natgillin/translations-raw huggingface dataset:
The active substance in Januvia, sitagliptin, is a dipeptidyl peptidase 4 (DPP-4) inhibitor.
Zdravilna učinkovina zdravila Januvia, sitagliptin, je zaviralec dipeptidil peptidaze 4 (DPP- 4).
It works by blocking the breakdown of ‘ incretin’ hormones in the body.
Deluje tako, da zavre razgrajevanje „ inkretinskih “ hormonov telesa.
By increasing levels of incretin hormones in the blood, sitagliptin stimulates the pancreas to produce more insulin when blood sugar levels are high.
Sitagliptin s povečanjem ravni inkretinskih hormonov v krvi spodbudi trebušno slinavko k tvorjenju večjih količin insulina, če so ravni krvnega sladkorja previsoke.
Sitagliptin does not work when the blood sugar is low.
Sitagliptin nima učinka, kadar so ravni krvnega sladkorja nizke.
7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel.
Sitagliptin tudi zmanjša količino sladkorja, ki ga tvorijo jetra, tako da poviša raven insulina in zniža raven hormona 7 Westferry Circus, Canary Wharf, London, E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. glukagona.
The effects of Januvia were first tested in experimental models before being studied in humans.
Učinki zdravila Januvia so bili najprej preskušeni na poskusnih modelih, nato pa so jih raziskali pri ljudeh.
Januvia was studied in five main studies lasting up to a year, involving almost 4,000 patients with type 2 diabetes whose blood sugar levels were not adequately controlled.
Zdravilo Januvia je bilo raziskano v petih glavnih študijah, ki so trajale največ eno leto in so vključevale skoraj 4000 bolnikov s sladkorno boleznijo tipa 2, katerih ravni krvnega sladkorja ni bilo mogoče ustrezno nadzorovati.
Four of the studies compared Januvia to placebo (a dummy treatment), either taken alone (two studies involving 1,262 patients), or as an add-on to metformin (in 702 patients) or to the PPAR gamma agonist pioglitazone (in 353 patients).
V štirih študijah so primerjali zdravilo Januvia s placebom (zdravilom brez zdravilne učinkovine), ki so ju bolniki jemali same (dve študiji, ki sta vključevali 1262 bolnikov) ali kot dodatek zdravljenju z metforminom (pri 702 bolnikih) oziroma agonistom PPARγ pioglitazonom (pri 353 bolnikih).
The fifth study compared Januvia to glipizide (a sulphonylurea), as an add-on to metformin in 1,172 patients.
V peti študiji so pri 1172 bolnikih primerjali zdravilo Januvia z glipizidom (sulfonilsečnino), ki so ga uporabili kot dodatek pri zdravljenju z metforminom.
An additional study compared Januvia to placebo, when used as an add-on to treatment with glimepiride (another sulphonylurea), with or without metformin, in 441 patients.
V dodatni študiji so pri 441 bolnikih primerjali zdravilo Januvia s placebom, kadar se uporabi kot dodatek zdravljenju z glimepiridom (druga vrsta sulfonilsečnine), z metforminom ali brez njega.
In all studies, the main measure of effectiveness was the change in the level of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.
Pri vseh študijah je bilo glavno merilo učinkovitosti sprememba količine snovi v krvi imenovane glikoziliran hemoglobin (HbA1c), ki kaže na učinkovitost nadzora ravni krvnega sladkorja.
Januvia was more effective than placebo when it was taken alone or in combination with other antidiabetes medicines.
Zdravilo Januvia je bilo učinkovitejše od placeba, ko so ga bolniki jemali samega ali v kombinaciji z drugimi zdravili proti sladkorni bolezni.
In combination with metformin, a daily dose of 100 mg Januvia reduced HbA1c by 0.70% (from 7.96 to 7.26%) after 24 weeks, compared to a fall of 0.08% in the patients adding placebo.
V kombinaciji z metforminom je dnevni odmerek 100 mg zdravila Januvia po 24 tednih znižal HbA1c za 0, 70% (z 7, 96 na 7, 26%), v primerjavi z znižanjem za 0, 08% pri bolnikih, ki so kot dodatno zdravilo prejemali placebo.
In combination with pioglitazone, 100 mg Januvia reduced HbA1c levels by 0.88% after 24 weeks, compared to 0.18% in the patients adding placebo.
V kombinaciji s pioglitazonom je 100 mg odmerek zdravila Januvia v 24 tednih znižal HbA1c za 0, 88%, v primerjavi z 0, 18% pri bolnikih, ki so kot dodatek prejemali placebo.
In the study comparing Januvia and glipizide as an add-on to metformin, glipizide was initially more effective than Januvia in reducing HbA1c levels.
V študiji v kateri so kot dodatka zdravljenju z metforminom primerjali zdravilo Januvia in glipizid, je bil slednji v začetni fazi pri nižanju ravni HbA1c učinkovitejši kot zdravilo Januvia.
However, in patients continuing to take Januvia or glipizide, the two medicines had similar levels of effectiveness after a year of treatment.
Vendar pa sta bili obe zdravili po enem letu zdravljenja pri bolnikih, ki so nadaljevali jemanje zdravil Januvia ali glipizida, podobno učinkoviti.
Januvia was also more effective than placebo when it was added to glimepiride (with and without metformin).
Zdravilo Januvia je bilo učinkovitejše od placeba tudi kot dodatek glimepiridu (z metforminom ali brez njega).
This reduced HbA1c levels after 24 weeks by 0.30% in patients receiving Januvia and glimepiride, and by 0.60% in the patients who were also taking also taking metformin in addition to Januvia and glimepiride.
HbA1c ravni so se po 24 tednih znižale za 0, 30% pri bolnikih, ki so jemali zdravilo Januvia in glimepirid, ter za 0, 60% pri bolnikih, ki so poleg zdravila Januvia in glimepirida prejemali še metformin.
The most common side effect when taking Januvia with other medicines is hypoglycaemia.
Najpogostejši neželeni učinek pri jemanju zdravila Januvia skupaj z drugimi zdravili je hipoglikemija.
This is seen in more than 1 patient in 10 when Januvia is taken with a sulphonylurea (with or without metformin) and in between 1 and 10 patients in 100 when Januvia is taken with a PPAR gamma agonist.
Opaziti jo je pri več kot enem bolniku od 10, kadar se zdravilo Januvia jemlje skupaj s sulfonilsečnino (z metforminom ali brez njega) ter med 1 in 10 bolniki od 100, kadar se jemlje skupaj z agonistom PPARγ.
When Januvia is taken with metformin only, the most common side effect (seen in between 1 and 10 patients in 100) is nausea (feeling sick).
Kadar se zdravilo Januvia jemlje skupaj z metforminom, je najpogostejši neželeni učinek (opažen pri najmanj enem in največ 10 bolnikih od 100) navzeja (občutek slabosti).
For the full list of all side effects reported with Januvia, see the Package Leaflet.
Za celoten opis neželenih učinkov, o katerih so poročali pri uporabi zdravila Januvia, glejte navodilo za uporabo.
Januvia should not be used in people who may be hypersensitive (allergic) to sitagliptin or any of the other ingredients.
Zdravila Januvia ne smejo prejemati osebe, ki utegnejo biti preobčutljive za (alergične na) sitagliptin ali katero koli drugo sestavino zdravila.
The Committee for Medicinal Products for Human Use (CHMP) decided that Januvia’ s benefits are greater than its risks for the treatment of patients with type 2 diabetes mellitus to improve glycaemic control in combination with metformin and/ or a sulphonylurea, or a PPAR gamma agonist, when diet and exercise plus the other medicines do not provide adequate glycaemic control.
Odbor za zdravila za uporabo v humani medicini (CHMP) je sklenil, da so koristi zdravila Januvia večje z njim povezanih tveganj pri zdravljenju bolnikov s sladkorno boleznijo tipa 2 in izboljšanju nadzorovanja glikemije v kombinaciji z metforminom in/ ali sulfonilsečnino ali agonistom PPARγ, kadar dieta in telesna vadba ter druga zdravila ne privedejo do primernega nadzora glikemije.
The Committee recommended that Januvia be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Januvia odobri dovoljenje za promet.
Other information about Januvia:
Druge informacije o zdravilu Januvia:
The European Commission granted a marketing authorisation valid throughout the European Union for Januvia to Merck Sharp & Dohme Ltd. on 21 March 2007.
Evropska komisija je dovoljenje za promet z zdravilom Januvia, veljavno po vsej Evropski uniji, odobrila družbi Merck Sharp & Dohme Ltd. dne 21. marca 2007.
The full EPAR for Januvia can be found here.
Celotno Evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Januvia je na voljo tukaj.
Each tablet contains sitagliptin phosphate monohydrate, equivalent to 25 mg sitagliptin.
Ena tableta vsebuje sitagliptinijev fosfat monohidrat, kar ustreza 25 mg sitagliptina.
Round, pink film-coated tablet with “ 221” on one side.
Okrogla rožnata filmsko obložena tableta z oznako “ 221 ” na eni strani.
For patients with type 2 diabetes mellitus, Januvia is indicated:
Pri bolnikih s sladkorno boleznijo tipa 2 je zdravilo Januvia indicirano:
• to improve glycaemic control in combination with metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control.
v kombinaciji z metforminom za izboljšanje urejenosti glikemije, če urejenost sladkorne bolezni z dieto in telesno vadbo ter zdravljenjem z metforminom samim ni zadostna.
• to improve glycaemic control in combination with 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.
v kombinaciji s sulfonilsečnino za izboljšanje urejenosti glikemije, če urejenost sladkorne bolezni z dieto in telesno vadbo ter zdravljenjem z največjim dovoljenim odmerkom sulfonilsečnine same ni zadostna, zdravljenje z metforminom pa zaradi kontraindikacij ali intolerance ni primerno.
• to improve glycaemic control in combination with a sulphonylurea and metformin when diet and exercise plus dual therapy with these agents do not provide adequate glycaemic control.
v kombinaciji s sulfonilsečnino in metforminom za izboljšanje urejenosti glikemije, če urejenost sladkorne bolezni z dieto in telesno vadbo ter zdravljenjem s tema zdraviloma ni zadostna.
For patients with type 2 diabetes mellitus in whom use of a PPARγ agonist (i. e. a thiazolidinedione) is appropriate, Januvia is indicated:
Pri bolnikih s sladkorno boleznijo tipa 2, pri katerih je primerna uporaba agonista PPARγ (npr. tiazolidindiona), je zdravilo Januvia indicirano:
• in combination with the PPARγ agonist when diet and exercise plus the PPARγ agonist alone do not provide adequate glycaemic control.
•
The dosage of metformin or PPARγ agonist should be maintained, and sitagliptin administered concomitantly.
v kombinaciji z agonistom PPARγ, če urejenost sladkorne bolezni z dieto in telesno vadbo ter zdravljenjem z agonistom PPARγ samim ni zadostna.
(See section 4.4.)
4. 2 Odmerjanje in način uporabe
If a dose of Januvia is missed, it should be taken as soon as the patient remembers.
(Glejte poglavje 4. 4.) Če bolnik izpusti odmerek zdravila Januvia, ga mora vzeti takoj, ko se spomni.
2 Patients with renal insufficiency For patients with mild renal insufficiency (creatinine clearance [CrCl] ≥ 50 ml/ min), no dosage adjustment for Januvia is required.
2 Bolniki z ledvično insuficienco Pri bolnikih z blago ledvično insuficienco (kreatininski očistek [CrCl] ≥ 50 ml/ min) odmerka zdravila Januvia ni treba prilagajati.
Clinical study experience with Januvia in patients with moderate or severe renal insufficiency is limited.
Izkušnje iz kliničnih študij z zdravilom Januvia so pri bolnikih z zmerno ali s hudo ledvično insuficienco omejene.
Therefore, use of Januvia is not recommended in this patient population (see section 5.2).
Pri tej skupini bolnikov uporabe zdravila Januvia ne priporočamo (glejte poglavje 5. 2).
Patients with hepatic insufficiency No dosage adjustment is necessary for patients with mild to moderate hepatic insufficiency.
Bolniki z jetrno insuficienco Pri bolnikih z blago do zmerno jetrno insuficienco odmerka ni treba prilagajati.
Januvia has not been studied in patients with severe hepatic insufficiency.
Pri bolnikih s hudo jetrno insuficienco uporaba zdravila Januvia ni raziskana.
Elderly No dosage adjustment is necessary based on age.
Starejši bolniki Prilagajanje odmerka glede na starost ni potrebno.
Limited safety data is available in patients ≥ 75 years of age and care should be exercised.
Pri teh bolnikih je potrebna previdnost.
Paediatric population Januvia is not recommended for use in children below 18 years of age due to a lack of data on its safety and efficacy.
Otroci Zaradi pomanjkanja podatkov o varnosti in učinkovitosti uporabe zdravila Januvia pri otrocih, mlajših od 18 let, ne priporočamo.
Hypersensitivity to the active substance or to any of the excipients (see section 4.4 and 4.8).
Preobčutljivost za zdravilno učinkovino ali katerokoli pomožno snov (glejte poglavji 4. 4 in 4. 8).
General Januvia should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
Splošno Zdravila Januvia se ne sme uporabljati pri bolnikih s sladkorno boleznijo tipa 1 ali za zdravljenje diabetične ketoacidoze.
Hypoglycaemia when used in combination with other anti-hyperglycaemic agents In clinical trials of Januvia as monotherapy and as part of combination therapy with agents not known to cause hypoglycaemia (i. e. metformin or pioglitazone), 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 Januvia kot samostojnega zdravila in v kombinaciji z drugimi zdravili za katere ni znano, da povzročijo hipoglikemijo (npr. metformin ali pioglitazon), so pri bolnikih, ki so jemali sitagliptin, poročali o podobnih deležih hipoglikemije kot pri bolnikih, ki so jemali placebo.
When sitagliptin was added to a sulphonylurea, the incidence of hypoglycaemia was increased over that of placebo (see section 4.8).
Če so bolniki, ki so se že zdravili s sulfonilsečnino, začeli jemati še sitagliptin, je bila pojavnost hipoglikemije večja od pojavnosti pri placebu (glejte poglavje 4. 8).
Therefore, to reduce the risk of hypoglycaemia, a lower dose of sulphonylurea may be considered (see section 4.2).
Zato je za zmanjšanje tveganja za pojav hipoglikemije odmerek sulfonilsečnine morda treba zmanjšati (glejte poglavje 4. 2).
The use of sitagliptin in combination with insulin has not been adequately studied.
Uporaba sitagliptina v kombinaciji z insulinom ni ustrezno raziskana.
Renal insufficiency As the experience is limited, patients with moderate to severe renal insufficiency should not be treated with Januvia (see section 5.2).
Ledvična insuficienca Zaradi nezadostnih izkušenj z zdravilom bolniki z zmerno ali s hudo ledvično insuficienco zdravila Januvia ne smejo jemati (glejte poglavje 5. 2).
Hypersensitivity Reactions Postmarketing reports of serious hypersensitivity reactions in patients treated with Januvia have been reported.
Preobčutljivostne reakcije V postmarketinških raziskavah so poročali o resnih preobčutljivostnih reakcijah pri bolnikih, ki so bili zdravljeni z zdravilom Januvia.
These reactions include anaphylaxis, angioedema, and exfoliative skin conditions including Stevens-Johnson syndrome.
Te reakcije vključujejo anafilaksijo, angiodem in luščenje kože, vključno s Steven- Johnson- ovim sindromom.
Onset of these reactions occurred within the first 3 months after initiation of treatment with Januvia, with some reports occurring after the first dose.
Reakcije so nastopile v prvih 3 mesecih po pričetku zdravljenja z zdravilom Januvia, v nekaterih primerih pa že po prvem odmerku.
(See section 4.8).
4. 5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
4.5 Interaction with other medicinal products and other forms of interaction
Učinki drugih zdravil na sitagliptin
3 Metformin:
3 V nadaljevanju navedeni klinični podatki kažejo, da je pri sočasni uporabi drugih zdravil tveganje za pojav klinično pomembnih interakcij majhno.
Co-administration of multiple twice-daily doses of 1000 mg metformin with 50 mg sitagliptin did not meaningfully alter the pharmacokinetics of sitagliptin in patients with type 2 diabetes.
Pri bolnikih s sladkorno boleznijo tipa 2 se pri večkratnem sočasnem dajanju metformina v odmerku 1. 000 mg dvakrat na dan in sitagliptina v odmerku 50 mg farmakokinetika sitagliptina ni pomembneje spremenila.
A study was conducted to assess the effect of cyclosporine, a potent inhibitor of p-glycoprotein, on the pharmacokinetics of sitagliptin.
Izvedena je bila študija, ki je ovrednotila učinek ciklosporina, močnega zaviralca p - glikoproteina, na farmakokinetiko sitagliptina.
Coadministration 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.
Pri sočasnem dajanju sitagliptina v obliki enkratnega 100 mg peroralnega odmerka in ciklosporina v obliki enkratnega 600 mg peroralnega odmerka sta se vrednosti AUC in Cmax sitagliptina povečali, in sicer AUC za približno 29%, Cmax pa za približno 68%.
These changes in sitagliptin pharmacokinetics were not considered to be clinically meaningful.
Te spremembe farmakokinetike sitagliptina niso veljale za klinično pomembne.
The renal clearance of sitagliptin was not meaningfully altered.
Ledvični očistek sitagliptina se ni pomembneje spremenil.
Therefore, meaningful interactions would not be expected with other p-glycoprotein inhibitors.
Pomembnejše interakcije z drugimi zaviralci p - glikoproteina torej niso pričakovane.
In vitro studies indicated that the primary enzyme responsible for the limited metabolism of sitagliptin is CYP3A4, with contribution from CYP2C8.
In vitro študije so pokazale, da je CYP3A4 primarni encim, ki je odgovoren za omejeno presnovo sitagliptina ob sodelovanju 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 CYP3A4, pri očistku sitagliptina majhno vlogo.
Metabolism may play a more significant role in the elimination of sitagliptin in the setting of severe renal insufficiency or ESRD.
Pri bolnikih s hudo ledvično insuficienco ali boleznijo ledvic v končnem stadiju (ESRD – end- stage renal disease) ima lahko presnova pri izločanju sitagliptina pomembnejšo vlogo.
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.
Pri bolnikih s hudo ledvično insuficienco ali ESRD lahko močni zaviralci CYP3A4 (npr. 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.
V klinični študiji niso ovrednotili učinkov močnih zaviralcev CYP3A4 v primeru ledvične insuficience.
In vitro transport studies showed that sitagliptin is a substrate for p-glycoprotein and OAT3.
Študije prenosa 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.
Probenecid je in vitro zaviral prenos sitagliptina s pomočjo OAT3, vendar pa je tveganje za pojav klinično pomembnih interakcij majhno.
Concomitant administration of OAT3 inhibitors has not been evaluated in vivo.
Sočasna uporaba zaviralcev OAT3 in vivo ni bila ovrednotena.
Effects of sitagliptin on other medicinal products In vitro data suggest that sitagliptin does not inhibit nor induce CYP450 isoenzymes.
In vitro podatki kažejo, da sitagliptin ne zavira in ne inducira 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).
V kliničnih študijah sitagliptin ni pomembneje spremenil farmakokinetike metformina, gliburida, simvastatina, rosiglitazona, varfarina ali peroralnih kontraceptivov, kar daje in vivo dokaz za majhno dovzetnost za medsebojno delovanje s substrati za CYP3A4, CYP2C8, CYP2C9 in prenašalci organskih kationov.
Sitagliptin had a small effect on plasma digoxin concentrations, and may be a mild inhibitor of p- glycoprotein in vivo.
Sitagliptin ima majhen učinek na koncentracije digoksina v plazmi in je in vivo lahko blagi zaviralec p- glikoproteina.
Sitagliptin had a small effect on plasma digoxin concentrations.
Sitagliptin ima majhen učinek na koncentracije digoksina v plazmi.
Following administration of 0.25 mg digoxin concomitantly with 100 mg of Januvia 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 dajanju digoksina v odmerku 0, 25 mg skupaj z zdravilom Januvia v odmerku 100 mg na dan sta se vrednosti AUC in Cmax digoksina v plazmi povečale, in sicer AUC za približno 11%, Cmax pa za približno 18%.
However, patients at risk of digoxin toxicity should be monitored for this when sitagliptin and digoxin are administered concomitantly.
Prilagajanja odmerka digoksina ne priporočamo, vendar pa je bolnike s tveganjem za pojav toksičnosti digoksina med sočasnim zdravljenjem s sitagliptinom in digoksinom treba nadzorovati.
Pregnancy There are no adequate data from the use of Januvia in pregnant women.
Nosečnost Ni zadostnih podatkov o uporabi zdravila Januvia pri nosečnicah.
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).
Due to lack of human data, Januvia should not be used during pregnancy.
Zaradi pomanjkanja podatkov pri ljudeh se zdravilo Januvia med nosečnostjo ne sme uporabljati.
Lactation It is unknown whether sitagliptin is excreted in human breast milk.
Dojenje Ni znano, če se sitagliptin izloča v materino mleko pri ljudeh.
Animal studies have shown excretion of sitagliptin in breast milk.
Študije na živalih so pokazale, da se sitagliptin izloča z mlekom.
Januvia should not be used during breast-feeding.
Med dojenjem se zdravilo Januvia ne sme uporabljati.
However, when driving or operating machines, it should be taken into account that dizziness and somnolence have been reported.
4 Študij o vplivu na sposobnost vožnje in upravljanja s stroji niso izvedli, vendar pa je pri vožnji ali upravljanju s stroji treba upoštevati, da so poročali o pojavu omotice in zaspanosti.
In 9 large clinical trials of up to 2 years in duration, over 2700 patients have received treatment with Januvia 100 mg per day alone or in combination with metformin, a sulphonylurea (with or without metformin) or a PPARγ agent.
Med 9 obsežnimi kliničnimi preskušanji, ki so trajala do 2 leti, se je z zdravilom Januvia v odmerku 100 mg na dan samim ali v kombinaciji z metforminom, s sulfonilsečnino (z metforminom ali brez) ali z agonistom PPARγ zdravilo več kot 2. 700 bolnikov.
In these trials, the rate of discontinuation due to adverse experiences considered drug-related was 0.8% with 100 mg per day and 1.5% with other treatments.
Med temi preskušanji je bil delež izključitev zaradi z zdravilom povezanih neželenih učinkov pri odmerjanju 100 mg na dan 0, 8%, pri drugih oblikah zdravljenja pa 1, 5%.
No adverse reactions considered as drug-related were reported in patients treated with sitagliptin occurring in excess (> 0.2% and difference > 1 patient) of that in patients treated with control.
Pri bolnikih, ki so se zdravili s sitagliptinom, niso poročali o z zdravilom povezanih neželenih učinkih, ki bi se pojavili pogosteje (> 0, 2% in razlika > 1 bolnik) kot pri bolnikih, ki so se zdravili s kontrolnim zdravilom.