FrancophonIA/ELRC3.0 huggingface dataset:
English: Following subcutaneous administration, the protracted action profile is based on three mechanisms: self-association, which results in slow absorption; binding to albumin; and higher enzymatic stability towards the dipeptidyl peptidase IV (DPP-IV) and neutral endopeptidase (NEP) enzymes, resulting in a long plasma half-life.
Croatian: profil produljenog djelovanja zasniva se na tri mehanizma: samoudruživanje, što dovodi do polagane apsorpcije; vezanje za albumin i viša enzimatska stabilnost prema enzimima dipeptidil peptidazi-4 (DPP-IV) i neutralnoj endopeptidazi (NEP), što rezultira dugim poluvijekom u plazmi.
English: • this product contains a fixed combination of insulin degludec plus liraglutide (a GLP1-based product) which constitutes a new treatment paradigm in the treatment of patients with type 2 diabetes.
Croatian: • ovaj lijek sadrži fiksnu kombinaciju degludek inzulina i liraglutida (lijeka na bazi GLP-1), što predstavlja novu paradigmu u liječenju bolesnika sa šećernom bolešću tipa 2.
English: *Self-measured plasma glucose.
Croatian: *Samoizmjerena razina glukoze u plazmi.
English: IDegLira=Xultophy, GLP-1 RA=GLP-1 receptor agonist
Croatian: IDegLira=Xultophy, GLP-1 RA=agonist GLP-1 receptora
English: mg/dL
Croatian: mmol/l mg/dl
English: The educational materials are aimed at increasing awareness about the fact Xultophy contains a fixed combination of insulin degludec and liraglutide (a GLP1-based product) and at minimising the risk of medication errors with Xultophy.
Croatian: Svrha edukacijskih materijala je osvijestiti činjenicu da Xultophy sadrži fiksnu kombinaciju degludek inzulina i liraglutida (lijeka na bazi GLP-1) i minimizirati rizik od medikacijskih pogrešaka kod primjene lijeka Xultophy.
English: 2 Check the flow
Croatian: 2 Provjerite protok
English: Because of lack of experience, Xultophy should not be used during breast-feeding.
Croatian: Zbog nedostatka iskustva, Xultophy se ne smije koristiti tijekom dojenja.
English: In rare cases, the presence of such antibodies may necessitate adjustment of the Xultophy dose in order to correct a tendency to hyper- or hypoglycaemia.
Croatian: U rijetkim slučajevima, prisutnost takvih protutijela može zahtijevati prilagodbu doze lijeka Xultophy kako bi se izbjegla sklonost hiperglikemiji ili hipoglikemiji.
English: Xultophy (dose steps)
Croatian: Xultophy (odmjerni koraci)
English: The same titration algorithm was applied for basal insulin comparators.
Croatian: Isti algoritam titracije primijenjen je i za usporedne bazalne inzuline.
English: The most frequently reported adverse reactions during treatment with Xultophy were hypoglycaemia and gastrointestinal adverse reactions (see section ‘Description of selected adverse reactions' below).
Croatian: Najčešće prijavljene nuspojave tijekom liječenja lijekom Xultophy bile su hipoglikemija i gastrointestinalne nuspojave (vidjeti dio „Opis odabranih nuspojava“ u nastavku).
English: The following data are based upon studies with insulin degludec and liraglutide individually.
Croatian: Sljedeći podaci temelje se na ispitivanjima s degludek inzulinom i liraglutidom pojedinačno.
English: The differences are considered of no clinical relevance since Xultophy is initiated and titrated according to the individual patient's blood glucose targets.
Croatian: Razlike se ne smatraju klinički značajnima jer se Xultophy počinje davati i titrira prema ciljnim vrijednostima glukoze u krvi pojedinog bolesnika.
English: Upon initiation of Xultophy treatment in patients on warfarin or other coumarin derivatives more frequent monitoring of INR (International Normalised Ratio) is recommended.
Croatian: Nakon uvođenja liječenja lijekom Xultophy u bolesnika na varfarinu ili drugim kumarinskim derivatima preporučuje se češće praćenje INR-a (međunarodni normalizirani omjer, engl.
English: Get help from a person with good eyesight who is trained to use the Xultophy pre-filled pen.
Croatian: Zatražite pomoć osobe koja dobro vidi i koja je naučila kako koristiti Xultophy napunjenu brizgalicu.
English: Examples dose steps selected dose steps selected
Croatian: Primjeri odabrano odmjernih koraka odabrana odmjerna koraka
English: Xultophy must not be added to infusion fluids.
Croatian: Xultophy se ne smije dodavati u infuzijske otopine.
English: It contains 3 mL of Xultophy solution.
Croatian: Sadrži 3 ml otopine lijeka Xultophy.
English: When Xultophy is added to sulfonylurea therapy, a reduction in the dose of sulfonylurea should be considered (see section 4.4).
Croatian: Kada se Xultophy dodaje liječenju sulfonilurejom, treba razmotriti smanjenje doze sulfonilureje (vidjeti dio 4.4).
English: Liraglutide N
Croatian: Liraglutid N
English: Patients (%) achieving HbA1c ≤6.5% All patients
Croatian: Bolesnici (%) koji su postigli HbA1c ≤6,5%
English: Xultophy can be administered at any time of the day, preferably at the same time of the day.
Croatian: Xultophy se može primijeniti u bilo koje doba dana, po mogućnosti u isto vrijeme svakoga dana.
English: The cardiovascular safety of insulin degludec as compared to insulin glargine was confirmed (HR 0.91 [0.78; 1.06]) (Figure 7).
Croatian: Potvrđena je kardiovaskularna sigurnost degludek inzulina u odnosu na glargin inzulin (omjer hazarda 0,91 [0,78; 1,06]) (Slika 7).
English: There is no experience with Xultophy in children and adolescents under 18 years old.
Croatian: Nema iskustva s primjenom lijeka Xultophy u djece i adolescenata mlađih od 18 godina.
English: Xultophy can be used in elderly patients but if you are elderly you may need to check your blood sugar level more often.
Croatian: Primjena u starijih bolesnika (65 godina ili stariji) Xultophy se može primjenjivati u starijih bolesnika, ali ako ste stariji možda ćete morati češće kontrolirati razinu šećera u krvi.
English: See also section 2 ‘Important information about some of the ingredients of Xultophy' for information on sodium.
Croatian: Za podatke o natriju također pogledajte dio 2 „Važne informacije o nekim sastojcima lijeka Xultophy“.
English: • If the needle is removed earlier, you may see a stream of solution coming from the needle tip.
Croatian: • Ako iglu izvučete ranije, mogli biste vidjeti mlaz otopine iz vrha igle.
English: If you do not check the flow, you may get too little medicine, or no medicine at all.
Croatian: Ako ne provjerite protok, možete primijeniti premalo ili nimalo lijeka.
English: The ratio of mitogenic relative to metabolic potency for insulin degludec is unchanged compared to human insulin.
Croatian: Omjer mitogenog i metaboličkog potencijala degludek inzulina nepromijenjen je u usporedbi s onim za humani inzulin.
English: Always check the pen label before you inject your medicine to ensure that you use the correct pen.
Croatian: Uvijek provjerite naljepnicu na brizgalici prije injiciranja lijeka kako biste bili sigurni da koristite odgovarajuću brizgalicu.
English: This is because the dosing of your Xultophy injections, food or exercise may need to be changed.
Croatian: To je stoga što će možda biti potrebno promijeniti dozu Xultophy injekcije, prehranu ili tjelovježbu.
English: • eat too little or miss a meal
Croatian: • vježbate više nego obično • jedete premalo ili preskočite obrok
English: The study population included patients ≥65 years (n=4,329) and ≥75 years (n=836) and patients with mild (n=3,907), moderate (n=1,934) or severe (n=224) renal impairment.
Croatian: Ispitivana populacija uključivala je bolesnike u dobi od ≥ 65 godina (n=4329) i one u dobi od ≥ 75 godina (n=836) te bolesnike s blagim (n=3907), umjerenim (n=1934) ili teškim (n=224)
English: Insulin degludec (Tresiba)
Croatian: Degludek inzulin (Tresiba)
English: Patients whose blood glucose control is greatly improved (e.g. by intensified therapy) may experience a change in their usual warning symptoms of hypoglycaemia and must be advised accordingly.
Croatian: U bolesnika u kojih je znatno poboljšana regulacija glikemije (primjerice intenziviranjem liječenja), može doći do promjene uobičajenih upozoravajućih simptoma hipoglikemije te ih o tome treba primjereno savjetovati.
English: The dose selector changes the number of dose steps.
Croatian: Izbornik doze mijenja broj odmjernih koraka.
English: Always use this medicine exactly as your doctor has told you.
Croatian: Kako primjenjivati Xultophy Uvijek primijenite ovaj lijek točno onako kako Vam je rekao liječnik.
English: Limited data are available with regard to overdose of Xultophy.
Croatian: Dostupni su ograničeni podaci vezani uz predoziranje lijekom Xultophy.
English: In this context, relevant precautions as reflected in the SmPC should be emphasised.
Croatian: U tom se kontekstu moraju naglasiti odgovarajuće mjere opreza, kako su navedene u sažetku opisa svojstava lijeka.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Croatian: • Plan upravljanja rizikom (RMP) Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), koji se nalazi u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim ažuriranim verzijama RMP-a.
English: If it shows less than 50, the number shown is the number of dose steps left in your pen.
Croatian: Ako pokazuje manje od 50, prikazani broj je broj preostalih odmjernih koraka u brizgalici.
English: The MAH shall provide educational materials prior to launch targeting all physicians and nurses who are expected to be involved in the treatment and management of diabetic patients and all pharmacists who are expected to dispense Xultophy.
Croatian: Nositelj odobrenja će prije stavljanja lijeka u promet pripremiti edukacijske materijale za sve liječnike i medicinske sestre za koje se očekuje da će sudjelovati u liječenju i zbrinjavanju bolesnika sa šećernom bolešću te sve ljekarnike za koje se očekuje da će izdavati Xultophy.
English: Your blood sugar level may either rise or fall.
Croatian: Vam razina šećera u krvi mogla porasti ili pasti.
English: • Turn the dose selector to select 2 dose steps.
Croatian: • Okrenite izbornik doze kako biste odabrali 2 odmjerna koraka.
English: • The use of Xultophy is not recommended in patients with inflammatory bowel disease or delayed gastric emptying (diabetic gastroparesis).
Croatian: • Primjena lijeka Xultophy ne preporučuje se u bolesnika s upalnom bolesti crijeva ili odgođenim pražnjenjem želuca (dijabetička gastropareza).
English: In vitro data suggest that the potential for pharmacokinetic drug interactions related to CYP interaction and protein binding is low for both liraglutide and insulin degludec.
Croatian: In vitro podaci upućuju na to da je potencijal za farmakokinetičke interakcije lijekova koje se odnose na interakcije s CYP enzimima i vezanje za proteine niska i za liraglutid i za degludek inzulin.
English: Xultophy is used to improve blood glucose (sugar) levels in adult patients with type 2 diabetes mellitus.
Croatian: Xultophy se koristi za poboljšanje razine glukoze (šećera) u krvi u odraslih bolesnika sa šećernom bolešću tipa
English: • Ensuring you use the right medicine - Always check the pen label before each injection to avoid accidentally confusing Xultophy with other products.
Croatian: • Provjerite koristite li odgovarajuću vrstu lijeka - uvijek provjerite naljepnicu na brizgalici prije svakog injiciranja kako biste izbjegli slučajnu zabunu između lijeka Xultophy i drugih lijekova.
English: At baseline, HbA1c was 8.4% in both treatment groups and after 2 years HbA1c was 7.5% both with insulin degludec and insulin glargine.
Croatian: Na početku ispitivanja, vrijednost HbA1c iznosila je 8,4% u obje skupine, a nakon 2 godine 7,5% i za degludek inzulin i za glargin inzulin.
English: The trials were of 26 weeks duration randomising between 199 and 833 patients to Xultophy.
Croatian: Ispitivanja su trajala 26 tjedana, a između 199 i 833 bolesnika bilo je randomizirano u skupinu koja je primala
English: You may see a drop of solution at the needle tip after injecting.
Croatian: Možda ćete vidjeti kapljicu otopine na vrhu igle nakon injiciranja.
English: Xultophy must not be administered intravenously or intramuscularly.
Croatian: Xultophy se ne smije primjenjivati intravenski ili intramuskularno.
English: Patients treated with Xultophy should be advised of the potential risk of dehydration in relation to gastrointestinal side effects and take precautions to avoid fluid depletion.
Croatian: Bolesnike liječene lijekom Xultophy treba upozoriti na mogući rizik od dehidracije zbog gastrointestinalnih nuspojava i na to da poduzmu mjere opreza kako bi izbjegli gubitak tekućine.
English: The dose steps dialled equal the number shown in the dose counter.
Croatian: Odabrani odmjerni koraci jednaki su broju prikazanom na brojčaniku doze.
English: In all trials, the starting dose was given according to label and a twice-weekly titration regimen for Xultophy was used (see Table 2).
Croatian: U svim je ispitivanjima početna doza primijenjena sukladno odobrenom doziranju te je primijenjen režim titracije dvaput tjedno za Xultophy (vidjeti Tablicu 2).
English: Xultophy must not be used if the solution does not appear clear and colourless.
Croatian: Xultophy se ne smije primijeniti ako otopina nije bistra i bezbojna.
English: General effects from diabetes treatment
Croatian: Opći učinci liječenja šećerne bolesti
English: Listed below are the most common medicines, which may affect your Xultophy treatment.
Croatian: U nastavku su navedeni najčešći lijekovi koji mogu utjecati na Vaše liječenje lijekom Xultophy.
English: Always watch the dose counter to know how many dose steps you inject.
Croatian: Uvijek motrite brojčanik doze kako biste znali koliko odmjernih koraka injicirate.
English: Turn the dose selector until the dose counter stops.
Croatian: Okrećite izbornik doze sve dok se brojčanik doze ne zaustavi.
English: Xultophy must not be drawn from the cartridge of the pre-filled pen into a syringe (see section 4.4).
Croatian: Xultophy se ne smije izvlačiti iz uloška napunjene brizgalice u štrcaljku (vidjeti dio 4.4).
English: In six studies, Xultophy produced clinically and statistically significant improvements in glycaemic control versus comparators as measured by glycated haemaglobin A1c (HbA1c), whereas one study demonstrated a similar reduction of HbA1c in both treatment arms.
Croatian: U šest je ispitivanja Xultophy ostvario klinički i statistički značajna poboljšanja regulacije glikemije u odnosu na usporedne lijekove, mjereno vrijednošću glikiranog hemoglobina A1c (HbA1c), dok je jedno ispitivanje pokazalo slično sniženje vrijednosti HbA1c u obje liječene skupine.
English: Transfer from insulin glargine (100 units/mL)
Croatian: Prijelaz s glargin inzulina (100 jedinica/ml)
English: Populations not studied
Croatian: Neispitivane populacije
English: This might be due to the slower increase in the dose of the liraglutide component during treatment initiation when using Xultophy as compared to using liraglutide alone.
Croatian: Razlog tomu je možda sporije povećanje doze liraglutida kao sastavnice tijekom uvođenja liječenja lijekom Xultophy u usporedbi s primjenom samog liraglutida.
English: • Belching (eructation) and wind (flatulence).
Croatian: • podrigivanje i vjetrovi (flatulencija)
English: Now turn over for information on how to use your pre-filled pen.
Croatian: Sada okrenite stranicu za informacije kako koristiti napunjenu brizgalicu.
English: Liraglutide action is mediated via a specific interaction with GLP-1 receptors and improves glycaemic control by lowering fasting and postprandial blood glucose.
Croatian: Djelovanje liraglutida posredovano je specifičnom interakcijom s GLP-1 receptorima i poboljšava regulaciju glikemije snižavanjem glukoze u krvi natašte i nakon obroka.
English: Xultophy pre-filled pen and needle (example)
Croatian: Xultophy napunjena brizgalica i igla (primjer)
English: Patients treated with Xultophy overall experienced less gastrointestinal side effects than patients treated with liraglutide.
Croatian: Bolesnici liječeni lijekom Xultophy ukupno su imali manje gastrointestinalnih nuspojava nego bolesnici liječeni liraglutidom.
English: Add on to sulfonylurea ± metformin
Croatian: Dodatak sulfonilureji ± metforminu
English: The following serious side effects may happen with this medicine:
Croatian: Kod primjene ovog lijeka mogu se pojaviti sljedeće ozbiljne nuspojave:
English: The prolonged effect of Xultophy may delay recovery from hypoglycaemia.
Croatian: Produljeno djelovanje lijeka Xultophy može odgoditi oporavak od hipoglikemije.
English: Xultophy is a clear and colourless solution.
Croatian: Xultophy je bistra i bezbojna otopina.
English: Dosing with liraglutide during mid-gestation caused a reduction in maternal weight and foetal growth with equivocal effects on ribs in rats and skeletal variation in the rabbit.
Croatian: Doziranje liraglutida tijekom srednjeg gestacijskog razdoblja uzrokovalo je smanjenje majčine težine i fetalnog rasta, uz dvosmislene učinke na rebra kod štakora te skeletne promjene u kunića.
English: Intensification of therapy with insulin, a component of Xultophy, with abrupt improvement in glycaemic control may be associated with temporary worsening of diabetic retinopathy, while longterm improved glycaemic control decreases the risk of progression of diabetic retinopathy.
Croatian: Intenziviranje terapije inzulinom, sastavnicom lijeka Xultophy, s naglim poboljšanjem regulacije glikemije može biti povezano s privremenim pogoršanjem dijabetičke retinopatije, dok dugoročno poboljšanje regulacije glikemije smanjuje rizik napredovanja dijabetičke retinopatije.
English: A number of substances affect glucose metabolism and may require dose adjustment of Xultophy.
Croatian: Postoji niz tvari koje utječu na metabolizam glukoze i mogu zahtijevati prilagodbu doze lijeka Xultophy.
English: Anaphylactic reactions may potentially be life threatening.
Croatian: Anafilaktičke reakcije mogu biti opasne po život.
English: • insulin degludec - a long-acting basal insulin which lowers your blood sugar levels.
Croatian: • degludek inzulin - dugodjelujući bazalni inzulin koji snižava razine šećera u krvi
English: Xultophy is for subcutaneous use only.
Croatian: Xultophy je namijenjen samo za supkutanu primjenu.
English: When Xultophy is used in patients with mild, moderate or severe renal impairment, glucose monitoring is to be intensified and the dose adjusted on an individual basis.
Croatian: Kada se Xultophy koristi u bolesnika s blagim, umjerenim ili teškim oštećenjem bubrega, treba pojačano pratiti razinu glukoze te individualno prilagoditi dozu.
English: Body weight was reduced by 0.4 kg with an estimated treatment difference between Xultophy and insulin degludec of -2.80 kg (p<0.0001), and the rate of confirmed hypoglycaemia remained 1.8 events per patient year of exposure maintaining a significant reduction in overall risk of confirmed hypoglycaemia compared to insulin degludec.
Croatian: Tjelesna težina smanjila se za 0,4 kg, uz procijenjenu razliku između liječenja lijekom Xultophy i degludek inzulinom od -2,80 kg (p<0,0001), a stopa potvrđene hipoglikemije ostala je 1,8 događaja po bolesnik-godini izloženosti, čime je održano značajno smanjenje ukupnog rizika od potvrđene hipoglikemije u usporedbi s degludek inzulinom.
English: Animal reproduction studies with insulin degludec have not revealed any adverse effects on fertility.
Croatian: Ispitivanja reprodukcije na životinjama s degludek inzulinom ne ukazuju na bilo kakve štetne učinke na plodnost.
English: IDegLira=Xultophy, IDeg=insulin degludec, Lira=liraglutide, obs. rate=observed rate, PYE=patient year of exposure
Croatian: IDegLira=Xultophy, IDeg=degludek inzulin, Lira=liraglutid, primij. stopa=primijećena stopa, PYE= bolesnik-godina izloženosti
English: Comparator treatments comprised basal insulin, GLP-1 RA therapy, placebo and a basal bolus regimen.
Croatian: Usporedne terapije obuhvaćale su bazalni inzulin, liječenje agonistom GLP-1 receptora, placebo i bazal-bolus režim.
English: The proportion was significantly larger than observed with insulin degludec (40.9%, odds ratio 2.28, p <0.0001) and similar to that observed with liraglutide (57.7%, odds ratio 1.13, p=0.3184).
Croatian: Taj je udio bio značajno veći nego onaj primijećen s degludek inzulinom (40,9%; omjer šansi: 2,28; p<0,0001), a sličan onome primijećenom s liraglutidom (57,7%; omjer šansi: 1,13; p=0,3184).
English: • dehydration (loss of fluids from the body) can happen if you are feeling or being sick (nausea or vomiting) or have diarrhoea - it is important to drink plenty of fluids to stop dehydration.
Croatian: • dehidracija (gubitak tekućina iz tijela) može nastupiti u slučaju mučnine ili povraćanja ili ako imate proljev - važno je piti puno tekućine kako biste spriječili dehidraciju.
English: Xultophy can be used in patients with mild or moderate hepatic impairment.
Croatian: Xultophy se može primjenjivati u bolesnika s blagim ili umjerenim oštećenjem jetre.
English: Some patients with longstanding type 2 diabetes mellitus and heart disease or previous stroke, who were treated with pioglitazone and insulin, experienced the development of heart failure.
Croatian: U nekih bolesnika koji dugo boluju od šećerne bolesti tipa 2 i imaju srčanu bolest ili su imali moždani udar, a liječeni su pioglitazonom i inzulinom, došlo je do razvoja zatajivanja srca.
English: Insulin degludec (units) Liraglutide (mg)
Croatian: Degludek inzulin (jedinice) Liraglutid (mg)
English: Inflammatory bowel disease and diabetic gastroparesis There is no experience with Xultophy in patients with inflammatory bowel disease and diabetic gastroparesis.
Croatian: Upalna bolest crijeva i dijabetička gastropareza Nema iskustva s lijekom Xultophy u bolesnika s upalnom bolesti crijeva i dijabetičkom gastroparezom.
English: Basal insulin and sulfonylurea/glinides were discontinued at randomisation.
Croatian: Liječenje bazalnim inzulinom i sulfonilurejom/glinidima prekinuto je pri randomizaciji.
English: Hypoglycaemia may occur if the Xultophy dose is higher than required.
Croatian: Hipoglikemija može nastupiti ako je doza lijeka Xultophy veća od potrebne.
English: What to do if you get low blood sugar:
Croatian: Što učiniti ako osjetite nisku razinu šećera u krvi:
English: There is no clinical experience with the use of Xultophy, insulin degludec or liraglutide in pregnant women.
Croatian: Nema kliničkog iskustva s primjenom lijeka Xultophy, degludek inzulina ili liraglutida u trudnica.
English: Insulin degludec is a basal insulin that forms soluble multi-hexamers upon subcutaneous injection, resulting in a depot from which insulin degludec is continuously and slowly absorbed into the circulation leading to a flat and stable glucose-lowering effect of insulin degludec with a low day-today variability in insulin action.
Croatian: Degludek inzulin je bazalni inzulin koji tvori topive multiheksamere nakon supkutane injekcije, što rezultira stvaranjem depoa iz kojega se degludek inzulin neprestano i sporo apsorbira u cirkulaciju, što dovodi do ravnomjernog i stabilnog učinka degludek inzulina na snižavanje razine glukoze s malom varijabilnošću u djelovanju inzulina dan za danom.
English: If it shows 50, at least 50 dose steps are left in your pen.
Croatian: Ako pokazuje 50, to znači da je najmanje 50 odmjernih koraka preostalo u brizgalici.
English: Xultophy improves glycaemic control through the sustained lowering of fasting plasma glucose levels and postprandial glucose levels after all meals.
Croatian: Xultophy poboljšava regulaciju glikemije dugotrajnim smanjenjem razina glukoze u plazmi natašte i postprandijalnih razina glukoze nakon svih obroka.
English: In the LEADER trial, no long-term clinical impact of increased heart rate on the risk of cardiovascular events was observed with liraglutide (a component of Xultophy) (see section 5.1).
Croatian: U ispitivanju LEADER nije opažen dugoročan klinički ujecaj povećane srčane frekvencije na rizik od kardiovaskularnih događaja kod primjene liraglutida (sastavnica lijeka Xultophy) (vidjeti dio 5.1).