natgillin/translations-raw huggingface dataset:
In vitro data showed that sitagliptin is not an inhibitor of CYP isozymes CYP3A4, 2C8, 2C9, 2D6, 1A2, 2C19 or 2B6, and is not an inducer of CYP3A4 and CYP1A2.
In vitro pridobljeni podatki kažejo, da sitagliptin ni zaviralec izoencimov CYP CYP3A4, 2C8, 2C9, 2D6, 1A2, 2C19 ali 2B6 in ni induktor CYP3A4 ter CYP1A2.
Combination Therapy Studies
Študije kombiniranega zdravljenja
In a two-day study in healthy subjects, sitagliptin alone increased active GLP-1 concentrations, whereas metformin alone increased active and total GLP-1 concentrations to similar extents.
V dvodnevni študiji pri zdravih osebah je sitagliptin sam povečal koncentracijo aktivnega GLP-1, pri čemer je tudi sam metformin v podobnem obsegu povečal koncentracijo aktivnega in celokupnega GLP-1.
Hypoglycaemia has been reported in combination with sulphonylurea (4.7 %-13.8 %) and insulin (9.6 %) (see section 4.4).
O hipoglikemiji so poročali pri kombinaciji s sulfonilsečnino (4,7 % - 13,8 %) in z insulinom (9,6 %) (glejte poglavje 4.4).
Two studies were conducted to evaluate the efficacy and safety of sitagliptin monotherapy.
Izvedeni sta bili dve študiji, ki sta ovrednotili učinkovitost in varnost sitagliptina kot samostojnega zdravila.
These included hypoglycaemia (frequency very common with the combination of sulphonylurea and metformin), influenza (common with insulin (with or without metformin)), nausea and vomiting (common with metformin), flatulence (common with metformin or pioglitazone), constipation (common with the combination of sulphonylurea and metformin), peripheral oedema (common with pioglitazone or the combination of pioglitazone and metformin), somnolence and diarrhoea (uncommon with metformin), and dry mouth (uncommon with insulin (with or without metformin)).
Ti so vključevali hipoglikemijo (pogostnost - zelo pogosta v kombinaciji s sulfonilsečnino in metforminom), gripo (pogostnost - pogosta z insulinom (z ali brez metformina)), navzeo in bruhanje (pogostnost - pogosta z metforminom), flatulenco (pogostnost - pogosta z metforminom ali pioglitazonom), zaprtje (pogostnost - pogosta v kombinaciji s sulfonilsečnino in metforminom), periferni edem (pogostnost - pogosta s pioglitazonom ali v kombinaciji s pioglitazonom in metforminom), zaspanost in diarejo (pogostnost - občasna z metforminom) in suha usta (pogostnostobčasna z insulinom (z ali brez metformina)).
The effect of potent CYP3A4 inhibitors in the setting of renal impairment has not been assessed in a clinical study.
Učinkov močnih zaviralcev CYP3A4 pri ledvični okvari v klinični študiji niso ovrednotili.
The renal clearance of sitagliptin was not meaningfully altered.
Ledvični očistek sitagliptina se ni pomembno spremenil.
In this study, the proinsulin to insulin ratio, a marker of efficiency of insulin synthesis and release, improved with sitagliptin and deteriorated with glipizide treatment.
V tej študiji se je razmerje proinsulin/insulin, ki je označevalec učinkovitosti sinteze in sproščanja insulina, pri zdravljenju s sitagliptinom izboljšalo, pri zdravljenju z glipizidom pa poslabšalo.
Hazard Ratio (95% CI)
Razmerje ogroženosti (95 % IZ)
The improvement in glycaemic control observed with this medicinal product may be mediated by enhancing the levels of active incretin hormones.
Izboljšanje urejenosti glikemije, ki so ga opazili pri tem zdravilu, je lahko posledica povečanja količine aktivnih inkretinov.
No dose adjustment is necessary based on gender, race, or body mass index (BMI).
Na osnovi spola, rase ali indeksa telesne mase (ITM) odmerka ni treba prilagajati.
Treatment may be administered without regard to the timing of dialysis.
Zdravilo se lahko zaužije ne glede na čas dialize.
Sitagliptin prevents the hydrolysis of incretin hormones by DPP-4, thereby increasing plasma concentrations of the active forms of GLP-1 and GIP.
Sitagliptin preprečuje hidrolizo inkretinov z DPP-4 in tako povečuje plazemske koncentracije aktivnih oblik GLP-1 in GIP.
Digoxin: Sitagliptin had a small effect on plasma digoxin concentrations.
Digoksin: Sitagliptin je imel majhen učinek na koncentracijo digoksina v plazmi.
When used in combination with metformin and/or a PPAR agonist, the dose of metformin and/or PPAR agonist should be maintained, and Ristaben administered concomitantly.
Pri uporabi v kombinaciji z metforminom in/ali agonistom PPAR je treba odmerek metformina in/ali agonista PPAR ohraniti in zdravilo Ristaben uporabljati sočasno.
Taking this medicine in combination with medicines called sulphonylureas or with insulin can cause hypoglycaemia, which may affect your ability to drive and use machines or work without safe foothold.
Jemanje tega zdravila v kombinaciji z zdravili, imenovanimi sulfonilsečnine, ali z insulinom lahko povzroči hipoglikemijo, ki lahko vpliva na sposobnost vožnje in upravljanja strojev ali na delo v nevarnem okolju.
It is not known if sitagliptin is dialysable by peritoneal dialysis.
Ni znano, če se sitagliptin odstrani s peritonealno dializo.
The European Medicines Agency has deferred the obligation to submit the results of studies with Ristaben in one or more subsets of the paediatric population in type 2 diabetes mellitus (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je odstopila od obveze za predložitev rezultatov študij z zdravilom Ristaben za vse skupine pediatrične populacije za sladkorno bolezen tipa 2 (za podatek o uporabi pri pediatrični populaciji glejte poglavje 4.2).
C]sitagliptin dose to healthy subjects, approximately 100 % of the administered radioactivity was eliminated in faeces (13 %) or urine (87 %) within one week of dosing.
C]sitagliptina zdravim osebam se je v enem tednu po prejemu odmerka približno 100 % prejete radioaktivnosti izločilo z blatom (13 %) ali urinom (87 %).
Overall, sitagliptin improved glycaemic control when used as monotherapy or in combination treatment (see Table 2).
Na splošno je sitagliptin izboljšal urejenost glikemije, če se je uporabljal sam ali v kombinaciji z drugimi zdravili (glejte preglednico 2).
In clinical studies, approximately 13.5 % of the dose was removed over a 3- to 4-hour haemodialysis session.
V kliničnih študijah se je med 3- do 4-urno hemodializo odstranilo približno 13,5 % odmerka.
In patients with normal renal function, metabolism, including via CYP3A4, plays only a small role in the clearance of sitagliptin.
Pri bolnikih z normalnim delovanjem ledvic ima presnova, vključno s presnovo preko CYP3A4, le majhno vlogo pri očistku sitagliptina.
Type 2 diabetes is a condition in which your body does not make enough insulin, and the insulin that your body produces does not work as well as it should.
Sladkorna bolezen tipa 2 je stanje, pri katerem v telesu ne nastaja dovolj insulina, delovanje nastalega insulina pa ni ustrezno.
In another study involving 91 patients with type 2 diabetes and chronic renal impairment (creatinine clearance < 50 ml/min), the safety and tolerability of treatment with sitagliptin at 25 or 50 mg once daily were generally similar to placebo.
V še eni študiji, ki je vključevala 91 bolnikov s sladkorno boleznijo tipa 2 in s kronično ledvično okvaro (kreatininski očistek < 50 ml/min), sta bili varnost in tolerabilnost zdravljenja s sitagliptinom v odmerkih 25 ali 50 mg enkrat na dan na splošno podobni kot pri placebu.
It is not known if this medicine passes into breast milk.
Ni znano, če se to zdravilo izloča v materino mleko.
Merck Sharp & Dohme Ltd. Shotton Lane, Cramlington Northumberland NE23 3JU United Kingdom
Merck Sharp & Dohme Ltd. Shotton Lane, Cramlington Northumberland NE23 3JU Velika Britanija
Sitagliptin is primarily eliminated unchanged in urine, and metabolism is a minor pathway.
Sitagliptin se primarno izloča z urinom v nespremenjeni obliki, presnova pa je manj pomemben način izločanja.
Other potential causes for the event should be assessed, and alternative treatment for diabetes initiated.
Oceniti morate tudi ostale možne vzroke za nastali zaplet ter začeti sladkorno bolezen zdraviti z drugimi zdravili.
The mean glipizide dose used in the comparator group was 10 mg per day with approximately 40 % of patients requiring a glipizide dose of  5 mg/day throughout the study.
Povprečni odmerek glipizida, ki so ga uporabili v primerjalni skupini, je bil 10 mg na dan, pri čemer je ves čas študije približno 40 % bolnikov potrebovalo odmerek glipizida  5 mg/dan.
Because there is a dosage adjustment based upon renal function, assessment of renal function is recommended prior to initiation of Ristaben and periodically thereafter.
Ker prilagoditev odmerka temelji na ledvični funkciji, pred začetkom zdravljenja z zdravilom Ristaben in periodično tekom zdravljenja priporočamo oceno ledvične funkcije.
After a median follow up of 3 years, sitagliptin, when added to usual care, did not increase the risk of major adverse cardiovascular events or the risk of hospitalization for heart failure compared to usual care without sitagliptin in patients with type 2 diabetes (Table 3).
Po 3 letih spremljanja (mediana) sitagliptin pri bolnikih s sladkorno boleznijo tipa 2, dodan običajnemu zdravljenju, ni povečal tveganja za pomembne neželene srčno-žilne dogodke ali tveganja za hospitalizacijo zaradi srčnega popuščanja v primerjavi z bolniki, ki so prejemali običajno zdravljenje brez sitagliptina (preglednica 3).
In vitro transport studies showed that sitagliptin is a substrate for p-glycoprotein and organic anion transporter-3 (OAT3).
Študije transporta in vitro so pokazale, da je sitagliptin substrat za p-glikoprotein in organski anionski prenašalec-3 (OAT3).
C]sitagliptin oral dose, approximately 16 % of the radioactivity was excreted as metabolites of sitagliptin.
C]sitagliptina se je približno 16 % radioaktivnosti izločilo v obliki presnovkov sitagliptina.
OAT3 mediated transport of sitagliptin was inhibited in vitro by probenecid, although the risk of clinically meaningful interactions is considered to be low.
In vitro je probenecid zaviral transport sitagliptina, ki ga uravnava OAT3, čeprav se smatra, da je tveganje za klinično pomembne interakcije majhno.
If you stop taking Ristaben
Če ste prenehali jemati zdravilo Ristaben
For adult patients with type 2 diabetes mellitus, Ristaben is indicated to improve glycaemic control:
Pri odraslih bolnikih s sladkorno boleznijo tipa 2 je zdravilo Ristaben indicirano za izboljšanje urejenosti glikemije:
Baseline HbA1c was 8.74 % and baseline insulin dose was 37 IU/day.
Začetna vrednost HbA1c je znašala 8,74 %, začetni odmerek insulina pa je bil 37 i.e./dan.
Sitagliptin was modestly removed by haemodialysis (13.5 % over a 3- to 4-hour haemodialysis session starting 4 hours postdose).
Sitagliptin se je zmerno odstranil s hemodializo (13,5 % pri 3- do 4-urni hemodializi, ki se začne 4 ure po odmerku).
The clinical relevance of hOAT-3 in sitagliptin transport has not been established.
Klinični pomen hOAT-3 pri transportu sitagliptina ni bil dokazan.
Animal studies have shown excretion of sitagliptin in breast milk.
Študije na živalih so pokazale, da se sitagliptin izloča v mleko.
Since hepatotoxicity has been shown to correlate with induction of hepatic neoplasia in rats, this increased incidence of hepatic tumours in rats was likely secondary to chronic hepatic toxicity at this high dose.
Ker je bila pri podganah dokazana povezava med hepatotoksičnostjo in indukcijo jetrnih neoplazij, je bila pojavnost jetrnih tumorjev pri podganah najverjetneje povečana zaradi kronične hepatotoksičnosti pri tem velikem odmerku.
This medicine can be used alone or in combination with certain other medicines (insulin, metformin, sulphonylureas, or glitazones) that lower blood sugar, which you may already be taking for your diabetes together with a food and exercise plan.
To zdravilo se lahko uporablja samo ali v kombinaciji z določenimi drugimi zdravili za zniževanje krvnega sladkorja (insulinom, metforminom, sulfonilsečninami ali glitazoni), ki jih za zdravljenje sladkorne bolezni morda že jemljete ob sočasni načrtovani prehrani in telesni aktivnosti.
Studies in animals have shown reproductive toxicity at high doses (see section 5.3).
Študije na živalih so pri velikih odmerkih pokazale vpliv na sposobnost razmnoževanja (glejte poglavje 5.3).
For both GLP-1 and GIP, stimulation of insulin release is enhanced as glucose rises above normal concentrations.
Oba, GLP-1 in GIP, močneje stimulirata sproščanje insulina, ko se koncentracije glukoze zvišajo nad normalne vrednosti.
Hypoglycaemia when used in combination with other anti-hyperglycaemic medicinal products In clinical trials of Ristaben as monotherapy and as part of combination therapy with medicinal products not known to cause hypoglycaemia (i.e. metformin and/or a PPAR agonist), rates of hypoglycaemia reported with sitagliptin were similar to rates in patients taking placebo.
Hipoglikemija pri zdravljenju v kombinaciji z ostalimi antihiperglikemiki V kliničnih preskušanjih zdravila Ristaben kot samostojnega zdravila in v kombinaciji z drugimi zdravili za katere ni znano, da povzročijo hipoglikemijo (tj. metforminom in/ali agonistom PPAR), so pri bolnikih, ki so jemali sitagliptin, poročali o podobnih deležih hipoglikemije kot pri bolnikih, ki so jemali placebo.
During controlled clinical trials in healthy subjects, single doses of up to 800 mg sitagliptin were administered.
V nadzorovanih kliničnih preskušanjih so zdrave osebe prejemale enkratne odmerke do 800 mg sitagliptina.
In vitro data suggest that sitagliptin does not inhibit nor induce CYP450 isoenzymes.
Podatki in vitro kažejo, da sitagliptin ne zavira in ne inducira izoencimov CYP450.
Effects of sitagliptin on other medicinal products
Učinki sitagliptina na druga zdravila
Some adverse reactions were observed more frequently in studies of combination use of sitagliptin with other anti-diabetic medicinal products than in studies of sitagliptin monotherapy.
Nekatere neželene učinke so opazili pogosteje v študijah kombinirane uporabe sitagliptina z drugimi zdravili za zdravljenje sladkorne bolezni kot v študijah samostojnega zdravljenja s sitagliptinom.
The incidence of hypoglycaemia in the sitagliptin group (6.2 %) was significantly lower than that in the glipizide group (17.0 %).
Pojavnost hipoglikemije v skupini na sitagliptinu (6,2 %) je bila pomembno manjša kot v skupini na glipizidu (17,0 %).
The activity of GLP-1 and GIP is limited by the DPP-4 enzyme, which rapidly hydrolyzes the incretin hormones to produce inactive products.
Aktivnost GLP-1 in GIP je omejena z encimom DPP-4, ki inkretine hitro hidrolizira do neaktivnih oblik.
However, because sitagliptin is primarily renally eliminated, severe hepatic impairment is not expected to affect the pharmacokinetics of sitagliptin.
Ker pa se sitagliptin primarno izloča skozi ledvice, ne pričakujemo, da bi huda jetrna okvara vplivala na farmakokinetiko sitagliptina.
In Phase I multiple-dose studies, there were no dose-related clinical adverse reactions observed with sitagliptin with doses of up to 600 mg per day for periods of up to 10 days and 400 mg per day for periods of up to 28 days.
V študijah večkratnih odmerkov I. faze niso opazili od odmerka odvisnih kliničnih neželenih učinkov sitagliptina pri odmerkih do 600 mg na dan v obdobju do 10 dni in 400 mg na dan v obdobju do 28 dni.
This medicine has no or negligible influence on the ability to drive and use machines.
To zdravilo nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
14 film-coated tablets 28 film-coated tablets 30 film-coated tablets 56 film-coated tablets 84 film-coated tablets 90 film-coated tablets 98 film-coated tablets 50 x 1 film-coated tablets
14 filmsko obloženih tablet 28 filmsko obloženih tablet 30 filmsko obloženih tablet 56 filmsko obloženih tablet 84 filmsko obloženih tablet 90 filmsko obloženih tablet 98 filmsko obloženih tablet 50 x 1 filmsko obložena tableta
The incidence of hypoglycaemia was not significantly different between the treatment groups (sitagliptin, 6.3 %; glipizide, 10.8 %).
Pojavnost hipoglikemije se med zdravljenima skupinama ni pomembno razlikovala (sitagliptin 6,3 %, glipizid 10,8 %)
Body weight decreased from baseline in both groups (sitagliptin, -0.6 kg; metformin -1.9 kg).
Telesna masa se je v primerjavi z izhodiščem zmanjšala v obeh skupinah (sitagliptin -0,6 kg; metformin -1,9 kg).
Hypoglycaemia has been observed when sitagliptin was used in combination with insulin or a sulphonylurea.
Hipoglikemijo so opazili pri uporabi sitagliptina v kombinaciji z insulinom ali sulfonilsečnino.
The study population included 2,004 patients ≥ 75 years of age and 3,324 patients with renal impairment (eGFR < 60 mL/min/1.73 m
Študijska populacija je vključevala 2.004 bolnike, stare ≥ 75 let, in 3.324 bolnikov z okvaro ledvic (eGFR < 60 ml/min/1,73 m
Additional adverse experiences reported regardless of causal relationship to medication that occurred more frequently in patients treated with sitagliptin (not reaching the 5 % level, but occurring with an incidence of > 0.5 % higher with sitagliptin than that in the control group) included osteoarthritis and pain in extremity.
Dodatna neželena učinka, o katerima so poročali ne glede na vzročno povezanost z zdravilom in ki sta se pojavila pogosteje pri bolnikih, zdravljenih s sitagliptinom (nista dosegala 5 % pojavnosti, vendar z > 0,5 % višjo pojavnostjo pri sitagliptinu kot v kontrolni skupini), sta bila osteoartritis in bolečina v okončinah.
Pharmacotherapeutic group: Drugs used in diabetes, Dipeptidyl peptidase 4 (DPP-4) inhibitors, ATC code: A10BH01
Farmakoterapevtska skupina: Zdravila za zdravljenje diabetesa, Inhibitorji dipeptidil peptidaze 4 (DPP-4), oznaka ATC: A10BH01
Ciclosporin: A study was conducted to assess the effect of ciclosporin, a potent inhibitor of p-glycoprotein, on the pharmacokinetics of sitagliptin.
Ciklosporin: Izvedena je bila študija, ki je ovrednotila učinek ciklosporina, močnega zaviralca p-glikoproteina, na farmakokinetiko sitagliptina.
Treatment by stratum (metformin and insulin use) interactions were not significant (p > 0.10).
Vpliv izbranih sočasnih zdravljenj (metformin in insulin) na učinek sitagliptina ni bil značilen (p > 0,10).
Both treatments were added to usual care targeting regional standards for HbA1c and CV risk factors.
Tako sitagliptin kot placebo sta bila dodana običajnemu zdravljenju glede na regionalne smernice za HbA1c in srčno-žilne dejavnike tveganja.
A single-dose, open-label study was conducted to evaluate the pharmacokinetics of a reduced dose of sitagliptin (50 mg) in patients with varying degrees of chronic renal impairment compared to normal healthy control subjects.
Izvedena je bila odprta študija z enkratnim odmerkom, v kateri so ovrednotili farmakokinetiko zmanjšanega odmerka sitagliptina (50 mg) pri bolnikih z različnimi stopnjami kronične ledvične okvare v primerjavi z zdravimi kontrolnimi preiskovanci.
What Ristaben looks like and contents of the pack
Izgled zdravila Ristaben in vsebina pakiranja
In patients taking pre-mixed insulin, the mean daily dose was 70.9 U/day.
Pri bolnikih, ki so prejemali dvofazni insulin, je bil povprečni dnevni odmerek 70,9 enot/dan.
Frequency not known: kidney problems (sometimes requiring dialysis), vomiting, joint pain, muscle pain, back pain, interstitial lung disease, bullous pemphigoid (a type of skin blister)
Neznana pogostnost: težave z ledvicami (ki včasih zahtevajo dializo), bruhanje, bolečine v sklepih, bolečine v mišicah, bolečine v hrbtu, intersticijska pljučna bolezen, bulozni pemfigoid (tip kožnega mehurja)
Secondary cardiovascular endpoints included the first occurrence of cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke; first occurrence of the individual components of the primary composite; all-cause mortality; and hospital admissions for congestive heart failure.
Sekundarni srčno-žilni opazovani dogodki so vključevali prvi pojav srčno-žilne smrti, miokardnega infarkta brez smrtnega izida ali možganske kapi brez smrtnega izida; prvi pojav posameznih komponent primarnega sestavljenega dogodka; umrljivost zaradi vseh vzrokov ter sprejem v bolnišnico zaradi kongestivnega srčnega popuščanja.
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-1 - glucagon-like peptide-1) in od glukoze odvisni insulinotropni polipeptid (GIPglucose-dependent insulinotropic polypeptide), se izločajo iz črevesja ves dan, njihova količina pa se po jedi poveča.
Since co-administration of a high-fat meal with sitagliptin had no effect on the pharmacokinetics, Ristaben may be administered with or without food.
Sočasno zaužitje sitagliptina ter obroka z veliko maščobami ni vplivalo na farmakokinetiko, zato se zdravilo Ristaben lahko jemlje s hrano ali brez nje.
Characteristics in patients
Značilnosti pri bolnikih
Following administration of 0.25 mg digoxin concomitantly with 100 mg of sitagliptin daily for 10 days, the plasma AUC of digoxin was increased on average by 11 %, and the plasma Cmax on average by 18 %.
Po 10-dnevnem odmerjanju 0,25 mg digoksina v kombinaciji s 100 mg sitagliptina dnevno se je vrednost AUC digoksina v plazmi povečala povprečno za 11 %, vrednost Cmax pa povprečno za 18 %.
There was also a significant difference between groups with respect to change from baseline body weight (sitagliptin -0.6 kg; glipizide +1.2 kg).
Pomembna razlika med skupinama je bila tudi v spremembi telesne mase glede na izhodišče (sitagliptin -0,6 kg, glipizid +1,2 kg).
Human data are lacking.
Podatkov za ljudi ni na voljo.
Six metabolites were detected at trace levels and are not expected to contribute to the plasma DPP-4 inhibitory activity of sitagliptin.
Šest presnovkov je bilo odkritih v sledeh, zanje pa se ne pričakuje, da sodelujejo pri zaviralnemu delovanju sitagliptina na DPP-4 v plazmi.
Caution should be exercised in patients with a history of pancreatitis.
Previdnost je potrebna pri bolnikih, ki so v preteklosti že imeli pankreatitis.
In a clinical study sitagliptin had a small effect on plasma digoxin concentrations indicating that sitagliptin may be a mild inhibitor of p-glycoprotein.
V klinični študiji je sitagliptin imel majhen učinek na koncentracije digoksina v plazmi, kar kaže, da je sitagliptin lahko blagi zaviralec p-glikoproteina.
In addition, after 12 weeks, the mean reductions in HbA1c (sitagliptin -0.59 %; placebo -0.18 %) and FPG (sitagliptin -25.5 mg/dL; placebo -3.0 mg/dL) were generally similar to those observed in other monotherapy studies in patients with normal renal function (see section 5.2).
Poleg tega sta bili po 12 tednih povprečni zmanjšanji vrednosti HbA1c (sitagliptin -0,59 %, placebo -0.18 %) in vrednosti glukoze v plazmi na tešče (sitagliptin -25,5 mg/dl, placebo -3.0 mg/dl) na splošno podobni kot v drugih študijah s samostojnim zdravilom pri bolnikih z normalno ledvično funkcijo (glejte poglavje
Co-administration of sitagliptin and metformin had an additive effect on active GLP-1 concentrations.
Sočasno jemanje sitagliptina in metformina ima aditivni učinek na koncentracijo aktivnega GLP-1.
However, dizziness and drowsiness have been reported, which may affect your ability to drive or use machines.
Vendar pa so poročali o pojavu omotice in zaspanosti, ki lahko vplivata na vašo sposobnost upravljanja vozil in strojev.
HbA1c results in placebo-controlled monotherapy and combination therapy studies*
Preglednica 2: Vrednosti HbA1c v s placebom nadzorovanih študijah pri samostojnem in kombiniranem zdravljenju*
The incidence of hypoglycaemia was 25.2 % in patients treated with sitagliptin and insulin (with or without metformin) and 36.8 % in patients treated with placebo and insulin (with or without metformin).
Pojavnost hipoglikemije je bila pri bolnikih, ki so prejemali sitagliptin in insulin (z ali brez metformina) 25,2 %, pri bolnikih, ki so prejemali placebo in insulin (z ali brez metformina) pa 36,8 %.
All myocardial infarction (fatal and non-fatal)
Vsi primeri miokardnega infarkta (s smrtnim izidom in brez njega)
- The active substance is sitagliptin.
- Učinkovina je sitagliptin.