FrancophonIA/ELRC3.0 huggingface dataset:
English: * Documented, symptomatic hypoglycaemia with blood glucose ≤ 3.9 mmol/L † Dulaglutide 1.5 mg dose only.
Slovenian: * Dokumentirana simptomatska hipoglikemija s krvno glukozo ≤ 3,9 mmol/l.
English: If less than 3 days (72 hours) remain before the next scheduled dose, the missed dose should be skipped and the next dose should be administered on the regularly scheduled day.
Slovenian: Če so do naslednjega predpisanega odmerka ostali manj kot 3 dnevi (72 ur), je treba zamujeni odmerek preskočiti, naslednji odmerek pa dati na naslednji predpisani dan.
English: The safety and efficacy of dulaglutide was also investigated in an active controlled study (liraglutide 1.8 mg daily) of 26 weeks duration, both in combination with metformin.
Slovenian: Varnost in učinkovitost dulaglutida so preučevali tudi študiji, nadzorovani z aktivno primerjavo (liraglutid 1,8 mg na dan), ki je trajala 26 tednov, obakrat v kombinaciji z metforminom.
English: Additionally, in a 52-week clinical study in patients with type 2 diabetes and moderate to severe renal impairment (eGFR [by CKD-EPI] <60 and ≥15 mL/min/1.73 m2), the pharmacokinetic profile of Trulicity 0.75 mg and 1.5 mg once weekly was similar to that demonstrated in previous clinical studies.
Slovenian: Poleg tega je bil v 52-tedenski klinični študiji, ki je vključila bolnike s sladkorno boleznijo tipa 2 in z zmerno do hudo okvaro delovanja ledvic (eGFR [po CKDEPI] < 60 in ≥ 15 ml/min/1,73 m2) farmakokinetični profil zdravila Trulicity 0,75 mg in 1,5 mg, danega enkrat na teden, podoben tistemu, ki so ga dokazali v predhodnih kliničnih študijah.
English: The safety and efficacy of dulaglutide was investigated in a placebo and active controlled (sitagliptin 100 mg daily) study of 104 weeks duration, all in combination with metformin.
Slovenian: Varnost in učinkovitost zdravila Trulicity sta bili raziskani v študiji, nadzorovani s placebom in aktivno primerjavo (sitagliptin 100 mg na dan), ki je trajala 104 tedne, vedno v kombinaciji z metforminom.
English: Dulaglutide delays gastric emptying and has the potential to impact the rate of absorption of concomitantly administered oral medicinal products.
Slovenian: Dulaglutid zakasni praznjenje želodca in lahko vpliva na hitrost absorpcije sočasno vzetih peroralnih zdravil.
English: • Inject your dose using another syringe.
Slovenian: • Svoj odmerek si injicirajte z drugo injekcijsko brizgo.
English: It is important to avoid dehydration by drinking plenty of fluids.
Slovenian: Pomembno je, da pijete veliko tekočine in se tako izognete dehidraciji.
English: If the pen has been frozen, DO NOT USE.
Slovenian: Če je bil peresnik zamrznjen, GA NE UPORABITE.
English: Dulaglutide coadministration with sitagliptin increased dulaglutide exposure and Cmax by approximately 38 % and 27 %, respectively, and median tmax increased approximately 24 hours.
Slovenian: Sočasno dajanje dulaglutida in sitagliptina je povečalo izpostavljenost dulaglutidu in Cmax za približno 38 % in 27 %, mediani tmax pa je naraščal v obdobju približno 24 ur.
English: There was a general increase in tmax of dulaglutide with increased hepatic impairment.
Slovenian: Opazili so tudi splošno povečanje časa tmax dulaglutida ob povečani okvari delovanja jeter.
English: No dosage adjustment is required in patients with mild, moderate or severe renal impairment (eGFR <90 to ≥15 mL/min/1.73m2).
Slovenian: Pri bolnikih z blago, zmerno ali hudo okvarjenim delovanjem ledvic (eGFR < 90 do ≥ 15 ml/min/1,73m2) prilagoditev odmerka ni potrebna.
English: Do not use this medicine after the expiry date which is stated on the pen label and on the carton after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na oznaki peresnika in na škatli poleg oznake „Uporabno do/EXP“.
English: When Trulicity is added to existing metformin and/or sodium-glucose co-transporter 2 inhibitor (SGLT2i) therapy, the current dose of metformin and/or SGLT2i can be continued.
Slovenian: Če je zdravilo Trulicity dodano obstoječemu zdravljenju z metforminom in/ali zaviralcem natrijevih glukoznih koprenašalcev 2 (SGLT2), je mogoče nadaljevati s trenutnim odmerkom metformina in/ali zaviralca SGLT2.
English: Glass syringe (type I) encased in a disposable pen.
Slovenian: Steklena brizga (tip I) je vložena v peresnik za enkratno uporabo.
English: It should not be administered intravenously or intramuscularly.
Slovenian: Zdravila Trulicity se ne sme aplicirati intravensko ali intramuskularno.
English: Do not put the needle cover back on - this may result in an accidental needle stick injury to your hand.
Slovenian: • Ne nameščajte znova pokrovčka igle - to bi lahko povzročilo poškodbo vaše dlani zaradi vboda z iglo.
English: - you are taking a sulphonylurea or insulin for your diabetes, as low blood sugar (hypoglycaemia) can occur.
Slovenian: - jemljete sulfonilsečnino ali insulin za zdravljenje vaše sladkorne bolezni, saj lahko pride do nizkega krvnega sladkorja (hipoglikemija).
English: Following coadministration with 2 consecutive doses of dulaglutide, sitagliptin AUC(0-τ) and Cmax decreased by approximately 7.4 % and 23.1 %, respectively.
Slovenian: Po sočasnem dajanju z dvema zaporednima odmerkoma dulaglutida sta se AUC(0-τ) in Cmax sitagliptina zmanjšala za približno 7,4 % in 23,1 %.
English: Following a first dose of 1 and 3 mg dulaglutide, paracetamol Cmax was reduced by 36 % and 50 %, respectively, and the median tmax occurred later (3 and 4 hours, respectively).
Slovenian: Po prvem odmerku 1 in 3 mg dulaglutida se je največja koncentracija Cmax paracetamola znižala za 36 % in 50 %, mediana časa do maksimalne serumske koncentracije tmax pa je nastopila pozneje (3 in 4 ure pozneje).
English: Storage and Handling Disposal of Pen Commonly Asked Questions Other Information Where to Learn More
Slovenian: Shranjevanje in rokovanje Odlaganje peresnika Pogosto zastavljena vprašanja Druge informacije
English: In addition, there was significantly lower perceived frequency of hyperglycaemia and hypoglycaemia compared to exenatide twice daily.
Slovenian: Poleg tega so bolniki navedli značilno nižjo zaznano pogostnost hiperglikemije in hipoglikemije v primerjavi z eksenatidom dvakrat na dan.
English: Patients at target HbA1c
Slovenian: Bolniki, ki so dosegli ciljno vrednost HbA1c
English: Sitagliptin tmax increased approximately 0.5 hours following coadministration with dulaglutide compared to sitagliptin alone.
Slovenian: tmax sitagliptina se je povečal približno 0,5 ure po sočasnem dajanju dulaglutida v primerjavi z dajanjem samega sitagliptina.
English: Place the clear base flat and firmly against your skin at the injection site.
Slovenian: • Prozorno podnožje plosko in trdno namestite na kožo na mestu injiciranja.
English: INFORMATION IN BRAILLE TRULICITY 1.5 mg
Slovenian: PODATKI V BRAILLOVI PISAVI TRULICITY 1,5 mg
English: When it is added to existing therapy of a sulphonylurea or insulin, a reduction in the dose of sulphonylurea or insulin may be considered to reduce the risk of hypoglycaemia (see sections 4.4 and 4.8).
Slovenian: Če je zdravilo Trulicity dodano obstoječemu zdravljenju s sulfonilsečnino ali insulinu, je treba razmisliti o zmanjšanju odmerka sulfonilsečnine ali insulina za zmanjšanje tveganja hipoglikemije (glejte poglavji 4.4 in 4.8).
English: Trulicity can be taken out of the fridge for up to 14 days at a temperature not above 30ºC.
Slovenian: Zdravilo Trulicity lahko vzamete iz hladilnika in ga hranite pri temperaturi, ki ne presega 30 °C, največ 14 dni.
English: If you stop using Trulicity
Slovenian: Če ste prenehali jemati zdravilo Trulicity
English: Change in body weight
Slovenian: Sprememba v telesni masi
English: Trulicity contains sodium
Slovenian: Zdravilo Trulicity vsebuje natrij
English: When it is used in combination with a sulphonylurea or insulin, patients should be advised to take precautions to avoid hypoglycaemia while driving and using machines (see section 4.4).
Slovenian: Bolnike je treba opozoriti, naj ob uporabi zdravila Trulicity v kombinaciji s sulfonilsečnino ali insulinom upoštevajo previdnostne ukrepe, da se izognejo hipoglikemiji med vožnjo in upravljanjem s stroji (glejte poglavje 4.4).
English: The instructions for using the syringe, included with the package leaflet, must be followed carefully.
Slovenian: Navodila za uporabo injekcijske brizge, ki so priložena navodilu za uporabo zdravila, je treba natančno upoštevati.
English: When initiating treatment with Trulicity, you may in some cases experience loss of fluids/dehydration, e.g. in case of vomiting, nausea and/or diarrhoea which may lead to a decrease in kidney function.
Slovenian: Pri uvedbi zdravljenja z zdravilom Trulicity morda lahko pride do izgube tekočine/dehidracije, npr. ob bruhanju, slabosti in/ali driski, kar lahko privede do zmanjšanega delovanja ledvic.
English: Dulaglutide was studied in a 52 week active controlled monotherapy study in comparison to metformin.
Slovenian: Dulaglutid so preučevali v 52-tedenski aktivno nadzirani študiji monoterapije v primerjavi z metforminom.
English: After coadministration of steady state digoxin with 2 consecutive doses of dulaglutide, overall exposure (AUCτ) and tmax of digoxin were unchanged; and Cmax decreased by up to 22 %.
Slovenian: Po sočasnem dajanju digoksina v stanju dinamičnega ravnovesja in dveh zaporednih odmerkov dulaglutida sta celokupna izpostavljenost (AUCτ) in tmax digoksina ostala nespremenjena, Cmax digoksina pa se je zmanjšal do 22 %.
English: Steady-state plasma concentrations were achieved between 2 to 4 weeks of once-weekly administration of dulaglutide (1.5 mg).
Slovenian: Plazemske koncentracije v stanju dinamičnega ravnovesja so bile dosežene po 2 do 4 tednih aplikacije dulaglutida (1,5 mg) enkrat na teden.
English: For complete information about proper storage, read the Information for the patient.
Slovenian: Za celotne informacije o primernem shranjevanju preberite Navodilo za uporabo.
English: atrioventricular block (AVB)
Slovenian: Preiskave sinusna tahikardija, atrioventrikularni blok prve stopnje (AVB)
English: These changes are consistent with the gastric emptying delay of dulaglutide and within the pharmacokinetic variability of metformin and thus are not clinically relevant.
Slovenian: povzročeno z dulaglutidom in so zajete v farmakokinetični variabilnosti metformina, zato niso klinično pomembne.
English: The dose can be administered at any time of day, with or without meals.
Slovenian: Odmerek se lahko aplicira v katerem koli delu dneva, neodvisno od obrokov hrane.
English: LIST OF EXCIPIENTS Excipients: Sodium citrate; citric acid, anhydrous; mannitol; polysorbate 80; water for injections
Slovenian: Pomožne snovi: natrijev citrat, brezvodna citronska kislina, manitol, polisorbat 80, voda za injekcije.
English: This medicine contains less than 1 mmol sodium (23 mg) per 0.75 mg or 1.5 mg, that is to say essentially ‘sodium-free'.
Slovenian: To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na 0,75 mg ali 1,5 mg, kar v bistvu pomeni »brez natrija«.
English: But be sure to choose a different injection site within that area.
Slovenian: vendar pa morate na tem delu izbirati različna mesta injiciranja.
English: What if there is a drop of liquid on the tip of the needle when I remove the needle cover?
Slovenian: Kaj če opazim kapljico tekočine na konici igle, ko odstranim pokrovček igle?
English: Gently release the skin.
Slovenian: • Nežno izpustite kožno gubo.
English: Following dulaglutide coadministration, S- and R-warfarin exposure and R-warfarin Cmax were unaffected, and S-warfarin Cmax decreased by 22 %.
Slovenian: Po sočasni aplikaciji dulaglutida ni prišlo do vpliva na izpostavljenost S- in R-varfarina ter na Cmax za Rvarfarin, opazili pa so 22% zmanjšanje Cmax S-varfarina.
English: The mean absolute bioavailability of dulaglutide following single-dose subcutaneous administration of single 1.5 mg and 0.75 mg doses was 47 % and 65%, respectively.
Slovenian: Povprečna absolutna biološka uporabnost dulaglutida po subkutani aplikaciji enkratnih odmerkov 1,5 mg in 0,75 mg je bila 47 % in 65 %.
English: Heart rate increase
Slovenian: - povečan srčni utrip
English: Another person may give you the injection in your upper arm.
Slovenian: • Druga oseba vam lahko da injekcijo v nadlaket.
English: Storage and Handling Disposal of Syringe Commonly Asked Questions Other Information Where to Learn More
Slovenian: Shranjevanje in rokovanje Odlaganje injekcijske brizge Pogosto zastavljena vprašanja Druge informacije
English: Coadministration of multiple dulaglutide doses with steady state lisinopril caused no clinically relevant changes in the AUC or Cmax of lisinopril.
Slovenian: Ko so aplicirali več odmerkov dulaglutida s sočasno aplikacijo lisinoprila v stanju dinamičnega ravnovesja, to ni klinično pomembno vplivalo na AUC ali Cmax lisinoprila.
English: The mean baseline dose of insulin glargine was 37 units/day for patients receiving placebo and 41 units/day for patients receiving Trulicity 1.5mg.
Slovenian: Povprečni izhodiščni odmerek insulina glargina je bil 37 enot/dan za bolnike, ki so prejemali placebo, in 41 enot/dan za bolnike, ki so prejemali zdravilo
English: The most frequent adverse reactions leading to discontinuation for 0.75 mg and 1.5 mg dulaglutide, respectively, were nausea (1.0%, 1.9 %), diarrhoea (0.5%, 0.6 %), and vomiting (0.4%, 0.6 %), and were generally reported within the first 4-6 weeks.
Slovenian: Najpogostejši neželeni učinki, zaradi katerih je prišlo do prekinitve za dulaglutid v odmerkih 0,75 mg in 1,5 mg so bili slabost (1,0 % oziroma 1,9 %), driska (0,5 % oziroma 0,6 %) in bruhanje (0,4 % oziroma 0,6 %), o njih pa so na splošno poročali v prvih 4-6 tednih.
English: Dulaglutide dosing of male and female juvenile rats did not produce memory deficits at 91-fold the human exposure.
Slovenian: Odmerjanje dulaglutida mladim podganjim samcem in samicam, ki je bilo 91-krat večje od izpostavljenosti pri človeku, ni povzročilo okvar spomina.
English: The mean apparent clearance of dulaglutide 0.75 mg and 1.5 mg at steady state was 0.111 L/h and 0.107 L/h with an elimination half-life of 4.5 and 4.7 days, respectively.
Slovenian: Povprečni navidezni očistek dulaglutida 0,75 mg in 1,5 mg v stanju dinamičnega ravnovesja je bil 0,111 l/h in 0,107 l/h z razpolovnim časom izločanja 4,5 in 4,7 dni.
English: A similar percentage of patients achieved HbA1c targets of < 8.0 % at 26 and 52 weeks with both dulaglutide doses as well as insulin glargine.
Slovenian: Podoben odstotek bolnikov je dosegel ciljne vrednosti HbA1c < 8,0 % v 26. in 52. tednu, tako z odmerki dulaglutida kot insulina glargina.
English: Following coadministration of multiple dose dulaglutide with steady state metformin (immediate release formula [IR]), metformin AUCτ increased up to 15 % and Cmax decreased up to 12 %, respectively, with no changes in tmax.
Slovenian: (zdravilo s takojšnjim sproščanjem [IR - immediate release]), je AUCτ metformina narasla do 15 %, Cmax pa se je zmanjšal do 12 %, brez sprememb v tmax.
English: This medicinal product contains less than 1 mmol sodium (23 mg) per 1.5 mg dose, i.e. essentially ‘sodium- free'.
Slovenian: Vsebnost natrija To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek 1,5 mg, kar v bistvu pomeni »brez natrija«.
English: In a 52 week study, Trulicity 1.5 mg and 0.75 mg were compared to titrated insulin glargine as add-on to prandial insulin lispro to evaluate the effect on glycaemic control and safety of patients with moderate to severe chronic kidney disease (eGFR [by CKD-EPI] <60 and ≥15 mL/min/1.73 m2).
Slovenian: Uporaba pri bolnikih z okvarjenim delovanjem ledvic V 52-tedenski študiji so odmerka zdravila Trulicity 1,5 mg in 0,75 mg primerjali s titriranim insulinom glarginom kot dodatkom prandialnemu insulinu lispro, za ocenjevanje učinka na glikemični nadzor in varnost bolnikov z zmerno do hudo ledvično boleznijo (eGFR [po CKD-EPI] < 60 in ≥ 15 ml/min/1,73 m2).
English: If there are less then 3 days before your next dose is due, skip the dose and inject the next one on your regular scheduled day.
Slovenian: Če pa ostanejo manj kot 3 dnevi do vašega naslednjega predpisanega odmerka, preskočite odmerek in vzemite naslednji odmerek na naslednji predpisani dan.
English: Cases of anaphylactic reaction have been rarely reported with marketed use of dulaglutide.
Slovenian: V času trženja dulaglutida so redko poročali o primerih anafilaktične reakcije.
English: Dehydration
Slovenian: dehidracija
English: These observations are not clinically relevant.
Slovenian: Te ugotovitve niso klinično pomembne.
English: Marketing Authorisation Holder Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.
Slovenian: Imetnik dovoljenja za promet z zdravilom Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, Nizozemska
English: Non-clinical data reveal no special hazards for humans based on conventional studies of safety pharmacology or repeat-dose toxicity.
Slovenian: Neklinični podatki na osnovi običajnih študij farmakološke varnosti in toksičnosti pri ponavljajočih se odmerkih ne kažejo posebnega tveganja za človeka.
English: Please read these Instructions for use and the Information for the patient carefully and completely before using your pre-filled syringe.
Slovenian: Natančno in v celoti preberite ta navodila za uporabo in navodilo za bolnika, preden začnete z uporabo svoje napolnjene injekcijske brizge Trulicity.
English: • Store your syringe in the refrigerator.
Slovenian: • Svoj peresnik shranjujte v hladilniku.
English: • If you have any questions or problems with your Trulicity pen, contact your doctor, pharmacist or nurse.
Slovenian: • Če imate vprašanja ali težave z vašo napolnjeno injekcijsko brizgo Trulicity, se obrnite na zdravnika, farmacevta ali medicinsko sestro.
English: 1 UNCAP Pull off and discard the needle cover.
Slovenian: • Snemite in zavrzite pokrovček igle.
English: What you need to know before you use Trulicity
Slovenian: Kaj morate vedeti, preden boste uporabili zdravilo Trulicity Ne uporabljajte zdravila Trulicity
English: Type 2 diabetes patients were randomly allocated to either Trulicity 1.5 mg (4,949) or placebo (4,952) both in addition to standards of care for type 2 diabetes (the 0.75 mg dose was not administered in this study).
Slovenian: Bolnikom s sladkorno boleznijo tipa 2 je bilo naključno dodeljeno zdravljenje z zdravilom Trulicity 1,5 mg (4949) ali s placebom (4952), oboje poleg standardnega zdravljenja za sladkorno bolezen tipa 2.
English: It is unknown whether dulaglutide is excreted in human milk.
Slovenian: Ni znano, ali se dulaglutid izloča v materino mleko.
English: Dulaglutide improves glycaemic control through the sustained effects of lowering fasting, pre-meal and postprandial glucose concentrations in patients with type 2 diabetes starting after the first dulaglutide administration and is sustained throughout the once weekly dosing interval.
Slovenian: Dulaglutid izboljšuje glikemično urejenost prek trajnih učinkov zniževanja koncentracije glukoze pri bolnikih s sladkorno boleznijo tipa 2, in sicer koncentracije glukoze na tešče, pred obroki in po zaužitju hrane.
English: Drops of liquid on the tip of the needle are not unusual and will not affect your dose.
Slovenian: Kapljice tekočine niso nič neobičajnega in ne bodo vplivale na vaš odmerek.
English: Dulaglutide 1.5 mg once weekly and insulin glargine (n=150)
Slovenian: Dulaglutid 1,5 mg enkrat na teden in insulin glargin (n=150)
English: A significant and sustained reduction in HbA1c levels from baseline to month 60 was observed with Trulicity vs placebo, in addition to standard of care (-0.29 % vs 0.22 %; estimated treatment difference -0.51 % [-0.57; -0.45]; p < 0.001).
Slovenian: Pri zdravilu Trulicity so v primerjavi s placebom (oboje so bolniki prejemali poleg standardnega zdravljenja), opazili pomembno in trajno znižanje vrednosti HbA1c od izhodišča do 60. meseca (-0,29 % v primerjavi z 0,22 %; ocenjena razlika med zdravljenjema -0,51 % [-0,57; -0,45]; p < 0,001).
English: The severe hypoglycaemia event incidences were 2.4% and 3.4%, and rates were 0.05 and 0.06 events/patient/year.
Slovenian: Pojavnost dogodkov hude hipoglikemije je znašala 2,4 % oziroma 3,4 %, stopnje pa 0,05 oziroma 0,06 dogodkov/bolnika/leto.
English: A drop of liquid on the tip of the needle is not unusual and will not affect your dose.
Slovenian: Kapljica tekočine ni nič neobičajnega in ne bo vplivala na vaš odmerek.
English: Contact your doctor if you have any questions or concerns.
Slovenian: V primeru vprašanj ali pomislekov se obrnite na zdravnika.
English: Combination therapy with SGLT2 inhibitor with or without metformin The safety and efficacy of dulaglutide as add-on to sodium-glucose co-transporter 2 inhibitor (SGLT2i) therapy (96% with and 4% without metformin) were investigated in a placebo controlled study of 24 weeks duration.
Slovenian: Varnost in učinkovitost dulaglutida kot dodatka zdravljenju z zaviralcem natrijevih glukoznih koprenašalcev 2 (SGLT2i) (pri 96 % z metforminom in pri 4 % brez metformina) so preučevali v študiji, nadzorovani s placebom, ki je trajala 24 tednov.
English: A greater percentage of patients achieved HbA1c targets of < 7.0 % or ≤ 6.5 % at 26 weeks and < 7.0 % at 52 weeks than with insulin glargine.
Slovenian: Večji odstotek bolnikov je dosegel ciljne vrednosti HbA1c < 7,0 % ali ≤ 6,5 % v 26. tednu in < 7,0 % v 52. tednu kot z insulinom glarginom.
English: Two cases of severe hypoglycaemia were observed with Trulicity 1.5mg and two cases of severe hypoglycaemia were observed with insulin glargine.
Slovenian: Opazili so dva primera hude hipoglikemije z zdravilom Trulicity 1,5 mg in dva primera hude hipoglikemije z insulinom glarginom.
English: Trulicity is used: on its own if your blood sugar is not properly controlled by diet and exercise alone, and you can't take metformin (another diabetes medicine).
Slovenian: - samostojno, če vaš krvni sladkor ni ustrezno uravnan samo z dieto in telesno vadbo in ne smete jemati metformina (drugo zdravilo za zdravljenje sladkorne bolezni).
English: Unlock by turning the lock ring.
Slovenian: Odklenite z obračanjem zaklepnega obroča.
English: Gently grasp a fold of skin at the injection site.
Slovenian: Nežno primite kožno gubo na mestu injiciranja.
English: The pre-filled syringe is for single-use only.
Slovenian: Napolnjeni peresnik je namenjen le za enkratno uporabo.
English: # p < 0.05 dulaglutide treatment group compared to liraglutide.
Slovenian: # p < 0,05 skupina, zdravljena z dulaglutidom v primerjavi z liraglutidom.
English: For dulaglutide 0.75 mg, adverse reaction met frequency for next lower incidence grouping.
Slovenian: † Samo za dulaglutid v odmerku 1,5 mg. Za dulaglutid v odmerku 0,75 mg je neželeni učinek ustrezal pogostnosti za naslednjo najnižjo razvrstitev po incidenci.
English: 100 mg once daily (n=315)
Slovenian: 100 mg enkrat na dan (n=315)
English: Combination therapy with titrated basal insulin, with or without metformin In a 28 week placebo controlled study, Trulicity1.5 mg was compared to placebo as add-on to titrated basal insulin glargine (88% with and 12% without metformin) to evaluate the effect on glycaemic control and safety.
Slovenian: Kombinirano zdravljenje s titriranim bazalnim insulinom z metforminom ali brez njega V 28-tedenski študiji, nadzorovani s placebom, so primerjali zdravilo Trulicity 1,5 mg s placebom kot dodatek titriranemu bazalnemu insulinu glarginu (88 % z metforminom in 12 % brez metformina) za oceno učinka glikemičnega nadzora in varnosti.
English: PLACE AND UNLOCK PRESS AND HOLD
Slovenian: NAMESTITE IN ODKLENITE PRITISNITE IN DRŽITE
English: Treatment with Trulicity 1.5mg in combination with glimepiride resulted in a statistically significant reduction in HbA1c compared to placebo with glimepiride at 24 weeks.
Slovenian: Zdravljenje z zdravilom Trulicity 1,5 mg v kombinaciji z glimepiridom je v 24. tednu povzročilo statistično pomembno zmanjšanje HbA1c, v primerjavi s placebom z glimepiridom.
English: Hypoglycaemia* (when used in combination with insulin, glimepiride, metformin† or metformin plus glimepiride)
Slovenian: Presnovne in prehranske motnje hipoglikemija* (ob uporabi v kombinaciji z insulinom, glimepiridom, metforminom† ali metforminom in glimepiridom)