FrancophonIA/ELRC3.0 huggingface dataset:
English: It is especially important to mention the following: cimetidine, a medicine used to treat stomach problems ketoconazole which is used to treat fungal infections bronchodilators (beta-2 agonists) which are used to treat asthma diltiazem which is used for high blood pressure rifampicin, an antibiotic used to treat infections such as tuberculosis corticosteroids, which are used to treat inflammation in diseases like asthma and arthritis carbamazepine, phenobarbital or phenytoin, which are used to control fits (seizures) or long-term pain medicines which increase urine production (diuretics) medicines used to treat pain and inflammation (NSAID and COX-2-inhibitors, such as ibuprofen and celecoxib) certain medicines for the treatment of high blood pressure (ACE inhibitors and angiotensin II receptor antagonists).
Slovenian: Posebno pomembno je omeniti naslednje: cimetidin, zdravilo za zdravljenje želodčnih težav ketokonazol, ki se uporablja za zdravljenje glivičnih okužb bronhodilatatorje (agoniste beta-2), ki se uporabljajo za zdravljenje astme diltiazem, ki se uporablja pri visokem krvnem tlaku rifampicin, antibiotik, ki se uporablja za zdravljenje okužb, kot je tuberkuloza kortikosteroide, ki se uporabljajo za zdravljenje vnetja pri boleznih, kot sta astma in artritis karbamazepin, fenobarbital ali fenitoin, ki se uporabljajo za obvladovanje napadov krčev (konvulzij) ali dolgotrajno obvladovanje bolečin zdravila, ki povečajo nastajanje urina (diuretiki) zdravila za zdravljenje bolečine in vnetja (nesteroidna protivnetna zdravila in zaviralci COX-2, kot sta ibuprofen in celekoksib) nekatera zdravila za zdravljenje visokega krvnega tlaka (zaviralci ACE in antagonisti receptorjev angiotenzinaII).
English: When this medicinal product is used in combination with insulin, a lower dose of insulin may be required to reduce the risk of hypoglycaemia (see section 4.4).
Slovenian: Kadar se to zdravilo uporablja v kombinaciji z insulinom, bo za zmanjšanje tveganja za pojav hipoglikemije morda potreben manjši odmerek insulina (glejte poglavje 4.4).
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 (RHD) of 5 mg/day.
Slovenian: Raven brez učinka (NOEL) za te spremembe je 1-kratna človeška izpostavljenost saksagliptinu in 2-kratna človeška izpostavljenost njegovemu glavnemu presnovku, dosežena s priporočenim odmerkom (RHD) za človeka 5 mg na dan.
English: Saxagliptin was rapidly absorbed after oral administration in the fasted state, with maximum plasma concentrations (Cmax) of saxagliptin and its major metabolite attained within 2 and 4 hours (Tmax), respectively.
Slovenian: Saksagliptin se je po peroralni uporabi na tešče hitro absorbiral; največjo koncentracijo v plazmi (Cmax) je dosegel v 2 urah, njegov glavni presnovek pa v 4 urah (tmax).
English: Add-on/initial combination with metformin studies 24-weeks Saxa 5 mg daily add-on to metformin; Study CV181014 (n=186) Saxa 5 mg daily initial combination with metformin; Study CV181039 Overall population (n=306) Baseline HbA1c ≥ 10% stratum (n=107)
Slovenian: Študije s saksagliptinom kot dodatkom/uvodno kombinacijo z metforminom 24 tednov saksagliptin 5 mg dnevno kot dodatek metforminu; študija CV181014 (n = 186) saksagliptin 5 mg dnevno v uvodni kombinaciji z metforminom; študija CV181039 Celotna populacija (n = 306) Izhodiščni HbA1c ≥ 10 % stratum (n = 107)
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: After a mean follow up of 2 years, the trial met its primary safety endpoint demonstrating saxagliptin does not increase the cardiovascular risk in patients with type 2 diabetes compared to placebo when added to current background therapy.
Slovenian: Po povprečno 2-letnem spremljanju je preskušanje doseglo svoj primarni opazovani dogodek varnosti in je dokazalo, da saksagliptin, dodan trenutnemu osnovnemu zdravljenju, v primerjavi s placebom pri bolnikih s sladkorno boleznijo tipa 2 ne poveča tveganja za pojav kardiovaskularnega dogodka.
English: In rats, minor developmental toxicity was limited to an increased incidence of delayed ossification (“wavy ribs”); associated maternal toxicity was limited to weight decrements of 5-6% over the course of gestation days 13 through 18, and related reductions in maternal food consumption.
Slovenian: Pri podganah so bili blažji razvojni toksični učinki omejeni na večjo incidenco zapoznele osifikacije ("valovita rebra"); spremljajoči toksični učinki na samice-matere so bili omejeni na zmanjšanje telesne mase za 5-6 % od 13. do 18. dne gestacije ter na s tem povezano manjše uživanje hrane pri samicah.
English: Metformin stimulates intracellular glycogen synthesis by acting on glycogen synthase.
Slovenian: Metformin spodbuja znotrajcelično sintezo glikogena z delovanjem na glikogen-sintazo.
English: In controlled clinical trials, maximum metformin plasma levels (Cmax) did not exceed 4 μg/mL, even at maximum doses.
Slovenian: Največja koncentracija metformina v plazmi (Cmax) v kontroliranih kliničnih preskušanjih, tudi ob največjih odmerkih, ni presegla 4 µg/ml.
English: This medicinal product must therefore not be used in women who are breast-feeding (see section 4.3).
Slovenian: Ženske, ki dojijo, zato ne smejo uporabljati tega zdravila (glejte poglavje 4.3).
English: Iron oxide yellow (E172)
Slovenian: rumeni železov oksid (E172).
English: Using CYP3A4 inducers like carbamazepine, dexamethasone, phenobarbital, phenytoin, and rifampicin may reduce the glycaemic lowering effect of saxagliptin (see section 4.5).
Slovenian: Uporaba induktorjev CYP3A4, npr. karbamazepina, deksametazona, fenobarbitala, fenitoina ali rifampicina, lahko zmanjša vpliv saksagliptina na zmanjšanje glukoze v krvi (glejte poglavje 4.5).
English: Your doctor will decide when you must stop and when to restart your treatment with Komboglyze.
Slovenian: Zdravnik se bo odločil, kdaj morate z jemanjem zdravila Komboglyze prenehati in kdaj lahko nadaljujete.
English: Table 3 Frequency of additional adverse reactions by system organ class
Slovenian: Preglednica 3 Pogostnosti dodatnih neželenih učinkov po organskih sistemih
English: When this medicinal product is used in combination with a sulphonylurea, a lower dose of the sulphonylurea may be required to reduce the risk of hypoglycaemia (see section 4.4).
Slovenian: Če je to zdravilo uporabljeno s sulfonilsečnino, je lahko za zmanjšanje tveganja za hipoglikemijo potreben manjši odmerek sulfonilsečnine (glejte poglavje 4.4).
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: When used as add-on to metformin plus a sulphonylurea, the overall incidence of reported hypoglycaemia was 10.1% for saxagliptin 5 mg and 6.3% for placebo.
Slovenian: Če je bilo zdravilo uporabljeno kot dodatek metforminu v kombinaciji s sulfonilsečnino, je bila celotna incidenca opisanih hipoglikemij 10,1 % s 5 mg saksagliptina in 6,3 % s placebom.
English: The percent of subjects with reported on-treatment events of major hypoglycaemia (defined as an event that required assistance of another person) was higher in the saxagliptin group than in the placebo group (2.1% and 1.6%, respectively).
Slovenian: Odstotek preiskovancev, ki so med zdravljenjem poročali o hujši hipoglikemiji (ta je bila opredeljena kot dogodek, ki je zahteval pomoč druge osebe), je bil med prejemniki saksagliptina višji (2,1 %) kot med prejemniki placeba (1,6 %).
English: Nervous system disorders Headache
Slovenian: Bolezni živčevja glavobol pogosti
English: Some patients have experienced constipation at a frequency not known (cannot be determined from the available data) when saxagliptin was used alone or in combination.
Slovenian: Nekaterim bolnikom se je med uporabo saksagliptina samega ali v kombinaciji pojavila zaprtost, katere pogostnost je neznana (ni mogoče oceniti iz razpoložljivih podatkov).
English: Saxagliptin plus metformin was not associated with significant changes from baseline in fasting serum lipids compared to metformin alone.
Slovenian: Kombinacija saksagliptina in metformina v primerjavi s samim metforminom ni bila povezana z značilnimi spremembami serumskih lipidov na tešče od izhodišča.
English: If any of the above apply to you, or if you are not sure, talk to your doctor or pharmacist before taking this medicine.
Slovenian: Če kaj od naštetega velja za vas, ali če ste negotovi, se posvetujte z zdravnikom ali farmacevtom, preden vzamete to zdravilo.
English: The overall incidence of AEs in patients treated with saxagliptin 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 saksagliptin, podobna kot pri prejemnikih placeba (72,5 % v primerjavi z 72,2 %).
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 človeškem serumu je in vitro zanemarljiva.
English: The metabolism of saxagliptin is primarily mediated by cytochrome P450 3A4/5 (CYP3A4/5).
Slovenian: Presnova saksagliptina poteka predvsem s citokromom P450 3A4/5 (CYP3A4/5).
English: Discontinuation of therapy due to AEs was higher in patients who received saxagliptin 5 mg as compared to placebo (3.3% as compared to 1.8%).
Slovenian: Prekinitev zdravljenja zaradi neželenih učinkov je bilo več pri bolnikih, ki so dobivali 5 mg saksagliptina, kot med tistimi, ki so dobivali placebo (3,3 % v primerjavi z 1,8 %).
English: Preclinical data for metformin reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.
Slovenian: Predklinični podatki za metformin na osnovi običajnih študij farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih, genotoksičnosti, kancerogenega potenciala in vpliva na sposobnost razmnoževanja ne kažejo posebnega tveganja za človeka.
English: Skin and subcutaneous tissue disorders Urticaria, erythema, pruritus
Slovenian: Bolezni kože in podkožja urtikarija, eritem, srbenje zelo redki
English: If you are not sure, talk to your doctor or pharmacist before taking this medicine.
Slovenian: Če ste negotovi, se posvetujte z zdravnikom ali farmacevtom, preden vzamete to zdravilo.
English: EU/1/11/731/007 28 film-coated tablets EU/1/11/731/008 56 film-coated tablets EU/1/11/731/009 60 film-coated tablets EU/1/11/731/010 112 (2 packs of 56) film-coated tablets EU/1/11/731/011 196 (7 packs of 28) film-coated tablets EU/1/11/731/012 60x1 film-coated tablets EU/1/11/731/014 14 film-coated tablets
Slovenian: EU/1/11/731/007 28 filmsko obloženih tablet EU/1/11/731/008 56 filmsko obloženih tablet EU/1/11/731/009 60 filmsko obloženih tablet EU/1/11/731/010 112 (2 pakiranji s 56) filmsko obloženih tablet EU/1/11/731/011 112 (7 pakiranj z 28) filmsko obloženih tablet EU/1/11/731/012 60 x 1 filmsko obložena tableta EU/1/11/731/014 14 filmsko obloženih tablet
English: 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 combination with metformin (initial or add-on therapy).
Slovenian: 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 kombinaciji z metforminom (začetno ali dodatno zdravljenje).
English: Anaphylactic reactions including anaphylactic shock (see sections 4.3 and 4.4)
Slovenian: občasni anafilaktična reakcija vključno z anafilaktičnim šokom (glejte poglavji 4.3 in 4.4)
English: • Printing ink: shellac, indigo carmine aluminium lake (E132).
Slovenian: • Črnilo za napis: šelak, indigotin (E132).
English: Co-administration of multiple doses of saxagliptin (2.5 mg twice daily) and metformin (1,000 mg twice daily) did not meaningfully alter the pharmacokinetics of either saxagliptin or metformin in patients with type 2 diabetes.
Slovenian: Sočasna uporaba več odmerkov saksagliptina (2,5 mg dvakrat na dan) in metformina (1000 mg dvakrat na dan) pri bolnikih s sladkorno boleznijo tipa 2 ni pomembno spremenila farmakokinetike saksagliptina ali metformina.
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 saxagliptin was used alone or in combination.
Slovenian: Nekaterim bolnikom se med uporabo saksagliptina samega ali v kombinaciji nekoliko zmanjša število ene vrste belih krvnih celic (limfocitov), kar se pokaže na preiskavi krvi.
English: If you are taking insulin or an antidiabetic medicine known as ‘sulphonylurea', your doctor may want to reduce your dose of insulin or the sulphonylurea when you take either of them together with this medicine, in order to avoid low blood sugar;
Slovenian: če uporabljate insulin ali katero od zdravil proti sladkorni bolezni, ki se imenujejo "sulfonilsečnine", vam bo zdravnik v izogib nizkemu krvnemu sladkorju morda zmanjšal vaš odmerek insulina ali sulfonilsečnine, ki ga boste uporabili skupaj s temzdravilom.
English: • infection of the structures that carry urine (urinary tract infection)
Slovenian: • okužba organov, po katerih poteka izločanje seča (okužba sečil)
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 z drugimi induktorji CYP3A4/5 razen rifampicinom (npr. s karbamazepinom, deksametazonom, fenobarbitalom in fenitoinom) ni raziskana; povzroči lahko zmanjšanje plazemske koncentracije saksagliptina in povečanje koncentracije njegovega glavnega presnovka.
English: saxagliptin, part of a class of medicines called DPP-4 inhibitors (dipeptidyl peptidase-4 inhibitors), and metformin, part of a class of medicines called biguanides.
Slovenian: saksagliptin, ki ga uvrščamo med zdravila, imenovana zaviralci DPP-4 (zaviralci dipeptidilpeptidaze 4) in metformin, ki ga uvrščamo med zdravila, imenovana bigvanidi.
English: EU/1/11/731/001 28 film-coated tablets EU/1/11/731/002 56 film-coated tablets EU/1/11/731/003 60 film-coated tablets EU/1/11/731/004 112 (2 packs of 56) film-coated tablets EU/1/11/731/005 196 (7 packs of 28) film-coated tablets EU/1/11/731/006 60x1 film-coated tablets EU/1/11/731/013 14 film-coated tablets
Slovenian: EU/1/11/731/001 28 filmsko obloženih tablet EU/1/11/731/002 56 filmsko obloženih tablet EU/1/11/731/003 60 filmsko obloženih tablet EU/1/11/731/004 112 (2 pakiranji s 56) filmsko obloženih tablet EU/1/11/731/005 112 (7 pakiranj z 28) filmsko obloženih tablet EU/1/11/731/006 60 x 1 filmsko obložena tableta EU/1/11/731/013 14 filmsko obloženih tablet
English: Hepatic impairment This medicinal product must not be used in patients with hepatic impairment (see sections 4.3 and
Slovenian: Okvara jeter Tega zdravila se ne sme uporabljati pri bolnikih z okvaro jeter (glejte poglavji 4.3 in 4.5).
English: For patients switching from separate tablets of saxagliptin and metformin Patients switching from separate tablets of saxagliptin and metformin should receive the doses of saxagliptin and metformin already being taken.
Slovenian: Bolniki, ki prehajajo z ločenih tablet saksagliptina in metformina Bolniki, ki prehajajo z ločenih tablet saksagliptina in metformina, morajo prejeti saksagliptin in metformin v odmerkih kot ju že jemljejo.
English: Nederland AstraZeneca BV Tel: +31 79 363 2222
Slovenian: AstraZeneca BV Tel: +31 79 363 2222
English: Monitoring of renal function is necessary to prevent metformin-associated lactic acidosis, particularly in the elderly (see sections 4.3, 4.4 and 5.2).
Slovenian: Da bi preprečili laktacidozo, povezano z metforminom, je treba kontrolirati delovanje ledvic; to še posebej velja za starejše bolnike (glejte poglavja 4.3, 4.4 in 5.2).
English: After 12 weeks, the saxagliptin group (n=74) had a greater HbA1c mean reduction from baseline than the placebo group (n=86) (-0.6% vs. -0.2%, respectively, difference of -0.34%, from a mean baseline HbA1c of 7.9% for the saxagliptin group and 8.0% for the placebo group), and a greater FPG reduction (-13.73 mg/dL versus -4.22 mg/dL) but without statistical significance (p=0.12, 95% CI [-21.68; 2.66]).
Slovenian: Po 12 tednih je bilo povprečno zmanjšanje HbA1c od izhodišča v skupini s saksagliptinom (n = 74) večje kot v skupini s placebom (n = 86) (saksagliptin: -0,6 %, placebo: -0,2 %; razlika -0,34 % za povprečni izhodiščni HbA1c, ki je bil v skupini s saksagliptinom 7,9 % in v skupini s placebom 8,0 %) in izrazitejše zmanjšanje FPG (-13,73 mg/dl v primerjavi z -4,22 mg/dl vendar brez statistične pomembnosti (p = 0,12, 95 % [-21,68; 2,66]).
English: Decreased lymphocyte counts were reported in 0.5% of saxagliptin-treated patients and 0.4% of placebo-treated patients.
Slovenian: Zmanjšanje števila limfocitov so zabeležili pri 0,5 % bolnikov, zdravljenih s saksagliptinom, in pri 0,4 % bolnikov, ki so prejemali placebo.
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 are shown in Table 2.
Slovenian: Preglednica 2 prikazuje neželene učinke, ki so bili zabeleženi pri ≥ 5 % bolnikov, zdravljenih s 5 mg saksagliptina, in pogosteje kot pri bolnikih, ki so dobivali placebo, ali pri ≥ 2 % bolnikov zdravljenih s 5 mg saksagliptina, in ≥ 1 % pogosteje kot s placebom.
English: 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.
Slovenian: Pri opicah cynomolgus je saksagliptin v odmerkih ≥ 3 mg/kg/dan povzročil reverzibilne spremembe (kraste, razjede in nekroze) na koži okončin (rep, prsti, modnik in/ali nos).
English: Difference from dapagliflozin + metformin (adjusted mean (95% CI)
Slovenian: Razlika v primerjavi s kombinacijo dapagliflozin + metformin (prilagojeno povprečje (95 % IZ)
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: In randomised, controlled, double-blind clinical trials (including developmental and postmarketing experience), over 17,000 patients with type 2 diabetes have been treated with saxagliptin.
Slovenian: V randomiziranih, kontroliranih, dvojno slepih kliničnih preskušanjih (vključno z izkušnjami med obdobjem razvoja in po začetku trženja zdravila) je saksagliptin prejemalo več kot 17000 bolnikov s sladkorno boleznijo tipa 2.
English: Following a 5 mg single oral dose of saxagliptin to healthy subjects, the mean plasma AUC values for saxagliptin and its major metabolite were 78 ng·h/mL and 214 ng·h/mL, respectively.
Slovenian: Po enkratnem peroralnem odmerku 5 mg saksagliptina pri zdravih preiskovancih je bila AUC saksagliptina 78 ng·h/ml in njegovega glavnega presnovka 214 ng·h/ml.
English: Effects on fertility were observed in male and female rats at high doses producing overt signs of toxicity (see section 5.3).
Slovenian: Pri podganjih samcih in samicah so učinke na plodnost opazili pri velikih odmerkih, ki so povzročili očitne znake toksičnosti (glejte poglavje 5.3).
English: • Film-coating: polyvinyl alcohol, macrogol 3350, titanium dioxide (E171), talc (E553b), iron oxide yellow (E172).
Slovenian: • Filmska obloga: polivinilalkohol, makrogol 3350, titanov dioksid (E171), smukec (E553b),
English: Studies in animals have shown reproductive toxicity at high doses of saxagliptin alone or in combination with metformin (see section 5.3).
Slovenian: Študije na živalih so pokazale toksične učinke na sposobnost razmnoževanja pri velikih odmerkih samega saksagliptina ali saksagliptina v kombinaciji z metforminom (glejte poglavje 5.3).
English: • Take this medicine by mouth.
Slovenian: • To zdravilo zaužijte.
English: In rabbits, the effects of saxagliptin were limited to minor skeletal variations observed only at maternally toxic doses (NOEL 158 and 224 times the human exposure for saxagliptin and the major metabolite, respectively at RHD).
Slovenian: Pri kuncih so bili učinki saksagliptina omejeni na manjše skeletne spremembe, opazne le pri maternalnih toksičnih odmerkih (NOEL 158-kratnik človeške izpostavljenosti saksagliptinu in 224-kratnik človeške izpostavljenosti njegovemu glavnemu presnovku pri RHD).
English: Across clinical studies, the incidence of laboratory AEs was similar in patients treated with saxagliptin 5 mg compared to patients treated with placebo.
Slovenian: V kliničnih študijah je bila incidenca laboratorijskih neželenih učinkov podobna pri bolnikih, ki so dobivali 5 mg saksagliptina, in pri bolnikih, ki so dobivali placebo.
English: As monotherapy: dizziness (common) and fatigue (common).
Slovenian: Kot monoterapija: omotica (pogosto) in utrujenost (pogosto).
English: As add-on to metformin and a sulphonylurea: dizziness (common), fatigue (common) and flatulence (common).
Slovenian: Kot dodatek metforminu in sulfonilsečnini: omotica (pogosto), utrujenost (pogosto) in flatulenca (pogosto).
English: Food had relatively modest effects on the pharmacokinetics of saxagliptin in healthy subjects.
Slovenian: Pri zdravih prostovoljcih je hrana razmeroma zmerno vplivala na farmakokinetiko saksagliptina.
English: Frequency of adverse reactions
Slovenian: Pogostnost neželenega učinka
English: Mean HbA1c change is the difference between the saxagliptin 5 mg + dapagliflozin + metformin and dapagliflozin + metformin groups (p< 0.0001).
Slovenian: Povprečna sprememba HbA1je razlika med skupinama saksagliptin 5 mg + dapagliflozin + metformin in dapagliflozin + metformin (p< 0.0001).
English: Deutschland AstraZeneca GmbH Tel: +49 41 03 7080
Slovenian: AstraZeneca GmbH Tel: +49 41 03 7080
English: In addition, some patients have reported rash and skin reactions (hypersensitivity) while taking saxagliptin.
Slovenian: Poleg tega so nekateri bolniki med jemanjem saksagliptina navedli izpuščaj in kožne reakcije (preobčutljivost).
English: No animal studies have been conducted with the combination of products in Komboglyze to evaluate carcinogenesis, mutagenesis, or impairment of fertility.
Slovenian: Študije na živalih za oceno kancerogenosti, mutagenosti ali okvare plodnosti kombinacije učinkovin v zdravilu Komboglyze niso bile izvedene.