FrancophonIA/ELRC3.0 huggingface dataset:
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: Therefore the CHMP recommends the variation to the terms of the marketing authorisations for Invokana, Vokanamet, Forxiga, Edistride, Xigduo, Ebymect, Jardiance and Synjardy.
Maltese: Għalhekk is-CHMP jirrakkomanda l-varjazzjoni għat-termini tal-awtorizzazzjoni għat-tqegħid fis-suq għal Invokana, Vokanamet, Forxiga, Edistride, Xigduo, Ebymect, Jardiance u Synjardy.
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 % talpazjenti kellhom storja ta' mard kardjovaskulari (minbarra l-pressjoni għolja) fil-linja bażi u 67.9 % kellhom pressjoni għolja.
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 % placebo).
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: Xigduo combines two anti-hyperglycaemic medicinal products with different and complementary mechanisms of action to improve glycaemic control in patients with type 2 diabetes: dapagliflozin, a sodium glucose co-transporter 2 (SGLT2) inhibitor, and metformin hydrochloride, a member of the biguanide class.
Maltese: Xigduo jgħaqqad żewġ prodotti mediċinali għal kontra l-ipergliċemija b'mekkaniżmi ta' azzjoni differenti u kumplimentari biex itejjeb il-kontroll gliċemiku f'pazjenti bid-dijabete tat-tip 2: dapagliflozin, impeditur tal-kotrasportatur 2 tas-sodium-glucose (SGLT2), u metformin hydrochloride, membru tal-klassi biguanide.
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: • in combination with other glucose-lowering medicinal products, including insulin, in patients inadequately controlled with metformin and these medicinal products (see sections 4.4, 4.5 and 5.1 for available data on different combinations)
Maltese: • f'kombinazzjoni ma' prodotti mediċinali oħra li jbaxxu l-glukożju, inkluża l-insulina, f'pazjenti mhux ikkontrollati adegwatament b'metformin u b'dawn il-prodotti mediċinali (ara sezzjonijiet 4.4, 4.5 u 5.1 għat-tagħrif disponibbli dwar kombinazzjonijiet differenti)
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 l-linja bażi tal-indiċi tal-massa tal-ġisem (BMI).
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 %
English: At Week 104 for insulin (with or without additional oral glucose-lowering medicinal products, including metformin), the HbA1c reductions were -0.71 % and -0.06 % adjusted mean change from baseline for dapagliflozin 10 mg and placebo, respectively.
Maltese: Fil-ġimgħa 104 għall-insulina (bi prodotti mediċinali orali addizzjonali li jbaxxu l-glukożju jew mingħajrhom, inkluż metformin), it-tnaqqis fl-HbA1c kien ta' bidla medja aġġustata ta' -0.71 % u -0.06 % mil-linja bażi għal 10 mg dapagliflozin u plaċebo, rispettivament.
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: 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 flinformazzjoni dwar il-prodott deskritti hawn fuq.
English: The most commonly reported adverse reaction related to renal function was increased serum creatinine.
Maltese: L-iktar reazzjoni avversa komuni li ġiet irrapportata marbuta mal-funzjoni renali kienet iżżieda tal-kreatinina fis-serum.
English: The meal resulted in a delay of 1 to 2 hours in the peak concentrations and a decrease in the maximum plasma concentration of 29 % of dapagliflozin and 17 % of metformin.
Maltese: L-ikla rriżultat f'ittardjar ta' siegħa sa sagħtejn filkonċentrazzjonijiet massimi u fi tnaqqis fil-konċentrazzjoni massima fil-plażma ta' 29 % għal dapagliflozin u 17 % għal metformin.
English: Mean changes from baseline in haematocrit were 2.30 % for dapagliflozin 10 mg versus -0.33 % for placebo.
Maltese: Il-bidliet medji mil-linja bażi fl-ematokrit kienu 2.30 % għal 10 mg dapagliflozin kontra -0.33 % għal plaċebo.
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: At Week 208, adjusted mean change from baseline in HbA1c was -0.10 % for dapagliflozin and 0.20 % for glipizide, respectively.
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, rispettivament.
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: HbA1c (%) Baseline (mean) Change from baseline Difference from placebo d
Maltese: HbA1c (%) Linja bażi (medja)
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 tal-istudju 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: As an add-on therapy to metformin in an active-controlled non-inferiority study, dapagliflozin resulted in a statistically significant body weight change compared with glipizide of -4.65 kg at 52 weeks (p < 0.0001, Table 2) that was sustained at 104 and 208 weeks (-5.06 kg and -4.38 kg, respectively).
Maltese: Bħala terapija miżjuda ma' metformin fi studju kkontrollat attivament dwar nuqqas ta' inferjorità, dapagliflozin wassal għal bidla statistikament sinifikanti fil-piż tal-ġisem meta mqabbel ma' glipizide ta'4.65 kg fil-ġimgħa 52 (p < 0.0001, Tabella 2) li kienet sostnuta sal-ġimgħat 104 u 208 (-5.06 kg u -4.38 kg rispettivament).
English: Xigduo is not recommended for use in patients with GFR < 60 mL/min (see section 4.4).
Maltese: Xigduo mhuwiex rakkomandat biex jintuża fuq pazjenti b'GFR < 60 mL/min (ara sezzjoni 4.4).
English: film-coating: polyvinyl alcohol (E1203), macrogol 3350 (E1520(iii)), talc (E553b), titanium dioxide (E171), iron oxides (E172).
Maltese: • Is-sustanzi l-oħra huma: qalba tal-pillola: hydroxypropyl cellulose (E463), microcrystalline cellulose (E460(i)), magnesium stearate (E470b), sodium starch glycolate. kisja b'rita: polyvinyl alcohol (E1203), macrogol 3350 (E1520(iii)), talc (E553b), titanium dioxide (E171), iron oxides (E172).
English: OTHER
Maltese: d
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: EU/1/13/900/009 Xigduo 5 mg/1000 mg 56 tablets EU/1/13/900/010 Xigduo 5 mg/1000 mg 60 tablets EU/1/13/900/011 Xigduo 5 mg/1000 mg 60 x 1 tablet (unit dose) EU/1/13/900/012 Xigduo 5 mg/1000 mg 196 (2 x 98) tablets (multipack)
Maltese: Xigduo 5 mg/1,000 mg pilloli miksijin b'rita EU/1/13/900/007 Xigduo 5 mg/1000 mg 14-il pillola EU/1/13/900/008 Xigduo 5 mg/1000 mg 28 pillola EU/1/13/900/009 Xigduo 5 mg/1000 mg 56 pillola EU/1/13/900/010
English: The steady-state 24-hour urinary glucose excretion was highly dependent on renal function and 85, 52, 18 and 11 g of glucose/day was excreted by subjects with type 2 diabetes mellitus and normal renal function or mild, moderate or severe renal impairment, respectively.
Maltese: It-tneħħija tal-glukożju fl-awrina fl-istat fiss f'24 siegħa kienet tiddependi ħafna mill-funzjoni renali u 85, 52, 18 u 11 g ta' glukożju kuljum tneħħew minn pazjenti bid-dijabete (diabetes mellitus) tattip 2 u b'funzjoni renali normali jew b'indeboliment renali ħafif, moderat jew sever, rispettivament.
English: Diagnostic laboratory findings are decreased blood pH (< 7.35), increased plasma lactate levels above 5 mmol/l, and an increased anion gap and lactate/pyruvate ratio.
Maltese: Sejbiet dijanjostiċi tal-laboratorju huma tnaqqis fil-pH tad-demm (< 7.35), żieda fil-livelli ta' lactate fil-plażma (>5 mmol/l) u żieda fl-anion gap u l-proporzjon ta' lactate/pyruvate.
English: When Xigduo is used in combination with insulin or an insulin secretagogue such as sulphonylurea, a lower dose of insulin or sulphonylurea may be considered to reduce the risk of hypoglycaemia (see sections 4.5 and 4.8).
Maltese: Meta Xigduo jintuża f'kombinazzjoni mal-insulina jew ma' sekretagoga tal-insulina bħal sulphonylurea, tista' tiġi kkunsidrata doża iktar baxxa ta' insulina jew ta' sulphonylurea biex jitnaqqas ir-riskju ta' ipogliċemija (ara sezzjonijiet 4.5 u 4.8).
English: deficiency h,§
Maltese: h,§
English: Race There were no clinically relevant differences in systemic exposures between White, Black or Asian races.
Maltese: Ma kienx hemm differenzi klinikament rilevanti fl-esponimenti sistemiċi bejn ir-razez bojod, suwed jew Ażjatiċi.
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 with healthy matched control subjects.
Maltese: F'pazjenti b'indeboliment tal-fwied ħafif jew moderat (Klassijiet Child-Pugh A u B), is-Cmax u l-AUC medji ta' dapagliflozin kienu sa 12 % u 36 % ogħla, rispettivament, meta mqabbla ma' individwi korrispondenti b'saħħithom bħala kontroll.
English: Xigduo 5 mg/850 mg film-coated tablets and Xigduo 5 mg/1,000 mg film-coated tablets are available in PVC/PCTFE/Alu blister.
Maltese: Xigduo 5 mg/850 mg pilloli miksijin b'rita u Xigduo 5 mg/1,000 mg pilloli miksijin b'rita jiġu f'folja talPVC/PCTFE/Alu.
English: EU/1/13/900/007 Xigduo 5 mg/1000 mg 14 tablets EU/1/13/900/008 Xigduo 5 mg/1000 mg 28 tablets
Maltese: EU/1/13/900/012 Xigduo 5 mg/1000 mg 196 (2 x 98) pillola (pakkett multiplu)
English: • decreased vitamin B12 levels in the blood
Maltese: • livelli mnaqqsa ta' vitamina
English: Having considered all available data, the PRAC was of the view that the growing data on amputation in the CANVAS and CANVAS-R trial confirm an increased amputation risk for canagliflozin; it is unlikely that the difference in amputation risk seen with canagliflozin compared to placebo is a finding by chance.
Maltese: Wara li kkunsidra d-data disponibbli kollha, il-PRAC kien tal-fehma li d-data li dejjem qed tiżdied dwar lamputazzjonijiet fil-prova ta' CANVAS u CANVAS-R tikkonferma riskju miżjud ta' amputazzjoni għal cangliflozin; mhuwiex probabbli li d-differenza fir-riskju ta' amputazzjoni li dehret b'canagliflozin meta mqabbel mal-plaċebo hija sejba b'kumbinazzjoni.
English: Dapagliflozin as an add-on to metformin alone or metformin plus sitagliptin, sulphonylurea or insulin (with or without additional oral glucose-lowering medicinal products, including metformin) resulted in statistically significant body weight reduction up to 24 weeks (p < 0.0001, Tables 3, 4 and 5).
Maltese: Dapagliflozin bħala żieda ma' metformin waħdu jew ma' metformin flimkien ma' sitagliptin, sulphonylurea jew mal-insulina (bi prodotti mediċinali orali addizzjonali li jbaxxu l-glukożju jew mingħajrhom, inkluż metformin) irriżulta fi tnaqqis statistikament sinifikanti fil-piż tal-ġisem sa 24 ġimgħa (p < 0.0001, Tabelli 3, 4 u 5).
English: Hypoglycaemia (when used with SU or insulin)
Maltese: Ipogliċemija (meta użat ma' SU jew malinsulina)
English: A Direct Healthcare Professional Communication (DHPC) was circulated on 2 May 2016 to inform healthcare professionals that a two-fold higher incidence of lower limb amputation (primarily of the toe) had been seen in a clinical trial with canagliflozin; in addition, the need to counsel patients about the importance of routine preventative foot care was highlighted.
Maltese: Fit-2 ta' Mejju 2016, ġiet iċċirkolata Komunikazzjoni Diretta tal-Professjonisti fil-Qasam tal-Kura tasSaħħa (DHPC, Direct Healthcare Professional Communication) sabiex tinforma lill-professjonisti filqasam tal-kura tas-saħħa li fi prova klinika b'canagliflozin, ġiet innutata inċidenza ta' darbtejn aktar finnumru ta' amputazzjonijiet tan-naħa ta' isfel tar-riġlejn (primarjament tas-saba' tas-sieq); barra minn hekk, ġie enfasizzat il-bżonn li l-pazjenti jingħataw parir dwar l-importanza ta' kura tas-saqajn preventiva ta' rutina.
English: For studies of dapagliflozin 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 dwar dapagliflozin bħala żieda ma' metformin jew bħala żieda ma' sitagliptin (b'metformin jew mingħajru), il-frekwenza ta' episodji minuri ta' ipogliċemija kienet simili (< 5 %) bejn il-gruppi ta' kura, inkluż il-plaċebo sa 102 ġimgħat ta' kura.
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 dapagliflozin 10 mg and placebo, respectively).
Maltese: Flisudju dwar iż-żieda ma' metformin, it-tnaqqis fl-HbA1c kien sostnut sal-ġimgħa 102 (bidla medja aġġustata ta' -0.78 % u 0.02 % mil-linja bażi għal 10 mg dapagliflozin u plaċebo, rispettivament).
English: The proportion of subjects remaining in the study at Week 104 was 72.4 % for the group treated with dapagliflozin 10 mg and 54.8 % for the placebo group.
Maltese: Il-proporzjon tal-pazjenti li kienu baqgħu fl-istudju fil-ġimgħa 104 kien ta' 72.4 % għall-grupp ittrattat b'10 mg dapagliflozin u ta' 54.8 % għall-grupp tal-plaċebo.
English: See section 4.4 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: The proportion of subjects remaining in the study at Week 104 and Week 208 was 56.2 % and 39.7 % for the group treated with dapagliflozin and 50.0 % and 34.6 % for the group treated with glipizide.
Maltese: Il-proporzjon ta' pazjenti li kien baqa' flistudju fil-Ġimgħa 104 u fil-Ġimgħa 208 kien ta' 56.2 % u 39.7 % għall-grupp ikkurat b'dapagliflozin u ta' 50.0 % u 34.6 % għall-grupp ikkurat bi glipizide.
English: In subjects ≥ 65 years of age, adverse reactions of volume depletion, most commonly reported as hypotension, were reported in 1.7 % and 0.8 % of dapagliflozin-treated subjects and placebo-treated subjects, respectively (see section 4.4).
Maltese: F'pazjenti ta' ≥ 65 sena, ġew irrapportati reazzjonijiet avversi ta' tnaqqis fil-volum, irrapportati l-aktar bħala pressjoni tad-demm baxxa, f'1.7 % u f'0.8 % tal-individwi ttrattati b'dapagliflozin u ta' dawk ittrattati bi plaċebo, rispettivament (ara sezzjoni 4.4).
English: Results of a 24-week placebo-controlled study of dapagliflozin in add-on combination with metformin and a sulphonylurea
Maltese: Riżultati ta' studju kkontrollat bi plaċebo ta' 24 ġimgħa ta' dapagliflozin f'kombinazzjoni miżjuda ma' metformin u sulphonylurea
English: In patients with normal renal function or mild renal impairment (baseline eGFR ≥ 60 mL/min/1.73 m2) this grouping of reactions were reported in 1.3 % and 0.8 % of patients who received dapagliflozin 10 mg and placebo, respectively.
Maltese: F'pazjenti b'funzjoni renali normali jew b'indeboliment renali ħafif (eGFR tal-linja bażi ≥ 60 mL/min/1.73 m2) dan ir-raggruppament ta' reazzjonijiet ġie rrapportat f'1.3 % u 0.8 % tal-pazjenti li rċevew dapagliflozin 10 mg u plaċebo, rispettivament.
English: • The PRAC also considered that additional information on amputation events should be collected through appropriate case report forms (CRFs) for clinical trials, follow-up questionnaires for postmarketing cases, use of common MedDRA preferred term (PT) lists for amputation preceding events, and appropriate meta-analyses of large studies including cardiovascular outcome studies.
Maltese: • Il-PRAC ikkunsidra wkoll li għandha tinġabar informazzjoni addizzjonali dwar avvenimenti ta' amputazzjoni permezz ta' formoli ta' rapporti ta' każijiet (CRFs, case report forms) xierqa għal provi kliniċi, kwestjonarji ta' segwitu għal każijiet ta' wara t-tqegħid fis-suq, l-użu ta' listi komuni ta' termini ppreferuti (PT, preferred term) ta' MedDRA għal avvenimenti ta' qabel amputazzjoni, u metaanaliżi ta' studji kbar inkluż studji ta' eżitu kardjovaskulari.
English: Haematocrit increased Creatinine renal clearance decreased Dyslipidaemia
Maltese: KONDIZZJONIJIET JEW RESTRIZZJONIJIET FIR-RIGWARD TAL-UŻU SIGUR U EFFIKAĊI TAL-PRODOTT MEDIĊINALI
English: Following coadministration of dapagliflozin with mefenamic acid (an inhibitor of UGT1A9), a 55 % increase in dapagliflozin systemic exposure was seen, but with no clinically meaningful effect on 24-hour urinary glucose excretion.
Maltese: Wara l-għoti ta' dapagliflozin flimkien ma' mefenamic acid (impeditur ta' UGT1A9), ġiet innotata żieda ta' 55 % fl-esponiment sistemiku ta' dapagliflozin, imma mingħajr effett kliniku sinifikanti fuq it-tneħħija tal-glukożju fl-awrina f'24 siegħa.
English: The CANVAS and CANVAS-R studies and the CREDENCE and DECLARE Studies are planned to be completed in 2017 and 2020, respectively.
Maltese: L-istudji CANVAS u CANVAS-R u lIstudji CREDENCE u DECLARE huma ppjanati li jitlestew fl-2017 u fl-2020, rispettivament.
English: These clinically relevant glycaemic effects were sustained in long-term extensions up to 104 weeks.
Maltese: Dawn l-effetti gliċemiċi klinikament rilevanti kienu sostnuti f'estensjonijiet fit-tul sa 104 ġimgħat.
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 Il-kura fit-tul b'metformin ġiet assoċjata ma' tnaqqis fl-assorbiment tal-vitamina
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 short-term 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: 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 u l-preżenza ta' prodott mediċinali orali li jbaxxi lglukożju valur-p < 0.0001 kontra plaċebo + insulina ± prodott mediċinali orali li jbaxxi l-glukożju valur-p < 0.05 kontra plaċebo + insulina ± prodott mediċinali orali li jbaxxi l-glukożju Żieda fid-dożi tal-insulina (inkluż insulina li taħdem għal żmien qasir, intermedja jew bażali) kienet permessa biss jekk il-pazjenti kienu jissodisfaw il-kriterji FPG definiti minn qabel Ħamsin fil-mija tal-pazjenti kienu fuq monoterapija bl-insulina fil-linja bażi; 50 % kienu fuq prodott jew żewġ prodotti mediċinali orali li jbaxxu l-glukożju miżjuda mal-insulina:
English: In a pre-specified pooled analysis of 13 placebo-controlled studies, treatment with dapagliflozin 10 mg resulted in a systolic blood pressure change from baseline of -3.7 mmHg and diastolic blood pressure of1.8 mmHg versus -0.5 mmHg systolic and -0.5 mmHg diastolic blood pressure for placebo group at Week 24.
Maltese: F'analiżi miġbura speċifikata minn qabel ta' 13-il studju kkontrollat bi plaċebo, il-kura b'10 mg dapagliflozin irriżultat f'bidla ta' -3.7 mmHg fil-pressjoni sistolika tad-demm mil-linja bażi u ta'1.8 mmHg fil-pressjoni dijastolika tad-demm kontra -0.5 mmHg fil-pressjoni sistolika tad-demm u0.5 mmHg fil-pressjoni dijastolika għall-grupp tal-plaċebo fil-ġimgħa 24.
English: In an analysis of 5 placebo-controlled dapagliflozin add-on to metformin studies, the safety results were similar to that of the pre-specified pooled analysis of 12 placebo-controlled dapagliflozin studies (see Dapagliflozin, Summary of the safety profile below).
Maltese: F'analiżi ta' 5 studji kkontrollati bi plaċebo dwar dapagliflozin miżjud ma' metformin, ir-riżultati ta' sigurtà kienu simili għal dawk tal-analiżi miġbura speċifikata minn qabel ta' 12-il studju dwar dapagliflozin kkontrollati bi plaċebo (ara Dapagliflozin, Sommarju tal-profil ta' sigurtà hawn taħt).