FrancophonIA/ELRC3.0 huggingface dataset:
English: Based on these results, no dose adjustment for warfarin is required when co-administered with lixisenatide; however, frequent monitoring of INR in patients on warfarin and/or coumarin derivatives is recommended at the time of initiation or ending of lixisenatide treatment.
Croatian: Na temelju tih rezultata, nije potrebna prilagodba doze varfarina pri istodobnoj primjeni s liksisenatidom, međutim, u bolesnika koji primaju varfarin i/ili kumarinske derivate preporučuje se često praćenje INR-a na početku i na završetku liječenja liksisenatidom.
English: Consistent with the potentially immunogenic properties of medicinal products containing proteins or peptides, patients may develop anti-lixisenatide antibodies following treatment with Lyxumia and, at the end of the main 24-week treatment period in placebo-controlled studies, 69.8% of lixisenatide patients had a positive antibody status.
Croatian: Sukladno potencijalno imunogenim svojstvima lijekova koji sadrže proteine ili peptide, u bolesnika se nakon liječenja lijekom Lyxumia mogu razviti protutijela na liksisenatid, pa je do kraja osnovnog 24-tjednog razdoblja liječenja u placebom kontroliranim ispitivanjima 69,8% bolesnika liječenih liksisenatidom bilo pozitivno na protutijela na liksisenatid.
English: Sulphonylurea as background therapy with or without metformin Lixisenatide 20 mcg (N= 570)
Croatian: Sulfonilureja kao osnovna terapija sa ili bez metofrmina liksisenatid 20 µg (N=570)
English: Pull off the outer and inner needle caps.
Croatian: Povucite i skinite vanjski i unutarnji zatvarač igle.
English: Sanofi-Aventis Deutschland GmbH Brüningstrasse 50, Industriepark Höchst 65926 Frankfurt am Main Germany
Croatian: Sanofi-Aventis Deutschland GmbH Brüningstrasse 50, Industriepark Höchst 65926 Frankfurt am Main Njemačka
English: The most common adverse reactions which led to treatment discontinuation in the lixisenatide group were nausea (3.1%) and vomiting (1.2%).
Croatian: Najčešće nuspojave koje su dovele do prekida liječenja u skupini liječenoj liksisenatidom bile su mučnina (3,1%) i povraćanje (1,2%).
English: Press the injection button all the way in. You may feel or hear a “click”.
Croatian: Možda ćete osjetiti ili čuti "klik".
English: No dose adjustment is required for patients with mild or moderate renal impairment.
Croatian: Nije potrebna prilagodba doze u bolesnika s blagim ili umjerenim oštećenjem funkcije bubrega.
English: • Activation is done to make sure that the pen is working correctly and that the dose for your first injection is correct.
Croatian: • Svrha je aktivacije provjeriti radi li brizgalica ispravno i je li odmjerena točna doza za prvu injekciju.
English: Step 2 Attach a needle and remove the needle caps
Croatian: Korak 2 Pričvrstite iglu i uklonite zatvarače igle
English: In addition, hypoglycaemia (when Lyxumia was used in combination with a sulphonylurea and/or a basal insulin) and headache occurred.
Croatian: Osim toga, javile su se hipoglikemija (kada se Lyxumia primjenjivala u kombinaciji sa sulfonilurejom i/ili bazalnim inzulinom) i glavobolja.
English: Figure 1: Forest plot: analyses of each individual cardiovascular event -- ITT population
Croatian: Slika 1: Grafikon raspona pouzdanosti: analiza svakog pojedinačnog kardiovaskularnog događaja - u populaciji predviđenoj za liječenje (ITT populacija)
English: Add-on treatment to metformin alone
Croatian: Dodatak liječenju samo metforminom
English: • Always read the "Instructions for Use" provided in the box.
Croatian: "Upute za uporabu" priložene u kutiji.
English: What Lyxumia looks like and contents of the pack Lyxumia is a clear and colourless solution for injection (injection) filled in a glass cartridge inserted in a pre-filled pen.
Croatian: Lyxumia je bistra i bezbojna otopina za injekciju (injekcija) u staklenom ulošku koji je umetnut u napunjenu brizgalicu.
English: If you forget to use Lyxumia
Croatian: Ako ste zaboravili primijeniti lijek Lyxumia
English: In a study in healthy volunteers, a transient rise in heart rate has been observed after administration of lixisenatide 20 mcg.
Croatian: U ispitivanju na zdravim dobrovoljcima opaženo je prolazno povećanje srčane frekvencije nakon primjene liksisenatida u dozi od 20 µg.
English: In the subset of patients (5.2%) with the highest antibody concentrations, the mean improvement in HbA1c at Week 24 and at Week 76 was in a clinically relevant range; however there was variability in the glycaemic response and 1.9% had no decrease in HbA1c.
Croatian: U podskupini bolesnika (5,2%) s najvišim koncentracijama protutijela, srednja vrijednost poboljšanja HbA1c u 24. tjednu i u 76. tjednu bila je u klinički značajnom rasponu, međutim, bilo je varijabilnosti u glikemijskom odgovoru, a u 1,9% bolesnika nije došlo do smanjenja HbA1c.
English: Step E. Remove and throw away the needle after each injection
Croatian: Uklonite i bacite iglu nakon svake injekcije
English: This is shown by the placement of the black plunger in the dose scale.
Croatian: To možete odrediti prema položaju crnog klipa na skali za doziranje.
English: Starting dose: dosing is initiated at 10 mcg lixisenatide once daily for 14 days.
Croatian: Početna doza: doziranje počinje s 10 µg liksisenatida jedanput na dan tijekom 14 dana.
English: Lyxumia 20 micrograms solution for injection EU/1/12/811/002 (1 pre-filled pen) EU/1/12/811/003 (2 pre-filled pens) EU/1/12/811/004 (6 pre-filled pens)
Croatian: Lyxumia 20 mikrograma otopina za injekciju EU/1/12/811/002 (1 napunjena brizgalica) EU/1/12/811/003 (2 napunjene brizgalice) EU/1/12/811/004 (6 napunjenih brizgalica)
English: Tel: 800 13 12 12 (domande di tipo tecnico) 800 536389 (altre domande)
Croatian: Tel: 800 13 12 12 (domande di tipo tecnico)
English: Body weight change from baseline in a range from -0.38 kg to -1.80 kg was also observed in lixisenatide patients receiving stable basal insulin dose, alone or in combination with metformin or a sulphonylurea.
Croatian: Promjena tjelesne težine u odnosu na početnu vrijednost u rasponu od -0,38 kg do -1,80 kg također je opažena i u bolesnika liječenih liksisenatidom koji su primali stabilnu dozu bazalnog inzulina samog ili u kombinaciji s metforminom ili sulfonilurejom.
English: 1 pre-filled pen of 3 ml (14 doses)
Croatian: 1 napunjena brizgalica od 3 ml (14 doza)
English: Once the green 10 micrograms Lyxumia pen is empty you must continue your treatment by taking your next injection when it is due, using the purple 20 microgram Lyxumia pen.
Croatian: Kada ispraznite zelenu Lyxumia brizgalicu od 10 mikrograma, nastavite liječenje uzimanjem sljedeće injekcije kada je to potrebno, uporabom ljubičaste Lyxumia brizgalice od 20 mikrograma.
English: A further delay in tmax and a reduced Cmax of paracetamol have been predicted with the 20 mcg maintenance dose.
Croatian: Očekuje se daljnja odgoda tmax i smanjeni Cmax paracetamola nakon primjene doze održavanja od 20 µg.
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 bolesnika u završnoj fazi bubrežne bolesti.
English: About Your Treatment Initiation pack
Croatian: O pakiranju za početak liječenja
English: Reduction of the dose of the sulphonylurea or the basal insulin may be considered to reduce the risk of hypoglycaemia (see section 4.2).
Croatian: Može se razmotriti smanjenje doze sulfonilureje ili bazalnog inzulina kako bi se smanjio rizik od hipoglikemije (vidjeti dio 4.2).
English: Do not freeze Lyxumia once it has been activated.
Croatian: Nemojte zamrzavati Lyxumia brizgalicu nakon aktivacije.
English: Pharmacotherapeutic group: Drugs used in Diabetes, Glucagon-like peptide-1 (GLP-1) analogues, ATC code: A10BJ03
Croatian: Farmakoterapijska skupina: Lijekovi za liječenje šećerne bolesti, analozi peptida-1 nalik glukagonu (GLP-1), ATK oznaka: A10BJ03
English: This is to make sure that it is working correctly and that the dose for your first injection is correct.
Croatian: Svrha toga je provjeriti radi li brizgalica ispravno i je li odmjerena točna doza za prvu injekciju.
English: Lyxumia is used with other medicines for diabetes when they are not enough to control your blood sugar levels.These may include:
Croatian: Lyxumia se primjenjuje s drugim lijekovima za liječenje šećerne bolesti kada oni nisu dovoljni za kontrolu razine šećera u krvi.
English: In a 24-week open-label study, lixisenatide administered before the main meal of the day was non-inferior to lixisenatide administered before breakfast in terms of HbA1c reduction (LS mean change from baseline: -0.65% versus -0.74%).
Croatian: U otvorenom ispitivanju koje je trajalo 24 tjedna, liksisenatid primijenjen prije glavnog dnevnog obroka bio je neinferioran u odnosu na liksisenatid primijenjen prije doručka u snižavanju vrijednosti HbA1c (srednja vrijednost promjene od početne vrijednosti, metodom najmanjih kvadrata: -0,65% naspram -0,74%).
English: There was no difference in the overall safety profile in patients regardless of the antibody status with the exception of an increase of the incidence of injection site reactions (4.7% in antibody positive patients compared to 2.5% in antibody-negative patients during the entire treatment period).
Croatian: Nisu primijećene razlike među bolesnicima u ukupnom profilu sigurnosti primjene, neovisno o statusu protutijela, izuzevši povećanu incidenciju reakcija na mjestu injekcije (u 4,7% bolesnika s pozitivnim protutijelima u usporedbi s 2,5% bolesnika s negativnim protutijelima tijekom čitavog razdoblja liječenja).
English: This study consisted of a 12-week run-in period with introduction and titration of insulin glargine and of a 24-week treatment period during which patients receive either lixisenatide or placebo in combination with insulin glargine and metformin with or without thiazolidinediones.
Croatian: To se ispitivanje sastojalo od 12-tjednog uvodnog razdoblja tijekom kojega je uveden i titriran inzulin glargin te od 24-tjednog razdoblja liječenja tijekom kojega su bolesnici primali ili liksisenatid ili placebo u kombinaciji s inzulinom glarginom i metforminom, s ili bez tiazolidindiona.
English: Skin and subcutaneous tissue disorders
Croatian: Poremećaji kože i potkožnog tkiva urtikarija
English: Lyxumia comes as a pre-filled pen for injection.
Croatian: Lyxumia dolazi u obliku napunjene brizgalice za injekciju.
English: • Low blood sugar (hypoglycaemia (“hypo”) especially when Lyxumia is used with insulin or a sulphonylurea
Croatian: • niska razina šećera u krvi (hipoglikemija), osobito kada se Lyxumia primjenjuje s inzulinom ili sulfonilurejom
English: Lyxumia contains the active substance lixisenatide.
Croatian: Lyxumia sadrži djelatnu tvar liksisenatid.
English: Do not use this Lyxumia Treatment Initiation pack.
Croatian: Nemojte upotrijebiti to Lyxumia pakiranje za početak liječenja.
English: How to activate your new Lyxumia pen
Croatian: Kako aktivirati novu Lyxumia brizgalicu
English: Some medicines such as antibiotics or stomach resistant 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 Lyxumia injection.
Croatian: Neke lijekove koji se ne smiju predugo zadržavati u želucu, poput antibiotika ili želučanootpornih tableta ili kapsula, možda ćete morati uzeti najmanje jedan sat prije ili četiri sata nakon injekcije lijeka Lyxumia.
English: In a pharmacokinetic study in elderly non-diabetic subjects, administration of lixisenatide 20 mcg resulted in a mean increase of lixisenatide AUC by 29% in the elderly population (11 subjects aged 65 to 74 years and 7 subjects aged ≥75 years) compared to 18 subjects aged 18 to 45 years, likely related to reduced renal function in the older age group.
Croatian: U farmakokinetičkom ispitivanju starijih osoba koje ne boluju od šećerne bolesti primjena liksisenatida u dozi od 20 µg dovela je do srednjeg povećanja AUC-a liksisenatida od 29% u starijoj populaciji (11 ispitanika u dobi od 65 do 74 godina i 7 ispitanika u dobi od ≥ 75 godina) u usporedbi s 18 ispitanika u dobi od 18 do 45 godina, što je vjerojatno povezano sa smanjenom funkcijom bubrega u starijoj dobnoj skupini.
English: To inject a dose with the purple 20 micrograms Lyxumia pen, follow all steps in Section 3.
Croatian: Da biste injicirali dozu ljubičastom Lyxumia brizgalicom od 20 mikrograma slijedite sve korake navedene u dijelu 3.
English: • Post-prandial glucose
Croatian: • Glukoza nakon obroka
English: The plunger will move along the dose scale after each injection.
Croatian: Klip će se nakon svake injekcije pomaknuti duž skale za doziranje.
English: It is not known if Lyxumia passes into your milk.
Croatian: Nije poznato izlučuje li se Lyxumia u majčino mlijeko.
English: The table also includes adverse reactions with a frequency ≥1% in the Lyxumia group if the frequency was greater than 2 times the frequency for all comparators group.
Croatian: Tablica također uključuje nuspojave s učestalošću ≥ 1% u skupini koja je primala lijek Lyxumia, ako je učestalost bila više od 2 puta veća od učestalosti u svim skupinama koje su primale usporedne lijekove.
English: Lyxumia should not be used during pregnancy.
Croatian: Lyxumia se ne smije primjenjivati u trudnoći.
English: Pharmacotherapeutic group: Drugs used in Diabetes, Glucagon-like peptide-1 (GLP-1) analogues , ATC code: A10BJ03.
Croatian: Farmakoterapijska skupina: Lijekovi za liječenje šećerne bolesti, analozi peptida-1 nalik glukagonu (GLP-1), ATK oznaka: A10BJ03.
English: Treatment with Lyxumia resulted in reductions in 2-hour post-prandial glucose after a test-meal statistically superior to placebo whatever the background treatment.
Croatian: Liječenje lijekom Lyxumia rezultiralo je smanjenjem razine glukoze postprandijalno, 2 sata nakon testnog obroka, koje je bilo statistički superiorno u odnosu na placebo bez obzira na osnovno liječenje.
English: How to use Lyxumia Always use this medicine exactly as your doctor, pharmacist or nurse has told you.
Croatian: Uvijek primijenite ovaj lijek točno onako kako su Vam rekli liječnik, ljekarnik ili medicinska sestra.
English: Lyxumia should not be used with a combination of both basal insulin and sulphonylurea
Croatian: Lyxumia se ne smije primjenjivati u kombinaciji s oboje, bazalnim inzulinom i sulfonilurejom
English: • Do not soak, wash or put liquid on (lubricate) your Lyxumia pen, this may damage it.
Croatian: • Nemojte namakati, prati ni podmazivati Lyxumia brizgalicu jer je to može oštetiti.
English: Harzard Ratio with 95% CI
Croatian: Omjer hazarda s 95% IP
English: Learning how to use the pre-filled pens Before you use the pen for the first time, your doctor or nurse will show how to inject Lyxumia.
Croatian: Prije nego što prvi puta upotrijebite brizgalicu, liječnik ili medicinska sestra pokazat će Vam kako trebate injicirati lijek Lyxumia.
English: Lyxumia should not be given in combination with basal insulin and a sulphonylurea due to increased risk of hypoglycaemia (see section 4.4).
Croatian: Lyxumia se ne smije primjenjivati u kombinaciji s bazalnim inzulinom i sulfonilurejom zbog povećanog rizika od hipoglikemije (vidjeti dio 4.4).
English: EU/1/12/811/003 - 2 pens
Croatian: EU/1/12/811/003 - 2 brizgalice
English: Administration of the oral contraceptive 1 hour or 4 hours after lixisenatide did not affect AUC and t1/2 of ethinylestradiol and levonorgestrel, whereas Cmax of ethinylestradiol was decreased by 52% and 39% respectively and Cmax of levonorgestrel was decreased by 46% and 20%, respectively and median tmax was delayed by 1 to 3 hours.
Croatian: Primjena oralnog kontraceptiva 1 sat odnosno 4 sata nakon liksisenatida nije utjecala na AUC ni t1/2 etinilestradiola i levonorgestrela, ali je smanjila Cmax etinilestradiola za 52% odnosno 39% te Cmax levonorgestrela za 46% odnosno 20%, dok je medijan tmax bio odgođen za 1 do 3 sata.
English: • Do not try to take liquid out of the cartridge using a syringe.
Croatian: • Nemojte pokušavati izvući tekućinu iz uloška pomoću štrcaljke.
English: EU/1/12/811/004 - 6 pens
Croatian: EU/1/12/811/004 - 6 brizgalica
English: Pen Date of activation
Croatian: Brizgalica Datum aktivacije
English: The window remains white after activation.
Croatian: Prozorčić nakon aktivacije ostaje bijele boje.
English: Purple 20 micrograms pen activation The purple 20 micrograms Lyxumia pen must also be activated before use.
Croatian: Ljubičasta Lyxumia brizgalica od 20 mikrograma također se prije uporabe mora aktivirati.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (28 DAYS TREATMENT INITIATION PACK)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA (PAKIRANJE ZA PRVIH 28 DANA LIJEČENJA)
English: When Lyxumia is added to existing therapy of a sulphonylurea or a basal insulin, a reduction in the dose of the sulphonylurea or the basal insulin may be considered to reduce the risk of hypoglycaemia.
Croatian: Kada se Lyxumia dodaje postojećoj terapiji sulfonilurejom ili bazalnim inzulinom, treba razmotriti smanjenje doze sulfonilureje ili bazalnog inzulina kako bi se smanjio rizik od hipoglikemije.
English: At the end of the main 24-week treatment period, 32.2% of the patients having a positive antibody status had an antibody concentration above the lower limit of quantification, and at the end of the entire 76-week treatment period, 44.7% of the patients had an antibody concentration above the lower limit of quantification.
Croatian: Na kraju osnovnog 24-tjednog razdoblja liječenja u 32,2% bolesnika koji su imali pozitivan nalaz protutijela, koncentracija je bila iznad donje granice mjerljivosti, dok je na kraju ukupnog 76-tjednog razdoblja liječenja koncentraciju protutijela iznad donje granice mjerljivosti imalo 44,7% bolesnika.
English: These are the thigh, abdomen or upper arm.
Croatian: To su bedro, trbuh ili nadlaktica.
English: Throw away a used Lyxumia pen after 14 days.
Croatian: Nakon 14 dana bacite upotrijebljenu Lyxumia brizgalicu.
English: No effects on paracetamol Cmax and tmax were observed when paracetamol was administered 1 hour before lixisenatide.
Croatian: Nisu opaženi učinci na Cmax ni tmax paracetamola nakon njegove primjene 1 sat prije liksisenatida.
English: After concomitant administration of warfarin 25 mg with repeated dosing of lixisenatide 20 mcg, there were no effects on AUC or INR (International Normalised Ratio) while Cmax was reduced by 19% and tmax was delayed by 7 hours.
Croatian: Nakon istodobne primjene varfarina u dozi od 25 mg i ponovljenih doza liksisenatida od 20 µg nije bilo učinaka na AUC ni INR (internacionalni normalizirani omjer), dok se Cmax smanjio za 19%, a tmax odgodio za 7 sati.
English: Too much Lyxumia can make you feel sick or be sick.
Croatian: Prevelika količina lijeka Lyxumia može izazvati mučninu ili povraćanje.
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 istraživanjima embriofetalnog razvoja opažene su malformacije, zastoj u rastu, zakašnjelo okoštavanje i učinci na skeletu pri svim dozama u štakora (omjer izloženosti 5 puta veći od onog u ljudi) te pri visokim dozama u kunića (omjer izloženosti 32 puta veći od onog u ljudi).
English: Based on these results, no dose adjustment for digoxin is required when co-administered with lixisenatide.
Croatian: Na temelju tih rezultata, nije potrebna prilagodba doze digoksina pri istodobnoj primjeni s liksisenatidom.
English: Speak to your doctor, nurse or pharmacist about how to dispose of sharps.
Croatian: Razgovarajte sa svojim liječnikom, medicinskom sestrom ili ljekarnikom o tome kako odložiti oštre dijelove.
English: Turn over
Croatian: Okrenuti
English: Packs containing 1, 2 and 6 purple pre-filled pens.
Croatian: Pakiranje sadrži 1, 2 ili 6 ljubičastih napunjenih brizgalica.
English: Step 4 Press and hold the injection button to remove excess liquid
Croatian: Korak 4 Pritisnite dugme za injiciranje i držite ga pritisnutim da biste uklonili višak tekućine
English: Within each system organ class, adverse reactions are presented in order of decreasing frequency.
Croatian: Unutar svakog organskog sustava nuspojave su navedene u padajućem nizu prema učestalosti.
English: Each pack of 2 pre-filled pens for a 4 week treatment schedule contains: 1 pre-filled pen of 3 ml for 14 doses of 10 micrograms 1 pre-filled pen of 3 ml for 14 doses of 20 micrograms
Croatian: Jedno pakiranje s 2 napunjene brizgalice za 4 tjedna liječenja sadrži: 1 napunjenu brizgalicu od 3 ml za 14 doza od 10 mikrograma 1 napunjenu brizgalicu od 3 ml za 14 doza od 20 mikrograma
English: The table presents adverse reactions that occurred with an incidence >5% if the frequency was higher among Lyxumia treated patients than patients treated with all comparators.
Croatian: Tablica prikazuje nuspojave koje su se javljale s incidencijom > 5% ako je njihova učestalost bila viša među bolesnicima liječenima lijekom Lyxumia nego među onima koji su primali usporedne lijekove.
English: When to inject
Croatian: Kada injicirati lijek
English: Check that the activation window is now white.
Croatian: Provjerite je li prozorčić za aktivaciju sada bijele boje.
English: No C-cell carcinoma was observed in mice and C-cell carcinoma occurred in rats with an exposure ratio relative to exposure at human therapeutic dose of about 900-fold.
Croatian: Karcinom C-stanica nije opažen u miševa, a u štakora se javio kod razine izloženosti približno 900 puta veće od izloženosti u ljudi nakon primjene terapijske doze.
English: In a clinical study, the addition of lixisenatide to pioglitazone with or without metformin, in patients not adequately controlled with pioglitazone, resulted in an HbA1c decrease from baseline of 0.90%, compared to a decrease from baseline of 0.34% in the placebo group at the end of the 24-week main treatment period.
Croatian: Na kraju osnovnog 24-tjednog razdoblja liječenja u kliničkom ispitivanju dodatak liksisenatida pioglitazonu, sa ili bez metformina, u bolesnika koji nisu odgovarajuće kontrolirani pioglitazonom rezultirao je smanjenjem vrijednosti HbA1c od 0,90% u odnosu na početne vrijednosti u usporedbi sa smanjenjem od 0,34% u skupini na placebu.
English: Body weight Body weight has no clinically relevant effect on lixisenatide AUC.
Croatian: Tjelesna težina nema klinički značajan učinak na AUC liksisenatida.
English: Keep the cap on the pen in order to protect from light.
Croatian: Držati zatvarač na brizgalici radi zaštite od svjetlosti.
English: Ask your doctor, pharmacist or nurse about how to inject correctly.
Croatian: Pitajte svog liječnika, ljekarnika ili medicinsku sestru kako pravilno injicirati lijek.
English: The incidence of nausea was higher in the lixisenatide group (26.1%) compared to the placebo group (6.2%) and the incidence of vomiting was higher in the lixisenatide group (10.5%) than in the placebo group (1.8%).
Croatian: Incidencija mučnine bila je viša u skupini na liksisenatidu (26,1%) nego u skupini koja je primala placebo (6,2%), a incidencija povraćanja bila je viša u skupini na liksisenatidu (10,5%) nego u skupini koja je primala placebo (1,8%).
English: There is no therapeutic experience in patients with severe renal impairment (creatinine clearance less than 30 ml/min) or end-stage renal disease and therefore, it is not recommended to use lixisenatide in these populations (see section 5.2).
Croatian: Nema terapijskog iskustva u bolesnika s teškim oštećenjem funkcije bubrega (klirens kreatinina manji od 30 ml/min) ni u bolesnika u završnoj fazi bubrežne bolesti pa se stoga u toj populaciji ne preporučuje primjena liksisenatida (vidjeti dio 5.2).
English: Do not stop using Lyxumia without talking with your doctor.
Croatian: Ako prestanete primjenjivati lijek Lyxumia Nemojte prestati primjenjivati lijek Lyxumia bez savjetovanja s liječnikom.
English: • Do not store your Lyxumia pen with the needle attached.
Croatian: • Nemojte čuvati Lyxumia brizgalicu s pričvršćenom iglom.