FrancophonIA/ELRC3.0 huggingface dataset:
English: The fact that Maviret can be given without ribavirin and without dose adjustments in patients with severe kidney problems is a further advantage in comparison with similar medicines.
Maltese: Il-fatt li Maviret jista' jingħata mingħajr ribavirin u mingħajr aġġustamenti fid-doża f'pazjenti bi problemi severi fil-kliewi huwa vantaġġ ieħor meta mqabbel ma' mediċini simili.
English: The active substances in Maviret, glecaprevir and pibrentasvir, block two proteins essential for the hepatitis C virus to multiply.
Maltese: Is-sustanzi attivi f'Maviret, il-gleċaprevir u l-pibrentasvir, jimblukkaw żewġ proteini li huma essenzjali biex il-virus tal-epatite Ċ jimmultiplika.
English: How does Maviret work?
Maltese: Kif jaħdem Maviret?
English: As for all medicines, data on the use of Maviret are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Maviret hija ssorveljata kontinwament.
English: Why is Maviret authorised in the EU?
Maltese: Għaliex Maviret huwa awtorizzat fl-UE?
English: What measures are being taken to ensure the safe and effective use of Maviret?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Maviret?
English: Side effects reported with Maviret are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati b'Maviret huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: The most common side effects with Maviret (which may affect more than 1 in 10 people) are headache and tiredness.
Maltese: L-effetti sekondarji l-aktar komuni b'Maviret (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10 persuni) huma wġigħ ta' ras u għeja.
English: There are 6 varieties (genotypes) of the hepatitis C virus and Maviret has been shown to be effective at clearing all genotypes from the blood.
Maltese: Hemm sitt varjetajiet (ġenotipi) tal-virus tal-epatite Ċ u Maviret intwera li huwa effettiv biex ineħħi lġenotipi kollha mid-demm.
English: By blocking these proteins, Maviret stops the hepatitis C virus from multiplying and infecting new cells.
Maltese: Billi jimblokka dawn ilproteini, Maviret iwaqqaf il-virus tal-epatite Ċ milli jimmultiplika u jinfetta ċelloli ġodda.
English: A/Michigan/45/2015 (H1N1)pdm09 - like strain (A/Michigan/45/2015, NYMC X-275)………………………………...15 micrograms HA** A/Hong Kong/4801/2014 (H3N2) - like strain (A/Hong Kong/4801/2014, NYMC X-263B)........................15 micrograms HA** B/Brisbane/60/2008 - like strain (B/Brisbane/60/2008, wild type)…………………………………………………………….….15 micrograms HA**
Maltese: X-263B) ................... 15-il mikrogramma HA** Razza simili għal B/Brisbane/60/2008 (B/Brisbane/60/2008, tat-tip selvaġġ) ........................................... 15-il mikrogramma HA**
English: Per 0.1 ml dose * propagated in fertilised hens' eggs from healthy chicken flocks ** haemagglutinin
Maltese: Kull doża ta' 0.1 ml ippropogat fil-bajd fertilizzat tat-tiġieġ minn gruppi ta' tiġieġ b'saħħithom ** emagglutinin
English: MA (EU) number (Invented) name Strength Pharmaceutical
Maltese: Numru tal-MA Isem (ivvintat) Qawwa Għamla
English: Influenza virus (inactivated, split) of the following strains*:
Maltese: --1 Virus tal-influwenza (inattivat, maqsum) tar-razez li ġejjin*:
English: C]-dapagliflozin dose, 96 % was recovered, 75 % in urine and 21 % in feces.
Maltese: C]-dapagliflozin, 96 % kien rekuperat, 75 % fl-awrina u 21 % flippurgar.
English: Vulvovaginal pruritus Pruritus genital
Maltese: Prurite vulvovaġinali Prurite ġenitali
English: Fifty-one percent (51 %) of the subjects were men, 84 % were White, 9 % were Asian, 3 % were Black and 4 % were of other racial groups.
Maltese: Wieħed u ħamsin filmija (51 %) tal-individwi kienu rġiel, 84 % kienu Bojod, 9 % kienu Ażjatiċi, 3 % kienu Suwed u 4 % kienu minn gruppi ta' razzez oħra.
English: Results at Week 52 (LOCF
Maltese: Tabella 3 Riżultati ma' Ġimgħa 52 (LOCF
English: • if you are 75 years old or older, you should not start taking Edistride.
Maltese: • jekk għandek 75 sena jew aktar m'għandekx tibda tieħu Edistride.
English: Eighty percent (80 %) of the subjects had a body mass index (BMI)  27.
Maltese: Tmenin fil-mija (80 %) tal-individwi kellhom indiċi tal-massa talġisem (BMI) ≥ 27.
English: Nocturia Renal impairment
Maltese: Nokturja Indeboliment renali
English: Dapagliflozin is approximately 91 % protein bound.
Maltese: Madwar 91 % ta' dapagliflozin jintrabat mal-proteini.
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).
Maltese: Edistride mhux rakkomandat għall-użu f'pazjenti b'indeboliment renali moderat għal sever (pazjenti bi clearance tal-krejatinina [CrCl] < 60 ml/min jew rata stmata tal-filtrazzjoni millglomeruli [eGFR] < 60 ml/min/1.73 m2, ara sezzjonijiet 4.4, 4.8, 5.1 u 5.2).
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).
Maltese: Fil-ġimgħat 52, 104 u 208, proporzjon inqas b'mod sinifikanti fil-grupp ikkurat b'dapagliflozin (3.5 %, 4.3 % and 5.0 %, rispettivament) kellu mill-anqas episodju wieħed ta' ipogliċemija meta mqabbel mal-grupp fuq kura bi glipizide (40.8 %, 47 % u 50.0 % rispettivament).
English: Other medicines and Edistride
Maltese: Mediċini oħra u Edistride
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 li dapagliflozin ngħata flimkien ma' rifampicin (induttur ta' varji trasportaturi attivi u metabolizzatur tal-mediċina), tnaqqis ta' 22 % fl-esponiment sistemiku ta' dapagliflozin (AUC) deher, iżda ma kienx hemm sinifikat kliniku fuq l-eskrezzjoni ta' glukows fuq 24-siegħa.
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.
Maltese: Vulvovaġinite, balanite u infezzjonijiet ġenitali relatati Vulvovaġinite, balanite u infezzjonijiet ġenitali relatati kienu rrappurtati f'5.5 % u 0.6 % tal-individwi li rċievew dapagliflozin 10 mg u plaċebo, rispettivament.
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: F'Ġimgħat 24 u 104, ġew irrapportati episodji minuri ta' ipogliċemija, rispettivament, f'40.3 % u 53.1 % tas-suġġetti li rċievew dapagliflozin 10 mg flimkien mal-insulina u f'34.0 % u f'41.6 % tassuġġetti li rċievew flimkien mal-insulina.
English: 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: 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: 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.
Maltese: Effett ta' dapagliflozin fuq prodotti mediċinali oħra Fi studji ta' interazzjoni li saru f'individwi b'saħħithom, l-aktar permezz ta' mudell b'doża waħda, dapagliflozin ma bidilx il-farmakokinetika ta' metformin, pioglitazone, sitagliptin, glimepiride, hydrochlorothiazide, bumetanide, valsartan, digoxin (sottostrat ta' P-gp) jew warfarin (S-warfarin, sottostrat ta' CYP2C9), jew l-effetti kontra l-koagulazzjoni ta' warfarina hekk kif imkejjel mill-INR.
English: Fifty-two percent (52 %) had mild renal impairment and 11 % had moderate renal impairment.
Maltese: Tnejn u ħamsin fil-mija (52 %) kellhom indeboliment renali ħafif u 11 % kellhom indeboliment renali moderat.
English: Combination of a single dose of dapagliflozin 20 mg and simvastatin (a CYP3A4 substrate) resulted in a 19 % increase in AUC of simvastatin and 31 % increase in AUC of simvastatin acid.
Maltese: Taħlita ta' doża waħda ta' dapagliflozin 20 mg u simvastatin (sottostrat ta' CYP3A4) wasslet għal żieda ta' 19 % fl-AUC ta' simvastatin u 31 % żieda fl-AUC ta; aċidu ta' simvastatin.
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.
Maltese: Fi stat fiss (20 mg dapagliflozin darba kuljum għal 7 ijiem), individwi b'dijabete mellitus tat-tip 2 u indeboliment renali ħafif, moderat jew sever (hekk kif determinat mill-clearance mill-plażma ta' iohexol) kellu esponimenti sistemiċi medji ta' dapagliflozin ta' 32 %, 60 % u 87 % ogħla, rispettivament, minn dawk l-individwi b'dijabete mellitus tat-tip 2 u funzjoni renali normali.
English: The hazard ratio comparing dapagliflozin to comparator was 0.79 (95 % Confidence interval [CI]: 0.58, 1.07), indicating that in this analysis Edistride is not associated with an increase in cardiovascular risk in patients with type 2 diabetes mellitus.
Maltese: Il-proporzjon ta' riskju li jqabbel lil dapagliflozin ma' prodott ta' paragun kien ta' 0.79 (95 % Intervall ta' fiduċja [CI]: 0.58, 1.07), li jindika li f'din l-analiżi dapagliflozin mhuwiex assoċjat ma' żieda fir-riskju kardjovaskulari f'pazjenti b'dijabete (diabetes mellitus) tat-tip 2.
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.
Maltese: Il-pilloli Edistride 5 mg u l-pilloli Edistride 10 mg jiġu ġo folji tal-aluminju f'daqsijiet ta' pakketti ta' 14, 28 jew 98 pilloli miksijin b'rita ġo folji mhux imtaqqbin tal-kalendarju u 30x1 jew 90x1 pilloli miksijin b'rita ġo folji imtaqqbin b'doża individwali.
English: Investigations
Maltese: Investigazzjonijie
English: The absolute oral bioavailability of dapagliflozin following the administration of a 10 mg dose is 78 %.
Maltese: Il-bijodisponibilità orali assoluta ta' dapagliflozin wara l-għotja ta' doża ta' 10 mg hija 78 %.
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'individwi b'indeboliment epatiku sever (klassi Child-Pugh C) il-medja Cmax u AUC ta' dapagliflozin kienu 40 % u 67 % ogħla minn kontrolli b'saħħithom imqabbla, rispettivament.
English: • Edistride 10 mg film-coated tablets are yellow and diamond-shaped approximately 1.1 x 0.8 cm diagonally.
Maltese: • Edistride 10 mg pilloli miksijin b'rita huma sofor u b'forma ta' djamant madwar 1.1 x 0.8 cm mid-dijagonali.
English: • Edistride 5 mg film-coated tablets are yellow and round with diameter of 0.7 cm.
Maltese: • Edistride 5 mg pilloli miksijin b'rita huma sofor u tondi b'dijametru ta' 0.7 cm.
English: Mean percent change from baseline for dapagliflozin 10 mg versus placebo, respectively, was: total cholesterol 2.5 % versus 0.0 %; HDL cholesterol 6.0 % versus 2.7 %; LDL cholesterol 2.9 % versus -1.0 %; triglycerides -2.7 % versus -0.7 %.
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 Il-bidla medja perċentwali mil-linja bażi għal 10 mg dapagliflozin meta mqabbla ma' plaċebo, rispettivament, kienet: kolesterol totali 2.5 % kontra 0.0 %; kolesterol HDL 6.0 % kontra 2.7 %; kolesterol LDL 2.9 % kontra1.0 %; trigliċeridi -2.7 % kontra -0.7 %.
English: The CHMP, as a consequence, considers that the benefit-risk balance of Invokana, Vokanamet, Forxiga, Edistride, Xigduo, Ebymect, Jardiance and Synjardy remain favourable subject to the amendments to the product information described above.
Maltese: Konsegwentement, is-CHMP ikkunsidra li l-bilanċ bejn il-benefiċċju u r-riskju ta' Invokana, Vokanamet, Forxiga, Edistride, Xigduo, Ebymect, Jardiance u Synjardy jibqa' favorevoli soġġett għall-emendi fl-informazzjoni dwar il-prodott deskritti hawn fuq.
English: In the clinical program, 34.4 % of subjects had a history of cardiovascular disease (excluding hypertension) at baseline and 67.9 % had hypertension.
Maltese: Fil-programm kliniku, 34.4 % tal-pazjenti kellhom storja ta' mard kardjovaskulari (minbarra l-pressjoni għolja) fil-linja bażi u 67.9 % kellhom pressjoni għolja.
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.
Maltese: Ġew irrappurtati episodji minuri ta' ipogliċemija fi 12.8 % talpazjenti li rċevew dapagliflozin 10 mg flimkien ma' metformin u sulphonylurea u fi 3.7 % tal-pazjenti li rċevew plaċebo flimkien ma' metformin u sulphonylurea.
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).
Maltese: Reazzjonijiet relatati mat-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 lplaċebo, rispettivament; reazzjonijiet serji seħħew f'< 0.2 % tal-individwi u kienu bilanċati bejn dapagliflozin 10 mg u l-plaċebo (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: 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 %
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 vs 9.3 % plaċebo).
English: (95 % CI) Subjects (%) achieving: HbA1c < 7 % (LOCF) Adjusted for baseline Body weight (kg) (LOCF) Baseline (mean) Change from baseline Difference from placebo c
Maltese: (95 % CI) Individwi (%) li kisbu: HbA1c < 7 % (LOCF) Aġġustat għal-linja bażi Piż tal-ġisem (kg) (LOCF) Linja bażi (medja) Bidla mil-Linja bażi Differenza mill-Plaċebo c
English: Results of 24-week placebo-controlled studies of dapagliflozin in add-on combination with sulphonylurea (glimepiride) or metformin and a sulphonylurea
Maltese: Riżultati ta' studji kkontrollati bil-plaċebo fuq 24 ġimgħa b'dapagliflozin f'taħlita miżjud ma' sulphonylurea (glimepiride) jew metformin u sulphonylurea
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).
Maltese: F'individwi ta' ≥ 65 sena, reazzjonijiet avversi relatati mal-indeboliment jew insuffiċjenza renali kienu rrappurtati f'7.7 % tal-individwi ikkurati b'dapagliflozin u 3.8 % tal-individwi ikkurati bi plaċebo (ara sezzjoni 4.4).
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)
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: 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
Maltese: Edistride 5 mg pilloli miksijin b'rita EU/1/15/1052/001 14-il pillola miksija b'rita EU/1/15/1052/002 28 pillola miksija b'rita EU/1/15/1052/003 98 pillola miksija b'rita EU/1/15/1052/004 30 x 1 (doża waħda) pillola miksija b'rita EU/1/15/1052/005 90 x 1 (doża waħda) pillola miksija b'rita
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: 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: Rare cases of diabetic ketoacidosis (DKA), including life-threatening cases, have been reported in clinical trials and post-marketing in patients treated with SGLT2 inhibitors, including dapagliflozin.
Maltese: Każijiet rari ta' ketoaċidożi dijabetika (DKA), inkluż każijiet ta' theddida għall-ħajja, ġew irrapportati fi provi kliniċi u wara t-tqegħid fis-suq, ikkurati b'inibituri SGLT2, inkluż dapagliflozin.
English: Haematocrit increased Creatinine renal clearance decreased Dyslipidaemia
Maltese: KONDIZZJONIJIET JEW RESTRIZZJONIJIET FIRRIGWARD TAL-UŻU SIGUR U EFFIKAĊI TAL-PRODOTT MEDIĊINALI
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
Maltese: Edistride 10 mg pilloli miksijin b'rita EU/1/15/1052/006 14-il pillola miksija b'rita EU/1/15/1052/007 28 pillola miksija b'rita EU/1/15/1052/008 98 pillola miksija b'rita EU/1/15/1052/009 30 x 1 (doża waħda) pillola miksija b'rita EU/1/15/1052/010 90 x 1 (doża waħda) pillola miksija b'rita
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: 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.
Maltese: F'individwi b'indeboliment epatiku ħafif jew moderat (Klassijiet Child-Pugh A u B) is-Cmax u AUC medji ta' dapagliflozin kienu sa' 12 % u 36 % ogħla, rispettivament, meta mqabbla ma' individwi b'saħħithom imqabbla għall-kontroll.
English: At 52,
Maltese: IU/kuljum u 18.3
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.
Maltese: F'Ġimgħa 104 għall-insulina (bi jew mingħajr prodotti mediċinali li jbaxxu l-livell ta' glukożju orali addizzjonali), it-tnaqqis fl-HbA1c kien bidla medja aġġustata ta' -0.71 % u -0.06 % mil-linja bażi għal dapagliflozin 10 mg u plaċebo, rispettivament.
English: At Week 208, adjusted mean change from baseline in HbA1c was -0.10 % for dapagliflozin and 0.20 % for glipizide.
Maltese: Fil-Ġimgħa 208, it-tibdil medju aġġustat mil-linja bażi f'HbA1c kien ta' -0.10 % għal dapagliflozin u ta' 0.20 % għal glipizide.
English: Each tablet contains dapagliflozin propanediol monohydrate equivalent to10 mg dapagliflozin.
Maltese: Kull pillola fiha dapagliflozin propanediol monohydrate ekwivalenti għal 10 mg dapagliflozin.
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.
Maltese: Fil-Ġimgħa 48, meta miżjud ma' sitagliptin (bi jew mingħajr metformin), it-tibdil medju aġġustat mil-linja bażi għal dapagliflozin 10 mg u plaċebo kien ta' -0.30 % u 0.38 %, rispettivament.
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).
Maltese: Għall-istudju miżjud ma' metformin, tnaqqis fl-Hb1Ac kien sostnut sa' Ġimgħa 102 (-0.78 % u 0.02 % bidla aġġustata mil-linja bażi għal dapagliflozin 10 mg u plaċebo, rispettivament).
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 % tal-pazjenti li rċevew dapagliflozin 10 mg u plaċebo, rispettivament.
English: For studies of dapagliflozin in monotherapy, as add-on to metformin or as add-on to sitagliptin (with or without metformin), the frequency of minor episodes of hypoglycaemia was similar (< 5 %) between treatment groups, including placebo up to 102 weeks of treatment.
Maltese: Għal studji ta' dapagliflozin f'monoterapija, bħala sustanza miżjuda ma' metformin jew bħala sustanza miżjuda ma' sitagliptin (bi jew mingħajr metformin), il-frekwenza ta' episodji minuri ta' ipogliċemija kienet simili (< 5 %) bejn il-gruppi ta' kura, inkluż il-plaċebo sa 102 ġimgħat ta' kura.
English: In a number of cases, the presentation of the condition was atypical with only moderately increased blood glucose values, below 14 mmol/l (250 mg/dl).
Maltese: F'numru ta' każijiet, il-preżentazzjoni tal-kundizzjoni kienet atipika b'żieda moderata biss fil-valuri tal-glucose fid-demm, inqas minn 14 mmol/l (250 mg/dl).