FrancophonIA/ELRC3.0 huggingface dataset:
English: Once you see several drops or a stream of liquid coming out of the tip of the needle, the setup is complete.
Slovenian: Ko se na konici igle pojavi nekaj kapelj ali curek tekočine, je priprava končana.
English: Concomitant medicinal products
Slovenian: Sočasna uporaba zdravil
English: Do not repeat Section 2 for routine use, if you do, you will run out of Byetta before 30 days of use.
Slovenian: Pri vsakodnevni uporabi ne ponavljajte Poglavja 2, sicer vam bo zmanjkalo zdravila Byetta še pred potekom 30 dni uporabe.
English: In patients treated with 5 mcg or 10 mcg immediate-release exenatide, 36% reported at least one episode of nausea.
Slovenian: Pri bolnikih zdravljenih s 5 μg ali 10 μg eksenatida v obliki s takojšnjim sproščanjem, so v 36 % poročali o najmanj eni epizodi navzee.
English: There was no tumorigenic response in male rats or either sex of mice.
Slovenian: Pri samcih podgan ali miših kateregakoli spola tumorogenega odgovora ni bilo.
English: Two placebo-controlled studies were conducted: one of 16 and one of 26 weeks duration, with 121 and 111 immediate-release exenatide and 112 and 54 placebo treated patients respectively, added to existing thiazolidinedione treatment, with or without metformin.
Slovenian: Opravljeni sta bili dve s placebom nadzorovani študiji: ena je trajala 16 in druga 26 tednov, v katerih je bilo poleg obstoječega zdravljenja s tiazolidindionom, z ali brez metformina, 121 in 111 bolnikov zdravljenih z eksenatidom v obliki s takojšnjim sproščanjem ter 112 in 54 bolnikov s placebom.
English: There have been spontaneously reported events of acute pancreatitis with exenatide.
Slovenian: Spontano so poročali o primerih akutnega pankreatitisa pri uporabi eksenatida.
English: • Do not use Byettaafter the expiry date, which is stated on the label and the carton after ‘EXP'.
Slovenian: • Zdravila Byetta ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki in škatli poleg oznake 'EXP'.
English: Rapid weight loss
Slovenian: Hitra izguba telesne mase
English: Insert needle into skin using hygienic injection technique recommended by your healthcare professional.
Slovenian: Vbodite iglo v kožo z uporabo higienske tehnike injiciranja, ki jo priporoča vaš zdravstveni delavec.
English: If you forget to use Byetta
Slovenian: Če ste pozabili uporabiti zdravilo Byetta
English: The incidence and type of other adverse events observed were similar to those seen in the 30-week controlled clinical trials with a sulphonylurea, metformin or both.
Slovenian: Pojavnost in vrsta drugih opaženih neželenih učinkov sta bili podobni kot pri 30-tedenskih nadzorovanih kliničnih študijah s sulfonilsečnino, metforminom ali obojim.
English: Please see the accompanying Package Leaflet.
Slovenian: Prosimo, glejte priloženo Navodilo za uporabo.
English: Exenatide suppresses glucagon secretion which is known to be inappropriately elevated in type 2 diabetes.
Slovenian: Eksenatid zavre izločanje glukagona, ki je pri diabetesu tipa 2 neustrezno povečano.
English: The proportion of patients achieving HbA1c < 7% and HbA1c ≤ 6.5% was 56% and 42% with immediate-release exenatide and 29% and 13% with placebo.
Slovenian: Delež bolnikov, ki je dosegel HbA1c <7% in HbA1c ≤6,5% je bil pri eksenatidu v obliki s takojšnjim sproščanjem 56 % oziroma 42 % ter pri placebu 29 % oziroma 13 %.
English: The effect of immediate-release exenatide to slow gastric emptying may reduce the extent and rate of absorption of orally administered medicinal products.
Slovenian: Učinek eksenatida v obliki s takojšnjim sproščanjem, da upočasni praznjenje želodca, lahko zmanjša obseg in stopnjo absorpcije zdravil za peroralno uporabo.
English: How long can I use a Byetta pen?
Slovenian: Kako dolgo lahko uporabljam injekcijski peresnik Byetta?
English: For additional information contact your healthcare professional.
Slovenian: Za dodatne informacije se obrnite na zdravstvenega delavca.
English: The outer needle shield will be used when you are removing the needle from the pen after the injection.
Slovenian: Zunanjo zaščito igle boste uporabili pri odstranjevanju igle z injekcijskega peresnika po injiciranju.
English: In the 30-week placebo-controlled clinical trials, concomitant use of immediate-release exenatide and HMG CoA reductase inhibitors was not associated with consistent changes in lipid profiles (see section 5.1).
Slovenian: V 30-tedenskih s placebom nadzorovanih kliničnih preskušanjih sočasne uporabe eksenatida v obliki s takojšnjim sproščanjem in zaviralcev HMG CoA reduktaze niso povezovali s posledičnimi spremembami v profilu maščob (glejte poglavje 5.1).
English: Gastroresistant formulations containing substances sensitive for degradation in the stomach, such as proton pump inhibitors, should be taken at least 1 hour before or more than 4 hours after immediate-release exenatide injection.
Slovenian: Gastrorezistentne oblike, ki vsebujejo učinkovine, občutljive na razgradnjo v želodcu, kot so zaviralci protonske črpalke, naj bolniki vzamejo najmanj 1 uro pred ali več kot 4 ure po injiciranju eksenatida v obliki s takojšnjim sproščanjem.
English: In use pen: 30 days
Slovenian: 3 leta Injekcijski peresnik v uporabi: 30 dni
English: This treatment effect was comparable to that of insulin glargine in a 26-week study (mean insulin dose 24.9 IU/day, range 4-95 IU/day, at the end of study) and biphasic insulin aspart in a 52-week study (mean insulin dose 24.4
Slovenian: Ta učinek zdravljenja je bil primerljiv z učinkom insulina glargin v 26-tedenski študiji (povprečni odmerek insulina 24,9 i.e./dan, razpon 4-95 i.e./dan, ob koncu študije) in dvofaznega insulina aspart v 52tedenski študiji (povprečni odmerek insulina 24,4 i.e./dan, razpon 3-78 i.e./dan, ob koncu študije).
English: Two strengths of Byetta are available: Byetta 5 micrograms and Byetta 10 micrograms.
Slovenian: Zdravilo Byetta je na voljo v dveh jakostih: Byetta 5 mikrogramov (µg) in Byetta 10 mikrogramov (µg).
English: The immediate-release exenatide arm compared to placebo had significantly lowered postprandial blood glucose excursions at the morning meal (- 2.0 versus0.2 mmol/l) and evening meal (- 1.6 versus + 0.1 mmol/l), there was no difference between treatments at midday.
Slovenian: Eksenatid v obliki s takojšnjim sproščanjem je v primerjavi s placebom signifikantno znižala nivo postprandialne glukoze v krvi po jutranjem (- 2,0 v primerjavi z - 0,2 mmol/l) in večernem obroku (- 1,6 v primerjavi z + 0,1 mmol/l), medtem ko pri zdravljenju sredi dneva ni bilo razlik.
English: If you use this medicine in combination with a sulphonylurea or insulin, low blood sugar (hypoglycaemia) can occur.
Slovenian: Če uporabljate to zdravilo v kombinaciji s sulfonilsečnino ali insulinom, lahko pride do nizkega sladkorja v krvi (hipoglikemije).
English: Why do I see particles in the cartridge after I finish my injection?
Slovenian: Zakaj po koncu injiciranja v vložku vidim delce?
English: In studies in patients treated with immediate-release exenatide and a sulphonylurea (with or without metformin), the incidence of hypoglycaemia was increased compared to placebo (23.5% and 25.2% versus 12.6% and 3.3%) and appeared to be dependent on the doses of both immediate-release exenatide and the sulphonylurea.
Slovenian: Incidenca hipoglikemije je bila višja v študijah pri bolnikih zdravljenih z eksenatidom v obliki s takojšnjim sproščanjem in sulfonilsečnino (z ali brez metformina) v primerjavi s placebom (23,5 % in 25,2 % proti 12,6 % in 3,3 %) in je kazalo, da je odvisna od odmerkov tako eksenatida v obliki s takojšnjim sproščanjem kot sulfonilsečnine.
English: The most frequently reported adverse reaction was nausea.
Slovenian: Neželeni učinek, o katerem so najpogosteje poročali, je bila navzea.
English: Altered renal function, including acute renal failure, worsened chronic renal failure, renal impairment, increased serum creatinine
Slovenian: Sprememba delovanja ledvic, vključno z akutno odpovedjo ledvic, poslabšanjem kronične odpovedi ledvic, okvaro ledvic, zvišanjem kreatinina v serumu
English: Immediate-release exenatide (Byetta) therapy should be initiated at 5 mcg exenatide per dose administered twice daily (BID) for at least one month in order to improve tolerability.
Slovenian: Zdravljenje z eksenatidom v obliki s takojšnjim sproščanjem (zdravilo Byetta) začnemo s 5 μg eksenatida na odmerek danim dvakrat na dan za najmanj en mesec z namenom izboljšanja prenašanja.
English: In a single-dose pharmacokinetic study in 13 patients with type 2 diabetes and between the ages of 12 and 16 years, administration of exenatide (5 mcg) resulted in slightly lower mean AUC (16% lower) and Cmax (25% lower) compared to those observed in adults.
Slovenian: V farmakokinetični študiji enkratnega odmerka pri 13 bolnikih z diabetesom tipa 2, v starosti med 12 in 16 let, je dajanje eksenatida (5 g) rahlo znižalo srednje vrednosti AUC (16 % nižje) in Cmax (25 % nižje) v primerjavi z vrednostmi, ki so jih opazili pri odraslih.
English: Table 1 lists adverse reactions reported of immediate-release exenatide from clinical trials and spontaneous reports (not observed in clinical trials, frequency not known).
Slovenian: Preglednica 1 prikazuje neželene učinke, zabeležene z eksenatidom v obliki s takojšnjim sproščanjem v kliničnih preskušanjih, in spontano poročane primere (neopaženi v kliničnih preskušanjih, neznana pogostnost).
English: If you do, you will run out of Byetta before 30 days of use.
Slovenian: Če jo ponavljate, vam bo zmanjkalo zdravila Byetta, še preden bo preteklo 30 dni uporabe.
English: A.MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Slovenian: A. IZDELOVALCI, ODGOVORNI ZA SPROŠČANJE SERIJ
English: In patients at increased risk of hypoglycaemia reducing the dose of basal insulin should be considered (see section 4.8).
Slovenian: Pri bolnikih, ki imajo povečano tveganje za hipoglikemijo, je morda potrebno razmisliti o zmanjšanju odmerka bazalnega insulina (glejte poglavje 4.8).
English: In female rats given exenatide for 2 years, an increased incidence of benign thyroid C-cell adenomas was observed at the highest dose, 250 mcg/kg/day, a dose that produced an exenatide plasma exposure 130-fold the human clinical exposure.
Slovenian: Pri samicah podgan, ki so dobivale eksenatid 2 leti, so opisovali večjo incidenco benignih ščitničnih adenomov C-celic pri največjem odmerku, 250 µg/kg/dan, odmerku eksenatida v plazmi, ki povzroči 130-kratno izpostavljenost humane klinične izpostavljenosti.
English: When immediate-release exenatide is added to sulphonylurea therapy, a reduction in the dose of sulphonylurea should be considered to reduce the risk of hypoglycaemia (see section 4.4.).
Slovenian: Kadar eksenatid v obliki s takojšnjim sproščanjem dodamo zdravljenju s sulfonilsečnino, moramo premisliti o zmanjšanju odmerka sulfonilsečnine za zmanjšanje tveganja za hipoglikemijo (glejte poglavje 4.4).
English: No adjustment to paracetamol dosing is required based on these study results.
Slovenian: Na osnovi rezultatov te študije, prilagoditev odmerjanja paracetamola ni potrebna.
English: In a 30-week, open-label, active comparator-controlled, noninferiority study, the safety and efficacy of immediate-release exenatide (n=315) versus titrated insulin lispro three times daily (n=312) on a background of optimized basal insulin glargine and metformin in patients with type 2 diabetes was evaluated.
Slovenian: V 30-tedenski odprti, s primerjalno zdravilno učinkovino kontrolirani študiji neinferiornosti so ocenjevali varnost in učinkovitost eksenatida v obliki s takojšnjim sproščanjem (n=315) v primerjavi s titriranim insulinom lispro trikrat na dan (n=312), uporabljenih poleg optimizirane sheme bazalnega insulina glargina in metformina pri bolnikih s sladkorno boleznijo tipa 2.
English: In three insulin-comparator controlled trials (n=790) comparable efficacy and adverse events were observed in immediate-release exenatide-treated patients regardless of antibody titre.
Slovenian: V treh z insulinom primerjalnih nadzorovanih preskušanjih (n=790) so opazili primerljivo učinkovitost in neželene učinke pri bolnikih zdravljenih z eksenatidom v obliki s takojšnjim sproščanjem ne glede na titer protiteles.
English: Throw away any Byetta pen that has been frozen.
Slovenian: Zavrzite vsak injekcijski peresnik Byetta, ki je bil zamrznjen.
English: • injection site reactions (redness)
Slovenian: • reakcije na mestu injiciranja (rdečina)
English: IMPORTANT INFORMATION ABOUT YOUR BYETTA PEN
Slovenian: POMEMBNE INFORMACIJE O VAŠEM INJEKCIJSKEM PERESNIKU BYETTA
English: Solution for injection 1 pen (60 doses) 3 pens (3 x 60 doses)
Slovenian: Raztopina za injiciranje 1 injekcijski peresnik (60 odmerkov) 3 injekcijski peresniki (3 x 60 odmerkov)
English: These medicinal products should be taken in a standardised way in relation to immediate-release exenatide injection.
Slovenian: Ta zdravila naj se jemljejo na standardni način glede injiciranja eksenatida v obliki s takojšnjim sproščanjem.
English: Byetta should be injected into your abdomen, thigh, or upper arm using the injection technique recommended by your healthcare professional.
Slovenian: Zdravilo Byetta morate injicirati v trebuh, stegno ali nadlaket z uporabo tehnike injiciranja, ki jo priporoča vaš zdravstveni delavec.
English: Administration of a combination oral contraceptive (30 mcg ethinyl estradiol plus 150 mcg levonorgestrel) one hour before immediate-release exenatide (10 mcg BID) did not alter the AUC, Cmax or Cmin of either ethinyl estradiol or levonorgestrel.
Slovenian: Dajanje kombinacije peroralnega kontraceptiva (30 μg etinilestradiola in 150 μg levonorgestrela) eno uro pred dajanjem eksenatida v obliki s takojšnjim sproščanjem (10 μg dvakrat na dan) ni spremenilo AUC, Cmax ali Cmin etinilestradiola ali levonorgestrela.
English: Doses higher than 10 mcg BID are not recommended.
Slovenian: Odmerkov, večjih od 10 μg dvakrat na dan, ne priporočamo.
English: Byetta is indicated for treatment of type 2 diabetes mellitus in combination with: - metformin - sulphonylureas - thiazolidinediones - metformin and a sulphonylurea - metformin and a thiazolidinedione in adults who have not achieved adequate glycaemic control on maximally tolerated doses of these oral therapies.
Slovenian: Zdravilo Byetta je indicirano za zdravljenje diabetesa mellitusa tipa 2 v kombinaciji z: -metforminom -sulfonilsečninami -tiazolidindioni -metforminom in sulfonilsečnino -metforminom in tiazolidindionom pri odraslih, ki niso dosegli zadostnega glikemičnega nadzora pri maksimalnih odmerkih teh peroralnih zdravil, ki jih bolniki še prenašajo.
English: Lower glucagon concentrations lead to decreased hepatic glucose output.
Slovenian: Nižje koncentracije glukagona vodijo v manjše sproščanje jetrne glukoze.
English: Hence, no restriction in timing of intake of these medicinal products in relation to immediate-release exenatide injection are needed.
Slovenian: Zato časovne omejitve jemanja teh zdravil glede na injiciranje eksenatida v obliki s takojšnjim sproščanjem niso potrebne.
English: The most frequent adverse reactions were mainly gastrointestinal related (nausea, vomiting and diarrhoea).
Slovenian: Najpogostejši neželeni učinki so bili večinoma povezani s prebavili (navzea, bruhanje in diareja).
English: • Pull off inner needle shield and throw away.
Slovenian: • Snemite notranjo zaščito igle in jo zavrzite.
English: In the clinical studies patients on a sulphonylurea combination, with mild renal impairment had an increased incidence of hypoglycaemia compared to patients with normal renal function.
Slovenian: V kliničnih študijah pri bolnikih z blago okvaro ledvic, ki so jemali kombinacijo s sulfonilsečnino, je bila incidenca hipoglikemije večja v primerjavi z bolniki z normalnim delovanjem ledvic.
English: Most episodes of hypoglycaemia were mild to moderate in intensity, and resolved with oral administration of carbohydrate.
Slovenian: Večina epizod hipoglikemije je bila po intenzivnosti blaga do zmerna in so jih odpravili s peroralnim dajanjem ogljikovih hidratov.
English: • The injection button was not pushed in all the way and a complete dose was not delivered.
Slovenian: • Gumba za injiciranje niste pritisnili do konca in niste prejeli celotnega odmerka.
English: Byetta 10 mcg: Each dose contains 88 mcg metacresol.
Slovenian: Byetta 10 μg: En odmerek vsebuje 88 μg metakrezola.
English: • Pen preparation is complete when the is in the centre of the dose window AND you have seen a stream or several drops come from the needle tip.
Slovenian: • Priprava injekcijskega peresnika je zaključena, ko je v sredini okenca za odmerjanje IN je iz konice igle izšel curek ali nekaj kapelj.
English: • The pen is now ready to reset.
Slovenian: • Injekcijski peresnik je sedaj pripravljen za ponovno nastavitev.
English: Immediate-release exenatide should be used with caution and dose escalation from 5 mcg to 10 mcg should proceed conservatively in patients > 70 years.
Slovenian: Eksenatid v obliki s takojšnjim sproščanjem moramo uporabljati previdno ter previdno višati odmerek od 5 μg do 10 μg pri bolnikih > 70 let.
English: Most episodes of nausea were mild to moderate and occurred in a dose-dependent fashion.
Slovenian: Večina epizod navzee so bile blage do zmerne in so se pojavljale v odvisnosti od odmerka.
English: keep out air bubbles, reduce needle clogs, and decrease the risk of infection.
Slovenian: To bo preprečilo iztekanje zdravila Byetta, nastanek zračnih mehurčkov, zmanjšalo zamaške v igli in zmanjšalo tveganje za infekcijo.
English: When immediate-release exenatide was used in combination with basal insulin therapy the incidence and types of other adverse events observed were similar to those seen in the controlled clinical trials with exenatide as monotherapy, with metformin and/or sulphonylurea or a thiazolidinedione, with or without metformin.
Slovenian: Ko se je eksenatid v obliki s takojšnjim sproščanjem uporabljalo v kombinaciji z bazalnim insulinom, sta bili pogostnost in vrste drugih neželenih učinkov podobni tistim, ki so jih opazili v nadzorovanih kliničnih preskušanjih pri monoterapiji z eksenatidom, z metforminom in/ali sulfonilsečnino ali tiazolidindionom, z ali brez metformina.
English: Immediate-release exenatide lowered HbA1c from 8.21 (n=228) and 8.6% (n=222) by 1.13 and 1.01% while insulin glargine lowered from 8.24 (n=227) by 1.10% and biphasic insulin aspart from 8.67 (n=224) by 0.86%.
Slovenian: Eksenatid v obliki s takojšnjim sproščanjem je zmanjšalo HbA1C z 8,21 (n=228) in 8,6 % (n=222) za 1,13 in 1,01 %, medtem, ko je insulin glargin zmanjšal z 8,24 (n=227) za 1,10 % in dvofazni insulin aspart z 8,67 (n=224) za 0,86 %.
English: How to use Byetta
Slovenian: Kako uporabljati zdravilo Byetta
English: All patients assigned to immediate-release exenatide initially received 5 mcg BID for four weeks.
Slovenian: Vsi bolniki, razvrščeni na zdravljenje z eksenatidom v obliki s takojšnjim sproščanjem, so sprva štiri tedne prejemali po 5 µg dvakrat na dan.
English: Anaphylactic reaction Metabolism and nutrition disorders Hypoglycaemia (with metformin and a sulphonylurea) Hypoglycaemia (with a sulphonylurea) Decreased appetite Dehydration, generally associated with nausea, vomiting and/or diarrhoea.
Slovenian: Anafilaktična reakcija Presnovne in prehranske motnje Hipoglikemija (z metforminom in sulfonilsečnino) Hipoglikemija (s sulfonilsečnino) Zmanjšan apetit Dehidracija, na splošno povezana z navzeo, bruhanjem in/ali diarejo Bolezni živčevja Glavobol
English: Do not use Byetta:
Slovenian: Ne uporabljajte zdravila Byetta
English: Byetta 5 mcg: Each dose contains 44 mcg metacresol.
Slovenian: Byetta 5 μg: En odmerek vsebuje 44 μg metakrezola.
English: • STOP taking this medicineand contact your doctor immediately if you experience severe and persistent stomach pain, with or without vomiting, because you could have an inflamed pancreas (pancreatitis).
Slovenian: • Če se vam pojavijo hude in dolgotrajne bolečine v trebuhu, z bruhanjem ali brez njega, PRENEHAJTE z jemanjem tega zdravila in takoj pokličite svojega zdravnika, kajti lahko imate vnetje trebušne slinavke (pankreatitis).
English: What Byetta looks like and contents of the pack
Slovenian: Izgled zdravila Byetta in vsebina pakiranja
English: In these studies the incidence of hypoglycaemia was similar for immediate-release exenatide and insulin treatment.
Slovenian: V teh študijah je bila incidenca hipoglikemije podobna za zdravljenje z eksenatidom v obliki s takojšnjim sproščanjem in insulinom.
English: Following a basal insulin optimization (BIO) phase, patients with HbA1c7.0% were randomized to add either immediate-release exenatide or insulin lispro to their existing regimen of insulin glargine and metformin.
Slovenian: Po fazi optimizacije bazalnega insulina (OBI) so bolnike s HbA1c > 7,0 % randomizirali ali na eksenatid v obliki s takojšnjim sproščanjem ali na insulin lispro, oba dodana obstoječemu zdravljenju z insulinom glarginom in metforminom.
English: Diabetic ketoacidosis has been reported in insulin-dependent patients after rapid discontinuation or dose reduction of insulin (see section 4.2)
Slovenian: Pri bolnikih, odvisnih od insulina, so po hitri ukinitvi ali zmanjšanju odmerka insulina poročali o diabetični ketoacidozi (glejte poglavje 4.2).
English: Type I glass cartridge with a (bromobutyl) rubber plunger, rubber disc, and aluminium seal.
Slovenian: Vložek iz stekla tipa I z (bromobutilnim) gumijastim batom, gumijasto opno in aluminijastim pokrovčkom.
English: Make sure that the 5 with the line under it is in the centre of the dose window.
Slovenian: Prepričajte se, da je podčrtana 5 na sredini okenca za odmerjanje.
English: There have been uncommon, spontaneously reported events of altered renal function, including increased serum creatinine, renal impairment, worsened chronic renal failure and acute renal failure, sometimes requiring hemodialysis.
Slovenian: Občasno so spontano poročali o primerih spremenjenega delovanja ledvic, vključno z zvišanjem kreatinina v serumu, okvaro ledvic, poslabšanjem kronične odpovedi ledvic in akutno odpovedjo ledvic, z občasno potrebo po hemodializi.
English: If you stop using Byetta
Slovenian: Če ste prenehali uporabljati zdravilo Byetta
English: Since immediate-release exenatide has been marketed, acute pancreatitis has been reported with a frequency not known and acute renal failure has been reported uncommonly (see section 4.4).
Slovenian: Po začetku trženja eksenatida v obliki s takojšnjim sproščanjem so poročali o akutnem pankreatitisu z neznano pogostnostjo in o akutni odpovedi ledvic z občasno pogostnostjo (glejte poglavje 4.4).
English: • White particles may appear on the outside tip of the cartridge during normal use.
Slovenian: • Med običajno uporabo se na zunanjem koncu vložka lahko pojavijo beli delci.
English: Note: If the needle is not secure, you may not get your full dose.
Slovenian: Opomba: Če igla ni dobro nameščena, se lahko zgodi, da ne dobite celotnega odmerka.
English: • Mark the date when you first used your pen and the date 30 days later in the spaces below:
Slovenian: • V poseben prostor spodaj vpišite datum vaše prve uporabe injekcijskega peresnika in datum po 30 dnevih:
English: • decreased in kidney function
Slovenian: • zmanjšano delovanje ledvic
English: Exenatide is not recommended for use in patients with end-stage renal disease or severe renal impairment (creatinine clearance < 30 ml/min) (see section 4.4).
Slovenian: Uporabe eksenatida ne priporočamo bolnikom s končno stopnjo bolezni ledvic ali hudo okvaro ledvic (očistek kreatinina < 30 ml/min) (glejte poglavje 4.4).
English: 6.1 List of excipients metacresol mannitol glacial acetic acid sodium acetate trihydrate water for injections
Slovenian: 6.1 Seznam pomožnih snovi metakrezol manitol koncentrirana ocetna kislina; ledocet natrijev acetat trihidrat voda za injekcije
English: STEP B Attach the Needle
Slovenian: KORAK B Pritrdite iglo
English: For placebo-treated or insulin-treated patients, < 1% withdrew due to nausea or vomiting.
Slovenian: < 1 % bolnikov, ki so dobivali placebo ali insulin, so zdravljenje prekinili zaradi navzee ali bruhanja.