natgillin/translations-raw huggingface dataset:
In a study in patients with type 2 diabetes and chronic renal insufficiency (creatinine clearance < 50 ml/ min), the safety and tolerability of reduced doses of sitagliptin were investigated and generally similar to placebo.
V študiji pri bolnikih s sladkorno boleznijo tipa 2 in kroni no ledvi no insuficienco (kreatininski o istek < 50 ml/ min) so raziskovali varnost in prenašanje zmanjšanih odmerkov sitagliptina, ki sta bili na splošno podobni kot pri placebu.
In addition, the reductions in HbA1c and FPG with sitagliptin compared to placebo were generally similar to those observed in other monotherapy studies in patients with normal renal function (see section 5.2).
Pri zdravljenju s sitagliptinom je bilo zmanjšanje vrednosti HbA1C in vrednosti glukoze v plazmi na teš e v primerjavi s placebom na splošno podobno zmanjšanju, opaženemu pri drugih študijah z enim samim zdravilom pri bolnikih z normalnim delovanjem ledvic (glejte poglavje 5. 2).
The number of patients with moderate to severe renal insufficiency was too low to confirm safe use of sitagliptin in this type of patients.
Število bolnikov z zmerno do hudo ledvi no insuficienco je bilo premajhno, da bi lahko tudi pri njih potrdili varnost uporabe sitagliptina.
Sitagliptin 100 mg once daily provided significant improvements in glycaemic parameters compared with placebo in two 24-week studies of sitagliptin as add-on therapy, one in combination with metformin and one in combination with pioglitazone.
V dveh 24- tedenskih študijah dodatnega zdravljenja s sitagliptinom (v eni v kombinaciji z metforminom, v drugi v kombinaciji s pioglitazonom) so se v primerjavi s placebom pri uporabi sitagliptina v odmerku 100 mg enkrat na dan glikemi ni parametri pomembno izboljšali.
Change from baseline in body weight was similar for patients treated with sitagliptin relative to placebo.
Pri bolnikih, ki so prejemali sitagliptin, je bila sprememba telesne mase od izhodiš a podobna kot pri bolnikih, ki so prejemali placebo.
In these studies there was a similar incidence of hypoglycaemia reported for patients treated with sitagliptin or placebo.
V teh študijah so pri bolnikih, ki so prejemali sitagliptin, poro ali o podobni pojavnosti hipoglikemije, kot pri bolnikih, ki so prejemali placebo.
A 24-week placebo-controlled study was designed to evaluate the efficacy and safety of sitagliptin (100 mg once daily) added to glimepiride alone or glimepiride in combination with metformin.
Zasnovana je bila 24- tedenska s placebom nadzorovana študija, v kateri so vrednotili u inkovitost in varnost sitagliptina (100 mg enkrat na dan), e so ga dodali glimepiridu samemu ali glimepiridu v kombinaciji z metforminom.
The addition of sitagliptin to either glimepiride alone or to glimepiride and metformin provided significant improvements in glycaemic parameters.
V primerjavi s placebom so se pri dodatku sitagliptina glimepiridu samemu ali glimepiridu in metforminu glikemi ni parametri pomembno izboljšali.
Patients treated with sitagliptin had a modest increase in body weight compared to those given placebo.
Bolnikom, ki so prejemali sitagliptin, se je telesna masa v primerjavi z bolniki, ki so prejemali placebo, zmerno pove ala.
In a 24-week placebo-controlled factorial study of initial therapy, sitagliptin 50 mg twice daily in combination with metformin (500 mg or 1000 mg twice daily) provided significant improvements in glycaemic parameters compared with either monotherapy.
8 V 24- tedenski s placebom nadzorovani faktorski študiji za etnega 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 glikemi ne parametre v primerjavi z zdravljenjem z vsakim zdravilom posebej.
The incidence of hypoglycaemia was similar across treatment groups.
Pri bolnikih, ki so se zdravili samo s sitagliptinom, se telesna masa v primerjavi z izhodiš em ni spremenila.
Table 2.
9 Tabla 2:
Mean change from
Srednja sprememba vrednosti
change in HbA1c (%) at
S placebom korigirana srednja
baseline HbA1c (%) † at Week 24
HbA1c od izhodiš a (%) v 24. tednu †
Week 24† (95% CI)
sprememba
Monotherapy Studies Sitagliptin 100 mg once daily§
vrednosti HbA1c (%) v 24. tednu †
-0.6‡
Sitagliptin 100 mg
(N= 193) Sitagliptin 100 mg once daily (N= 229) Combination Therapy Studies Sitagliptin 100 mg once daily added to
izhodiš u (%) Študije samostojnega zdravljenja
-0.6
(95%
(-0.8, -0.4) -0.8‡ (-1.0, -0.6) -0.7‡
interval zaupanja) - 0, 6 ‡
ongoing metformin therapy (N=453)
enkrat na dan§ (N = 193) Sitagliptin 100 mg
-0.7
8, 0 - 0, 5
(-0.8, -0.5)
(- 0, 8, - 0, 4) - 0, 8 ‡
8
enkrat na dan (N = 229) Sitagliptin 100 mg
Placebo-corrected mean
8, 0 - 0, 6 Študije kombiniranega zdravljenja
Mean
(- 1, 0, - 0, 6)
Mean change from
enkrat na dan, dodan k - 0, 7 ‡ že potekajo emu
change in HbA1c (%) at
zdravljenju z
baseline HbA1c (%)
- 0, 7
Week 24† (95% CI)
(- 0, 8, - 0, 5)
Sitagliptin 100 mg once daily added to -0.7‡ ongoing pioglitazone therapy (N=163) Sitagliptin 100 mg once daily added to
metforminom (N = 453) Sitagliptin 100 mg enkrat na dan, dodan k - 0, 7 ‡ že potekajo emu
(-0.9, -0.5) -0.6‡
(- 0, 9, - 0, 5)
ongoing glimepiride therapy (N=102) Sitagliptin 100 mg once daily added to
pioglitazonom (N = 163) Sitagliptin 100 mg enkrat na dan, dodan k - 0, 6 ‡ že potekajo emu
ongoing glimepiride + metformin therapy (N=115) Initial therapy (twice daily):
10 Sitagliptin 100 mg enkrat na dan, dodan k že potekajo emu - 0, 9 ‡
-0.9‡ (-1.1, -0.7) -1.6‡
(- 1, 1, - 0, 7)
Sitagliptin 50 mg + metformin 500 mg (N=183) Initial therapy (twice daily):
sitagliptin 50 mg + metformin 500 mg (N = 183) Za etno zdravljenje (dvakrat na dan):
* All Patients Treated Population (an intention-to-treat analysis). † Least squares means adjusted for prior antihyperglycaemic therapy status and baseline value. ‡ p < 0.001 compared to placebo or placebo + combination treatment. § HbA1c (%) at week 18.
* Vsi zdravljeni bolniki (analiza vklju enih bolnikov “ intention- to- treat analysis ”). † Najmanjša kvadratna vrednost, prilagojena na predhodni status zdravljenja sladkorne bolezni in izhodiš no vrednost. ‡ p < 0, 001 v primerjavi s placebom ali placebom + kombiniranim zdravljenjem. § HbA1c (%) v 18. tednu.
In a study comparing the efficacy and safety of the addition of TESAVEL 100 mg once daily or glipizide (a sulphonylurea agent) in patients with inadequate glycaemic control on metformin monotherapy, sitagliptin was similar to glipizide in reducing HbA1c.
V študiji, kjer so pri bolnikih z nezadostno urejeno glikemijo pri zdravljenju samo z metforminom primerjali u inkovitost in varnost dodajanja zdravila TESAVEL v odmerku 100 mg enkrat na dan ali glipizida (sulfonilse nina), je bil sitagliptin pri zmanjšanju vrednosti HbA1c podobno u inkovit kot glipizid.
The mean glipizide dose used in the comparator group was 10 mg per day with approximately 40% of patients requiring a glipizide dose of ≤ 5 mg/ day throughout the study.
Približno 40% bolnikov je ves as študije potrebovalo glipizid v odmerku ≤ 5 mg/ dan.
However, more patients in the sitagliptin group discontinued due to lack of efficacy than in the glipizide group.
Vendar pa je bilo v skupini, ki je prejemala sitagliptin, zaradi pomanjkanja u inkovitosti izklju enih ve bolnikov kot v skupini, ki je prejemala glipizid.
Patients treated with sitagliptin exhibited a significant mean decrease from baseline in body weight compared to a significant weight gain in patients administered glipizide (-1.5 vs. +1.1 kg).
Pri bolnikih, ki so se zdravili s sitagliptinom, se je srednja vrednost telesne mase v primerjavi z izhodiš em pomembno zmanjšala, pri bolnikih, ki so prejemali glipizid pa pomembno pove ala (- 1, 5 vs. +1, 1 kg).
In this study, the proinsulin to insulin ratio, a marker of efficiency of insulin synthesis and release, improved with sitagliptin and deteriorated with glipizide treatment.
V tej študiji se je pri zdravljenju s sitagliptinom razmerje proinsulin/ insulin, ki je ozna evalec u inkovitosti sinteze in sproš anja insulina, izboljšalo, pri zdravljenju z glipizidom pa poslabšalo.
Absorption Following oral administration of a 100-mg dose to healthy subjects, sitagliptin was rapidly absorbed, with peak plasma concentrations (median Tmax) occurring 1 to 4 hours post-dose, mean plasma AUC of sitagliptin was 8.52 μ M• hr, Cmax was 950 nM.
Najve je plazemske koncentracije (srednji Tmax) so bile dosežene v 1 do 4 urah po prejemu odmerka.
The absolute bioavailability of sitagliptin is approximately 87%.
Srednja vrednost AUC sitagliptina v plazmi je bila 8, 52 µM• ur, Cmax pa 950 nM.
Since coadministration of a high-fat meal with TESAVEL had no effect on the pharmacokinetics, TESAVEL may be administered with or without food.
Ker jemanje zdravila TESAVEL skupaj z obrokom z visoko vsebnostjo maš ob ne vpliva na farmakokinetiko, se zdravilo TESAVEL lahko jemlje skupaj s hrano ali brez nje.
Plasma AUC of sitagliptin increased in a dose-proportional manner.
Vrednost AUC sitagliptina v plazmi se je pove evala sorazmerno z odmerkom.
Dose-proportionality was not established for Cmax and C24hr (Cmax increased in a greater than dose-proportional manner and C24hr increased in a less than dose-proportional manner).
Za vrednosti Cmax in C24ur sorazmernost z odmerkom ni bila ugotovljena (pove evanje vrednosti Cmax je bilo nekoliko ve je, pove evanje vrednosti C24ur pa nekoliko manjše kot pri od odmerka odvisnem na inu).
Distribution The mean volume of distribution at steady state following a single 100-mg intravenous dose of sitagliptin to healthy subjects is approximately 198 liters.
Porazdelitev Pri zdravih osebah je srednji volumen porazdelitve v stanju dinami nega ravnovesja po enkratnem 100 mg intravenskem odmerku sitagliptina približno 198 litrov.
9 Metabolism Sitagliptin is primarily eliminated unchanged in urine, and metabolism is a minor pathway.
Presnova je manj pomemben na in izlo anja.
Approximately 79% of sitagliptin is excreted unchanged in the urine.
Približno 79% sitagliptina se izlo i z urinom v nespremenjeni obliki.
Following a [14C]sitagliptin oral dose, approximately 16% of the radioactivity was excreted as metabolites of sitagliptin.
Po peroralnem odmerku [14C] sitagliptina se je približno 16% radioaktivnosti izlo ilo v obliki presnovkov sitagliptina.
Six metabolites were detected at trace levels and are not expected to contribute to the plasma DPP-4 inhibitory activity of sitagliptin.
Zanje se ne pri akuje, da sodelujejo pri zaviralnemu delovanju sitagliptina na DPP- 4 v plazmi.
Elimination Following administration of an oral [14C]sitagliptin dose to healthy subjects, approximately 100% of the administered radioactivity was eliminated in faeces (13%) or urine (87%) within one week of dosing.
Izlo anje Po dajanju peroralnega odmerka [14C] sitagliptina zdravim osebam se je v enem tednu po prejemu odmerka približno 100% prejete radioaktivnosti izlo ilo z blatom (13%) ali urinom (87%).
The apparent terminal t1/ 2 following a 100-mg oral dose of sitagliptin was approximately 12.4 hours.
Po prejemu 100 mg peroralnega odmerka sitagliptina je navidezni kon ni t1/ 2 znašal približno 12, 4 ure.
Sitagliptin accumulates only minimally with multiple doses.
Kopi enje sitagliptina po ve kratnih odmerkih je minimalno.
The renal clearance was approximately 350 ml/ min.
Ledvi ni o istek je bil približno 350 ml/ min.
Elimination of sitagliptin occurs primarily via renal excretion and involves active tubular secretion.
Izlo anje sitagliptina poteka primarno preko ledvi ne sekrecije in vklju uje aktivno tubularno sekrecijo.
Sitagliptin is a substrate for human organic anion transporter-3 (hOAT-3), which may be involved in the renal elimination of sitagliptin.
Sitagliptin je substrat za humani organski anionski prenašalec- 3 (hOAT- 3; “ human organic anion transporter- 3 ”), ki bi lahko bil vklju en v izlo anje sitagliptina preko ledvic.
The clinical relevance of hOAT-3 in sitagliptin transport has not been established.
Klini ni pomen hOAT- 3 pri transportu sitagliptina ni bil dokazan.
However, cyclosporine, a p-glycoprotein inhibitor, did not reduce the renal clearance of sitagliptin.
Sitagliptin je tudi substrat za p- glikoprotein, ki je prav tako lahko vklju en pri izlo anju sitagliptina preko ledvic, vendar pa ciklosporin, zaviralec p - glikoproteina, ni zmanjšal ledvi nega o istka sitagliptina.
In vitro, sitagliptin did not inhibit OAT3 (IC50=160 μ M) or p-glycoprotein (up to 250 μ M) mediated transport at therapeutically relevant plasma concentrations.
In vitro sitagliptin pri terapevtsko pomembnih plazemskih koncentracijah ni zaviral prenosa s pomo jo OAT3 (IC50=160 µM) ali p- glikoproteina (do 250 µM).
In a clinical study sitagliptin had a small effect on plasma digoxin concentrations indicating that sitagliptin may be a mild inhibitor of p-glycoprotein.
V klini ni študiji je sitagliptin imel majhen u inek na koncentracije digoksina v plazmi, kar kaže, da je sitagliptin lahko blagi zaviralec p- glikoproteina.
Characteristics in patients The pharmacokinetics of sitagliptin were generally similar in healthy subjects and in patients with type 2 diabetes.
Zna ilnosti pri bolnikih Pri zdravih osebah in bolnikih s sladkorno boleznijo tipa 2 je farmakokinetika sitagliptina na splošno podobna.
Renal insufficiency A single-dose, open-label study was conducted to evaluate the pharmacokinetics of a reduced dose of sitagliptin (50-mg) in patients with varying degrees of chronic renal insufficiency compared to normal healthy control subjects.
Ledvi na insuficienca Izvedena je bila odprta študija z eni samim odmerkom, ki je ovrednotila farmakokinetiko zmanjšanega odmerka sitagliptina (50 mg) pri bolnikih z razli nimi stopnjami kroni ne ledvi ne insuficience v primerjavi z zdravimi kontrolnimi osebami.
The study included patients with renal insufficiency classified on the basis of creatinine clearance as mild (50 to < 80 ml/ min), moderate (30 to < 50 ml/ min), and severe (< 30 ml/ min), as well as patients with end-stage renal disease (ESRD) on hemodialysis.
V študijo so bili vklju eni tako bolniki z ledvi no insuficienco, ki je bila na podlagi kreatininskega o istka ocenjena kot blaga (50 do < 80 ml/ min), zmerna (30 do < 50 ml/ min) ali huda (< 30 ml/ min), kot bolniki z ESRD, ki so se zdravili s hemodializo.
Patients with mild renal insufficiency did not have a clinically meaningful increase in the plasma concentration of sitagliptin as compared to normal healthy control subjects.
V primerjavi z zdravimi kontrolnimi osebami pri bolnikih z blago ledvi no insuficienco plazemske koncentracije sitagliptina niso bile pomembneje pove ane.
An approximately 2-fold increase in the plasma AUC of sitagliptin was observed in patients with moderate renal insufficiency, and an approximately 4-fold increase was observed in patients with severe renal insufficiency and in patients with ESRD on hemodialysis, as compared to normal healthy control subjects.
Pri bolnikih z zmerno ledvi no insuficienco so bile opažene približno 2- krat ve je vrednosti plazemske AUC sitagliptina kot pri zdravih kontrolnih osebah.
TESAVEL is not recommended for use in patients with moderate or severe renal insufficiency including those with ESRD since experience in these patients is too limited.
Pri bolnikih s hudo ledvi no insuficienco in pri bolnikih z ESRD, ki so se zdravili s hemodializo, pa so bile opažene približno 4- krat ve je vrednosti plazemske AUC sitagliptina kot pri zdravih kontrolnih osebah.
(See section 4.2.)
Ker so izkušnje pri bolnikih z zmerno ali s hudo ledvi no insuficienco, vklju no z bolniki z ESRD preve omejene, uporabe zdravila TESAVEL pri teh bolnikih ne priporo amo (glejte poglavje 4. 2).
Hepatic insufficiency No dosage adjustment for TESAVEL is necessary for patients with mild or moderate hepatic insufficiency (Child-Pugh score ≤ 9).
Jetrna insuficienca Pri bolnikih z blago ali zmerno jetrno insuficienco (ocena po Child- Pugh- u ≤ 9) odmerka ni treba prilagajati.
There is no clinical experience in patients with severe hepatic insufficiency (Child-Pugh score > 9).
Pri bolnikih s hudo jetrno insuficienco (ocena po Child- Pugh- u > 9) ni klini nih izkušenj.
However, because sitagliptin is primarily renally eliminated, severe hepatic insufficiency is not expected to affect the pharmacokinetics of sitagliptin.
Ker se sitagliptin primarno izlo a preko ledvic, ne pri akujemo, da bi huda jetrna insuficienca vplivala na farmakokinetiko sitagliptina.
10 Elderly No dosage adjustment is required based on age.
12 Starejši bolniki Prilagajanje odmerka glede na starost ni potrebno.
Age did not have a clinically meaningful impact on the pharmacokinetics of sitagliptin based on a population pharmacokinetic analysis of Phase I and Phase II data.
Pri analizi populacijske farmakokinetike na osnovi podatkov I. in II. faze starost ni imela klini nega pomena za farmakokinetiko sitagliptina.
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% ve je kot pri mlajših osebah.
Other patient characteristics No dosage adjustment is necessary based on gender, race, or body mass index (BMI).
Druge zna ilnosti pri bolnikih Na osnovi spola, rase ali indeksa telesne mase (ITM) odmerka ni treba prilagajati.
These characteristics had no clinically meaningful effect on the pharmacokinetics of sitagliptin based on a composite analysis of Phase I pharmacokinetic data and on a population pharmacokinetic analysis of Phase I and Phase II data.
Na osnovi sestavljene analize farmakokineti nih podatkov I. faze in analize populacijske farmakokinetike na osnovi podatkov I. in II. faze te zna ilnosti nimajo klini nega pomena za farmakokinetiko sitagliptina.
Renal and liver toxicity were observed in rodents at systemic exposure values 58 times the human exposure level, while the no-effect level was found at 19 times the human exposure level.
Pri glodavcih so pri sistemski izpostavljenosti, ki je bila 58- krat ve ja od izpostavljenosti pri loveku, opazili toksi nost za ledvice in jetra.
Incisor teeth abnormalities were observed in rats at exposure levels 67 times the clinical exposure level; the no- effect level for this finding was 58-fold based on the 14-week rat study.
Pri podganah so pri izpostavljenosti, ki je bila 67- krat ve ja od izpostavljenosti pri klini ni uporabi, opazili anomalije sekalcev.
The relevance of these findings for humans is unknown.
Pomen teh ugotovitev za loveka ni znan.
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.
Nekateri od njih so kazali na toksi nost za živ evje, npr. dihanje z odprtimi usti, slinjenje, bljuvanje bele spenjene vsebine, ataksija, tresenje, zmanjšana aktivnost in/ ali zgrbljena drža.
In addition, very slight to slight skeletal muscle degeneration was also observed histologically at doses resulting in systemic exposure levels of approximately 23 times the human exposure level.
Poleg tega so pri odmerkih s posledi no sistemsko izpostavljenostjo, približno 23- krat ve jo od izpostavljenosti loveka pri klini ni uporabi, s histološko preiskavo ugotovili zelo blago do blago degeneracijo skeletne miši nine.
A no-effect level for these findings was found at an exposure 6-fold the clinical exposure level.
Za to ugotovitev je bila vrednost brez u inka 6- krat ve ja od izpostavljenosti pri klini ni uporabi.
Sitagliptin has not been demonstrated to be genotoxic in preclinical studies.
V predklini nih študijah ni bilo dokazano, da bi sitagliptin deloval genotoksi no.
In rats, there was an increased incidence of hepatic adenomas and carcinomas at systemic exposure levels 58 times the human exposure level.
Pri podganah so pri sistemski izpostavljenosti, ki je bila 58- krat ve ja od izpostavljenosti loveka pri klini ni uporabi, opazili ve jo pojavnost jetrnih adenomov in karcinomov.
Since hepatotoxicity has been shown to correlate with induction of hepatic neoplasia in rats, this increased incidence of hepatic tumors in rats was likely secondary to chronic hepatic toxicity at this high dose.
Ker je bila pri podganah dokazana povezava med hepatotoksi nostjo in indukcijo jetrnih neoplazij, obstaja verjetnost, da je pri podganah pojavnost jetrnih tumorjev pove ana sekundarno zaradi kroni ne hepatotoksi nosti pri tem velikem odmerku.
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 vrednost brez u inka) te neoplasti ne spremembe nimajo pomena za klini no uporabo pri loveku.
No adverse effects upon fertility were observed in male and female rats given sitagliptin prior to and throughout mating.
Pri samcih in samicah podgan, ki so sitagliptin prejemali/ prejemale pred in med parjenjem, niso opazili neželenih u inkov na plodnost.
Reproductive toxicity studies showed a slight treatment-related increased incidence of fetal rib malformations (absent, hypoplastic and wavy ribs) in the offspring of rats at systemic exposure levels more than 29 times the human exposure levels.
Pri študijah vplivov na sposobnost razmnoževanja so pri mladi ih podgan pri sistemski izpostavljenosti, ki je bila ve kot 29- krat ve ja od izpostavljenosti loveka, opazili nekoliko ve jo z zdravilom povezano pojavnost malformacij plodovih reber (izostala, hipoplasti na in valovita rebra).
Maternal toxicity was seen in rabbits at more than 29 times the human exposure levels.
Pri kuncih je bila toksi nost za mater opažena pri izpostavljenosti, ki je bila ve kot 29- krat ve ja od izpostavljenosti loveka.
4:1).
Pri doje ih podganah se je sitagliptin v znatnih koli inah izlo al z mlekom (razmerje mleko/ plazma 4: 1).
11 calcium hydrogen phosphate, anhydrous (E341) croscarmellose sodium (E468) magnesium stearate (E470b) sodium stearyl fumarate
Jedro tablete: mikrokristalna celuloza (E460) kalcijev hidrogenfosfat, brezvodni (E341) natrijev karmelozat, premreženi (E468) magnezijev stearat (E470b) natrijev stearilfumarat
Film coating: polyvinyl alcohol macrogol 3350 talc (E553b) titanium dioxide (E171) red iron oxide (E172) yellow iron oxide (E172)
Filmska obloga: polivinilalkohol makrogol 3350 smukec (E553b) titanov dioksid (E171) rde i železov oksid (E172) rumeni železov oksid (E172)
EU/ 1/ 07/ 435/ 001 EU/ 1/ 07/ 435/ 002 EU/ 1/ 07/ 435/ 003 EU/ 1/ 07/ 435/ 004 EU/ 1/ 07/ 435/ 005 EU/ 1/ 07/ 435/ 006
14 EU/ 1/ 07/ 435/ 003 EU/ 1/ 07/ 435/ 004 EU/ 1/ 07/ 435/ 005 EU/ 1/ 07/ 435/ 006
14 Patients with renal insufficiency For patients with mild renal insufficiency (creatinine clearance [CrCl] ≥ 50 ml/ min), no dosage adjustment for TESAVEL is required.
16 Bolniki z ledvi no insuficienco Pri bolnikih z blago ledvi no insuficienco (kreatininski o istek [CrCl] ≥ 50 ml/ min) odmerka zdravila TESAVEL ni treba prilagajati.
If a hypersensitivity reaction is suspected, discontinue TESAVEL, assess for other potential causes for the event, and institute alternative treatment for diabetes (see section 4.8).
17 4. 5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij
The effects of potent CYP3A4 inhibitors in the setting of renal insufficiency has not been assessed in a clinical study.
V klini ni študiji niso ovrednostili u inkov mo nih zaviralcev CYP3A4 v primeru ledvi ne insuficience.
Lactation It is unknown whether sitagliptin is excreted in human breast milk.
18 Dojenje Ni znano, e se sitagliptin izlo a v materino mleko pri ljudeh.
16 4.8 Undesirable effects
4. 8 Neželeni u inki
Investigations blood glucose decreased *
19 Preiskave Zmanjšana koncentracija glukoze v krvi *