FrancophonIA/ELRC3.0 huggingface dataset:
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 talinsulina 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: Hypoglycaemia (when used with SU or insulin)
Maltese: Ipogliċemija (meta użat ma' SU jew mal-insulina)
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 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 ta' SGLT2, u metformin hydrochloride, membru tal-klassi biguanide.
English: Avoid excessive alcohol intake while taking Xigduo since this may increase the risk of lactic acidosis (see “Warnings and precautions”).
Maltese: Evita konsum eċċessiv ta' alkoħol waqt li tkun qed tieħu Xigduo peress li dan jista' jżid ir-riskju ta' aċidożi lattika (ara s-sezzjoni “Twissijiet u prekawzjonijiet”).
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: Each tablet contains a fixed dose of dapagliflozin and metformin (see section 2).
Maltese: Kull pillola fiha doża fissa ta' dapagliflozin u metformin (ara sezzjoni 2).
English: Risk of volume depletion with dapagliflozin should also be taken into account (see sections 4.4 and 5.2).
Maltese: Ir-riskju ta' tnaqqis tal-volum b'dapagliflozin għandu jitqies ukoll (ara sezzjonijiet 4.4 u 5.2).
English: Heart failure or cardiovascular death
Maltese: Cardiocvascular death
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, 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) għall-plaċebo (p=0.001).
English: Xigduo should not be initiated in patients with GFR < 60 mL/min and should be discontinued at GFR persistently below 45 mL/min (see section 4.2).
Maltese: Xigduo m'għandux jinbeda f'pazjenti b'GFR < 60 mL/min u għandu jitwaqqaf f'GFR li b'mod persistenti tkun taħt 45 mL/min (ara sezzjoni 4.2).
English: Each Xigduo 5 mg/850 mg film-coated tablet (tablet) contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin and 850 mg metformin hydrochloride.
Maltese: Kull Xigduo 5 mg/850 mg pillola miksija b'rita (pillola) fiha dapagliflozin propanediol monohydrate ekwivalenti għal 5 mg dapagliflozin u 850 mg metformin hydrochloride.
English: Urinary tract infection includes the following preferred terms, listed in order of frequency reported: urinary tract infection, cystitis, Escherichia urinary tract infection, genitourinary tract infection, pyelonephritis, trigonitis, urethritis, kidney infection and prostatitis.
Maltese: Infezzjoni tal-passaġġ urinarju tinkludi t-termini ppreferuti li ġejjin, elenkati f'ordni skont il-frekwenza rrapportata: infezzjoni fil-passaġġ urinarju, ċistite, infezzjoni tal-passaġġ urinarju b'Escherichia, infezzjoni tal-passaġġ ġenitourinarju, pajelonefrite, trigonite, uretrite, infezzjoni tal-kliewi u prostatite.
English: Cardiovascular and renal outcomes
Maltese: Eżiti kardjovaskulari u renali
English: The formation of dapagliflozin 3-O-glucuronide is mediated by UGT1A9, an enzyme present in the liver and kidney, and CYP-mediated metabolism was a minor clearance pathway in humans.
Maltese: Il-formazzjoni ta' dapagliflozin 3-O-glucuronide hija medjata minn UGT1A9, enzima preżenti fil-fwied u fil-kliewi, u l-metaboliżmu permezz ta' CYP kien mogħdija ta' eliminazzjoni minuri fil-bniedem.
English: Combination therapy of dapagliflozin 10 mg and prolonged-release exenatide resulted in a significantly greater reduction in systolic blood pressure at Week 28 (-4.3 mmHg) compared to dapagliflozin alone (-1.8 mmHg, p < 0.05) and prolonged-release exenatide alone (-1.2 mmHg, p < 0.01).
Maltese: Terapija kkombinata ta' dapagliflozin 10 mg u exenatide li jerħi l-mediċina bil-mod irriżultat f'tnaqqis konsiderevolment ikbar fi pressjoni tad-demm s fit-28 Ġimgħa (-4.3 mmHg) meta mqabbel ma' dapagliflozin waħdu (-1.8 mmHg, p < 0.05) u exenatide li jerħi l-mediċina bil-mod waħdu (-1.2 mmHg, p < 0.01).
English: Pharmacotherapeutic group: Drugs used in diabetes, Combinations of oral blood glucose-lowering drugs, ATC code: A10BD15
Maltese: Mediċini użati fid-dijabete, kombinazzjonijiet ta' mediċini orali li jbaxxu l-glukożju fid-demm, Kodiċi ATC:
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 talglukożju 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) tat-tip 2 u b'funzjoni renali normali jew b'indeboliment renali ħafif, moderat jew sever, rispettivament.
English: In the placebo group there was an increase of 10.5 IU/day and 18.3 IU/day from baseline (mean average dose of 84 and 92 IU/day) at Weeks 48 and 104, respectively.
Maltese: IU kuljum u 18.3 IU kuljum mil-linja bażi (doża medja ta' 84 u 92 IU kuljum) filġimgħat 48 u 104, rispettivament.
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say it is essentially ‘sodium-free'.
Maltese: Xigduo fih inqas minn 1 mmol sodium (23 mg) f'kull doża, jiġifieri huwa essenzjalment “mingħajr sodium”.
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 3) 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 3) li kienet sostnuta sal-ġimgħat 104 u 208 (-5.06 kg u -4.38 kg rispettivament).
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' metmorfin f'pazjenti li ma ġewx ikkurati preċedentement Total ta' 1,236 pazjent li ma ngħatawx mediċina 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' metmorfin f'pazjenti li ma ġewx ikkurati preċedentement kontra terapija bil-monokomponenti.
English: • genital infection (thrush) of your penis or vagina (signs may include irritation, itching, unusual discharge or odour)
Maltese: • infezzjoni ġenitali (traxx) tal-pene jew tal-vaġina (sinjali jistgħu jinkludu irritazzjoni, ħakk, nixxija jew riħa mhux normali)
English: At Week 12 for both studies, dapagliflozin 10 mg plus usual antidiabetic treatment provided improvement in HbA1c and decreased the placebo-corrected systolic blood pressure on average by 3.1 and 4.3 mmHg, respectively.
Maltese: F'Ġimgħa 12 għaż-żewġ studji, dapagliflozin 10 mg flimkien ma' kura antidijabetika normali ta titjib f'HbA1c u naqqas il-pressjoni tad-demm sistolika kkoreġuta bi plaċebo bħala medja bi 3.1 u 4.3 mmHg, rispettivament.
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 4, 5 and 6).
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 4, 5 u 6).
English: Dapagliflozin 10 mg demonstrated superiority versus placebo in preventing the composite of hospitalisation for heart failure or cardiovascular death (Figure 1).
Maltese: Dapagliflozin 10 mg wera superjorità kontra plaċebo fil-prevenzjoni tal-kompost ta' rikoveru l-isptar għal insuffiċjenza tal-qalb jew mewt kardjovaskulari (Figura 1).
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: Urinary tract infection
Maltese: Myocardial infarction
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: The primary assessment of safety and tolerability was conducted in a pre-specified pooled analysis of 13 short-term (up to 24 weeks) placebo-controlled studies with 2,360 subjects treated with dapagliflozin 10 mg and 2,295 treated with placebo.
Maltese: Il-valutazzjoni primarja tas-sigurtà u t-tollerabbiltà saret f'analiżi miġbura speċifikata minn qabel ta' 13-il studju ta' perjodu qasir (sa 24 ġimgħa) ikkontrollati bi plaċebo b'2,360 individwu kkurati b'10 mg dapagliflozin u 2,295 ittrattati bi plaċebo.
English: Haematocrit increased Creatinine renal clearance decreased during initial treatment Dyslipidaemia
Maltese: KONDIZZJONIJIET JEW RESTRIZZJONIJIET FIR-RIGWARD TAL-UŻU SIGUR U EFFIKAĊI TAL-PRODOTT MEDIĊINALI
English: Metformin is excreted by the kidney, and moderate to severe renal insufficiency increases the risk of lactic acidosis (see section 4.4).
Maltese: Metformin jitneħħa mill-kliewi, u insuffiċjenza tal-kliewi moderata għal severa żżid ir-riskju ta' aċidożi lattika (ara sezzjoni 4.4).
English: Dapagliflozin acts independently of insulin secretion and insulin action.
Maltese: Dapagliflozin jaġixxi indipendentament mit-tnixxija tal-insulina u mill-azzjoni tal-insulina.
English: HbA1c analysed using LRM (Longitudinal repeated measures analysis) Least squares mean adjusted for baseline value p-value < 0.0001 versus placebo + oral glucose-lowering medicinal product(s)
Maltese: Il-medja tal-inqas kwadri aġġustata għall-valur tal-linja bażi valur-p < 0.0001 kontra plaċebo + prodott(i) mediċinali orali li jbaxxi(u) l-glukożju
English: Urticaria Erythema Pruritus
Maltese: Popolazzjoni pedjatrika
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: Dapagliflozin does not inhibit other glucose transporters important for glucose transport into peripheral tissues and is > 1,400 times more selective for SGLT2 versus SGLT1, the major transporter in the gut responsible for glucose absorption.
Maltese: Dapagliflozin ma jimpedixxix trasportaturi oħrajn tal-glukożju li huma importanti għat-trasport talglukożju f'tessuti periferali u huwa > 1,400 darba iktar selettiv għal SGLT2 milli għal SGLT1, ittrasportatur ewlieni fil-musrana li huwa responsabbli għall-assorbiment tal-glukożju.
English: Each tablet contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin and 850 mg of metformin hydrochloride.
Maltese: Kull pillola fiha dapagliflozin propanediol monohydrate ekwivalenti għal 5 mg dapagliflozin u 850 mg ta' metformin hydrochloride.
English: Reporting suspected adverse reactions after authorisation of the medicinal product is important.
Maltese: Huwa importanti li jiġu rrappurtati reazzjonijiet avversi suspettati wara l-awtorizzazzjoni ta' dan il-prodott mediċinali.
English: Each Xigduo 5 mg/1,000 mg film-coated tablet (tablet) contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin and 1,000 mg metformin hydrochloride.
Maltese: Kull Xigduo 5 mg/1,000 mg pillola miksija b'rita (pillola) fiha dapagliflozin propanediol monohydrate ekwivalenti għal 5 mg dapagliflozin u 1,000 mg metformin hydrochloride.
English: In the dapagliflozin cardiovascular outcomes study with 17,160 type 2 diabetes mellitus patients and a median exposure time of 48 months, a total of 6 cases of Fournier's gangrene were reported, one in the dapagliflozin-treated group and 5 in the placebo group.
Maltese: Fl-istudju tal-eżiti kardjovaskulari b'dapagliflozin bi 17,160 pazjent bid-dijabete mellitus tat-tip 2 u żmien ta' esponiment medjan ta' 48 xahar, ġie rrapportat total ta' 6 każijiet ta' kankrena ta' Fournier, wieħed filgrupp ikkurat b'dapagliflozin u 5 fil-grupp ikkurat bi plaċebo.
English: Adverse reactions related to increased creatinine were grouped (e.g. decreased renal creatinine clearance, renal impairment, increased blood creatinine and decreased glomerular filtration rate).
Maltese: Reazzjonijiet avversi relatati ma' żieda fil-kreatinina ġew raggruppati (eż. tnaqqis fl-eliminazzjoni talkreatinina mill-kliewi, indeboliment renali, żieda tal-kreatinina fid-demm u rata mnaqqsa ta' filtrazzjoni glomerulari).
English: • if you are using medicines used to treat pain and inflammation (NSAID and COX-2-inhibitors, such as ibuprofen and celecoxib).
Maltese: • jekk qed tuża mediċini użati biex jittrattaw l-uġigħ u l-infjammazzjoni (NSAID u inibituri ta' COX2, bħal ibuprofen u celecoxib).
English: • Necrotising fasciitis of the perineum or Fournier's gangrene, a serious soft tissue infection of the genitals or the area between the genitals and the anus, seen very rarely.
Maltese: • Faxxite nekrotizzanti tal-perinew jew kankrena ta' Fournier, infezzjoni tat-tessut artab serja talġenitali jew tal-parti bejn il-ġenitali u l-anus, li tidher f'każijiet rari ħafna.
English: Skin and subcutaneous tissue disorders
Maltese: Disturbi muskoluskeletriċi u tattessuti konnettivi
English: Consumption of alcohol and medicinal products containing alcohol should be avoided.
Maltese: Għandu jiġi evitat il-konsum tal-alkoħol u ta' prodotti mediċinali li fihom l-alkoħol.
English: Xigduo 5 mg/850 mg film-coated tablets Xigduo 5 mg/1,000 mg film-coated tablets dapagliflozin/metformin hydrochloride
Maltese: Xigduo 5 mg/850 mg pilloli miksijin b'rita Xigduo 5 mg/1,000 mg pilloli miksijin b'rita dapagliflozin/metformin hydrochloride
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 Kombinazzjoni miżjuda Sulphonylurea + Metformin
English: • if you are using bronchodilators (beta-2 agonists) which are used to treat asthma.
Maltese: • jekk qed tuża bronkodilaturi (agonisti beta-2) li jintużaw għall-kura tal-ażżma.
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 2 u/jew marda renali fl-aħħar stadju (dijaliżi ≥ 90 jum jew trapjant tal-kliewi, eGFR < 15 mL/min/1.73 m 2 sostnuta kkonfermata) u/jew mewt renali jew kardjovaskulari.
English: In the dapagliflozin cardiovascular outcomes study, including elderly patients and patients with renal impairment (eGFR less than 60 mL/min/1.73 m2), eGFR decreased over time in both treatment groups.
Maltese: Fl-istudju tal-eżiti kardjovaskulari b'dapagliflozin, inkluż pazjenti anzjani u pazjenti b'indeboliment renali (eGFR inqas minn 60 mL/min/1.73 m2), l-eGFR naqset maż-żmien fiż-żewġ gruppi ta' kura.
English: Urine glucose
Maltese: Kontroll gliċemiku
English: SUMMARY OF PRODUCT CHARACTERISTICS
Maltese: Components of the composite endpoints
English: •Xigduo5mg/850mg are 9.5x20mm oval, brown film-coated tablets.
Maltese: • Xigduo 5 mg/850 mg huma 9.5 x 20 mm pilloli miksijin b'rita ovali, kannella.
English: 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: Dapagliflozin Effect on Cardiovascular Events (DECLARE) was an international, multicentre, randomised, double-blind, placebo-controlled clinical study conducted to determine the effect of dapagliflozin compared with placebo on cardiovascular outcomes when added to current background therapy.
Maltese: Dapagliflozin Effect on Cardiovascular Events (Effett ta' Dapagliflozin fuq l-Avvenimenti Kardjovaskulari) (DECLARE) kien studju kliniku internazzjonali, multiċentriku, randomizzat, doubleblind, ikkontrollat bi plaċebo li sar biex jiddetermina l-effett ta' dapagliflozin meta mqabbel ma' plaċebo fuq l-eżiti kardjovaskulari meta jiżdied ma' terapija ta' sfond attwali.
English: Long-term treatment with metformin has been associated with a decrease in vitamin B12 absorption which may very rarely result in clinically significant vitamin B12 deficiency (e.g. megaloblastic anaemia).
Maltese: B12 li rari ħafna jista' jwassal għal defiċjenza klinikament sinifikanti tal-vitamina
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: • increases in urea (shown in laboratory blood tests)
Maltese: • żidiet fl-urea (murija fit-testijiet tad-demm tal-laboratorju)
English: Decreased renal function in elderly patients is frequent and asymptomatic.
Maltese: Funzjoni renali mnaqqsa f'pazjenti akbar fl-età hija frekwenti u asintomatika.
English: p-values for the secondary endpoints and for single components are nominal.
Maltese: Il-valuri p għall-punti tat-tmiem sekondarji u għall-komponenti uniċi huma nominali.
English: As expected, dapagliflozin 5 mg administered twice daily compared with 10 mg dapagliflozin once daily resulted in lower peak dapagliflozin plasma concentrations (Cmax) and higher trough plasma dapagliflozin concentrations (Cmin).
Maltese: Kif kien mistenni, 5 mg dapagliflozin mogħtija darbtejn kuljum imqabbla ma' 10 mg dapagliflozin darba kuljum irriżultaw f'konċentrazzjonijiet massimi aktar baxxi ta' dapagliflozin filplażma (Cmax) u konċentrazzjonijiet l-iżjed baxxi ogħla ta' dapagliflozin fil-plażma (Cmin).
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: At 48 weeks, the difference for dapagliflozin as add-on to metformin plus sitagliptin compared with placebo was -2.07 kg. At 102 weeks, the difference for dapagliflozin as add-on to metformin compared with placebo or as add-on to insulin compared with placebo was -2.14 and -2.88 kg, respectively.
Maltese: Fil-ġimgħa 102, id-differenza għal dapagliflozin bħala żieda ma' metformin meta mqabbel ma' plaċebo jew bħala żieda mal-insulina meta mqabbel ma' plaċebo kienet ta' -2.14 u2.88 kg, rispettivament.
English: Insulin and insulin secretagogues, such as sulphonylureas, cause hypoglycaemia.
Maltese: L-insulina u s-sekretagogi tal-insulina, bħas-sulphonylureas, jikkawżaw l-ipogliċemija.
English: Xigduo 5 mg/850 mg film-coated tablets Xigduo 5 mg/1,000 mg film-coated tablets
Maltese: Xigduo 5 mg/850 mg pilloli miksijin b'rita Xigduo 5 mg/1,000 mg pilloli miksijin b'rita
English: The treatment benefit of dapagliflozin over placebo was observed both in patients with and without established cardiovascular disease, with and without heart failure at baseline, and was consistent across key subgroups, including age, gender, renal function (eGFR) and region.
Maltese: Il-benefiċċju tal-kura ta' dapagliflozin meta mqabbla ma' plaċebo kien osservat kemm f'pazjenti bi u mingħajr marda kardjovaskulari stabbilita, bi u mingħajr insuffiċjenza tal-qalb fil-linja bażi, u kien konsistenti fost is-sottogruppi ewlenin, inkluż l-età, is-sess, il-funzjoni renali (eGFR) u r-reġjun.
English: EXP
Maltese: Erb.
English: Increased incidence or severity of renal pelvic dilatation was observed in adult offspring of treated dams, although only at the highest dose tested (associated maternal and pup dapagliflozin exposures were 1,415 times and 137 times, respectively, the human values at the maximum recommended human dose).
Maltese: Ġiet osservata żieda fl-inċidenza jew fis-severità tad-dilatazzjoni tal-pelvi renali fl-ulied adulti tal-ommijiet li ġew ittrattati, imma biss għallogħla doża li ġiet ittestjata (l-esponimenti assoċjati materni u tal-frieħ għal dapagliflozin kienu 1,415-il darba u 137 darba, rispettivament, iktar mill-valuri umani għad-doża massima rrakkomandata għallbnedmin).
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 irreazzjonijiet kienu aktar komuni f'pazjenti b'eGFR tal-linja bażi ≥ 30 u < 60 mL/min/1.73 m dapagliflozin 10 mg kontra 9.3% plaċebo).
English: • weight decreased
Maltese: Sustained eGFR decrease
English: Results at Week 24 of a placebo-controlled study of dapagliflozin in diabetic patients with an eGFR ≥ 45 to < 60 mL/min/1.73 m
Maltese: Riżultati f'Ġimgħa 24 ta' studju kkontrollat bi plaċebo ta' dapagliflozin f'pazjenti dijabetiċi b'eGFR ≥ 45 sa < 60 mL/min/1.73 m