FrancophonIA/ELRC3.0 huggingface dataset:
English: The exposure of the active metabolite and the plasma DPP-4 activity inhibition over a dose interval were not influenced by rifampicin (see section 4.4).
Slovenian: Rifampicin v odmernem intervalu ni vplival na izpostavljenost aktivnemu presnovku ali na zavrtje aktivnosti DPP-4 v plazmi (glejte poglavje 4.4).
English: Difference from dapagliflozin + metformin (adjusted mean (95 % CI)
Slovenian: Razlika od dapagliflozina + metformina (prilagojeno povprečje (95 % IZ)
English: Skin and subcutaneous tissue disorders
Slovenian: Bolezni kože in podkožja izpuščaj dermatitis
English: Subjects with adverse events of renal impairment had lower mean eGFR values at baseline of 61.8 ml/min/1.73m2 compared to 93.6 ml/min/1.73m2 in the overall population.
Slovenian: Preiskovanci z neželenim učinkom okvare ledvic so imeli izhodiščno nižjo eGFR (61,8 ml/min/1,73 m2) kot celotna populacija
English: This medicinal product has not been studied in severe renal impairment (CrCl < 30 ml/min or eGFR < 30 ml/min/1.73 m2) or end-stage renal disease (ESRD).
Slovenian: To zdravilo ni bilo raziskano pri bolnikih s hudo okvaro ledvic (očistek kreatinina < 30 ml/min ali eGFR < 30 ml/min/1,73 m2) in bolnikih s končno odpovedjo ledvic.
English: The steady-state 24-hour urinary glucose excretion was highly dependent on renal function and 85, 52, 18 and 11 g of glucose/day was excreted by subjects with type 2 diabetes mellitus and normal renal function or mild, moderate or severe renal impairment, respectively.
Slovenian: Štiriindvajseturno izločanje glukoze v urinu v stanju dinamičnega ravnovesja je bilo močno odvisno od delovanja ledvic: pri bolnikih s sladkorno boleznijo tipa 2 z normalnim delovanjem ledvic je bilo 85 g glukoze/dan, z blago okvaro ledvic 52 g/dan, z zmerno okvaro 18 g/dan in s hudo okvaro 11 g/dan.
English: In patients with normal renal function or mild renal impairment (baseline eGFR ≥ 60 ml/min/1.73m2), events related to decreased renal function were reported in 1.3 % and 0.8 % of patients who received dapagliflozin 10 mg and placebo, respectively.
Slovenian: Pri bolnikih z normalnim delovanjem ledvic ali blago okvaro ledvic (izhodiščni eGFR ≥ 60 ml/min/1,73 m2) so o neželenih učinkih, povezanih z zmanjšanim delovanjem ledvic, poročali pri 1,3 % prejemnikov 10 mg dapagliflozina in 0,8 % prejemnikov placeba.
English: Effects on fertility were observed using saxagliptin 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 saksagliptina, ki so povzročili očitne znake toksičnosti (glejte poglavje 5.3).
English: Do not take Qtern if any of the above apply to you.
Slovenian: Ne vzemite zdravila Qtern, če kaj od naštetega velja za vas.
English: Three hundred twenty (320) subjects were randomised equally into either the dapagliflozin added to saxagliptin plus metformin treatment group or placebo plus saxagliptin plus metformin treatment group.
Slovenian: Tristodvajset (320) bolnikov so v enakem številu randomizirali ali na dapagliflozin, dodan saksagliptinu in metforminu, ali na placebo, dodan saksagliptinu in metforminu.
English: Add-on therapy with saxagliptin in patients inadequately controlled on dapagliflozin plus metformin A 24-week randomised, double-blind, placebo-controlled study conducted on patients with type 2 diabetes mellitus and inadequate glycaemic control (HbA1c ≥ 7 % and ≤ 10.5 %) on metformin and dapagliflozin alone, compared the sequential addition of 5 mg saxagliptin to 10 mg dapagliflozin and metformin, to the addition of placebo to 10 mg dapagliflozin and metformin, 153 patients were randomised into the saxagliptin added to dapagliflozin plus metformin treatment group, and 162 patients were randomised into the placebo added to dapagliflozin plus metformin treatment group.
Slovenian: 24-tedenska randomizirana, dvojno slepa, s placebom kontrolirana študija pri bolnikih s sladkorno boleznijo tipa 2 in neustrezno urejeno glikemijo (HbA1c ≥ 7 % in ≤ 10,5 %) z metforminom in dapagliflozinom samima, je primerjala zaporedno dodajanje 5 mg saksagliptina kombinaciji 10 mg dapagliflozina in metformina ter dodajanje placeba k 10 mg dapagliflozina in metforminu; 153 bolnikov je bilo randomiziranih na saksagliptin, dodan dapagliflozinu in metforminu, 162 bolnikov pa na placebo, dodan dapagliflozinu in metforminu.
English: Qtern contains the active substances saxagliptin and dapagliflozin.
Slovenian: Zdravilo Qtern vsebuje učinkovini saksagliptin in dapagliflozin.
English: Pharmacokinetic interactions
Slovenian: Farmakodinamično medsebojno delovanje
English: An increase in cases of lower limb amputation (primarily of the toe) has been observed in ongoing long-term, clinical studies with another SGLT2 inhibitor.
Slovenian: V dolgoročnih kliničnih študijah z drugim zaviralcem SGLT2, ki še potekajo, so opazili povečano število primerov amputacij na spodnjih okončinah (predvsem prstov na nogah).
English: Saxagliptin produced reversible skin lesions (scabs, ulcerations and necrosis) in extremities (tail, digits, scrotum and/or nose) in cynomolgus monkeys.
Slovenian: Pri opicah cynomolgus je saksagliptin povzročil reverzibilne kožne spremembe (kraste, razjede in nekrozo) na udih (rep, prsti, modnik in/ali nos).
English: Pack sizes of 14, 28, and 98 film-coated tablets in calendar blisters Pack size of 30 film-coated tablets in blisters
Slovenian: Velikosti pakiranj s 14, 28 in 98 filmsko obloženimi tabletami v koledarskih pretisnih omotih.
English: Saxagliptin: 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 (saxagliptin metabolite) were 22 %, 7 % and 33 % lower, respectively, than those observed in healthy subjects.
Slovenian: Saksagliptin: V primerjavi z zdravimi osebami je bila pri bolnikih z blago okvaro jeter (Child-Pugh razred A) izpostavljenost saksagliptinu 1,1-krat večja in izpostavljenost BMS-510849 (presnovek saksagliptina) 22 % manjša, z zmerno okvaro jeter (Child-Pugh razred B) 1,4-krat večja oziroma 7 %
English: Adverse events of genital infection were reported in 3.0 % in the saxagliptin plus dapagliflozin plus metformin group, 0.9 % of saxagliptin plus metformin group and 5.9 % of subjects in the dapagliflozin plus metformin group.
Slovenian: O neželenem učinku okužbe spolovil so poročali pri 3,0 % prejemnikov kombinacije saksagliptina, dapagliflozina in metformina, pri 0,9 % prejemnikov kombinacije saksagliptina in metformina ter pri 5,9 % prejemnikov kombinacije dapagliflozina in metformina.
English: There is limited experience in clinical trials in patients with hepatic impairment.
Slovenian: Pri bolnikih z okvaro jeter je izkušenj iz kliničnih preskušanj malo.
English: 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.
Slovenian: V študiji pre- in postnatalnega razvoja pri podganah je saksagliptin ob maternalnih toksičnih odmerkih povzročil zmanjšanje telesne mase mladičev; NOEL je bila 488-kratnik človeške izpostavljenosti saksagliptinu in 45-kratnik človeške izpostavljenosti njegovemu glavnemu presnovku, dosežene s priporočenim odmerkom za človeka).
English: If you are not sure, talk to your doctor, pharmacist, or nurse before taking Qtern.
Slovenian: Če ste negotovi, se pred začetkom jemanja zdravila Qtern posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
English: Qtern is not expected to affect you being able to drive a car or use any tools or machines.
Slovenian: Ni pričakovati, da bi zdravilo Qtern vplivalo na sposobnost vožnje in upravljanja strojev.
English: Indigo carmine aluminium lake (E132)
Slovenian: Črnilo šelak indigotin (E132)
English: Dapagliflozin + Metformin Adjusted mean change from baseline
Slovenian: Dapagliflozin + metformin Prilagojena povprečna sprememba od izhodišča
English: At high doses in rats, saxagliptin caused reduced ossification (a developmental delay) of the foetal pelvis and decreased foetal body weight (in the presence of maternal toxicity), with a NOEL 303 and 30 times the human exposure for saxagliptin and the major metabolite, respectively, at RHD.
Slovenian: V velikih odmerkih je saksagliptin pri podganah zmanjšal osifikacijo (razvojna upočasnitev) medenice plodov in telesno maso plodov (v prisotnosti toksičnih učinkov pri samicah materah); NOEL je bila 303-kratnik človeške izpostavljenosti saksagliptinu in 30-kratnik človeške izpostavljenosti njegovemu glavnemu presnovku, dosežene s priporočenim odmerkom za človeka.
English: In subjects ≥ 65 years of age, a higher proportion of subjects treated with dapagliflozin had adverse reactions related to volume depletion and renal impairment or failure compared with placebo (see section 4.8).
Slovenian: Med bolniki, starimi ≥ 65 let, je imelo neželene učinke, povezane z zmanjšanjem volumna in okvaro ali odpovedjo ledvic, več bolnikov, zdravljenih z dapagliflozinom, kot bolnikov, ki so prejemali placebo (glejte poglavje 4.8).
English: There have been post-marketing reports of serious urinary tract infections including urosepsis and pyelonephritis requiring hospitalisation in patients receiving dapagliflozin and other SGLT2 inhibitors.
Slovenian: V obdobju trženja zdravila so pri bolnikih, ki so prejemali dapagliflozin in druge zaviralce SGLT2, poročali o resnih okužbah sečil, vključno z urosepso in pielonefritisom, ki so zahtevali sprejem v bolnišnico.
English: AstraZeneca AB Gärtunavägen SE-151 85 Södertälje Sweden
Slovenian: AstraZeneca AB Gärtunavägen SE-151 85 Södertälje Švedska
English: Saxagliptin: Body weight had a small and non-clinically meaningful impact on saxagliptin exposure.
Slovenian: Saksagliptin: Vpliv telesne mase na izpostavljenost saksagliptinu je majhen in klinično ni pomemben.
English: Adjusted mean change from baseline by baseline HbA1c
Slovenian: Prilagojena povprečna sprememba od izhodišča glede na izhodiščni HbA1c
English: Saxagliptin/dapagliflozin combination: In the pooled safety analysis, urinary tract infections (UTIs) were balanced across the 3 treatment groups: 5.7 % in the saxagliptin plus dapagliflozin plus metformin group, 7.4 % in the saxagliptin plus metformin group and 5.6 % in the dapagliflozin plus metformin group.
Slovenian: Kombinacija saksagliptina/dapagliflozina: V kumulativni analizi varnosti so bile okužbe sečil uravnotežene med 3 terapevtskimi skupinami: o njih so poročali pri 5,7 % bolnikov v skupini s kombinacijo saksagliptina, dapagliflozina in metformina, 7,4 % v skupini s kombinacijo saksagliptina in metformina in 5,6 % v skupini s kombinacijo dapagliflozina in metformina.
English: N is the number of randomised and treated patients with baseline and at least 1 post-baseline efficacy measurement.
Slovenian: LPM = longitudinalne ponovljene meritve (z uporabo vrednosti pred reševalnim ukrepanjem) N je število randomiziranih in zdravljenih bolnikov, ki so imeli izhodiščno in vsaj še 1 poizhodiščno meritev učinkovitosti.
English: LRM = Longitudinal repeated measures (using values prior to rescue).
Slovenian: LPM = longitudinalne ponovljene meritve (z uporabo vrednosti pred reševalnim ukrepanjem) Randomizirani in zdravljeni bolniki z izhodiščno in vsaj še eno poizhodiščno meritvijo učinkovitosti.
English: Hypoglycaemia (when used with SU)
Slovenian: Presnovne in prehranske motnje hipoglikemija (med uporabo s SS)
English: Saxagliptin 5 mg + metformin N=176
Slovenian: 5 mg saksagliptina + metformin N = 176
English: Elevated haematocrit
Slovenian: Zvišanje hematokrita
English: AstraZeneca AB SE-151 85 Södertälje Sweden
Slovenian: AstraZeneca AB SE-151 85 Södertälje Švedska
English: Immunocompromised patients, such as patients who have undergone organ transplantation or patients diagnosed with human immunodeficiency syndrome have not been studied in the saxagliptin clinical programme.
Slovenian: Saksagliptin v kliničnem programu ni bil raziskan pri imunsko oslabelih bolnikih, npr. bolnikih po presaditvi organa ali bolnikih s sindromom človeške imunske pomanjkljivosti.
English: General disorders and administration site conditions
Slovenian: Splošne težave in spremembe na mestu aplikacije utrujenost
English: Dapagliflozin 10 mg + metformin N=179
Slovenian: 10 mg dapagliflozina + metformin N = 179
English: Qtern can be used in patients with mild or moderate hepatic impairment.
Slovenian: Zdravilo Qtern se lahko uporablja pri bolnikih z blago ali zmerno okvaro jeter.
English: - Dexamethasone - a steroid medicine.
Slovenian: To je steroidno zdravilo.
English: Evidence of sustained glucose excretion was seen in subjects with type 2 diabetes mellitus given dapagliflozin 10 mg/day for up to 2 years.
Slovenian: Pri bolnikih s sladkorno boleznijo tipa 2, ki so dobivali 10 mg dapagliflozina na dan do 2 leti, so ugotovili ohranjeno izločanje glukoze.
English: In the pooled safety data, urinary tract infections were frequently reported across the 3 treatment groups: 5.7 % in the saxagliptin plus dapagliflozin plus metformin group 7.4 % in the saxagliptin plus metformin group and 5.6 % in the dapagliflozin plus metformin group at 52 weeks (see section 4.8).
Slovenian: V kumulativnih podatkih o varnosti so o okužbah sečil pogosto poročali v 3 terapevtskih skupinah: po 52 tednih so o njih poročali pri 5,7 % bolnikov v skupini s kombinacijo saksagliptina, dapagliflozina in metformina, pri 7,3 % v skupini s kombinacijo saksagliptina in metformina in pri 5,9 % v skupini s kombinacijo dapagliflozina in metformina (glejte poglavje 4.8).
English: Add-on therapy with dapagliflozin in patients inadequately controlled on saxagliptin plus metformin A 24-week randomised, double-blind, placebo-controlled study compared the sequential addition of 10 mg dapagliflozin to 5 mg saxagliptin and metformin to the addition of placebo to 5 mg saxagliptin (DPP-4 inhibitor) and metformin in patients with type 2 diabetes mellitus and inadequate glycaemic control (HbA1c ≥ 7% and ≤ 10.5%).
Slovenian: 24-tedenska randomizirana, dvojno slepa, s placebom kontrolirana študija je primerjala zaporedno dodajanje 10 mg dapagliflozina kombinaciji 5 mg saksagliptina in metformina ter dodajanje placeba k 5 mg saksagliptina (zaviralec DPP-4) in metformina pri bolnikih s sladkorno boleznijo tipa 2 in neustrezno urejeno glikemijo (HbA1c ≥ 7 % in ≤ 10,5 %).
English: Lipids
Slovenian: Lipidi
English: Urinary tract infection includes the following preferred terms: urinary tract infection, Escherichia urinary tract infection, pyelonephritis, and prostatitis.
Slovenian: Okužba sečil obsega naslednje prednostne izraze: okužba sečil, okužba sečil z Escherichio, pielonefritis in prostatitis.
English: Fungal infection
Slovenian: Okužbe sečil
English: Each tablet contains saxagliptin hydrochloride equivalent to 5 mg saxagliptin and dapagliflozin propanediol monohydrate equivalent to 10 mg dapagliflozin.
Slovenian: Ena tableta vsebuje saksagliptinijev klorid v količini, ki ustreza 5 mg saksagliptina, in dapagliflozin-propandiolmonohidrat v količini, ki ustreza 10 mg dapagliflozina.
English: It may be taken at any time of day with or without food.
Slovenian: Zdravilo Qtern se jemlje peroralno, enkrat na dan, kadar koli tekom dneva, s hrano ali brez nje.
English: Non-clinical studies of either saxagliptin or dapagliflozin revealed no special hazard for humans based on conventional studies of safety pharmacology, genotoxicity or carcinogenicity.
Slovenian: Predklinične študije na osnovi običajnih študij farmakološke varnosti, genotoksičnosti in kancerogenosti ne kažejo posebnega tveganja za človeka ne pri saksagliptinu ne pri dapagliflozinu.
English: Qtern 5 mg/10 mg tablets saxagliptin/dapagliflozin
Slovenian: Qtern 5 mg/10 mg tablete saksagliptin/dapagliflozin
English: The group with saxagliptin sequentially added to dapagliflozin and metformin achieved statistically significant (p-value < 0.0001) greater reductions in HbA1c versus the group with placebo sequentially added to dapagliflozin plus metformin group at 24 weeks (see table 4).
Slovenian: Skupina, ki je dobila saksagliptin, zaporedno dodan dapagliflozinu in metforminu, je po 24 tednih dosegla statistično značilno (vrednost p < 0,0001) večje znižanje HbA1c kot skupina, ki je dobila placebo, zaporedno dodan dapagliflozinu in metforminu (glejte preglednico 4).
English: The proportion of patients achieving HbA1c < 7.0 % at Week 24 in the add-on therapy with dapagliflozin to saxagliptin plus metformin trial was higher in the dapagliflozin plus saxagliptin plus metformin group 38.0 % (95 % CI [30.9, 45.1]) compared to the placebo plus saxagliptin plus metformin group 12.4 % (95 % CI [7.0, 17.9]).
Slovenian: Delež bolnikov, ki so 24. teden dosegli HbA1c < 7,0 % v preskušanju, v katerem je bil dapagliflozin dodan saksagliptinu in metforminu, je bil večji v skupini s kombinacijo dapagliflozina, saksagliptina in metformina (38,0 %; 95 % IZ: 30,9-45,1) kot v skupini s kombinacijo placeba, saksagliptina in metformina (12,4 %; 95 % IZ: 7,0-17,9).
English: Saxagliptin 5 mg + dapagliflozin 10 mg + metformin N=179
Slovenian: 5 mg saksagliptina + 10 mg dapagliflozina + metformin N = 179
English: - Symptoms of a serious allergic reaction seen rarely, (may affect up to 1 in 1,000 people), which may include: - Rash - Raised red patches on your skin (hives) - Swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing.
Slovenian: - Med simptomi resne alergijske reakcije, ki je redka (pojavi se lahko pri največ 1 od 1.000 bolnikov), so lahko: - izpuščaj - dvignjene rdeče lise na koži (koprivnica)
English: Saxagliptin/dapagliflozin combination: Events related to volume depletion (hypotension, dehydration, and hypovolemia) were reflective of the adverse events with dapagliflozin and were reported in two subjects (0.4 %) in the saxagliptin plus dapagliflozin plus metformin group (serious adverse event [SAE] of syncope and an AE of urine output decreased), and 3 subjects (0.9 %) in the dapagliflozin plus metformin group (2 AEs of syncope and 1 of hypotension).
Slovenian: Kombinacija saksagliptina/dapagliflozina: Učinki, povezani z zmanjšanjem volumna (hipotenzija, dehidracija in hipovolemija) so odražali neželene učinke dapagliflozina; poročali so jih pri 2 preiskovancih (0,4 %), ki sta prejemala kombinacijo saksagliptina, dapagliflozina in metformina (resen neželeni učinek sinkopa in neželeni učinek zmanjšano izločanje urina), in pri 3 preiskovancih (0,9 %), ki so prejemali kombinacijo dapagliflozina in metformina (2 primera neželenega učinka sinkopa in 1 neželeni učinek hipotenzija).
English: Saxagliptin + Metformin Adjusted mean change from baseline
Slovenian: Saksagliptin + metformin Prilagojena povprečna sprememba od izhodišča
English: Manufacturer AstraZeneca AB Gärtunavägen SE-151 85 Södertälje Sweden
Slovenian: Izdelovalec AstraZeneca AB Gärtunavägen SE-151 85 Södertälje Švedska
English: Pharmacotherapeutic group: Drugs used in diabetes, combinations of oral blood glucose lowering drugs, ATC code: A10BD21
Slovenian: Farmakoterapevtska skupina: zdravila za zdravljenje diabetesa, kombinacije peroralnih antidiabetikov.
English: Experience in NYHA class III-IV is limited with saxagliptin.
Slovenian: Izkušenj s saksagliptinom v razredih III. in IV. po NYHA je malo.
English: The incidence of hypoglycaemia was low (1.4 %) in subjects treated with saxagliptin plus dapagliflozin plus metformin group.
Slovenian: Pojavnost hipoglikemije je bila v skupini, ki je prejemala kombinacijo saksagliptina z dapagliflozinom in metforminom, majhna (1,4 %).
English: Arthralgia
Slovenian: Artralgija
English: (sulphonylurea), a reduction in the dose of sulphonylurea may be required to minimize the risk of hypoglycaemia (see section 4.8).
Slovenian: Če je zdravilo Qtern uporabljeno v kombinaciji z insulinskim sekretagogom (sulfonilsečnino), je lahko potrebno zmanjšanje odmerka sulfonilsečnine, da bi zmanjšali tveganje za hipoglikemijo (glejte poglavje 4.8).
English: See corresponding subsections below for events in the dapagliflozin programme.
Slovenian: Za dogodke v programu dapagliflozina glejte ustrezna podpoglavja v nadaljevanju.
English: Ulcerative and necrotic skin lesions have been reported in extremities of monkeys in non-clinical toxicology studies with saxagliptin (see section 5.3).
Slovenian: V predkliničnih toksikoloških študijah saksagliptina so poročali o ulcerativnih in nekrotičnih kožnih spremembah na udih opic (glejte poglavje 5.3).
English: The pooled safety analysis comprised 3 treatment groups: saxagliptin plus dapagliflozin plus metformin (492 subjects), saxagliptin plus metformin (336 subjects), and dapagliflozin plus metformin (341 subjects).
Slovenian: Kumulativna analiza varnosti je obsegala 3 terapevtske skupine: saksagliptin z dapagliflozinom in metforminom (492 preiskovancev), saksagliptin z metforminom (336 preiskovancev) in dapagliflozin z metforminom (341 preiskovancev).Varnostne značilnosti kombinirane uporabe saksagliptina in dapagliflozina ter metformina so bile podobne neželenim učinkom, ugotovljenim za vsako posamezno od teh učinkovin.
English: The group with dapagliflozin sequentially added to saxagliptin and metformin achieved statistically significant (p-value < 0.0001) greater reductions in HbA1c versus the group with placebo sequentially added to saxagliptin plus metformin group at 24 weeks (see table 4).
Slovenian: Skupina, ki je dobila dapagliflozin, zaporedno dodan saksagliptinu in metforminu, je po 24 tednih dosegla statistično značilno (vrednost p < 0,0001) večje znižanje HbA1c kot skupina, ki je dobila placebo, zaporedno dodan saksagliptinu in metforminu (glejte preglednico 5).
English: Saxagliptin/dapagliflozin combination: The incidence of hypoglycaemia was low (1.4 %) in the saxagliptin plus dapagliflozin plus metformin group, 0.3 % in the saxagliptin plus metformin group, and 1.8 % in the dapagliflozin plus metformin group.
Slovenian: Kombinacija saksagliptina/dapagliflozina: Pojavnost hipoglikemij je bila majhna, zabeležili so jih pri 1,4 % bolnikov v skupini s kombinacijo saksagliptina, dapagliflozina in metformina, 0,3 % v skupini s kombinacijo saksagliptina in metformina in 1,8 % v skupini s kombinacijo dapagliflozina in metformina.
English: Skin disorders
Slovenian: Bolezni kože
English: Joint pain, which may be severe, has been reported in post-marketing reports for DPP-4 inhibitors (see section 4.8).
Slovenian: V obdobju trženja so med uporabo zaviralcev DPP-4 poročali o bolečinah v sklepih, ki so lahko hude glejte poglavje 4.8).
English: diarrhoea, dyspepsia
Slovenian: Bolezni sečil disurija, poliurija
English: However, the differences in exposure were not considered clinically meaningful.
Slovenian: Vendar te razlike ne veljajo za klinično pomembne.
English: Use in patients at risk for volume depletion, hypotension and/or electrolyte imbalances Due to dapagliflozin's mechanism of action, Qtern increases diuresis associated with a modest decrease in blood pressure (see section 5.1), which may be more pronounced in patients with very high blood glucose concentrations.
Slovenian: To je povezano z zmernim znižanjem krvnega tlaka (glejte poglavje 5.1), ki je lahko izrazitejše pri bolnikih z zelo visoko koncentracijo glukoze v krvi.
English: Saxagliptin/dapagliflozin combination: In the pooled safety analysis, the incidence of adverse events related to decreased renal function was 2.0 % subjects in the saxagliptin plus dapagliflozin plus metformin group, 1.8 % subjects in the saxagliptin plus metformin group, and 0.6 % subjects in the dapagliflozin plus metformin group.
Slovenian: Kombinacija saksagliptina/dapagliflozina: V kumulativni analizi varnosti je bila pojavnost neželenih učinkov, povezanih z zmanjšanjem delovanja ledvic, 2,0 % pri prejemnikih kombinacije saksagliptina, dapagliflozina in metformina, 1,8 % pri prejemnikih kombinacije saksagliptina in metformina ter 0,6 % pri prejemnikih kombinacije dapagliflozina in metformina.