FrancophonIA/ELRC3.0 huggingface dataset:
English: These injection site reactions were generally mild and usually did not lead to withdrawal from studies.
Croatian: Ove reakcije na mjestu injekcije uglavnom su bile blage i obično nisu vodile do prekida sudjelovanja u ispitivanju.
English: In both studies, decreases in HbA1c were evident in both treatment groups as early as the first post-treatment HbA1c measurement (Weeks 4 or
Croatian: U oba ispitivanja smanjenja HbA1c bila su očita u obje liječene skupine već prilikom prvog mjerenja HbA1c nakon primjene liječenja (tjedni 4 ili 6).
English: The vital status was known at the end of the study for 98.9% and 98.8% of the patients in the prolonged-release exenatide and placebo group, respectively.
Croatian: Na kraju je ispitivanja vitalni status bio poznat za 98,9% bolesnika liječenih eksenatidom s produljenim oslobađanjem i za 98,8% onih koji su primali placebo.
English: For prolonged-release exenatide treated patients, the incidence of potentially immunogenic injection site reactions (most commonly pruritus with or without erythema) during the 30-week and the two 26-week studies was 9%.
Croatian: U bolesnika liječenih eksenatidom s produljenim oslobađanjem incidencija potencijalno imunogenih reakcija na mjestu injekcije (najčešće pruritus s eritemom ili bez njega) tijekom 30-tjednog i dva 26tjedna ispitivanja bila je 9%.
English: Myocardial Infarction
Croatian: Infarkt miokarda
English: During the controlled period of the clinical studies, injection site reactions were observed more frequently in patients treated with Bydureon BCise versus comparator-treated patients (24% versus 4% with immediate-release exenatide).
Croatian: Tijekom kontroliranog razdoblja kliničkih ispitivanja reakcije na mjestu injekcije opažene su češće u bolesnika liječenih lijekom Bydureon BCise nego u bolesnika koji su primali usporedni lijek (24% naspram 4% kod eksenatida s trenutnim oslobađanjem).
English: After shaking the pen, look through both sides of the window.
Croatian: Nakon što protresete brizgalicu, pogledajte kroz obje strane prozorčića.
English: Injection site reactions were observed more frequently in prolonged-release exenatide treated patients versus comparator-treated patients (16% versus range of 2-7%) during the 6-month controlled phase of studies.
Croatian: Reakcije na mjestu injekcije opažene su češće u bolesnika liječenih eksenatidom s produljenim oslobađanjem naspram bolesnika koji su primali usporedni lijek (16% naspram raspona od 2-7%) tijekom 6-mjesečne kontrolirane faze ispitivanja.
English: Paracetamol Cmax decreased by 16% (fasting) and5 % (fed) and tmax was increased from approximately 1 hour in the control period to 1.4 hours (fasting) and 1.3 hours (fed).
Croatian: Cmax paracetamola smanjen je za 16% (natašte) odnosno 5% (nakon obroka), a tmax se povećao s otprilike 1 sat u kontrolnom razdoblju na 1,4 sata (natašte) odnosno 1,3 sata (nakon obroka).
English: Due to the long washout period of prolonged-release exenatide, women of childbearing potential should use contraception during treatment with prolonged-release exenatide.
Croatian: S obzirom na dug period ispiranja eksenatida s produljenim oslobađanjem iz organizma, žene reproduktivne dobi moraju koristiti kontracepciju tijekom liječenja eksenatidom s produljenim oslobađanjem.
English: • Push the pen against your skin.
Croatian: • Pritisnite brizgalicu na kožu.
English: If the orange rod does not appear, contact the local representative of the Marketing Authorisation Holder (see section 6 of the Package Leaflet for a list of contacts by country).
Croatian: Ako se narančasti klip nije pojavio, obratite se lokalnom predstavniku nositelja odobrenja za stavljanje lijeka u promet (pogledajte dio 6. upute o lijeku za popis kontaktnih podataka po zemljama).
English: There are no adequate data from the use of prolonged-release exenatide in pregnant women.
Croatian: Nema odgovarajućih podataka o primjeni eksenatida s produljenim oslobađanjem u trudnica.
English: Green label
Croatian: Zelena naljepnica
English: Increased heart rate
Croatian: Povećanje srčane frekvencije
English: The single-dose kit has a spare needle (not shown) in case you need it.
Croatian: Jednodozni set sadrži rezervnu iglu (nije prikazana), za slučaj potrebe bijeli zatvarač
English: If you don't see clumps you are ready to inject.
Croatian: Ako ne vidite grudice, lijek je spreman za injiciranje.
English: Steady-state exenatide concentrations are maintained during the one-week interval between doses with minimal peak to trough fluctuation from this average therapeutic concentration.
Croatian: Stanje dinamičke ravnoteže koncentracija eksenatida održava se tijekom intervala od jednog tjedna između doza, uz minimalne fluktuacije najviše i najniže koncentracije u odnosu na ovu prosječnu terapijsku koncentraciju.
English: In addition, injection site reactions (pruritus, nodules, erythema), hypoglycaemia (with a sulphonylurea), and headache occurred.
Croatian: Osim toga, javljale su se reakcije na mjestu injekcije (svrbež, noduli, eritem), hipoglikemija (sa sulfonilurejom) i glavobolja.
English: If you do not inject your dose right away, small clumps of medicine may form in the pen and you may not get your full dose.
Croatian: Ako dozu ne injicirate odmah, u brizgalici se mogu stvoriti sitne grudice lijeka pa možda nećete primiti cijelu dozu.
English: INSTRUCTIONS FOR THE USER Read these instructions carefully before use Read also the Package Leaflet in your carton
Croatian: Prije uporabe pažljivo pročitajte ove upute Također pročitajte Uputu o lijeku koja se nalazi u kutiji
English: In a proportion of these the glycaemic response to prolonged-release exenatide was absent at the end of the controlled period of studies; 2.6% of patients showed no glucose improvement with higher titre antibodies whereas 1.6% showed no improvement while antibody negative.
Croatian: U jednog dijela tih bolesnika je na kraju kontroliranog dijela ispitivanja izostao glikemijski odgovor na eksenatid s produljenim oslobađanjem; 2,6% bolesnika nije pokazalo poboljšanje razine glukoze uz viši titar protutijela, dok 1,6% bolesnika nije imalo poboljšanje razine glukoze uz negativan nalaz protutijela.
English: You do not have to save any parts.
Croatian: Ne trebate čuvati dijelove seta.
English: The medicine can still be fully mixed but it will take more shaking and more time.
Croatian: On se i dalje može pravilno promiješati, ali ga treba snažnije i dulje tresti.
English: Rate based on prolonged-release exenatide spontaneous reports data (unknown denominator).
Croatian: Stopa na temelju podataka iz spontanih prijava za eksenatid s produljenim oslobađanjem (nepoznati nazivnik).
English: The solvent should only be used if it is clear and free of particulate matter.
Croatian: Otapalo se smije koristiti samo ako je bistro i ne sadrži čestice.
English: Treatment with prolonged-release exenatide and dapagliflozin combination at Week 28 resulted in a significant mean change reduction of -4.3±0.8 mmHg in systolic blood pressure compared to prolonged-release exenatide alone of -1.2±0.8 mmHg (p<0.01) or to dapagliflozin alone of -1.8±0.8 mmHg (p<0.05).
Croatian: Kombinirano liječenje eksenatidom s produljenim oslobađanjem i dapagliflozinom rezultiralo je značajno većim smanjenjem sistoličkog krvnog tlaka od -4,3±0,8 mmHg u 28. tjednu u usporedbi sa smanjenjem kod samog eksenatida s produljenim oslobađanjem od -1,2±0,8 mmHg (p<0,01) ili kod samog dapagliflozina od -1,8±0,8 mmHg (p<0,05).
English: N=number of patients in each treatment group, SE = standard error, CI= confidence interval, *p-value <0.001 (adjusted for multiplicity).
Croatian: N=broj bolesnika u svakoj liječenoj skupini, SE=standardna pogreška, CI=interval pouzdanosti, *p-vrijednost <0,001 (prilagođeno za multiplicitet).
English: In clinical studies of Bydureon BCise, acute pancreatitis occurred in 0.4% of patients.
Croatian: U kliničkim ispitivanjima lijeka Bydureon BCise, akutni pankreatitis pojavio se u 0,4% bolesnika.
English: - If you have severe kidney disease or you are on dialysis, as the use of this medicine is not recommended.
Croatian: - Ako imate tešku bolest bubrega ili ako ste na dijalizi, jer se primjena ovog lijeka ne preporučuje.
English: Not known (frequency cannot be estimated from the available data) In addition some other side effects have been reported .
Croatian: Nuspojave nepoznate učestalosti (učestalost se ne može procijeniti iz dostupnih podataka) Dodatno, prijavljene su neke druge nuspojave.
English: -Placebo favored->
Croatian: -U korist placeba->
English: Powder poly (D,L-lactide-co-glycolide) sucrose
Croatian: Prašak poli(D,L-laktid-ko-glikolid) saharoza
English: No pharmacokinetics study of prolonged-release exenatide has been conducted in the paediatric population.
Croatian: Nisu provedena farmakokinetička ispitivanja eksenatida s produljenim oslobađanjem u pedijatrijskoj populaciji.
English: The incidence of hypoglycaemia was increased when prolonged-release exenatide was used in combination with a sulphonylurea (24.0% versus 5.4%) (see section 4.4).
Croatian: Incidencija hipoglikemije je bila povećana kada se eksenatid s produljenim oslobađanjem primjenjivao u kombinaciji sa sulfonilurejom (24,0% naspram 5,4%) (vidjeti dio 4.4).
English: Sulphonylureas
Croatian: Sulfonilureja
English: • Tap the prefilled pen firmly until a uniformly cloudy suspension with no clumps is obtained.
Croatian: • Čvrsto lupkajte napunjenom brizgalicom sve dok ne dobijete jednoliko mutnu suspenziju bez grudica.
English: The results of two studies with Bydureon BCise and six long-term clinical studies of prolonged-release exenatide are presented below; these studies comprised 1766 subjects (556 treated with Bydureon BCise), 53% men and 47% women, 304 subjects (17%) were ≥ 65 years of age.
Croatian: Rezultati dvaju ispitivanja lijeka Bydureon BCise i šest dugotrajnih kliničkih ispitivanja eksenatida s produljenim oslobađanjem prikazani su u nastavku; ovim je ispitivanjima obuhvaćeno 1766 ispitanika (556 liječenih lijekom Bydureon BCise), od čega 53% muškaraca i 47% žena; 304 ispitanika (17%) imala su ≥65 godina.
English: CLICK!
Croatian: KLIK!
English: Holding the pen with the orange cap straight up helps prevent the medicine from leaking.
Croatian: Držanje brizgalice s narančastim zatvaračem usmjerenim prema gore pomaže spriječiti istjecanje lijeka.
English: If a dose is missed, it should be administered as soon as practical, provided the next regularly scheduled dose is due in 3 days or more.
Croatian: Ako se propusti doza, treba je primijeniti što je prije praktično moguće, pod uvjetom da je do sljedeće redovite doze preostalo 3 dana ili više.
English: Dapagliflozin 10 mg QD
Croatian: Dapagliflozin 10 mg jedanput dnevno
English: Blood glucose self-monitoring is necessary to adjust the dose of sulphonylurea and of insulin, particularly when prolonged-release exenatide therapy is started and insulin is reduced.
Croatian: Samokontrola razine glukoze u krvi nužna je radi prilagođavanja doze sulfonilureje ili inzulina, posebice ako je započeta terapija eksenatidom s produljenim oslobađanjem, a inzulin je smanjen.
English: Severe allergic reactions (anaphylaxis) have been reported rarely (may affect up to 1 in 1,000 people).
Croatian: Prijavljene su teške alergijske reakcije (anafilaksija) (rijetko) (mogu se javiti u do 1 na 1000 osoba).
English: These reactions were less commonly observed in antibody-negative patients (4%) compared with antibody-positive patients (13%), with a greater incidence in those with higher titre antibodies.
Croatian: Te su reakcije manje često opažene u bolesnika koji su imali negativan nalaz protutijela (4%) u usporedbi s bolesnicima koji su bili pozitivni na protutijela (13%), s incidencijom većom u onih s višim titrom protutijela.
English: Most adverse reactions associated with prolonged-release exenatide were mild to moderate in intensity.
Croatian: Većina nuspojava povezanih s eksenatidom s produljenim oslobađanjem bila je blagog do umjerenog intenziteta.
English: What should I do if I have trouble attaching the needle?
Croatian: Što trebam učiniti ako imam poteškoća s pričvršćivanjem igle?
English: However, after you unlock it, you must complete the preparation steps right away and inject to get the full dose.
Croatian: Međutim, nakon što otključate brizgalicu, morate odmah dovršiti pripremne korake i injicirati lijek da biste primili cijelu dozu.
English: To be sure you get your full dose, press the injection button with your thumb until you hear a click.
Croatian: Kako biste bili sigurni da ste injicirali cijelu dozu, palcem pritišćite gumb za injiciranje sve dok ne čujete klik.
English: Table 1: Adverse reactions of Bydureon BCise identified from clinical studies
Croatian: Tablica 1: Nuspojave lijeka Bydureon BCise identificirane u kliničkim ispitivanjima
English: Fasting lipids The prolonged-release exenatide formulations have shown no negative effects on lipid parameters.
Croatian: Formulacije eksenatida s produljenim oslobađanjem nisu pokazale negativne učinke na lipidne parametre.
English: Pens stored vertically (with the needle up or down) are more difficult to mix.
Croatian: Ako se brizgalica čuva u okomitom položaju (s iglom okrenutom prema gore ili dolje), teže je promiješati lijek.
English: - The other ingredients are: poly (D,L-lactide-co-glycolide), sucrose and medium chain triglyceride.
Croatian: - Drugi sastojci su: poli(D,L-laktid-ko-glikolid), saharoza i trigliceridi srednje duljine lanca.
English: by pushing and screwing it onto the top of the pen until it is tight.
Croatian: tako što ćete je pritisnuti i čvrsto naviti na vrh brizgalice.
English: The pen contains an integrated needle.
Croatian: Brizgalica ima ugrađenu iglu.
English: NOT Mixed Well
Croatian: Nije pomiješana
English: A study of 26-week duration has been conducted, in which prolonged-release exenatide 2 mg is compared to insulin glargine once daily.
Croatian: Provedeno je ispitivanje u trajanju od 26 tjedana, u kojemu se eksenatid s produljenim oslobađanjem u dozi od 2 mg uspoređivao s inzulinom glarginom primijenjenim jednom dnevno.
English: There have been spontaneously reported events of acute pancreatitis with prolonged-release exenatide.
Croatian: Zabilježeni su spontano prijavljeni slučajevi akutnog pankreatitisa kod primjene eksenatida s produljenim oslobađanjem.
English: Remove the needle from your skin and replace it with the spare needle from the carton.
Croatian: Izvadite iglu iz kože i zamijenite je rezervnom iglom koja se nalazi u kutiji.
English: Prolonged-release exenatide should not be used during pregnancy and the use of insulin is recommended.
Croatian: Eksenatid s produljenim oslobađanjem se ne smije primjenjivati tijekom trudnoće, već se preporučuje primjena inzulina.
English: Therefore, the use of this medicinal product is not recommended in patients with severe gastrointestinal disease.
Croatian: Stoga se ne preporučuje primjena ovog lijeka u bolesnika s teškom gastrointestinalnom bolešću.
English: Furthermore, in the clinical studies, patients on a sulphonylurea combination, with mild renal impairment had an increased incidence of hypoglycaemia compared to patients with normal renal function.
Croatian: Nadalje, u kliničkim ispitivanjima u bolesnika s blagim oštećenjem bubrega, koji su primali kombinaciju sa sulfonilurejom imali su povećanu incidenciju hipoglikemije u usporedbi s bolesnicima s normalnom bubrežnom funkcijom.
English: A. Let your pen warm up.
Croatian: Pustite da se brizgalica ugrije.
English: Hold the pen up to the light and look through both sides and the bottom of the window.
Croatian: Podignite brizgalicu, usmjerite ju prema svjetlosti i pogledajte kroz obje bočne strane i donji dio prozorčića.
English: Also read the Package Leaflet in your carton.
Croatian: Pročitajte i Uputu o lijeku priloženu u kutiji.
English: You should inject this medicine immediately after mixing the suspension.
Croatian: Ovaj lijek morate injicirati odmah nakon miješanja suspenzije.
English: I'm ready to inject my dose.
Croatian: Spreman sam injicirati dozu.
English: Each kit should be used by one person only and is for single use.
Croatian: Svaki set smije koristiti samo jedna osoba i namijenjen je za jednokratnu uporabu.
English: The pen must be removed from the refrigerator for at least 15 minutes prior to injection.
Croatian: Brizgalica se mora izvaditi iz hladnjaka najmanje 15 minuta prije injiciranja.
English: The finished medicinal product is comprised of the suspension-filled cartridge assembled into the pen device.
Croatian: Gotov lijek sastoji se od uloška napunjenog suspenzijom koji je uklopljen u brizgalicu.
English: What if the device malfunctions and I cannot remove the orange cap?
Croatian: Što ako se brizgalica zaglavi i ne mogu skinuti narančasti zatvarač?
English: When used in combination with a sulphonylurea, patients should be advised to take precautions to avoid hypoglycaemia while driving and using machines.
Croatian: Kada se primjenjuje u kombinaciji sa sulfonilurejom, bolesnicima treba savjetovati da poduzmu mjere opreza kako bi izbjegli hipoglikemiju za vrijeme upravljanja vozilima i rada sa strojevima.
English: The solution should have NO CLUMPS and be uniformly cloudy.
Croatian: Otopina NE SMIJE sadržavati GRUDICE i mora biti jednoliko mutna.
English: The incidence of withdrawal due to adverse events during the 30-week controlled study was 6% for prolonged-release exenatide treated patients, 5% for immediate-release exenatide treated patients.
Croatian: Incidencija prekida liječenja zbog nuspojava tijekom 30-tjednog kontroliranog ispitivanja bila je 6% za bolesnike liječene eksenatidom s produljenim oslobađanjem, a 5% za bolesnike liječene eksenatidom s trenutnim oslobađanjem.
English: Based on hypoglycaemic events that have symptoms consistent with hypoglycaemia with a concomitant glucose value of <54 mg/dl (3 mmol/l) prior to treatment.
Croatian: Na temelju događaja hipoglikemije praćenih simptomima koji odgovaraju hipoglikemiji, uz vrijednost glukoze < 54 mg/dl (3 mmol/l) prije liječenja.
English: When the medicine is mixed well, it should look cloudy.
Croatian: Kada je lijek dobro izmiješan, treba izgledati mutno.
English: Hold the needle against your skin for 15 seconds.
Croatian: Držite iglu ubodenom u kožu 15 sekundi.
English: Placebo + Insulin glargine
Croatian: Placebo + inzulin glargin
English: A container is not included in the carton.
Croatian: Spremnik nije uključen u pakiranje.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with prolonged-release exenatide in one or more subsets of the paediatric population in type 2 diabetes mellitus (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove je odgodila obvezu podnošenja rezultata ispitivanja eksenatida s produljenim oslobađanjem u jednoj ili više podskupina pedijatrijske populacije u šećernoj bolesti tipa 2 (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni ).
English: Approximately 42% of patients developed low titre antibodies to exenatide and 32% of patients developed high titre antibodies at any time during the studies.
Croatian: U približno 42% bolesnika razvili su se niski titri protutijela na eksenatid, dok su u 32% bolesnika zabilježeni visoki titri protutijela u nekom trenutku tijekom ispitivanja.
English: How do I know if the medicine is fully mixed?
Croatian: Kako ću znati je li lijek potpuno pomiješan?
English: Removing the needle cover
Croatian: Skidanje poklopca s igle
English: - If you lose weight too quickly (more than 1.5kg 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), jer to može uzrokovati probleme poput žučnih kamenaca.
English: There have been uncommon events of altered renal function with exenatide, including increased serum creatinine, renal impairment, worsened chronic renal failure and acute renal failure, sometimes requiring haemodialysis.
Croatian: Zabilježeni su manje česti slučajevi promijenjene bubrežne funkcije s primjenom eksenatida, uključujući povišen serumski kreatinin, oštećenje bubrega, pogoršanje kroničkog zatajivanja bubrega i akutno zatajenje bubrega, zbog kojeg je ponekad bila potrebna hemodijaliza.
English: In a 28-week open-label study (oral medication-blinded), Bydureon BCise was compared to sitagliptin and placebo in subjects also using metformin ≥ 1,500 mg daily.
Croatian: U 28-tjednom otvorenom ispitivanju (uz zaslijepljenu primjenu oralnih lijekova), Bydureon BCise uspoređivao se sa sitagliptinom i placebom u ispitanika koji su primjenjivali i metformin u dozi od ≥ 1500 mg na dan.
English: When prolonged-release exenatide is added to existing metformin and/or thiazolidinedione therapy, the current dose of metformin and/or thiazolidinedione can be continued.
Croatian: Kada se eksenatid s produljenim oslobađanjem dodaje postojećoj terapiji metforminom i/ili tiazolidindionom, može se nastaviti dotadašnjom dozom metformina i/ili tiazolidindiona.
English: These reactions were less commonly observed in antibody-negative patients (16%) and patients with low titre antibodies (16%) compared with those with high titre antibodies (27%).
Croatian: Te su reakcije manje često opažene u bolesnika koji su imali negativan nalaz protutijela (16%) i onih s niskim titrom protutijela (16%) nego u bolesnika s visokim titrom protutijela (27%).
English: For instructions on the preparation of the medicinal product before administration, see section 6.6 and the “Instructions for the User”.
Croatian: Za uputu o pripremi lijeka prije primjene vidjeti dio 6.6 i „Upute za korisnika“.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with prolonged-release exenatide formulations in one or more subsets of the paediatric population in type 2 diabetes mellitus (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove je odgodila obvezu podnošenja rezultata ispitivanja formulacija eksenatida s produljenim oslobađanjem u jednoj ili više podskupina pedijatrijske populacije u šećernoj bolesti tipa 2 (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni ).
English: If you still cannot push the plunger all the way down, withdraw the needle.
Croatian: Ako i dalje ne možete potisnuti klip do kraja, izvucite iglu.
English: With one hand, hold the syringe near the black dashed Dose Line.
Croatian: Jednom rukom držite štrcaljku blizu crne isprekidane oznake doze.
English: If you stop using Bydureon
Croatian: Ako prestanete primjenjivati Bydureon
English: In addition, a double-blind, placebo-controlled cardiovascular outcome study (EXSCEL) enrolled 14,752 subjects with type 2 diabetes and any level of CV risk when added to the current usual care.
Croatian: Osim toga, provedeno je i dvostruko slijepo, placebom kontrolirano ispitivanje kardiovaskularnih ishoda (EXSCEL) u kojem se eksenatid primjenjivao kao dodatak trenutnom standardnom liječenju i koje je obuhvatilo 14 752 bolesnika sa šećernom bolešću tipa 2 i bilo kojom razinom kardiovaskularnog rizika.
English: In your other hand, hold the vial.
Croatian: U drugoj ruci držite bočicu.
English: If a different glucose-lowering treatment is started after the discontinuation of prolonged-release exenatide, consideration should be given to the prolonged release of the product (see section 5.2).
Croatian: Ako se nakon obustave eksenatida s produljenim oslobađanjem započinje primjena drugog lijeka za snižavanje glukoze, treba uzeti u obzir produljeno oslobađanje lijeka (vidjeti dio 5.2).
English: INR should be monitored during initiation of prolonged-release exenatide therapy in patients on warfarin and/or cumarol derivatives (see sections 4.4 and 4.8).
Croatian: Treba pratiti vrijednosti INR-a tijekom započinjanja terapije eksenatidom s produljenim oslobađanjem u bolesnika na varfarinu i/ili derivatima kumarola (vidjeti dio 4.8).
English: Remove the needle and replace it with the spare needle from your kit.
Croatian: Skinite iglu i zamijenite ju rezervnom iglom iz seta.