FrancophonIA/ELRC3.0 huggingface dataset:
English: In the pooled safety analysis, cardiovascular (CV) events that were adjudicated and confirmed as CV events were reported in a total of 1.0% of subjects in the saxagliptin plus dapagliflozin plus metformin group, 0.6% in the saxagliptin plus metformin group, and 0.9% in the dapagliflozin plus metformin group.
Maltese: Fl-analiżi tas-sigurtà miġbura, avvenimenti kardjovaskulari (CV) li ġew aġġudikati u kkonfermati bħala avvenimenti CV ġew irrappurtati f'total ta' 1.0 % tal-individwi fil-grupp ta' saxagliptin u dapagliflozin u metformin, 0.6 % fil-grupp ta' saxagliptin u metformin, u 0.9 % fil-grupp ta' dapagliflozin u metformin.
English: The safety and efficacy of the fixed-dose combination of metformin/saxagliptin/dapagliflozin was evaluated in five randomised, double-blind, active/placebo-controlled clinical trials in adult subjects with type 2 diabetes mellitus.
Maltese: Is-sigurtà u l-effikaċja tal-kombinazzjoni ta' doża fissa ta' metformin/saxagliptin/dapagliflozin ġiet evalwata f'ħames provi kliniċi randomizzati, double-blind, attivi/ikkontrollati bil-plaċebo f'individwi adulti b'dijabete mellitus tat-tip 2.
English: medicines to lower blood pressure including ACE inhibitors (such as enalapril or ramipril), angiotensin II receptor antagonists (such as losartan or candesartan); insulin, sulphonylureas (such as glimepiride) or pioglitazone to lower your blood sugar; medicines that increase urine production and lower blood pressure (diuretics).
Maltese: mediċini li jbaxxu l-pressjoni tad-demm inkluż inibituri ta' ACE (bħal enalapril jew ramipril), antagonisti tar-riċettur anġjotensina II (bħal losartan jew candesartan). insulina, sulphonylureas (bħal glimepiride) jew pioglitazone biex ibaxxu z-zokkor fid-demm tiegħek. mediċini li jżidu l-produzzjoni tal-awrina u jbaxxu l-pressjoni tad-demm (dijuretiċi).
English: The same recommendations for monitoring of renal function apply to elderly patients as to all patients (see sections 4.2, 4.4, 4.8 and 5.1).
Maltese: L-istess rakkomandazzjonijiet għall-monitoraġġ tal-funzjoni tal-kliewi japplikaw għal pazjenti anzjanti daqskemm għall-pazjenti kollha (ara sezzjonijiet 4.2, 4.4, 4.8 u 5.1).
English: taste disturbance
Maltese: disturb fittogħma
English: Lactic acidosis Vitamin B12 deficiency
Maltese: Aċidożi lattika Defiċjenza tal
English: Proportion of patients achieving HbA1c < 7% in study MB102129 and study CV181168 The proportion of patients achieving HbA1c < 7.0% at week 24 in the add-on therapy with dapagliflozin 10 mg to saxagliptin 5 mg plus metformin trial was higher in the dapagliflozin 10 mg and saxagliptin 5 mg plus metformin group 38.0% (95% CI [30.9, 45.1]) compared to the placebo plus saxagliptin 5 mg plus metformin group 12.4% (95% CI [7.0, 17.9]).
Maltese: Il-proporzjon ta' pazjenti li kisbu HbA1c < 7.0% f'ġimgħa 24 fit-terapija miżjuda mal-prova ta' dapagliflozin 10 mg ma' saxagliptin 5 mg u metformin kien ogħla fil-grupp ta' dapagliflozin 10 mg u saxagliptin 5 mg u metformin 38.0% (95% CI [30.9, 45.1]) meta mqabbel mal-grupp ta' plaċebo u saxagliptin 5 mg u metformin 12.4% (95% CI
English: Swallow the tablets whole with half a glass of water.
Maltese: Ibla' l-pilloli sħaħ ma' nofs tazza ilma.
English: In patients with decreased renal function, the plasma and blood half-life of metformin is prolonged and the renal clearance is decreased, leading to increased levels of metformin in plasma, (see sections 4.2, 4.3 and 4.4).
Maltese: F'pazjenti b'funzjoni tal-kliewi indebolita, il-half-life filplażma u fid-demm ta' metformin titwal u t-tneħħija mill-kliewi titnaqqas, u twassal għal livelli miżjuda ta' metformin fil-plażma, (ara sezzjonijiet 4.2, 4.3 u 4.4).
English: Upper respiratory tract infection includes the following preferred terms: nasopharyngitis, influenza, upper respiratory tract infection, pharyngitis, rhinitis, sinusitis, pharyngitis bacterial, tonsillitis, acute tonsillitis, laryngitis, viral pharyngitis, and viral upper respiratory tract infection.
Maltese: Infezzjoni fl-apparat respiratorju ta' fuq tinkludi t-termini ppreferuti li ġejjin: nażofarinġite, influwenza, infezzjoni fl-apparat respiratorju ta' fuq, farinġite, rinite, sinusite, farinġite batterika, tonsillite, tonsillite akua, larinġite, farinġite virali, u infezzjoni virali fl-apparat respiratorju ta' fuq.
English: The safety profile is based on pooled analysis of three placebo controlled phase 3 clinical trials in 1,169 patients for up to 52 weeks, of which 492 patients received a combination of saxagliptin 5 mg, dapagliflozin 10 mg, plus metformin (see section 5.1).
Maltese: Il-profil tas-sigurtà huwa bbażat fuq analiżi miġbura ta' tliet provi kliniċi kkontrollati bi plaċebo ta' fażi 3 f'1,169 pazjent sa 52 ġimgħa, li minnhom 492 pazjent irċivew kombinazzjoni ta' saxagliptin 5 mg, dapagliflozin 10 mg, u metformin (ara sezzjoni 5.1).
English: The increase in simvastatin and simvastatin acid exposures are not considered clinically relevant.
Maltese: Madankollu, id-differenzi fl-esponiment ma tqisux bħala klinikament sinifikanti.
English: Saxagliptin: The mean plasma terminal half-life (t1/2) values for saxagliptin and its major metabolite are 2.5 hours and 3.1 hours, respectively, and the mean t1/2 value for plasma DPP-4 inhibition was 26.9 hours.
Maltese: Il-valuri tal-half-life terminali tal-plażma medjana (t1/2) għal saxagliptin u l-metabolit maġġuri tiegħu huma 2.5 sigħat u 3.1 sigħat, rispetivament, u l-valur t1/2 medju għall-inibizzjoni ta' DPP-4 fil-plażma kien 26.
English: Use in patients treated with pioglitazone
Maltese: Użu f'pazjenti ttrattati b'pioglitazone
English: In studies conducted in healthy subjects, neither the pharmacokinetics of saxagliptin nor its major metabolite were meaningfully altered by dapagliflozin, metformin, glibenclamide, pioglitazone, digoxin, diltiazem, simvastatin, omeprazole, antacids or famotidine.
Maltese: Fi studji f'individwi b'saħħithom, la l-farmakokinetika ta' saxagliptin u lanqas il-metabolit maġġuri tiegħu ma nbidlu b'mod sinifikanti minn dapagliflozin, metformin, glibenclamide, pioglitazone, digoxin, diltiazem, simvastatin, omeprazole, antaċidi jew famotidine.
English: In subjects with moderate to severe renal impairment (patients with GFR < 60 mL/min), a higher proportion of subjects treated with dapagliflozin had adverse reactions of increase in creatinine, phosphorus, parathyroid hormone (PTH), and hypotension, compared with placebo.
Maltese: F'individwi b'indeboliment tal-kliewi moderat sa sever (pazjenti b'GFR < 60 mL/min), proporzjon ogħla ta' individwi ttrattati b'dapagliflozin kellhom reazzjonijiet avversi ta' żieda fil-kreatinina, fosforu, ormon tal-paratirojd (PTH), u pressjoni baxxa, meta mqabbla mal-plaċebo.
English: Following a 5 mg single oral dose of saxagliptin to healthy subjects, the mean plasma AUC values for saxagliptin and its major metabolite were 78 ng h/mL and 214 ng h/mL, respectively.
Maltese: Wara doża orali waħda ta' 5 mg ta' saxagliptin lil individwi b'saħħithom, il-valuri ta' AUC fil-plażma medji għal saxagliptin u lmetabolit maġġuri tiegħu kienu 78 ng h/mL u 214 ng h/mL, rispettivament.
English: pancreatic cancer with hepatic metastases, and invasive ductal breast carcinoma in the saxagliptin plus dapagliflozin plus metformin group.
Maltese: Dawn inkludew avvenimenti avversi ta' neoplażmu gastriku, kanċer pankreatiku b'metastasijiet epatiċi, u karċinoma tas-sider duttali invażiva fil-grupp ta' saxagliptin u dapagliflozin u metformin.
English: pruritus
Maltese: pruritu
English: The saxagliptin and dapagliflozin group achieved significantly greater reductions in HbA1c versus either the saxagliptin group or dapagliflozin group at 24 weeks (see Table 3).
Maltese: Il-grupp ta' saxagliptin u dapagliflozin kiseb tnaqqis sinifikament akbar fl-HbA1c kontra jew il-grupp ta' saxagliptin jew dapagliflozin wara 24 ġimgħa (ara Tabella 2).
English: Saxagliptin: Saxagliptin was rapidly absorbed after oral administration in the fasted state, with maximum plasma concentrations (Cmax) of saxagliptin and its major metabolite attained within 2 and 4 hours (Tmax), respectively.
Maltese: Saxagliptin ġie assorbit b'mod rapidu wara għoti orali fl-istat sajjem, b'konċentrazzjonijiet massimi fil-plażma (Cmax) ta' saxagliptin u l-metabolit maġġuri tiegħu li nkisbu fi żmien sagħtejn u 4 sigħat (Tmax), rispettivament.
English: The reported adverse reactions of vulvovaginitis, balanitis and related genital infections from pooled safety analysis were reflective of the safety profile of dapagliflozin.
Maltese: Ir-reazzjonijiet avversi rrappurtati ta' vulvovaġinite, balanite u infezzjonijiet ġenitali relatati millanaliżi tas-sigurtà mibura kienu jirriflettu l-profil tas-sigurtà ta' dapagliflozin.
English: Dapagliflozin: Adverse reactions related to increased creatinine have been reported for dapagliflozin as a mono-component.
Maltese: Ġew irrappurtati reazzjonijiet avversi relatati ma' żieda fil-kreatinina għal dapagliflozin bħal monokomponent.
English: Risk of volume depletion with this medicinal product should also be taken into account (see sections 4.4 and 5.2).
Maltese: Għandu jiġi kkunsidrat ukoll ir-riskju ta' tnaqqis fil-volum b'dan il-prodott mediċinali (ara sezzjonijiet 4.4 u 5.2).
English: Dapagliflozin may add to the diuretic effect of thiazide and loop diuretics and may increase the risk of dehydration and hypotension (see section 4.4).
Maltese: Dapagliflozin jista' jżid mal-effett dijuretiku ta' thiazide u dijuretiiċ loop u jista' jżid ir-riskju ta' deidratazzjoni u pressjoni baxxa (ara sezzjoni 4.4).
English: The overall incidence rates of hypoglycaemia in two 52-week studies comparing the combination therapy to glimepiride (SU) were: for the 1
Maltese: Ir-rati tal-inċidenza globali ta' ipogliċemija f'żewġ studji ta' 52 ġimgħa li qabblu t-terapija kombinata ma' glimepiride (SU) kienu: għall-1
English: At week 52, the adjusted mean change in HbA1c from baseline was -1.35% for the saxagliptin 5 mg and dapagliflozin 10 mg plus metformin group (N=218), compared to -0.98% for the glimepiride plus metformin group (N=212) (difference -0.37%, 95% CI [-0.57, -0.18], p < 0.001).
Maltese: F'ġimgħa 52, il-bidla medja aġġustata fl-HbA1c mil-linja bażi kienet -1.35 % għall-grupp ta' saxagliptin 5 mg u dapagliflozin 10 mg u metformin (N=218), meta mqabbel ma' -0.98 % għall-grupp ta' glimepiride u metformin (N=212) (differenza -0.37%, 95% CI
English: Modified-release tablets
Maltese: TAL-PRODOTT MEDIĊINALI
English: Qtrilmet 1,000 mg/2.5 mg/5 mg modified-release tablets:
Maltese: Qtrilmet 1,000 mg/2.5 mg/5 mg pilloli b'rilaxx modifikat:
English: The combination of saxagliptin 5 mg and dapagliflozin 10 mg added to metformin consistently demonstrated greater reductions in HbA1c irrespective of baseline HbA1c compared with saxagliptin 5 mg or dapagliflozin 10 mg alone added to metformin.
Maltese: Ilkombinazzjoni ta' saxagliptin 5 mg u dapagliflozin 10 mg miżjuda ma' metformin uriet b'mod konsistenti tnaqqis akbar fl-HbA1c irrispettivament mill-HbA1c fil-linja bażi mqabbel ma' saxagliptin 5 mg jew dapagliflozin 10 mg waħdu miżjud ma' metformin.
English: No non-clinical studies have been conducted in metformin/saxagliptin/dapagliflozin combination.
Maltese: Ma sarux studji mhux kliniċi fil-kombinazzjoni ta' metformin/ saxagliptin/dapagliflozin .
English: Qtrilmet 850 mg/2.5 mg/5 mg modified-release tablets:
Maltese: Qtrilmet 850 mg/2.5 mg/5 mg pilloli b'rilaxx modifikat:
English: Qtrilmet 1,000 mg/2.5 mg/5 mg modified-release tablets
Maltese: Qtrilmet 1,000 mg/2.5 mg/5 mg pilloli b'rilaxx modifikat
English: Patients were randomised to one of three double-blind treatment groups to receive saxagliptin 5 mg and dapagliflozin 10 mg added to metformin, saxagliptin 5 mg and placebo added to metformin, or dapagliflozin 10 mg and placebo added to metformin.
Maltese: Il-pazjenti ġew randomizzati għal wieħed mit-tliet gruppi ta' trattament double-blind biex jirċievu saxagliptin 5 mg u dapagliflozin 10 mgmiżjud ma' metformin, saxagliptin 5 mg u plaċebo miżjud ma' metformin, jew dapagliflozin 10 mg u plaċebo miżjud ma' metformin.
English: Available pharmacodynamic/toxicological data in animals have shown excretion of dapagliflozin/metabolites in milk, as well as pharmacologically-mediated effects in breast-feeding offspring (see section 5.3).
Maltese: Dejta farmakodinamika/tossikoloġika fl-annimali uriet li kien hemm eliminazzjoni ta' dapagliflozin/metaboliti fil-ħalib tas-sider, kif ukoll effetti medjati farmakoloġikament fit-treddigħ tan-nisel (ara 5.3)..
English: Qtrilmet 850 mg/2.5 mg/5 mg modified-release tablets
Maltese: Qtrilmet 850 mg/2.5 mg/5 mg pilloli b'rilaxx modifikat
English: The majority of the genital infection adverse reactions were reported in females (84% of subjects with a genital infection), were mild or moderate in intensity, of single occurrence, and most patients continued on therapy.
Maltese: Il-maġġoranza tal-avvenimenti avversi ta' infezzjoni ġenitali ġew irrappurtati fin-nisa (84% tal-individwi b'infezzjoni ġenitali), kienu ħfief jew moderati fl-intensità, ta' okkorrenza waħda, u ħafna mill-pazjenti komplew fuq it-terapija.
English: Very rare decreased vitamin B12 levels in the blood abnormalities in liver function tests, inflammation of the liver (hepatitis) redness of the skin (erythema), itching, or an itchy rash (hives)
Maltese: B12 fid-demm - anormalitajiet fit-testijiet tal-funzjoni tal-fwied, infjammazzjoni tal-fwied (epatite) - ħmura tal-ġilda (eritema), ħakk, jew raxx bil-ħakk (ħorriqija)
English: Change from baseline (adjusted mean (95% CI)
Maltese: Bidla millinja bażi (medja aġġustata (95% CI)
English: * LRM = Longitudinal repeated measures using values prior to rescue.
Maltese: * LRM = Miżuri ripetuti lonġitudinali permezz ta' valuri qabel is-salvataġġ.
English: Glycaemic control should be assessed, especially at the beginning, when it is used concomitantly with a potent CYP3A4/5 inducer (see section 4.5).
Maltese: Il-kontroll gliċemiku għandu jiġi vvalutat, speċjalment fil-bidu, meta jintuża b'mod konkomitanti ma' induttur qawwi ta' CYP3A4/5 (ara sezzjoni 4.5).
English: Saxagliptin: After a single dose of saxagliptin in subjects with mild, moderate or severe renal impairment (or ESRD) classified on the basis of creatinine clearance the mean AUC values of saxagliptin were 1.2-, and up to 2.1- and 4.5- fold higher, respectively, than AUC values in subjects with normal renal function.
Maltese: Wara doża waħda ta' saxagliptin f'individwi b'indeboliment tal-kliewi ħafif, moderat jew sever (jew ESRD) ikklassifikat abbażi ta' tneħħija tal-kreatinina, il-valuri tal-AUC medji ta' saxagliptin kienu 1.2, u sa 2.1 u 4.5 drabi ogħla, rispettivament, mill-valuri tal-AUC f'individwi b'funzjoni tal-kliewi normali.
English: Qtrilmet 850 mg/2.5 mg/5 mg modified-release tablets metformin hydrochloride/saxagliptin/dapagliflozin
Maltese: Qtrilmet 850 mg/2.5 mg/5 mg pilloli b'rilaxx modifikat metformin hydrochloride/saxagliptin/dapagliflozin
English: Use in patients at risk for volume depletion, hypotension, and/or electrolyte imbalances
Maltese: Użu f'pazjenti b'riskju għal tnaqqis fil-volum, pressjoni baxxa, u/jew żbilanċ fl-elettroliti
English: Adverse reaction reported for the combined use of saxagliptin and metformin.
Maltese: Reazzjoni avversa rrappurtata għall-użu kkombinat ta' saxagliptin u metformin.
English: Qtrilmet 1,000 mg/2.5 mg/5 mg modified-release tablets metformin hydrochloride/saxagliptin/dapagliflozin
Maltese: Qtrilmet 1,000 mg/2.5 mg/5 mg pilloli b'rilaxx modifikat metformin hydrochloride/saxagliptin/dapagliflozin
English: Each tablet contains 1,000 mg of metformin hydrochloride, saxagliptin hydrochloride equivalent to 2.5 mg saxagliptin and dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin.
Maltese: Kull pillola fiha 1,000 mg ta' metformin hydrochloride, saxagliptin hydrochloride ekwivalenti għal 2.5 mg saxagliptin u dapagliflozin propanediol monohydrate ekwivalenti għal 5 mg dapagliflozin.
English: The increases in creatinine were generally transient during continuous treatment or reversible after discontinuation of treatment.
Maltese: Iż-żidiet fil-kreatinina kienu ġeneralment temporanji waqt trattament kontinwu jew riversibbli wara t-twaqqif tat-trattament.
English: What Qtrilmet looks like and contents of the pack Qtrilmet 850 mg/2.5 mg/5 mg modified-release tablets are beige, biconvex, 11 x 21 mm oval tablet, with 3005 debossed on one side.
Maltese: Qtrilmet 850 mg/2.5 mg/5 mg pilloli b'rilaxx modifikat huma pilloli beige, bikonvessi, 11 x 21 mm ovali, b'3005 imnaqqxa fuq naħa waħda.
English: A 24-week randomised, double-blind, placebo-controlled study with a 28-week extension compared the sequential addition of 10 mg dapagliflozin to 5 mg saxagliptin and metformin to the addition of placebo to 5 mg saxagliptin (DPP-4 inhibitor) and metformin in patients with type 2 diabetes mellitus and inadequate glycaemic control (HbA1c ≥ 7% and ≤ 10.5%).
Maltese: Studju ta' 24 ġimgħa, randomizzat, double-blind, ikkontrollat bi plaċebo b'estensjoni ta' 28 ġimgħa qabbel iż-żieda sekwenzjali ta' 10 mg dapagliflozin ma' 5 mg saxagliptin u metformin maż-żieda tal plaċebo ma' 5 mg saxagliptin (inibitur ta' DPP-4) u metformin f'pazjenti b'dijabete mellitus tat-tip 2 ukontroll gliċemiku inadegwat (HbA1c ≥ 7% u ≤ 10.
English: Saxagliptin: Saxagliptin produced reversible skin lesions (scabs, ulcerations and necrosis) in extremities (tail, digits, scrotum and/or nose) in cynomolgus monkeys.
Maltese: Saxagliptin ipproduċa leżjonijiet tal-ġilda riversibbli (qxur, ulċerazzjonijiet u nekrożi) f'estremitajiet (denb, swaba', skrotum u/jew imnieħer) f'xadini cynomolgus.
English: CV deaths were balanced across the treatment groups.
Maltese: L-imwiet CV kienu bbilanċjati fil-gruppi ta' trattament.
English: EU/1/19/1401/001 14 modified-release tablets EU/1/19/1401/002 28 modified-release tablets EU/1/19/1401/003 56 modified-release tablets EU/1/19/1401/004 60 modified-release tablets EU/1/19/1401/005 196 modified-release tablets EU/1/19/1401/006 14 modified-release tablets (calendar blister) EU/1/19/1401/007 28 modified-release tablets (calendar blister) EU/1/19/1401/008 56 modified-release tablets (calendar blister) EU/1/19/1401/009 196 modified-release tablets (calendar blister)
Maltese: EU/1/19/1401/001 14-il pillola b'rilaxx modifikat EU/1/19/1401/002 28 pillola b'rilaxx modifikat EU/1/19/1401/003 56 pillola b'rilaxx modifikat EU/1/19/1401/004 60 pillola b'rilaxx modifikat EU/1/19/1401/005 196 pillola b'rilaxx modifikat EU/1/19/1401/006 14-il pillola b'rilaxx modifikat (folja kalendarja)
English: Mon. Tue. Wed. Thu. Fri. Sat. Sun.
Maltese: Jekk ikollok xi dubju, kellem lit-tabib, lill-ispiżjar, jew lill-infermier tiegħek qabel tieħu Qtrilmet.
English: Dapagliflozin: Dapagliflozin was rapidly and well absorbed after oral administration.
Maltese: Dapagliflozin ġie assorbit b'mod rapidu u tajjeb wara għoti orali.
English: for renal function with GFR levels approaching moderate renal impairment and in elderly patients, at least 2 to 4 times per year.
Maltese: - Għal funzjoni tal-kliewi b'livelli ta' GFR li jqarrbu indeboliment tal-kliewi moderat u f'pazjenti anzjani, tal-inqas darbtejn sa 4 darbiet fis-sena.
English: Metformin is contraindicated in patients with GFR of < 30 mL/min and this treatment should be temporarily interrupted in the presence of conditions that alter renal function (see section 4.3).
Maltese: Metformin huwa kontraindikat f'pazjenti b'GFR ta' < 30 mL/min u dan it-trattament għandu jiġi interrott b'mod temporanju fil-preżenza ta' kondizzjonijiet li jibdlu l-funzjoni tal-kliewi (ara sezzjoni 4.3).
English: EU/1/19/1401/024 14 modified-release tablets EU/1/19/1401/025 28 modified-release tablets EU/1/19/1401/026 56 modified-release tablets EU/1/19/1401/027 60 modified-release tablets EU/1/19/1401/028 196 modified-release tablets
Maltese: EU/1/19/1401/024 14-il pillola b'rilaxx modifikat EU/1/19/1401/025 28 pillola b'rilaxx modifikat EU/1/19/1401/026 56 pillola b'rilaxx modifikat EU/1/19/1401/027 60 pillola b'rilaxx modifikat EU/1/19/1401/028 196 pillola b'rilaxx modifikat
English: Add-on therapy with saxagliptin in patients inadequately controlled on dapagliflozin plus metformin
Maltese: Terapija miżjuda ma' saxagliptin f'pazjenti kkontrollati b'mod inadegwat fuq dapagliflozin u metformin
English: The most effective method to remove lactate and metformin is haemodialysis.
Maltese: L-aktar metodu effettiv biex jitneħħa lactate u metformin huwa l-emodijalisi.
English: EU/1/19/1401/015 14 modified-release tablets EU/1/19/1401/016 28 modified-release tablets EU/1/19/1401/017 56 modified-release tablets EU/1/19/1401/018 60 modified-release tablets EU/1/19/1401/019 196 modified-release tablets EU/1/19/1401/020 14 modified-release tablets (calendar blister) EU/1/19/1401/021 28 modified-release tablets (calendar blister) EU/1/19/1401/022 56 modified-release tablets (calendar blister) EU/1/19/1401/023 196 modified-release tablets (calendar blister)
Maltese: EU/1/19/1401/015 14-il pillola b'rilaxx modifikat EU/1/19/1401/016 28 pillola b'rilaxx modifikat EU/1/19/1401/017 56 pillola b'rilaxx modifikat EU/1/19/1401/018 60 pillola b'rilaxx modifikat EU/1/19/1401/019 196 pillola b'rilaxx modifikat EU/1/19/1401/020 14-il pillola b'rilaxx modifikat (folja kalendarja)
English: Metformin No clinically relevant interaction has been identified.
Maltese: Dawn id-differenzi ma tqisux bħala klinikament sinifikanti.
English: At week 24, the adjusted mean change in HbA1c from baseline was -1.67% for the saxagliptin 5 mg and dapagliflozin 10 mg plus metformin with or without SU group (N=319), which was noninferior to the change of -1.54% in the insulin glargine plus metformin with or without SU group (N=312) (difference -0.13%, 95% CI [-0.30, 0.03]).
Maltese: F'ġimgħa 24, il-bidla medja aġġustata fl-HbA1c mil-linja bażi kienet -1.67 % għall-grupp ta' saxagliptin 5 mg u dapagliflozin 10 mg u metformin ma' jew mingħajr SU (N=319), li ma kinitx inferjuri għall-bidla ta' -1.54 % fil-grupp ta' insulin glargine u metformin ma' jew mingħajr SU (N=312) (differenza -0.13%, 95% CI
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 (see section 2 “Diabetic skin and foot problems”).
Maltese: - Faxxite nekrotizzanti tal-perinew jew gangrene ta' Fournier, infezzjoni serja tat-tessut artab talġenitali jew il-parti bejn il-ġenitali u l-anus (ara sezzjoni 2 “Ġilda dijabetika u problemi fissaqajn”).
English: High overdose may lead to lactic acidosis (see sections 2 and 4).
Maltese: Doża eċċessiva għolja tista' twassal għal aċidożi lattika (ara sezzjonijiet 2 u 4).
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: Kombinazzjoni ta' doża waħda ta' dapagliflozin 20 mg u simvastatin (substrat ta' CYP3A4) irriżultat f'żieda ta' 19 %
English: Increased incidence or severity of renal pelvic dilatation was observed in adult offspring of treated dams, although only at the highest dose tested (at maternal and pup dapagliflozin exposures of 1,415 times and 137 times, respectively, the human values at the maximum recommended human dose [MRHD]).
Maltese: Ġiet osservata inċidenza jew severità miżjuda ta' dilatazzjoni pelvika tal-kliewi f'nisel adult ta' nisa kkurati, għalkemm bl-ogħla doża ttestjata biss (f'esponimenti fl-omm u fil-frieħ ta' dapagliflozin ta' 1,415 darbiet u 137 darbiet, rispettivament, ilvaluri tal-bniedem bid-doża massima rakkomandata fil-bniedem [MRHD]).
English: The majority of patients in this study had a baseline HbA1c of > 8% (see Table 4).
Maltese: Il-maġġoranza tal-pazjenti f'dan l-istudju kellhom HbA1c fil-linja bażi ta' > 8% (ara Tabella 3).
English: RHD).
Maltese: Erb.
English: EU/1/19/1401/010 14 modified-release tablets EU/1/19/1401/011 28 modified-release tablets EU/1/19/1401/012 56 modified-release tablets EU/1/19/1401/013 60 modified-release tablets EU/1/19/1401/014 196 modified-release tablets
Maltese: EU/1/19/1401/010 14-il pillola b'rilaxx modifikat EU/1/19/1401/011 28 pillola b'rilaxx modifikat EU/1/19/1401/012 56 pillola b'rilaxx modifikat EU/1/19/1401/013 60 pillola b'rilaxx modifikat EU/1/19/1401/014 196 pillola b'rilaxx modifikat