natgillin/translations-raw huggingface dataset:
I kontrollerede kliniske forsøg med kombinationen af vildagliptin 100 mg daglig plus metformin blev der ikke rapporteret nogen udtræden på grund af bivirkninger hverken i gruppen, der blev behandlet med vildagliptin 100 mg daglig plus metformin, eller i gruppen, der blev behandlet med placebo plus metformin.
In controlled clinical trials with the combination of vildagliptin 100 mg daily plus metformin, no withdrawal due to adverse reactions was reported in ei ther the vildagliptin 100 mg daily plus metformin or the placebo plus metformin treatment groups.
I kliniske forsøg var hyppigheden af hypoglykæmi almindelig hos patienter, der modtog vildagliptin kombineret med metformin (1%), og ikke almindelig hos patienter, som modtog placebo + metformin (0, 4%).
In clinical trials, the incidence of hypoglycaemia was common in patients receiving vildagliptin in combination with metformin (1%) and uncommon in patients receiving placebo + metformin (0.4%).
Ingen alvorlige hypoglykæmihændelser blev rapporteret i vildagliptin- armene.
No severe hypoglycaemic events were reported in the vildagliptin arms.
I kliniske forsøg ændrede vægten sig ikke fra baseline, når vildagliptin 100 mg daglig blev tilføjet metformin (+0, 2 kg og - 1, 0 kg for henholdvis vildagliptin og placebo).
In clinical trials, weight did not change from baseline when vildagliptin 100 mg daily was added to metformin (+0.2 kg and -1.0 kg for vildagliptin and placebo, respectively).
Bivirkninger rapporteret hos patienter, der modtog vildagliptin 100 mg som monoterapi i dobbeltblindede studier (N=1855)
Table 2
Øvre luftvejsinfektioner Næsesvælgrumskatar
Upper respiratory tract infection Nasopharyngitis
Den samlede hyppighed af udtræden af kontrollerede monoterapiforsøg på grund af bivirkninger var ikke større for de patienter, der modtog behandling med vildagliptin- doser på 100 mg daglig (0, 3%) end for de patienter, der fik placebo (0, 6%) eller sammenligningsstoffer (0, 5%).
The overall incidence of withdrawals from controlled monotherapy trials due to adverse reactions was no greater for patients treated with vildagliptin at doses of 100 mg daily (0.3%) than for placebo (0.6%) or comparators (0.5%).
I sammenlignende kontrollerede monoterapistudier var hypoglykæmi ikke almindelig, rapporteret hos 0, 4% (7 ud af 1. 855) af de patienter, som blev behandlet med vildagliptin 100 mg daglig, sammenlignet med 0, 2% (2 ud af 1. 082) af patienterne i de grupper, der blev behandlet med et aktivt
In comparative controlled monotherapy studies, hypoglycaemia was uncommon, reported in 0.4% (7 of 1,855) of patients treated with vildagliptin 100 mg daily compared to 0.2% (2 of 1,082) of patients in the groups treated with an active comparator or placebo, with no serious or severe events reported.
I kliniske forsøg ændrede vægten sig ikke fra baseline, når vildagliptin 100 mg daglig blev administreret som monoterapi (- 0, 3 kg og - 1, 3 kg for henholdsvis vildagliptin og placebo).
7 In clinical trials, weight did not change from baseline when vildagliptin 100 mg daily was administered as monotherapy (-0.3 kg and -1.3 kg for vildagliptin and placebo, respectively).
Kendte bivirkninger for metforminkomponenten
Known adverse reactions for metformin component
Metabolisme Meget
Metabolism and nutrition disorders
og ernæring sjælden Reduktion af vitamin B12- absorption og laktatacidose *
Decrease of vitamin B12 absorption and lactic acidosis*
Mave- tarmkanalen Lever
Gastrointestinal disorders
Meget almindelig og galdeveje Meget sjælden
Very common
Kvalme, opkastning, diare, mavesmerter og appetitløshed Unormale værdier ved leverfunktionstests eller hepatitis **
Liver function test abnormalities or hepatitis**
* En reduktion af vitamin B12- absorption med reduktion af serumniveauer er observeret meget sjældent hos patienter, der blev behandlet i længere tid med metformin.
*A decrease in vitamin B12 absorption with decrease in serum levels has been very rarely observed in patients treated long-term with metformin.
Hensyntagen til en sådan ætiologi anbefales, hvis en patient udviser megaloblastisk anæmi. ** Isolerede tilfælde af unormale værdier ved leverfunktionstests eller hepatitis, der afhjælpes ved seponering af metformin, er rapporteret.
Consideration of such aetiology is recommended if a patient presents with megaloblastic anaemia. **Isolated cases of liver function test abnormalities or hepatitis resolving upon metformin discontinuation have been reported.
Gastrointestinale bivirkninger opstår oftest i begyndelsen af behandlingen og ophører spontant i de fleste tilfælde.
Gastrointestinal undesirable effects occur most frequently during initiation of therapy and resolve spontaneously in most cases.
Vildagliptin Data vedrørende overdosering af vildagliptin er begrænsede.
Vildagliptin Information regarding overdose with vildagliptin is limited.
Tre andre forsøgspersoner oplevede ødem i fødderne med paræstesi i to tilfælde.
At 600 mg, one subject experienced oedema of the feet and hands, and increases in creatine phosphokinase (CPK), AST, C-reactive protein (CRP) and myoglobin levels.Three other subjects experienced oedema of the feet, with paraesthesia in two cases.
Metformin En stor overdosis metformin (eller samtidig eksisterende risiko for laktatacidose) kan medføre laktatacidose, der er et akut medicinsk tilfælde og skal behandles på hospitalet.
Metformin A large overdose of metformin (or co-existing risk of lactic acidosis) may lead to lactic acidosis, which is a medical emergency and must be treated in hospital.
Behandling Den mest effektive metode til at fjerne metformin er hæmodialyse.
Management The most effective method of removing metformin is haemodialysis.
Kombinationer af orale lægemidler til reduktion af blodsukkeret, ATC- kode:
Combinations of oral blood glucose lowering drugs, ATC code:
Eucreas kombinerer to antihyperglykæmiske midler med komplementære virkningsmekanismer for at forbedre den glykæmiske kontrol hos patienter med type 2- diabetes: vildagliptin, der tilhører klassen af ø- celle- forstærkere, og metformin- hydrochlorid, der tilhører klassen af biguanider.
Eucreas combines two antihyperglycaemic agents with complimentary mechanisms of action to improve glycaemic control in patients with type 2 diabetes: vildagliptin, a member of the islet enhancer class, and metformin hydrochloride, a member of the biguanide class.
Vildagliptin, der tilhører klassen af ø- celle- forstærkere, er en potent og selektiv dipeptidyl- peptidase- 4 (DPP- 4) - hæmmer.
Vildagliptin, a member of the islet enhancer class, is a potent and selective dipeptidyl-peptidase-4 (DPP-4) inhibitor.
Metformin virker primært ved at reducere den endogene glukoseproduktion i leveren.
Metformin acts primarily by decreasing endogenous hepatic glucose production.
Når vildagliptin blev administreret til patienter, hvis glykæmiske kontrol ikke var tilfredsstillende trods behandling med metformin monoterapi, forekom der yderligere statistisk signifikante middelreduktioner i HbA1c efter 6 måneders behandling sammenlignet med placebo (der var en forskel mellem grupperne på - 0, 7% til - 1, 1% for vildagliptin ved henholdsvis 50 mg og 100 mg).
Vildagliptin added to patients whose glycaemic control was not satisfactory despite treatment with metformin monotherapy resulted after 6-month treatment in additional statistically significant mean reductions in HbA1c compared to placebo (between group differences of -0.7% to -1.1% for vildagliptin 50 mg and 100 mg, respectively).
Andelen af patienter, der opnåede en reduktion i HbA1c på ≥ 0, 7% fra baseline, var statistisk signifikant højere i gruppen, der modtog vildagliptin og metformin (henholdsvis 46% og 60%) i forhold til gruppen, der modtog metformin plus placebo (20%).
The proportion of patients who achieved a decrease in HbA1c of ≥ 0.7% from baseline was statistically significantly higher in both vildagliptin plus metformin groups (46% and 60%, respectively) versus the metformin plus placebo group (20%).
Vildagliptin Vildagliptin virker primært ved at hæmme DPP- 4, det enzym, der er ansvarligt for nedbrydningen af inkretin- hormonerne GLP- 1 (glucagonlignende peptid 1) og GIP (glukoseafhængigt insulinotropt polypeptid).
Vildagliptin Vildagliptin acts primarily by inhibiting DPP-4, the enzyme responsible for the degradation of the incretin hormones GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic polypeptide).
Administration af vildagliptin medfører en hurtig og fuldstændig hæmning af DPP- 4- aktiviteten, hvilket medfører øget fastende og postprandiale endogene værdier for inkretinhormonerne GLP- 1 og GIP.
The administration of vildagliptin results in a rapid and complete inhibition of DPP-4 activity resulting in increased fasting and postprandial endogenous levels of the incretin hormones GLP-1 and GIP.
Ved at øge de endogene niveauer af disse inkretinhormoner øger vildagliptin betacellernes følsomhed over for glukose, og dermed forbedres den glukoseafhængige insulinsekretion.
By increasing the endogenous levels of these incretin hormones, vildagliptin enhances the sensitivity of beta cells to glucose, resulting in improved glucose-dependent insulin secretion.
Hos personer uden diabetes (normal glykæmi) stimulerer vildagliptin ikke insulinsekretionen eller reducerer glukoseniveauerne.
In non-diabetic (normal glycaemic) individuals, vildagliptin does not stimulate insulin secretion or reduce glucose levels.
Vildagliptin forbedrer alfacellernes følsomhed over for glukose ved at øge de endogene GLP- 1 - niveauer, og det resulterer i mere glukosepassende glucagonsekretion.
By increasing endogenous GLP-1 levels, vildagliptin also enhances the sensitivity of alpha cells to glucose, resulting in more glucose-appropriate glucagon secretion.
Den større øgning af insulin/ glucagon- ratioen under hyperglykæmi på grund af forhøjede inkretinhormonniveauer bevirker, at der sker et fald i fastende og postprandial glukoseproduktion i leveren, hvilket fører til nedsat glykæmi.
The enhanced increase in the insulin/glucagon ratio during hyperglycaemia due to increased incretin hormone levels results in a decrease in fasting and postprandial hepatic glucose production, leading to reduced glycaemia.
Den kendte virkning at forhøjede GLP- 1- niveauer forsinker ventrikeltømningen blev ikke observeret med vildagliptin- behandling.
The known effect of increased GLP-1 levels delaying gastric emptying is not observed with vildagliptin treatment.
Metformin Metformin er et biguanid med antihyperglykæmiske virkninger, der sænker både det basale og postprandiale blodsukker.
Metformin Metformin is a biguanide with antihyperglycaemic effects, lowering both basal and postprandial plasma glucose.
9 Metformin kan udøve den glucosesænkende effekt via tre mekanismer:
Metformin may exert its glucose -lowering effect via three mechanisms:
- ved reduktion af glukoseproduktionen i leveren gennem hæmning af glukoneogenesen og
- by reduction of hepatic glucose production through inhibition of gluconeogenesis and
glykogenolysen;
glycogenolysis;
- i musklerne ved i beskeden grad at øge insulinfølsomheden og derved forbedre den perifere
- in muscle, by modestly increasing insulin sensitivity, improving peripheral glucose uptake and
glukoseoptagelse og – udnyttelse;
utilisation;
- ved at forsinke glukoseabsorption i tarmsystemet.
- by delaying intestinal glucose absorption.
Metformin stimulerer den intracellulære glykogensyntese ved at virke på glykogensyntase og øger transportkapaciteten for specifikke typer membran- glukosetransportører (GLUT- 1 og GLUT- 4).
Metformin stimulates intracellular glycogen synthesis by acting on glycogen synthase and increases the transport capacity of specific types of membrane glucose transporters (GLUT-1 and GLUT-4).
Dette er påvist ved terapeutiske doser i kontrollerede, mellemlange eller langsigtede kliniske studier: metformin reducerer serum- niveauer af total kolesterol, LDL- kolesterol og triglycerider.
This has been shown at therapeutic doses in controlled, medium-term or long-term clinical studies: metformin reduces serum levels of total cholesterol, LDL cholesterol and triglycerides.
Det prospektive, randomiserede studie UKPDS (UK Prospective Diabetes Study) har fastslået den langsigtede fordel ved intensiv styring af blodsukker ved type 2- diabetes.
The prospective randomised UKPDS (UK Prospective Diabetes Study) study has established the long- term benefit of intensive blood glucose control in type 2 diabetes.
- en signifikant reduktion i den absolutte risiko for diabetesrelaterede komplikationer i
- a significant reduction in the absolute risk of any diabetes-related complication in the metformin
metformin- gruppen (29, 8 hændelser/ 1. 000 patientår) i forhold til diæt alene (43, 3 hændelser/ 1. 000 patientår), p=0, 0023, og i forhold til grupperne med kombineret sulfonylurea - og insulin- monoterapi (40, 1 hændelser/ 1. 000 patientår), p=0, 0034;
group (29.8 events/1,000 patient -ye ars) versus diet alone (43.3 events/1,000 patient-years), p=0.0023, and versus the combined sulphonylurea and insulin monotherapy groups (40.1 events/1,000 patient-years), p=0.0034;
- en signifikant reduktion i den absolutte risiko for diabetesrelateret dødelighed; metformin
- a significant reduction in the absolute risk of diabetes-related mortality: metformin
7, 5 hændelser/ 1. 000 patientår, diæt alene 12, 7 hændelser/ 1. 000 patientår, p=0, 017;
7.5 events/1,000 patient -ye ars, diet alone 12.7 events/1,000 patient-years, p=0.017;
- en signifikant reduktion i den absolutte risiko for generel dødelighed; metformin
- a significant reduction in the absolute risk of overall mortality: metformin
13, 5 hændelser/ 1. 000 patientår i forhold til diæt alene 20, 6 hændelser/ 1. 000 patientår (p=0, 011) og i forhold til de kombinerede sulfonylurea - og insulin- monoterapigrupper 18, 9 hændelser/ 1. 000 patientår (p=0, 021);
13.5 events/1,000 patient -ye ars versus diet alone 20.6 events/1,000 patient-years (p=0.011), and versus the combined sulphonylurea and insulin monotherapy groups 18.9 events/1,000 patient- years (p=0.021);
- en signifikant reduktion i den absolutte risiko for myokardieinfarkt: metformin
- a significant reduction in the absolute risk of myocardial infarction: metformin
11 hændelser/ 1. 000 patientår, diæt alene 18 hændelser/ 1. 000 patientår, (p=0, 01).
11 events/1,000 patient-years, diet alone 18 events/1,000 patient-years (p=0.01).
Eucreas Absorption Bioækvivalens er påvist mellem Eucreas ved tre dosisstyrker (50 mg/ 500 mg, 50 mg/ 850 mg og 50 mg/ 1000 mg) i forhold til fri kombination af vildagliptin - og metforminhydrochloridtabletter ved de tilsvarende doser.
Eucreas Absorption Bioequivalence has been demonstrated between Eucreas at three dose strengths (50 mg/500 mg, 50 mg/850 mg and 50 mg/1000 mg) versus free combination of vildagliptin and metformin hydrochloride tablets at the corresponding doses.
Mad påvirker ikke absorptionsomfang og - hastighed for vildagliptin fra Eucreas.
Food does not affect the extent and rate of absorption of vildagliptin from Eucreas.
Absorptionshastighed og - omfang for metformin fra Eucreas 50 mg/ 1000 mg blev reduceret ved indgivelse med mad, som er afspejlet af en reduktion i Cmax på 26%, AUC på 7% og forsinket Tmax (2, 0 til 4, 0 t).
The rate and extent of absorption of metformin from Eucreas 50 mg/1000 mg were decreased when given with food as reflected by the decrease in Cmax by 26%, AUC by 7% and delayed Tmax (2.0 to 4.0 h).
Vildagliptin Absorption Efter oral administration hos fastende absorberes vildagliptin hurtigt med maksimale plasmakoncentrationer ved 1, 7 timer.
Vildagliptin Absorption Following oral administration in the fasting state, vildagliptin is rapidly absorbed with peak plasma concentrations observed at 1.7 hours.
Mad forsinker tiden til maksimal plasmakoncentration en anelse til 2, 5 time, men ændrer ikke den samlede eksponering (AUC).
Food slightly delays the time to peak plasma concentration to 2.5 hours, but does not alter the overall exposure (AUC).
Administration af vildagliptin sammen med mad resulterede i et fald i Cmax (19%) sammenlignet med dosering i den fastende tilstand.
Administration of vildagliptin with food resulted in a decreased Cmax (19%) compared to dosing in the fasting state.
Den absolutte biotilgængelighed er 85%.
The absolute bioavailability is 85%.
10 Fordeling Vildagliptins plasmaproteinbinding er lav (9, 3%), og vildagliptin fordeles ligeligt mellem plasma og erytrocytter.
Distribution The plasma protein binding of vildagliptin is low (9.3%) and vildagliptin distributes equally between plasma and red blood cells.
Biotransformation Metabolisering er den vigtigste eliminationsvej for vildagliptin hos mennesker, idet den udgør 69% af dosis.
10 Biotransformation Metabolism is the major elimination pathway for vildagliptin in humans, accounting for 69% of the dose.
Hovedmetabolitten (LAY 151) er farmakologisk inaktiv og er hydrolyseproduktet af cyanodelen, som udgør 57% af dosis, efterfulgt af amidhydrolyseproduktet (4% af dosis).
The major metabolite (LAY 151) is pharmacologically inactive and is the hydrolysis product of the cyano moiety, accounting for 57% of the dose, followed by the amide hydrolysis product (4% of dose).
DPP- 4 bidrager delvist til hydrolysen af vildagliptin på basis af et in vivo- studie af rotter med DPP- 4- mangel.
DPP-4 contributes partially to the hydrolysis of vildagliptin based on an in vivo study using DPP-4 deficient rats.
Derfor forventes den metaboliske clearance for vildagliptin ikke at blive påvirket af samtidig administration af præparater, der er CYP 450- hæmmere og/ eller - induktorer.
Vildagliptin is not metabolised by CYP 450 enzymes to any quantifiable extent, and accordingly the metabolic clearance of vildagliptin is not anticipated to be affected by co- medications that are CYP 450 inhibitors and/or inducers.
In vitro- studier har vist, at vildagliptin ikke hæmmer/ inducerer CYP 450- enzymer.
In vitro studies demonstrated that vildagliptin does not inhibit/induce CYP 450 enzymes.
Derfor vil vildagliptin sandsynligvis ikke påvirke den metaboliske clearance af samtidigt administrerede præparater, som metaboliseres af CYP 1A2, CYP 2C8, CYP 2C9, CYP 2C19, CYP 2D6, CYP 2E1 eller CYP 3A4/ 5.
Therefore, vildagliptin is not likely to affect metabolic clearance of co-medications metabolised by CYP 1A2, CYP 2C8, CYP 2C9, CYP 2C19, CYP 2D6, CYP 2E1 or CYP 3A4/5.
85% af dosis udskilt i urinen, og 15% af dosis genfindes i fæces.
Elimination Following oral administration of [14C] vildagliptin, approximately 85% of the dose was excreted into the urine and 15% of the dose was recovered in the faeces.
Renal udskillelse af uændret vildagliptin udgjorde 23% af dosis efter oral administration.
Renal excretion of the unchanged vildagliptin accounted for 23% of the dose after oral administration.
Efter intravenøs administration til raske forsøgspersoner er den totale plasma - og renale clearance af vildagliptin henholdsvis 41 og 13 l/ t.
After intravenous administration to healthy subjects, the total plasma and renal clearances of vildagliptin are 41 and 13 l/h, respectively.
Den gennemsnitlige eliminationshalveringstid efter intravenøs administration er ca.
The mean elimination half-life after intravenous administration is approximately 2 hours.
3 timer.
The elimination half-life after oral administration is approximately 3 hours.
Linearitet/ non- linearitet Cmax for vildagliptin og arealet under plasmakoncentrations - mod tidskurven (AUC) steg omtrent dosisproportionalt over det terapeutiske dosisinterval.
Linearity / non-linearity The Cmax for vildagliptin and the area under the plasma concentrations versus time curves (AUC) increased in an approximately dose proportional manner over the therapeutic dose range.
Karakteristika hos patienten Køn:
Characteristics in patients Gender:
Vildagliptins DPP- 4- hæmning er ikke afhængig af køn.
DPP-4 inhibition by vildagliptin is not affected by gender.
Hos raske ældre forsøgspersoner (≥ 70 år) steg den samlede eksponering for vildagliptin (100 mg en gang daglig) med 32%, og den maksimale plasmakoncentration steg med 18% sammenlignet med unge raske forsøgspersoner (18- 40 år).
In healthy elderly subjects (≥ 70 years), the overall exposure of vildagliptin (100 mg once daily) was increased by 32%, with an 18% increase in peak plasma concentration as compared to young healthy subjects (18-40 years).
Vildagliptins DPP- 4- hæmning er ikke afhængig af alder.
DPP-4 inhibition by vildagliptin is not affected by age.
Hos forsøgspersoner med mild, moderat eller stærkt nedsat leverfunktion (Child - Pugh- A- C) var der ingen klinisk signifikante forandringer (maksimalt ~30%) i eksponeringen af vildagliptin.
In subjects with mild, moderate or severe hepatic impairment (Child-Pugh A-C) there were no clinically significant changes (maximum ~30%) in exposure to vildagliptin.
Hos forsøgspersoner med let, moderat eller svært nedsat nyrefunktion var den systemiske eksponering for vildagliptin øget (Cmax 8- 66%, AUC 32- 134%), og den totale body - clearance var reduceret sammenlignet med forsøgspersoner med normal nyrefunktion.
In subjects with mild, moderate, or severe renal impairment, systemic exposure to vildagliptin was increased (Cmax 8-66%; AUC 32-134%) and total body clearance was reduced compared to subjects with normal renal function.
Etnisk gruppe:
Ethnic group:
Begrænsede data antyder, at race ikke har nogen større betydning for vildagliptins farmakokinetik.
Limited data suggest that race does not have any major influence on vildagliptin pharmacokinetics.
Metformin Absorption Efter en oral dosis metformin nås den maksimale plasmakoncentration Cmax efter ca.
Metformin Absorption After an oral dose of metformin, the maximum plasma concentration (Cmax) is achieved after about 2.5 h..
Efter en oral dosis var den ikke- absorberede fraktion, der blev genfundet i fæces, 20- 30%.
After an oral dose, the non-absorbed fraction recovered in faeces was 20-30%.
11 Efter oral administration er metformins absorption mætbar og ufuldstændig.
After oral administration, metformin absorption is saturable and incomplete.
Det antages, at farmakokinetikken for metformins absorption er ikke- lineær.
It is assumed that the pharmacokinetics of metformin absorption are non-linear.
Ved de normale metformindoser og doseringsplaner nås steady- state plasmakoncentrationer inden for 24- 48 timer og er generelt mindre end 1 µg/ ml.
At the usual metformin doses and dosing schedules, steady state plasma concentrations are reached within 24-48 h and are generally less than 1 µg/ml.
I kontrollerede kliniske forsøg oversteg de maksimale metformin plasmaværdier (Cmax) ikke 4 µg/ ml, selv ikke ved maksimumdoser.
In controlled clinical trials, maximum metformin plasma levels (Cmax) did not exceed 4 µg/ml, even at maximum doses.
Mad forsinker og reducerer omfanget af absorptionen af metformin en smule.
11 Food slightly delays and decreases the extent of the absorption of metformin.
Efter administration af en dosis på 850 mg var den maksimale plasmakoncentration 40% lavere, AUC blev reduceret med 25% og tiden til maksimal plasmakoncentration blev forøget med 35 minutter.
Following administration of a dose of 850 mg, the plasma peak concentration was 40% lower, AUC was decreased by 25% and time to peak plasma concentration was prolonged by 35 minutes.
Fordeling Plasmaproteinbindingen er forsvindende lille.
Distribution Plasma protein binding is negligible.
Det gennemsnitlige fordelingsvolumen (Vd) varierede mellem 63- 276 liter.
The mean volume of distribution (Vd) ranged between 63-276 litres.
Udskillelse Metformin udskilles gennem nyrerne.
Elimination Metformin is eliminated by renal excretion.
Renal clearance af metformin er > 400 ml/ min., hvilket er tegn på at metformin elimineres ved glomerular filtrering og tubulær sekretion.
Renal clearance of metformin is > 400 ml/min, indicating that metformin is eliminated by glomerular filtration and tubular secretion.
Vildagliptin Der blev observeret intrakardielle impulsledningsforsinkelser hos hunde med en NOEL (No Observed Effect Level) på 15 mg/ kg (7 gange human eksponering baseret på Cmax).
Vildagliptin Intra-cardiac impulse conduction delays were observed in dogs with a no-effect dose of 15 mg/kg (7- fold human exposure based on Cmax).