FrancophonIA/ELRC3.0 huggingface dataset:
English: It is given, with metformin, when other medicines are not enough on their own to control your blood sugar levels.
Croatian: Primjenjuje se s metforminom kada drugi lijekovi nisu sami dovoljni za kontrolu razine šećera u krvi.
English: Suliqua is an injectable diabetes medicine that contains two active substances:
Croatian: Suliqua je lijek u obliku injekcije za liječenje šećerne bolesti koji sadrži dvije djelatne tvari:
English: After holding and slowly counting to 10, release the injection button.
Croatian: Nakon što ste držeći dugme pritisnutim polako brojali do 10, otpustite dugme za injiciranje.
English: Check that the medicine is clear.
Croatian: Provjerite je li lijek bistar.
English: A. Make sure a needle is attached and the dose is set to ‘0'.
Croatian: Uvjerite se da je igla pričvršćena i doza postavljena na '0'
English: If you do, it could lead to very high blood sugar (hyperglycaemia) and a build-up of acid in the blood (ketoacidosis).
Croatian: Ako to napravite, to može dovesti do vrlo visoke razine šećera u krvi (hiperglikemija) i nakupljanja kiseline u krvi (ketoacidoza).
English: • Fibrates, for lowering high levels of blood fats.
Croatian: • fibrate, za snižavanje visokih razina masnoća u krvi
English: • Sulfonamide antibiotics, to treat infections.
Croatian: • sulfonamidne antibiotike, za liječenje infekcije
English: Prior to launch of Suliqua in each Member State, the Marketing Authorisation Holder (MAH) must agree the content and format of the educational materials for Suliqua, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Croatian: Prije stavljanja u promet lijeka Suliqua u svakoj državi članici, nositelj odobrenja za stavljanje lijeka u promet mora dogovoriti s nadležnim nacionalnim tijelom sadržaj i oblik edukacijskih materijala, uključujući sredstva komunikacije, način distribucije, kao i sve ostale aspekte programa.
English: Your blood sugar level may either rise or fall if you drink alcohol.
Croatian: Razina šećera u krvi može porasti ili pasti ako pijete alkohol.
English: As a peptide, lixisenatide is eliminated through glomerular filtration, followed by tubular reabsorption and subsequent metabolic degradation, resulting in smaller peptides and amino acids, which are reintroduced in the protein metabolism.
Croatian: Kao peptid, liksisenatid se eliminira glomerularnom filtracijom nakon čega slijedi tubularna reapsorpcija i zatim metabolička razgradnja, što rezultira nastankom manjih peptida i aminokiselina, koji ponovno ulaze u metabolizam proteina.
English: Hypoglycaemia can be very serious and is very common with medicine containing insulin (may affect more than 1 in 10 people).
Croatian: Hipoglikemija može biti vrlo ozbiljna i vrlo je česta uz liječenje inzulinom (može se javiti u više od 1 na 10 osoba).
English: You can select your dose in steps of 1 dose step.
Croatian: Možete odabrati svoju dozu u koracima od 1 odmjernog koraka
English: There is no therapeutic experience in patients with severe renal impairment (creatinine clearance less than 30 ml/min) or end-stage renal disease.
Croatian: Nema terapijskog iskustva u bolesnika s teškim oštećenjem funkcije bubrega (klirens kreatinina manji od 30 ml/min) ili završnom fazom bubrežne bolesti.
English: Do not use this medicine after the expiry date which is stated on the carton and on the label of the pen after “EXP”.
Croatian: Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i naljepnici brizgalice iza oznake "EXP".
English: The MAH shall ensure that, in each Member State where Suliqua is marketed, all healthcare professionals who are expected to prescribe, dispense and patients who are expected to use Suliqua, have access to/are provided with the following educational package:
Croatian: Nositelj odobrenja mora osigurati da, u svakoj državi članici na čijem se tržištu Suliqua nalazi, svi zdravstveni radnici za koje se očekuje da će propisivati i izdavati lijek Suliqua te bolesnici za koje se očekuje da će primjenjivati lijek Suliqua, imaju pristup ili im se dostavi sljedeći edukacijski paket:
English: 10-40 dose steps SoloStar
Croatian: 10-40 odmjernih koraka SoloStar
English: • You can clean the outside of your pen by wiping it with a damp cloth (water only).
Croatian: Vanjski dio svoje brizgalice možete prebrisati vlažnom krpom (samo voda).
English: This could be a sign of of inflamed pancreas (acute pancreatitis).
Croatian: Ovo može biti znak upale gušterače (akutni pankreatitis).
English: You should check your blood sugar level more often.
Croatian: Trebali biste češće provjeravati razinu šećera u krvi.
English: • For any other basal insulin the same rule as for insulin glargine (100 units/ml) should be applied
Croatian: • Za bilo koji drugi bazalni inzulin treba primijeniti isto pravilo kao i za inzulin glargin (100 jedinica/ml)
English: • Do not touch the injection button yet.
Croatian: Nemojte još dirati dugme za injiciranje.
English: Metformin was a mandatory background therapy and 58% of patients received a second OAD at screening, being a sulfonylurea in 54% of patients.
Croatian: Metformin je bio obvezna osnovna terapija i 58% bolesnika primilo je drugi oralni antidijabetik na probiru, koji je u 54% bolesnika bio sulfonilureja.
English: However, the patient's ability to concentrate and react may be impaired as a result of hypoglycaemia or hyperglycaemia or, for example, as a result of visual impairment.
Croatian: Međutim, bolesnikova sposobnost koncentracije i reagiranja može biti umanjena zbog hipoglikemije ili hiperglikemije ili, na primjer, zbog oštećenja vida.
English: STEP 1: Check your pen
Croatian: KORAK 1: Pregledajte Vašu brizgalicu
English: Keep the needle straight and screw it onto the pen until fixed.
Croatian: Držeći iglu ravno, navijte je na brizgalicu dok ne bude dobro pričvršćena.
English: Use in elderly patients (65 years and older) If you are 65 years or older, talk to your doctor as you may need a lower dose.
Croatian: Primjena u starijih bolesnika (65 godina i starijih) Ako imate 65 ili više godina, razgovarajte sa svojim liječnikom jer ćete možda trebati nižu dozu.
English: • Always use needles that are compatible for use with Suliqua pen.
Croatian: Uvijek upotrijebite igle koje su kompatibilne za uporabu sa Suliqua brizgalicom.
English: The injection sites should be rotated within the same region (abdomen, deltoid, or thigh) from one injection to the next to reduce the risk of lipodystrophy (see section 4.8).
Croatian: Mjesto injiciranja mora se mijenjati unutar istog područja (abdomen, deltoidno područje ili bedro) od injekcije do injekcije kako bi se smanjio rizik od lipodistrofije (vidjeti dio 4.8).
English: • Sympathomimetic medicines such as epinephrine (adrenaline), salbutamol and terbutaline, for asthma.
Croatian: • simpatomimetičke lijekove kao što je epinefrin (adrenalin), salbutamol i terbutalin -za liječenje astme
English: In case of gastrointestinal adverse reactions, appropriate supportive treatment should be initiated according to the patient's clinical signs and symptoms.
Croatian: U slučaju nuspojava probavnog sustava, treba započeti prikladno potporno liječenje u skladu s bolesnikovim kliničkim znakovima i simptomima.
English: (-1.63 to -0.57)
Croatian: (-1,63 do -0,57)
English: If a patient wishes to become pregnant, or pregnancy occurs, treatment with Suliqua should be discontinued.
Croatian: Ako bolesnica želi zatrudnjeti ili zatrudni, liječenje lijekom Suliqua treba prekinuti.
English: After 30 weeks of treatment with Suliqua in two phase 3 trials, the incidence of formation of antiinsulin glargine antibodies was 21.0% and 26.2%.
Croatian: Nakon 30 tjedana liječenja lijekom Suliqua u dva klinička ispitivanja faze 3, incidencija stvaranja protutijela na inzulin glargin bila je 21,0% i 26,2%.
English: This may cause too low blood sugar which is sometimes followed by too high blood sugar.
Croatian: To može uzrokovati prenizak šećer u krvi nakon kojeg ponekad može uslijediti previsok šećer u krvi.
English: This medicine contains metacresol which may cause allergic reactions.
Croatian: Ovaj lijek sadrži metakrezol, koji može uzrokovati alergijske reakcije.
English: Lixisenatide is a peptide and is not metabolised by cytochrome P450.
Croatian: Liksisenatid je peptid i ne metabolizira se pomoću citokroma P450.
English: Animal studies did not indicate direct harmful effects with respect to male and female fertility in rats.
Croatian: Ispitivanja na životinjama nisu ukazala na izravne štetne učinke na plodnost u mužjaka i ženki štakora.
English: You should know what they are so that you can take the right action if your blood sugar level changes and help stop it becoming too high or too low.
Croatian: Morate ih poznavati kako biste znali što učiniti ako se promijeni razina šećera u krvi i kako spriječiti da ona postane previsoka ili preniska.
English: In both studies the dose was titrated once weekly, based on fasting self-measured plasma glucose values.
Croatian: U oba je ispitivanja doza titrirana jednom tjedno, na temelju samoizmjerenih razina glukoze u plazmi.
English: Stomach pain, fast and deep breathing, feeling sleepy or passing out (becoming unconscious) may be signs of a serious condition (ketoacidosis) resulting from lack of insulin.
Croatian: Bol u trbuhu, brzo i duboko disanje, pospanost ili čak gubitak svijesti mogu biti znakovi ozbiljnog stanja (ketoacidoza) koje je nastalo zbog manjka inzulina.
English: Suliqua should be injected once a day within one hour prior to a meal.
Croatian: Suliqua se treba injicirati jednom dnevno unutar jednog sata prije obroka.
English: Your dose of Suliqua is administered as ‘dose steps'.
Croatian: Vaša doza lijeka Suliqua primjenjuje se u "odmjernim koracima".
English: The time course of action of insulins, including Suliqua, may vary between individuals and within the same individual.
Croatian: Profil djelovanja inzulina kroz vrijeme, uključujući lijek Suliqua, može varirati između pojedinaca i kod pojedine osobe.
English: *You will not see the plunger until you have injected a few doses
Croatian: *Klip se neće vidjeti dok ne injicirate nekoliko doza
English: Some (1.7%) patients taking insulin containing therapy, including Suliqua have experienced erythema, local edema, and pruritus at the site of injection.
Croatian: Neki bolesnici (1,7%) koji primaju liječenje koje sadrži inzulin, uključujući lijek Suliqua, doživjeli su eritem, lokalni edem i svrbež na mjestu injekcije.
English: • Foods containing sugar, such as dextrose tablets or a sugary drink (at least 20 grams).
Croatian: • hranu koja sadrži šećer, kao što su tablete glukoze ili šećerni napitak (barem 20 grama).
English: Suliqua must not be drawn from the cartridge of the pre-filled pen into a syringe to avoid dosing errors and potential overdose (see section 4.4).
Croatian: Suliqua se ne smije izvlačiti iz uloška napunjene brizgalice u štrcaljku kako bi se izbjegle pogreške u doziranju i moguće predoziranje (vidjeti dio 4.4).
English: There have been few reported events of acute pancreatitis with lixisenatide although a causal relationship has not been established.
Croatian: Prijavljeno je nekoliko slučajeva akutnog pankreatitisa prilikom primjene liksisenatida iako uzročna veza nije bila utvrđena.
English: • Only use needles that are compatible with Suliqua pen (see “Instructions for Use”).
Croatian: • Koristite samo one igle koje su kompatibilne sa Suliqua brizgalicom (vidjeti "Upute za uporabu").
English: Other side effects Tell your doctor, pharmacist or nurse if you notice any of the following side effects: Common: may affect up to 1 in 10 people
Croatian: Druge nuspojave Obavijestite svog liječnika, ljekarnika ili medicinsku sestru ako primijetite sljedeće nuspojave: Česte: mogu se javiti u manje od 1 na 10 osoba
English: • You have an injury, infection or fever or have had an operation.
Croatian: • ako ste ozlijeđeni, imate infekciju ili vrućicu ili ako ste imali operaciju.
English: In the presence of anti-lixisenatide antibodies, lixisenatide exposure and variability in exposure are markedly increased regardless of the dose level.
Croatian: U prisutnosti protutijela na liksisenatid, izloženost liksisentidu i varijabilnost u izloženosti se značajno povećavaju neovisno o dozi.
English: In each of the active-controlled trials, treatment with Suliqua produced clinically and statistically significant improvements in hemoglobin A1c (HbA1c).
Croatian: U svakom od aktivno kontroliranih ispitivanja, liječenje lijekom Suliqua dovelo je do klinički i statistički značajnog poboljšanja vrijednosti hemoglobina A1c (HbA1c).
English: At screening 64.4% of patients were receiving insulin glargine as basal insulin and 95.0% received at least 1 concomitant OAD.
Croatian: Na probiru je 64,4% bolesnika primalo inzulin glargin kao bazalni inzulin i 95,0% istodobno je primalo barem 1 oralni antidijabetik.
English: You should learn to recognise the signs when your blood sugar is falling - so you can take action to stop it getting worse.
Croatian: Morate naučiti prepoznati znakove koji upućuju na pad razine šećera u krvi kako biste mogli poduzeti mjere kojima ćete spriječiti daljnje pogoršanje.
English: • Only use your pen for up to 28 days after its first use.
Croatian: Koristite brizgalicu do najviše 28 dana nakon prve uporabe.
English: Uncommon: may affect up to 1 in 100 people
Croatian: Manje česte: mogu se javiti u manje od 1 na 100 osoba
English: INFORMATION IN BRAILLE Suliqua 10 - 40
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Suliqua 10-40
English: • When you may need a higher or lower dose.
Croatian: • Vam reći kada ćete možda trebati injicirati veću ili manju dozu lijeka
English: • If you cannot select your full prescribed dose, use a new pen or inject the remaining dose steps and use a new pen to complete your dose.
Croatian: Ako ne možete odabrati cijelu propisanu dozu, upotrijebite novu brizgalicu ili injicirajte preostale odmjerene korake i upotrijebite novu brizgalicu da upotpunite svoju dozu.
English: Suliqua should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis.
Croatian: Suliqua se ne smije koristiti u bolesnika sa šećernom bolešću tipa 1 ili za liječenje dijabetičke ketoacidoze.
English: Your doctor may tell you to use a different dose of Suliqua compared to your previous insulin dose.
Croatian: Vaš liječnik Vam može reći da primijenite različitu dozu lijeka Suliqua u odnosu na dozu inzulina koju ste prethodno primjenjivali.
English: • Always check the label of the pen before use to make sure you have the correct pen.
Croatian: • Uvijek provjerite naljepnicu na brizgalici prije uporabe kako biste bili sigurni da imate odgovarajuću brizgalicu.
English: Mixing or diluting can change its time/action profile and mixing can cause precipitation.
Croatian: Miješanje ili razrjeđivanje može promijeniti vrijeme i način djelovanja lijeka, a miješanje može uzrokovati taloženje.
English: Gastrointestinal adverse reactions (nausea, vomiting and diarrhoea) were frequently reported adverse reactions during the treatment period.
Croatian: Nuspojave probavnog sustava (mučnina, povraćanje i proljev) bile su često prijavljene nuspojave tijekom razdoblja liječenja.
English: In approximately 93% of the patients, anti-insulin glargine antibodies showed cross-reactivity to human insulin.
Croatian: U približno 93% bolesnika, protutijela na inzulin glargin pokazala su križnu reaktivnost s humanim inzulinom.
English: The starting dose of Suliqua isbased on previous anti-diabetic treatment, and in order not to exceed the recommended lixisenatide starting dose of 10 mcg:
Croatian: Početna doza lijeka Suliqua temelji se na prethodnom liječenju antidijabeticima i kako se ne bi prekoračila preporučena početna doza liksisenatida od 10 mikrograma:
English: • The time you eat meals and use your medicine.
Croatian: • rasporedu uzimanja obroka i uporabi lijeka
English: • If you do not follow all of these instructions, you may get too much or too little of Suliqua.
Croatian: • ako ne budete slijedili ove upute, možete primijeniti previše ili premalo lijeka Suliqua
English: The incidence of the primary endpoint was similar in the lixisenatide (13.4%) and placebo (13.2%) groups: the hazard ratio (HR) for lixisenatide versus placebo was 1.017, with an associated 2-sided 95% confidence interval (CI) of 0.886 to 1.168.
Croatian: Incidencija primarnog ishoda bila je slična u skupinama za liksisenatid (13,4%) i placebo (13,2%): omjer hazarda (OH) za liksisenatid u usporedbi s placebom bio je 1,017, s dvostranim 95% intervalom pouzdanosti (IP) od 0,886 do 1,168.
English: Paediatric population No studies have been performed with Suliqua in children and adolescents below 18 years of age.
Croatian: Pedijatrijska populacija Nisu provedena ispitivanja sa lijekom Suliqua u djece i adolescenata ispod 18 godina starosti.
English: • Skin and allergic reactions at the injection site: The signs may include reddening, unusually intense pain when injecting, itching, hives, swelling or inflammation.
Croatian: • kožne i alergijske reakcije na mjestu injiciranja: znakovi mogu uključivati crvenilo, neuobičajeno jaku bol prilikom injiciranja, svrbež, koprivnjaču, oticanje ili upalu.
English: The safety and effectiveness of Suliqua on glycaemic control were evaluated in two randomised clinical studies in patients with type 2 diabetes mellitus:
Croatian: Sigurnost i učinkovitost lijeka Suliqua u kontroli glikemije ocijenjena je u dva randomizirana klinička ispitivanja u bolesnika sa šećernom bolešću tipa 2:
English: [12.2 to 24.0]
Croatian: [12,2 do 24,0]
English: Tell your relatives, friends and close colleagues to get medical help straight away if you are not able to swallow or if you pass out (become unconscious).
Croatian: Obavijestite rodbinu, prijatelje i bliske suradnike da odmah potraže medicinsku pomoć ako ne možete gutati ili ako se onesvijestite.
English: • Monoamine oxidase inhibitors (MAOIs), for depression or Parkinson´s disease.
Croatian: • inhibitore monoaminooksidaze (MAO inhibitori), za liječenje depresije ili Parkinsonove bolesti
English: This helps stop blocked needles, contamination, and infection.
Croatian: To će pomoći spriječiti začepljenje igle, onečišćenje i infekciju.
English: Your doctor may tell you to use Suliqua with other medicines for high blood sugar.
Croatian: Liječnik će Vam možda reći da uzimate lijek Suliqua sa drugim lijekovima za liječenje visoke razine šećera u krvi.
English: • Medicines to relieve pain and lower fever, such as pentoxifylline, propoxyphene and salicylates
Croatian: • lijekove za ublažavanje boli ili smanjenje vrućice, kao što je pentoksifilin, propoksifen i salicilati
English: • Ensure that your patients and their caretakers are adequately informed on how to use insulin glargine/lixisenatide.
Croatian: • Osigurajte da su vaši bolesnici i njihovi njegovatelji odgovarajuće informirani kako koristiti inzulin glargin/liksisenatid
English: • Isoniazid, for tuberculosis.
Croatian: • izoniazid, za liječenje tuberkuloze
English: • Try again if the needle does not come off the first time.
Croatian: Pokušajte ponovno ako se igla ne odvoji nakon prvog pokušaja.
English: STEP 4: Select the dose
Croatian: KORAK 4: Odaberite dozu
English: Suliqua is to be dosed in accordance with the individual patient's need for insulin.
Croatian: Suliqua se treba dozirati u skladu s potrebama pojedinog bolesnika za inzulinom.
English: Reaching lower HbA1c levels and achieving greater HbA1c reduction did not increase rates of hypoglycaemia with combination treatment versus insulin glargine alone (see section 4.8).
Croatian: Dosezanje nižih razina HbA1c i postizanje većeg smanjenja vrijednosti HbA1c nije povećalo stopu hipoglikemije u kombiniranom liječenju naspram samog inzulina glargina (vidjeti dio 4.8).
English: The primary activity of insulin, including insulin glargine, is regulation of glucose metabolism.
Croatian: Primarno djelovanje inzulina, uključujući i inzulin glargin, jest regulacija metabolizma glukoze.
English: • Any other medicine to treat diabetes.
Croatian: • bilo koji drugi lijek za liječenje šećerne bolesti
English: 30-60 dose steps SoloStar
Croatian: 30-60 odmjernih koraka SoloStar
English: There are no adequate data from the use of lixisenatide in pregnant women.
Croatian: Nema odgovarajućih podataka o primjeni liksisenatida u trudnica.
English: • Patient Guide.
Croatian: • Vodič za bolesnike
English: A large amount of data on pregnant women (more than 1,000 pregnancy outcomes) with insulin glargine indicate no specific adverse effects of insulin glargine on pregnancy and no specific malformative nor feto/neonatal toxicity of insulin glargine.
Croatian: Velika količina podataka o trudnicama (više od 1000 iznesenih trudnoća) izloženih inzulinu glarginu nije ukazala na specifične štetne učinke inzulina glargina na trudnoću ni na specifičnu malformativnu ili feto/neonatalnu toksičnost inzulina glargina.
English: To avoid mistakes, always check the medicine pack and label on the pen before each injection to make sure you have the correct pen, especially if you inject more than one medicine.
Croatian: Da izbjegnete pogreške, uvijek provjerite pakiranje lijeka i naljepnicu na brizgalici prije svakog injiciranja kako bi bili sigurni da imate odgovarajuću brizgalicu, a posebice ako injicirate više od jednog lijeka.
English: If you see air bubbles • You may see air bubbles in the medicine.
Croatian: Možda ćete vidjeti mjehuriće zraka u lijeku.
English: Non-clinical data for insulin glargine reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.
Croatian: Neklinički podaci za inzulin glargin ne upućuju na posebnu opasnost za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti, kancerogenog potencijala i reproduktivne toksičnosti.
English: Use Suliqua once a day, within 1 hour before a meal.
Croatian: Primijenite lijek Suliqua jednom dnevno, unutar sat vremena prije obroka.
English: • Remove the needle before throwing your pen away.
Croatian: Skinite iglu prije nego što bacite brizgalicu.
English: Suliqua has not been studied in combination with DPP-4 inhibitors, sulfonylureas, glinides, pioglitazone and SGLT-2 inhibitors.
Croatian: Suliqua nije ispitivana u kombinaciji s inhibitorima DPP-4, sulfonilurejama, glinidima, pioglitazonom i inhibitorima SGLT-2.
English: The median duration of study follow-up was 25.8 and 25.7 months in the lixisenatide group and the placebo group, respectively.
Croatian: Medijan trajanja praćenja ispitivanja bio je 25,8 mjeseci za skupinu liječenu s liksisenatidom i 25,7 mjeseci za placebo skupinu.
English: The lixisenatide dose is increased or decreased along with insulin glargine dose and also depends on which pen is used.
Croatian: Doza liksisenatida se povećava ili smanjuje zajedno s dozom inzulina glargina i također ovisi o tome koja se brizgalica koristi.
English: (-2.79 to -1.96)
Croatian: (-2,79 do -1,96)
English: The solution should be clear, colourless and water-like.
Croatian: Otopina treba biti bistra, bezbojna i vodenasta.
English: Do not freeze or place next to the freezer compartment or a freezer pack.
Croatian: Ne zamrzavati ili čuvati blizu odjeljka za zamrzavanje ili rashladnog uloška.
English: • Your low blood sugar comes on slowly.
Croatian: • razina šećera u krvi sporo pada
English: • For doses >40 dose steps/day titration must be continued with Suliqua (30-60) pen.
Croatian: • Za doze >40 odmjernih koraka/dan, titracija se mora nastaviti sa Suliqua (30-60) brizgalicom.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Suliqua in all subsets of the paediatric population for treatment of type 2 diabetes mellitus (see section 4.2 for information on paediatric use).
Croatian: Europska agencija za lijekove izuzela je obvezu podnošenja rezultata ispitivanja lijeka Suliqua u svim podskupinama pedijatrijske populacije za liječenje šećerne bolesti tipa 2 (vidjeti dio 4.2 za informacije o pedijatrijskoj primjeni).