natgillin/translations-raw huggingface dataset:
The following reflects the pharmacokinetic properties of Qtern unless stated that the presented data are from administration of saxagliptin or dapagliflozin.
V nadaljevanju so prikazane farmakokinetične lastnosti zdravila Qtern, razen kjer je navedeno, da prikazani podatki izvirajo iz uporabe saksagliptina ali dapagliflozina.
Another secondary endpoint, all-cause mortality, occurred at a rate of 5.1 % in the saxagliptin group and 4.6 % in the placebo group.
Drug sekundarni opazovani dogodek, umrljivost zaradi vseh vzrokov, se je v skupini s saksagliptinom pojavil v 5,1 % in v skupini s placebom v 4,6 % (glejte preglednico 5).
There is no experience in clinical trials with dapagliflozin in NYHA class III-IV.
Iz kliničnih preskušanj dapagliflozina ni izkušenj v razredih III. in IV. po NYHA.
Geometric mean steady-state dapagliflozin Cmax and AUCτ values following once daily 10 mg doses of dapagliflozin were 158 ng/ml and 628 ng h/ml, respectively.
Geometrična sredina Cmax in AUCτ dapagliflozina v stanju dinamičnega ravnovesja po odmerkih 10 mg enkrat na dan sta bili 158 ng/ml in 628 ng h/ml.
If any of the above apply to you (or if you are not sure), talk to your doctor before taking Qtern.
Če kaj od naštetega velja za vas (ali če niste prepričani), se posvetujte z zdravnikom, preden vzamete zdravilo Qtern.
Serum creatinine was further evaluated in those patients with events related to decreased renal function, and most observed increases in creatinine were ≤ 0.5 mg/dl from baseline.
Pri bolnikih, ki so imeli učinke, povezane z zmanjšanim delovanjem ledvic, so nadalje spremljali kreatinin v serumu in večina opaženih zvišanj kreatinina je bila ≤ 0,5 mg/dl od izhodišča.
- Necrotising fasciitis of the perineum or Fournier's gangrene, a serious soft tissue infection of the genitals or the area between the genitals and the anus.
- Nekrotizirajoči fasciitis presredka ali Fournierjeva gangrena, resna okužba mehkega tkiva spolovil ali predela med spolovili in zadnjikom.
Saxagliptin: 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.
Saksagliptin: Saksagliptin se je po peroralni uporabi na tešče hitro absorbiral; najvišjo koncentracijo v plazmi (Cmax) je dosegel v 2 urah, njegov glavni presnovek pa v 4 urah (tmax).
Saxagliptin: The in vitro protein binding of saxagliptin and its major metabolite in human serum is negligible.
Saksagliptin: Vezava saksagliptina in njegovega glavnega presnovka na beljakovine v človeškem serumu je in vitro zanemarljiva.
- printing ink: shellac, indigo carmine aluminium lake (E132).
- črnilo za napis: šelak, indigotin (E132).
Cardiovascular death, MI and stroke were observed with a hazard ratio of 0.77 (95 % CI: 0.54, 1.10).
Srčno-žilno smrt, miokardni infarkt in možgansko kap so zabeležili z razmerjem ogroženosti 0,77 (95 % IZ: 0,54, 1,10).
In studies of embryo-foetal development in rabbits, dapagliflozin caused neither maternal nor developmental toxicities at any dose tested; the highest dose tested corresponded to a systemic exposure 1191 times the MRHD.
V študijah embrio-fetalnega razvoja pri kuncih dapagliflozin ni v nobenem od testiranih odmerkov povzročil ne maternalnih ne razvojnih toksičnih učinkov; največji testirani odmerek je ustrezal sistemski izpostavljenosti, 1191-krat večji od tiste pri največjem priporočenem odmerku za človeka).
Saxagliptin has effects on fertility in male and female rats at high doses producing overt signs of toxicity.
Saksagliptin vpliva na plodnost podganjih samcev in samic v velikih odmerkih, ki povzročijo očitne znake toksičnosti.
Dapagliflozin: In the 21-study active- and placebo-controlled pool, the overall proportion of subjects with malignant or unspecified tumours was similar between those treated with dapagliflozin (1.50 %) and placebo/comparator (1.50 %), and there was no carcinogenicity or mutagenicity signal in animal data (see section 5.3).
Dapagliflozin: V kumulativni analizi 21 z aktivno učinkovino in placebom kontroliranih študij je bil celotni delež oseb z malignimi ali neopredeljenimi tumorji med bolniki, zdravljenimi z dapagliflozinom (1,50 %) in bolniki, zdravljenimi s placebom/primerjalnim zdravilom (1,50 %) podoben, pa tudi na živalih dobljeni podatki niso pokazali kancerogenosti ali mutagenosti (glejte poglavje 5.3).
There were no clinically relevant differences observed in saxagliptin pharmacokinetics between males and females.
Med moškimi in ženskami niso opažali klinično pomembnih razlik v farmakokinetiki saksagliptina.
The formation of dapagliflozin 3-O-glucuronide is mediated by UGT1A9, an enzyme present in the liver and kidney, and CYP-mediated metabolism was a minor clearance pathway in humans.
Nastajanje dapagliflozin-3-O-glukuronida poteka z encimom UGT1A9, ki je prisoten v jetrih in ledvicah; presnova s sistemom CYP je pri človeku manj pomembna pot očistka.
Qtern contains lactose (milk sugar).
Zdravilo Qtern vsebuje laktozo (mlečni sladkor).
There are no data from the use of saxagliptin and dapagliflozin in pregnant women.
Podatkov o uporabi saksagliptina in dapagliflozina pri nosečnicah ni.
Upper respiratory tract infection includes the following preferred terms: nasopharyngitis, influenza, upper respiratory tract infection, pharyngitis, rhinitis, sinusitis, pharyngitis bacterial, tonsillitis, acute tonsillitis, laryngitis, viral pharyngitis, and viral upper respiratory tract infection.
Okužba zgornjih dihal vključuje naslednje prednostne izraze: nazofaringitis, gripa, okužba zgornjih dihal, faringitis, rinitis, sinuzitis, bakterijski faringitis, tonzilitis, akutni tonzilitis, laringitis, virusni faringitis in virusna okužba zgornjih dihal
SAVOR was a CV outcome trial in 16,492 patients with HbA1c ≥ 6.5 % and < 12 % (12,959 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.
Študija SAVOR je bila preskušanje srčno-žilnih izidov pri 16.492 bolnikih s HbA1c ≥ 6,5 % in < 12 % (12.959 z ugotovljeno srčno-žilno boleznijo in 3.533 takšnih, ki so imeli le več dejavnikov tveganja), randomiziranih na saksagliptin (n = 8.280) ali placebo (n = 8.212), dodan regionalnemu standardnemu zdravljenju glede HbA1c in srčno-žilnih dejavnikov tveganja.
- if you often get infections of the urinary tract or have a serious infection of the urinary tract, including urosepsis or pyelonephritis, which can cause fever and/or chills, burning sensation when passing water (urinating), blood in urine, pain in your back or side.
- če imate pogosto okužbe sečil, ali če imate hudo okužbo sečil, vključno z urosepso ali pielonefritisom, ki lahko povzročijo zvišano telesno temperaturo in/ali mrzlico, pekoč občutek pri uriniranju, kri v urinu in bolečine v ledjih ali hrbtu.
If a patient presents with severe joint pain, continuation of therapy should be individually assessed.
Če se pojavijo hude bolečine v sklepih, je treba pri vsakem bolniku posebej pretehtati, ali naj še naprej jemlje zdravilo.
Available pharmacodynamic/toxicological data in animals have shown excretion of dapagliflozin/metabolites in milk, as well as pharmacologically-mediated effects in breast-feeding offspring (see section 5.3).
Farmakodinamični in toksikološki podatki za živali, ki so na voljo, kažejo na izločanje dapagliflozina oz. njegovih presnovkov v mleko ter farmakološke učinke pri dojenih mladičih (glejte poglavje 5.3).
Direct administration of dapagliflozin to weanling juvenile rats and indirect exposure during late pregnancy (corresponding to the second and third trimesters of pregnancy with respect to human renal maturation) and lactation are each associated with increased incidence and/or severity of renal pelvic and tubular dilatations in progeny.
Neposredna uporaba dapagliflozina pri nedavno odstavljenih podganjih mladičih in posredna izpostavljenost med pozno brejostjo (to ustreza drugemu in tretjemu trimesečju nosečnosti glede na dozorevanje ledvic pri človeku) in obdobjem dojenja sta bili povezani z večjo pojavnostjo in/ali izrazitostjo razširitev ledvičnega meha in tubulov pri potomstvu.
This medicinal product should not be used in patients with moderate to severe renal impairment (patients with creatinine clearance [CrCl] < 60 ml/min or estimated glomerular filtration rate [eGFR] < 60 ml/min/1.73 m2, see sections 4.4, 4.8, 5.1 and 5.2).
Tega zdravila se ne sme uporabljati pri bolnikih z zmerno do hudo okvaro ledvic (očistek kreatinina < 60 ml/min ali ocenjena hitrost glomerularne filtracije [eGFR - estimated glomerular filtration rate] < 60 ml/min/1,73 m2, glejte poglavja 4.4, 4.8, 5.1 in 5.2).
In rats, dapagliflozin was neither embryolethal nor teratogenic at exposures up to 1441 times the human values at the MRHD.
Pri podganah dapagliflozin ni bil ne embrioletalen ne teratogen pri izpostavljenostih, ki so bile do 1441-krat večje od vrednosti pri človeku med uporabo največjega priporočenega odmerka za človeka.
- Diabetic ketoacidosis, seen rarely (may affect up to 1 in 1,000 people) These are the signs of diabetic ketoacidosis (see also section 2 Warnings and precautions): - increased levels of “ketone bodies” in your urine or blood - rapid weight loss - feeling sick or being sick - stomach pain - excessive thirst - fast and deep breathing - confusion - unusual sleepiness or tiredness - a sweet smell to your breath, a sweet or metallic taste in your mouth or a different odour to your urine or sweat.
- Diabetična ketoacidoza je redka (lahko se pojavi pri največ 1 od 1.000 bolnikov) Znaki diabetične ketoacidoze (glejte tudi poglavje 2, Opozorila in previdnostni ukrepi) so: - zvišana raven "ketonskih teles" v urinu ali krvi - hitra izguba telesne mase - slabost ali bruhanje - bolečine v trebuhu - prekomerna žeja - hitro in globoko dihanje - zmedenost - neobičajna zaspanost ali utrujenost - sladek vonj izdihanega zraka, sladek ali kovinski okus v ustih ali spremenjen vonj urina ali znoja.
Dapagliflozin: Dapagliflozin was rapidly and well absorbed after oral administration.
Dapagliflozin: Dapagliflozin se po peroralni uporabi hitro in dobro absorbira.
Qtern 5 mg/10 mg film-coated tablets
Qtern 5 mg/10 mg filmsko obložene tablete
It is important to continue to follow the advice on diet and exercise given to you by your doctor, pharmacist or nurse.
Pomembno je, da še naprej upoštevate navodila za dieto in telesno dejavnost, ki vam jih je dal zdravnik, farmacevt ali medicinska sestra.
If pregnancy is detected, treatment with Qtern should be discontinued.
Če bolnica zanosi, je treba prenehati zdravljenje z zdravilom Qtern.
The mean total systemic clearance of dapagliflozin administered intravenously was 207 ml/min.
Povprečni skupni sistemski očistek intravensko uporabljenega dapagliflozina je bil 207 ml/min.
Saxagliptin: The Cmax and AUC of saxagliptin and its major metabolite increased proportionally to the saxagliptin dose.
Saksagliptin: Cmax in AUC saksagliptina in njegovega glavnega presnovka so naraščale sorazmerno z odmerkom saksagliptina.
Mechanism of action for dapagliflozin
Mehanizem delovanja dapagliflozina
UNIQUE IDENTIFIER 2D BARCODE
EDINSTVENA OZNAKA - DVODIMENZIONALNA ČRTNA KODA
Rash is also noted as an adverse reaction for this medicinal product (see section 4.8).
Izpuščaj je zabeležen tudi kot neželen učinek tega zdravila (glejte poglavje 4.8).
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.
Raven brez učinka (NOEL - 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 5 mg/dan.
Subjects at higher risk for hospitalisation for heart failure, irrespective of treatment assignment, could be identified by known risk factors for heart failure such as baseline history of heart failure or impaired renal function.
Bolnike z večjim tveganjem za sprejem v bolnišnico zaradi srčnega popuščanja je bilo mogoče (ne glede na prejeto zdravljenje) prepoznati po znanih dejavnikih tveganja za srčno popuščanje, npr. po izhodiščni anamnezi srčnega popuščanja ali okvarjenem delovanju ledvic.
Kidney function Your kidneys should be checked before you start taking and whilst you are on this medicine.
Delovanje ledvic je treba preveriti, preden začnete jemati to zdravilo, in ga preverjati med zdravljenjem.
The coadministration of saxagliptin and CYP3A4/5 inducers, other than rifampicin (such as carbamazepine, dexamethasone, phenobarbital and phenytoin) has not been studied and may result in decreased plasma concentration of saxagliptin and increased concentration of its major metabolite.
Sočasna uporaba saksagliptina z drugimi induktorji CYP3A4/5 razen rifampicina (npr. s karbamazepinom, deksametazonom, fenobarbitalom in fenitoinom) ni raziskana; povzroči lahko znižanje koncentracije saksagliptina v plazmi in zvišanje koncentracije njegovega glavnega presnovka.
The efficacy of dapagliflozin is dependent on renal function, and efficacy is reduced in patients who have moderate renal impairment and likely absent in patients with severe renal impairment (see section 4.2).
Učinkovitost dapagliflozina je odvisna od delovanja ledvic: pri bolnikih z zmerno okvaro ledvic je učinkovitost manjša, pri bolnikih s hudo okvaro ledvic pa je zdravilo verjetno neučinkovito (glejte poglavje 4.2).
Dapagliflozin: Dapagliflozin exposure was found to decrease with increased weight.
Dapagliflozin: Izpostavljenost dapagliflozinu se s povečevanjem telesne mase zmanjšuje.
Qtern combines saxagliptin and dapagliflozin with complementary mechanisms of action to improve glycaemic control.
Zdravilo Qtern vsebuje saksagliptin in dapagliflozin, ki imata dopolnjujoča se mehanizma delovanja za izboljšanje urejenosti glikemije.
In subjects with moderate renal impairment (patients with CrCl < 60 ml/min or eGFR < 60 ml/min/1.73 m2), a higher proportion of subjects treated with dapagliflozin had adverse reactions of increase in creatinine, phosphorus, parathyroid hormone (PTH) and hypotension, compared with placebo.
Med bolniki z zmerno okvaro ledvic (očistek kreatinina < 60 ml/min ali eGFR < 60 ml/min/1,73 m2) je v primerjavi s placebom večji delež bolnikov, zdravljenih z dapagliflozinom, imel neželene učinke zvišanja količine kreatinina, fosforja, paratiroidnega hormona (PTH) in hipotenzijo.
Dapagliflozin: Following coadministration of dapagliflozin with rifampicin (an inducer of various active transporters and drug-metabolising enzymes) a 22 % decrease in dapagliflozin systemic exposure (AUC) was observed, but with no clinically meaningful effect on 24-hour urinary glucose excretion.
Dapagliflozin: Po sočasnem dajanju dapagliflozina in rifampicina (induktorja različnih aktivnih prenašalcev in encimov za presnovo zdravil) so zabeležili 22-odstotno zmanjšanje sistemske izpostavljenosti (AUC) dapagliflozinu, vendar brez klinično pomembnega vpliva na 24-urno izločanje glukoze v urinu.
Mechanism of action for saxagliptin
Mehanizem delovanja saksagliptina
Saxagliptin/dapagliflozin combination: Overall, the pharmacokinetics of saxagliptin and dapagliflozin were not affected in clinically relevant manner when administered as Qtern compared with independent doses of saxagliptin and dapagliflozin.
Kombinacija saksagliptina/dapagliflozina: Farmakokinetika saksagliptina in dapagliflozina se ni klinično pomembno spremenila, če sta bila uporabljena v obliki zdravila Qtern, v primerjavi s samostojnima odmerkoma saksagliptina in dapagliflozina.
The intra-subject coefficients of variation for saxagliptin Cmax and AUC were less than
Intraindividualna koeficienta variacije Cmax in AUC saksagliptina sta bila manj kot 12 %.
Limited data from clinical trials with dapagliflozin suggest that DKA occurs with common frequency when patients with type 1 diabetes are treated with SGLT2 inhibitors.
Maloštevilni podatki iz kliničnih preskušanj kažejo, da je DKA pri zdravljenju bolnikov s sladkorno boleznijo tipa 1 z zaviralci SGLT2 pogosta.
Saxagliptin assessment of vascular outcomes recorded in patients with diabetes mellitus - thrombolysis in myocardial infarction (SAVOR) study
Študija SAVOR: ocena žilnih izidov, zabeleženih pri bolnikih s sladkorno boleznijo ob saksagliptinutromboliza pri miokardnem infarktu
These medicinal products did not alter the pharmacokinetics of saxagliptin or its major active metabolite.
Ta zdravila niso spremenila farmakokinetike saksagliptina ali njegovega glavnega presnovka.
However, renal function and risk of volume depletion should be taken into account in elderly patients (≥ 65 years).
Vendar pa je treba pri starejših bolnikih (≥ 65 let) upoštevati delovanje ledvic in tveganje za zmanjšanje volumna.
- This medicine is used if your diabetes cannot be controlled with other oral diabetes medicines,
- To zdravilo uporabljamo, če sladkorne bolezni ni mogoče obvladati z drugimi peroralnimi zdravili za sladkorno bolezen, hkrati z dieto in telesno dejavnostjo.
Vulvovaginitis, balanitis and related genital infections Saxagliptin/dapagliflozin combination: The reported adverse events of vulvovaginitis, balanitis and related genital infections from pooled safety analysis were reflective of the safety profile of dapagliflozin.
Vulvovaginitis, balanitis in sorodne okužbe spolovil Kombinacija saksagliptina/dapagliflozina: Poročani neželeni učinki vulvovaginitis, balanitis in sorodne okužbe spolovil v kumulativni analizi varnosti odražajo varnostne značilnosti dapagliflozina.
C-saxagliptin, 24 %, 36 %, and 75 % of the dose was excreted in the urine as saxagliptin, its active metabolite, and total radioactivity, respectively.
C-saksagliptina se je v urinu izločilo 24 % radioaktivnosti v obliki saksagliptina, 36 % v obliki njegovega aktivnega presnovka in 75 % celotne radioaktivnosti.
The mean steady-state volume of distribution of dapagliflozin was 118 l.
Povprečni volumen porazdelitve dapagliflozina v stanju dinamičnega ravnovesja je bil 118 l.
Saxagliptin: The biotransformation of saxagliptin is primarily mediated by cytochrome P450 3A4/5 (CYP3A4/5).
Saksagliptin: Biotransformacija saksagliptina poteka predvsem preko citokroma P450 3A4/5 (CYP3A4/5).
Dapagliflozin improves both fasting and post-prandial plasma glucose levels by reducing renal glucose reabsorption leading to urinary glucose excretion.
Dapagliflozin izboljša koncentracijo glukoze v plazmi na tešče in postprandialno, ker zmanjša ledvično reabsorpcijo glukoze in tako povzroči izločanje glukoze v urinu.
Be aware that either uro-genital infection or perineal abscess may precede necrotising fasciitis.
Zavedajte se, da se pred nekrotizirajočim fasciitisom lahko pojavi urogenitalna infekcija ali perinealni absces.
No dose adjustment is recommended.
Odmerka ni potrebno prilagajati.
Haematocrit values > 55 % were reported in 1.3 % of the subjects treated with dapagliflozin 10 mg versus 0.4 % of placebo subjects.
O vrednostih hematokrita > 55 % so poročali pri 1,3 % preiskovancev, zdravljenih z 10 mg dapagliflozina, in pri 0,4 % preiskovancev, ki so prejemali placebo.
Saxagliptin/dapagliflozin combination: Malignant and unspecified neoplasms were reported in 3 subjects included in the pooled safety data.
Kombinacija saksagliptina/dapagliflozina: O malignih in neopredeljenih novotvorbah so poročali pri 3 bolnikih, zajetih v kumulativnih podatkih o varnosti.
Qtern, fixed dose combination of saxagliptin and dapagliflozin, is indicated in adults aged 18 years and older with type 2 diabetes mellitus: - to improve glycaemic control when metformin and/or sulphonylurea (SU) and one of the monocomponents of Qtern do not provide adequate glycaemic control, - when already being treated with the free combination of dapagliflozin and saxagliptin.
Zdravilo Qtern (fiksna kombinacija saksagliptina in dapagliflozina) je indicirano pri odraslih, starih 18 let ali več, s sladkorno boleznijo tipa 2: - za izboljšanje urejenosti glikemije, če metformin in/ali sulfonilsečnina (SS) ter ena od posameznih učinkovin v zdravilu Qtern ne zagotovijo ustrezne urejenosti glikemije, - v primeru, da se bolnik že zdravi s prosto kombinacijo dapagliflozina in saksagliptina.
Dapagliflozin, a selective inhibitor of sodium-glucose co-transporter 2 (SGLT2), inhibits renal glucose reabsorption independently of insulin.
Dapagliflozin, selektiven zaviralec natrij-glukoznega soprenašalca 2 (SGLT2), v ledvicah zavre reabsorpcijo glukoze neodvisno od insulina.
The effect of saxagliptin and dapagliflozin on fertility in humans has not been studied.
Vpliv saksagliptina in dapagliflozina na plodnost pri človeku ni raziskan.
The inhibition of plasma DPP-4 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 DPP-4 za vsaj 24 ur po peroralni uporabi zaradi svoje velike moči, velike afinitete in obsežne vezave na aktivno mesto.
Saxagliptin/dapagliflozin combination: Data from the saxagliptin plus dapagliflozin plus metformin treatment arms of 3 Phase 3 trials, demonstrated trends of mean percent increases from baseline (rounded to the nearest tenth) in total cholesterol (Total C), (ranging from 0.4 % to 3.8 %), LDL-C (ranging from 2.1 % to 6.9 %) and HDL-C (ranging 2.3 % to 5.2 %) along with mean percent decreases from baseline in triglycerides (ranging from -3.0 % to -10.8 %).
Kombinacija saksagliptina/dapagliflozina: Podatki terapevtskih skupin s kombinacijo saksagliptina, dapagliflozina in metformina iz 3 preskušanj 3. faze so pokazali trend povprečnega odstotnega zvišanja od izhodišča (zaokroženo na najbližjo desetinko) pri celokupnem holesterolu (cel-h), (od 0,4 % do 3,8 %), h-LDL (od 2,1 % do 6,9 %) in h-HDL (od 2,3 % do 5,2 %), hkrati s povprečnim odstotnim znižanjem od izhodišča pri trigliceridih (od -3,0 % do -10,8 %).
HbA1c subgroup analysis by baseline HbA1c at week 24 in randomised subjects
Analiza HbA1c v podskupinah randomiziranih bolnikov po 24 tednih glede na izhodiščni HbA1c
The increased urinary glucose excretion with SGLT2 inhibition produces an osmotic diuresis, and can result in a reduction in systolic BP.
Večje izločanje glukoze v urinu zaradi zavrtja SGLT2 povzroči osmotsko diurezo in lahko zniža sistolični krvni tlak.
Caution is warranted if Qtern is used in patients who have known risk factors for hospitalisation for heart failure, such as a history of heart failure or moderate to severe renal impairment.
Zdravilo Qtern je treba uporabljati previdno pri bolnikih z znanimi dejavniki tveganja za hospitalizacijo zaradi srčnega popuščanja, npr. pri bolnikih z anamnezo srčnega popuščanja ali z zmerno do hudo okvaro ledvic.
If renal function falls below CrCl < 60 ml/min or eGFR < 60 ml/min/1.73 m2, Qtern treatment should be discontinued.
Če se delovanje ledvic zmanjša pod očistek kreatinina < 60 ml/min ali eGFR < 60 ml/min/1,73 m2, je treba zdravljenje z zdravilom Qtern prekiniti.
Dapagliflozin 3-O-glucuronide or other metabolites do not contribute to the glucose-lowering effects.
Dapagliflozin-3-O-glukuronid in drugi presnovki ne znižujejo glukoze.
Adverse reactions reported in ≥ 2 % of subjects treated with the combined use of saxagliptin + dapagliflozin in the pooled safety analysis, or if reported in < 2 % in the pooled safety analysis, they were based on the individual mono-components data.
Neželeni učinki, o katerih so poročali pri ≥ 2 % bolnikov, zdravljenih s kombinacijo saksagliptina in dapagliflozina v kumulativni analizi varnosti, ali so o njih poročali pri < 2 % v kumulativni analizi varnosti in so temeljili na podatkih o posameznih učinkovinah.
One trial with saxagliptin and dapagliflozin added concomitantly to metformin was conducted for 24 weeks.
Eno preskušanje, v katerem so saksagliptin in dapagliflozin sočasno dodali metforminu, je trajalo 24 tednov.
Using CYP3A4 inducers like carbamazepine, dexamethasone, phenobarbital, phenytoin, and rifampicin may reduce the glycaemic lowering effect of Qtern.
Uporaba induktorjev CYP3A4, npr. karbamazepina, deksametazona, fenobarbitala, fenitoina ali rifampicina, lahko zmanjša vpliv zdravila Qtern na znižanje glukoze v krvi.