bydureon is and what it is used for What you need to know before you use Bydureon How to use Bydureon
Croatian: Što je Bydureon i za što se koristi Što morate znati prije nego počnete primjenjivati Bydureon Kako primjenjivati Bydureon
English: Improvements in blood pressure were maintained through 52 weeks.
Croatian: Poboljšanje krvnog tlaka bilo je održano tijekom 52 tjedna.
English: The percentage of these subjects with positive antibody titres, in particular high titres, peaked at approximately weeks 8 to 16 of dosing and then diminished over time.
Croatian: Postotak tih ispitanika s pozitivnim titrima protutijela, osobito visokim titrima, bio je najviši nakon približno 8 - 16 tjedana primjene, a zatim se s vremenom smanjio.