FrancophonIA/ELRC3.0 huggingface dataset:
English: In the completed Phase III studies, it was observed that approximately 90% of the patients were able to remain on the once daily maintenance dose of 20 mcg Lyxumia at the end of the main 24-week treatment period.
Slovenian: V dokončanih študijah III. faze so ugotovili, da je lahko na koncu glavnega 24-tedenskega obdobja zdravljenja približno 90 % bolnikov ostalo na vzdrževalnem odmerku 20 mcg zdravila Lyxumia enkrat na dan.
English: What Lyxumia is and what it is used for
Slovenian: Kaj je zdravilo Lyxumia in za kaj ga uporabljamo
English: The reduction in Cmax is of limited clinical relevance and no dose adjustment for oral contraceptives is required.
Slovenian: Znižanje Cmax nima večjega kliničnega pomena in odmerka kontraceptivov ni treba prilagoditi.
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.
Slovenian: Pri miših niso opazili karcinoma celic C. Pri podganah se je karcinom celic C pojavil pri približno 900-kratnem razmerju izpostavljenosti v primerjavi s terapevtskim odmerkom pri človeku.
English: In subjects with mild (creatinine clearance calculated by the Cockcroft-Gault formula 60-90 ml/min), moderate (creatinine clearance 30-60 ml/min) and severe renal impairment (creatinine clearance 15-30 ml/min), AUC was increased by 46%, 51% and 87%, respectively.
Slovenian: Med preiskovanci z blago (očistek kreatinina, izračunan po Cockcroft-Gaultovi formuli 60-90 ml/min), zmerno (očistek kreatinina 30-60 ml/min) in hudo okvaro ledvic (očistek kreatinina 15-30 ml/min) je bila AUC zvišana za 46 %, 51% in 87 %.
English: Before activation of the pen:
Slovenian: Pred aktivacijo peresnika:
English: • Store your unused Lyxumia pens in the refrigerator, 2°C to 8°C.
Slovenian: • Neuporabljene peresnike Lyxumia shranjujte v hladilniku pri temperaturi od 2 do 8°C.
English: The results of the primary and secondary composite efficacy endpoints and the results of all the individual components of the composite endpoints are shown in Figure 1.
Slovenian: Slika 1 prikazuje rezultate primarnega in sekundarnih sestavljenih opazovanih dogodkov učinkovitosti in rezultate vseh posameznih sestavin sestavljenih opazovanih dogodkov.
English: Do not use this Lyxumia pack.
Slovenian: Ne uporabite tega pakiranja zdravila Lyxumia.
English: After 12-week of optimal insulin glargine titration with or without metformin, inadequately controlled patients were randomised to add single dose of lixisenatide or a single dose (QD) of insulin glulisine (both before the largest meal) or insulin glulisine administered three times a day (TID) for 26 weeks.
Slovenian: Po 12 tednih optimalnega titriranja insulina glargina (z metforminom ali brez njega) so neustrezno nadzorovane bolnike za 26 tednov randomizirali ali na dodatek enega samega odmerka liksisenatida ali enega samega odmerka (enkrat na dan) insulina glulizina (obe zdravili so bolniki uporabili pred največjim obrokom) ali na insulin glulizin, uporabljen trikrat na dan.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially “sodium-free”.
Slovenian: To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni 'brez natrija'.
English: Too much Lyxumia can make you feel sick or be sick.
Slovenian: Prevelik odmerek zdravila Lyxumia lahko povzroči slabost ali občutek slabosti.
English: Metformin as background therapy
Slovenian: Metformin kot osnovno zdravljenje
English: Important information about some of the ingredients of Lyxumia This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially “sodium-free”.
Slovenian: Pomembne informacije o nekaterih sestavinah zdravila Lyxumia Zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek; kar v bistvu pomeni "brez natrija".
English: If you use more Lyxumia than you should, talk to your doctor immediately.
Slovenian: Če ste uporabili večji odmerek zdravila Lyxumia, kot bi smeli Če ste uporabili večji odmerek zdravila Lyxumia, kot bi smeli, se nemudoma posvetujte s svojim zdravnikom.
English: Throw away a used Lyxumia pen after 14 days.
Slovenian: Uporabljeni peresnik Lyxumia po 14 dneh zavrzite.
English: Inject only one dose each day.
Slovenian: Vsak dan injicirajte en sam odmerek.
English: Lyxumia should not be used during pregnancy.
Slovenian: Zdravila Lyxumia se ne sme uporabljati med nosečnostjo.
English: Use of GLP-1 receptor agonists may be associated with gastrointestinal adverse reactions.
Slovenian: Uporaba agonistov receptorjev GLP-1 je lahko povezana s neželenimi učinki v prebavilih.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 3 ml (14 doses)
Slovenian: VSEBINA, IZRAŽENA Z MASO, PROSTORNINO ALI ŠTEVILOM ENOT 3 ml (14 odmerkov)
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).
Slovenian: Klinično učinkovitost in varnost zdravila Lyxumia so ocenili v devetih randomiziranih, dvojno slepih, s placebom kontroliranih kliničnih študijah, ki so zajele 4.508 bolnikov s sladkorno boleznijo tipa 2 (2.869 bolnikov randomiziranih na liksisenatid, 47,5 % moških in 52,5 % žensk, 517 jih je bilo starih ≥ 65 let).
English: After multiple dose administration in patients with type 2 diabetes, mean terminal half-life was approximately 3 hours and the mean apparent clearance (CL/F) about 35 L/h.
Slovenian: Po uporabi več odmerkov pri sladkornih bolnikih tipa 2 je bil povprečni končni razpolovni čas približno 3 ure in povprečni navidezni očistek (CL/F) približno 35 L/uro.
English: • This pen is only for one person.
Slovenian: • Ta peresnik je namenjen le za uporabo pri eni sami osebi.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (28 DAYS TREATMENT INITIATION PACK)
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA (PAKIRANJE ZA 28-DNEVNO UVEDBO ZDRAVLJENJA)
English: Pull the needle out of your skin and remove the needle from the pen.
Slovenian: Potegnite iglo iz kože in odstranite iglo s peresnika.
English: Patients received stable dose(s) of oral antidiabetic drug(s) (OAD) and/or basal insulin as background therapy.
Slovenian: Bolniki so prejemali stabilen odmerek enega ali več peroralnih antidiabetikov (POAD) in/ali bazalni insulin kot osnovno zdravljenje.
English: What you need to know before you use Lyxumia
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Lyxumia
English: Keep the injection button pressed in and slowly count to 5 to get the full dose.
Slovenian: Držite gumb za injiciranje pritisnjen in počasi preštejte do 5, da boste dobili celotni odmerek.
English: • Cystitis
Slovenian: • cistitis
English: Lyxumia is indicated for the treatment of adults with type 2 diabetes mellitus to achieve glycaemic control in combination with oral glucose-lowering medicinal products and/or basal insulin when these, together, with diet and exercise, do not provide adequate glycaemic control (see sections 4.4 and 5.1 for available data on the different combinations).
Slovenian: Zdravilo Lyxumia je indicirano za zdravljenje odraslih s sladkorno boleznijo tipa 2 za doseganje urejenosti glikemije v kombinaciji z peroralnimi antidiabetiki in/ali bazalnim insulinom takrat, ko uporaba teh zdravil skupaj z dieto in telesno dejavnostjo ne zagotavlja ustrezne urejenosti glikemije (glejte poglavji 4.4 in 5.1 za podatke o različnih kombinacijah, ki so na voljo)
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.
Slovenian: Preglednica prikazuje neželene učinke, ki so se pojavili z incidenco > 5 %, če je bila pogostnost med prejemniki zdravila Lyxumia večja kot med prejemniki vseh primerjalnih zdravil.
English: Pull off the outer and inner needle caps.
Slovenian: Snemite zunanji in notranji pokrovček igle.
English: It is unknown if Lyxumia is excreted in human milk.
Slovenian: Ni znano, ali se zdravilo Lyxumia pri človeku izloča v materinem mleku.
English: When used in combination with a sulphonylurea or a basal insulin, patients should be advised to take precautions to avoid hypoglycaemia while driving and using machines.
Slovenian: Pri uporabi zdravila v kombinaciji s sulfonilsečnino ali bazalnim insulinom je treba bolnike opozoriti, naj upoštevajo previdnostne ukrepe za preprečitev hipoglikemije med vožnjo in upravljanjem s stroji.
English: Patients receiving medicinal products of either a narrow therapeutic ratio or medicinal products that require careful clinical monitoring should be followed closely, especially at the time of initiation of lixisenatide treatment.
Slovenian: Bolnike, ki prejemajo zdravila, ki imajo bodisi ozko terapevtsko razmerje ali zahtevajo skrbno klinično spremljanje, je treba bolnika natančno spremljati, zlati v času uvedbe zdravljenja z liksisenatidom.
English: The injection is administered once daily, within the hour prior to any meal of the day.
Slovenian: Injekcija se uporablja enkrat na dan, v eni uri pred katerim koli dnevnim obrokom.
English: First activate your new pen
Slovenian: Najprej aktivirajte novi peresnik
English: In addition, hypoglycaemia (when Lyxumia was used in combination with a sulphonylurea and/or a basal insulin) and headache occurred.
Slovenian: Poleg tega sta se pojavljala hipoglikemija (če je bilo zdravilo Lyxumia uporabljeno v kombinaciji s sulfonilsečnino in/ali bazalnim insulinom) in glavobol.
English: This is because low blood sugar (hypoglycaemia) can occur.
Slovenian: Pojavi se vam namreč lahko nizek krvni sladkor (hipoglikemija).
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)
Slovenian: Lyxumia 20 mikrogramov raztopina za injiciranje EU/1/12/811/002 (1 napolnjen injekcijski peresnik) EU/1/12/811/003 (2 napolnjena injekcijska peresnika) EU/1/12/811/004 (6 napolnjenih injekcijskih peresnikov)
English: Sanofi-Aventis Deutschland GmbH Brüningstrasse 50, Industriepark Höchst 65926 Frankfurt am Main Germany
Slovenian: Sanofi-Aventis Deutschland GmbH Brüningstrasse 50, Industriepark Höchst 65926 Frankfurt am Main Nemčija
English: Patients (%) achieving HbA1c <7.0% Mean body weight (kg) Baseline
Slovenian: Bolniki (%), ki so dosegli HbA1c < 7,0 % Povprečna telesna masa (kg)
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.
Slovenian: Ko je zeleni peresnik Lyxumia 10 mikrogramov prazen, morate zdravljenje nadaljevati z naslednjo injekcijo, ko je zanjo čas; za to injekcijo morate uporabiti škrlaten injekcijski peresnik Lyxumia 20 mikrogramov.
English: Lixisenatide has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis and therefore, the use of lixisenatide is not recommended in these patients.
Slovenian: Liksisenatid ni raziskan pri bolnikih s hudimi boleznimi prebavil, vključno s hudo gastroparezo, zato uporaba liksisenatida pri teh bolnikih ni priporočljiva.
English: Do not store with a needle attached.
Slovenian: Ne shranjujte s pritrjeno iglo.
English: If pancreatitis is suspected, lixisenatide should be discontinued ; if acute pancreatitis is confirmed, lixisenatide should not be restarted.
Slovenian: V primeru suma na pankreatitis je treba zdravljenje z liksisenatidom prekiniti; če je diagnoza akutnega pankreatitisa potrjena, se zdravljenja z liksisenatidom ne sme ponovno uvesti.
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.
Slovenian: Zdravljenje z zdravilom Lyxumia je postprandialno glukozo 2 uri po testnem obroku znižalo statistično značilno bolje kot placebo, ne glede na osnovno zdravljenje.
English: No such increase for tmax was observed when atorvastatin was administered in the evening and lixisenatide in the morning but the AUC and Cmax of atorvastatin were increased by 27% and 66%, respectively.
Slovenian: Takšnega podaljšanja tmax niso opazili, če je bil atorvastatin uporabljen zvečer in liksisenatid zjutraj, toda AUC atorvastatina se je zmanjšala za 27 %, njegova Cmax pa za 66 %.
English: Treatment Initiation pack - Contains two pre-filled pens each with 14 doses.
Slovenian: Pakiranje za uvedbo zdravljenja - vsebuje dva napolnjena injekcijska peresnika; v vsakem peresniku je 14 odmerkov.
English: This helps prevent contamination of Lyxumia or possible needle blockage.
Slovenian: Tako boste preprečili kontaminacijo zdravila Lyxumia in morebitno zamašitev igle.
English: If still no liquid comes out, your Lyxumia pen may be damaged.
Slovenian: Če še vedno ne priteče nič tekočine, je peresnik Lyxumia morda pokvarjen.
English: These changes are not clinically relevant and therefore, no dose adjustment for atorvastatin is required when co-administered with lixisenatide.
Slovenian: Te spremembe niso klinično pomembne, zato med sočasno uporabo z liksisenatida odmerka atorvastatina ni treba prilagoditi.
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.
Slovenian: V kliničnih študijah so odmerke do 30 mcg liksisenatida dvakrat na dan uporabljali pri sladkornih bolnikih tipa 2 v 13-tedenski študiji.
English: Lixisenatide slows gastric emptying thereby reducing the rate at which meal-derived glucose appears in the circulation.
Slovenian: Liksisenatid upočasni praznjenje želodca in tako zmanjša hitrost, s katero se glukoza iz obroka pojavi v krvnem obtoku.
English: When you are not using the pen, keep the cap on the pen in order to protect from light.
Slovenian: Kadar peresnika ne uporabljate, pokrovček obdržite na peresniku za zagotovitev zaščite pred svetlobo.
English: • You can clean the outside of your Lyxumia pen by wiping it with a damp cloth.
Slovenian: • Zunanjost peresnika Lyxumia lahko očistite tako, da ga obrišete z vlažno krpico.
English: Starting dose: dosing is initiated at 10 mcg lixisenatide once daily for 14 days.
Slovenian: Začetni odmerek: zdravljenje je treba začeti z 10 mcg liksisenatida enkrat na dan 14 dni.
English: It is not known if Lyxumia passes into your milk.
Slovenian: Ni znano, ali zdravilo Lyxumia prehaja v materino mleko.
English: sanofi-aventis groupe 54, rue La Boétie F - 75008 Paris France
Slovenian: sanofi-aventis groupe 54, rue La Boétie F - 75008 Pariz Francija
English: Press the injection button all the way in. You may feel or hear a “click”.
Slovenian: Morda boste čutili ali slišali "klik".
English: Animal studies did not indicate direct harmful effects with respect to male and female fertility in rats.
Slovenian: Študije na živalih pri podganah niso pokazale neposrednih ali posrednih škodljivih učinkov na plodnost samcev in samic.
English: 1 pre-filled pen of 3 ml (14 doses) 2 pre-filled pens of 3 ml (2x14 doses) 6 pre-filled pens of 3 ml (6x14 doses)
Slovenian: 1 napolnjen injekcijski peresnik s 3 ml (14 odmerkov) 2 napolnjena injekcijska peresnika s 3 ml (2 x 14 odmerkov) 6 napolnjenih injekcijskih peresnikov s 3 ml (6 x 14 odmerkov)
English: Add-on treatment to metformin alone
Slovenian: Dodatek zdravljenju z metforminom samim
English: Sanofi-Aventis Deutschland GmbH Industriepark Höchst - 65926 Frankfurt am Main Germany
Slovenian: Sanofi Aventis Deutschland GmbH Industriepark Höchst - 65926 Frankfurt am Main Nemčija
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.
Slovenian: Po prenehanju zdravljenja je bilo nekaj pacientov s pozitivnimi protitelesi spremljanih glede izvida protiteles; koncetracija protiteles se je v 3 mesecih znižala za približno 90 % in v 6 mesecih za 30 % ali dlje.
English: Gastro-resistant formulations containing substances sensitive to stomach degradation, should be administered 1 hour before or 4 hours after lixisenatide injection.
Slovenian: Gastrorezistentne oblike, ki vsebujejo učinkovine, občutljive na razgradnjo v želodcu, je treba uporabiti 1 uro pred injiciranjem liksisenatida ali 4 ure po injiciranju.
English: Inject Lyxumia in the hour before any meal of the day.
Slovenian: Zdravilo Lyxumia injicirajte v uri pred katerim koli dnevnim obrokom.
English: Mean HbA1c (±SD) in the lixisenatide and placebo groups was 7.72 (±1.32)% and 7.64 (±1.28)% at baseline and 7.46 (±1.51)% and 7.61 (±1.48)% at 24 months, respectively.
Slovenian: Povprečni HbA1c (± standardni odklon) je bil izhodiščno v skupini z liksisenatidom 7,72 (± 1,32) % in v skupini s placebom 7,64 (± 1,28) %, po 24 mesecih pa v prvi 7,46 (± 1,51) % in v drugi 7,61 (± 1,48) %.
English: Ask your doctor, pharmacist or nurse which needle gauge and length is best for you.
Slovenian: Svojega zdravnika, farmacevta ali medicinsko sestro vprašajte, katera številka in dolžina igle je za vas najprimernejša.
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%).
Slovenian: Incidenca navzee je bila v skupini z liksisenatidom večja (26,1 %) kot v skupini s placebom (6,2 %), prav tako je bila večja incidenca bruhanja (skupina z liksisenatidom 10,5 %, skupina s placebom 1,8 %).
English: Check that the activation window is orange.
Slovenian: Prepričajte se, da je aktivacijsko okence oranžno.
English: There have been few reported events of acute pancreatitis with lixisenatide although a causal relationship has not been established.
Slovenian: Z liksisenatidom so bili opisani maloštevilni primeri akutnega pankreatitisa, a vzročne povezanosti niso ugotovili.
English: • Low blood sugar (hypoglycaemia (“hypo”) especially when Lyxumia is used with insulin or a sulphonylurea
Slovenian: • Nizek sladkor v krvi (hipoglikemija (»hipa«)), še posebej, kadar z zdravilom Lyxumia jemljete druge insuline ali sulfonilsečnino.
English: Patients treated with lixisenatide should be advised of the potential risk of dehydration in relation to gastrointestinal adverse reactions and take precautions to avoid fluid depletion.
Slovenian: Bolnike, ki prejemajo liksisenatid, je treba seznaniti z možnim tveganjem za dehidracijo, povezano s neželenimi učinki v prebavilih; naročiti jim je treba, naj upoštevajo previdnostne ukrepe za preprečitev pomanjkanja tekočine.
English: Step B. Attach a new needle and remove the needle caps
Slovenian: Korak B. Namestite novo iglo in odstranite pokrovčka igle
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).
Slovenian: Pri bolnikih s hudo okvaro ledvic (očistek kreatinina < 30 ml/min) ali s končno odpovedjo ledvic terapevtskih izkušenj ni, zato liksisenatida v teh populacijah ni priporočljivo uporabljati (glejte poglavje 5.2).
English: After concomitant administration of lixisenatide 20 mcg and digoxin 0.25 mg at steady state, the AUC of digoxin was not affected.
Slovenian: Po sočasni uporabi 20 mcg liksisenatida in 0,25 mg digoksina v stanju dinamičnega ravnovesja se AUC digoksina ni spremenila.
English: • Each Lyxumia pen contains 14 pre-set doses.
Slovenian: • En peresnik Lyxumia vsebuje 14 prednastavljenih odmerkov.
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.
Slovenian: Pomožne snovi: 85 % glicerol, natrijev acetat trihidrat, metionin, metakrezol (za dodatne informacije glejte navodilo za uporabo), klorovodikova kislina in raztopina natrijevega hidroksida (za prilagoditev pH), voda za injekcije.
English: Ask your doctor, pharmacist or nurse about how to inject correctly.
Slovenian: Svojega zdravnika, farmacevta ali medicinsko sestro vprašajte, kako pravilno injicirati zdravilo.
English: An increased incidence of gastrointestinal disorders was observed.
Slovenian: Opažali so večjo incidenco prebavnih motenj.
English: Lixisenatide stimulates insulin secretion when blood glucose is increased but not at normoglycaemia, which limits the risk of hypoglycaemia.
Slovenian: Liksisenatid spodbudi izločanje insulina, če je krvni sladkor zvišan, ne pa tudi med normoglikemijo; to zmanjša tveganje za hipoglikemijo.
English: When administered once daily, lixisenatide improves glycaemic control through the immediate and sustained effects of lowering both post-prandial and fasting glucose concentrations in patients with type 2 diabetes.
Slovenian: Liksisenatid med uporabo enkrat na dan sladkornim bolnikom tipa 2 izboljša urejenost glikemije s takojšnjim in stalnim učinkom, tako da zmanjša postprandialno koncentracijo glukoze in koncentracijo glukoze na tešče.
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.
Slovenian: V primeru peroralno uporabljenih zdravil, katerih učinkovitost je še posebej odvisna od pražnih koncentracij (kot so npr. antibiotiki), je treba bolnikom svetovati, naj takšna zdravila vzamejo vsaj 1 uro pred injiciranjem liksisenatida ali 4 ure po injiciranju.
English: Hydrochloric acid (for pH adjustment) Sodium hydroxide solution (for pH adjustment) Water for injections
Slovenian: Klorovodikova kislina (za prilagoditev pH) Raztopina natrijevega hidroksida (za prilagoditev pH) Voda za injekcije
English: Patients receiving Lyxumia with a sulphonylurea or with a basal insulin may have an increased risk of hypoglycaemia.
Slovenian: Bolniki, ki dobivajo zdravilo Lyxumia s sulfonilsečnino ali z bazalnim insulinom, imajo lahko večje tveganje za hipoglikemijo.
English: If not, do not use this pen.
Slovenian: Če ni, peresnika ne uporabite.
English: Lyxumia should not be given in combination with basal insulin and a sulphonylurea due to increased risk of hypoglycaemia (see section 4.4).
Slovenian: Zdravilo Lyxumia se ne sme uporabljati v kombinaciji z bazalnim insulinom in sulfonilsečnino, zaradi povečanega tveganja za hipoglikemijo (glejte poglavje 4.4).
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.
Slovenian: Preglednica prikazuje tudi neželene učinke, ki so se med prejemniki zdravila Lyxumia pojavili s pogostnostjo ≥ 1 %, če je bila pogostnost večja kot 2kratna pogostnost v vseh primerjalnih skupinah.
English: Line up the needle with the pen.
Slovenian: Uravnajte iglo s peresnikom.
English: Table 1: Adverse reactions reported in placebo- and active-controlled phase III studies during the entire treatment period (including the period beyond the main 24-week treatment period in studies with ≥76 weeks of total treatment).
Slovenian: Preglednica 1: Neželeni učinki, zabeleženi v študijah III. faze, kontroliranih s placebom ali zdravilno učinkovino, med celotnim obdobjem zdravljenja (vključno z obdobjem, ki zajema več kot 24-tedensko obdobje zdravljenja v študijah, v katerih je celotno zdravljenje trajalo ≥ 76 tednov).
English: There are no clinically relevant differences in the rate of absorption when lixisenatide is administered subcutaneously in the abdomen, thigh, or arm.
Slovenian: Hitrost absorpcije se ne razlikuje klinično pomembno, če je liksisenatid injiciran subkutano v trebuh, stegno ali roko.