natgillin/translations-raw huggingface dataset:
Haematocrit values >55 % were reported in 1.3 % of the subjects treated with dapagliflozin 10 mg versus 0.4 % of placebo subjects.
Vrednosti hematokrita > 55 % so bile zabeležene pri 1,3 % preiskovancev, zdravljenih z 10 mg dapagliflozina, in pri 0,4 % tistih, ki so prejemali placebo.
Subjects with mean daily insulin dose reduction of at least 10 % (%)
Preiskovanci z znižanjem povprečnega dnevnega odmerka insulina za vsaj
Adverse reactions in dapagliflozin and metformin immediate-release clinical trial and postmarketing data
Neželeni učinki dapagliflozina in metformina s takojšnjim sproščanjem na podlagi kliničnih preskušanj in postmarketinških podatkov Organski sistem
In subjects with mild or moderate hepatic impairment (Child-Pugh classes A and B), mean Cmax and AUC of dapagliflozin were up to 12 % and 36 % higher, respectively, compared with healthy matched control subjects.
Pri preiskovancih z blago ali zmerno okvaro jeter (Child-Pugh A in B) je bila Cmax dapagliflozina do 12 % večja, njegova AUC pa do 36 % večja kot pri ujemajočih se zdravih primerjalnih osebah.
Treatment with dapagliflozin as an add-on to either metformin alone (dapagliflozin 10 mg QD or dapagliflozin 5 mg BID) or metformin plus sitagliptin, sulphonylurea or insulin resulted in statistically significant reductions in fasting plasma glucose (-1.90 to -1.20 mmol/l [-34.2 to -21.7 mg/dl]) compared with placebo (-0.58 to 0.18 mmol/l [-10.4 to 3.3 mg/dl]) at Week 16 (5 mg BID) or Week 24.
Zdravljenje z dapagliflozinom kot dodatkom bodisi metforminu samemu (dapagliflozin 10 mg enkrat na dan ali dapagliflozin 5 mg dvakrat na dan) bodisi metforminu v kombinaciji s sitagliptinom, sulfonilsečnino ali insulinom je statistično značilno znižalo glukozo v plazmi na tešče (-1,90 do -1,20 mmol/l [-34,2 do -21,7 mg/dl]) v primerjavi s placebom (-0,58 do 0,18 mmol/l [-10,4 do 3,3 mg/dl]) po 16 tednih (5 mg dvakrat na dan) ali 24 tednih.
In an add-on to metformin and a sulphonylurea study, up to 24 weeks, minor episodes of hypoglycaemia were reported in 12.8 % of subjects who received dapagliflozin 10 mg plus metformin and a sulphonylurea and in 3.7 % of subjects who received placebo plus metformin and a sulphonylurea.
V študiji dodatka metforminu in sulfonilsečnini, v obdobju do 24 tednov, so blage hipoglikemije zabeležili pri 12,8 % preiskovancev, ki so prejemali 10 mg dapagliflozina skupaj z metforminom in sulfonilsečnino, ter pri 3,7 % preiskovancev, ki so prejemali placebo skupaj z metforminom in sulfonilsečnino.
- a significant reduction of the absolute risk of any diabetes-related complication in the metformin group (29.8 events/1,000 patient-years) versus diet alone (43.3 events/1,000 patient-years), p=0.0023, and versus the combined sulphonylurea and insulin monotherapy groups (40.1 events/1,000 patient-years), p=0.0034; - a significant reduction of the absolute risk of any diabetes-related mortality: metformin 7.5 events/1,000 patient-years, diet alone 12.7 events/1,000 patient-years, p=0.017; - a significant reduction of the absolute risk of overall mortality: metformin 13.5 events/1,000 patient-years versus diet alone 20.6 events/1,000 patient-years, (p=0.011), and versus the combined sulphonylurea and insulin monotherapy groups 18.9 events/1,000 patient-years (p=0.021); - a significant reduction in the absolute risk of myocardial infarction: metformin 11 events/1,000 patient-years, diet alone 18 events/1,000 patient-years, (p=0.01).
- značilno zmanjšanje absolutnega tveganja za umrljivost, povezano s sladkorno boleznijo: metformin 7,5 dogodka/1000 bolnik-let, dieta sama 12,7 dogodka/1000 bolnik-let, p = 0,017; - značilno zmanjšanje absolutnega tveganja za celotno umrljivost: metformin 13,5 dogodka/1000 bolnik-let v primerjavi s samo dieto 20,6 dogodka/1000 bolnik-let (p = 0,011) in v primerjavi z združenimi podatki skupin monoterapije s sulfonilsečnino in z insulinom 18,9 dogodka/1000 bolnik-let, (p = 0,021); - značilno zmanjšanje absolutnega tveganja za miokardni infarkt: metformin 11 dogodkov/1000 bolnik-let, dieta sama 18 dogodkov/1000 bolnik-let (p = 0,01).
Treatment with dapagliflozin plus metformin at all doses produced clinically relevant and statistically significant improvements in HbA1c and fasting plasma glucose compared with placebo in combination with metformin.
Zdravljenje s kombinacijo dapagliflozina in metformina je v primerjavi s kombinacijo placeba in metformina v vseh odmerkih klinično pomembno in statistično značilno izboljšalo HbA1c in glukozo v plazmi na tešče.
LOCF: Last observation (prior to or on the date of the first insulin up-titration, if needed) carried forward All randomised subjects who took at least one dose of double-blind study medicinal product during the short-term double-blind period Least squares mean adjusted for baseline value and presence of oral glucose-lowering medicinal product p-value < 0.0001 versus placebo + insulin ± oral glucose-lowering medicinal product p-value < 0.05 versus placebo + insulin ± oral glucose-lowering medicinal product Up-titration of insulin regimens (including short-acting, intermediate, and basal insulin) was only allowed if subjects met pre-defined FPG criteria.
LOCF: prenos zadnjega opažanja (pred ali na datum prvega zvišanja insulina, če je bilo potrebno) Vsi randomizirani preiskovanci, ki so prejeli vsaj en odmerek dvojno slepljenega raziskovanega zdravila med kratkoročnim dvojno slepim obdobjem Povprečje najmanjših kvadratov, korigirano za izhodiščno vrednost in prisotnost peroralnega antidiabetika Vrednost p < 0,0001 v primerjavi s kombinacijo placeba + insulina ± peroralnega antidiabetika Vrednost p < 0,05 v primerjavi s kombinacijo placeba + insulina ± peroralnega antidiabetika Zviševanje insulinskih shem (vključno s kratkodelujočim, srednjedolgodelujočim in bazalnim insulinom) je bilo dovoljeno le, če so bolniki izpolnjevali vnaprej določena merila glukoze v plazmi na tešče.
The proportion of subjects remaining in the study at Week 104 was 72.4 % for the group treated with dapagliflozin 10 mg and 54.8 % for the placebo group.
Delež preiskovancev, ki so 104. teden še ostali v študiji, je bil v skupini z 10 mg dapagliflozina 72,4 % in v skupini s placebom 54,8 %.
In studies with dapagliflozin in add-on combination with metformin, minor episodes of hypoglycaemia were reported at similar frequencies in the group treated with dapagliflozin 10 mg plus metformin (6.9 %) and in the placebo plus metformin group (5.5 %).
V študijah dapagliflozina v kombinaciji z metforminom so bile blage hipoglikemije podobno pogoste v skupini, zdravljeni z 10 mg dapagliflozina skupaj z metforminom (6,9 %), kot v skupini, ki je prejemala placebo in metformin (5,5 %).
- hypersensitivity to the active substances or to any of the excipients listed in section 6.1; - any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis); - diabetic pre-coma; - severe renal failure (GFR < 30 mL/min) (see sections 4.4 and 5.2); - acute conditions with the potential to alter renal function such as: dehydration, severe infection, shock; - acute or chronic disease which may cause tissue hypoxia such as: cardiac or respiratory failure, recent myocardial infarction, shock; - hepatic impairment (see sections 4.2, 4.4 and 5.2); - acute alcohol intoxication, alcoholism (see section 4.5).
- diabetično predkomo, - hudo okvaro ledvic (GFR < 30 ml/min) (glejte poglavji 4.4 in 5.2), - akutnimi motnjami, ki lahko spremenijo delovanje ledvic, kot so npr.: dehidracija, huda okužba, šok, - akutnimi ali kroničnimi boleznimi, ki lahko povzročijo hipoksijo tkiv, kot so npr.: srčno popuščanje ali respiratorna insuficienca, nedaven miokardni infarkt, šok, - okvaro jeter (glejte poglavja 4.2, 4.4 in 5.2), - akutno intoksikacijo z alkoholom, alkoholizmom (glejte poglavje 4.5).
• Metformin is contraindicated in patients with GFR of < 30 mL/min and should be temporarily discontinued in the presence of conditions that alter renal function (see section 4.3).
• Če se delovanje ledvic zmanjša pod GFR < 60 ml/min je treba zdravljenje prekiniti.• Metformin je kontraindiciran pri bolnikih z GFR < 30 ml/min in ga je treba začasno prenehati uporabljati v primeru motenj, ki lahko zmanjšajo delovanje ledvic (glejte poglavje 4.3).
Hydroxypropyl cellulose (E463) Microcrystalline cellulose (E460(i)) Magnesium stearate (E470b) Sodium starch glycolate type A
Hidroksipropilceluloza (E463) Mikrokristalna celuloza (E460(i)) Magnezijev stearat (E470b) Natrijev karboksimetilškrob, vrsta A
These are signs of a severe infection of the urinary tract: - fever and/or chills - burning sensation when passing water (urinating) - pain in your back or side.
- zvišana telesna temperatura in/ali mrzlica - pekoč občutek pri odvajanju vode (uriniranju) - bolečine v hrbtu ali ledveno
In subjects ≥ 65 years of age, adverse reactions related to renal impairment or failure were reported in 7.7 % of subjects treated with dapagliflozin and 3.8 % of subjects treated with placebo (see section 4.4).
Pri preiskovancih, starih 65 let ali več, so neželene učinke, povezane z okvaro ali odpovedjo ledvic, zabeležili pri 7,7 % tistih, ki so prejemali dapagliflozin, in pri 3,8 % tistih, ki so prejemali placebo (glejte poglavje 4.4).
During clinical trials, 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).
Med kliničnimi preskušanji je bil celotni delež oseb z malignimi ali nespecificiranimi tumorji med tistimi, ki so prejemali dapagliflozin (1,50 %), in tistimi, ki so prejemali placebo/primerjalno zdravilo (1,50 %), podoben.
• Urinary tract infection, seen commonly (may affect up to 1 in 10 people).
• Okužba sečil, ki se pojavi pogosto (pojavi se lahko pri največ 1 od 10 bolnikov).
In subjects with severe hepatic impairment (Child-Pugh class C) mean Cmax and AUC of dapagliflozin were 40 % and 67 % higher than matched healthy controls, respectively.
Pri bolnikih s hudo okvaro jeter (Child-Pugh C) je bila povprečna Cmax dapagliflozina do 40 % večja in njegova AUC do 67 % večja kot pri ujemajočih se zdravih primerjalnih osebah.
See section 4.4 Reported in ≥ 2 % of subjects and ≥ 1 % more and at least 3 more subjects treated with dapagliflozin 10 mg compared to placebo.
Glejte poglavje 4.4 Opisano pri ≥ 2 % preiskovancev ter pri ≥ 1 % več in pri vsaj 3 preiskovancih več med uporabo 10 mg dapagliflozina kot med uporabo placeba.
(95 % CI) Subjects (%) achieving: HbA1c < 7 % Adjusted for baseline
% IZ) Preiskovanci (%), ki so dosegli: HbA1c < 7 % Korigirano za izhodišče
Use in patients at risk for volume depletion, hypotension and/or electrolyte imbalances Due to its mechanism of action, dapagliflozin increases diuresis associated with a modest decrease in blood pressure (see section 5.1), which may be more pronounced in patients with high blood glucose concentrations.
Zaradi svojega mehanizma delovanja dapagliflozin poveča diurezo ob spremljajočem zmernem znižanju krvnega tlaka (glejte poglavje 5.1), ki je lahko izrazitejše pri bolnikih z visoko koncentracijo glukoze v krvi.
Therefore a lower dose of insulin or an insulin secretagogue may be required to reduce the risk of hypoglycaemia when used in combination with metformin (see sections 4.2 and 4.8)
Zato bo morda, za zmanjšanje tveganja za hipoglikemijo, potreben manjši odmerek insulina ali insulinskega sekretagoga, če je uporabljen v kombinaciji z metforminom (glejte poglavji 4.2 in 4.8).
This grouping of reactions was reported in 3.2 % and 1.8 % of patients who received dapagliflozin 10 mg and placebo, respectively.
Ta skupina učinkov je bila opisana pri 3,2 % bolnikov, ki so prejemali 10 mg dapagliflozina, in pri 1,8 % tistih, ki so prejemali placebo.
Abbreviations: QD: once daily; BID: twice daily Metformin ≥ 1500 mg/day; Sitagliptin 100 mg/day LOCF: Last observation (prior to rescue for rescued subjects) carried forward Placebo-controlled 16-week study All randomised subjects who took at least one dose of double-blind study medicinal product during the short-term double-blind period Least squares mean adjusted for baseline value p-value < 0.0001 versus placebo + oral glucose-lowering medicinal product p-value < 0.05 versus placebo + oral glucose-lowering medicinal product The percent change in body weight was analysed as a key secondary endpoint (p < 0.0001); absolute body weight change (in kg) was analysed with a nominal p-value (p < 0.0001).
Metformin ≥ 1500 mg/dan, Sitagliptin 100 mg/dan LOCF: prenos zadnjega opažanja (pred rešilnim zdravljenjem za preiskovance s takšnim zdravljenjem) [Last observation carried forward] S placebom kontrolirana 16-tedenska študija Vsi randomizirani preiskovanci, ki so prejeli vsaj en odmerek dvojno slepljenega raziskovanega zdravila med kratkoročnim dvojno slepim obdobjem Povprečje najmanjših kvadratov, korigirano za izhodiščno vrednost Vrednost p < 0,0001 v primerjavi s kombinacijo placebo + peroralni antidiabetik Vrednost p < 0,05 v primerjavi s kombinacijo placebo + peroralni antidiabetik Odstotek spremembe telesne mase so analizirali kot sekundarni opazovani dogodek (p < 0,0001); absolutno spremembo telesne mase (v kg) so analizirali z nominalno vrednostjo p (p < 0,0001).
EU/1/13/900/009 Xigduo 5 mg/1000 mg 56 tablets EU/1/13/900/010 Xigduo 5 mg/1000 mg 60 tablets EU/1/13/900/011 Xigduo 5 mg/1000 mg 60 x 1 tablet (unit dose) EU/1/13/900/012 Xigduo 5 mg/1000 mg 196 (2 x 98) tablets (multipack)
Xigduo 5 mg/1000 mg filmsko obložene tablete EU/1/13/900/007 Xigduo 5 mg/1000 mg 14 tablet EU/1/13/900/008 Xigduo 5 mg/1000 mg 28 tablet EU/1/13/900/009 Xigduo 5 mg/1000 mg 56 tablet EU/1/13/900/010 Xigduo 5 mg/1000 mg 60 tablet EU/1/13/900/011 Xigduo 5 mg/1000 mg 60 x 1 tableta (enkratni odmerek) EU/1/13/900/012 Xigduo 5 mg/1000 mg 196 (2 x 98) tablet (skupno pakiranje)
At Week 104 for insulin (with or without additional oral glucose-lowering medicinal products, including metformin), the HbA1c reductions were -0.71 % and -0.06 % adjusted mean change from baseline for dapagliflozin 10 mg and placebo, respectively.
104. teden je bilo z insulinom (z dodatnim peroralnim antidiabetikom (vključno z metforminom) ali brez njega) znižanje HbA1c -0,71 % oziroma -0,06 % (korigirana povprečna sprememba z 10 mg dapagliflozina oziroma s placebom).
In a pre-specified analysis of subjects with baseline HbA1c ≥ 9.0 %, treatment with dapagliflozin 10 mg resulted in statistically significant reductions in HbA1c at Week 24 as an add-on to metformin (adjusted mean change from baseline: -1.32 % and -0.53 % for dapagliflozin and placebo, respectively).
Vnaprej specificirana analiza preiskovancev z izhodiščnim HbA1c ≥ 9,0 % je pokazala, da je zdravljenje z 10 mg dapagliflozina kot dodatka metforminu do 24. tedna statistično značilno znižalo HbA1c (korigirana povprečna sprememba od izhodišča: dapagliflozin -1,32 % in placebo -0,53 %).
• Xigduo 5 mg/1,000 mg are 10.5 x 21.5 mm oval, yellow film-coated tablets.
•Zdravilo Xigduo 5 mg/1000 mg so 10,5 x 21,5 mm velike, ovalne, rumene filmsko obložene tablete.
At Weeks 24 and 104, minor episodes of hypoglycaemia were reported, respectively, in 40.3 % and 53.1 % of subjects who received dapagliflozin 10 mg plus insulin and in 34.0 % and 41.6 % of the subjects who received placebo plus insulin.
Do 24. oziroma 104. tedna so blage hipoglikemije zabeležili pri 40,3 % oziroma 53,1 % prejemnikov kombinacije 10 mg dapagliflozina in insulina ter pri 34,0 % oziroma 41,6 % prejemnikov kombinacije placeba in insulina.
Hypoglycaemia (when used with SU or insulin)
Presnovne in prehranske motnje hipoglikemija (med uporabo s sulfonilsečninam i ali insulinom)
After an oral dose of metformin, tmax is reached in 2.5 h. Absolute bioavailability of a 500 mg or 850 mg metformin tablet is approximately 50-60 % in healthy subjects.
Absolutna biološka uporabnost tablete 500 mg ali 850 mg metformina je pri zdravih preiskovancih približno 50-60 %.
Haematocrit increased Creatinine renal clearance decreased Dyslipidaemia
Preiskave zvišan hematokrit zmanjšan ledvični očistek kreatinina dislipidemija zvišanje kreatinina v krvi
At Week 48 for metformin plus sitagliptin, the adjusted mean change from baseline for dapagliflozin 10 mg and placebo was -0.44 % and 0.15 %, respectively.
Po 48 tednih uporabe kombinacije metformina in sitagliptina je bila korigirana povprečna sprememba od izhodišča z 10 mg dapagliflozina -0,44 % in s placebom 0,15 %.
For the add-on to metformin study, HbA1c reductions were sustained through Week 102 (-0.78 % and 0.02 % adjusted mean change from baseline for dapagliflozin 10 mg and placebo, respectively).
V študiji dodatka metforminu se je znižanje HbA1c ohranilo do 102. tedna (korigirana povprečna sprememba od izhodišča z 10 mg dapagliflozina -0,78 % in s placebom 0,02 %).
In a separate analysis of subjects on insulin plus metformin, similar reductions in HbA1C to those seen in the total study population were seen in subjects treated with dapagliflozin with insulin plus metformin.
V ločeni analizi preiskovancev, ki so prejemali insulin in metformin, so pri preiskovancih, zdravljenih z dapagliflozinom v kombinaciji z insulinom in metforminom, ugotovili podobna znižanja HbA1c kot v celotni študijski populaciji.
No dose adjustment is recommended for patients with mild renal impairment, GFR 60 - 89 mL/min.
Bolnikom z blago okvaro ledvic, GFR 60 - 89 ml/min, odmerka ni treba prilagoditi.
Urinary tract infections were more frequently reported for dapagliflozin compared to placebo in a pooled analysis up to 24 weeks (see section 4.8).
Okužbe sečil so bile v kumulativni analizi obdobja do 24 tednov z dapagliflozinom pogostejše kot s placebom (glejte poglavje 4.8).
In a 52-week, active-controlled non-inferiority study (with 52- and 104-week extension periods), dapagliflozin 10 mg was evaluated as add-on therapy to metformin compared with a sulphonylurea
V 52-tedenski, z zdravilno učinkovino kontrolirani študiji neinferiornosti (z 52-tedenskim in 104-tedenskim obdobjem podaljšanja) so 10 mg dapagliflozina ocenjevali kot dodatek zdravljenju z metforminom v primerjavi s sulfonilsečnino (glipizid) kot dodatkom zdravljenju z metforminom pri bolnikih z neustrezno urejenostjo glikemije (HbA1c > 6,5 % in ≤ 10 %).
Vulvovaginal pruritus Pruritus genital
Motnje reprodukcije in dojk vulvovaginaln o srbenje srbenje spolovil
Dapagliflozin as an add-on with either metformin alone, metformin in combination with sitagliptin, sulphonylurea or insulin (with or without additional oral glucose-lowering medicinal products, including metformin) resulted in statistically significant mean reductions in HbA1c at 24 weeks compared with subjects receiving placebo (p < 0.0001; Tables 3, 4 and 5).
Dapagliflozin kot dodatek bodisi metforminu samemu, metforminu v kombinaciji s sitagliptinom, sulfonilsečnino ali insulinom (z dodatnimi peroralnimi antidiabetiki (vključno z metforminom) ali brez njih) je po 24 tednih statistično značilno znižal HbA1c v primerjavi s prejemniki placeba (p < 0.0001, preglednice 3, 4 in 5).
In subjects ≥ 65 years of age, a higher proportion of subjects treated with dapagliflozin had adverse reactions related to renal impairment or failure compared with placebo.
Med preiskovanci, starimi 65 let ali več, je bil delež neželenih učinkov, povezanih z okvaro ali odpovedjo ledvic, večji med prejemniki dapagliflozina kot med prejemniki placeba.
At steady-state (20 mg once-daily dapagliflozin for 7 days), subjects with type 2 diabetes mellitus and mild, moderate or severe renal impairment (as determined by iohexol plasma clearance) had mean systemic exposures of dapagliflozin of 32 %, 60 % and 87 % higher, respectively, than those of subjects with type 2 diabetes mellitus and normal renal function.
V primerjavi z bolniki s sladkorno boleznijo tipa 2 z normalnim delovanjem ledvic so imeli v stanju dinamičnega ravnovesja (uporaba dapagliflozina 20 mg enkrat na dan 7 dni) bolniki s sladkorno boleznijo tipa 2 z blago okvaro ledvic sistemsko izpostavljenost dapagliflozinu večjo za 32 %, tisti z zmerno okvaro za 60 % in tisti s hudo okvaro za 87 % (stopnja okvare je bila ugotovljena s plazemskim očistkom ioheksola).
At Week 208, adjusted mean change from baseline in HbA1c was -0.10 % for dapagliflozin and 0.20 % for glipizide, respectively.
208. teden je bila korigirana povprečna sprememba HbA1c od izhodišča z dapagliflozinom -0,10 % in z glipizidom 0,20 %.
• redness of the skin (erythema),itching or an itchy rash (hives)
• pordelost kože (rdečica), srbenje ali srbeč izpuščaj (koprivnica)
• Xigduo 5 mg/850 mg are 9.5 x 20 mm oval, brown film-coated tablets.
• Zdravilo Xigduo 5 mg/850 mg so 9,5 x 20 mm velike, ovalne, rjave filmsko obložene tablete.
Mean changes from baseline in haematocrit were 2.30 % for dapagliflozin 10 mg versus -0.33 % for placebo.
Povprečni odstotek spremembe hematokrita od izhodišča je bil 2,30 % z 10 mg dapagliflozina in -0,33 % s placebom.
Talk to your doctor, pharmacist or nurse before taking this medicine, and during treatment:
Pred začetkom jemanja tega zdravila in med zdravljenjem se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro:
In an add-on to insulin study up to 104 weeks, episodes of major hypoglycaemia were reported in 0.5 % and 1.0 % of subjects in dapagliflozin 10 mg plus insulin at Weeks 24 and 104, respectively, and in 0.5 % of subjects treated with placebo plus insulin groups at Weeks 24 and 104.
V študiji dodatka k insulinu do 104 tedne so hude hipoglikemije do 24. oziroma 104. tedna zabeležili pri 0,5 % oziroma 1,0 % prejemnikov kombinacije 10 mg dapagliflozina in insulina ter pri 0,5 % prejemnikov kombinacije placeba in insulina.
In subjects ≥ 65 years of age, adverse reactions of volume depletion, most commonly reported as hypotension, were reported in 1.7 % and 0.8 % of dapagliflozin-treated subjects and placebo-treated subjects, respectively (see section 4.4).
Pri preiskovancih, starih 65 let ali več, so neželeni učinek pomanjkanja volumna (najpogosteje opisan kot hipotenzija) zabeležili pri 1,7 % tistih, ki so prejemali dapagliflozin, in pri 0,8 % tistih, ki so prejemali placebo (glejte poglavje 4.4).
Reactions related to volume depletion (including, reports of dehydration, hypovolaemia or hypotension) were reported in 1.1 % and 0.7 % of subjects who received dapagliflozin 10 mg and placebo, respectively; serious reactions occurred in < 0.2 % of subjects balanced between dapagliflozin 10 mg and placebo (see section 4.4).
O učinkih, povezanih s pomanjkanjem volumna (vključno z dehidracijo, hipovolemijo ali hipotenzijo) so poročali pri 1,1 % oseb, ki so prejemale 10 mg dapagliflozina, in 0,7 % oseb, ki so prejemale placebo.
At Week 104, adjusted mean change from baseline in HbA1c was -0.32 % for dapagliflozin and -0.14 % for glipizide, respectively.
104. teden je bila korigirana povprečna sprememba HbA1c od izhodišča z dapagliflozinom -0,32 % in z glipizidom -0,14 %.
Talc (E553b) Titanium dioxide (E171) Iron oxide yellow (E172) Iron oxide red (E172)
Polivinilalkohol (E1203) Makrogol 3350 (E1520(iii)) Smukec (E553b) Titanov dioksid (E171) Rumeni železov oksid (E172) Rdeči železov oksid (E172)
The following adverse reactions have been identified in the placebo-controlled dapagliflozin plus metformin clinical trials, dapagliflozin clinical trials and metformin clinical trials and post-marketing experience.
V s placebom kontroliranih kliničnih preskušanjih kombinacije dapagliflozina in metformina, kliničnih preskušanjih dapagliflozina, kliničnih preskušanjih metformina in med obdobjem po odobritvi dovoljenja za promet so ugotovili naslednje neželene učinke.
Fifty percent of subjects were on insulin monotherapy at baseline; 50 % were on 1 or 2 oral glucose-lowering medicinal product(s) in addition to insulin: Of this latter group, 80 % were on metformin alone, 12 % were on metformin plus sulphonylurea therapy, and the rest were on other oral glucose-lowering medicinal products.
Petdeset odstotkov bolnikov je bilo izhodiščno na monoterapiji z insulinom; 50 % jih je poleg insulina jemalo 1 ali 2 peroralna antidiabetika.
HbA1c (%) Baseline (mean) Change from baseline Difference from placebo c
HbA1c (%) Izhodišče (povprečje) Sprememba od izhodišča Razlika v primerjavi s placebom