FrancophonIA/ELRC3.0 huggingface dataset:
English: Inadequate insulin doses (missed insulin dose or insulin pump failure) were the most common precipitating factors.
Slovenian: Najpogostejši sprožilni dejavnik so bili nezadostni odmerki insulina (zaradi izpuščenega odmerka insulina ali odpovedi delovanja insulinske črpalke).
English: Statistically significant reductions in body weight were demonstrated for dapagliflozin compared with placebo (Table 11).
Slovenian: Z dapagliflozinom je bilo v primerjavi s placebom dokazano statistično značilno zmanjšanje telesne mase (preglednica 11).
English: Edistride5mg tablets are available in aluminium blisters in pack sizes of 14, 28 or 98film-coated tablets in non-perforated calendar blisters and 30x1 or 90x1 film-coated tablets in perforated unit dose blisters.
Slovenian: Zdravilo Edistride 5 mg filmsko obložene tablete je 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: Before initiating treatment with dapagliflozin:
Slovenian: Pred uvedbo zdravljenja z dapagliflozinom:
English: At Week 52, the adjusted mean changes in body weight from baseline for dapagliflozin 5 mg relative to placebo were -2.56 kg and -3.50 kg, in the two studies, respectively.
Slovenian: Po 52 tednih je bila prilagojena povprečna sprememba telesne mase od izhodišča s 5 mg dapagliflozina v primerjavi s placebom -2,56 kg v prvi študiji in -3,50 kg v drugi študiji.
English: When needed, insulin dose reduction should be done cautiously to avoid ketosis and DKA (see section 4.2).
Slovenian: Če je odmerek insulina treba zmanjšati, je zmanjšanje treba izvesti previdno, da bi se izognili ketozi in DKA (glejte poglavje 4.2).
English: Type 2 diabetes:
Slovenian: Sladkorna bolezen tipa 2:
English: Rare cases of DKA, including life-threatening and fatal cases, have been reported in patients treated with SGLT2 inhibitors, including dapagliflozin.
Slovenian: Pri bolnikih, zdravljenih z zaviralci SGLT2, tudi z dapagliflozinom, so poročali o redkih primerih DKA, vključno s smrtno nevarnimi primeri in primeri s smrtnim izidom.
English: Edistride10mg tablets are available in aluminium blisters in pack sizes of 14, 28 or 98film-coated tablets in non-perforated calendar blisters and 30x1 or 90x1 film-coated tablets in perforated unit dose blisters.
Slovenian: Zdravilo Edistride 10 mg filmsko obložene tablete je 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: Temporary interruption of treatment with dapagliflozin is recommended for patients who develop volume depletion until the depletion is corrected (see section 4.8).
Slovenian: Če se pri bolniku pojavi zmanjšanje volumna, je priporočljivo začasno prekiniti zdravljenje z dapagliflozinom dokler zmanjšanje ni odpravljeno (glejte poglavje 4.8).
English: If ketones are elevated (blood beta-hydroxybutyrate reading 0.6 mmol/L or greater), treatment with dapagliflozin should not be started until the ketone levels are normal
Slovenian: Če so ketoni zvišani (koncentracija beta-hidroksibutirata v krvi 0,6 mmol/l ali več), se zdravljenja z dapagliflozinom ne sme uvesti, dokler koncentracija ketonov ni normalna (glejte poglavje 4.2).
English: Statistically significant increases in the percentage of glucose readings falling within the range of > 70 mg/dL to ≤ 180 mg/dL from baseline to Week 24 for dapagliflozin 5 mg relative to placebo were +9.11% and +9.02% in the two studies, respectively (p < 0.0001).
Slovenian: V teh dveh študijah so od izhodišča do 24. tedna ugotovili statistično značilno večji odstotek odčitkov glukoze v razponu od > 70 mg/dl do ≤ 180 mg/dl s 5 mg dapagliflozina kot s placebom (+9,11 % v eni in +9,02 % v drugi študiji).
English: As an add-on therapy to metformin in an active-controlled non-inferiority study, dapagliflozin resulted in a statistically significant body weight reduction compared with glipizide of -4.65 kg at 52 weeks (p < 0.0001, Table 4) that was sustained at 104 and 208 weeks (-5.06 kg and -4.38 kg, respectively).
Slovenian: Dapagliflozin je kot dodatek zdravljenju z metforminom v z učinkovino kontrolirani študiji neinferiornosti, v primerjavi z glipizidom, statistično značilno znižal telesno maso za -4,65 kg po 52 tednih (p < 0,0001, preglednica 4); znižanje se je 104. in 208. teden ohranilo (-5,06 kg po 104 in -4,38 kg po 208 tednih).
English: Non-inferior to glipizide + metformin p-value < 0.0001
Slovenian: Povprečje najmanjših kvadratov, prilagojeno za izhodiščno vrednost Neinferiorno glede na glipizid + metformin Vrednost p < 0,0001
English: What Edistride contains
Slovenian: Kaj vsebuje zdravilo Edistride
English: As an add-on therapy to metformin in an active-controlled non-inferiority study, dapagliflozin resulted in a statistically significant body weight reduction compared with glipizide of -4.65 kg at 52 weeks (p < 0.0001, Table 3) that was sustained at 104 and 208 weeks (-5.06 kg and -4.38 kg, respectively).
Slovenian: Dapagliflozin je kot dodatek zdravljenju z metforminom v z učinkovino kontrolirani študiji neinferiornosti, v primerjavi z glipizidom, statistično značilno znižal telesno maso za -4,65 kg po 52 tednih (p < 0,0001, preglednica 3); znižanje se je 104. in 208. teden ohranilo (-5,06 kg po 104 in -4,38 kg po 208 tednih).
English: Skin and subcutaneous tissue disorders
Slovenian: Bolezni kože in podkožja izpuščaj angioedem
English: What Edistride is used for
Slovenian: Za kaj uporabljamo zdravilo Edistride
English: Statistically significant (p < 0.0001) differences in percent reduction of total insulin dose from baseline for dapagliflozin 5 mg relative to placebo at Week 24 were -8.80% and -10.78% in the two studies, respectively.
Slovenian: Razliki v odstotku znižanja celotnega odmerka insulina od izhodišča do 24. tedna med 5 mg dapagliflozina in placebom sta bili statistično značilni (p < 0,0001), in sicer -8,80 % v prvi študiji in -10,78 % v drugi študiji.
English: The adjusted mean changes for dapagliflozin 5 mg relative to placebo in the mean amplitude of glucose excursion from baseline to Week 24 were -0.96 mmol/L (-17.30 mg/dL) and -0.55 mmol/L (-9.85 mg/dL) in the two studies, respectively (p < 0.0001).
Slovenian: Prilagojeni povprečni spremembi povprečne amplitude odmikov glukoze s 5 mg dapagliflozina v primerjavi s placebom od izhodišča do 24. tedna sta bili -0,96 mmol/l (-17,30 mg/dl) v prvi študiji in -0,55 mmol/l (-9,85 mg/dl) v drugi študiji (p < 0,0001).
English: In the 13-study safety pool, reactions suggestive of 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: V kumulativni obravnavi 13 študij o varnosti so o učinkih, ki so nakazovali zmanjšanje volumna (vključno s poročili o dehidraciji, hipovolemiji ali hipotenziji) poročali pri 1,1 % oseb, ki so prejemale 10 mg dapagliflozina, in 0,7 % oseb, ki so prejemale placebo.
English: CALENDAR BLISTERS NON-PERFORATED 5 mg
Slovenian: NEPERFORIRANI KOLEDARSKI PRETISNI OMOTI 5 mg
English: Results of 24-week (LOCF a) placebo-controlled studies of dapagliflozin in add-on combination with metformin or sitagliptin (with or without metformin) Add-on combination
Slovenian: Rezultati 24-tedenskih (LOCF 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: What Edistride is
Slovenian: Kaj je zdravilo Edistride
English: HbA1c (%) Baseline (mean) Change from baseline Difference from placebo c
Slovenian: HbA1c (%) Izhodiščno (povprečje) Sprememba od izhodišča Razlika v primerjavi s placebom c
English: CALENDAR BLISTERS NON-PERFORATED 10 mg
Slovenian: NEPERFORIRANI KOLEDARSKI PRETISNI OMOTI 10 mg
English: a) in a placebo-controlled study of dapagliflozin in combination with insulin (alone or with oral glucose-lowering medicinal products)
Slovenian: Rezultati s placebom kontrolirane študije dapagliflozina v kombinaciji z insulinom (samim ali skupaj s peroralnim antidiabetikom) po 24 tednih (LOCF
English: Edistride should not be initiated in patients with a GFR < 60 mL/min and should be discontinued at GFR persistently below 45 mL/min.
Slovenian: Zdravila Edistride se ne sme uvesti pri bolnikih z GFR < 60 ml/min.
English: Dapagliflozin 10 mg + insulin ± oral glucose-lowering medicinal products
Slovenian: Parameter dapagliflozin 10 mg + insulin ± peroralni antidiabetiki placebo + insulin ± peroralni antidiabetiki
English: Edistride 10 mg tablets dapagliflozin
Slovenian: Edistride 10 mg tablete dapagliflozin
English: Change from baseline Difference from placebo 95% CI
Slovenian: Razlika v primerjavi s placebom (95 % IZ)
English: Treatment with dapagliflozin resulted in reductions in HbA1c and body weight compared with placebo (Table 10).
Slovenian: Zdravljenje z dapagliflozinom je v primerjavi s placebom doseglo znižanje HbA1c in telesne mase (preglednica 10).
English: Glipizide + metformin
Slovenian: Parameter dapagliflozin + metformin glipizid + metformin
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: Each Edistride 5 mg film-coated tablet (tablet) contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin.
Slovenian: Ena tableta zdravila Edistride 5 mg filmsko obložene tablete vsebuje dapagliflozin-propandiol monohidrat, kolikor ga ustreza 5 mg dapagliflozina.
English: How to store Edistride
Slovenian: Shranjevanje zdravila Edistride
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: Rash includes the following preferred terms, listed in order of frequency in clinical studies: rash, rash generalised, rash pruritic, rash macular, rash maculo-papular, rash pustular, rash vesicular, and rash erythematous.
Slovenian: Izpuščaj vključuje naslednje prednostne izraze, naštete v zaporedju po pogostnosti v kliničnih študijah: izpuščaj, generaliziran izpuščaj, srbeč izpuščaj, makularen izpuščaj, makulo-papularen izpuščaj, pustularen izpuščaj, vezikularen izpuščaj in eritematozen izpuščaj.
English: Each tablet contains dapagliflozin propanediol monohydrate equivalent to 10 mg dapagliflozin.
Slovenian: Ena tableta vsebuje dapagliflozin-propandiol monohidrat, kolikor ga ustreza 10 mg dapagliflozina.
English: The following adverse reactions have been identified in the placebo-controlled clinical studies and postmarketing surveillance.
Slovenian: V s placebom kontroliranih kliničnih študij in iz nadzora v obdobju trženja so ugotovili naslednje neželene učinke.
English: Edistride 5 mg tablets dapagliflozin
Slovenian: Edistride 5 mg tablete dapagliflozin
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 Zmanjšanje volumna vključuje, npr. vnaprej definirane prednostne izraze: dehidracija, hipovolemija, hipotenzija.
English: OUTER CARTON 10 mg
Slovenian: ZUNANJA ŠKATLA 10 mg
English: Change from baseline Difference from glipizide + metformin c
Slovenian: Izhodišče (povprečje) Sprememba od izhodišča Razlika glede na glipizid + metformin c
English: • Your doctor may start you on a 5 mg dose if you have a liver problem.
Slovenian: • Če imate kakšne težave z jetri, lahko zdravnik zdravljenje začne z odmerkom 5 mg.
English: Each tablet contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin.
Slovenian: Ena tableta vsebuje dapagliflozin-propandiol monohidrat, kolikor ga ustreza 5 mg dapagliflozina.
English: Placebo Dapagliflozin 10 mg
Slovenian: Monoterapija dapagliflozin 10 mg placebo
English: At Week 52, adjusted mean changes from baseline in HbA1c relative to placebo were -0.33% and -0.20% for patients treated with dapagliflozin 5 mg, in the two studies, respectively.
Slovenian: Po 52 tednih je bila prilagojena povprečna sprememba HbA1c od izhodišča s 5 mg dapagliflozina v primerjavi s placebom -0,33 % v prvi študiji in -0,20 % v drugi.
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,
English: Each Edistride 10 mg film-coated tablet (tablet) contains dapagliflozin propanediol monohydrate equivalent to 10 mg dapagliflozin.
Slovenian: Ena tableta zdravila Edistride 10 mg filmsko obložene tablete vsebuje dapagliflozin-propandiol monohidrat, kolikor ga ustreza 10 mg dapagliflozina.
English: Type 2 diabetes mellitus
Slovenian: Sladkorna bolezen tipa 2
English: - on its own - if you cannot tolerate metformin.
Slovenian: • Zdravnik vam lahko predpiše zdravilo Edistride: - samo - če ne prenesete metformina.
English: Before initiating dapagliflozin
Slovenian: Pred uvedbo dapagliflozina:
English: BLISTERS PERFORATED UNIT DOSE 10 mg
Slovenian: PERFORIRANI PRETISNI OMOTI ZA POSAMEZNI ODMEREK 10 mg
English: Edistride 10 mg film-coated tablets
Slovenian: Edistride 10 mg filmsko obložene tablete
English: • urinary tract infection, seen commonly (may affect up to 1 in 10 people).
Slovenian: • okužba sečil, ki je pogosta (lahko se pojavi pri največ 1 od 10 bolnikov).
English: BLISTERS PERFORATED UNIT DOSE 5 mg
Slovenian: PERFORIRANI PRETISNI OMOTI ZA POSAMEZNI ODMEREK 5 mg
English: HbA1c (%) Baseline (mean) Change from baseline
Slovenian: HbA1c (%) Izhodišče (povprečje) Sprememba od izhodišča
English: OUTER CARTON 5 mg
Slovenian: ZUNANJA ŠKATLA 5 mg
English: Edistride is used for the type of diabetes called type 2 diabetes - where your body does not make enough insulin or is not able to use the insulin it produces properly.
Slovenian: Pri tej vrsti sladkorne bolezni v telesu ne nastaja dovolj insulina ali pa telo ne more ustrezno uporabiti insulina, ki nastaja.
English: The combination of dapagliflozin 10 mg and prolonged-release exenatide demonstrated significantly greater weight reductions compared to either medicinal product alone (Table 9).
Slovenian: Pri kombiniranem zdravljenju z 10 mg dapagliflozina in eksenatidom v obliki s podaljšanim sproščanjem je bilo doseženo značilno večje zmanjšanje telesne mase kot pri kateri od obeh zdravil samih (preglednica 9).
English: Results at Week 24 (LOCF a) of a placebo-controlled study of dapagliflozin as monotherapy
Slovenian: Rezultati s placebom kontrolirane študije dapagliflozina kot monoterapije po 24 tednih (LOCF
English: Body weight (kg) Baseline (mean) Change from baseline Difference from placebo c
Slovenian: Telesna masa (kg) Izhodišče (povprečje) Sprememba od izhodišča Razlika glede na glipizid + metformin c
English: Percent change from baseline Difference in percent change from placebo c
Slovenian: Razlika glede na placebo c
English: The combination of dapagliflozin 10 mg and prolonged-release exenatide demonstrated significantly greater weight reductions compared to either medicinal product alone (Table 8).
Slovenian: Pri kombiniranem zdravljenju z 10 mg dapagliflozina in eksenatidom v obliki s podaljšanim sproščanjem je bilo doseženo značilno večje zmanjšanje telesne mase kot pri kateri od obeh zdravil samih (preglednica 8).
English: Edistride and other diabetes medicines
Slovenian: Zdravilo Edistride in druga zdravila za sladkorno bolezen Sladkorna bolezen tipa 1:
English: EU/1/15/1052/007 28 film-coated tablets
Slovenian: EU/1/15/1052/007 28 filmsko obloženih tablet
English: Edistride 5 mg film-coated tablets
Slovenian: Edistride 5 mg filmsko obložene tablete
English: A double-blind, placebo-controlled study of 24-week duration (with an additional extension period) was conducted to evaluate the safety and efficacy of monotherapy with Edistride in subjects with inadequately controlled type 2 diabetes mellitus.
Slovenian: Za oceno varnosti in učinkovitosti monoterapije z zdravilom Edistride pri osebah z neustrezno urejeno sladkorno boleznijo tipa 2 so izvedli 24-tedensko, dvojno slepo, s placebom kontrolirano študijo (z dodatnim obdobjem podaljšanja).
English: Do not drive or use any tools or machines, if you feel dizzy taking Edistride.
Slovenian: Če med jemanjem zdravila Edistride občutite omotico, ne vozite in ne uporabljajte orodij ali strojev.
English: EU/1/15/1052/008 98 film-coated tablets
Slovenian: EU/1/15/1052/008 98 filmsko obloženih tablet
English: Talk to your doctor, pharmacist or nurse before taking Edistride:
Slovenian: Pred začetkom jemanja zdravila Edistride se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro:
English: The combination treatment with dapagliflozin 10 mg and prolonged-release exenatide group showed superior reductions in HbA1c from baseline compared to dapagliflozin alone and prolonged-release exenatide alone (Table 9).
Slovenian: V primerjavi s samim dapagliflozinom ali samim eksenatidom v obliki s podaljšanim sproščanjem je kombinirano zdravljenje z 10 mg dapagliflozina in eksenatidom v obliki s podaljšanim sproščanjem bolj znižalo HbA1c v primerjavi z izhodiščem (preglednica 9).
English: Dapagliflozin as an add-on with either metformin, glimepiride, metformin and a sulphonylurea, sitagliptin (with or without metformin) or insulin resulted in statistically significant reductions in HbA1c at 24 weeks compared with subjects receiving placebo (p < 0.0001; Tables 5, 6 and 7).
Slovenian: Dapagliflozin je kot dodatek bodisi k metforminu, glimepiridu, metforminu in sulfonilsečnini, sitagliptinu (z ali brez metformina) ali insulinu po 24 tednih statistično značilno zmanjšal HbA1c v primerjavi z osebami, ki so prejemale placebo (p < 0,0001; Preglednice 5, 6 in 7).
English: EU/1/15/1052/006 14 film-coated tablets
Slovenian: EU/1/15/1052/006 14 filmsko obloženih tablet
English: 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: EU/1/15/1052/009 30 x 1 (enkratni odmerek) filmsko obložena tableta EU/1/15/1052/010 90 x 1 (enkratni odmerek) filmsko obložena tableta
English: EU/1/15/1052/003 98 film-coated tablets
Slovenian: EU/1/15/1052/003 98 filmsko obloženih tablet
English: Stop taking Edistride and see a doctor as soon as possible if you notice any of the following serious side effects:
Slovenian: Če opazite katerega od naslednjih resnih neželenih učinkov, prenehajte z jemanjem zdravila Edistride in čim prej obiščite zdravnika:
English: EU/1/15/1052/001 14 film-coated tablets
Slovenian: EU/1/15/1052/001 14 filmsko obloženih tablet
English: 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: 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: EU/1/15/1052/002 28 film-coated tablets
Slovenian: EU/1/15/1052/002 28 filmsko obloženih tablet
English: EU/1/15/1052/004 30 x 1 (unit dose) film-coated tablets EU/1/15/1052/005 90 x 1 (unit dose) film-coated tablets
Slovenian: EU/1/15/1052/004 30 x 1 (enkratni odmerek) filmsko obložena tableta EU/1/15/1052/005 90 x 1 (enkratni odmerek) filmsko obložena tableta
English: Dizziness
Slovenian: Zmerno
English: - At blood ketone readings over 3.0 mmol/L (or urine ketones reading +++) you probably have diabetic ketoacidosis, go to the emergency department without delay and stop taking Edistride.
Slovenian: - Če je koncentracija ketonov v krvi več kot 3,0 mmol/l (ali če je rezultat testiranja ketonov v urinu +++), verjetno imate diabetično ketoacidozo.
English: Following an 8-week lead-in period to optimise each patient's diabetes management (glycaemic control including hyperglycaemia and hypoglycaemia, diet and exercise patterns), a total of 1,646 patients with HbA1c ≥ 7.5% and ≤ 10.5% were randomised to 5 mg dapagliflozin once daily, 10 mg dapagliflozin once daily or placebo once daily.
Slovenian: bolnikov s HbA1c ≥ 7,5 % in ≤ 10,5 %, randomizirali na 5 mg dapagliflozina enkrat na dan, 10 mg dapagliflozina enkrat na dan ali placebo enkrat na dan.
English: Edistride 5 mg film-coated tablets dapagliflozin
Slovenian: Edistride 5 mg filmsko obložene tablete dapagliflozin
English: Blood urea increased Weight decreased
Slovenian: **,b povečanje sečnine v krvi zmanjšanje telesne mase
English: Edistride 5 mg Tablets
Slovenian: Zdravilo Edistride 5 mg tablete:
English: Results at Week 52 (LOCF a) in an active-controlled study comparing dapagliflozin to glipizide as add-on to metformin
Slovenian: Rezultati z učinkovino kontrolirane študije, ki je primerjala dapagliflozin z glipizidom kot dodatkom k metforminu po 52 tednih (LOCF
English: • DKA may occur in patients treated with dapagliflozin even if blood glucose levels are below 14
Slovenian: • DKA se lahko pojavi pri bolnikih, ki prejemajo dapagliflozin, tudi če imajo koncentracijo glukoze v krvi pod 14 mmol/l (250 mg/dl).
English: Edistride 10 mg film-coated tablets dapagliflozin
Slovenian: Edistride 10 mg filmsko obložene tablete dapagliflozin
English: Dapagliflozin 10 mg as an add-on to metformin, glimepiride, metformin and a sulphonylurea, sitagliptin (with or without metformin) or insulin resulted in statistically significant body weight reduction at 24 weeks (p < 0.0001, Tables 5 and 6).
Slovenian: 10 mg dapagliflozina kot dodatka bodisi metforminu, glimepiridu, metforminu in sulfonilsečnini sitagliptinu (z ali brez metformina) ali insulinu, je do 24. tedna statistično značilno zmanjšalo telesno maso (p < 0,0001, preglednici 5 in 6).
English: Diabetic ketoacidosis (when used in type 2 diabetes mellitus)
Slovenian: b,i,k zmanjšanje volumna b,e žeja diabetična ketocidoza (v primeru uporabe pri sladkorni bolezni tipa 2)
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 30 x 1 in 90 x 1 filmsko obloženo tableto v perforiranih pretisnih omotih za posamezni odmerek.
English: Seek medical advice immediately and stop taking Edistride if levels persist and symptoms present.
Slovenian: Če koncentracija traja in so prisotni simptomi, nemudoma poiščite zdravniški nasvet in prenehajte jemati zdravilo Edistride.
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
Slovenian: Vsi randomizirani preiskovanci, ki so vzeli vsaj en odmerek dvojno slepljenega raziskovanega zdravila med kratkoročnim dvojno slepim obdobjem
English: (95% CI) Subjects (%) achieving: HbA1c < 7% Adjusted for baseline
Slovenian: (95 % IZ) Preiskovanci (%), ki so dosegli: HbA1c < 7 % Prilagojeno za izhodišče Telesna masa (kg) Izhodišče (povprečje) Sprememba od izhodišča Razlika v primerjavi s placebom c
English: Special populations: Elderly patients (≥65 years old)
Slovenian: Posebne skupine bolnikov: Starejši bolniki (≥ 65 let)