FrancophonIA/ELRC3.0 huggingface dataset:
English: In the study of patients inadequately controlled on metformin with baseline HbA1c from 7.5-11.0%, among the subgroup of patients with a baseline HbA1c ≥ 10%, the combination of ertugliflozin 5 mg or 15 mg with sitagliptin resulted in reductions of HbA1c of 2.35% and 2.66%, respectively, compared to 2.10%, 1.30%, and 1.82% for ertugliflozin 5 mg, ertugliflozin 15 mg, and sitagliptin alone, respectively.
Slovenian: Učinkovitost pri bolnikih z izhodiščnim HbA1c ≥ 10 % V študiji pri bolnikih z nezadostno nadzorovano hiperglikemijo ob zdravljenju z metforminom z izhodiščnim HbA1c od 7,5 do 11,0 % je med podskupino bolnikov z izhodiščnim HbA1c ≥ 10 % kombinacija ertugliflozina 5 mg oz. 15 mg s sitagliptinom zmanjšala HbA1c za 2,35 % oz. 2,66 % v primerjavi z 2,10 %, 1,30 % oz. 1,82 % za ertugliflozin 5 mg, ertugliflozin 15 mg oz. sitagliptinuporabljenih samostojno.
English: Steglujan should be discontinued when eGFR is persistently less than 45 ml/min/1.73 m 2 or CrCl is persistently less than 45 ml/min.
Slovenian: Zdravilo Steglujan je treba ukiniti, kadar je eGFR neprestano manj kot 45 ml/min/1,73 m 2 ali CrCl neprestano manj kot 45 ml/min.
English: Table 4: Results at Week-26 from a combination therapy study of ertugliflozin and sitagliptin*
Slovenian: Preglednica 4: Rezultati študije kombiniranega zdravljenja z ertugliflozinom in sitagliptinom po 26. tednih*
English: The safety of concomitantly administered ertugliflozin and sitagliptin has been evaluated in 990 patients with type 2 diabetes mellitus treated for 26 weeks in three studies; a factorial study of ertugliflozin 5 mg or 15 mg in combination with sitagliptin 100 mg once daily compared to the individual components, a placebo-controlled study of ertugliflozin 5 mg or 15 mg as add-on therapy to sitagliptin 100 mg and metformin once daily, and a placebo-controlled study of initial therapy with ertugliflozin 5 mg or 15 mg once daily in combination with sitagliptin 100 mg once daily (see section 5.1).
Slovenian: Varnost sočasne uporabe ertugliflozina in sitagliptina so ocenili pri 990 bolnikih s sladkorno boleznijo tipa 2, ki so bili 26 tednov zdravljeni v treh študijah: faktorski študiji ertugliflozina v odmerku 5 mg ali 15 mg v kombinaciji s sitagliptinom v odmerku 100 mg enkrat na dan v primerjavi s posameznima sestavinama; s placebom nadzorovani študiji ertugliflozina v odmerku 5 mg ali 15 mg dodanega sitagliptinu v odmerku 100 mg in metforminu enkrat na dan; in s placebom nadzorovani študiji začetnega zdravljenja z ertugliflozinom v odmerku 5 mg ali 15 mg enkrat na dan v kombinaciji s 100 mg sitagliptina enkrat na dan (glejte poglavje 5.1).
English: In vitro, sitagliptin did not inhibit OAT3 (IC50=160 M) or p-glycoprotein (up to 250 M) mediated transport at therapeutically relevant plasma concentrations.
Slovenian: Sitagliptin in vitro pri terapevtsko pomembnih plazemskih koncentracijah ni zaviral prenosa z OAT3 (IC50 = 160 M) ali s p-glikoproteinom (do 250 M).
English: In drug interaction studies, sitagliptin did not have clinically meaningful effects on the pharmacokinetics of the following: metformin, rosiglitazone, glyburide, simvastatin, warfarin, and oral contraceptives.
Slovenian: V kliničnih študijah medsebojnega delovanja sitagliptin ni imel klinično pomembnega učinka na farmakokinetiko metformina, rosiglitazona, gliburida, simvastatina, varfarina in peroralnih kontraceptivov.
English: These patients, who were not receiving any background antihyperglycaemic treatment, were randomised to ertugliflozin 5 mg or ertugliflozin 15 mg in combination with sitagliptin (100 mg) or to placebo, once daily (see Table 4).
Slovenian: Te bolnike, ki niso prejemali nobenega osnovnega antihiperglikemičnega zdravljenja, so randomizirali tako, da so prejemali ertugliflozin 5 mg ali ertugliflozin 15 mg v kombinaciji s sitagliptinom (100 mg) ali placebo enkrat na dan (glejte preglednico 4).
English: Least squares means adjusted for treatment, time, prior antihyperglycaemic medication.
Slovenian: povprečja po metodi najmanjših kvadratov, prilagojena za zdravljenje, čas in predhodno antihiperglikemično zdravljenje p < 0,001 v primerjavi s placebom
English: Steglujan 5 mg/100 mg film-coated tablets EU/1/18/1266/001
Slovenian: Steglujan 5 mg/100 mg filmsko obložene tablete EU/1/18/1266/001
English: Fatal and non-fatal haemorrhagic and necrotising pancreatitis
Slovenian: hemoragični in nekrotizirajoči pankreatitis s smrtnim izidom ali brez
English: TECOS (trial evaluating cardiovascular outcomes with sitagliptin) The cardiovascular safety study with sitagliptin (TECOS) included 7,332 patients treated with sitagliptin, 100 mg daily (or 50 mg daily if the baseline eGFR was ≥ 30 and < 50 ml/min/1.73 m2), and
Slovenian: TECOS (Trial Evaluating Cardiovascular Outcomes with Sitagliptin) Študija srčno-žilne varnosti s sitagliptinom (TECOS) je v populaciji z namenom zdravljenja vključevala 7.332 bolnikov, ki so prejemali 100 mg sitagliptina na dan (ali 50 mg na dan, če so imeli izhodiščno eGFR ≥ 30 in < 50 ml/min/1,73 m2), in 7.339 bolnikov, ki so prejemali placebo.
English: If a hypersensitivity reaction is suspected, Steglujan should be discontinued.
Slovenian: Če obstaja sum na preobčutljivostno reakcijo, morate prenehati zdravljenje z zdravilom Steglujan.
English: • yeast infections of the penis
Slovenian: Pogosti • glivične okužbe penisa,
English: The combination of ertugliflozin 5 or 15 mg with sitagliptin resulted in statistically significant placebo-corrected reductions in 2-hour PPG of 3.46 and 3.87 mmol/l.
Slovenian: Kombinacija 5 mg oz. 15 mg ertugliflozina s sitagliptinom je statistično značilno znižala za placebo korigirano koncentracijo glukoze 2 uri po obroku za 3,46 oz. 3,87 mmol/l.
English: No studies in lactating animals have been conducted with the combined components of Steglujan.
Slovenian: Študij s kombiniranima sestavinama zdravila Steglujan na doječih živalih niso izvedli.
English: There are no data from the use of Steglujan in pregnant women.
Slovenian: O uporabi zdravila Steglujan pri nosečnicah ni podatkov.
English: Table 3: Results at Week 26 from an add-on study of ertugliflozin in combination with metformin and sitagliptin*
Slovenian: Preglednica 3: Rezultati študije dodatka ertugliflozina v kombinaciji z metforminom in sitagliptinom po 26 tednih*
English: Diabetic Ketoacidosis (ertugliflozin)
Slovenian: Diabetična ketoacidoza (ertugliflozin)
English: Ertugliflozin and Sitagliptin
Slovenian: Ertugliflozin in sitagliptin
English: Since coadministration of a high-fat meal with sitagliptin had no effect on the pharmacokinetics, Steglujan may be administered with or without food.
Slovenian: Sočasno zaužitje sitagliptina ter obroka z veliko maščobami ni vplivalo na farmakokinetiko, zato se zdravilo Steglujan lahko jemlje s hrano ali brez nje.
English: , Haemoglobin increased
Slovenian: , zvišanje hemoglobina zvišanje BUN
English: Assessment of renal function is recommended prior to initiation of Steglujan and periodically thereafter (see section 4.4).
Slovenian: Pred uvedbo zdravila Steglujan je priporočljivo oceniti delovanje ledvic in te kontrole pozneje redno ponavljati (glejte poglavje 4.4).
English: Ertugliflozin as add-on combination therapy with metformin and sitagliptin A total of 463 patients, with type 2 diabetes inadequately controlled on metformin (≥ 1,500 mg/day) and sitagliptin 100 mg once daily participated in a randomised, double-blind, multi-centre, 26-week, placebo-controlled study to evaluate the efficacy and safety of ertugliflozin.
Slovenian: Ertugliflozin kot dodatek h kombiniranemu zdravljenju z metforminom in sitagliptinom Skupno 463 bolnikov s sladkorno boleznijo tipa 2, neustrezno urejenih s kombinacijo metformina (≥ 1.500 mg/dan) in 100 mg sitagliptina enkrat na dan, je sodelovalo v randomizirani, dvojno slepi, multicentrični, 26-tedenski, s placebom nadzorovani študiji za oceno učinkovitosti in varnosti ertugliflozina.
English: Paediatric No studies with sitagliptin have been performed in paediatric patients.
Slovenian: Pediatrični bolniki Pri pediatričnih bolnikih študij s sitagliptinom niso izvedli.
English: Hypersensitivity reactions including anaphylactic responses*
Slovenian: Bolezni imunskega sistema neznana pogostnost preobčutljivostne reakcije, vključno z anafilaktičnimi odzivi*
English: Patients were randomised to ertugliflozin 5 mg, ertugliflozin 15 mg, or placebo administered once daily in addition to continuation of background metformin and sitagliptin therapy (see Table 3).
Slovenian: Bolnike so randomizirali tako, da so prejemali ertugliflozin 5 mg, ertugliflozin 15 mg ali placebo enkrat na dan kot dodatek k osnovnemu zdravljenju z metforminom in sitagliptinom (glejte preglednico 3).
English: Following administration of an oral C]-ertugliflozin solution to healthy subjects, approximately 41% and 50% of the drug-related radioactivity was eliminated in faeces and urine, respectively.
Slovenian: C]-ertugliflozina pri zdravih osebah se je v blatu izločilo približno 41 % z zdravilom povezane radioaktivnosti in v urinu približno 50 %.
English: Packs of 14, 28, 30, 84, 90 and 98 film-coated tablets in non-perforated blisters.
Slovenian: Alu/PVC/PA/Alu pretisni omoti Pakiranja po 14, 28, 30, 84, 90 in 98 filmsko obloženih tablet v neperforiranih pretisnih omotih.
English: Patients with type 2 diabetes inadequately controlled on metformin monotherapy (≥ 1,500 mg/day) were randomised to one of five active-treatment arms: ertugliflozin 5 mg or 15 mg, sitagliptin 100 mg, or sitagliptin 100 mg in combination with 5 mg or 15 mg ertugliflozin administered once daily in addition to continuation of background metformin therapy (see Table 2).
Slovenian: Bolnike s sladkorno boleznijo tipa 2 in neustrezno urejene s samostojnim zdravljenjem z metforminom (≥ 1.500 mg/dan) so randomizirali v eno od petih skupin z aktivnim zdravljenjem: ertugliflozin 5 mg ali 15 mg, sitagliptin 100 mg ali sitagliptin 100 mg v kombinaciji s 5 mg ali 15 mg ertugliflozina enkrat na dan ob hkratnem nadaljevanju osnovnega zdravljenja z metforminom (glejte preglednico 2).
English: Incidence rate per patientyears*
Slovenian: Delež pojavnosti na 100 bolnik-let*
English: When Steglujan is used in combination with insulin or an insulin secretagogue, a lower dose of insulin or the insulin secretagogue may be required to reduce the risk of hypoglycaemia (see sections 4.4, 4.5, and 4.8).
Slovenian: Če se zdravilo Steglujan uporablja v kombinaciji z insulinom ali insulinskim sekretagogom, bo morda potreben manjši odmerek insulina ali insulinskega sekretagoga, da bi se zmanjšalo tveganje za hipoglikemijo (glejte poglavja 4.4, 4.5 in 4.8).
English: The proportion of subjects having any occurrence of BUN values ≥50% increase and value >ULN was numerically higher in the ertugliflozin 5 mg group and higher in the 15 mg group (7.9% and 9.8%, respectively) relative to the placebo group (5.1%).
Slovenian: Delež oseb, pri katerih so se vrednosti dušika sečnine v krvi (BUN - blood urea nitrogen) kadar koli zvišale za ≥ 50 % in bile > ZMN, je bil številčno večji v skupini, ki je prejemala 5 mg oz. 15 mg ertugliflozina (7,9 % oz. 9,8 %) glede na skupino, ki je prejemala placebo (5,1 %).
English: In vitro assessment of sitagliptin
Slovenian: Ocena sitagliptina in vitro
English: 1, Blood creatinine increased/Glomerular filtration rate decreased
Slovenian: 1, zvišanje kreatinina v krvi/zmanjšanje hitrosti glomerulne filtracije okvara ledvične funkcije a,2
English: Renal and liver toxicity were observed in rodents at systemic exposure values 58 times the human exposure level, while the no-effect level was found at 19 times the human exposure level.
Slovenian: Pri glodalcih so pri sistemski izpostavljenosti, ki je bila 58-krat večja od izpostavljenosti pri človeku, opazili škodljive učinke na ledvice in jetra, izpostavljenost brez škodljivih učinkov pa je bila 19-krat večja od izpostavljenosti pri človeku.
English: There is no clinical experience in patients with severe hepatic impairment (Child-Pugh score > 9).
Slovenian: Pri bolnikih s hudo okvaro jeter (ocena po Child-Pugh-u > 9) kliničnih izkušenj ni.
English: Arthralgia a,2
Slovenian: artropatija a,2
English: These characteristics had no clinically meaningful effect on the pharmacokinetics of sitagliptin based on a composite analysis of Phase 1 pharmacokinetic data and on a population pharmacokinetic analysis of Phase 1 and Phase 2 data.
Slovenian: Na osnovi sestavljene analize farmakokinetičnih podatkov iz 1. faze in analize populacijske farmakokinetike na osnovi podatkov iz 1. in 2. faze te značilnosti nimajo kliničnega pomena za farmakokinetiko sitagliptina.
English: Additionally, when added on to background metformin and sitagliptin therapy, ertugliflozin 5 mg and 15 mg resulted in statistically significant placebo subtracted reductions in SBP of 2.9 and 3.9 mmHg, respectively.
Slovenian: Prav tako je z dodajanjem k osnovnemu zdravljenju z metforminom in sitagliptinom prišlo do statistično pomembnih s placebom korigiranih znižanj SBP (za ertugliflozin 5 mg 2,9 mmHg, za ertugliflozin 15 mg pa 3,9 mmHg).
English: Baseline (mean) Change from baseline (LS mean Difference from Sitagliptin Ertugliflozin 5 mg Ertugliflozin 15 mg (LS mean
Slovenian: Izhodišče (povprečje) Sprememba od izhodišča (povprečje LS Razlika v primerjavi s sitagliptinom ertugliflozinom 5 mg ertugliflozinom 15 mg (povprečje LS
English: p< 0.001 compared to corresponding dose of ertugliflozin or sitagliptin (based on adjusted odds ratio comparisons from a logistic regression model using multiple imputation for missing data values).
Slovenian: † povprečja po metodi najmanjših kvadratov so prilagojena na podlagi longitudinalnega modela z vključenimi členi za zdravljenje, čas in interakcijo med časom in zdravljenjem ‡ p < 0,001 v primerjavi s placebom § p < 0,001 v primerjavi s placebom (na podlagi primerjave prilagojenih razmerij obetov iz modela logistične regresije z uporabo metode večkratne imputacije za manjkajoče podatke)
English: The level of digoxin in your blood may need to be checked if you are taking it with Steglujan.
Slovenian: Med sočasnim jemanjem z zdravilom Steglujan vam bodo morda morali preveriti vrednosti digoksina v krvi.
English: Acute renal failure a,2
Slovenian: akutna odpoved ledvic a,2
English: Incidenc e rate per 100 patientyears* N (%)
Slovenian: Delež pojavnosti na 100 bolniklet*
English: o Tablet coat: hypromellose (E464), hydroxypropyl cellulose (E463), titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172), iron oxide black (E172), carnauba wax (E903).
Slovenian: • Druge sestavine zdravila so: o Jedro tablete: mikrokristalna celuloza (E460), kalcijev hidrogenfosfat (brezvodni), premreženi natrijev karmelozat, natrijev stearilfumarat (E487), magnezijev stearat (E470b) o Filmska obloga: hipromeloza (E464), hidroksipropilceluloza (E463), titanov dioksid (E171), rdeči železov oksid (E172), rumeni železov oksid (E172), črni železov oksid (E172), karnauba vosek (E903)
English: In a pre-/post-natal development study performed in rats sitagliptin showed no adverse effects.
Slovenian: Študije, izvedene s sitagliptinom na podganah, niso pokazale neželenih vplivov na pre-/post-natalni razvoj.
English: Sitagliptin is a member of a class of oral antihyperglycaemic agents called dipeptidyl peptidase 4 (DPP-4) inhibitors.
Slovenian: Sitagliptin spada v skupino peroralnih antidiabetikov, imenovanih zaviralci DPP-4.
English: What Steglujan is used for
Slovenian: Za kaj uporabljamo zdravilo Steglujan
English: How to store Steglujan
Slovenian: Kako jemati zdravilo Steglujan
English: Steglujan should not be used during breast-feeding.
Slovenian: Zdravila Steglujan se med dojenjem ne sme uporabljati.
English: Sitagliptin is modestly dialysable.
Slovenian: Sitagliptin se zmerno dializira.
English: Cutaneous vasculitis a,
Slovenian: bulozni pemfigoid a,
English: The apparent terminal t1/2 following a 100-mg oral dose of sitagliptin was approximately
Slovenian: Po prejemu 100 mg peroralnega odmerka sitagliptina je navidezni končni t1/2 znašal približno 12,4 ure.
English: When used in monotherapy, ertugliflozin 5 and 15 mg resulted in statistically significant placebocorrected reductions in 2-hour post-prandial glucose (PPG) of 3.83 and 3.74 mmol/l.
Slovenian: Pri samostojnem zdravljenju je ertugliflozin statistično značilno znižal za placebo korigirano koncentracijo glukoze 2 uri po obroku, in sicer odmerek 5 mg za 3,83 mmol/l in odmerek 15 mg za 3,74 mmol/l.
English: Headache Dizziness
Slovenian: Srčno popuščanje
English: Hypoglycaemia has been observed when sitagliptin was used in combination with insulin or a sulphonylurea.
Slovenian: Med uporabo sitagliptina v kombinaciji z insulinom ali s sulfonilsečnino so opažali hipoglikemijo.
English: Adverse reaction with sitagliptin.
Slovenian: Neželeni učinki, povezani s sitagliptinom.
English: Steglujan should not be initiated in patients with an eGFR below 60 ml/min/1.73 m 2 or CrCl below 60 ml/min.
Slovenian: Zdravila Steglujan se ne sme uvesti pri bolnikih z eGFR pod 60 ml/min/1,73 m ali CrCl pod
English: No dose adjustment of Steglujan is necessary in patients with mild or moderate hepatic impairment.
Slovenian: Pri bolnikih z blago ali zmerno okvaro jeter prilagoditev odmerka zdravila Steglujan ni potrebna.
English: Secondary Outcome Cardiovascular death
Slovenian: Srčno-žilna smrt
English: 0.5% for ertugliflozin 5 mg, ertugliflozin 15 mg and the comparator group and for subjects with eGFR 45 to < 60 mL/min/1.73 m2, the incidence was 6.4%, 3.7% and 0% respectively.
Slovenian: Med osebami z eGFR < 60 ml/min/1,73 m2 je bila pojavnost v skupini s 5 mg ertugliflozina 5,1 %, v skupini s 15 mg ertugliflozina 2,6 % in v primerjalni skupini 0,5 %, med osebami z eGFR od 45 do < 60 ml/min/1,73 m2 pa so bile pojavnosti 6,4 % v skupini s 5 mg ertugliflozina, 3,7 % v skupini s 15 mg ertugliflozina in 0 % v primerjalni skupini.
English: • nausea/vomiting
Slovenian: • siljenje na bruhanje/bruhanje.
English: CI)
Slovenian: a
English: Back pain a,2
Slovenian: bolečine v hrbtu a,2
English: Primary Composite Endpoint (Cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or hospitalisation for unstable angina)
Slovenian: Primarni sestavljeni opazovani dogodek (Srčno-žilna smrt, miokardni infarkt brez smrtnega izida, možganska kap brez smrtnega izida ali sprejem v bolnišnico zaradi nestabilne angine pektoris) 839 (11,4)
English: No dose adjustment of Steglujan is recommended based on age.
Slovenian: Prilagoditev odmerka zdravila Steglujan glede na starost ni potrebna.
English: Therefore, a lower dose of insulin or an insulin secretagogue may be required to reduce the risk of hypoglycaemia when used in combination with Steglujan (see sections 4.2, 4.4, and 4.8).
Slovenian: Za zmanjšanje tveganja za hipoglikemijo bo zato v kombinaciji z zdravilom Steglujan morda potreben manjši odmerek insulina ali insulinskega sekretagoga (glejte poglavja 4.2, 4.4 in 4.8).
English: No dose adjustment for sitagliptin is necessary for patients with mild or moderate hepatic impairment (Child-Pugh score  9).
Slovenian: Pri bolnikih z blago ali zmerno okvaro jeter (ocena po Child-Pugh-u  9) odmerka sitagliptina ni treba prilagoditi.
English: Temporary interruption of treatment with Steglujan should be considered until the fluid loss is corrected.
Slovenian: Dokler izguba tekočine ni odpravljena, pride v poštev začasna prekinitev zdravljenja z zdravilom Steglujan.
English: Sitagliptin is also a substrate of P-gp, which may also be involved in mediating the renal elimination of sitagliptin.
Slovenian: Sitagliptin je tudi substrat za p-glikoprotein, ki je prav tako lahko vključen pri izločanju sitagliptina skozi ledvice, vendar pa ciklosporin, zaviralec p-glikoproteina, ni zmanjšal ledvičnega očistka sitagliptina.
English: If pancreatitis is suspected, Steglujan and other potentially suspect medicinal products should be discontinued; if acute pancreatitis is confirmed, Steglujan should not be restarted.
Slovenian: Ob sumu na pankreatitis je treba prenehati z jemanjem zdravila Steglujan in drugih zdravil, ki bi lahko povzročila pankreatitis.
English: Do not drive or use any tools or machines if you feel dizzy while taking Steglujan.
Slovenian: Če se med jemanjem zdravila Steglujan počutite omotični, ne upravljajte vozil in ne uporabljajte nobenega orodja ali strojev.
English: Consideration may also be given to stopping treatment with ertugliflozin/sitagliptin in patients who develop events which may precede amputation such as lower-extremity skin ulcer, infection, osteomyelitis or gangrene.
Slovenian: Pri bolnikih, pri katerih se pojavijo dogodki, ki lahko vodijo do amputacije, kot so kožne razjede na spodnjih okončinah, okužba, osteomielitis ali gangrena, je treba razmisliti o prekinitvi zdravljenja z ertugliflozinom/sitagliptinom.
English: In addition, patients should be alerted to the risk of hypoglycaemia when Steglujan is used in combination with insulin or an insulin secretagogue and to the elevated risk of adverse reactions related to volume depletion, such as postural dizziness (see sections 4.2, 4.4, and
Slovenian: Če se zdravilo Steglujan uporablja v kombinaciji z insulinom ali insulinskim sekretagogom, je treba poleg tega bolnike opozoriti na tveganje za hipoglikemijo in na povečano tveganje za neželene učinke, povezane s hipovolemijo, kot je posturalna omotica (glejte poglavja 4.2, 4.4 in 4.8).
English: Following oral administration of a 100-mg dose to healthy subjects, sitagliptin was rapidly absorbed, with peak plasma concentrations (median Tmax) occurring 1 to 4 hours post-dose.
Slovenian: Po peroralni uporabi 100 mg odmerka pri zdravih osebah se je sitagliptin hitro absorbiral; največje koncentracije v plazmi (mediana vrednost tmax) so se pojavile v 1 do 4 urah po odmerku, povprečna vrednost AUC sitagliptina v plazmi je bila 8,52 M•ur, vrednost Cmax je bila 950 nM. Absolutna biološka uporabnost sitagliptina je približno 87 %.
English: Steglujan 5 mg/100 mg film-coated tablets Steglujan 15 mg/100 mg film-coated tablets
Slovenian: Steglujan 5 mg/100 mg filmsko obložene tablete Steglujan 15 mg/100 mg filmsko obložene tablete
English: Death from any cause
Slovenian: Smrt zaradi katerega koli vzroka 547 (7,5)
English: Steglujan 15 mg/100 mg tablets ertugliflozin/sitagliptin
Slovenian: Steglujan 15 mg/100 mg tablete ertugliflozin/sitagliptin
English: The proportion of subjects having at least 1 increase in haemoglobin > 2.0 g/dL was higher in the ertugliflozin 5 mg and 15 mg groups (4.7% and 4.1%, respectively) compared to the placebo group (0.6%).
Slovenian: Mediana sprememb v odstotkih od izhodišča za 5 mg oz. 15 mg ertugliflozina v primerjavi s placebom je znašala za trigliceride -3,9 % oz. -1,7 % za ertugliflozin in 4,5 % za placebo Delež oseb z najmanj 1 povečanjem hemoglobina > 2,0 g/dl je bil večji v skupinah, v katerih so prejemali 5 mg oz. 15 mg ertugliflozina (4,7 % oz. 4,1 %) kot v skupini, ki je prejemala placebo (0,6 %).
English: The mean volume of distribution at steady state following a single 100-mg intravenous dose of sitagliptin to healthy subjects is approximately 198 l. The fraction of sitagliptin reversibly bound to plasma proteins is low (38%).
Slovenian: Pri zdravih osebah je povprečni volumen porazdelitve v stanju dinamičnega ravnovesja po enkratnem 100 mg intravenskem odmerku sitagliptina približno 198 litrov.
English: Steglujan 15 mg/100 mg film-coated tablets
Slovenian: Steglujan 15 mg/100 mg filmsko obložene tablete
English: Steglujan 5 mg/100 mg film-coated tablets Steglujan 15 mg/100 mg film-coated tablets ertugliflozin/sitagliptin
Slovenian: Steglujan 5 mg/100 mg filmsko obložene tablete Steglujan 15 mg/100 mg filmsko obložene tablete ertugliflozin/sitagliptin
English: Immune system disorders
Slovenian: Po uporabi peroralne raztopine
English: Steglujan 5 mg/100 mg tablets ertugliflozin/sitagliptin
Slovenian: Steglujan 5 mg/100 mg tablete ertugliflozin/sitagliptin
English: Therefore, a lower dose of insulin or insulin secretagogue may be required to minimise the risk of hypoglycaemia when used in combination with Steglujan (see sections 4.2 and 4.5).
Slovenian: Da bi zmanjšali tveganje za hipoglikemijo, bo pri uporabi v kombinaciji z zdravilom Steglujan morda potreben manjši odmerek insulina ali insulinskega sekretagoga (glejte poglavji 4.2 in 4.5).