natgillin/translations-raw huggingface dataset:
The efficacy and safety of ertugliflozin in combination with sitagliptin have been studied in 3 multicentre, randomised, double-blind, placebo- and active comparator-controlled, Phase 3 clinical studies involving 1,985 patients with type 2 diabetes.
Učinkovitost in varnost ertugliflozina v kombinaciji s sitagliptinom so preučevali v 3 multicentričnih, randomiziranih, dvojno slepih, s placebom ali primerjalno učinkovino nadzorovanih kliničnih študijah 3. faze, ki so vključevale 1.985 bolnikov s sladkorno boleznijo tipa 2.
Incretin hormones, including glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), are released by the intestine throughout the day, and levels are increased in response to a meal.
Inkretini, med katere spadata glukagonu podobni peptid 1 (GLP-1glucagon-like peptide-1) in od glukoze odvisni insulinotropni polipeptid (GIP - glucose-dependent insulinotropic polypeptide), se izločajo iz črevesja ves dan, njihova količina pa se po jedi poveča.
Interaction studies conducted in patients with type 2 diabetes or healthy volunteers suggest that metformin and ciclosporin had no clinically relevant effect on the pharmacokinetics of sitagliptin.
Študije medsebojnega delovanja, ki so jih izvedli pri bolnikih s sladkorno boleznijo tipa 2 ali zdravih prostovoljcih kažejo na to, da metformin in ciklosporin nista imela klinično pomembnega učinka na farmakokinetiko sitagliptina.
What Steglujan is and what it is used for
Kaj je zdravilo Steglujan in za kaj ga uporabljamo
EU/1/18/1266/007 (14 film-coated tablets) EU/1/18/1266/008 (28 film-coated tablets) EU/1/18/1266/009 (30 film-coated tablets) EU/1/18/1266/010 (30x1 film-coated tablets) EU/1/18/1266/011 (84 film-coated tablets) EU/1/18/1266/012 (90 film-coated tablets) EU/1/18/1266/014 (98 film-coated tablets)
EU/1/18/1266/007 (14 filmsko obloženih tablet) EU/1/18/1266/008 (28 filmsko obloženih tablet) EU/1/18/1266/009 (30 filmsko obloženih tablet) EU/1/18/1266/010 (30 x 1 filmsko obložena tableta) EU/1/18/1266/011 (84 filmsko obloženih tablet) EU/1/18/1266/012 (90 filmsko obloženih tablet ) EU/1/18/1266/014 (98 filmsko obloženih tablet)
Effects of sitagliptin on other medicinal products
Vpliv sitagliptina na druga zdravila
Patients 65 years and older treated with ertugliflozin, had a higher incidence of adverse reactions related to volume depletion compared to younger patients.
Pri bolnikih, starih 65 let ali več, zdravljenih z ertugliflozinom, je bila pojavnost neželenih učinkov, povezanih s hipovolemijo, večja kot pri mlajših bolnikih.
EU/1/18/1266/001 (14 film-coated tablets) EU/1/18/1266/002 (28 film-coated tablets) EU/1/18/1266/003 (30 film-coated tablets) EU/1/18/1266/004 (30x1 film-coated tablets) EU/1/18/1266/005 (84 film-coated tablets) EU/1/18/1266/006 (90 film-coated tablets) EU/1/18/1266/013 (98 film-coated tablets)
EU/1/18/1266/001 (14 filmsko obloženih tablet) EU/1/18/1266/002 (28 filmsko obloženih tablet) EU/1/18/1266/003 (30 filmsko obloženih tablet) EU/1/18/1266/004 (30 x 1 filmsko obložena tableta) EU/1/18/1266/005 (84 filmsko obloženih tablet) EU/1/18/1266/006 (90 filmsko obloženih tablet) EU/1/18/1266/013 (98 filmsko obloženih tablet)
In case of conditions that may lead to fluid loss (e.g., gastrointestinal illness), careful monitoring of volume status (e.g., physical examination, blood pressure measurements, laboratory tests including haematocrit) and electrolytes is recommended for patients receiving Steglujan.
V primeru stanj, ki lahko povzročijo izgubo tekočine (npr. bolezni prebavil), se pri bolnikih, ki prejemajo zdravilo Steglujan, priporoča skrbno spremljanje volumskega stanja (npr. s fizikalnim pregledom, meritvami krvnega tlaka, laboratorijskimi preiskavami, vključno s hematokritom) in elektrolitov.
• flu
• gripa,
Therefore, Steglujan should not be used during pregnancy.
Zdravila Steglujan se zato med nosečnostjo ne sme uporabljati.
• Sitagliptin belongs to a group of medicines called DPP-4 (dipeptidyl peptidase-4) inhibitors.
• Sitagliptin spada v skupino zdravil, imenovanih zaviralci DPP-4 (dipeptidil-peptidaze 4).
This medicine has no or negligible influence on the ability to drive and use machines.
Zdravilo Steglujan nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
Patients [n (%)] with HbA1c < 7% Body Weight (kg)
Bolniki [n (%)] s HbA1c < 7 % Telesna masa (kg)
In a clinical study sitagliptin had a small effect on plasma digoxin concentrations indicating that sitagliptin may be a mild inhibitor of P-gp.
V klinični študiji je sitagliptin imel majhen učinek na koncentracije digoksina v plazmi, kar kaže, da je sitagliptin lahko blagi zaviralec p-glikoproteina.
Steglujan is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control:
Zdravilo Steglujan je indicirano pri odraslih, starih 18 let ali več, s sladkorno boleznijo tipa 2 kot dodatek k dieti in telesni aktivnosti za izboljšanje urejenosti glikemije:
• in patients already being treated with the combination of ertugliflozin and sitagliptin as separate tablets.
• pri bolnikih, ki že prejemajo kombinacijo ertugliflozina in sitagliptina v ločenih tabletah.
How to store Steglujan 6.
Kako jemati zdravilo Steglujan 4.
• The active substances are ertugliflozin and sitagliptin.
• Učinkovini sta ertugliflozin in sitagliptin.
Therefore, symptomatic hypotension may occur after initiating Steglujan (see section 4.8), particularly in patients with impaired renal function (eGFR less than 60 ml/min/1.73 m2 or CrCl less than
Po uvedbi zdravila Steglujan se zato lahko pojavi simptomatska hipotenzija (glejte poglavje 4.8), zlasti pri bolnikih z okvarjenim delovanjem ledvic (eGFR manj kot 60 ml/min/1,73 m ali CrCl manj kot
In the intention-to-treat population, among patients who were using insulin and/or a sulphonylurea at baseline, the incidence of severe hypoglycaemia was 2.7% in sitagliptin-treated patients and 2.5% in placebo-treated patients; among patients who were not using insulin and/or a sulphonylurea at baseline, the incidence of severe hypoglycaemia was 1.0% in sitagliptin-treated patients and 0.7% in placebo-treated patients.
V populaciji z namenom zdravljenja je bila med bolniki, ki so v izhodišču uporabljali insulin in/ali sulfonilsečnino, pojavnost hude hipoglikemije 2,7 % med tistimi, ki so prejemali sitagliptin, in 2,5 % med tistimi, ki so prejemali placebo; med bolniki, ki v izhodišču niso prejemali insulina in/ali sulfonilsečnine, je bila pojavnost hude hipoglikemije 1,0 % med bolniki, ki so prejemali sitagliptin, in 0,7 % med tistimi, ki so prejemali placebo.
Administration of Steglujan with food decreased ertugliflozin Cmax by 29% and had no meaningful effect on ertugliflozin AUCinf, or on sitagliptin AUCinf and Cmax.
Uporaba zdravila Steglujan s hrano je zmanjšala Cmax ertugliflozina za 29 % in ni pomembno vplivala na AUCinf ertugliflozina ter na AUCinf in Cmax sitagliptina.
Post-marketing reports of serious hypersensitivity reactions in patients treated with sitagliptin have been reported (see section 4.8).
V obdobju trženja zdravila so poročali o resnih preobčutljivostnih reakcijah pri bolnikih, ki so bili zdravljeni s sitagliptinom (glejte poglavje 4.8).
Steglujan combines two antihyperglycaemic agents with complementary mechanisms of action to improve glycaemic control in patients with type 2 diabetes: ertugliflozin, a SGLT2 inhibitor, and sitagliptin phosphate, a DPP-4 inhibitor.
Zdravilo Steglujan je kombinacija dveh antihiperglikemičnih učinkovin s komplementarnima mehanizmoma delovanja, namenjenih izboljšanju urejenosti glikemije pri bolnikih s sladkorno boleznijo tipa 2: ertugliflozina, zaviralca SGLT2, in sitagliptinijevega fosfata, zaviralca dipeptidil-peptidaze 4 (DPP-4).
Before initiating Steglujan, factors in the patient history that may predispose to ketoacidosis should be considered.
Pred uvedbo zdravila Steglujan je treba glede na bolnikovo anamnezo upoštevati dejavnike, ki bi lahko povečali nagnjenost h ketoacidozi.
What Steglujan is Steglujan contains two active substances, ertugliflozin and sitagliptin.
Kaj je zdravilo Steglujan Zdravilo Steglujan vsebuje dve različni učinkovini, ertugliflozin in sitagliptin.
In patients tolerating the starting dose, the dose may be increased to 15 mg ertugliflozin/100 mg sitagliptin, once daily, if additional glycaemic control is needed.
Pri bolnikih, ki prenašajo začetni odmerek, se odmerek lahko poveča na 15 mg ertugliflozina/100 mg sitagliptina enkrat na dan, če je potrebno dodatno urejanje glikemije.
Hypromellose (E464) Hydroxypropyl cellulose (E463) Titanium dioxide (E171) Iron oxide red (E172) Iron oxide yellow (E172) Iron oxide black (E172) Carnauba wax (E903)
Obloga tablete hipromeloza (E464) hidroksipropilceluloza (E463) titanov dioksid (E171) rdeči železov oksid (E172) rumeni železov oksid (E172) črni železov oksid (E172) karnauba vosek (E903)
In patients with type 2 diabetes with hyperglycaemia, these changes in insulin and glucagon levels lead to lower haemoglobin A1c (HbA1c) and lower fasting and post-prandial glucose concentrations.
Pri bolnikih s sladkorno boleznijo tipa 2 s hiperglikemijo se zaradi spremembe količine insulina in glukagona zmanjša količina hemoglobina A1c (HbA1c) in zmanjša koncentracija glukoze na tešče in po obroku.
Steglujan has been shown to be bioequivalent to coadministration of corresponding doses of ertugliflozin and sitagliptin tablets.
Pokazalo se je, da je zdravilo Steglujan bioekvivalentno sočasni uporabi ustreznih odmerkov tablet ertugliflozina in sitagliptina.
After 26-weeks of treatment, the combination of ertugliflozin 5 mg or 15 mg and sitagliptin 100 mg resulted in statistically significant reductions in systolic blood pressure (SBP) compared to sitagliptin alone (-2.8 and -3.0 mmHg for E5/S100 and E15/S100 respectively) or placebo (-4.4 and -6.4 mmHg for E5/S100 and E15/S100, respectively).
Po 26-tedenskem zdravljenju je pri kombinaciji ertugliflozina v odmerku 5 mg ali 15 mg in sitagliptina v odmerku 100 mg prišlo do statistično značilnega znižanja sistoličnega krvnega tlaka (SBP - systolic blood pressure) v primerjavi s samim sitagliptinom (-2,8 mmHg za E5/S100 in -3,0 mmHg za E15/S100) ali v primerjavi s placebom (-4,4 mmHg za E5/S100 in -6,4 mmHg za E15/S100).
There have been post-marketing reports of bullous pemphigoid in patients taking DPP-4 inhibitors including sitagliptin.
V obdobju trženja so pri bolnikih, ki jemljejo zaviralce DPP-4, vključno s sitagliptinom, poročali o buloznem pemfigoidu.
The recommended starting dose is 5 mg ertugliflozin/100 mg sitagliptin once daily.
Priporočeni začetni odmerek je 5 mg ertugliflozina/100 mg sitagliptina enkrat na dan.
Due to the mechanism of action of ertugliflozin, patients taking Steglujan will test positive for glucose in their urine.
Zaradi mehanizma delovanja ertugliflozina bodo rezultati testov glukoze v urinu pri bolnikih, ki jemljejo zdravilo Steglujan, pozitivni.
Microcrystalline cellulose (E460) Calcium hydrogen phosphate (anhydrous) Croscarmellose sodium Sodium stearyl fumarate (E487) Magnesium stearate (E470b)
Jedro tablete mikrokristalna celuloza (E460) kalcijev hidrogenfosfat (brezvodni) premreženi natrijev karmelozat natrijev stearilfumarat (E487) magnezijev stearat (E470b)
Blood and lymphatic system disorders
Bolezni krvi in limfatičnega sistema redki trombocitopenija
In patients with volume depletion, correcting this condition prior to initiation of Steglujan is recommended (see section 4.4).
Pri bolnikih s hipovolemijo je priporočljivo to stanje odpraviti pred uvedbo zdravila Steglujan (glejte poglavje 4.4).
Sitagliptin is not a substrate for OCT2 or OAT1 or peptide transporter 1/2 (PEPT1/2) transporters.
Sitagliptin ni substrat za prenašalce OCT2 ali OAT1 ali PEPT1/2.
• The recommended dose of Steglujan is one tablet once a day.
Koliko zdravila morate vzeti • Priporočeni odmerek zdravila Steglujan je ena tableta enkrat na dan.
• swelling of the hands or legs
• otekanje dlani ali nog,
For this reason, it is possible that potent CYP3A4 inhibitors (i.e., ketoconazole, itraconazole, ritonavir, clarithromycin) could alter the pharmacokinetics of sitagliptin in patients with severe renal impairment or ESRD.
Zato je mogoče, da pri bolnikih s hudo ledvično okvaro ali končno ledvično odpovedjo močni zaviralci encima CYP3A4 (kot so ketokonazol, itrakonazol, ritonavir, klaritromicin) spremenijo farmakokinetiko sitagliptina.
Pharmacokinetic drug interaction studies with Steglujan have not been performed; however, such studies have been conducted with ertugliflozin and sitagliptin, the individual active substances of Steglujan.
Farmakokinetičnih študij medsebojnega delovanja zdravil z zdravilom Steglujan niso izvedli, so pa takšne študije izvedli z ertugliflozinom in sitagliptinom, posameznima učinkovinama v zdravilu Steglujan.
Because of how Steglujan works, your urine will test positive for sugar (glucose) while you are on this medicine.
Zaradi načina delovanja zdravila Steglujan boste imeli med jemanjem tega zdravila pozitiven rezultat izvida za prisotnost sladkorja (glukoze) v urinu.
In the pool of placebo-controlled studies, the incidence of documented hypoglycemia was increased for ertugliflozin 5 mg and 15 mg (5.0% and 4.5%) compared to placebo (2.9%).
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 %).
In addition to the adverse reactions described in the table above, adverse experiences reported regardless of causal relationship to medication and occurring in at least 5% and more commonly in patients treated with sitagliptin included upper respiratory tract infection and nasopharyngitis.
Poleg zgoraj opisanih neželenih učinkov so ne glede na vzročno povezanost z zdravilom poročali o naslednjih neželenih učinkih s pojavnostjo najmanj 5 % in pogosteje pri bolnikih, zdravljenih s sitagliptinom: okužba zgornjih dihal in nazofaringitis.
Sitagliptin Pharmacokinetic interactions
Sitagliptin Farmakokinetične interakcije
When blood glucose concentrations are normal or elevated, GLP-1 and GIP increase insulin synthesis and release from pancreatic beta cells by intracellular signalling pathways involving cyclic AMP.
Če je koncentracija glukoze v krvi normalna ali zvišana, GLP-1 in GIP preko znotrajceličnih signalnih mehanizmov, ki vključujejo ciklični AMP, povečata sintezo in sproščanje insulina iz beta celic trebušne slinavke.
Warnings and precautions Talk to your doctor, pharmacist, or nurse before and while taking Steglujan if you:
Opozorila in previdnostni ukrepi Pred začetkom jemanja zdravila Steglujan in med njegovim jemanjem se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro:
Cases of inflammation of the pancreas (pancreatitis) have been reported in patients receiving sitagliptin (see section 4).
Pri bolnikih, ki so prejemali sitagliptin, so poročali o primerih vnetja trebušne slinavke (pankreatitisa) (glejte poglavje 4).
Talk with your doctor about the best way to feed your baby if you take Steglujan.
Če jemljete zdravilo Steglujan, se z zdravnikom posvetujte o najboljšem načinu za hranjenje dojenčka.
Table 2: Results at Week 26 from a factorial study with ertugliflozin and sitagliptin as add-on combination therapy with metformin compared to individual components alone*
Preglednica 2: Rezultati faktorske študije z ertugliflozinom in sitagliptinom kot dodatkom h kombiniranemu zdravljenju z metforminom v primerjavi s posameznimi komponentami po 26 tednih*
Ertugliflozin is not expected to be effective in these patients.
Pri teh bolnikih ni pričakovati učinkovitosti ertugliflozina.
The analysis of hospitalisation for heart failure was adjusted for a history of heart failure at baseline.
Analiza hospitalizacij zaradi srčnega popuščanja je upoštevala (tj. je bila prilagojena za) anamnezo srčnega popuščanja v izhodišču.
No effects of ertugliflozin or sitagliptin on fertility were observed in animal studies (see section 5.3).
V študijah na živalih niso opazili vplivov ertugliflozina ali sitagliptina na plodnost (glejte poglavje 5.3).
The TECOS was a randomised study in 14,671 patients in the intention-to-treat population with an HbA1c of ≥ 6.5 to 8.0% with established CV disease who received sitagliptin (7,332) 100 mg daily (or 50 mg daily if the baseline eGFR was ≥ 30 and < 50 ml/min/1.73 m2) or placebo (7,339) added to usual care targeting regional standards for HbA1c and CV risk factors.
TECOS je bila randomizirana študija, ki je v populaciji z namenom zdravljenja vključevala 14.671 bolnikov s HbA1c ≥ 6,5 do 8,0 % in potrjeno srčno-žilno boleznijo, ki so prejemali sitagliptin v odmerku 100 mg na dan (7.332 bolnikov) (ali 50 mg na dan, če so imeli izhodiščno eGFR ≥ 30 in < 50 ml/min/1,73 m2) ali placebo (7.339 bolnikov), dodana običajnemu zdravljenju glede na regionalne smernice za HbA1c in srčno-žilne dejavnike tveganja.
In vitro studies indicate that the primary enzyme responsible for the limited metabolism of sitagliptin is CYP3A4, with contribution from CYP2C8.
Študije in vitro so pokazale, da je primarni encim, odgovoren za omejeno presnovo sitagliptina, CYP3A4, pri presnovi pa sodeluje tudi CYP2C8.
CrCl is persistently below 45 ml/min due to a reduction of efficacy.
45 ml/min, je treba zdravilo Steglujan ukiniti zaradi zmanjšane učinkovitosti.
Steglujan is expected to have diminished efficacy in elderly patients with renal impairment (see sections 4.2 and 4.8).
Pričakovati je, da ima zdravilo Steglujan pri starejših bolnikih z okvaro ledvic zmanjšano učinkovitost (glejte poglavji 4.2 in 4.8).
What Steglujan looks like and contents of the pack
Izgled zdravila Steglujan in vsebina pakiranja
The incidence of adjudication-confirmed pancreatitis events was 0.3% in sitagliptin-treated patients and 0.2% in placebo-treated patients.
Pojavnost s presojo potrjenega pankreatitisa je bila 0,3 % med prejemniki sitagliptina in 0,2 % med prejemniki placeba.
Table 5: Rates of composite cardiovascular outcomes and key secondary outcomes
Preglednica 5: Deleži sestavljenih srčno-žilnih izidov in ključnih sekundarnih izidov sitagliptin 100 mg placebo
Steglujan 15 mg/100 mg film-coated tablets EU/1/18/1266/007
Steglujan 15 mg/100 mg filmsko obložene tablete EU/1/18/1266/007
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.
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.
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.
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.
Table 4: Results at Week-26 from a combination therapy study of ertugliflozin and sitagliptin*
Preglednica 4: Rezultati študije kombiniranega zdravljenja z ertugliflozinom in sitagliptinom po 26. tednih*
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).
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).
In vitro, sitagliptin did not inhibit OAT3 (IC50=160 M) or p-glycoprotein (up to 250 M) mediated transport at therapeutically relevant plasma concentrations.
Sitagliptin in vitro pri terapevtsko pomembnih plazemskih koncentracijah ni zaviral prenosa z OAT3 (IC50 = 160 M) ali s p-glikoproteinom (do 250 M).
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.
V kliničnih študijah medsebojnega delovanja sitagliptin ni imel klinično pomembnega učinka na farmakokinetiko metformina, rosiglitazona, gliburida, simvastatina, varfarina in peroralnih kontraceptivov.
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).
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).
Least squares means adjusted for treatment, time, prior antihyperglycaemic medication.
povprečja po metodi najmanjših kvadratov, prilagojena za zdravljenje, čas in predhodno antihiperglikemično zdravljenje p < 0,001 v primerjavi s placebom
Steglujan 5 mg/100 mg film-coated tablets EU/1/18/1266/001
Steglujan 5 mg/100 mg filmsko obložene tablete EU/1/18/1266/001
Fatal and non-fatal haemorrhagic and necrotising pancreatitis
hemoragični in nekrotizirajoči pankreatitis s smrtnim izidom ali brez
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
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.
If a hypersensitivity reaction is suspected, Steglujan should be discontinued.
Če obstaja sum na preobčutljivostno reakcijo, morate prenehati zdravljenje z zdravilom Steglujan.
• yeast infections of the penis
Pogosti • glivične okužbe penisa,
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.
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.
No studies in lactating animals have been conducted with the combined components of Steglujan.
Študij s kombiniranima sestavinama zdravila Steglujan na doječih živalih niso izvedli.
There are no data from the use of Steglujan in pregnant women.
O uporabi zdravila Steglujan pri nosečnicah ni podatkov.
Table 3: Results at Week 26 from an add-on study of ertugliflozin in combination with metformin and sitagliptin*
Preglednica 3: Rezultati študije dodatka ertugliflozina v kombinaciji z metforminom in sitagliptinom po 26 tednih*