FrancophonIA/ELRC3.0 huggingface dataset:
English: More information is given below in "Other medicines and Vokanamet".
Maltese: Aktar informazzjoni hija mogħtija taħt f'“Mediċini oħra u Vokanamet”.
English: Renal impairment Patients with a baseline eGFR < 60 mL/min/1.73 m2 had a higher incidence of adverse reactions associated with volume depletion (e.g., postural dizziness, orthostatic hypotension, hypotension) with incidence rates of 5.3, 5.1, and 3.1 events per 100 patient-years of exposure for canagliflozin 100 mg, canagliflozin 300 mg, and placebo, respectively (see sections 4.2 and 4.4).
Maltese: Indeboliment tal-kliewi Pazjenti b'eGFR < 60 mL/min/1.73 m2 fil-linja bażi kellhom inċidenza ogħla ta' reazzjonijiet avversi assoċjati ma' tnaqqis fil-volum (eż., sturdament mal-waqqaf, pressjoni baxxa ortostatika, pressjoni baxxa) b'rati ta' inċidenza ta' 5.3, 5.1, u 3.1 avvenimenti għal kull 100 sena ta' esponiment ta' pazjent għal canagliflozin 100 mg, canagliflozin 300 mg, u plaċebo, rispettivament (ara sezzjonijiet 4.2 u 4.4).
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 once daily, 1.3% for canagliflozin 300 mg once daily, 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 darba kuljum, 1.3% għal canagliflozin 300 mg darba kuljum, u 1.1% għall-plaċebo.
English: The reductions in RTG led to increased UGE in subjects with type 2 diabetes treated with either 100 mg or 300 mg once daily of canagliflozin ranging from 77 g/day to 119 g/day across the phase 1 studies; the UGE observed translates to a loss of 308 kcal/day to 476 kcal/day.
Maltese: It-tnaqqis fl-RTG wassal għal żieda filUGE f'individwi b'dijabete tat-tip 2 kkurati b'100 mg jew 300 mg ta' canagliflozin darba kuljum fuq medda bejn 77 g/jum u 119-il g/jum tul l-istudji kollha tal-fażi 1; il-UGE osservat ifisser telf ta' 308 kkal/jum sa 476 kkal/jum.
English: The majority of patients with a baseline eGFR 45 mL/min/1.73 m 2 to < 60 mL/min/1.73 m 2 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: 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% talpazjenti 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: , Blood urea increased b, p
Maltese: , Żieda fil-urea fid-demm b,p
English: The racial distribution of patients who received canagliflozin was 72% White, 16% Asian, 5% Black, and 8% other groups.
Maltese: Id-distribuzzjoni tar-razez talpazjenti li rċevew canagliflozin kienet 72% Bojod, 16% Asjatiċi, 5% Suwed, u 8% gruppi oħra. 17% tal-pazjenti kienu ta' dixxendenza Spanjola. 58% tal-pazjenti kienu rġiel.
English: Diabetic ketoacidosis
Maltese: Prodotti mediċinali katjoniċi
English: Phimosis was reported at a rate of 0.39 and 0.07 events per 100 patient-years on canagliflozin and placebo, respectively.
Maltese: Fimosi kienet irrappurtata bir-rata ta' 0.39 u 0.07 każ għal kull 100 sena ta' pazjent fuq canagliflozin u plaċebo, rispettivament.
English: Lower limb infections, diabetic foot ulcers, peripheral arterial disease, and gangrene, were the most common medical events associated with the need for an amputation in both treatment groups (see section 4.4).
Maltese: Infezzjonijiet, ulċeri tad-dijabete, mard tal-arterji periferal, u kankrena fir-riġel, kienu l-aktar avvenimenti mediċi komuni assoċjati mal-ħtieġa ta' amputazzjoni fiż-żewġ gruppi ta' trattament (ara sezzjoni 4.4).
English: Candidal balanitis or balanoposthitis occurred in male patients at a rate of 2.98 and 0.79 events per 100 patient-years on canagliflozin and placebo, respectively.
Maltese: Balanite kandidjali jew balanopostite seħħet f'pazjenti rġiel bir-rata ta' 2.98 u 0.79 każ għal kull 100 sena ta' pazjent fuq canagliflozin u plaċebo, rispettivament.
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: F'żewġ studji ta' 52 ġimgħa kkontrollati b'mod attiv li qabblu canagliflozin ma' glimepiride u sitagliptin, tnaqqis medju miżmum u statistikament sinifikanti filperċentwal tal-piż tal-ġisem għal canagliflozin bħala terapija miżjuda ma' metformin kien -4.2% u -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: • in combination with other medicinal products for the treatment of diabetes, in patients insufficiently controlled with metformin and these medicinal products
Maltese: • flimkien ma' prodotti mediċinali oħra għat-trattament tad-dijabete, f'pazjenti mhux ikkontrollati b'mod suffiċjenti b'metformin u dawn il-prodotti mediċinali
English: Glycaemic efficacy and safety
Maltese: Effikaċja u sigurtà gliċemika
English: Patients (%) achieving HbA1c < 7% 45.5 Body weight
Maltese: Pazjenti (%) li kisbu HbA1c < 7% 45.5
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 irriskju ta' aċidożi lattika.
English: Figure 1: Time to first occurrence of MACE
Maltese: Figura 1: Żmien għall-ewwel okkkorrenza ta' MACE
English: Secondary endpoints within a sequential conditional hypothesis testing were all-cause mortality and cardiovascular mortality.
Maltese: Punti finali sekondarji fl-ittestjar tal-ipotesi kondizzjonali sekwenzjali kienu mortalità minn kull kawża u mortalità kardjovaskulari.
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: Bl-użu ta' stimulu ta' ikla mħallta, canagliflozin bħala monoterapija jew terapija miżjuda ma' prodott wieħed jew żewġ prodotti mediċinali li jbaxxu l-glukożju mogħtija mill-ħalq, meta mqabbel ma' plaċebo, naqqas il-glukożju wara l-ikel (PPG - postprandial glukożju) mill-linja bażi b'-1.5 mmol/L sa -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: Cationic medicinal products that are eliminated by renal tubular secretion (e.g., cimetidine) may interact with metformin by competing for common renal tubular transport systems.
Maltese: Prodotti mediċinali katjoniċi li jiġu eliminati permezz ta' sekrezzjoni mit-tubuli tal-kilwa (eż., cimetidine) jista' jkollhom interazzjoni ma' metformin billi jikkompetu għall-istess sistemi tubulari tal-kliewi għat-trasport.
English: This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium free'.
Maltese: Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull pillola, li tista' tgħid hija bażikament ‘bla sodium'.
English: Cardiac failure
Maltese: Amputazzjoni fir-riġel
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 tal-addome (CT - computed tomography) għal stima talkompożizzjoni 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: In addition, an 18-week double-blind, placebo-controlled phase 2 study with twice daily dosing (canagliflozin 50 mg or 150 mg as add-on therapy with metformin 500 mg) was conducted in 279 patients in which 186 patients were treated with canagliflozin as add-on therapy with metformin.
Maltese: Barra dan, sar studju ta' 18-il ġimgħa tal-fażi 2 double-blind u kkontrollat bi plaċebo b'għoti tad-doża darbtejn kuljum (canagliflozin 50 mg jew 150 mg bħala terapija miżjuda ma' metformin 500 mg) f'279 pazjent li fih 186 pazjent kienu kkurati b'canagliflozin bħala terapija miżjuda ma' metformin.
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: 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 % għall-plaċebo.
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'mod konsistenti maż-żieda mistennija fl-ipogliċemija meta prodott mediċinali li ma jkunx assoċjat mal-ipogliċemija jiżdied malinsulina u/jew ma' sulphonylurea, żieda fl-avvenimenti/episodji ta' ipogliċemija dehret meta canagliflozin żdied mal-insulina u/jew ma' wieħed mis-sulphonylureas (ara sezzjoni 4.8).
English: EU/1/14/918/010 (150 mg/1000 mg - 20 film-coated tablets) EU/1/14/918/011 (150 mg/1000 mg - 60 film-coated tablets)
Maltese: EU/1/14/918/010 (150 mg/1000 mg - 20 pillola miksija b'rita) EU/1/14/918/011 (150 mg/1000 mg - 60 pillola miksija b'rita)
English: The higher doses of canagliflozin (100 mg/kg) in male and female rats increased the incidence of pheochromocytomas and renal tubular tumours.
Maltese: Iddożi ogħla ta' canagliflozin (100 mg/kg) f'firien irġiel u nisa żiedu l-inċidenza ta' feokromoċitomi u tumuri tat-tubuli tal-kliewi.
English: Least squares mean adjusted for covariates including baseline value and stratification factor Adjusted p = 0.001
Maltese: Medja tal-least squares għal kovarjati inklużi l-valur tal-linja bażi u l-fattur ta' stratifikazzjoni p = 0.001 aġġustat p < 0.01 aġġustat p < 0.05 aġġustat
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 incidence rates of 5.3, 6.1 and 2.4 events per 100 patient-years of exposure for 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'rati ta' inċidenza ta' 5.3, 6.1, u 2.4 avveniment għal kull 100 sena ta' esponiment ta' pazjent għal canagliflozin 100 mg, canagliflozin 300 mg, u fil-grupp ta' kontroll, rispettivament.
English: Studies in animals with canagliflozin have shown reproductive toxicity (see section 5.3).
Maltese: Studji f'annimali b'canagliflozin urew effett tossiku fuq is-sistema riproduttiva (ara sezzjoni 5.3).
English: Vokanamet is indicated in adults with type 2 diabetes mellitus as an adjunct to diet and exercise:
Maltese: Vokanamet hu indikat għall-użu fl-adulti b'dijabete mellitus tat-tip 2 biex jiżdied mad-dieta u leżerċizzju:
English: The amputation results for the Integrated CANVAS Program are shown in table 2.
Maltese: Ir-riżultati tal-amputazzjoni għall-Programm Integrat CANVAS qed jintwerew f'tabella 2.
English: • necrotising fasciitis of the perineum or Fournier's gangrene, a serious soft tissue infection of the genitals or the area between the genitals and the anus.
Maltese: • fasciitis nekrotika tal-perineum jew kankrena ta' Fournier, infezzjoni serja tat-tessut artab tal ġenitali jew taż-żona bejn il-ġenitali u l-anus.
English: Mean baseline eGFR was 62.5, 64.7, and 63.5 mL/min/1.73 m2 for canagliflozin 100 mg, canagliflozin 300 mg, and the control group, respectively (see sections 4.2 and
Maltese: 63.5 mL/min/1.73 m2 għal canagliflozin 100 mg, canagliflozin 300 mg, u l-grupp ta' kontroll, rispettivament (ara sezzjonijiet 4.2 u 4.4).
English: Severe allergic reaction (rare, may affect up to 1 in 1,000 people) Possible signs of severe allergic reaction may include:
Maltese: Sinjali possibbli ta' reazzjoni allerġika severa jistgħu jinkludu:
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: Minbarra dan, f'pazjenti bħal dawn kienu rrappurtati aktar avvenimenti ta' livelli ogħla ta' potassium u żidiet akbar filkreatinina tas-serum u fin-nitroġenu tal-urea fid-demm (BUN - blood urea nitrogen) (ara sezzjoni 4.8).
English: Change from baseline (adjusted mean) -0.82 Difference from glimepiride (adjusted mean) (95% CI)
Maltese: Bidla mil-linja bażi (medja aġġustata) Differenza minn glimepiride (medja aġġustata) (95% CI)
English: Patients (%) achieving HbA1c < 7% 43.2 Body weight
Maltese: Pazjenti (%) li kisbu HbA1c < 7% 43.2 Piż tal-ġisem
English: EU/1/14/918/007 (150 mg/850 mg - 20 film-coated tablets) EU/1/14/918/008 (150 mg/850 mg - 60 film-coated tablets)
Maltese: EU/1/14/918/007 (150 mg/850 mg - 20 pillola miksija b'rita) EU/1/14/918/008 (150 mg/850 mg - 60 pillola miksija b'rita)
English: Baseline renal function was normal or mildly impaired in 80% of patients and moderately impaired in 20% of patients (mean eGFR 77 mL/min/1.73 m2).
Maltese: Il-funzjoni tal-kliewi fil-linja bażi kienet normali jew indebolita b'mod ħafif fi 80% tal-pazjenti u indebolita b'mod moderat f'20% tal-pazjent (medja tal-eGFR 77 mL/min/1.73 m2).
English: Each 150 mg/850 mg tablet contains canagliflozin hemihydrate, equivalent to 150 mg of canagliflozin and 850 mg of metformin hydrochloride.
Maltese: Kull pillola ta' 150 mg/850 mg fiha canagliflozin hemihydrate, ekwivalenti għal 150 mg ta' canagliflozin u 850 mg ta' metformin hydrochloride.
English: Before initiating Vokanamet, consider factors in the patient history that may increase the risk for amputation.
Maltese: Qabel ma tibda Vokanamet, qis fatturi fl-istorja tal-pazjent li jistgħu jżidu r-riskju ta' amputazzjoni.
English: Lower limb amputation
Maltese: Amputazzjonijiet fir-riġel
English: 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 bil-plaċebo, meta ntuża bħala monoterapija jew miżjud ma' metformin.
English: Canagliflozin dosed with a titration regimen produced clinically and statistically significant (p < 0.001) results relative to placebo in glycaemic control, including HbA1c and change from baseline FPG, and a statistically significant (p < 0.01) improvement in the percentage of patients achieving HbA1c < 7%.
Maltese: HbA1c u bidla fl-FPG mil-linja bażi, u titjib sinifikanti b'mod statistiku (p < 0.01) fil-perċentwal ta' pazjenti li kisbu HbA1c < 7%.
English: See section 4.4 and description of AR below.
Maltese: Ara sezzjoni 4.4 u d-deskrizzjoni ta' AR taħt.
English: Vital status was obtained for 99.6% of subjects across the studies.
Maltese: L-istat vitali inkiseb għal 99.6% tal-individwi fl-istudji kollha.
English: A dedicated study demonstrated that co-administration of canagliflozin 50 mg and 150 mg dosed twice daily as dual therapy with metformin produced clinically and statistically significant results relative to placebo in glycemic control, including HbA1c, the percentage of patients achieving HbA1c < 7%, change from baseline FPG, and in reductions in body weight as shown in table 5.
Maltese: Studju assenjat wera li l-għoti ta' dożi ta' canagliflozin 50 mg u 150 mg darbtejn kuljum bħala terapija doppja flimkien ma' metformin ipproduċa riżultati sinifikanti b'mod kliniku u statistiku meta mqabbel mal-plaċebo fil-kontroll ġliċemiku, fosthom HbA1c, il-perċentwal ta' pazjenti li kisbu HbA1c < 7%, bidla fil-FPG fil-linja bażi, u tnaqqis fill-piż tal-ġisem kif muri f'tabella 5.
English: Furthermore, canagliflozin was studied as triple therapy with metformin and sitagliptin and dosed with a titration regimen, using a starting dose of 100 mg and titrated to 300 mg as early as week 6 in patients requiring additional glycaemic control who had appropriate eGFR and were tolerating canagliflozin 100 mg (table 4).
Maltese: Barra dan, canagliflozin ġie studjat bħala terapija tripla ma' metformin u sitagliptin u d-doża ngħatat bi skeda ta' titrazzjoni, bl-użu ta' doża tal-bidu ta' 100 mg titratata għal 300 mg sa minn ġimgħa 6 f'pazjenti li kienu jeħtieġu kontroll gliċemiku addizzjonali li kellhom eGFR xieraq u kienu qed jittolleraw canagliflozin 100 mg (tabella 4).
English: 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: Bidliet perċentwali medji mil-linja bażi fil-phosphate fis-serum kienu 3.6% u 5.1% għal canagliflozin 100 mg u 300 mg, meta mqabbla ma' 1.5% għall-plaċebo.
English: The incidence rates for larger decreases in eGFR (> 30%) at any time during treatment were 7.3, 8.1, and 6.5 events per 100 patient-years of exposure for canagliflozin 100 mg, canagliflozin 300 mg, and placebo, respectively.
Maltese: Ir-rati ta' inċidenza għal tnaqqis akbar fl-eGFR (> 30%) fi kwalunkwe żmien waqt it-trattament kienu 7.3, 8.1, u 6.5 avvenimenti għal kull 100 sena ta' esponiment ta' pazjent għal canagliflozin 100 mg, canagliflozin 300 mg, u plaċebo, rispettivament.
English: Excipient(s) with known effect Each tablet contains less than 1 mmol sodium (23 mg), and is essentially sodium-free (see section 6).
Maltese: Kull pillola fiha anqas minn 1 mmol sodium (23 mg), u hija essenzjalment mingħajr sodium (ara sezzjoni 6).
English: Table 1: Tabulated list of adverse reactions (MedDRA) from placebo e and active-controlled studies e and from postmarketing experience
Maltese: Tabella 1: Lista f'tabella ta' reazzjonijiet avversi (MedDRA) minn studji kkontrollati bi plaċebo e u b'mod attiv e u mill-esperjenza ta' wara t-tqegħid fis-suq Klassi tas-sistemi u tal-organi Frekwenza
English: For patients with a baseline eGFR 30 mL/min/1.73 m2 to < 60 mL/min/1.73 m2, the incidence rates were 5.2 on canagliflozin 100 mg and 5.4 on canagliflozin 300 mg compared to 3.1 events per 100 patient-years of exposure in the control group.
Maltese: Għal pazjenti b'eGFR minn 30 mL/min/1.73 m2 sa < 60 mL/min/1.73 m2 fil-linja bażi, ir-rati tal-inċidenzi kienu 5.2 fuq canagliflozin 100 mg u 5.4 fuq canagliflozin 300 mg meta mqabbla ma' 3.1 każ għal kull 100 sena ta' esponiment ta' pazjent fil-grupp ta' kontroll.
English: EU/1/14/918/004 (50 mg/1000 mg - 20 film-coated tablets) EU/1/14/918/005 (50 mg/1000 mg - 60 film-coated tablets)
Maltese: EU/1/14/918/004 (50 mg/1000 mg - 20 pillola miksija b'rita) EU/1/14/918/005 (50 mg/1000 mg - 60 pillola miksija b'rita)
English: Canagliflozin 100 mg once daily as dual therapy with metformin produced similar reductions in HbA1c from baseline and 300 mg produced superior (p < 0.05) reductions in HbA1c compared to glimepiride, thus demonstrating non-inferiority.
Maltese: Canagliflozin 100 mg darba kuljum bħala terapija doppja ma' metformin ipproduċa tnaqqis jixxiebah fl-HbA1c millinja bażi u t-300 mg pproduċiet tnaqqis superjuri (p < 0.05) fl-HbA1c meta mqabbla ma' glimepiride, biex b'hekk wera li ma kienx inferjuri.
English: Mean percent changes from baseline in blood urea nitrogen were 17.1% and 18.0% for canagliflozin 100 mg and 300 mg, respectively, compared to 2.7% for placebo.
Maltese: Bidliet perċentwali medji mil-linja bażi tan-nitroġenu mill-urea fid-demm kienu 17.1% u 18.0% għal canagliflozin 100 mg u 300 mg, rispettivament, meta mqabbla ma' 2.7% għall-plaċebo.
English: Vulvovaginal candidiasis includes the terms vulvovaginal candidiasis, vulvovaginal mycotic infection, vulvovaginitis, vaginal infection, vulvitis, and genital infection fungal.
Maltese: Kandidjasi vulvovaġinali tinkludi t-termini kandidjasi vulvovaġinali, infezzjoni vulvovaġinali mikotika, vulvovaġinite, infezzjoni fil-vaġina, vulvite, u infezzjoni fil-ġenitali bil-fungu.
English: EU/1/14/918/001 (50 mg/850 mg - 20 film-coated tablets) EU/1/14/918/002 (50 mg/850 mg - 60 film-coated tablets)
Maltese: EU/1/14/918/001 (50 mg/850 mg - 20 pillola miksija b'rita) EU/1/14/918/002 (50 mg/850 mg - 60 pillola miksija b'rita)
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: 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% għall-plaċebo.
English: In three studies conducted in special populations (elderly 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 anzjani, pazjenti b'eGFR minn 30 mL/min/1.73 m2 sa < 50 mL/min/1.73 m2 u pazjenti b'mard kardjovaskulari jew riskju akbar ta' mard kardjovaskulari), canagliflozin żdied mal-kuri stabbli attwali tad-dijabete tal-pazjenti (dieta, monoterapija, jew terapija kkombinata).
English: Baseline (mean) in kg
Maltese: Linja bażi (medja) f'kg
English: In patients with an eGFR < 60 mL/min/1.73 m 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 m jew CrCl < 60 mL/min, kienet irrappurtata inċidenza akbar ta' reazzjonijiet avversi assoċjati ma' tnaqqis fil-volum (eż., sturdament skont il-pożizzjoni, pressjoni baxxa ortostatika, pressjoni baxxa), b'mod partikolari bid-doża ta' 300 mg.
English: ТП„Мундифарма медикъл ООД“ ул.
Maltese: M'għandekx tieħu din il-mediċna jekk inti qed tredda'.
English: After 104 weeks of treatment, canagliflozin did not adversely affect bone mineral density.
Maltese: Wara 104 ġimgħat ta' kura, canagliflozin m'affettwax id-densita tal-minerali tal-għadam b'mod negattiv.
English: d.o.o.
Maltese: U L-UŻU C.