FrancophonIA/ELRC3.0 huggingface dataset:
English: • Swallow the tablet whole with a half glass of water.
Maltese: • Ibla' l-pillola sħiħa ma' nofs tazza ilma.
English: Elderly patients may be at a greater risk for volume depletion, are more likely to be treated with diuretics, and to have impaired renal function.
Maltese: Pazjenti anzjani jistgħu jkunu f'riskju akbar ta' tnaqqis fil-volum, għandhom aktar mnejn li jkunu kkurati b'dijuretiċi, u li jkollhom funzjoni indebolita tal-kliewi.
English: Patients with eGFR 45 mL/min/1.73 m2 to < 60 mL/min/1.73 m2 In a pooled analysis of patients (N = 721) with a baseline eGFR 45 mL/min/1.73 m2 to
Maltese: Pazjenti b'eGFR minn 45 mL/min/1.73 m2 sa < 60 mL/min/1.73 m2 F'analiżi kollettiva ta' pazjenti (N = 721) b'eGFR minn 45 mL/min/1.73 m2 sa < 60 mL/min/1.73 m2
English: Each film-coated tablet contains canagliflozin hemihydrate, equivalent to 100 mg canagliflozin.
Maltese: Kull pillola fiha canagliflozin hemihydrate, ekwivalenti għal 100 mg canagliflozin.
English: Protein binding is independent of canagliflozin plasma concentrations.
Maltese: L-irbit mal-proteini huwa indipendenti mill-konċentrazzjonijiet ta' canagliflozin fil-plażma.
English: • low blood sugar levels (hypoglycaemia) - when taking this medicine with insulin or a sulphonylurea (such as glimepiride or glipizide).
Maltese: • livelli baxxi ta' zokkor fid-demm (ipogliċemija) - meta tieħu din il-mediċina mal-insulina jew xi sulphonylurea (bħal glimepiride jew glipizide).
English: Increases in serum creatinine of 10-11% and BUN of approximately 12% were observed with both doses of canagliflozin.
Maltese: Kienu osservati żidiet ta' 10-11% fil-kreatinina fis-serum u ta' madwar 12% f'BUN biż-żewġ dożi ta' canagliflozin.
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, 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, rispettivament.
English: In patients ≥ 75 years of age, a higher incidence of adverse reactions associated with volume depletion (e.g., postural dizziness, orthostatic hypotension, hypotension) was reported.
Maltese: F'pazjenti li għandhom ≥ 75 sena, kienet irrappurtata inċidenza ogħla ta' reazzjonijiet avversi assoċjata ma' tnaqqis fil-volum (eż., sturdament mal-waqqaf, pressjoni baxxa ortostatika, pressjoni baxxa).
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, respectively, compared to the combination of glimepiride and metformin (1.0%) and -2.5% for canagliflozin 300 mg in combination with metformin and a sulphonylurea compared to sitagliptin in combination with metformin and a sulphonylurea (0.3%).
Maltese: F'żewġ studji ta' 52 ġimgħa kkontrollati b'mod attiv li qabblu canagliflozin ma' glimepiride u sitagliptin, tnaqqis medju miżmum u sinifikanti statistikament fil-perċentwal tal-piż tal-ġisem għal canagliflozin bħala terapija miżjuda ma' metformin kien -4.2% u -4.7% għal canagliflozin 100 mg u 300 mg, rispettivament, meta mqabbel ma' glimepiride flimkien ma' metformin (1.0%) u -2.5% għal canagliflozin 300 mg flimkien ma' metformin u wieħed mis-sulphonylureas meta mqabbel ma' sitagliptin flimkien ma' metformin u wiehed mis-sulphonylureas (0.3%).
English: 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, rispettivament, meta mqabbla ma' 1.5 % għal plaċebo.
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: Therapy
Maltese: Terapija
English: Statistically significant (p < 0.001) changes from baseline HbA1c relative to placebo of -0.57% and -0.70% were observed for 100 mg and 300 mg, respectively (see sections 4.2 and 4.8).
Maltese: Kienu osservati bidliet sinifikanti statistikament (p < 0.001) ta' -0.57% u -0.70% mil-linja bażi ta' HbA1c meta mqabbla ma' plaċebo għal 100 mg u 300 mg, rispettivament (ara sezzjonijiet 4.2 u 4.8).
English: • digoxin or digitoxin (medicines used for certain heart problems).
Maltese: • digoxin jew digitoxin (mediċini li jintużaw għal ċerti problemi tal-qalb).
English: In four placebo-controlled studies, treatment with canagliflozin as monotherapy or add-on therapy with one or two oral glucose-lowering medicinal products resulted in mean changes from baseline relative to placebo in FPG of -1.2 mmol/L to -1.9 mmol/L for canagliflozin 100 mg and -1.9 mmol/L to -2.4 mmol/L for canagliflozin 300 mg, respectively.
Maltese: F'erba' studji kkontrollati bi plaċebo, kura b'canagliflozin bħala monoterapija jew terapija miżjuda ma' prodott wieħed jew żewġ prodotti mediċinali li jbaxxu l-glukows mogħtija mill-ħalq wasslet għal tibdil medju mil-linja bażi f'FPG ta' -1.2 mmol/L sa -1.9 mmol/L għal canagliflozin 100 mg u -1.9 mmol/L sa -2.4 mmol/L għal canagliflozin 300 mg, rispettivament meta mqabbla ma' plaċebo.
English: “CFZ” on one side and “100” on the other side.
Maltese: b'“CFZ” fuq naħa waħda u “100” fuq in-naħa l-oħra.
English: A subset of patients (N = 208) from the active-controlled dual therapy study with metformin who underwent dual energy X-ray densitometry (DXA) and abdominal computed tomography (CT) scans for evaluation of body composition demonstrated that approximately two-thirds of the weight loss with canagliflozin was due to loss of fat mass with similar amounts of visceral and abdominal subcutaneous fat being lost.
Maltese: Sottosett ta' pazjenti (N = 208) mill-istudju b'terapija doppja b'metformin ikkontrollat b'mod attiv li sarulhom scans ta' densitometrija b'żewg raġġi X b'enerġija differenti (DXA - dual energy X-ray densitometry) u tomografija komputerizzata (CT - computed tomography) tal-addome għal stima tal kompożizzjoni tal-ġisem urew li madwar żewġ terzi tat-telf ta' piż b'canagliflozin kien minħabba telf ta' massa tax-xaħam b'ammonti jixxiebhu ta' telf ta' xaħam tal-vixxri u minn taħt il-ġilda tal-addome.
English: • The starting dose of Invokana is one 100 mg tablet each day.
Maltese: • Id-doża tal-bidu ta' Invokana hija pillola waħda ta' 100 mg kuljum.
English: In general, canagliflozin produced clinically and statistically significant (p<0.001) results relative to placebo in glycaemic control, including HbA1c, the percentage of patients achieving HbA1c < 7%, change from baseline fasting plasma glucose (FPG), and 2-hour postprandial glucose (PPG).
Maltese: canagliflozin ipproduċa riżultati sinifikanti (p < 0.001) b'mod kliniku u statistikament sinifikanti filkontroll gliċemiku, inkluż HbA1c, il-perċentwal ta' pazjenti li kisbu HbA1c < 7%, bidla mil-linja bażi tal-glukows fil-plażma waqt is-sawm (FPG - fasting plasma glukows), u l-glukows sagħtejn wara ikla
English: When canagliflozin was added to insulin therapy, hypoglycaemia was observed in 49.3%, 48.2%, and 36.8% of patients treated with canagliflozin 100 mg, canagliflozin 300 mg, and placebo, respectively, and severe hypoglycaemia occurred in 1.8%, 2.7%, and 2.5% of patients treated with canagliflozin 100 mg, canagliflozin 300 mg, and placebo, respectively.
Maltese: Meta canagliflozin żdied ma' terapija blinsulina, kienet osservata ipogliċemija f'49.3%, 48.2%, u 36.8% tal-pazjenti kkurati b'canagliflozin 100 mg, canagliflozin 300 mg, u bi plaċebo, rispettivament, u ipogliċemija qawwija seħħet f'1.8%,
English: For patients receiving canagliflozin, 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 canagliflozin, 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: In patients ≥ 75 years of age, the incidences were 4.9% on canagliflozin 100 mg and 8.7% on canagliflozin 300 mg compared to 2.6% in the control group (see sections 4.2 and 4.4).
Maltese: F'pazjenti ≥ 75 sena, l-inċidenzi kienu 4.9% fuq canagliflozin 100 mg u 8.7% fuq canagliflozin 300 mg meta mqabbla ma' 2.6% fil-grupp ta' kontroll (ara sezzjonijiet 4.2 u
English: In a study comparing canagliflozin 300 mg to sitagliptin 100 mg in triple therapy with metformin and a sulphonylurea, canagliflozin demonstrated non-inferior (p<0.05) and superior (p<0.05) reduction in HbA1c relative to sitagliptin.
Maltese: Fi studju li qabbel canagliflozin 300 mg ma' sitagliptin 100 mg f'terapija tripla ma' metformin u wieħed mis sulphonylureas, canagliflozin wera tnaqqis mhux inferjuri (p < 0.05) u superjuri (p < 0.05) f'HbA1c meta mqabbel ma' sitagliptin.
English: Adverse reactions leading to discontinuation of ≥ 0.5% of all canagliflozin-treated patients in these studies were vulvovaginal candidiasis (0.7% of female patients) and balanitis or balanoposthitis (0.5% of male patients).
Maltese: Reazzjonijiet avversi li wasslu għat-twaqqif f'≥ 0.5% tal pazjenti kollha kkurati b'canagliflozin f'dawn l-istudji kienu kandidjasi vulvovaġinali (0.7% talpazjenti nisa) u balanite jew balanopostite (0.5% tal-pazjenti rġiel).
English: N/Ac Compared to sitagliptin as triple therapy with metformin and sulphonylurea (52 weeks)
Maltese: N/Ac Imqabbel ma' sitagliptin bħala terapija tripla ma' metformin u sulphonylurea (52 ġimgħa)
English: Blood creatinine increased**, k, Blood urea increased**, l, Blood potassium increased**, m, Blood phosphate increasedn
Maltese: Żieda fil-kreatinina fid-demm**,k, Żieda fil-urea fid-demm **,l, Żieda fil-potassium fid-demm**, m, Żieda fil-phosphate fid-demmn
English: Hypoglycaemia in add-on therapy with insulin or insulin secretagogues The frequency of hypoglycaemia was low (approximately 4%) among treatment groups, including placebo, when used as monotherapy or as an add-on to metformin.
Maltese: Il-frekwenza tal-ipogliċemija kienet baxxa (madwar 4%) fost il-gruppi tal-kura, inkluż il-plaċebo, meta intuża bħala monoterapija jew miżjud ma' metformin.
English: Metabolism and nutrition disorders very common
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni komuni ħafna
English: Consistent with the expected increase of hypoglycaemia when a medicinal product not associated with hypoglycaemia is added to insulin and/or sulphonylurea, an increase in hypoglycaemia episodes/events was seen when canagliflozin was added to insulin and/or a sulphonylurea (see section 4.8).
Maltese: B'konsistenza maż-żieda mistennija fl-ipogliċemija meta prodott mediċinali mhux assoċjat mal-ipogliċemija jiżdied malinsulina u/jew ma' sulphonylurea, dehret żieda fl-episodji/każijiet ta' ipogliċemija meta canagliflozin żdied mal-insulina u/jew ma' wieħed mis-sulphonylureas (ara sezzjoni 4.8).
English: In the pooled analysis of the four 26-week, placebo-controlled studies, the incidence of all adverse reactions related to volume depletion (e.g., postural dizziness, orthostatic hypotension, hypotension, dehydration, and syncope) was 1.2% for canagliflozin 100 mg, 1.3% for canagliflozin 300 mg, and 1.1% for placebo.
Maltese: Reazzjonijiet avversi marbuta ma' tnaqqis fil-volum Fl-analiżi kollettiva tal-erba' istudji ta' 26 ġimgħa kkontrollati bil-plaċebo, l-inċidenza tarreazzjonijiet avversi kollha marbuta ma' tnaqqis fil-volum (eż., sturdament mal-waqqaf, pressjoni baxxa ortostatika, pressjoni baxxa, deitratazzjoni, u sinkope) kienet 1.2% għal canagliflozin 100 mg, 1.3% għal canagliflozin 300 mg, u 1.1% għall-plaċebo.
English: PHARMACEUTICAL PARTICULARS
Maltese: Farmakoġenetika
English: Body weight Baseline (mean) in kg
Maltese: Piż tal-ġisem Linja bażi (medja) f'kg
English: Using a mixed-meal challenge, canagliflozin as monotherapy or add-on therapy with one or two oral glucose-lowering medicinal products reduced postprandial glucose (PPG) from baseline relative to placebo by -1.5 mmol/L to -2.7 mmol/L for canagliflozin 100 mg and -2.1 mmol/L to -3.5 mmol/L for 300 mg, respectively, due to reductions in the pre-meal glucose concentration and reduced postprandial glucose excursions.
Maltese: plaċebo, naqqas il-glukows wara l-ikel (PPG - postprandial glukows) mill-linja bażi b'-1.5 mmol/L sa -2.7 mmol/L għal canagliflozin 100 mg u -2.1 mmol/L sa -3.5 mmol/L għal 300 mg, rispettivament, minħabba tnaqqis fil-konċentrazzjoni tal-glukows qabel l-ikel u tnaqqis ta' ħruġ ta' glukows wara likel.
English: e Bone fracture was reported in 0.7% and 0.6% for canagliflozin 100 mg and 300 mg, respectively, compared to 0.3%
Maltese: e Ksur fl-għadam ġie rrappurtat f'0.7% u 0.6% għal canagliflozin 100 mg u 300 mg, rispettivament, meta mqabbel ma'
English: In an embryo-foetal development study in rats, ossification delays of metatarsal bones were observed at systemic exposures 73 times and 19 times higher than the clinical exposures at the 100 mg and 300 mg doses.
Maltese: Fi studju tal-iżvilupp tal-embriju u tal-fetu fil-firien, kien osservat dewmien fl-ossifikazzjoni tal għadam metatarsali f'esponimenti sistemiċi ta' 73 darba u 19-il darba ogħla mill-esponimenti kliniċi bid-dożi ta' 100 mg u 300 mg.
English: for placebo.
Maltese: Plaċebo
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 weriex farmakokinetika li tiddependi mill-ħin, u akkumula fil-plażma sa 36% wara ħafna dożi ta' 100 mg u 300 mg.
English: 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%. 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: However, patients should be alerted to the risk of hypoglycaemia when canagliflozin is used as add-on therapy with insulin or an insulin secretagogue, and to the elevated risk of adverse reactions related to volume depletion, such as postural dizziness (see sections 4.2, 4.4 and 4.8).
Maltese: Madankollu, il-pazjenti għandhom jiġu mwissija dwar ir-riskju ta' ipogliċemija meta canagliflozin jintuża bħala terapija miżjuda mal-insulina jew ma' sustanza li tikkawża t-tnixxija talinsulina, u għar-riskju ogħla ta' reazzjonijiet avversi marbuta ma' tnaqqis fil-volum, bħal ma huwa sturdament mal-waqqaf (ara sezzjonijiet 4.2, 4.4 u 4.8).
English: The majority of patients with a baseline eGFR 45 mL/min/1.73 m2 to < 60 mL/min/1.73 m2 were on insulin and/or a sulphonylurea (85% [614/721]).
Maltese: Il-biċċa l-kbira tal-pazjenti b'eGFR minn 45 mL/min/1.73 m2 sa < 60 mL/min/1.73 m2 fil-linja bażi kienu fuq l-insulina u/jew wieħed mis-sulphonylureas (85% [614/721]).
English: Co-administration of a high-fat meal with canagliflozin had no effect on the pharmacokinetics of canagliflozin; therefore,
Maltese: Interazzjonijiet farmakokinetiċi Effetti ta' prodotti mediċinali oħra fuq canagliflozin
English: Canagliflozin has not been studied in severe renal impairment (eGFR < 30 mL/min/1.73 m2 or CrCl < 30 mL/min) or ESRD.
Maltese: Canagliflozin m'għandux jinbeda f'pazjenti b'eGFR < 60 mL/min/1.73 m2 jew CrCl < 60 mL/min.
English: Each film-coated tablet contains canagliflozin hemihydrate, equivalent to 300 mg canagliflozin.
Maltese: Kull pillola miksija b'rita fiha canagliflozin hemihydrate, ekwivalenti għal 300 mg canagliflozin.
English: In three studies conducted in special populations (older patients, patients with an eGFR of 30 mL/min/1.73 m2 to < 50 mL/min/1.73 m2 and patients with or at high risk for cardiovascular disease), canagliflozin was added to patients' current stable diabetes treatments (diet, monotherapy, or combination therapy).
Maltese: Fi tliet studji li saru f'popolazzjonijiet speċjali (pazjenti akbar fl-età, pazjenti b'eGFR minn 30 mL/min/1.73 m2 sa < 50 mL/min/1.73 m2 u pazjenti b'mard jew f'riskju ogħli ta' mard kardjovaskulari), canagliflozin żdied mal-kura attwali, stabbli, tad-dijabete tal-pazjenti (dieta, monoterapija, jew terapija kkombinta).
English: Additional safety analyses (including long-term data) from data across the entire canagliflozin programme (placebo- and active-controlled studies) were conducted to assess reported adverse reactions in order to identify adverse reactions (see table 1) (see sections 4.2 and 4.4).
Maltese: (inkluż dejta fuq perjodu twil ta' żmien) minn dejta mill-programm sħiħ ta' canagliflozin (studji kkontrollati bil-plaċebo u b'mod attiv) saru biex jiġu stmati r-reazzjonijiet avversi rrappurtati sabiex jiġu identifikati reazzjonijiet avversi (ara tabella 1) (ara sezzjonijiet 4.2 u 4.4).
English: A study in juvenile rats administered canagliflozin from day 1 through day 90 postnatal did not show increased sensitivity compared to effects observed in adults rats.
Maltese: Studju f'firien żgħażagħ fejn canagliflozin ingħata minn jum 1 sa jum 90 wara t-twelid ma weriex żieda fis-sensittività meta tqabbel mal-effetti osservati fil-firien adulti.
English: - Prior to initiation of concomitant medicinal products that may reduce renal function and periodically thereafter - For renal function approaching moderate renal impairment, at least 2 times to 4 times per year.
Maltese: - Għal funzjoni tal-kliewi li toqrob lejn indeboliment moderat tal-kliewi, mill-inqas darbtejn sa 4 darbiet fis-sena.
English: Janssen-Cilag Polska Sp. z o.o.
Maltese: Janssen-Cilag Polska Sp. z o.o. Eesti filiaal Lõõtsa
English: f Polyuria or pollakiuria includes the terms polyuria, pollakiuria, micturition urgency, nocturia, and urine output increased.
Maltese: f Poliurja jew pollakijurja jinkludu t-termini poliurja, pollakijurja, urġenza biex wieħed jagħmel l-awrina, nokturja, u żieda fl-ammont tal-awrina.
English: A lower proportion of patients treated with canagliflozin 100 mg (5.6%) and canagliflozin 300 mg (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 (5.6%) u canagliflozin 300 mg (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: 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 ġenitali bil-fungu.
English: In a pre- and postnatal development study, canagliflozin administered to female rats from gestation day 6 to lactation day 20 resulted in decreased body weights in male and female offspring at maternally toxic doses > 30 mg/kg/day (exposures ≥ 5.9 times the human exposure to canagliflozin at the MHRD).
Maltese: Fi studju ta' żvilupp qabel u wara t-twelid, canagliflozin mogħti lill-firien nisa mill-jum 6 ta' ġestazzjoni sa jum 20 ta' treddigħ wassal għal tnaqqis fil-piż tal-ġisem tal-frieħ irġiel u nisa b'dożi > 30 mg/kg/jum (esponimenti ta' ≥ 5.9 darbiet l-esponiment uman għal canagliflozin bl
English: In interaction studies, canagliflozin at steady-state had no clinically relevant effect on the pharmacokinetics of metformin, oral contraceptives (ethinyl estradiol and levonorgestrol), glibenclamide, paracetamol, hydrochlorothiazide, or warfarin.
Maltese: Fi studji ta' interazzjoni, canagliflozin fl-istat fiss ma kellu l-ebda effett rilevanti b'mod kliniku fuq il farmakokinetika ta' metformin, kontraċettivi mill-ħalq (ethinyl estradiol u levonorgestrol),
English: Two hundred eleven (211) patients from the clinical study in older patients participated in a body composition substudy using DXA body composition analysis.
Maltese: Mitejn u ħdax-il pazjent (211) mill-istudju kliniku ta' pazjenti akbar fl-età ipparteċipaw f'sottostudju ta' kompożizzjoni tal-ġisem bl-użu tal-analiżi
English: The hazard ratio for the composite primary endpoint (time to event of cardiovascular death, non-fatal stroke, non-fatal myocardial infarction, and unstable angina requiring hospitalisation) for canagliflozin (both doses pooled) versus combined active and placebo comparators was 0.91 (95% CI: 0.68; 1.22); therefore, there was no evidence of an increase in cardiovascular risk with canagliflozin relative to comparators.
Maltese: (żmien għall-każ ta' mewt kardjovaskulari, puplesija mhux fatali, infart mijokardijaku mhux fatali, u anġina mhux stabbli fejn il-persuna jkollha bżonn tiddaħħal l-isptar) għal canagliflozin (iż-żewġ dożi flimkien) versus il-kumparaturi attivi u plaċebo kkombinati kien 0.91 (95% CI: 0.68; 1.22); għalhekk, ma kien hemm l-ebda evidenza ta' żieda fir-riskju kardjovaskulari b'canagliflozin meta mqabbel malkumparaturi.
English: The Cmax of canagliflozin was moderately increased by 13%, 29%, and 29% in subjects with mild, moderate, and severe renal failure, respectively, but not in subjects on haemodialysis.
Maltese: Is-Cmax ta' canagliflozin żdied b'mod moderat bi 13%, b'29%, u b'29% f'individwi b'insuffiċjenza ħafifa, moderata u qawwija tal-kliewi, rispettivament, iżda mhux fl-individwi li kienu fuq l emodijalisi.
English: Table 1: Tabulated list of adverse reactions (MedDRA) from placebo-controlled studiesa and from postmarketing experience
Maltese: Tabella 1: Lista f'tabella ta' reazzjonijiet avversi (MedDRA) minn studji kkontrollati bi plaċeboa u mill-esperjenza ta' wara t-tqegħid fis-suq
English: Each tablet contains100 mg or 300 mg of canagliflozin.
Maltese: Kull pillola fiha 100 mg jew 300 mg ta' canagliflozin.
English: Caution should be exercised in patients for whom a canagliflozin-induced drop in blood pressure could pose a risk, such as patients with known cardiovascular disease, patients with an eGFR < 60 mL/min/1.73 m2, patients on anti-hypertensive therapy with a history of hypotension, patients on diuretics, or elderly patients (≥ 65 years of age) (see sections 4.2 and 4.8).
Maltese: Għandu jkun hemm kawtela f'pazjenti fejn tnaqqis fil-pressjoni ikkawżat minn canagliflozin jista' jkun ta' riskju għalihom, bħal f'pazjenti magħrufa li għandhom mard tal-qalb, pazjenti b'eGFR < 60 mL/min/1.73 m2, pazjenti li qegħdin fuq terapija kontra l-pressjoni għolja bi storja ta' pressjoni baxxa, pazjenti fuq dijuretiċi, jew pazjenti anzjani (età ≥ 65 sena) (ara sezzjonijiet 4.2 u 4.8).
English: Based on AUC exposure, the NOEL of 30 mg/kg/day for pheochromocytomas and renal tubular tumours is approximately 4.5 times the exposure at the daily clinical dose of 300 mg. Based on preclinical and clinical mechanistic studies, Leydig cell tumours, renal tubule tumours, and pheochromocytomas are considered to be rat-specific.
Maltese: Abbażi ta' esponiment bl-AUC, in-NOEL ta' 30 mg/kg/kuljum għal feokromoċitomi u tumuri tat-tubuli tal-kliewi huwa madwar 4.5 drabi aktar mill-esponiment bid-doża klinika ta' kuljum ta' 300 mg.