FrancophonIA/ELRC3.0 huggingface dataset:
English: Fifty percent (50%) had mild renal impairment and 11% had moderate renal impairment.
Maltese: Tnejn u ħamsin fil-mija (50%) kellhom indeboliment renali ħafif u 11% kellhom indeboliment renali moderat.
English: Vulvovaginal pruritus Pruritus genital
Maltese: Prurite vulvovaġin ali Prurite ġenitali
English: Combination therapy of dapagliflozin 10 mg and prolonged-release exenatide resulted in significantly greater reductions in FPG at Week 28: -3.66 mmol/L (-65.8 mg/dL), compared to -2.73 mmol/L (-49.2 mg/dL) for dapagliflozin alone (p < 0.001) and -2.54 mmol/L (-45.8 mg/dL) for exenatide alone (p < 0.001).
Maltese: Terapija kkombinata ta' dapagliflozin 10 mg u exenatide li jerħi l-mediċina bil-mod irriżultat f'tnaqqis konsiderevolment ikbar fl-FPG fit-28 Ġimgħa -3.66 mmol/L (-65.8 mg/dL), meta mqabbel ma' -2.73 mmol/L (-49.2 mg/dL) għal dapagliflozin waħdu (p < 0.001) u -2.54 mmol/L (-45.8 mg/dL) għal exenatide waħdu (p < 0.001).
English: • Patients with excessive alcohol consumption or who use illicit drugs.
Maltese: • Pazjenti b'konsum eċċessiv tal-alkoħol jew li jużaw droga illegali.
English: Geometric mean steady-state dapagliflozin Cmax and AUCτ values following once daily 10 mg doses of dapagliflozin were 158 ng/mL and 628 ng h/mL, respectively.
Maltese: Valuri tas-Cmax u l-AUCτ ta' dapagliflozin fl-istat fiss medju ġejometriku wara dożi ta' 10 mg darba kuljum ta' dapagliflozin kienu 158 ng/mL u 628 ng h/mL, rispettivament.
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Pazjenti li għandhom problemi ereditarji rari ta' intolleranza għall-galactose, nuqqas ta' lactase totali jew malassorbiment tal-glukows-galactose m'għandhomx jieħdu din ilmediċina.
English: Ketone monitoring:
Maltese: Monitoraġġ tal-“ketone”:
English: The mean steady-state volume of distribution of dapagliflozin was 118 liters.
Maltese: Il-volum tad-distribuzzjoni medju fl-istat fiss ta' dapagliflozin kien 118-il litru.
English: Edistride contains the active substance dapagliflozin.
Maltese: Edistride fih is-sustanza attiva li tissejjaħ dapagliflozin.
English: Results at Week 24 (LOCF
Maltese: Riżultati f'Ġimgħa 24 (LOCF
English: • Guidance to the physician for assessing whether the patient is eligible for dapagliflozin prescription, e.g. patient selection criteria including adherence to insulin treatment and insulin thresholds, patient's beta-hydroxybutyrate (BHB) < 0.6 mmol/L or urine ketones < 1+, BMI ≥ 27 kg/m2, absence of DKA risk factors.
Maltese: • Gwida għat-tabib għall-valutazzjoni ta' jekk il-pazjent huwiex eleġibbli għal preskrizzjoni ta' dapagliflozin, eż. kriterji tal-għażla tal-pazjent inkluż konformità mal-kura bl-insulina u limiti tal-insulina, beta-hydroxybutyrate (BHB) tal-pazjent < 0.6 mmol/L jew “ketones” fl-awrina < 1+, BMI ≥ 27 kg/m2, nuqqas ta' fatturi ta' riskju ta' DKA.
English: Rare cases of DKA, including life-threatening and fatal cases, have been reported in patients treated with SGLT2 inhibitors, including dapagliflozin.
Maltese: Każijiet rari ta' DKA, inklużi każijiet ta' theddida għall-ħajja u fatali, ġew irrapportati f'pazjenti kkurati b'inibituri SGLT2, inkluż dapagliflozin.
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.
Maltese: Raxx jinkludi t-termini ppreferuti li ġejjin, elenkati skont il-frekwenza fi studji kliniċi: raxx, raxx ġeneralizzat, raxx pruritiku, raxx makulari, raxx makulo-papulari, raxx pustulari, raxx vexxikulari, u raxx eretematuż.
English: (95% CI) Subjects (%) achieving: HbA1c < 7% Adjusted for baseline
Maltese: (95% CI) Individwi (%) li kisbu: HbA1c < 7% (LOCF)
English: Add-on combination therapy
Maltese: Terapija kombinata miżjuda
English: In addition, dapagliflozin reduced the new onset of sustained albuminuria (hazard ratio 0.79 [95% CI 0.72, 0.87]) and led to greater regression of macroalbuminuria (hazard ratio 1.82 [95% CI 1.51, 2.20]) compared with placebo.
Maltese: • Barra minn hekk, dapagliflozin naqqas il-bidu ġdid ta' albuminurja sostnuta ( (proporzjon ta' periklu 0.79 [95% CI 0.72, 0.87]) u wassal għal rigressjoni ta' makroalbuminurja (proporzjon ta' periklu 1.82 [95% CI 1.51, 2.20]) meta mqabbel ma' plaċebo.
English: Vulvovaginitis, balanitis and related genital infections includes, e.g. the predefined preferred terms: vulvovaginal mycotic infection, vaginal infection, balanitis, genital infection fungal, vulvovaginal candidiasis, vulvovaginitis, balanitis candida, genital candidiasis, genital infection, genital infection male, penile infection, vulvitis, vaginitis bacterial, vulval abscess.
Maltese: Vulvovaġinite, balanite u infezzjonijiet relatati jinkludu, eż. iżda mhumiex limitati, għat-termini preferiti definiti minn qabel, infezzjoni mikotika vulvovaġinali, infezzjoni fil-vaġina, balanite, infezzjoni ġenitali tal-fungu, kandidijasi vulvovaġinali, vulvovaġinite, balanite kandida, kandidijasi ġenitali, infezzjoni ġenitali, infezzjoni ġenital fl-irġiel, infezzjoni tal-pene, vulvite, vaginite batterika, axxess fil-vulva.
English: Treatment with dapagliflozin 10 mg as a monotherapy or as an add-on to either metformin, glimepiride, metformin and a sulphonylurea, sitagliptin (with or without metformin) or insulin resulted in statistically significant reductions in FPG (-1.90 to -1.20 mmol/L [-34.2 to -21.7 mg/dL]) compared to placebo (-0.33 to 0.21 mmol/L [-6.0 to 3.8 mg/dL]).
Maltese: Kura b'dapagliflozin 10 mg bħala monoterapija jew miżjud ma' metformin, glimipiride, metformin u sulphonylurea, sitagliptin (bi jew mingħajr metformin) jew insulina wasslet għal tnaqqis statistikament sinifikanti tal-glukows fl-FPG (-1.90 għal -1.20 mmol/L [-34.2 għal -21.7 mg/dL]) imqabbel malplaċebo (-0.33 għal 0.21 mmol/L [-6.0 għal 3.8 mg/dL]).
English: Alu/Alu blister
Maltese: Folja Alu/Alu
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).
Maltese: Fil-ġabra ta' 13-il studju ta' sigurtà, reazzjonijiet li jissuġġerixxu tnaqqis tal-volum (inklużi rapporti ta' deidratazzjoni, ipovolumja jew pressjoni baxxa) kienu rrappurtati f'1.1% u 0.7% tal-individwi li rċievew dapagliflozin 10 mg u l-plaċebo, rispettivament; reazzjonijiet serji seħħew f'< 0.2% talindividwi u kienu bilanċati bejn dapagliflozin 10 mg u l-plaċebo (ara sezzjoni 4.4).
English: Excipient with known effect: Each 5 mg tablet contains 25 mg of lactose anhydrous.
Maltese: Kull pillola ta' 5 mg fiha 25 mg ta' lactose anhydrous.
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).
Maltese: Żidiet statistikament sinifikanti fil-perċentwal tal-qari tal-glucose li jaqgħu fil-medda ta' > 70 mg/dL sa ≤ 180 mg/dL mil-linja bażi sa Ġimgħa 24 għal dapagliflozin 5 mg relattiv għal plaċebo kienu +9.11% u +9.02% fiż-żewġ studji, rispettivament (p < 0.0001).
English: Superiority of dapagliflozin over placebo was not demonstrated for MACE (p=0.172).
Maltese: Is-superjorità ta' dapagliflozin fuq plaċebo ma ntweritx għal MACE (p= 0.172).
English: Edistride 10 mg tablets dapagliflozin
Maltese: Edistride 10 mg pilloli dapagliflozin
English: There is limited experience in clinical studies in patients with hepatic impairment.
Maltese: Hemm esperjenza limitata fi studji kliniċi f'pazjenti b'indeboliment epatiku.
English: Haematocrit increased Creatinine renal clearance decreased during initial treatment Dyslipidaemia
Maltese: KONDIZZJONIJIET JEW RESTRIZZJONIJIET FIRRIGWARD TAL-UŻU SIGUR U EFFIKAĊI TAL-PRODOTT MEDIĊINALI
English: Results of 24-week placebo-controlled studies of dapagliflozin in add-on combination with sulphonylurea (glimepiride) or metformin and a sulphonylurea Add-on combination Sulphonylurea (glimepiride
Maltese: Riżultati ta' studji kkontrollati bil-plaċebo fuq 24 ġimgħa b'dapagliflozin f'taħlita miżjud ma' sulphonylurea (glimepiride) jew metformin u sulphonylurea
English: 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
Maltese: Medja tal-anqas kwadri aġġustata għall-valur tal-linja bażi valur-p < 0.0001 kontra plaċebo + prodott mediċinali orali li jbaxxi l-glukows valur-p < 0.05 kontra plaċebo + prodott mediċinali li jbaxxi l-glukows
English: Insulin dose
Maltese: Doża tal-insulina
English: The number of patients with severe hypoglycaemia was balanced across treatment groups (6.9% and 7.5% at Week 24 in the dapagliflozin 5 mg and placebo groups, respectively).
Maltese: In-numru ta' pazjenti b'ipogliċemija severa kien ibbilanċjat fil-gruppi talkura (6.9% u 7.5% f'Ġimgħa 24 fil-gruppi ta' dapagliflozin 5 mg u plaċebo, rispettivament).
English: Effect of other medicinal products on dapagliflozin Interaction studies conducted in healthy subjects, using mainly a single-dose design, suggest that the pharmacokinetics of dapagliflozin are not altered by metformin, pioglitazone, sitagliptin, glimepiride, voglibose, hydrochlorothiazide, bumetanide, valsartan, or simvastatin.
Maltese: Effett ta' prodotti mediċinali oħra fuq dapagliflozin Studji dwar interazzjoni li saru f'individwi b'saħħithom, permezz ta' mudell b'doża waħda, jindikaw li l-farmakokinetika ta' dapagliflozin ma tiġix mibdula b'metformin, pioglitiazone, sitagliptin, glimepride, voglibose, hydrochlorothiazide, bumetanide, valsartan, jew simvastatin.
English: In the 13-study safety pool, urinary tract infections were more frequently reported for dapagliflozin 10 mg compared to placebo (4.7% versus 3.5%, respectively; see section 4.4).
Maltese: Fil-ġabra ta' 13-il studju ta' sigurtà, l-infezzjonijiet fil-passaġġ tal-awrina kollha rrappurtati f'individwi b'dapagliflozin 10 mg meta mqabbel mal-plaċebo (4.7% kontra 3.5%, rispettivament, ara sezzjoni 4.4).
English: Edistride 5 mg tablets dapagliflozin
Maltese: Edistride 5 mg pilloli dapagliflozin
English: The mean total systemic clearance of dapagliflozin administered intravenously was 207 mL/min.
Maltese: Il-clearance medja totali sistemika ta' dapagliflozin mogħti minn ġol-vina kienet 207 mL/min.
English: Necrotising fasciitis of the perineum (Fournier's gangrene) Postmarketing cases of necrotising fasciitis of the perineum (also known as Fournier's gangrene) have been reported in female and male patients taking SGLT2 inhibitors (see section 4.8).
Maltese: Faxxite nekrotizzanti tal-perinew (kankrena ta' Fournier) Ġew irrappurtati każijiet ta' wara t-tqegħid fis-suq ta' faxxite nekrotizzanti tal-perinew (magħrufa wkoll bħala kankrena ta' Fournier) f'pazjenti nisa u rġiel li kienu qed jieħdu inibituri ta' SGLT2 (ara sezzjoni 4.8).
English: Laboratorio Tau, S. A. Tel: +34 91 301 91 00
Maltese: Tel: +34 91 301 91 00
English: They have “5” on one side and “1427” on the other side.
Maltese: fuq naħa u “1427” fuq in-naħa l-oħra.
English: Results at Week 24 (LOCF a) of a placebo-controlled study of dapagliflozin as monotherapy
Maltese: Tabella 3. Riżultati f'Ġimgħa 24 (LOCF a) ta' studju kontrollat bi plaċebo b'dapagliflozin bħala monoterapija
English: Yellow, biconvex, approximately 1.1 x 0.8 cm diagonally diamond-shaped, film-coated tablets with “10” engraved on one side and “1428” engraved on the other side.
Maltese: Pilloli sofor, konvessi miż-żewġ naħat, forma ta' djamant bi dijagonali ta' madwar 1.1 x 0.8 cm, miksijin b'rita b'“10” imnaqqax fuq naħa u “1428” imnaqqax fuq in-naħa l-oħra.
English: • Risk factors for diabetic ketoacidosis (DKA) should be assessed (see section 4.4).
Maltese: • Għandhom jiġu vvalutati l-fatturi ta' riskju għal ketoaċidożi dijabetika (DKA) (ara sezzjoni 4.4).
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).
Maltese: Fi studju fejn ġie miżjud glimepiride, fil-Ġimgħat 24 u 48, episodji minuri ta' ipogliċemija kienu rrappurtati b'mod aktar frekwenti fil-grupp ikkurat b'dapagliflozin 10 mg ma' glimepiride (6.0% u 7.9% rispettivament) milli fil-grupp bi plaċebo ma' glimepiride (2.1% u 2.1% rispettivament).
English: In patients with eGFR < 60 mL/min/1.73 m2 at baseline, there were 19 events of serious adverse events suggestive of volume depletion in the dapagliflozin group and 13 events in the placebo group.
Maltese: F'pazjenti b'eGFR < 60 mL/min/1.73 m2 fil-linja bażi, kien hemm 19-il avveniment ta' avvenimenti avversi serji li jissuġġerixxu tnaqqis fil-volum fil-grupp ta' dapagliflozin u 13il avveniment fil-grupp ta' plaċebo.
English: Columns 1 and 2, HbA1c analysed using LOCF (see footnote d); Columns 3 and 4, HbA1c analysed using LRM (see footnote e)
Maltese: Kolonni 1 u 2, HbA1c analizzat bl-użu tal- LOCF (ara n-nota tal-qiegħ d); Kolonni 3 u 4, HbA1c analizzat bl-użu talLRM (ara n-nota tal-qiegħ e) Medja tal-anqas kwadri aġġustata għall-valur tal-linja bażi LOCF: L-aħħar osservazzjoni (qabel is-salvataġġ għal individwi salvati) imressqa 'l quddiem eLRM:
English: Not evaluated for statistical significance as a result of the sequential testing procedure for secondary end points
Maltese: Mhux evalwat għas-sinifikat statistiku bħala konsegwenza tal-proċedura tat-testing f'sekwenza għall-fini sekondarji
English: Reported by the investigator as possibly related, probably related or related to study treatment and reported in ≥ 0.2% of subjects and ≥ 0.1% more and at least 3 more subjects treated with dapagliflozin 10 mg compared to placebo.
Maltese: Irrapportati mill-investigaturi bħala possibbilment relatati, probabbilment relatati jew relatati mal-kura talistudju u rrapportati f'≥ 0.2 % tal-individwi u ≥ 0.1% iktar u mill-inqas 3 individwi iktar ittrattati b'10 mg dapagliflozin meta mqabbla ma' plaċebo.
English: • Dapagliflozin is not a substitute for insulin (and does not alter insulin-sensitivity).
Maltese: Dapagliflozin mhuwiex sostitut għall-insulina (u ma jibdilx is-sensittività għall-insulina).
English: Mean difference in change from baseline between combination and single medicinal product (95% CI)
Maltese: Differenza medja fil-bidla mil-linja bażi bejn ilkombinazzjoni u l-prodott mediċinali uniku (95% CI)
English: Excipient with known effect: Each 10 mg tablet contains 50 mg of lactose anhydrous.
Maltese: Kull pillola ta' 10 mg fiha 50 mg ta' lactose anhydrous.
English: These reactions were more common in patients with baseline eGFR ≥ 30 and < 60 mL/min/1.73 m2 (18.5% dapagliflozin 10 mg versus 9.3%
Maltese: Dawn ir-reazzjonijiet kienu aktar komuni f'pazjenti b'eGFR tal-linja bażi ≥ 30 u < 60 mL/min/1.73 m2 (18.5% dapagliflozin 10 mg kontra 9.3% plaċebo).
English: Dapagliflozin as an adjunct to adjustable insulin was studied in two 24-week randomised, doubleblind, placebo-controlled clinical studies with a 28-week extension to evaluate the efficacy and safety in adult patients with type 1 diabetes mellitus and inadequate glycaemic control (defined as HbA1c ≥ 7.5%) on insulin alone.
Maltese: Dapagliflozin bħala żieda ma' insulina aġġustabbli ġie studjat f'żewġ studji kliniċi ta' 24 ġimgħa, randomised, double-blind, ikkontrollati bi plaċebo b'estensjoni ta' 28 ġimgħa biex jiġu evalwati leffikaċja u s-sigurtà f'pazjenti adulti b'dijabete mellitus tat-tip 1 u b'kontroll gliċemiku inadegwat (definit bħala HbA1c ≥ 7.5%) fuq l-insulina biss.
English: Haematocrit values >55% were reported in 1.3% of the subjects treated with dapagliflozin 10 mg versus 0.4% of placebo subjects.
Maltese: Valuri tal-ematokrit >55% ġew irrapportati f'1.3% tal-individwi kkurati b'10 mg dapagliflozin meta mqabbel ma' 0.4% tal-individwi fuq plaċebo
English: In the pooled 52-week data, events of DKA were reported in 22 (4.0%) patients in the dapagliflozin 5 mg group and 6 (1.1%) patients in the placebo group, with corresponding incidence rates per 100 patient years of 4.62 for dapagliflozin 5 mg and 1.27 for placebo.
Maltese: Fid-dejta miġbura ta' 52 ġimgħa, l-avvenimenti ta' DKA ġew irrapportati fi 22 (4.0 %) pazjent fil-grupp ta' dapagliflozin 5 mg u 6 (1.1%) pazjenti fil-grupp tal-plaċebo, b'rati ta' inċidenza korrispondenti għal kull 100 sena tal-pazjent ta' 4.62 għal dapagliflozin 5 mg u 1.27 għal plaċebo.
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).
Maltese: It-tibdil medju aġġustat għal dapagliflozin 5 mg relattiv għal plaċebo fl-amplitudni medja ta' eskursjoni tal-glucose mil-linja bażi sa Ġimgħa 24 kien -0.96 mmol/L (-17.30 mg/dL) u -0.55 mmol/L (-9.85 mg/dL), fiż-żewġ studji, rispettivament (p < 0.0001).
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).
Maltese: F'analiżi speċifikata minn qabel ta' individwi b'HbA1c ≥ 9 % mal-linja bażi, kura b'dapagliflozin 10 mg wasslet għal tnaqqis statistikament sinifikanti fl-HbA1c f'Ġimgħa 24 bħala monoterapija (bidla medja aġġustata mil-linja bażi: -2.04% u 0.19% għal dapagliflozin 10 mg u plaċebo, rispettivament) u bħala terapija miżjud ma' metformin (bidla medja aġġustata mil-linja bażi: -1.32% u -0.53% għal dapagliflozin u plaċebo rispettivament).
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.
Maltese: Differenzi statistikament sinifikanti (p < 0.0001) fit-tnaqqis perċentwali tad-doża totali ta' insulina mil-linja bażi għal dapagliflozin 5 mg relattiv għal plaċebo f'Ġimgħa 24 kienu -8.80% u -10.
English: 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 shortterm 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.
Maltese: Medja tal-anqas kwadri aġġustata għall-valur tal-linja bażi u l-preżenza ta' prodott mediċinali li jbaxxi l-glukows valur-p < 0.0001 kontra plaċebo + insulina ± prodott mediċinali orali li jbaxxi l-glukows valur-p < 0.05 kontra plaċebo + insulina ± prodott mediċinali orali li jbaxxi l-glukows Żieda gradwali fir-reġimens tal-insulina (inklużi insulina li taħdem malajr, intermedja, u basali) kien permess biss jekk l-individwi laħqu kriterji FPG stabiliti minn qabel.
English: In combination with metformin in drug-naive patients A total of 1,236 drug-naive patients with inadequately controlled type 2 diabetes (HbA1c ≥ 7.5% and ≤ 12%) participated in two active-controlled studies of 24 weeks duration to evaluate the efficacy and safety of dapagliflozin (5 mg or 10 mg) in combination with metformin in drug-naive patients versus therapy with the monocomponents.
Maltese: F'kombinazzjoni ma' metformin f'pazjenti li ma ġewx ikkurati preċedentement Total ta' 1,236 pazjent li ma ġewx ikkurati preċedentement b'dijabete tat-tip 2 mhux ikkontrollata b'mod adegwat (HbA1c ≥ 7.5% u ≤ 12%) ipparteċipaw f'żewġ studji kkontrollati b'mod attiv ta' durata ta' 24 ġimgħa sabiex jevalwaw l-effikaċja u s-sigurtà ta' dapagliflozin (5 mg jew 10 mg) f'kombinazzjoni ma' metformin f'pazjenti li ma ġewx ikkurati preċedentement kontra terapija bilmonokomponenti.
English: In a dedicated study in diabetic patients with an eGFR ≥ 45 to < 60 mL/min/1.73 m2, treatment with dapagliflozin demonstrated reductions in FPG at Week 24: -1.19 mmol/L (-21.46 mg/dL) compared to -0.27 mmol/L (-4.87 mg/dL) for placebo (p=0.001).
Maltese: Fi studju dedikat f'pazjenti dijabetiċi b'eGFR ≥ 45 sa < 60 mL/min/1.73 m2, il-kura b'dapagliflozin uriet tnaqqis fil-FPG f'Ġimgħa 24: -1.19 mmol/L (-21.46 mg/dL) meta mqabbel ma' -0.27 mmol/L (-4.87 mg/dL) għal plaċebo (p=0.001).
English: Once-daily treatment with dapagliflozin resulted in statistically significant (p < 0.0001) reductions in HbA1c compared to placebo (Table 3).
Maltese: Kura ta' darba kuljum b'dapagliflozin wasslet għal tnaqqis statistikament sinifikanti (p < 0.0001) fl-HbA1c meta mqabbel mal-plaċebo (Tabella 3).
English: Reported in ≥ 2% of subjects and ≥ 1% more and at least 3 more subjects treated with dapagliflozin 10 mg compared to placebo.
Maltese: Irrapportati f'≥ 2% tal-individwi u ≥ 1% aktar u għallinqas 3 individwi aktar ikkurati b'10 mg dapagliflozin meta mqabbel ma' plaċebo.
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
Maltese: Daqsjiet tal-pakketti ta' 14, 28 u 98 pilloli miksijin b'rita ġo folji mhux imtaqba b'kalendarju Daqsijiet tal-pakketti ta' 30x1 u 90x1 pilloli miksijin b'rita ġo folji imtaqba b'doża individwali
English: This grouping of reactions was reported in 3.2% and 1.8% of patients who received dapagliflozin 10 mg and placebo, respectively.
Maltese: Dan ir-raggruppament ta' reazzjonijiet ġie rrapportat fi 3.2% u f'1.8% talpazjenti li rċevew dapagliflozin 10 mg u plaċebo, rispettivament.
English: HbA1c (%) Baseline (mean) Change from baseline Difference from placebo 95% CI
Maltese: HbA1c (%) Linja bażi (medja) Bidla mil-linja bażi Differenza minn plaċebo (95% CI)
English: Eighty-one percent (81%) of the subjects had a body mass index (BMI)  27.
Maltese: Wieħed u tmenin fil-mija (81 %) tal-individwi kellhom indiċi tal-massa tal-ġisem (BMI) ≥ 27.
English: a) in a placebo-controlled study of dapagliflozin in combination with insulin (alone or with oral glucose-lowering medicinal products)
Maltese: a) b'dapagliflozin f'taħlita miżjud mal-insulina (waħidha jew ma' prodotti mediċinali orali li jbaxxu l-glukows)
English: The recommended actions are listed in Table 1.
Maltese: L-azzjonijiet rakkomandati huma elenkati fit-Tabella 1.
English: In total, 22.4% had had diabetes for ≤ 5 years, mean duration of diabetes was 11.9 years.
Maltese: B'kollox, 22.4% kellhom id-dijabete għal ≤ 5 snin, id-durata medja tad-dijabete kienet 11.9 snin.
English: Diabetic ketoacidosis b,i,k
Maltese: Għatx ketoaċidożi dijabetika b,i
English: Renal composite endpoint defined as: sustained confirmed ≥ 40% decrease in eGFR to eGFR <60 mL/min/1.73 m2 and/or end-stage renal disease (dialysis ≥ 90 days or kidney transplantation, sustained confirmed eGFR < 15 mL/min/1.73 m and/or renal or cardiovascular death.
Maltese: Punt tat-tmiem kompost renali defnit bħala: tnaqqis sostnut ikkonfermat ta' ≥ 40% fl-eGFR sa eGFR <60 mL/min/1.73 m u/jew marda renali fl-aħħar stadju (dijaliżi ≥ 90 jum jew trapjant tal-kliewi, eGFR < 15 mL/min/1.73 m2 sostnuta kkonfermata) u/jew mewt renali jew kardjovaskulari.