FrancophonIA/ELRC3.0 huggingface dataset:
English: In the rat fertility and embryonic development study, male and female rats were administered ertugliflozin at 5, 25, and 250 mg/kg/day.
Slovenian: V študiji plodnosti in razvoja zarodka pri podganah so podganji samci in samice prejemali ertugliflozin v odmerkih 5, 25 in 250 mg/kg/dan.
English: The safety of concomitantly administered ertugliflozin and metformin has been evaluated in 1,083 patients with type 2 diabetes mellitus treated for 26 weeks in a pool of two placebo-controlled trials: as ertugliflozin add on therapy to metformin and as ertugliflozin add-on therapy to sitagliptin and metformin (see section 5.1).
Slovenian: Varnost sočasne uporabe ertugliflozina in metformina so ocenili pri 1.083 bolnikih s sladkorno boleznijo tipa 2, ki so se 26 tednov zdravili v dveh združenih, s placebom nadzorovanih preskušanjih: z ertugliflozinom kot dodatnim zdravilom k metforminu in z ertugliflozinom kot dodatnim zdravilom k sitagliptinu in metforminu (glejte poglavje 5.1).
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, acute toxicity, repeated dose toxicity, genotoxicity, and carcinogenic potential.
Slovenian: Predklinični podatki na osnovi običajnih študij farmakološke varnosti, akutne toksičnosti, toksičnosti pri ponavljajočih se odmerkih, genotoksičnosti in kancerogenega potenciala ne kažejo posebnega tveganja za človeka.
English: Maximum daily dose is 15 mg.
Slovenian: Največji dnevni odmerek je 15 mg.
English: Segluromet contains two active substances, ertugliflozin and metformin.
Slovenian: Zdravilo Segluromet vsebuje dve različni učinkovini, imenovani ertugliflozin in metformin.
English: Erythema 2, Pruritus 2, Urticaria
Slovenian: Bolezni kože in podkožja zelo redki eritem 2, pruritus 2, urtikarija
English: Ertugliflozin causes an osmotic diuresis, which may lead to intravascular volume contraction.
Slovenian: Ertugliflozin povzroči osmotsko diurezo, kar lahko povzroči zmanjšanje intravaskularnega volumna.
English: Hypoglycaemia with concomitant use of insulin and insulin secretagogues Ertugliflozin may increase the risk of hypoglycaemia when used in combination with insulin and/or an insulin secretagogue, which are known to cause hypoglycaemia (see section 4.8).
Slovenian: Hipoglikemija med sočasno uporabo z insulinom in insulinskimi sekretagogi Ertugliflozin lahko poveča tveganje za hipoglikemijo, če se uporablja v kombinaciji z insulinom in/ali insulinskim sekretagogom, za katera je znano, da povzročata hipoglikemijo (glejte poglavje 4.8).
English: In the pool of placebo-controlled studies, the incidence of documented hypoglycaemia was increased for ertugliflozin 5 mg and 15 mg (5.0% and 4.5%) compared to placebo (2.9%).
Slovenian: V združenih s placebom nadzorovanih študijah je bila pojavnost dokumentirane hipoglikemije pri ertugliflozinu v odmerku 5 mg in 15 mg povečana (5,0 % in 4,5 %) v primerjavi s placebom (2,9 %).
English: The incidence of urinary tract infections was not notably different in the ertugliflozin 5 mg and 15 mg groups (4.0% and 4.1%) and the placebo group (3.9%).
Slovenian: Pojavnost okužb urinarnega trakta se ni znatno razlikovala med skupinama s 5 mg in 15 mg ertugliflozina (4,0 % in 4,1 %) ter skupino s placebom (3,9 %).
English: Active-controlled study of ertugliflozin versus glimepiride as add-on combination therapy with metformin
Slovenian: Z učinkovino nadzorovana študija ertugliflozina v primerjavi z glimepiridom kot dodatkom h kombiniranemu zdravljenju z metforminom
English: No effects of ertugliflozin or metformin on fertility were observed in animal studies (see section 5.3).
Slovenian: V študijah na živalih niso opazili vplivov ertugliflozina ali metformina na plodnost (glejte poglavje 5.3).
English: Segluromet should not be used during breast-feeding.
Slovenian: Zdravila Segluromet se med dojenjem ne sme uporabljati.
English: Food had no meaningful effect on AUCinf of ertugliflozin or metformin, but reduced mean ertugliflozin Cmax by approximately 41% and metformin Cmax by approximately 29% compared to the fasted condition.
Slovenian: Hrana ni pomembno vplivala na AUCinf ertugliflozina ali metformina, a je v primerjavi s stanjem na tešče zmanjšala povprečno Cmax ertugliflozina za približno 41 % in povprečno Cmax metformina za približno
English: In patients with volume depletion, correcting this condition prior to initiation of Segluromet is recommended (see section 4.4).
Slovenian: Pri bolnikih s hipovolemijo je priporočljivo le to odpraviti pred uvedbo zdravila Segluromet (glejte poglavje 4.4).
English: Table 5: Results at Week 52 from an active-controlled study comparing ertugliflozin to glimepiride as add-on therapy in patients inadequately controlled on metformin*
Slovenian: Preglednica 5: Rezultati s primerjalno učinkovino nadzorovane študije za primerjavo ertugliflozina in glimepirida kot dodatka k zdravljenju pri bolnikih, neustrezno urejenih z metforminom, po 52 tednih*
English: In a Phase 1 clinical pharmacology study in patients with type 2 diabetes and mild, moderate, or severe renal impairment (as determined by eGFR), following a single-dose administration of 15 mg ertugliflozin, the mean increases in AUC of ertugliflozin were ≤ 1.7-fold, compared to subjects with normal renal function.
Slovenian: V klinični farmakološki študiji 1. faze so pri bolnikih s sladkorno boleznijo tipa 2 in blago, zmerno ali hudo okvaro ledvic (določeno glede na eGFR) v primerjavi osebami z normalnim delovanjem ledvic po uporabi enkratnega odmerka 15 mg ertugliflozina ugotovili povprečno ≤ 1,7-kratno povečanje AUC ertugliflozina.
English: In the pre- and post-natal development study, decreased post-natal growth and development were observed in rats administered ertugliflozin gestation day 6 through lactation day 21 at ≥ 100 mg/kg/day (estimated 239 times the human exposure at the maximum clinical dose of 15 mg/day, based on AUC).
Slovenian: V študiji prenatalnega in postnatalnega razvoja so ugotovili zmanjšano postnatalno rast in razvoj pri podganah, ki so dobivale ertugliflozin od 6. dne gestacije do 21. dne dojenja v odmerku ≥ 100 mg/kg/dan (ocenjeni 239-kratnik izpostavljenosti pri človeku med uporabo največjega kliničnega odmerka 15 mg/dan na podlagi AUC).
English: Limited data from controlled pharmacokinetic studies of metformin in healthy elderly subjects suggest that total plasma clearance of metformin is decreased, the half-life is prolonged, and Cmax is increased, compared to healthy young subjects.
Slovenian: Maloštevilni podatki nadzorovanih farmakokinetičnih študij metformina pri zdravih starejših osebah v primerjavi z zdravimi mladimi osebami kažejo manjši celotni plazemski očistek metformina, daljši razpolovni čas in večjo Cmax.
English: In patients with moderate renal impairment taking insulins, SU, or meglitinides as background medication, documented hypoglycaemia was 36%, 27% and 36% for ertugliflozin 5 mg, ertugliflozin 15 mg, and placebo, respectively (see sections 4.2, 4.4, and 4.5).
Slovenian: Pri bolnikih z zmerno okvaro ledvic, ki so kot osnovno zdravilo uporabljali insuline, sulfonilsečnine ali meglitinide, je bil delež dokumentiranih hipoglikemij pri 5 mg ertugliflozina 36 %, pri 15 mg ertugliflozina 27 % in pri placebu 36 % (glejte poglavja 4.2, 4.4 in 4.5).
English: Includes: pollakiuria, micturition urgency, polyuria, urine output increased, and nocturia.
Slovenian: Vključuje polakisurijo, nujno potrebo po uriniranju, poliurijo, večje izločanje urina in nikturijo.
English: Ertugliflozin-related neoplastic findings included an increased incidence of benign adrenal medullary pheochromocytoma in male rats at 15 mg/kg/day.
Slovenian: Med neoplastičnimi učinki, povezanimi z ertugliflozinom, je bila večja pojavnost benignih feokromocitomov nadledvične sredice pri podganjih samcih ob odmerku 15 mg/kg/dan.
English: In trials with SGLT2 inhibitors, patients with a history of genital mycotic infections and uncircumcised males were more likely to develop genital mycotic infections (see section 4.8).
Slovenian: V preskušanjih z zaviralci SGLT2 je pri bolnikih z glivičnimi okužbami spolovil v anamnezi in pri neobrezanih moških obstajala večja verjetnost za razvoj glivičnih okužb spolovil (glejte poglavje 4.8).
English: In patients tolerating a total daily dose of ertugliflozin 5 mg, the dose can be increased to a total daily dose of ertugliflozin 15 mg if additional glycaemic control is needed.
Slovenian: Pri bolnikih, ki prenašajo celokupni dnevni odmerek 5 mg ertugliflozina, se odmerek lahko poveča na celokupni dnevni odmerek 15 mg ertugliflozina, če urejenost glikemije ni zadostna.
English: Least squares means adjusted for treatment, time, prior antihyperglycaemic medication (monotherapy or dual therapy), baseline eGFR (continuous) and the interaction of time by treatment.
Slovenian: povprečja po metodi najmanjših kvadratov, prilagojena za zdravljenje, čas, predhodno antihiperglikemično zdravljenje (v obliki samostojnega ali kombiniranega zdravljenja), izhodiščno eGFR (kontinuirano) in interakcijo med časom in zdravljenjem.
English: Segluromet must be discontinued prior to or at the time of the imaging procedure and not restarted until at least 48 hours after, provided that renal function has been re-evaluated and found to be stable (see sections 4.2 and 4.4).
Slovenian: Zdravilo Segluromet je treba pred slikanjem ali v času slikanja ukiniti in se ga sme ponovno uvesti najmanj 48 ur pozneje, če je bilo delovanje ledvic ponovno ovrednoteno in ocenjeno kot stabilno (glejte poglavji 4.2 in 4.4).
English: When ertugliflozin was administered to juvenile rats from post-natal day (PND) 21 to PND 90, a period of renal development corresponding to the late second and third trimesters of human pregnancy, increased kidney weights, dilatation of the renal pelvis and tubules, and renal tubular mineralization were seen at an exposure 13 times the maximum clinical dose of 15 mg/day, based on AUC.
Slovenian: V primeru uporabe ertugliflozina pri podganjih mladičih od 21. do 90. postnatalnega dne (to obdobje razvoja ledvic ustreza poznemu drugemu in tretjemu mesecu nosečnosti pri človeku) so ugotovili večjo maso ledvic, razširitev ledvičnega meha in tubulov in mineralizacijo ledvičnih tubulov pri izpostavljenostih, ki so bile na podlagi AUC 13-kratnik največjega kliničnega odmerka 15 mg/dan.
English: Interaction studies conducted in healthy subjects, using a single dose design, suggest that the pharmacokinetics of ertugliflozin are not altered by sitagliptin, metformin, glimepiride, or simvastatin.
Slovenian: Študije medsebojnega delovanja, ki so jih izvedli pri zdravih osebah z uporabo enkratnega odmerka, kažejo, da sitagliptin, metformin, glimepirid ali simvastatin ne spremenijo farmakokinetike ertugliflozina.
English: Ertugliflozin did not adversely affect developmental outcomes in rats and rabbits at maternal exposures that were 239 and 1,069 times, respectively, the human exposure at the maximum clinical dose of 15 mg/day, based on AUC.
Slovenian: Ertugliflozin ni neugodno vplival na razvoj pri podganah in kuncih pri maternalni izpostavljenosti, ki je na podlagi AUC ustrezala 239-kratni (podgane) in 1.069-kratni (kunci) izpostavljenosti pri človeku med uporabo največjega kliničnega odmerka 15 mg/dan.
English: • if you are taking medicines used to treat pain and inflammation (NSAID and COX-2-inhibitors,
Slovenian: • če jemljete zdravila za zdravljenje bolečin in vnetja (nesteroidna protivnetna zdravila in zaviralce COX-2, kot sta ibuprofen in celekoksib).
English: Male genital mycotic infections occurred more commonly in uncircumcised males.
Slovenian: Glivične okužbe spolovil pri moških so bile pogostejše pri neobrezanih moških.
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: 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. sitagliptin uporabljenih samostojno.
English: The dosage should be individualised on the basis of the patient's current regimen, effectiveness, and tolerability using the recommended daily dose of 5 mg or 15 mg of ertugliflozin, while not exceeding the maximum recommended daily dose of metformin.
Slovenian: Priporočeni odmerek je ena tableta dvakrat na dan. Odmerjanje mora biti prilagojeno posameznemu bolniku na podlagi njegove trenutne sheme, učinkovitosti in prenašanja zdravljenja, z uporabo priporočenega dnevnega odmerka 5 mg ali 15 mg ertugliflozina, ne da bi pri tem prekoračili največji priporočeni dnevni odmerek metformina.
English: No effects on fertility were observed at 250 mg/kg/day (approximately 386 times human unbound exposure at the MRHD of 15 mg/day based on AUC comparisons).
Slovenian: Pri odmerku 250 mg/kg/dan niso opažali vplivov na plodnost (gre za približno 386-kratnik izpostavljenosti nevezanemu zdravilu pri človeku ob MRHD 15 mg/dan na podlagi primerjave AUC).
English: In the pool of three placebo-controlled clinical trials, female genital mycotic infections (e.g., genital candidiasis, genital infection fungal, vaginal infection, vulvitis, vulvovaginal candidiasis, vulvovaginal mycotic infection, vulvovaginitis) occurred in 9.1%, 12%, and 3.0% of females treated with ertugliflozin 5 mg, ertugliflozin 15 mg, and placebo, respectively.
Slovenian: V združenih podatkih iz treh s placebom nadzorovanih kliničnih preskušanj so se glivične okužbe ženskih spolovil (npr. genitalna kandidiaza, genitalna glivična okužba, okužba nožnice, vulvitis, vulvovaginalna kandidiaza, vulvovaginalna glivična okužba, vulvovaginitis) pojavile pri 9,1 % žensk, ki so prejemale 5 mg ertugliflozina, pri 12 % žensk, ki so prejemale 15 mg ertugliflozina, in pri 3,0 % tistih, ki so prejemale placebo.
English: • The active substances are ertugliflozin and metformin.
Slovenian: • Učinkovini sta ertugliflozin in metformin.
English: • fast heart beat
Slovenian: • hitro bitje srca.
English: Ertugliflozin or ertugliflozin glucuronides do not meaningfully inhibit P-gp, OCT2, OAT1, or OAT3 transporters or transporting polypeptides OATP1B1 and OATP1B3 at clinically relevant concentrations in vitro.
Slovenian: Ertugliflozin ali njegovi glukuronidi ne zavirajo pomembno prenašalcev P-glikoproteina, OCT2, OAT1 ali OAT3 ali prenašalnih polipeptidov OATP1B1 in OATP1B3 v klinično pomembnih koncentracijah in vitro.
English: • blood tests may show changes in the amount of urea in your blood
Slovenian: • preiskave krvi lahko pokažejo spremembe v koncentraciji sečnine v krvi,
English: There were no clinically meaningful differences in the ertugliflozin Cmax values among the different renal function groups.
Slovenian: Med skupinami z različnim delovanjem ledvic niso ugotovili klinično pomembnih razlik v Cmax ertugliflozina.
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 3).
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 3).
English: Overall, ertugliflozin is unlikely to affect the pharmacokinetics of concurrently administered drugs eliminated by these enzymes.
Slovenian: V splošnem ni verjetno, da bi ertugliflozin vplival na farmakokinetiko sočasno uporabljenih zdravil, ki se izločajo z delovanjem teh encimov.
English: Metformin is an antihyperglycaemic agent which improves glucose tolerance in patients with type 2 diabetes, lowering both basal and post-prandial plasma glucose.
Slovenian: Metformin je antihiperglikemična učinkovina, ki pri bolnikih s sladkorno boleznijo tipa 2 izboljša toleranco za glukozo z znižanjem bazalne in postprandialne koncentracije glukoze v plazmi.
English: For ertugliflozin 5 mg and 15 mg, respectively, the placebo-corrected reductions in FPG were 1.92 and 2.44 mmol/l as monotherapy, 1.48 and 2.12 mmol/l as add-on to metformin, and 1.40 and 1.74 mmol/l as add-on to metformin and sitagliptin.
Slovenian: Za ertugliflozin v odmerku 5 mg in 15 mg so bila za placebo korigirana znižanja glukoze v plazmi na tešče: 1,92 oz. 2,44 mmol/l kot samostojno zdravljenje, 1,48 oz. 2,12 mmol/l kot dodatek k metforminu in 1,40 oz. 1,74 mmol/l kot dodatek k metforminu in sitagliptinu.
English: Adverse reaction with ertugliflozin.
Slovenian: Neželeni učinki, povezani z ertugliflozinom.
English: As add-on to metformin and sitagliptin, ertugliflozin 5 mg and 15 mg resulted in statistically significant placebo-corrected reductions in SBP of 2.9 mmHg and 3.9 mmHg, respectively.
Slovenian: Kot dodatek k metforminu in sitagliptinu je ertugliflozin v odmerku 5 mg mg povzročil statistično značilno s placebom korigirano znižanje SBP za 2,9 mmHg in v odmerku 15 mg za 3,9 mmHg.
English: Following single-dose oral administration of 5 mg and 15 mg of ertugliflozin, peak plasma concentrations (median Tmax) of ertugliflozin occur at 1 hour post-dose under fasted conditions.
Slovenian: Po enkratnem peroralnem odmerku 5 mg ali 15 mg ertugliflozina na tešče se največja koncentracija ertugliflozina v plazmi (mediani tmax) pojavi 1 uro po odmerku.
English: Assess renal function more frequently in elderly patients.
Slovenian: Pri starejših bolnikih je treba pogosteje ocenjevati delovanje ledvic.
English: Rare cases of DKA, including life-threatening and fatal cases, have been reported in clinical trials and post-marketing in patients treated with sodium glucose co-transporter-2 (SGLT2) inhibitors, and cases have been reported in clinical trials with ertugliflozin.
Slovenian: V kliničnih preskušanjih in v času trženja zdravila so pri bolnikih, zdravljenih z zaviralci natrijevih glukoznih koprenašalcev 2 (SGLT2 - sodium glucose co-transporter-2), poročali o redkih primerih DKA, vključno z življenjsko nevarnimi in smrtnimi primeri; o takšnih primerih so poročali tudi v kliničnih preskušanjih z ertugliflozinom.
English: Segluromet should be discontinued when GFR is persistently below 45 ml/min due to a reduction of efficacy.
Slovenian: Če je GFR neprestano manjša od 45 ml/min, je treba zdravilo Segluromet ukiniti zaradi zmanjšane učinkovitosti.
English: In the study of ertugliflozin in combination with metformin in patients with baseline HbA1c from 7.0-10.5%, the placebo-corrected reductions in HbA1c for the subgroup of patients in the study with baseline HbA1c ≥ 9% were 1.31% and 1.43% with ertugliflozin 5 mg and 15 mg, respectively.
Slovenian: Učinkovitost pri bolnikih z izhodiščnim HbA1c ≥ 9 % V študiji ertugliflozina v kombinaciji z metforminom pri bolnikih z izhodiščnim HbA1c od 7,0 do 10,5 % sta bili za placebo korigirani znižanji HbA1c v podskupini bolnikov z izhodiščnim HbA1c ≥ 9 % s 5 mg ertugliflozina 1,31 % in s 15 mg ertugliflozina 1,43 %.
English: Pharmacologically mediated effects were observed in juvenile rats treated with ertugliflozin (see section 5.3).
Slovenian: Pri mladih podganah, ki so prejemale ertugliflozin, so opažali farmakološko posredovane učinke (glejte poglavje 5.3).
English: Ertugliflozin 5 mg Ertugliflozin 15 mg Glimepiride
Slovenian: ertugliflozin 5 mg ertugliflozin 15 mg glimepirid
English: The combination of ertugliflozin 5 or 15 mg and sitagliptin resulted in incremental FPG reductions of 0.46 and 0.65 mmol/l compared to the ertugliflozin alone or 1.02 and 1.28 mmol/l compared to sitagliptin alone, respectively.
Slovenian: Kombinacija ertugliflozina v odmerku 5 mg oz. 15 mg in sitagliptina je povzročila dodatno znižanje glukoze v plazmi na tešče za 0,46 oz. 0,65 mmol/l v primerjavi s samim ertugliflozinom in za 1,02 oz. 1,28 mmol/l v primerjavi s samim sitagliptinom.
English: Mean percent changes from baseline for ertugliflozin 5 mg and 15 mg versus placebo, respectively, were LDL-C 5.8% and 8.4% versus 3.2%; total cholesterol 2.8% and 5.7% versus 1.1%; however, HDL-C 6.2% and 7.6% versus 1.9%.
Slovenian: Povprečne spremembe v odstotkih od izhodišča za 5 mg oz. 15 mg ertugliflozina v primerjavi s placebom so znašale: za LDL-C 5,8 % oz. 8,4 % za ertugliflozin in 3,2 % za placebo, za celokupni holesterol 2,8 % oz. 5,7 % za ertugliflozin in 1,1 % za placebo, za HDL-C pa 6,2 % oz. 7,6 % za ertugliflozin in 1,9 % za placebo.
English: Median percent changes from baseline for ertugliflozin 5 mg and 15 mg versus placebo, respectively, were triglycerides -3.9% and -1.7% versus 4.5%.
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.
English: • Inhibitors of both OCT1 and OCT2 (such as crizotinib, olaparib) may alter efficacy and renal elimination of metformin.
Slovenian: • zaviralci OCT1 in OCT2 (kot sta krizotinib, olaparib) lahko spremenijo učinkovitost in izločanje metformina skozi ledvice.
English: These increases in ertugliflozin AUC are not considered clinically relevant.
Slovenian: To povečanje AUC ertugliflozina ne velja za klinično pomembno.
English: These patients, who were receiving metformin monotherapy (≥ 1,500 mg/day), were randomised to ertugliflozin 5 mg, ertugliflozin 15 mg, or glimepiride administered once daily in addition to continuation of background metformin therapy.
Slovenian: Te bolnike, ki so prejemali metformin v obliki monoterapije (≥ 1.500 mg/dan), so randomizirali tako, da so prejemali ertugliflozin 5 mg, ertugliflozin 15 mg ali glimepirid enkrat na dan kot dodatek nadaljevanju osnovnega zdravljenja z metforminom.
English: GFR ml/min
Slovenian: GFR ml/min metformin ertugliflozin
English: Diabetic ketoacidosis (ertugliflozin)
Slovenian: Diabetična ketoacidoza (ertugliflozin)
English: Change from baseline (LS mean Difference from glimepiride (LS mean
Slovenian: Sprememba od izhodišča (povprečje LS Razlika v primerjavi z glimepiridom (povprečje LS
English: In a 52-week, active-controlled study versus glimepiride, reductions from baseline in SBP were 2.2 mmHg and 3.8 mmHg for ertugliflozin 5 mg and 15 mg, respectively, while subjects treated with glimepiride had an increase in SBP from baseline of 1.0 mmHg.
Slovenian: V 52-tedenski, s primerjalno učinkovino nadzorovani študiji, so bila v primerjavi z glimepiridom znižanja SBP od izhodišča za ertugliflozin 5 mg 2,2 mmHg, za ertugliflozin 15 mg pa 2, 8 mmHg, med tem ko je bilo pri osebah, ki so prejemale glimepirid, zvišanje SBP od izhodišča 1,0 mmHg.
English: Genital mycotic infections (ertugliflozin)
Slovenian: Glivične okužbe spolovil (ertugliflozin)
English: Segluromet should be discontinued prior to or at the time of the imaging procedure and not restarted until at least 48 hours after, provided that renal function has been re-evaluated and found to be stable (see sections 4.2 and
Slovenian: Zdravilo Segluromet je treba pred slikanjem ali v času slikanja ukiniti in se ga sme ponovno uvesti najmanj 48 ur pozneje, pod pogojem, da je bilo delovanje ledvic ponovno ovrednoteno in ocenjeno kot stabilno (glejte poglavji 4.2 in 4.5).
English: Ertugliflozin causes an osmotic diuresis, which may lead to intravascular volume contraction and adverse reactions related to volume depletion.
Slovenian: Ertugliflozin povzroči osmotsko diurezo, kar lahko povzroči zmanjšanje intravaskularnega volumna in neželene učinke, povezane s hipovolemijo.
English: Hypotension/Volume depletion
Slovenian: Hipotenzija/hipovolemija