FrancophonIA/ELRC3.0 huggingface dataset:
English: The clinical efficacy and safety of Lyxumia were evaluated in nine randomised double-blind, placebo-controlled clinical studies including 4,508 patients with type 2 diabetes (2,869 patients randomised to lixisenatide, 47.5% men and 52.5% women, and 517 were ≥65 years of age).
Croatian: Klinička djelotvornost i sigurnost primjene lijeka Lyxumia procijenjene su u devet randomiziranih, dvostruko slijepih, placebom kontroliranih kliničkih ispitivanja koja su uključila 4508 bolesnika sa šećernom bolešću tipa 2 (2869 bolesnika randomiziranih na liksisenatid, od kojih 47,5% muškaraca i 52,5% žena, te 517 u dobi od ≥ 65 godina).
English: • You can clean the outside of your Lyxumia pen by wiping it with a damp cloth.
Croatian: • Vanjsku površinu Lyxumia brizgalice možete očistiti vlažnom krpicom.
English: • Each Lyxumia pen contains 14 pre-set doses.
Croatian: • Jedna Lyxumia brizgalica sadrži 14 prethodno odmjerenih doza.
English: Lixisenatide 20 mcg Placebo (N= 170)
Croatian: liksisenatid 20 µg placebo (N=170)
English: Lixisenatide slows gastric emptying thereby reducing the rate at which meal-derived glucose appears in the circulation.
Croatian: Liksisenatid usporava pražnjenje želuca i tako smanjuje brzinu kojom glukoza iz obroka dolazi u cirkulaciju.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially “sodium-free”.
Croatian: Ovaj lijek sadrži manje od 1 mmol natrija (23 mg) po dozi, tj. zanemarive količine natrija.
English: Hepatic dysfunction is not expected to affect the pharmacokinetics of lixisenatide.
Croatian: Ne očekuje se da bi oštećenje funkcije jetre moglo utjecati na farmakokinetiku liksisenatida.
English: Reduction from baseline in the AUC0:30-4:30 h of plasma glucose after a test-meal was: -12.61 h*mmol/L (-227.25 h*mg/dl) in the lixisenatide group and -4.04 h*mmol/L (-72.83 h*mg/dl) in the liraglutide group.
Croatian: Nakon testnog obroka smanjenje AUC0:30-4:30 h glukoze u plazmi u odnosu na početne vrijednosti iznosilo je: -12,61 h*mmol/l (-227,25 h*mg/dl) u skupini koja je primala liksisenatid te -4,04 h*mmol/l (-72,83 h*mg/dl) u skupini koja je primala liraglutid.
English: Anaphylactic reactions were reported in 0.2% of the lixisenatide treated patients vs. none in the placebo group.
Croatian: Anafilaktičke reakcije prijavljene su u 0,2% bolesnika liječenih liksisenatidom, naspram niti jednog bolesnika iz placebo skupine.
English: Line up the needle with the pen.
Croatian: Poravnajte iglu s brizgalicom.
English: Mean body weight
Croatian: Tjelesna težina
English: Add-on combination therapy with a basal insulin
Croatian: Dodatak kombiniranoj terapiji s bazalnim inzulinom
English: Table 5: Active-controlled study in combination with basal insulin with or without metformin (26-week results) - (mITT) and safety population
Croatian: Tablica 5: Aktivnim lijekom kontrolirano ispitivanje u kombinaciji s bazalnim inzulinom, s ili bez metformina (rezultati nakon 26 tjedana) - modificirana populacija koju se planiralo liječiti (mITT, engl. modified intent-to-treat) i sigurnosna populacija
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 peroralne lijekove čija djelotvornost uvelike ovisi o graničnim koncentracijama, poput antibiotika, uzmu najmanje 1 sat prije ili 4 sata nakon injekcije liksisenatida.
English: Table 2: Placebo-controlled studies in combination with metformin (24-week results).
Croatian: Tablica 2: Placebom kontrolirana ispitivanja u kombinaciji s metforminom (rezultati nakon 24 tjedna)
English: Injection sites
Croatian: Mjesta za injiciranje
English: Step 3 Pull the injection button out
Croatian: Korak 3 Izvucite dugme za injiciranje
English: The incidence of nausea was 24.5% in the lixisenatide group compared to 35.1% in the exenatide twice daily group and the incidence of symptomatic hypoglycaemia with lixisenatide was 2.5% during the 24-week main treatment period compared to 7.9% in the exenatide group.
Croatian: Incidencija mučnine bila je 24,5% u skupini na liksisenatidu u usporedbi s 35,1% u skupini na eksenatidu dvaput na dan, dok je incidencija simptomatske hipoglikemije tijekom osnovnog 24-tjednog razdoblja liječenja bila 2,5% kod primjene liksisenatida i 7,9% u skupini na eksenatidu.
English: If still no liquid comes out, your Lyxumia pen may be damaged.
Croatian: Ako tekućina i dalje ne izlazi, možda je Lyxumia brizgalica oštećena.
English: Pen needles are not included.
Croatian: Pakiranje ne sadrži igle za brizgalicu.
English: Front
Croatian: Sprijeda
English: In an active-controlled study, Lyxumia once daily showed an HbA1c reduction of -0.79% compared to -0.96% with exenatide twice daily at the end of the main 24-week treatment period with a mean treatment difference of 0.17% (95% CI: 0.033, 0.297) and a similar percentage of patients achieved an HbA1c less than 7% in the lixisenatide group (48.5%) and in the exenatide group (49.8%).
Croatian: Na kraju osnovnog 24-tjednog razdoblja liječenja u ispitivanju kontroliranom aktivnim lijekom, Lyxumia primijenjena jedanput na dan dovela je do smanjenja vrijednosti HbA1c od -0,79% u usporedbi s -0,96% kod primjene eksenatida dvaput na dan, sa srednjom vrijednošću razlika između liječenja od 0,17% (95% CI: 0,033; 0,297), dok je vrijednost HbA1c manju od 7% postigao sličan postotak bolesnika i u skupini na liksisenatidu (48,5%) i u onoj na eksenatidu (49,8%).
English: Add-on treatment to pioglitazone alone or in combination with metformin
Croatian: Dodatak liječenju samim pioglitazonom ili u kombinaciji s metforminom
English: Lyxumia can be used with 29 to 32 gauge disposable pen needles.
Croatian: Lyxumia se može primijeniti jednokratnom iglom za brizgalicu veličine 29 do 32 G.
English: Back
Croatian: Straga
English: Lixisenatide INSTRUCTIONS FOR USE
Croatian: Lyxumia liksisenatid UPUTE ZA UPORABU
English: • The dose from then onwards will be 20 micrograms once a day -using the purple pen.
Croatian: • Nakon toga doza će biti 20 mikrograma jedanput na dan, a injicira se ljubičastom brizgalicom.
English: Gender Gender has no clinically relevant effect on the pharmacokinetics of lixisenatide.
Croatian: Spol Spol nema klinički značajan učinak na farmakokinetiku liksisenatida.
English: Table 3: Placebo-controlled study in combination with a sulphonylurea (24-week results)
Croatian: Tablica 3: Placebom kontrolirano ispitivanje u kombinaciji sa sulfonilurejom (rezultati nakon 24 tjedna)
English: Allergic reactions possibly associated with lixisenatide (such as anaphylactic reaction, angioedema and urticaria) have been reported in 0.4% of lixisenatide patients while possibly associated allergic reactions occurred in less than 0.1% of placebo patients during the main 24-week treatment period.
Croatian: Tijekom osnovnog 24-tjednog razdoblja liječenja alergijske reakcije moguće povezane s liksisenatidom (poput anafilaktičke reakcije, angioedema i urtikarije) prijavljene su u 0,4% bolesnika liječenih liksisenatidom, no u manje od 0,1% bolesnika koji su primali placebo.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (MAINTENANCE PACK)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA (PAKIRANJE ZA TERAPIJU ODRŽAVANJA)
English: This is because low blood sugar (hypoglycaemia) can occur.
Croatian: U tom slučaju može doći do niske razine šećera u krvi (hipoglikemije).
English: Lyxumia 10 micrograms solution for injection EU/1/12/811/001 (1 pre-filled pen)
Croatian: Lyxumia 10 mikrograma otopina za injekciju EU/1/12/811/001 (1 napunjena brizgalica)
English: Check that the activation window is orange.
Croatian: Provjerite je li prozorčić za aktivaciju narančaste boje.
English: Lixisenatide 20 mcg (N= 327)
Croatian: liksisenatid 20 µg (N=327)
English: During the 24-week treatment period, 22.4% lixisenatide patients reported at least one symptomatic hypoglycaemic event compared to 13.5% in the placebo group.
Croatian: Tijekom 24-tjednog razdoblja liječenja 22,4% bolesnika na liksisenatidu prijavilo je najmanje jedan simptomatski hipoglikemijski događaj, u usporedbi s 13,5% bolesnika na placebu.
English: You do not need to replace the needle between activation and your first injection.
Croatian: Za primjenu prve injekcije ne morate iglu kojom ste izvršili aktivaciju zamijeniti novom.
English: Patients receiving Lyxumia with a sulphonylurea or with a basal insulin may have an increased risk of hypoglycaemia.
Croatian: U bolesnika koji lijek Lyxumia primaju sa sulfonilurejom ili bazalnim inzulinom može postojati povećan rizik od hipoglikemije.
English: Contact your doctor, pharmacist or nurse if you need help.
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri ako trebate pomoć.
English: In patients taking Lyxumia in monotherapy, symptomatic hypoglycaemia occurred in 1.7% of lixisenatide treated patients and in 1.6% of placebo treated patients.
Croatian: U bolesnika koji su uzimali lijek Lyxumia kao monoterapiju simptomatska hipoglikemija javila se u 1,7% bolesnika liječenih liksisenatidom i u 1,6% bolesnika koji su primali placebo.
English: - The other ingredients are glycerol 85 %, sodium acetate trihydrate, methionine, metacresol, hydrochloric acid (for pH adjustment), sodium hydroxide solution (for pH adjustment) and water for injections.
Croatian: - Drugi sastojci su glicerol 85%, natrijev acetat trihidrat, metionin, metakrezol, kloridna kiselina (za podešavanje pH), otopina natrijeva hidroksida (za podešavanje pH) i voda za injekcije.
English: Lixisenatide should not be given in combination with basal insulin and a sulphonylurea due to increased risk of hypoglycaemia.
Croatian: Liksisenatid se ne smije primjenjivati u kombinaciji s bazalnim inzulinom i sulfonilurejom zbog povećanog rizika od hipoglikemije.
English: It is preferable that the prandial injection of Lyxumia is performed before the same meal every day, when the most convenient meal has been chosen.
Croatian: Kad se odabere najprikladniji obrok, poželjno je da se prandijalna injekcija lijeka Lyxumia primjeni prije tog istog obroka svaki dan.
English: If you use Lyxumia with a sulphonylurea or a basal insulin, you may get low blood sugar (hypoglycaemia).
Croatian: Ako lijek Lyxumia primjenjujete sa sulfonilurejom ili bazalnim inzulinom, može Vam se spustiti razina šećera u krvi (hipoglikemija).
English: During clinical studies, doses up to 30 mcg of lixisenatide twice a day were administered to type 2 diabetic patients in a 13-week study.
Croatian: Tijekom kliničkih ispitivanja liksisenatid u dozama do 30 µg dvaput na dan primjenjivan je u bolesnika sa šećernom bolešću tipa 2 u sklopu 13-tjednog ispitivanja.
English: Nausea was reported in 14.7% and 15.5% of patients, and symptomatic hypoglycaemia in 5.8% and 2.2% of patients, main meal group and breakfast group, respectively.
Croatian: Mučnina je zabilježena u 14,7% bolesnika u skupini s primjenom uz glavni obrok i u 15,5% bolesnika u skupini s primjenom uz doručak, a simptomatska hipoglikemija u 5,8% bolesnika u skupini s primjenom uz glavni obrok i u 2,2% bolesnika u skupini s primjenom uz doručak.
English: Lixisenatide 20 mcg (N= 154)
Croatian: liksisenatid 20 µg (N=154)
English: Each cartridge is assembled into a disposable pen.
Croatian: Svaki uložak ugrađen je u brizgalicu za jednokratnu uporabu.
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 niti u bolesnika u završnoj fazi bubrežne bolesti (vidjeti dijelove 4.2. i 5.2).
English: However, when used in combination with a sulphonylurea or a basal insulin, blood glucose monitoring or blood glucose selfmonitoring may become necessary to adjust the doses of the sulphonylurea or the basal insulin.
Croatian: Međutim, kada se primjenjuje u kombinaciji sa sulfonilurejom ili bazalnim inzulinom, praćenje ili samopraćenje razine glukoze u krvi može biti potrebno radi prilagodbe doza sulfonilureje ili bazalnog inzulina.
English: During the 24-week main treatment period, nausea was reported in 23.5% in the lixisenatide group compared to 10.6% in the placebo group and symptomatic hypoglycaemia was reported in 3.4% of the lixisenatide patients compared to 1.2% in the placebo group.
Croatian: Tijekom osnovnog 24-tjednog razdoblja liječenja mučnina je prijavljena u 23,5% bolesnika na liksisenatidu te u 10,6% bolesnika koji su primali placebo, a simptomatska hipoglikemija prijavljena je u 3,4% bolesnika na liksisenatidu u usporedbi s 1,2% bolesnika u skupini na placebu.
English: Upper respiratory tract infection
Croatian: Infekcije i infestacije influenca infekcija gornjeg respiratornog trakta cistitis virusna infekcija
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: • Drowsiness (somnolence)
Croatian: • omamljenost (izrazita pospanost)
English: Basal insulin as background therapy Alone or in combination with a sulphonylurea *
Croatian: Bazalni inzulin kao osnovna terapija sam ili u kombinaciji sa sulfonilurejom *
English: One case of anaphylactoid reaction was reported during clinical trials with lixisenatide.
Croatian: Tijekom kliničkih ispitivanja s liksisenatidom prijavljen je jedan slučaj anafilaktoidne reakcije.
English: At the end of the 24-week main treatment period, 52.3% of the lixisenatide patients achieved an HbA1c less than 7% compared to 26.4% in the placebo group.
Croatian: Na kraju osnovnog 24-tjednog razdoblja liječenja u 52,3% bolesnika na liksisenatidu vrijednost HbA1c bila je manja od 7%, u usporedbi s 26,4% bolesnika na placebu.
English: Lyxumia given with a basal insulin alone, or with a combination of a basal insulin and metformin, or a combination of a basal insulin and a sulphonylurea resulted in statistically significant reductions in HbA1c and in 2-hour post-prandial glucose after a test- meal compared to placebo.
Croatian: Kada se Lyxumia primjenjivala samo s bazalnim inzulinom ili u kombinaciji s bazalnim inzulinom i metforminom ili u kombinaciji s bazalnim inzulinom i sulfonilurejom, došlo je do statistički značajnog smanjenja vrijednosti HbA1c i glukoze postprandijalno 2 sata nakon testnog obroka u usporedbi s placebom.
English: When lixisenatide 20 mcg and atorvastatin 40 mg were co-administered in the morning for 6 days, the exposure to atorvastatin was not affected, while Cmax was decreased by 31% and tmax was delayed by 3.25 hours.
Croatian: Istodobna jutarnja primjena liksisenatida u dozi od 20 µg i atorvastatina u dozi od 40 mg tijekom 6 dana nije utjecala na izloženost atorvastatinu, ali je smanjila njegov Cmax za 31% i odgodila tmax za 3,25 sati.
English: Mean body weight (kg) Baseline
Croatian: Srednja vrijednost tjelesne težine (kg)
English: Excipients: glycerol 85%, sodium acetate trihydrate, methionine, metacresol (see leaflet for further information), hydrochloric acid and sodium hydroxide solution (for pH adjustment), water for injections.
Croatian: Pomoćne tvari: glicerol 85%, natrijev acetat trihidrat, metionin, metakrezol (za dodatne informacije vidjeti uputu o lijeku), kloridna kiselina i otopina natrijevog hidroksida (za podešavanje pH), voda za injekcije.
English: The reductions with Lyxumia ranged from 4.51 to 7.96 mmol/L (81.2 to 143.3 mg/dl) from baseline at the end of the main 24-week treatment period across all studies in which post-prandial glucose was measured; 26.2% to 46.8% of patients had a 2-hour post-prandial glucose value below 7.8 mmol/L (140.4 mg/dl).
Croatian: Na kraju osnovnog 24-tjednog razdoblja liječenja u svim ispitivanjima u kojima se mjerila razina glukoze nakon obroka, smanjenja postignuta lijekom Lyxumia kretala su se u rasponu od 4,51 do 7,96 mmol/l (81,2 do 143,3 mg/dl) u odnosu na početne vrijednosti: 26,2% do 46,8% bolesnika imalo je vrijednost glukoze 2 sata nakon obroka ispod 7,8 mmol/l (140,4 mg/dl).
English: Black plunger
Croatian: Crni klip
English: After concomitant administration of lixisenatide 20 mcg and ramipril 5 mg during 6 days, the AUC of ramipril was increased by 21% while the Cmax was decreased by 63%.
Croatian: Nakon istodobne primjene liksisenatida u dozi od 20 µg i ramiprila u dozi od 5 mg tijekom 6 dana, AUC ramiprila povećao se za 21%, dok se Cmax se smanjio za 63%.
English: Overall, the incidence of severe symptomatic hypoglycaemia was uncommon (0.4% in lixisenatide patients and 0.2% in placebo patients) during the entire treatment period of the Phase III placebocontrolled studies.
Croatian: Sveukupno je incidencija teške simptomatske hipoglikemije tijekom cijelog razdoblja liječenja u kontroliranim ispitivanjima faze III bila manje česta (0,4% u bolesnika liječenih liksisenatidom i 0,2% u bolesnika koji su primali placebo).
English: You must start your treatment with the green pen of Lyxumia 10 micrograms.
Croatian: Liječenje morate započeti zelenom Lyxumia brizgalicom od 10 mikrograma.
English: Contact your doctor, pharmacist or nurse for help.
Croatian: Obratite se svom liječniku, ljekarniku ili medicinskoj sestri za pomoć.
English: • The purple pen contains 14 pre-set doses; each dose contains 20 micrograms of Lyxumia.
Croatian: • Ljubičasta brizgalica sadrži 14 prethodno odmjerenih doza; jedna doza sadrži 20 mikrograma lijeka Lyxumia.
English: For the maintenance dose Lyxumia 20 micrograms solution for injection is available.
Croatian: Za dozu održavanja dostupna je Lyxumia 20 mikrograma otopina za injekciju.
English: Then use the purple 20 micrograms Lyxumia pen.
Croatian: Zatim možete upotrijebiti ljubičastu Lyxumia brizgalicu od 20 mikrograma.
English: Insulin glargine was continuously titrated during this period.
Croatian: U tom se razdoblju doza inzulina glargina neprekidno titrirala.
English: Primary composite endpoint CV death, non-fatal MI, non-fatal stroke, or hospitalization for unstable angina
Croatian: Primarni kompozitni ishod KV smrt, nefatalni IM 406 (13,4%) 399 (13,2%) nefatalni moždani udar , ili hospitalizacija zbog nestabilne angine
English: Do not store with a needle attached.
Croatian: Ne čuvati s pričvršćenom iglom.
English: Step D. Press and hold the injection button to inject the dose
Croatian: Pritisnite dugme za injiciranje i držite ga pritisnutim da biste injicirali dozu
English: • Glycaemic control
Croatian: • Kontrola glikemije
English: Age has no clinically relevant effect on the pharmacokinetics of lixisenatide.
Croatian: Dob nema klinički značajan učinak na farmakokinetiku liksisenatida.
English: • Handle your Lyxumia pen with care.
Croatian: • Oprezno rukujte Lyxumia brizgalicom.
English: Based on these results, no dose adjustment for ramipril is required when co-administered with lixisenatide.
Croatian: Na temelju tih rezultata, nije potrebno prilagođavati dozu ramiprila pri istodobnoj primjeni s liksisenatidom.
English: INFORMATION IN BRAILLE Lyxumia 20
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Lyxumia 20
English: Remove the protective seal from the outer needle cap.
Croatian: Skinite zaštitu s vanjskog zatvarača igle.
English: The delay of gastric emptying with lixisenatide may reduce the rate of absorption of orally administered medicinal products.
Croatian: Liksisenatid odgađa pražnjenje želuca, što može smanjiti brzinu apsorpcije peroralno primijenjenih lijekova.
English: Put the outer needle cap on a flat surface.
Croatian: Stavite vanjski zatvarač igle na ravnu površinu.
English: The antibody status (positive or negative) is not predictive of the reduction of HbA1c for an individual patient.
Croatian: Smanjenje vrijednosti HbA1c u pojedinog bolesnika ne može se predvidjeti na temelju statusa protutijela (pozitivan ili negativan).
English: Lyxumia should not be used during breast-feeding.
Croatian: Lyxumia se ne smije primjenjivati tijekom dojenja.
English: How to use Lyxumia
Croatian: Kako primjenjivati lijek Lyxumia
English: Common side effects: may affect up to 1 in 10 people
Croatian: Česte nuspojave: mogu se javiti u manje od 1 na 10 osoba
English: Add-on treatment to a sulphonylurea alone or in combination with metformin
Croatian: Dodatak liječenju samom sulfonilurejom ili u kombinaciji s metforminom
English: In addition, a double-blind, placebo-controlled cardiovascular outcome study (ELIXA) enrolled 6,068 type 2 diabetes patients with previous acute coronary syndrome (3,034 randomised to lixisenatide,
Croatian: Dodatno, dvostruko slijepo, placebom kontrolirano ispitivanje kardiovaskularnog ishoda (ELIXA) uključilo je 6068 bolesnika sa šećernom bolešću tipa 2 koji su ranije imali akutni koronarni sindrom (3034 randomiziranih na liksisenatid, uključujući 198 bolesnika u dobi od ≥75 godina i 655 bolesnika s umjerenim oštećenjem bubrega).
English: After stopping the treatment, few antibody positive patients were followed up for antibody status; the percentage decreased to approximately 90% within 3 months and 30% at 6 months or beyond.
Croatian: Postotak se smanjio na približno 90% unutar 3 mjeseca, a nakon 6 ili više mjeseci iznosio je 30%.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (INITIATION PACK)
Croatian: PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA (PAKIRANJE ZA POČETAK LIJEČENJA)
English: In parallel, glucagon secretion is suppressed.
Croatian: Istovremeno se suprimira lučenje glukagona.
English: • Always use a new needle for each injection.
Croatian: • Za svaku injekciju upotrijebite novu iglu.
English: Inject Lyxumia into the skin (subcutaneously) of your stomach area (abdomen), upper leg (thigh) or upper arm.
Croatian: Gdje injicirati lijek Injicirajte lijek Lyxumia pod kožu (supkutano) na području trbuha, natkoljenice (bedra) ili nadlaktice.
English: If pancreatitis is suspected, lixisenatide should be discontinued ; if acute pancreatitis is confirmed, lixisenatide should not be restarted.
Croatian: Posumnja li se na pankreatitis, treba prekinuti primjenu liksisenatida.
English: Hypoglycaemia (in combination with a sulphonylurea and / or a basal insulin)
Croatian: Poremećaji metabolizma i prehrane hipoglikemija (u kombinaciji sa sulfonilurejom i/ili bazalnim inzulinom)
English: One green 10 microgram pen (Lyxumia 10 micrograms solution for injection), each dose contains 10 micrograms in 0.2 ml.
Croatian: Jedna zelena brizgalica od 10 mikrograma (Lyxumia 10 mikrograma otopina za injekciju), svaka doza sadrži 10 mikrograma u 0,2 ml.
English: When Lyxumia is used in combination with metformin alone, symptomatic hypoglycaemia occurred in 7.0% of lixisenatide patients and in 4.8% of placebo patients during the entire treatment period.
Croatian: Kada se Lyxumia primjenjivala u kombinaciji samo s metforminom, simptomatska hipoglikemija se tijekom cijelog razdoblja liječenja javila u 7,0% bolesnika liječenih liksisenatidom i u 4,8% bolesnika koji su primali placebo.
English: Rubber seal
Croatian: O Lyxumia brizgalici
English: Some severe allergic reactions (such as anaphylaxis) have been reported uncommonly in patients receiving Lyxumia.
Croatian: U bolesnika koji primaju lijek Lyxumia manje često su prijavljene neke teške alergijske reakcije (poput anafilaksije).
English: If a dose is missed, it should be injected within the hour prior to the next meal.
Croatian: Ako bolesnik propusti dozu lijeka Lyxumia, propuštenu dozu mora injicirati unutar sat vremena prije sljedećeg obroka.
English: When Lyxumia is used in combination with a basal insulin with or without metformin, symptomatic hypoglycaemia occurred in 42.1% of lixisenatide patients and in 38.9% of placebo patients during the entire treatment period (3.2% absolute difference).
Croatian: Kada se Lyxumia primjenjivala u kombinaciji s bazalnim inzulinom, sa ili bez metformina, simptomatska hipoglikemija se tijekom cijelog razdoblja liječenja javila u 42,1% bolesnika liječenih liksisenatidom i u 38,9% bolesnika koji su primali placebo (apsolutna razlika 3,2%).