natgillin/translations-raw huggingface dataset:
There is increased risk of lactic acidosis in acute alcohol intoxication (particularly in the case of fasting, malnutrition or hepatic insufficiency) due to the metformin active substance of Efficib (see section 4.4).
Ker je v zdravilu Efficib zdravilna učinkovina metformin, obstaja pri akutni zastrupitvi z alkoholom (še posebno v primerih stradanja, podhranjenosti ali jetrne insuficience) povečana nevarnost laktacidoze (glejte poglavje 4. 4).
Cationic agents that are eliminated by renal tubular secretion (e. g., cimetidine) may interact with metformin by competing for common renal tubular transport systems.
Kationske učinkovine, ki se izločajo z ledvično tubularno sekrecijo (npr. cimetidin), lahko vstopijo v interakcije z metforminom zaradi kompeticije za skupne tubularne transportne sisteme v ledvicah.
A study conducted in seven normal healthy volunteers showed that cimetidine, administered as 400 mg twice daily, increased metformin systemic exposure (AUC) by 50% and Cmax by 81%.
Študija, ki so jo izvedli pri sedmih zdravih prostovoljcih, je pokazala, da uporaba cimetidina v odmerku 400 mg dvakrat na dan, poveča sistemsko izpostavljenost metforminu (AUC) za 50%, vrednost Cmax pa za 81%.
Therefore, close monitoring of glycaemic control, dose adjustment within the recommended posology and changes in diabetic treatment should be considered when cationic agents that are eliminated by renal tubular secretion are co-administered.
Pri sočasnem jemanju kationskih učinkovin, ki se izločajo z ledvično tubularno sekrecijo, je zato treba pretehtati možnost skrbnega spremljanja urejenosti glikemije, prilagoditve odmerkov znotraj priporočenih vrednosti in spremembe zdravljenja sladkorne bolezni.
Therefore, Efficib should be discontinued prior to, or at the time of the test and not reinstituted until 48 hours afterwards, and only after renal function has been re-evaluated and found to be normal (see section 4.4).
Zdravljenje se sme nadaljevati šele 48 ur po posegu in šele, ko se ugotovi normalno delovanje ledvic (glejte poglavje 4. 4).
Combination requiring precautions for use Glucocorticoids (given by systemic and local routes) beta-2-agonists, and diuretics have intrinsic hyperglycaemic activity.
Kombinacije, ki zahtevajo previdnost pri uporabi Glukokortikoidi (dani sistemsko ali lokalno), beta- 2- agonisti in diuretiki imajo intrinzično hiperglikemično aktivnost.
If necessary, the dose of the anti-hyperglycaemic medicinal product should be adjusted during therapy with the other medicinal product and on its discontinuation.
Po potrebi odmerek antidiabetika prilagodite med zdravljenjem z drugim zdravilom ali po ukinitvi drugega zdravila.
If necessary, the dose of the antihyperglycaemic medicinal product should be adjusted during therapy with the other medicinal product and on its discontinuation.
Po potrebi odmerek antidiabetikov prilagodimo med zdravljenjem z drugim zdravilom in ob ukinitvi drugih zdravil.
Effects of other medicinal products on sitagliptin Clinical data described below suggest that the risk for clinically meaningful interactions following co- administration of other medicinal products is low.
Učinek drugih zdravil na sitagliptin Spodaj opisani klinični podatki kažejo, da je tveganje za klinično pomembne interakcije pri sočasni uporabi drugih zdravil majhno.
A study was conducted to assess the effect of cyclosporine, a potent inhibitor of p-glycoprotein, on the pharmacokinetics of sitagliptin.
Opravili so študijo za oceno učinka ciklosporina, močnega zaviralca p- glikoproteina, na farmakokinetiko sitagliptina.
Co-administration of a single 100 mg oral dose of sitagliptin and a single 600 mg oral dose of cyclosporine increased the AUC and Cmax of sitagliptin by approximately 29% and 68%, respectively.
Sočasna uporaba enega 100- miligramskega peroralnega odmerka sitagliptina in enega 600- miligramskega peroralnega odmerka ciklosporina je povečala vrednost AUC sitagliptina za 29%, vrednost Cmax sitagliptina pa za približno 68%.
These changes in sitagliptin pharmacokinetics were not considered to be clinically meaningful.
Menijo, da te spremembe farmakokinetike sitagliptina niso klinično pomembne.
Therefore, meaningful interactions would not be expected with other p-glycoprotein inhibitors.
Zato ni pričakovati pomembnih interakcij z drugimi zaviralci p- glikoproteina.
5 In vitro studies indicated 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.
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 prek CYP3A4, le majhno vlogo pri očistku sitagliptina.
Metabolism may play a more significant role in the elimination of sitagliptin in the setting of severe renal insufficiency or ESRD.
Presnova ima lahko pomembnejšo vlogo pri izločanju sitagliptina pri hudi ledvični insuficienci ali pri končni fazi ledvične bolezni (End Stage Renal Disease – ESRD).
For this reason, it is possible that potent CYP3A4 inhibitors (i. e., ketoconazole, itraconazole, ritonavir, clarithromycin) could alter the phamacokinetics of sitagliptin in patients with severe renal insufficiency or ESRD.
Zato je mogoče, da pri bolnikih s hudo ledvično insuficienco ali ESRD močni zaviralci encima CYP3A4 (tj. ketokonazol, itrakonazol, ritonavir, klaritromicin) spremenijo farmakokinetiko sitagliptina.
The effects of potent CYP3A4 inhibitors in the setting of renal insufficiency has not been assessed in a clinical study.
Učinkov močnih zaviralcev encima CYP3A4 pri ledvični insuficienci v kliničnih študijah niso ocenjevali.
In vitro transport studies showed that sitagliptin is a substrate for p-glycoprotein and OAT3.
5 Študije transporta in vitro so pokazale, da je sitagliptin substrat za p- glikoprotein in OAT3.
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 menijo, da je tveganje za klinično pomembne interakcije majhno.
Concomitant administration of OAT3 inhibitors has not been evaluated in vivo.
Sočasne uporabe zaviralcev OAT3 in vivo niso ocenjevali.
Effects of sitagliptin on other medicinal products In vitro data suggest that sitagliptin does not inhibit nor induce CYP450 isoenzymes.
Učinek sitagliptina na druga zdravila Podatki in vitro kažejo, da sitagliptin ne zavira in ne spodbuja izoencimov CYP450.
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).
To je in vivo pokazatelj, da je nagnjenost k povzročanju interakcij s substrati encimov CYP3A4, CYP2C8, CYP2C9 in organskih kationskih transporterjev (OCT) majhna.
Sitagliptin had a small effect on plasma digoxin concentrations, and may be a mild inhibitor of p-glycoprotein in vivo.
Sitagliptin je imel majhen učinek na koncentracijo digoksina v plazmi, lahko pa je blagi zaviralec p- glikoproteina in vivo.
Sitagliptin had a small effect on plasma digoxin concentrations.
Sitagliptin je imel majhen učinek na koncentracije digoksina v plazmi.
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 odmerjanju 0, 25 mg digoksina sočasno s 100 mg sitagliptina vsak dan v obdobju 10 dni se je vrednost AUC digoksina v plazmi povečala povprečno za 11%, vrednost Cmax v plazmi pa povprečno za 18%.
No dose adjustment of digoxin is recommended.
Prilagajanja odmerka digoksina ne priporočamo.
Studies in animals have shown reproductive toxicity at high doses of sitagliptin (see section 5.3).
Študije na živalih so pri velikih odmerkih sitagliptina pokazale njegov škodljiv vpliv na sposobnost razmnoževanja (glejte poglavje 5. 3).
A limited amount of data suggest the use of metformin in pregnant women is not associated with an increased risk of congenital malformations.
Majhno število podatkov nakazuje, da uporaba metformina pri nosečnicah ni povezana s povečanim tveganjem za prirojene malformacije.
Animal studies with metformin do not indicate harmful effects with respect to pregnancy, embryonic or foetal development, parturition or postnatal development (see also section 5.3).
Študije na živalih z metforminom ne kažejo na neposredne ali posredne škodljive vplive na nosečnost, razvoj zarodka/ plodu, porod ali postnatalni razvoj (glejte tudi poglavje 5. 3).
Efficib should not be used during pregnancy.
Bolnice med nosečnostjo ne smejo uporabljati zdravila Efficib.
If a patient wishes to become pregnant or if a pregnancy occurs, treatment with Efficib should be discontinued and switched to insulin treatment as soon as possible.
Če želi bolnica zanositi ali če zanosi, je treba zdravljenje z zdravilom Efficib prekiniti in čim prej preiti na zdravljenje z insulinom.
No studies in lactating animals have been conducted with the combined active substances of Efficib.
Študij s kombinacijo zdravilnih učinkovin zdravila Efficib na doječih živalih niso opravili.
In studies performed with the individual active substances, both sitagliptin and metformin are excreted in the milk of lactating rats.
V študijah, opravljenih s posameznima zdravilnima učinkovinama, sta se sitagliptin in metformin izločala v mleku doječih podgan.
Efficib must therefore not be used in women who are breast-feeding (see section 4.3).
Zato ženske, ki dojijo, zdravila Efficib ne smejo uporabljati (glejte poglavje 4. 3).
No studies on the effects on the ability to drive and use machines have been performed with Efficib.
Študij o vplivu na sposobnost vožnje in upravljanja s stroji z zdravilom Efficib niso izvedli.
However, when driving or operating machines, it should be taken into account that dizziness and somnolence have been reported with sitagliptin.
Vendar pa je treba pri vožnji in upravljanju strojev upoštevati, da so pri uporabi sitagliptina poročali o omotici in zaspanosti.
In addition, patients should be alerted to the risk of hypoglycaemia when Efficib is used in combination with other sulfonylurea agents.
Poleg tega je treba bolnike, ki jemljejo zdravilo Efficib skupaj z drugimi zdravili, ki vsebujejo sulfonilsečnino, opozoriti na tveganje za pojav hipoglikemije.
6 4.8 Undesirable effects
4. 8 Neželeni učinki
There have been no therapeutic clinical trials conducted with Efficib tablets however bioequivalence of Efficib with co-administered sitagliptin and metformin has been demonstrated (see section 5.2).
Kliničnih terapevtskih preskušanj z zdravilom Efficib niso izvedli, vendar pa so dokazali bioekvivalenco zdravila Efficib in sočasne uporabe sitagliptina in metformina (glejte poglavje 5. 2).
Sitagliptin and metformin Adverse reactions considered as drug related reported in excess (> 0.2% and difference > 1 patient) of placebo and in patients receiving sitagliptin in combination with metformin in double-blind studies are listed below as MedDRA preferred term by system organ class and absolute frequency (Table 1).
Pogostnost je
Frequencies are defined as: very common (≥ 1/ 10); common (≥ 1/ 100 to < 1/ 10); uncommon (≥ 1/ 1,000 to < 1/ 100); rare (≥ 1/ 10,000 to < 1/ 1,000); very rare (< 1/ 10,000).
6 opredeljena kot: zelo pogosti (≥ 1/ 10); pogosti (≥ 1/ 100 do < 1/ 10); občasni (≥ 1/ 1. 000 do < 1/ 100); redki (≥ 1/ 10. 000 do < 1/ 1. 000); zelo redki (< 1/ 10. 000).
Table 1.
Tabela 1:
The frequency of adverse reactions identified from placebo-controlled clinical studies
Pogostnost neželenih učinkov iz kliničnih študij, ki so bile nadzorovane s placebom
Sitagliptin with Metformin1
Sitagliptin v kombinaciji z metforminom1
Sitagliptin with Metformin and a Sulphonylurea2
Sitagliptin v kombinaciji z metforminom in s sulfonilsečnino2
blood glucose decreased
znižanje glukoze v krvi
Nervous system disorders somnolence
Bolezni živčevja zaspanost
diarrhoea nausea constipation upper abdominal pain
diareja navzeja zaprtje bolečina v zgornjem delu trebuha
Uncommon Common Uncommon
občasni pogosti občasni
Metabolism and nutrition disorders hypoglycaemia* *
Presnovne in prehranske motnje hipoglikemija * *
In clinical trials of sitagliptin as monotherapy and sitagliptin as part of combination therapy with metformin, rates of hypoglycaemia reported with sitagliptin were similar to rates in patients taking placebo.
metforminom so pri bolnikih, ki so prejemali sitagliptin, poročali o podobnem deležu hipoglikemije kot pri bolnikih, ki so prejemali placebo.
1 In this placebo-controlled 24-week study of sitagliptin 100 mg once daily added to ongoing metformin, the incidence of adverse reactions considered as drug-related in patients treated with sitagliptin added to ongoing metformin compared to treatment with placebo added to ongoing metformin was 9.3% and 10.1%, respectively.
1 V tej 24- tedenski s placebom nadzorovani študiji z odmerkom 100 mg sitagliptina enkrat na dan v kombinaciji z metforminom je bila pogostnost z zdravilom povezanih neželenih učinkov pri bolnikih, ki so se zdravili s kombinacijo sitagliptin/ metformin, 9, 3- odstotna, pri bolnikih, ki so se zdravili s kombinacijo placebo/ metformin, pa 10, 1- odstotna.
In an additional 1-year study of sitagliptin 100 mg once daily added to ongoing metformin, the incidence of adverse reactions considered as drug-related in patients treated with sitagliptin added to ongoing metformin compared to sulphonylurea added to ongoing metformin was 14.5% and 30.3%, respectively.
V dodatni 1- letni študiji z odmerkom sitagliptina 100 mg enkrat na dan v kombinaciji z metforminom je bila pogostnost z zdravilom povezanih neželenih učinkov pri bolnikih, ki so se zdravili s kombinacijo sitagliptin/ metformin, 14, 5- odstotna, pri bolnikih, ki so prejemali kombinacijo sulfonilsečnina/ metformin, pa 30, 3- odstotna.
In pooled studies of up to 1 year in duration comparing sitagliptin added to ongoing metformin to a sulphonylurea agent added to ongoing metformin, adverse reactions considered as drug-related reported in patients treated with sitagliptin 100 mg occurring in excess (> 0.2% and difference > 1 patient) of that in patients receiving the sulphonylurea agent are as follows: anorexia (Metabolism and nutritional disorders; frequency uncommon) and weight decreased (Investigations; frequency uncommon).
Pri metaanalizi študij, ki so trajale do 1 leta in so primerjale kombinacijo sitagliptin/ metformin s kombinacijo sulfonilsečnina/ metformin, so pri bolnikih, ki so se zdravili s sitagliptinom v odmerku 100 mg, poročali o naslednjih z zdravilom povezanih neželenih učinkih, ki so se pojavili pogosteje (> 0, 2% in razlika > 1 bolnik) kot pri bolnikih, ki so prejemali sulfonilsečnino: anoreksija (Presnovne in prehranske motnje; pogostnost občasna) in zmanjšanje telesne mase (Preiskave; pogostnost občasna).
2 In this 24-week placebo-controlled study of sitagliptin 100 mg once daily added to ongoing combination treatment with glimepiride and metformin, the overall incidence of adverse reactions considered as drug-related in patients treated with the addition of sitagliptin to the ongoing treatment
2 V tej 24- tedenski s placebom primerjani študiji z odmerkom 100 mg sitagliptina enkrat na dan v kombinaciji z glimepiridom in metforminom je bila skupna pojavnost z zdravilom povezanih neželenih učinkov pri bolnikih, ki so se zdravili s sitagliptinom v kombinaciji z glimepiridom in metforminom, 18, 1- odstotna, pri bolnikih, ki so se zdravili s placebom v kombinaciji z glimepiridom in metforminom, pa 7, 1- odstotna.
7 with glimepiride and metformin was 18.1% compared to treatment with the addition of placebo to the ongoing treatment with glimepiride and metformin which was 7.1%.
Pri bolnikih, ki so prejemali
In a 24-week study of initial combination therapy with sitagliptin and metformin administered twice daily (sitagliptin/ metformin 50 mg/ 500 mg or 50 mg/ 1,000 mg), the overall incidence of adverse reactions considered as drug-related in patients treated with the combination of sitagliptin and metformin compared to patients treated with placebo was 14.0% and 9.7%, respectively.
7 sitagliptin in metformin, je bila skupna pojavnost z zdravilom povezanih neželenih učinkov primerljiva s pojavnostjo pri uporabi metformina samega (14, 0% v obeh skupinah) in večja kot pri uporabi sitagliptina samega (6, 7%), pri čemer so bile razlike v primerjavi z uporabo sitagliptina samega predvsem posledica neželenih učinkov v prebavilih.
The overall incidence of adverse reactions considered as drug-related in patients treated with the combination of sitagliptin and metformin was comparable to metformin alone (14.0% each) and greater than sitagliptin alone (6.7%), with the differences relative to sitagliptin alone primarily due to gastrointestinal adverse reactions.
Dodatne informacije o posameznih učinkovinah v fiksni kombinaciji odmerkov
Additional information on the individual active substances of the fixed dose combination Sitagliptin In addition, in monotherapy studies of up to 24 weeks in duration of sitagliptin 100 mg once daily alone compared to placebo, adverse reactions considered as drug-related reported in patients treated with sitagliptin in excess (> 0.2% and difference > 1 patient) of that in patients receiving placebo are headache, hypoglycaemia, constipation, and dizziness.
Sitagliptin Poleg tega so v študijah samostojnega zdravljenja, ki so trajale do 24 tednov, v katerih so primerjali sitagliptin v odmerku 100 mg enkrat na dan in placebo, poročali o naslednjih neželenih učinkih, za katere so menili, da so povezani z uporabo zdravila in so se pojavili pogosteje pri bolnikih, ki so prejemali sitagliptin (> 0, 2% in razlika > 1 bolnik), kot pri bolnikih, ki so prejemali placebo: glavobol, hipoglikemija, zaprtje in omotica.
In addition to the drug related adverse reactions described above, adverse events (reported regardless of causal relationship to medicinal product) occurring in at least 5% and more commonly in patients treated with sitagliptin included upper respiratory tract infection and nasopharyngitis.
Poleg zgoraj navedenih neželenih učinkov, povezanih z zdravilom, sta bila neželena učinka (o katerih so poročali ne glede na vzročno povezavo z zdravilom), ki sta se pojavila pri vsaj 5% bolnikov in pogosteje pri bolnikih, ki so prejemali sitagliptin, okužba zgornjih dihal in nazofaringitis.
Additional adverse events 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.
Med dodatnimi neželenimi učinki, ki so se pojavljali pogosteje pri bolnikih, ki so prejemali sitagliptin (ki niso dosegali 5- odstotne pogostnosti, vendar pa je bila pogostnost pri bolnikih, ki so prejemali sitagliptin > 0, 5% večja kot pri kontrolni skupini), so bili osteoartritis in bolečine v okončinah.
Across clinical studies, a small increase in white blood cell (WBC) count (approximately 200 cells/ microl difference in WBC vs placebo; mean baseline WBC approximately 6,600 cells/ microl) was observed due to an increase in neutrophils.
V kliničnih študijah so opazili manjše povečanje števila levkocitov (razlika v številu levkocitov v primerjavi s placebom približno 200 celic/ mikroliter; povprečno število levkocitov v izhodišču približno 6. 600 celic/ mikroliter), kar je bila posledica povečanja števila nevtrofilcev.
This observation was seen in most but not all studies.
To razliko so opazili pri večini, vendar pa ne v vseh študijah.
This change in laboratory parameters is not considered to be clinically relevant.
Ta sprememba laboratorijskih parametrov ne velja za klinično pomembno.
No clinically meaningful changes in vital signs or in ECG (including in QTc interval) were observed with sitagliptin treatment.
Med zdravljenjem s sitagliptinom niso opazili klinično pomembnih sprememb vitalnih znakov ali EKG- ja (vključno z intervalom QTc).
During post-marketing experience of Efficib or sitagliptin, one of the active substances of Efficib, the following additional adverse reactions have been reported (frequency not known): hypersensitivity reactions including anaphylaxis, angioedema, rash, urticaria, and exfoliative skin conditions including Stevens-Johnson syndrome (see section 4.4).
V obdobju trženja zdravila Efficib ali sitagliptina, eno od zdravilnih učinkovin zdravila Efficib, so poročali o naslednjih neželenih učinkih (pogostnost ni znana): preobčutljivostne reakcije, vključno z anafilaktičnimi reakcijami, angioedemom, izpuščajem, urtikarijo in eksfoliativnimi stanji na koži, vključno s Stevens- Johnsonovim sindromom (glejte poglavje 4. 4).
Clinical Trial Data and Post-marketing data
Podatki iz kliničnih preskušanj in postmarketinški podatki
Table 2 presents adverse reactions by system organ class and by frequency category.
V tabeli 2 so prikazani neželeni učinki po organskih sistemih in pogostnosti.
Frequency categories are based on information available from metformin Summary of Product Characteristics available in the EU.
Kategorije pogostnosti temeljijo na informacijah iz povzetka glavnih značilnosti zdravila, ki je na voljo v EU.
The frequency of metformin adverse reactions identified from clinical trial and postmarketing data
Pogostnost neželenih učinkov metformina, ugotovljenih v kliničnih preskušanjih in iz postmarketinških podatkov
metallic taste
kovinski okus
8 Adverse reaction
8 Bolezni kože in podkožja urtikarija, eritem, pruritis
Frequency
zelo redki
gastrointestinal symptomsa
laktacidoza pomanjkanje vitamina B12b
Very common
zelo redki zelo redki
Skin and subcutaneous disorders urticaria, erythema, pruritis
Bolezni jeter, žolčnika in žolčevodov okvare delovanja jeter, hepatitis
Metabolism and nutrition disorders
Gastrointestinalni simptomi, kot so navzeja, bruhanje, diareja, bolečine v trebuhu in izguba apetita, a
Hepatobiliary disorders liver function disorders, hepatitis a
se najpogosteje pojavijo ob začetku zdravljenja in večinoma spontano prenehajo.
Gastrointestinal symptoms such as nausea, vomiting, diarrhoea, abdominal pain occur most frequently during initiation of therapy and resolve spontaneously in b
Dolgotrajno zdravljenje z metforminom je povezano z zmanjšanjem absorpcije vitamina B12, kar b
Long-term treatment with metformin has been associated with a decrease in vitamin B12 absorption which may very rarely result in clinically significant vitamin B12 deficiency (e. g., megaloblastic anaemia).
lahko zelo redko povzroči klinično pomembno pomanjkanje vitamina B12 (npr. megaloblastno anemijo).
No data are available with regard to overdose of Efficib.
Podatki o prevelikem odmerjanju zdravila Efficib niso na voljo.
During controlled clinical trials in healthy subjects, single doses of up to 800 mg sitagliptin were generally well tolerated.
V nadzorovanih kliničnih preskušanjih so zdrave osebe na splošno dobro prenašale enkratne odmerke do 800 mg sitagliptina.
Minimal increases in QTc, not considered to be clinically relevant, were observed in one study at a dose of 800 mg sitagliptin.
V eni študiji so pri odmerku 800 mg sitagliptina opazili majhno povečanje intervala QTc, ki ni bilo klinično pomembno.
There is no experience with doses above 800 mg in humans.
Izkušenj z odmerki, večjimi od 800 mg, pri človeku ni.
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 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 pri odmerkih do 600 mg na dan v obdobju 10 dni in 400 mg na dan v obdobju do 28 dni.
Sitagliptin is modestly dialyzable.
Sitagliptin se zmerno dializira.