FrancophonIA/ELRC3.0 huggingface dataset:
English: Frequency categories 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 <1/1,000); very rare (<1/10,000) and not known
Croatian: Kategorije učestalost su sljedeće: 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) i nepoznato (ne može se procijeniti iz dostupnih podataka).
English: Tell them what could happen if your blood sugar gets low, including the risk of passing out.
Croatian: Recite im što se može dogoditi zbog niske razine šećera u krvi, uključujući rizik od nesvjestice.
English: Xultophy with alcohol
Croatian: Xultophy s alkoholom
English: • liraglutide - a ‘GLP-1 analogue' that helps your body make more insulin during meals and lowers the amount of sugar made by your body.
Croatian: • liraglutid - ‘analog GLP-1' koji pomaže Vašem tijelu stvoriti više inzulina tijekom obroka i smanjuje količinu šećera koje stvara
English: You will need it after the injection, to safely remove the needle from the pen.
Croatian: Trebat će Vam nakon injiciranja da na siguran način skinete iglu s brizgalice.
English: Contents of the pack and other information What Xultophy contains
Croatian: Sadržaj pakiranja i druge informacije Što Xultophy sadrži
English: Mean change Estimated difference
Croatian: Srednja vrijednost promjene Procijenjena razlika
English: Diarrhoea and vomiting were reported in 7.5% and 3.9% of patients, respectively.
Croatian: Proljev i povraćanje prijavljeni su u 7,5% odnosno 3,9% bolesnika.
English: Talk to your doctor, pharmacist or nurse before using Xultophy.
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije nego primijenite Xultophy.
English: • Swelling of arms or legs (peripheral oedema) - when you first start using your medicine, your body may keep more water than it should.
Croatian: • oticanje ruku ili nogu (periferni edem) - kada prvi puta počnete primjenjivati ovaj lijek, Vaše tijelo može zadržavati više vode nego bi trebalo.
English: Dose counter stopped: 42 dose steps left
Croatian: Primjer Zaustavljeni brojčanik doze: preostala su 42 odmjerna koraka
English: No interaction study has been performed.
Croatian: Nisu provedena ispitivanja interakcija.
English: Patients who forget a dose are advised to take it upon discovery and then resume their usual once-daily dosing schedule.
Croatian: Bolesnicima koji zaborave jednu dozu, preporučuje se da je primijene čim to primijete te da se nakon toga vrate uobičajenom rasporedu doziranja jednom dnevno.
English: This should be kept in mind if treatment with the combination of pioglitazone and Xultophy is considered.
Croatian: Ovo treba imati na umu ako se razmatra liječenje kombinacijom pioglitazona i lijeka Xultophy.
English: The local tissue reactions in the two studies in rabbits and pigs, respectively, were limited to mild inflammatory reactions.
Croatian: Lokalne reakcije tkiva u dvama ispitivanjima provedenima u kunića odnosno svinja bile su ograničene na blage upalne reakcije.
English: • Caregivers must be very careful when handling used needles - to prevent needle injury and cross-infection.
Croatian: • Osobe koje skrbe za bolesnika trebaju biti osobito oprezne pri rukovanju rabljenim iglama - kako bi spriječili ozljede iglom i križne infekcije.
English: Never touch the dose counter when you inject.
Croatian: Nikada ne dirajte brojčanik doze kada injicirate lijek.
English: You can select up to 50 dose steps per dose.
Croatian: Možete odabrati do 50 odmjernih koraka po dozi.
English: The dose selector clicks differently when turned forward, backward or past the number of dose steps left.
Croatian: Izbornik doze drugačije ‘klikne' kad se okreće unaprijed, unazad ili preko broja preostalih odmjernih koraka.
English: Dose End of trial
Croatian: Doza na kraju ispitivanja
English: If you keep injecting in the same place, these changes can become more severe and affect the amount of medicine your body gets from the pen.
Croatian: Ako nastavite s injiciranjem u isto mjesto, promjene mogu postati teže te mogu utjecati na količinu lijeka koju dobivate iz brizgalice
English: • Allergic reactions (hypersensitivity) such as rash, itching and swelling of the face.
Croatian: • alergijske reakcije (preosjetljivost) poput osipa, svrbeža i oticanja lica
English: Interaction studies did not show any clinically relevant delay of absorption.
Croatian: Ispitivanja interakcija nisu pokazala klinički značajnu odgodu apsorpcije.
English: If the needle is blocked, you will not inject any medicine.
Croatian: Ako je igla začepljena, nećete injicirati nimalo lijeka.
English: • Do not try to repair your pen or pull it apart.
Croatian: • Nemojte pokušavati popraviti brizgalicu niti je rastaviti.
English: Liraglutide is a Glucagon-Like Peptide-1 (GLP-1) analogue with 97% sequence homology to human GLP-1 that binds to and activates the GLP-1 receptor (GLP-1R).
Croatian: Liraglutid je analog glukagonu sličnog peptida-1 (GLP-1) s podudarnošću sekvence od 97% s humanim GLP-1 koji se veže na GLP-1 receptor (GLP-1R) i aktivira ga.
English: Liraglutide was superior in preventing MACE vs placebo (Figure 6).
Croatian: Liraglutid je bio superioran u prevenciji MACE događaja u odnosu na placebo (Slika 6).
English: What Xultophy looks like and contents of the pack
Croatian: Kako Xultophy izgleda i sadržaj pakiranja
English: If you have signs of low blood sugar, take actions to increase your blood sugar level straight away.
Croatian: Ako imate znakove niske razine šećera u krvi, odmah poduzmite korake kako biste povećali razinu šećera u krvi.
English: • Eat glucose tablets or another high sugar snack - like sweets, biscuits or fruit juice (always carry glucose tablets or a high sugar snack, just in case).
Croatian: • Uzmite tablete glukoze ili drugi međuobrok bogat šećerom poput slatkiša, keksa ili voćnog soka (za svaki slučaj, uvijek nosite sa sobom tablete glukoze ili međuobrok bogat šećerom).
English: The pre-filled pen is for use by one person only.
Croatian: Napunjena brizgalica namijenjena je uporabi samo jedne osobe.
English: For frequencies of hypoglycaemia, please see section 5.1.
Croatian: Za učestalosti hipoglikemije, molimo vidjeti dio 5.1.
English: No data is available beyond 52 weeks of treatment.
Croatian: Nisu dostupni podaci za liječenje dulje od 52 tjedna.
English: • If you are also taking a sulfonylurea (such as glimepiride or glibenclamide), your doctor may tell you to lower your sulfonylurea dose depending on your blood sugar levels.
Croatian: • Ako uzimate i sulfonilureju (kao što je glimepirid ili glibenklamid), liječnik Vam može reći da smanjite dozu sulfonilureje ovisno o razinama šećera u krvi.
English: Having low or high blood sugar can affect your ability to drive or use any tools or machines.
Croatian: Niska ili visoka razina šećera u krvi može utjecati na Vašu sposobnost upravljanja vozilom ili rukovanja alatima ili strojevima.
English: The Xultophy clinical development programme included approximately 1,900 patients treated with Xultophy.
Croatian: Klinički razvojni program lijeka Xultophy uključivao je približno 1900 bolesnika liječenih lijekom
English: Carefully read the ‘Instructions on how to use' on the other side of this leaflet and use the pen as described.
Croatian: Pažljivo pročitajte ‘Upute za uporabu' na poleđini ove upute o lijeku i koristite brizgalicu kako je opisano.
English: • You do not have to use Xultophy with a meal.
Croatian: • Xultophy ne morate primijeniti uz obrok.
English: • acetylsalicylic acid (and medicines called ‘salicylates') - for pain and mild fever
Croatian: • acetilsalicilatnu kiselinu (i lijekove koji se nazivaju ‘salicilati') - za bol i blagu vrućicu
English: If pancreatitis is suspected, Xultophy should be discontinued; if acute pancreatitis is confirmed, Xultophy should not be restarted.
Croatian: Ako se sumnja na pankreatitis, treba prekinuti primjenu lijeka Xultophy; ako se potvrdi akutni pankreatitis, liječenje lijekom Xultophy se ne smije ponovno započeti.
English: If no drop appears, you will not inject any medicine, even though the dose counter may move.
Croatian: Ako se kapljica ne pojavi, nećete injicirati nimalo lijeka, iako će se brojčanik doze možda pomicati.
English: The half-life of insulin degludec is approximately 25 hours and the half-life of liraglutide is approximately 13 hours.
Croatian: Poluvijek degludek inzulina iznosi približno 25 sati, a poluvijek liraglutida približno 13 sati.
English: The long-term improvements in blood sugar control may ease the eye problems.
Croatian: Dugoročno poboljšanje regulacije razine šećera u krvi može ublažiti probleme s očima.
English: If you use more Xultophy than you should
Croatian: Ako primijenite više lijeka Xultophy nego što ste trebali
English: You can carry Xultophy with you and keep it at room temperature (no more than 30°C) or in a refrigerator (2°C to 8°C) for up to 21 days.
Croatian: Xultophy možete nositi sa sobom i čuvati na sobnoj temperaturi (ne iznad 30ºC) ili u hladnjaku (2ºC do 8ºC) do 21 dan.
English: • Dehydration (loss of fluid from the body) - it is important to drink plenty of fluids to stop dehydration.
Croatian: • dehidracija (gubitak tekućine iz tijela) - važno je piti puno tekućine kako biste spriječili dehidraciju
English: • you have had an injection of glucagon
Croatian: • ste primijenili injekciju glukagona
English: • If it is not possible to use Xultophy at the same time every day, it can be used at a different time of the day.
Croatian: • Ako ne možete primijeniti Xultophy u isto vrijeme svakog dana, možete ga primijeniti u drugo doba dana.
English: • have not used enough Xultophy, keep using less Xultophy than you need, forget to use Xultophy or stop using Xultophy without talking to your doctor.
Croatian: • niste primijenili dovoljno lijeka Xultophy; primjenjujete manje lijeka Xultophy nego što Vam je potrebno; zaboravite primijeniti Xultophy ili prestanete primjenjivati Xultophy bez prethodnog razgovora s liječnikom.
English: Gastrointestinal adverse reactions may occur more frequently at the beginning of Xultophy therapy and usually diminish within a few days or weeks on continued treatment.
Croatian: Gastrointestinalne nuspojave mogu biti češće na početku liječenja lijekom Xultophy, a obično se smanjuju unutar nekoliko dana ili tjedana neprekidnog liječenja.
English: Do not use Xultophy:
Croatian: Nemojte primjenjivati Xultophy:
English: They may make it harder to recognise the warning signs of low blood sugar (see section 4 ‘Warning signs of low blood sugar - these may come on suddenly')
Croatian: Oni mogu otežati prepoznavanje upozoravajućih znakova niske razine šećera u krvi (vidjeti dio 4 ‘Upozoravajući znakovi niske razine šećera u krvi mogu se pojaviti iznenada')
English: • Check that the solution in your pen is clear and colourless.
Croatian: • Provjerite da je otopina u Vašoj brizgalici bistra i bezbojna.
English: Do not use the pen scale, it only shows approximately how much solution is left in your pen.
Croatian: Ne koristite skalu na brizgalici, ona samo približno pokazuje koliko je otopine preostalo u brizgalici.
English: Tell your doctor if you are taking warfarin or other blood thinners as you might need to have blood tests more often to measure how thick your blood is (called ‘International Normalised Ratio' or INR test).
Croatian: Obavijestite svog liječnika ako uzimate varfarin ili druge lijekove za razrjeđivanje krvi jer ćete možda morati češće raditi krvne pretrage radi mjerenja gustoće krvi (naziva se „Međunarodni normalizirani omjer“ ili INR test).
English: The non-clinical development programme for insulin degludec/liraglutide included pivotal combination toxicity studies of up to 90 days duration in a single relevant species (Wistar rats) to support the clinical development programme.
Croatian: Neklinički razvojni program za degludek inzulin/liraglutid uključivao je pivotalna ispitivanja toksičnosti kombinacije u trajanju do 90 dana u samo jednoj značajnoj vrsti (štakori Wistar) kako bi podupro klinički razvojni program.
English: Apart from a slight decrease in the number of live implants, animal studies with liraglutide did not indicate harmful effects with respect to fertility.
Croatian: Osim neznatnog sniženja broja živih implantata, ispitivanja na životinjama s liraglutidom nisu ukazala na štetne učinke na plodnost.
English: Xultophy is to be dosed in accordance with the individual patient's needs.
Croatian: Xultophy se treba dozirati sukladno individualnim potrebama bolesnika.
English: Insulin degludec and liraglutide are extensively bound to plasma proteins (>99% and >98%, respectively).
Croatian: Degludek inzulin i liraglutid u velikoj se mjeri vežu za proteine plazme (>99% odnosno >98%).
English: • Insulin secretion/beta-cell function Xultophy improves beta-cell function compared to insulin degludec as measured by the homeostasis model assessment for beta-cell function (HOMA-β).
Croatian: • Lučenje inzulina/funkcija beta stanica Xultophy poboljšava funkciju beta stanica u usporedbi s degludek inzulinom, što je izmjereno homeostatskim modelom za procjenu funkcije beta stanica (HOMA-β).
English: If you split the dose wrongly, you will inject too little or too much medicine.
Croatian: Ako pogrešno podijelite dozu, injicirat ćete premalo ili previše lijeka.
English: If you have a serious allergic reaction to any of the ingredients in Xultophy, stop using Xultophy and see a doctor straight away.
Croatian: Ako imate ozbiljnu alergijsku reakciju na bilo koji sastojak lijeka Xultophy, prestanite primjenjivati Xultophy i odmah posjetite liječnika.
English: If you select and inject the wrong dose, your blood sugar level may get high or low.
Croatian: Ako ste odabrali i injicirali pogrešnu dozu, razina šećera u Vašoj krvi može porasti ili pasti.
English: If you drop it or suspect a problem, attach a new needle and check the flow before you inject.
Croatian: Ako Vam ispadne ili mislite da nešto nije u redu s njom, pričvrstite novu iglu i provjerite protok prije injiciranja.
English: It is important always to check the flow before you inject.
Croatian: Važno je da uvijek provjerite protok prije injiciranja.
English: Alcohol may intensify or reduce the hypoglycaemic effect of Xultophy.
Croatian: Alkohol može pojačati ili smanjiti hipoglikemijski učinak lijeka Xultophy.
English: • Check the name and coloured label of your pen, to make sure that it contains Xultophy.
Croatian: • Provjerite naziv i obojanu naljepnicu na brizgalici kako biste bili sigurni da sadrži Xultophy.
English: Octreotide/lanreotide may either increase or decrease the Xultophy requirement.
Croatian: Oktreotid/lanreotid mogu ili povećati ili smanjiti potrebu za lijekom Xultophy.
English: Important things to know before you use this medicine:
Croatian: Važne stvari koje morate znati prije nego počnete primjenjivati ovaj lijek:
English: This may lead to high blood sugar level.
Croatian: To može dovesti do visoke razine šećera u krvi.
English: Liraglutide reduces body weight and body fat mass through mechanisms involving reduced hunger and lowered energy intake.
Croatian: Liraglutid snižava tjelesnu težinu i količinu masnog tkiva kroz mehanizme koji obuhvaćaju smanjenje gladi i sniženje unosa energije.
English: It is prescribed when these medicines (used alone or with GLP-1 treatment or with basal insulin) are not enough to control your blood sugar levels.
Croatian: Propisuje se kada ti lijekovi (sami ili u kombinaciji s agonistom GLP-1 receptora ili bazalnim inzulinom) nisu dovoljni za regulaciju razine šećera u krvi.
English: • Take a new needle, and tear off the paper tab.
Croatian: • Uzmite novu iglu i otrgnite papirnatu naljepnicu.
English: Some medicines affect your blood sugar level - this may mean your Xultophy dose has to change.
Croatian: Neki lijekovi utječu na razinu šećera u krvi - to može značiti da je potrebno promijeniti Vašu dozu lijeka Xultophy.
English: The pre-filled pen can provide from 1 up to 50 dose steps in one injection in increments of one dose step.
Croatian: Napunjena brizgalica može isporučiti dozu od 1 do 50 odmjernih koraka po injekciji u stupnjevima od jednog odmjernog koraka.
English: Novo Allé, Bagsværd, 2880, Denmark Name and address of the manufacturer responsible for batch release Novo Nordisk A/S
Croatian: Novo Allé, Bagsværd, 2880, Danska Naziv i adresa proizvođača odgovornog za puštanje serije lijeka u promet
English: Once empty, it must be disposed of.
Croatian: Nakon što se isprazni,
English: Solution for injection 1x3 mL
Croatian: Otopina za injekciju 1x3 ml
English: A small drop may remain at the needle tip, but it will not be injected.
Croatian: Na vrhu igle može ostati kapljica, ali neće biti injicirana.
English: In animal studies, peripheral administration of liraglutide led to uptake in specific brain regions involved in regulation of appetite, where liraglutide, via specific activation of the GLP1R, increased key satiety and decreased key hunger signals, thereby leading to lower body weight.
Croatian: U ispitivanjima na životinjama periferna primjena liraglutida rezultirala je unosom u određene dijelove mozga koji sudjeluju u regulaciji apetita, pri čemu je liraglutid putem specifične aktivacije GLP-1R povećao ključne signale sitosti i smanjio ključne signale gladi te time doveo do manje tjelesne težine.
English: • monoamine oxidase (MAO) inhibitors - for depression
Croatian: • inhibitore monoaminooksidaze (MAO inhibitore) - za depresiju
English: If a patient wishes to become pregnant, or pregnancy occurs, treatment with Xultophy should be discontinued.
Croatian: Ako bolesnica planira trudnoću ili zatrudni, liječenje lijekom Xultophy treba prekinuti.
English: If a drop of solution still does not appear, dispose of the pen and use a new one.
Croatian: Ako se još uvijek ne pojavi kapljica otopine, brizgalicu bacite u otpad i uzmite novu.
English: • Hives (red bumps on your skin that are sometimes itchy).
Croatian: • koprivnjača (crvene izbočine na koži, ponekad praćene svrbežom)
English: Furthermore, concomitant illness, especially infections, may lead to hyperglycaemia and thereby cause an increased requirement for antidiabetic treatment.
Croatian: Nadalje, istodobne bolesti, posebice infekcije, mogu dovesti do hiperglikemije te time prouzrokovati povećanu potrebu za liječenjem antidijabeticima.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Xultophy in all subsets of the paediatric population for treatment of type 2 diabetes mellitus (see section 4.2 for information on paediatric use).
Croatian: Pedijatrijska populacija Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka Xultophy u svim podskupinama pedijatrijske populacije za liječenje šećerne bolesti tipa 2 (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).
English: If so, the full dose will not be delivered, and you should increase the frequency of checking your blood sugar level.
Croatian: Ako je tako, nije isporučena cijela doza i trebate češće kontrolirati razinu šećera u krvi.
English: Do not use Xultophy if you are pregnant or plan to become pregnant.
Croatian: Nemojte primjenjivati Xultophy ako ste trudni ili planirate trudnoću.
English: During 24 hours following administration of a single radiolabelled [3H]-liraglutide dose to healthy subjects, the major component in plasma was intact liraglutide.
Croatian: Tijekom 24 sata od primjene jedne doze radioaktivno obilježenog [3H]-liraglutida u zdravih ispitanika glavna sastavnica u plazmi bio je nepromijenjeni liraglutid.
English: What you need to know before you use Xultophy Do not use Xultophy:
Croatian: Što morate znati prije nego počnete primjenjivati Xultophy Nemojte primjenjivati Xultophy:
English: Other medicines and Xultophy
Croatian: Drugi lijekovi i Xultophy
English: Table 1 Adverse reactions reported in phase 3 controlled studies MedDRA System organ class Frequency
Croatian: Tablica 1 Nuspojave prijavljene u kontroliranim ispitivanjima faze 3 MedDRA klasifikacija organskih sustava
English: Antidiabetic medicinal products, monoamine oxidase inhibitors (MAOI), beta-blockers, angiotensin converting enzyme (ACE) inhibitors, salicylates, anabolic steroids and sulfonamides.
Croatian: Antidijabetici, inhibitori monoaminooksidaze (MAO inhibitori), beta-blokatori, inhibitori angiotenzin konvertirajućeg enzima (ACE inhibitori), salicilati, anabolički steroidi i sulfonamidi.
English: • oral contraceptives - birth control pills
Croatian: • oralne kontraceptive - tablete za sprječavanje začeća
English: Pioglitazone - tablets used for the treatment of type 2 diabetes mellitus.
Croatian: Pioglitazon - tablete koje se koriste za liječenje šećerne bolesti tipa 2.
English: • Increase of pancreatic enzymes, such as lipase and amylase.
Croatian: • porast enzima gušterače, kao što su lipaza i amilaza.
English: It is not known if Xultophy affects the baby.
Croatian: Nije poznato utječe li Xultophy na dijete.
English: Always keep the cap on the pre-filled pen when you are not using it in order to protect it from light.
Croatian: Uvijek držite zatvarač na napunjenoj brizgalici kad je ne koristite, radi zaštite od svjetlosti.
English: • have or have had a thyroid disease.
Croatian: • ako imate ili ste nekada imali bolest štitnjače.
English: The MAH shall ensure that healthcare professionals are informed that all patients who have been prescribed Xultophy should be trained on the correct use of the prefilled pen before prescribing or dispensing Xultophy.
Croatian: Nositelj odobrenja mora se pobrinuti da zdravstveni radnici budu obaviješteni o tome da svi bolesnici kojima je propisan Xultophy moraju biti educirani o pravilnoj uporabi napunjene brizgalice prije nego što im se propiše ili izda Xultophy.
English: • when to check your blood sugar level
Croatian: • kada provjeriti razinu šećera u krvi
English: Xultophy is given once daily by subcutaneous administration.
Croatian: Xultophy se primjenjuje supkutano jednom dnevno.
English: Treatment with Xultophy should be initiated at the moment the next dose of the long-acting GLP-1 receptor agonist would have been taken.
Croatian: Liječenje lijekom Xultophy treba započeti u trenutku kad je trebala biti primijenjena sljedeća doza dugodjelujućeg agonista GLP-1 receptora.
English: Xultophy can be added to existing oral antidiabetic treatment.
Croatian: Xultophy se može dodati postojećem liječenju oralnim antidijabeticima.
English: No studies have been conducted with the insulin degludec/liraglutide combination to evaluate carcinogenesis, mutagenesis or impairment of fertility.
Croatian: Nisu provedena ispitivanja s kombinacijom degludek inzulina/liraglutida s ciljem procjene kancerogenosti, mutagenosti ili poremećaja plodnosti.
English: Figure 6 Forest plot of analyses of individual cardiovascular event types - FAS population
Croatian: Slika 6 Grafikon raspona pouzdanosti (engl. forest plot) za analize pojedinačnih vrsta kardiovaskularnih događaja - FAS populacija
English: Novo Allé, Bagsværd, 2880, Denmark
Croatian: Novo Allé, Bagsværd, 2880, Danska
English: • growth hormone - for low levels of growth hormone
Croatian: • hormon rasta - za niske razine hormona rasta
English: • Always keep your pen and needles out of sight and reach of others, especially children.
Croatian: • Brizgalicu i igle uvijek čuvajte izvan pogleda i dohvata drugih,
English: When your pen contains less than 50 dose steps, the dose counter stops at the number of dose steps left.
Croatian: Ako Vaša brizgalica sadrži manje od 50 odmjernih koraka, brojčanik doze zaustavlja se na broju preostalih odmjernih koraka.
English: Table 5 Results at 26-weeks - Transfer from basal insulin
Croatian: Tablica 5 Rezultati u 26. tjednu - Prijelaz s bazalnog inzulina
English: In combination with sulfonylurea, the risk of hypoglycaemia may be lowered by a reduction in the dose of sulfonylurea.
Croatian: U kombinaciji sa sulfonilurejom, rizik od hipoglikemije može se smanjiti snižavanjem doze sulfonilureje.