FrancophonIA/ELRC3.0 huggingface dataset:
English: Overall, the level of glycaemic control (HbA1c) in patients treated with Bydureon BCise with low titre antibodies at the last visit (-1.1% to -1.5%) was comparable to that observed in those without antibody titres (-1.1% to -1.4%).
Croatian: Sveukupno je razina glikemijske kontrole (HbA1c) u bolesnika liječenih lijekom Bydureon BCise koji su pri posljednjem posjetu imali nizak titar protutijela (-1,1% do -1,5%) bila usporediva s onom opaženom u bolesnika bez titara protutijela (-1,1% do -1,4%).
English: Treatment with prolonged-release exenatide resulted in significant reductions in fasting plasma/serum glucose concentrations, these reductions were observed as early as 4 weeks.
Croatian: Liječenje eksenatidom s produljenim oslobađanjem rezultiralo je značajnim smanjenjima koncentracija glukoze u plazmi/serumu natašte, ta smanjenja su se vidjela već nakon 4 tjedna.
English: These include: cavity containing pus (abscess) and swollen, or red area of skin that feels hot and tender (cellulitis).
Croatian: One uključuju: šupljinu ispunjenu gnojem (apsces) i otečeni, crveni dio kože vruć i osjetljiv na dodir (celulitis).
English: If you do see any dry powder, shake vigorously while continuing to push down on the plunger with your thumb.
Croatian: Ako vidite suhi prašak, snažno tresite dok palcem i dalje pritišćete klip.
English: Also be sure you twisted the knob until it stopped, the orange label disappeared, and the injection button appears.
Croatian: Također provjerite jeste li okrenuli kotačić do kraja, je li narančasta naljepnica nestala i je li se pojavio gumb za injiciranje.
English: Event Rate HR (95% CI)1
Croatian: Stopa događaja HR (95% CI)1
English: Reversibility of altered renal function has been observed with supportive treatment and discontinuation of potentially causative medicinal products, including exenatide.
Croatian: Opažena je reverzibilnost promijenjene bubrežne funkcije nakon uvođenja potpornog liječenja i obustave lijekova koji su je potencijalno mogli uzrokovati, uključujući eksenatid.
English: On average in the phase 3 studies, 12% of the patients had higher titre antibodies.
Croatian: U prosjeku je u ispitivanjima faze 3, 12% bolesnika imalo povišen titar protutijela.
English: Patients and caregivers should be trained by their healthcare professional.
Croatian: Zdravstveni djelatnici trebaju obučiti bolesnike i njegovatelje.
English: Prolonged-release exenatide was associated with a significantly lower incidence of episodes of hypoglycaemia than basal insulin in patients also receiving metformin therapy (3% versus 19%) and in patients also receiving metformin plus sulphonylurea therapy (20% versus 42%).
Croatian: Eksenatid s produljenim oslobađanjem je bio povezan sa značajno nižom incidencijom epizoda hipoglikemije nego bazalni inzulin u bolesnika koji su također primali terapiju metforminom (3% naspram 19%) te u bolesnika koji su također primali terapiju metforminom i sulfonilurejom (20% naspram 42%).
English: Bydureon is indicated in adults 18 years and older with type 2 diabetes mellitus to improve glycaemic control in combination with other glucose-lowering medicinal products including basal insulin, when the therapy in use, together with diet and exercise, does not provide adequate glycaemic control.
Croatian: Bydureon je indiciran u odraslih od 18 godina i starijih sa šećernom bolesti tipa 2 za poboljšanje kontrole glikemije u kombinaciji s drugim lijekovima za snižavanje glukoze u krvi uključujući bazalni inzulin, kada trenutna terapija, uz dijetu i tjelovježbu, ne omogućava adekvatnu kontrolu glikemije.
English: Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to  1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1000), very rare (< 1/10,000) and not known (cannot be estimated from the available data).
Croatian: Učestalosti su definirane kao: vrlo često (≥ 1/10), često (≥ 1/100 i < 1/10), manje često (≥ 1/1000 i < 1/100), rijetko (≥ 1/10 000 i < 1/1000), vrlo rijetko (< 1/10 000), te nepoznata učestalost (ne može se procijeniti iz dostupnih podataka).
English: Prolonged-release exenatide should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
Croatian: Eksenatid s produljenim oslobađanjem se ne smije primjenjivati u bolesnika sa šećernom bolešću tipa 1 ni za liječenje dijabetičke ketoacidoze.
English: When exenatide was used in combination with metformin and/or a thiazolidinedione, no increase in the incidence of hypoglycaemia was observed over that of placebo in combination with metformin and/or a thiazolidinedione which may be due to this glucose-dependent insulinotropic mechanism (see section
Croatian: Kada se eksenatid primjenjivao u kombinaciji s metforminom i/ili tiazolidindionom, nije opaženo povećanje incidencije hipoglikemije u odnosu na placebo u kombinaciji s metforminom i/ili tiazolidindionom, što može biti zbog ovog inzulinotropnog mehanizma ovisnog o glukozi (vidjeti dio 4.4).
English: This is what the broken-off cap looks like.
Croatian: Ovako izgleda odlomljeni zatvarač.
English: Do not use tools or try to force the cap off.
Croatian: Nemojte koristiti alat niti silom pokušavati skinuti zatvarač.
English: To get your full dose the medicine must be mixed well.
Croatian: Da biste primili cijelu dozu, lijek mora biti dobro pomiješan.
English: Put the covered needle down.
Croatian: Odložite pokrivenu iglu.
English: All patients with missing endpoint data are imputed as non-responders.
Croatian: Svi bolesnici bez podataka za mjeru ishoda uračunati su kao oni koji nisu odgovorili na terapiju.
English: This will let the pen warm up to room temperature.
Croatian: To će omogućiti da se brizgalica ugrije na sobnu temperaturu.
English: This incidence was increased when it was used in combination with a sulphonylurea (26.1 %) compared to no sulphonylurea (0.9%) (see section 4.4).
Croatian: Ta je incidencija bila povećana kada se lijek primjenjivao u kombinaciji sa sulfonilurejom (26,1%) u odnosu na primjenu bez sulfonilureje (0,9%) (vidjeti dio 4.4).
English: HR=hazard ratio, CI=confidence interval
Croatian: HR (engl. hazard ratio), omjer hazarda; CI (engl. confidence interval), interval pouzdanosti
English: Exenatide vs Placebo: HR (95% CI)
Croatian: Eksenatid u odnosu na placebo: HR (95% CI)
English: BCise is the name of the pre-filled pen device used to inject your Bydureon medicine.
Croatian: BCise je naziv napunjene brizgalice koja se koristi za injiciranje lijeka Bydureon.
English: Bydureon is injected into your skin (subcutaneously).
Croatian: Bydureon se injicira pod kožu (supkutano).
English: • Hold the pen by the end with the orange label and tap the pen firmly against the palm of your hand.
Croatian: • Uhvatite brizgalicu za onaj kraj na kojem se nalazi narančasta naljepnica i snažno lupkajte njome o dlan.
English: Amongst patients treated with Bydureon BCise evaluable for antibodies (N = 393), the incidence of potentially immunogenic injection site reactions (most commonly injection site nodule) during the two studies was approximately 20%.
Croatian: Među bolesnicima liječenima lijekom Bydureon BCise u kojih se mogla odrediti razina protutijela (N = 393), incidencija potencijalno imunogenih reakcija na mjestu injekcije (najčešće čvorić na mjestu injekcije) tijekom dvaju ispitivanja iznosila je približno 20%.
English: Once you mix the medicine, you must inject it immediately.
Croatian: Nakon što pomiješate lijek, morate ga odmah injicirati.
English: When prolonged-release exenatide was added to basal insulin, no initial dose adjustment of insulin was required.
Croatian: Kada je eksenatid s produljenim oslobađanjem dodan bazalnom inzulinu, nije bila potrebna prilagodba inicijalne doze inzulina.
English: Prepare to safely dispose of used needles and syringes.
Croatian: Pripremite se za sigurno odlaganje upotrijebljenih igala i štrcaljki.
English: The most frequent adverse reactions during the clinical studies were gastrointestinal-related (mainly nausea (8 %), which tended to dissipate with continued treatment), headache (4 %) and injection site reactions, such as injection site pruritus (3 %) and injection site erythema (2 %).
Croatian: Najčešće nuspojave tijekom kliničkih ispitivanja bile su nuspojave vezane uz gastrointestinalni trakt (uglavnom mučnina [8%], koja se obično povukla s nastavkom liječenja), glavobolja (4%) i reakcije na mjestu injekcije, kao što su svrbež na mjestu primjene injekcije (3%) i eritem na mjestu primjene injekcije (2%).
English: During the controlled period of the clinical study comparing Bydureon BCise with immediate-release exenatide, nausea was reported in 9.6% and 20.5% of patients in each group.
Croatian: Tijekom kontroliranog razdoblja kliničkog ispitivanja u kojem se lijek Bydureon BCise uspoređivao s eksenatidom s trenutnim oslobađanjem, mučnina je prijavljena u 9,6% odnosno 20,5% bolesnika.
English: A total of 14,752 patients were randomised 1:1 to either prolonged-release exenatide 2 mg once weekly or placebo, added to the current usual care which could include SGLT2 inhibitors.
Croatian: Ukupno su 14 752 bolesnika bila randomizirana u omjeru 1:1 za primanje eksenatida s produljenim oslobađanjem u dozi od 2 mg jednom tjedno ili placeba kao dodatka trenutnom standardnom liječenju koje je moglo uključivati inhibitore SGLT2.
English: Last Observation Carried Forward (LOCF).
Croatian: Prijenos posljednje zabilježene vrijednosti (engl. last observation carried forward, LOCF).
English: The liquid in the syringe should be clear and free of particles.
Croatian: Tekućina u štrcaljki mora biti bistra i bez čestica.
English: Discontinuation of treatment
Croatian: Obustava liječenja
English: The air bubbles will not harm you or affect your dose.
Croatian: Mjehurići zraka Vam neće naškoditi niti će utjecati na dozu.
English: But be sure to choose a different injection site in that area.
Croatian: Međutim, svakako odaberite različito mjesto injekcije na tom području.
English: Administration of the oral contraceptive 35 minutes after exenatide did not affect AUC but resulted in a reduction of the Cmax of ethinyl estradiol by 45%, and Cmax of levonorgestrel by 27-41%, and a delay in tmax by 2-4 h due to delayed gastric emptying.
Croatian: Primjena oralnog kontraceptiva 35 minuta nakon eksenatida nije utjecala na AUC, ali je rezultirala smanjenjem Cmax etinilestradiola za 45% i smanjenjem Cmax levonorgestrela za 27-41% te odgodom tmax za 2-4 sata zbog produljenog pražnjenja želuca.
English: The needle is attached to the pen and covered by the orange cap.
Croatian: Igla je pričvršćena za brizgalicu i prekrivena narančastim zatvaračem.
English: You will need a puncture-resistant container that:
Croatian: Trebat će Vam neprobojan spremnik:
English: With your other hand, hold the needle cover.
Croatian: Drugom rukom držite poklopac igle.
English: Important information about some of the ingredients of Bydureon This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially “sodium-free”.
Croatian: Važne informacije o nekim sastojcima lijeka Bydureon Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) po dozi, tj. zanemarive količine natrija.
English: Always use this medicine exactly as your doctor, pharmacist, or diabetes nurse has told you.
Croatian: Uvijek primijenite ovaj lijek točno onako kako su Vam rekli Vaš liječnik, ljekarnik ili medicinska sestra u dijabetološkoj ambulanti.
English: Prior to initiation of prolonged-release exenatide, it is strongly recommended that patients and caregivers be trained by their healthcare professional.
Croatian: Prije početka liječenja eksenatidom s produljenim oslobađanjem, izrazito se preporučuje da zdravstveni djelatnici obuče bolesnike i njegovatelje.
English: 2 Connecting the parts 3 Mixing the medicine and filling the syringe 4 Injecting the medicine
Croatian: Spajanje dijelova 3. Miješanje lijeka i punjenje štrcaljke 4. Injiciranje lijeka
English: See the Common Questions & Answers for what to do if you do not see the orange rod in the window after injection.
Croatian: Pogledajte dio s čestim pitanjima i odgovorima za upute o tome što učiniti ako se nakon injekcije u prozorčiću ne pojavi narančasti klip.
English: If pancreatitis is suspected, the use of this medicinal product should be discontinued; if acute pancreatitis is confirmed, it should not be restarted.
Croatian: Sumnja li se na pankreatitis, treba prekinuti primjenu ovog lijeka; ako je potvrđen akutni pankreatitis, ne smije se ponovo početi primjenjivati.
English: It is normal to see a few drops of medicine inside the orange cap after you unscrew it.
Croatian: Normalno je da u narančastom zatvaraču bude nekoliko kapljica lijeka kada ga skinete.
English: Weight loss was sustained over 7 years in these patients.
Croatian: U tih bolesnika, gubitak tjelesne težine je bio održan tijekom 7 godina.
English: Rapid weight loss
Croatian: Nagli gubitak težine
English: Powder: white to off-white powder.
Croatian: Prašak: bijeli do bjelkasti prašak.
English: Across 12 studies of prolonged-release exenatide most episodes (99.9% n = 649) of hypoglycaemia were minor, and resolved with oral administration of carbohydrate.
Croatian: U 12 je studija eksenatida s produljenim oslobađanjem većina epizoda (99,9% n=649) hipoglikemije bila manja, i povukla se peroralnom primjenom ugljikohidrata.
English: - If you have severe problems with your stomach emptying (including gastroparesis) or food digestion, as the use of this medicine is not recommended.
Croatian: - Ako imate teških problema s pražnjenjem želuca (uključujući gastroparezu) ili probavom hrane, jer se primjena ovog lijeka ne preporučuje.
English: The mean HbA1c was 8.1%.
Croatian: Srednja vrijednost HbA1c iznosila je 8,1%.
English: This will help you get the correct dose of medicine.
Croatian: To će vam pomoći da primijenite točnu dozu lijeka.
English: What you need to know before you use Bydureon
Croatian: Što morate znati prije nego počnete primjenjivati Bydureon
English: Exenatide is cleared primarily by the kidney; therefore hepatic dysfunction is not expected to affect blood concentrations of exenatide.
Croatian: Eksenatid se primarno odstranjuje putem bubrega; stoga se ne očekuje da će disfunkcija jetre utjecati na koncentracije eksenatida u krvi.
English: After removing the needle, look for the orange rod in the window as a way to tell that the dose has been given.
Croatian: Nakon što izvučete iglu, pogledajte je li se u prozorčiću pojavio narančasti klip, koji je znak da je doza primijenjena.
English: Mixing the medicine and filling the syringe
Croatian: Miješanje lijeka i punjenje štrcaljke
English: Digoxin and lisinopril
Croatian: Digoksin i lizinopril
English: The most frequent adverse reactions were mainly gastrointestinal related (nausea which was the most frequent reaction and associated with the initiation of treatment and decreased over time, and diarrhoea).
Croatian: Najčešće nuspojave uglavnom su bile vezane uz gastrointestinalni trakt (mučnina koja je bila najčešća nuspojava i povezivala se s početkom liječenja te se smanjivala tijekom vremena, i proljev).
English: Press the injection button with your thumb until you hear a click.
Croatian: Palcem pritišćite gumb za injiciranje sve dok ne čujete klik.
English: Only unlock the pen when you are ready to inject.
Croatian: Otključajte brizgalicu tek kada budete spremni injicirati lijek.
English: Plasma/serum glucose
Croatian: Glukoza u plazmi/serumu
English: Prolonged-release exenatide did not increase the cardiovascular risk in patients with type 2 diabetes mellitus compared to placebo when added to current usual care (HR:0.91; 95% CI: 0.832, 1.004; P<0.001 for non-inferiority) see Figure1.
Croatian: U usporedbi s placebom, eksenatid s produljenim oslobađanjem nije povećao kardiovaskularni rizik u bolesnika sa šećernom bolešću tipa 2 kad se primjenjivao kao dodatak trenutnom standardnom liječenju (HR: 0,91; 95% CI: 0,832; 1,004; P < 0,001 za neinferiornost) (vidjeti Sliku 1).
English: CV-related death
Croatian: Smrt zbog KV uzroka
English: Air bubbles in syringe
Croatian: Mjehuriće zraka u štrcaljki
English: Prolonged-release exenatide in combination with basal insulin showed no clinically significant differences in the incidence of hypoglycaemic episodes compared to insulin.
Croatian: Eksenatid s produljenim oslobađanjem u kombinaciji s bazalnim inzulinom nije pokazao klinički značajne razlike u incidenciji hipoglikemijskih epizoda u usporedbi s inzulinom.
English: • nausea (nausea is most common when starting this medicine, but decreases over time in most patients)
Croatian: • mučnina (mučnina je najčešća u početku liječenja ovim lijekom, a u većine se bolesnika smanjuje s vremenom)
English: There is little experience with this medicine in patients with kidney problems.
Croatian: Malo je iskustva s primjenom ovog lijeka u bolesnika s bubrežnim tegobama.
English: Placebo n (%)
Croatian: Placebo n (% Stopa događaja n (%)
English: Bydureon BCise pen should be stored as follows:
Croatian: Bydureon BCise brizgalicu treba čuvati na sljedeći način:
English: Overall, the level of glycaemic control (HbA1c) was comparable to that observed in those without antibody titres.
Croatian: Ukupno je razina kontrole glikemije (HbA1c) bila usporediva s onim opaženim u bolesnika koji nisu imali titar protutijela.
English: The suspension must be mixed by shaking hard for at least 15 seconds.
Croatian: Suspenzija se mora promiješati žustrim protresanjem tijekom najmanje 15 sekundi.
English: After you lift the pen from your skin, the green shield will move back up to lock over the needle.
Croatian: Kada podignete brizgalicu s kože, zeleni zaštitni pokrov pomaknut će se i ponovno prekriti iglu.
English: The day of weekly administration can be changed if necessary as long as the last dose was administered at least three days before.
Croatian: Ako je potrebno, može se promijeniti dan primjene lijeka, pod uvjetom da je posljednja doza primijenjena barem tri dana prije.
English: Have what you need ready in order to safely dispose of used needles and syringes.
Croatian: Pripremite sve što Vam je potrebno kako biste na siguran način odložili upotrijebljene igle i štrcaljke.
English: The reductions in body weight were sustained at Week 52.
Croatian: Smanjenja tjelesne težine održala su se do 52. tjedna.
English: The results of a study using paracetamol as a marker of gastric emptying suggest that the effect of prolonged-release exenatide to slow gastric emptying is minor and not expected to cause clinically significant reductions in the rate and extent of absorption of concomitantly administered oral medicinal products.
Croatian: Rezultati ispitivanja u kojemu se paracetamol koristio kao pokazatelj pražnjenja želuca ukazuju na to da je učinak eksenatida s produljenim oslobađanjem na usporavanje želučanog pražnjenja neznatan i ne očekuje se klinički značajno smanjenje brzine i opsega apsorpcije istodobno primijenjenih peroralnih lijekova.
English: Shake for at least 15 seconds.
Croatian: Tresite brizgalicu najmanje 15 sekundi.
English: − Needle is hidden.
Croatian: Igla je skrivena.
English: ACS=acute coronary syndrome; CI=confidence interval; CV=cardiovascular; HF=heart failure; HR=hazard ratio; MACE=major adverse cardiac event; MI=myocardial infarction; n=number of patients with an event; N=number of patients in treatment group.
Croatian: AKS, akutni koronarni sindrom; CI, interval pouzdanosti; HR, omjer hazarda; KV, kardiovaskularni; MACE, veliki kardiovaskularni štetni događaj; n, broj bolesnika s događajem; N, broj bolesnika u liječenoj skupini.
English: The use of this medicinal product does not require additional self-monitoring.
Croatian: Primjena ovog lijeka ne zahtijeva dodatnu samokontrolu glikemije.
English: Table 1: Adverse reactions of prolonged-release exenatide identified from clinical studies and spontaneous reports
Croatian: Tablica 1: Nuspojave eksenatida s produljenim oslobađanjem identificirane u kliničkim ispitivanjima i spontanim prijavama
English: In 30-week placebo-controlled clinical studies with immediate-release exenatide, concomitant use of exenatide and HMG CoA reductase inhibitors was not associated with consistent changes in lipid profiles (see section 5.1).
Croatian: U 30-tjednim placebom kontroliranim kliničkim ispitivanjima eksenatida s trenutnim oslobađanjem, istodobna primjena eksenatida i inhibitora HMG KoA reduktaze nije bila povezana s konzistentnim promjenama lipidnih profila (vidjeti dio 5.1).
English: How do I know if I injected my full dose?
Croatian: Kako ću znati jesam li injicirao cijelu dozu?
English: Concomitant medicinal products included angiotensin converting enzymes inhibitors, angiotensin-II antagonists, non-steroidal anti-inflammatory medicinal products and diuretics.
Croatian: Istodobno primijenjeni lijekovi uključivali su inhibitore angiotenzin konvertirajućih enzima, antagoniste angiotenzina II, nesteroidne protuupalne lijekove i diuretike.
English: Figure 2: Forest Plot: Analysis of Primary and Secondary Endpoints (intent to treat patients)
Croatian: Slika 2: Grafikon raspona pouzdanosti: Analiza primarnih i sekundarnih mjera ishoda (bolesnici predviđeni za liječenje)
English: While holding the pen upright with the needle cover uppermost, twist the knob anticlockwise until the orange label disappears and the injection button is released.
Croatian: Držeći brizgalicu uspravno sa zatvaračem igle na vrhu, okrećite kotačić u smjeru suprotnom od kazaljke na satu sve dok narančasta naljepnica ne nestane i dok se ne oslobodi gumb za injiciranje.
English: Prolonged-release exenatide has not been studied in patients with severe gastrointestinal disease, including gastroparesis.
Croatian: Eksenatid s produljenim oslobađanjem se nije ispitivao u bolesnika s teškom gastrointestinalnom bolešću, uključujući gastroparezu.
English: How do I know that the medicine is mixed well?
Croatian: Kako ću znati da je lijek dobro pomiješan?
English: No pharmacokinetic study has been performed in patients with hepatic insufficiency.
Croatian: Nisu provedena farmakokinetička ispitivanja u bolesnika s insuficijencijom jetre.
English: Hold Upright
Croatian: Držite uspravno
English: The risk of hypoglycaemia was increased when prolonged-release exenatide was used in combination with a sulphonylurea in clinical studies.
Croatian: Rizik od hipoglikemije bio je povećan kada se eksenatid s produljenim oslobađanjem u kliničkim ispitivanjima primjenjivao u kombinaciji sa sulfonilurejom.
English: Each pen can only be used by one person and is for single use.
Croatian: Svaku brizgalicu smije koristiti samo jedna osoba i namijenjena je za jednokratnu uporabu.
English: If you still cannot push the button all the way in, remove the needle from your skin.
Croatian: Ako ni tada ne možete pritisnuti gumb do kraja, izvadite iglu iz kože.
English: One study was of 24 weeks in duration (n = 252) and the other of 30 weeks (n = 295) followed by an open-labelled extension where all patients were treated with prolonged-release exenatide 2 mg once weekly for a further 7 years (n = 258).
Croatian: Jedno je ispitivanje trajalo 24 tjedna (n=252), a drugo 30 tjedana (n=295), nakon čega je slijedio otvoreni produžetak ispitivanja u kojem su svi bolesnici liječeni eksenatidom s produljenim oslobađanjem u dozi od 2 mg jednom tjedno tijekom narednih 7 godina (n=258).
English: In the 4 comparator-controlled studies, the proportion of patients who had both a reduction in weight and HbA1c ranged from 70 to 79% (the proportion of patients who had a reduction of HbA1c ranged from 88 to 96%).
Croatian: U 4 ispitivanja kontrolirana usporednim lijekom, udio bolesnika u koji su imali i smanjenje tjelesne težine i sniženje razine HbA1c kretao se u rasponu od 70 do 79% (udio bolesnika koji su imali smanjenje HbA1c kretao se u rasponu od 88% do 96%).
English: After the suspension is fully mixed, the preparation steps must be completed immediately and the suspension injected subcutaneously.
Croatian: Nakon što se suspenzija potpuno pomiješa, odmah treba dovršiti pripremne korake i supkutano je injicirati.
English: Each carton also contains one spare needle.
Croatian: Svaka kutija sadrži i jednu rezervnu iglu.
English: The solvent should be visually inspected prior to use.
Croatian: Otapalo se prije uporabe mora vizualno provjeriti.