FrancophonIA/ELRC3.0 huggingface dataset:
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.
Slovenian: Če je bilo zdravilo Lyxumia uporabljeno v kombinaciji samo z metforminom, se je med celotnim obdobjem zdravljenja simptomatska hipoglikemija pojavila pri 7,0 % prejemnikov liksisenatida in pri 4,8 % prejemnikov placeba.
English: • Keep your Lyxumia pens in a safe place out of the reach and sight of children.
Slovenian: • Peresnike Lyxumia shranjujte na varnem mestu, nedosegljivo otrokom.
English: Use is not recommended in patients with severe renal impairment or end-stage renal disease (see sections 4.2 and 5.2).
Slovenian: Pri bolnikih s hudo okvaro ledvic ali končno odpovedjo ledvic tega zdravila ni priporočljivo uporabljati (glejte poglavji 4.2 in 5.2).
English: Date of activation Date to throw away
Slovenian: Datum, ko je peresnik treba zavreči
English: Speak to your doctor, nurse or pharmacist about how to dispose of sharps.
Slovenian: Z zdravnikom, medicinsko sestro ali farmacevtom se pogovorite o tem, kako odlagati ostre odpadke.
English: Mean HbA1c (%) Baseline LS mean change from baseline Patients (%) achieving HbA1c
Slovenian: Povprečni HbA1c (%) Izhodišče Povprečna sprememba od izhodišča Bolniki (%), ki so dosegli HbA1c
English: Lyxumia should not be used during breast-feeding.
Slovenian: Zdravila Lyxumia se ne sme uporabljati med obdobjem dojenja.
English: • Once activated, store your Lyxumia pen below 30°C.
Slovenian: • Ko je peresnik Lyxumia aktiviran, ga shranjujte pri temperaturi do 30 °C.
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.
Slovenian: Med monoterapijo z zdravilom Lyxumia se je simptomatska hipoglikemija pojavila pri 1,7 % prejemnikov liksisenatida in pri 1,6 % prejemnikov placeba.
English: Gender Gender has no clinically relevant effect on the pharmacokinetics of lixisenatide.
Slovenian: Spol Spol nima klinično pomembnih učinkov na farmakokinetiko liksisenatida.
English: About Your Treatment Initiation pack
Slovenian: O pakiranju za uvedbo zdravljenja
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.
Slovenian: Zdravilo Lyxumia, uporabljeno z bazalnim insulinom samim ali v kombinaciji z bazalnim insulinom in metforminom ali v kombinaciji z bazalnim insulinom in sulfonilsečnino, je v primerjavi s placebom doseglo statistično značilno znižanje HbA1c in postprandialne glukoze 2 uri po testnem obroku.
English: Mean HbA1c (%) Baseline LS mean change from baseline Patients (%) achieving HbA1c <7.0% Mean duration of treatment with basal insulin at baseline (years) Mean change in basal insulin dose (U) Baseline LS mean change from baseline Mean body weight (kg) Baseline LS mean change from baseline *performed in Asian population
Slovenian: Povprečni HbA1c (%) Izhodišče Povprečna sprememba od izhodišča Bolniki (%), ki so dosegli HbA1c < 7,0 % 28,3 Povprečno trajanje zdravljenja z bazalnim insulinom od izhodišča (leta) Povprečna sprememba odmerka bazalnega insulina (e) Izhodiščne Povprečna sprememba od izhodišča Povprečna telesna masa (kg) Izhodišče Povprečna sprememba od izhodišča
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.
Slovenian: Opravljena je bila študija farmakokinetike pri starejših preiskovancih brez sladkorne bolezni; v starejši populaciji (11 preiskovancev v starosti od 65 do 74 let in 7 preiskovancev, starih ≥ 75 let) je uporaba 20 mcg liksisenatida povzročila povprečno povečanje AUC za 29 % v primerjavi z 18 preiskovanci, starimi od 18 do 45 let; to je verjetno povezano z zmanjšanim delovanjem ledvic v starejši starostni skupini.
English: PHARMACEUTICAL FORM Solution for injection (injection).
Slovenian: FARMACEVTSKA OBLIKA raztopina za injiciranje (injekcija) Bistra, brezbarvna raztopina.
English: In parallel, glucagon secretion is suppressed.
Slovenian: Vzporedno s tem pride do zavrtja izločanja glukagona.
English: • Do not freeze Lyxumia pens and do not use Lyxumia if it has been frozen.
Slovenian: • Peresnika Lyxumia ne smete zamrzniti; če je zdravilo Lyxumia zmrznilo, ga ne smete uporabiti.
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.
Slovenian: Med glavnim 24-tedenskim obdobjem zdravljenja so alergijske reakcije ki bi lahko bile v povezavi z liksisenatidom (npr. anafilaktična reakcija, angioedem in urtikarija) zabeležili pri 0,4 % prejemnikih liksisenatida , kjer je bil pojav možnih alergijskih reakcij in pri manj kot 0,1 % prejemnikov placeba.
English: Step 4 Press and hold the injection button to remove excess liquid
Slovenian: 4. korak Pritisnite gumb za injiciranje in ga držite, da boste odstranili odvečno tekočino
English: For the maintenance dose Lyxumia 20 micrograms solution for injection is available.
Slovenian: Za vzdrževalni odmerek je na voljo Lyxumia 20 mikrogramov raztopina za injiciranje.
English: Step A. Pull off the pen cap and check the pen
Slovenian: Korak A. Snemite pokrovček peresnika in peresnik preverite
English: These are the thigh, abdomen or upper arm.
Slovenian: Ti predeli so stegno, trebuh in zgornji del roke (nadlaket).
English: (for example, if you have vision problems), only use it if you have help.
Slovenian: • Če ne morete v celoti slediti navodilom, ali če ne morete ravnati s peresnikom (na primer ker imate težave z vidom), peresnik uporabite le v primeru, da imate pomoč.
English: • Indigestion (dyspepsia)
Slovenian: • težave z želodcem (dispepsija)
English: Body weight Body weight has no clinically relevant effect on lixisenatide AUC.
Slovenian: Telesna masa Telesna masa nima klinično pomembnega vpliva na AUC liksisenatida.
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).
Slovenian: Če je bilo zdravilo Lyxumia uporabljeno v kombinaciji z bazalnim insulinom (z metforminom ali brez njega), se je simptomatska hipoglikemija med celotnim obdobjem zdravljenja pojavila pri 42,1 % prejemnikov liksenatida in pri 38,9 % prejemnikov placeba (absolutna razlika 3,2 %).
English: Step C. Pull the injection button
Slovenian: Korak C. Potegnite gumb za injiciranje
English: Patients with type 2 diabetes with basal insulin combined with 1-3 oral anti-diabetic agents were enrolled in an open-label randomised study for insulin intensification.
Slovenian: Odprta, randomizirana študija intenzifikacije insulina je zajela bolnike s sladkorno boleznijo tipa 2 z bazalnim insulinom v kombinaciji z 1 do 3 peroralnimi antidiabetičnimi zdravili.
English: • The purple pen contains 14 pre-set doses; each dose contains 20 micrograms of Lyxumia.
Slovenian: • Škrlatni peresnik vsebuje 14 prednastavljenih odmerkov; vsak odmerek vsebuje 20 mikrogramov zdravila Lyxumia.
English: Check that the activation window is white.
Slovenian: Preverite, da je aktivacijsko okence belo.
English: When to inject
Slovenian: Kdaj injicirati zdravilo
English: For the starting dose Lyxumia 10 micrograms solution for injection is available.
Slovenian: Za začetni odmerek je na voljo Lyxumia 10 mikrogramov raztopina za injiciranje.
English: Over 2,600 patients have received Lyxumia either alone or in combination with metformin, a sulphonylurea (with or without metformin) or a basal insulin (with or without metformin, or with or without a sulphonylurea) in 8 large placebo- or active-controlled phase III studies.
Slovenian: V 8 velikih, s placebom ali zdravilno učinkovino kontroliranih preskušanjih III. faze je zdravilo Lyxumia prejemalo 2.600 bolnikov, bodisi samo bodisi v kombinaciji z metforminom, sulfonilsečnino (z metforminom ali brez njega) ali bazalnim insulinom (z metforminom ali brez njega oz. s sulfonilsečnino ali brez nje).
English: At the end of the 24-week treatment period, 56.3% of the lixisenatide patients achieved an HbA1c less than 7 % compared to 38.5% in the placebo group.
Slovenian: Ob koncu 24-tedenskega obdobja zdravljenja je HbA1c pod 7 % doseglo 56,3 % bolnikov, ki so prejemali liksenatid, in 38,5 % bolnikov, ki so prejemali placebo.
English: Hepatic dysfunction is not expected to affect the pharmacokinetics of lixisenatide.
Slovenian: Ni pričakovati, da bi moteno delovanj jeter vplivalo na farmakokinetiko liksisenatida.
English: Step 1 Pull off the pen cap and check the pen
Slovenian: 1. korak Snemite pokrovček peresnika in peresnik preverite
English: Treatment with Lyxumia in combination with metformin and/or a sulphonylurea resulted in a sustained body weight change from baseline in all controlled studies in a range from -1.76 kg to2.96 kg at the end of the main 24-week treatment period.
Slovenian: Zdravljenje z zdravilom Lyxumia v kombinaciji z metforminom in/ali sulfonilsečnino je na koncu glavnega 24-tedenskega obdobja zdravljenja v vseh kontroliranih študijah v primerjavi z izhodiščem povzročilo trajno znižanje telesne mase za 1,76 do 2,96 kg.
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.
Slovenian: Ob koncu 24 tedenskega glavnega obdobja zdravljenja je HbA1c pod 7 % doseglo 52,3 % bolnikov, ki so prejemali liksenatid, in 26,4 % bolnikov, ki so prejemali placebo.
English: Lixisenatide INSTRUCTIONS FOR USE
Slovenian: Lyxumia liksisenatid NAVODILA ZA UPORABO
English: • Do not soak, wash or put liquid on (lubricate) your Lyxumia pen, this may damage it.
Slovenian: • Injekcijskega peresnika Lyxumia ne smete namakati, umivati ali mazati, ker ga s tem lahko poškodujete.
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.
Slovenian: Med 24-tedenskim obdobjem zdravljenja je vsaj eno simptomatsko hipoglikemijo navedlo 22,4 % prejemnikov liksisenatida in 13,5 % prejemnikov placeba.
English: • If you think your Lyxumia pen may be damaged, do not use it. Get a new one.
Slovenian: • Če menite, da je peresnik Lyxumia poškodovan, ga ne uporabite.
English: Lyxumia can be used with 29 to 32 gauge disposable pen needles.
Slovenian: Zdravilo Lyxumia je mogoče uporabiti z iglami za peresnik za enkratno uporabo številka 29 do 32.
English: You must start your treatment with the green pen of Lyxumia 10 micrograms.
Slovenian: Zdravljenje morate začeti z zelenim peresnikom Lyxumia 10 mikrogramov.
English: • Fasting plasma glucose
Slovenian: • Glukoza v plazmi na tešče
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Lyxumia 10 micrograms solution for injection Each dose (0.2 ml) contains 10 micrograms (mcg) of lixisenatide (50 mcg per ml).
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Lyxumia 10 mikrogramov raztopina za injiciranje En odmerek (0,2 ml) vsebuje 10 mikrogramov (mcg) liksisenatida (50 mcg na ml).
English: Age has no clinically relevant effect on the pharmacokinetics of lixisenatide.
Slovenian: Starost nima klinično pomembnega vpliva na farmakokinetiko liksisenatida.
English: INFORMATION IN BRAILLE Lyxumia 20
Slovenian: PODATKI V BRAILLOVI PISAVI Lyxumia 20
English: Insulin glulisine TID
Slovenian: Liksisenatid Insulin glulizin enkrat na dan
English: INFORMATION IN BRAILLE Lyxumia 10
Slovenian: PODATKI V BRAILLOVI PISAVI Lyxumia 10
English: A further delay in tmax and a reduced Cmax of paracetamol have been predicted with the 20 mcg maintenance dose.
Slovenian: V primeru vzdrževalnega odmerka 20 mikrogramov je predvidoma mogoče pričakovati dodatno podaljšanje tmax in zmanjšanje Cmax paracetamola.
English: Keep this leaflet for future reference.
Slovenian: Shranite navodila za poznejšo uporabo.
English: One green 10 microgram pen (Lyxumia 10 micrograms solution for injection), each dose contains 10 micrograms in 0.2 ml.
Slovenian: En zeleni 10 mikrogramski peresnik (Lyxumia 10 mikrogramov raztopina za injiciranje); vsak odmerek vsebuje 10 mikrogramov v 0,2 ml.
English: Maintenance dose: a fixed maintenance dose of 20 mcg lixisenatide once daily is started on Day 15.
Slovenian: Vzdrževalni odmerek: od 15. dne po začetku zdravljenja je stalni vzdrževalni odmerek 20 mcg liksisenatida enkrat na dan.
English: Where to inject
Slovenian: Kam injicirati zdravilo
English: Hypoglycaemia (in combination with a sulphonylurea and / or a basal insulin)
Slovenian: Presnovne in prehranske motnje hipoglikemija (v kombinaciji s sulfonilsečnino in/ali bazalnim insulinom)
English: Step E. Remove and throw away the needle after each injection
Slovenian: Korak E. Iglo po vsakem injiciranju odstranite in zavrzite
English: Ethnic origin had no clinically relevant effect on the pharmacokinetics of lixisenatide based on the results of pharmacokinetic studies in Caucasian, Japanese and Chinese subjects.
Slovenian: Na podlagi rezultatov farmakokinetičnih študij pri belskih, japonskih in kitajskih preiskovancih, etnično poreklo nima klinično pomembnega vpliva na farmakokinetiko liksisenatida.
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.
Slovenian: V prvi skupini (uporaba pri glavnem obroku) so navzeo zabeležili pri 14,7 % bolnikov in simptomatsko hipoglikemijo pri 5,8 %, v drugi skupini (uporaba pri zajtrku) pa navzeo pri 15,5 % bolnikov in simptomatsko hipoglikemijo pri 2,2 %.
English: • Do not try to take liquid out of the cartridge using a syringe.
Slovenian: • Ne poskušajte z brizgo izvleči tekočine iz vsebnika peresnika Lyxumia.
English: Lixisenatide 20 mcg (N= 160)
Slovenian: Liksisenatid 20 mcg (N=160)
English: During the entire treatment period, when Lyxumia was given with a sulphonylurea alone, symptomatic hypoglycaemia occurred in 22.7% of lixisenatide treated patients versus 15.2% with placebo (7.5% absolute difference).
Slovenian: Med celotnim obdobjem zdravljenja se je med uporabo zdravila Lyxumia skupaj s samo sulfonilsečnino hipoglikemija pojavila pri 22,7 % prejemnikov zdravila Lyxumia in pri 15,2 % prejemnikov placeba (absolutna razlika 7,5 %).
English: • If you think your Lyxumia pen may be damaged, do not use it. Do not try to repair the pen.
Slovenian: • Če menite, da je peresnik Lyxumia pokvarjen, ga ne uporabite.
English: Mean HbA1c (%) Baseline
Slovenian: Povprečna vrednost HbA1c (%)
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.
Slovenian: Med 24-tedenskim glavnim obdobjem zdravljenja so navzeo zabeležili pri 23,5 % prejemnikov liksenatida in 10,6 % prejemnikov placeba, simptomatsko hipoglikemijo pa pri 3,4 % prejemnikov liksenatida in pri 1,2 % prejemnikov placeba.
English: Lixisenatide 20 mcg (N= 154)
Slovenian: Liksisenatid 20 mcg (N = 154)
English: Lixisenatide 20 mcg (N= 570)
Slovenian: Liksisenatid 20 mcg (N = 570)
English: Lixisenatide 20 mcg (N= 327)
Slovenian: Liksisenatid 20 mcg (N = 327)
English: Lyxumia must be injected under the skin and can be injected in any of the areas shown above in blue.
Slovenian: Injicirate ga lahko v kateri koli predel, ki je na zgornji sliki označen z modro barvo.
English: The effect of some medicines you swallow might be affected by Lyxumia.
Slovenian: Zdravilo Lyxumia lahko vpliva na nekatera zaužita zdravila.
English: Step 3 Pull the injection button out
Slovenian: 3. korak Izvlecite gumb za injiciranje
English: Step C. Pull the injection button out
Slovenian: Korak C. Izvlecite gumb za injiciranje
English: • Replace the pen cap after each use in order to protect from light.
Slovenian: • Po vsaki uporabi na peresnik spet namestite njegov pokrovček, da boste zdravilo zaščitili pred svetlobo.
English: INFORMATION IN BRAILLE Lyxumia
Slovenian: PODATKI V BRAILLOVI PISAVI Lyxumia
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
Slovenian: 1 napolnjen injekcijski peresnik s 3 ml za 14 odmerkov po 10 mikrogramov 1 napolnjen injekcijski peresnik s 3 ml za 14 odmerkov po 20 mikrogramov
English: In patients taking Lyxumia in combination with a sulphonylurea and metformin, symptomatic hypoglycaemia occurred in 22.0% of lixisenatide treated patients and in 18.4% of placebo treated patients during the entire treatment period (3.6% absolute difference).
Slovenian: Pri bolnikih, ki so zdravilo uporabljali v kombinaciji s sulfonilsečnino in metforminom, se je simptomatska hipoglikemija med celotnim obdobjem zdravljenja pojavila pri 22,0 % prejemnikov liksenatida in pri 18,4 % prejemnikov placeba (absolutna razlika 3,6 %).
English: These side effects were mostly mild and usually go away over time.
Slovenian: Ta neželena učinka sta po navadi blaga in običajno ščasoma mineta.
English: Injection sites
Slovenian: Mesta injiciranja
English: Injections site reactions were reported in 3.9% of the patients receiving Lyxumia while they were reported in 1.4% of patients receiving placebo during the main 24-week treatment period.
Slovenian: Reakcije na mestu injiciranja so med glavnim 24-tedenskim obdobjem zdravljenja zabeležili pri 3,9 % prejemnikov zdravila Lyxumia in 1,4 % prejemnikov placeba.
English: Upper respiratory tract infection
Slovenian: Infekcijske in parazitske bolezni gripa okužba zgornjih dihal cistitis virusna okužba
English: Each pre-filled pen contains 14 doses, each dose contains 10 micrograms in 0.2 ml.
Slovenian: En napolnjen injekcijski peresnik vsebuje 14 odmerkov; vsak odmerek vsebuje 10 mikrogramov v 0,2 ml.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Lyxumia 10 mcg injection
Slovenian: IME ZDRAVILA IN POT(I) UPORABE Lyxumia 10 mcg injekcija liksisenatid subkutana uporaba
English: • The dose from then onwards will be 20 micrograms once a day -using the purple pen.
Slovenian: • Zdravljenje nadaljujemo z odmerkom 20 mikrogramov enkrat na dan - injiciran s škrlatnim peresnikom.
English: Lyxumia 20 micrograms solution for injection Each dose (0.2 ml) contains 20 micrograms (mcg) of lixisenatide (100 mcg per ml).
Slovenian: Lyxumia 20 mikrogramov raztopina za injiciranje En odmerek (0,2 ml) vsebuje 20 mikrogramov (mcg) liksisenatida (100 mcg na ml).
English: Each green pen of Lyxumia 10 micrograms solution for injection contains 3 ml of solution , delivering 14 doses of 10 micrograms.
Slovenian: En zeleni peresnik zdravila Lyxumia 10 mikrogramov raztopina za injiciranje vsebuje 3 ml raztopine in omogoča uporabo 14 odmerkov po 10 mikrogramov.
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.
Slovenian: Če je bil paracetamol uporabljen 1 uro po injiciranju 10 mcg liksisenatida, se je Cmax paracetamola znižala za 29 %, njegov mediani tmax pa se je podaljšal za 2,0 uri; če je bil uporabljen 4 ure po injiciranju, je bilo znižanje Cmax 31 % in podaljšanje tmax 1,75 ure.
English: Contact your doctor, pharmacist or nurse for advice on checking your blood sugar.
Slovenian: Za nasvet o kontroliranju krvnega sladkorja se obrnite na svojega zdravstvenega delavca.
English: Morning (N= 255)
Slovenian: Zjutraj (N =
English: Mean systolic and diastolic blood pressure reductions up to 2.1 mmHg and up to 1.5 mmHg respectively were observed in phase III placebo-controlled studies.
Slovenian: V študijah III. faze, kontroliranih s placebom, so opažali povprečno znižanje sistoličnega krvnega tlaka do 2,1 mmHg in diastoličnega krvnega tlaka do 1,5 mmHg.
English: Each purple pen of Lyxumia 20 micrograms solution for injection contains 3 ml of solution , delivering 14 doses of 20 micrograms.
Slovenian: En škrlatni peresnik zdravila Lyxumia 20 mikrogramov raztopina za injiciranje vsebuje 3 ml raztopine in omogoča uporabo 14 odmerkov po 20 mikrogramov.
English: Each pre-filled pen contains 14 doses, each dose contains 20 micrograms in 0.2 ml.
Slovenian: En napolnjen injekcijski peresnik vsebuje 14 odmerkov; vsak odmerek vsebuje 20 mikrogramov v 0,2 ml.
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.
Slovenian: Znižanje AUC0:30-4:30h glukoze v plazmi po testnem obroku v primerjavi z izhodiščem je bilo v skupini z liksisenatidom -12.61 h*mmol/l
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON (MAINTENANCE PACK)
Slovenian: PODATKI NA ZUNANJI OVOJNINI ZUNANJA OVOJNINA (PAKIRANJE ZA VZDRŽEVALNO ZDRAVLJENJE)
English: Reversible testicular and epididymal lesions were seen in dogs treated with lixisenatide.
Slovenian: Pri psih, ki so prejemali liksenatid, so ugotovili reverzibilne lezije mod in obmodka.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each dose (0.2 ml) contains 10 or 20 micrograms lixisenatide.
Slovenian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN En odmerek (0,2 ml) vsebuje 10 ali 20 mikrogramov liksisenatida.
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 placebo-controlled studies.
Slovenian: V celoti je bila incidenca hudih simptomatskih hipoglikemij med celotnim obdobjem zdravljenja v študijah III. faze, kontroliranih s placebom, občasna (0,4 % med prejemniki zdravila Lyxumia in 0,2 % med prejemniki placeba).
English: When Lyxumia was given with a sulphonylurea and a basal insulin, symptomatic hypoglycaemia occurred in 47.2% of lixisenatide treated patients compared to 21.6% with placebo (25.6% absolute difference).
Slovenian: Če je bilo zdravilo Lyxumia uporabljeno s sulfonilsečnino in bazalnim insulinom, se je simptomatska hipoglikemija pojavila pri 47,2 % prejemnikov zdravila Lyxumia in pri 21,6 % prejemnikov placeba (absolutna razlika 25,6 %).
English: Nausea and vomiting were the most frequently reported adverse reactions during the main 24-week treatment period.
Slovenian: Najpogostejša neželena učinka med glavnim 24-tedenskim obdobjem zdravljenja sta bila navzea in bruhanje.
English: In 2-year subcutaneous carcinogenicity studies, non-lethal C-cell thyroid tumours were seen in rats and mice and are considered to be caused by a non-genotoxic GLP-1 receptor-mediated mechanism to which rodents are particularly sensitive.
Slovenian: V 2-letnih študijah karcenogenosti pri subkutani uporabi, so pri podganah in miših opazili nesmrtonosne C-celične tumorje ščitnice.
English: Harzard Ratio with 95% CI
Slovenian: Razmerje ogroženosti s 95 % IZ
English: Keep
Slovenian: Shranite
English: One purple 20 microgram pen (Lyxumia 20 micrograms solution for injection), each dose contains 20 micrograms in 0.2 ml.
Slovenian: En škrlatni 20 mikrogramski peresnik (Lyxumia 20 mikrogramov raztopina za injiciranje); vsak odmerek vsebuje 20 mikrogramov v 0,2 ml.
English: You do not need to replace the needle between activation and your first injection.
Slovenian: Ko ste peresnik aktivirali, vam pred injiciranjem ni treba zamenjati igle.
English: Pack size of 1 pre-filled pen.
Slovenian: Velikost pakiranja z 1 napolnjenim injekcijskim peresnikom.