FrancophonIA/ELRC3.0 huggingface dataset:
English: In the 30-week immediate-release exenatide comparator study both prolonged-release and immediate-release exenatide significantly reduced systolic blood pressure from base line (4.7±1.1 mmHg and 3.4±1.1 mmHg, respectively); the difference between the treatments was not significant.
Slovenian: V 30-tedenski primerjalni študiji z eksenatidom v obliki s takojšnim sproščanjem sta tako eksenatid v obliki s podaljšanim sproščanjem kot eksenatid v obliki s takojšnim sproščanjem značilno znižala sistolični krvni tlak v primerjavi z začetnim (4,7±1,1 mmHg in 3,4±1,1 mmHg).
English: Each dose should be administered in the abdomen, thigh, or the back of the upper arm as a subcutaneous injection immediately after suspension of the powder in the solvent.
Slovenian: Vsak odmerek moramo kot subkutano injekcijo dati v trebuh, stegno ali nadlaket takoj po pripravi suspenzije iz praška in vehikla.
English: If pancreatitis is suspected, prolonged-release exenatide should be discontinued; if acute pancreatitis is confirmed, prolonged-release exenatide should not be restarted.
Slovenian: Če je akutni pankreatitis potrjen, se zdravljenja z eksenatidom v obliki s podaljšanim sproščanjem ne sme ponovno uvesti.
English: In the prolonged-release exenatide clinical studies, background therapies included diet and exercise, metformin, a sulphonylurea, a thiazolidinedione, a combination of oral glucose-lowering medicinal products or a basal insulin.
Slovenian: V kliničnih študijah eksenatida v obliki s podaljšanim sproščanjem so osnovna zdravljenja obsegala dieto in fizično aktivnost, metformin, sulfonilsečnino, tiazolidindion, kombinacijo peroralnih antidiabetikov ali bazalni insulin.
English: by pushing and screwing it onto the top of the pen until it is tight.
Slovenian: E. Namestite iglo na peresnik tako, da jo potisnete ali privijete na vrh peresnika, dokler ni trdno nameščena.
English: Prolonged-release exenatide resulted in a statistically significant reduction in HbA1c compared to patients receiving immediate-release exenatide (Table 2).
Slovenian: Eksenatid v obliki s podaljšanim sproščanjem je v primerjavi z bolniki, ki so se zdravili z eksenatidom v obliki s takojšnim sproščanjem, statistično značilno znižalo HbA1c (Preglednica 2).
English: If you miss a dose and there are 3 days or more until your next dose is due, then take the missed dose as soon as it is possible to do so. For your next injection you can return to your chosen injection day.
Slovenian: Če izpustite odmerek zdravila, in so do naslednjega odmerka še 3 dnevi ali več, pozabljeni odmerek uporabite, takoj kot je to mogoče.
English: The prolonged-release exenatide and dapagliflozin treatment group showed superior reductions in HbA1c from baseline compared to prolonged-release exenatide alone and dapagliflozin alone (Table 7).
Slovenian: Bolniki, ki so prejemali eksenatid v obliki s podaljšanim sproščanjem in dapagliflozin, so dosegli boljše znižanje HbA1c v izhodišču v primerjavi s tistimi, ki so prejemali ali sam eksenatid v obliki s podaljšanim sproščanjem ali sam dapagliflozin (preglednica 7).
English: • Store in a refrigerator (2°C to 8°C).
Slovenian: • Shranjujte v hladilniku (od 2 do 8 °C).
English: Mean difference in change from baseline versus immediate-release exenatide (95%
Slovenian: Sprememba od izhodišča (± SE) Povprečna razlika v spremembi od izhodišča v primerjavi z eksenatidom v obliki s takojšnjim sproščanjem (95 % IZ)
English: If pancreatitis is suspected, the use of this medicinal product should be discontinued; if acute pancreatitis is confirmed, it should not be restarted.
Slovenian: Če je akutni pankreatitis potrjen, se zdravljenja ne sme ponovno uvesti.
English: Prolonged-release exenatide resulted in a statistically significant reduction in HbA1c compared to patients receiving immediate-release exenatide (Table 4).
Slovenian: Eksenatid v obliki s podaljšanim sproščanjem je v primerjavi z bolniki, ki so se zdravili z eksenatidom v obliki s takojšnim sproščanjem, statistično značilno znižal HbA1c (Preglednica 4).
English: DO NOT use a pen past its expiration date.
Slovenian: NE UPORABITE peresnika po izteku roka uporabnosti.
English: Keep pushing on the plunger with your thumb to keep the plunger in place.
Slovenian: Nadaljujte s pritiskanjem palca na bat, da bo le ta pri miru.
English: Bydureon BCise demonstrated superiority to immediate-release exenatide in reducing HbA1c from baseline to Week 28 (Table 2).
Slovenian: Zdravilo Bydureon BCise je v primerjavi z eksenatidom v obliki s takojšnim sproščanjem superiorno znižalo HbA1c od izhodišča do 28. tedna (preglednica 2).
English: - If you have any further questions, ask your doctor, pharmacist, or diabetes nurse.
Slovenian: - Če imate dodatna vprašanja, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro v diabetološki ambulanti.
English: Mean difference in change from baseline between combination and single active medicinal product (95%CI)
Slovenian: Povprečna razlika v spremembi od izhodišča med kombinacijo in samostojnim zdravljenjem z učinkovino (95 % IZ)
English: Change in fasting serum glucose (mmol/l) (± SE)
Slovenian: Sprememba v glukozi na tešče (mmol/l) (±SE)
English: A reduction in systolic blood pressure was observed in the 4 comparator-controlled prolonged-release exenatide studies (2.9 mmHg to 4.7 mmHg).
Slovenian: V 4 s primerjalnimi zdravili kontroliranih študijah z eksenatidom v obliki s podaljšanim sproščanjem, so opazili znižanje sistoličnega krvnega tlaka (2,9 mmHg do 4,7 mmHg).
English: Prolonged-release exenatide was superior to placebo in reducing body weight at Week 28 (Table 6).
Slovenian: Eksenatid v obliki s podaljšanim sproščanjem je v primerjavi s placebom bolj zmanjšal telesno maso do 28. tedna (preglednica 6).
English: No pharmacokinetic study has been performed in patients with hepatic insufficiency.
Slovenian: Pri bolnikih z okvaro jeter farmakokinetičnih študij niso opravili.
English: Test your blood glucose levels regularly, it is particularly important to do this if you are also using a sulphonylurea.
Slovenian: To je še posebej pomembno, če sočasno jemljete tudi sulfonilsečnino.
English: B. Firmly tap the pen to mix.
Slovenian: B. Odločno potrkajte s peresnikom, da se zdravilo premeša.
English: Bydureon must be injected immediately after mixing.
Slovenian: Zdravilo Bydureon je potrebno injicirati takoj po mešanju.
English: Twist the needle onto the syringe until snug.
Slovenian: Iglo do konca privijte v injekcijsko brizgo.
English: Check that you have fully screwed on the pen needle.
Slovenian: Najprej preverite, če ste odstranili modri pokrovček.
English: • intestinal obstruction (blockage in intestine)
Slovenian: Injekcijska brizga znotraj tekočina (vehikel)
English: Shake hard again until well mixed.
Slovenian: Ponovno močno potrkajte, dokler ni dobro zmešano.
English: - In the solvent: carmellose sodium, sodium chloride, polysorbate 20, sodium dihydrogen phosphate monohydrate, disodium phosphate heptahydrate, water for injection and sodium hydroxide (for pH adjustment).
Slovenian: - V vehiklu: natrijev karmelozat, natrijev klorid, polisorbat 20, natrijev dihidrogen fosfat monohidrat, natrijev hidrogen fosfat heptahidrat, voda za injekcije in natrijev hidroksid (za prilagoditev pH).
English: Table 2: Results of two studies of prolonged-release versus immediate-release exenatide in combination with diet and exercise alone, metformin and/or sulphonylurea and metformin and/or thiazolidinedione (intent to treat patients)
Slovenian: Preglednica 2: Rezultati dveh študij z eksenatidom v obliki s podaljšanim sproščanjem proti eksenatidu v obliki s takojšnim sproščanjem v kombinaciji z dieto in fizično aktivnostjo samima, metforminom in/ali sulfonilsečnino in metforminom in/ali tiazolidindionom (bolniki z-namenomzdravljenja)
English: No dose adjustment is necessary for patients with mild renal impairment (creatinine clearance 50 to 80 ml/min).
Slovenian: Pri bolnikih z blago okvaro ledvic (očistek kreatinina 50 do 80 ml/min) odmerka ni potrebno prilagajati.
English: After suspension, the delivered dose is 2 mg/0.65 ml.
Slovenian: Po suspendiranju je prejeti odmerek 2 mg/0,65 ml.
English: It is normal for air bubbles to be in the pen.
Slovenian: Normalno je, da so v peresniku mehurčki.
English: Prolonged-release exenatide demonstrated superiority to placebo in reducing HbA1c from baseline to Week 28 (Table 6).
Slovenian: Eksenatid v obliki s podaljšanim sproščanjem je v primerjavi s placebom dokazano bolj znižal HbA1c od izhodišča do 28. tedna (preglednica 6).
English: Withdraw the needle.
Slovenian: Izvlecite iglo.
English: Table 4: Results of two studies of prolonged-release versus immediate-release exenatide in combination with diet and exercise alone, metformin and/or sulphonylurea and metformin and/or thiazolidinedione (intent to treat patients)
Slovenian: Preglednica 4: Rezultati dveh študij z eksenatidom v obliki s podaljšanim sproščanjem proti eksenatidu v obliki s takojšnim sproščanjem v kombinaciji z dieto in fizično aktivnostjo samima, metforminom in/ali sulfonilsečnino in metforminom in/ali tiazolidindionom (bolniki z-namenomzdravljenja)
English: *p <0.01, **p < 0.001. p-values are all adjusted p-values for multiplicity.
Slovenian: *Vrednost p < 0,001 (korigirana za večkratne primerjave).
English: - In the solvent: carmellose sodium, sodium chloride, polysorbate 20, sodium dihydrogen phosphate monohydrate, disodium phosphate heptahydrate and water for injection.
Slovenian: - V vehiklu: natrijev karmelozat, natrijev klorid, polisorbat 20, natrijev dihidrogen fosfat monohidrat, natrijev hidrogen fosfat heptahidrat in voda za injekcije.
English: Most adverse reactions were mild to moderate in intensity.
Slovenian: Večina neželenih učinkov je bila blagih dozmernih.
English: How do I dispose of my Bydureon pen?
Slovenian: Kako naj zavržem peresnik Bydureon?
English: Each vial contains 2 mg of exenatide.
Slovenian: Ena viala vsebuje 2 mg eksenatida.
English: Removed Cap
Slovenian: Odstranjeni pokrovček
English: Patients (%) achieving HbA1c ≤7% Mean body weight (kg) Baseline
Slovenian: Bolniki (%), ki so dosegli HbA1c ≤7 % Povprečna telesna masa (kg) Izhodišče
English: Immediaterelease exenatide 10 mcg twice daily
Slovenian: 10 mg dapagliflozina enkrat na dan
English: You should dispose of the pen safely after each use, as instructed by your doctor or diabetes nurse.
Slovenian: Peresnik varno zavrzite po vsaki uporabi, kot vam je naročil zdravnik ali medicinska sestra v diabetološki ambulanti.
English: Bydureon BCise demonstrated superiority to both sitagliptin and placebo in reducing HbA1c from baseline to Week 28 (Table 3).
Slovenian: Zdravilo Bydureon BCise je tako v primerjavi s sitagliptinom kot v primerjavi s placebom superiorno znižalo HbA1c od izhodišča do 28. tedna (preglednica 3).
English: Reversibility of altered renal function has been observed with supportive treatment and discontinuation of potentially causative medicinal products, including exenatide.
Slovenian: S podpornim zdravljenjem ter ukinitvijo potencialno vzročnih zdravil, vključno z eksenatidom, so opazili reverzibilnost spremenjenega delovanja ledvic.
English: After suspension, the mixture should only be used if it is white to off white and cloudy.
Slovenian: Po suspendiranju se lahko mešanico uporabi le, če je ta bela do belkasta in motna.
English: Do not use tools or try to force the cap off.
Slovenian: Pokrovčka ne poskušajte odstraniti z orodji ali s silo.
English: Cover
Slovenian: Pokrovček
English: STEP 3: Prepare the Pen
Slovenian: KORAK: Priprava peresnika
English: VIAL LABEL
Slovenian: NALEPKA NA VEHIKLU
English: A mean increase in heart rate (HR) of 2.4 beats per minute (bpm) from baseline (74 bpm) was observed in the controlled period of the Bydureon BCise clinical studies.
Slovenian: Med kontroliranim obdobjem kliničnih študij z zdravilom Bydureon BCise so opazili povprečno zvišanje srčnega utripa za 2,4 utripa na minuto v primerjavi z začetno vrednostjo (74 utripov na minuto).
English: The combination of prolonged-release exenatide and dapagliflozin demonstrated significantly greater weight reductions compared to either medicinal product alone (Table 7).
Slovenian: S kombinacijo eksenatida v obliki s podaljšanim sproščanjem in dapagliflozina je bilo dokazano značilno večje zmanjšanje telesne mase kot z eno ali drugo učinkovino samo (preglednica 7).
English: Mean difference change from baseline between treatments (95% CI) versus pioglitazone
Slovenian: Srednja vrednost spremembe od začetne vrednosti med zdravljenji (95 % IZ) proti pioglitazonu
English: Thigh
Slovenian: • zgaga
English: There were no episodes of major hypoglycaemia in the prolonged-release exenatide with insulin group.
Slovenian: V skupini, ki je prejemala eksenatid v obliki s podaljšanim sproščanjem skupaj z insulinom, ni bilo hudih hipoglikemij.
English: Just like you might break a stick, you are breaking off the cap.
Slovenian: Pokrovček odlomite tako, kot bi razlomili leseno palčko.
English: The combination of prolonged-release exenatide and dapagliflozin demonstrated significantly greater weight reductions compared to either medicinal product alone (Table 5).
Slovenian: S kombinacijo eksenatida v obliki s podaljšanim sproščanjem in dapagliflozina je bilo dokazano značilno večje zmanjšanje telesne mase kot z eno ali drugo učinkovino samo (preglednica 5).
English: INNER CARTON MULTIPACK OF 3 X (4 SINGLE-DOSE PRE-FILLED PENS) - WITH NO BLUE BOX
Slovenian: NOTRANJA ŠKATLA SKUPNEGA PAKIRANJA PO 3 X (4 NAPOLNJENI INJEKCIJSKI PERESNIKI Z ENKRATNIM ODMERKOM) - BREZ MODREGA OKENCA
English: Knob
Slovenian: Gumb
English: Sitagliptin 100 mg QD
Slovenian: Sitagliptin 100 mg 1x/dan
English: Table 5: Results of one 26-week study of prolonged-release exenatide versus insulin glargine in combination with metformin alone or metformin and sulphonylurea (intent to treat patients)
Slovenian: Preglednica 5: Rezultati 26-tedenske študije z eksenatidom v obliki s podaljšanim sproščanjem v primerjavi z insulinom glarginom v kombinaciji z metforminom samim ali metforminom in sulfonilsečnino (bolniki z-namenom-zdravljenja)
English: Bydureon must be injected immediately after suspension of the powder in the solvent.
Slovenian: Zdravilo Bydureon je potrebno po pripravi suspenzije praška in vehikla nemudoma injicirati.
English: - If you get any side effects, talk to your doctor, pharmacist, or diabetes nurse.
Slovenian: - Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro v diabetološki ambulanti.
English: Mean difference in change from baseline between treatments (95% CI) N=number of patients in each treatment group, SE = standard error, CI= confidence interval, *p-value <0.001 (adjusted for multiplicity).
Slovenian: Povprečna razlika v spremembi od izhodišča med zdravljenjema (95 % IZ) N = število bolnikov v vsaki zdravljeni skupini, SE = standardna napaka (standardna napaka), IZ = interval zaupanja.
English: You should dispose of the pen safely, with the needle still attached, after use, as instructed by your doctor or diabetes nurse.
Slovenian: Peresnik s še vedno nameščeno iglo varno zavrzite po uporabi, kot vam je naročil zdravnik ali medicinska sestra v diabetološki ambulanti.
English: Bydureon 2 mg powder for injection exenatide
Slovenian: Bydureon 2 mg prašek za injiciranje eksenatid s.c.
English: INNER CARTON, MULTIPACK OF 3 X (4 SINGLE-DOSE KITS) - WITH NO BLUE BOX
Slovenian: NOTRANJA ŠKATLA SKUPNEGA PAKIRANJA PO 3 x (4 enoodmerni seti) - brez modrega okenca
English: Single-dose pre-filled pen
Slovenian: bat bel pokrovček
English: Needles (2)
Slovenian: injekcijska brizga igli (2)
English: While holding the pen upright with the needle cover uppermost, slowly turn the knob anticlockwise.
Slovenian: Držite peresnik pokonci s pokrovčkom igle, obrnjenim navzgor in počasi obračajte gumb v nasprotni smeri urinega kazalca.
English: No clinically meaningful differences were observed in steady state exenatide concentrations or tolerability in patients with mild to moderate renal impairment (eGFR 30 to 89 ml/min/1.73m receiving Bydureon BCise, compared to those with normal renal function.
Slovenian: Pri bolnikih z blago do zmerno okvaro ledvic (eGFR od 30 do 89 ml/min/1,73 m2), ki so prejemali zdravilo Bydureon BCise, v primerjavi z bolniki z normalnim delovanjem ledvic niso opažali klinično pomembnih razlik ne v koncentraciji eksenatida v stanju dinamičnega ravnovesja ne v prenašanju zdravila.
English: Syringe
Slovenian: Stegno
English: • Each pen can be kept at room temperature not to exceed 30°C for no more than a total of 4 weeks,
Slovenian: • Če je treba, je peresnik mogoče največ 4 tedne hraniti na sobni temperaturi, ki ne presega 30 °C.
English: OUTER CARTON MULTIPACK OF 3 X (4 SINGLE-DOSE PRE-FILLED PENS) - INCLUDING THE BLUE BOX
Slovenian: ZUNANJA ŠKATLA SKUPNEGA PAKIRANJA PO 3 X (4 NAPOLNJENI INJEKCIJSKI PERESNIKI Z ENKRATNIM ODMERKOM) - VKLJUČNO Z MODRIM OKENCEM
English: • The pen may be kept for up to 4 weeks below 30°C prior to use.
Slovenian: • Peresnik je lahko pred uporabo do 4 tedne shranjen na temperaturi do 30 ºC.
English: Table 4: Results of one 26-week study of prolonged-release exenatide versus sitagliptin and versus pioglitazone in combination with metformin (intent to treat patients)
Slovenian: Preglednica 4: Rezultati 26-tedenske študije z eksenatidom v obliki s podaljšanim sproščanjem v primerjavi s sitagliptinom in v primerjavi s pioglitazonom v kombinaciji z metforminom (bolniki z-namenom-zdravljenja)
English: Table 6: Results of one 26-week study of prolonged-release exenatide versus sitagliptin and versus pioglitazone in combination with metformin (intent to treat patients)
Slovenian: Preglednica 6: Rezultati 26-tedenske študije z eksenatidom v obliki s podaljšanim sproščanjem v primerjavi s sitagliptinom in v primerjavi s pioglitazonom v kombinaciji z metforminom (bolniki z-namenom-zdravljenja)
English: Prolonged-release exenatide
Slovenian: Eksenatid v obliki s podaljšanim sproščanjem
English: Use only the supplied custom needles with the pen.
Slovenian: S peresnikom uporabite le priložene prilagojene igle.
English: Require third-party assistance to resolve because of impairment in consciousness or behaviour and has glucose value of <54 mg/dL (3 mmol/L) OR 3.
Slovenian: Na podlagi hipoglikemij, ki 1. povzročijo izgubo zavesti, konvulzije ali komo in minejo po dajanju glukagona ali glukoze ALI 2. zaradi spremenjene zavesti ali vedenja za razrešitev zahtevajo pomoč nekoga tretjega ter jih spremlja koncentracija glukoze v krvi < 54 mg/dl (3 mmol/l) ALI 3. povzročijo simptome, značilne za hipoglikemijo, ter jih ob tem spremlja koncentracija glukoze pred zdravljenjem < 54 mg/dl (3 mmol/l).
English: Flatulence
Slovenian: Imunogenost
English: with the needle attached, in a puncture-resistant container.
Slovenian: E. Ustrezno zavrzite peresnik z nameščeno iglo v vsebnik, odporen proti prebadanju.
English: Table 8: Results of one 28-week study of prolonged-release exenatide versus placebo in combination with insulin glargine alone or with metformin (intent to treat patients)
Slovenian: Preglednica 8: Rezultati 28-tedenske študije eksenatida v obliki s podaljšanim sproščanjem v primerjavi s placebom v kombinaciji z insulinom glarginom samim ali skupaj z metforminom (bolniki z-namenom-zdravljenja)
English: STEP 2: Mix the medicine
Slovenian: KORAK: Zdravilo premešajte
English: The pre-filled pen must be stored flat.
Slovenian: Napolnjen injekcijski peresnik je treba shranjevati v vodoravnem položaju.
English: After suspension, each pen delivers a dose of 2 mg in 0.65 ml.
Slovenian: Po suspendiranju je prejeti odmerek v enem peresniku 2 mg/0,65 ml.
English: OUTER CARTON, MULTIPACK OF 3 X (4 SINGLE-DOSE KITS) - INCLUDING THE BLUE BOX
Slovenian: ZUNANJA ŠKATLA SKUPNEGA PAKIRANJA PO 3 X (4 ENOODMERNI SETI)VKLJUČNO Z MODRIM OKENCEM
English: Table 3: Results of one 26-week study of prolonged-release exenatide versus insulin glargine in combination with metformin alone or metformin and sulphonylurea (intent to treat patients)
Slovenian: Preglednica 3: Rezultati 26-tedenske študije z eksenatidom v obliki s podaljšanim sproščanjem v primerjavi z insulinom glarginom v kombinaciji z metforminom samim ali metforminom in sulfonilsečnino (bolniki z-namenom-zdravljenja)
English: This medicine is available in a pack size of 4 single-dose pre-filled pens (BCise) and a multipack containing 12 (3 packs of 4) single-dose pre-filled pens (BCise).
Slovenian: To zdravilo je na voljo v pakiranju s 4 napolnjenimi injekcijskimi peresniki z enkratnim odmerkom (BCise) in v skupnem pakiranju, ki vsebuje 12 (3 pakiranja po 4) napolnjenih injekcijskih peresnikov z enkratnim odmerkom (BCise).
English: You must take your injection of Bydureon immediately after mixing it.
Slovenian: Zdravilo Bydureon morate uporabiti takoj po mešanju.
English: Pack size of 4 single-dose kits and a multipack consisting of 12 (3 packs of 4) single-dose kits.
Slovenian: Velikosti pakiranja so 4 enoodmerni seti in veliko pakiranje, ki vsebuje 12 (3 pakiranja po 4) enoodmernih setov.
English: If you get any side effects, talk to your doctor, pharmacist or diabetes nurse.
Slovenian: Če opazite katerega koli izmed neželenih učinkov, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro v diabetološki ambulanti.
English: The frequency of adverse reactions of Bydureon BCise identified from clinical studies are summarised in Table 1 below.
Slovenian: Preglednica 1, spodaj, povzema pogostnost neželenih učinkov zdravila Bydureon BCise, ugotovljenih v kliničnih študijah.
English: This medicine is available in pack of 4 single-dose pre-filled pens, and a multipack containing 12 (3 packs of 4) single-dose pre-filled pens.
Slovenian: To zdravilo je na voljo v pakiranju s 4 napolnjenimi injekcijskimi peresniki z enkratnim odmerkom in v skupnem pakiranju, ki vsebuje 12 (3 pakiranja po 4) napolnjenih injekcijskih peresnikov z enkratnim odmerkom.
English: Prolonged-release exenatide must be injected immediately after suspension of the powder in the solvent.
Slovenian: Eksenatid v obliki s podaljšanim sproščanjem je potrebno po pripravi suspenzije praška in vehikla nemudoma injicirati.
English: Both Bydureon BCise and sitagliptin patients achieved a reduction in weight at Week 28 compared to baseline (Table 3).
Slovenian: Telesna masa se je od izhodišča do 28. tedna znižala tako bolnikom v skupini z zdravilom Bydureon BCise kot bolnikom v skupini s sitagliptinom (preglednica 3).
English: Change from baseline (± SE) Mean difference in change from baseline between treatments (95% CI) Patients (%) achieving HbA1c ≤7% Mean body weight (kg) Baseline
Slovenian: Sprememba v HbA1c glede na izhodišče (±SE) Povprečna vrednost spremembe od izhodiščne vrednosti med zdravljenji (95 % IZ) Bolniki (%), ki so dosegli HbA1c ≤ 7 % Sprememba v glukozi na tešče (mmol/l) (±SE) Povprečna telesna masa (kg)
English: The powder inside is your medicine
Slovenian: Viala zeleni pokrovček prašek znotraj je vaše zdravilo modri pokrovček igla pokrovček za iglo
English: • tiredness (fatigue)
Slovenian: • zapora črevesa (blokada v črevesu)
English: Solvent carmellose sodium sodium chloride polysorbate 20 sodium dihydrogen phosphate monohydrate disodium phosphate heptahydrate water for injections sodium hydroxide (for pH adjustment)
Slovenian: Vehikel natrijev karmelozat natrijev klorid polisorbat 20 natrijev dihidrogen fosfat monohidrat natrijev hidrogen fosfat heptahidrat voda za injekcije natrijev hidroksid (za prilagoditev ph)
English: Least squares means.
Slovenian: Povprečje po metodi najmanjših kvadratov.
English: Bydureon BCise 2 mg QW
Slovenian: Zdravilo Bydureon BCise 2 mg 1x/teden
English: A mean increase in heart rate (HR) of 2.6 beats per minute (bpm) from baseline (74 bpm) was observed in pooled prolonged-release exenatide clinical studies.
Slovenian: V združenih kliničnih študijah z eksenatidom v obliki s podaljšanim sproščanjem so opazili povprečno zvišanje srčnega utripa za 2,6 utripa na minuto v primerjavi z začetno vrednostjo (74 utripov na minuto).
English: QW=once weekly, QD=once daily, SE = standard error, CI= confidence interval, N=number of patients.
Slovenian: SE = standardna napaka (standard error), IZ = interval zaupanja, N = število bolnikov.