FrancophonIA/ELRC3.0 huggingface dataset:
English: Difference from canagliflozin 300 mg (adjusted mean) (95% CI)
Maltese: Differenza minn canagliflozin 300 mg (medja aġġustata) (95% CI)
English: For study results with respect to combination of therapies, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1.
Maltese: Għar-riżultati tal-istudji dwar kombinazzjonijiet ta' terapiji, effetti fuq il-kontroll gliċemiku u avvenimenti kardjovaskulari, u l-popolazzjonijiet studjati, ara sezzjonijiet 4.4, 4.5, u 5
English: Dizziness postural a, Syncope
Maltese: Sturdament mal-waqqaf a, Sinkope
English: Patients had an overall mean age of 59.5 years (range 21 years to 96 years), with 3,135 patients ≥ 65 years of age and 513 patients ≥ 75 years of age.
Maltese: Il-pazjenti kellhom età globali medja ta' 59.5 sena (medda minn 21 sena sa 96 sena), bi 3,135 pazjent li kellhom ≥ 65 sena u 513-il pazjent li kellhom ≥ 75 sena.
English: , Blood potassium increased b, q
Maltese: , Żieda fil-potassium fid-demm b,q
English: 1,5-AG assay
Maltese: Assaġġ 1,5-AG
English: Lactic acidosis, Vitamin B12 deficiency
Maltese: Aċidożi lattika, Defiċjenza tal-vitamina
English: Safety data profiles from individual pivotal studies (including studies in moderately renally impaired patients; older patients [≥ 55 years of age to ≤ 80 years of age]; patients with increased CV-risk) were generally consistent with the adverse reactions identified in this table.
Maltese: Profili ta' dejta ta' sigurtà minn studji individwali pivitali (inkluż studji f'pazjenti b'indeboliment moderat tal-kliewi; pazjenti ikbar fl-età [età ta' ≥ 55 sena sal-età ta' ≤ 80 sena]; pazjenti b'żieda fir-riskju kardjovaskulari) ġeneralment kienu konsistenti mar-reazzjonijiet avversi identifikati f'din it-tabella.
English: Table 6: Efficacy results from active-controlled clinical studies Compared to glimepiride as dual therapy with metformin (52 weeks) Canagliflozin + metformin Glimepiride (titrated) + metformin (N = 482)
Maltese: Tabella 6: Riżultati ta' effikaċja minn studji kliniċi kkontrollati b'mod attiv Imqabbel ma' glimepiride bħala terapija doppja ma' metformin (52 ġimgħa) Canagliflozin + metformin Glimepiride (titrat) + metformin (N = 482)
English: Multipack: 180 (3 packs of 60) film-coated tablets
Maltese: U KONTENUT Pakkett b'ħafna: 180 (3 pakketti ta' 60) pillola miksija b'rita
English: If Fournier's gangrene is suspected, Vokanamet should be discontinued and prompt treatment (including antibiotics and surgical debridement) should be instituted.
Maltese: Jekk ikun hemm suspett ta' kankrena ta' Fournier, Vokanamet għandu jitwaqqaf u jinbeda trattament fil-pront (li jinkludi antibijotiċi u t-tneħħija kirurġika tal-parti affettwata).
English: 90.7% of subjects in the canagliflozin group uptitrated to 300 mg
Maltese: 90.7% tal-individwi fil-grupp ta' canagliflozin ittitraw 'il fuq sa 300 mg
English: • a significant reduction of the absolute risk of any diabetesrelated complication in the metformin group (29.8 events/1,000 patient-years) versus diet alone (43.3 events/1,000 patient-years), p = 0.0023, and versus the combined sulphonylurea and insulin monotherapy groups (40.1 events/1,000 patient-years), p = 0.0034
Maltese: • tnaqqis sinifikanti fir-riskju assolut ta' kwalunkwe kumplikazzjoni marbuta mad-dijabete filgrupp ta' metformin (29.8 każ/1,000 sena ta' pazjent) kontra id-dieta waħedha (43.3 każ/1,000 sena ta' pazjent), p = 0.0023, u kontra il-gruppi kkombinati ta' monoterapija b'sulphonylurea u insulina (40.1 każ/1,000 sena ta' pazjent), p = 0.0034
English: Placebo + metformin and sulphonylurea (N = 156)
Maltese: Plaċebo + metformin u sulphonylurea (N = 156)
English: Gastro-intestinal symptoms
Maltese: Sintomi gastrointestinali
English: Figure 2: Treatment effect for the primary composite endpoint and its components
Maltese: Figura 2: Effett tat-trattament fuq l-iskop finali kompost primarju u l-komponenti tiegħu
English: Table 2: Integrated analysis of amputations in CANVAS and CANVAS-R Placebo
Maltese: Tabella 2: Analiżi integrata ta' amputazzjonijiet f'CANVAS u CANVAS-R Plaċebo N = 4,344
English: Placebo + metformin and sitagliptin (N = 106)
Maltese: Plaċebo + metformin u sitagliptin (N = 106)
English: At baseline, patients were treated with one or more antidiabetic medications including metformin (77%), insulin (50%), and sulfonylurea (43%).
Maltese: Fil-linja bażi, ilpazjenti kienu ttrattati b'mediċina waħda jew aktar ta' kontra d-dijabete inklużi metformin (77%), insulina (50%), u sulfonylurea (43%).
English: Interaction studies suggest that the pharmacokinetics of canagliflozin are not altered by metformin, hydrochlorothiazide, oral contraceptives (ethinyl estradiol and levonorgestrol), ciclosporin, and/or probenecid.
Maltese: Studji ta' interazzjoni jissuġġerixxu li l-farmakokinetika ta' canagliflozin ma tinbidilx b'metformin, hydrochlorothiazide, kontraċettivi mill-ħalq (ethinyl estradiol u levonorgestrol), ciclosporin, u/jew probenecid.
English: Vokanamet is contraindicated in patients with severe renal failure (eGFR < 30 mL/min) (see section 4.3).
Maltese: Vokanamet huwa kontraindikat f'pazjenti b'indeboliment sever tal-kliewi (eGFR < 30 mL/min) (ara sezzjoni 4.3).
English: The pack sizes are cartons of 20 and 60 tablets, and multipack cartons of 180 tablets (3 bottles containing 60 tablets each).
Maltese: Id-daqsijiet talpakketti huma kartun ta' 20 u 60 pillola u kartun b'ħafna ta' 180 pillola (3 fliexken li fihom 60 pillola l-wieħed).
English: Rash includes the terms rash erythematous, rash generalised, rash macular, rash maculopapular, rash papular, rash pruritic, rash pustular, and rash vesicular.
Maltese: Raxx jinkludi t-termini raxx eritematuż, raxx mifrux, raxx makulari, raxx makulopapulari, raxx papulari, raxx pruritiku, raxx pustulari u raxx vesikulari.
English: C]canagliflozin dose to healthy subjects, 41.5%, 7.0%, and 3.2% of the administered radioactive dose was recovered in faeces as canagliflozin, a hydroxylated metabolite, and an O-glucuronide metabolite, respectively.
Maltese: C] canagliflozin mill-ħalq lil individwi f'saħħithom, 41.5%, 7.0%, u 3.2% tad-doża radjuattiva mogħtija ġew irkuprati fl-ippurgar bħala canagliflozin, metabolit idroksilat, u metabolit O-glukuronajd, rispettivament.
English: Patients (%) achieving HbA1c < 7% 32 Fasting plasma glucose (mg/dL) Baseline (mean)
Maltese: Pazjenti (%) li kisbu HbA1c < 7% Glukożju fil-plażma waqt is-sawm (mg/dL) Linja bażi (medja)
English: Decreases in eGFR (-3.4 and -4.7 mL/min/1.73 m2) were reported with canagliflozin 100 mg and canagliflozin 300 mg, respectively, compared to the control group (-4.2 mL/min/1.73 m2).
Maltese: Kien irrappurtat tnaqqis fl-eGFR (-3.4 u -4.7 mL/min/1.73 m2) b'canagliflozin 100 mg u canagliflozin 300 mg, rispettivament, meta mqabbel mal-grupp ta' kontroll (-4.2 mL/min/1.73 m2).
English: The CANVAS Program compared the risk of experiencing a Major Adverse Cardiovascular Event (MACE) defined as the composite of cardiovascular death, nonfatal myocardial infarction and nonfatal stroke, between canagliflozin and placebo on a background of standard of care treatments for diabetes and atherosclerotic cardiovascular disease.
Maltese: Il-Programm CANVAS qabbel irriskju li wieħed ikollu Avveniment Kardjovaskulari Avvers Maġġuri (MACE, Major Adverse Cardiovascular Event) ddefinit bħala l-kompost ta' mewt kardjovaskulari, infart mijokardijaku mhux fatali, u puplesija mhux fatali, bejn canagliflozin u plaċebo fuq sfond ta' trattamenti standard ta' kura għad-dijabete u mard ateroskleotiku kardjovaskulari.
English: Patients (%) achieving HbA1c < 7% 19.8 Body weight
Maltese: Pazjenti (%) li kisbu HbA1c < 7% 19.8
English: Diabetic ketoacidosis b, h
Maltese: Ketoaċidożi tad-dijabete b,h
English: Canagliflozin reduced the risk for heart failure requiring hospitalization compared to placebo (HR: 0.67; 95% CI (0.52, 0.87)).
Maltese: Canagliflozin naqqas ir-riskju ta' insuffiċjenza tal-qalb li tkun teħtieġ rikoverar l-isptar meta mqabbel mal-plaċebo (HR: 0.67; 95% CI (0.52, 0.87)).
English: Kochanowskiego 45a PL - 01-864 Warszawa Tel.: +48 22 866 87 12
Maltese: Kochanowskiego 45a PL - 01-864
English: Consistent with the mechanism of sodium glucose co-transporter 2 (SGLT2) inhibition with increased UGE, vulvovaginal candidiasis in females and balanitis or balanoposthitis in males were reported in clinical studies with canagliflozin (see section 4.8).
Maltese: F'konsistenza mal-mekkaniżmu ta' inibizzjoni tal-kotrasportatur 2 ta' sodium u glukożju (SGLT2sodium glukożju co-transporter 2) b'żieda fil-UGE, kienet irrappurtata kandidjasi vulvovaġinali finnisa u balanite jew balanopostite fl-irġiel fi studji kliniċi b'canagliflozin (ara sezzjoni 4.8).
English: A total of 10,501 patients with type 2 diabetes participated in ten double-blind, controlled clinical efficacy and safety studies conducted to evaluate the effects of canagliflozin on glycaemic control, including 5,151 patients treated with canagliflozin in combination with metformin.
Maltese: Total ta' 10,501 pazjent b'dijabete tat-tip 2 pparteċipaw f'għaxar studji ta' sigurtà u effikaċja klinika, double-blind, ikkontrollati, li saru biex jistmaw l-effetti ta' canagliflozin fuq il-kontroll gliċemiku, inklużi 5,151 pazjent ikkurati b'canagliflozin flimkien ma' metformin.
English: Titanium dioxide (E171) Iron oxide red (E172) Iron oxide black (E172)
Maltese: Titanium dioxide (E171) Iron oxide aħmar (E172) Iron oxide iswed (E172)
English: Canagliflozin 100 mg and canagliflozin 300 mg in combination with metformin XR resulted in a statistically significant greater improvement in HbA1c compared to their respective canagliflozin doses (100 mg and 300 mg) alone or metformin XR alone (table 7).
Maltese: Canagliflozin 100 mg u canagliflozin 300 mg flimkien ma' metformin XR wasslu għal titjib sinifikanti b'mod statistiku akbar fl-HbA1c meta mqabbel mad-dożi rispettivi ta' canagliflozin (100 mg u 300 mg) waħdu jew metformin XR waħdu (tabella 7).
English: Hypotension a, Orthostatic hypotension
Maltese: Pressjoni baxxa a, Pressjoni baxxa ortostatika
English: In interaction studies, canagliflozin at steady-state had no clinically relevant effect on the pharmacokinetics of metformin, oral contraceptives (ethinyl estradiol and levonorgestrol), glibenclamide, paracetamol, hydrochlorothiazide, or warfarin.
Maltese: Fi studji ta' interazzjoni, canagliflozin fl-istat fiss ma kellu l-ebda effett rilevanti b'mod kliniku fuq ilfarmakokinetika ta' metformin, kontraċettivi mill-ħalq (ethinyl estradiol u levonorgestrol), glibenclamide, paracetamol, hydrochlorothiazide, jew warfarin.
English: Titanium dioxide (E171) Iron oxide yellow (E172)
Maltese: Titanium dioxide (E171) Iron oxide isfar (E172)
English: The safety of canagliflozin was evaluated in 18,248 patients with type 2 diabetes, including 13,791 patients treated with canagliflozin in combination with metformin.
Maltese: Is-sigurtà ta' canagliflozin ġiet stmata f'18,248 pazjent bid-dijabete tat-tip 2, inkluż 13,791 pazjent ikkurati b'canagliflozin flimkien ma' metformin.
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: Kura fit-tul b'metformin ġiet assoċjata ma' tnaqqis fl-assorbiment tal-vitamina B12, li b'mod rari ħafna jista' jwassal għal defiċjenza sinifikanti b'mod kliniku ta' vitamina
English: Vokanamet is contraindicated in patients with hepatic impairment due to the active substance metformin (see sections 4.3 and 5.2).
Maltese: Vokanamet huwa kontraindikat f'pazjenti b'indeboliment tal-fwied minħabba s-sustanza attiva metformin (ara sezzjonijiet 4.3 u 5.2).
English: Circumcision was performed at rates of 0.31 and 0.09 events per 100 patient-years on canagliflozin and placebo, respectively (see section 4.4).
Maltese: Ċirkonċiżjoni saret bir-rati ta' 0.31 u 0.09 każ għal kull 100 sena ta' pazjent fuq canagliflozin u plaċebo, rispettivament (ara sezzjoni 4.4).
English: When canagliflozin was added to insulin therapy, hypoglycaemia was observed in 49.3%, 48.2%, and 36.8% of patients treated with canagliflozin 100 mg once daily, canagliflozin 300 mg once daily, and placebo, respectively, and severe hypoglycaemia occurred in 1.8%, 2.7%, and 2.5% of patients treated with canagliflozin 100 mg once daily, canagliflozin 300 mg once daily, and placebo, respectively.
Maltese: Meta canagliflozin żdied ma' terapija blinsulina, kienet osservata ipogliċemija f'49.3%, 48.2%, u 36.8% tal-pazjenti kkurati b'canagliflozin 100 mg darba kuljum, canagliflozin 300 mg darba kuljum, u bi plaċebo, rispettivament, u ipogliċemija qawwija seħħet f'1.8%, 2.7%, u 2.5% tal-pazjenti kkurati b'canagliflozin 100 mg darba kuljum, canagliflozin 300 mg darba kuljum, u bi plaċebo, rispettivament.
English: Sixty-six percent of subjects had a history of established cardiovascular disease, with 56% having a history of coronary disease, 19% with cerebrovascular disease, and 21% with peripheral vascular disease; 14% had a history of heart failure.
Maltese: Sitta u sittin fil-mija tal-individwi kellhom storja ta' mard kardjovaskulari stabbilit, b'56% li kellhom storja ta' mard koronarju, 19% b'mard ċerebrovaskulari, u 21% b'mard vaskulari periferali; 14% kellhom storja ta' insuffiċjenza tal-qalb.
English: Patients with a baseline eGFR 45 mL/min/1.73 m2 to < 60 mL/min/1.73 m2 treated with canagliflozin 100 mg and
Maltese: Pazjenti b'eGFR minn 45 mL/min/1.73 m2 sa < 60 mL/min/1.73 m2 fil-linja bażi, ttrattati b'canagliflozin 100 mg u
English: 1 x 20 film-coated tablets
Maltese: 1 x 20 pillola miksija b'rita
English: Patients in the pooled canagliflozin groups (pooled analysis of canagliflozin 100 mg, canagliflozin 300 mg, and canagliflozin up-titrated from 100 mg to 300 mg) had a lower rate of MACE as compared to placebo: 2.69 versus 3.15 patients per 100 patient-years (HR of the pooled analysis: 0.86; 95% CI
Maltese: Pazjenti fil-gruppi kollettivi ta' canagliflozin (analiżi kollettiva ta' canagliflozin 100 mg, canagliflozin 300 mg, u canagliflozin miżjud minn 100 mg sa 300 mg) kellhom rata aktar baxxa ta' MACE meta mqabbla ma' plaċebo: 2.69 kontra 3.15 pazjent għal kull 100 sena ta' pazjent (HR tal-analiżi kollettiva: 0.86; 95% CI (0.75, 0.97).
English: Suomi/Finland Mundipharma Oy Rajatorpantie 41B FI-01640 Vantaa/Vanda Puh/Tel: +358 9 8520 2065
Maltese: Suomi/Finland Mundipharma Oy Rajatorpantie 41B FI-01640
English: Multipack containing 180 (3 x 60) film-coated tablets.
Maltese: Pakkett b'ħafna li fih 180 (3 x 60) pillola miksija b'rita.
English: A total of 714 patients ≥ 55 years of age to ≤ 80 years of age (227 patients 65 years of age to < 75 years of age and 46 patients 75 years of age to ≤ 80 years of age) with inadequate glycaemic control on current diabetes treatment (glucose-lowering medicinal products and/or diet and exercise) participated in a double-blind, placebo-controlled study over 26 weeks.
Maltese: Total ta' 714-il pazjent li kellhom ≥ 55 sena sa ≤ 80 sena (227 pazjent b'età minn 65 sena sa < 75 sena u 46 pazjent b'età minn 75 sena sa < 80 sena) b'kontroll ġliċemiku mhux xieraq bil-kura attwali taddijabete (prodotti mediċinali li jbaxxu l-glukożju u/jew dieta u eżerċizzju) pparteċipaw fi studju double-blind ikkontrollat bi plaċebo fuq perjodu ta' 26 ġimgħa.
English: In the CANVAS Program, for time to first adjudicated nephropathy event (doubling of serum creatinine, need for renal-replacement therapy, and renal death), the HR was 0.53 (95% CI: 0.33, 0.84) for canagliflozin (0.15 events per 100 patient-years) versus placebo (0.28 events per 100 patient-years).
Maltese: Fil-Programm CANVAS, għaż-żmien tal-ewwel avveniment iġġudikat ta' nefropatija (kreatinina doppja fis-serum, ħtieġa ta' terapija ta' sostituzzjoni tal-kliewi, u mewt renali), l-HR kien 0.53 (95% CI: 0.33, 0.84) għal canagliflozin (0.15 avveniment għal kull 100 sena ta' pazjent) kontra plaċebo (0.28 avveniment għal kull 100 sena ta' pazjent).
English: A paediatric phase 1 study examined the pharmacokinetics and pharmacodynamics of canagliflozin in children and adolescents ≥ 10 to < 18 years of age with type 2 diabetes mellitus.
Maltese: Studju pedjatriku ta' fażi 1 eżamina l-farmakokinetika u l-farmakodinamika ta' canagliflozin fi tfal u adolexxenti fl-etajiet ta' bejn ≥ 10 sa < 18-il sena b'dijabete mellitus ta' tip 2.
English: Blood creatinine increased b, o
Maltese: Żieda fil-kreatinina fid-demm b,o
English: Canagliflozin was compared to glimepiride as dual therapy with metformin and compared to sitagliptin as triple therapy with metformin and a sulphonylurea (table 6).
Maltese: Canagliflozin ġie mqabbel ma' glimepiride bħala terapija doppja ma' metformin u mqabbel ma' sitagliptin bħala terapija tripla ma' metformin u wieħed mis-sulphonylureas (tabella 6).
English: Improvement in homeostasis model assessment for beta-cell function (HOMA beta-cell) and improved beta-cell insulin secretion response to a mixed-meal challenge has been observed in clinical studies with canagliflozin.
Maltese: Kien osservat titjib fl-istima tal-mudell tal-omeostasi għall-funzjoni taċċellula beta (HOMA beta-cell - homeostasis model assessment for beta-cell function) u titjib firrispons ta' tnixxija tal-insulina miċ-ċelluli beta għal stimulu ta' ikla mħallta fi studji kliniċi b'canagliflozin.
English: Following oral administration of an 850 mg tablet, a 40% lower plasma peak concentration, a 25% decrease in AUC, and a 35-minute prolongation of time to peak plasma concentration were observed.
Maltese: Wara għoti mill-ħalq ta' pillola ta' 850 mg, kien osservat tnaqqis ta' 40% fl-ogħla konċentrazzjonijiet fil-plażma, tnaqqis ta' 25% fl-AUC, u tul ta' 35 minuta aktar fil-ħin biex tintlaħaq l-ogħla konċentrazzjoni filplażma.
English: Efficacy parameter
Maltese: Parametri ta' effikaċja
English: Urinary tract infections were more frequently reported for canagliflozin 100 mg and 300 mg once daily (5.9% versus 4.3%, respectively) compared to 4.0% with placebo.
Maltese: Infezzjonijiet fl-apparat tal-awrina kienu rrappurtati b'mod aktar frekwenti għal canagliflozin 100 mg u 300 mg darba kuljum (5.9% kontra 4.3%, rispettivament) meta mqabbla ma' 4.0% bi plaċebo.
English: • if you have had a lower limb amputation.
Maltese: • jekk kellek amputazzjoni fir-riġel.
English: The Leydig cell tumours are associated with an increase in luteinising hormone (LH), which is a known mechanism of Leydig cell tumour formation in rats.
Maltese: Reazzjonijiet avversi elenkati taħt huma kklassifikati skont ilfrekwenza u l-klassi tas-sistemi u tal-organi.
English: In CANVAS, subjects were randomly assigned 1:1:1 to canagliflozin 100 mg, canagliflozin 300 mg, or matching placebo.
Maltese: F'CANVAS, l-individwi ġew assenjati b'mod arbitrarju 1:1:1 għal canagliflozin 100 mg, canagliflozin 300 mg, jew plaċebo jaqbel magħhom.
English: When canagliflozin/metformin was administered at 60/300 mg/kg/day (exposure levels 11 and 13 times the clinical exposure for canagliflozin and metformin, respectively, at 300/2000 mg doses), the effects were more pronounced compared to metformin alone.
Maltese: Meta canagliflozin/metformin ingħata b'60/300 mg/kg/jum (livelli ta' esponiment 11 u 13-il darba aktar mill-esponiment kliniku għal canagliflozin u metformin, rispettivament, b'dożi ta' 300/2000 mg), l-effetti kienu jidhru ħafna aktar meta mqabbla ma' metformin waħdu.
English: 1 x 60 film-coated tablets
Maltese: 1 x 60 pillola miksija b'rita
English: Canagliflozin as add-on therapy to insulin (with or without other glucose-lowering medicinal products).
Maltese: Canagliflozin bħala terapija miżjuda mal-insulina (ma' prodotti mediċinali oħra li jbaxxu l-glukożju jew mingħajrhom).
English: In the clinical development programme, 1,085 patients with a baseline eGFR 30 mL/min/1.73 m2 to
Maltese: Fil-programm ta' żvilupp kliniku, kienu evalwati 1,085 pazjent b'eGFR minn 30 mL/min/1.73 m2 sa < 60 mL/min/1.73 m2 fil-linja bażi.
English: This effect at the 300 mg dose of canagliflozin may, in part, be due to local inhibition of intestinal SGLT1 (an important intestinal glucose transporter) related to transient high concentrations of canagliflozin in the intestinal lumen prior to medicinal product absorption (canagliflozin is a low potency inhibitor of the SGLT1 transporter).
Maltese: Parti minn dan leffett bid-doża ta' 300 mg ta' canagliflozin jista' jkun minħabba inibizzjoni lokali ta' SGLT1 talintestini (trasportatur importanti tal-glukożju fl-intestini) marbuta ma' konċentrazzjonijiet temporanji għoljin ta' canagliflozin fil-kavità tal-intestini qabel l-assorbiment tal-prodott mediċinali (canagliflozin huwa inibitur b'qawwa baxxa tat-trasportatur SGLT1).
English: The effect of canagliflozin on cardiovascular events in adults with type 2 diabetes who had established cardiovascular (CV) disease or were at risk for CVD (two or more CV risk factors), was evaluated in the CANVAS Program (integrated analysis of the CANVAS and the CANVAS-R study).
Maltese: L-effett ta' canagliflozin fuq l-avvenimenti kardjovaskulari f'adulti b'dijabete tat-tip 2 li kellhom mard kardjovaskulari (CV, cardiovascular) stabbilit jew li kienu f'riskju għal CVD (żewġ fatturi ta' riskju CV jew aktar), ġie vvalutat fil-Programm CANVAS (analiżi integrata tal-istudju CANVAS u CANVAS-R).
English: Results for the 100 mg and 300 mg canagliflozin doses were consistent with results for the combined dose groups.
Maltese: Riżultati għad-dożi ta' 100 mg u 300 mg canagliflozin kienu konsistenti mar-riżultati għall-gruppi taddoża kombinata.
English: In an embryo-foetal development study in rats, ossification delays of metatarsal bones were observed at systemic exposures 73 times and 19 times higher than the clinical exposures at the 100 mg and 300 mg doses.
Maltese: Fi studju tal-iżvilupp tal-embriju u tal-fetu fil-firien, kien osservat dewmien fl-ossifikazzjoni talgħadam metatarsali f'esponimenti sistemiċi ta' 73 darba u 19-il darba ogħla mill-esponimenti kliniċi bid-dożi ta' 100 mg u 300 mg.
English: Patients in CANVAS and CANVAS-R were followed for an average of 5.7 and 2.1 years, respectively.
Maltese: Pazjenti f'CANVAS u CANVAS-R ġew segwiti għal medja ta' 5.7 u 2.1 sena, rispettivament.
English: Regardless of treatment with canagliflozin or placebo, the risk of amputation was highest in patients with a baseline history of prior amputation, peripheral vascular disease, and neuropathy.
Maltese: Irrispettivament mit-trattament b'canagliflozin jew plaċebo, ir-risku ta' amputazzjoni kien l-ogħla f'pazjenti li kellhom storja ta' amputazzjoni preċedenti, mard vaskulari periferali, u newropatija fil-linja bażi.
English: • Hepatic impairment, acute alcohol intoxication, alcoholism (see sections 4.2 and 4.5).
Maltese: deidratazzjoni, infezzjoni qawwija, xokk (ara sezzjoni 4.4);
English: EU/1/14/918/003 (50 mg/850 mg - 180 film-coated tablets) EU/1/14/918/006 (50 mg/1000 mg - 180 film-coated tablets) EU/1/14/918/009 (150 mg/850 mg - 180 film-coated tablets) EU/1/14/918/012 (150 mg/1000 mg - 180 film-coated tablets)
Maltese: EU/1/14/918/003 (50 mg/850 mg - 180 pillola miksija b'rita) EU/1/14/918/006 (50 mg/1000 mg - 180 pillola miksija b'rita) EU/1/14/918/009 (150 mg/850 mg - 180 pillola miksija b'rita) EU/1/14/918/012 (150 mg/1000 mg - 180 pillola miksija b'rita)
English: The metabolism of canagliflozin is primarily via glucuronide conjugation mediated by UDP glucuronosyl transferase 1A9 (UGT1A9) and 2B4 (UGT2B4).
Maltese: Effetti ta' prodotti mediċinali oħra fuq canagliflozin Il-metaboliżmu ta' canagliflozin iseħħ primarjament permezz ta' konjugazzjoni tal-glukuronajd medjata minn UDP glucuronosyl transferase 1A9 (UGT1A9) u 2B4 (UGT2B4). Canagliflozin huwa ttrasportat mill-glikoproteina-P (P-gp) u mill-Proteina ta' Reżistenza tal-Kanċer tas-Sider (BCRPBreast Cancer Resistance Protein).
English: A substudy of patients with baseline HbA1c > 10% to ≤ 12% with canagliflozin as monotherapy resulted in reductions from baseline in HbA1c (not placebo-adjusted) of -2.13% and -2.56% for canagliflozin 100 mg and 300 mg, respectively.
Maltese: Sottostudju ta' pazjenti b'HbA1c > 10% sa ≤ 12% fil-linja bażi b'canagliflozin bħala monoterapija wassal għal tnaqqis ta' -2.13% u -2.56% fl-HbA1c mill-linja bażi (mhux aġġustat bil-plaċebo) għal canagliflozin 100 mg u 300 mg, rispettivament.