natgillin/translations-raw huggingface dataset:
Your doctor may decide to temporarily or permanently stop your treatment with Steglujan.
Zdravnik bo morda odločil, da z zdravljenjem z zdravilom Steglujan začasno ali trajno prenehate.
(For study results with respect to combinations and effects on glycaemic control, see sections 4.4, 4.5, and 5.1)
(Za rezultate študij glede kombiniranega zdravljenja in učinkov na urejenost glikemije glejte poglavja 4.4, 4.5 in 5.1.)
The effects on kidney and bone did not fully reverse after the 1 month recovery period.
Vplivi na ledvice in kosti po 1-mesečnem obdobju okrevanja niso povsem izginili.
The European Medicines Agency has waived the obligation to submit the results of studies with Steglujan in all subsets of the paediatric population in the treatment of type 2 diabetes (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Steglujan za vse podskupine pediatrične populacije za zdravljenje sladkorne bolezni tipa 2 (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
• Sitagliptin helps to increase the levels of insulin produced after a meal.
• Sitagliptin pomaga povečati količino insulina, ki nastane po obroku.
Ertugliflozin and sitagliptin are present in the milk of lactating rats.
Ertugliflozin in sitagliptin sta prisotna v mleku doječih podgan.
• have or have had gallstones, alcohol dependence or very high levels of triglycerides (a form of fat) in your blood.
• če imate ali ste v preteklosti imeli žolčne kamne, odvisnost od alkohola ali zelo visoko koncentracijo trigliceridov (vrste maščob) v krvi.
There is no information regarding the presence of Steglujan or its individual components in human milk, the effects on the breast-fed infant, or the effects on milk production.
Glede prisotnosti zdravila Steglujan ali njegovih posameznih sestavin v materinem mleku, njegovih učinkih na dojenega otroka ali njegovih učinkih na nastajanje mleka ni podatkov.
What Steglujan is and what it is used for 2.
Kaj je zdravilo Steglujan in za kaj ga uporabljamo 2.
Approximately 79% of sitagliptin is excreted unchanged in the urine.
Približno 79 % sitagliptina se izloči z urinom v nespremenjeni obliki.
Use of dipeptidyl peptidase-4 (DPP-4) inhibitors has been associated with a risk of developing acute pancreatitis.
Uporaba zaviralcev dipeptidil peptidaze 4 (DPP-4) je povezana s tveganjem za razvoj akutnega pankreatitisa.
• if you are taking other medicines that lower the amount of sugar in your blood, such as insulin or medicines that increase insulin release from the pancreas.
• če jemljete druga zdravila, ki znižujejo sladkor v krvi, kot so insulin ali zdravila, ki povečajo sproščanje insulina iz trebušne slinavke.
• Steglujan can be used alone or with some other medicines that lower blood sugar.
• Zdravilo Steglujan se lahko uporablja samostojno ali skupaj s kakšnimi drugimi zdravili za zniževanje krvnega sladkorja.
The safety and efficacy of Steglujan in patients with type 1 diabetes have not been established and Steglujan should not be used for treatment of patients with type 1 diabetes.
Varnost in učinkovitost zdravila Steglujan pri bolnikih s sladkorno boleznijo tipa 1 nista bili dokazani in se ga ne sme uporabljati za zdravljenje bolnikov s sladkorno boleznijo tipa 1.
• have or have had a disease of the pancreas (such as pancreatitis).
• če imate ali ste v preteklosti imeli bolezen trebušne slinavke (kot je pankreatitis).
• Severe and persistent pain in the abdomen (stomach area) which might reach through to your back with or without nausea and vomiting, as these could be signs of an inflamed pancreas (pancreatitis).
• hudo in dolgotrajno bolečino v abdomnu (predelu trebuha), ki se lahko širi tudi v hrbet, s sočasno slabostjo in bruhanjem ali brez tega, saj lahko ti znaki kažejo na vnetje trebušne slinavke (pankreatitis).
• when metformin and/or a sulphonylurea (SU) and one of the monocomponents of Steglujan do not provide adequate glycaemic control.
• če metformin in/ali sulfonilsečnina in ena od komponent zdravila Steglujan ne zagotavljajo ustrezne urejenosti glikemije.
Because increases of this magnitude are not clinically relevant, dosage adjustment in these patients is not necessary.
Ker povečanja v tem obsegu niso klinično pomembna, pri teh bolnikih prilagoditev odmerka ni potrebna.
Patients with an eGFR < 30 ml/min/1.73 m2 were not to be enrolled in the study.
Bolniki z eGFR < 30 ml/min/1,73 m2 niso smeli biti vključeni v študijo.
Resolution of pancreatitis has been observed after discontinuation of sitagliptin (with or without supportive treatment), but very rare cases of necrotising or haemorrhagic pancreatitis and/or death have been reported.
Opazili so, da je po prenehanju jemanja sitagliptina pankreatitis izzvenel (z ali brez podpornega zdravljenja), v zelo redkih primerih pa so poročali o nekrotizirajočem ali hemoragičnem pankreatitisu in/ali smrti.
The safety and efficacy of Steglujan in children under 18 years of age have not been established.
Varnost in učinkovitost zdravila Steglujan pri otrocih, mlajših od 18 let, nista bili dokazani.
Across the 3 studies, 16.2% to 29.9% of patients were ≥ 65 years of age and 2.3% to 2.8% were ≥ 75 years of age.
V teh 3 študijah je bilo od 16,2 do 29,9 % bolnikov starih ≥ 65 let in od 2,3 do 2,8 % ≥ 75 let.
• A serious allergic reaction (frequency not known), including rash, hives, blisters on the skin/peeling skin and swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing.
• resno alergijsko reakcijo (pogostnost je neznana), ki vključuje izpuščaj, koprivnico, mehurje na koži/luščenje kože in otekanje obraza, ustnic, jezika ter žrela, kar lahko povzroči težave pri dihanju ali požiranju.
Before initiating ertugliflozin/sitagliptin, consider factors in the patient history that may increase the risk for amputation.
Pred uvedbo ertugliflozina/sitagliptina je treba upoštevati dejavnike iz bolnikove anamneze, ki lahko povečajo tveganje za amputacijo.
The effect of Steglujan on fertility in humans has not been studied.
Vpliva zdravila Steglujan na plodnost pri ljudeh niso preučevali.
If you take more Steglujan than you should If you take too much Steglujan, talk to a doctor or pharmacist straight away.
Če ste vzeli večji odmerek zdravila Steglujan, kot bi smeli Če vzamete preveč zdravila Steglujan, se takoj posvetujte z zdravnikom ali farmacevtom.
Rare • reduced number of platelets
Redki • zmanjšano število krvnih ploščic
Hospitalisation for unstable angina
Sprejem v bolnišnico zaradi nestabilne angine pektoris
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 preko CYP3A4, le majhno vlogo v očistku sitagliptina.
Across the 3 studies, the racial distribution ranged from 72.9% to 90.4% White, 0.0% to 20.3% Asian, 1.9% to 4.5% Black and 4.8% to 5.4% Other.
V teh 3 študijah je bila rasna porazdelitev naslednja: od 72,9 % do 90,4 % je bilo belcev, od 0,0 % do 20,3 % Azijcev, od 1,9 % do 4,5 % črncev in od 4,8 do 5,4 % drugih.
You should not take this medicine during pregnancy.
Tega zdravila med nosečnostjo ne smete uporabljati.
There is limited experience with Steglujan in patients ≥ 75 years of age.
Podatkov glede izkušenj z zdravilom Steglujan pri bolnikih, starih ≥ 75 let, je malo.
However, when driving or using machines, it should be taken into account that dizziness and somnolence have been reported with sitagliptin.
Vendar pa je treba pri vožnji ali upravljanju strojev upoštevati, da so pri uporabi sitagliptina poročali o omotici in zaspanosti.
What you need to know before you take Steglujan
Kaj morate vedeti, preden boste vzeli zdravilo Steglujan
The incidence and type of adverse reactions in these three studies were similar to the adverse reactions seen with ertugliflozin and are described below in Table 1.
Pojavnost in vrsta neželenih učinkov iz teh treh študij sta bili podobni neželenim učinkom za ertugliflozin in so opisani spodaj v preglednici 1.
Because of the high safety margin (19-fold at this no-effect level), these neoplastic changes are not considered relevant for the situation in humans.
Zaradi visoke meje varnosti (19-kratna izpostavljenost brez škodljivega učinka) teh neoplastičnih sprememb nimamo za pomembne pri klinični uporabi pri človeku.
These medical conditions can increase your chance of getting pancreatitis (see section 4).
Ta zdravstvena stanja lahko povečajo možnost za pojav pankreatitisa (glejte poglavje 4).
It is not known if Steglujan can harm your unborn baby.
Ni znano, ali lahko zdravilo Steglujan škoduje nerojenemu otroku.
Elderly subjects (65 to 80 years) had approximately 19% higher plasma concentrations of sitagliptin compared to younger subjects.
Pri starejših bolnikih (65 do 80 let) so bile plazemske koncentracije sitagliptina približno za 19 % večje kot pri mlajših osebah.
If you forget to take Steglujan
Če ste pozabili vzeti zdravilo Steglujan
Stop taking Steglujan and contact a doctor straight away if you notice any of the following serious side effects:
Prenehajte jemati zdravilo Steglujan in se takoj posvetujte z zdravnikom, če opazite katerega koli od naslednjih resnih neželenih učinkov:
Steglujan should not be used to treat this condition.
Zdravila Steglujan se ne sme uporabljati za zdravljenje te bolezni.
Effects of other medicinal products on sitagliptin
Vpliv drugih zdravil na sitagliptin
If Fournier's gangrene is suspected, Steglujan should be discontinued and prompt treatment (including antibiotics and surgical debridement) should be instituted.
Če obstaja sum na Fournierjevo gangreno, je treba zdravilo Steglujan ukiniti in uvesti takojšnje zdravljenje (vključno z antibiotiki in kirurško odstranitvijo prizadetega tkiva).
Analysis in the Intention-to-Treat Population
Analiza populacije z namenom zdravljenja
• take other diabetes medicines: you are more likely to get low blood sugar with certain medicines.
• če jemljete druga zdravila za sladkorno bolezen: pri določenih zdravilih imate večjo verjetnost za pojav nizkega krvnega sladkorja.
Ertugliflozin in combination with sitagliptin
Ertugliflozin v kombinaciji s sitagliptinom
• osteoarthritis
• osteoartritis,
The improvement in glycaemic control observed with this medicinal product may be mediated by enhancing the levels of active incretin hormones.
Izboljšanje urejenosti glikemije, ki so ga opazili pri tem zdravilu, je lahko posledica povečanja količine aktivnih hormonov inkretinov.
Following administration of 0.25 mg digoxin concomitantly with 100 mg of sitagliptin daily for 10 days, the plasma AUC of digoxin was increased on average by 11% and the plasma Cmax on average by 18%.
Po 10-dnevnem odmerjanju 0,25 mg digoksina v kombinaciji s 100 mg sitagliptina dnevno se je vrednost AUC digoksina v plazmi povečala povprečno za 11 %, vrednost Cmax pa povprečno za 18 %.
In clinical studies, approximately 13.5% of the dose was removed over a 3- to 4-hour haemodialysis session.
V kliničnih študijah se je med 3- do 4-urno hemodializo odstranilo približno 13,5 % odmerka.
In patients with type 2 diabetes treated with ertugliflozin in combination with sitagliptin, the improvement in HbA1c was similar across subgroups defined by age, sex, and race, and duration of type 2 diabetes mellitus.
Pri bolnikih s sladkorno boleznijo tipa 2, zdravljenih z ertugliflozinom v kombinaciji s sitagliptinom, je bilo izboljšanje HbA1c pri podskupinah, opredeljenih glede na starost, spol in raso in trajanje sladkorne bolezni tipa 2 podobno.
However, because sitagliptin is primarily renally eliminated, severe hepatic impairment is not expected to affect the pharmacokinetics of sitagliptin.
Ker pa se sitagliptin primarno izloča skozi ledvice, ne pričakujemo, da bi huda okvara jeter vplivala na farmakokinetiko sitagliptina.
After a median follow up of 3 years, sitagliptin, when added to usual care, did not increase the risk of major adverse cardiovascular events or the risk of hospitalisation for heart failure compared to usual care without sitagliptin in patients with type 2 diabetes (see Table 5).
Po 3 letih spremljanja (mediana) sitagliptin pri bolnikih s sladkorno boleznijo tipa 2, dodan običajnemu zdravljenju, ni povečal tveganja za pomembne neželene srčno-žilne dogodke ali tveganja za hospitalizacijo zaradi srčnega popuščanja v primerjavi z bolniki, ki so prejemali običajno zdravljenje brez sitagliptina (glejte preglednico 5).
If you stop taking Steglujan
Če ste prenehali jemati zdravilo Steglujan
Because renal function abnormalities can occur after initiating ertugliflozin, and sitagliptin is known to be substantially excreted by the kidneys, renal function should be assessed more frequently in elderly patients.
Ker se po uvedbi ertugliflozina lahko pojavijo nepravilnosti delovanja ledvic, sitagliptin pa se v veliki meri izloča skozi ledvice, je pri starejših bolnikih potrebno pogosteje oceniti delovanje ledvic.
• Steglujan can be used instead of taking both ertugliflozin and sitagliptin as separate tablets.
• Zdravilo Steglujan se lahko uporablja namesto jemanja ertugliflozina in sitagliptina v ločenih tabletah.
Steglujan is available in Alu/PVC/PA/Alu blisters.
Tablete zdravila Steglujan so na voljo v Alu/PVC/PA/Alu pretisnih omotih.
These included hypoglycaemia (frequency very common with the combination of sulphonylurea and metformin), influenza (common with insulin (with or without metformin)), nausea and vomiting (common with metformin), flatulence (common with metformin or pioglitazone), constipation (common with the combination of sulphonylurea and metformin), peripheral oedema (common with pioglitazone or the combination of pioglitazone and metformin), somnolence and diarrhoea (uncommon with metformin), and dry mouth (uncommon with insulin (with or without metformin)).
Ti so vključevali hipoglikemijo (pogostnost - zelo pogosta v kombinaciji s sulfonilsečnino in metforminom), gripo (pogostnost - pogosta z insulinom (z ali brez metformina)), navzeo in bruhanje (pogostnost - pogosta z metforminom), flatulenco (pogostnost - pogosta z metforminom ali pioglitazonom), konstipacijo (pogostnost - pogosta v kombinaciji s sulfonilsečnino in metforminom), periferni edem (pogostnost - pogosta s pioglitazonom ali v kombinaciji s pioglitazonom in metforminom), zaspanost in diarejo (pogostnost - občasna z metforminom) in suha usta (pogostnostobčasna z insulinom (z ali brez metformina)).
Taking this medicine in combination with insulin or medicines that increase insulin release from the pancreas can cause blood sugar levels to drop too low (hypoglycaemia), which may cause symptoms such as shaking, sweating or changes in vision and may affect your ability to drive and use machines.
Jemanje tega zdravila v kombinaciji z insulinom ali zdravili, ki povečajo izločanje insulina iz trebušne slinavke, lahko povzroči preveliko znižanje krvnega sladkorja (hipoglikemijo), kar lahko povzroči simptome, kot so tresenje, potenje ali sprememba vida, ter lahko poslabša sposobnost upravljanja vozil in strojev.
In the event of an overdose with Steglujan, employ the usual supportive measures (e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring including obtaining an electrocardiogram, and institute supportive treatment) as dictated by the patient's clinical status.
V primeru prevelikega odmerjanja zdravila Steglujan je treba uporabiti običajne podporne ukrepe (npr. odstraniti neabsorbirano vsebino iz prebavil, uvesti klinični nadzor, vključno z elektrokardiogramom, in podporno zdravljenje), kot narekuje bolnikovo klinično stanje.
• Steglujan lowers blood sugar levels in adult patients (aged 18 years and older) with type 2
• Zdravilo Steglujan znižuje vrednosti krvnega sladkorja pri odraslih bolnikih (starih 18 let ali več) s sladkorno boleznijo tipa 2.
Before initiating Steglujan, volume status should be assessed and corrected if indicated.
Pred uvedbo zdravila Steglujan je treba oceniti volumsko stanje (volemijo) in ga korigirati, če je potrebno.
Patients [N (%)] with HbA1c < 7% 66 (26.4) Body weight (kg)
Bolniki [n (%)] s HbA1c < 7 % 66 (26,4) Telesna masa (kg)
In vitro transport studies showed that sitagliptin is a substrate for P-gp and OAT3.
Študije transporta in vitro so pokazale, da je sitagliptin substrat za p-glikoprotein in OAT3.
Additional adverse experiences reported regardless of causal relationship to medication that occurred more frequently in patients treated with sitagliptin (not reaching the 5% level, but occurring with an incidence of > 0.5% higher with sitagliptin than that in the control group) included osteoarthritis and pain in extremity.
Dodatna neželena učinka, o katerima so poročali ne glede na vzročno povezanost z zdravilom in ki sta se pojavila pogosteje pri bolnikih, zdravljenih s sitagliptinom (nista dosegala 5 % pojavnosti, vendar z > 0,5 % višjo pojavnostjo pri sitagliptinu kot v kontrolni skupini), sta bila osteoartritis in bolečina v okončinah.
In patients where DKA is suspected or diagnosed, treatment with Steglujan should be discontinued immediately.
Pri bolnikih s sumom na DKA ali z diagnosticirano DKA je treba zdravljenje z zdravilom Steglujan takoj ukiniti.
C]sitagliptin oral dose, approximately 16% of the radioactivity was excreted as metabolites of sitagliptin.
C]sitagliptina se je približno 16 % radioaktivnosti izločilo v obliki presnovkov sitagliptina.
The study population included 2,004 patients ≥ 75 years of age and 3,324 patients with renal impairment (eGFR < 60 ml/min/1.73 m
Študijska populacija je vključevala 2.004 bolnike, stare ≥ 75 let, in 3.324 bolnikov z okvaro ledvic (eGFR < 60 ml/min/1,73 m
Other medicines and Steglujan
Druga zdravila in zdravilo Steglujan
• interstitial lung disease
• intersticijska pljučna bolezen,
No drug interactions studies have been performed with Steglujan and other medicinal products; however, such studies have been conducted with the individual active substances.
Študij medsebojnega delovanja z zdravilom Steglujan in drugimi zdravili niso izvedli; so pa take študije izvedli s posameznima učinkovinama.
Hypoglycaemia has been reported in combination with sulphonylurea (4.7%-13.8%) and insulin (9.6%) (see section 4.4).
O hipoglikemiji so poročali pri kombinaciji s sulfonilsečnino (4,7 % - 13,8 %) in z insulinom (9,6 %) (glejte poglavje 4.4).
The effects of a high-fat meal on the pharmacokinetics of ertugliflozin and sitagliptin when administered as Steglujan tablets are comparable to those reported for the individual tablets.
Vplivi obroka z visoko vsebnostjo maščob na farmakokinetiko ertugliflozina in sitagliptina v obliki tablet zdravila Steglujan so bili podobni tistim, o katerih so poročali za posamezne tablete.
In vitro data suggest that sitagliptin does not inhibit or induce CYP450 isoenzymes.
Podatki in vitro kažejo, da sitagliptin ne zavira in ne inducira izoencimov CYP450.
If you notice any of the serious side effects above, stop taking this medicine and contact a doctor straight away.
Če opazite katerega koli izmed zgoraj navedenih resnih neželenih učinkov, prenehajte jemati to zdravilo in se takoj posvetujte z zdravnikom.
Pharmacotherapeutic group: Drugs used in diabetes, combinations of oral blood glucose lowering drugs, ATC code: A10BD24.
Farmakoterapevtska skupina: zdravila za zdravljenje diabetesa, kombinacije peroralnih antidiabetikov, oznaka ATC: A10BD24
• You need to keep following your food and exercise plan while taking Steglujan.
• Med jemanjem zdravila Steglujan se morate še naprej držati načrta prehrane in telesne aktivnosti.
• painful urination
• boleče uriniranje,
In Phase 1 multiple-dose studies, there were no dose-related clinical adverse reactions observed with sitagliptin with doses of up to 600 mg per day for periods of up to 10 days and 400 mg per day for periods of up to 28 days.
V študijah večkratnih odmerkov 1. faze niso opazili od odmerka odvisnih kliničnih neželenih učinkov sitagliptina pri odmerkih do 600 mg na dan v obdobju do 10 dni in 400 mg na dan v obdobju do 28 dni.
For patients treated with ertugliflozin who are being switched to Steglujan, the dose of ertugliflozin can be maintained.
Pri bolnikih, zdravljenih z ertugliflozinom, ki preidejo na zdravilo Steglujan, je mogoče odmerek ertugliflozina ohraniti.
The activity of GLP-1 and GIP is limited by the DPP-4 enzyme, which rapidly hydrolyses the incretin hormones to produce inactive products.
Aktivnost GLP-1 in GIP je omejena z encimom DPP-4, ki inkretine hitro hidrolizira do neaktivnih oblik.
Monitoring of renal function is recommended as follows: - Prior to Steglujan initiation and periodically during treatment (see section 4.2).
Delovanje ledvic je priporočljivo spremljati: - pred uvedbo zdravila Steglujan in periodično med zdravljenjem (glejte poglavje 4.2).
Steglujan has not been studied in patients with severe hepatic impairment and is not recommended for use in these patients (see section 5.2).
Zdravila Steglujan niso preučevali pri bolnikih s hudo okvaro jeter in njegova uporaba pri teh bolnikih ni priporočljiva (glejte poglavje 5.2).
Over the course of the study, the overall estimated mean (SD) difference in HbA1c between the sitagliptin and placebo groups was 0.29% (0.01), 95% CI (-0.32, -0.27); p< 0.001.
Med potekom študije je bila celokupna ocenjena povprečna (standardni odklon) razlika v HbA1c med skupino, ki je prejemala sitagliptin, in skupino, ki je prejemala placebo, 0,29 % (0,01), 95 % IZ (-0,32; -0,27), p < 0,001.
• bullous pemphigoid (a type of skin blister)
• bulozni pemfigoid (tip kožnega mehurja).
Experience in New York Heart Association (NYHA) class I-II is limited, and there is no experience in clinical studies with Steglujan in NYHA class III-IV.
Izkušenj pri razredih I in II po NYHA (New York Heart Association - NYHA) je malo, izkušenj iz kliničnih študij z zdravilom Steglujan pri razredih III in IV po NYHA pa ni.
• blood tests may show changes in the amount of red blood cells in your blood (called haemoglobin)
• preskave krvi lahko pokažejo spremembe v številu rdečih krvnih celic v krvi (imenovanih hemoglobin),
Coadministration of sitagliptin and metformin had an additive effect on active GLP-1 concentrations.
Sočasno jemanje sitagliptina in metformina ima aditivni učinek na koncentracijo aktivnega GLP-1.
There were no additional adverse reactions identified in these three trials that included sitagliptin relative to the three placebocontrolled studies with ertugliflozin (see below).
V teh treh preskušanjih, ki so vključevala sitagliptin, niso ugotovili dodatnih neželenih učinkov glede na tri s placebom nadzorovane študije z ertugliflozinom (glejte spodaj).
The fixed-dose combination of ertugliflozin and sitagliptin should not be used in patients with severe renal impairment, with end-stage renal disease (ESRD), or receiving dialysis.
Kombinacije fiksnih odmerkov ertugliflozina in sitagliptina se ne sme uporabljati pri bolnikih s hudo okvaro ledvic, končno odpovedjo ledvic (ESRD - end-stage renal disease) ali bolnikih na dializi.
However, dizziness and drowsiness have been reported with sitagliptin, which may affect your ability to drive or use machines.
Vendar pa so pri sitagliptinu poročali o pojavu omotice in zaspanosti, ki lahko vplivata na vašo sposobnost upravljanja vozil in strojev.
C]-sitagliptin dose to healthy subjects, approximately 100% of the administered radioactivity was eliminated in faeces (13%) or urine (87%) within one week of dosing.
C]sitagliptina zdravim osebam se je v enem tednu po prejemu odmerka približno 100 % prejete radioaktivnosti izločilo z blatom (13 %) ali urinom (87 %).
• if you are allergic to ertugliflozin or sitagliptin or any of the other ingredients of this medicine
• če ste alergični na ertugliflozin ali sitagliptin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Compared to normal healthy control subjects, plasma AUC of sitagliptin was increased modestly in patients with GFR ≥ 45 to < 90 mL/min.
V primerjavi z normalnimi zdravimi kontrolnimi osebami je bila pri bolnikih z GFR ≥ 45 do < 90 ml/min plazemska AUC zmerno povečana.
General Steglujan should not be used in patients with type 1 diabetes mellitus.
Splošno Zdravila Steglujan se ne sme uporabljati pri bolnikih s sladkorno boleznijo tipa 1.