FrancophonIA/ELRC3.0 huggingface dataset:
English: Onglyza is indicated in adult patients with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control:
Slovenian: Zdravilo Onglyza je indicirano pri odraslih bolnikih s sladkorno boleznijo tipa 2 kot dodatek k dieti in telesni dejavnosti za izboljšanje urejenosti glikemije:
English: If a serious hypersensitivity reaction to saxagliptin is suspected, Onglyza should be discontinued, assess for other potential causes for the event, and institute alternative treatment for diabetes (see section 4.8).
Slovenian: Če se pojavi sum na resno preobčutljivostno reakcijo, je potrebno prekiniti zdravljenje z zdravilom Onglyza, preučiti morebitne druge vzroke za dogodek, in uvesti drugo zdravljenje za sladkorno bolezen (glejte poglavje 4.8).
English: After an oral glucose load, this DPP4 inhibition resulted in a 2- to 3-fold increase in circulating levels of active incretin hormones, including glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), decreased glucagon concentrations and increased glucose-dependent beta-cell responsiveness, which resulted in higher insulin and C-peptide concentrations.
Slovenian: Po peroralni obremenitvi z glukozo je to zavrtje DPP4 povzročilo 2- do 3-kraten porast koncentracije aktivnih inkretinskih hormonov v obtoku vključno z glukagonu podobnim peptidom-1 (GLP-1) in od glukoze odvisnim insulinotropnim polipeptidom (GIP), zmanjšalo je koncentracijo glukagona in povečalo od glukoze odvisno odzivnost celic beta, zaradi česar sta se povečali koncentracija insulina in C-peptida.
English: You should call your doctor if you experience the following side effect: • Severe joint pain.
Slovenian: Posvetujte se z zdravnikom, če se vam pojavijo naslednji neželeni učinki: • hude bolečine v sklepih.
English: No carcinogenic potential was observed in two-year carcinogenicity assays with mice and rats.
Slovenian: V dveletnih preizkušanjih kancerogenosti pri miših in podganah niso odkrili kancerogenega potenciala.
English: The study included patients with renal impairment classified on the basis of creatinine clearance as mild (approximately GFR ≥ 45 to < 90 mL/min), moderate (approximately GFR ≥ 30 to < 45 mL/min), or severe (approximately GFR < 30 mL/min), as well as patients with ESRD on haemodialysis.
Slovenian: Študija je zajela bolnike, pri katerih so okvaro ledvic na podlagi očistka kreatinina razvrstili kot blago (GFR približno ≥ 45 do < 90 ml/min), zmerno (GFR približno ≥ 30 do < 45 ml/min) ali hudo (GFR približno < 30 ml/min), kot tudi bolnike s končno odpovedjo ledvic na hemodializi.
English: Improvements in HbA1c following treatment with saxagliptin 2.5 mg were sustained up to Week 52, however, the number of patients who completed 52 weeks without modification of other antihyperglycaemic treatment was low (26 subjects in the saxagliptin group versus 34 subjects in the placebo group).
Slovenian: Izboljšanje HbA1c se je ohranilo do 52. tedna po zdravljenju z 2,5 mg saksagliptina, toda število bolnikov, ki so dokončali 52 tednov brez prilagoditve drugih antihiperglikemičnih zdravljenj, je bilo majhno (26 bolnikov v skupini s saksagliptinom in 34 bolnikov v skupini s placebom).
English: The overall incidence of adverse events in patients treated with Onglyza in this trial was similar to placebo (72.5% versus 72.2%, respectively).
Slovenian: Celotna incidenca neželenih učinkov je bila pri bolnikih, ki so v tem preskušanju prejemali zdravilo Onglyza, podobna kot pri prejemnikih placeba (72,5 % v primerjavi z 72,2 %).
English: Similar HbA1c reductions versus placebo were achieved for patients receiving saxagliptin 5 mg add-on to insulin regardless of metformin use (−0.4% for both subgroups).
Slovenian: Podobna zmanjšanja HbA1c v primerjavi s placebom so bila dosežena pri bolnikih, ki so prejemali 5 mg saksagliptina kot dodatek insulinu, ne glede na uporabo metformina (-0,4 % za obe podskupini).
English: When Onglyza is used in combination with insulin or a sulphonylurea, a lower dose of the insulin or sulphonylurea may be required to reduce the risk of hypoglycaemia (see section 4.4).
Slovenian: Če je zdravilo Onglyza uporabljeno v kombinaciji z insulinom ali sulfonilsečnino, je lahko za zmanjšanje tveganja za hipoglikemijo potreben manjši odmerek insulina ali sulfonilsečnine (glejte poglavje 4.4).
English: You are advised to follow the recommendations for skin and foot care that you are given by your doctor or nurse.
Slovenian: Upoštevajte priporočila za nego kože in stopal, ki vam jih je dal zdravnik ali medicinska sestra.
English: Some patients have had the following additional side effects while taking Onglyza alone: • Common: dizziness, diarrhoea and stomach ache.
Slovenian: Nekateri bolniki so imeli med jemanjem samega zdravila Onglyza dodatne neželene učinke: • Pogosti: omotica, driska in bolečine v trebuhu.
English: The time for saxagliptin to reach Cmax (Tmax) was increased by approximately 0.5 hours with food compared with the fasted state.
Slovenian: Čas do Cmax saksagliptina (tmax) se je s hrano podaljšal za približno 0,5 ure v primerjavi z uporabo na prazen želodec.
English: Primary composite endpoint: MACE Secondary composite endpoint: MACE plus All-cause mortality
Slovenian: Sekundarni sestavljeni opazovani dogodek: MACE plus
English: Saxagliptin with a sulphonylurea (glibenclamide)
Slovenian: Saksagliptin s sulfonilsečnino (glibenklamid)
English: In the confirmatory full analysis set, mean reductions were -0.4% and -0.6% respectively for saxagliptin and sitagliptin, with median reductions of -0.5% for both groups.
Slovenian: Potrditvena analiza polnega nabora je pokazala s saksagliptinom povprečno znižanje za 0,4 % in s sitagliptinom za -0,6 %; mediano znižanje je bilo v obeh skupinah -0,5 %.
English: If applicable, remember to take these other medicines as directed by your doctor to achieve the best results for your health.
Slovenian: Tudi to drugo zdravilo morate jemati po zdravnikovih navodilih, da boste najbolj koristili svojemu zdravju.
English: Onglyza 5 mg film-coated tablets EU/1/09/545/001-010
Slovenian: Onglyza 5 mg filmsko obložene tablete EU/1/09/545/001-010
English: Reductions in HbA1c from baseline to Week 24 were observed in all evaluated subgroups defined by baseline HbA1c, with greater reductions observed in patients with a baseline HbA1c ≥ 10% (see Table 2).
Slovenian: Zmanjšanje HbA1c od izhodišča do 24. tedna so opazili v vseh ocenjenih podskupinah, določenih glede na izhodiščni HbA1c; večja zmanjšanja so ugotovili pri bolnikih, ki so imeli izhodiščni HbA1c ≥ 10 % (glejte preglednico 2).
English: What Onglyza looks like and contents of the pack
Slovenian: Izgled zdravila Onglyza in vsebina pakiranja
English: Assessment of renal function is recommended prior to initiation of Onglyza, and in keeping with routine care, renal assessment should be done periodically thereafter (see sections 4.2 and 5.2).
Slovenian: Oceno delovanja ledvic je priporočljivo opraviti pred uvedbo zdravila Onglyza in jo pozneje redno opravljati v okviru rednih pregledov bolnika (glejte poglavji 4.2 in 5.2).
English: You should stop taking Onglyza and see your doctor immediately if you experience the following symptoms of low blood sugar: trembling, sweating, anxiety, blurred vision, tingling lips, paleness, mood change, vagueness or confusion (hypoglycaemia); Seen very commonly (may affect more than 1 in 10 people).
Slovenian: Nehajte jemati zdravilo Onglyza in nemudoma pojdite k zdravniku, če se vam pojavijo naslednji simptomi nizkega krvnega sladkorja: tresenje, znojenje, tesnoba, zamegljen vid, mravljinčenje v ustnicah, bledica, sprememba razpoloženja, nejasnost ali zmedenost (hipoglikemija); zelo pogosti (pojavijo se lahko pri več kot 1 od 10 bolnikov).
English: Onglyza must not be used in patients who have had any serious hypersensitivity reaction to a dipeptidyl peptidase-4 (DPP4) inhibitor (see section 4.3).
Slovenian: Zdravila Onglyza ne smejo dobiti bolniki, ki so imeli kakšno resno preobčutljivostno reakcijo na zaviralec dipeptidilpeptidaze 4 (DPP4) (glejte poglavje 4.3).
English: In subjects with mild (Child-Pugh Class A), moderate (Child-Pugh Class B), or severe (Child-Pugh Class C) hepatic impairment the exposures to saxagliptin were 1.1-, 1.4- and 1.8-fold higher, respectively, and the exposures to BMS-510849 were 22%, 7%, and 33% lower, respectively, than those observed in healthy subjects.
Slovenian: Pri preiskovancih z blago (Child-Pugh razred A), zmerno (Child-Pugh razred B) ali hudo (Child-Pugh razred C) jetrno okvaro, je bila izpostavljenost saksagliptinu 1,1-, 1,4- in 1,8- krat večja in izpostavljenost BMS-510849 je bila 22 %, 7 % in 33 % manjša kot pri zdravih preiskovancih.
English: The safety and efficacy of saxagliptin as triple oral therapy in combination with metformin and a thiazolidinedione have not been established.
Slovenian: Varnost in učinkovitost saksagliptina v kombinirani tritirni peroralni terapiji z metforminom in tiazolidindionom nista ugotovljeni.
English: The in vitro protein binding of saxagliptin and its major metabolite in human serum is negligible.
Slovenian: Vezava saksagliptina in njegovega glavnega presnovka na beljakovine v humanem serumu in vitro je zanemarljiva.
English: Onglyza is used alone or together with insulin or other anti-diabetic medicines.
Slovenian: Zdravilo Onglyza se uporablja samostojno ali skupaj z insulinom ali drugimi zdravili proti sladkorni bolezni (antidiabetiki).
English: The no effect level (NOEL) for the lesions is 1 and 2 times the human exposure of saxagliptin and the major metabolite respectively, at the recommended human dose of 5 mg/day (RHD).
Slovenian: Raven brez učinka (NOEL - The no effect level) za te spremembe je 1-kratna človeška izpostavljenost saksagliptinu in 2-kratna človeška izpostavljenost njegovemu glavnemu presnovku, dosežena s priporočenim odmerkom za človeka (RHD - recommended human dose) 5 mg na dan.
English: • if you are allergic to saxagliptin or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Ne jemljite zdravila Onglyza - če ste alergični na saksagliptin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: The study population included those ≥65 years (n=8561) and ≥ 75 years (n=2330), with normal or mild renal impairment (n=13,916) as well as moderate (n=2240) or severe (n=336) renal impairment.
Slovenian: Populacija v preskušanju je zajela bolnike, stare ≥ 65 let (n = 8.561) in ≥ 75 let (n = 2.330), z normalnim delovanjem ledvic ali blago okvaro ledvic (n = 13.916) ter tudi zmerno (n = 2.240) ali hudo (n = 336) okvaro ledvic.
English: The Cmax and AUC of saxagliptin and its major metabolite increased proportionally to the saxagliptin dose.
Slovenian: Cmax in AUC saksagliptina in njegovega glavnega presnovka so naraščale sorazmerno odmerku saksagliptina.
English: Mechanism of action and pharmacodynamic effects Saxagliptin is a highly potent (Ki: 1.3 nM), selective, reversible, competitive, DPP4 inhibitor.
Slovenian: Saksagliptin je zelo močan (Ki: 1,3 nM), selektiven, reverzibilen in kompetitiven zaviralec DPP4.
English: Reductions in HbA1c were seen across subgroups including gender, age, race, and baseline body mass index (BMI) and higher baseline HbA1c was associated with a greater adjusted mean change from baseline with saxagliptin.
Slovenian: Zmanjšanje HbA1c so ugotovili tudi po podskupinah, vključno po spolu, starosti, rasi in izhodiščnem indeksu telesne mase (ITM); večji izhodiščni HbA1c je bil med uporabo saksagliptina povezan z večjo korigirano povprečno spremembo v primerjavi z izhodiščem.
English: Onglyza 2.5 mg film-coated tablets EU/1/09/545/011-015
Slovenian: Onglyza 2,5 mg filmsko obložene tablete EU/1/09/545/011-015
English: Randomised and treated patients with baseline and at least 1 post baseline efficacy measurement.
Slovenian: Randomizirani in zdravljeni bolniki z izhodiščno in vsaj še eno poizhodiščno meritvijo učinkovitosti.
English: Onglyza contains lactose
Slovenian: Zdravilo Onglyza vsebuje laktozo
English: When used as add-on combination therapy with metformin plus sulphonylurea, the overall incidence of reported hypoglycaemia was 10.1% for Onglyza 5 mg and 6.3% for placebo.
Slovenian: Če je bilo zdravilo uporabljeno kot dodatek kombiniranemu zdravljenju z metforminom in sulfonilsečnino, je bila celotna incidenca opisanih hipoglikemij 10,1 % z zdravilom Onglyza 5 mg in 6,3 % s placebom.
English: A total of 22% of the administered radioactivity was recovered in faeces representing the fraction of the saxagliptin dose excreted in bile and/or unabsorbed medicinal product from the gastrointestinal tract.
Slovenian: Vsega skupaj 22 % aplicirane radioaktivnosti se je pojavilo v blatu; to predstavlja z žolčem izločeni in/ali iz prebavil neabsorbirani del odmerka saksagliptina.
English: The overall incidence of reported hypoglycaemia (recorded in daily patient diaries) was 17.1% in subjects treated with Onglyza and 14.8% among patients treated with placebo.
Slovenian: Celotna incidenca zabeleženih hipoglikemij (vpisanih v dnevne dnevnike bolnikov) je bila 17,1 % med prejemniki zdravila Onglyza in 14,8 % med prejemniki placeba.
English: Rash is also noted as an adverse reaction for Onglyza (see section 4.8).
Slovenian: Izpuščaj je zabeležen tudi kot neželen učinek zdravila Onglyza (glejte poglavje 4.8).
English: p=0.0157 compared to placebo.
Slovenian: p = 0,0157 v primerjavi s placebom.
English: • Common: dizziness, tiredness, stomach ache and flatulence.
Slovenian: • Pogosti: omotica, utrujenost, bolečine v trebuhu in flatulenca.
English: The co-administration of saxagliptin and CYP3A4/5 inducers, other than rifampicin (such as carbamazepine, dexamethasone, phenobarbital and phenytoin) have not been studied and may result in decreased plasma concentration of saxagliptin and increased concentration of its major metabolite.
Slovenian: Sočasna uporaba saksagliptina in induktorjev CYP3A4/5, razen rifampicina (kot so karbamazepin, deksametazon, fenobarbital in fenitoin) ni raziskana; povzroči lahko zmanjšanje koncentracije saksagliptina in poveča koncentracijo njegovega glavnega presnovka v plazmi.
English: Placebo-corrected mean change in HbA1c (%) at Week 24 (95% CI)
Slovenian: S placebom korigirana povprečna sprememba HbA1c (%) 24. teden (95% CI)
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say it is essentially ‘sodium-free'.
Slovenian: Vsebnost natrija To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni ‘brez natrija'.
English: Decreased lymphocyte counts were reported in 0.5% of Onglyza treated patients and 0.4% of placebotreated patients.
Slovenian: Zmanjšanje števila limfocitov so zabeležili pri 0,5 % bolnikov, zdravljenih z zdravilom Onglyza, in pri 0,4 % bolnikov, ki so prejemali placebo.
English: • Study CV181057: add-on to insulin (+/-metformin) Overall population (n=300)
Slovenian: • preskušanje CV181057: dodatek insulinu (+/-metformin) celotna populacija (n = 300)
English: If you forget to take Onglyza
Slovenian: Če ste pozabili vzeti zdravilo Onglyza
English: In patients with type 2 diabetes, administration of saxagliptin led to inhibition of DPP4 enzyme activity for a 24-hour period.
Slovenian: Bolnikom s sladkorno boleznijo tipa 2 je uporaba saksagliptina za 24 ur zavrla delovanje encima DPP4.
English: Effects on fertility were observed in male and female rats at high doses producing overt signs of toxicity.
Slovenian: Pri podganjih samcih in samicah so opazili učinke na plodnost pri velikih odmerkih, ki so povzročili očitne znake toksičnosti.
English: It is unknown whether saxagliptin is excreted in human breast milk.
Slovenian: Ni znano, ali se saksagliptin pri človeku izloča v materino mleko.
English: Discontinuation of therapy due to adverse events was higher in patients who received saxagliptin 5 mg as compared to placebo (3.3% as compared to 1.8%).
Slovenian: Zaradi neželenih učinkov je zdravljenje prekinilo več bolnikov, ki so dobivali 5 mg saksagliptina, kot tistih, ki so dobivali placebo (3,3 % v primerjavi z 1,8 %).
English: If you have severe liver problems, then Onglyza is not recommended for you.
Slovenian: Če imate hude težave z jetri, zdravilo Onglyza za vas ni priporočljivo.
English: Adverse reactions reported in ≥ 5% of patients treated with saxagliptin 5 mg and more commonly than in patients treated with placebo or that were reported in ≥ 2% of patients treated with saxagliptin 5 mg and ≥ 1% more frequently compared to placebo from the pooled analysis of five studies of glycaemic control, plus an additional active-controlled study of initial combination with metformin are shown in Table 1.
Slovenian: Neželene učinke, ki so bili poročani pri  5 % bolnikih, ki so dobivali 5 mg saksagliptina in so bolj pogosti kot pri bolnikih, ki so dobivali placebo, ali tiste, ki so bili poročani pri  2 % bolnikih, ki so dobivali 5 mg saksagliptina in so  1 % bolj pogosti v primerjavi s placebom, iz kumulativne analize petih študij urejenosti glikemije ter ene dodatne, z učinkovino kontrolirane študije začetne kombinacije z metforminom prikazuje preglednica 1.
English: Saxagliptin in combination with a fixed, intermediate dose of a sulphonylurea (glibenclamide 7.5 mg) was compared to titration to a higher dose of glibenclamide (approximately 92% of patients in the placebo plus glibenclamide group were uptitrated to a final total daily dose of 15 mg).
Slovenian: Saksagliptin v kombinaciji s stalnim, srednje velikim odmerkom sulfonilsečnine (7,5 mg glibenklamida) so primerjali s povečevanjem odmerka glibenklamida (približno 92 % bolnikom v skupini s placebom in glibenklamidom so odmerek povečevali do končnega celotnega dnevnega odmerka 15 mg).
English: The corresponding plasma Cmax values were 24 ng/ml and 47 ng/ml, respectively.
Slovenian: Ustrezna plazemska Cmax saksagliptina je bila 24 ng/ml in njegovega glavnega presnovka 47 ng/ml.
English: p-value <0.001 for noninferiority (based on HR <1.3) compared to placebo.
Slovenian: Vrednost p za neinferiornost < 0,001 (na podlagi razmerja ogroženosti < 1,3) v primerjavi s placebom.
English: Using CYP3A4 inducers like carbamazepine, dexamethasone, phenobarbital, phenytoin, and rifampicin may reduce the glycaemic lowering effect of Onglyza (see section 4.5).
Slovenian: Uporaba induktorjev CYP3A4, npr. karbamazepina, deksametazona, fenobarbitala, fenitoina ali rifampicina, lahko zmanjša učinek zdravila Onglyza na zmanjšanje glukoze v krvi (glejte poglavje 4.5).
English: When used as add-on to insulin (with or without metformin), the overall incidence of reported hypoglycaemia was 18.4% for Onglyza 5 mg and 19.9% for placebo.
Slovenian: Kot dodatek insulinu (z ali brez metformina): celokupna incidenca poročanih primerov hipoglikemije je bila 18,4 % za zdravilo Onglyza in 19,9 % za placebo.
English: The recommended dose of Onglyza is one 5 mg tablet once a day.
Slovenian: Priporočeni odmerek zdravila Onglyza je ena 5 mg tableta enkrat na dan.
English: Some patients have had a small reduction in the number of one type of white blood cells (lymphocytes) shown in a blood test when Onglyza was used alone or in combination.
Slovenian: Nekaterim bolnikom se med uporabo zdravila Onglyza samega ali v kombinaciji nekoliko zmanjša število ene vrste belih krvnih celic (limfocitov), kar se pokaže na preiskavi krvi.
English: You should not take this medicine if you are breast-feeding or plan to breast-feed.
Slovenian: Tega zdravila ne smete jemati, če dojite ali nameravate dojiti.
English: p-value = 0.99 for superiority (based on HR <1.0) compared to placebo.
Slovenian: Vrednost p za superiornost = 0,99 (na podlagi razmerja ogroženosti < 1,0) v primerjavi s placebom.
English: This may be used to treat inflammation in different body parts and organs.
Slovenian: • deksametazon (steroidno zdravilo); uporablja se lahko za zdravljenje vnetja v različnih telesnih delih in organih.
English: Onglyza contains less than 1 mmol sodium (23 mg) per dose, i.e. is essentially ‘sodium-free'.
Slovenian: Zdravilo Onglyza vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni ‘brez natrija'.
English: If you stop taking Onglyza
Slovenian: Če ste prenehali jemati zdravilo Onglyza
English: What Onglyza contains - The active substance is saxagliptin.
Slovenian: Kaj vsebuje zdravilo Onglyza - Učinkovina je saksagliptin.
English: • Carbamazepine, phenobarbital or phenytoin.
Slovenian: • karbamazepin, fenobarbital ali fenitoin; uporabljajo se lahko za obvladovanje napadov krčev
English: No dose adjustment is necessary for patients with mild or moderate hepatic impairment (see section 5.2).
Slovenian: Bolnikom z blago ali zmerno okvaro jeter odmerka ni treba prilagoditi (glejte poglavje 5.2).
English: Lactose monohydrate Cellulose, microcrystalline (E460i) Croscarmellose sodium (E468) Magnesium stearate
Slovenian: Jedro tablete: laktoza monohidrat mikrokristalna celuloza (E460i) premreženi natrijev karmelozat (E468) magnezijev stearat
English: Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes MellitusThrombolysis in Myocardial Infarction (SAVOR) Study SAVOR was a CV outcome trial in 16,492 patients with HbA1c ≥6.5% and <12% (12959 with established CV disease; 3533 with multiple risk factors only) who were randomised to saxagliptin (n=8280) or placebo (n=8212) added to regional standards of care for HbA1c and CV risk factors.
Slovenian: Preskušanje SAVOR (Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus - Thrombolysis in Myocardial Infarction - Ocena žilnih izidov, zabeleženih pri bolnikih s sladkorno boleznijo ob saksagliptinu) - tromboza in miokardni infarkt Preskušanje SAVOR je bilo preskušanje kardiovaskularnih izidov pri 16.492 bolnikih s HbA1c ≥ 6,5 % in < 12 % (12.959 z ugotovljeno kardiovaskularno boleznijo in 3.533 takšnih, ki so imeli le več dejavnikov tveganja), randomiziranih na saksagliptin (n = 8.280) ali placebo (n = 8.212), dodana regionalnemu standardnemu zdravljenju, glede HbA1c in kardiovaskularnih dejavnikov tveganja.
English: • 2.5 mg film-coated tablets are pale yellow to light yellow, biconvex, round.
Slovenian: • 2,5 mg filmsko obložene tablete so bledo rumene do svetlo rumene, na obeh straneh izbočene, okrogle.
English: Some patients have experienced constipation at an unknown frequency (cannot be determined from the available data) when Onglyza was used alone or in combination.
Slovenian: Nekaterim bolnikom se je med uporabo zdravila Onglyza samega ali v kombinaciji pojavila zaprtost, katere pogostnost je neznana (ni je mogoče določiti iz razpoložljivih podatkov).
English: Do not use this medicine after the expiry date which is stated on the blister and the carton after EXP.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na pretisnem omotu in na škatli poleg oznake Uporabno do. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: Administration with food (a high-fat meal) resulted in no change in saxagliptin Cmax and a 27% increase in AUC compared with the fasted state.
Slovenian: V primerjavi z uporabo na prazen želodec uporaba s hrano (mastnim obrokom) ni spremenila Cmax saksagliptina, AUC pa se je povečala za 27 %.
English: Saxagliptin as add-on to metformin plus a sulphonylurea
Slovenian: Saksagliptin kot dodatek metforminu in sulfonilsečnini
English: The inhibition of plasma DPP4 activity by saxagliptin for at least 24 hours after oral administration of saxagliptin is due to high potency, high affinity, and extended binding to the active site.
Slovenian: Saksagliptin zavre plazemsko aktivnost DPP4 za vsaj 24 ur po peroralni uporabi zaradi svoje velike moči, velike afinitete in obsežne vezave na aktivno mesto.