natgillin/translations-raw huggingface dataset:
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).
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.
• if you are allergic to saxagliptin or any of the other ingredients of this medicine (listed in section 6).
Ne jemljite zdravila Onglyza - če ste alergični na saksagliptin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
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.
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.
The Cmax and AUC of saxagliptin and its major metabolite increased proportionally to the saxagliptin dose.
Cmax in AUC saksagliptina in njegovega glavnega presnovka so naraščale sorazmerno odmerku saksagliptina.
Mechanism of action and pharmacodynamic effects Saxagliptin is a highly potent (Ki: 1.3 nM), selective, reversible, competitive, DPP4 inhibitor.
Saksagliptin je zelo močan (Ki: 1,3 nM), selektiven, reverzibilen in kompetitiven zaviralec DPP4.
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.
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.
Onglyza 2.5 mg film-coated tablets EU/1/09/545/011-015
Onglyza 2,5 mg filmsko obložene tablete EU/1/09/545/011-015
Randomised and treated patients with baseline and at least 1 post baseline efficacy measurement.
Randomizirani in zdravljeni bolniki z izhodiščno in vsaj še eno poizhodiščno meritvijo učinkovitosti.
Onglyza contains lactose
Zdravilo Onglyza vsebuje laktozo
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.
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.
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.
Vsega skupaj 22 % aplicirane radioaktivnosti se je pojavilo v blatu; to predstavlja z žolčem izločeni in/ali iz prebavil neabsorbirani del odmerka saksagliptina.
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.
Celotna incidenca zabeleženih hipoglikemij (vpisanih v dnevne dnevnike bolnikov) je bila 17,1 % med prejemniki zdravila Onglyza in 14,8 % med prejemniki placeba.
Rash is also noted as an adverse reaction for Onglyza (see section 4.8).
Izpuščaj je zabeležen tudi kot neželen učinek zdravila Onglyza (glejte poglavje 4.8).
p=0.0157 compared to placebo.
p = 0,0157 v primerjavi s placebom.
• Common: dizziness, tiredness, stomach ache and flatulence.
• Pogosti: omotica, utrujenost, bolečine v trebuhu in flatulenca.
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.
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.
Placebo-corrected mean change in HbA1c (%) at Week 24 (95% CI)
S placebom korigirana povprečna sprememba HbA1c (%) 24. teden (95% CI)
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say it is essentially ‘sodium-free'.
Vsebnost natrija To zdravilo vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni ‘brez natrija'.
Decreased lymphocyte counts were reported in 0.5% of Onglyza treated patients and 0.4% of placebotreated patients.
Zmanjšanje števila limfocitov so zabeležili pri 0,5 % bolnikov, zdravljenih z zdravilom Onglyza, in pri 0,4 % bolnikov, ki so prejemali placebo.
• Study CV181057: add-on to insulin (+/-metformin) Overall population (n=300)
• preskušanje CV181057: dodatek insulinu (+/-metformin) celotna populacija (n = 300)
If you forget to take Onglyza
Če ste pozabili vzeti zdravilo Onglyza
In patients with type 2 diabetes, administration of saxagliptin led to inhibition of DPP4 enzyme activity for a 24-hour period.
Bolnikom s sladkorno boleznijo tipa 2 je uporaba saksagliptina za 24 ur zavrla delovanje encima DPP4.
Effects on fertility were observed in male and female rats at high doses producing overt signs of toxicity.
Pri podganjih samcih in samicah so opazili učinke na plodnost pri velikih odmerkih, ki so povzročili očitne znake toksičnosti.
It is unknown whether saxagliptin is excreted in human breast milk.
Ni znano, ali se saksagliptin pri človeku izloča v materino mleko.
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%).
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 %).
If you have severe liver problems, then Onglyza is not recommended for you.
Če imate hude težave z jetri, zdravilo Onglyza za vas ni priporočljivo.
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.
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.
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).
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).
The corresponding plasma Cmax values were 24 ng/ml and 47 ng/ml, respectively.
Ustrezna plazemska Cmax saksagliptina je bila 24 ng/ml in njegovega glavnega presnovka 47 ng/ml.
p-value <0.001 for noninferiority (based on HR <1.3) compared to placebo.
Vrednost p za neinferiornost < 0,001 (na podlagi razmerja ogroženosti < 1,3) v primerjavi s placebom.
Using CYP3A4 inducers like carbamazepine, dexamethasone, phenobarbital, phenytoin, and rifampicin may reduce the glycaemic lowering effect of Onglyza (see section 4.5).
Uporaba induktorjev CYP3A4, npr. karbamazepina, deksametazona, fenobarbitala, fenitoina ali rifampicina, lahko zmanjša učinek zdravila Onglyza na zmanjšanje glukoze v krvi (glejte poglavje 4.5).
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.
Kot dodatek insulinu (z ali brez metformina): celokupna incidenca poročanih primerov hipoglikemije je bila 18,4 % za zdravilo Onglyza in 19,9 % za placebo.
The recommended dose of Onglyza is one 5 mg tablet once a day.
Priporočeni odmerek zdravila Onglyza je ena 5 mg tableta enkrat na dan.
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.
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.
You should not take this medicine if you are breast-feeding or plan to breast-feed.
Tega zdravila ne smete jemati, če dojite ali nameravate dojiti.
p-value = 0.99 for superiority (based on HR <1.0) compared to placebo.
Vrednost p za superiornost = 0,99 (na podlagi razmerja ogroženosti < 1,0) v primerjavi s placebom.
This may be used to treat inflammation in different body parts and organs.
• deksametazon (steroidno zdravilo); uporablja se lahko za zdravljenje vnetja v različnih telesnih delih in organih.
Onglyza contains less than 1 mmol sodium (23 mg) per dose, i.e. is essentially ‘sodium-free'.
Zdravilo Onglyza vsebuje manj kot 1 mmol (23 mg) natrija na odmerek, kar v bistvu pomeni ‘brez natrija'.
If you stop taking Onglyza
Če ste prenehali jemati zdravilo Onglyza
What Onglyza contains - The active substance is saxagliptin.
Kaj vsebuje zdravilo Onglyza - Učinkovina je saksagliptin.
• Carbamazepine, phenobarbital or phenytoin.
• karbamazepin, fenobarbital ali fenitoin; uporabljajo se lahko za obvladovanje napadov krčev
No dose adjustment is necessary for patients with mild or moderate hepatic impairment (see section 5.2).
Bolnikom z blago ali zmerno okvaro jeter odmerka ni treba prilagoditi (glejte poglavje 5.2).
Lactose monohydrate Cellulose, microcrystalline (E460i) Croscarmellose sodium (E468) Magnesium stearate
Jedro tablete: laktoza monohidrat mikrokristalna celuloza (E460i) premreženi natrijev karmelozat (E468) magnezijev stearat
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.
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.
• 2.5 mg film-coated tablets are pale yellow to light yellow, biconvex, round.
• 2,5 mg filmsko obložene tablete so bledo rumene do svetlo rumene, na obeh straneh izbočene, okrogle.
Some patients have experienced constipation at an unknown frequency (cannot be determined from the available data) when Onglyza was used alone or in combination.
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).
Do not use this medicine after the expiry date which is stated on the blister and the carton after EXP.
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.
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.
V primerjavi z uporabo na prazen želodec uporaba s hrano (mastnim obrokom) ni spremenila Cmax saksagliptina, AUC pa se je povečala za 27 %.
Saxagliptin as add-on to metformin plus a sulphonylurea
Saksagliptin kot dodatek metforminu in sulfonilsečnini
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.
Saksagliptin zavre plazemsko aktivnost DPP4 za vsaj 24 ur po peroralni uporabi zaradi svoje velike moči, velike afinitete in obsežne vezave na aktivno mesto.
A 12-week, multi-centre, randomised, double-blind, placebo-controlled study was conducted to evaluate the treatment effect of saxagliptin 2.5 mg once daily compared with placebo in 170 patients (85 patients on saxagliptin and 85 on placebo) with type 2 diabetes (HbA1c 7.0-11%) and renal impairment (moderate [n=90]; severe [n=41]; or ESRD [n=39]).
Izvedena je bila 12-tedenska multicentrična, randomizirana, dvojno slepa, s placebom kontrolirana študija za oceno učinka zdravljenja s saksagliptinom 2,5 mg enkrat na dan v primerjavi s placebom pri 170 bolnikih (85 bolnikov na saksagliptinu in 85 na placebu) s sladkorno boleznijo tipa 2 (HbA1c 7,0-11 %) in okvaro ledvic (zmerno [n = 90], hudo [n = 41] ali končno odpovedjo ledvic [n = 39]).
• 5 mg film-coated tablets are pink, biconvex, round.
• 5 mg filmsko obložene tablete so rožnate, na obeh straneh izbočene, okrogle.
Pack sizes of 30x1 and 90x1 film-coated tablets in perforated unit dose blisters.
Velikost pakiranj: 30x1 in 90x1 filmsko obloženih tablet v perforiranih pretisnih omotih za enkratni odmerek.
The reduction in FPG was slightly less in the saxagliptin-group and there were more discontinuations (3.5% vs. 1.2%) due to lack of efficacy based on FPG criteria during the first 24 weeks of the study.
Znižanje glukoze v plazmi na tešče je bilo v skupini s saksagliptinom nekoliko manjše in v prvih 24 tednih študije so zabeležili več prekinitev zdravljenja (3,5 % v primerjavi z 1,2 %) zaradi neučinkovitosti, ocenjene na podlagi glukoze v plazmi na tešče.
14 film-coated tablets 28 film-coated tablets 30x1 film-coated tablets 56 film-coated tablets 90x1 film-coated tablets 98 film-coated tablets
14 filmsko obloženih tablet 28 filmsko obloženih tablet 30x1 filmsko obloženih tablet 56 filmsko obloženih tablet 90x1 filmsko obloženih tablet 98 filmsko obloženih tablet
• 5 mg tablets are available in pack sizes of 14, 28, 56, or 98 film-coated tablets in non-perforated blisters, 14, 28, 56, or 98 film-coated tablets in non-perforated calendar blisters and 30x1 or 90x1 film-coated tablets in perforated unit dose blisters.
• 5 mg tablete so na voljo v pakiranjih po 14, 28, 56 ali 98 filmsko obloženih tablet v neperforiranih pretisnih omotih, 14, 28, 56 ali 98 filmsko obloženih tablet v neperforiranih koledarskih pretisnih omotih ter 30x1 ali 90x1 filmsko obloženih tablet v perforiranih pretisnih omotih za enkratni odmerek.
Patients treated with saxagliptin exhibited a significant decrease from baseline in body weight compared to a weight gain in patients administered glipizide (-1.1 vs. +1.1 kg).
Pri bolnikih, zdravljenih s saksagliptinom, so v primerjavi z izhodiščem ugotovili značilno zmanjšanje telesne mase, pri zdravljenih z glipizidom pa povečanje telesne mase (-1,1 kg v primerjavi s +1,1 kg).
Treatment with saxagliptin 5 mg once daily produced clinically relevant and statistically significant improvements in haemoglobin A1c (HbA1c), fasting plasma glucose (FPG) and postprandial glucose (PPG) compared to placebo in monotherapy, in combination with metformin (initial or add-on therapy), in combination with a sulphonylurea, and in combination with a thiazolidinedione (see Table 2).
Zdravljenje s 5 mg saksagliptina enkrat na dan je klinično pomembno in statistično značilno izboljšalo hemoglobin A1c (HbA1c), glukozo v plazmi na tešče in postprandialno glukozo v primerjavi s placebom v monoterapiji, v kombinaciji z metforminom (začetno ali dodatno zdravljenje), v kombinaciji s katero od sulfonilsečnin ali v kombinaciji s katerim od tiazolidindionov (glejte preglednico 2).
Symptoms of a serious allergic reaction (seen rarely, may affect up to 1 in 1,000 people) may include: o Rash o Raised red patches on your skin (hives) o Swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing.
Simptomi resne alergijske reakcije lahko vključujejo: o izpuščaj o izbočene rdeče lise na koži (koprivnico) o otekanje obraza, ustnic, jezika in žrela, kar lahko povzroči težave pri dihanju ali požiranju.
p=0.0059 compared to placebo.
p = 0,0059 v primerjavi s placebom.
• 2.5 mg tablets are available in pack sizes of 14, 28, or 98 film-coated tablets in non-perforated calendar blisters and 30x1 or 90x1 film-coated tablets in perforated unit dose blisters.
• 2,5 mg tablete so na voljo v pakiranjih po 14, 28 ali 98 filmsko obloženih tablet v neperforiranih koledarskih pretisnih omotih ter 30x1 ali 90x1 filmsko obloženih tablet v perforiranih pretisnih omotih za enkratni odmerek.
The recommended dose of Onglyza is 5 mg once a day.
Priporočeni odmerek zdravila Onglyza je 5 mg enkrat na dan.
Musculoskeletal and connective tissue disorders Arthralgia
Bolezni mišično skeletnega sistema in vezivnega tkiva artralgija občasni mialgija
14 film-coated tablets 28 film-coated tablets 30x1 film-coated tablets 90x1 film-coated tablets 98 film-coated tablets
14 filmsko obloženih tablet 28 filmsko obloženih tablet 30x1 filmsko obloženih tablet 90x1 filmsko obloženih tablet 98 filmsko obloženih tablet
In randomised, controlled, double-blind clinical trials (including developmental and postmarketing experience), over 17,000 patients with type 2 diabetes have been treated with Onglyza.
V randomiziranih, kontroliranih, dvojno slepih kliničnih preskušanjih (vključno z izkušnjami med obdobjem razvoja in po začetku trženja zdravila) je zdravilo Onglyza prejemalo več kot 17.000 bolnikov s sladkorno boleznijo tipa 2.
Onglyza 5 mg tablets are pink, biconvex, round, film-coated tablets, with “5” printed on one side and “4215” printed on the other side, in blue ink.
Onglyza 5 mg tablete so rožnate, bikonveksne, okrogle filmsko obložene tablete, ki imajo z modrim barvilom na eni strani natisnjeno oznako “5” in na drugi “4215”.
Onglyza 2.5 mg tablets are pale yellow to light yellow, biconvex, round, film-coated tablets, with “2.5” printed on one side and “4214” printed on the other side, in blue ink.
Onglyza 2,5 mg tablete so bledo rumene do svetlo rumene, bikonveksne, okrogle, filmsko obložene tablete, ki imajo z modrim barvilom na eni strani natisnjeno oznako “2,5” in na drugi “4214”.
In cynomolgus monkeys saxagliptin produced reversible skin lesions (scabs, ulcerations and necrosis) in extremities (tail, digits, scrotum and/or nose) at doses ≥ 3 mg/kg/day.
Pri opicah cynomolgus je saksagliptin v odmerkih ≥ 3 mg/kg/dan povzročil reverzibilne spremembe (kraste, razjede in nekrozo) na udih (rep, prsti, modnik in/ali nos).
Because the dose should be limited to 2.5 mg based upon renal function, assessment of renal function is recommended prior to initiation of treatment, and, in keeping with routine care, renal assessment should be done periodically thereafter (see sections 4.4 and 5.2).
Ker je treba odmerek omejiti na 2,5 mg glede na delovanje ledvic, je pred uvedbo zdravljenja treba oceniti delovanje ledvic.
Saxagliptin should be used with caution in patients with moderate hepatic impairment, and is not recommended for use in patients with severe hepatic impairment (see section 4.2).
Saksagliptin naj se uporablja previdno pri bolnikih z zmerno okvaro jeter in ga ni priporočljivo uporabljati pri bolnikih s hudo okvaro jeter (glejte poglavje 4.2).
Ulcerative and necrotic skin lesions have been reported in extremities of monkeys in non-clinical toxicology studies (see section 5.3).
V nekliničnih toksikoloških študijah so poročali o ulcernativnih in nekrotične kožnih spremembah na udih opic (glejte poglavje 5.3).
If you are having haemodialysis then Onglyza is not recommended for you;
Če imate hemodializo, zdravilo Onglyza za vas ni priporočljivo,
Saxagliptin significantly decreased HbA1c compared with placebo; the HbA1c change for saxagliptin was -0.9% at Week 12 (HbA1c change of -0.4% for placebo).
Saksagliptin je v primerjavi s placebom značilno znižal HbA1c: sprememba HbA1c s saksagliptinom je bila 12. teden -0,9 % (s placebom -0,4 %).
• Study D1680L00006: add-on to metformin plus SU (n=257)
• preskušanje D1680L00006: dodatek k metforminu v kombinaciji s SU (n = 257)
How to take Onglyza
Kako jemati zdravilo Onglyza
Saxagliptin as monotherapy
Saksagliptin kot monoterapija
After 52 weeks, the saxagliptin and glipizide groups had similar mean reductions from baseline in HbA1c in the per-protocol analysis (-0.7% vs. -0.8%, respectively, mean baseline HbA1c of 7.5% for both groups).
Po 52 tednih so v analizi skupin po protokolu s saksagliptinom in glipizidom ugotovili podobno povprečno zmanjšanje vrednosti HbA1c v primerjavi z izhodiščem (-0,7 % v prvi skupini v primerjavi z -0,8 % v drugi skupini, povprečni izhodiščni HbA1c je bil v obeh skupinah 7,5 %).
In a pre- and postnatal developmental study in rats, saxagliptin caused decreased pup weight at maternally toxic doses, with NOEL 488 and 45 times the human exposure for saxagliptin and the major metabolite, respectively at RHD.
V študiji pre- in postnatalnega razvoja pri podganah je saksagliptin ob maternalnih toksičnih odmerkih povzročil zmanjšanje mase mladičev; NOEL je bila 488-kratnik človeške izpostavljenosti saksagliptinu in 45-kratnik človeške izpostavljenosti njegovemu glavnemu presnovku pri RHD.
The exposure of the active metabolite and the plasma DPP4 activity inhibition over a dose interval were not influenced by rifampicin (see section 4.4).
Rifampicin ni vplival na izpostavljenost aktivnemu presnovku in zavrtju aktivnosti plazemske DPP4 v odmernem intervalu (glejte poglavje 4.4).
Mean absolute lymphocyte counts remained stable with daily dosing up to 102 weeks in duration.
Med 102 tedna trajajočo vsakodnevno uporabo je povprečno absolutno število limfocitov ostalo stabilno.
p<0.0001 compared to placebo.
p < 0,0001v primerjavi s placebom.
Saxagliptin should be used with caution in patients with moderate hepatic impairment, and is not recommended for use in patients with severe hepatic impairment (see section 4.4).
Saksagliptin naj se uporablja previdno pri bolnikih z zmerno okvaro jeter in ga ni priporočljivo uporabljati pri bolnikih s hudo okvaro jeter (glejte poglavje 4.4).
• Tablet core: lactose monohydrate; cellulose, microcrystalline (E460i); croscarmellose sodium (E468); magnesium stearate.
• Jedro tablete: laktoza monohidrat, mikrokristalna celuloza (E460i), premreženi natrijev karmelozat (E468), magnezijev stearat.
A1C was lower with saxagliptin compared to placebo in an exploratory analysis.
V eksplorativni analizi je bil A1c s saksagliptinom nižji kot s placebom.
Initial therapy with the combination of saxagliptin 5 mg plus metformin (n=306) provided significant improvements in HbA1c, FPG, and PPG compared to with either saxagliptin (n=317) or metformin alone (n=313) as initial therapy.
Začetno zdravljenje s kombinacijo 5 mg saksagliptina in metformina (n = 306) je značilno izboljšalo HbA1c, glukozo v plazmi na tešče in postprandialno glukozo bistveno bolj kot začetna monoterapija s saksagliptinom (n = 317) ali metforminom (n = 313).
• Printing ink: shellac; indigo carmine aluminium lake (E132).
• Barvilo za tisk: šelak, indigotin (E132).