FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: - Pomožne snovi so 85 % glicerol, natrijev acetat trihidrat, metionin, metakrezol, klorovodikova kislina (za uravnavanje pH), raztopina natrijevega hidroksida (za prilagoditev pH) in voda za injekcije.
English: Do not use this Lyxumia Treatment Initiation pack.
Slovenian: Ne uporabite tega pakiranja zdravila Lyxumia za uvedbo zdravljenja.
English: Lyxumia 10 micrograms solution for injection EU/1/12/811/001 (1 pre-filled pen)
Slovenian: Lyxumia 10 mikrogramov raztopina za injiciranje EU/1/12/811/001 (1 napolnjen injekcijski peresnik)
English: Sulphonylurea as background therapy with or without metformin
Slovenian: Sulfonilsečnina kot osnovno zdravljenje, z metforminom ali brez njega
English: The plunger will move along the dose scale after each injection.
Slovenian: Bat se bo po vsakem injiciranju pomaknil vzdolž merila odmerka.
English: The window remains white after activation.
Slovenian: Okence po aktivaciji ostane belo.
English: Marketing Authorisation Holder sanofi-aventis groupe 54, rue La Boétie F - 75008 Paris
Slovenian: Imetnik dovoljenja za promet sanofi-aventis groupe 54, rue La Boétie F - 75008 Pariz Francija
English: Check that the activation window is now white.
Slovenian: Preverite, da je aktivacijsko okence zdaj belo.
English: If a dose is missed, it should be injected within the hour prior to the next meal.
Slovenian: Če bolnik izpusti odmerek, ga mora injicirati v teku ene ure pred naslednjim obrokom.
English: Add-on combination therapy with a basal insulin
Slovenian: Dodatek kombiniranemu zdravljenju z bazalnim insulinom
English: You should seek immediate medical attention if you experience symptoms like swelling of the face, tongue or throat which causes difficulty with breathing.
Slovenian: Če se vam pojavijo simptomi, kot so otekanje obraza, jezika ali žrela, ki povzročajo težave z dihanjem, morate nemudoma poiskati zdravniško pomoč.
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.
Slovenian: Uporaba peroralnega kontraceptiva 1 uro ali 4 ure po liksisenatidu ni vplivala na AUC in t1/2 etinilestradiola in levonorgestrela, toda Cmax etinilestradiola se je zmanjšala za 52 % (1 ura) oziroma 39 % (4 ure), Cmax levonorgestrela pa za 46 % (1 ura) in 20 % (4 ure); mediani tmax se je podaljšal za 1 do 3 ure.
English: - you are also taking a sulphonylurea or a basal insulin.
Slovenian: - če sočasno jemljete tudi kakšno sulfonilsečnino ali uporabljate bazalni insulin.
English: There is no therapeutic experience in patients with severe renal impairment (creatinine clearance less than 30 ml/min) or end-stage renal disease.
Slovenian: Terapevtskih izkušenj pri bolnikih s hudo okvaro ledvic (očistek kreatinina <30 ml/min) ali s končno odpovedjo ledvic ni.
English: Keep the cap on the pen in order to protect from light.
Slovenian: Pokrovček obdržite na peresniku za zagotovitev zaščite pred svetlobo.
English: Lixisenatide 20 mcg Placebo (N= 170)
Slovenian: Liksisenatid 20 mcg Placebo (N = 170)
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.
Slovenian: V podskupini bolnikov (5,2 %) z najvišjo koncentracijo protiteles je bilo povprečno izboljšanje HbA1c 24. in 76. tednu v klinično pomembnem območju, obstajala pa je variabilnost, kar zadeva glikemičen odziv in pri 1,9 % bolnikov ni bilo znižanja pri HbA1c.
English: Purple 20 micrograms pen activation The purple 20 micrograms Lyxumia pen must also be activated before use.
Slovenian: Tudi škrlatni peresnik Lyxumia 20 mikrogramov je treba pred uporabo aktivirati.
English: It is an injectable medicine used to help your body to control your blood sugar level when it is too high.
Slovenian: Uporablja se za uravnavanje koncentracije krvnega sladkorja, kadar je ta previsoka.
English: The addition of lixisenatide led to a significantly greater HbA1c decrease of 0.71% in the lixisenatide group compared to 0.40% in the placebo group.
Slovenian: Dodatek liksisenatida je v skupini z liksisenatidom povzročil značilno večje znižanje HbA1c (za 0,71 %) kot v skupini s placebom (0,40 %).
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.
Slovenian: Po sočasni uporabi 25 mg varfarina med ponavljajočim se odmerjanjem 20 mcg liksisenatida se AUC in INR (internacionalno normalizirano razmerje) nista spremenila, Cmax se je znižala za 19 %, tmax pa se je podaljšal za 7 ur.
English: Step D. Press and hold the injection button to inject the dose
Slovenian: Korak D. Pritisnite in držite gumb za injiciranje, da boste injicirali odmerek
English: Skin and subcutaneous tissue disorders
Slovenian: Bolezni kože in podkožja urtikarija
English: Keep the injection button pressed in and slowly count to 5 in order to expel the last drops.
Slovenian: Držite gumb za injiciranje pritisnjen in počasi preštejte do 5,da boste iztisnili zadnje kapljice.
English: Do not use this medicine after the expiry date which is stated on the pen label and on the carton after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki peresnika in na škatli poleg oznake EXP. Datum izteka roka uporabnosti se nanaša na zadnji dan navedenega meseca.
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.
Slovenian: Če je zdravilo Lyxumia dodano obstoječemu zdravljenju s sulfonilsečnino ali bazalnemu insulinu, pride v poštev zmanjšanje odmerka sulfonilsečnine ali bazalnega insulina, da bi zmanjšali tveganje za hipoglikemijo.
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.
Slovenian: Znižanje telesne mase od 0,38 kg do 1,80 kg v primerjavi z izhodiščem so zabeležili tudi pri prejemnikih zdravila Lyxumia, ki so uporabljali bazalni insulin sam ali v kombinaciji z metforminom ali sulfonilsečnino.
English: How to activate your new Lyxumia pen
Slovenian: Kako aktivirate nov peresnik Lyxumia
English: The pen can be used for 14 days when stored at a temperature below 30°C.
Slovenian: Peresnik, ki je shranjen na temperaturi do 30 °C, lahko uporabljate 14 dni.
English: Following subcutaneous administration to patients with type 2 diabetes, the rate of lixisenatide absorption is rapid and not influenced by the dose administered.
Slovenian: Absorpcija liksisenatida po subkutanem injiciranju pri sladkornih bolnikih tipa 2 je hitra in uporabljeni odmerek nanjo ne vpliva.
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.
Slovenian: Vendar pa je treba podaljšanje tmax, opaženo po uporabi paracetamola od 1 do 4 ure po liksisenatidu, upoštevati v primeru, ko je zaradi učinkovitosti potreben hiter začetek delovanja.
English: • Do not store your Lyxumia pen with the needle attached.
Slovenian: • Peresnika Lyxumia ne shranjujte z nameščeno iglo.
English: 1 pre-filled pen of 3 ml (14 doses)
Slovenian: 1 napolnjen injekcijski peresnik s 3 ml (14 odmerkov)
English: If you have any further questions on the use of this medicine, ask your doctor, nurse or pharmacist.
Slovenian: Če imate dodatna vprašanja o uporabi tega zdravila, se posvetujte s svojim zdravnikom, medicinsko sestro ali s farmacevtom.
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).
Slovenian: Za zmanjšanje tveganja za hipoglikemijo pride v poštev zmanjšanje odmerka sulfonilsečnine ali bazalnega insulina (glejte poglavje 4.2).
English: There is no therapeutic experience with lixisenatide in patients with type 1 diabetes mellitus and it should not be used in these patients.
Slovenian: Pri bolnikih s sladkorno boleznijo tipa 1 terapevtskih izkušenj z liksisenatidom ni, zato se ga pri teh bolnikih ne sme uporabljati.
English: How to use Lyxumia
Slovenian: Kako uporabljati zdravilo Lyxumia
English: The rate of symptomatic hypoglycaemic events was lower with lixisenatide (36%) compared to insulin glulisine QD and TID (47% and 52%, respectively).
Slovenian: Delež simptomatskih hipoglikemij je bil z liksisenatidom manjši (36 %) kot z insulinom glulizinom enkrat na dan (47 %) in trikrat na dan (52 %).
English: Excipient(s) with known effects
Slovenian: Pomožne snovi z znanim učinkom
English: Table 2: Placebo-controlled studies in combination with metformin (24-week results).
Slovenian: Preglednica 2: S placebom kontrolirane študije v kombinaciji z metforminom (24-tedenski rezultati).
English: Put the outer needle cap on a flat surface.
Slovenian: Položite zunanji pokrovček igle na ravno površino.
English: Basal insulin as background therapy Alone or in combination with a sulphonylurea *
Slovenian: Bazalni insulin kot osnovno zdravljenje Sam ali v kombinaciji s sulfonilsečnino*
English: Patients with hepatic impairment No dose adjustment is needed in patients with hepatic impairment (see section 5.2).
Slovenian: Bolniki z okvaro jeter Bolnikom z okvaro jeter odmerka ni treba prilagoditi (glejte poglavje 5.2).
English: How to store Lyxumia 6.
Slovenian: Shranjevanje zdravila Lyxumia 6.
English: Anaphylactic reactions were reported in 0.2% of the lixisenatide treated patients vs. none in the placebo group.
Slovenian: Anafilaktične reakcije so bile opisane pri 0,2 % prejemnikov liksisenatida in pri nobenem prejemniku placeba.
English: What Lyxumia contains - The active substance is lixisenatide.
Slovenian: Kaj vsebuje zdravilo Lyxumia - Zdravilna učinkovina je liksisenatid.
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.
Slovenian: Na podlagi teh rezultatov odmerka varfarina med sočasno uporabo z liksisenatidom ni treba prilagoditi, je pa v času uvedbe zdravljenja ali ob koncu zdravljenja z zdravilom Lyxumia priporočljivo pogosto kontrolirati INR bolnikov, ki prejemajo varfarin in/ali oziroma kumarinske derivate.
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).
Slovenian: Varnostne značilnosti se med bolniki v celoti niso razlikovale ne glede na izvid protiteles, z izjemo večje incidence reakcij na mestu injiciranja (4,7 % pri bolnikih s pozitivnim izvidom protiteles v primerjavi s 2,5 % pri bolnikih z negativnim izvidom protiteles med celotnim obdobjem zdravljenja) .
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).
Slovenian: Varnostne značilnosti se med bolniki v celoti niso razlikovale ne glede na izvid protiteles, z izjemo večje incidence reakcij na mestu injiciranja (4,7 % pri bolnikih s pozitivnim izvidom protiteles v primerjavi s 2,5 % pri bolnikih z negativnim izvidom protiteles med celotnim obdobjem zdravljenja).
English: Of lixisenatide-treated patients with HbA1c measurement, 79.3% had either a negative antibody status or an antibody concentration below the lower limit of quantification and the other 20.7% of patients had a quantified antibody concentration.
Slovenian: Med bolniki, zdravljenimi z liksisenatidom merjenem z HbA1c, je imelo negativen izvid protiteles ali koncentracijo protiteles pod spodnjo mejo kvantifikacije 79,3 % bolnikov; preostalih 20,7 % je imelo koncentracijo, ki jo je bilo mogoče določiti kvantitativno.
English: The delay of gastric emptying with lixisenatide may reduce the rate of absorption of orally administered medicinal products.
Slovenian: Upočasnitev praznjenja želodca, ki jo povzroči liksenatid, lahko zmanjša hitrost absorpcije peroralno uporabljenih zdravil.
English: Packs containing 1, 2 and 6 purple pre-filled pens.
Slovenian: Pakiranje z 1, 2 in 6 škrlatnimi napolnjenimi injekcijskimi peresniki.
English: Lixisenatide should not be given in combination with basal insulin and a sulphonylurea due to increased risk of hypoglycaemia.
Slovenian: Liksisenatida se ne sme uporabljati v kombinaciji z bazalnim insulinom in sulfonilsečnino, ker se poveča tveganje za hipoglikemijo.
English: Table 3: Placebo-controlled study in combination with a sulphonylurea (24-week results)
Slovenian: Preglednica 3: S placebom kontrolirana študija v kombinaciji s sulfonilsečnino (24-tedenski rezultati)
English: Remove the protective seal from the outer needle cap.
Slovenian: Odstranite zaščitni pečat z zunanjega pokrovčka igle.
English: Some severe allergic reactions (such as anaphylaxis) have been reported uncommonly in patients receiving Lyxumia.
Slovenian: Občasno so bile pri bolnikih, ki so prejemali zdravilo Lyxumia, opisane nekatere hude alergijske reakcije (npr. anafilaksija).
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.
Slovenian: Sočasna uporaba 20 mcg liksisenatida in 40 mg atorvastatina zjutraj 6 dni ni vplivala na izpostavljenost atorvastatinu, a Cmax se je znižala za 31 % in tmax se je podaljšal za 3,25 ure.
English: Non-clinical data reveal no special hazards for humans based on conventional studies of safety pharmacology and toxicology.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti in toksikologije ne kažejo posebnih tveganj za človeka.
English: • Handle your Lyxumia pen with care.
Slovenian: • S peresnikom Lyxumia ravnajte previdno.
English: Add-on treatment to pioglitazone alone or in combination with metformin
Slovenian: Dodatek zdravljenju s pioglitazonom samim ali v kombinaciji z metforminom
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.
Slovenian: Incidenca navzee je bila v skupini, ki je prejemala zdravilo Lyxumia 24,5 % in v skupini, ki je prejemala eksenatid dvakrat na dan 35,1 %, incidenca simptomatskih hipoglikemij pa je bila med 24tedenskim glavnim obdobjem zdravljenja z zdravilom Lyxumia 2,5 % in z eksenatidom 7,9 %.
English: Squeeze the outer needle cap to grip the needle and use it to unscrew the needle from the pen.
Slovenian: Stisnite zunanji pokrovček igle, da boste prijeli iglo, in ga uporabite, da iglo odvijete s peresnika.
English: Lyxumia should not be used with a combination of both basal insulin and sulphonylurea
Slovenian: Zdravilo Lyxumia se ne sme uporabljati v kombinaciji z bazalnim insulinom in sulfonilsečninami.
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.
Slovenian: Bolnikom, ki niso bili ustrezno urejeni s pioglitazonom, je dodatek liksenatida pioglitazonu (z metforminom ali brez njega) v klinični študiji do konca 24-tedenskega glavnega obdobja zdravljenja znižal HbA1c za 0,90 % v primerjavi z izhodiščem, medtem ko so pri prejemnikih placeba zabeležili znižanje za 0,34 % v primerjavi z izhodiščem.
English: This is shown by the placement of the black plunger in the dose scale.
Slovenian: Število odmerkov kaže položaj črnega bata na merilu odmerka.
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).
Slovenian: Znižanja od izhodišča so bila na koncu glavnega 24-tedenskega obdobja zdravljenja z zdravilom Lyxumia v razponu od 4,51 do 7,96 mmol/L (81,2 do 143,3 mg/dl) v vseh študijah, v katerih so merili postprandialno glukozo; od 26,2 % do 46,8 % bolnikov je imelo postprandialno glukozo po 2 urah pod 7,8 mmol/L (140,4 mg/dl).
English: Lyxumia in combination with metformin, a sulphonylurea, pioglitazone or a combination of these agents showed statistically significant reductions in HbA1c, in fasting plasma glucose and in 2-hour post-prandial glucose after a test-meal compared to placebo at the end of the main 24-week treatment period (tables 2 and 3).
Slovenian: Zdravilo Lyxumia v kombinaciji z metforminom, sulfonilsečnino, pioglitazonom ali kombinacijo teh zdravil je v primerjavi s placebom na koncu glavnega 24-tedenskega obdobja zdravljenja doseglo pomembno statistično značilno znižanje HbA1c, glukoze v plazmi na tešče in postprandialne glukoze 2 uri po testnem obroku (preglednici 2 in 3).
English: • Activate the pen on the same day as your first injection.
Slovenian: • Aktivirajte peresnik na dan, ko boste zdravilo prvič injicirali.
English: Lyxumia is used with other medicines for diabetes when they are not enough to control your blood sugar levels.These may include:
Slovenian: Zdravilo Lyxumia se uporablja skupaj z drugimi zdravili za zdravljenje sladkorne bolezni, kadar ta ne zadoščajo za uravnavanje koncentracije krvnega sladkorja.
English: EU/1/12/811/004 - 6 pens
Slovenian: EU/1/12/811/004 - 6 peresnikov
English: Treatment initiation pack
Slovenian: Pakiranje za uvedbo zdravljenja
English: Lyxumia contains the active substance lixisenatide.
Slovenian: Zdravilo Lyxumia vsebuje zdravilno učinkovino liksisenatid.
English: Pack containing 1 green pre-filled pen.
Slovenian: Pakiranje z 1 zelenim napolnjenim injekcijskim peresnikom.
English: If you use Lyxumia with a sulphonylurea or a basal insulin, you may get low blood sugar (hypoglycaemia).
Slovenian: Če uporabljate zdravilo Lyxumia skupaj s sulfonilsečnino ali bazalnim insulinom, se vam lahko pojavi nizek krvni sladkor (hipoglikemija).
English: Then use the purple 20 micrograms Lyxumia pen.
Slovenian: Potem uporabite škrlatni peresnik Lyxumia 20 mikrogramov.
English: Cardiac arrhythmias particularly tachycardia (0.8% vs <0.1%) and palpitations (1.5% vs 0.8%) have been reported in lixisenatide patients compared to placebo treated patients.
Slovenian: Pri prejemnikih liksenatida so bile v primerjavi s prejemniki placeba opisane motnje srčnega ritma, zlasti tahikardija (0,8 % v primerjavi z < 0,1 %) in palpitacije (1,5 % v primerjavi z 0,8 %).
English: Common side effects: may affect up to 1 in 10 people
Slovenian: Pogosti neželeni učinki: pojavijo se lahko pri največ 1 od 10 oseb
English: One case of anaphylactoid reaction was reported during clinical trials with lixisenatide.
Slovenian: Med kliničnimi preskušanji liksisenatida je bil opisan en primer anafilaktične reakcije.
English: Add-on treatment to a sulphonylurea alone or in combination with metformin
Slovenian: Dodatek zdravljenju s sulfonilsečnino samo ali v kombinaciji z metforminom
English: EU/1/12/811/003 - 2 pens
Slovenian: EU/1/12/811/003 - 2 peresnika
English: To inject a dose with the purple 20 micrograms Lyxumia pen, follow all steps in Section 3.
Slovenian: Uporaba škrlatnega peresnika 20 mikrogramov Za injiciranje odmerka s škrlatnim peresnikom Lyxumia 20 mikrogramov sledite vsem korakom v 3. poglavju.
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,
Slovenian: Poleg tega je dvojno slepa, s placebom kontrolirana študija srčno-žilnih izidov (ELIXA) zajela 6.068 bolnikov s sladkorno boleznijo tipa 2 in predhodnim akutnim koronarnim sindromom (3.034 bolnikov randomiziranih na liksisenatid, vključno z 198 bolniki, starimi ≥75 let in 655 bolniki z zmerno okvaro ledvic).
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%.
Slovenian: Po sočasni 6-dnevni uporabi 20 mcg liksisenatida in 5 mg ramiprila se je AUC ramiprila povečala za 21 %, njegova Cmax pa se je znižala za 63 %.
English: However, when used in combination with a sulphonylurea or a basal insulin, blood glucose monitoring or blood glucose self-monitoring may become necessary to adjust the doses of the sulphonylurea or the basal insulin.
Slovenian: Toda pri uporabi zdravila Lyxumia v kombinaciji s sulfonilsečnino ali bazalnim insulinom je lahko kontrola ali samokontrola glukoze v krvi potrebna za prilagoditev odmerkov sulfonilsečnine ali bazalnega insulina.
English: • The green pen contains 14 pre-set doses; each dose contains 10 micrograms of Lyxumia.
Slovenian: • Zeleni peresnik vsebuje 14 prednastavljenih odmerkov; vsak odmerek vsebuje 10 mikrogramov zdravila Lyxumia.
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%).
Slovenian: V študiji, kontrolirani z zdravilno učinkovino, je zdravilo Lyxumia enkrat na dan na koncu glavnega 24-tedenskega obdobja zdravljenja doseglo neinferiorno znižanje HbA1c v primerjavi z eksenatidom dvakrat na dan (Lyxumia -0,79 %, eksenatid -0,96 %); HbA1c manj kot 7 % je dosegel podoben delež bolnikov v skupini z zdravilom Lyxumia (48,5 %) kot v skupini z eksenatidom (49,8 %).
English: Injection button
Slovenian: Gumb za injiciranje
English: Based on these results, no dose adjustment for digoxin is required when co-administered with lixisenatide.
Slovenian: Na podlagi teh rezultatov odmerka digoksina med sočasno uporabo z liksisenatidom ni treba prilagoditi.
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%).
Slovenian: Kar zadeva znižanje HbA1c, je bila v 24-tedenski odprti študiji uporaba liksisenatida pred glavnim dnevnim obrokom neinferiorna uporabi liksisenatida pred zajtrkom (povprečna sprememba od izhodišča po metodi najmanjših kvadratov (NK): -0,65 % v primerjavi z -0,74 %).
English: It allows continued monitoring of the benefit/risk balance of the medicinal product.
Slovenian: Poročanje o domnevnih neželenih učinkih zdravila po izdaji dovoljenja za promet je pomembno.Omogoča namreč stalno spremljanje razmerja med koristmi in tveganji zdravila.
English: Step 2 Attach a needle and remove the needle caps
Slovenian: 2. korak Namestite iglo in odstranite pokrovčka igle