natgillin/translations-raw huggingface dataset:
Film coating: poly(vinyl alcohol) macrogol 3350 talc (E553b) titanium dioxide (E171) red iron oxide (E172) yellow iron oxide (E172)
Filmska obloga: poli(vinilalkohol) makrogol 3350 smukec (E553b) titanov dioksid (E171) rdeči železov oksid (E172) rumeni železov oksid (E172)
These characteristics had no clinically meaningful effect on the pharmacokinetics of sitagliptin based on a composite analysis of Phase I pharmacokinetic data and on a population pharmacokinetic analysis of Phase I and Phase II data.
Na osnovi sestavljene analize farmakokinetičnih podatkov iz I. faze in analize populacijske farmakokinetike na osnovi podatkov iz I. in II.
Analysis in the Intention-to-Treat Population
Analiza populacije z namenom zdravljenja Število bolnikov
This medicine is unlikely to cause low blood sugar because it does not work when your blood sugar is low.
Ker zdravilo ne deluje, ko je krvni sladkor nizek, je verjetnost za prekomerno znižanje krvnega sladkorja majhna.
- The other ingredients are: In the tablet core: microcrystalline cellulose (E460), calcium hydrogen phosphate, anhydrous (E341), croscarmellose sodium (E468), magnesium stearate (E470b), and sodium stearyl fumarate.
- Druge sestavine zdravila so: V jedru tablete: mikrokristalna celuloza (E460), brezvodni kalcijev hidrogenfosfat (E341), premreženi natrijev karmelozat (E468), magnezijev stearat (E470b) in natrijev stearilfumarat.
Sitagliptin, but not metformin, increased active GIP concentrations.
Sitagliptin je povečal koncentracijo aktivnega GIP, metformin pa ne.
There was no meaningful change from baseline in body weight in either group.
V nobeni skupini ni bilo nobenih pomembnih razlik v telesni masi glede na začetne vrednosti.
• a sulphonylurea when diet and exercise plus maximal tolerated dose of a sulphonylurea alone do not provide adequate glycaemic control and when metformin is inappropriate due to contraindications or intolerance.
• s sulfonilsečnino, če urejenost glikemije z dieto in s telesno aktivnostjo ter z zdravljenjem z največjim toleriranim odmerkom sulfonilsečnine same ni zadostna, zdravljenje z metforminom pa zaradi kontraindikacij ali intolerance ni primerno.
Compared to normal healthy control subjects, plasma AUC of sitagliptin was increased by approximately 1.2-fold and 1.6-fold in patients with mild renal impairment (GFR ≥ 60 to < 90 mL/min) and patients with moderate renal impairment (GFR ≥ 45 to < 60 mL/min), respectively.
V primerjavi z zdravimi kontrolnimi preiskovanci je bila plazemska AUC sitagliptina pri bolnikih z blago ledvično okvaro (GFR ≥ 60 do < 90 ml/min) približno 1,2-krat večja, pri bolnikih z zmerno ledvično okvaro (GFR ≥ 45 do < 60 ml/min) pa približno 1,6-krat večja.
Sitagliptin was not carcinogenic in mice.
Pri miših sitagliptin ni deloval kancerogeno.
The level of digoxin in your blood may need to be checked if taking with Ristaben.
Med sočasnim jemanjem z zdravilom Ristaben vam bodo morda morali preveriti vrednosti digoksina v krvi.
For patients with moderate renal impairment (GFR  45 to < 60 mL/min), no dosage adjustment is required.
Pri bolnikih z zmerno ledvično okvaro (GFR  45 do < 60 ml/min) odmerka ni treba prilagoditi.
The overall incidence of serious adverse events in patients receiving sitagliptin was similar to that in patients receiving placebo.
Celotna pojavnost resnih neželenih dogodkov je bila pri bolnikih, ki so prejemali sitagliptin, podobna kot pri tistih, ki so prejemali placebo.
Tablet core: microcrystalline cellulose (E460) calcium hydrogen phosphate, anhydrous (E341) croscarmellose sodium (E468) magnesium stearate (E470b) sodium stearyl fumarate
Jedro tablete: mikrokristalna celuloza (E460) kalcijev hidrogenfosfat, brezvodni (E341) natrijev karmelozat, premreženi (E468) magnezijev stearat (E470b) natrijev stearilfumarat
To achieve plasma concentrations of sitagliptin similar to those in patients with normal renal function, lower dosages are recommended in patients with GFR < 45 mL/min (see section 4.2).
Za doseg podobnih plazemskih koncentracij sitagliptina, kot so pri bolnikih z normalno ledvično funkcijo, se pri bolnikih z GFR < 45 ml/min priporočajo manjši odmerki zdravila (glejte poglavje 4.2).
as dual oral therapy in combination with
kot kombinacija dveh peroralnih zdravil, in sicer v kombinaciji
For patients with mild renal impairment (glomerular filtration rate [GFR]  60 to < 90 ml/min), no dose adjustment is required.
Pri bolnikih z blago ledvično okvaro (ocena glomerulne filtracije [GFR - glomerular filtration rate]  60 do < 90 ml/min) odmerka ni treba prilagoditi.
Incisor teeth abnormalities were observed in rats at exposure levels 67 times the clinical exposure level; the no-effect level for this finding was 58-fold based on the 14-week rat study.
Pri podganah so v 14-tedenski študiji pri izpostavljenosti, ki je bila 67-krat večja od izpostavljenosti pri klinični uporabi, opazili nepravilnosti zob sekalcev; izpostavljenost brez škodljivega učinka je bila 58-krat večja od izpostavljenosti pri klinični uporabi.
In rats, there was an increased incidence of hepatic adenomas and carcinomas at systemic exposure levels 58 times the human exposure level.
Pri podganah so pri sistemski izpostavljenosti, ki je bila 58-krat večja od izpostavljenosti človeka pri klinični uporabi, opazili večjo pojavnost jetrnih adenomov in karcinomov.
Ristaben is a member of a class of oral anti-hyperglycaemic agents called dipeptidyl peptidase 4 (DPP-4) inhibitors.
Zdravilo Ristaben spada v skupino peroralnih antidiabetikov, imenovanih zaviralci dipeptidil peptidaze 4 (DPP-4).
The primary cardiovascular endpoint was a composite of the first occurrence of cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for unstable angina.
Primarni srčno-žilni opazovani dogodek je bil sestavljen iz prvega pojava srčno-žilne smrti, miokardnega infarkta brez smrtnega izida, možganske kapi brez smrtnega izida ali hospitalizacije zaradi nestabilne angine pektoris.
After 54 weeks, the mean reduction from baseline in HbA1c was -0.76 % with sitagliptin and -0.64 % with glipizide (Per-Protocol Analysis).
Po 54 tednih je bilo povprečno zmanjšanje HbA1c glede na izhodišče za sitagliptin -0,76 %, za glipizid pa -0,64 % (Per-Protocol analiza).
The tablet film coating contains: poly(vinyl alcohol), macrogol 3350, talc (E553b), titanium dioxide (E171), red iron oxide (E172), and yellow iron oxide (E172).
Filmska obloga tablete vsebuje: poli(vinilalkohol), makrogol 3350, smukec (E553b), titanov dioksid (E171), rdeči železov oksid (E172) in rumeni železov oksid (E172).
After 54 weeks, the mean reduction from baseline in HbA1c was -0.72 % with sitagliptin and -0.87 % with glipizide.
Po 54 tednih je bilo povprečno zmanjšanje vrednosti HbA1c glede na izhodišče za sitagliptin -0,72 %, za glipizid pa -0,87 %.
* Incidence rate per 100 patient-years is calculated as 100 × (total number of patients with ≥ 1 event during eligible exposure period per total patient-years of follow-up).
Sprejem v bolnišnico zaradi nestabilne angine pektoris Smrt zaradi katerega koli vzroka Sprejem v bolnišnico zaradi srčnega popuščanja * Pojavnost na 100 bolnik-let je izračunana kot 100 × (celotno število bolnikov z ≥ 1 dogodkom med ustreznim obdobjem izpostavljenosti na celotno število bolnik-let spremljanja).
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.
The Trial Evaluating Cardiovascular Outcomes 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 7,339 patients treated with placebo in the intention-to-treat population.
Preskušanje TECOS (Trial Evaluating Cardiovascular Outcomes with Sitagliptin) je v populaciji z namenom zdravljenja vključevalo 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.
Some patients have experienced the following side effects while taking sitagliptin in combination with insulin (with or without metformin):
Pri nekaterih bolnikih, ki so jemali sitagliptin v kombinaciji z insulinom (z metforminom ali brez), so se pojavili naslednji neželeni učinki:
Patients treated with sitagliptin had a modest increase in body weight compared to those given placebo.
Bolnikom, ki so prejemali sitagliptin, se je telesna masa v primerjavi z bolniki, ki so prejemali placebo, zmerno povečala.
The addition of sitagliptin to pioglitazone and metformin provided significant improvements in glycaemic parameters.
Pri dodatku sitagliptina pioglitazonu in metforminu so se glikemični parametri pomembno izboljšali.
With higher insulin levels, tissue glucose uptake is enhanced.
Zaradi višje koncentracije insulina se poveča vstop glukoze v tkiva.
The usual recommended dose is: one 100mg film-coated tablet once a day by mouth
Običajni priporočeni odmerek je: - ena 100 mg filmsko obložena tableta,
Sitagliptin 100 mg once daily (N= 193) Sitagliptin 100 mg once daily (N= 229)
Sitagliptin 100 mg enkrat na dan (N = 229)
Ristaben should not be used during breast-feeding.
Med dojenjem se zdravila Ristaben ne sme jemati.
Nervous system disorders headache
Bolezni živčevja glavobol pogosti omotica občasni
A 26-week placebo-controlled study was designed to evaluate the efficacy and safety of sitagliptin (100 mg once daily) added to the combination of pioglitazone and metformin.
Zasnovana je bila 26-tedenska s placebom nadzorovana študija, v kateri so vrednotili učinkovitost in varnost sitagliptina (100 mg enkrat na dan), če so ga dodali kombinaciji pioglitazona in metformina.
Metabolism and nutrition disorders hypoglycaemia
Presnovne in prehranske motnje hipoglikemija pogosti
Primary Composite Endpoint (Cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for unstable angina)
Primarni sestavljeni opazovani dogodek (Srčno-žilna smrt, miokardni infarkt brez smrtnega izida, možganska kap brez smrtnega izida ali sprejem v bolnišnico zaradi nestabilne angine pektoris)
Always take this medicine exactly as your doctor has told you.
Za urejenost sladkorne bolezni zdravilo jemljite tako dolgo, kot vam je predpisal zdravnik.
Transient treatment-related physical signs, some of which suggest neural toxicity, such as open-mouth breathing, salivation, white foamy emesis, ataxia, trembling, decreased activity, and/or hunched posture were observed in dogs at exposure levels approximately
Pri psih so pri izpostavljenosti, ki je bila približno 23-krat večja od izpostavljenosti pri klinični uporabi, opazili z zdravljenjem povezane prehodne fizične znake, med katerimi so nekateri kazali na škodljive učinke na živčevje, npr. dihanje z odprtimi usti, slinjenje, bruhanje bele spenjene vsebine, ataksija, tresenje, zmanjšana aktivnost in/ali zgrbljena drža.
Some patients have experienced different types of stomach discomfort when starting the combination of sitagliptin and metformin together (frequency is common).
Po začetku zdravljenja s kombinacijo sitagliptina in metformina so se pri nekaterih bolnikih pojavile različne prebavne težave (pojavijo se pogosto).
No dose adjustment is necessary for patients with mild to moderate hepatic impairment.
Pri bolnikih z blago do zmerno jetrno okvaro odmerka ni treba prilagoditi.
Plasma AUC of sitagliptin was increased approximately 2-fold in patients with moderate renal impairment (GFR ≥ 30 to < 45 mL/min), and approximately 4-fold in patients with severe renal impairment (GFR < 30 mL/min), including in patients with ESRD on haemodialysis.
Pri bolnikih z zmerno ledvično okvaro (GFR ≥ 30 do < 45 ml/min) je bila plazemska AUC sitagliptina približno 2-krat večja, pri bolnikih s hudo ledvično okvaro (GFR < 30 ml/min), vključno s tistimi s končno ledvično odpovedjo na hemodializi, pa približno 4-krat večja.
A 24-week placebo-controlled study was designed to evaluate the efficacy and safety of sitagliptin (100 mg once daily) added to insulin (at a stable dose for at least 10 weeks) with or without metformin (at least 1,500 mg).
Zasnovana je bila 24-tedenska s placebom nadzorovana študija, v kateri so vrednotili učinkovitost in varnost sitagliptina (100 mg enkrat na dan), če so ga dodali insulinu (vsaj 10 tednov stabilen odmerek) z ali brez metformina (vsaj 1.500 mg).
In addition, very slight to slight skeletal muscle degeneration was also observed histologically at doses resulting in systemic exposure levels of approximately 23 times the human exposure level.
Poleg tega so pri odmerkih, ki so povzročili približno 23-krat večjo sistemsko izpostavljenost od izpostavljenosti človeka pri klinični uporabi, s histološko preiskavo ugotovili zelo blago do blago degeneracijo skeletnih mišic.
Tabulated list of adverse reactions
Tabelarični pregled neželenih učinkov
A 24-week placebo-controlled study involving 660 patients was designed to evaluate the insulin-sparing efficacy and safety of sitagliptin (100 mg once daily) added to insulin glargine with or without metformin (at least 1,500 mg) during intensification of insulin therapy.
Zasnovana je bila 24-tedenska s placebom nadzorovana študija, ki je vključevala 660 bolnikov in v kateri so vrednotili učinkovitost varčevanja z insulinom in varnost sitagliptina (100 mg enkrat na dan), ki so ga tekom intenziviranja insulinskega zdravljenja dodajali insulinu glargin, z ali brez metformina (najmanj 1.500 mg).
• a PPAR agonist and metformin when use of a PPAR agonist is appropriate and when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.
• z agonistom PPAR in z metforminom, če je uporaba agonista PPAR primerna in če urejenost glikemije z dieto in s telesno aktivnostjo ter z dvojnim zdravljenjem s tema zdraviloma ni zadostna.
Mean change from baseline HbA1c (%)
Srednja sprememba vrednosti HbA1c od izhodišča (%)
A 24-week placebo-controlled study was designed to evaluate the efficacy and safety of sitagliptin (100 mg once daily) added to glimepiride alone or glimepiride in combination with metformin.
Zasnovana je bila 24-tedenska s placebom nadzorovana študija, v kateri so vrednotili učinkovitost in varnost sitagliptina (100 mg enkrat na dan), če so ga dodali glimepiridu samemu ali glimepiridu v kombinaciji z metforminom.
Adverse reactions were identified through postmarketing surveillance.
Neželeni učinki so bili zabeleženi v obdobju trženja zdravila.
To achieve plasma concentrations of sitagliptin similar to those in patients with normal renal function, lower dosages are recommended in patients with GFR < 45 mL/min, as well as in ESRD patients requiring haemodialysis or peritoneal dialysis (see section 4.2 and 5.2).
Za doseg podobnih plazemskih koncentracij sitagliptina, kot so pri bolnikih z normalno ledvično funkcijo, se pri bolnikih z GFR < 45 ml/min ter bolnikih s končno ledvično odpovedjo, ki potrebujejo hemodializo ali peritonealno dializo, priporočajo manjši odmerki zdravila (glejte poglavji 4.2 in 5.2).
Renal and liver toxicity were observed in rodents at systemic exposure values 58 times the human exposure level, while the no-effect level was found at 19 times the human exposure level.
Pri glodavcih so pri sistemski izpostavljenosti, ki je bila 58-krat večja od izpostavljenosti pri človeku, opazili škodljive učinke na ledvice in jetra, izpostavljenost brez škodljivih učinkov pa je bila 19-krat večja od izpostavljenosti pri človeku.
A no-effect level for these findings was found at an exposure 6-fold the clinical exposure level.
Pri tem je bila izpostavljenost brez škodljivega učinka 6-krat večja od izpostavljenosti pri klinični uporabi.
The decrease in body weight with the combination of sitagliptin and metformin was similar to that observed with metformin alone or placebo; there was no change from baseline for patients on sitagliptin alone.
Zmanjšanje telesne mase je bilo pri uporabi kombinacije sitagliptina in metformina podobno kot pri uporabi metformina samega ali placeba.
Incidence rate per patientyears*
Pojavnost na 100 bolniklet*
Rates of Composite Cardiovascular Outcomes and Key Secondary Outcomes
Deleži sestavljenih srčno-žilnih izidov in ključnih sekundarnih izidov sitagliptin 100 mg placebo
Round, pink film-coated tablet with “221” on one side.
Okrogla, rožnata filmsko obložena tableta z oznako “221” na eni strani.
- If you get any side effects, talk to your doctor, pharmacist, or nurse.
- Če opazite kateri koli neželeni učinek, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
Sitagliptin 100 mg once daily added to ongoing insulin (+/- metformin) therapy (N=305)
Sitagliptin 100 mg enkrat na dan, dodan k že obstoječemu zdravljenju z insulinom (+/- metformin) (N = 305)
Blood and lymphatic system disorders thrombocytopenia
Bolezni krvi in limfatičnega sistema trombocitopenija redki
In a pre-/postnatal development study performed in rats sitagliptin showed no adverse effects.
Študije, izvedene s sitagliptinom na podganah, niso pokazale neželenih vplivov na pre-/post-natalni razvoj.
The addition of sitagliptin to insulin provided significant improvements in glycaemic parameters.
Pri dodatku sitagliptina insulinu so se glikemični parametri pomembno izboljšali.
The pharmacokinetics of sitagliptin were generally similar in healthy subjects and in patients with type 2 diabetes.
Pri zdravih osebah in bolnikih s sladkorno boleznijo tipa 2 je farmakokinetika sitagliptina na splošno podobna.
Round, beige film-coated tablet with “277” on one side.
okrogla, sivorjava filmsko obložena tableta z oznako “277” na eni strani
No adverse effects upon fertility were observed in male and female rats given sitagliptin prior to and throughout mating.
Pri samcih in samicah podgan, ki so sitagliptin prejemali pred in med obdobjem parjenja, niso opazili neželenih učinkov na plodnost.
Sitagliptin is renally excreted.
Sitagliptin se izloča skozi ledvice.
Sitagliptin is also a substrate of p-glycoprotein, which may also be involved in mediating the renal elimination of sitagliptin.
Sitagliptin je tudi substrat za p-glikoprotein, ki je prav tako lahko vključen pri izločanju sitagliptina skozi ledvice, vendar pa ciklosporin, zaviralec p-glikoproteina, ni zmanjšal ledvičnega očistka sitagliptina.
Frequency not known fatal and non-fatal haemorrhagic and necrotizing pancreatitis
Bolezni prebavil zaprtje občasni bruhanje neznana pogostnost akutni pankreatitis neznana pogostnost smrtni in nesmrtni hemoragični in nekrotizirajoči pankreatitis neznana pogostnost
If you get any side effects, talk to your doctor, pharmacist, or nurse.
Če opazite katerega koli izmed neželenih učinkov, se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
Sitagliptin may be a mild inhibitor of p-glycoprotein in vivo.
Sitagliptin lahko in vivo blago zavira p-glikoprotein.
In clinical studies, sitagliptin did not meaningfully alter the pharmacokinetics of metformin, glyburide, simvastatin, rosiglitazone, warfarin, or oral contraceptives, providing in vivo evidence of a low propensity for causing interactions with substrates of CYP3A4, CYP2C8, CYP2C9, and organic cationic transporter (OCT).
V kliničnih študijah sitagliptin ni pomembno spremenil farmakokinetike metformina, gliburida, simvastatina, rosiglitazona, varfarina ali peroralnih kontraceptivov.
If pancreatitis is suspected, Ristaben and other potentially suspect medicinal products should be discontinued; if acute pancreatitis is confirmed, Ristaben should not be restarted.
Ob sumu na pankreatitis je treba prenehati z jemanjem zdravila Ristaben in drugih zdravil, ki bi lahko povzročila pankreatitis.
Sitagliptin 100 mg once daily added to ongoing glimepiride therapy (N=102)
Sitagliptin 100 mg enkrat na dan, dodan k že obstoječemu zdravljenju z glimepiridom (N = 102)
Ristaben contains the active substance sitagliptin which is a member of a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors) that lowers blood sugar levels in adult patients with type 2 diabetes mellitus.
Zdravilo Ristaben vsebuje učinkovino sitagliptin, ki spada v skupino zdravil, imenovano zaviralci DPP-4 (zaviralci dipeptidil peptidaze 4).
Paediatric No studies with Ristaben have been performed in paediatric patients.
Otroci Pri otrocih študij z zdravilom Ristaben niso izvedli.
Change from baseline in body weight was similar for patients treated with sitagliptin relative to placebo.
Sprememba telesne mase glede na začetno vrednost je bila podobna pri bolnikih, ki so se zdravili s sitagliptinom, in pri bolnikih, ki so prejemali placebo.
No dose adjustment for Ristaben is necessary for patients with mild or moderate hepatic impairment (Child-Pugh score  9).
Pri bolnikih z blago ali zmerno jetrno okvaro (ocena po Child-Pugh-u  9) odmerka ni treba prilagoditi.
Sitagliptin 100 mg once daily added to ongoing metformin therapy (N=453)
Sitagliptin 100 mg enkrat na dan, dodan k že obstoječemu zdravljenju z metforminom (N = 453)
Mean change from baseline HbA1c
S placebom korigirana srednja sprememba vrednosti HbA1c
Secondary Composite Endpoint (Cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke)
Sekundarni sestavljeni opazovani dogodek (Srčno-žilna smrt, miokardni infarkt brez smrtnega izida ali možganska kap brez smrtnega izida)
Number of patients
Starejši bolniki
In a study comparing the efficacy and safety of the addition of sitagliptin 100 mg once daily or glipizide (a sulphonylurea) in patients with inadequate glycaemic control on metformin monotherapy, sitagliptin was similar to glipizide in reducing HbA1c.
V študiji so primerjali učinkovitost in varnost dodatnega zdravljenja s sitagliptinom v odmerku 100 mg enkrat na dan ali z glipizidom (sulfonilsečnina) pri bolnikih z nezadostno urejeno glikemijo pri zdravljenju samo z metforminom.
Frequency not known exfoliative skin conditions including Stevens-Johnson syndrome
Pogostnost neželenega učinka kožni vaskulitis neznana pogostnost eksfoliativna stanja na koži, vključno s Stevens-Johnsonovim sindromom neznana pogostnost bulozni pemfigoid neznana pogostnost
- type 1 diabetes - diabetic ketoacidosis (a complication of diabetes with high blood sugar, rapid weight loss,
- sladkorno bolezen tipa 1 - diabetično ketoacidozo (zaplet sladkorne bolezni z visokim krvnim sladkorjem, hitrim hujšanjem, siljenjem na bruhanje ali bruhanjem) - kakršne koli težave z ledvicami v sedanjosti ali v preteklosti - alergijsko reakcijo na zdravilo Ristaben (glejte poglavje 4)
Sitagliptin 100 mg once daily added to ongoing pioglitazone therapy (N=163)
Sitagliptin 100 mg enkrat na dan, dodan k že obstoječemu zdravljenju s pioglitazonom (N = 163)
Sitagliptin is modestly dialysable.
Odstranitev sitagliptina z dializo je zmerna.
Some patients have experienced the following side effects while taking sitagliptin in combination with pioglitazone and metformin:
Pri nekaterih bolnikih, ki so jemali sitagliptin v kombinaciji s pioglitazonom in metforminom, so se pojavili naslednji neželeni učinki:
A study comparing sitagliptin at 25 or 50 mg once daily to glipizide at 2.5 to 20 mg/day was conducted in patients with moderate to severe renal impairment.
Pri bolnikih z zmerno do hudo ledvično okvaro so izvedli študijo za primerjavo sitagliptina v odmerkih 25 ali 50 mg enkrat na dan in glipizida v odmerkih 2,5 do 20 mg/dan.
In these studies there was a similar incidence of hypoglycaemia reported for patients treated with sitagliptin or placebo.
V teh študijah so pri bolnikih, ki so prejemali sitagliptin, poročali o podobni pojavnosti hipoglikemije, kot pri bolnikih, ki so prejemali placebo.