FrancophonIA/ELRC3.0 huggingface dataset:
English: These arrows show the direction to pull or turn the dose knob in the next step.
Croatian: Ove strelice pokazuju smjer u kojem treba povući ili okretati gumb za doziranje u sljedećem koraku.
English: • A small air bubble is normal.
Croatian: • Mali mjehurić zraka je uobičajen.
English: Gender and race Gender and race have no clinically relevant influence on exenatide pharmacokinetics.
Croatian: Spol i rasa Spol i rasa nemaju klinički značajnog utjecaja na farmakokinetiku eksenatida.
English: Table 2: Combined results of the 30-week placebo-controlled studies (intent to treat patients)
Croatian: Tablica 2: Kombinirani rezultati 30-tjednih placebom kontroliranih ispitivanja (svi bolesnici s namjerom liječenja)
English: In the event of overdose, appropriate supportive treatment (possibly given parenterally) should be initiated according to the patient's clinical signs and symptoms.
Croatian: U slučaju predoziranja treba započeti odgovarajuće potporno liječenje (po mogućnosti parenteralno) u skladu s bolesnikovim kliničkim znakovima i simptomima.
English: Immediate-release exenatide has shown no adverse effects on lipid parameters.
Croatian: Eksenatid s trenutnim oslobađanjem nije pokazala štetne učinke na lipidne parametre.
English: Byetta is available in pack sizes of 1 and 3 pre-filled pens.
Croatian: Byetta je dostupna u veličinama pakiranja od 1 i 3 napunjene brizgalice.
English: Instructions for use Byetta is for use by one person only.
Croatian: Upute za uporabu Lijek Byetta smije primjenjivati samo jedna osoba.
English: • When it is time for your next routine dose, go to Section 3, Step 1, and repeat Steps 1 -7.
Croatian: • Kada dođe vrijeme za Vašu sljedeću redovnu dozu, idite na Dio 3., Korak 1., i ponovite Korake 1 - 7.
English: This medicine may reduce your appetite, the amount of food you eat, and your weight.
Croatian: Ovaj lijek može smanjiti tek, količinu hrane koju jedete kao i tjelesnu težinu.
English: If the cartridge contains a small amount or looks empty, obtain a new Byetta pen.
Croatian: Ako uložak sadrži malu količinu lijeka ili se čini da je prazan, nabavite novu Byetta brizgalicu.
English: - If you are allergic to exenatide or any of the other ingredients of this medicine (listed in section 6).
Croatian: - ako ste alergični na eksenatid ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: Read this section completely before you begin.
Croatian: Pročitajte ovaj dio u cijelosti prije nego započnete s uporabom.
English: Severe allergic reactions (anaphylaxis) have been reported rarely (may affect up to 1 in 1,000 people).
Croatian: Teške alergijske reakcije (anafilaksija) prijavljene su rijetko (mogu se javiti u do 1 na 1000 osoba).
English: • STOP taking this medicineand 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 osjetite jaku i ustrajnu bol u trbuhu, s povraćanjem ili bez njega, jer biste mogli imati upalu gušterače (pankreatitis).
English: Overall, the percentage of antibody positive patients was consistent across clinical trials.
Croatian: U cjelini, postotak bolesnika pozitivnih na protutijela bio je podjednak u svim kliničkim ispitivanjima.
English: Do not use Byetta if it has been frozen.
Croatian: Ne koristite lijek Byetta ako bilo zamrznut.
English: • nausea, (nausea is most common when first 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: Changes in LDL-C or total cholesterol are possible, however, no predetermined dose adjustment is required.
Croatian: Promjene LDL ili ukupnog kolesterola su moguće, međutim, nije potrebna unaprijed utvrđena prilagodba doze.
English: What Byetta looks like and contents of the pack
Croatian: Kako Byetta izgleda i sadržaj pakiranja
English: If you are having problems using your Byetta pen, contact your healthcare professional.
Croatian: Ako imate poteškoća s uporabom Byetta brizgalice, obratite se svom zdravstvenom radniku.
English: Metformin or sulphonylureas
Croatian: Metformin ili sulfonilureja
English: There was no tumorigenic response in male rats or either sex of mice.
Croatian: Nije opažen tumorogeni odgovor kod mužjaka štakora niti kod miševa oba spola.
English: There have been spontaneously reported events of acute pancreatitis with exenatide.
Croatian: Spontano su prijavljeni događaji akutnog pankreatitisa sa eksenatidom.
English: • itching (with or without rash)
Croatian: • svrbež (sa ili bez osipa)
English: • If any part of your pen appears broken or damaged, do not use the pen.
Croatian: • Ako Vam se čini da je neki dio brizgalice slomljen ili oštećen, nemojte je koristiti.
English: Solution for injection 1 pen (60 doses) 3 pens (3 x 60 doses)
Croatian: Otopina za injekciju 1 brizgalica (60 doza) 3 brizgalice (3 x 60 doza)
English: What should I do if Byetta does not come out of the needle tip after four tries during New Pen Setup?
Croatian: Što trebam učiniti ako Byetta ne izlazi iz vrha igle nakon 4 pokušaja tijekom Podešavanja nove brizgalice?
English: No clinically relevant effects on Cmax or AUC were observed.
Croatian: Nisu zabilježeni klinički značajni učinci na Cmax ni AUC.
English: • Swelling of theface, tongue or throat(angioedema)
Croatian: • oticanje lica, jezika ili grla (angioedem)
English: Do not repeat Section 2 for routine use, if you do, you will run out of Byetta before 30 days of use.
Croatian: Ne ponavljajte korake u Dijelu 2. kod redovite uporabe, jer će Vam, ako to učinite, ponestati lijeka Byetta prije isteka 30 dana uporabe.
English: • If needed, wipe the outside of the pen with a clean, damp cloth.
Croatian: • Ako je potrebno, prebrišite vanjski dio brizgalice čistom, vlažnom krpom.
English: In addition some other side effects have been reported (frequency not known, cannot be estimated from the available data).
Croatian: Osim navedenih, prijavljene su i neke druge nuspojave (učestalost im je nepoznata, tj. ne može se procijeniti iz dostupnih podataka).
English: • Do not share your pen or needles as this may risk transmission of infectious agents.
Croatian: • Nemojte dijeliti svoju brizgalicu niti igle s drugim osobama jer to nosi rizik od prijenosa zaraznih čestica.
English: • Tell your doctorif 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 vrijednosti triglicerida.
English: If you stop using this medicine this can affect your blood sugar levels.
Croatian: Prestanak primjene ovog lijeka može utjecati na razinu šećera u krvi.
English: If pancreatitis is suspected, exenatide should be discontinued; if acute pancreatitis is confirmed, exenatide should not be restarted.
Croatian: Posumnja li se na pankreatitis, treba prekinuti primjenu eksenatida; ako je potvrđen akutni pankreatitis, eksenatid se ne smije ponovo početi primjenjivati.
English: Exenatide is not a substitute for insulin.
Croatian: Eksenatid nije zamjena za inzulin.
English: If is in the dose window:
Croatian: Ako je u prozorčiću za doziranje :
English: However, exenatide does not impair the normal glucagon response and other hormone responses to hypoglycaemia.
Croatian: Međutim, eksenatid ne umanjuje normalan odgovor glukagona i drugih hormona na hipoglikemiju.
English: An additional 6% of patients had higher titre antibodies at 30 weeks.
Croatian: Dodatnih 6% bolesnika imalo je viši titar protutijela u 30. tjednu.
English: Pancreatitis can be a serious, potentially life-threatening medical condition.
Croatian: Pankreatitis može biti ozbiljna bolest koja može biti opasna po život.
English: These medical conditions can increase your chance of getting pancreatitis, or getting it again, whether or not you are taking this medicine.
Croatian: Ova medicinska stanja mogu povećati rizik od pankreatitisa, odnosno ponovne pojave pankreatitisa, bez obzira uzimate li ovaj lijek ili ne.
English: NEW PEN SETUP - DO THIS ONE TIME ONLY
Croatian: PODEŠAVANJE NOVE BRIZGALICE - UČINITE OVO SAMO JEDANPUT
English: About half of this 6% (3% of the total patients given immediate-release exenatide in the controlled studies), had no apparent glycaemic response to immediate-release exenatide.
Croatian: Približno polovica od tih 6% (3% ukupnog broja bolesnika koji su primili eksenatid s trenutnim oslobađanjem u kontroliranim ispitivanjima) nije imala vidljiv glikemijski odgovor na trenutno oslobađajući eksenatid.
English: For routine use, do not repeat the New Pen Setup.
Croatian: Prilikom redovite uporabe nemojte ponavljati korake za podešavanje nove brizgalice.
English: You may remove them with an alcohol wipe or alcohol swab.
Croatian: Možete ih ukloniti rupčićem ili vatom natopljenom alkoholom.
English: Do not use this medicine after your meal.
Croatian: Ne smijete primijeniti ovaj lijek nakon obroka.
English: • Attach a new needle and repeat New Pen Setup, Steps B - E, in Section 2 of this user manual.
Croatian: • Pričvrstite novu iglu i ponovite Podešavanje nove brizgalice, Korake B-E, u Dijelu 2. ovih Uputa za uporabu.
English: 4.7 Effects on ability to drive and use machines
Croatian: 4.7 Učinci na sposobnost upravljanja vozilima i rada sa strojevima
English: Date of first use Date to throw away pen
Croatian: Datum prve uporabe Datum kada brizgalicu treba baciti u otpad
English: 60 doses (2.4 ml)
Croatian: 60 doza (2,4 ml)
English: Now that you have done the New Pen Setup, follow Section 3 for all of your injections.
Croatian: Sada kada ste dovršili podešavanje nove brizgalice, slijedite upute u Dijelu 3. za svaku injekciju.
English: In most patients who develop antibodies, antibody titres diminish over time and remain low through 82 weeks.
Croatian: U većine bolesnika koji razviju protutijela, razina titra se tijekom vremena smanjuje te ostaje niska tijekom 82 tjedna.
English: Byetta is not an insulin and should therefore not be used as a substitute for insulin.
Croatian: Lijek Byetta nije inzulin te se stoga ne smije koristiti kao zamjena za inzulin.
English: Byetta with food
Croatian: Byetta s hranom
English: The active substance in this medicine slows stomach emptying so food passes more slowly through your stomach.
Croatian: Djelatna tvar ovog lijeka usporava pražnjene želuca, pa hrana sporije prolazi kroz želudac.
English: • If you do not see a stream or several drops come from the needle tip, repeat Steps C & D.
Croatian: • Ako iz vrha igle ne izađe mlaz ili nekoliko kapi, ponovite korake C i D.
English: How long can I use a Byetta pen?
Croatian: Koliko dugo mogu koristiti Byetta brizgalicu?
English: • Changes in INR (measurement of blood thinning) have been reported when used together with warfarin.
Croatian: • promjene vrijednosti INR-a (mjerilo zgrušavanja krvi) prijavljene su kada je lijek primijenjen zajedno s varfarinom.
English: Long-term controlled 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 osobama iz dugoročnih kontroliranih ispitivanja podaci su malobrojni, no ne ukazuju na izrazite promjene u izloženosti eksenatidu s povećanjem dobi do približno 75 godina.
English: The small amount of Byetta used in the New Pen Setup will not affect the 30-day supply of Byetta.
Croatian: Mala količina lijeka Byetta iskorištena prilikom podešavanja nove brizgalice neće utjecati na 30-dnevnu zalihu lijeka Byetta.
English: If you are over 70 years old or have problems with your kidneys it may take longer than 30 days to tolerate the Byetta 5 micrograms dose and so your doctor may not increase your dose.
Croatian: Ako ste stariji od 70 godina ili imate tegoba s bubrezima, možda će Vam trebati više od 30 dana da počnete dobro podnositi dozu lijeka Byetta od 5 mikrograma te Vam liječnik možda neće povećati dozu.
English: Resolution of pancreatitis has been observed with supportive treatment but very rare cases of necrotising or hemorrhagic pancreatitis and/or death have been reported.
Croatian: Opaženo je da uz potporno liječenje dolazi do povlačenja pankreatitisa, ali su prijavljeni vrlo rijetki slučajevi nekrotizirajućeg ili hemoragičnog pankreatitsa i/ili smrti.
English: EXP Discard pen 30 days after first use.
Croatian: EXP Brizgalicu baciti 30 dana nakon prve uporabe.
English: You will not need to test your sugar levels on a day-by-day basis to set the dose of Byetta.
Croatian: Nećete morati svakodnevno kontrolirati razinu šećera u krvi kako biste odredili dozu lijeka Byetta.
English: Detailed information on this medicine is available on the European Medicines Agency web site: 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: Do I need to do the New Pen Setup before every dose?
Croatian: Moram li izvršiti Podešavanje nove brizgalice prije svake doze?
English: STEP 4 Inject the Dose
Croatian: KORAK 4. Injicirajte dozu
English: The most frequently reported single adverse reaction was nausea which was associated with the initiation of treatment and decreased over time.
Croatian: Najčešće prijavljena pojedinačna nuspojava bila je mučnina koja se povezivala s početkom liječenja i smanjivala tijekom vremena.
English: These reactions have usually been mild and usually did not result in discontinuation of immediate-release exenatide.
Croatian: Te su reakcije obično bile blage i uglavnom nisu dovele do obustave liječenja eksenatidom s trenutnim oslobađanjem.
English: Injection site reactions have been reported in approximately 5.1% of subjects receiving immediate-release exenatide in long-term (16 weeks or longer) controlled trials.
Croatian: Reakcije na mjestu injekcije prijavljene su u približno 5,1% ispitanika koji su primali eksenatid s trenutnim oslobađanjem u dugoročnim (16 tjedana ili dulje) kontroliranim ispitivanjima.
English: Nonclinical studies have shown that exenatide is predominantly eliminated by glomerular filtration with subsequent proteolytic degradation.
Croatian: Neklinička istraživanja pokazala su da se eksenatid uglavnom eliminira glomerularnom filtracijom s naknadnom proteolitičkom razgradnjom.
English: Check the symbol in the dose window.
Croatian: Provjerite simbol u prozorčiću za doziranje.
English: Note: This needs to be done after each injection
Croatian: Ovo je potrebno napraviti nakon svake injekcije.
English: • This pen is not recommended for use by people who are blind or who cannot see well enough.
Croatian: • Uporaba ove brizgalice ne preporučuje se slijepim i slabovidnim osobama.
English: 60 doses (1.2 ml)
Croatian: 60 doza (1,2 ml)
English: − For tablets that you need to take with food, it may be best if they are taken at a meal at a time when this medicine is not being administered.
Croatian: - Tablete koje morate uzimati s hranom je možda najbolje uzimati uz onaj obrok uz koji ne primjenjujete ovaj lijek.
English: You need to use the pen correctly in order to get the most benefit from Byetta.
Croatian: Brizgalicu morate upotrebljavati na pravilan način kako biste imali najviše koristi od lijeka Byetta.
English: Paracetamol was used as a model medicinal product to evaluate the effect of exenatide on gastric emptying.
Croatian: Paracetamol se koristio kao modelni lijek za procjenu učinka eksenatida na pražnjenje želuca.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with immediate-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 trenutnim oslobađanjem u jednoj ili više podskupina pedijatrijske populacije u šećernoj bolesti tipa 2 (vidjeti dio 4.2 za informacije o primjeni u pedijatriji).
English: • The purpose of the setup is to make sure that your Byettapen is ready to use for the next 30 days.
Croatian: • Svrha podešavanja jest osigurati da je Byetta brizgalica spremna za uporabu sljedećih 30 dana.
English: Your doctor is now prescribing Byetta as an additional medicine to help control your blood sugar.
Croatian: Liječnik Vam je sada propisao lijek Byetta kao dodatni lijek koji pomaže regulirati razinu šećera u krvi.
English: In use pen: 30 days
Croatian: Brizgalica u uporabi: 30 dana.
English: Paracetamol AUC, Cmax and tmax were not significantly changed when paracetamol was given 1 hour before immediate-release exenatide injection.
Croatian: AUC, Cmax i tmax paracetamola nisu se značajno promijenili kada se paracetamol davao sat vremena prije injekcije eksenatida s trenutnim oslobađanjem.
English: Check with your doctor, pharmacist, or diabetes nurse if you are not sure.
Croatian: Provjerite sa svojim liječnikom, ljekarnikom ili medicinskom sestrom u dijabetološkoj ambulanti ako niste sigurni.
English: For instructions for using the pen, see section 6.6 and the user manual included with the leaflet.
Croatian: Za uputu o uporabi brizgalice vidjeti dio 6.6 i Priručnik koji je priložen uz Uputu o lijeku.
English: Examination of antibody-positive specimens from one long-term uncontrolled study revealed no significant cross-reactivity with similar endogenous peptides (glucagon or GLP-1).
Croatian: Ispitivanjem uzoraka pozitivnih na protutijela iz jednog dugoročnog nekontroliranog ispitivanja nije utvrđena značajna križna reaktivnost sa sličnim endogenim peptidima (glukagonom ili GLP-1).
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: perzistirajućom, jakom boli u abdomenu.
English: Digoxin, lisinopril and warfarin
Croatian: Digoksin, lizinopril i varfarin
English: What Byetta contains
Croatian: Što Byetta sadrži
English: Keep your pen and needles out of the sight and reach of children.
Croatian: Čuvajte svoju brizgalicu i igle izvan pogleda i dohvata djece.
English: Do not use an extra dose or increase the amount of your next dose to make up for the one you missed.
Croatian: Nemojte primijeniti dvostruku dozu ili povećati količinu sljedeće doze kako biste nadoknadili zaboravljenu dozu.
English: • Avoid tightly pinching the skin before injecting.
Croatian: • Nemojte čvrsto stiskati kožu prije injiciranja.
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 određena stanja koja mogu utjecati na hidrataciju, uključujući mučninu, povraćanje i/ili proljev i/ili bolesnika koji su uzimali lijekove koji utječu na bubrežnu funkciju/stanje hidratacije.
English: Severe gastrointestinal disease
Croatian: Teške gastrointestinalne bolesti
English: If a patient wishes to become pregnant, or pregnancy occurs, treatment with exenatide should be discontinued.
Croatian: Ako bolesnica želi zatrudnjeti ili dođe do trudnoće, treba obustaviti liječenje eksenatidom.
English: • If you repeat the New Pen Setup before each routine dose, you will not have enough Byetta for 30 days.
Croatian: • Ako ponovite korake za Podešavanje nove brizgalice prije svake redovne doze, nećete imati dovoljno lijeka Byetta za 30 dana.
English: - If you have type 1 diabetes or diabetic ketoacidosis (a dangerous condition that can occur in diabetes), as you should not use this medicine.
Croatian: Ako imate šećernu bolest tipa 1 ili dijabetičku ketoacidozu (opasno stanje koje se može javiti kod šećerne bolesti), ne smijete primjenjivati ovaj lijek.
English: Byetta should not be used if particles appear or if the solution is cloudy and/or coloured.
Croatian: Byetta se ne smije upotrijebiti ako su vidljive čestice ili je otopina zamućena i/ili obojana.
English: The reduction in Cmax is of limited clinical relevance and no adjustment of dosing of oral contraceptives is required.
Croatian: Smanjenje Cmax je od malog kliničkog značaja te nije potrebno prilagođavati dozu oralnih kontraceptiva.
English: Read these instructions carefully BEFORE using your Byetta pen.
Croatian: Pažljivo pročitajte ove upute PRIJE uporabe Byetta brizgalice.
English: The dose of immediate-release exenatide does not need to be adjusted on a day-by-day basis depending on self-monitored glycaemia.
Croatian: Dozu eksenatida s trenutnim oslobađanjem nije potrebno svakodnevno prilagođavati ovisno o samokontroli glikemije.
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 unutarstaničnim signalnim putevima.
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: Caution should be exercised in patients with a history of pancreatitis.
Croatian: Potreban je oprez kod bolesnika s pankreatitisom u povijesti bolesti.
English: Injection needles are not included.
Croatian: Igle za injekciju nisu uključene.
English: This may happen if the skin is pinched too tightly or if the pressure on the injection button is released before the needle is removed from the skin.
Croatian: To se može dogoditi ako ste prečvrsto stisnuli kožu ili ako ste otpustili gumb za injiciranje prije nego što ste iglu izvadili iz kože.
English: The medicine in Byetta helps your body to increase the production of insulin when your blood sugar is high.
Croatian: Lijek u lijeku Byetta pomaže vašem organizmu da poveća stvaranje inzulina kada su razine šećera u krvi visoke.
English: Exenatide has minor influence on the ability to drive and use machines.
Croatian: Exenatid malo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: Pharmacotherapeutic group: Glucagon-like peptide-1 (GLP-1) analogues, ATC code: A10BJ01.
Croatian: Farmakoterapijska skupina: Analozi receptora peptida-1 nalik glukagonu (GLP-1), ATK oznaka: A10BJ01.
English: Using too much of this medicine can cause nausea, vomiting, dizziness, or symptoms of low blood sugar (see section 4).
Croatian: Primjena prevelike doze ovog lijeka može izazvati mučninu, povraćanje, omaglicu ili simptome niske razine šećera u krvi (pogledajte dio 4).
English: If such medicinal products are to be administered with food, patients should be advised to, if possible, take them with a meal when immediate-release exenatide is not administered.
Croatian: . Ako se takvi lijekovi moraju uzimati s hranom, bolesnike treba uputiti da ih po mogućnosti uzimaju uz onaj obrok uz koji ne primjenjuju eksenatid s trenutnim oslobađanjem
English: Patients who develop 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 antiexenatide antibodies.
Croatian: Bolesnici koji razviju protutijela na eksenatid češće imaju reakcije na mjestu injekcije (primjerice, crvenilo kože i svrbež), ali inače imaju slične stope i vrste štetnih događaja kao i oni koji nisu razvili protutijela na eksenatid.
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 niske razine šećera u krvi uključuju glavobolju, omamljenost, slabost, omaglicu, smetenost, razdražljivost, glad, ubrzani otkucaji srca, znojenje i osjećaj nervoze.