FrancophonIA/ELRC3.0 huggingface dataset:
English: Examples of signs that your blood sugar level is falling too much or too fast include: sweating, clammy skin, feeling anxious, fast or irregular heartbeat, high blood pressure and palpitations.
Croatian: Primjeri znakova koji Vam govore da razina šećera u krvi previše ili prebrzo pada su: znojenje, ljepljiva koža, tjeskoba, ubrzani ili nepravilni otkucaji srca, visok krvni tlak i osjećaj lupanja srca.
English: The Outcome Reduction with Initial Glargine Intervention trial (i.e., ORIGIN) was an open-label, randomised, 12,537 patient study that compared LANTUS to standard care on the time to first occurrence of a major adverse cardiovascular event (MACE).
Croatian: Outcome Reduction with Initial Glargine Intervention) bilo je otvoreno, randomizirano ispitivanje s 12 537 bolesnika koje je usporedilo lijek LANTUS sa standardnim liječenjem u vremenu do prve pojave velikog štetnog kardiovaskularnog događaja (engl. major adverse cardiovascular event, MACE).
English: Dosage titration
Croatian: Titracija doze
English: The dose should be adjusted on an individual basis, based on glucose monitoring.
Croatian: Dozu treba individualno prilagoditi, na temelju praćenja razina glukoze.
English: Consistent with a relatively constant concentration/time profile of insulin glargine over 24 hours with no pronounced peak when administered alone, the glucose utilisation rate/time profile was similar when given in the insulin glargine/lixisenatide combination.
Croatian: U skladu s relativno konstantnim profilom koncentracija/vrijeme inzulina glargina tijekom 24 sata bez izražene vršne koncentracije kad se primjenjuje zasebno, profil iskorištenja glukoze kroz vrijeme bio je sličan kad se dala kombinacija inzulin glargin/liksisenatid.
English: If you have kidney or liver problems If you have kidney or liver problems, talk to your doctor as you may need a lower dose.
Croatian: Ako imate probleme s bubrezima ili jetrom, razgovarajte sa svojim liječnikom jer ćete možda trebati nižu dozu.
English: • A reminder on the need to report all medication errors with Suliqua will be part of patient guide.
Croatian: • Podsjetnik o nužnosti prijave svih medikacijskih pogrešaka s primjenom lijekom Suliqua bit će dio vodiča za bolesnika.
English: In subjects with mild (creatinine clearance calculated by the Cockcroft-Gault formula 60-90 ml/min), moderate (creatinine clearance 30-60 ml/min) and severe renal impairment (creatinine clearance 15-30 ml/min) AUC of lixisenatide was increased by 46%, 51% and 87%, respectively.
Croatian: U ispitanika s blagim (klirens kreatinina 60-90 ml/min izračunat prema Cockcroft-Gaultovoj formuli), umjerenim (klirens kreatinina 30-60 ml/min) i teškim oštećenjem funkcije bubrega (klirens kreatinina 15-30 ml/min) AUC liksisenatida je bio povećan za 46%, 51% odnosno 87%.
English: No animal studies have been conducted with the combination of insulin glargine and lixisenatide to evaluate repeated dose toxicity, carcinogenesis, genotoxicity, or toxicity to reproduction.
Croatian: Nisu provedena ispitivanja na životinjama s kombinacijom inzulina glargina i liksisenatida kako bi se ocijenila toksičnost ponovljenih doza, kancerogenosti, genotoksičnosti i reproduktivne toksičnosti.
English: The ELIXA study was a randomised, double-blind, placebo-controlled, multinational study that evaluated cardiovascular (CV) outcomes during treatment with lixisenatide in patients (n=6068) with type 2 diabetes mellitus after a recent Acute Coronary Syndrome.
Croatian: ELIXA ispitivanje bilo je randomizirano, dvostruko slijepo, placebom kontrolirano, multinacionalno ispitivanje koje je procijenilo kardiovaskularne (KV) ishode tijekom liječenja liksisenatidom u bolesnika (n = 6068) sa šećernom bolešću tipa 2 koji su nedavno imali akutni koronarni sindrom.
English: Lixisenatide stimulates insulin secretion when blood glucose is increased but not at normoglycaemia, which limits the risk of hypoglycaemia.
Croatian: Liksisenatid potiče lučenje inzulina kada je povećana razina glukoze u krvi, ali ne i tijekom normoglikemije, što ograničava rizik od hipoglikemije.
English: The randomised type 2 diabetes population had the following characteristics: Mean age was 58.4 years with the majority (57.1%) being aged of 50 to 64 years, and 50.6 percent were male.
Croatian: Randomizirana populacija sa šećernom bolešću tipa 2 imala je sljedeća obilježja: srednja vrijednost dobi bila je 58,4 godina s većinom (57,1%) između 50 i 64 godine, te su 50,6% bili muškarci.
English: No dose adjustment is required for lixisenatide in patients with mild or moderate renal impairment.
Croatian: Nije potrebna prilagodba doze za liksisenatid u bolesnika s blagim ili umjerenim oštećenjem funckije bubrega.
English: • Diuretics, for high blood pressure or fluid retention.
Croatian: • diuretike, za liječenje visokog krvnog tlaka ili zadržavanja tekućine
English: • Pharmacists are encouraged to check that patients and caretakers are able to read the strength of Suliqua, the dose range of the pre filled pen and the dose counter of the pre filled pen before dispensing insulin glargine/lixisenatide.
Croatian: • Ljekarnici se potiču da provjere mogu li bolesnici i njegovatelji pročitati jačinu lijeka Suliqua, raspon doze napunjene brizgalice i brojač doza na napunjenoj brizgalici prije izdavanja inzulina glargina/liksisenatida.
English: Exposure to insulin glargine following administration of the insulin glargine/lixisenatide combination was 86-88 % compared to administration of separate simultaneous injections of insulin glargine and lixisenatide.
Croatian: Izloženost inzulinu glarginu nakon primjene kombinacije inzulina glargina i liksisenatida iznosila je 86-88% u odnosu na zasebnu istodobnu primjenu injekcija inzulina glargina i liksisenatida.
English: In addition, under the influence of sympatholytic medicinal products such as beta-blockers, clonidine, guanethidine and reserpine, the signs of adrenergic counter-regulation may be reduced or absent.
Croatian: Osim toga, pod utjecajem simpatolitika poput beta blokatora, klonidina, gvanetidina i rezerpina, znakovi adrenergičke proturegulacije mogu oslabjeti ili potpuno izostati.
English: No increase in mean heart rate was seen in all Phase 3 studies with Suliqua.
Croatian: Nije opaženo povećanje srednje vrijednosti srčane frekvencije u svim ispitivanjima faze 3 s lijekom Suliqua.
English: Patients treated with Suliqua should be advised of the potential risk of dehydration in relation to gastrointestinal adverse reactions and take precautions to avoid fluid depletion.
Croatian: Bolesnike liječene lijekom Suliqua treba upozoriti na mogući rizik od dehidracije povezan s gastrointestinalnim nuspojavama te savjetovati da poduzmu mjere opreza kako bi izbjegli gubitak tekućine.
English: There are no clinically relevant differences in the rate of absorption when lixisenatide as monotherapy is administered subcutaneously in the abdomen, deltoid, or thigh.
Croatian: Nema klinički značajnih razlika u brzini apsorpcije kada se liksisenatid kao monoterapija primjenjuje supkutano u abdomen, deltoidno područje ili bedro.
English: At the end of the run-in period, patients who remained inadequately controlled (HbA1c between 7% and 10%) were randomised to either Suliqua, insulin glargine or lixisenatide.
Croatian: Na kraju uvodnog razdoblja, bolesnici koji su ostali nedovoljno regulirani (HbA1c između 7% i 10%) randomizirani su na lijek Suliqua, inzulin glargin ili liksisenatid.
English: Suliqua has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis and therefore, the use of Suliqua is not recommended in these patients.
Croatian: Lijek Suliqua nije ispitivan u bolesnika s teškom gastrointestinalnom bolešću, uključujući tešku gastroparezu, stoga se primjena lijeka Suliqua u tih bolesnika ne preporučje.
English: If blood sugar remains very low for too long it may cause brain damage and may be life-threatening.
Croatian: Ako razina šećera predugo ostane vrlo niska to može uzrokovati oštećenje mozga te može biti opasno po život.
English: The dose window on the pen shows the number of dose steps.
Croatian: Prozorčić za prikaz doze na brizgalici pokazuje broj odmjernih koraka.
English: Cases of generalised allergic reaction including anaphylactic reaction and angioedema have been reported during marketed use of insulin glargine and lixisenatide.
Croatian: Slučajevi generalizirane alergijske reakcije uključujući anafilaktičku reakciju i angioedem prijavljene su za inzulin glargin i liksisenatid nakon stavljanja u promet.
English: Suliqua combines two active substances with complementary mechanisms of action to improve glycaemic control: insulin glargine, a basal insulin analog (mainly targeting fasting plasma glucose), and lixisenatide, a GLP-1 receptor agonist (mainly targeting postprandial glucose).
Croatian: Suliqua kombinira dvije djelatne tvari s komplementarnim mehanizmima djelovanja kako bi se poboljšala kontrola glikemije: inzulin glargin, analog bazalnog inzulina (većinski djeluje na razinu glukoze u plazmi natašte) i liksisenatid, agonist GLP-1 receptora (većinski djeluje na razinu glukoze nakon obroka).
English: C. Throw away the used needle in a puncture resistant container (see “Throwing your pen away” at the end of this Instructions for Use).
Croatian: Bacite iskorištenu iglu u neprobojan spremnik. (pogledajte 'Odlaganje brizgalice' na kraju ovih Uputa za uporabu).
English: • You are taking or have taken certain other medicines (see section 2, "Other medicines and
Croatian: • Uzimate ili ste prestali uzimati neke druge lijekove (pogledajte dio 2. "Drugi lijekovi i
English: • If you find it hard to press the injection button in, do not force it as this may break your pen.
Croatian: Ako Vam je teško pritisnuti dugme za injiciranje do kraja, nemojte ga pritiskati na silu jer biste mogli slomiti brizgalicu.
English: Only in this case, it is okay to inject a partial dose of less than 10 dose steps.
Croatian: Samo u ovom slučaju je u redu injicirati djelomičnu dozu manju od 10 odmjernih koraka.
English: *Not included in the pre-specified step-down testing procedure **2 hour PPG minus the pre-meal glucose value
Croatian: *nije uključeno u unaprijed određenom step-down postupku **vrijednost glukoze 2h nakon obroka minus vrijednost glukoze prije obroka
English: Drink or foods that contain artificial sweeteners (such as diet drinks) do not help treat low blood sugar.
Croatian: Napici ili hrana zaslađena umjetnim zaslađivačima (primjerice dijetalni napici) ne pomažu u liječenju niskog šećera u krvi.
English: Press the injection button all the way in.
Croatian: Pritisnite dugme za injiciranje do kraja.
English: Suliqua is to be injected subcutaneously in the abdomen, deltoid, or thigh.
Croatian: Suliqua se injicira supkutano u abdomen, deltoidno područje ili bedro.
English: Some medicines such as antibiotics, oral contraceptives, statins (medicines like atorvastatin to lower cholesterol), acidresistant tablets or capsules that should not stay too long in your stomach may need to be taken at least one hour before or four hours after your Suliqua injection.
Croatian: Neki lijekovi kao što su antibiotici, oralni kontraceptivi, statini (lijekovi poput atorvastatina za smanjenje kolesterola), želučanootporne tablete ili kapsule koji se ne smiju predugo zadržavati u želucu možda ćete morati uzeti najmanje jedan sat prije ili četiri sata nakon injekcije lijeka Suliqua.
English: The GLP-1 receptor is the target for native GLP-1, an endogenous incretin hormone that potentiates glucose-dependent insulin secretion from beta cells and suppresses glucagon from alpha cells in the pancreas.
Croatian: GLP-1 receptor ciljno je mjesto za prirodni GLP-1, endogeni inkretinski hormon koji pojačava o glukozi ovisno lučenje inzulina iz beta stanica gušterače i potiskuje lučenje glukagona iz alfa stanica gušterače.
English: • If the patient starts with the Suliqua (10-40) pen, the dose may be titrated up to 40 dose steps with this pen.
Croatian: • Ako bolesnik počinje s primjenom Suliqua (10-40) brizgalice, doza se može titrirati do maksimalno 40 odmjernih koraka pomoću ove brizgalice.
English: This pen is peach coloured with an orange injection button.
Croatian: Ova brizgalica je boje breskve sa narančastim dugmetom za injiciranje.
English: In in vitro studies, lixisenatide did not affect the activity of cytochrome P450 isozymes or human transporters tested.
Croatian: U ispitivanjima in vitro, liksisenatid nije utjecao na aktivnost ispitivanih izoenzima citokroma P450 ni humanih transportera.
English: Animal data do not indicate reproductive toxicity with insulin glargine.
Croatian: Podaci dobiveni na životinjama ne ukazuju na reproduktivnu toksičnost inzulina glargina.
English: The main reasons for not entering the randomized phase were FPG value >13.9 mmol/L and HbA1c value <7% or >10% at the end of the run-in phase
Croatian: Glavni razlozi neulaska u randomiziranu fazu bili su razina glukoze u plazmi natašte >13,9 mmol/l i vrijednost HbA1c <7% ili >10% na kraju uvodnog razdoblja.
English: Mild episodes of hypoglycaemia can usually be treated with oral carbohydrates.
Croatian: Blage epizode hipoglikemije obično se mogu liječiti peroralnom primjenom ugljikohidrata.
English: For lixisenatide no dose adjustment is required based on age.
Croatian: Za liksisenatid nije potrebna prilagodba doze s obzirom na dob.
English: • Diazoxide, for high blood pressure.
Croatian: • diazoksid, za liječenje visokog krvnog tlaka
English: Do not inject Suliqua.
Croatian: Nemojte injicirati lijek Suliqua.
English: The label must always be checked before each injection to avoid medication errors between Suliqua and other injectable anti-diabetic medicinal products, including the 2 different pens of Suliqua (see section 4.4).
Croatian: Prije svake injekcije uvijek se mora provjeriti naljepnica kako ne bi došlo do medikacijskih pogrešaka zbog zamjene lijeka Suliqua i drugih antidijabetičkih lijekova koji se injiciraju, a to uključuje i dvije različite brizgalice lijeka Suliqua (vidjeti dio 4.4).
English: If necessary, you might need to test your blood sugar more often.
Croatian: Ako je potrebno, češće mjerite razinu šećera u krvi.
English: After multiple-dose administration in patients with type2 diabetes, mean terminal half-life was approximately 3 hours and the mean apparent clearance (CL/F) about 35 L/h.
Croatian: Nakon primjene višekratnih doza u bolesnika sa šećernom bolešću tipa 2 srednja vrijednost terminalnog poluvijeka bila je približno 3 sata, a prividni srednji klirens (CL/F) približno 35 l/h.
English: • Pentamidine, for some parasite infections.
Croatian: • pentamidin, za liječenje infekcije parazitima.
English: Only in this case, it is okay to inject a partial dose of less than 30 dose steps.
Croatian: Samo u ovom slučaju je u redu injicirati djelomičnu dozu manju od 30 odmjernih koraka.
English: A postprandial injection of Lixisenatide also slows gastric emptying thereby reducing the rate at which meal-derived glucose is absorbed and appears in the circulation.
Croatian: Injekcija liksisenatida nakon obroka također usporava pražnjenje želuca i time smanjuje brzinu kojom se glukoza iz obroka apsorbira i pojavljuje u cirkulaciji.
English: • insulin glargine: a long-acting type of insulin which helps control blood sugar (glucose)
Croatian: • inzulin glargin: dugodjelujući oblik inzulina koji pomaže u kontroli šećera (glukoze) u krvi tijekom dana
English: The differentiation between the pen strengths is based on the dose range of the pen.
Croatian: Razlika između jačina brizgalica temelji se na rasponu doza u brizgalici.
English: These changes are not clinically relevant and, therefore, no dose adjustment for atorvastatin is required when co-administered with lixisenatide.
Croatian: Te promjene nisu klinički značajne i stoga nije potrebna prilagodba doze atorvastatina pri istodobnoj primjeni s liksisenatidom.
English: • Explain what the patient should anticipate regarding dysglycemia and potential adverse reactions.
Croatian: • Objasnite bolesniku što može očekivati u pogledu poremećaja razine glukoze u krvi i mogućih nuspojava.
English: In embryo-foetal development studies, malformations, growth retardation, ossification retardation and skeletal effects were observed in rats at all doses (5-fold exposure ratio compared to human exposure) and in rabbits at high doses (32-fold exposure ratio compared to human exposure) of lixisenatide.
Croatian: U ispitivanjima embriofetalnog razvoja opažene su malformacije, zastoj u rastu, zakašnjelo okoštavanje i učinci na skeletu pri svim dozama liksisenatida u štakora (omjer izloženosti 5 puta veći od onog u ljudi) te pri visokim dozama liksisenatida u kunića (omjer izloženosti 32 puta veći od onog u ljudi).
English: What Suliqua is and what it is used for What you need to know before you use Suliqua How to use Suliqua
Croatian: Što je Suliqua i za što se koristi Što morate znati prije nego počnete primjenjivati lijek Suliqua Kako primjenjivati lijek Suliqua Moguće nuspojave
English: In a pre-specified analysis of this primary endpoint, the differences observed were consistent with regard to baseline HbA1c (<8% or ≥8%) or baseline OAD use (metformin alone or metformin plus second OAD).
Croatian: U prethodno određenoj analizi ove mjere primarnog ishoda, opažene su razlike bile dosljedne s obzirom na početnu vrijednost HbA1c (<8% ili ≥8%) ili na početnu primjenu oralnih antidijabetika (samo metformin ili metformin uz drugi oralni antidijabetik).
English: As lixisenatide is cleared primarily by the kidney, no pharmacokinetic study has been performed in patients with acute or chronic hepatic impairment.
Croatian: Budući da se klirens liksisenatida odvija prvenstveno putem bubrega, nisu provedena farmakokinetička ispitivanja u bolesnika s akutnim ili kroničnim oštećenjem funkcije jetre.
English: D. Pull off the inner needle cap and throw away.
Croatian: Skinite unutarnji zatvarač s igle i bacite ga.
English: Suliqua is indicated in combination with metformin for the treatment of adults with type 2 diabetes mellitus to improve glycaemic control when this has not been provided by metformin alone or metformin combined with another oral glucose lowering medicinal product or with basal insulin (see section 4.4 and 5.1 for available data on the different combinations).
Croatian: Suliqua je indicirana u kombinaciji s metforminom za liječenje odraslih sa šećernom bolešću tipa 2 radi poboljšanja kontrole glikemije, kada ona nije postignuta samo metforminom ili metforminom u kombinaciji s drugim oralnim lijekovima za snižavanje razine glukoze u krvi ili s bazalnim inzulinom (vidjeti dijelove 4.4 i 5.1 za dostupne podatke o različitim kombinacijama).
English: Do not use Suliqua:
Croatian: Nemojte primijeniti lijek Suliqua:
English: • Angiotensin converting enzyme (ACE) inhibitors, for heart problems or high blood pressure.
Croatian: • inhbitore angiotenzin konvertirajućeg enzima (ACE inhibitori), za liječenje srčanih tegoba ili visokog krvnog tlaka
English: Turn the dose selector until the dose pointer lines up with your dose.
Croatian: Okrećite izbornik doze sve dok se pokazivač doze ne poravna s Vašom dozom.
English: • Change the needle (see STEP 6 Remove the needle and STEP 2 Attach a new needle) then do a safety test (see STEP 3).
Croatian: Promijenite iglu (pogledajte KORAK 6 Uklonite iglu i KORAK 2 Pričvrstite novu iglu) i onda napravite test sigurnosti (pogledajte KORAK 3).
English: In patients treated with Suliqua, the incidence of related nausea, diarrhoea and vomiting was 8.4%, 2.2% and 2.2%, respectively.
Croatian: U bolesnika liječenih lijekom Suliqua, incidencija povezanih mučnina bila je 8,4%, incidencija povezanih proljeva 2,2%, a incidencija povezanih povraćanja bila je 2,2%.
English: • If you turn past your dose, you can turn back down.
Croatian: Ako premašite dozu, možete je vratiti natrag.
English: Always use another Suliqua (10-40) pen to complete your dose and no other pen.
Croatian: Uvijek upotrijebite drugu Suliqua brizgalicu (10-40) da upotpunite svoju dozu, a ne neku drugu brizgalicu.
English: You should test your blood sugar straight away after taking glucose to check that you really have hypoglycaemia.
Croatian: Preporučuje se da odmah nakon uzimanja glukoze izmjerite razinu šećera u krvi kako biste provjerili imate li zaista hipoglikemiju.
English: • Do not put the inner needle cap back on.
Croatian: Nemojte vraćati natrag unutarnji zatvarač na iglu.
English: Substances that may enhance the blood-glucose-lowering effect and increase susceptibility to hypoglycaemia include anti-hyperglycaemic medicinal products, angiotensin converting enzyme (ACE) inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase (MAO) inhibitors, pentoxifylline, propoxyphene, salicylates and sulfonamide antibiotics.
Croatian: Tvari koje mogu pojačati učinak snižavanja razine glukoze u krvi i povećati sklonost hipoglikemiji uključuju lijekove protiv hiperglikemije, inhibitore angiotenzin konvertirajućeg enzima (ACE), dizopiramid, fibrate, fluoksetin, inhibitore monoaminooksidaze (MAO), pentoksifilin, propoksifen, salicilate i sulfonamidske antibiotike.
English: During this run-in phase metformin treatment was optimised and any other OADs were discontinued.
Croatian: Tijekom uvodnog razdoblja, optimizirano je liječenje metforminom i prekinuto je liječenje bilo kojim drugim oralnim antidijabetikom.
English: This can help to spot mild hypoglycaemic episodes.
Croatian: To Vam može pomoći u prepoznavanju blagih epizoda hipoglikemije.
English: Other signs include: headaches, feeling very hungry, feeling sick (nausea) or being sick (vomiting), feeling tired, sleepy, restless, sleeping problems, aggressive behaviour, difficulty concentrating, slow reactions, depression, feeling confused, difficulty speaking (sometimes total loss of speech), changes in your sight, trembling, being unable to move (paralysis), tingling in the hands or arms, feeling numb and tingling often around the mouth, feeling dizzy, loss of self-control, being unable to look after yourself, fits, passing out.
Croatian: Drugi znakovi uključuju: glavobolje, osjećaj jake gladi, mučninu ili povraćanje, umor, pospanost, nemir, probleme sa spavanjem, agresivno ponašanje, poteškoće s koncentracijom, usporene reakcije, depresiju, smetenost, poteškoće s govorom (ponekad potpun gubitak sposobnosti govora), promjene vida, drhtavicu, nemogućnost kretanja (paraliza), trnce u šakama i rukama, utrnulost i trnce u području oko usta, omaglicu , gubitak samokontrole, nesposobnost vođenja brige o samom sebi, napadaje, gubitak svijesti.
English: Insulin and its analogs lower blood glucose by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production.
Croatian: Inzulin i njegovi analozi snižavaju razinu glukoze u krvi potičući periferni unos glukoze, posebno u skeletnu muskulaturu i masno tkivo te inhibirajući stvaranje glukoze u jetri.
English: • Glucagon, for very low blood sugar.
Croatian: • glukagon, za liječenje vrlo niske razine šećera u krvi
English: • Changes where the injection is given: If you inject Suliqua too often in the same place, you may develop dents at the site, caused by a loss of fat under the skin (lipoatrophy) or you may develop lumps, caused by a build up of fat under the skin (lipohypertrophy).
Croatian: • promjene na mjestu injiciranja: ako učestalo injicirate lijek Suliqua na isto mjesto mogu se javiti udubljenja uzrokovana gubitkom potkožnog masnog tkiva (lipoatrofija) ili kvržice uzrokovane nakupljanjem potkožnog masnog tkiva (lipohipertrofija).