FrancophonIA/ELRC3.0 huggingface dataset:
English: In a 52-week, active-controlled non-inferiority study (with 52- and 104-week extension periods), Edistride was evaluated as add-on therapy to metformin compared with a sulphonylurea (glipizide) as add-on therapy to metformin in subjects with inadequate glycaemic control (HbA1c > 6.5 % and ≤ 10 %).
Slovenian: V 52-tedenski, z zdravilno učinkovino kontrolirani študiji neinferiornosti (z 52-tedenskim in 104-tedenskim obdobjem podaljšanja), so zdravilo Edistride ocenjevali kot dodatek k zdravljenju z metforminom v primerjavi s sulfonilsečnino (glipizid) kot dodatkom k zdravljenju z metforminom pri osebah z neustrezno urejenostjo glikemije (HbA1c > 6,5 % in ≤ 10 %).
English: Edistride 5 mg tablets and Edistride 10 mg tablets are available in aluminium blisters in pack sizes of 14, 28 or 98 film-coated tablets in non-perforated calendar blisters and 30x1 or 90x1 film-coated tablets in perforated unit dose blisters.
Slovenian: Zdravili Edistride 5 mg in 10 mg filmsko obložene tablete sta na voljo v pretisnih omotih v velikostih pakiranj s 14, 28 ali 98 filmsko obloženimi tabletami v neperforiranih koledarskih omotih ter s 30 x 1 ali 90 x 1 filmsko obloženo tableto v perforiranih pretisnih omotih za posamezni odmerek.
English: Increased incidence or severity of renal pelvic dilatation was observed in adult offspring of treated dams, although only at the highest dose tested (associated maternal and pup dapagliflozin exposures were 1,415 times and 137 times, respectively, the human values at the maximum recommended human dose).
Slovenian: Večjo pojavnost in izrazitost razširitve ledvičnega meha so opažali pri odraslem potomstvu obravnavanih samic-mater, vendar le pri največjem preskušanem odmerku (pri katerem je bila izpostavljenost mater dapagliflozinu 1415-krat in mladičev 137-krat večja od izpostavljenosti človeka pri največjemu priporočenemu odmerku za človeka).
English: 104 and 208 weeks, a significantly lower proportion of subjects in the group treated with dapagliflozin (3.5 %, 4.3 % and 5.0 %, respectively) experienced at least one event of hypoglycaemia compared to the group treated with glipizide (40.8 %, 47.0 % and 50.0 %, respectively).
Slovenian: 52., 104. in 208. teden je imel vsaj eno hipoglikemijo značilno manjši delež oseb, ki so prejemale dapagliflozin (3,5 %, 4,3 % in 5,0 %) v primerjavi s skupino, zdravljeno z glipizidom (40,8 %, 47,0 % in 50,0 %).
English: Subjects with mean daily insulin dose reduction of at least 10 % (%)
Slovenian: Osebe z zmanjšanjem povprečnega dnevnega odmerka insulina za vsaj
English: 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.
Slovenian: Blage hipoglikemije so zabeležili pri 12,8 % bolnikov, ki so prejemali 10 mg dapagliflozina ter metformin in sulfonilsečnino, in pri 3,7 % bolnikov, ki so prejemali placebo ter metformin in sulfonilsečnino.
English: Neither maternal nor developmental toxicities were observed in rabbits at any dose tested; the highest dose tested is associated with a systemic exposure multiple of approximately 1,191 times the maximum recommended human dose.
Slovenian: Pri kuncih niso pri nobenem od odmerkov ugotovili niti maternalne niti razvojne toksičnosti; največji preskušani odmerek je bil povezan s sistemsko izpostavljenostjo, ki je bila približno 1191-krat tolikšna kot pri največjemu priporočenemu odmerku za človeka.
English: 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.
Slovenian: 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 z urinom.
English: 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 to healthy matched control subjects.
Slovenian: Pri osebah z blago ali zmerno okvaro jeter (razreda A in B po Child-Pughu) sta bila povprečna Cmax in AUC dapagliflozina večja do 12 % oziroma do 36 % v primerjavi z usklajenimi zdravimi primerjalnimi osebami.
English: Vulvovaginitis, balanitis and related genital infections Vulvovaginitis, balanitis and related genital infections were reported in 5.5 % and 0.6 % of subjects who received dapagliflozin 10 mg and placebo, respectively.
Slovenian: Vulvovaginitis, balanitis in sorodne okužbe spolovil O vulvovaginitisu, balanitisu in sorodnih okužbah spolovil so poročali pri 5,5 % oseb, ki so prejemale 10 mg dapagliflozina, in 0,6 % oseb, ki so prejemale placebo.
English: Edistride has not been studied in severe renal impairment (CrCl < 30 ml/min or eGFR < 30 ml/min/1.73 m 2) or end-stage renal disease (ESRD).
Slovenian: Zdravilo Edistride ni bilo raziskano pri hudi okvari ledvic (CrCl < 30 ml/min ali eGFR < 30 ml/min/1,73 m 2) ali pri končni odpovedi ledvic (ESRD - end-stage renal disease).
English: If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Slovenian: Če imate dodatna vprašanja o uporabi tega zdravila, se posvetujte s svojim zdravnikom, s farmacevtom ali z medicinsko sestro.
English: Primary episodes occurred at a rate of 1.62 % per patient-year in subjects treated with dapagliflozin and 2.06 % in comparator-treatment subjects, per patient-year.
Slovenian: Delež primarnega dogodka je bil pri osebah, ki so prejemale dapagliflozin 1,62 % na bolnikleto in pri osebah, ki so prejemale primerjalno zdravilo 2,06 % na bolnik-leto.
English: Edistride is not recommended for use 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).
Slovenian: Zdravila Edistride ni priporočljivo uporabljati pri bolnikih z zmerno do hudo okvaro ledvic (bolnikih s kreatininskim očistkom [CrCl] < 60 ml/min ali z ocenjeno hitrostjo glomerulne filtracije [eGFR] < 60 ml/min/1,73 m2, glejte poglavja 4.4, 4.8, 5.1 in 5.2).
English: These reactions were more common in patients with baseline eGFR ≥ 30 and < 60 ml/min/1.73 m2 (18.5 % dapagliflozin 10 mg vs 9.3 %
Slovenian: Te reakcije so bile pogostejše pri bolnikih z izhodiščno ocenjeno hitrostjo glomerularne filtracije [eGFR] ≥ 30 in < 60 ml/min/1,73 m2 (18,5 % z 10 mg dapagliflozina in 9,3 % s placebom).
English: In an add-on to glimepiride study, at weeks 24 and 48, minor episodes of hypoglycaemia were reported more frequently in the group treated with dapagliflozin 10 mg plus glimepiride (6.0 % and 7.9 %, respectively) than in the placebo plus glimepiride group (2.1 % and 2.1 %, respectively).
Slovenian: V študiji dodatka h glimepiridu (24. in 48. teden) so o blagih hipoglikemijah pogosteje poročali v skupini, ki je prejemala 10 mg dapagliflozina in glimepirid (6,0 % in 7,9 %) kot v skupini, ki je prejemala placebo in glimepirid (2,1 % in 2,1 %).
English: Effect of dapagliflozin on other medicinal products In interaction studies conducted in healthy subjects, using mainly a single-dose design, dapagliflozin did not alter the pharmacokinetics of metformin, pioglitazone, sitagliptin, glimepiride, hydrochlorothiazide, bumetanide, valsartan, digoxin (a P-gp substrate) or warfarin (S-warfarin, a CYP2C9 substrate), or the anticoagulatory effects of warfarin as measured by INR.
Slovenian: V študijah medsebojnega delovanja pri zdravih preiskovancih, ki so bile v glavnem izvedene po raziskovalnem načrtu z uporabo enkratnega odmerka, dapagliflozin ni spremenil farmakokinetike metformina, pioglitazona, sitagliptina, glimepirida, hidroklorotiazida, bumetanida, valsartana, digoksina (ki je substrat P-gp) ali varfarina (S-varfarina, ki je substrat CYP2C9); prav tako ni spremenil antikoagulantnih učinkov varfarina, merjenih z INR.
English: Following coadministration of dapagliflozin with mefenamic acid (an inhibitor of UGT1A9), a 55 % increase in dapagliflozin systemic exposure was seen, but with no clinically meaningful effect on 24-hour urinary glucose excretion.
Slovenian: Po sočasnem dajanju dapagliflozina in mefenaminske kisline (zaviralca UGT1A9), so zabeležili 55-odstotno povečanje sistemske izpostavljenosti dapagliflozinu, vendar brez klinično pomembnega učinka na 24-urno izločanje glukoze z urinom.
English: 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).
Slovenian: Pri osebah, starih ≥ 65 let, so o neželenih učinkih povezanih z okvaro ledvic ali odpovedjo, poročali pri 7,7 % oseb, ki so prejemale dapagliflozin in 3,8 % oseb, ki so prejemale placebo (glejte poglavje 4.4).
English: Microcrystalline cellulose (E460i) Lactose, anhydrous Crospovidone (E1202) Silicon dioxide (E551) Magnesium stearate (E470b)
Slovenian: Jedro tablete mikrokristalna celuloza (E460i) laktoza, brezvodna krospovidon (E1202) silicijev dioksid (E551) magnezijev stearat (E470b)
English: Urinary tract infection includes the following preferred terms, listed in order of frequency reported: urinary tract infection, cystitis, Escherichia urinary tract infection, genitourinary tract infection, pyelonephritis, trigonitis, urethritis, kidney infection and prostatitis.
Slovenian: Okužbe sečil obsegajo naslednje prednostne izraze, naštete v zaporedju opisanih pogostnosti: okužba sečil, cistitis, okužba sečil z Escherichio, okužba genitourinarnega trakta, pielonefritis, trigonitis, uretritis, okužba ledvic in prostatitis
English: Edistride is not recommended for use in patients with moderate to severe renal impairment (patients with CrCl < 60 ml/min or eGFR < 60 ml/min/1.73 m2).
Slovenian: Zdravila Edistride ni priporočljivo uporabljati pri bolnikih z zmerno do hudo okvaro ledvic (bolnikih s CrCl < 60 ml/min ali eGFR < 60 ml/min/1,73 m 2).
English: 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.
Slovenian: Pri osebah s hudo okvaro jeter (razred C po Child-Pughu) je bila povprečna Cmax dapagliflozina 40 % večja in njegova AUC 67 % večja kot pri usklajenih zdravih primerjalnih osebah.
English: Remember to take these other medicine(s) as your doctor has told you.
Slovenian: Pri jemanju teh drugih zdravil upoštevajte navodila svojega zdravnika.
English: Haematocrit increased Creatinine renal clearance decreased Dyslipidaemia
Slovenian: Preiskave povečan hematokrit zmanjšan ledvični očistek kreatinina dislipidemija povečanje kreatinina v krvi
English: Reported in ≥ 2 % of subjects and ≥ 1 % more and at least 3 more subjects treated with dapagliflozin 10 mg compared to placebo.
Slovenian: Opisano pri ≥ 2 % preiskovancev ter pri ≥ 1 % več in pri vsaj 3 preiskovancih več med uporabo 10 mg dapagliflozina kot med uporabo placeba.
English: In patients with normal renal function or mild renal impairment (baseline eGFR ≥ 60 ml/min/1.73 m2) this grouping of reactions 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 (izhodiščna ocenjena hitrost glomerularne filtracije [eGFR] ≥ 60 ml/min/1,73 m2) je bila ta skupina učinkov opisana pri 1,3 % bolnikov, ki so prejemali 10 mg dapagliflozina, in pri 0,8 % tistih, ki so prejemali placebo.
English: Monitoring of renal function is recommended as follows: • Prior to initiation of dapagliflozin and at least yearly, thereafter (see sections 4.2, 4.8, 5.1 and
Slovenian: • Pred začetkom zdravljenja z dapagliflozinom in nato vsaj enkrat letno (glejte poglavja 4.2, 4.8, 5.1 in 5.2).
English: Edistride contains the active substance dapagliflozin.
Slovenian: Zdravilo Edistride vsebuje zdravilno učinkovino dapagliflozin.
English: 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 a monotherapy (adjusted mean change from baseline: -2.04 % and 0.19 % for dapagliflozin 10 mg and placebo, respectively) and as an add-on to metformin (adjusted mean change from baseline: -1.32 % and -0.53 % for dapagliflozin and placebo, respectively).
Slovenian: V predhodno določeni analizi oseb z izhodiščno vrednostjo HbA1c ≥ 9,0 %, je zdravljenje z 10 mg dapagliflozina povzročilo statistično pomembna zmanjšanja HbA1c po 24. tednih tako v monoterapiji (prilagojena povprečna sprememba od izhodišča: -2,04 % za 10 mg dapagliflozina in 0,19 % za placebo) kot pri zdravljenju z dodatkom k metforminu (prilagojena povprečna sprememba od izhodišča: -1,32 % za dapagliflozin in -0,53 % za placebo).
English: film-coating: polyvinyl alcohol (E1203), titanium dioxide (E171), macrogol 3350, talc (E553b),
Slovenian: filmska obloga: polivinilalkohol (E1203), titanov dioksid (E171), makrogol 3350, smukec (E553b), rumeni železov oksid (E172).
English: tablet core: microcrystalline cellulose (E460i), anhydrous lactose (see section 2 ‘Edistride contains lactose'), crospovidone (E1202), silicon dioxide (E551), magnesium stearate (E470b).
Slovenian: • Druge sestavine zdravila so: jedro tablete: mikrokristalna celuloza (E460i), brezvodna laktoza (glejte poglavje 2 "Zdravilo Edistride vsebuje laktozo"), krospovidon (E1202), silicijev dioksid (E551), magnezijev stearat (E470b).
English: At Week 48 when added to sitagliptin (with or without metformin), the adjusted mean change from baseline for dapagliflozin 10 mg and placebo was -0.30 % and 0.38 %, respectively.
Slovenian: V 48. tednu študije dodatka k sitagliptinu (z ali brez metformina) je bila prilagojena povprečna sprememba od izhodišča -0,30 % z 10 mg dapagliflozina in 0,38 % s placebom.
English: 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).
Slovenian: Pri osebah, starih ≥ 65 let, so o pomanjkanju volumna kot neželenemu učinku, najpogosteje poročali kot o hipotenziji in jo zabeležili pri 1,7 % oseb, ki so prejemale dapagliflozin in pri 0,8 % oseb, ki so prejemale placebo (glejte poglavje 4.4).
English: At Week 104 for insulin (with or without additional oral glucose-lowering medicinal products), the HbA1c reductions were -0.71 % and -0.06 % adjusted mean change from baseline for dapagliflozin 10 mg and placebo, respectively.
Slovenian: 104. teden je bilo z insulinom povzročeno (z dodatnim peroralnim antidiabetikom ali brez njega) znižanje HbA1c -0,71 % oziroma0,06 % prilagojene povprečne spremembe od izhodišča z 10 mg dapagliflozina oziroma s placebom.
English: Dapagliflozin + metformin
Slovenian: Parameter dapagliflozin + metformin glipizid + metformin
English: 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.
Slovenian: V primerjavi z osebami s sladkorno boleznijo tipa 2 in normalnim delovanjem ledvic so v stanju dinamičnega ravnovesja (20 mg dapagliflozina enkrat na dan, 7 dni) imele osebe s sladkorno boleznijo tipa 2 in z blago okvaro ledvic povprečno sistemsko izpostavljenost dapagliflozinu večjo za 32 %, tiste z zmerno okvaro 60 % in tiste s hudo okvaro 87 % (stopnja okvare je bila ugotovljena s plazemskim očistkom joheksola).
English: At Week 208, adjusted mean change from baseline in HbA1c was -0.10 % for dapagliflozin and 0.20 % for glipizide.
Slovenian: 208. teden je bila prilagojena povprečna sprememba HbA1c od izhodišča pri dapagliflozinu -0,10 % in pri glipizidu 0,20 %.
English: • The other ingredients are:
Slovenian: Ob upoštevanju naslednjega:
English: In the extension period, HbA1c reductions were sustained through Week 102 (-0.61 %, and -0.17 % adjusted mean change from baseline for dapagliflozin 10 mg and placebo, respectively).
Slovenian: V obdobju podaljšanja se je zmanjšanje HbA1c ohranilo do 102. tedna (prilagojena povprečna sprememba od izhodišča -0,61 % z 10 mg dapagliflozina in -0,17 % s placebom).
English: • Edistride 10 mg film-coated tablets are yellow and diamond-shaped approximately 1.1 x 0.8 cm diagonally.
Slovenian: • Tablete zdravila Edistride 10 mg filmsko obložene tablete so rumene barve in rombaste oblike s približnimi diagonalami 1,1 x 0,8 cm. Na eni strani imajo vtisnjeno oznako "10" in na drugi strani "1428".
English: Edistride 5 mg film-coated tablets EU/1/15/1052/001 14 film-coated tablets EU/1/15/1052/002 28 film-coated tablets EU/1/15/1052/003 98 film-coated tablets EU/1/15/1052/004 30 x 1 (unit dose) film-coated tablets EU/1/12/1052/005 90 x 1 (unit dose) film-coated tablets
Slovenian: Edistride 5 mg filmsko obložene tablete EU/1/15/1052/001 14 filmsko obloženih tablet EU/1/15/1052/002 28 filmsko obloženih tablet EU/1/15/1052/003 98 filmsko obloženih tablet EU/1/15/1052/004 30 x 1 (enkratni odmerek) filmsko obložena tableta EU/1/12/1052/005 90 x 1 (enkratni odmerek) filmsko obložena tableta
English: LOCF: Last observation (prior to rescue for rescued subjects) carried forward All randomised subjects who took at least one dose of double-blind study medication during the short-term double-blind period Least squares mean adjusted for baseline value p-value < 0.0001 versus placebo Not evaluated for statistical significance as a result of the sequential testing procedure for secondary end points
Slovenian: LOCF: Prenos zadnjega opažanja (pred rešilnim zdravljenjem za preiskovance s takšnim zdravljenjem) [Last observation carried forward]) Vsi randomizirani preiskovanci, ki so prejeli vsaj en odmerek dvojno slepljenega raziskovanega zdravila v kratkoročnem dvojno slepem obdobju Povprečje najmanjših kvadratov, prilagojeno za izhodiščno vrednost Vrednost p < 0,0001 v primerjavi s placebom
English: Edistride 10 mg film-coated tablets EU/1/15/1052/006 14 film-coated tablets EU/1/15/1052/007 28 film-coated tablets EU/1/15/1052/008 98 film-coated tablets EU/1/15/1052/009 30 x 1 (unit dose) film-coated tablets EU/1/15/1052/010 90 x 1 (unit dose) film-coated tablets
Slovenian: Edistride 10 mg filmsko obložene tablete EU/1/15/1052/006 14 filmsko obloženih tablet EU/1/15/1052/007 28 filmsko obloženih tablet EU/1/15/1052/008 98 filmsko obloženih tablet EU/1/15/1052/009 30 x 1 (enkratni odmerek) filmsko obložena tableta EU/1/12/1052/010 90 x 1 (enkratni odmerek) filmsko obložena tableta
English: 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 10 mg and placebo, respectively).
Slovenian: V študiji dodatka k metforminu se je zmanjšanje HbA1c ohranilo do 102. tedna (prilagojena povprečna sprememba od izhodišča -0,78 % z 10 mg dapagliflozina in 0,02 % s placebom).
English: 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).
Slovenian: O učinkih, povezanih s pomanjkanjem volumna (vključno s poročili o dehidraciji, hipovolemiji ali hipotenziji) so poročali pri 1,1 % oseb, ki so prejemale 10 mg dapagliflozina, in 0,7 % oseb, ki so prejemale placebo.
English: At Week 104, adjusted mean change from baseline in HbA1c was -0.32 % for dapagliflozin and -0.14 % for glipizide.
Slovenian: 104. teden je bila prilagojena povprečna sprememba HbA1c od izhodišča pri dapagliflozinu -0,32 % in pri glipizidu -0,14 %.
English: Results of 24-week placebo-controlled studies of dapagliflozin in add-on combination with sulphonylurea (glimepiride) or metformin and a sulphonylurea
Slovenian: Rezultati 24-tedenskih s placebom kontroliranih študij dapagliflozina kot dodatka h kombinaciji s sulfonilsečnino (glimepirid) ali z metforminom in sulfonilsečnino Dodatek h kombinaciji sulfonilsečnina (glimepirid sulfonilsečnina + metformin dapagliflozin 10 mg placebo dapagliflozin 10 mg placebo
English: a) placebo-controlled studies of dapagliflozin in add-on combination with metformin or sitagliptin (with or without metformin) Add-on combination
Slovenian: a), s placebom kontroliranih študij dapagliflozina kot dodatka h kombinaciji z metforminom ali sitagliptinom (z ali brez metformina) Dodatek h kombinaciji metformin zaviralec DPP-4 (sitagliptin  metformin dapagliflozin 10 mg placebo dapagliflozin 10 mg placebo
English: (95 % CI) Subjects (%) achieving: HbA1c < 7 % (LOCF) Adjusted for baseline Body weight (kg) (LOCF) Baseline (mean) Change from baseline Difference from placebo c
Slovenian: (95 % IZ) Preiskovanci (%), ki so dosegli: HbA1c < 7 % (LOCF) Prilagojeno za izhodišče Telesna masa (kg) (LOCF) Izhodiščno (povprečje) Sprememba od izhodišča Razlika v primerjavi s placebom c
English: LOCF: Last observation carried forward
Slovenian: LOCF: Prenos zadnjega opažanja (pred rešilnim zdravljenjem za preiskovance s takšnim zdravljenjem) [Last observation carried forward]
English: (95 % CI) Subjects (%) achieving: HbA1c < 7 % Adjusted for baseline Body weight (kg) Baseline (mean) Change from baseline Difference from placebo c
Slovenian: (95 % IZ) Preiskovanci (%), ki so dosegli: HbA1c < 7% Prilagojeno za izhodišče Telesna masa (kg) Izhodišče (povprečje) Sprememba od izhodišča Razlika glede na placebo c
English: In an add-on to insulin study, episodes of major hypoglycaemia were reported in 0.5 % and 1.0 % of subjects treated with 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.
Slovenian: V študiji dodatka k insulinu 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.
English: The mean change from baseline in HbA1c at 24 weeks was -0.44 % and -0.33 %, for dapagliflozin 10 mg and placebo, respectively.
Slovenian: Povprečna sprememba HbA1c od izhodišča za 10 mg dapagliflozina je bila 24. teden -0,44 % in -0,33 % za placebo.
English: Columns 1 and 2, HbA1c analysed using LOCF (see footnote d); Columns 3 and 4, HbA1c analysed using LRM (see footnote e) Least squares mean adjusted for baseline value LOCF: Last observation (prior to rescue for rescued subjects) carried forward LRM: Longitudinal repeated measures analysis p-value < 0.0001 versus placebo + oral glucose-lowering medicinal product(s)
Slovenian: Stolpca 1 in 2, HbA1c analiziran po metodi LOCF (glejte opombo d), stolpca 3 in 4, HbA1c analiziran z metodo LRM (glejte opombo e)
English: Pack sizes of 14, 28 and 98 film-coated tablets in non-perforated calendar blisters Pack sizes of 30x1 and 90x1 film-coated tablets in perforated unit dose blisters
Slovenian: Velikosti pakiranj s 14, 28 in 98 filmsko obloženimi tabletami v neperforiranih koledarskih pretisnih omotih.
English: a) in an active-controlled study comparing dapagliflozin to glipizide as add-on to metformin
Slovenian: Rezultati z zdravilno učinkovino kontrolirane študije, ki je primerjala dapagliflozin z glipizidom kot dodatkom k metforminu po 52 tednih (LOCF
English: • Edistride 5 mg film-coated tablets are yellow and round with diameter of 0.7 cm.
Slovenian: • Tablete zdravila Edistride 5 mg filmsko obložene tablete so rumene barve, okrogle oblike s premerom 0,7 cm. Na eni strani imajo vtisnjeno oznako "5" in na drugi strani "1427".
English: Lietuva
Slovenian: Slovenija