FrancophonIA/ELRC3.0 huggingface dataset:
English: No dedicated cardiovascular outcome trial has been conducted with Suliqua.
Croatian: Nije provedeno nijedno kliničko ispitivanje kardiovaskularnog ishoda s lijekom Suliqua.
English: When to inject Suliqua
Croatian: Kada injicirati lijek Suliqua
English: If you stop using Suliqua
Croatian: Ako prestanete primjenjivati lijek Suliqua
English: If you notice signs of your blood sugar being too low (hypoglycaemia), take action to increase your blood sugar level straight away (see the box at the end of this leaflet).
Croatian: Ako primijetite znakove preniske razine šećera u krvi (hipoglikemija) odmah poduzmite mjere za povećanje razine šećera u krvi (pogledajte okvir na kraju ove upute).
English: At Week 30, Suliqua provided statistically significant improvement in HbA1c (p-value <0.0001) compared to insulin glargine.
Croatian: U 30. tjednu primjena lijeka Suliqua dovela je do statistički značajnog poboljšanja HbA1c (pvrijednost <0,0001) u usporedbi s inzulinom glarginom.
English: • Suliqua is supplied in a pre-filled pen and must only be used with this device; healthcare professionals must never use a syringe to withdraw insulin glargine/lixisenatide from a pre filled pen or dosing errors and serious harm can result.
Croatian: • Lijek Suliqua je dostupan u obliku napunjene brizgalice i smije se koristiti samo s tom brizgalicom; zdravstveni radnici ne smiju nikada koristiti štrcaljku za izvlačenje inzulina glargina/liksisenatida iz napunjene brizgalice jer to može dovesti do pogreške u doziranju i ozbiljne opasnosti za bolesnike.
English: Injection button
Croatian: Dugme za injiiranje
English: [8.1 to 22.4]
Croatian: [8,1 do 22,4]
English: • Suliqua is supplied in a pre-filled pen and must only be used with this device; patients, carers and healthcare professionals must never use a syringe to withdraw insulin glargine/lixisenatide from a pre-filled pen or dosing errors and serious harm can result.
Croatian: • Lijek Suliqua je dostupan u obliku napunjene brizgalice i smije se koristiti samo s tom brizgalicom; bolesnici, njegovatelji i zdravstevni radnici nikada ne smiju koristiti štrcaljku kako bi izvukli inzulin glargin/liksisenatid iz napunjene brizgalice jer to može dovesti do pogrešaka u doziranju i ozbiljne opasnosti za bolesnike.
English: Nasopharyngitis Upper respiratory tract infection
Croatian: Infekcije i infestacije nazofaringitis infekcije gornjih dišnih puteva
English: Hypoglycaemia and gastrointestinal adverse reactions may develop if a patient is dosed with more Suliqua than required.
Croatian: Hipoglikemija i nuspojave probavnog sustava mogu se razviti ako je bolesnik dobio veću dozu lijeka Suliqua nego što je potrebno.
English: Results at 30 weeks - Add-on to metformin clinical study (mITT population) Suliqua
Croatian: Rezultati u 30. tjednu -Kliničko ispitivanje lijeka kao dodatka metforminu - (modificirana populacija predviđena ze liječenje (engl. modified-intent-to-treat - mITT populacija))
English: A. Take a new needle and peel off the protective seal.
Croatian: Uzmite novu iglu i odlijepite zaštitni pokrov
English: STEP 2: Attach a new needle
Croatian: KORAK 2: Pričvrstite novu iglu
English: 30-60 dose steps (1 dose step = 1 unit of insulin glargine + 0.33 micrograms of lixisenatide)
Croatian: 30-60 odmjernih koraka (1 odmjerni korak = 1 jedinica inzulina glargina + 0,33 mikrograma liksisenatida)
English: Figure - Mean HbA1c (%) at start of screening, at randomization, Each Time Point (Completers) and at Week 30 - mITT population
Croatian: Slika - srednja vrijednost HbA1c (%) na početku probira, u vrijeme randomizacije, u svakoj vremenskoj točki (bolesnici koji su završili ispitivanje) i u 30. tjednu - mITT populacija
English: While using this medicine be aware of the following and talk to your doctor, pharmacist or nurse before using Suliqua:
Croatian: Prilikom korištenja ovog lijeka obratite pozornost na sljedeće i obratite se svom liječniku, ljekarniku ili medicinskoj sestri prije korištenja lijeka Suliqua:
English: Your blood sugar level may rise (hyperglycaemia) if you take:
Croatian: Razina šećera u krvi može porasti (hiperglikemija) ako uzmete:
English: Medicine that may reduce warning signs of low blood sugar Beta-blockers and some other medicines (such as clonidine, guanethidine, reserpine - for high blood pressure) may make it harder to recognise warning signs of your low blood sugar levels (hypoglycaemia).
Croatian: Lijekovi koji mogu smanjiti upozoravajuće znakove niskog šećera u krvi: Beta blokatori i neki drugi lijekovi (kao što su klonidin, gvanetidin, rezerpin -za liječenje visokog krvnog tlaka) mogu otežati prepoznavanje simptoma koji upozoravaju na nisku razinu šećera u krvi (hipoglikemija).
English: These other medicines may include oral anti-diabetics (such as metformin, sulfonylurea medicines) or insulin.
Croatian: Ti drugi lijekovi mogu biti lijekovi za liječenje šećerne bolesti koji se uzimaju kroz usta (poput metformina, lijekova derivata sulfonilureje) ili inzulin.
English: With Suliqua, it may take longer to recover from low blood sugar because it contains a long-acting insulin (insulin glargine).
Croatian: Kad primjenjujete lijek Suliqua oporavak od niske razine šećera u krvi može duže potrajati jer Suliqua sadrži dogodjelujući inzulin (inzulin glargin).
English: • Do not use the pen if your single daily dose is less than 30 dose steps, shown as white numbers on a black background.
Croatian: Nemojte upotrijebiti brizgalicu ako je Vaša pojedinačna dnevna doza manja od 30 odmjernih koraka, a koja se prikazuje kao bijeli broj na crnoj površini.
English: When administered 1 or 4 hours after 10 mcg lixisenatide, Cmax of paracetamol was decreased by 29% and 31%, respectively and median tmax was delayed by 2.0 and 1.75 hours, respectively.
Croatian: Nakon primjene paracetamola 1 sat odnosno 4 sata nakon primjene 10 µg liksisenatida, Cmax paracetamola smanjio se za 29% odnosno 31%, a medijan tmax odgodio se za 2,0 odnosno 1,75 sati.
English: Patients screened had type 2 diabetes were treated with basal insulin for at least 6 months, receiving a stable daily dose of between 15 and 40 U alone or combined with 1 or 2 OADs (metformin or a sulfonylurea or a glinide or a SGLT-2 inhibitor or a DPP-4 inhibitor), had an HbA1c between 7.5% and 10% (mean HbA1c of 8.5% at screening) and a FPG less than or equal to 10.0 mmol/L or 11.1 mmol/L depending on their previous anti-diabetic treatment.
Croatian: Probrani bolesnici sa šećernom bolešću tipa 2 koji su liječeni bazalnim inzulinom barem 6 mjeseci, primajući stabilne dnevne doze od 15 do 40 jedinica samostalno ili u kombinaciji s jednim ili dva oralna antidijabetika (metformin, ili sulfonilureja, ili glinid, ili SGLT-2 inhibitor, ili DPP-4 inhibitor), imali su vrijednosti HbA1c između 7,5% i 10% (srednja vrijednost HbA1c 8,5% na probiru) i razine glukoze u plazmi natašte manje ili jednake 10,0 mmol/l ili 11,1 mmol/l, ovisno o njihovom prethodnom liječenju antidijabeticima.
English: There is no clinical data on exposed pregnancies from controlled clinical studies with use of Suliqua, insulin glargine, or lixisenatide.
Croatian: Nema kliničkih podataka o trudnicama izloženim lijeku Suliqua, inzulinu glarginu ili liksisenatidu u kontroliranim kliničkim ispitivanja.
English: Your blood sugar level may fall (hypoglycaemia) if you take:
Croatian: Razina šećera u krvi može pasti (hipoglikemija) ako uzmete:
English: The cardiovascular safety of insulin glargine and lixisenatide has been established in the ORIGIN and ELIXA clinical trials, respectively.
Croatian: Kardiovaskularna sigurnost inzulina glargina utvrđena je u kliničkom ispitivanju ORIGIN, a kardiovaskularna sigurnost liksisenatida utvrđena je u kliničkom ispitivanju ELIXA.
English: • Explain to your patient that: You are prescribing a number of dose steps which corresponds to a set number of units of insulin plus a fixed amount lixisenatide For Suliqua, one dose step always contains one unit of insulin, regardless of the Suliqua pre filled pen being used (10-40 pen or 30 60 pen) The dose counter of the pen device shows the number of dose steps to be injected,
Croatian: • Objasnite Vašem bolesniku sljedeće: Propisali ste mu broj odmjernih koraka koji odgovaraju određenom broju jedinica inzulina uz dodatak fiksne količine liksisenatida Jedan odmjerni korak lijeka Suliqua uvijek sadrži jednu jedinicu inzulina, neovisno o tome koju Suliqua napunjenu brizgalicu koriste (10-40 brizgalicu ili 30-60 brizgalicu)
English: Frequent glucose monitoring and dose adjustment may be necessary for Suliqua in patients with hepatic impairment.
Croatian: Redovito praćenje glukoze i prilagodba doze lijeka Suliqua mogu biti potrebni u bolesnika s oštećenjem funkcije jetre.
English: The re-use of insulin pen needles increases the risk of blocked needles, which may cause under- or overdosing.
Croatian: Ponovno korištenje igala inzulinskih brizgalica povećava rizik od začepljenja igala, što može uzrokovati subdoziranje ili predoziranje.
English: • Do not use the pen if your single daily dose is less than 10 dose steps, shown as white numbers on a black background.
Croatian: Nemojte upotrijebiti brizgalicu ako je Vaša pojedinačna dnevna doza manja od 10 odmjernih koraka, a koja se prikazuje kao bijeli broj na crnoj površini.
English: • Oestrogens and progestogens, such as in the contraceptive pill for birth control or use of oestrogens for bone loss (osteoporosis).
Croatian: • estrogene i progestagene, poput onih u kontracepcijskoj piluli za sprečavanje začeća ili primjena estrogena za liječenje osteoporoze (gubitka koštane mase)
English: 10-40 dose steps (1 dose step = 1 unit of insulin glargine + 0.5 micrograms of lixisenatide)
Croatian: 10-40 odmjernih koraka (1 odmjerni korak = 1 jedinica inzulina glargina + 0,5 mikrograma liksisenatida)
English: Handle your pen with care • If you think that your pen may be damaged, do not try to fix it. Use a new one.
Croatian: Ako mislite da bi Vaša brizgalica mogla biti oštećena, nemojte je pokušavati popraviti.
English: • Indigestion (dyspepsia)
Croatian: • probavne smetnje (dispepsija)
English: The pen may be stored for a maximum of 28 days out of the refrigerator, but below 25°C.
Croatian: Nakon prve uporabe ili ako se lijek nosi kao rezervni Brizgalica se može čuvati najdulje 28 dana izvan hladnjaka, ali na temperaturi ispod 25°C.
English: • Do not use your pen after the expiry date.
Croatian: • Nemojte koristiti brizgalicu nakon isteka roka valjanosti.
English: You must always check the label before each injection to avoid mix-ups between Suliqua and other insulins.
Croatian: Prije svake injekcije uvijek morate provjeriti naljepnicu na brizgalici kako biste izbjegli zamjenu lijeka Suliqua i drugih inzulina.
English: Increase in heart rate has been reported with GLP1RA use and a transient increase was also observed in some studies with lixisenatide.
Croatian: Povećanje srčane frekvencije prijavljeno je s primjenom GLP1RA (agonisti receptora za peptid sličan glukagonu-1), a također je opaženo i prolazno povećanje u nekim ispitivanjima liksisenatida.
English: • The prescription must state the dose range and strength of the Suliqua pre filled pen and the number of dose steps to be administered.
Croatian: • Na receptu je potrebno navesti raspon doza i jačinu lijeka Suliqua u napunjenoj brizgalici te broj odmjernih koraka koji se moraju primijeniti
English: Many factors may affect your blood sugar level.
Croatian: Na razinu šećera u krvi mogu utjecati brojni faktori.
English: Keep the pen in the outer carton in order to protect from light.
Croatian: Čuvajte brizgalicu u vanjskom pakiranju radi zaštite od svjetlosti.
English: Before injecting Suliqua
Croatian: Prije nego što injicirate lijek Suliqua
English: What you need to know before you use Suliqua Do not use Suliqua:
Croatian: Što morate znati prije nego počnete primjenjivati lijek Suliqua
English: If you do, you might not get your full dose (underdosing) or get too much (overdosing) as the needle could block.
Croatian: Ako to učinite igla se može začepiti i možda nećete primiti cijelu dozu (subdoziranje) ili ćete primiti preveliku dozu (predoziranje).
English: Suliqua (30-60) pen contains insulin glargine and lixisenatide.
Croatian: Suliqua (30-60) brizgalica sadrži inzulin glargin i liksisenatid.
English: The delay of gastric emptying with lixisenatide may reduce the rate of absorption of orally administered medicinal products.
Croatian: Odgoda pražnjenja želuca uz liksisenatid može smanjiti brzinu apsorpcije peroralno primijenjenih lijekova.
English: • The other ingredients are: glycerol 85%, methionine, metacresol, zinc chloride, concentrated hydrochloric acid and sodium hydroxide (for pH adjustment) and water for injections.
Croatian: • Drugi sastojci su: glicerol 85%, metionin, metakrezol, cinkov klorid, koncentrirana kloridna kiselina i natrijev hidroksid (za podešavanje pH) i voda za injekcije.
English: Insulin glargine daily dose Baseline (mean) Endpoint (mean) LS insulin dose change at week 30 (mean) *Not included in the pre-specified step-down testing procedure **2 hour PPG minus the pre-meal glucose value
Croatian: Dnevna doza inzulina glargina Početna vrijednost (srednja vrijednost) Kraj ispitivanja (srednja vrijednost) Promjena doze inzulina u 30.tjednu dobivena metodom najmanjih kvadrata (srednja vrijednost) *nije uključeno u unaprijed određenom step-down postupku **vrijednost glukoze 2h nakon obroka minus vrijednost glukoze prije obroka
English: For oral medicinal products that are particularly dependent on threshold concentrations for efficacy, such as antibiotics, patients should be advised to take those medicinal products at least 1 hour before or 4 hours after lixisenatide injection.
Croatian: Bolesnicima treba savjetovati da oralne lijekove čija djelotvornost uvelike ovisi o graničnim koncentracijama, poput antibiotika, uzmu najmanje 1 sat prije ili 4 sata nakon injekcije liksisenatida.
English: If this happens: - change the needle (see STEP 6 and STEP 2), - then repeat the safety test (STEP 3).
Croatian: Promijenite iglu (pogledajte KORAK 6 Uklonite iglu i KORAK 2 Pričvrstite novu iglu) i onda napravite test sigurnosti (pogledati KORAK 3).
English: It is not known if Suliqua harms your unborn child. Suliqua should not be used if breast-feeding.
Croatian: Nije poznato može li Suliqua naškoditi nerođenom djetetu.
English: • Take care when handling needles to prevent needle injury and cross-infection.
Croatian: Budite oprezni kada rukujete iglom kako biste spriječili ozljedu iglom i prijenos infekcije.
English: • If the patient starts with the Suliqua (30-60) pen, the dose may be titrated up to 60 dose steps with this pen.
Croatian: • Ako je bolesnik počeo terapiju sa Suliqua (30-60) brizgalicom, doza se može titrirati do 60
English: In parallel, glucagon secretion is suppressed.
Croatian: Istodobno, suprimira se lučenje glukagona.
English: Handling needles • Take care when handling needles to prevent needle injury and cross-infection.
Croatian: Rukovanje iglama Budite oprezni kada rukujete iglama kako biste spriječili ozljedu iglom i prijenos infekcije.
English: For in use storage conditions, see section 6.3
Croatian: Uvjete čuvanja nakon otvaranja vidjeti u dijelu 6.3.
English: Clinical study in patients with Type 2 diabetes insufficiently controlled on OAD treatment A total of 1170 patients with type 2 diabetes were randomised in an open label, 30-week, activecontrolled study to evaluate the efficacy and safety of Suliqua compared to the individual components, insulin glargine (100 units/ml) and lixisenatide (20 mcg).
Croatian: Ukupno 1170 bolesnika sa šećernom bolešću tipa 2 randomizirano je u otvorenom, 30-tjednom, aktivno kontroliranom ispitivanju kako bi se procijenila djelotvornost i sigurnost lijeka Suliqua u usporedbi s pojedinačnim sastavnicama, inzulinom glarginom (100 jedinica/ml) i liksisenatidom (20 µg).
English: If your blood sugar gets too low, see the advice in the box at the end of this leaflet.
Croatian: Ako šećer u krvi postane prenizak, pogledajte savjete u uokvirenom tekstu na kraju ove upute o lijeku.
English: Administration of Suliqua may cause formation of antibodies against insulin glargine and/or lixisenatide.
Croatian: Primjena lijeka Suliqua može uzrokovati stvaranje protutijela na inzulin glargin i/ili na likisenatid.
English: What to do if you experience hypoglycaemia?
Croatian: Što učiniti u slučaju hiperglikemije?
English: • Always perform a safety test. See STEP 3.
Croatian: • Uvijek napravite test sigurnosti.
English: • One dose step contains one unit of insulin glargine plus a fixed amount of lixisenatide.
Croatian: • Jedan odmjerni korak sadrži jednu jedinicu inzulina glargina uz dodatak fiksne količine liksisenatida.
English: The combination of insulin glargine and lixisenatide has no impact on the pharmacodynamics of of insulin glargine.
Croatian: Kombinacija inzulina glargina i liksisenatida nema učinak na farmakodinamiku inzulina glargina.
English: Always keep the cap on the pen when you are not using it in order to protect it from light.
Croatian: Kada ne koristite brizgalicu, uvijek na njoj držite zatvarač radi zaštite od svjetlosti.
English: For dose steps from 30-60 units, Suliqua 100 units/ml + 33 micrograms/ml solution for injection in a pre-filled pen is available.
Croatian: Za odmjerne korake od 30-60 jedinica, dostupna je Suliqua 100 jedinica/ml + 33 mikrograma/ml otopina za injekciju u napunjenoj brizgalici.
English: • Do not use a syringe to remove medicine from your pen.
Croatian: Nemojte upotrijebiti štrcaljku za izvlačenje lijeka iz svoje brizgalice.
English: • Use this pen only to inject single daily doses from 10 to 40 dose steps.
Croatian: Upotrijebite ovu brizgalicu samo za injiciranje jedne dnevne doze od 10 do 40 odmjernih koraka.
English: Clinical study in patients with Type 2 diabetes insufficiently controlled on basal insulin A total of 736 patients with type 2 diabetes participated in a randomised, 30-week, active-controlled, open-label, 2-treatment arm, parallel-group, multicenter study to evaluate the efficacy and safety of Suliqua compared to insulin glargine (100 units/ml).
Croatian: Ukupno 736 bolesnika sa šećernom bolešću tipa 2 sudjelovalo je u randomiziranom, 30-tjednom, aktivno kontroliranom, otvorenom, multicentričnom ispitivanju s paralelnim skupinama u 2 skupine liječenja kako bi se procijenila djelotvornost i sigurnost lijeka Suliqua u usporedbi s inzulinom glarginom (100 jedinica/ml).
English: LIST OF EXCIPIENTS glycerol 85%, methionine, metacresol (see leaflet for further information), zinc chloride, concentrated hydrochloric acid and sodium hydroxide (for pH adjustment), water for injections.
Croatian: POPIS POMOĆNIH TVARI glicerol 85%, metionin, metakrezol (za dodatne informacije vidjeti uputu o lijeku), cinkov klorid, koncentrirana kloridna kiselina i natrijev hidroksid (za podešavanje pH), voda za injekcije.
English: • Your blood sugar is often too low.
Croatian: • ako Vam je razina šećera u krvi često preniska
English: • You have just started Suliqua treatment- if low blood sugar occurs, it may be more likely to happen in the morning.
Croatian: • ako ste upravo započeli liječenje lijekom Suliqua - ako se pojavi niska razina šećera,
English: • Only use this pen to inject single daily doses from 30 to 60 dose steps.
Croatian: Upotrijebite ovu brizgalicu samo za injiciranje jedne dnevne doze od 30 do 60 odmjernih koraka.
English: Reasons why hypoglycaemia may happen:
Croatian: Razlozi zbog kojih dolazi do hipoglikemije:
English: Insulin glargine has not been studied in patients with renal impairment.
Croatian: Inzulin glargin nije ispitivan u bolesnika s oštećenjem funkcije bubrega.
English: • Suliqua is injected under the skin (subcutaneous use or “SC”).
Croatian: • Lijek Suliqua se injicira potkožno (supkutana primjena ili s.c)
English: • Do not put your pen back in the refrigerator.
Croatian: Nemojte vraćati brizgalicu ponovno u hladnjak.
English: • Keep your pen at room temperature, below 25°C.
Croatian: Čuvajte brizgalicu na sobnoj tempraturi, ispod 25°C.
English: Suliqua (10-40) pen contains insulin glargine and lixisenatide.
Croatian: Suliqua (10-40) brizgalica sadrži inzulin glargin i liksisenatid.
English: • The active substances are insulin glargine and lixisenatide.
Croatian: • Djelatne tvari su inzulin glargin i liksisenatid.
English: The re-use of needles increases the risk of blocked needles which may cause under- or overdosing.
Croatian: Ponovna uporaba istih igala povećava rizik od začepljenja što može uzrokovati primjenu premale ili prevelike doze.
English: Each pen contains 3 ml of solution for injection, equivalent to 300 units insulin glargine and 100 micrograms lixisenatide.
Croatian: Jedna brizgalica sadrži 3 ml otopine za injekciju, što odgovara 300 jedinica inzulina glargina i 100 mikrograma liksisenatida.
English: Results at 30 weeks -Study Type 2 Diabetes Uncontrolled on Basal Insulin mITT population Suliqua
Croatian: - Ispitivanje šećerne bolesti tipa 2 nedovoljno kontrolirane bazalnim inzulinom (mITT populacija)
English: The apparent volume of distribution of lixisenatide after subcutaneous administration of insulin glargine/lixisenatide combinations (Vz/F) is approximately 100 L. The apparent volume of distribution of insulin glargine after subcutaneous administration of the insulin glargine/lixisenatide combinations (Vss/F) is approximately 1700 L.
Croatian: Prividan volumen distribucije inzulina glargina nakon supkutane primjene kombinacije inzulina glargina i liksisenatida (Vss/F) iznosi približno 1700 l.
English: If your blood sugar is too high, follow the guidance for hyperglycaemia (see information in the box at the end of this leaflet).
Croatian: Ako Vam je šećer u krvi previsok, slijedite upute za slučaj hiperglikemije (vidjeti uokvireni tekst na kraju ove upute o lijeku).
English: Gender has no clinically relevant effect on the pharmacokinetics of lixisenatide
Croatian: Spol nema klinički značajan učinak na farmakokinetiku liksisenatida.
English: Effect of gastric emptying on oral medicinal products The delay of gastric emptying with lixisenatide may reduce the rate of absorption of orally administered medicinal products.
Croatian: Učinak pražnjenja želuca na peroralno primijenjene lijekove Liksisentid odgađa pražnjenje želuca što može smanjiti brzinu apsorpcije peroralno primijenjenih lijekova.
English: The effect of some medicines you swallow might be affected by Suliqua.
Croatian: Suliqua može utjecati na učinak nekih lijekova koje uzimate kroz usta.
English: SoloStar Clear colourless solution.
Croatian: SoloStar Bistra, bezbojna otopina.
English: • Cold, runny nose, sore throat
Croatian: • prehlada, curenje iz nosa, bolno grlo
English: Insulin glargine daily dose LS insulin dose at week 30 (mean)
Croatian: Dnevna doza inzulina glargina Doza inzulina dobivena metodom najmanjih kvadrata u 30.tjednu (srednja vrijednost)
English: • Suliqua 100 units/ml + 33 micrograms/ml pre-filled pen delivers dose steps from 30-60 units of insulin glargine in combination with 10-20 mcg lixisenatide (Suliqua (30-60) pen).
Croatian: • Suliqua 100 jedinica/ml + 33 mikrograma/ml napunjena brizgalica može isporučiti dozu u odmjernim koracima od 30-60 jedinica inzulina glargina u kombinaciji sa 10-20 mikrograma liksisenatida (Suliqua (30-60) brizgalica).