FrancophonIA/ELRC3.0 huggingface dataset:
English: Each MACE component positively contributed to the overall composite, as shown in Figure 2.
Maltese: Kull komponent ta' MACE ikkontribwixxa b'mod pożittiv għall-kompost totali, kif muri f'Figura 2.
English: The Cmax of canagliflozin was moderately increased by 13%, 29%, and 29% in subjects with mild, moderate, and severe renal failure, respectively, but not in subjects on haemodialysis.
Maltese: Is-Cmax ta' canagliflozin żdied b'mod moderat bi 13%, b'29%, u b'29% f'individwi b'insuffiċjenza ħafifa, moderata u qawwija tal-kliewi, rispettivament, iżda mhux fl-individwi li kienu fuq lemodijalisi.
English: In a cardiovascular study (CANVAS) of 4,327 treated subjects with established or at least two risk factors for cardiovascular disease, the incidence rates of all adjudicated bone fracture were 1.6, 1.8, and 1.1 per 100 patient-years of follow-up to canagliflozin 100 mg, canagliflozin 300 mg, and placebo, respectively, with the fracture imbalance initially occurring within the first 26 weeks of therapy.
Maltese: Fi studju kardjovaskulari (CANVAS) ta' 4,327 individwu ttrattat li kellhom mard kardjovaskulari stabbilit jew mill-inqas żewġ fatturi ta' riskju ta' mard kardjovaskulari, ir-rati ta' inċidenza ta' kull ksur iġġudikat fl-għadam kienu 1.6, 1.8, u 1.1 għal kull 100 sena ta' segwitu ta' pazjent fuq canagliflozin 100 mg, canagliflozin 300 mg, u plaċebo, rispettivament, bl-iżbilanċ fil-ksur li fil-bidu jseħħ fi żmien l-ewwel 26 ġimgħa ta' terapija.
English: Canagliflozin increased the incidence of testicular Leydig cell tumours in male rats at all doses tested (10, 30, and 100 mg/kg); the lowest dose of 10 mg/kg is approximately 1.5 times the clinical dose of 300 mg based on AUC exposure.
Maltese: L-ogħla doża ta' 100 mg/kg ipprovdiet doża sa 14-il darba aktar mid-doża klinika ta' 300 mg abbażi ta' esponiment bl-AUC. Canagliflozin żied l-inċidenza ta' tumuri taċ-ċellula ta' Leydig tat-testikoli f'firien irġiel bid-dożi kollha ttestjati (10, 30, u 100 mg/kg); l-aktar doża baxxa ta' 10 mg/kg hija madwar 1.5 drabi aktar mid-doża klinika ta' 300 mg abbażi ta' esponiment bl-AUC.
English: Patients with eGFR 45 mL/min/1.73 m 2 to < 60 mL/min/1.73 m In a pooled analysis of patients (N = 721) with a baseline eGFR 45 mL/min/1.73 m 2 to
Maltese: Pazjenti b'eGFR minn 45 mL/min/1.73 m2 sa < 60 mL/min/1.73 m F'ġabra ta' analiżi ta' pazjenti (N = 721) b'eGFR minn 45 mL/min/1.73 m2 sa < 60 mL/min/1.73 m fil-linja bażi, canagliflozin ipprovda tnaqqis li kellu sinifikat kliniku f'HbA1c meta mqabbel malplaċebo, b'-0.
English: At the last post-baseline value, incidence rates of such decreases were 3.3 for patients treated with canagliflozin 100 mg, 2.7 for canagliflozin 300 mg, and 3.7 events per 100 patient-years of exposure for placebo (see section 4.4).
Maltese: Fl-aħħar valur wara l-linja bażi, ir-rati tal-inċidenza ta' tnaqqis bħal dan kienu 3.3 għal pazjenti ttrattati b'canagliflozin 100 mg, 2.7 għal canagliflozin 300 mg, u 3.7 avvenimenti għal kull 100 sena ta' esponiment ta' pazjent għall-plaċebo (ara sezzjoni 4.4).
English: Each 50 mg/850 mg tablet contains canagliflozin hemihydrate, equivalent to 50 mg of canagliflozin and 850 mg of metformin hydrochloride.
Maltese: Kull pillola ta' 50 mg/850 mg fiha canagliflozin hemihydrate, ekwivalenti għal 50 mg ta' canagliflozin u 850 mg ta' metformin hydrochloride.
English: In CANVAS-R, subjects were randomly assigned 1:1 to canagliflozin 100 mg or matching placebo, and titration to 300 mg was permitted (based on tolerability and glycaemic needs) after Week 13.
Maltese: F'CANVAS-R, l-individwi ġew assenjati b'mod arbitrarju 1:1 għal canagliflozin 100 mg jew plaċebo jaqbel miegħu, u titrazzjoni għal 300 mg kienet permessa (abbażi tat-tollerabbiltà u l-ħtiġijiet gliċemiċi) wara Ġimgħa 13.
English: Vulvovaginal candidiasis (including vulvovaginitis and vulvovaginal mycotic infection) was reported in 10.4% and 11.4% of female patients treated with canagliflozin 100 mg once daily and canagliflozin
Maltese: Kandidjasi vulvovaġinali (inkluż vulvovaġinite u infezzjoni vulvovaġinali mikotika) kienet irrappurtata f'10.4% u 11.4% tal-pazjenti nisa kkurati b'canagliflozin 100 mg darba kuljum u canagliflozin 300 mg darba kuljum, rispettivament, meta mqabbla ma' 3.2% f'pazjenti nisa kkurati bi plaċebo.
English: Balanitis or balanoposthitis includes the terms balanitis, balanoposthitis, balanitis candida, and genital infection fungal.
Maltese: Balanite jew balanopostite jinkludu t-termini balanite, balanopostite, balanite candida, u infezzjoni fil-ġenitali bilfungu.
English: In a pooled analysis of clinical data, increases in canagliflozin AUC of 26% were observed in UGT1A9*1/*3 carriers and 18% in
Maltese: F'analiżi kollettiva ta' dejta klinika, żidiet ta' 26% fl-AUC ta' canagliflozin kienu osservati f'individwi li jkollhom UGT1A9*1/*3 u 18% f'dawk li jkollhom UGT2B4*2/*2.
English: Therefore, the canagliflozin dose should be limited to 100 mg daily in patients with eGFR < 60 mL/min/1.73 m 2 or CrCl < 60 mL/min and canagliflozin should not be used in patients with an eGFR < 45 mL/min/1.73 m 2 or CrCl < 45 mL/min (see section 4.2).
Maltese: Għalhekk, id-doża ta' canagliflozin għandha tiġi limitata għal 100 mg darba kuljum f'pazjenti b'eGFR < 60 mL/min/1.73 m2 jew CrCl < 60 mL/min u canagliflozin m'għandux jintuża f'pazjenti b'eGFR < 45 mL/min/1.73 m2 jew CrCl < 45 mL/min (ara sezzjoni 4.2). Canagliflozin ma ġiex studjat f'indeboliment sever tal-kliewi (eGFR < 30 mL/min/1.73 m2 jew CrCl < 30 mL/min) jew mard tal kliewi fl-aħħar stadju (ESRD, end-stage renal disease).
English: The tablet is beige, capsule-shaped, 21 mm in length, film-coated, and debossed with “CM” on one side and “551” on the other side.
Maltese: Il-pillola hija ‘beige', għamla ta' kapsula, b'tul ta' 21 mm, miksija b'rita, u mnaqqxa b'“CM” fuq naħa waħda u “551” fuq in-naħa l-oħra.
English: - 150 mg/850 mg tablets: macrogol 3350, poly(vinylalcohol), talc, titanium dioxide (E171), and iron oxide yellow (E172).
Maltese: - pilloli ta' 150 mg/850 mg: macrogol (3350), poly(vinylalcohol), talc, titanium dioxide (E 171), u iron oxide isfar (E172).
English: Each tablet contains canagliflozin hemihydrate, equivalent to 150 mg canagliflozin, and 1000 mg metformin hydrochloride.
Maltese: Kull pillola fiha canagliflozin hemihydrate, ekwivalenti għal 150 mg canagliflozin, u 1000 mg metformin hydrochloride.
English: Each 150 mg/1000 mg tablet contains canagliflozin hemihydrate, equivalent to 150 mg of canagliflozin and 1000 mg of metformin hydrochloride.
Maltese: Vokanamet 150 mg/1000 mg pilloli miksijin b'rita Kull pillola fiha canagliflozin hemihydrate, ekwivalenti għal 150 mg ta' canagliflozin, u 1000 mg ta' metformin hydrochloride.
English: Table 3: The frequency of metformin adverse reactions identified from clinical study and postmarketing data
Maltese: Tabella 3: Il-frekwenza ta' reazzjonijiet avversi ta' metformin identifikata minn dejta minn studju kliniku u minn meta l-prodott tqiegħed fis-suq Klassi tas-sistemi u tal-organi
English: As metformin is recommended to be administered with a meal to reduce the incidence of gastrointestinal adverse reactions, it is recommended that Vokanamet be taken with a meal to reduce gastrointestinal intolerability associated with metformin.
Maltese: Minħabba li metformin huwa rrakkomandat li jingħata mal-ikel biex titnaqqas l-inċidenza ta' reazzjonijiet gastrointestinali avversi, huwa rrakkomandat li Vokanamet jingħata mal-ikel biex titnaqqas l-intollerabiltà gastrointestinali assoċjata ma' metformin.
English: The overall incidence rate of elevated serum potassium was higher in patients with moderate renal impairment with incidence rates of 4.9, 6.1, and 5.4 events per 100 patient-years of exposure for canagliflozin 100 mg, canagliflozin 300 mg, and placebo, respectively.
Maltese: Ir-rata tal-inċidenza totali ta' żieda fil-livell tal-potassium fis-serum kienet ogħla f'pazjenti b'indeboliment moderat tal-kliewi b'rati ta' inċidenza ta' 4.9, 6.1, u 5.4 avvenimenti għal kull 100 sena ta' esponiment ta' pazjent għal canagliflozin 100 mg, canagliflozin 300 mg, u plaċebo, rispettivament.
English: In a pooled analysis of 13 placebo-controlled and active-controlled studies, the safety profile of canagliflozin in elderly patients was generally consistent with younger patients.
Maltese: F'analiżi kollettiva ta' 13-il studju kkontrollati bi plaċebo u b'mod attiv, il-profil ta' sigurtà ta' canagliflozin f'pazjenti anzjani kien ġeneralment konsistenti ma' dak ta' pazjenti iżgħar fl-età.
English: In placebo-controlled studies, treatment with canagliflozin 100 mg and 300 mg resulted in mean reductions in systolic blood pressure of -3.9 mmHg and -5.3 mmHg, respectively, compared to placebo (-0.1 mmHg) and a smaller effect on diastolic blood pressure with mean changes for canagliflozin 100 mg and 300 mg of -2.1 mmHg and -2.5 mmHg, respectively, compared to placebo (-0.3 mmHg).
Maltese: Fi studji kkontrollati bi plaċebo, it-trattament b'canagliflozin 100 mg u 300 mg wassal għal tnaqqis medju ta' -3.9 mmHg u -5.3 mmHg, rispettivament fil-pressjoni tad-demm sistolika, meta mqabbel ma' plaċebo (-0.1 mmHg) u effett iżgħar fuq il-pressjoni tad-demm dijastolika b'bidliet medji ta' -2.1 mmHg u -2.5 mmHg għal canagliflozin 100 mg u 300 mg, rispettivament, meta mqabbel ma' plaċebo (-0.3 mmHg).
English: Change from baseline (adjusted mean) -0.45 Difference from placebo (adjusted mean) (95% CI)
Maltese: Bidla mil-linja bażi (medja aġġustata) Differenza mill-plaċebo (medja aġġustata) (95% CI)
English: Each tablet contains canagliflozin hemihydrate, equivalent to 50 mg canagliflozin, and 1000 mg metformin hydrochloride.
Maltese: Kull pillola fiha canagliflozin hemihydrate, ekwivalenti għal 50 mg canagliflozin, u 1000 mg metformin hydrochloride.
English: Each tablet contains canagliflozin hemihydrate, equivalent to 150 mg canagliflozin, and 850 mg metformin hydrochloride.
Maltese: Kull pillola fiha canagliflozin hemihydrate, ekwivalenti għal 150 mg canagliflozin, u 850 mg metformin hydrochloride.
English: - 150 mg/1000 mg tablets: macrogol 3350, poly(vinylalcohol), talc, titanium dioxide (E171), iron oxide red (E172) and iron oxide black (E172).
Maltese: - pilloli ta' 150 mg/1000 mg: macrogol (3350), poly(vinylalcohol), talc, titanium dioxide (E 171), iron oxide aħmar (E172) u iron oxide iswed (E172).
English: 20 film-coated tablets 60 film-coated tablets
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 20 pillola miksijin b'rita
English: Table 4: Efficacy results from placebo-controlled clinical studies Dual therapy with metformin (26 weeks)
Maltese: Tabella 4: Riżultati ta' effikaċja minn studji kliniċi kkontrollati bi plaċebo Terapija doppja ma' metformin (26 ġimgħa) Canagliflozin + metformin
English: PC SN NN
Maltese: Kif taħżen Vokanamet
English: In the combined canagliflozin group, the HR for all-cause mortality versus placebo was 0.87 (0.74,
Maltese: Mortalità minn kull kawża Fil-grupp ikkombinat ta' canagliflozin, l-HR għall-mortalità minn kull kawża kontra plaċebo kien 0.87
English: In patients with moderate renal impairment, increases in serum creatinine of 9.2 µmol/L and BUN of approximately 1.0 mmol/L were observed with both doses of canagliflozin.
Maltese: F'pazjenti b'indeboliment moderat tal-kliewi, kienu osservati żidiet ta' 9.2 µmol/L fil-kreatinina fisserum u ta' madwar 1.0 mmol/L f'BUN biż-żewġ dożi ta' canagliflozin.
English: Available pharmacodynamic/toxicological data in animals have shown excretion of canagliflozin/metabolites in milk, as well as pharmacologically mediated effects in breast-feeding offspring and juvenile rats exposed to canagliflozin (see section 5.3).
Maltese: Dejta farmakodinamika/tossikoloġika fl-annimali uriet li kien hemm eliminazzjoni ta' canagliflozin/metaboliti fil-ħalib, kif ukoll effetti medjati b'mod farmakoloġiku fi frieħ ta' firien li qed jitreddgħu u f'firien żgħażagħ esposti għal canagliflozin (ara sezzjoni 5.3). Metformin huwa eliminat fil-ħalib tas-sider tal-bniedem f'ammonti żgħar.
English: Each tablet contains canagliflozin hemihydrate, equivalent to 50 mg canagliflozin, and 850 mg metformin hydrochloride.
Maltese: Kull pillola fiha canagliflozin hemihydrate, ekwivalenti għal 50 mg canagliflozin, u 850 mg metformin hydrochloride.
English: recent myocardial infarction, shock;
Maltese: insuffiċjenza kardijaka jew respiratorja, infart mijokardijaku riċenti, xokk;
English: Mean percent changes from baseline in blood potassium were 0.5% and 1.0% for canagliflozin 100 mg and 300 mg, respectively, compared to 0.6% for placebo.
Maltese: Bidliet perċentwali medji mil-linja bażi fil-potassium fid-demm kienu 0.5% u 1.0% għal canagliflozin 100 mg u 300 mg, rispettivament, meta mqabbla ma' 0.6% għall-plaċebo.
English: Polyuria or pollakiuria includes the terms polyuria, pollakiuria, micturition urgency, nocturia, and urine output increased.
Maltese: Polijurja jew pollakijurja jinkludu t-termini polijurja, pollakijurja, urġenza biex wieħed jagħmel l-awrina, nokturja, u żieda fl-ammont tal-awrina.
English: In other type 2 diabetes studies with canagliflozin, which enrolled a general diabetic population of 8,114 patients, no difference in lower limb amputation risk was observed relative to control.
Maltese: Fi studji oħra ta' dijabete tat-tip 2 b'canagliflozin, li rreġistraw fihom popolazzjoni dijabetika ġenerali ta' 8,114-il pazjent, ma kienet osservata l-ebda differenza fir-riskju ta' amputazzjoni fir-riġel meta mqabbla mal-kontroll.
English: 300 mg exhibited mean improvements in percent change in body weight relative to placebo of -1.8% and -2.0%, respectively.
Maltese: 300 mg urew titjib medju fil-perċentwal ta' bidla fil-piż tal-ġisem ta' -1.8% and -2.0%, rispettivament meta mqabbla mal-plaċebo.
English: Increases in urinary glucose excretion with canagliflozin can falsely lower 1,5-anhydroglucitol (1,5-AG) levels and make measurements of 1,5-AG unreliable in assessing glycemic control.
Maltese: Żidiet fit-tneħħija tal-glukożju fl-awrina b'canagliflozin jistgħu jnaqqsu l-livelli ta' 1,5-anhydroglucitol (1,5-AG) b'mod falz u b'hekk kejl ta' 1,5-AG ma jkunx affidabbli biex jiġi stmat il-kontroll gliċemiku.
English: - 50 mg/1000 mg tablets: macrogol 3350, poly(vinylalcohol), talc, titanium dioxide (E171), iron oxide yellow (E172), and iron oxide red (E172).
Maltese: - pilloli ta' 50 mg/1000 mg: macrogol (3350), poly(vinylalcohol), talc, titanium dioxide (E 171), iron oxide isfar (E172), u iron oxide aħmar (E172).
English: Film-coating: - 50 mg/850 mg tablets: macrogol 3350, poly(vinylalcohol), talc, titanium dioxide (E171), iron oxide red (E172) and iron oxide black (E172).
Maltese: Kisja tar-rita: - pilloli ta' 50 mg/850 mg: macrogol (3350), poly(vinylalcohol), talc, titanium dioxide (E 171), iron oxide aħmar (E172) u iron oxide iswed (E172).
English: Difference from metformin XR (adjusted mean) (95% CI) Percent of patients achieving HbA1c
Maltese: Differenza minn metformin XR (medja aġġustata) (95% CI)
English: In general, canagliflozin produced clinically and statistically significant (p < 0.001) results relative to placebo in glycaemic control, including glycosylated haemoglobin (HbA1c), the percentage of patients achieving HbA1c < 7%, change from baseline fasting plasma glucose (FPG), and 2-hour postprandial glucose (PPG).
Maltese: Canagliflozin ġie studjat bħala, terapija doppja ma' metformin, terapija doppja ma' wieħed missulphonylureas, terapija tripla ma' metformin u wieħed mis-sulphonylureas, terapija tripla ma' metformin u pioglitazone, bħala terapija miżjuda mal-insulina u bħala monoterapija (tabella 4). Filbiċċa l-kbira, canagliflozin ipproduċa riżultati sinifikanti (p < 0.001) b'mod kliniku u statistiku filkontroll gliċemiku, inkluż emoglobina glikosilata (HbA1c), il-perċentwal ta' pazjenti li kisbu HbA1c < 7%, bidla mil-linja bażi tal-glukożju fil-plażma waqt is-sawm (FPG - fasting plasma glucose), u l-glukożju sagħtejn wara ikla (PPG - postprandial glucose) meta mqabbel ma' plaċebo.
English: For patients on loop diuretics, the incidence rates were 5.0 on canagliflozin 100 mg and 5.7 on canagliflozin 300 mg compared to 4.1 events per 100 patient-years of exposure in the control group.
Maltese: Għal pazjenti fuq dijuretiċi loop, ir-rati talinċidenzi kienu 5.0 fuq canagliflozin 100 mg u 5.7 fuq canagliflozin 300 mg meta mqabbla ma' 4.1 każ għal kull 100 sena ta' esponiment ta' pazjent fil-grupp ta' kontroll.
English: Add-on therapy with insulin d (18 weeks)
Maltese: Terapija miżjuda mal-insulina d (18-il ġimgħa) Canagliflozin + insulina
English: In patients with type 2 diabetes who had established cardiovascular disease or at least two risk factors for cardiovascular disease, canagliflozin was associated with an approximately 2-fold increased risk of lower limb amputation as observed in the Integrated CANVAS Program comprised of CANVAS and CANVAS-R, two large, long-term, randomised, placebo-controlled trials evaluating 10,134 patients.
Maltese: F'pazjenti b'dijabete tat-tip 2 li kellhom mard kardjovaskulari stabbilit jew mill-anqas żewġ fatturi ta' riskju għal mard kardjovaskulari, canagliflozin kien assoċjat ma' żieda ta' madwar darbtejn aktar ta' amputazzjoni fir-riġel kif ġie osservat fil-Programm Integrat CANVAS li kien magħmul minn CANVAS u CANVAS-R, żewġ provi kbar, fit-tul, arbitrarji, kkontrollati bil-plaċebo li evalwaw 10,134 pazjent.
English: The tablet is pink, capsule-shaped, 20 mm in length, film-coated, and debossed with “CM” on one side and “358” on the other side.
Maltese: Il-pillola hija roża, għamla ta' kapsula, b'tul ta' 20 mm, miksija b'rita, u mnaqqxa b'“CM” fuq naħa waħda u “358” fuq in-naħa l-oħra.
English: Pharmacokinetic drug interaction studies with Vokanamet have not been performed; however, such studies have been conducted with the individual active substances (canagliflozin and metformin).
Maltese: Interazzjoni ma' prodotti mediċinali oħra u forom oħra ta' interazzjoni Ma sarux studji dwar interazzjonijiet farmakokinetiċi tal-mediċina b'Vokanamet; madankollu, studji bħal dawn saru bis-sustanzi attivi individwali (canagliflozin u metformin).
English: Hypoglycaemia in add-on therapy with insulin or insulin secretagogues
Maltese: Glukożju fil-plażma waqt is-sawm
English: Care should be taken when increasing the dose of Vokanamet containing 50 mg of canagliflozin to 150 mg of canagliflozin in patients ≥ 75 years of age, patients with known cardiovascular disease, or other patients for whom the initial canagliflozin-induced diuresis poses a risk (see section 4.4).
Maltese: Għandu jkun hemm attenzjoni meta tiżdied id-doża ta' Vokanamet li fih minn 50 mg ta' canagliflozin sa 150 mg ta' canagliflozin f'pazjenti ≥ 75 sena, pazjenti magħrufa li għandhom mard kardjovaskulari, jew pazjenti oħra li għalihom id-dijuresi tal-bidu b'canagliflozin tista' tkun ta' riskju (ara sezzjoni 4.4).
English: Patients treated with canagliflozin regardless of baseline eGFR experienced an initial fall in mean eGFR.
Maltese: Pazjenti ttrattati b'canagliflozin irrispettivament mill-eGFR fil-linja bażi kellhom tnaqqis inizjali filmedja tal-eGFR.
English: The tablet is purple, capsule-shaped, 22 mm in length, film-coated, and debossed with “CM” on one side and “611” on the other side.
Maltese: Il-pillola hija vjola, għamla ta' kapsula, b'tul ta' 22 mm, miksija b'rita, u mnaqqxa b'“CM” fuq naħa waħda u “611” fuq in-naħa l-oħra.
English: In long-term clinical studies of canagliflozin in type 2 diabetes patients with established cardiovascular disease (CVD) or at least 2 risk factors for CVD, an approximately 2-fold increased risk of lower limb amputation (primarily of the toe and midfoot), has been observed in patients treated with canagliflozin (see section 4.8).
Maltese: Fi studji kliniċi fit-tul ta' canagliflozin f'pazjenti b'dijabete tat-tip 2 b'mard kardjovaskulari (CVD, cardiovascular disease) stabbilit jew b'mill-anqas 2 fatturi ta' riskju għal CVD, ġiet osservata żieda ta' madwar darbtejn aktar fir-riskju ta' amputazzjoni fir-riġel (l-aktar ta' saba' tas-sieq u nofs is-sieq), f'pazjenti ttrattati b'canagliflozin (ara sezzjoni 4.8).
English: In one of the dedicated long-term cardiovascular studies (CANVAS), where patients were generally older with a higher rate of diabetes complications, the incidence rates of adverse reactions related to volume depletion were 2.3 with canagliflozin 100 mg, 2.9 with canagliflozin 300 mg, and 1.9 with placebo, events per 100 patient-years.
Maltese: F'wieħed mill-istudji kardjovaskulari assenjati fit-tul (CANVAS), fejn il-pazjenti kienu ġeneralment ikbar fl-età b'rata ogħla ta' kumplikazzjonijiet tad-dijabete, ir-rati tal-inċidenza ta' reazzjonijiet avversi marbuta ma' tnaqqis fil-volum kienu 2.3 b'canagliflozin 100 mg, 2.9 b'canagliflozin 300 mg, u 1.9 bi plaċebo, avvenimenti għal kull 100 sena ta' pazjent.
English: In patients ≥ 75 years of age, the incidence rates were 5.3 on canagliflozin 100 mg and 6.1 on canagliflozin 300 mg compared to 2.4 events per 100 patient-years of exposure in the control group (see sections 4.2 and 4.4).
Maltese: F'pazjenti ≥ 75 sena, ir-rati tal-inċidenzi kienu 5.3 fuq canagliflozin 100 mg u 6.1 fuq canagliflozin 300 mg meta mqabbla ma' 2.4 każ għal kull 100 sena ta' esponiment ta' pazjent fil-grupp ta' kontroll (ara sezzjonijiet 4.2 u 4.4).
English: The bottles contain 20 or 60 film-coated tablets.
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 60 pillola miksijin b'rita.
English: Canagliflozin is an orally-active inhibitor of SGLT2.
Maltese: Canagliflozin huwa inibitur ta' SGLT2 attiv meta mogħti mill-ħalq.
English: The prospective randomised (UKPDS) study has established the long-term benefit of intensive blood glucose control in type 2 diabetes.
Maltese: L-istudju randomised prospettiv (UKPDS) stabbilixxa l-benefiċċju fit-tul ta' kontroll intensiv talglukożju fid-demm f'dijabete tat-tip 2.
English: Component of a 3 bottle multipack, can not be sold separately.
Maltese: Komponent ta' pakkett b'ħafna ta' 3 fliexken, ma jistax jinbiegħ separat.
English: Table 3 presents adverse reactions by SOC and by frequency category reported in patients who received metformin as monotherapy and that were not observed in patients receiving canagliflozin.
Maltese: Tabella 3 tippreżenta reazzjonijiet avversi skont SOC u skont il-kategorija ta' frekwenza rrappurtata f'pazjenti li rċivew metformin bħala monoterapija u li ma kinux osservati f'pazjenti li rċivew canagliflozin.
English: If an inducer of these UGT enzymes must be co-administered with canagliflozin, increasing the dose to Vokanamet containing 150 mg twice daily may be considered if patients are currently tolerating canagliflozin 50 mg twice daily and require additional glycaemic control (see sections 4.2 and 4.4).
Maltese: Jekk induttur ta' dawn l-enzimi UGT jkollu jingħata flimkien ma' canagliflozin, għandha titqies żieda fid-doża għal Vokanamet li fih 150 mg darbtejn kuljum jekk f'dak iż-żmien ilpazjenti jkunu qed jittolleraw canagliflozin 50 mg darbtejn kuljum, u jkunu jeħtieġu kontroll gliċemiku addizzjonali (ara sezzjonijiet 4.2 u 4.4).
English: Both improvement in glycaemic control and reduction of cardiovascular morbidity and mortality are an integral part of the treatment of type 2 diabetes.
Maltese: Kemm it-titjib tal-kontroll gliċemiku kif ukoll it-tnaqqis ta' morbidità u mortalità kardjovaskulari huma parti integrali mit-trattament tad-dijabete tat-tip 2.
English: p < 0.001 compared to placebo.
Maltese: p < 0.001 meta mqabbel ma' plaċebo.
English: Change from baseline (adjusted mean) -1.03 Difference from sitagliptin (adjusted mean) (95% CI)
Maltese: Bidla mil-linja bażi (medja aġġustata) Differenza minn sitagliptin (medja aġġustata) (95% CI)
English: Bioequivalence studies in healthy subjects demonstrated that Vokanamet 50 mg/850 mg, 50 mg/1000 mg, 150 mg/850 mg, and 150 mg/1000 mg combination tablets are bioequivalent to co-administration of corresponding doses of canagliflozin and metformin as individual tablets.
Maltese: Studji ta' bijoekwivalenza f'individwi f'saħħithom urew li l-pilloli kombinati ta' Vokanamet 50 mg/850 mg, 50 mg/1000 mg, 150 mg/850 mg, u 150 mg/1000 mg huma bijoekwivalenti għal għoti ta' dożi li jaqblu magħhom ta' canagliflozin flimkien ma' metformin bħala pilloli individwali.