FrancophonIA/ELRC3.0 huggingface dataset:
English: Non-clinical data reveal no safety concern for humans based on studies of safety pharmacology, repeated dose toxicity, carcinogenic potential, and toxicity to reproduction.
Croatian: Neklinički podaci ne ukazuju na poseban rizik za sigurnost ljudi na temelju ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, kancerogenosti i reproduktivne toksičnosti.
English: These findings in rodents are caused by a non-genotoxic, specific GLP-1 receptor-mediated mechanism to which rodents are particularly sensitive.
Croatian: specifičnim mehanizmom posredovanim GLP-1 receptorom, na koji su glodavci osobito osjetljivi.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČI BIOLOŠKIH DJELATNIH TVARI I PROIZVOĐAČI ODGOVORNI ZA PUŠTANJE SERIJE LIJEKA U PROMET
English: Always dispose of the needle after each injection to ensure the use of a sharp needle and prevent blocked needles.
Croatian: Nakon svakog injiciranja uvijek bacite iglu u otpad kako biste bili sigurni da ćete upotrijebiti oštru iglu i kako biste spriječili začepljenje igala.
English: Transfer of patients from insulin glargine (100 units/mL) to Xultophy or intensification of insulin glargine in patients inadequately controlled on insulin glargine (20-50 units) and metformin were studied in a 26 week trial.
Croatian: Prijelaz bolesnika s glargin inzulina (100 jedinica/ml) na Xultophy ili intenziviranje liječenja glargin inzulinom u bolesnika nedovoljno reguliranih glargin inzulinom (20-50 jedinica) i metforminom ispitivalo se u 26-tjednom ispitivanju.
English: Administration of Xultophy may cause formation of antibodies against insulin degludec and/or liraglutide.
Croatian: Primjena lijeka Xultophy može uzrokovati stvaranje protutijela na degludek inzulin i/ili liraglutid.
English: After first opening: Store at a maximum of 30°C or store in a refrigerator (2°C - 8°C).
Croatian: Nakon prvog otvaranja: čuvati na temperaturi od najviše 30ºC ili čuvati u hladnjaku (2ºC-8ºC).
English: EU/1/14/947/001 1 pre-filled pen EU/1/14/947/002 3 pre-filled pens EU/1/14/947/003 5 pre-filled pens
Croatian: EU/1/14/947/002 3 napunjene brizgalice EU/1/14/947/003 5 napunjenih brizgalica
English: Similarly, in a 26-week clinical trial, patients with type 2 diabetes and moderate renal impairment (CrCl 30-59 mL/min) had 26% lower liraglutide exposure when compared with a separate trial including patients with type 2 diabetes with normal renal function or mild renal impairment.
Croatian: Slično tome, u jednom 26-tjednom kliničkom ispitivanju, izloženost liraglutidu u bolesnika sa šećernom bolešću tipa 2 i umjerenim oštećenjem bubrega (CrCl: 30-59 ml/min) bila je smanjena za 26% u usporedbi sa zasebnim ispitivanjem koje je uključivalo bolesnike sa šećernom bolešću tipa 2 i normalnom funkcijom bubrega ili blagim oštećenjem bubrega.
English: Dispose of the needle safely after each use.
Croatian: Nakon svake primjene iglu bacite na siguran način.
English: In patients inadequately controlled on metformin alone or in combination with pioglitazone, Xultophy reduced mean systolic blood pressure by 1.8 mmHg compared to a reduction of 0.7 mmHg with insulin degludec and 2.7 mmHg with liraglutide.
Croatian: U bolesnika nedovoljno reguliranih metforminom samim ili u kombinaciji s pioglitazonom, Xultophy je smanjio srednju vrijednost sistoličkog krvnog tlaka za 1,8 mmHg, dok je smanjenje ostvareno uz degludek inzulin iznosilo 0,7 mmHg, a uz liraglutid 2,7 mmHg.
English: Glucose monitoring is to be intensified and the dose adjusted on an individual basis.
Croatian: Treba pojačano pratiti razinu glukoze te individualno prilagoditi dozu.
English: Estimated difference, insulin degludec dose
Croatian: Procijenjena razlika, doza degludek inzulina
English: Pre-breakfast plasma glucose* Dose adjustment (twice weekly) mmol/L
Croatian: Glukoza u plazmi prije doručka* Prilagodba doze (dvaput tjedno)
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ BIOLOŠKIH DJELATNIH TVARI I PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE LIJEKA U PROMET
English: Name and address of the manufacturer of the biological active substances Novo Nordisk A/S
Croatian: Naziv i adresa proizvođača bioloških djelatnih tvari
English: Thyroid adverse events, such as goitre have been reported in clinical trials with GLP-1 receptor agonists including liraglutide, and in particular in patients with pre-existing thyroid disease.
Croatian: Štetni događaji povezani sa štitnjačom, kao što je struma, prijavljeni su u kliničkim ispitivanjima s agonistima GLP-1 receptora uključujući liraglutid, a osobito u bolesnika s prethodno postojećom bolesti štitnjače.
English: No studies have been performed with Xultophy in children and adolescents below 18 years of age.
Croatian: Pedijatrijska populacija Nisu provedena ispitivanja s lijekom Xultophy u djece i adolescenata mlađih od 18 godina.
English: Insulin degludec, maximum 50 units allowed
Croatian: Xultophy Degludek inzulin, najveća dopuštena doza: 50 jedinica
English: In addition, constipation, dyspepsia, gastritis, abdominal pain, gastroesophageal reflux disease, abdominal distension, eructation, flatulence and decreased appetite have been reported in up to 3.6% of patients treated with Xultophy.
Croatian: gastroezofagealna refluksna bolest, distenzija abdomena, podrigivanje, flatulencija i smanjen apetit prijavljeni su u do 3,6% bolesnika liječenih lijekom Xultophy.
English: 5 After your injection • Lead the needle tip into the outer needle cap on a flat surface without touching the needle or the outer cap.
Croatian: • Uvedite vrh igle u vanjski zatvarač igle na ravnoj površini ne dodirujući iglu ili vanjski zatvarač.
English: Rate of confirmed hypoglycaemia* per patient year of exposure (percentage of patients)
Croatian: Stopa potvrđene hipoglikemije* po bolesnik-godini izloženosti (postotak bolesnika)
English: • Inflamed pancreas (pancreatitis).
Croatian: • upala gušterače (pankreatitis)
English: Insulin degludec N (%)
Croatian: Degludek inzulin N (%)
English: Liraglutide
Croatian: Liraglutid
English: Your blood sugar level may fall if you take:
Croatian: Razina šećera u krvi može pasti ako uzimate:
English: The mean daily insulin dose at end of trial was 36 units for patients treated with Xultophy and 54 units for patients treated with insulin glargine.
Croatian: Na kraju ispitivanja srednja vrijednost dnevne doze inzulina iznosila je 36 jedinica za bolesnike liječene lijekom Xultophy te 54 jedinice za bolesnike liječene glargin inzulinom.
English: • Lower appetite, feeling or being sick (nausea or vomiting), diarrhoea, constipation, indigestion (dyspepsia), inflamed lining of the stomach (gastritis), stomach ache, heartburn or bloatingthese usually go away after a few days or weeks.
Croatian: • smanjen tek, mučnina ili povraćanje, proljev, zatvor, probavne tegobe (dispepsija), upala sluznice želuca (gastritis), bol u trbuhu, žgaravica ili nadutost - te nuspojave uglavnom nestaju nakon nekoliko dana ili tjedana
English: No cardiovascular outcomes trials have been performed with Xultophy.
Croatian: Nisu provedena ispitivanja kardiovaskularnih ishoda kod primjene lijeka Xultophy.
English: Very few patients developed insulin degludec specific antibodies, antibodies cross-reacting to human insulin or anti-liraglutide antibodies following treatment with Xultophy.
Croatian: Vrlo je malo bolesnika nakon liječenja lijekom Xultophy razvilo specifična protutijela na degludek inzulin, protutijela koja križno reagiraju na humani inzulin ili protutijela na liraglutid.
English: CI: 95% confidence interval.
Croatian: CI: 95%
English: Figure 1 Mean HbA1c (%) by treatment week (left) and rate of confirmed hypoglycaemia per patient year of exposure vs mean HbA1c (%) (right) in patients with type 2 diabetes mellitus inadequately controlled on metformin alone or in combination with pioglitazone
Croatian: Slika 1 Srednja vrijednost HbA1c (%) po tjednu liječenja (lijevo) i stopa potvrđene hipoglikemije po bolesnik-godini izloženosti u odnosu na srednju vrijednost HbA1c (%) (desno) u bolesnika sa šećernom bolešću tipa 2 nedovoljno reguliranih metforminom, samim ili u kombinaciji pioglitazonom
English: When transferring from basal insulin therapy, the recommended starting dose of Xultophy is 16 dose steps (16 units insulin degludec and 0.6 mg liraglutide) (see section 4.4 and 5.1).
Croatian: Prilikom prelaska s liječenja bazalnim inzulinom, preporučena početna doza lijeka Xultophy je 16 odmjernih koraka (16 jedinica degludek inzulina i 0,6 mg liraglutida) (vidjeti dijelove 4.4 i 5.1).
English: Concomitant diseases in the kidney, liver or diseases affecting the adrenal, pituitary or thyroid gland may require changes of the Xultophy dose.
Croatian: Istodobne bolesti bubrega, jetre, nadbubrežne žlijezde, hipofize ili štitnjače mogu zahtijevati promjenu doze lijeka Xultophy.
English: The rate of nocturnal hypoglycaemic events was significantly lower with Xultophy compared to insulin glargine (estimated treatment ratio 0.17, p<0.001).
Croatian: Stopa noćnih hipoglikemijskih događaja bila je značajno niža uz Xultophy nego uz glargin inzulin (procijenjeni terapijski omjer: 0,17;
English: Substances added to Xultophy may cause degradation of the active substances.
Croatian: Tvari dodane lijeku Xultophy mogu izazvati razgradnju djelatnih tvari.
English: They may include cold sweats, cool pale skin, fatigue, nervousness or tremor, anxiousness, unusual tiredness or weakness, confusion, difficulty in concentration, drowsiness, excessive hunger, vision changes, headache, nausea and palpitation.
Croatian: Simptomi hipoglikemije obično se javljaju naglo, a mogu uključivati: hladan znoj, hladnu blijedu kožu, umor, nervozu ili tremor, anksioznost, neuobičajen umor ili slabost, konfuziju, poteškoće s koncentracijom, omamljenost, izrazitu glad, promjene vida, glavobolju, mučninu i palpitacije.
English: The recommended starting dose of Xultophy is 10 dose steps (10 units insulin degludec and 0.36 mg liraglutide).
Croatian: Preporučena početna doza lijeka Xultophy je 10 odmjernih koraka (10 jedinica degludek inzulina i 0,36 mg liraglutida).
English: The following substances may increase the Xultophy requirement: Oral contraceptives, thiazides, glucocorticoids, thyroid hormones, sympathomimetics, growth hormones and danazol.
Croatian: Oralni kontraceptivi, tiazidi, glukokortikoidi, hormoni štitnjače, simpatomimetici, hormon rasta i danazol.
English: Liraglutide exposure was decreased by 13-23% in patients with mild to moderate hepatic impairment compared to healthy subjects.
Croatian: U usporedbi sa zdravim ispitanicima, izloženost liraglutidu bila je smanjena za 13-23% u bolesnika s blažim do umjerenim oštećenjem jetre.
English: The percentage of patients experiencing severe or blood-glucose confirmed symptomatic hypoglycaemia was 12.9% in the Xultophy group and 19.5% in the insulin glargine group (estimated treatment ratio 0.42 [95% CI: 0.23; 0.75]).
Croatian: Postotak bolesnika koji su doživjeli tešku hipoglikemiju ili simptomatsku hipoglikemiju potvrđenu mjerenjem glukoze u krvi iznosio je 12,9% u skupini koja je primala Xultophy te 19,5% u skupini koja je primala glargin inzulin (procijenjeni omjer liječenja iznosio je 0,42 [95% CI: 0,23; 0,75].
English: The pen can dial up to a maximum of 50 dose steps.
Croatian: Brizgalicom možete odmjeriti najviše 50 odmjernih koraka.
English: Your blood sugar level may rise if you take:
Croatian: Razina šećera u krvi može porasti ako uzimate:
English: 4 Inject your dose
Croatian: 3 Odaberite dozu
English: Keep the cap on the pre-filled pen in order to protect from light.
Croatian: Zatvarač držati na napunjenoj brizgalici radi zaštite od svjetlosti.
English: Patients (%) achieving HbA1c <7% All patients
Croatian: Bolesnici (%) koji su postigli HbA1c <7%
English: A drop of solution should appear at the needle tip.
Croatian: Na vrhu igle bi se trebala pojaviti kapljica otopine.
English: The dose counter on the pen shows the number of dose steps.
Croatian: Brojčanik doze na brizgalici pokazuje broj odmjernih koraka.
English: Pharmacotherapeutic group: Drugs used in diabetes.
Croatian: Farmakoterapijska skupina: Pripravci za liječenje šećerne bolesti.
English: In a second trial, the transfer from basal insulin to Xultophy or insulin degludec was investigated in a 26-week randomised, double-blind trial in patients inadequately controlled on basal insulin (20-40 units) and metformin alone or in combination with sulfonylurea/glinides.
Croatian: Drugo ispitivanje prijelaza s bazalnog inzulina na Xultophy ili degludek inzulin bilo je 26-tjedno randomizirano, dvostruko slijepo ispitivanje provedeno u bolesnika nedovoljno reguliranih bazalnim inzulinom (20-40 jedinica) i metforminom, samim ili u kombinaciji sa sulfonilurejom/glinidima.
English: Interaction studies with Xultophy have not been performed.
Croatian: Nisu provedena ispitivanja interakcija s lijekom Xultophy.
English: Solution for injection 5 pre-filled pens of 3 mL.
Croatian: 5 napunjenih brizgalica od 3 ml.
English: Pack sizes of 1, 3, 5 and a multipack containing 10 (2 packs of 5) pens of 3 mL.
Croatian: Veličine pakiranja od 1, 3 ili 5 brizgalica i višestruko pakiranje koje sadrži 10 (2 pakiranja po 5)
English: Liraglutide exposure was lowered by 33%, 14%, 27% and 26%, in patients with mild (creatinine clearance, CrCl 50-80 mL/min), moderate (CrCl 30-50 mL/min), and severe (CrCl <30 mL/min) renal impairment and in end-stage renal disease requiring dialysis, respectively.
Croatian: Izloženost liraglutidu bila je smanjena za 33% u bolesnika s blažim oštećenjem bubrega (klirens kreatinina, CrCl 50-80 ml/min), za 14% u bolesnika s umjerenim oštećenjem bubrega (CrCl 30-50 ml/min), za 27% u bolesnika s teškim oštećenjem bubrega
English: • Keep the needle in your skin after the dose counter has returned to 0
Croatian: • Zadržite iglu u koži nakon što se brojčanik doze vrati na 0 i polako brojite do 6.
English: Xultophy has a stable pharmacodynamic profile with a duration of action reflecting the combination of the individual action profiles of insulin degludec and liraglutide that allows for administration of Xultophy once daily at any time of the day with or without meals.
Croatian: Xultophy ima stabilan farmakodinamički profil i trajanje djelovanja koje odražava kombinaciju pojedinačnih profila djelovanja degludek inzulina i liraglutida, što omogućuje primjenu lijeka
English: There is no difference in the pharmacokinetics of insulin degludec between healthy subjects and patients with hepatic impairment.
Croatian: Ne postoje razlike u farmakokinetici degludek inzulina između zdravih ispitanika i bolesnika s oštećenjem jetre.
English: There is no clinical experience with the use of Xultophy during breast-feeding.
Croatian: Nema kliničkog iskustva s primjenom lijeka Xultophy tijekom dojenja.
English: Xultophy is used with oral medicines for diabetes (such as metformin, pioglitazone and sulfonylurea medicines).
Croatian: Xultophy i lijekovi za šećernu bolest koji se uzimaju kroz usta Xultophy se koristi s lijekovima za šećernu bolest koji se uzimaju kroz usta (kao što su metformin, pioglitazon i lijekovi iz skupine sulfonilureja).
English: Therapy with GLP-1 receptor agonists should be discontinued prior to initiation of Xultophy.
Croatian: Liječenje agonistima GLP-1 receptora mora se prekinuti prije početka terapije lijekom Xultophy.
English: There is no therapeutic experience in patients with congestive heart failure New York Heart Association (NYHA) class IV and Xultophy is therefore not recommended for use in these patients.
Croatian: New York Heart Association) klasifikaciji pa se stoga primjena lijeka Xultophy ne preporučuje u tih bolesnika.
English: • Insert the needle into your skin as your doctor or nurse has shown you.
Croatian: 4 Injicirajte dozu • Zabodite iglu pod kožu kako Vam je pokazao Vaš liječnik ili medicinska sestra.
English: IDegLira=Xultophy, IDeg=insulin degludec
Croatian: IDegLira=Xultophy, IDeg=degludek inzulin
English: The percentage of patients experiencing severe or blood-glucose confirmed symptomatic hypoglycaemia was 19.8% in the Xultophy group and 52.6% in the basal-bolus insulin group, and the estimated rate ratio was 0.11 [95% CI: 0.08-0.17].
Croatian: Postotak bolesnika koji su doživjeli tešku hipoglikemiju ili simptomatsku hipoglikemiju potvrđenu mjerenjem glukoze u krvi iznosio je 19,8% u skupini koja je primala Xultophy te 52,6% u skupini koja je primala bazal-bolus inzulin, a procijenjeni omjer stopa iznosio je 0,11 [95% CI: 0,08-0,17].
English: If your blood sugar gets low, see the advice in section 4 ‘Low blood sugar (hypoglycaemia)'.
Croatian: Ako dođe do pada razine šećera u krvi, pogledajte savjete u dijelu 4. ‘Niska razina šećera u krvi (hipoglikemija)'.
English: IDegLira=Xultophy, IGlar=insulin glargine
Croatian: IDegLira=Xultophy, IGlar= glargin inzulin
English: • low blood sugar (hypoglycaemia) - if your blood sugar is low, follow the advice in section 4 ‘Low blood sugar (hypoglycaemia)'.
Croatian: • niska razina šećera u krvi (hipoglikemija) - ako je razina šećera u Vašoj krvi niska, slijedite savjet naveden u dijelu 4. ‘Niska razina šećera u krvi (hipoglikemija)'.
English: The rate per patient year of exposure (percentage of patients) of severe hypoglycaemia defined as an episode requiring assistance of another person was 0.01 (2 patients out of 825) for Xultophy, 0.01 (2 patients out of 412) for insulin degludec and 0.00 (0 patients out of 412) for liraglutide.
Croatian: Stopa teške hipoglikemije, definirane kao epizoda u kojoj je potrebna pomoć druge osobe, po bolesnik-godini izloženosti (postotak bolesnika) bila je 0,01 (2 bolesnika od 825) za Xultophy, 0,01 (2 bolesnika od 412) za degludek inzulin i 0,00 (0 bolesnika od 412) za liraglutid.
English: Xultophy contains less than 1 mmol sodium (23 mg) per dose, therefore the medicinal product is essentially ‘sodium-free'.
Croatian: Xultophy sadrži manje od 1 mmol (23 mg) natrija po dozi, tj. zanemarive količine natrija.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING MULTIPACK LABEL
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU NALJEPNICA NA VIŠESTRUKOM PAKIRANJU
English: Transfer to Xultophy from doses of basal insulin <20 and >50 units has not been studied.
Croatian: Prelazak s doza bazalnog inzulina <20 i >50 jedinica na lijek Xultophy nije ispitivan.
English: The blood glucose-lowering effect of insulin degludec is due to the facilitated uptake of glucose following the binding of insulin to receptors on muscle and fat cells and to the simultaneous inhibition of glucose output from the liver.
Croatian: Učinak degludek inzulina na snižavanje razine glukoze u krvi posljedica je olakšanog ulaska glukoze nakon vezanja inzulina za receptore na mišićnim i masnim stanicama te istovremene inhibicije otpuštanja glukoze iz jetre.
English: Xultophy should therefore be used with caution in these patients.
Croatian: Stoga je potreban oprez kod primjene lijeka Xultophy u tih bolesnika.
English: Treatment with Xultophy compared to a basal-bolus insulin regimen consisting of basal insulin (insulin glargine 100 units/mL) in combination with bolus insulin (insulin aspart) studied in a 26-week trial in patients with type 2 diabetes mellitus inadequately controlled on insulin glargine and metformin demonstrated a similar reduction of HbA1c in the two groups (mean value from 8.2% to 6.7% in both groups).
Croatian: U 26-tjednom ispitivanju provedenom u bolesnika sa šećernom bolešću tipa 2 nedovoljno reguliranih glargin inzulinom i metforminom, u kojem se ispitivalo liječenje lijekom Xultophy u usporedbi s bazal-bolus režimom koji se sastojao od bazalnog inzulina (glargin inzulina od 100 jedinica/ml) u kombinaciji s bolus inzulinom (aspart inzulinom), zapaženo je slično smanjenje vrijednosti HbA1c u obje liječene skupine (srednja vrijednost iznosila je od 8,2% do 6,7% u obje skupine).
English: Glycerol, phenol, zinc acetate, hydrochloric acid and sodium hydroxide (for pH adjustment), and water for injections
Croatian: glicerol, fenol, cinkov acetat, kloridnu kiselinu i natrijev hidroksid (za podešavanje pH) i vodu za injekcije.
English: Xultophy contains less than 1 mmol sodium (23 mg) per dose.
Croatian: Važne informacije o nekim sastojcima lijeka Xultophy Xultophy sadrži manje od 1 mmol (23 mg) natrija po dozi.
English: The rate per patient year of exposure (percentage of patients) of severe hypoglycaemia was 0.02 (2 patients out of 288) for Xultophy and 0.00 (0 patients out of 146) for placebo.
Croatian: Stopa teške hipoglikemije po bolesnik-godini izloženosti (postotak bolesnika) bila je 0,02 (2 bolesnika od 288) za Xultophy i 0,00 (0 bolesnika od 146) za placebo.
English: Compared to baseline, there was a mean reduction in body weight of 0.9 kg for Xultophy and a mean increase of 2.6 kg for patients treated with a basal-bolus regimen and the estimated treatment difference was -3.57 kg [95% CI:4.19; -2.95].
Croatian: U odnosu na početak ispitivanja, u bolesnika liječenih lijekom Xultophy zabilježeno je srednje smanjenje tjelesne težine za 0,9 kg, a u bolesnika liječenih bazal-bolus režimom srednje povećanje za 2,6 kg te je procijenjena razlika između liječenja iznosila -3,57 kg [95% CI: -4,19; -2,95].
English: PARTICULARS TO APPEAR ON THE INNER PACKAGING CARTON FOR MULTIPACK
Croatian: PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKIRANJU KUTIJA ZA VIŠESTRUKO PAKIRANJE
English: Transfer from basal insulin therapies
Croatian: Prijelaz s liječenja bazalnim inzulinom
English: Baseline, End of trial and change values are observed Last observation carried forward.
Croatian: Početne vrijednosti, vrijednosti na kraju ispitivanja i vrijednosti promjene dobivene su metodom prenesene posljednje zabilježene vrijednosti (engl. last observation carried forward).
English: The overall exposure of insulin degludec was equivalent following administration of Xultophy versus insulin degludec alone while the Cmax was higher by 12%.
Croatian: Ukupna izloženost degludek inzulinu nakon primjene lijeka Xultophy bila je ekvivalentna onoj nakon primjene samog degludek inzulina, dok je Cmax bio 12% viši.
English: CI: confidence interval
Croatian: interval pouzdanosti.
English: • Do not use Xultophy if you have type 1 diabetes mellitus or if you have ‘ketoacidosis' (a condition with a build-up of acid in the blood).
Croatian: • Nemojte primjenjivati lijek Xultophy ako imate šećernu bolest tipa 1 ili ako imate ‘ketoacidozu'
English: A drop of solution may appear at the needle tip.
Croatian: Na vrhu igle može se pojaviti kapljica otopine.
English: • high blood sugar (hyperglycaemia) - if your blood sugar is high, follow the advice in section 4 ‘High blood sugar (hyperglycaemia)'.
Croatian: • visoka razina šećera u krvi (hiperglikemija) - ako je razina šećera u Vašoj krvi visoka, slijedite savjet naveden u dijelu 4. ‘Visoka razina šećera u krvi (hiperglikemija)'.
English: 3 Select your dose • Turn the dose selector to select the dose you need.
Croatian: • Okrenite izbornik doze kako biste odabrali potrebnu dozu.
English: Description of selected adverse reactions
Croatian: Opis odabranih nuspojava Hipoglikemija
English: The 95% confidence interval is stated in ‘[]' *Confirmed hypoglycaemia defined as severe hypoglycaemia (episode requiring assistance of another person) and/or minor hypoglycaemia (plasma glucose <3.1 mmol/L irrespective of symptoms)
Croatian: *Potvrđena hipoglikemija definirana kao teška hipoglikemija (epizoda u kojoj je potrebna pomoć druge osobe) i/ili lakša hipoglikemija
English: Compared to baseline, Xultophy resulted in an unchanged mean body weight compared to a mean weight increase of 2.0 kg for patients treated with insulin glargine (estimated treatment difference -1.92 kg [95% CI: -2.64; -1.19]).
Croatian: U odnosu na početak ispitivanja, Xultophy je rezultirao nepromijenjenom srednjom vrijednosti tjelesne težine u usporedbi sa srednjom vrijednosti povećanja tjelesne težine od 2,0 kg u bolesnika liječenih glargin inzulinom (procijenjena razlika u liječenju -1,92 kg [95% CI: -2,64; -1,19]).
English: Please read these instructions carefully before using your Xultophy pre filled pen.
Croatian: Prije uporabe Vaše Xultophy napunjene brizgalice, molimo pažljivo pročitajte ove upute.