natgillin/translations-raw huggingface dataset:
-2.1‡ (-2.3, -1.8)
HbA1c (%) v 18. tednu. §
* 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.
9 V študiji, kjer so pri bolnikih z nezadostno urejeno glikemijo pri zdravljenju samo z metforminom primerjali učinkovitost in varnost dodajanja zdravila Januvia v odmerku 100 mg enkrat na dan ali glipizida (sulfonilsečnina), je bil sitagliptin pri zmanjšanju vrednosti HbA1c podobno učinkovit kot glipizid.
In a study comparing the efficacy and safety of the addition of Januvia 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.
Srednji odmerek glipizida, ki je bil uporabljen v primerjalni skupini je bil 10 mg na dan.
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 čas 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 učinkovitosti izključenih več 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 izhodiščem pomembno zmanjšala, pri bolnikih, ki so prejemali glipizid pa pomembno povečala (- 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 označevalec učinkovitosti sinteze in sproščanja insulina, izboljšalo, pri zdravljenju z glipizidom pa poslabšalo.
The incidence of hypoglycaemia in the sitagliptin group (4.9%) was significantly lower than that in the glipizide group (32.0%).
Pojavnost hipoglikemije je bila v skupini, ki je prejemala sitagliptin (4, 9%) pomembno manjša kot v skupini, ki je prejemala glipizid (32, 0%).
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.
Največje 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 Januvia had no effect on the pharmacokinetics, Januvia may be administered with or without food.
Ker jemanje zdravila Januvia skupaj z obrokom z visoko vsebnostjo maščob ne vpliva na farmakokinetiko, se zdravilo Januvia lahko jemlje skupaj s hrano ali brez nje.
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 (povečevanje vrednosti Cmax je bilo nekoliko večje, povečevanje vrednosti C24ur pa nekoliko manjše kot pri od odmerka odvisnem načinu).
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 dinamičnega ravnovesja po enkratnem 100 mg intravenskem odmerku sitagliptina približno 198 litrov.
The fraction of sitagliptin reversibly bound to plasma proteins is low (38%).
Frakcija na plazemske proteine reverzibilno vezanega sitagliptina je majhna (38%).
9 Metabolism Sitagliptin is primarily eliminated unchanged in urine, and metabolism is a minor pathway.
Presnova je manj pomemben način izločanja.
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 pričakuje, da sodelujejo pri zaviralnemu delovanju sitagliptina na DPP- 4 v plazmi.
In vitro studies indicated that the primary enzyme responsible for the limited metabolism of sitagliptin was CYP3A4, with contribution from CYP2C8.
In vitro študije so pokazale, da je primarni encim, odgovoren za omejeno presnovo sitagliptina, CYP3A4 s sodelovanjem CYP2C8.
In vitro data showed that sitagliptin is not an inhibitor of CYP isozymes CYP3A4, 2C8, 2C9, 2D6, 1A2, 2C19 or 2B6, and is not an inducer of CYP3A4 and CYP1A2.
In vitro podatki kažejo, da sitagliptin ni zaviralec izoencimov CYP CYP3A4, 2C8, 2C9, 2D6, 1A2, 2C19 ali 2B6 in ni induktor CYP3A4 ter CYP1A2.
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.
Izločanje Po dajanju peroralnega odmerka [14C] sitagliptina zdravim osebam se je v enem tednu po prejemu odmerka približno 100% prejete radioaktivnosti izločilo 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 končni t1/ 2 znašal približno 12, 4 ure.
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 vključen v izločanje sitagliptina preko ledvic.
The clinical relevance of hOAT-3 in sitagliptin transport has not been established.
Klinični pomen hOAT- 3 pri transportu sitagliptina ni bil dokazan.
Sitagliptin is also a substrate of p-glycoprotein, which may also be involved in mediating the renal elimination of sitagliptin.
Sitagliptin je tudi substrat za p- glikoprotein, ki je prav tako lahko vključen pri izločanju sitagliptina preko ledvic, vendar pa ciklosporin, zaviralec p -
However, cyclosporine, a p-glycoprotein inhibitor, did not reduce the renal clearance of sitagliptin.
10 glikoproteina, ni zmanjšal ledvičnega očistka 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 pomočjo 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 klinični študiji je sitagliptin imel majhen učinek na koncentracije digoksina v plazmi, kar kaže, da je sitagliptin lahko blagi zaviralec p- glikoproteina.
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.
Ledvična insuficienca Izvedena je bila odprta študija z eni samim odmerkom, ki je ovrednotila farmakokinetiko zmanjšanega odmerka sitagliptina (50 mg) pri bolnikih z različnimi stopnjami kronične ledvične 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 vključeni tako bolniki z ledvično insuficienco, ki je bila na podlagi kreatininskega očistka 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 ledvično insuficienco plazemske koncentracije sitagliptina niso bile pomembneje povečane.
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 ledvično insuficienco so bile opažene približno 2- krat večje vrednosti plazemske AUC sitagliptina kot pri zdravih kontrolnih osebah.
Januvia 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 ledvično insuficienco in pri bolnikih z ESRD, ki so se zdravili s hemodializo, pa so bile opažene približno 4- krat večje vrednosti plazemske AUC sitagliptina kot pri zdravih kontrolnih osebah.
(See section 4.2.)
Ker so izkušnje pri bolnikih z zmerno ali s hudo ledvično insuficienco, vključno z bolniki z ESRD preveč omejene, uporabe zdravila Januvia pri teh bolnikih ne priporočamo (glejte poglavje 4. 2).
Hepatic insufficiency No dosage adjustment for Januvia 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 kliničnih izkušenj.
However, because sitagliptin is primarily renally eliminated, severe hepatic insufficiency is not expected to affect the pharmacokinetics of sitagliptin.
Ker se sitagliptin primarno izloča preko ledvic, ne pričakujemo, da bi huda jetrna insuficienca vplivala na farmakokinetiko sitagliptina.
10 Elderly No dosage adjustment is required based on age.
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 kliničnega 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% večje kot pri mlajših osebah.
Other patient characteristics No dosage adjustment is necessary based on gender, race, or body mass index (BMI).
Druge značilnosti 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 farmakokinetičnih podatkov I. faze in analize populacijske farmakokinetike na osnovi podatkov I. in II. faze te značilnosti nimajo kliničnega 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 večja od izpostavljenosti pri človeku, opazili toksičnost 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 večja od izpostavljenosti pri klinični uporabi, opazili anomalije sekalcev.
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 toksičnost za živčevje, npr. dihanje z odprtimi usti, slinjenje, bljuvanje bele spenjene vsebine, ataksija, tresenje, zmanjšana aktivnost in/ ali zgrbljena
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 posledično sistemsko izpostavljenostjo, približno 23- krat večjo od izpostavljenosti človeka pri klinični uporabi, s histološko preiskavo ugotovili zelo blago do blago degeneracijo skeletne mišičnine.
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 učinka 6- krat večja od izpostavljenosti pri klinični uporabi.
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 učinka) te neoplastične spremembe nimajo pomena za klinično uporabo pri človeku.
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 učinkov na plodnost.
In a pre-/ postnatal development study performed in rats sitagliptin showed no adverse effects.
Študije, izvedene s sitagliptinom na podganah, niso pokazale neželenih vplivov na pre - / post- natalni razvoj.
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 mladičih podgan pri sistemski izpostavljenosti, ki je bila več kot 29- krat večja od izpostavljenosti človeka, opazili nekoliko večjo z zdravilom povezano pojavnost malformacij plodovih reber (izostala, hipoplastična in valovita rebra).
Maternal toxicity was seen in rabbits at more than 29 times the human exposure levels.
Pri kuncih je bila toksičnost za mater opažena pri izpostavljenosti, ki je bila več kot 29- krat večja od izpostavljenosti človeka.
Because of the high safety margins, these findings do not suggest a relevant risk for human reproduction.
Zaradi visoke meje varnosti te ugotovitve ne kažejo na relevantno tveganje za razmnoževanje pri ljudeh.
4:1).
Pri doječih podganah se je sitagliptin v znatnih količinah izločal z mlekom (razmerje mleko/ plazma 4: 1).
Tablet core: microcrystalline cellulose (E460) calcium hydrogen phosphate, anhydrous (E341)
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) rdeči železov oksid (E172) rumeni železov oksid (E172)
This medicinal product does not require any special storage conditions.
12 Za shranjevanje zdravila niso potrebna posebna navodila.
Opaque blisters (PVC/ PE/ PVDC and aluminum).
Neprozorni pretisni omoti (PVC/ PE/ PVDC in aluminij).
Packs of 14, 28, 56, 84 or 98 film-coated tablets and 50 x 1 film-coated tablets in perforated unit dose blisters.
Pakiranja po 14, 28, 56, 84 ali 98 filmsko obloženih tablet in 50 x 1 filmsko obložena tableta v perforiranih pretisnih omotih za enkratni odmerek.
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/.
Podrobne informacije o zdravilu so objavljene na spletni strani Evropske agencije za zdravila (EMEA) http: // www. emea. europa. eu /.
Each tablet contains sitagliptin phosphate monohydrate, equivalent to 50 mg sitagliptin.
Ena tableta vsebuje sitagliptinijev fosfat monohidrat, kar ustreza 50 mg sitagliptina.
Round, light beige film-coated tablet with “ 112” on one side.
Okrogla svetlo sivorjava filmsko obložena tableta z oznako “ 112 ” na eni strani.
• in combination with the PPARγ agonist when diet and exercise plus the PPARγ agonist alone do not provide adequate glycaemic control.
v kombinaciji z agonistom PPARγ, če urejenost sladkorne bolezni z dieto in telesno vadbo ter zdravljenjem z agonistom PPARγ samim ni zadostna.
The dose of Januvia is 100 mg once daily.
Odmerek zdravila Januvia je 100 mg enkrat na dan.
The dosage of metformin or PPARγ agonist should be maintained, and sitagliptin administered concomitantly.
Z zdravljenjem z metforminom ali agonistom PPARγ je treba nadaljevati, sitagliptin pa uporabljati sočasno.
When Januvia is used in combination with a sulphonylurea, a lower dose of the sulphonylurea may be considered to reduce the risk of hypoglycaemia.
Pri uporabi zdravila Januvia v kombinaciji s sulfonilsečnino je odmerek sulfonilsečnine morda treba zmanjšati, da se tako zmanjša tveganje za pojav hipoglikemije.
(See section 4.4.)
(Glejte poglavje 4. 4.)
14 Patients with renal insufficiency For patients with mild renal insufficiency (creatinine clearance [CrCl] ≥ 50 ml/ min), no dosage adjustment for Januvia is required.
14 Bolniki z ledvično insuficienco Pri bolnikih z blago ledvično insuficienco (kreatininski očistek [CrCl] ≥ 50 ml/ min) odmerka zdravila Januvia ni treba prilagajati.
15 Metformin:
15 V nadaljevanju navedeni klinični podatki kažejo, da je pri sočasni uporabi drugih zdravil tveganje za pojav klinično pomembnih interakcij majhno.
The effects of potent CYP3A4 inhibitors in the setting of renal insufficiency has not been assessed in a clinical study.
V klinični študiji niso ovrednostili učinkov močnih zaviralcev CYP3A4 v primeru ledvične insuficience.
16 4.7 Effects on ability to drive and use machines
4. 7 Vpliv na sposobnost vožnje in upravljanja s stroji
However, when driving or operating machines, it should be taken into account that dizziness and somnolence have been reported.
16 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 clinical trials of Januvia as monotherapy and sitagliptin as part of combination therapy with metformin or pioglitazone, rates of hypoglycaemia reported with sitagliptin were similar to rates in patients taking placebo.
17 * V kliničnih preskušanjih zdravila Januvia kot samostojnega zdravila in sitagliptina v kombinaciji z metforminom ali pioglitazonom, so pri bolnikih, ki so prejemali sitagliptin, poročali o podobnem deležu hipoglikemije kot pri bolnikih, ki so prejemali placebo.
17 1 In this placebo-controlled 24-week study of sitagliptin 100 mg once daily in combination with metformin, the incidence of adverse reactions considered as drug-related in patients treated with sitagliptin/ metformin compared to treatment with placebo/ metformin was 9.3% and 10.1%, respectively.
1 V tej 24- tedenski s placebom nadzorovani študiji s 100 mg odmerkom sitagliptina enkrat na dan v kombinaciji z metforminom je bila pojavnost z zdravilom povezanih neželenih učinkov pri bolnikih, ki so se zdravili s kombinacijo sitagliptin/ metformin 9, 3- odstotna, pri bolnikih, ki so se zdravili s kombinacijo placebo/ metformin pa 10, 1- odstotna.
18 No clinically meaningful changes in vital signs or in ECG (including in QTc interval) were observed with Januvia treatment.
Med zdravljenjem z zdravilom Januvia niso opazili klinično pomembnih sprememb vitalnih znakov ali EKG- ja (vključno z intervalom QTc).
Sitagliptin prevents the hydrolysis of incretin hormones by DPP-4, thereby increasing plasma concentrations of the active forms of GLP-1 and GIP.
19 preprečuje hidrolizo inkretinov z DPP- 4 in tako povečuje plazemske koncentracije aktivnih oblik GLP- 1 in GIP.
19 highly selective inhibitor of the enzyme DPP-4 and does not inhibit the closely-related enzymes DPP-8 or DPP-9 at therapeutic concentrations.
Sitagliptin je močan in visoko selektiven zaviralec encima DPP- 4 in pri terapevtskih koncentracijah ne zavira tesno povezanih encimov DPP- 8 ali DPP- 9.
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 ledvično insuficienco je bilo premajhno, da bi lahko tudi pri njih potrdili varnost uporabe sitagliptina.
Table 2.
20 Tabela 2:
baseline HbA1c (%)
S placebom korigirana srednja
Week 24†
sprememba vrednosti HbA1c (%) vrednost HbA1c od izhodišča (%) v Študija v 24. tednu † HbA1c v 24. tednu † Sitagliptin 100 mg enkrat
Monotherapy Studies
izhodišču (%) Študije samostojnega zdravljenja
at Week 24†
(95% interval zaupanja) - 0, 6 ‡
Sitagliptin 100 mg once daily§
na dan§ (N = 193) Sitagliptin 100 mg enkrat
* 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.
21 V študiji, kjer so pri bolnikih z nezadostno urejeno glikemijo pri zdravljenju samo z metforminom primerjali učinkovitost in varnost dodajanja zdravila Januvia v odmerku 100 mg enkrat na dan ali glipizida (sulfonilsečnina), je bil sitagliptin pri zmanjšanju vrednosti HbA1c podobno učinkovit kot glipizid.
In a study comparing the efficacy and safety of the addition of Januvia 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 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 čas študije potrebovalo glipizid v odmerku ≤ 5 mg/ dan.
21 Metabolism Sitagliptin is primarily eliminated unchanged in urine, and metabolism is a minor pathway.
Presnova je manj pomemben način izločanja.
However, cyclosporine, a p-glycoprotein inhibitor, did not reduce the renal clearance of sitagliptin.
22 glikoproteina, ni zmanjšal ledvičnega očistka sitagliptina.
22 Elderly No dosage adjustment is required based on age.
Starejši bolniki Prilagajanje odmerka glede na starost ni potrebno.
This medicinal product does not require any special storage conditions.
24 Za shranjevanje zdravila niso potrebna posebna navodila.
Each tablet contains sitagliptin phosphate monohydrate, equivalent to 100 mg sitagliptin.
Ena tableta vsebuje sitagliptinijev fosfat monohidrat, kar ustreza 100 mg sitagliptina.
Round, beige film-coated tablet with “ 277” on one side.
Okrogla sivorjava filmsko obložena tableta z oznako “ 277 ” na eni strani.
26 Patients with renal insufficiency For patients with mild renal insufficiency (creatinine clearance [CrCl] ≥ 50 ml/ min), no dosage adjustment for Januvia is required.
26 Bolniki z ledvično insuficienco Pri bolnikih z blago ledvično insuficienco (kreatininski očistek [CrCl] ≥ 50 ml/ min) odmerka zdravila Januvia ni treba prilagajati.
27 Metformin:
27 V nadaljevanju navedeni klinični podatki kažejo, da je pri sočasni uporabi drugih zdravil tveganje za pojav klinično pomembnih interakcij majhno.