FrancophonIA/ELRC3.0 huggingface dataset:
English: If a dose is missed, it should be administered as soon as possible and within 5 days after the missed dose.
Slovenian: V primeru izpuščenega odmerka je treba odmerek injicirati čim prej, znotraj 5 dni po izpuščenem odmerku.
English: • it is 5 days or less since you should have used Ozempic, use it as soon as you remember.
Slovenian: • je od izpuščenega odmerka zdravila Ozempic minilo 5 dni ali manj, zdravilo uporabite takoj ko se spomnite.
English: If a drop still does not appear, dispose of the pen and use a new one.
Slovenian: Če kapljice še vedno ni, injekcijski peresnik zavrzite in uporabite novega.
English: The total number of primary component MACE endpoints was 254, including 108 (6.6%) with semaglutide and 146 (8.9%) with placebo.
Slovenian: Skupno število primarnih opazovanih dogodkov MACE je bilo 254, od teh 108 (6,6 %) med prejemniki semaglutida in 146 (8,9 %) med prejemniki placeba.
English: • Do not expose your pen to dust, dirt or liquid.
Slovenian: • Injekcijskega peresnika ne izpostavljajte prahu, umazaniji ali tekočinam.
English: Your doctor may reduce your dose of these medicines before you start using this medicine.
Slovenian: Zdravnik lahko pred uvedbo zdravljenja z zdravilom Ozempic odmerek teh zdravil zmanjša.
English: During induced hypoglycaemia, semaglutide compared to placebo did not alter the counter regulatory responses of increased glucagon and did not impair the decrease of C-peptide in patients with type 2-diabetes.
Slovenian: Med inducirano hipoglikemijo semaglutid v primerjavi s placebom ni spremenil protiregulacijskih odzivov zvišanja koncentracije glukagona ter ni okrnil znižanja koncentracije C-peptida pri bolnikih s sladkorno boleznijo tipa 2.
English: MedDRA system organ class
Slovenian: MedDRA organski sistem
English: • The starting dose is 0.25 mg once a week for four weeks.
Slovenian: • Začetni odmerek je 0,25 mg enkrat na teden za obdobje štirih tednov.
English: • you develop diabetic ketoacidosis - a complication of diabetes with high blood sugar, breathing difficulty, confusion, excessive thirst, a sweet smell to the breath or a sweet or metallic taste in the mouth.
Slovenian: • če se vam pojavi diabetična ketoacidoza; to je zaplet sladkorne bolezni z visokim sladkorjem v krvi, težkim dihanjem, zmedenostjo, hudo žejo, sladkobnim zadahom in sladkim ali kovinskim okusom v ustih.
English: Semaglutide did not change the overall exposure or Cmax of metformin following dosing of 500 mg twice daily over 3.5 days.
Slovenian: Semaglutid ni spremenil celotne izpostavljenosti metforminu ali njegove Cmax po uporabi 500 mg paracetamola dvakrat na dan v obdobju 3,5 dneva.
English: There is no specific antidote for overdose with semaglutide.
Slovenian: Specifičnega protistrupa za preveliko odmerjanje semaglutida ni.
English: This was shown with a single dose of 0.5 mg semaglutide for patients with different degrees of renal impairment (mild, moderate, severe or patients in dialysis) compared with subjects with normal renal function.
Slovenian: To je bilo dokazano z enkratnim odmerkom 0,5 mg semaglutida pri bolnikih z različnimi stopnjami okvare ledvic (blaga, zmerna, huda ali bolniki na dializi) v primerjavi z osebami z normalnim delovanjem ledvic.
English: There are limited data from the use of semaglutide in pregnant women.
Slovenian: Podatkov o uporabi semaglutida pri nosečnicah je malo.
English: • Caregivers must be very careful when handling used needles to prevent needle injury and cross infection.
Slovenian: • Osebe, ki skrbijo za bolnika, morajo biti pri ravnanju z uporabljenimi iglami zelo pazljive, da se ne bi zbodle in okužile.
English: There were 2,358 patients with normal or mild renal impairment, 832 with moderate and 107 with severe or end stage renal impairment.
Slovenian: Normalno delovanje ledvic ali blago okvaro ledvic je imelo 2.358 bolnikov, zmerno okvaro 832 bolnikov in hudo okvaro ali končno odpoved ledvic 107 bolnikov.
English: Inject your dose
Slovenian: Injicirajte odmerek
English: The findings coincided with marked maternal body weight loss of up to 16%.
Slovenian: Ti izsledki so sovpadali z izrazitim zmanjšanjem telesne mase samic do 16 %.
English: Semaglutide should be discontinued at least 2 months before a planned pregnancy due to the long half-life (see section 5.2).
Slovenian: Zaradi dolgega razpolovnega časa je treba semaglutid prenehati uporabljati vsaj 2 meseca pred načrtovano nosečnostjo (glejte poglavje 5.2).
English: The European Medicines Agency has deferred the obligation to submit the results of studies with semaglutide in one or more subsets of the paediatric population in type 2 diabetes (see section 4.2).
Slovenian: Evropska agencija za zdravila (EMA) je začasno odložila obvezo za predložitev rezultatov študij s semaglutidom za vse podskupine pediatrične populacije za sladkorno bolezen tipa 2 (glejte poglavje
English: Your pen is designed to be used with NovoFine and NovoTwist disposable needles up to a length of 8 mm.
Slovenian: Injekcijski peresnik je namenjen za uporabo z iglami NovoFine ali NovoTwist za enkratno uporabo, dolžine do 8 mm.
English: If no drop appears, repeat step 2 ‘Check the flow' up to 6 times.
Slovenian: Če se kapljica ne pojavi, do 6-krat ponovite korake pod točko 2, "Preverjanje pretoka".
English: Severe hypoglycaemia was primarily observed when semaglutide was used with a sulfonylurea (1.2% of subjects, 0.03 events/patient year) or insulin (1.5% of subjects, 0.02 events/patient year).
Slovenian: Hude hipoglikemije so bile opisane predvsem v primerih, ko je bil semaglutid uporabljen s sulfonilsečnino (1,2 % bolnikov, 0,03 primera/bolnik-leto) ali z insulinom (1,5 % bolnikov, 0,02 primera/bolnik-leto).
English: In clinical trials up to 1 year involving 4,807 patients with type 2 diabetes, adverse events related to diabetic retinopathy were reported in similar proportions of subjects treated with semaglutide (1.7%) and comparators (2.0%).
Slovenian: V kliničnih preskušanjih, ki so trajala do 1 leto in so vključevala 4.807 bolnikov s sladkorno boleznijo tipa 2, so o neželenih učinkih, povezanih z diabetično retinopatijo, poročali pri podobnem deležu bolnikov, zdravljenih s semaglutidom (1,7 %), in bolnikov, ki so prejemali primerjalna zdravila
English: (2°C - 8°C) away from the cooling element.
Slovenian: 8 °C) ter proč od zamrzovalnega razdelka.
English: • Keep the needle in your skin after the dose counter has returned to 0 and count slowly to 6.
Slovenian: • Ko se števec odmerka vrne na 0, pustite iglo v koži in počasi preštejte do 6.
English: • The best places to give the injection are the front of your thighs, the front of your waist
Slovenian: • Najprimernejša mesta za injiciranje so sprednji del stegna, sprednji del trebuha ali nadlaket.
English: Most events were mild to moderate in severity and of short duration.
Slovenian: Večina teh učinkov je bila blagih do zmernih in so bili kratkotrajni.
English: With semaglutide, the insulin secretion rate in patients with type 2 diabetes was comparable to that of healthy subjects.
Slovenian: S semaglutidom je bila hitrost izločanja insulina pri bolnikih s sladkorno boleznijo tipa 2 primerljiva tisti pri zdravih osebah.
English: Flow check symbol selected
Slovenian: izbran je simbol za preverjanje pretoka
English: Semaglutide should be used with caution in patients receiving oral medicinal products that require rapid gastrointestinal absorption.
Slovenian: Semaglutid je treba uporabljati previdno pri bolnikih, zdravljenih s peroralnimi zdravili, ki zahtevajo hitro absorpcijo iz prebavil.
English: In patients with type 2 diabetes clearance of semaglutide was approximately 0.05 L/h.
Slovenian: Pri bolnikih s sladkorno boleznijo tipa 2 je bil očistek semaglutida približno 0,05 l/h.
English: If you are blind or have poor eyesight and cannot read the dose counter on the pen, do not use this pen without help.
Slovenian: Če ste slepi ali slabovidni in ne morete odčitati števca odmerka na injekcijskem peresniku, sami ne uporabljajte injekcijskega peresnika.
English: Systematic evaluation of diabetic retinopathy complication was only performed in the cardiovascular outcomes trial.
Slovenian: Zapleti diabetične retinopatije so bili sistematično ovrednoteni le v sklopu preskušanja srčno-žilnih izidov.
English: However, upon initiation of semaglutide treatment in patients on warfarin or other coumarin derivatives, frequent monitoring of INR is recommended.
Slovenian: Vseeno je pri bolnikih, ki jemljejo varfarin ali druge kumarinske derivate, po uvedbi semaglutida priporočljivo pogosto nadzirati INR.
English: Figure 4 Forest plot: analyses of time to first occurrence of the composite outcome, its components and all cause death (SUSTAIN 6)
Slovenian: Drevesni diagram: analiza časa do prvega pojava sestavljenega izida po posameznih elementih MACE in do pojava smrti zaradi vseh vzrokov (SUSTAIN 6)
English: • Do not try to repair your pen or pull it apart.
Slovenian: • Injekcijskega peresnika ne poskušajte popraviti ali ga razstaviti.
English: In female rats, an increase in oestrous length and a small reduction in number of ovulations were observed at doses associated with maternal body weight loss (see section 5.3).
Slovenian: Pri podganjih samicah je bilo opaženo podaljšanje estrusa in majhno zmanjšanje števila ovulacij ob odmerkih, ki so bili povezani z zmanjšanjem telesne mase samic (glejte poglavje 5.3).
English: • If the needle is removed earlier, you may see a stream of solution coming from the needle tip.
Slovenian: • Če iglo izvlečete prej, bo iz konice igle morda izteklo nekaj raztopine.
English: In patients with diabetic retinopathy treated with insulin and semaglutide, an increased risk of developing diabetic retinopathy complications has been observed (see section 4.8).
Slovenian: Pri bolnikih z diabetično retinopatijo, zdravljenih z insulinom in semaglutidom, so opažali večje tveganje za zaplete diabetične retinopatije (glejte poglavje 4.8).
English: Women of childbearing potential are recommended to use contraception when treated with semaglutide.
Slovenian: Ženske v rodni dobi Priporočljivo je, da ženske v rodni dobi med zdravljenjem s semaglutidom uporabljajo kontracepcijo.
English: • with other medicines for diabetes - when they are not enough to control your blood sugar levels.
Slovenian: • skupaj z drugimi zdravili za zdravljenje sladkorne bolezni, če ta zdravila ne zadostujejo za ureditev koncentracije krvnega sladkorja.
English: The efficacy of semaglutide was not impacted by age, gender, race, ethnicity, BMI at baseline, body weight (kg) at baseline, diabetes duration and level of renal function impairment.
Slovenian: Na učinkovitost semaglutida niso vplivali starost, spol, rasa, etnično poreklo, izhodiščni indeks telesne mase (ITM), izhodiščna telesna masa (kg), trajanje sladkorne bolezni ali stopnja okvare delovanja ledvic.
English: The most frequent adverse events leading to discontinuation were gastrointestinal.
Slovenian: Najpogostejši neželeni učinki, ki so povzročili prekinitev, so bili neželeni učinki na prebavilih.
English: This should be considered when treating patients, with impaired renal function as nausea, vomiting, and diarrhoea may cause dehydration which could cause a deterioration of renal function (see section 4.8).
Slovenian: To je treba upoštevati pri zdravljenju bolnikov z okvarjenim delovanjem ledvic, kajti naveza, bruhanje in driska lahko povzročijo dehidracijo, ta pa lahko poslabša delovanje ledvic (glejte poglavje 4.8).
English: Semaglutide reduces body weight and body fat mass through lowered energy intake, involving an overall reduced appetite.
Slovenian: Semaglutid zmanjšuje telesno maso in maso telesnega maščevja z zmanjšanjem energijskega vnosa, kot posledico splošnega zmanjšanja apetita.
English: In this trial, adjudicated events of diabetic retinopathy complications occurred in more patients treated with semaglutide (3.0%) compared to placebo (1.8%).
Slovenian: V tem preskušanju so se presojeni zapleti diabetične retinopatije med zdravljenjem s semaglutidom pojavili pri več bolnikih (3,0 %) kot med uporabo placeba (1,8 %).
English: Table 1 Adverse reactions from long-term controlled phase 3a trials including the cardiovascular outcomes trial
Slovenian: Neželeni učinki iz dolgotrajnih kontroliranih preskušanj faze 3a, vključno s preskušanjem srčno-žilnih izidov
English: Dose counter stopped: 1 mg left
Slovenian: števec odmerka se je ustavil: preostal je 1 mg
English: The risk reduction in the primary composite outcome was mainly driven by decreases in the rate of non-fatal stroke (39%) and non-fatal myocardial infarction (26%) (figure 3).
Slovenian: Glavna razloga za zmanjšanje tveganja za primarni sestavljeni izid sta bila zmanjšanje deleža možganskih kapi brez smrtnega izida (39 %) in miokardnega infarkta brez smrtnega izida (26 %) (slika 3).
English: • After four weeks your doctor will increase your dose to 0.5 mg once a week.
Slovenian: • Po štirih tednih vam bo zdravnik odmerek povečal na 0,5 mg enkrat na teden.
English: • as monotherapy when metformin is considered inappropriate due to intolerance or contraindications
Slovenian: kot dodatek k dieti in telesni vadbi: • kot monoterapija, kadar metformin zaradi intolerance ali kontraindikacij ni primeren,
English: If you forget to use Ozempic
Slovenian: Če ste pozabili uporabiti zdravilo Ozempic
English: Table 1 lists adverse reactions identified in all phase 3a trials in patients with type 2 diabetes mellitus (further described in section 5.1).
Slovenian: Preglednica 1 prikazuje neželene učinke, ugotovljene v vseh preskušanjih faze 3a pri bolnikih s sladkorno boleznijo tipa 2 (preskušanja so dodatno opisana v poglavju 5.1).
English: • inflamed stomach (‘gastritis') - the signs include stomach ache, feeling sick (nausea) or being sick (vomiting)
Slovenian: • vnetje želodca ("gastritis"); med znaki so lahko bolečine v trebuhu, slabost (navzea) ali bruhanje
English: Combination with sulfonylurea monotherapy
Slovenian: Kombinacija z monoterapijo s sulfonilsečnino
English: In animal studies, semaglutide attenuates the development of atherosclerosis by preventing aortic plaque progression and reducing inflammation in the plaque.
Slovenian: V študijah na živalih je semaglutid zmanjšal razvoj ateroskleroze s preprečevanjem napredovanja aortnih plakov in z zmanjšanjem vnetja v njih.
English: After at least 4 weeks with a dose of 0.5 mg once weekly, the dose can be increased to 1 mg once weekly to further improve glycaemic control.
Slovenian: Po vsaj 4 tednih zdravljenja z odmerkom 0,5 mg enkrat na teden je mogoče odmerek za dodatno izboljšanje urejenosti glikemije povečati na 1 mg enkrat na teden.
English: • Before your first injection with each new pen, check the flow.
Slovenian: • Pred injiciranjem zdravila z novim injekcijskim peresnikom vedno preverite pretok.
English: Do not use this medicine if you are breast-feeding, as it is unknown if it passes into breast milk.
Slovenian: Če dojite, ne jemljite tega zdravila, saj ni znano, ali zdravilo prehaja v materino mleko.
English: Ozempic should not be administered intravenously or intramuscularly.
Slovenian: Zdravila Ozempic se ne sme injicirati intravensko ali intramuskularno.
English: NovoFine Plus needles are included in the package.
Slovenian: Igle NovoFine Plus so priložene pakiranju.
English: The cartridge is assembled into a disposable pre-filled pen made of polypropylene, polyoxymethylene, polycarbonate and acrylonitrile butadiene styrene.
Slovenian: Vložek je vgrajen v napolnjen injekcijski peresnik za enkratno uporabo iz polipropilena, polioksimetilena, polikarbonata in akrilonitrilbutadien-stirena.
English: The risk of hypoglycaemia can be lowered by reducing the dose of sulfonylurea or insulin when initiating treatment with semaglutide (see section 4.8).
Slovenian: Tveganje za hipoglikemijo je mogoče zmanjšati z zmanjšanjem odmerka sulfonilsečnine ali insulina ob začetku zdravljenja s semaglutidom (glejte poglavje 4.8).
English: Paediatric population Semaglutide has not been studied in paediatric patients.
Slovenian: Pediatrična populacija Uporaba semaglutida pri pediatričnih bolnikih ni raziskana.
English: Preclinical data reveal no special hazards for humans based on conventional studies of safety pharmacology, repeat-dose toxicity or genotoxicity.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih in genotoksičnosti ne kažejo posebnega tveganja za človeka.
English: Few episodes (0.1% of subjects, 0.001 events/patient year) were observed with semaglutide in combination with oral antidiabetics other than sulfonylureas.
Slovenian: Malo takšnih primerov (0,1 % bolnikov, 0,001 primerov/bolnik-leto) je bilo zabeleženih med uporabo semaglutida skupaj z nesulfonilsečninskimi peroralnimi antidiabetiki.
English: If a patient wishes to become pregnant, or pregnancy occurs, semaglutide should be discontinued.
Slovenian: Če želi bolnica zanositi ali če zanosi, je treba zdravljenje s semaglutidom prekiniti.
English: These delays had no impact upon fertility and reproductive capacity of either sex, or on the ability of the females to maintain pregnancy.
Slovenian: Ta upočasnitev ni vplivala na plodnost in sposobnost razmnoževanja ne pri samcih ne pri samicah; prav tako ni vplivala na sposobnost samic za ohranitev brejosti.
English: If necessary you can change the day of your weekly injection of this medicine as long as it has been at least 3 days since your last injection of it. After selecting a new dosing day, continue with once a week dosing.
Slovenian: Če želite, lahko dan v tednu, ko si injicirate to zdravilo, spremenite; edini pogoj je, da so od zadnjega injiciranja zdravila minili najmanj 3 dnevi.
English: Ozempic 0.5 mg (46% and 13%) and 1 mg (52 - 62% and 21 - 24%) compared with the active comparators sitagliptin (18% and 3%) and exenatide ER (17% and 4%).
Slovenian: 0,5 mg (46 % in 13 %) in 1 mg (52-62 % in 21-24 %) zdravila Ozempic kot s primerjalnima zdraviloma sitagliptinom (18 % in 3 %) in eksenatidom ER (17 % in 4 %).
English: Ozempic should not be used if it does not appear clear and colourless or almost colourless.
Slovenian: Zdravila Ozempic se ne sme uporabiti, če raztopina ni bistra in brezbarvna ali skoraj brezbarvna.
English: Do not take a double dose to make up for a forgotten dose.
Slovenian: Ne injicirajte dvojnega odmerka, če ste si pozabili injcirati prejšnji odmerek.
English: In addition, semaglutide treatment increased fasting insulin concentrations compared to placebo.
Slovenian: Poleg tega je zdravljenje s semaglutidom v primerjavi s placebom povečalo koncentracijo insulina na tešče.
English: Treatment with semaglutide resulted in a 26% risk reduction in the primary composite outcome of death from cardiovascular causes, non-fatal myocardial infarction or non-fatal stroke.
Slovenian: Zdravljenje s semaglutidom je povzročilo 26odstotno zmanjšanje tveganja za primarni sestavljeni izid smrti zaradi srčno-žilnih vzrokov, miokardnega infarkta brez smrtnega izida ali možganske kapi brez smrtnega izida.
English: See figure 4 for results on primary and secondary cardiovascular endpoints.
Slovenian: Za rezultate glede primarnih in sekundarnih srčno-žilnih dogodkov glejte sliko 4.
English: In SUSTAIN 6 (see subsection Cardiovascular disease) 123 patients were on sulfonylurea monotherapy at baseline.
Slovenian: V preskušanju SUSTAIN 6 (glejte podpoglavje Srčno-žilne bolezni) je 123 bolnikov izhodiščno prejemalo monoterapijo s sulfonilsečnino.
English: • Check that the solution in your pen is clear and colourless.
Slovenian: • Preverite, ali je raztopina v injekcijskem peresniku bistra in brezbarvna.
English: After first use: Store below 30°C or in a refrigerator (2°C to 8°C).
Slovenian: Po prvi uporabi: Shranjujte pri temperaturi do 30 °C ali v hladilniku (2 °C do 8 °C).
English: Semaglutide caused marked reductions in maternal body weight and reductions in embryonic survival and growth.
Slovenian: Semaglutid je povzročil izrazito zmanjšanje telesne mase samic ter zmanjšanje preživetja in rasti zarodkov.
English: It is important that you continue with your diet and exercise plan as told by your doctor, pharmacist or nurse.
Slovenian: Pomembno je, da še naprej upoštevate svojo dieto in načrt telesne vadbe, kot vam je naročil zdravnik,
English: What Ozempic is and what it is used for What you need to know before you use Ozempic How to use Ozempic
Slovenian: Kaj je zdravilo Ozempic in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Ozempic Kako uporabljati zdravilo Ozempic Možni neželeni učinki
English: Semaglutide lowered fasting glucose after the first dose.
Slovenian: Semaglutid je znižal glukozo na tešče že po prvem odmerku.
English: Before first use: Store in a refrigerator (2°C to 8°C).
Slovenian: Pred prvo uporabo: Shranjujte v hladilniku (2 °C do 8 °C).
English: • diarrhoea - this usually goes away over time
Slovenian: • driska - po navadi sčasoma mine
English: 1 pen and 4 disposable needles (4 doses) 3 pens and 12 disposable needles (12 doses)
Slovenian: 1 injekcijski peresnik in 4 igle za enkratno uporabo (4 odmerki) 3 injekcijski peresniki in 12 igel za enkratno uporabo (12 odmerkov)
English: The pharmacokinetics of semaglutide were evaluated in patients with different degrees of hepatic impairment (mild, moderate, severe) compared with subjects with normal hepatic function in a study with a single-dose of 0.5 mg semaglutide.
Slovenian: Farmakokinetiko semaglutida so pri bolnikih z različnimi stopnjami okvare jeter (blaga, zmerna, huda) v primerjavi z osebami z normalnim delovanjem jeter ocenili v študiji z enkratnim odmerkom 0,5 mg semaglutida.
English: MARKETING AUTHORISATION NUMBERS EU/1/17/1251/002
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/17/1251/002
English: In patients with type 2 diabetes, treatment with semaglutide 1 mg resulted in reductions in glucose in terms of absolute change from baseline (mmol/L) and relative reduction compared to placebo (%) for fasting glucose (1.6 mmol/L; 22% reduction), 2 hour postprandial glucose (4.1 mmol/L; 37% reduction), mean 24 hour glucose concentration (1.7 mmol/L; 22% reduction) and postprandial glucose excursions over 3 meals (0.6-1.1 mmol/L) compared with placebo.
Slovenian: Pri bolnikih s sladkorno boleznijo tipa 2 je zdravljenje z 1 mg semaglutida doseglo znižanje koncentracije glukoze tako glede absolutne spremembe od izhodišča (mmol/l) kot relativnega zmanjšanja v primerjavi s placebom (%), in sicer znižanje koncentracije glukoze na tešče (1,6 mmol/l, 22 % znižanje), glukoze 2 uri postprandialno (4,1 mmol/l; 37 % znižanje), povprečne 24-urne koncentracije glukoze (1,7 mmol/l, 22 % znižanje) ter postprandialnih odmikov glukoze preko 3 obrokov (0,6-1,1 mmol/l) v primerjavi s placebom.
English: • Turn the dose selector to select 0.5 mg.
Slovenian: • Zavrtite izbirnik odmerka, da boste izbrali 0,5 mg.
English: The starting dose is 0.25 mg semaglutide once weekly.
Slovenian: Začetni odmerek je 0,25 mg semaglutida enkrat na teden.
English: Body weight has an effect on the exposure of semaglutide.
Slovenian: Telesna masa vpliva na izpostavljenost semaglutidu.
English: When it is used in combination with a sulfonylurea or insulin, patients should be advised to take precautions to avoid hypoglycaemia while driving and using machines (see section 4.4).
Slovenian: Če je uporabljeno v kombinaciji s sulfonilsečnino ali insulinom, je treba bolnikom naročiti, naj upoštevajo previdnostne ukrepe za preprečitev hipoglikemij med vožnjo in upravljanjem strojev (glejte poglavje
English: The primary endpoint was time from randomisation to first occurrence of a major adverse cardiovascular event (MACE): cardiovascular death, non-fatal myocardial infarction or non-fatal stroke.
Slovenian: Primarni opazovani dogodek je bil čas od randomizacije do prvega pojava katerega od pomembnih srčno-žilnih neželenih dogodkov (MACE - Major Adverse Cardiovascular Events): srčno-žilne smrti, miokardnega infarkta brez smrtnega izida ali možganske kapi brez smrtnega izida.
English: • feeling sick (nausea) - this usually goes away over time
Slovenian: • slabost (navzea) - po navadi sčasoma mine