FrancophonIA/ELRC3.0 huggingface dataset:
English: Canagliflozin was studied as monotherapy, dual therapy with metformin, dual therapy with a sulphonylurea, triple therapy with metformin and a sulphonylurea, triple therapy with metformin and pioglitazone, and as an add-on therapy with insulin (table 3).
Maltese: Canagliflozin ġie studjat bħala monoterapija, terapija doppja ma' metformin, terapija doppja ma' wieħed mis-sulphonylureas, terapija tripla ma' metformin u wieħed mis-sulphonylureas, terapija tripla ma' metformin u pioglitazone, u bħala terapija miżjuda mal-insulina (tabella 3).
English: In a pooled analysis of clinical data, increases in canagliflozin AUC of 26% were observed in UGT1A9*1/*3 carriers and 18% in UGT2B4*2/*2 carriers.
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: 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 Invokana on glycaemic control.
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' Invokana fuq il-kontroll gliċemiku.
English: Urinary tract infections were more frequently reported for canagliflozin 100 mg and 300 mg (5.9% versus 4.3%, respectively) compared to 4.0% with placebo.
Maltese: Infezzjonijiet fl-apparat tal-awrina kienu rrappurtati b'mod aktar komuni għal canagliflozin 100 mg u 300 mg (5.9% kontra 4.3%, rispettivament) meta mqabbla ma' 4.0% bi plaċebo.
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 glukows (SGLT2sodium glukows 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: • Invokana 100 mg film-coated tablets (tablets) are yellow, capsule-shaped, 11 mm long, with
Maltese: • Invokana 100 mg pilloli miksijin b'rita (pilloli) huma sofor, għamla ta' kapsula, twal 11-il mm,
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 5).
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 5).
English: • The active substance is canagliflozin.
Maltese: X'fih Invokana • Is-sustanza attiva hija canagliflozin.
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, canagliflozin 300 mg, and placebo, respectively, and severe hypoglycaemia occurred in 1.8%, 2.7%, and 2.5% of patients treated with canagliflozin 100 mg, canagliflozin 300 mg, 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, canagliflozin 300 mg, u bi plaċebo, rispettivament, u ipogliċemija qawwija seħħet f'1.8%, 2.7%, u 2.5% tal-pazjenti kkurati b'canagliflozin 100 mg, canagliflozin 300 mg, u bi plaċebo, rispettivament.
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
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: Each tablet contains canagliflozin hemihydrate, equivalent to 100 mg canagliflozin.
Maltese: Kull pillola fiha canagliflozin hemihydrate, ekwivalenti għal 100 mg canagliflozin.
English: Patients with a baseline eGFR 45 mL/min/1.73 m 2 to < 60 mL/min/1.73 m 2 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 kkurati b'canagliflozin 100 mg u
English: Blood creatinine increased b,o
Maltese: Żieda fil-kreatinina fid-demm b,o
English: The safety of canagliflozin was evaluated in 18,248 patients with type 2 diabetes, including 11,078 patients treated with canagliflozin and 7,170 patients treated with comparator who received medicinal product in 14 double-blind, controlled phase 3 and phase 4 clinical studies.
Maltese: Is-sigurtà ta' canagliflozin kienet evalwata f'18,248 pazjent b'dijabete tat-tip 2, inkluż 11,078 pazjent ikkurati b'100 mg canagliflozin u 7,170 pazjent trattati b'kumparatur , li rċivew il-prodott mediċinali f'14-il studju kliniku tal-fażi 3 u tal-fażi 4 fejn la l-investigaturi u lanqas l-individwi ma kienu jafu liema sustanza qed tintuża u kkontrollati.
English: In the pooled analysis of the four 26-week, placebo-controlled studies, the incidence of all adverse reactions related to volume depletion (e.g., postural dizziness, orthostatic hypotension, hypotension, dehydration, and syncope) was 1.2% for canagliflozin 100 mg, 1.3% for canagliflozin 300 mg, and 1.1% for placebo.
Maltese: Fl-analiżi kollettiva tal-erba' istudji ta' 26 ġimgħa kkontrollati bil-plaċebo, l-inċidenza tarreazzjonijiet avversi kollha marbuta ma' tnaqqis fil-volum (eż., sturdament mal-waqqaf, pressjoni baxxa ortostatika, pressjoni baxxa, deitratazzjoni, u sinkope) kienet 1.2% għal canagliflozin 100 mg, 1.3% għal canagliflozin 300 mg, u 1.1% għall-plaċebo.
English: Additional safety analyses (including long-term data) from data across the entire canagliflozin programme (placebo- and active-controlled studies) were conducted to assess reported adverse reactions in order to identify adverse reactions (see table 1) (see sections 4.2 and 4.4).
Maltese: Analiżi addizzjonali ta' sigurtà (inkluż dejta fuq perjodu twil ta' żmien) minn dejta mill-programm sħiħ ta' canagliflozin (studji kkontrollati bil-plaċebo u b'mod attiv) saru biex jiġu stmati r-reazzjonijiet avversi rrappurtati sabiex jiġu identifikati reazzjonijiet avversi (ara tabella 1) (ara sezzjonijiet 4.2 u 4.4).
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this medicine.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għall-galactose, b'defiċjenza totali ta' lactase, jew b'assorbiment ħażin tal-glukows-galactose m'għandhomx jieħdu din il-mediċina.
English: The Leydig cell tumours are associated with an increase in luteinizing 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: The metabolism of canagliflozin is primarily via glucuronide conjugation mediated by UDP glucuronosyl transferase 1A9 (UGT1A9) and 2B4 (UGT2B4).
Maltese: 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: In the combined canagliflozin group, the HR for all-cause mortality versus placebo was 0.87 (0.74,
Maltese: Fil-grupp ikkombinat ta' canagliflozin, l-HR għall-mortalità minn kull kawża kontra plaċebo kien 0.87
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-glukows jew mingħajrhom).
English: Canagliflozin 300 mg + metformin and sulphonylurea (N = 377)
Maltese: Canagliflozin 300 mg + metformin u sulphonylurea (N = 377)
English: In patients with an eGFR 45 mL/min/1.73 m2 to < 60 mL/min/1.73 m2 or CrCl 45 mL/min to < 60 mL/min taking canagliflozin 100 mg who are receiving concurrent therapy with a UGT enzyme inducer and who require additional glycaemic control, other glucose-lowering therapies should be considered (see sections 4.2 and 4.4).
Maltese: < 60 mL/min/1.73 m2 jew CrCl 45 mL/min sa < 60 mL/min li jkunu qed jieħdu canagliflozin 100 mg jkunu qed jirċievu kura b'induttur tal-enzima UGT flimkien miegħu u li jkunu jeħtieġu kontroll gliċemiku addizzjonali, għandhom jitqiesu terapiji oħra li baxxu l-glukows (ara sezzjonijiet 4.2 u 4.4).
English: Canagliflozin was compared to glimepiride as dual therapy with metformin and compared to sitagliptin as triple therapy with metformin and a sulphonylurea (table 4).
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 4).
English: Each tablet contains canagliflozin hemihydrate, equivalent to 300 mg canagliflozin.
Maltese: Kull pillola fiha canagliflozin hemihydrate, ekwivalenti għal 300 mg canagliflozin.
English: In a study comparing canagliflozin 300 mg to sitagliptin 100 mg in triple therapy with metformin and a sulphonylurea, canagliflozin demonstrated non-inferior (p < 0.05) and superior (p < 0.05) reduction in HbA1c relative to sitagliptin.
Maltese: Fi studju li qabbel canagliflozin 300 mg ma' sitagliptin 100 mg f'terapija tripla ma' metformin u wieħed mis sulphonylureas, canagliflozin wera tnaqqis mhux inferjuri (p < 0.05) u superjuri (p < 0.05) f'HbA1cmeta mqabbel ma' sitagliptin.
English: The reductions in RTG led to increased UGE in subjects with type 2 diabetes treated with either 100 mg or 300 mg of canagliflozin ranging from 77 g/day to 119 g/day across the phase 1 studies; the UGE observed translates to a loss of 308 kcal/day to 476 kcal/day.
Maltese: It-tnaqqis fl-RTG wassal għal żieda filUGE f'individwi b'dijabete tat-tip 2 kkurati b'100 mg jew 300 mg ta' canagliflozin fuq medda bejn 77 g/jum u 119-il g/jum tul l-istudji tal-fażi 1; il-UGE osservat ifisser telf ta' 308 kcal/jum sa 476 kcal/jum.
English: Efficacy Parameter
Maltese: Parametri ta' Effikaċja
English: Fasting plasma glucose
Maltese: Effikaċja u sigurtà gliċemika
English: , Blood urea increased b,p
Maltese: , Żieda fil-urea fid-demm b,p
English: Increases in urinary glucose excretion with Invokana 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-glukows fl-awrina b'Invokana 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: The efficacy of canagliflozin is dependent on renal function, and efficacy is reduced in patients who have moderate renal impairment and likely absent in patients with severe renal impairment (see section 4.2).
Maltese: L-effikaċja ta' canagliflozin tiddependi fuq il-funzjoni tal-kliewi, u l-effikaċja tonqos f'pazjenti li għandhom indeboliment moderat tal-kliewi u x'aktarx tkun assenti f'pazjenti b'indeboliment qawwi tal-kliewi (ara sezzjoni 4.2).
English: Figure 1: Time to First Occurrence of MACE
Maltese: Figura 1: Żmien għall-ewwel okkkorrenza ta' MACE
English: Using a mixed-meal challenge, canagliflozin as monotherapy or add-on therapy with one or two oral glucose-lowering medicinal products reduced postprandial glucose (PPG) from baseline relative to placebo by -1.5 mmol/L to -2.7 mmol/L for canagliflozin 100 mg and -2.1 mmol/L to -3.5 mmol/L for 300 mg, respectively, due to reductions in the pre-meal glucose concentration and reduced postprandial glucose excursions.
Maltese: Bl-użu ta' stimulu ta' ikla mħallta, canagliflozin bħala monoterapija jew terapija miżjuda ma' prodott wieħed jew żewġ prodotti mediċinali li jbaxxu l-glukows mogħtija mill-ħalq, meta mqabbel ma' plaċebo, naqqas il-glukows wara l-ikel (PPG - postprandial glukows) mill-linja bażi b'-1.5 mmol/L sa -2.7 mmol/L għal canagliflozin 100 mg u -2.1 mmol/L sa -3.5 mmol/L għal 300 mg, rispettivament, minħabba tnaqqis fil-konċentrazzjoni tal-glukows qabel l-ikel u tnaqqis ta' ħruġ ta' glukows wara likel.
English: Renal impairment For patients with an eGFR 60 mL/min/1.73 m 2 to < 90 mL/min/1.73 m 2 or CrCl 60 mL/min to
Maltese: Indeboliment tal-kliewi Għal pazjenti b'eGFR minn 60 mL/min/1.73 m 2 sa < 90 mL/min/1.73 m 2 jew CrCl minn 60 mL/min sa
English: Table 1: Tabulated list of adverse reactions (MedDRA) from placebo e and active-controlled studies e and from postmarketing experience
Maltese: Tabella 1: Lista f'tabella ta' reazzjonijiet avversi (MedDRA) minn studji kkontrollati bi plaċebo e u b'mod attiv e u mill-esperjenza ta' wara t-tqegħid fis-suq
English: In general, canagliflozin produced clinically and statistically significant (p < 0.001) results relative to placebo in glycaemic control, including HbA1c, the percentage of patients achieving HbA1c < 7%, change from baseline fasting plasma glucose (FPG), and 2-hour postprandial glucose (PPG).
Maltese: Fil-biċċa l-kbira, canagliflozin ipproduċa riżultati sinifikanti (p < 0.001) b'mod kliniku u statistikament sinifikanti filkontroll gliċemiku, inkluż HbA1c, il-perċentwal ta' pazjenti li kisbu HbA1c < 7%, bidla mil-linja bażi tal-glukows fil-plażma waqt is-sawm (FPG - fasting plasma glukows), u l-glukows sagħtejn wara ikla (PPG - postprandial glukows) meta mqabbel ma' plaċebo.
English: EU/1/13/884/003 (90 film-coated tablets) EU/1/13/884/004 (100 film-coated tablets)
Maltese: EU/1/13/884/001 (10 pilloli miksija b'rita) EU/1/13/884/002 (30 pillola miksija b'rita) EU/1/13/884/003 (90 pillola miksija b'rita) EU/1/13/884/004 (100 pillola miksija b'rita)
English: Body Weight Baseline (mean) in kg % change from baseline (adjusted mean) Difference from metformin XR (adjusted mean) (95% CI)
Maltese: Linja bażi (medja) f'kg % ta' bidla millinja bażi (medja aġġustata) Differenza minn metformin XR (medja aġġustata) (95% CI)
English: A subset of patients (N = 208) from the active-controlled dual therapy study with metformin who underwent dual energy X-ray densitometry (DXA) and abdominal computed tomography (CT) scans for evaluation of body composition demonstrated that approximately two-thirds of the weight loss with canagliflozin was due to loss of fat mass with similar amounts of visceral and abdominal subcutaneous fat being lost.
Maltese: Sottosett ta' pazjenti (N = 208) mill-istudju b'terapija doppja b'metformin ikkontrollat b'mod attiv li sarulhom scans ta' densitometrija b'żewg raġġi X b'enerġija differenti (DXA - dual energy X-ray densitometry) u tomografija komputerizzata (CT - computed tomography) tal-addome għal stima talkompożizzjoni tal-ġisem urew li madwar żewġ terzi tat-telf ta' piż b'canagliflozin kien minħabba telf ta' massa tax-xaħam b'ammonti jixxiebhu ta' telf ta' xaħam tal-vixxri u minn taħt il-ġilda tal-addome.
English: N/A Compared to sitagliptin as triple therapy with metformin and sulphonylurea (52 weeks)
Maltese: N/A Imqabbel ma' sitagliptin bħala terapija tripla ma' metformin u sulphonylurea (52 ġimgħa)
English: Invokana contains the active substance canagliflozin which belongs to a group of medicines called “blood-glucose lowering drugs.”
Maltese: Invokana fih is-sustanza attiva canagliflozin li tagħmel parti minn grupp ta' mediċini msejħa “mediċini li jbaxxu l-glukows fid-demm.
English: Before initiating Invokana, consider factors in the patient history that may increase the risk for amputation.
Maltese: Qabel ma tibda Invokana, qis fatturi fl-istorja tal-pazjent li jistgħu jżidu r-riskju ta' amputazzjoni.
English: Patients ≥ 75 years of age had a higher incidence of adverse reactions related to volume depletion (such as postural dizziness, orthostatic hypotension, hypotension) with incidence rates of 5.3, 6.1, and 2.4 events per 100 patient-years of exposure for canagliflozin 100 mg, canagliflozin 300 mg, and in the control group, respectively.
Maltese: Pazjenti ta' ≥ 75 sena kellhom inċidenza ogħla ta' reazzjonijiet avversi marbuta ma' tnaqqis fil-volum (bħal sturdament mal-waqqaf, pressjoni baxxa ortostatika, pressjoni baxxa) b'rati ta' inċidenza ta' 5.3, 6.1, u 2.4 avveniment għal kull 100 sena ta' esponiment ta' pazjenti għal canagliflozin 100 mg, canagliflozin 300 mg, u fil-grupp ta' kontroll, rispettivament.
English: Canagliflozin dosed with a titration regimen produced clinically and statistically significant (p < 0.001) results relative to placebo in glycaemic control, including HbA1c and change from baseline fasting plasma glucose (FPG), and a statistically significant (p < 0.01) improvement in the percentage of patients achieving HbA1c < 7%.
Maltese: HbA1c u bidla fil-glukożju fil-plażma waqt is-sawm (FPG, fasting plasma glucose) mil-linja bażi, u titjib sinifikanti b'mod statistiku (p < 0.01) fil-perċentwal ta' pazjenti li kisbu HbA1c < 7%.
English: Therefore, the canagliflozin dose should be limited to 100 mg once 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 tkun limitata għal 100 mg darba kuljum f'pazjenti b'eGFR < 60 mL/min/1.73 m 2 jew CrCl < 60 mL/min u canagliflozin m'għandux jintuża f'pazjenti b'eGFR < 45 mL/min/1.73 m 2 jew CrCl < 45 mL/min (ara sezzjoni 4.2).
English: Patients (%) achieving HbA1c < 7% 44.5 Body weight
Maltese: Pazjenti (%) li kisbu HbA1c < 7% 44.5
English: The frequency of hypoglycaemia was low (approximately 4%) among treatment groups, including placebo, when used as monotherapy or as an add-on to metformin.
Maltese: Il-frekwenza tal-ipogliċemija kienet baxxa (madwar 4%) fost il-gruppi tal-kura, inkluż il-plaċebo, meta intuża bħala monoterapija jew miżjud ma' metformin.
English: A total of 10,134 patients were treated in two dedicated cardiovascular studies, exposed for a mean of 149 weeks (exposed for a mean of 223 weeks in CANVAS and 94 weeks in CANVAS-R), and 8,114 patients treated in 12 double blind, controlled phase 3 and phase 4 clinical studies, followed for a mean of 49 weeks.
Maltese: Total ta' 10,134 pazjent ġew ittrattati f'żewġ studji kardjovaskulari assenjati, esposti għal medja ta' 149 ġimgħa (esposti għal medja ta' 223 ġimgħa f'CANVAS u 94 ġimgha f'CANVAS-R), u 8,114-il pazjent ittrattat fi 12-il studju kliniku tal-fażi 3 u tal-fażi 4 fejn la l-investigaturi u lanqas l-individwi ma kienu jafu liema sustanza qed tintuża, segwiti għal madwar 49 ġimgħa.
English: ТП„Мундифарма медикъл ООД“ ул.
Maltese: Din il-mediċina m'għandhiex bżonn ħażna speċjali.
English: This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium free'.
Maltese: Din il-mediċina fiha inqas minn 1 mmol sodium (23 mg) f'kull pillola, li tista' tgħid hija bażikament ‘bla sodium'.
English: Invokana 100 mg film-coated tablets Invokana 300 mg film-coated tablets canagliflozin
Maltese: Invokana 100 mg pilloli miksijin b'rita Invokana 300 mg pilloli miksijin b'rita canagliflozin
English: Furthermore, canagliflozin was studied as triple therapy with metformin and sitagliptin and dosed with a titration regimen, using a starting dose of 100 mg and titrated to 300 mg as early as week 6 in patients requiring additional glycaemic control who had appropriate eGFR and were tolerating canagliflozin 100 mg (table 3).
Maltese: Barra dan, canagliflozin ġie studjat bħala terapija tripla ma' metformin u sitagliptin u d-doża ngħatat bi skeda ta' titrazzjoni, bl-użu ta' doża tal-bidu ta' 100 mg titratata għal 300 mg sa minn ġimgħa 6 f'pazjenti li kienu jeħtieġu kontroll gliċemiku addizzjonali li kellhom eGFR xieraq u kienu qed jittolleraw canagliflozin 100 mg (tabella 3).
English: Canagliflozin was negligibly removed by haemodialysis.
Maltese: Effetti ta' canagliflozin fuq prodotti mediċinali oħra
English: Canagliflozin 100 mg as dual therapy with metformin produced similar reductions in HbA1c from baseline and 300 mg produced superior (p < 0.05) reductions in HbA1c compared to glimepiride, thus demonstrating non-inferiority.
Maltese: Canagliflozin 100 mg bħala terapija doppja ma' metformin ipproduċa tnaqqis jixxiebah fl-HbA1c mil-linja bażi u t300 mg pproduċiet tnaqqis superjuri (p < 0.05) fl-HbA1c meta mqabbla ma' glimepiride, biex b'hekk wera li ma kienx inferjuri.
English: • stomach pain
Maltese: Plaċebo Cana
English: d.o.o.
Maltese: Cana vs.
English: Change from baseline (adjusted mean) Difference from glimepiride (adjusted mean) (95% CI)
Maltese: Bidla mil-linja bażi (medja aġġustata) Differenza minn glimepiride (medja aġġustata) (95% CI)
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 b'mard kardjovaskulari stabbilit jew b'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: Least squares mean adjusted for covariates including baseline value and stratification factor Adjusted p = 0.001
Maltese: Medja tal-least squares għall-kovarjati inklużi l-valur tal-linja bażi u l-fattur ta' stratifikazzjoni p = 0.001 aġġustat p < 0.01 aġġustat p < 0.05 aġġustat
English: < 60 mL/min/1.73 m 2, canagliflozin provided clinically meaningful reduction in HbA1c compared to placebo, with -0.47% for canagliflozin 100 mg and -0.52% for canagliflozin 300 mg.
Maltese: 47% għal canagliflozin 100 mg u -0.52% għal canagliflozin 300 mg.
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'analiżi kollettiva ta' pazjenti (N = 721) b'eGFR minn 45 mL/min/1.73 m2 sa < 60 mL/min/1.73 m fil-linja bażi, canagliflozin pprovda tnaqqis ta' sinifikat kliniku f'HbA1c meta mqabbel ma' plaċebo, b'-0.
English: CYP3A4-mediated (oxidative) metabolism of canagliflozin is minimal (approximately 7%) in humans.
Maltese: Filbnedmin metaboliżmu (ossidattiv) ta' canagliflozin medjat minn CYP3A4 huwa minimu (madwar
English: • unusual sleepiness or tiredness
Maltese: • infezzjonijiet fil-passaġġ tal-awrina
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 sistolika tad-demm, meta mqabbel ma' plaċebo (-0.1 mmHg) u effett iżgħar fuq il-pressjoni 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).