FrancophonIA/ELRC3.0 huggingface dataset:
English: Hypoglycaemia may occur if the dose of Suliqua is higher than required.
Croatian: Hipoglikemija se može javiti ako je doza lijeka Suliqua viša nego što je potrebno.
English: Pharmacotherapeutic group: Drugs used in diabetes, insulins and analogues for injection, long-acting.
Croatian: Farmakoterapijska skupina:pripravci za liječenje šećerne bolesti, inzulini i analozi za injiciranje, dugog djelovanja.
English: • Patients who are blind or with poor vision must be instructed to always get assistance from another person who has good vision and is trained in using insulin glargine/lixisenatide pen device.
Croatian: • Slijepi ili slabovidni bolesnici moraju se uputiti da uvijek traže pomoć druge osobe koja dobro vidi i obučena je u korištenju napunjene brizgalice s inzulinom glarginom/liksisenatidom
English: Paediatric population There is no relevant use of Suliqua in the paediatric population.
Croatian: Pedijatrijska populacija Nema relevantne primjene lijeka Suliqua u pedijatrijskoj populaciji.
English: To avoid dosing errors and potential overdose, neither the patients nor healthcare professionals should ever use a syringe to draw the medicinal product from the cartridge in the pre-filled pen into a syringe.
Croatian: Kako bi se izbjegle pogreške u doziranju i moguće predoziranje, bolesnici i zdravstveni radnici nikad ne bi smjeli koristiti štrcaljku kako bi izvukli lijek iz uloška napunjene brizgalice u štrcaljku.
English: It is recommended to optimise glycaemic control via dose adjustment based on fasting plasma glucose (see section 5.1).
Croatian: Preporučuje se optimizirati kontrolu glikemije putem prilagodbe doze na temelju razina glukoze u plazmi natašte (vidjeti dio 5.1).
English: • Your low blood sugar is always around “normal” or your diabetes control has greatly improved recently.
Croatian: • imate gotovo normalnu razinu šećera ili ako Vam se kontrola šećerne bolesti nedavno znatno poboljšala
English: Check the name and expiry date on the label of your pen.
Croatian: Provjerite naziv i rok valjanosti na naljepnici Vaše brizgalice.
English: In a 28-day placebo-controlled study in patients with type 2 diabetes 5 to 20 mcg lixisenatide resulted in a statistically significant decreases in postprandial blood glucose after breakfast, lunch and dinner.
Croatian: U 28-dnevnom placebom kontroliranom kliničkom ispitivanju u bolesnika sa šećernom bolešću tipa 2, primjena 5 µg do 20 µg liksisenatida rezultirala je statistički značajnim smanjenjem postprandijalne razine glukoze u krvi nakon doručka, ručka i večere.
English: The most frequently reported adverse reactions during treatment with Suliqua were hypoglycaemia and gastrointestinal adverse reactions (see section 'Description of selected adverse reactions' below).
Croatian: Najčešće prijavljene nuspojave tijekom liječenja lijekom Suliqua bile su hipoglikemija i gastrointestinalne nuspojave (vidjeti dio „Opis odabranih nuspojava“ niže).
English: Based on these results, no dose adjustment for paracetamol is required but the delayed tmax observed when paracetamol is administered 1-4 hours after lixisenatide should be taken into account when a rapid onset of action is required for efficacy.
Croatian: Na temelju ovih rezultata, nije potrebna prilagodba doze paracetamola, ali se odgođeni tmax primijećen kod primjene paracetamola 1 do 4 sata poslije liksisenatida mora uzeti u obzir kada je za djelotvornost potreban brz početak djelovanja.
English: Events per patient-year, n
Croatian: Događaji po bolesnikgodini, n
English: • Fluoxetine, for depression.
Croatian: • fluoksetin, za liječenje depresije
English: • Do not use the pen if the medicine looks cloudy, coloured or contains particles.
Croatian: Nemojte upotrijebiti brizgalicu ako lijek izgleda zamućeno, obojeno ili sadrži čestice.
English: Suliqua is not recommended in women of childbearing potential not using contraception.
Croatian: Suliqua se ne preporučuje u žena reproduktivne dobi koje ne primjenjuju kontracepciju.
English: • You find it hard to recognise when your blood sugar is too low.
Croatian: • ako teško prepoznajete kada Vam je razina šećera u krvi preniska.
English: This type 2 diabetes population had the following characteristics: Mean age was 60.0 years with the majority (56.3%) being aged of 50 to 64 years, and 53.3 percent were female.
Croatian: Ova populacija sa šećernom bolešću tipa 2 imala je sljedeće karakteristike: srednja vrijednost dobi bila je 60,0 godina s većinom bolesnika (56,3%) između 50 i 64 godine, a 53,3% bile su žene.
English: If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist or nurse before using this medicine.
Croatian: Ako se bilo što od gore navedenog odnosi na Vas (ili ako niste sigurni) obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije primjene ovog lijeka.
English: In 2-year subcutaneous carcinogenicity study in mice, 3 cases of adenocarcinoma in the endometrium were seen in the mid dose group with a statistically significant increase, corresponding to an exposure ratio of 97-fold.
Croatian: U 2-godišnjem ispitivanju kancerogenosti nakon supkutane primjene u miševa, u skupini koja je primala srednju dozu opažena su 3 slučaja adenokarcinoma u endometriju, uz statistički značajan porast koji odgovara omjeru izloženosti od 97 puta.
English: Ask your doctor or nurse if you are not sure which foods you should eat.
Croatian: Obratite se svom liječniku ili medicinskoj sestri ako niste sigurni kakvu hranu bi trebali jesti.
English: • Beta-blockers or clonidine, for high blood pressure.
Croatian: • beta blokatore ili klonidin, za liječenje visokog krvnog tlaka
English: Hypoglycaemia was the most frequently reported observed adverse reaction during treatment with Suliqua (see section 4.8).
Croatian: Hipoglikemija je bila najčešće prijavljena zapažena nuspojava tijekom liječenja lijekom Suliqua (vidjeti dio 4.8).
English: • lixisenatide: a “GLP-1 analogue” that helps the body produce its own additional insulin in response to increases in blood sugar, and slows the absorption of sugar from foods
Croatian: • liksisenatid: 'GLP-1 analog' koji pomaže tijelu da stvara dodatni vlastiti inzulin kao odgovor na povišeni šećer u krvi te usporava apsorpciju šećera iz hrane
English: MACE was defined as the composite of CV death, nonfatal myocardial infarction and nonfatal stroke.
Croatian: MACE je definiran kao kompozit kardiovaskularne smrti, nefatalnog infarkta miokarda i nefatalnog moždanog udara.
English: In the event of blocked needles, patients must follow the instructions described in the Instructions for Use accompanying the package leaflet (see section 6.6).
Croatian: U slučaju začepljenih igala, bolesnici moraju slijediti upute opisane u Uputama za uporabu koje su priložene uz uputu o lijeku (vidjeti dio 6.6).
English: If you use another anti-diabetic medicine, discuss with your doctor whether you should stop using that medicine when starting Suliqua.
Croatian: Ako koristite drugi lijek za liječenje šećerne bolesti, raspravite sa svojim liječnikom trebate li prestati koristiti taj lijek kada započinjete s lijekom Suliqua.
English: • If you have any questions about your treatment speak to your healthcare professional.
Croatian: • Ako imate bilo kakvih pitanja u vezi liječenja obratite se zdravstvenom radniku.
English: Use is not recommended in patients with severe renal impairment or end-stage renal disease (see sections 4.2 and 5.2).
Croatian: Ne preporučuje se primjena u bolesnika s teškim oštećenjem funkcije bubrega ili završnom fazom bubrežne bolesti (vidjeti dijelove 4.2 i 5.2).
English: In rare cases, the presence of such antibodies may necessitate adjustment of the Suliqua dose in order to correct a tendency for hyperglycaemia or hypoglycaemia.
Croatian: U rijetkim slučajevima, prisutnost takvih protutijela može zahtijevati prilagodbu doze lijeka Suliqua kako bi se korigirala sklonost hiperglikemiji ili hipoglikemiji.
English: Therefore Suliqua should not be given in combination with a sulfonylurea.
Croatian: Stoga se lijek Suliqua ne smije primjenjivati u kombinaciji sa sulfonilurejom.
English: In 2-year subcutaneous carcinogenicity studies, non-lethal C-cell thyroid tumors were seen in rats and mice and are considered to be caused by a non-genotoxic GLP-1 receptor-mediated mechanism to which rodents are particularly sensitive.
Croatian: U 2-godišnjim ispitivanjima kancerogenosti nakon supkutane primjene u štakora i miševa primijećeni su nesmrtonosni tumori C-stanica štitnjače za koje se smatra da su uzrokovani negenotoksičnim mehanizmom posredovanim receptorom GLP-1, na koji su glodavci iznimno osjetljivi.
English: (-0.21 to 0.43)
Croatian: (-0,21 do 0,43)
English: • This will make sure you get your full dose.
Croatian: Tako ćete biti sigurni da ste primili cijelu dozu.
English: Discard the pen after this time period.
Croatian: Bacite brizgalicu nakon isteka tog vremenskog razdoblja.
English: STEP 6: Remove the needle
Croatian: KORAK 6: Uklonite iglu
English: • Clozapine, olanzapine and phenothiazine derivatives, for mental health problems.
Croatian: • klozapin, olanzapin i derivate fenotiazina, za liječenje mentalnih poremećaja
English: • The prescription should mention the pre-filled pen type you need (Suliqua 10-40 pen or 30-60 pen) and the number of dose steps to be injected.
Croatian: • Na receptu treba biti navedena vrsta napunjene brizgalice koja Vam je potrebna (Suliqua 10-40 brizgalica i 30-60 brizgalica) i broj odmjernih koraka koji se injiciraju.
English: In controlled clinical trials in adults with insulin glargine (100 units/ml), subgroup analyses based on age, race, and gender did not show differences in safety and efficacy.
Croatian: U kontroliranim kliničkim ispitivanjima odraslih osoba liječenih inzulinom glarginom (100 jedinica/ml), analiza podskupina prema dobi, rasi i spolu nije ukazala na razlike u sigurnosti i djelotvornosti.
English: [1.4 to 2.6]
Croatian: [1,4 do 2,6]
English: Never use a syringe to remove the solution from the pen to avoid dosing errors and potential overdose.
Croatian: Nikada nemojte štrcaljkom izvlačiti otopinu iz brizgalice kako bi izbjegli pogreške prilikom doziranja i moguće predoziranje.
English: A metabolism study in diabetic patients who received insulin glargine alone indicates that insulin glargine is rapidly metabolised at the carboxyl terminus of the B chain to form two active metabolites, M1 (21A-Gly-insulin) and M2 (21A-Gly-des-30B-Thr-insulin).
Croatian: Ispitivanje metabolizma u bolesnika sa šećernom bolešću koji su primili samo inzulin glargin ukazuje da se inzulin glargin brzo metabolizira na karboksilnim krajevima B lanca pri čemu nastaju dva aktivna metabolita: M1 (21A-Gly-inzulin) i M2 (21A-Gly-des-30B-Thr-inzulin).
English: • You have not injected your Suliqua or not injected enough.
Croatian: • niste injicirali lijek Suliqua ili ga niste injicirali dovoljno.
English: • You have recently changed from animal insulin to a manufactured insulin, like there is in
Croatian: • ste nedavno prešli s inzulina životinjskog podrijetla na sintetski inzulin kao što je onaj u lijeku
English: Following administration of a single dose of paracetamol 1000 mg, paracetamol AUC and t1/2 were unchanged whatever the timing of its administration (before or after the lixisenatide injection).
Croatian: Nakon primjene jedne doze paracetamola od 1000 mg, AUC i t1/2 paracetamola bili su nepromijenjeni neovisno o vremenu primjene (prije ili nakon injekcije liksisenatida).
English: • Your healthcare professional will explain the design and features of your Suliqua pen, including how the dose counter of the pre-filled pen device shows the number of dose steps to be injected.
Croatian: • Zdravstveni radnik će Vam objasniti dizajn i značajke Vaše Suliqua brizgalice, uključujući i način kako brojač doza na napunjenoj brizgalici pokazuje broj odmjernih koraka koji se injiciraju.
English: Shelf-life after first use of the pen: 28 days
Croatian: Rok valjanosti nakon prve uporabe brizgalice: 28 dana Brizgalice u uporabi
English: Suliqua must not be mixed with any other insulin or diluted.
Croatian: Suliqua se ne smije miješati ni s jednim drugim inzulinom niti razrjeđivati.
English: Do not soak, wash or lubricate the pen.
Croatian: Nemojte namakati, prati niti podmazivati brizgalicu.
English: No pharmacokinetic interactions are known for insulin glargine.
Croatian: Nisu poznate farmakokinetičke interakcije za inzulin glargin.
English: • loss of fluids from your body (dehydration) e.g. in case of vomiting and diarrhoea.
Croatian: • gubitak tekućine iz tijela (dehidracija) npr. u slučaju povraćanja ili proljeva.
English: In case of hypoglycaemia, the rescue mechanism of glucagon secretion is preserved.
Croatian: U slučaju hipoglikemije, očuvan je mehanizam spašavanja lučenjem glukagona.
English: • you have diabetic ketoacidosis (a complication of diabetes that occurs when the body is unable to use glucose because there is not enough insulin) since this medicine will not be right for you.
Croatian: • imate dijabetičku ketoacidozu (komplikaciju šećerne bolesti koja se javlja kada tijelo ne može iskoristiti glukozu jer nema dovoljno inzulina) jer ovaj lijek neće biti prikladan za Vas.
English: • For information on the treatment of hyperglycaemia, see the box at the end of this leaflet.
Croatian: • Za informacije o liječenju hiperglikemije, pogledajte uokvireni tekst na kraju ove upute o lijeku.
English: • For twice daily basal insulin or insulin glargine (300 units/ml), the total daily dose previously used should be reduced by 20% to choose the Suliqua starting dose.
Croatian: • Za bazalni inzulin primijenjen dvaput dnevno ili inzulin glargin (300 jedinica/ml), prethodno primijenjena ukupna dnevna doza treba se smanjiti za 20% kako bi se odredila početna doza lijeka Suliqua.
English: How to read the dose window
Croatian: Kako očitati prozorčić za prikaz doze
English: There is no experience with Suliqua in children and adolescents aged less than 18 years; therefore, the use of Suliqua is not recommended in this age group.
Croatian: Nema iskustva s primjenom lijeka Suliqua u djece i adolescenata mlađih od 18 godina; stoga se primjena lijeka Suliqua ne preporučuje u ovoj dobnoj skupini.
English: • Make sure you have the correct medicine.
Croatian: • Uvjerite se da imate odgovarajući lijek.
English: More severe episodes of hypoglycaemia with coma, seizure, or neurologic impairment may be treated with intramuscular/subcutaneous glucagon or concentrated intravenous glucose.
Croatian: Teže epizode hipoglikemije popraćene komom, napadajima ili neurološkim oštećenjima mogu se liječiti intramuskularnom/supkutanom primjenom glukagona ili intravenskom primjenom koncentrirane glukoze.
English: • A reminder on the need to report all medication errors with Suliqua will be part of the healthcare professional guide.
Croatian: • Podsjetnik o nužnosti prijavljivanja svih medikacijskih pogrešaka s lijekom Suliqua bit će dio vodiča za zdravstvane radnike
English: Since Suliqua may cause stomach side effects, the medicine has not been studied in patients with severe stomach or gut problems.
Croatian: S obzirom da lijek Suliqua može uzrokovati nuspojave povezane sa želucem, lijek nije bio ispitivan u bolesnika sa teškim želučanim ili crijevnim problemima.
English: [-0.420 to 0.038]
Croatian: [-0,420 do 0,038]
English: • Tell patients to closely monitor their blood sugar levels when starting insulin glargine/lixisenatide which contains insulin glargine and a non-insulin active substance (lixisenatide).
Croatian: • Objasnite bolesnicima da moraju pažljivo nadzirati razinu šećera u krvi kad započinju liječenje s inzulinom glarginom/liksisenatidom koji sadrži inzulin glargin i i djelatnu tvar koja nije inzulin (liksisenatid)
English: It is not known if Suliqua passes into your milk.
Croatian: Nije poznato izlučuje li se Suliqua u majčino mlijeko.
English: • If the patient has been transferred from a different pre filled pen device, highlight the differences in design between the two devices (focus on colour differentiation, warning statements on carton/label and other safety design features such as tactile elements on the prefilled pen).
Croatian: • Ako je bolesnik prešao s drugog lijeka u napunjenoj brizgalici na lijek Suliqua, naglasite razlike u dizajnu između dvije brizgalice (osobito obratite pažnju na razlike u boji, upozorenjima na kutiji/ naljepnici brizgalice te drugim sigurnosnim značajkama kao što su taktilni elementi na napunjenoj brizgalici).
English: Use of GLP-1 receptor agonists may be associated with gastrointestinal adverse reactions.
Croatian: Primjena agonista GLP-1 receptora može biti povezana s gastrointestinalnim nuspojavama.
English: • Healthcare Professional Guide;
Croatian: • Vodič za zdravstvene radnike
English: Use of glucagon-like peptide-1 (GLP-1) receptor agonists has been associated with a risk of developing acute pancreatitis.
Croatian: Primjena agonista receptora peptida nalik glukagonu-1 (GLP-1) povezana je s rizikom od razvoja akutnog pankreatitisa.
English: Important information about some of the ingredients of Suliqua This medicine contains less than 1 mmol (23 mg) sodium per dose.
Croatian: Važne informacije o nekim sastojcima lijeka Suliqua Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) po dozi, tj. zanemarive količine natrija.
English: • You have severe kidney or liver disease, or some other disease such as hypothyroidism.
Croatian: • ako bolujete od teške bubrežne ili jetrene bolesti ili neke druge bolesti kao što je hipotireoza.
English: • Somatropin, a growth hormone.
Croatian: • somatotropin, hormon rasta
English: The dose must be individualised based on clinical response and is titrated based on the patient's need for insulin.
Croatian: Doza se mora individualno prilagoditi na temelju kliničkog odgovora i titrira se na temelju bolesnikove potrebe za inzulinom.
English: A number of substances affect glucose metabolism and may require dose adjustment of Suliqua.
Croatian: Brojne tvari utječu na metabolizam glukoze i mogu zahtijevati prilagodbu doze lijeka Suliqua.
English: Suliqua should be used with caution in patients receiving oral medicinal products that require rapid gastrointestinal absorption, require careful clinical monitoring or have a narrow therapeutic ratio.
Croatian: Suliqua se treba primjenjivati s oprezom u bolesnika koji uzimaju peroralne lijekove koji zahtijevaju brzu gastrointestinalnu apsorpciju, pomno kliničko praćenje ili imaju uzak terapijski indeks.
English: In the elderly, progressive deterioration of renal function may lead to a steady decrease in insulin requirements.
Croatian: U starijih osoba, progresivno pogoršanje bubrežne funkcije može dovesti do stalnog smanjenja potrebe za inzulinom.
English: Factors increasing the susceptibility to hypoglycaemia require particularly close monitoring and may necessitate dose adjustment.
Croatian: Čimbenici koji povećavaju podložnost hipoglikemiji zahtijevaju posebno strog nadzor i mogu zahtijevati prilagodbu doze.
English: - Never re-use needles.
Croatian: -Nikada nemojte ponovo koristiti iste igle.
English: Cardiovascular outcome studies
Croatian: Ispitivanja kardiovaskularnog ishoda
English: The following table describes the rate of documented symptomatic hypoglycaemia (≤3.9 mmol/L) and severe hypoglycaemia for both Suliqua and the comparator.
Croatian: Sljedeća tablica opisuje stopu zabilježenih simptomatskih hipoglikemija (≤3,9 mmol/l) i teških hipoglikemija i za lijek Suliqua i za lijek koji služi za usporedbu.
English: The dose of Suliqua must be individualised based on clinical response and is titrated based on the patient's need for insulin (see section 4.2).
Croatian: Doza lijeka Suliqua mora se individualizirati na temelju kliničkog odgovora i titrirati na temelju bolesnikove potrebe za inzulinom (vidjeti dio 4.2).
English: At all time points, 30-week mean plasma glucose values were lower in the Suliqua group than in both the insulin glargine group and the lixisenatide group, with the only exception of the pre-breakfast value which was similar between the Suliqua group and the insulin glargine group.
Croatian: U svim vremenskim točkama, srednje vrijednosti glukoze u plazmi tijekom 30 tjedana bile su niže u skupini s lijekom Suliqua nego u skupinama s inzulinom glarginom i liksisenatidom, uz jedinu iznimku vrijednosti prije doručka koje su bile slične u skupinama s lijekom Suliqua i u skupini s inzulinom glarginom.
English: • You are taking or have stopped taking certain other medicines (see section 2, "Other medicines and Suliqua").
Croatian: • uzimate ili ste uzimali neke druge lijekove (vidjeti dio 2. "Drugi lijekovi i Suliqua").
English: • When medicine comes out of the needle tip, your pen is working correctly, the dose selector will be reset to “0”.
Croatian: Kada lijek izlazi kroz vrh igle, Vaša brizgalica radi ispravno i pokazivač doze će se ponovo namjestiti na '0'.
English: • You inject too much Suliqua.
Croatian: • Injicirali ste previše lijeka Suliqua.
English: • Always follow the “Instructions for use” that come with this package leaflet.
Croatian: • uvijek pratite 'Upute za uporabu' priložene ovoj uputi o lijeku
English: Read the Package Leaflet and these Instructions for Use first
Croatian: Najprije pročitajte uputu o lijeku i ove upute za uporabu
English: Select 2 dose steps by turning the dose selector until the dose pointer is at the 2 mark.
Croatian: Odaberite 2 odmjerna koraka okretanjem izbornika doze sve dok pokazivač doze ne pokazuje oznaku 2.
English: The following related adverse reactions from clinical investigations are listed below by system organ class and in order of decreasing frequency (very common: ≥1/10; common: ≥1/100 to <1/10;
Croatian: Sljedeće nuspojave povezane s primjenom lijeka iz kliničkih ispitivanja navedene su niže prema klasifikaciji po organskim sustavima i redom po padajućoj učestalosti (vrlo često: ≥1/10; često: ≥1/100 do <1/10; manje često: ≥1/1000 do <1/100; rijetko: ≥1/10 000 do <1/1000; vrlo rijetko:
English: In clinical studies with insulin glargine (100 units/ml) the glucose-lowering effect on a molar basis (i.e., when given at the same doses) of intravenous insulin glargine is approximately the same as that for human insulin.
Croatian: U kliničkim ispitivanjima inzulina glargina (100 jedinica/ml) učinak snižavanja glukoze na molarnoj osnovi (tj. kad je primijenjen u istim dozama) intravenskog inzulina glargina bio je približno isti kao i za ljudski inzulin.
English: Insulin inhibits lipolysis and proteolysis, and enhances protein synthesis.
Croatian: Inzulin inhibira lipolizu i proteolizu te pojačava sintezu proteina.
English: Following a standardised labelled test meal, in the study referred to above, it was confirmed that lixisenatide slows gastric emptying, thereby reducing the rate of postprandial glucose absorption.
Croatian: Nakon standardiziranog i označenog testnog obroka, u ispitivanju koje je navedeno iznad, potvrđeno je da liksisenatid usporava pražnjenje želuca, time smanjujući brzinu apsorpcije glukoze nakon obroka.
English: Lixisenatide is a glucagon-like peptide (GLP1) receptor agonist.
Croatian: Liksisenatid je agonist receptora peptida nalik glukagonu-1 (GLP-1).
English: It is unknown whether insulin glargine or lixisenatide is excreted in human milk.
Croatian: Nije poznato izlučuju li se inzulin glargin ili liksisenatid u mlijeko u ljudi.
English: Having too low or too high blood sugar (see information in the box at the end of this leaflet)can affect your ability to drive and use tools or machines.
Croatian: Preniska ili previsoka razina šećera u krvi (pogledajte uokvirene informacije na kraju ove upute o lijeku) može utjecati na Vašu sposobnost upravljanja vozilima, alatima ili strojevima.
English: Previous therapy
Croatian: Prethodna terapija
English: Suliqua is not recommended in patients with severe renal impairment and end-stage renal disease as there is no sufficient therapeutic experience with use of lixisenatide.
Croatian: Suliqua se ne preporučuje u bolesnika s teškim oštećenjem funkcije bubrega i završnom fazom bubrežne bolesti jer nema dovoljno terapijskog iskustva s uporabom liksisenatida.