FrancophonIA/ELRC3.0 huggingface dataset:
English: The powder in one chamber must be mixed with the solvent in the other chamber of the pre-filled pen.
Slovenian: Prašek v enem prekatu je potrebno zmešati z vehiklom v drugem prekatu napolnjenega injekcijskega peresnika.
English: Hold the pen up straight with the orange cap toward the ceiling.
Slovenian: Držite peresnik pokonci in obrnjen tako, da oranžni pokrovček gleda proti stropu.
English: 1 vial of 2 mg exenatide
Slovenian: 1 vialo z 2 mg eksenatida
English: Lift the vial with the orange connector now attached out of its package.
Slovenian: Dvignite vialo - oranžni povezovalec bo sedaj odstranjen iz ovojnine.
English: Clinical experience in patients with moderate renal impairment (creatinine clearance 30 to 50 ml/min) is limited.
Slovenian: Kliničnih izkušenj pri bolnikih z zmerno okvaro ledvic (očistek kreatinina 30 do 50 ml/min) je malo.
English: Fasting lipids Prolonged-release exenatide has shown no negative effects on lipid parameters.
Slovenian: Za eksenatid v obliki s podaljšanim sproščanjem niso ugotovili nobenega neugodnega učinka na parametre lipidov.
English: For subcutaneous use only
Slovenian: Samo za subkutano uporabo
English: The absorption properties of exenatide reflect the extended release properties of the prolonged-release exenatide formulation.
Slovenian: Absorpcijske lastnosti eksenatida odražajo podaljšano sproščanje eksenatida v obliki s podaljšanim sproščanjem.
English: When this medicine is used with a medicine that contains a sulphonylurea, episodes of low blood sugar (hypoglycaemia, generally mild to moderate) can occur.
Slovenian: Pri uporabi tega zdravila sočasno z zdravilom, ki vsebuje sulfonilsečnino, lahko pride do epizod nizkega sladkorja v krvi (hipoglikemije, na splošno blage do zmerno hude).
English: Pre-filled pen is for single-use only.
Slovenian: Napolnjen injekcijski peresnik je le za enkratno uporabo.
English: Patients on pioglitazone gained weight (Table 4).
Slovenian: Bolniki na pioglitazonu so pridobili na telesni masi (Preglednica 4).
English: The dose of your sulphonylurea medicine may need to be reduced while you use this medicine.
Slovenian: Med vašo uporabo tega zdravila boste morda morali znižati odmerek vašega zdravila s sulfonilsečnino.
English: • hypoglycaemia (low blood sugar) when this medicine is used with a medicine that does not contain a sulphonylurea
Slovenian: • hipoglikemija (nizek krvni sladkor) v primeru uporabe z zdravilom, ki ne vsebuje sulfonilsečnine
English: Powder poly (D,L-lactide-co-glycolide) sucrose
Slovenian: Prašek poli (D,L-laktid koglikolid) saharoza
English: However, as renal function generally declines with age, consideration should be given to the patient's renal function (see Renal impairment) (see section 5.2).
Slovenian: Ker pa se delovanje ledvic z leti slabša, je pozornost potrebno posvetiti bolnikovemu delovanju ledvic (glejte Okvara ledvic) (glejte poglavje 5.2).
English: Hold the syringe near the black dashed Dose Line.
Slovenian: Injekcijsko brizgo držite blizu črne odmerne črte.
English: There have been spontaneously reported events of acute pancreatitis with prolonged-release exenatide.
Slovenian: Obstajajo tudi spontana poročila o primerih akutnega pankreatitisa pri uporabi eksenatida v obliki s podaljšanim sproščanjem.
English: You may see a few drops of liquid on the needle or in the cover.
Slovenian: Na igli ali na pokrovčku lahko opazite nekaj kapljic tekočine.
English: Its use is commonly associated with gastrointestinal adverse reactions, including nausea, vomiting, and diarrhoea.
Slovenian: Uporabo zdravila pogosto povezujejo z neželenimi učinki na prebavila, vključno z navzeo, bruhanjem in drisko.
English: In interaction studies of the effect of immediate-release exenatide on digoxin and lisinopril there were no clinical relevant effects on Cmax or AUC, however, a delay in tmax of about 2 h was observed.
Slovenian: V študijah medsebojnega delovanja učinka eksenatida v obliki s takojšnim sproščanjem na digoksin in lizinopril niso ugotovili nobenih klinično pomembnih učinkov na Cmax ali AUC.
English: Rate based on twelve prolonged-release exenatide completed long-term efficacy and safety studies n = 2868 total.
Slovenian: Pogostnost na podlagi dvanajstih dokončanih dolgoročnih študij učinkovitosti in varnosti eksenatida v obliki s podaljšanim sproščanjem, n skupaj = 2868.
English: Hold Upright
Slovenian: Ne zamrzujte.
English: Clinically and statistically significantly more subjects on prolonged-release compared to immediate-release exenatide patients achieved an HbA1c reduction of ≤ 7 % or < 7 % in the two studies (p <0.05 and p ≤0.0001, respectively).
Slovenian: Klinično in statistično značilno več oseb, ki so se zdravile z eksenatidom v obliki s podaljšanim sproščanjem, je v primerjavi z eksenatidom v obliki s takojšnim sproščanjem doseglo znižanje HbA1c ≤ 7 % ali < 7 % v obeh študijah (p < 0,05 in p ≤ 0,0001).
English: §nominal p-value <0.001.
Slovenian: §nominalni p < 0,001.
English: Pull the plunger down beyond the black dashed Dose Line.
Slovenian: Bat povlecite navzdol preko s črno označene odmerne črte.
English: • Refer to the Common questions and answers
Slovenian: • glejte Pogosta vprašanja in odgovori
English: Fasting lipids The prolonged-release exenatide formulations have shown no negative effects on lipid parameters.
Slovenian: Za eksenatid v oblikah s podaljšanim sproščanjem niso ugotovili nobenega neugodnega učinka na parametre lipidov.
English: Step 3: Inject your dose
Slovenian: 3. korak: Injicirajte odmerek
English: • hypoglycaemia (low blood sugar) when taken with a medicine that contains a sulphonylurea.
Slovenian: • hipoglikemija (nizek krvni sladkor) v primeru uporabe z zdravilom, ki vsebuje sulfonilsečnino.
English: For all patients completing the uncontrolled study extension of 7 years (n = 122 of 258 patients included in the extension phase), HbA1c gradually increased over time from Week 52 onwards, but was still reduced compared to baseline after 7 years (-1.5%).
Slovenian: Pri vseh bolnikih, ki so zaključili 7-letno nekontrolirano podaljšano študijo (n = 122 od 258 bolnikov, ki so bili vključeni v podaljšano fazo), se je HbA1c skozi obdobje od 52. tedna naprej postopno povečeval, toda po 7 letih je bil še vedno znižan v primerjavi z izhodiščem (-1,5 %).
English: Unless a trained person can help to inject this medicine it is not recommended for people who are blind or cannot see well.
Slovenian: To zdravilo ni priporočljivo za slepe in slabovidne osebe, če nimajo na voljo usposobljene osebe za pomoč pri injiciranju.
English: To reduce the risk of hypoglycaemia associated with the use of a sulphonylurea, reduction in the dose of sulphonylurea may be considered (see sections 4.2 and 4.4).
Slovenian: Da se izognemo tveganju za hipoglikemijo, povezano z uporabo sulfonilsečnine, je potrebno razmisliti o zmanjšanju odmerka sulfonilsečnine (glejte poglavji 4.2 in 4.4).
English: Multi-pack of 3 x (4 single dose kits).
Slovenian: Veliko pakiranje 3 x (4 enoodmerni seti).
English: B. Twist knob to release injection button.
Slovenian: B. Zasukajte gumb, da boste sprostili gumb za injiciranje.
English: Keep pushing on the plunger with your thumb until it stops, and hold it in place.
Slovenian: Nadaljujte s pritiskanjem palca na bat, dokler se ne ustavi, ter ga nato držite.
English: Exenatide slows gastric emptying, thereby reducing the rate at which meal-derived glucose appears in the circulation.
Slovenian: Eksenatid upočasni praznjenje želodca, s čimer zmanjša hitrost, s katero se glukoza iz obroka pojavi v krvnem obtoku.
English: The concurrent use of prolonged-release exenatide with D-phenylalanine derivatives (meglitinides), alpha-glucosidase inhibitors, dipeptidyl peptidase-4 inhibitors or other GLP-1 receptor agonists has not been studied.
Slovenian: Sočasne uporabe eksenatida v obliki s podaljšanim sproščanjem z derivati D-fenilalanina (meglitinidi), zaviralci alfa-glukozidaze, zaviralci dipeptil peptidaze-4 ali drugih zaviralcev receptorjev GLP-1 niso preučevali.
English: In clinical studies of prolonged-release exenatide, approximately 45% of patients had low titre antibodies to exenatide at study endpoint.
Slovenian: Na koncu kliničnih študij z eksenatidom v obliki s podaljšanim sproščanjem je imelo približno 45 % bolnikov nizke titre protiteles proti eksenatidu.
English: The results of long-term clinical studies of prolonged-release exenatide are presented below; these studies comprised 1356 subjects treated with prolonged-release exenatide, 52% men and 48% women; 230 subjects (17%) were ≥ 65 years of age.
Slovenian: Te študije so vključevale 1356 oseb zdravljenih z eksenatidom v obliki s podaljšanim sproščanjem, 52 % moških in 48 % žensk; 230 oseb (17 %) je bilo starih ≥ 65 let.
English: Insert the needle into your skin (subcutaneously).
Slovenian: Zabodite iglo v kožo (subkutano).
English: • injection site reactions
Slovenian: • reakcije na mestu injiciranja
English: In a 28-week double-blind study, prolonged-release exenatide added to insulin glargine alone or with metformin was compared to placebo added to insulin glargine alone or with metformin.
Slovenian: V 28-tedenski dvojno slepi študiji so eksenatid v obliki s podaljšanim sproščanjem, dodan insulinu glarginu samemu ali skupaj z metforminom, primerjali s placebom, dodanem insulinu glarginu samemu ali skupaj z metforminom.
English: Remove the needle and replace it with the spare needle from your kit.
Slovenian: Odstranite iglo in jo zamenjajte z dodatno iglo, ki jo imate v setu.
English: INR should be monitored during initiation of prolonged-release exenatide therapy in patients on warfarin and/or cumarol derivatives (see sections 4.4 and 4.8).
Slovenian: Pri bolnikih, ki jemljejo varfarin in/ali derivate kumarola je med uvajanjem zdravljenja eksenatida v obliki s podaljšanim sproščanjem potrebno spremljati vrednosti INR (glejte poglavji 4.4 in 4.8).
English: Remember: You must take your injection of Bydureon immediately after mixing it.
Slovenian: Zapomnite si: Injekcijo Bydureon morate uporabiti takoj po mešanju.
English: The concurrent use of prolonged-release exenatide formulations with D-phenylalanine derivatives (meglitinides), alpha-glucosidase inhibitors, dipeptidyl peptidase-4 inhibitors or other GLP-1 receptor agonists has not been studied.
Slovenian: Sočasne uporabe eksenatida v oblikah s podaljšanim sproščanjem z derivati D-fenilalanina (meglitinidi), zaviralci alfa-glukozidaze, zaviralci dipeptil peptidaze-4 ali drugih zaviralcev receptorjev GLP-1 niso preučevali.
English: Each single-dose kit consists of one vial containing 2 mg exenatide powder, one pre-filled syringe containing 0.65 ml solvent, one vial connector, and two injection needles.
Slovenian: Vsak enoodmerni set vsebuje eno vialo z 2 mg praška eksenatida, eno napolnjeno injekcijsko brizgo z 0,65 ml vehikla, en povezovalec viale in dve injekcijski igli.
English: Frequency reported from the 28-week controlled treatment period of the prolonged-release exenatide as add-on to insulin glargine study (N=231).
Slovenian: Pogostnost, zabeležena med 28-tedenskim kontroliranim obdobjem zdravljenja v študiji eksenatida v obliki s podaljšanim sproščanjem kot dodatka insulinu glarginu (N = 231).
English: • does not leak,
Slovenian: • ne pušča,
English: In a 2-year rat carcinogenicity study with prolonged-release exenatide, an increased incidence of C-cell adenomas and C-cell carcinomas was observed at doses ≥ 2-fold the human systemic exposure based on AUC.
Slovenian: V 2-letni študiji karcinogenosti eksenatida v obliki s podaljšanim sproščanjem pri podganah so ob odmerkih, ki so bili na podlagi AUC ≥ 2-kratnik sistemske izpostavljenosti pri človeku, opažali večjo pojavnost adenomov celic C in karcinomov celic C. Klinični pomen teh ugotovitev trenutno ni znan.
English: Striped Label
Slovenian: Črtasta nalepka
English: Each single-dose kit contains one vial of 2 mg exenatide, one pre-filled syringe of 0.65 ml solvent, one vial connector, and two injection needles (one spare).
Slovenian: Vsak enoodmerni set vsebuje eno vialo z 2 mg eksenatida za suspenzijo za injiciranje, eno predhodno napolnjeno injekcijsko brizgo z 0,65 ml vehikla za injiciranje, en povezovalnik viale in dve injekcijski igli (ena dodatna).
English: Additional reductions in postprandial concentrations were also observed.
Slovenian: Opazili so tudi nadaljnje znižanje v koncentraciji glukoze po jedi.
English: Compared with insulin glargine treatment, prolonged-release exenatide demonstrated a superior change in HbA1c, significantly lowered mean body weight and was associated with fewer hypoglycaemic events (Table 5).
Slovenian: V primerjavi z insulinom glarginom je zdravljenje z eksenatidom v obliki s podaljšanim sproščanjem pokazalo večjo spremembo v HbA1c, značilno znižalo srednjo vrednost telesne mase in je bilo povezano z redkejšimi hipoglikemičnimi dogodki (Preglednica 5).
English: To be sure you get your full dose, press and hold the pen against your skin.
Slovenian: Da boste prepričani, da ste dobili celoten odmerek, peresnik pritisnite ob kožo in ga držite pritisnjenega obnjo.
English: Prolonged-release exenatide should not be used during breast-feeding.
Slovenian: Eksenatida v obliki s podaljšanim sproščanjem med dojenjem ne smemo uporabljati.
English: Withdrawal due to nausea or vomiting each occurred in < 1% for prolonged-release exenatide treated patients and 1% for immediate-release exenatide treated patients.
Slovenian: Prekinitev zaradi navzee ali bruhanja je bila pri bolnikih, ki so se zdravili z eksenatidom v obliki s podaljšanim sproščanjem, < 1 %, in pri bolnikih, ki so se zdravili z eksenatidom v obliki s takojšnim sproščanjem,
English: After suspension The suspension must be injected immediately after mixing the powder and the solvent.
Slovenian: Po suspendiranju Suspenzija mora biti injicirana nemudoma po mešanju praška in vehikla.
English: A clinically relevant effect of prolonged-release exenatide and immediate-release exenatide treated subjects was observed on HbA1c, regardless of the background anti-diabetic therapy in both studies.
Slovenian: Klinično pomemben učinek na HbA1c je bil opažen pri bolnikih, ki so se zdravili z eksenatidom v obliki s podaljšanim sproščanjem ali eksenatidom v obliki s takojšnim sproščanjem, neodvisno od osnovnega antidiabetičnega zdravljenja, v obeh študijah.
English: How to use Bydureon
Slovenian: Kako uporabljati zdravilo Bydureon
English: The expiration date is labelled EXP.
Slovenian: Datum izteka roka uporabnosti je označen z
English: Remove one pen from the refrigerator and let it stand at room temperature for at least 15 minutes.
Slovenian: Vzemite en peresnik iz hladilnika in ga vsaj 15 minut pustite na sobni temperaturi.
English: Slowly push
Slovenian: Pritisnite počasi
English: *p-value < 0.01.
Slovenian: *Vrednost p < 0,01.
English: The frequency of adverse reactions of prolonged-release exenatide identified from clinical studies and spontaneous reports (not observed in clinical studies, frequency not known) are summarised in Table 1 below.
Slovenian: Preglednica 1, spodaj, povzema pogostnost neželenih učinkov eksenatida v obliki s podaljšanim sproščanjem, ugotovljenih v kliničnih študijah in na podlagi spontanih poročil (neopaženi v kliničnih študijah, neznana pogostnost).
English: You should use contraception if you could potentially become pregnant during treatment with this medicine.
Slovenian: Če obstaja kakršna koli možnost, da bi med zdravljenjem s tem zdravilom zanosili, morate uporabljati kontracepcijo.
English: The finished medicinal product is comprised of the suspension-filled cartridge assembled into the pen device.
Slovenian: Dokončano zdravilo obsega s suspenzijo napolnjen vložek, vstavljen v peresnik.
English: Compared with insulin glargine treatment, prolonged-release exenatide demonstrated a superior change in HbA1c, significantly lowered mean body weight and was associated with fewer hypoglycaemic events (Table 3).
Slovenian: V primerjavi z insulinom glarginom je zdravljenje z eksenatidom v obliki s podaljšanim sproščanjem pokazalo večjo spremembo v HbA1c, značilno znižalo srednjo vrednost telesne mase in je bilo povezano z redkejšimi hipoglikemičnimi dogodki (Preglednica 3).
English: In the placebo-controlled study with insulin glargine, the change from baseline to Week 28 in fasting plasma glucose was -0.7 mmol/l for the prolonged-release exenatide group and -0.1 mmol/l for the placebo group.
Slovenian: V študiji z insulinom glarginom, kontrolirani s placebom, je bila sprememba koncentracije glukoze v plazmi na tešče od izhodišča do 28. tedna v skupini z eksenatidom v obliki s podaljšanim sproščanjem -0,7 mmol/l in v skupini s placebom -0,1 mmol/l.
English: In the placebo-controlled study with insulin glargine, the change from baseline to Week 28 in systolic blood pressure was -2.6 mmHg for the prolonged-release exenatide group and -0.7 mmHg for the placebo group.
Slovenian: V študiji z insulinom glarginom, kontrolirani s placebom, je bila sprememba sistoličnega krvnega tlaka od izhodišča do 28. tedna v skupini z eksenatidom v obliki s podaljšanim sproščanjem -2,6 mmHg in v skupini s placebom -0,7 mmHg.
English: When the medicine is mixed well, it should look cloudy.
Slovenian: Ko je zdravilo dobro zmešano, mora izgledati motno.
English: • hypoglycaemia (low blood sugar) when taken with an insulin
Slovenian: • hipoglikemija (nizek krvni sladkor) v primeru uporabe z insulinom
English: Prolonged-release exenatide demonstrated significantly greater weight reductions compared to sitagliptin.
Slovenian: Eksenatid v obliki s podaljšanim sproščanjem je pokazal značilno večje znižanje telesne mase v primerjavi s sitagliptinom.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Slovenian: PODATKI, KI MORAJO BITI NAVEDENI NA ZUNANJI OVOJNINI
English: Patients (%) achieving HbA1c ≤ 7% 62
Slovenian: Bolniki (%), ki so dosegli HbA1c ≤ 7 % 62
English: In a 28-week open-label study, Bydureon BCise was compared to immediate-release exenatide in subjects on a diet and exercise programme alone or with a stable regimen of oral glucose-lowering medicinal products.
Slovenian: V odprti 28-tedenski študiji so zdravilo Bydureon BCise primerjali z eksenatidom v obliki s takojšnjim sproščanjem pri bolnikih, ki so bili le na programu z dieto in telesno dejavnostjo ali na stabilni shemi zdravljenja s peroralnimi antidiabetiki.
English: C. Remove the needle cover,
Slovenian: D. Odstranite prekrivni papirček s pokrovčka igle.
English: To inject your full dose, push down on the plunger with your thumb until it stops.
Slovenian: Da boste injicirali celoten odmerek, pritisnite s palcem na bat, dokler se bat ne ustavi.
English: in either your stomach, thigh, or back of the arm. Each week you can use the same area of your body but choose a different injection site in that area.
Slovenian: Vsak teden lahko uporabite isti predel telesa, vendar pa morate na tistem predelu izbrati drugo mesto za injiciranje.
English: Follow the Instructions for the User to prepare and inject your dose.
Slovenian: Za pripravo in injiciranje odmerka upoštevajte Navodila za uporabnika.
English: Rare side effects • feeling jittery
Slovenian: Redki neželeni učinki • občutek živčnosti
English: Each dual-chamber pen contains exenatide powder and solvent in a Type 1 glass cartridge sealed at one end with a chlorobutyl rubber stopper and an aluminium seal, and at the other end with a chlorobutyl rubber piston.
Slovenian: En dvoprekatni injekcijski peresnik vsebuje prašek eksenatida in vehikel v steklenem vložku, narejenem iz stekla tipa I, ki je na eni strani zaprt z zamaškom iz klorobutilne gume in aluminijasto zaporo, na drugi strani pa z gumijastim batom iz klorobutilne gume.
English: The risk of hypoglycaemia was increased when prolonged-release exenatide was used in combination with a sulphonylurea in clinical studies.
Slovenian: V kliničnih študijah je bilo tveganje za hipoglikemijo povečano ob sočasni uporabi eksenatida v obliki s podaljšanim sproščanjem s sulfonilsečnino.
English: Keep pushing down on the plunger with your thumb and shake vigorously.
Slovenian: Nadaljujte s pritiskanjem navzdol in močno stresajte.
English: No dose adjustment is required based on age.
Slovenian: Pri starejših prilagajanja odmerka ni potrebno.
English: Overall, 9.3% of patients treated with Bydureon BCise reported nausea during the controlled period of both clinical studies.
Slovenian: V celoti je med kontroliranim obdobjem obeh kliničnih študij o navzei poročalo 9,3 % bolnikov, ki so bili zdravljeni z zdravilom Bydureon BCise.
English: The patient should be instructed to discard the pen safely after each injection.
Slovenian: Bolniku je potrebno naročiti, naj po vsakem injiciranju peresnik varno zavrže.
English: Bydureon contains the active substance exenatide.
Slovenian: Zdravilo Bydureon vsebuje učinkovino eksenatid.
English: Do not save it to use later.
Slovenian: Ne smete ga shraniti za poznejšo uporabo.
English: Common Questions and Answers
Slovenian: Pogosta vprašanja in odgovori
English: To mix, shake the pen hard until the white medicine is no longer on the bottom, top, or sides.
Slovenian: Da boste zdravilo premešali, močno stresajte peresnik, dokler na dnu, na vrhu in ob straneh ni več belega zdravila.
English: The powder is packaged in a 3 ml Type I glass vial sealed with a chlorobutyl rubber stopper and an aluminium seal with a plastic flip-off cap.
Slovenian: Prašek se nahaja v 3-mililitrski viali iz stekla tipa I s klorobutilnim gumijastim batom in aluminijastim pokrovčkom s plastičnim zamaškom.
English: Powder and solvent for prolonged-release suspension for injection.
Slovenian: Prašek in vehikel za suspenzijo s podaljšanim sproščanjem za injiciranje.
English: A reduction in HbA1c was observed over the course of the trial with an overall treatment difference of -0.53% (prolonged-release exenatide vs. placebo).
Slovenian: Med preskušanjem so opažali znižanje HbA1c; celotna razlika med terapevtskima skupinama je bila -0,53 % (eksenatid v obliki s podaljšanim sproščanjem v primerjavi s placebom).
English: Hydroxy methyl glutaryl coenzyme A reductase inhibitors Lovastatin AUC and Cmax were decreased approximately 40% and 28%, respectively, and tmax was delayed about 4 h when immediate-release exenatide was administered concomitantly with a single dose of lovastatin (40 mg) compared with lovastatin administered alone.
Slovenian: Zaviralci hidroksimetilglutaril koencim A reduktaze Ob dajanju eksenatida v obliki s takojšnim sproščanjem sočasno z enkratnim odmerkom lovastatina (40 mg) sta se vrednosti AUC in Cmax v primerjavi z dajanjem lovastatina samega zmanjšali za približno 40 % in 28 % in tmax se je podaljšal za približno 4 ure.
English: Immune system disorders Anaphylactic reaction Metabolism and nutrition disorders Hypoglycaemia (with a sulphonylurea)
Slovenian: Bolezni imunskega sistema anafilaktična reakcija Presnovne in prehranske motnje hipoglikemija (s sulfonilsečnino) hipoglikemija (z insulinom) zmanjšanje teka dehidracija
English: Use only the supplied needles with the pen.
Slovenian: Uporabljajte le igle, ki so priložene peresniku.
English: Most adverse reactions associated with prolonged-release exenatide were mild to moderate in intensity.
Slovenian: Večina neželenih učinkov, povezanih z eksenatidom v obliki s podaljšanim sproščanjem, je bila blaga do srednja huda.
English: There have been spontaneously reported cases of increased INR (International Normalized Ratio), sometimes associated with bleeding, with concomitant use of warfarin and exenatide (see section 4.5).
Slovenian: Ob sočasnem jemanju varfarina z eksenatidom so spontano poročali o primerih zvišane vrednosti INR (internacionalno normalizirano razmerje), ki je bila včasih povezana s krvavitvami (glejte poglavje 4.5).
English: Please see the package leaflet and “Instructions for the User” for additional information on suspension and administration.
Slovenian: Za dodatne informacije o suspendiranju in uporabi glejte navodilo za uporabo in “Navodila za uporabnika”.
English: Mean HbA1c (%)
Slovenian: Povprečna vrednost HbA1c (%)
English: The pens must be stored flat.
Slovenian: Peresnike je treba shranjevati v vodoravnem položaju.