FrancophonIA/ELRC3.0 huggingface dataset:
English: • blood tests may show changes related to kidney function (creatinine or urea) or potassium
Maltese: • testijiet tad-demm jistgħu juru tibdil marbut mal-funzjoni tal-kliewi (kreatinina jew urea) jew mal-potassium
English: Canagliflozin 100 mg and 300 mg as monotherapy and as dual or triple add-on therapy resulted in statistically significant reductions in the percentage of body weight at 26 weeks relative to placebo.
Maltese: Canagliflozin 100 mg u 300 mg bħala monoterapija u bħala terapija miżjuda doppja jew tripla wassal għal tnaqqis statistikament sinifikanti fil-perċentwal ta' piż tal-ġisem fis-26 ġimgħa meta mqabbel ma' plaċebo.
English: The SGLT2 transporter, expressed in the proximal renal tubules, is responsible for the majority of the reabsorption of filtered glucose from the tubular lumen.
Maltese: It-trasportatur SGLT2, maħruġ mit-tubuli prossimali tal-kliewi, huwa responsabbli għall-biċċa l-kbira tal-assorbiment mill-ġdid tal-glukows iffiltrat mill-kavità tat-tubuli.
English: Available pharmacodynamic/toxicological data in animals have shown excretion of canagliflozin/metabolites in milk, as well as pharmacologically mediated effects in breast-feeding offspring and juvenile rats exposed to canagliflozin (see section 5.3).
Maltese: canagliflozin/metaboliti fil-ħalib, kif ukoll effetti medjati b'mod farmakoloġiku fi frieħ li qed jitreddgħu u f'firien żgħażagħ esposti għal canagliflozin (ara sezzjoni 5.3).
English: Canagliflozin was compared to glimepiride as dual therapy with metformin and compared to sitagliptin as triple therapy with metformin and a sulphonylurea (table 3).
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 3). Canagliflozin
English: Add-on therapy
Maltese: Tfal u adolexxenti
English: Patients with renal impairment For patients with an eGFR 60 mL/min/1.73 m2 to < 90 mL/min/1.73 m2 or CrCl 60 mL/min to
Maltese: Għal pazjenti b'eGFR minn 60 mL/min/1.73 m2 sa < 90 mL/min/1.73 m2 jew CrCl minn 60 mL/min sa
English: Canagliflozin is an orally-active inhibitor of SGLT2.
Maltese: canagliflozin fil-kavità tal-intestini qabel l-assorbiment tal-prodott mediċinali (canagliflozin huwa inibitur b'qawwa baxxa tat-trasportatur ta' SGLT1).
English: Adverse reactions in table 1 are based on the pooled analysis of the four 26-week placebo-controlled studies (n=2,313) described above.
Maltese: Ir-reazzjonijiet avversi f'tabella 1 huma msejsa fuq analiżi kolettiva ta' l-erba' studji kliniċi ta' 26 ġimgħa kkontrollati bil-plaċebo (n = 2,313) deskritti fuq.
English: Effects of canagliflozin on other medicinal products Digoxin: The combination of canagliflozin 300 mg once daily for 7 days with a single dose of digoxin 0.5 mg followed by 0.25 mg daily for 6 days resulted in a 20% increase in AUC and a 36% increase in Cmax of digoxin, probably due to inhibition of P-gp.
Maltese: Il-kombinazzjoni ta' canagliflozin 300 mg darba kuljum għal 7 ijiem ma' doża waħda ta' digoxin 0.5 mg segwita minn 0.25 mg kuljum għal 6 ijiem wasslet għal żieda ta' 20% fl-AUC u żieda ta' 36% fis-Cmax ta' digoxin, probabbilment minħabba inibizzjoni ta' P-gp. Canagliflozin kien osservat li jinibixxi P-gp in vitro.
English: Rīga, LV-1004 Tel: +371 678 93561
Maltese: Tel: +371 678 93561
English: Postprandial glucose
Maltese: Dieta u eżerċizzju
English: Therefore, 1,5-AG assays should not be used for assessment of glycemic control in patients on canagliflozin.
Maltese: Għalhekk, assaġġi ta' 1,5-AG m'għandhomx jintużaw għal stima ta' kontroll gliċemiku f'pazjenti fuq canagliflozin.
English: In a cardiovascular study of 4,327 patients with known or at high risk for cardiovascular disease, the incidence rates of bone fracture were 1.6, 1.6, and 1.1 per 100 patient years of exposure 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 ta' 4,327 pazjent b'riskju magħruf jew kbir ta' mard kardjovaskulari, ir-rati ta' inċidenza ta' ksur fl-għadam kienu 1.6, 1.6, u 1.1 għal kull 100 sena ta' esponiment ta' pazjent għal canagliflozin 100 mg, canagliflozin 300 mg, u plaċebo, rispettivament, bl-iżbilanċ fil-ksur jseħħ filbidu fi żmien l-ewwel 26 ġimgħa ta' terapija.
English: • St. John's wort (an herbal medicine to treat depression)
Maltese: John's wort (mediċina magħmula mill-ħxejjex biex tikkura depressjoni)
English: 300 mg exhibited mean improvements in percent change in body weight relative to placebo of -1.8% and -2.0%, respectively.
Maltese: 300 mg urew titjib medju fil-perċentwal ta' bidla fil-piż tal-ġisem ta' -1.8% u -2.0%, rispettivament meta mqabbla ma'plaċebo.
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 missulphonylureas, canagliflozin wera tnaqqis mhux inferjuri (p < 0.05) u superjuri (p < 0.05) f'HbA1c meta mqabbel ma' sitagliptin.
English: For patients on loop diuretics, the incidences were 3.2% on canagliflozin 100 mg and 8.8% on canagliflozin 300 mg compared to 4.7% in the control group.
Maltese: Għal pazjenti fuq dijuretiċi loop, l-inċidenzi kienu 3.2% fuq canagliflozin 100 mg u 8.8% fuq canagliflozin 300 mg meta mqabbla ma' 4.7% filgrupp ta' kontroll.
English: Genital mycotic infections
Maltese: Infezzjonijiet mikotiċi tal-ġenitali
English: Ossification delays were also observed for the combination of canagliflozin and metformin, which were more prominent than for metformin alone at canagliflozin exposures 43 times and 12 times higher than clinical exposures at 100 mg and 300 mg doses.
Maltese: Dewmien flossifikazzjoni kien osservat ukoll bil-kombinazzjoni ta' canagliflozin u metformin, li kienu aktar prominenti milli għal metformin waħdu f'esponimenti ta' canagliflozin li kienu 43 darba u 12-il darba iktar mill-esponimenti kliniċi b'dożi ta' 100 mg u 300 mg.
English: In addition, in such patients more events of elevated potassium and greater increases in serum creatinine and blood urea nitrogen (BUN) were reported (see section 4.8).
Maltese: F'każijiet rari, ġiet irrappurtata fimosi u xi drabi saret ċirkonċiżjoni (ara sezzjoni 4.4).
English: Baseline (mean) in kg % change from baseline (adjusted mean)
Maltese: Linja bażi (medja) f'kg % ta' bidla mil-linja bażi (medja aġġustata)
English: Eesti filiaal Lõõtsa 2
Maltese: PROPRJETAJIET FARMAKOLOĠIĊI 5
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għall-galactose, bid defiċjenza ta' Lapp lactase, jew b'assorbiment ħażin tal-glukows-galactose m'għandhomx jieħdu dan il-prodott mediċinali.
English: In patients with an eGFR < 60 mL/min/1.73 m2 or CrCl < 60 mL/min, a higher incidence of adverse reactions associated with volume depletion (e.g., postural dizziness, orthostatic hypotension, hypotension) was reported, particularly with the 300 mg dose.
Maltese: F'pazjenti b'eGFR < 60 mL/min/1.73 m2 jew CrCl < 60 mL/min, kienet irrappurata inċidenza ogħla ta' reazzjonijiet avversi assoċjata ma' tnaqqis fil-volum (eż., sturdament mal-waqqaf, pressjoni baxxa ortostatika, pressjoni baxxa) b'mod partikolari bid-doża ta' 300 mg.
English: What Invokana contains
Maltese: X'fih Invokana
English: Temporary interruption of treatment with canagliflozin may be considered for patients who develop volume depletion while on canagliflozin therapy until the condition is corrected.
Maltese: Twaqqif temporanju tal-kura b'canagliflozin jista jitqies f'pazjenti li jiżviluppaw tnaqqis fil-volum waqt li jkunu fuq terapija b'canagliflozin sakemm il-kundizzjoni tiġi rregolata.
English: < 60 mL/min/1.73 m2, 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 (%) achieving HbA1c < 7% 19.8b
Maltese: Pazjenti (%) li kisbu HbA1c < 7% 19.
English: Tablet core
Maltese: Mhux applikabbli.
English: A pre-specified interim meta-analysis was conducted of adjudicated major cardiovascular events in the phase 2 and 3 clinical studies in 9,632 patients with type 2 diabetes, including 4,327 patients (44.9%) with cardiovascular disease or at high risk for cardiovascular disease who are participating in an ongoing cardiovascular study.
Maltese: Saret meta-analiżi interim speċifikata minn qabel ta' każijiet kardjovaskulari kbar iġġudikati fl-istudji kliniċi ta' fażijiet 2 u 3 f'9,632 pazjent b'dijabete tat-tip 2, inkluż 4,327 pazjent (44.9%) b'mard cardjovaskulari jew b'riskju ogħli ta' mard kardjovaskulari li qed jipparteċipaw fi studju kardjovaskulari li għadu għaddej.
English: Diabetic ketoacidosis (rare, may affect up to 1 in 1,000 people) These are the signs of diabetic ketoacidosis (see also section 2 Warnings and precautions): increased levels of “ketone bodies” in your urine or blood rapid weight loss feeling sick or being sick stomach pain excessive thirst fast and deep breathing confusion unusual sleepiness or tiredness a sweet smell to your breath, a sweet or metallic taste in your mouth or a different odour to your urine or sweat.
Maltese: Dawn huma s-sinjali ta' ketoaċidożi tad-dijabete (ara wkoll sezzjoni 2 Twissijiet u prekawzjonijiet): żieda fil-livelli ta' “sustanzi marbuta mal-keton” fl-awrina jew fid-demm tiegħek telf ta' piż f'daqqa tħossok imdardar jew tirremetti uġigħ fl-istonku għatx eċċessiv teħid tan-nifs mgħaġġel u fil-fond konfużjoni xejra ta' ngħas jew għeja mhux tas-soltu nifs b'riħa ħelwa, togħma ħelwa jew togħma ta' metall f'ħalqek jew riħa differenti fl awrina jew fl-għaraq tiegħek.
English: Canagliflozin-induced renal tubule tumours and pheochromocytomas in rats appear to be caused by carbohydrate malabsorption as a consequence of intestinal SGLT1 inhibitory activity of canagliflozin in the gut of rats; mechanistic clinical studies have not demonstrated carbohydrate malabsorption in humans at canagliflozin doses of up to 2-times the maximum recommended clinical dose.
Maltese: canagliflozin fuq SGLT1 tal-intestini fil-ġewwieni tal-firien; studji mekkanistiċi kliniċi ma urewx assorbiment ħażin fil-bnedmin b'dożi ta' canagliflozin sa darbtejn aktar mill-ogħla doża klinika rrakkomandata.
English: In patients with evidence of volume depletion, correcting this condition prior to initiation of canagliflozin is recommended (see section 4.4).
Maltese: F'pazjenti b'xhieda ta' tnaqqis fil-volum, korrezzjoni ta' din ilkundizzjoni huwa rrakkomandat qabel ma jinbeda canagliflozin (ara sezzjoni 4.4).
English: In the dedicated cardiovascular study, where patients were generally older with a higher rate of diabetes complications, the incidences of adverse reactions related to volume depletion were 2.8% with canagliflozin 100 mg, 4.6% with canagliflozin 300 mg, and 1.9% with placebo.
Maltese: kumplikazzjonijiet tad-dijabete, l-inċidenzi ta' reazzjonijiet avversi marbuta ma' tnaqqis fil-volum kienu 2.8% b'canagliflozin 100 mg, 4.6% b'canagliflozin 300 mg, u 1.9% bi plaċebo.
English: Compared to healthy subjects, plasma AUC of canagliflozin was increased by approximately 17%, 63%, and 50% in subjects with mild, moderate, and severe renal impairment, respectively, but was similar for ESRD subjects and healthy subjects.
Maltese: Meta mqabbla ma' individwi f'saħħithom, l-AUC ta' canagliflozin fil-plażma żdied b'madwar 17%, 63%, u 50% f'individwi b'indeboliment ħafif, moderat u qawwi tal-kliewi, rispettivament, iżda kien jixxiebah f'individwi b'ESRD u individwi f'saħħithom.
English: n Mean percent changes from baseline in serum phosphate were 3.6% and 5.1% for canagliflozin 100 mg and 300 mg,
Maltese: n Bidliet perċentwali medji mil-linja bażi fil-phosphate fis-serum kienu 3.6% u 5.1% għal canagliflozin 100 mg u
English: l Mean percent changes from baseline in blood urea nitrogen were 17.1% and 18.0% for canagliflozin 100 mg and
Maltese: l Bidliet perċentwali medji mil-linja bażi tan-nitroġenu mill-urea fid-demm kienu 17.1% u 18.0% għal canagliflozin
English: Vulvovaginal candidiasis includes the terms vulvovaginal candidiasis, vulvovaginal mycotic infection, vulvovaginitis,
Maltese: g Kandidjasi vulvovaġinali tinkludi t-termini terms kandidjasi vulvovaġinali, infezzjoni vulvovaġinali mikotika,
English: Change from baseline (adjusted mean) Difference from glimepiride (adjusted mean) (95% CI)
Maltese: Differenza minn glimepiride (medja aġġustata) (95% CI)
English: Mean changes from baseline in haematocrit were 2.4% and 2.5% for canagliflozin 100 mg and 300 mg, respectively, compared to 0.0% for placebo.
Maltese: j Bidliet medji mil-linja bażi fl-ematokrit kienu 2.4% u 2.5% għal canagliflozin 100 mg u 300 mg, rispettivament, meta mqabbla ma' 0.0% għal plaċebo.
English: At study endpoint, 3.0% of patients treated with canagliflozin 100 mg, 4.0% with canagliflozin 300 mg, and 3.3% with placebo had such decreases (see section 4.4).
Maltese: Meta l-istudju laħaq l-iskop finali, 3.0% tal-pazjenti kkurati b'canagliflozin 100 mg, 4.0% b'canagliflozin 300 mg, u 3.3% bi plaċebo kellhom tnaqqis bħal dan (ara sezzjoni 4.4).
English: If renal function falls persistently below eGFR 45 mL/min/1.73 m2 or CrCl < 45 mL/min,
Maltese: F'pazjenti b'eGFR 45 mL/min/1.73 m2 sa
English: Placebo (N=192)
Maltese: (N = 192)
English: Less than 1% of the dose was excreted as unchanged canagliflozin in urine.
Maltese: Inqas minn 1% mid-doża tneħħiet bħala canagliflozin mhux mibdul fl-awrina.
English: EXP
Maltese: CBC
English: The tablets contain lactose.
Maltese: Il-pilloli fihom il-lactose.
English: Uncommon
Maltese: mhux komuni
English: uncommon
Maltese: Mhux komuni
English: Johnson & Johnson România SRL Str. Tipografilor nr. 11-15 Clădirea S-Park, Corp A2, Etaj 5 013714 Bucureşti, ROMÂNIA Tel: +40 21 207 1800
Maltese: Tipografilor nr. 11-15 Clădirea S-Park, Corp A2, Etaj 5
English: % change from baseline (adjusted mean)
Maltese: % ta' bidla mil-linja bażi (medja aġġustata)
English: Vascular disorders uncommon
Maltese: Disturbi vaskulari mhux komuni
English: The risk of diabetic ketoacidosis must be considered in the event of non-specific symptoms such as nausea, vomiting, anorexia, abdominal pain, excessive thirst, difficulty breathing, confusion, unusual fatigue or sleepiness.
Maltese: Ir-riskju ta' ketoaċidożi tad-dijabete għandu jitqies f'każ ta' sintomi mhux speċifiċi bħal nawsja, rimettar, anoreksja, uġigħ fl-addome, għatx eċċessiv, diffikultà bit-tehid tan-nifs, konfużjoni, xejra ta' għeja jew ngħas mhux tas-soltu.
English: Canagliflozin may add to the effect of diuretics and may increase the risk of dehydration and hypotension (see section 4.4).
Maltese: Canagliflozin jista' jżid mal-effett tad-dijuretiċi u jista' jżid ir-riskju ta' deidratazzjoni u pressjoni baxxa (ara sezzjoni 4.4).
English: Therefore, the canagliflozin dose should be limited to 100 mg once daily in patients with eGFR < 60 mL/min/1.73 m2 or CrCl < 60 mL/min and canagliflozin should not be used in patients with an eGFR < 45 mL/min/1.73 m2 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 m2 jew CrCl < 60 mL/min u canagliflozin m'għandux jintuża f'pazjenti b'eGFR < 45 mL/min/1.73 m2 jew CrCl < 45 mL/min (ara sezzjoni 4.2). Canagliflozin ma ġiex studjat f'indeboliment qawwi tal-kliewi (eGFR < 30 mL/min/1.73 m2 jew CrCl < 30 mL/min) jew ESRD.
English: Diuretics
Maltese: Dijuretiċi
English: d Canagliflozin as add-on therapy to insulin (with or without other glucose-lowering medicinal products).
Maltese: c Ma jgħoddx f'dan il-każ. d Canagliflozin bħala terapija miżjuda mal-insulina (ma' prodotti mediċinali oħra li jbaxxu l-glukows jew mingħajrhom).
English: This was accompanied by a sustained reduction in serum uric acid concentration of approximately 20%.
Maltese: Dan kien akkumpanjat minn tnaqqis miżmum ta' madwar 20% fil-konċentrazzjoni tal-aċidu uriku fis-serum.
English: d.o.o.
Maltese: salvataġġ.
English: A total of 10,285 patients with type 2 diabetes participated in nine double-blind, controlled clinical efficacy and safety studies conducted to evaluate the effects of Invokana on glycaemic control.
Maltese: Effikaċja klinika u sigurtà Total ta' 10,285 pazjent b'dijabete tat-tip 2 pparteċipaw f'disa' studji ta' sigurtà u effikaċja klinika,
English: When canagliflozin is used as add-on therapy with insulin or an insulin secretagogue (e.g., sulphonylurea), a lower dose of insulin or the insulin secretagogue may be considered to reduce the risk of hypoglycaemia (see sections 4.5 and 4.8).
Maltese: Meta canagliflozin jintuża bħala terapija miżjuda mal-insulina jew ma' sustanza li tikkawża t-tnixxija tal-insulina (eż., sulphonylurea), doża aktar baxxa ta' insulina jew tas-sustanza li tikkawża t-tnixxija tal-insulina tista' titqies biex jitnaqqas ir-risku ta' ipogliċemija (ara sezzjonijiet 4.5 u 4.8).
English: Canagliflozin is not expected to be dialysable by peritoneal dialysis.
Maltese: Effetti ta' canagliflozin fuq prodotti mediċinali oħra Digoxin:
English: Adverse reaction
Maltese: Simvastatin:
English: O-glucuronidation is the major metabolic elimination pathway for canagliflozin, which is mainly glucuronidated by UGT1A9 and UGT2B4 to two inactive O-glucuronide metabolites.
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: Dabigatran: The effect of concomitant administration of canagliflozin (a weak P-gp inhibitor) on dabigatran etexilate (a P-gp substrate) has not been studied.
Maltese: Canagliflozin ma ġiex studjat f'pazjenti b'indebolimet qawwi tal-fwied u mhuwiex rrakkomanadat biex jintuża f'dawn il-pazjenti (ara sezzjoni 5.2).
English: The most commonly reported adverse reactions during treatment were hypoglycaemia in combination with insulin or a sulphonylurea, vulvovaginal candidiasis, urinary tract infection, and polyuria or pollakiuria (i.e., urinary frequency).
Maltese: Ir-reazzjonijiet avversi rrappurtati bl-aktar mod komuni waqt il-kura kienu ipogliċemija meta mogħti flimkien mal-insulina jew wieħed missulphonylureas, kandidjasi vulvovaġinali, infezzjoni fil-passaġġ tal-awrina, u polijurja jew pollakijurja (i.e., il-frekwenza tal-għamil tal-awrina).
English: Limited data from clinical trials suggest that DKA occurs with common frequency when patients with type 1 diabetes are treated with SGLT2 inhibitors.
Maltese: Dejta limitata minn provi kliniċi tissuġġerixxi li DKA isseħħ bi frekwenza komuni meta pazjenti b'dijabete tat-tip 1 jiġu ttrattati b'inibituri ta' SGLT2.
English: CYP3A4-mediated (oxidative) metabolism of canagliflozin is minimal (approximately 7%) in humans.
Maltese: Fil bnedmin metaboliżmu (ossidattiv) ta' canagliflozin medjat minn CYP3A4 huwa minimu (madwar
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: Użu f'pazjenti b'indeboliment tal-kliewi 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: Urine glucose
Maltese: GĦAMLA KWALITATTIVA
English: Canagliflozin should be discontinued when eGFR is persistently below 45 mL/min/1.73 m2 or CrCl persistently below 45 mL/min (see sections 4.4, 4.8, 5.1, and 5.2).
Maltese: - Qabel jinbeda canagliflozin u mill-inqas darba fis-sena, minn hemm 'il quddiem (ara sezzjonijiet 4.2, 4.8, 5.1, u 5.2)
English: h Balanitis or balanoposthitis includes the terms balanitis, balanoposthitis, balanitis candida, and genital infection fungal.
Maltese: L-insulina u sustanzi li jikkawżaw it-tnixxija tal-insulina, bħal ma huma sulphonylureas, jistgħu jikkawżaw ipogliċemija.
English: “Blood-glucose lowering drugs” are medicines used by adults to treat type 2 diabetes.
Maltese: ” “Mediċini li jbaxxu l-glukows fid-demm” huma mediċini użati mill-adulti biex jikkuraw dijabete tattip 2.
English: < 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 u għandhom bżonn kontroll gliċemiku iktar strett, id-doża tista' tiżdied għal 300 mg darba kuljum mill-ħalq (ara taħt u sezzjoni 4.4).
English: Hypoglycaemia in add-on therapy with insulin or insulin secretagogues
Maltese: L-insulina u sustanzi li jikkawżaw it-tnixxija tal-insulina
English: d Based on postmarketing experience with canagliflozin.
Maltese: Studji ma wrew l-ebda assorbiment ħażin talglukows b'canagliflozin.
English: b p<0.001 compared to placebo.
Maltese: b p < 0.001 meta mqabbel ma' plaċebo.
English: Invokana can be used by itself or along with other medicines you may be using to treat your type 2 diabetes (such as metformin, insulin, a DPP-4 inhibitor [such as sitagliptin, saxagliptin, or linagliptin], a sulphonylurea [such as glimepiride or glipizide], or pioglitazone) that lower blood sugar levels.
Maltese: Invokana jista' jintuża waħdu jew flimkien ma' mediċini oħra li inti tista' tkun qed tuża biex tikkura d dijabete tat-tip 2 tiegħek (bħal metformin, insulina, inibitur ta' DPP-4 [bħal sitagliptin, saxagliptin, jew linagliptin], xi sulphonylurea [bħal glimepiride jew glipizide], jew pioglitazone) li jbaxxu l-livelli taz-zokkor fid-demm.
English: MT-Ħal-Luqa LQA 6000 Tel: +356 2397 6000
Maltese: Tel: +356 2397 6000
English: • kidney failure (mainly as a consequence of loss of too much fluid from your body).
Maltese: • insuffiċjenza tal-kliewi (l-aktar bħala konsegwenza ta' wisq telf ta' fluwidu mill-ġisem tiegħek).
English: Canagliflozin is a low-clearance substance, with a mean systemic clearance of approximately 192 mL/min in healthy subjects following intravenous administration.
Maltese: Canagliflozin huwa sustanza bi tneħħija baxxa, b'medja ta' tneħħija sistemika ta' madwar 192 mL/min f'individwi f'saħħithom wata għoti fil-vina.
English: Studies in animals have shown reproductive toxicity (see section 5.3).
Maltese: Studji f'annimali urew effett tossiku fuq issistema riproduttiva (ara sezzjoni 5.3).
English: Invokana is available in PVC/aluminium perforated unit dose blisters.
Maltese: Invokana huwa disponibbli f'folji tal-PVC/aluminju b'toqob biex id-dożi jinqatgħu waħda waħda.
English: If an inducer of these UGT enzymes must be co-administered with canagliflozin, increasing the dose to 300 mg once daily may be considered if patients are currently tolerating canagliflozin 100 mg once daily, have an eGFR ≥ 60 mL/min/1.73 m2 or CrCl ≥ 60 mL/min, and require additional glycaemic control.
Maltese: għandha titqies żieda fid-doża għal 300 mg darba kuljum jekk f'dak iż-żmien il-pazjenti jkunu qed jittolleraw canagliflozin 100 mg darba kuljum, ikollhom eGFR ≥ 60 mL/min/1.73 m2 jew CrCl ≥ 60 mL/min, u jkunu jeħtieġu kontroll gliċemiku addizzjonali.
English: Approximately 58% of patients were male.
Maltese: Madwar 58% tal-pazjenti kienu rġiel.
English: • if you are allergic to canagliflozin or any of the other ingredients of this medicine (listed in section 6).
Maltese: • jekk inti allerġiku għal canagliflozin jew għal xi sustanza oħra ta' din il-mediċina (elenkati fis sezzjoni 6).
English: Do not use Invokana if the packaging is damaged or shows signs of tampering.
Maltese: Jista' jkun li mhux il-pakketti tad-daqsijiet kollha jkunu fis-suq.