FrancophonIA/ELRC3.0 huggingface dataset:
English: g Vulvovaginal candidiasis includes the terms vulvovaginal candidiasis, vulvovaginal mycotic infection, vulvovaginitis, vaginal infection, vulvitis, and genital infection fungal.
Maltese: g Kandidjasi vulvovaġinali tinkludi t-termini kandidjasi vulvovaġinali, infezzjoni vulvovaġinali mikotika, vulvovaġinite, infezzjoni fil-vaġina, vulvite, u infezzjoni fil-ġenitali bil-fungu.
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: k Mean percent changes from baseline in creatinine were 2.8% and 4.0% for canagliflozin 100 mg and 300 mg, respectively, compared to 1.5% for placebo.
Maltese: k Bidliet perċentwali medji mil-linja bażi fil-kreatinina kienu 2.8% u 4.0% għal canagliflozin 100 mg u 300 mg,
English: 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: Table 5: Efficacy results from active-controlled clinical studiesa
Maltese: Tabella 3: Riżultati ta' effikaċja minn studji kliniċi kkontrollati bi plaċeboa
English: In controlled clinical trials, Cmax did not exceed 5 μg/mL, even at maximum doses.
Maltese: Fi provi kliniċi kkontrollati, is-Cmax ma qabiżx il-5 μg/mL, anke bl-ogħla dożi.
English: Vokanamet 50 mg/850 mg film-coated tablets Vokanamet 50 mg/1000 mg film-coated tablets Vokanamet 150 mg/850 mg film-coated tablets Vokanamet 150 mg/1000 mg film-coated tablets
Maltese: Vokanamet 50 mg/850 mg pilloli miksijin b'rita Vokanamet 50 mg/1000 mg pilloli miksijin b'rita Vokanamet 150 mg/850 mg pilloli miksijin b'rita Vokanamet 150 mg/1000 mg pilloli miksijin b'rita
English: In two 52-week active-controlled studies comparing canagliflozin to glimepiride and sitagliptin, sustained and statistically significant mean reductions in the percentage of body weight for canagliflozin as add-on therapy to metformin were -4.2% and -4.7% for canagliflozin 100 mg and 300 mg once daily, respectively, compared to the combination of glimepiride and metformin (1.0%) and -2.5% for canagliflozin 300 mg once daily in combination with metformin and a sulphonylurea compared to sitagliptin in combination with metformin and a sulphonylurea (0.3%).
Maltese: -4.7% għal canagliflozin 100 mg u 300 mg darba kuljum, rispettivament, meta mqabbel ma' glimepiride flimkien ma' metformin (1.0%) u -2.5% għal canagliflozin 300 mg darba kuljum flimkien ma' metformin u wieħed mis-sulphonylureas meta mqabbel ma' sitagliptin flimkien ma' metformin u wieħed mis-sulphonylureas (0.3%).
English: Each 50 mg/1000 mg tablet contains 50 mg of canagliflozin and 1000 mg of metformin hydrochloride.
Maltese: Kull pillola ta' 50 mg/1000 mg fiha 50 mg ta' canagliflozin u 1000 mg ta' metformin hydrochloride.
English: These changes are not likely to be clinically relevant.
Maltese: Dan it-tibdil x'aktarx li mhuwiex rilevanti b'mod kliniku.
English: Adults with normal renal function (GFR ≥ 90 mL/min) The dose of glucose-lowering therapy with Vokanamet should be individualised on the basis of the patient's current regimen, effectiveness, and tolerability, using the recommended daily dose of 100 mg or 300 mg canagliflozin and not exceeding the maximum recommended daily dose of metformin orally.
Maltese: Adulti b'funzjoni renali normali (GFR≥ 90 mL/min) Id-doża tat-terapija li tbaxxi l-glukożju b'Vokanamet għandha tiġi individwalizzata abbażi tal-iskeda attwali tal-pazjent, l-effettività u t-tollerabilità, bl-użu tad-doża rrakkomandata ta' 100 mg jew 300 mg ta' canagliflozin kuljum filwaqt li ma tinqabiżx l-ogħla doża rrakkomadata ta' metformin kuljum mill ħalq.
English: Vokanamet 50 mg/1000 mg film-coated tablets Macrogol (3350)
Maltese: Vokanamet 50 mg/1000 mg pilloli miksijin b'rita Macrogol (3350)
English: In a study on embryo-fetal development in rats, metformin alone (300 mg/kg/day) caused absent/incomplete ossification, while canagliflozin alone (60 mg/kg/day) had no effects.
Maltese: Fi studju dwar l-iżvilupp tal-embriju u tal-fetu fil-firien, metformin waħdu (300 mg/kg/jum) ikkawża ossifikazzjoni nieqsa/mhux kompluta, filwaqt li canagliflozin waħdu (60 mg/kg/jum) ma kellu l-ebda effetti.
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 kardjovaskulari jew b'riskju ogħli ta' mard kardjovaskulari li qed jipparteċipaw fi studju kardjovaskulari li għadu għaddej.
English: (E171), iron oxide red (E172) and iron oxide black (E172).
Maltese: Titanium dioxide (E171) Iron oxide aħmar (E172) Iron oxide isfar (E172)
English: (i.e., urinary frequency).
Maltese: B12 (eż., anemija megaloblastika).
English: Each 150 mg/1000 mg tablet contains 150 mg of canagliflozin and 1000 mg of metformin hydrochloride.
Maltese: Kull pillola ta' 150 mg/1000 mg fiha 150 mg ta' canagliflozin u 1000 mg ta' metformin hydrochloride.
English: Decreased renal function in elderly patients is frequent and asymptomatic.
Maltese: Tnaqqis fil-funzjoni tal-kliewi f'pazjenti anzjani hija frekwenti u mingħajr sintomi.
English: Each film-coated tablet contains canagliflozin hemihydrate, equivalent to 150 mg canagliflozin, and 1000 mg metformin hydrochloride.
Maltese: Kull pillola miksija b'rita fiha canagliflozin hemihydrate, ekwivalenti għal 150 mg canagliflozin, u 1000 mg metformin hydrochloride.
English: PHARMACEUTICAL FORM AND CONTENTS 20 film-coated tablets
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT
English: Each film-coated tablet contains canagliflozin hemihydrate, equivalent to 150 mg canagliflozin, and 850 mg metformin hydrochloride.
Maltese: Kull pillola miksija b'rita fiha canagliflozin hemihydrate, ekwivalenti għal 150 mg canagliflozin, u 850 mg metformin hydrochloride.
English: Canagliflozin was compared to glimepiride as dual therapy with metformin and compared to sitagliptin as triple therapy with metformin and a sulphonylurea (table 5).
Maltese: sitagliptin bħala terapija tripla ma' metformin u wieħed mis-sulphonylureas (tabella 5).
English: h Balanitis or balanoposthitis includes the terms balanitis, balanoposthitis, balanitis candida, and genital infection fungal.
Maltese: h Balanite jew balanopostite jinkludu t-termini balanite, balanopostite, balanite candida, u infezzjoni fil-ġenitali bilfungu.
English: When canagliflozin was added to insulin therapy, hypoglycaemia was observed in 49.3%, 48.2%, and 36.8% of patients treated with canagliflozin 100 mg once daily, canagliflozin 300 mg once daily, and placebo, respectively, and severe hypoglycaemia occurred in 1.8%, 2.7%, and 2.5% of patients treated with canagliflozin 100 mg once daily, canagliflozin 300 mg once daily, and placebo, respectively.
Maltese: 100 mg darba kuljum, canagliflozin 300 mg darba kuljum, u bi plaċebo, rispettivament, u ipogliċemija qawwija seħħet f'1.8%, 2.7%, u 2.5% tal-pazjenti kkurati b'canagliflozin 100 mg darba kuljum,
English: Film-coating: - 50 mg/850 mg tablets: macrogol (3350), polyvinyl alcohol, talc, titanium dioxide
Maltese: Kisja tar-rita: - pilloli ta' 50 mg/850 mg: macrogol (3350), polyvinyl alcohol, talc, titanium dioxide (E 171), iron oxide aħmar (E172) u iron oxide iswed (E172).
English: However, as precautionary measures, consideration should be given to carefully monitoring patients with a higher risk for amputation events and counselling patients about the importance of routine preventative foot care and maintaining adequate hydration.
Maltese: Madankollu, bħala miżuri ta' prekawzjoni, għandu jitqies li pazjenti f'riskju akbar għal avvenimenti ta' amputazzjoni jiġu mmonitorjati b'attenzjoni u jingħataw pariri professjonali dwar l-importanza ta' kura ta' prevenzjoni bħala rutina fis-saqajn u li jżommu idratazzjoni adegwata.
English: Urine glucose
Maltese: Glukożju fl-awrina
English: Table 4: Efficacy results from placebo-controlled clinical study of canagliflozin dosed twice dailya
Maltese: 13-il darba aktar mill-esponiment kliniku għal canagliflozin u metformin, rispettivament, b'dożi ta'
English: Canagliflozin has not been studied in severe renal impairment (GFR < 30 mL/min ) or ESRD.
Maltese: Meta canagliflozin/metformin ingħata b'60/300 mg/kg/jum (livelli ta' esponiment 11 u
English: d p = 0.013 compared to placebo.
Maltese: c Ma jgħoddx f'dan il-każ. d p = 0.013 meta mqabbel ma' plaċebo.
English: A lower proportion of patients treated with canagliflozin 100 mg once daily (5.6%) and canagliflozin 300 mg once daily (4.9%) experienced at least one episode/event of hypoglycaemia over 52 weeks of treatment compared to the group treated with glimepiride (34.2%).
Maltese: Proporzjon iżgħar ta' pazjenti kkurati b'canagliflozin 100 mg darba kuljum (5.6%) u canagliflozin 300 mg darba kuljum (4.9%) kellhom tal-inqas episodju/każ wieħed ta' ipogliċemija fuq perjodu ta' 52 ġimgħa ta' kura meta mqabbel mal-grupp ikkurat b'glimepiride (34.2%).
English: Each film-coated tablet contains canagliflozin hemihydrate, equivalent to 50 mg canagliflozin, and 1000 mg metformin hydrochloride.
Maltese: Kull pillola miksija b'rita fiha canagliflozin hemihydrate, ekwivalenti għal 50 mg canagliflozin, u 1000 mg metformin hydrochloride.
English: • if you have uncontrolled diabetes, with, for example,severe hyperglycaemia (high blood glucose), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis (see “Risk of lactic acidosis” below) or ketoacidosis.
Maltese: • jekk għandek dijabete mhux ikkontrollata, b'pereżempju, ipergliċemija severa (glucose għoli fid-demm), dardir, rimettar, dijarea, telf mgħaġġel fil-piż, aċidożi lattika (ara "Riskju ta' aċidożi lattika" hawn taħt) jew ketoaċidożi.
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: Vokanamet is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control:
Maltese: Vokanamet hu indikat għall-użu fl-adulti minn età ta' 18-il sena 'l fuq b'dijabete mellitus tat-tip 2 biex jiżdied mad-dieta u l-eżerċizzju biex itejjeb il-kontroll gliċemiku:
English: Absolute bioavailability of a 500 mg or 850 mg metformin hydrochloride tablet is approximately 50-60% in healthy subjects.
Maltese: Il-bijodisponibbiltà assoluta ta' pillola ta' 500 mg jew 850 mg ta' metformin hydrochloride hija madwar 50-60% f'individwi f'saħħithom.
English: Each tablet contains canagliflozin hemihydrate, equivalent to 50 mg of canagliflozin, and 850 mg of metformin hydrochloride.
Maltese: Kull pillola fiha canagliflozin hemihydrate, ekwivalenti għal 50 mg ta' canagliflozin, u 850 mg ta' metformin hydrochloride.
English: n Mean percent changes from baseline in serum phosphate were 3.6% and 5.1% for canagliflozin 100 mg and 300 mg, compared to 1.5% for placebo.
Maltese: n Bidliet perċentwali medji mil-linja bażi fil-phosphate fis-serum kienu 3.6% u 5.1% għal canagliflozin 100 mg u
English: The intravascular administration of iodinated contrast agents in radiological studies may lead to renal failure, resulting in metformin accumulation and a risk of lactic acidosis.
Maltese: Doża eċċessiva għolja ta' metformin jew riskji komkomittanti jistgħu jwasslu għal aċidożi lattika.
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 from baseline relative to placebo by -1.5 mmol/L to -2.7 mmol/L for canagliflozin 100 mg once daily and -2.1 mmol/L to -3.5 mmol/L for canagliflozin 300 mg once daily, respectively, due to reductions in the pre-meal glucose concentration and reduced postprandial glucose excursions.
Maltese: -2.7 mmol/L għal canagliflozin 100 mg darba kuljum u -2.1 mmol/L sa -3.5 mmol/L għal 300 mg darba kuljum, rispettivament, minħabba tnaqqis fil-konċentrazzjoni tal-glukożju qabel l-ikel u tnaqqis ta' ħruġ ta' glukożju wara l-ikel.
English: - 150 mg/1000 mg tablets: macrogol (3350), polyvinyl alcohol, talc, titanium dioxide
Maltese: - pilloli ta' 150 mg/1000 mg: macrogol (3350), polyvinyl alcohol, talc, titanium dioxide (E 171), iron oxide aħmar (E172) u iron oxide iswed (E172).
English: • reduced body temperature and heartbeat
Maltese: • diffikultà biex tieħu n-nifs • temperatura tal-ġisem u taħbit tal-qalb imnaqqsa
English: Each film-coated tablet contains canagliflozin hemihydrate, equivalent to 50 mg canagliflozin, and 850 mg metformin hydrochloride.
Maltese: Kull pillola miksija b'rita fiha canagliflozin hemihydrate, ekwivalenti għal 50 mg canagliflozin, u 850 mg metformin hydrochloride.
English: Some studies indicate that taking canagliflozin may have contributed to the risk of lower limb amputation (mainly toe amputations).
Maltese: Xi studji jindikaw li t-teħid ta' canagliflozin jista' jkun li kkontribwixxa għar-riskju ta' amputazzjoni fir-riġel (l-aktar amputazzjoni ta' saba tas-sieq).
English: When Vokanamet is used as add-on therapy with insulin or an insulin secretagogue (e.g., a 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 Vokanamet 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: • Diabetic pre-coma;
Maltese: • Stat dijabetiku ta' qabel il-koma;
English: See section “Warning and precautions”.
Maltese: Ara s-sezzjoni “Twissijiet u prekawzjonijiet”.
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: Association) hija limitata, u ma hemm l-ebda esperjenza fi studji kliniċi b'canagliflozin fil-klassi IV
English: N/Ac a Intent-to-treat population using last observation in study.
Maltese: N/Ac a Popolazzjoni bl-intenzjoni li tiġi kkurata bl-użu tal-aħħar osservazzjoni fl-istudju.
English: - 50 mg/1000 mg tablets: macrogol (3350), polyvinyl alcohol, talc, titanium dioxide
Maltese: - pilloli ta' 50 mg/1000 mg: macrogol (3350), polyvinyl alcohol, talc, titanium dioxide (E 171), iron oxide isfar (E172), u iron oxide aħmar (E172).
English: 60 film-coated tablets.
Maltese: 60 pillola miksijin b'rita.
English: Temporary interruption of treatment with Vokanamet may be considered for patients who develop volume depletion while on Vokanamet therapy until the condition is corrected.
Maltese: Twaqqif temporanju tal-kura b'Vokanamet jista' jitqies f'pazjenti li jiżviluppaw tnaqqis fil-volum waqt li jkunu fuq terapija b'Vokanamet sakemm il-kundizzjoni tiġi rregolata.
English: As metformin is recommended to be administered with a meal to reduce the incidence of gastrointestinal adverse reactions, it is recommended that Vokanamet be taken with a meal to reduce gastrointestinal intolerability associated with metformin.
Maltese: Minħabba li metformin huwa rrakkomandat li jingħata mal-ikel biex titnaqqas l-inċidenza ta' reazzjonijiet gastrointestinali avversi, huwa rrakkomandat li
English: In patients with evidence of volume depletion, correcting this condition prior to initiation of Vokanamet is recommended (see section 4.4).
Maltese: F'pazjenti b'xhieda ta' tnaqqis fil-volum, korrezzjoni ta' din il-kundizzjoni huwa rrakkomandat qabel ma jinbeda Vokanamet (ara sezzjoni 4.4).
English: In a number of cases, the presentation of the condition was atypical with only moderately increased blood glucose values, below 14 mmol/L (250 mg/dl).
Maltese: F'numru ta' każijiet, il-preżentazzjoni tal-kundizzjoni ma kinitx tipika b'żieda moderata ta' inqas minn 14 mmol/L (250 mg/dl) biss fil-valuri tal-glukożju fid-demm.
English: Moderate increases (generally < 400 mL to 500 mL) in daily urine volume were seen that attenuated over several days of dosing.
Maltese: Dehru żidiet moderati (ġeneralment < 400 mL sa 500 mL) fil-volum ta' kuljum tal-awrina li naqsu fuq perjodu ta' diversi jiem ta' għoti tad-dożi.
English: SPECIAL STORAGE CONDITIONS Do not store above 30°C.
Maltese: Taħżinx f'temperatura 'l fuq minn 30oC.
English: Administration of Vokanamet 150 mg/1000 mg with food resulted in no change in overall exposure of canagliflozin.
Maltese: L-għoti ta' Vokanamet 150 mg/1000 mg mal-ikel ma wassal għall-ebda bidla fl-esponiment totali għal canagliflozin.
English: Urinary uric acid excretion was transiently increased by canagliflozin (increased by 19% compared to baseline on day 1 and then attenuating to 6% on day 2 and 1% on day 13).
Maltese: Ittneħħija tal-aċidu uriku fl-awrina żdiedet b'mod temporanju permezz ta' canagliflozin (żdiedet b'19% meta mqabbla mal-linja bażi f'jum 1 imbagħad naqset għal 6% f'jum 2 u 1% f'jum 13).
English: In general, canagliflozin produced clinically and statistically significant (p < 0.001) results relative to placebo in glycaemic control, including glycosylated haemoglobin (HbA1c), the percentage of patients achieving HbA1c < 7%, change from baseline fasting plasma glucose (FPG), and 2-hour postprandial glucose (PPG).
Maltese: Canagliflozin ġie studjat bħala, terapija doppja ma' metformin, terapija doppja ma' wieħed missulphonylureas, terapija tripla ma' metformin u wieħed mis-sulphonylureas, terapija tripla ma' metformin u pioglitazone, bħala terapija miżjuda mal-insulina u bħala monoterapija (tabella 3). Filbiċċa l-kbira, canagliflozin ipproduċa riżultati sinifikanti (p < 0.001) b'mod kliniku u statistiku fil kontroll gliċemiku, inkluż emoglobina glikosilata (HbA1c), il-perċentwal ta' pazjenti li kisbu HbA1c < 7%, bidla mil-linja bażi tal-glukożju fil-plażma waqt is-sawm (FPG - fasting plasma glucose),
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: Tumuri tat-tubuli tal-kliewi u feokromoċitomi fil-firien ikkaġunati b'canagliflozin jidhru li huma kkawżati minn assorbiment ħażin ta' karboidrati bħala konsegwenza ta' attività inibitorja ta' 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: Insulin and insulin secretagogues
Maltese: Glukożju fil-plażma waqt is-sawm
English: If an inducer of these UGT enzymes must be co-administered with canagliflozin, increasing the dose to Vokanamet containing 150 mg twice daily may be considered if patients are currently tolerating canagliflozin 50 mg twice daily and require additional glycaemic control (see sections 4.2 and 4.4).
Maltese: għandha titqies żieda fid-doża għal Vokanamet li fih 150 mg darbtejn kuljum jekk f'dak iż-żmien il pazjenti jkunu qed jittolleraw canagliflozin 50 mg darbtejn kuljum, u jkunu jeħtieġu kontroll gliċemiku addizzjonali (ara sezzjonijiet 4.2 u 4.4).
English: Studies in animals with canagliflozin have shown reproductive toxicity (see section 5.3).
Maltese: Ma kienu osservati l-ebda effetti ta' canagliflozin jew metformin fuq il-fertilità fi studji b'annimali (ara sezzjoni 5.3).
English: For patients on loop diuretics, the incidences were 3.2% on canagliflozin 100 mg once daily and 8.8% on canagliflozin 300 mg once daily compared to 4.7% in the control group.
Maltese: 100 mg darba kuljum u 8.8% fuq canagliflozin 300 mg darba kuljum meta mqabbla ma' 4.7% fil grupp ta' kontroll.
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-glukożju jew mingħajrhom).
English: The red blood cells most likely represent a secondary compartment of distribution.
Maltese: Iċ-ċelluli ħomor tad-demm x'aktarx jirrapreżentaw kompartiment sekondarju ta' distribuzzjoni.
English: In a pooled analysis of patients (N = 721) with a baseline GFR 45 mL/min to < 60 mL/min, 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: 100 mg u 300 mg, rispettivament, meta mqabbla ma' 2.7% għall-plaċebo. m Bidliet perċentwali medji mil-linja bażi fil-potassium fid-demm kienu 0.5% u 1.0% għal canagliflozin 100 mg u
English: The highest dose of 100 mg/kg provided up to 14 times the clinical dose of 300 mg based on AUC exposure.
Maltese: 10 mg/kg hija madwar 1.5 drabi aktar mid-doża klinika ta' 300 mg abbażi ta' esponiment bl-AUC.
English: Fasting plasma glucose
Maltese: Plaċebo +
English: For patients switching from separate tablets of canagliflozin and metformin For patients switching from separate tablets of canagliflozin and metformin, Vokanamet should be initiated at the same total daily dose of canagliflozin and metformin already being taken or the nearest therapeutically appropriate dose of metformin.
Maltese: Jekk inti diġà qed tieħu kemm canagliflozin kif ukoll metformin bħala pilloli separati, Vokanamet jista' jissostitwixxihom f'pillola waħda.
English: Uncommon (may affect up to 1 in 100 people)
Maltese: Deidratazzjoni (mhux komuni, tista' taffettwa sa persuna waħda minn kull 100)
English: • medicines that contain alcohol.
Maltese: • mediċini li fihom l-alkoħol.
English: Add-on therapy with insulin d
Maltese: Kif għandek tieħu din il-mediċina
English: Following oral administration of an 850 mg tablet, a 40% lower plasma peak concentration, a 25% decrease in AUC, and a 35-minute prolongation of time to peak plasma concentration were observed.
Maltese: tnaqqis ta' 25% fl-AUC, u tul ta' 35 minuta aktar fil-ħin biex tintlaħaq l-ogħla konċentrazzjoni filplażma.
English: Canagliflozin is not recommended for use in patients receiving loop diuretics.
Maltese: Canagliflozin, wieħed mis-sustanzi ta' Vokanamet, m'għandux jintuża waqt it-tqala.
English: The mean steady-state volume of distribution (Vd) of canagliflozin following a single intravenous infusion in healthy subjects was 83.5 litres, suggesting extensive tissue distribution.
Maltese: Il-medja tal-volum ta' distribuzzjoni (Vd - volume of distribution) ta' canagliflozin fl-istat fiss wara infużjoni waħda fil-vina f'individwi f'saħħithom kienet 83 litru, li tissuġġerixxi distribuzzjoni estensiva fit-tessuti.
English: • common: a metallic taste (taste disturbance)
Maltese: • komuni: togħma ta' metall (disturb fit-togħma)
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 ta' firien li qed jitreddgħu u f'firien żgħażagħ esposti għal canagliflozin (ara sezzjoni 5.3). Metformin huwa eliminat fil-ħalib tas-sider tal-bniedem f'ammonti żgħar.