natgillin/translations-raw huggingface dataset:
Patients treated with sitagliptin had a modest increase in body weight (+1.1 kg) compared to those given placebo.
Bolnikom, ki so prejemali sitagliptin, se je telesna masa v primerjavi z bolniki, ki so prejemali placebo, zmerno povečala (+1,1 kg).
Sitagliptin differs in chemical structure and pharmacological action from GLP-1 analogues, insulin, sulphonylureas or meglitinides, biguanides, peroxisome proliferator-activated receptor gamma (PPAR) agonists, alpha-glucosidase inhibitors, and amylin analogues.
Sitagliptin se po kemijski strukturi in farmakološkem delovanju razlikuje od analogov GLP-1, insulina, sulfonilsečnin ali meglitinidov, bigvanidov, agonistov receptorjev gama, aktiviranih s peroksisomskim proliferatorjem (PPAR), zaviralcev alfa-glukozidaze in analogov amilina.
In a 52-week 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 (-0.7 % mean change from baselines at week 52, with baseline HbA1c of approximately 7.5 % in both groups).
V 52-tedenski študiji, v kateri so primerjali učinkovitost in varnost dodatnega zdravljenja s sitagliptinom v odmerku 100 mg enkrat na dan ali z glipizidom (sulfonilsečnina) pri bolnikih z neustrezno urejenostjo glikemije s samostojnim zdravljenjem z metforminom, je sitagliptin povzročil podobno zmanjšanje HbA1c kot glipizid (-0,7 % povprečna sprememba glede na začetno vrednost po 52 tednih, pri izhodiščni vrednosti HbA1c približno 7,5 % v obeh skupinah).
In monotherapy studies of sitagliptin 100 mg once daily alone compared to placebo, adverse reactions reported were headache, hypoglycaemia, constipation, and dizziness.
V študijah samostojnega zdravljenja, v katerih so primerjali sitagliptin v odmerku 100 mg enkrat na dan in placebo, so poročali o naslednjih neželenih učinkih: glavobol, hipoglikemija, zaprtje in omotica.
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; telesna masa se pri bolnikih, ki so prejemali samo sitagliptin, v primerjavi z začetno vrednostjo ni spremenila.
When Ristfor is used in combination with insulin, a lower dose of insulin may be required to reduce the risk of hypoglycaemia (see section 4.4).
Kadar se zdravilo Ristfor uporablja v kombinaciji z insulinom, bo morda potreben manjši odmerek insulina za zmanjšanje tveganja za hipoglikemijo (glejte poglavje 4.4).
Co-administration of multiple doses of sitagliptin (50 mg twice daily) and metformin (1,000 mg twice daily) did not meaningfully alter the pharmacokinetics of either sitagliptin or metformin in patients with type 2 diabetes.
Pri sočasni uporabi večkratnih odmerkov sitagliptina (50 mg dvakrat na dan) in metformina (1.000 mg dvakrat na dan) se farmakokinetika sitagliptina ali metformina pri bolnikih s sladkorno boleznijo tipa 2 ni pomembno spremenila.
When Ristfor is used in combination with a sulphonylurea, a lower dose of the sulphonylurea may be required to reduce the risk of hypoglycaemia (see section 4.4).
Kadar se zdravilo Ristfor uporablja v kombinaciji s sulfonilsečnino, bo morda potreben manjši odmerek sulfonilsečnine za zmanjšanje tveganja za hipoglikemijo (glejte poglavje 4.4).
Intravascular administration of iodinated contrast agents may lead to contrast-induced nephropathy, resulting in metformin accumulation and an increased risk of lactic acidosis.
Intravaskularna aplikacija jodiranih kontrastnih sredstev lahko povzroči nefropatijo zaradi kontrastnega sredstva, ki povzroči kopičenje metformina in povečano tveganje laktacidoze.
As metformin and sitagliptin are excreted by the kidney, Ristfor should be used with caution as age increases.
Metformin in sitagliptin se izločata skozi ledvice, zato je pri uporabi zdravila Ristfor pri starejših potrebna previdnost.
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 vpliv na sposobnost razmnoževanja (glejte poglavje 5.3).
What Ristfor looks like and contents of the pack
Izgled zdravila Ristfor in vsebina pakiranja
Some patients have experienced the following side effects while taking metformin alone: Very common: nausea, vomiting, diarrhoea, stomach ache and loss of appetite.
Pri nekaterih bolnikih, ki so jemali samo metformin, so se pojavili naslednji neželeni učinki: Zelo pogosti: siljenje na bruhanje, bruhanje, driska, bolečine v trebuhu in izguba apetita.
Ristfor has no or negligible influence on the ability to drive and use machines.
Zdravilo Ristfor nima vpliva ali ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
Metformin is a biguanide with antihyperglycaemic effects, lowering both basal and postprandial plasma glucose.
Metformin je bigvanid z antihiperglikemičnimi učinki in znižuje koncentracijo glukoze v plazmi na tešče in po obroku.
Sitagliptin and metformin
Sitagliptin in metformin
By inhibiting the DPP-4 enzyme, sitagliptin increases the levels of two known active incretin hormones, glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP).
Z zaviranjem encima DPP-4 sitagliptin zviša raven dveh znanih inkretinskih hormonov, glukagonu podobnega peptida-1 (GLP-1 - glucagonlike peptide-1) in od glukoze odvisnega insulinotropnega polipeptida (GIP - glucose-dependent insulinotropic polypeptide).
Patients receiving Ristfor in combination with a sulphonylurea or with insulin may be at risk for hypoglycaemia.
Pri bolnikih, ki prejemajo zdravilo Ristfor v kombinaciji s sulfonilsečnino ali z insulinom, se lahko pojavi tveganje za hipoglikemijo.
Metformin stimulates intracellular glycogen synthesis by acting on glycogen synthase.
Metformin stimulira znotrajcelično sintezo glikogena tako, da deluje na glikogen-sintazo.
Table 3: Rates of Composite Cardiovascular Outcomes and Key Secondary Outcomes
Preglednica 3: Deleži sestavljenih srčno-žilnih izidov in ključnih sekundarnih izidov sitagliptin 100 mg placebo
In humans, independently of its action on glycaemia, metformin has favourable effects on lipid metabolism.
Neodvisno od učinkovanja na glikemijo metformin pri ljudeh ugodno vpliva na presnovo lipidov.
The apparent terminal t½ following a 100-mg oral dose of sitagliptin was approximately 12.4 hours.
Po prejemu 100 mg peroralnega odmerka sitagliptina je navidezni končni t1/2 znašal približno 12,4 ure.
Sitagliptin 100 mg
sitagliptin 100 mg placebo
There have been no therapeutic clinical trials conducted with Ristfor tablets however bioequivalence of Ristfor with co-administered sitagliptin and metformin has been demonstrated (see section 5.2).
Kliničnih terapevtskih preskušanj z zdravilom Ristfor niso izvedli, vendar pa so dokazali bioekvivalenco zdravila Ristfor in sočasne uporabe sitagliptina in metformina (glejte poglavje 5.2).
Patients treated with sitagliptin exhibited a significant mean decrease from baseline in body weight (-1.5 kg) compared to a significant weight gain in patients administered glipizide (+1.1 kg).
Pri bolnikih, ki so prejemali sitagliptin, so opazili pomembno povprečno zmanjšanje telesne mase glede na začetno vrednost (-1,5 kg) v primerjavi s pomembnim povečanjem telesne mase pri bolnikih, ki so prejemali glipizid (+1,1 kg).
Cases of inflammation of the pancreas (pancreatitis) have been reported in patients receiving Ristfor (see section 4).
Pri bolnikih, ki so prejemali zdravilo Ristfor, so poročali o primerih vnetja trebušne slinavke (pankreatitisa) (glejte poglavje 4).
When this medicine is used with a sulphonylurea medicine or with insulin, low blood sugar can occur and your doctor may reduce the dose of your sulphonylurea or insulin.
Nizek krvni sladkor se lahko pojavi pri jemanju tega zdravila skupaj z zdravilom s sulfonilsečnino ali z insulinom, zato vam bo zdravnik morda zmanjšal odmerek sulfonilsečnine ali insulina.
If a hypersensitivity reaction is suspected, Ristfor should be discontinued, other potential causes of the event should be assessed, and alternative treatment for diabetes should be instituted (see section 4.8).
Pri sumu na preobčutljivostne reakcije morate zdravljenje z zdravilom Ristfor prekiniti, oceniti druge morebitne vzroke za ta neželeni učinek in začeti zdraviti sladkorno bolezen z drugimi zdravili (glejte poglavje 4.8).
For this reason, it is possible that potent CYP3A4 inhibitors (i.e., ketoconazole, itraconazole, ritonavir, clarithromycin) could alter the pharmacokinetics of sitagliptin in patients with severe renal impairment or ESRD.
Zato je mogoče, da pri bolnikih s hudo ledvično okvaro ali končno ledvično odpovedjo močni zaviralci encima CYP3A4 (tj. ketokonazol, itrakonazol, ritonavir, klaritromicin) spremenijo farmakokinetiko sitagliptina.
Film coating poly(vinyl alcohol) macrogol 3350 talc (E553b) titanium dioxide (E171) iron oxide red (E172) iron oxide black (E172)
Filmska obloga poli(vinilalkohol) makrogol 3350 smukec (E553b) titanov dioksid (E171) rdeči železov oksid (E172) črni železov oksid (E172)
INTERMEDIATE CARTON for Multi-packs 2 packs - without blue box - 50 mg/1,000 mg film-coated tablets
NOTRANJA ŠKATLA za multi pakiranje, ki vključuje 2 pakiranji - brez blue box-a50 mg/1.000 mg filmsko obložene tablete
Analysis of the results for overweight patients treated with metformin after failure of diet alone showed: - a significant reduction of the absolute risk of any diabetes-related complication in the metformin group (29.8 events/1,000 patient-years) versus diet alone (43.3 events/1,000 patient-years), p=0.0023, and versus the combined sulphonylurea and insulin monotherapy groups (40.1 events/1,000 patient-years), p=0.0034 - a significant reduction of the absolute risk of any diabetes-related mortality: metformin 7.5 events/1,000 patient-years, diet alone 12.7 events/1,000 patient-years, p=0.017 - a significant reduction of the absolute risk of overall mortality: metformin 13.5 events/1,000 patient-years versus diet alone 20.6 events/1,000 patient-years, (p=0.011), and versus the combined sulphonylurea and insulin monotherapy groups 18.9 events/1,000 patient-years (p=0.021) - a significant reduction in the absolute risk of myocardial infarction: metformin 11 events/1,000 patient-years, diet alone 18 events/1,000 patient-years, (p=0.01).
Analize teh rezultatov pri bolnikih s preveliko telesno maso, ki so bili po neuspešnem zdravljenju samo z dieto zdravljeni z metforminom, so pokazale: - pomembno zmanjšanje absolutnega tveganja za kateri koli s sladkorno boleznijo povezani zaplet v skupini bolnikov, ki so se zdravili z metforminom (29,8 primerov/1.000 bolnik-let), v primerjavi s skupino bolnikov, ki je imela predpisano samo dieto (43,3 primerov/1.000 bolnik-let), p = 0,0023, ter v primerjavi s podatki za združeni skupini, v katerih so bolniki jemali sulfonilsečnino oziroma insulin v monoterapiji (40,1 primerov/1.000 bolnik-let), p = 0,0034; - pomembno zmanjšanje absolutnega tveganja za umrljivost, povezano s sladkorno boleznijo: metformin 7,5 primerov/1.000 bolnik-let, samo dieta 12,7 primerov/1.000 bolnik-let, p = 0,017; - pomembno zmanjšanje absolutnega tveganja za skupno umrljivost: metformin 13,5 primerov/1.000 bolnik-let, samo dieta 20,6 primerov/1.000 bolnik-let (p = 0,011), združeni skupini bolnikov na monoterapiji s sulfonilsečnino ali z insulinom 18,9 primerov/1.000 bolnik-let (p = 0,021); - pomembno zmanjšanje absolutnega tveganja za miokardni infarkt: metformin 11 primerov/1.000 bolnik-let, samo dieta 18 primerov/1.000 bolnik-let, (p = 0,01).
The NOEL in these studies was observed at exposures to sitagliptin of approximately 6 times the human exposure and to metformin of approximately 2.5 times the human exposure.
ki je bila približno 6-krat večja od izpostavljenosti pri človeku, in pri izpostavljenosti metforminu, ki je bila približno 2,5-krat večja od izpostavljenosti pri človeku.
Ristfor is indicated as an adjunct to diet and exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated with the combination of sitagliptin and metformin.
Zdravilo Ristfor je indicirano kot dodatek dieti in telesni aktivnosti za izboljšanje urejenosti glikemije pri bolnikih z neustrezno nadzorovano sladkorno boleznijo pri jemanju največjega odmerka samega metformina, ki ga prenašajo, ali pri bolnikih, ki že prejemajo kombinacijo sitagliptina in metformina.
In a 24-week placebo-controlled factorial study of initial therapy, sitagliptin 50 mg twice daily in combination with metformin (500 mg or 1,000 mg twice daily) provided significant improvements in glycaemic parameters compared with either monotherapy.
V 24-tedenski s placebom nadzorovani študiji začetnega zdravljenja je sitagliptin v odmerku 50 mg dvakrat na dan v kombinaciji z metforminom (500 mg ali 1.000 mg dvakrat na dan) pomembno izboljšal glikemične parametre v primerjavi z zdravljenjem z vsakim zdravilom posebej.
No studies in lactating animals have been conducted with the combined active substances of this medicinal product.
Študij s kombinacijo učinkovin tega zdravila na doječih živalih niso opravili.
No dose adjustment is needed for patients with mild renal impairment (glomerular filtration rate [GFR]  60 mL/min).
Pri bolnikih z blago ledvično okvaro (hitrost glomerulne filtracije [GFR - glomerular filtration rate]  60 ml/min) prilagoditev odmerka ni potrebna.
Capsule-shaped, red film-coated tablet with “577” debossed on one side.
Rdeče filmsko obložene tablete v obliki kapsule, z oznako "577" na eni strani.
You will need to stop taking Ristfor at the time of the X-ray and for 2 or more days after as directed by your doctor,
Zdravilo Ristfor morate prenehati jemati na dan rentgenskega pregleda in ga ne smete jemati še 2 ali več dni po njem, kot vam je naročil zdravnik, odvisno od delovanja vaših ledvic.
Post-marketing reports of serious hypersensitivity reactions in patients treated with sitagliptin have been reported.
V obdobju trženja so pri bolnikih, ki so prejemali sitagliptin, poročali o hudih preobčutljivostnih reakcijah.
Preclinical data for metformin reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.
Predklinični podatki za metformin na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih odmerkih, genotoksičnosti, kancerogenega potenciala in vpliva na sposobnost razmnoževanja ne kažejo posebnega tveganja za človeka.
Ristfor should not be used during pregnancy.
Bolnice med nosečnostjo ne smejo jemati zdravila Ristfor.
INTERMEDIATE CARTON for Multi-packs 2 packs - without blue box - 50 mg/850 mg film-coated tablets
NOTRANJA ŠKATLA za multi pakiranje, ki vključuje 2 pakiranji - brez blue box-a50 mg/850 mg filmsko obložene tablete
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.
180 film-coated tablets
180 filmsko obloženih tablet
- The other ingredients are: In the tablet core: microcrystalline cellulose (E460), povidone K 29/32 (E1201), sodium lauril sulfate, and sodium stearyl fumarate.
- Pomožne snovi so: V jedru tablete: mikrokristalna celuloza (E460), povidon K 29/32 (E1201), natrijev lavrilsulfat in natrijev stearilfumarat.
Mean baseline HbA1c (%)
Povprečna začetna vrednost HbA1c (%)
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 podlagi sestavljene analize farmakokinetičnih podatkov iz I. faze in analize populacijske farmakokinetike na podlagi podatkov iz I. in II.
Capsule-shaped, pink film-coated tablet with “515” debossed on one side.
Rožnate filmsko obložene tablete v obliki kapsule, z oznako "515" na eni strani.
Ristfor must be discontinued prior to or at the time of the imaging procedure and not restarted until at least 48 hours after, provided that renal function has been re-evaluated and found to be stable (see sections 4.3 and 4.4).
Zdravilo Ristfor je treba pred slikanjem ali v času slikanja ukiniti in se ga sme ponovno uvesti najmanj 48 ur pozneje, če je bilo delovanje ledvic ponovno ovrednoteno in ocenjeno kot stabilno (glejte poglavji 4.3 in 4.4).
If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Ristfor.
Če niste prepričani, če kar koli od navedenega velja za vas, se pred začetkom jemanja zdravila Ristfor, posvetujte z zdravnikom ali farmacevtom.
Other medicines and Ristfor
Druga zdravila in zdravilo Ristfor
84 film-coated tablets.
84 filmsko obloženih tablet.
Following an oral dose, the apparent terminal elimination half-life is approximately 6.5 h. When renal function is impaired, renal clearance is decreased in proportion to that of creatinine and thus the elimination half-life is prolonged, leading to increased levels of metformin in plasma.
V primeru oslabljenega delovanja ledvic se ledvični očistek zmanjša sorazmerno s kreatininskim in tako se razpolovni čas izločanja podaljša, kar vodi v zvišanje ravni metformina v plazmi.
98 film-coated tablets.
98 filmsko obloženih tablet.
In addition, the film coating contains: poly(vinyl alcohol), macrogol 3350, talc (E553b), titanium dioxide (E171), iron oxide red (E172), and iron oxide black (E172).
Poleg tega filmska obloga vsebuje: polivinilalkohol, makrogol 3350, smukec (E553b), titanov dioksid (E171), rdeči železov oksid (E172) in črni železov oksid (E172).
Ristfor is indicated as triple combination therapy with a peroxisome proliferator-activated receptor gamma (PPAR) agonist (i.e., a thiazolidinedione) as an adjunct to diet and exercise in patients inadequately controlled on their maximal tolerated dose of metformin and a PPAR agonist.
Zdravilo Ristfor je indicirano za trojno kombinirano zdravljenje z agonistom receptorja gama, aktiviranega s peroksisomskim proliferatorjem (PPAR - peroxisome proliferator-activated receptor gamma) (tj. s tiazolidindionom) kot dodatek dieti in telesni aktivnosti pri bolnikih z neustrezno nadzorovano sladkorno boleznijo pri jemanju največjega odmerka metformina, ki ga prenašajo, in agonista PPAR.
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 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.
112 film-coated tablets
112 filmsko obloženih tablet
Gastrointestinal symptoms were reported very commonly in clinical studies and post-marketing use of metformin.
V kliničnih študijah metformina in v času njegovega trženja so zelo pogosto poročali o gastrointestinalnih simptomih.
Ristfor is also indicated as add-on to insulin (i.e., triple combination therapy) as an adjunct to diet and exercise to improve glycaemic control in patients when stable dose of insulin and metformin alone do not provide adequate glycaemic control.
Zdravilo Ristfor je indicirano tudi kot dodatno zdravljenje k insulinu (tj. trojno kombinirano zdravljenje) kot dodatek dieti in telesni aktivnosti za izboljšanje urejenosti glikemije pri bolnikih, pri katerih s stabilnim odmerkom insulina in samim metforminom urejenost glikemije ni zadostna.
Some patients have experienced the following side effects while taking this medicine with a sulphonylurea such as glimepiride:
Pri nekaterih bolnikih, ki so jemali to zdravilo v kombinaciji s sulfonilsečnino, kot je glimepirid, so se pojavili naslednji neželeni učinki:
Adverse reactions were identified through post-marketing surveillance.
Neželeni učinki so bili zabeleženi v obdobju trženja zdravila.
For the different doses on metformin, Ristfor is available in strengths of 50 mg sitagliptin and 850 mg metformin hydrochloride or 1,000 mg metformin hydrochloride.
Za različne odmerke metformina je zdravilo Ristfor na voljo v jakostih po 50 mg sitagliptina in 850 mg metforminijevega klorida ali 1.000 mg metforminijevega klorida.
Close monitoring of glycaemic control, dose adjustment within the recommended posology and changes in diabetic treatment should be considered when such products are co-administered.
Pri sočasnem jemanju teh zdravil je treba razmisliti o skrbnem spremljanju urejenosti glikemije, prilagoditvi odmerkov znotraj priporočenih vrednosti in spremembi zdravljenja sladkorne bolezni.
The level of digoxin in your blood may need to be checked if taking with Ristfor.
Med sočasnim jemanjem z zdravilom Ristfor vam bodo morda morali preveriti vrednosti digoksina v krvi.
- if you have a severe infection or are dehydrated - if you are going to have an X-ray where you will be injected with a dye.
- če imate hudo okužbo ali ste dehidrirani.
The observed incidence of hypoglycaemia in patients treated with sitagliptin was similar to placebo.
Pojavnost hipoglikemije pri bolnikih, ki so prejemali sitagliptin, je bila podobna kot pri placebu.
For patients inadequately controlled on maximal tolerated dose of metformin monotherapy For patients not adequately controlled on metformin alone, the usual starting dose should provide sitagliptin dosed as 50 mg twice daily (100 mg total daily dose) plus the dose of metformin already being taken.
Pri bolnikih, pri katerih nadzor z metforminom samim ni ustrezen, mora običajni začetni odmerek zagotoviti 50 mg sitagliptina dvakrat na dan (skupni dnevni odmerek 100 mg) in odmerek metformina, ki ga že jemljejo.
Nervous system disorders somnolence
Bolezni živčevja zaspanost občasni
Sitagliptin 50 mg + metformin 1,000 mg (N=178)
Začetno zdravljenje (dvakrat na dan) sitagliptin 50 mg + metformin 1.000 mg (n = 178)
Tablet core microcrystalline cellulose (E460) povidone K29/32 (E1201) sodium lauril sulfate sodium stearyl fumarate
Jedro tablete mikrokristalna celuloza (E460) povidon K29/32 (E1201)
• medicines used to treat pain and inflammation (NSAID and COX-2-inhibitors, such as ibuprofen and celecoxib)
• zdravila za zdravljenje bolečine in vnetja (nesteroidna protivnetna zdravila in zaviralci COX-2,
The addition of sitagliptin to glimepiride and metformin provided significant improvements in glycaemic parameters.
Pri dodatku sitagliptina glimepiridu in metforminu so se glikemični parametri pomembno izboljšali.
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 23 times the clinical exposure level.
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, na primer dihanje z odprtimi usti, slinjenje, bruhanje bele spenjene vsebine, ataksija, tresenje, zmanjšana aktivnost in/ali zgrbljena drža.
Some patients have experienced the following side effects while taking this medicine in combination with pioglitazone:
Pri nekaterih bolnikih, ki so jemali to zdravilo v kombinaciji s pioglitazonom, so se pojavili naslednji neželeni učinki: