FrancophonIA/ELRC3.0 huggingface dataset:
English: • 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).
Maltese: • Metformin huwa kontraindikat f'pazjenti b'GFR <30 mL/min u għandu jitwaqqaf temporanjament filpreżenza ta' kundizzjonijiet li jibdlu l-funzjoni renali, ara sezzjoni 4.3).
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 l-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: Major events of hypoglycaemia were reported in 58 (0.7%) patients treated with dapagliflozin and 83 (1.0%) patients treated with placebo.
Maltese: Ġew irrappurtati avvenimenti maġġuri ta' ipogliċemija fi 58 (0.7%) pazjent ikkurati b'dapagliflozin u 83 (1.0%) pazjent ikkurati bi plaċebo.
English: Xigduo has been demonstrated to be bioequivalent with coadministered dapagliflozin and metformin (see section 5.2).
Maltese: Intwera li Xigduo huwa bijoekwivalenti għal dapagliflozin u metformin amministrati flimkien (ara sezzjoni 5.2).
English: Dosage in patients with renal impairment GFR mL/min
Maltese: Dożaġġ f'pazjenti b'indeboliment tal-kliewi GFR mL/min
English: 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.
Maltese: F'żieda għal studju ta' metformin u sulphonylurea, sa 24 ġimgħa, ġew irrapportati episodji minuri ta' ipogliċemija fi 12.8% tal-individwi li rċevew dapagliflozin 10 mg u metformin u sulphonylurea u fi 3.7% tal-individwi li rċevew plaċebo u metformin u sulphonylurea.
English: Volume depletion b,e
Maltese: Tnaqqis filvolum b,e
English: Dapagliflozin did not show any toxicity in healthy subjects at single oral doses up to 500 mg (50 times the maximum recommended human dose).
Maltese: Dapagliflozin ma weriex tossiċità f'individwi b'saħħithom f'dożi singoli orali sa 500 mg (50 darba iktar mid-doża massima rrakkomandata għall-bnedmin).
English: Maximum daily dose is 2000 mg.
Maltese: Id-doża massima ta' kuljum hija 2000 mg.
English: • If renal function falls persistently below GFR 45 mL/min, treatment should be discontinued.
Maltese: • Jekk il-funzjoni renali taqa' b'mod persistenti taħt GFR 45 mL/min, il-kura għandha titwaqqaf.
English: Glucocorticoids (given by systemic and local routes), beta-2 agonists, and diuretics have intrinsic hyperglycaemic activity.
Maltese: Il-glukokortikojdi (mogħtija permezz ta' rotot sistemiċi u lokali), l-agonisti beta-2, u d-dijuretiċi għandhom attività ipergliċemika intrinsika.
English: 60x1 film-coated tablets in perforated unit dose blisters.
Maltese: 60x1 pilloli miksijin b'rita f'folji perforati ta' doża waħda.
English: In a cardiovascular outcomes study (DECLARE), dapagliflozin as adjunct to standard care therapy reduced cardiovascular and renal events in patients with type 2 diabetes.
Maltese: Fi studju tal-eżiti kardjovaskulari (DECLARE), dapagliflozin bħala żieda ma' terapija ta' kura standard naqqas l-avvenimenti kardjovaskulari u renali f'pazjenti b'dijabete tat-tip 2.
English: However, the differences in exposure were not considered clinically meaningful.
Maltese: Madankollu, iddifferenzi fl-esponiment ma kinux meqjusin klinikament sinifikanti.
English: In the dapagliflozin cardiovascular outcomes study (see section 5.1), 8,574 patients received dapagliflozin 10 mg and 8,569 received placebo for a median exposure time of 48 months.
Maltese: Fl-istudju tal-eżiti kardjovaskulari b'dapagliflozin (ara sezzjoni 5.1), 8,574 pazjent irċivew dapagliflozin 10 mg u 8,569 irċivew plaċebo għal żmien medjan ta' esponiment ta' 48 xahar.
English: At 52, 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 with the group treated with glipizide (40.8%, 47% and 50.0%, respectively).
Maltese: Fil-ġimgħat 52, 104 u 208, proporzjon ferm aktar baxx ta' individwi mill-grupp ikkurat b'dapagliflozin (3.5%, 4.3% u 5.0% rispettivament) esperjenza mill-inqas avveniment wieħed ta' ipogliċemija meta mqabbel mal-grupp ikkurat bi glipizide (40.8%, 47% u 50.0% rispettivament).
English: OUTER CARTON - PART OF MULTIPACK - WITH BLUE BOX
Maltese: KARTUNA TA' BARRA - PARTI MINN PAKKETT MULTIPLU - BIL-KAXXA BLU
English: film-coating: polyvinyl alcohol (E1203),macrogol3350 (E1521), talc (E553b), titanium dioxide (E171), iron oxide yellow (E172), iron oxide red (E172) (only Xigduo 5 mg/850 mg).
Maltese: • Is-sustanzi l-oħra huma: qalba tal-pillola: hydroxypropyl cellulose (E463), microcrystalline cellulose (E460(i)), magnesium stearate (E470b), sodium starch glycolate (tip A). kisja b'rita: polyvinyl alcohol (E1203), macrogol 3350 (E1521), talc (E553b), titanium dioxide (E171), iron oxide yellow (E172), iron oxide red (E172) (Xigduo 5 mg/850 mg biss).
English: a) in a placebo-controlled study of dapagliflozin in combination with insulin (alone or with oral glucose-lowering medicinal products, including metformin)
Maltese: a) fi studju kkontrollat bi plaċebo dwar dapagliflozin f'kombinazzjoni mal-insulina (weħidha jew ma' prodotti mediċinali orali li jbaxxu l-glukożju, inkluż metformin)
English: Major adverse cardiovascular events
Maltese: Avvenimenti kardjovaskulari avversi maġġuri
English: • if you have problems with your kidneys.
Maltese: • jekk għandek problemi fil-kliewi.
English: Maximum daily dose is 3000 mg.
Maltese: Id-doża massima ta' kuljum hija 3000 mg.
English: SGLT2 is the predominant transporter responsible for reabsorption of glucose from the glomerular filtrate back into the circulation.
Maltese: SGLT2 huwa t-trasportatur predominanti responsabbli għar-riassorbiment tal-glukożju mill-filtrat talglomeruli lura fiċ-ċirkulazzjoni.
English: For study results with respect to combination of therapies, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1.
Maltese: Għar-riżultati tal-istudju fir-rigward ta' kombinazzjoni ta' terapiji, effetti fuq il-kontroll gliċemiku u avvenimenti kardjovaskulari, u l-popolazzjonijiet li ġew studjati, ara s-sezzjonijiet 4.4, 4.5 u 5
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 iddijabete għal ≤ 5 snin, id-durata medja tad-dijabete kienet 11.9 snin.
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: Il-valuri Cmax u AUCτ medji ġeometriċi ta' dapagliflozin fi stat fiss wara dożi ta' 10 mg dapagliflozin darba kuljum kienu ta' 158 ng/mL u 628 ng h/mL, rispettivament.
English: It is assumed that the pharmacokinetics of metformin absorption is non-linear.
Maltese: Huwa kkunsidrat li l-farmakokinetika tal-assorbiment ta' metformin mhijiex lineari.
English: In the 13-study safety pool, urinary tract infections were more frequently reported for dapagliflozin compared with placebo (4.7% versus 3.5%, respectively; see section 4.4).
Maltese: Fil-ġabra ta' 13-il studju ta' sigurtà, l-infezzjonijiet fil-passaġġ urinarju ġew irrapportati b'mod aktar frekwenti għal dapagliflozin meta mqabbel ma' plaċebo (4.7% kontra 3.5%, rispettivament; ara sezzjoni 4.4).
English: Figure 2: Treatment effects for the primary composite endpoints and their components, and the secondary endpoints and components
Maltese: Figura 2: Effetti tal-kura għall-punti tat-tmiem komposti primarji u l-komponenti tagħhom, u lpunti tat-tmiem sekondarji u l-komponenti
English: System organ class
Maltese: Sistema talklassifikazzjoni tal-organi
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 fil-glukożju 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: Rash includes the following preferred terms, listed in order of frequency in clinical trials: 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 provi kliniċi: raxx, raxx ġeneralizzat, raxx pruritiku, raxx makulari, raxx makulo-papulari, raxx pustulari, raxx vexxikulari, u raxx eretematuż.
English: Taste disturbance Dizziness
Maltese: Urtikarja Eritema Prurite
English: 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.
Maltese: Filġimgħa 48 għal metformin flimkien ma' sitagliptin, il-bidla medja aġġustata mil-linja bażi għal 10 mg dapagliflozin u plaċebo kienet ta' -0.44% u 0.15%, rispettivament.
English: Xigduo 5 mg/1,000 mg tablets dapagliflozin/metformin HCl
Maltese: Xigduo 5 mg/1,000 mg pilloli dapagliflozin/metformin HCl
English: 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.
Maltese: Fil-ġimgħat 24 u 104, ġew irrapportati episodji minuri ta' ipogliċemija, rispettivament, f'40.3% u fi 53.1% tal-individwi li rċevew 10 mg dapagliflozin flimkien mal-insulina u f'34.0% u f'41.6% tal-pazjenti li rċevew plaċebo flimkien mal-insulina.
English: 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 FPG (-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.
Maltese: Il-kura b'dapagliflozin bħala żieda jew ma' metformin waħdu (10 mg dapagliflozin QD jew 5 mg dapagliflozin BID) jew ma' metformin flimkien ma' sitagliptin, sulphonylurea jew mal-insulina rriżultat fi tnaqqis statistikament sinifikanti fl-FPG (-1.90 sa -1.20 mmol/L [-34.2 sa -21.7 mg/dL]) imqabbel ma' plaċebo (-0.58 sa 0.18 mmol/L [-10.4 sa 3.3 mg/dL]) fil-ġimgħa 16 (5 mg BID) jew fil-ġimgħa 24.
English: Vulvovaginitis, balanitis and related genital infections
Maltese: Vulvovaginite, balanite u infezzjonijiet ġenitali relatati
English: A study conducted in seven normal healthy volunteers showed that cimetidine, administered as 400 mg twice daily, increased metformin systemic exposure (AUC) by 50% and Cmax by 81%.
Maltese: Studju li sar fuq seba' voluntieri normali b'saħħithom wera li cimetidine, mogħti f'dożi ta' 400 mg darbtejn kuljum, żied l-esponiment sistemiku (AUC) ta' metfromin b'50% u Cmax b'81%.
English: The mean total systemic clearance of dapagliflozin administered intravenously was 207 mL/min.
Maltese: L-eliminazzjoni sistemika totali medja ta' dapagliflozin amministrat ġol-vini kienet ta' 207 mL/min.
English: Posology Adults with normal renal function (glomerular filtration rate [GFR] ≥ 90 mL/min)
Maltese: Pożoloġija Adulti b'funzjoni renali normali (rata tal-filtrazzjoni glomerulari
English: After an oral dose, the non-absorbed fraction recovered in faeces was 20-30%.
Maltese: Wara doża orali, il-frazzjoni mhux assorbita rkuprata fl-ippurgar kienet ta' 20-30%.
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: Xigduo 5 mg/850 mg tablets dapagliflozin/metformin HCl
Maltese: Xigduo 5 mg/850 mg pilloli dapagliflozin/metformin HCl
English: 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).
Maltese: QD: darba kuljum; BID: darbtejn kuljum Metformin ≥ 1500 mg kuljum; Sitagliptin 100 mg kuljum LOCF: L-aħħar osservazzjoni (qabel is-salvataġġ fil-każ ta' pazjenti salvati) miġjuba 'l quddiem Studju fuq 16-il ġimgħa kkontrollat bi plaċebo L-individwi kollha magħżula b'mod każwali li ħadu mill-inqas doża waħda ta' prodott mediċinali ta' studju doubleblind matul il-perjodu double-blind ta' terminu qasir Il-medja tal-inqas kwadri aġġustata għall-valur tal-linja bażi valur-p < 0.0001 kontra plaċebo + prodott mediċinali orali li jbaxxi l-glukożju valur-p < 0.05 kontra placebo + prodott mediċinali orali li jbaxxi l-glukożju Il-bidla perċentwali fil-piż tal-ġisem kienet analizzata bħala riżultat aħħari sekondarju ewlieni (p < 0.0001); ilbidla assoluta fil-piż tal-ġisem (f'kg) ġiet analizzata b'valur-p nominali (p < 0.0001).
English: In interaction studies conducted in healthy subjects, using mainly a single-dose design, dapagliflozin did not alter the pharmacokinetics of pioglitazone, sitagliptin, glimepiride, hydrochlorothiazide, bumetanide, valsartan, digoxin (a P-gp substrate) or warfarin (S-warfarin, a CYP2C9 substrate), or the anti-coagulatory effects of warfarin as measured by INR.
Maltese: L-effett ta' dapagliflozin fuq prodotti mediċinali oħrajn Fi studji dwar l-interazzjoni li saru fuq individwi b'saħħithom, prinċipalment bl-użu ta' disinn ta' doża waħda, dapagliflozin ma biddilx il-farmakokinetika ta' pioglitazone, sitagliptin, glimepiride, hydrochlorothiazide, bumetanide, valsartan, digoxin (sostrat ta' P-gp) jew warfarin (S-warfarin, sostrat ta' CYP2C9), jew l-effetti antikoagulanti ta' warfarin kif imkejlin mill-INR.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: Ir-rekwiżiti tar-rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikati fuq il-portal elettroniku Ewropew talmediċini.
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.
Maltese: F'pazjenti b'indeboliment tal-fwied sever (Klassi Child-Pugh C) is-Cmax u l-AUC medji ta' dapagliflozin kienu 40% u 67% ogħla minn ta' korrispondenti b'saħħithom bħala kontroll, rispettivament.
English: Maximum daily dose is 1000 mg.
Maltese: Id-doża massima ta' kuljum hija 1000 mg.
English: 10 tablets blister: {Sun/Moon symbol} 14 tablets blister: Mon. Tue. Wed. Thu. Fri. Sat. Sun. {Sun/Moon symbol}
Maltese: Folja ta' 10 pilloli: {Simbolu ta' Xemx/Qamar} Folja ta' 14-il pillola:
English: Events were generally balanced between treatment groups across subgroups of age, diuretic use, blood pressure and ACE-I/ARB use.
Maltese: L-avvenimenti kienu ġeneralment ibbilanċjati bejn il-gruppi ta' kura fost is-sottogruppi ta' età, użu dijuretiku, pressjoni tad-demm u użu ta' ACE-I/ARB.
English: The mean plasma terminal half-life (t1/2) for dapagliflozin was 12.9 hours following a single oral dose of dapagliflozin 10 mg to healthy subjects.
Maltese: Il-half-life (t1/2) terminali medja fil-plażma għal dapagliflozin kienet ta' 12.9-il sigħat wara doża orali waħda ta' 10 mg dapagliflozin mogħtija lil individwi b'saħħithom.
English: Subjects (%) achieving HbA1c 7%
Maltese: Individwi (%) li jilħqu HbA1c 7%
English: Cardiac failure There is no experience in clinical studies with dapagliflozin in NYHA class IV.
Maltese: Insuffiċjenza kardijaka M'hemmx esperjenza ta' studji kliniċi b'dapagliflozin fl-NYHA klassi IV.
English: Clinically relevant glycaemic effects were sustained in long-term extensions up to 104 weeks.
Maltese: L-effetti gliċemiċi klinikament rilevanti kienu sostnuti f'estensjonijiet fit-tul sa 104 ġimgħat.
English: HbA1c reductions were seen across subgroups including gender, age, race, duration of disease, and baseline body mass index (BMI).
Maltese: Deher tnaqqis fl-HbA1c fis-sottogruppi kollha inklużi s-sess, l-età, ir-razza, it-tul ta' żmien tal-marda, u llinja bażi tal-indiċi tal-massa tal-ġisem (BMI).
English: • if you often get infections of the urinary tract.
Maltese: • jekk spiss ikollok infezzjonijiet fl-apparat urinarju.
English: Add-on combination therapy
Maltese: Terapija ta' kombinazzjoni miżjuda
English: The increase in simvastatin and simvastatin acid exposures are not considered clinically relevant.
Maltese: Iż-żieda fl-esponimenti ta' simvastatin u simvastatin acid mhijiex meqjusa klinikament rilevanti.
English: Yellow, biconvex, 10.5 x 21.5 mm oval, film-coated tablets engraved with “5/1000” on one side and “1069” engraved on the other side.
Maltese: x 21.5 mm ovali, b'“5/1000” minquxa fuq naħa u “1069” minquxa fuq in-naħa l-oħra.
English: Rates of adverse events including dehydration or hypotension were similar to placebo, and there were no clinically meaningful dose-related changes in laboratory parameters, including serum electrolytes and biomarkers of renal function.
Maltese: Ir-rati ta' avvenimenti avversi, inklużi d-deidratazzjoni u l-pressjoni baxxa, kienu simili għal plaċebo, u ma kienx hemm bidliet klinikament sinifikanti relatati mad-doża fil-paramentri tal-laboratorju, inklużi l-elettroliti fis-serum u lbijomarkaturi tal-funzjoni renali.
English: 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 (glipizide) as add-on therapy to metformin in subjects with inadequate glycaemic control (HbA1c > 6.5% and ≤ 10%).
Maltese: Fi studju kkontrollat attivament ta' nuqqas ta' inferjorità fuq 52 ġimgħa (b'perjodi ta' estensjoni ta' 52 ġimgħa u 104 ġimgħat), 10 mg dapagliflozin ġew evalwati bħala terapija miżjuda ma' metformin meta mqabbla ma' sulphonylurea (glipizide) bħala terapija miżjuda ma' metformin f'pazjenti b'kontroll gliċemiku mhux adegwat (HbA1c > 6.5% u ≤ 10%).
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.
Maltese: Wara l-għoti ta' dapagliflozin flimkien ma' rifampicin (induttur ta' diversi trasportaturi attivi u enzimi li jaħdmu fil-metaboliżmu tal-mediċini) ġie osservat tnaqqis ta' 22% fl-esponiment sistemiku ta' dapagliflozin (AUC), imma mingħajr effett kliniku sinifikanti fuq it-tneħħija tal-glukożju fl-awrina f'24 siegħa.
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 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' pazjenti b'linja bażi tal-HbA1c ≥ 9.0%, il-kura b'10 mg dapagliflozin irriżultat fi tnaqqis statistikament sinifikanti fl-HbA1c fil-ġimgħa 24 bħala żieda ma' metformin (il-bidla medja aġġustata mil-linja bażi: -1.32% u -0.53% għal dapagliflozin u plaċebo, rispettivament).
English: 14 film-coated tablets 28 film-coated tablets 56 film-coated tablets 60 film-coated tablets 60xl film-coated tablets
Maltese: 14-il pillola miksija b'rita 28 pillola miksija b'rita 56 pillola miksija b'rita 60 pillola miksija b'rita 60xl pillola miksija b'rita
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 13-il avveniment fil-grupp ta' plaċebo.
English: The difference between groups was driven by reductions in events of the renal components; sustained eGFR decrease, end-stage renal disease and renal death (Figure 2).
Maltese: Id-differenza bejn il-gruppi kienet xprunata minn tnaqqis fl-avvenimenti tal-komponenti renali; tnaqqis sostnut fl-eGFR, marda tal-kliewi fl-aħħar stadju u mewt renali (Figura 2).
English: QD=once daily, QW=once weekly, N=number of patients, CI=confidence interval.
Maltese: QD=darba kuljum, QW=darba fil-ġimgħa, N=numru ta' pazjenti, CI=intervall ta' kunfidenza.
English: Administration of 5 mg dapagliflozin twice daily gave similar overall exposures (AUCss) over a 24-hour period as 10 mg dapagliflozin administered once daily.
Maltese: L-amministrazzjoni ta' 5 mg dapagliflozin darbtejn kuljum tat esponimenti totali simili (AUCss) fuq perjodu ta' 24 siegħa għal dawk ta' 10 mg dapagliflozin mogħtija darba kuljum.
English: Brown, biconvex, 9.5 x 20 mm oval, film-coated tablets engraved with “5/850” on one side and “1067” engraved on the other side.
Maltese: Pilloli miksijin b'rita kannella, ibbuzzati fuq iż-żewġ naħat, 9.5 x 20 mm ovali, b'“5/850” minquxa fuq naħa u “1067” minquxa fuq in-naħa l-oħra.
English: 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.
Maltese: Fi studju dwar żieda mal-insulina sa 104 ġimgħat, ġew irrapportati episodji maġġuri ta' ipogliċemija f'0.5% u 1.0% tal-individwi f'10 mg dapagliflozin flimkien mal-insulina fil-ġimgħat 24 u 104, rispettivament, u f'0.5% tal-individwi ttrattati bi gruppi ta' plaċebo flimkien mal-insulina fil-ġimgħat 24 u 104.
English: Necrotising fasciitis of the perineum (Fournier's gangrene) Post-marketing 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: In controlled clinical trials, maximum metformin plasma levels (Cmax) did not exceed 5 μg/mL, even at maximum doses.
Maltese: Fi provi kliniċi kkontrollati, il-livelli massimi ta' metformin filplażma (Cmax) ma qabżux l-5 μg/mL, anke b'dożi massimi.