FrancophonIA/ELRC3.0 huggingface dataset:
English: Gender, race/ethnicity, or body mass index had no clinically meaningful effect on the pharmacokinetics of canagliflozin based on a population pharmacokinetic analysis.
Maltese: Sess, razza/etniċità, jew indiċi tal-massa tal-ġisem ma kellhom l-ebda effett ta' sinifikat kliniku fuq ilfarmakokinetika ta' canagliflozin imsejsa fuq analiżi farmakokinetika tal-popolazzjoni.
English: Difference from placebo (adjusted mean) (97.5% CI)
Maltese: Differenza mill-plaċebo (medja aġġustata) (97.5% CI)
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieħed mill-eċċipjenti elenkati fis sezzjoni 6.1.
English: Age had no clinically meaningful effect on the pharmacokinetics of canagliflozin based on a population pharmacokinetic analysis (see sections 4.2, 4.4, and 4.8).
Maltese: L-età ma kellha l-ebda effett ta' sinifikat kliniku fuq il-farmakokinetika ta' canagliflozin imsejsa fuq analiżi farmakokinetika tal-popolazzjoni (ara sezzjonijiet 4.2, 4.4, u 4.8).
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: a 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: Patients had an overall mean age of 59.6 years (range 21 years to 96 years), with 3,082 patients ≥ 65 years of age and 510 patients ≥ 75 years of age.
Maltese: Il-pazjenti kellhom età globali medja ta' 59.6 sena (medda minn 21 sena sa 96 sena), bi 3,082 pazjent li kellhom ≥ 65 sena u 510 pazjenti li kellhom ≥ 75 sena.
English: Renal clearance of canagliflozin 100 mg and 300 mg doses ranged from 1.30 mL/min to 1.55 mL/min.
Maltese: Tneħħija mill-kliewi tad-dożi ta' 100 mg u 300 mg ta' canagliflozin kienet fuq medda minn 1.30 mL/min sa 1.55 mL/min.
English: Compared to glimepiride as dual therapy with metformin (52 weeks) Canagliflozin + metformin Glimepiride (titrated) + metformin (N = 482)
Maltese: Imqabbel ma' glimepiride bħala terapija doppja ma' metformin (52 ġimgħa) Canagliflozin + metformin Glimepiride (titrat) + metformin (N = 482)
English: Subsequently, the marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Maltese: Sussegwentement, id-detentur tal awtorizzazzjoni għat-tqegħid fis-suq għandu jippreżenta rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott f'konformità mar-rekwiżiti mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: Invokana 100 mg film-coated tablets Invokana 300 mg film-coated tablets canagliflozin
Maltese: Invokana 100 mg pilloli Invokana 300 mg pilloli canagliflozin
English: More information is given below in “Other medicines and Invokana”.
Maltese: Aktar informazzjoni hija mogħtija taħt f'“Mediċini oħra u Invokana”.
English: 300 mg, respectively, compared to 2.7% for placebo.
Maltese: 100 mg u 300 mg, rispettivament, meta mqabbla ma' 2.7% għal plaċebo.
English: Dual therapy with metformin (26 weeks) Canagliflozin + metformin
Maltese: Terapija doppja ma' metformin (26 ġimgħa) Canagliflozin + metformin
English: Nervous system disorders uncommon
Maltese: Disturbi fis-sistema nervuża mhux komuni
English: Canagliflozin 300 mg + metformin and sulphonylurea (N=377)
Maltese: Canagliflozin 300 mg + metformin u sulphonylurea (N = 377)
English: Sitagliptin 100 mg + metformin and sulphonylurea (N=378)
Maltese: Sitagliptin 100 mg + metformin u sulphonylurea (N = 378)
English: Janssen-Cilag A/S Hammerbakken 19 DK-3460 Birkerød Tlf: +45 45 94 82 82
Maltese: Birkerød Tlf: +45 45 94 82 82
English: Mūkusalas iela 101
Maltese: Mūkusalas iela 101 Rīga, LV-1004
English: In the clinical development programme, 1,085 patients with a baseline eGFR 30 mL/min/1.73 m2 to < 60 mL/min/1.73 m2 were evaluated.
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: 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 tad dijabete (prodotti mediċinali li jbaxxu l-glukows u/jew dieta u eżerċizzju) pparteċipaw fi studju double-blind ikkontrollat bi plaċebo fuq perjodu ta' 26 ġimgħa.
English: Table 3: Efficacy results from active-controlled clinical studiesa
Maltese: Tabella 3: Riżultati ta' effikaċja minn studji kliniċi kkontrollati b'mod attiva
English: Triple therapy with metformin and sulphonylurea (26 weeks) Canagliflozin + metformin and sulphonylurea
Maltese: Terapija tripla ma' metformin u sulphonylurea (26 ġimgħa) Canagliflozin + metformin u sulphonylurea
English: EU/1/13/884/001 (10 tablets) EU/1/13/884/002 (30 tablets) EU/1/13/884/003 (90 tablets) EU/1/13/884/004 (100 tablets)
Maltese: EU/1/13/884/001 (10 pilloli) EU/1/13/884/002 (30 pillola) EU/1/13/884/003 (90 pillola) EU/1/13/884/004 (100 pillola)
English: c Rash includes the terms rash erythematous, rash generalised, rash macular, rash maculopapular, rash papular, rash pruritic, rash pustular, and rash vesicular.
Maltese: c Raxx jinkludi t-termini raxx eritematuż, raxx mifrux, raxx makulari, raxx makulopapulari, raxx papulari, raxx pruritiku, raxx pustulari u raxx vesikulari.
English: The safety of canagliflozin was evaluated in 10,285 patients with type 2 diabetes, including 3,139 patients treated with canagliflozin 100 mg and 3,506 patients treated with canagliflozin 300 mg, who received medicinal product in nine double-blind, controlled phase 3 clinical studies.
Maltese: Is-sigurtà ta' canagliflozin kienet evalwata f'10,285 pazjent b'dijabete tat-tip 2, inkluż 3,139 pazjent ikkurati b'100 mg canagliflozin u 3,506 pazjent ikkurati bi 300 mg canagliflozin, li rċivew il-prodott mediċinali f'disa' studji kliniċi tal-fażi 3 ikkontrollati u double-blind.
English: 10 x 1 film-coated tablets 30 x 1 film-coated tablets 90 x 1 film-coated tablets 100 x 1 film-coated tablets
Maltese: Pillola miksija b'rita 10 x 1 pilloli miksija b'rita 30 x 1 pillola miksija b'rita 90 x 1 pillola miksija b'rita 100 x 1 pillola miksija b'rita
English: Relative to subjects with normal hepatic function, the geometric mean ratios for Cmax and AUC∞ of canagliflozin were 107% and 110%, respectively, in subjects with Child-Pugh class A (mild hepatic impairment) and 96% and 111%, respectively, in subjects with Child-Pugh class B (moderate) hepatic impairment following administration of a single 300 mg dose of canagliflozin.
Maltese: Meta mqabbla ma' individwi b'funzjoni normali tal-fwied, il-medja ġeometrika tal-proporzjonijiet għas-Cmax u l-AUC∞ ta' canagliflozin kienet 107% u 110%, rispettivament, f'individwi b'Child-Pugh tal-klassi A (indeboliment ħafif tal-fwied) u 96% u 111%, rispettivament, f'individwi b'indeboliment tal-fwied Child-Pugh tal-klassi B (moderat) wara għoti ta' doża waħda ta' 300 mg ta' canagliflozin.
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: 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: 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 trials (see section 4.8).
Maltese: sodium glukows co-transporter 2) b'żieda fil-UGE, kienet irrappurtata kandidjasi vulvovaġinali fin nisa u balanite jew balanopostite fl-irġiel fi provi kliniċi (ara sezzjoni 4.8).
English: Simvastatin: The combination of canagliflozin 300 mg once daily for 6 days with a single dose of simvastatin (CYP3A4 substrate) 40 mg resulted in a 12% increase in AUC and a 9% increase in Cmax of simvastatin and an 18% increase in AUC and a 26% increase in Cmax of simvastatin acid.
Maltese: simvastatin (sottostrat ta' CYP3A4) 40 mg wasslet għal żieda ta' 12% fl-AUC u żieda ta' 9% fis-Cmax ta' simvastatin u żieda ta' 18% fl-AUC u żieda ta' 26% fis-Cmax tal-aċidu ta' simvastatin.
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 fir rispons ta' tnixxija tal-insulina miċ-ċelluli beta għal stimulu ta' ikla mħallta fi studji kliniċi b'canagliflozin.
English: EU/1/13/884/005 (10 tablets) EU/1/13/884/006 (30 tablets) EU/1/13/884/007 (90 tablets) EU/1/13/884/008 (100 tablets)
Maltese: EU/1/13/884/005 (10 pilloli) EU/1/13/884/006 (30 pillola) EU/1/13/884/007 (90 pillola) EU/1/13/884/008 (100 pillola)
English: Adverse reactions listed below are classified according to frequency and system organ class (SOC).
Maltese: Reazzjonijiet avversi elenkati taħt huma kklassifikati skont il-frekwenza u l-klassi tas-sistemi u tal-organi (SOC).
English: Patients (%) achieving HbA1c < 7% 43.2b
Maltese: Pazjenti (%) li kisbu HbA1c < 7% 43.2b
English: Decreases in eGFR (-3.6% and -5.2%) were reported with canagliflozin 100 mg and canagliflozin 300 mg, respectively, compared to the control group (-3.0%) (see sections 4.2 and 4.4).
Maltese: Kien irrappurtat tnaqqis fl-eGFR (-3.6% u -5.2%) b'canagliflozin 100 mg u canagliflozin 300 mg, rispettivament, meta mqabbel mal-grupp ta' kontroll (-3.0%) (ara sezzjonijiet 4.2 u 4.4).
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% versus 4.3%, rispettivament) meta mqabbla ma' 4.0% bi plaċebo.
English: The incidence of hypoglycaemia episodes/events with canagliflozin 300 mg and sitagliptin 100 mg was 40.7% and 43.2%, respectively.
Maltese: L-inċidenza ta' episodji/każijiet ta' ipogliċemja b'canagliflozin 300 mg u sitagliptin 100 mg kienet 40.7% u 43.2%, rispettivament.
English: 58% of patients had a body mass index (BMI) ≥ 30 kg/m2.
Maltese: Tmienja u ħamsin fil-mija (58%) tal-pazjenti kellhom inidiċi talmassa tal-ġisem (BMI - body mass index) ta' ≥ 30 kg/m2.
English: Placebo + metformin and sulphonylurea (N=156)
Maltese: Plaċebo + metformin u sulphonylurea (N = 156)
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: hydrochlorothiazide, kontraċettivi mill-ħalq (ethinyl estradiol u levonorgestrol), ciclosporin, u/jew probenecid.
English: Patients (%) achieving HbA1c < 7% 45.5b
Maltese: Pazjenti (%) li kisbu HbA1c < 7% 45.5b
English: Experience in New York Heart Association (NYHA) class III is limited, and there is no experience in clinical studies with canagliflozin in NYHA class IV.
Maltese: Esperjenza fil-klassi III tal-Assoċjazzjoni tal-Qalb ta' New York (NYHA - New York Heart Association) hija limitata, u ma hemm l-ebda esperjenza fi studji kliniċi b'canagliflozin fil-klassi IV ta' NYHA.
English: • hives
Maltese: • dardir
English: Canagliflozin did not increase the incidence of tumours in male and female mice in a 2-year study at doses of 10, 30, and 100 mg/kg.
Maltese: Canagliflozin ma żiedx l-inċidenza ta' tumuri fi ġrieden irġiel u nisa fi studju ta' sentejn b'dożi ta' 10, 30, u 100 mg/kg.
English: i Mean percent increases from baseline for canagliflozin 100 mg and 300 mg versus placebo, respectively, were total cholesterol 3.4% and 5.2% versus 0.9%; HDL-cholesterol 9.4% and 10.3% versus 4.0%; LDL-cholesterol 5.7% and
Maltese: i Żidiet perċentwali medji mil-linja bażi għal canagliflozin 100 mg u 300 mg versus plaċebo, rispettivament, kienu kolesterol totali 3.4% u 5.2% versus 0.9%; kolesterol HDL 9.4% u 10.
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 2).
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 2).
English: A single-dose, open-label study evaluated the pharmacokinetics of canagliflozin 200 mg in subjects with varying degrees of renal impairment (classified using CrCl based on the Cockroft-Gault equation) compared to healthy subjects.
Maltese: Studju open-label, b'doża waħda evalwa l-farmakokinetika ta' canagliflozin 200 mg f'individwi bi gradi differenti ta' indeboliment tal-kliewi (klassifikati bl-użu ta' CrCl imsejsa fuq l-ekwazzjoni ta' Cockroft-Gault) mqabbla ma' individwi f'saħħithom.
English: Table 2: Efficacy results from placebo-controlled clinical studiesa
Maltese: Tabella 2: Riżultati ta' effikaċja minn studji kliniċi kkontrollati bi plaċeboa
English: EU/1/13/884/001 (100 mg - 10 tablets) EU/1/13/884/002 (100 mg - 30 tablets) EU/1/13/884/003 (100 mg - 90 tablets) EU/1/13/884/004 (100 mg - 100 tablets) EU/1/13/884/005 (300 mg - 10 tablets) EU/1/13/884/006 (300 mg - 30 tablets) EU/1/13/884/007 (300 mg - 90 tablets) EU/1/13/884/008 (300 mg - 100 tablets)
Maltese: (100 mg - 100 pillola) EU/1/13/884/005 (300 mg - 10 pillola) EU/1/13/884/006 (300 mg - 30 pillola) EU/1/13/884/007 (300 mg - 90 pillola) EU/1/13/884/008 (300 mg - 100 pillola)
English: Patients with renal impairment (eGFR < 60 mL/min/1.73 m2 or CrCl < 60 mL/min) Patients with a baseline eGFR < 60 mL/min/1.73 m2 or CrCl < 60 mL/min had a higher incidence of adverse reactions associated with volume depletion (e.g., postural dizziness, orthostatic hypotension, hypotension) with incidences of 4.7%, 8.1%, and 1.5% on canagliflozin 100 mg, canagliflozin 300 mg, and placebo, respectively (see sections 4.2 and 4.4).
Maltese: Pazjenti b'indeboliment tal-kliewi (eGFR < 60 mL/min/1.73 m2 jew CrCl < 60 mL/min) Pazjenti b'eGFR < 60 mL/min/1.73 m2 jew CrCl < 60 mL/min fil-linja bażi kellhom inċidenza ogħla ta' reazzjonijiet avversi assoċjati ma' tnaqqis fil-volum (eż., sturdament mal-waqqaf, pressjoni baxxa ortostatika, pressjoni baxxa) b'inċidenzi ta' 4.7%, 8.1%, u 1.5% meta kienu fuq canagliflozin 100 mg, canagliflozin 300 mg, u plaċebo, rispettivament (ara sezzjonijiet 4.2 u 4.4).
English: Canagliflozin showed no effects on fertility and early embryonic development in the rat at exposures up to 19 times the human exposure at the maximum recommended human dose (MRHD).
Maltese: Canagliflozin ma wera l-ebda effetti fuq il-fertilità u l-iżvilupp bikri tal-embriju fil-far f'esponimenti sa 19-il darba aktar mill-esponiment uman bid-doża massima rrakkomandata għall-bnedmin (MRHDmaximum recommended human dose).
English: respectively, compared to 1.5% for placebo.
Maltese: rispettivament, meta mqabbla ma' 1.5 % għal plaċebo.
English: Effects of other medicinal products on canagliflozin 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: k Mean percent changes from baseline in creatinine were 2.8% and 4.0% for canagliflozin 100 mg and 300 mg,
Maltese: k Bidliet perċentwali medji mil-linja bażi fil-kreatinina kienu 2.8% u 4.0% għal canagliflozin 100 mg u 300 mg,
English: Hypotension*, Orthostatic hypotension*
Maltese: Pressjoni baxxa*, Pressjoni baxxa ortostatika*
English: Latvija Janssen-Cilag Polska Sp. z o.o.
Maltese: Latvija Janssen-Cilag Polska Sp. z o.o. filiāle Latvijā
English: The primary assessment of safety and tolerability was conducted in a pooled analysis (n = 2,313) of four 26-week placebo-controlled clinical studies (monotherapy and add-on therapy with metformin, metformin and a sulphonylurea, and metformin and pioglitazone).
Maltese: L-istima primarja ta' sigurtà u tollerabbiltà saret f'analiżi kollettiva (n = 2,313) ta' erba' studji kliniċi ta' 26 ġimgħa kkontrollati bil-plaċebo (monoterapija u terapija miżjuda ma' metformin, metformin u wieħed mis-sulphonylureas, u metformin u pioglitazone).
English: Plasma Cmax and AUC of canagliflozin increased in a dose-proportional manner from 50 mg to 300 mg.
Maltese: Is-Cmax u l-AUC ta' canagliflozin fil-plażma żdiedu b'mod fi proporzjon mad-doża minn 50 mg sa 300 mg.
English: Biotransformation
Maltese: Bijotransformazzjoni
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 kkurati b'canagliflozin 100 mg u
English: Difference from sitagliptin (adjusted mean) (95% CI)
Maltese: Differenza minn sitagliptin (medja aġġustata) (95% CI)
English: Rare cases of diabetic ketoacidosis (DKA), including life-threatening cases, have been reported in clinical trials and post-marketing in patients treated with SGLT2 inhibitors, including canagliflozin.
Maltese: Każijiet rari ta' ketoaċidożi tad-dijabete (DKA - diabetic ketoacidosis), inkluż każijiet ta' theddida għall-ħajja, ġew irrappurtati fi provi kliniċi u wara t-tqegħid fis-suq f'pazjenti ttrattati b'inibituri ta' SGLT2, inkluż b'canagliflozin.
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 l-effett bid-doża ta' 300 mg ta' canagliflozin jista' jkun minħabba inibizzjoni lokali ta' SGLT1 tal-intestini (trasportatur importanti tal-glukows 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 ta' SGLT1).
English: Add-on therapy with other glucose-lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control (see sections 4.4, 4.5, and 5.1 for available data on different add-on therapies).
Maltese: Terapija miżjuda ma' prodotti mediċinali oħra li jbaxxu l-glukows inkluża l-insulina, meta dawn, flimkien mad-dieta u l-eżerċizzju, ma jipprovdux kontroll gliċemiku xieraq (ara sezzjonijiet 4.4, 4.5, u 5.1 għal dejta disponibbli dwar terapiji differenti miżjuda m'oħrajn).
English: Renal and urinary disorders common
Maltese: Disturbi fil-kliewi u fis-sistema urinarja komuni
English: System organ class
Maltese: Klassi tas-sistemi u tal-organi Frekwenza
English: The proportion of patients with larger decreases in eGFR (> 30%) at any time during treatment was 9.3%, 12.2%, and 4.9% with canagliflozin 100 mg, canagliflozin 300 mg, and placebo, respectively.
Maltese: Il-proporzjon ta' pazjenti bi tnaqqis akbar fl-eGFR (> 30%) fi kwalunkwe żmien waqt il-kura kien 9.3%, 12.2%, u 4.9% b'canagliflozin 100 mg, canagliflozin 300 mg, u plaċebo, rispettivament.
English: There is no clinical experience in patients with Child-Pugh class C (severe) hepatic impairment.
Maltese: Ma kien hemm l-ebda esperjenza klinika f'pazjenti b'indeboliment (qawwi) tal-fwied Child-Pugh tal-klassi Ċ.
English: Polyvinyl chloride/Aluminum (PVC/Alu) perforated unit dose blister.
Maltese: Folja ta' Polyvinyl chloride/Aluminum (PVC/Alu) b'linja toqob biex id-dożi jinqatgħu waħda waħda.
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 and canagliflozin 300 mg, respectively, compared to 3.2% in placebo-treated female patients.
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 u canagliflozin 300 mg, rispettivament, meta mqabbla ma' 3.2% f'pazjenti nisa kkurati bi plaċebo.
English: The higher doses of canagliflozin (100 mg/kg) in male and female rats increased the incidence of pheochromocytomas and renal tubular tumours.
Maltese: Id dożi ogħla ta' canagliflozin (100 mg/kg) f'firien irġiel u nisa żiedu l-inċidenza ta' feokromoċitomi u tumuri tat-tubuli tal-kliewi.
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 incidences of 4.9%, 8.7%, and 2.6% on 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'inċidenzi ta' 4.9%, 8.7%, u 2.6% meta kienu fuq canagliflozin 100 mg, canagliflozin 300 mg, u fil-grupp ta' kontroll, rispettivament.
English: vaginal infection, vulvitis, and genital infection fungal.
Maltese: vulvovaġinite, infezzjoni fil-vaġina, vulvite, u infezzjoni ġenitali bil-fungu.
English: When canagliflozin was added to a sulphonylurea therapy, hypoglycaemia was observed in 4.1%, 12.5%, and 5.8% of patients treated with canagliflozin 100 mg, canagliflozin 300 mg, and placebo, respectively (see sections 4.2 and 4.5).
Maltese: Meta canagliflozin żdied ma' terapija b'wieħed mis-sulphonylureas, ipogliċemija kienet osservata f'4.1%, 12.5%, u 5.8% tal-pazjenti kkurati b'canagliflozin 100 mg, canagliflozin 300 mg, u bi plaċebo, rispettivament (ara sezzjonijiet 4.2 u 4.5).
English: Candidal balanitis or balanoposthitis was reported in 4.2% and 3.7% of male patients treated with canagliflozin 100 mg and canagliflozin 300 mg, respectively, compared to 0.6% in placebo-treated male patients.
Maltese: Balanite jew balanopostite kandidjali kienet irrappurata f'4.2% u 3.7% tal-pazjenti rġiel ikkurati b'canagliflozin 100 mg u canagliflozin 300 mg, rispettivament, meta mqabbla ma' 0.6% f'pazjenti rġiel ikkurati bi plaċebo.
English: For patients with a baseline eGFR 30 mL/min/1.73 m2 to < 60 mL/min/1.73 m2, the incidences were 4.8% on canagliflozin 100 mg and 8.1% on canagliflozin 300 mg compared to 2.6% in the control group.
Maltese: Għal pazjenti b'eGFR minn 30 mL/min/1.73 m2 sa < 60 mL/min/1.73 m2 fil-linja bażi, l-inċidenzi kienu 4.8% fuq canagliflozin 100 mg u 8.1% fuq canagliflozin 300 mg meta mqabbla ma' 2.6% fil-grupp ta' kontroll.