FrancophonIA/ELRC3.0 huggingface dataset:
English: It is taken on its own, or it can be combined with a different type of diabetes medicine called a sulphonylurea.
Maltese: Dan jittieħed waħdu, jew jista' jiġi kombinat ma' tip ta' mediċina tad-dijabete differenti msejħa sulphonylurea.
English: urticaria
Maltese: urtikarja
English: Dyslipidaemia includes the following preferred terms: dyslipidaemia, hyperlipidaemia, hypercholesterolaemia, and hypertriglyceridaemia.
Maltese: Diżlipidemija tinkludi t-termini ppreferuti li ġejjin: diżlipidemija, iperlipidemija, iperkolesterolemija, u ipertrigliċeridemija.
English: Dapagliflozin: 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 darba kuljum dapagliflozin għal 7 ijiem), individwi b'dijabete mellitus tat-tip 2 u indeboliment ħafif, moderat jew sever tal-kliewi (kif iddeterminar minn tneħħija ta' iohexol fil-plażma) kellhom esponimenti sistemiċi ta' dapagliflozin ta' 32 %, 60 % u 87 % ogħla, rispettivament, minn dawk ta' individwi b'dijabete mellitus tat-tip 2 u funzjoni tal-kliewi normali.
English: Clinically relevant factors predictive of increased relative risk with saxagliptin treatment could not be definitively identified.
Maltese: Fatturi klinikament rilevanti predittivi ta' riskju relattiv miżjud bil-kura b'saxagliptin ma setgħux jiġu identifikati b'mod definittiv.
English: Anaphylactic reactions including anaphylactic shock
Maltese: Reazzjonijie anafilattiċi inkluż xokk anafilattiku
English: Qtrilmet contains the active substances metformin, saxagliptin, and dapagliflozin.
Maltese: Qtrilmet fih is-sustanzi attivi metformin, saxagliptin, u dapagliflozin .
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.
Maltese: B12 li f'każijiet rari ħafna tista' tirriżulta f'defiċjenza klinikament sinifikanti tal-vitamina B12.
English: Immunocompromised patients, such as patients who have undergone organ transplantation or patients diagnosed with human immunodeficiency syndrome have not been studied in the saxagliptin clinical programme.
Maltese: Pazjenti immunokompromessi, bħal pazjenti li sarilhom trapjant ta' organu jew pazjenti dijanjostikati b'sindrome tal-immunodefiċjenza umana ma ġewx studjati fil-programm kliniku b'saxagliptin.
English: Saxagliptin and its major metabolite are removed by haemodialysis (23% of dose over four hours).
Maltese: Saxagliptin u l-metabolit maġġuri tiegħu jitneħħew permezz ta' emodijalisi (23% tad-doża matul erba' sigħat).
English: n = number of subjects with non-missing baseline and a week 24 value.
Maltese: n = numru ta' individwi b'valur tal-linja bażi u ta' Ġimgħa 24 mhux nieqes.
English: Effect of other medicinal products on metformin, saxagliptin or dapagliflozin
Maltese: Effett ta' prodotti mediċinali oħra fuq metformin, saxagliptin jew dapagliflozin
English: The primary safety (non-inferiority) and efficacy (superiority) endpoint was a composite endpoint consisting of the time-to-first occurrence of any of the following major adverse CV events (MACE): CV death, nonfatal myocardial infarction, or nonfatal ischemic stroke.
Maltese: L-end-point tas-sigurtà (noninferjorità) u effikaċja (superjorità) primarja kien end-point kompost li jikkonsisti miż-żmien għall-ewwel okkorrenza ta' kwalunkwe avveniment CV avvers maġġuri milli ġejjin (MACE): mewta CV, infart mijokardijaku mhux fatali, jew puplesija iskemika mhux fatali.
English: The maximum recommended daily dose of Qtrilmet is metformin 2,000 mg/saxagliptin 5 mg/dapagliflozin 10 mg.
Maltese: Id-doża massima ta' kuljum rakkomandata ta' Qtrilmet hija 2,000 mg/saxagliptin 5 mg/dapagliflozin 10 mg.
English: Qtrilmet 850 mg/2.5 mg/5 mg modified-release tablets Macrogol (E1521)
Maltese: Qtrilmet 850 mg/2.5 mg/5 mg pilloli b'rilaxx modifikat Macrogol (E1521)
English: Use of DPP-4 inhibitors has been associated with a risk of developing acute pancreatitis.
Maltese: L-użu ta' inibituri ta' DPP-4 ġie assoċjat ma' riskju ta' żvilupp ta' pankreatite akuta.
English: Following coadministration of dapagliflozin with rifampicin (an inducer of uridine 5'-diphosphoglucuronosyl transferase [UGT] and CYP3A4/5), 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 konkomitanti ta' dapagliflozin ma' rifampicin (induttur ta' uridine 5'-diphosphoglucuronosyl transferase [UGT] u CYP3A4/5), ġie osservat tnaqqis ta' 22 % fl-esponiment sistemiku (AUC) ta' dapagliflozin, iżda bl-ebda effett klinikament sinifikanti fuq l-eskrezzjoni tal-glucose millawrina ta' 24 siegħa.
English: Dapagliflozin: 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 terminali tal-plażma medjana (t1/2) għal dapagliflozin kienet 12.9 sigħat wara doża orali waħda ta' dapagliflozin 10 mg lil individwi b'saħħithom.
English: Both saxagliptin and dapagliflozin can individually increase the risk of hypoglycaemia when combined with insulin or an insulin secretagogue (sulphonylurea).
Maltese: Kemm dapagliflozin kif ukoll saxagliptin jistgħu individwalment iżidu r-riskju ta' ipogliċemija meta jiġu kombinati ma' insulina jew sekretagog tal-insulina (sulphonylurea).
English: # Adverse reaction reported for dapagliflozin.
Maltese: Reazzjoni avversa rrappurtata għal dapagliflozin.
English: The average renal clearance of saxagliptin (~230 mL/min) was greater than the average estimated glomerular filtration rate (~120 mL/min), suggesting some active renal excretion.
Maltese: L-eliminazzjoni medja mill-kliewi ta' saxagliptin (~230 mL/min) kienet akbar mir-rata ta' filtrazzjoni glomerulari stmata (~120 mL/min), li tissuġġerixxi xi eskrezzjoni mill-kliewi attiva.
English: Qtrilmet 1,000 mg/2.5 mg/5 mg modified-release tablets Macrogol (E1521)
Maltese: Qtrilmet 1,000 mg/2.5 mg/5 mg pilloli b'rilaxx modifikat Macrogol (E1521)
English: Elderly patients are more likely to have impaired renal function, and may be at a greater risk for volume depletion.
Maltese: Pazjenti anzjani għandhom aktar probabbiltà li jkollhom funzjoni tal-kliewi indebolita, u jistgħu jkunu f'riskju akbar għal tnaqqis fil-volum.
English: Concomitant administration of saxagliptin with the potent CYP3A4/5 inducer rifampicin reduced Cmax and AUC of saxagliptin by 53% and 76%, respectively.
Maltese: L-għoti konkomitanti ta' saxagliptin mal-induttur qawwi ta' CYP3A4/5 rifampicin naqqas is-Cmax u lAUC ta' saxagliptin bi 53 % u 76 %, rispettivament.
English: In interaction studies conducted in healthy subjects, using mainly a single-dose design, dapagliflozin did not alter the pharmacokinetics of saxagliptin, metformin, pioglitazone (a CYP2C8 [major] and CYP3A4 [minor] substrate), sitagliptin, glimepiride (a CYP2C9 substrate), 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: Fi studji ta' interazzjoni li saru f'individwi b'saħħithom, li użaw prinċipalment tfassil ta' doża waħda, dapagliflozin ma biddilx sinifikament il-farmakokinetika ta' saxagliptin, metformin, pioglitazone (substrat ta' CYP2C8 [maġġuri] u CYP3A4 [minuri]), sitagliptin, glimepiride (substrat ta' CYP2C9), hydrochlorothiazide, bumetanide, valsartan, digoxin (substrat ta' P-gp) jew warfarin (S-warfarin, substrat ta' CYP2C9 ), jew l-effetti antikoagulatorji ta' warfarin kif imkejla mill-INR.
English: There were no clinically relevant differences observed in saxagliptin pharmacokinetics between males and females.
Maltese: Ma kien hemm l-ebda differenza klinikament rilevanti osservata fil-farmakokinetika ta' saxagliptin bejn l-irġiel u n-nisa.
English: The increased/decreased risk was not statistically significant in any of the organ systems.
Maltese: Ir-riskju miżjud/imnaqqas ma kienx statistikament sinifikanti fi kwalunkwe waħda mis-sistemi tal-organi.
English: There is no experience in clinical trials with dapagliflozin in NYHA class III-IV.
Maltese: M'hemmx esperjenza fil-provi kliniċi b'dapagliflozin fil-klassi III-IV ta' NYHA.
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għal galactose, defiċjenza totali ta' lactase, jew assorbiment ħażin ta' glucose-galactose m'għandhomx jieħdu dan il-prodott mediċinali.
English: Metformin hydrochloride: Metformin pharmacokinetic parameters did not differ significantly between normal subjects and patients with type 2 diabetes when analysed according to gender (males=19, females=16).
Maltese: Il-parametri farmakokinetiċi ta' metformin ma varjawx b'mod sinifikanti bejn individwi normali u pazjenti b'dijabete tat-tip 2 meta ġew analizzati skont is-sess (irġiel=19, nisa=16).
English: The modest lowering effects on BP were consistent over time and a similar number of patients had systolic BP < 130 mmHg or diastolic BP < 80 mmHg at week 24 across the treatment groups.
Maltese: Leffetti l-aktar modesti li jbaxxu fuq il-BP kienu konsistenti maż-żmien u numru simili ta' pazjenti kellhom BP sistolika < 130 mmHg jew BP dijastolika < 80 mmHg f'Ġimgħa 24 fil-gruppi ta' trattament.
English: The mean total systemic clearance of dapagliflozin administered intravenously was 207 mL/min.
Maltese: L-eliminazzjoni sistemika totali medja ta' dapagliflozin mogħti ġol-vini kienet 207 mL/min.
English: Using CYP3A4 inducers like glucocorticoids, beta-2 agonists, diuretics, carbamazepine, dexamethasone, phenobarbital, phenytoin, and rifampicin may reduce the glycaemic lowering effect of Qtrilmet.
Maltese: L-użu ta' indutturi ta' CYP3A4 bħal glukokortikojdi, agonisti tar-riċettur beta-2, dijuretiċi, carbamazepine, dexamethasone, phenobarbital, phenytoin, u rifampicin jista' jnaqqas l-effett tattnaqqis gliċemiku ta' Qtrilmet.
English: The safety profile of the combined use of metformin, saxagliptin and dapagliflozin is comparable to the adverse reactions identified for the respective mono-components.
Maltese: Il-profil tas-sigurtà tal-użu kombinat ta' metformin, saxagliptin u dapagliflozin huwa komparabbli marreazzjonijiet avversi identifikati għall-monokomponenti rispettivi.
English: The mean change from baseline was -1.50 kg (95% CI [-1.89, -1.11]) for the saxagliptin 5 mg and dapagliflozin 10 mg, plus metformin group, versus 2.14 kg (95% CI [1.75, 2.54]) in the insulin glargine plus metformin group.
Maltese: [-1.89, -1.11]) għall-grupp ta' saxagliptin 5 mg, dapagliflozin 10 mg u metformin, kontra 2.14 kg (95% CI [1.75, 2.54]) fil-grupp ta' insulin glargine u metformin.
English: Concomitant administration of saxagliptin with the potent inhibitor of CYP3A4/5 ketoconazole, increased the Cmax and AUC of saxagliptin by 62% and 2.5-fold, respectively, and the corresponding values for the active metabolite were decreased by 95% and 88%, respectively.
Maltese: L-għoti konkomitanti ta' saxagliptin mal-inibitur qawwi ta' CYP3A4/5 ketoconazole, żied is-Cmax u lAUC ta' saxagliptin bi 62 % u 2.5-drabi, rispettivament, u l-valuri korrispondenti għall-metabolit attiv tnaqqsu b'95 % u 88 %, rispettivament.
English: Another secondary endpoint, all-cause mortality, occurred at a rate of 5.1% in the saxagliptin group and 4.6% in the placebo group.
Maltese: End-point sekondarju ieħor, mortalità mill-kawżi kollha, seħħ b'rata ta' 5.1% fil-grupp ta' saxagliptin u 4.6 % fil-grupp tal-plaċebo.
English: Headache dizziness
Maltese: Medja aġġustata
English: In the pooled safety analysis, the overall incidence of hypoglycaemia (all reported events including those with central laboratory FPG ≤ 3.9 mmol/L) was 2.0% in subjects treated with dapagliflozin 10 mg and saxagliptin 5 mg plus metformin (combination therapy), 0.6% in the saxagliptin plus metformin group, and 2.3% in the dapagliflozin plus metformin group.
Maltese: Fl-analiżi tas-sigurtà miġbura, l-inċidenza globali ta' ipogliċemija (l-avvenimenti kollha rrappurtati inkluż dawk b'FPG ≤ 3.9 mmol/L ċentrali tal-laboratorju) kienet 2.0 % fl-individwi ttrattati b'dapagliflozin 10 mg u saxagliptin 5 mg u metformin (terapija kombinata), 0.6 % fil-grupp ta' saxagliptin u metformin, u 2.3 % fil-grupp ta' dapagliflozin u metformin.
English: Metformin Metformin is excreted unchanged in the urine.
Maltese: Metformin Metformin jiġi eliminat mhux mibdul fl-awrina.
English: The pack sizes are 14, 28, 56 and 196 modified-release tablets in calendar blisters and 14, 28, 56, 60 and 196 modified-release tablets in blisters.
Maltese: Id-daqsijiet tal-pakkett huma 14, 28, 56 u 196 pillola b'rilaxx modifikat f'folji kalendarji u 14, 28, 56, 60 u 196 pillola b'rilaxx modifikat f'folji.
English: PA/alu/PVC/alu blister Shelf life: 30 months
Maltese: Folja PA/alu/PVC/alu Żmien kemm idum tajjeb il-prodott mediċinali: 30 xahar
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 tal-laboratorju dijanjostiċi huma pH tad-demm imnaqqas (< 7.35), livelli tal-lactate fil-plażma miżjuda 'l fuq minn 5 mmol/L, u diskrepanza miżjuda tal-anjon u proporzjon ta' lactate/pyruvate.
English: Angioedema
Maltese: Anġjoedem
English: If renal function falls below GFR < 60 mL/min, treatment should be discontinued.
Maltese: Jekk il-funzjoni tal-kliewi taqa' taħt GFR < 60 mL/min, it-trattament għandu jitwaqqaf.
English: mL/min/1.73 m 2 in saxagliptin plus metformin, and 0.81 mL/min/1.73 m 2 in dapagliflozin plus metformin.
Maltese: Ilbidla fl-eGFR medja mil-linja bażi f'Ġimgħa 24 kienet -1.17 mL/min/1.73 m2 fil-grupp ta' saxagliptin u dapagliflozin u metformin, -0.46 mL/min/1.73 m 2 f'saxagliptin u metformin, u 0.81 mL/min/1.73 m f'dapagliflozin u metformin.
English: The adjusted percent of subjects with HbA1c < 7.0% at week 52 was 29.4% in the dapagliflozin and saxagliptin plus metformin group and 12.6% in the placebo and saxagliptin plus metformin group.
Maltese: Il-perċentwal aġġustat ta' individwi b'HbA1c < 7.0% f'ġimgħa 52 kien 29.4 % fil-grupp ta' dapagliflozin u saxagliptin u metformin u 12.6 % fil-grupp ta' plaċebo u saxagliptin u metformin.
English: Qtrilmet combines three anti-hyperglycaemic medicinal products with different and complementary mechanisms of action to improve glycaemic control in patients with type 2 diabetes: metformin hydrochloride, a member of the biguanide class, saxagliptin, a DPP-4 inhibitor and dapagliflozin, a SGLT2 inhibitor.
Maltese: Qtrilmet jikkombina tliet prodotti mediċinali antiipergliċemiċi b'mekkaniżmi ta' azzjoni differenti u kumplimentari biex itejjeb il-kontroll gliċemiku f'pazjenti b'dijabete tat-tip 2: metformin hydrochloride, membru tal-klassi ta' biguanide, saxagliptin, inibitur ta' DPP-4 u dapagliflozin, inibitur ta' SGLT2,.
English: One component of the secondary composite endpoint, hospitalisation for heart failure, occurred at a greater rate in the saxagliptin group (3.5%) compared with the placebo group (2.8%), with nominal statistical significance favouring placebo [HR=1.27; (95% CI 1.07, 1.51); P = 0.007].
Maltese: Komponent wieħed tal-end-point kompost sekondarju, rikoveru l-isptar għal insuffiċjenza tal-qalb, seħħ b'rata akbar fil-grupp ta' saxagliptin (3.5%) meta mqabbel mal-grupp tal-plaċebo (2.8%), b'sinifikanza statistika nominali li tiffavorixxi l-plaċebo [HR=1.27; (95% CI 1.07, 1.51); P = 0.007].
English: Green, biconvex, 11 x 21 mm oval tablet, with 3002 debossed on one side.
Maltese: Pillola ħadra, bikonvessa, 11 x 21 mm ovali, bi 3002 imnaqqxa fuq naħa waħda.
English: The hazard ratio comparing dapagliflozin to comparator was 0.79 (95% CI: 0.58, 1.07), indicating that in this analysis dapagliflozin is not associated with an increase in cardiovascular risk in patients with type 2 diabetes mellitus.
Maltese: Il-proporzjon ta' periklu li jqabbel dapagliflozin malkomparatur kien 0.79 (95% CI: 0.58, 1.07), li jindika li f'din l-analiżi dapagliflozin mhuwiex assoċjat ma' żieda fir-riskju kardjovaskulari f'pazjenti b'dijabete mellitus tat-tip 2.
English: In study MB102129 and study CV181168, treatment with Qtrilmet resulted in change from baseline for systolic blood pressure ranging from -1.3 to -2.2 mmHg and for diastolic blood pressure ranging from -0.5 to -1.2 mmHg caused by Qtrilmet's mild diuretic effect.
Maltese: Fl-istudju MB102129 u l-Istudju CV181168, it-trattament b'Qtrilmet irriżulta f'bidla mil-linja bażi għal pressjoni tad-demm sistolika li varjat minn -1.3 sa -2.2 mmHg u għal pressjoni tad-demm dijastolika li varjat minn -0.5 sa -1.2 mmHg ikkawżata mill-effett dijuretiku ħafif ta' Qtrilmet.
English: The mean duration of T2DM when entering the study was 7.7 years, mean baseline HbA1c of 7.9%.
Maltese: Id-durata medja ta' T2DM mad-dħul fl-istudju kienet 7.7 snin, HbA1c fil-linja bażi medja ta' 7.9 %.
English: Concomitant administration of saxagliptin with the moderate inhibitor of CYP3A4/5 diltiazem, increased the Cmax and AUC of saxagliptin by 63% and 2.1-fold, respectively, and the corresponding values for the active metabolite were decreased by 44% and 34%, respectively.
Maltese: L-għoti konkomitanti ta' saxagliptin mal-inibitur moderat ta' CYP3A4/5 diltiazem, żied is-Cmax u lAUC ta' saxagliptin bi 63 % u 2.1 darbiet, rispettivament, u l-valuri korrispondenti għall-metabolit attiv tnaqqsu b'44 % u 34 %, rispettivament.
English: The red blood cells most likely represent a secondary compartment of distribution.
Maltese: Iċ-ċelluli ħomor tad-demm wisq probabbli jirrappreżentaw kompartiment sekondarju ta' distribuzzjoni.
English: In rats, dapagliflozin was neither embryolethal nor teratogenic at exposures up to 1,441 times the human values at the MRHD.
Maltese: Fil-firien, dapagliflozin la kien tossiku għallembrijun u lanqas teratoġeniku b'esponimenti sa 1,441 darbiet il-valuri tal-bniedem bl-MRHD.
English: Qtrilmet 1,000 mg/2.5 mg/5 mg modified-release tablets are green, biconvex, 11 x 21 mm oval tablet, with 3002 debossed on one side.
Maltese: Qtrilmet 1,000 mg/2.5 mg/5 mg pilloli b'rilaxx modifikat huma pilloli ħodor, bikonvessi, 11 x 21 mm ovali, b'3002 imnaqqxa fuq naħa waħda.
English: The adjusted mean change from baseline was -3.11 kg (95% CI [-3.65, -2.57]) for the saxagliptin 5 mg and dapagliflozin 10 mg plus metformin group, and 0.95 kg (95% CI [0.38, 1.51]) for the glimepiride plus metformin group.
Maltese: Il-bidla medja aġġustata mil-linja bażi kienet -3.11 kg (95% CI [-3.65, -2.57]) għall-grupp ta' saxagliptin 5 mg u dapagliflozin 10 mg u metformin, u 0.95 kg (95% CI [0.38, 1.51]) għall-grupp ta' glimepiride u metformin.
English: Adverse reactions of genital infection were reported in 3.0% in the saxagliptin plus dapagliflozin plus metformin group, 0.9% of saxagliptin plus metformin group and 5.9% of subjects in the dapagliflozin plus metformin group.
Maltese: L-avvenimenti avversi ta' infezzjoni ġenitali ġew irrappurtati fi 3.0 % fil-grupp ta' saxagliptin u dapagliflozin u metformin, 0.9 % tal-grupp ta' saxagliptin u metformin u 5.9 % tal-individwi fil-grupp ta' dapagliflozin u metformin.
English: The difference in the adjusted mean change from baseline to week 52 between the treatment groups was -0.42% [95% CI: -0.64, -0.20].
Maltese: Iddifferenza fil-bidla medja aġġustata mil-linja bażi sa ġimgħa 52 bejn ilgruppi ta' trattament kienet -0.42% [95% CI:-0.64, -0.20].
English: PA/alu/PVC/alu blister
Maltese: Folja PA/alu/PVC/alu
English: No dose adjustment is recommended for Qtrilmet in patients with mild renal impairment, GFR 60-89 mL/min.
Maltese: Mhu rakkomandat l-ebda aġġustament fid-doża għal Qtrilmet f'pazjenti b'indeboliment tal-kliewi ħafif, GFR 60-89 mL/min.
English: Dapagliflozin dosed to maternal rats from gestation day 6 through postnatal day 21, and pups were indirectly exposed in utero and throughout lactation.
Maltese: Dapagliflozin ddożat lil firien materni mis-6 jum ta' ġestazzjoni sal-21 jum ta' wara t-twelid, u l-frieħ kienu esposti indirettament in utero u matul it-treddigħ.
English: Subjects with adverse events of renal impairment had lower mean eGFR values at baseline of 61.8 mL/min/1.73 m2 compared to
Maltese: L-individwi b'avvenimenti avversi ta' indeboliment tal-kliewi kellhom valuri eGFR aktar baxxi fil-linja bażi ta' 61.8 mL/min/1.73 m2 meta mqabbel ma' 93.6 mL/min/1.73 m2 fil-popolazzjoni globali.
English: Consumption of alcohol and medicinal products containing alcohol should be avoided.
Maltese: Il-konsum tal-alkoħol u prodotti mediċinali li fihom l-alkoħol għandhom jiġu evitati.
English: Pack size of 14, 28, 56 and 196 modified-release tablets in calendar blisters.
Maltese: Daqs tal-pakkett ta' 14, 28, 56 u 196 pillola b'rilaxx modifikat f'folji kalendarji.
English: Following coadministration of dapagliflozin with mefenamic acid (an inhibitor of UGT 1A9), 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 konkomitanti ta' dapagliflozin ma' mefenamic acid (induttur ta' UGT 1A9), ġie osservat tnaqqis ta' 55 % fl-esponiment sistemiku ta' dapagliflozin, iżda bl-ebda effett klinikament sinifikanti fuq l-eskrezzjoni tal-glucose mill-awrina ta' 24 siegħa.
English: Pack size of 14, 28, 56, 60 and 196 modified-release tablets in blisters.
Maltese: Daqs tal-pakkett ta' 14, 28, 56, 60 u 196 pillola b'rilaxx modifikat f'folji.
English: Saxagliptin 5 mg added to dapagliflozin 10 mg + metformin
Maltese: Saxagliptin 5 mg miżjud ma' dapagliflozin 10 mg + metformin
English: Urinary tract infection vulvovaginitis, balanitis and related genital infection gastroenteritis
Maltese: Infezzjoni flapparat talawrina vulvovaġinite, balanite u infezzjoni ġenitali relatata gastroenterie
English: Dapagliflozin: Dapagliflozin exposure increased proportional to the increment in dapagliflozin dose over the range of 0.1 to 500 mg and its pharmacokinetics did not change with time upon repeated daily dosing for up to 24 weeks.
Maltese: L-esponiment ta' dapagliflozin żdied proporzjonali għaż-żieda fid-doża ta' dapagliflozin fuq il-medda ta' 0.1 sa 500 mg u l-farmakokinetika tiegħu ma nbidlitx maż-żmien ma' dożaġġ ta' kuljum ripetut sa 24 ġimgħa.
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 tiġi medjata minn UGT1A9, enzima preżenti fil-fwied u l-kliewi, u metaboliżmu medjat minn CYP kien passaġġ ta' tneħħija minuri fil-bnedmin.
English: 41.4% (95% CI [34.5, 48.2]) of patients in the saxagliptin 5 mg and dapagliflozin 10 mg combination group achieved HbA1c levels of less than 7% compared to 18.3% (95% CI [13.0, 23.5]) patients in the saxagliptin 5 mg group and 22.2% (95% CI [16.1, 28.3]) patients in the dapagliflozin 10 mg group at week 24.
Maltese: [34.5, 48.2]) tal-pazjenti fil-grupp ikkombinat ta' saxagliptin 5 mg u dapagliflozin 10 mg kisbu livelli ta' HbA1c ta' inqas minn 7 % meta mqabbel ma' 18.3 % (95% CI [13.0, 23.5]) pazjenti fil-grupp ta' saxagliptin 5 mg u 22.2 % (95% CI [16.1, 28.3]) pazjenti fil-grupp ta' the dapagliflozin 10 mg f'Ġimgħa 24.
English: The adjusted mean changes from baseline in HbA1c for the dapagliflozin and saxagliptin plus metformin and placebo and saxagliptin plus metformin groups were -0.74% (95% CI: -0.90, -0.57) and 0.07% (95% CI: -0.13, 0.27), respectively.
Maltese: Il-bidliet medji aġġustati mil-linja bażi fl-HbA1c għall-gruppi ta' dapagliflozin u saxagliptin u metformin u plaċebo u saxagliptin u metformin kienu -0.74% (95% CI:0.90, -0.57) u 0.07% (95% CI: -0.
English: Decreased renal function in elderly patients is frequent and asymptomatic.
Maltese: Funzjoni tal-kliewi mnaqqsa f'pazjenti anzjani hija frekwenti u asintomatika.