FrancophonIA/ELRC3.0 huggingface dataset:
English: What you need to know before you use Bydureon
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Bydureon
English: Then choose a different injection site and finish taking the injection.
Slovenian: Nato izberite drugo mesto za injiciranje in dokončajte injiciranje.
English: When 1,000 mg paracetamol tablets were administered, either with or without a meal, following 14 weeks of prolonged-release exenatide therapy, no significant changes in paracetamol AUC were observed compared to the control period.
Slovenian: Ko so bolnikom po 14-tedenskem zdravljenju z eksenatidom v obliki s podaljšanim sproščanjem dali 1000 mg paracetamola, s hrano ali brez nje, niso opazili pomembnih sprememb v AUC v primerjavi s kontrolnim obdobjem.
English: International normalised ratio increased (see section
Slovenian: Preiskave zvišanje mednarodnega umerjenega razmerja (glejte poglavje 4.4)
English: Mean body weight (kg)
Slovenian: Povprečna telesna masa (kg)
English: If you do not inject Bydureon immediately, the medicine will start to form small clumps in the syringe.
Slovenian: Če zdravila Bydureon ne injicirate takoj, bodo v zdravilu začele nastajati grudice.
English: Each carton also contains one spare needle.
Slovenian: Vsaka škatla vsebuje tudi eno rezervno iglo.
English: Turn the knob from the Lock to the Unlock position until you hear a click.
Slovenian: Zasukajte gumb iz položaja "zaklenjeno" v položaj "odklenjeno", dokler ne zaslišite klika.
English: Be sure you are holding the pen at the end with the knob and the orange label.
Slovenian: Prepričajte se, da peresnik držite na koncu, na katerem sta gumb in oranžna nalepka.
English: Important information about some of the ingredients of Bydureon This medicine contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially “sodium-free”.
Slovenian: Pomembne informacije o nekaterih sestavinah zdravila Bydureon Zdravilo vsebuje manj kot 1 mmol natrija (23 mg) na odmerek, kar v bistvu pomeni “brez natrija”.
English: How do I know that the medicine is mixed well?
Slovenian: Kako vem, da je zdravilo dobro premešano?
English: For instructions on the preparation of the medicinal product before administration, see section 6.6 and the “Instructions for the User”.
Slovenian: Za navodila o pripravi zdravila pred dajanjem glejte poglavje 6.6 in “Navodila za uporabnika”.
English: If you have questions about taking Bydureon
Slovenian: Če imate vprašanje o jemanju zdravila Bydureon
English: Consistent with the potentially immunogenic properties of protein and peptide pharmaceuticals, patients may develop antibodies to exenatide following treatment with prolonged-release exenatide.
Slovenian: V skladu z morebitno imunogenimi lastnostmi beljakovinskih in peptidnih učinkovin, lahko bolniki po zdravljenju z eksenatidom v obliki s podaljšanim sproščanjem razvijejo protitelesa proti eksenatidu.
English: Therefore, no dose adjustments for medicinal products sensitive to delayed gastric emptying are required.
Slovenian: Zato ni potrebe po spreminjanju odmerka zdravil, ki so občutljiva na zakasnjeno praznjenje želodca.
English: In addition, hypoglycaemia with a sulphonylurea occurred very commonly (see Description of selected adverse reactions, below).
Slovenian: Poleg tega se je med uporabo s sulfonilsečninami zelo pogosto pojavila hipoglikemija (glejte Opis izbranih neželenih učinkov, spodaj).
English: In clinical studies of Bydureon BCise, acute pancreatitis occurred in 0.4% of patients.
Slovenian: V kliničnih študijah z zdravilom Bydureon BCise se je akutni pankreatitis pojavil pri 0,4 % bolnikov.
English: What should I do if the top of the plunger has been pushed past the black dashed Dose Line?
Slovenian: Kaj naj naredim, če je bil bat potisnjen preko črne odmerne črte?
English: It is normal to see a few drops of medicine inside the orange cap after you unscrew it.
Slovenian: Normalno je, da v oranžnem pokrovčku vidite nekaj kapljic zdravila, potem ko pokrovček odvijete.
English: Placebo + Insulin glargine
Slovenian: Placebo + insulin glargin
English: Prolonged-release exenatide should not be used during pregnancy and the use of insulin is recommended.
Slovenian: Med nosečnostjo se eksenatida v obliki s podaljšanim sproščanjem ne sme uporabljati in priporoča se uporaba insulina.
English: INSTRUCTIONS FOR THE USER Read these instructions carefully before use Read also the Package Leaflet in your carton
Slovenian: Pred uporabo natančno preberite ta navodila Preberite tudi navodilo za uporabo, priloženo v škatli
English: HR (active/placebo) and CI are based on Cox proportional hazards regression model, stratified by prior CV event, with treatment group only as explanatory variable.
Slovenian: Razmerje ogroženosti (učinkovina/placebo) in IZ temeljijo na Coxovem modelu sorazmernih ogroženosti, stratificiranem glede na predhoden SŽ dogodek in s terapevtsko skupino zgolj kot razlagalno spremenljivko.
English: While twisting, be sure to hold the orange connector.
Slovenian: Med privijanjem pazite, da držite oranžni povezovalec.
English: This is what the vial should now look like.
Slovenian: Tako naj bi sedaj izgledala viala.
English: Stomach
Slovenian: Trebuh
English: Most individual nodules did not interfere with study participation and resolved over time.
Slovenian: Večina nodulov ni vplivala na udeležbo v študiji in je sčasoma izzvenela.
English: You may see air bubbles.
Slovenian: Opazili boste zračne mehurčke.
English: The most frequently reported gastrointestinal adverse reaction was nausea.
Slovenian: Gastrointestinalni neželeni učinek, o katerem so najpogosteje poročali, je bila navzea.
English: You will need a puncture-resistant container that is large enough to hold the entire pen with a used needle attached.
Slovenian: Potrebovali boste vsebnik, odporen proti prebadanju, ki je dovolj velik, da drži celo pero z nameščeno uporabljeno iglo.
English: How do I know if I injected my full dose?
Slovenian: Kako naj vem, ali sem si injiciral celoten odmerek?
English: Patients who developed antibodies to exenatide tend to have more injection site reactions (for example: redness of skin and itching), but otherwise similar rates and types of adverse events as those with no antibodies to exenatide.
Slovenian: Pri bolnikih, ki so razvili protitelesa proti eksenatidu, se je pogosteje pojavila reakcija na mestu injiciranja (na primer rdečica na koži in srbenje), sicer pa so imeli podobne deleže in vrste neželenih učinkov kot tisti brez protiteles proti eksenatidu.
English: The suspension must be mixed by shaking hard for at least 15 seconds.
Slovenian: Suspenzijo je treba premešati, tako da se jo vsaj 15 sekund močno stresa.
English: • pain in the stomach area
Slovenian: • bolečina v predelu trebuha
English: During the controlled period of the clinical study comparing Bydureon BCise with immediate-release exenatide, nausea was reported in 9.6% and 20.5% of patients in each group.
Slovenian: Med kontroliranim obdobjem klinične študije, ki je primerjala zdravilo Bydureon BCise in eksenatid v obliki s takojšnim sproščanjem, so o navzei poročali pri 9,6 % bolnikov s prvim in pri 20,5 % bolnikov z drugim.
English: If the orange rod does not appear, contact the local representative of the Marketing Authorisation Holder (see section 6 of the Package Leaflet for a list of contacts by country).
Slovenian: Če se oranžna paličica ne pojavi, se obrnite na lokalnega predstavnika imetnika dovoljenja za promet z zdravilom (glejte poglavje 6 v navodilu za uporabo za seznam kontaktnih podatkov po državah).
English: When exenatide was used in combination with metformin and/or a thiazolidinedione, no increase in the incidence of hypoglycaemia was observed over that of placebo in combination with metformin and/or a thiazolidinedione which may be due to this glucose-dependent insulinotropic mechanism (see section
Slovenian: Ko so eksenatid uporabljali v kombinaciji z metforminom in/ali tiazolidindionom, niso opazili povečanja incidence hipoglikemije glede na placebo v kombinaciji z metforminom in/ali tiazolidindionom, kar je lahko zaradi tega od glukoze odvisnega insulinotropnega mehanizma (glejte poglavje 4.4).
English: B. While still holding the pen straight up, firmly unscrew the orange cap.
Slovenian: B. Medtem ko peresnik še vedno držite pokonci, odločno odvijte oranžni pokrovček.
English: After shaking the pen, look through both sides of the window.
Slovenian: Po pretresanju peresnika poglejte skozi obe strani okenca.
English: In 30-week placebo-controlled clinical studies with immediate-release exenatide, concomitant use of 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 kontroliranih kliničnih študijah sočasna uporaba eksenatida v obliki s takojšnim sproščanjem in zaviralcev HMG CoA reduktaze ni bila povezana s stalnimi spremembami lipidnega profila (glejte poglavje 5.1).
English: In patients treated with prolonged-release exenatide, generally 20% reported at least one episode of nausea compared to 34% of immediate-release exenatide patients.
Slovenian: Pri bolnikih, zdravljenih z eksenatidom v obliki s podaljšanim sproščanjem, so na splošno v 20 % poročali o najmanj eni epizodi navzee v primerjavi s 34 % pri zdravljenju z eksenatidom v obliki s takojšnim sproščanjem.
English: If you forget to use Bydureon You might like to choose a day that you always plan to make your Bydureon injection.
Slovenian: Če ste pozabili uporabiti zdravilo Bydureon Lahko si izberete dan, na katerega si boste dali vaše zdravilo Bydureon.
English: White to off-white opaque suspension.
Slovenian: bela do skoraj bela motna suspenzija
English: Overall, the level of glycaemic control (HbA1c) was comparable to that observed in those without antibody titres.
Slovenian: Celostno je bil nivo glikemične kontrole (HbA1c) primerljiv s tistim, ki so ga opazili pri bolnikih brez titra protiteles.
English: Plasma/serum glucose
Slovenian: Glukoza v plazmi/serumu
English: The tapping helps the medicine drip down along the sides of the vial.
Slovenian: Trkanje na vialo pomaga zdravilu steči dol ob steni viale.
English: System organ class /adverse reaction terms
Slovenian: Organski sistem /poimenovanje neželenih učinkov
English: - If you have severe kidney disease or you are on dialysis, as the use of this medicine is not recommended.
Slovenian: - Če imate hudo bolezen ledvic ali ste na dializi, ker uporaba tega zdravila v tem primeru ni priporočljiva.
English: Patients and caregivers should be trained by their healthcare professional.
Slovenian: Zdravstveni delavci morajo ustrezno poučiti bolnike in negovalce.
English: The most frequent adverse reactions during the clinical studies were gastrointestinal-related (mainly nausea (8 %), which tended to dissipate with continued treatment), headache (4 %) and injection site reactions, such as injection site pruritus (3 %) and injection site erythema (2 %).
Slovenian: Najpogostejši neželeni učinki v kliničnih študijah so bili povezani s prebavili (v glavnem navzea (8 %), ki je med nadaljevanjem zdravljenja praviloma izzvenela), glavobol (4 %) in reakcije na mestu injiciranja, na primer srbenje na mestu injiciranja (3 %) ter eritem na mestu injiciranja (2 %).
English: DO NOT proceed unless your medicine is mixed well
Slovenian: NE NADALJUJTE, dokler ni zdravilo dobro premešano
English: C. Disposal.
Slovenian: C. Odstranjevanje
English: If you do see any dry powder, shake vigorously while continuing to push down on the plunger with your thumb.
Slovenian: Če vidite suh prašek, močno stresite in sočasno s palcem pritiskajte na bat.
English: Across 12 studies of prolonged-release exenatide most episodes (99.9% n = 649) of hypoglycaemia were minor, and resolved with oral administration of carbohydrate.
Slovenian: V 12 študijah z eksenatidom v obliki s podaljšanim sproščanjem je bila večina epizod hipoglikemij (99,9, n = 649) blaga in rešena z dajanjem peroralnih ogljikovih hidratov.
English: It should be clear and free of particles.
Slovenian: Biti mora bistra in brez delcev.
English: Concomitant medicinal products included angiotensin converting enzymes inhibitors, angiotensin-II antagonists, non-steroidal anti-inflammatory medicinal products and diuretics.
Slovenian: Sočasno uporabljena zdravila so vključevala zaviralce angiotenzinske konvertaze, antagoniste angiotenzina II, nesteroidna protivnetna zdravila in diuretike.
English: Data in elderly are limited, but suggest no marked changes in exenatide exposure with increased age up to about 75 years old.
Slovenian: Podatkov o uporabi pri starejših je malo, vendar pa s staranjem vse do približno 75. leta ne kažejo izrazitih sprememb v izpostavljenosti eksenatidu.
English: Hold the needle against your skin for 15 seconds.
Slovenian: Držite iglo v koži 15 sekund.
English: − if you are using insulin, your doctor will tell you how to reduce the dose of insulin and will recommend that you monitor your blood sugar more frequently, in order to avoid hyperglycaemia (high blood sugar) and diabetic ketoacidosis (a complication of diabetes that occurs when the body is unable to break down glucose because there is not enough insulin).
Slovenian: - če uporabljate insulin; zdravnik vam bo povedal, kako zmanjšate odmerek insulina, ter vam priporočil pogostejše spremljanje sladkorja v krvi, da preprečite pojav hiperglikemije (visoka raven sladkorja v krvi) in diabetične ketoacidoze (zaplet pri sladkorni bolezni, ki nastopi, ko telo zaradi pomanjkanja insulina ni sposobno razgraditi glukoze).
English: What should I do if I have trouble attaching the needle?
Slovenian: Kaj naj naredim, če imam problem s pritrjevanjem igle?
English: − Is a single use, fixed dose pen that automatically injects your medicine.
Slovenian: − je peresnik za enkratno uporabo s fiksnim odmerkom, ki samodejno injicira zdravilo.
English: If you see white medicine, it is unmixed.
Slovenian: Če vidite belo zdravilo, suspenzija ni premešana.
English: The follow-up and extension phases of studies are included in the pool.
Slovenian: Vključeni so podatki faze spremljanja in faze podaljšanja študij.
English: 1 single-dose kit contains:
Slovenian: 1 enoodmerni set vsebuje:
English: CLICK!
Slovenian: KLIK!
English: The green shield hides the needle.
Slovenian: Zeleni ščitnik prekrije iglo.
English: Number at Risk
Slovenian: Število izpostavljenih tveganju
English: What should I do if I see air bubbles in the pen?
Slovenian: Kaj naj naredim, če v peresniku vidim mehurčke zraka?
English: Paracetamol Cmax decreased by 16% (fasting) and 5% (fed) and tmax was increased from approximately 1 hour in the control period to 1.4 hours (fasting) and 1.3 hours (fed).
Slovenian: Cmax paracetamola se je zmanjšal za 16 % (na tešče) in 5 % (po jedi) in tmax se je podaljšal iz približno 1 ure v kontrolnem obdobju na 1,4 ure (na tešče) in 1,3 ure (po jedi).
English: Hold the pen up to the light and look through both sides and the bottom of the window.
Slovenian: Peresnik držite pokonci proti svetlobi in poglejte skozi obe strani in dno okenca.
English: In both studies, decreases in HbA1c were evident in both treatment groups as early as the first post-treatment HbA1c measurement (Weeks 4 or
Slovenian: V obeh študijah je prišlo do znižanja HbA1c pri obeh skupinah že pri prvem merjenju HbA1c po začetku zdravljenja (4. in 6. teden).
English: Prolonged-release exenatide has not been studied in patients with severe gastrointestinal disease, including gastroparesis.
Slovenian: Uporabe eksenatida v obliki podaljšanim sproščanjem pri bolnikih s hudo boleznijo prebavil, vključno z gastroparezo, niso preučevali.
English: What should I do if I have trouble removing the needle cover?
Slovenian: Kaj naj naredim, če imam probleme z odstranjevanjem pokrovčka za iglo?
English: 1 pre-filled syringe of 0.65 ml solvent 1 vial connector
Slovenian: 1 predhodno napolnjeno injekcijsko brizgo z 0,65 ml vehikla 1 povezovalec viale
English: Approximately 42% of patients developed low titre antibodies to exenatide and 32% of patients developed high titre antibodies at any time during the studies.
Slovenian: Pri približno 42 % bolnikov so se pojavili nizki titri protiteles proti eksenatidu, visoki titri pa so se pojavili pri 32 % bolnikov, kadar koli med študijami.
English: This incidence was increased when it was used in combination with a sulphonylurea (26.1 %) compared to no sulphonylurea (0.9%) (see section 4.4).
Slovenian: Incidenca je bila večja, če je bilo zdravilo uporabljeno v kombinaciji s sulfonilsečnino (26,1 %), kot če je bilo uporabljeno brez sulfonilsečnine (0,9 %) (glejte poglavje 4.4).
English: There should not be any dry powder on the sides or bottom of the vial.
Slovenian: Na steni ali dnu viale ne sme biti suhega praška.
English: If you still cannot push the button all the way in, remove the needle from your skin.
Slovenian: Če gumba še vedno ne morete potisniti do konca noter, potegnite iglo iz kože.
English: The most frequent adverse reactions were mainly gastrointestinal related (nausea which was the most frequent reaction and associated with the initiation of treatment and decreased over time, and diarrhoea).
Slovenian: Najpogostejši neželeni učinki so bili večinoma povezani s prebavili (navzea, ki je bila najpogostejši učinek, povezana je bila s pričetkom zdravljenja in se je sčasoma zmanjšala, ter driska).
English: Only unlock the pen when you are ready to inject.
Slovenian: Peresnik odklenite, šele ko ste pripravljeni za injiciranje.
English: The single-dose kit has a spare needle (not shown) in case you need it.
Slovenian: Enoodmerni set vsebuje dodatno iglo (ni na sliki), v kolikor bi jo potrebovali.
English: These reactions were less commonly observed in antibody-negative patients (4%) compared with antibody-positive patients (13%), with a greater incidence in those with higher titre antibodies.
Slovenian: Te reakcije so bile manj pogoste pri bolnikih brez titrov protiteles (4 %) v primerjavi z bolniki s prisotnimi protitelesi (13 %), z večjo incidenco pri tistih z višjim titrom protiteles.
English: Your doctor or diabetes nurse should teach you how to inject this medicine before you use it for the first time.
Slovenian: Zdravnik ali medicinska sestra v diabetološki ambulanti vas mora pred prvo uporabo podučiti o tem, kako si injicirati to zdravilo.
English: These reactions were less commonly observed in antibody-negative patients (16%) and patients with low titre antibodies (16%) compared with those with high titre antibodies (27%).
Slovenian: Te reakcije so redkeje opažali pri bolnikih, ki so bili negativni za protitelesa (16 %), in bolnikih z nizkimi titri protiteles (16 %) kot pri bolnikih z visokimi titri protiteles (27 %).
English: Be sure to choose a different injection site in that area.
Slovenian: Pazite, da v tem delu izberete različno mesto injiciranja.
English: Prolonged-release exenatide in combination with basal insulin showed no clinically significant differences in the incidence of hypoglycaemic episodes compared to insulin.
Slovenian: Eksenatid v obliki s podaljšanim sproščanjem v kombinaciji z bazalnim insulinom ni pokazal klinično pomembnih razlik v pojavnosti hipoglikemij v primerjavi z insulinom.
English: A little bit of liquid may cling to the sides of the vial.
Slovenian: Nekaj tekočine bo lahko ostalo na steni viale.
English: • changes in INR (measurement of blood thinning) have been reported when used together with warfarin
Slovenian: • spremembe vrednosti INR (merilo za gostoto krvi) ob sočasni uporabi z varfarinom,
English: Prolonged-release exenatide did not increase the cardiovascular risk in patients with type 2 diabetes mellitus compared to placebo when added to current usual care (HR:0.91; 95% CI: 0.832, 1.004; P<0.001 for non-inferiority) see Figure1.
Slovenian: Eksenatid s podaljšanim sproščanjem pri bolnikih s sladkorno boleznijo tipa 2 v primerjavi s placebom ni povečal srčno-žilnega tveganja, če je bil dodan trenutnemu običajnemu zdravljenju (ROg: 0,91, 95 % IZ: 0,832; 1,004, p < 0,001 za neinferiornost); glejte sliko 1.
English: If you do not inject your dose right away, small clumps of medicine may form in the pen and you may not get your full dose.
Slovenian: Če odmerka ne injicirate takoj, lahko v peresniku nastanejo majhne grudice zdravila in tako ne dobite celotnega odmerka.
English: The suspension should be visually inspected prior to use.
Slovenian: Pred uporabo je treba suspenzijo pregledati.
English: Throw away any Bydureon kit that has been frozen.
Slovenian: Zavrzite vsak set zdravila Bydureon, ki je bil zamrznjen.
English: Exenatide is a glucagon-like peptide-1 (GLP-1) receptor agonist that exhibits several antihyperglycaemic actions of glucagon-like peptide-1 (GLP-1).
Slovenian: Eksenatid je agonist na receptorju za glukagonu podobnem peptidu-1 (GLP-1), ki kaže nekaj antihiperglikemičnih učinkov glukagonu podobnega peptida-1 (GLP-1).
English: The suspension should only be used if it is evenly mixed, white to off-white and cloudy, with no white medicine seen along the side, bottom or top of the pen window.
Slovenian: Suspenzijo se sme uporabiti, le če je enakomerno premešana, bela do skoraj bela in motna ter ni belega zdravila videti nikjer ob strani, na dnu ali na vrhu okenca peresnika.
English: You should not see any clumps in the liquid.
Slovenian: V tekočini ne smete videti nobenih grudic.
English: Wash your hands while the pen is warming up.
Slovenian: Medtem ko se peresnik ogreva, si umijte roke.
English: • Talk with your doctor, pharmacist or diabetes nurse • Read the Package Leaflet carefully
Slovenian: • Pogovorite se z zdravnikom ali medicinsko sestro v diabetološki ambulanti • Previdno preberite Navodilo za uporabo
English: For both prolonged-release exenatide formulations, the improvement in fasting plasma glucose concentrations was sustained through 52 weeks.
Slovenian: Za obe formulaciji eksenatida v obliki s podaljšanim sproščanje je izboljšanje v koncentraciji glukoze v plazmi na tešče trajalo vseh 52 tednov.
English: Bydureon is injected into your skin (subcutaneously).
Slovenian: Zdravilo Bydureon se injicira v kožo (subkutano).
English: If you stop using Bydureon
Slovenian: Če ste prenehali uporabljati zdravilo Bydureon
English: • Push the pen against your skin.
Slovenian: • pritisnite peresnik na kožo.
English: The incidence of hypoglycaemia was increased when prolonged-release exenatide was used in combination with a sulphonylurea (24.0% versus 5.4%) (see section 4.4).
Slovenian: Incidenca hipoglikemije je bila zvišana ob uporabi eksenatida v obliki s podaljšanim sproščanjem v kombinaciji s sulfonilsečnino (24,0 % proti 5,4 %) (glejte poglavje 4.4).
English: Green shield pops up
Slovenian: Zeleni ščitnik izskoči navzgor
English: A pharmacodynamic study with exenatide demonstrated in patients with type 2 diabetes (n = 13) a restoration of first phase insulin secretion and improved second phase insulin secretion in response to an intravenous bolus of glucose.
Slovenian: Farmakodinamične študije eksenatida so pokazale, da se pri bolnikih z diabetesom tipa 2 (n = 13) popravi prva faza izločanja insulina in izboljša druga faza izločanja insulina v odzivu na bolus injekcije glukoze.
English: What Bydureon is and what it is used for What you need to know before you use Bydureon How to use Bydureon
Slovenian: Kaj je zdravilo Bydureon in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Bydureon Kako uporabljati zdravilo Bydureon Možni neželeni učinki
English: After removing the needle, look for the orange rod in the window as a way to tell that the dose has been given.
Slovenian: Potem ko iglo odmaknete, preverite, ali je v okencu oranžna paličica; to vam pove, da je bil odmerek dan.
English: While holding the pen upright with the needle cover uppermost, twist the knob anticlockwise until the orange label disappears and the injection button is released.
Slovenian: Medtem ko držite peresnik pokonci s pokrovčkom igle, obrnjenim navzgor, obračajte gumb v nasprotni smeri urinega kazalca, dokler oranžna nalepka ne izgine in se sprosti gumb za injiciranje.
English: BCise is the name of the pre-filled pen device used to inject your Bydureon medicine.
Slovenian: BCise se imenuje napolnjen injekcijski peresnik, s katerim si injicirate vaše zdravilo Bydureon.