FrancophonIA/ELRC3.0 huggingface dataset:
English: Following co-administration of canagliflozin with rifampicin (an inducer of various active transporters and drug-metabolising enzymes), 51% and 28% decreases in canagliflozin systemic exposure (area under the curve, AUC) and peak concentration (Cmax) were observed.
Maltese: Wara għoti ta' canagliflozin ma' rifampicin (induttur ta' diversi trasportaturi attivi u enzimi li jimmetabolizzaw il-mediċini), kien osservat tnaqqis ta' 51% u 28% fl-esponiment sistemiku (żona taħt il-kurva, AUC - area under the curve) għal canagliflozin u fl-ogħla konċentrazzjoni (Cmax) ta' canagliflozin.
English: The pack sizes are cartons of 20, 60, and 180 tablets (3 bottles containing 60 tablets each).
Maltese: Id-daqsijiet talpakketti huma kartun ta' 20, 60, u 180 pillola (3 fliexken li fihom 60 pillola l-wieħed).
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 9.3% versus 1.3%; non-HDL-cholesterol 2.2% and 4.4% versus 0.7%; triglycerides 2.4% and 0.0% versus 7.6%.
Maltese: 3% versus 4.0%; kolesterol LDL 5.7% u 9.3% versus 1.3%; kolesterol mhux HDL 2.2% u 4.4% versus 0.7%; trigliċeridi 2.4% u 0.0% versus 7.6%.
English: • efavirenz or ritonavir (medicines used to treat HIV infection)
Maltese: • efavirenz jew ritonavir (mediċina li tintuża biex tikkura infezzjoni bl-HIV)
English: PHARMACEUTICAL FORM AND CONTENTS Multipack: 180 (3 packs of 60) film-coated tablets
Maltese: Pakkett b'ħafna: 180 (3 pakketti ta' 60) pillola miksija b'rita
English: In patients at increased risk of further progression of renal impairment and in the elderly, renal function should be assessed more frequently, e.g. every 3-6 months.
Maltese: F'pazjenti b'riskju akbar ta' aktar progressjoni ta' indeboliment renali u fl anzjani, il-funzjoni renali għandha tkun evalwata b'mod aktar frekwenti, eż. kull 3-6 xhur.
English: • Hypersensitivity to the active substances or any of the excipients (see section 6.1);
Maltese: • Sensittività eċċessiva għas-sustanzi attivi jew għal kwalunkwe wieћed mill-eċċipjenti (ara sezzjoni 6.1);
English: Placebo + metformin and sulphonylurea (N = 156)
Maltese: metformin u sulphonylurea (N = 156)
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: Ilpazjenti 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: The observed pharmacokinetic and pharmacodynamic responses were consistent with those found in adult subjects.
Maltese: Ir-risponsi farmakokinetiċi u farmakodinamiċi osservati kienu konsistenti ma' dawk osservati f'individwi adulti.
English: Enzyme inducers (such as St. John's wort [Hypericum perforatum], rifampicin, barbiturates, phenytoin, carbamazepine, ritonavir, efavirenz) may give rise to decreased exposure of canagliflozin.
Maltese: John's wort [Hypericum perforatum], rifampicin, barbiturati, phenytoin,
English: Effects of canagliflozin on other medicinal products Digoxin
Maltese: Effetti ta' canagliflozin fuq prodotti mediċinali oħra
English: Avoid excessive alcohol intake while taking this medicine since this may increase the risk of lactic acidosis.
Maltese: Evita konsum eċċessiv ta' alkoħol waqt li tkun qed tieħu din il-mediċina peress li dan jista' jżid ir riskju ta' aċidożi lattika.
English: • The active substances are canagliflozin and metformin hydrochloride.
Maltese: • Is-sustanzi attivi huma canagliflozin u metformin hydrochloride.
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) versus id-dieta waħedha (43.3 każ/1,000 sena ta' pazjent), p = 0.0023, u versus il-gruppi kkombinati ta' monoterapija b'sulphonylurea u insulina (40.1 każ/1,000 sena ta' pazjent), p = 0.0034
English: 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: Il-kombinazzjoni ta' canagliflozin 300 mg darba kuljum għal 6 ijiem ma' doża waħda ta' 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: Placebo (N = 93)
Maltese: (N = 93)
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 with canagliflozin (see section 4.8).
Maltese: sodium glukożju co-transporter 2) b'żieda fil-UGE, kienet irrappurtata kandidjasi vulvovaġinali fin nisa u balanite jew balanopostite fl-irġiel fi provi kliniċi b'canagliflozin (ara sezzjoni 4.8).
English: Lactic acidosis, Vitamin B12 deficiencya
Maltese: Aċidożi lattika, Defiċjenza tal-vitamina
English: Rare cases of diabetic ketoacidosis (DKA), including life-threatening and fatal cases, have been reported in patients treated with SGLT2 inhibitors, including canagliflozin.
Maltese: Każijiet rari ta' ketoaċidożi tad-dijabete (DKA - diabetic ketoacidosis), inkluż każijiet ta' theddida għall-ħajja u fatali, ġew irrappurtati f'pazjenti ttrattati b'inibituri ta' SGLT2, inkluż b'canagliflozin.
English: Decreases in GFR (-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-GFR (-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: Difference from glimepiride (adjusted mean) (95% CI)
Maltese: Differenza minn glimepiride (medja aġġustata) (95% CI)
English: Placebo + metformin (N = 183)
Maltese: metformin (N = 183)
English: Iron oxide yellow (E172)
Maltese: Iron oxide iswed (E172)
English: Titanium dioxide (E171) Iron oxide red (E172)
Maltese: Titanium dioxide (E171) Iron oxide isfar (E172)
English: * Related to volume depletion; see section 4.4.
Maltese: * Marbuta ma' tnaqqis fil-volum; ara sezzjoni 4.4. ** Ara sezzjoni 4.4.
English: ** See section 4.4. a 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: 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: b p < 0.05. c Not applicable.
Maltese: b p < 0.05.
English: Metabolism and nutrition disorders very rare
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni rari ħafna
English: Single dose study: After single doses of metformin hydrochloride 500 mg, paediatric patients have shown a similar pharmacokinetic profile to that observed in healthy adults.
Maltese: Wara dożi waħdiet ta' metformin hydrochloride 500 mg, pazjenti pedjatriċi urew profil farmakokinetiku jixbah lil dak osservat f'adulti f'saħħithom.
English: EU/1/14/918/003 (50 mg/850 mg - 180 tablets) EU/1/14/918/006 (50 mg/1000 mg - 180 tablets) EU/1/14/918/009 (150 mg/850 mg - 180 tablets) EU/1/14/918/012 (150 mg/1000 mg - 180 tablets)
Maltese: EU/1/14/918/003 (50 mg/850 mg - 180 pillola) EU/1/14/918/006 (50 mg/1000 mg - 180 pillola) EU/1/14/918/009 (150 mg/850 mg - 180 pillola) EU/1/14/918/012 (150 mg/1000 mg - 180 pillola)
English: Metformin may act via three mechanisms:
Maltese: Metformin jista' jaħdem permezz ta' tliet mekkaniżmi:
English: The risk of volume depletion associated with canagliflozin should be taken into account (see sections 4.3 and 4.4).
Maltese: Għandu jitqies ir-riskju ta' tnaqqis fil-volum assoċjat ma' canagliflozin (ara sezzjonijiet 4.3 u 4.4).
English: Vokanamet is not recommended in patients with hepatic impairment due to the active substance metformin (see sections 4.3 and 5.2).
Maltese: Vokanamet mhuwiex rrakkomandat f'pazjenti b'indeboliment tal-fwied minħabba s-sustanza attiva metformin (ara sezzjonijiet 4.3 u 5.2).
English: After repeated doses of 500 mg twice daily for 7 days in paediatric patients, the peak Cmax and AUC0-t were reduced by approximately 33% and 40%, respectively compared to diabetic adults who received repeated doses of 500 mg twice daily for 14 days.
Maltese: Wara dożi ripetuti ta' 500 mg darbtejn kuljum għal 7 ijiem f'pazjenti pedjatriċi, l-ogħla Cmax u AUC0-t tnaqqsu b'madwar 33% u 40%, rispettivament meta mqabbla ma' adulti dijabetiċi li rċivew dożi ripetuti ta' 500 mg darbtejn kuljum għal 14-il jum.
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-glukożju u/jew dieta u eżerċizzju) pparteċipaw fi studju double-blind ikkontrollat bi plaċebo fuq perjodu ta' 26 ġimgħa.
English: Frequency categories are based on information available from the metformin Summary of Product Characteristics.
Maltese: Il-kategoriji ta' frekwenza huma msejsa fuq informazzjoni disponibbli fis-Sommarju talKaratteristiċi tal-Prodott ta' metformin.
English: The majority of patients with a baseline GFR 45 mL/min to < 60 mL/min were on insulin and/or a sulphonylurea (85% [614/721]).
Maltese: Il-biċċa l-kbira tal-pazjenti b'GFR minn 45 mL/min sa < 60 mL/min fil-linja bażi kienu fuq l-insulina u/jew wieħed mis-sulphonylureas (85% [614/721]).
English: Placebo + insulin (N = 565)
Maltese: insulina (N = 565)
English: • cimetidine (medicine used to treat stomach problems)
Maltese: • cimetidine (mediċina użata biex tikkura problemi fl-istonku)
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% versus 4.3%, rispettivament) meta mqabbla ma' 4.0% bi plaċebo.
English: Nervous system disorders Common
Maltese: Disturbi fis-sistema nervuża komuni
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 300 mg once daily, respectively, compared to 3.2% in placebo-treated female patients.
Maltese: Infezzjonjiet mikotiċi fil-ġenitali 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: 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: The incidence of hypoglycaemia episodes/events with canagliflozin 300 mg once daily and sitagliptin 100 mg was 40.7% and 43.2%, respectively.
Maltese: L-inċidenza ta' episodji/każijiet ta' ipogliċemja b'canagliflozin 300 mg darba kuljum u sitagliptin 100 mg kienet 40.7% u 43.2%, rispettivament.
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 once daily, canagliflozin 300 mg once daily, 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 darba kuljum, canagliflozin 300 mg darba kuljum, u bi plaċebo, rispettivament (ara sezzjonijiet 4.2 u 4.5).
English: 58% of patients had a body mass index (BMI) ≥ 30 kg/m2.
Maltese: Tmienja u ħamsin fil-mija (58%) tal-pazjenti kellhom inidiċi tal-massa tal-ġisem (BMI - body mass index) ta' ≥ 30 kg/m2.
English: Other medicines and Vokanamet
Maltese: Mediċini oħra u Vokanamet
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-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: Liver function test abnormal, Hepatitis a 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: Riżultat mhux normali tat-test tal-funzjoni tal fwied, Epatite a 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 50 mg/850 mg film-coated tablets (tablets) are pink, capsule-shaped, 20 mm in length, and debossed with “CM” on one side and “358” on the other side.
Maltese: • Il-pilloli Vokanamet 50 mg/850 mg miksijin b'rita (pilloli) huma roża, forma ta' kapsula, b'tul ta' 20 mm, u mnaqqxa b'“CM” fuq naħa waħda u “358” fuq in-naħa l-oħra.
English: The safety of canagliflozin was evaluated in 10,285 patients with type 2 diabetes, including 5,151 patients treated with canagliflozin in combination with metformin.
Maltese: Is-sigurtà ta' canagliflozin ġiet stmata f'10,285 pazjent bid-dijabete tat-tip 2, inkluż 5,151 pazjent ikkurati b'canagliflozin flimkien ma' metformin.
English: Renal clearance of metformin is > 400 mL/min, indicating that metformin hydrochloride is eliminated by glomerular filtration and tubular secretion.
Maltese: Tneħħija ta' metformin mill-kliewi hija > 400 mL/min, li tindika li metformin hydrochloride jitneħħa permezz ta' filtrazzjoni mill-glomeruli u sekrezzjoni mit-tubuli.
English: For patients with a baseline GFR 30 mL/min to < 60 mL/min or CrCl 30 to < 60 mL/min, the incidences were 4.8% on canagliflozin 100 mg once daily and 8.1% on canagliflozin 300 mg once daily compared to 2.6% in the control group.
Maltese: Għal pazjenti b'GFR minn 30 mL/min2 sa < 60 mL/min fil-linja bażi jew CrCl minn 30 sa < 60 mL/min, l-inċidenzi kienu 4.8% fuq canagliflozin 100 mg darba kuljum u 8.1% fuq canagliflozin 300 mg darba kuljum meta mqabbla ma' 2.6% fil-grupp ta' kontroll.
English: Do not take Vokanamet
Maltese: Tiħux Vokanamet
English: A study conducted in seven normal healthy volunteers showed that cimetidine, administered as 400 mg twice daily, increased metformin AUC by 50% and Cmax by 81%.
Maltese: Studju li sar f'seba' voluntiera normali f'saħħithom wera li cimetidine, mogħti bħala 400 mg darbtejn kuljum, żied l-AUC ta' metformin b'50% u Cmax b'81%.
English: Overall, 0.7% of all female patients discontinued canagliflozin due to vulvovaginal candidiasis (see section 4.4).
Maltese: B'kollox, 0.7% tal-pazjenti nisa kollha waqqfu canagliflozin minħabba kandidjasi vulvovaġinali (ara sezzjoni 4.4).
English: Some medicinal products can adversely affect renal function which may increase the risk of lactic acidosis, e.g. NSAIDs, including selective cyclo-oxygenase (COX) II inhibitors, ACE inhibitors, angiotensin II receptor antagonists and diuretics, especially loop diuretics.
Maltese: NSAIDs, inklużi inibituri selettivi ta' cyclo-oxygenase (COX) II, inibituri ta' ACE,
English: Glucocorticoids (given by systemic and local routes), beta-2-agonists, and diuretics have intrinsic hyperglycaemic activity.
Maltese: Glukokortikojdi (mogħtija mir-rotta sistemika jew lokali), agonisti ta' beta 2, u dijuretiċi minnhom infushom għandhom attività iperġliċemika.
English: • Vokanamet 50 mg/1000 mg film-coated tablets (tablets) are beige, capsule-shaped, 21 mm in length, and debossed with “CM” on one side and “551” on the other side.
Maltese: • Il-pilloli Vokanamet 50 mg/1000 mg miksijin b'rita (pilloli) huma beġ, forma ta' kapsula, b'tul ta' 21 mm, u mnaqqxa b'“CM” fuq naħa waħda u “551” fuq in-naħa l-oħra.
English: Lower limb amputations
Maltese: Amputazzjonijiet fir-riġel
English: 50 mg twice daily (N = 93)
Maltese: 50 mg darbtejn kuljum (N = 93)
English: In a study comparing canagliflozin 300 mg once daily 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 darba kuljum ma' sitagliptin 100 mg darba kuljum f'terapija tripla ma' metformin u wieħed mis-sulphonylureas, canagliflozin wera tnaqqis mhux inferjuri (p < 0.05) u superjuri (p < 0.05) f'HbA1c meta mqabbel ma' sitagliptin.
English: • a significant reduction of the absolute risk of any diabetes-related mortality: metformin 7.5 events/1,000 patient-years, diet alone 12.7 events/1,000 patient-years, p = 0.017
Maltese: • tnaqqis sinifikanti fir-riskju assolut ta' kwalunkwe mortalità marbuta mad-dijabete: metformin 7.5 każ/1,000 sena ta' pazjent, dieta waħedha 12.7 każ/1,000 sena ta' pazjent, p = 0.
English: • Vokanamet 150 mg/1000 mg film-coated tablets (tablets) are purple, capsule-shaped, 22 mm in length, and debossed with “CM” on one side and “611” on the other side.
Maltese: • Il-pilloli Vokanamet 150 mg/1000 mg miksijin b'rita (pilloli) huma vjola, forma ta' kapsula, b'tul ta' 22 mm, u mnaqqxa b'“CM” fuq naħa waħda u “611” fuq in-naħa l-oħra.
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 once daily, respectively.
Maltese: Sottostudju ta' pazjenti b'HbA1c > 10% sa ≤ 12% fil-linja bażi, b'canagliflozin bħala monoterapija, wassal għal tnaqqis f'HbA1c (mhux aġġustat bi plaċebo) ta' -2.13% u -2.56% mil-linja bażi għal canagliflozin 100 mg u 300 mg darba kuljum, rispettivament.
English: • beta-2 agonists (such as salbutamol or terbutaline) used to treat asthma.
Maltese: • agonisti ta' beta 2 (bħal salbutamol jew terbutaline) li jintużaw għall-kura tal-ażma.
English: Iron oxide black (E172)
Maltese: Iron oxide aħmar (E172)
English: b p < 0.001 compared to placebo.
Maltese: b p < 0.001 meta mqabbel ma' plaċebo.
English: • Hepatic impairment, acute alcohol intoxication, alcoholism (see sections 4.2 and 4.5).
Maltese: • Indeboliment tal-fwied, intossikazzjoni akuta bl-alkoħol, alkoħoliżmu (ara sezzjonijiet 4.2 u
English: Plasma protein binding is negligible.
Maltese: L-irbit mal-proteini tal-plażma huwa insinifikanti.
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 once daily, canagliflozin 300 mg once daily, 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 darba kuljum, canagliflozin 300 mg darba kuljum, u fil-grupp ta' kontroll, rispettivament.
English: • in patients already being treated with the combination of canagliflozin and metformin as separate tablets.
Maltese: • f'pazjenti li diġà qed jiġu kkurati bil-kombinazzjoni ta' canagliflozin u metformin bħala pilloli separati.
English: • a significant reduction in the absolute risk of myocardial infarction: metformin 11 events/1,000 patient-years, diet alone 18 events/1,000 patient-years, (p = 0.01).
Maltese: • tnaqqis sinifikanti fir-riskju assolut ta' infart mijokardijaku: metformin 11-il każ/1,000 sena ta' pazjent, dieta waħedha 18-il każ/1,000 sena ta' pazjent, (p = 0.01).
English: If interrupted, consideration should be given to more frequent glucose monitoring.
Maltese: Jekk jitwaqqaf, għandu jitqies monitoraġġ aktar frekwenti talglukożju.
English: For patients receiving Vokanamet, in case of intercurrent conditions that may lead to volume depletion (such as a gastrointestinal illness), careful monitoring of volume status (e.g., physical examination, blood pressure measurements, laboratory tests including renal function tests), and serum electrolytes is recommended.
Maltese: Għal pazjenti li qegħdin jirċievu Vokanamet, f'każ ta' kondizzjonijiet interkurrenti li jistgħu jwasslu għal tnaqqis ta' volum (bħal fil-każ ta' mard gastrointestinali), huwa rrakkomandat monitoraġġ b'attenzjoni tal-istat tal-volum (eż., eżami fiżiku, kejl tal-pressjoni, testijiet tal-laboratorju inkluż testijiet tal-funzjoni tal-kliewi), u tal-elettroliti fis-serum.
English: • Swallow the tablet whole with at least a half glass of water.
Maltese: • Ibla' l-pillola sħiħa ma' mill-anqas nofs tazza ilma.
English: Each 150 mg/850 mg tablet contains 150 mg of canagliflozin and 850 mg of metformin hydrochloride.
Maltese: Kull pillola ta' 150 mg/850 mg fiha 150 mg ta' canagliflozin u 850 mg ta' metformin hydrochloride.
English: Steady-state was reached after 4 days to 5 days of once-daily dosing with canagliflozin 100 mg to 300 mg. Canagliflozin does not exhibit time-dependent pharmacokinetics, and accumulated in plasma up to 36% following multiple doses of 100 mg and 300 mg.
Maltese: L-istat fiss intlaħaq wara 4 ijiem sa 5 ijiem ta' għoti ta' doża darba kuljum b'canagliflozin 100 mg sa 300 mg. Canagliflozin ma jurix farmakokinetika li tiddependi mill-ħin, u akkumula fil-plażma sa 36% wara ħafna dożi ta' 100 mg u 300 mg.