FrancophonIA/ELRC3.0 huggingface dataset:
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 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 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: Table 1: Tabulated list of adverse reactions (MedDRA) from placebo-controlled studiesa and from postmarketing experience System organ class Frequency
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: • Vokanamet 150 mg/850 mg film-coated tablets (tablets) are light yellow, capsule-shaped, 21 mm in length, and debossed with “CM” on one side and “418” on the other side.
Maltese: • Il-pilloli Vokanamet 150 mg/850 mg miksijin b'rita (pilloli) huma sofor ċari, forma ta' kapsula, b'tul ta' 21 mm, u mnaqqxa b'“CM” fuq naħa waħda u “418” fuq in-naħa l-oħra.
English: Side effects when taking metformin alone that were not described for canagliflozin:
Maltese: Effetti sekondarji meta tieħu metformin waħdu li ma kinux deskritti għal canagliflozin:
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 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: e Bone fracture was reported in 0.7% and 0.6% for canagliflozin 100 mg and 300 mg, respectively, compared to 0.3% for placebo.
Maltese: e Ksur fl-għadam kien irrappurtat f'0.7% u 0.6% għal canagliflozin 100 mg u 300 mg, rispettivamnet, meta mqabbel ma' 0.3% għall-plaċebo.
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 once daily and -1.9 mmol/L to -2.4 mmol/L for canagliflozin 300 mg once daily, 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-glukożju 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 darba kuljum u -1.9 mmol/L sa -2.4 mmol/L għal canagliflozin 300 mg darba kuljum, rispettivament meta mqabbla ma' plaċebo.
English: Statistically significant (p < 0.001) changes from baseline HbA1c relative to placebo of -0.57% and -0.70% were observed for 100 mg once daily and 300 mg once daily, respectively (see sections 4.2 and 4.8).
Maltese: Kienu osservati bidliet sinifikanti b'mod statistiku (p < 0.001) ta' -0.57% u -0.70% mil-linja bażi ta' HbA1c meta mqabbla ma' plaċebo għal 100 mg darba kuljum u 300 mg darba kuljum, rispettivament (ara sezzjonijiet 4.2 u 4.8).
English: Vokanamet combines two oral glucose-lowering medicinal products with different and complementary mechanisms of action to improve glycaemic control in patients with type 2 diabetes: canagliflozin, an inhibitor of SGLT2 transporter, and metformin hydrochloride, a member of the biguanide class.
Maltese: Vokanamet jikkombina żewġ prodotti mediċinali li jittieħdu mill-ħalq li jbaxxu l-glukożju b'mekkaniżmi ta' azzjoni differenti u li jikkumplimentaw lil xulxin biex itejbu l-kontroll gliċemiku f'pazjenti b'dijabete tat-tip 2: canagliflozin, inibitur tat-traportatur SGLT2, u metformin hydrochloride, membru tal-klassi biguanide.
English: • in patients on their maximally tolerated doses of metformin along with other glucose-lowering medicinal products including insulin, when these do not provide adequate glycaemic control (see sections 4.4, 4.5, and 5.1 for available data on different add-on therapies)
Maltese: • f'pazjenti fuq l-ogħla doża ta' metformin li huma jistgħu jittolleraw flimkien ma' prodotti mediċinali oħra li jbaxxu l-glukożju inkluża l-insulina, meta dawn ma jipprovdux kontroll gliċemiku xieraq (ara sezzjonijiet 4.4, 4.5, u 5.1 għal dejta disponibbli dwar terapiji differenti miżjuda m'oħrajn).
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 canagliflozin/metformin hydrochloride
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 canagliflozin/metformin hydrochloride
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: L-effikaċja ta' canagliflozin hija dipendenti 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 sever talkliewi (ara sezzjoni 4.2).
English: Increases in urinary glucose excretion with canagliflozin can falsely lower 1,5-anhydroglucitol (1,5-AG) levels and make measurements of 1,5-AG unreliable in assessing glycemic control.
Maltese: 1,5-anhydroglucitol (1,5-AG) b'mod falz u b'hekk kejl ta' 1,5-AG ma jkunx affidabbli biex jiġi stmat il-kontroll gliċemiku.
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 kollettiva tal-erba' studji kliniċi ta' 26 ġimgħa kkontrollati bil-plaċebo (n = 2,313) deskritti fuq.
English: Vokanamet 150 mg/850 mg film-coated tablets Macrogol (3350)
Maltese: Vokanamet 150 mg/850 mg pilloli miksijin b'rita Macrogol (3350)
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 flipogliċemija meta prodott mediċinali li ma jkunx assoċjat mal-ipogliċemija jiżdied mal-insulina 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: However, patients should be alerted to the risk of hypoglycaemia when Vokanamet 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 Vokanamet 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: f Polyuria or pollakiuria includes the terms polyuria, pollakiuria, micturition urgency, nocturia, and urine output increased.
Maltese: f Polijurja jew pollakijurja jinkludu t-termini polijurja, pollakijurja, urġenza biex wieħed jagħmel l-awrina, nokturja, u żieda fl-ammont tal-awrina.
English: Metformin stimulates intracellular glycogen synthesis by acting on glycogen synthase.
Maltese: Metformin jistimula is-sintesi tal-glycogen ġewwa ċ-ċelluli billi jaħdem fuq glycogen synthase.
English: j 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% għall-plaċebo.
English: shock (see section 4.4);
Maltese: deidratazzjoni, infezzjoni qawwija, xokk (ara sezzjoni 4.4);
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 canagliflozin on glycaemic control, including 5,151 patients treated with canagliflozin in combination with metformin.
Maltese: double-blind, ikkontrollati, li saru biex jistmaw l-effetti ta' canagliflozin fuq il-kontroll gliċemiku, inklużi 5,151 pazjent ikkurati b'canagliflozin flimkien ma' metformin.
English: Vokanamet 150 mg/850 mg film-coated tablets
Maltese: Vokanamet 150 mg/850 mg pilloli miksijin b'rita
English: Each 50 mg/850 mg tablet contains 50 mg of canagliflozin and 850 mg of metformin hydrochloride.
Maltese: Kull pillola ta' 50 mg/850 mg fiha 50 mg ta' canagliflozin u 850 mg ta' metformin hydrochloride.
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 blMHRD) tossiċi għall-omm.
English: 150 mg twice daily (N = 93)
Maltese: 150 mg darbtejn kuljum (N = 93)
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: Il-proporzjon ta' periklu għall-iskop finali primarju kkombinat (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,
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 events 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 l-każijiet avversi rrappurtati sabiex jiġu identifikati reazzjonijiet avversi (ara tabella 1) (ara sezzjonijiet 4.2 u 4.4).
English: In patients ≥ 75 years of age, the incidences were 4.9% on canagliflozin 100 mg once daily and 8.7% on canagliflozin 300 mg once daily 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 darba kuljum u 8.7% fuq canagliflozin 300 mg darba kuljum meta mqabbla ma' 2.6% fil-grupp ta' kontroll (ara sezzjonijiet 4.2 u 4.4).
English: Canagliflozin 100 mg and 300 mg once daily in dual or triple add-on therapy with metformin resulted in statistically significant reductions in the percentage of body weight at 26 weeks relative to placebo.
Maltese: Canagliflozin 100 mg u 300 mg darba kuljum bħala monoterapija u bħala terapija miżjuda doppja jew tripla ma' metformin wassal għal tnaqqis statistikament sinifikanti fil-perċentwal ta' piż tal-ġisem fis26 ġimgħa meta mqabbel ma' plaċebo.
English: Compared to glimepiride as dual therapy with metformin (52 weeks) Canagliflozin + metformin
Maltese: Terapija doppja ma' metformin (26 ġimgħa) Canagliflozin + metformin
English: • if you have a diabetic pre-coma
Maltese: • jekk għandek pre-koma tad-dijabete
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 mil linja 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: 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-trasporatur SGLT2, maħruġ mit-tubuli prossimali tal-kliewi, huwa responsabbli għall-biċċa l-kbira tal-assorbiment mill-ġdid tal-glukożju iffiltrat mill-kavità tat-tubuli.
English: Vokanamet 50 mg/850 mg film-coated tablets Macrogol (3350)
Maltese: Vokanamet 50 mg/850 mg pilloli miksijin b'rita Macrogol (3350)
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 bil-plaċebo, meta ntuża bħala monoterapija jew miżjud ma' metformin.
English: d Based on postmarketing experience with canagliflozin.
Maltese: L-individwi rrispondew għal kura standard filwaqt li komplew bil-kura b'canagliflozin.
English: Surgical and medical procedures uncommon
Maltese: Proċeduri kirurġiċi u mediċi mhux komuni
English: Vokanamet 150 mg/1000 mg film-coated tablets
Maltese: Vokanamet 150 mg/1000 mg pilloli miksijin b'rita
English: Vokanamet 150 mg/850 mg film-coated tablets EU/1/14/918/007 (20 tablets) EU/1/14/918/008 (60 tablets) EU/1/14/918/009 (180 tablets)
Maltese: Vokanamet 150 mg/850 mg pilloli miksijin b'rita EU/1/14/918/007 (20 pillola) EU/1/14/918/008 (60 pillola) EU/1/14/918/009 (180 pillola)
English: Vokanamet 50 mg/850 mg film-coated tablets
Maltese: Vokanamet 50 mg/850 mg pilloli miksijin b'rita
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.
English: Co-administration of canagliflozin (300 mg once daily) and metformin (2000 mg once daily) had no clinically relevant effect on the pharmacokinetics of either canagliflozin or metformin.
Maltese: L-għoti ta' canagliflozin (300 mg darba kuljum) flimkien ma' metformin (2000 mg darba kuljum) ma kellu l-ebda effett rilevanti b'mod kliniku fuq il-farmakokinetika kemm ta' canagliflozin kif ukoll ta' metformin.
English: If no adequate strength of Vokanamet is available, individual monocomponents should be used instead of the fixed dose combination.
Maltese: Jekk ma tkunx disponibbli qawwa adegwata ta' Vokanamet, għandhom jiġu użati monokomponenti individwali minflok il-kombinazzjoni ta' doża fissa.
English: Table 2: The frequency of metformin adverse reactions identified from clinical trial and postmarketing data
Maltese: Tabella 2: Il-frekwenza ta' reazzjonijiet avversi ta' metformin identifikata minn dejta minn provi kliniċi u minn meta l-prodott tqiegħed fis-suq
English: Patients (%) achieving HbA1c < 7% Body weight
Maltese: Pazjenti (%) li kisbu HbA1c < 7%
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: 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: In an analysis of four 26-week, placebo-controlled studies (N = 2,313), treatment with canagliflozin 100 mg and 300 mg once daily resulted in mean reductions in systolic blood pressure of -3.9 mmHg and -5.3 mmHg, respectively, compared to placebo (-0.1 mmHg) and a smaller effect on diastolic blood pressure with mean changes for canagliflozin 100 mg once daily and 300 mg once daily of -2.1 mmHg and -2.5 mmHg, respectively, compared to placebo (-0.3 mmHg).
Maltese: 100 mg u 300 mg darba kuljum wasslet għal tnaqqis medju ta' -3.9 mmHg u -5.3 mmHg, rispettivament fil-pressjoni sistolika meta mqabbla mal-plaċebo (-0.1 mmHg) u effett iżgħar fuq il-pressjoni dijastolika b'bidliet medji għal canagliflozin 100 mg darba kuljum u 300 mg darba kuljum ta' -2.1 mmHg u -2.5 mmHg, rispettivament, meta mqabbla mal-plaċebo (-0.3 mmHg).
English: It is assumed that the pharmacokinetics of metformin absorption are non-linear.
Maltese: Wieħed jassumi li l-farmakokinetika tal-assorbiment ta' metformin mhix lineari.
English: In a pooled analysis of clinical data, increases in canagliflozin AUC of 26% were observed in UGT1A9*1/*3 carriers and 18% in UGT2B4*2/*2 carriers.
Maltese: UGT1A9*1/*3 u 18% f'dawk li jkollhom UGT2B4*2/*2.
English: In this pooled analysis, patients on loop diuretics, patients with a baseline GFR 30 mL/min to < 60 mL/min, and patients ≥ 75 years of age had generally higher incidences of these adverse reactions.
Maltese: F'din l-analiżi kollettiva, pazjenti fuq dijuretiċi ‘loop', patients b'GFR minn 30 mL/min sa < 60 mL/min fil-linja bażi, u pazjenti ≥ 75 sena ġeneralment kellhom inċidenzi ogħla ta' dawn irreazzjonijiet avversi.
English: Patients with a baseline GFR 45 mL/min to < 60 mL/min treated with canagliflozin 100 mg and 300 mg exhibited mean improvements in percent change in body weight relative to placebo of -1.8% and -2.0%, respectively.
Maltese: < 60 mL/min fil-linja bażi, ttrattati b'canagliflozin 100 mg u 300 mg urew titjib medju fil-perċentwal ta' bidla fil-piż tal-ġisem ta' -1.8% and -2.0%, rispettivament meta mqabbla mal-plaċebo.
English: - 150 mg/850 mg tablets: macrogol (3350), polyvinyl alcohol, talc, titanium dioxide
Maltese: - pilloli ta' 150 mg/850 mg: macrogol (3350), polyvinyl alcohol, talc, titanium dioxide (E 171), u iron oxide isfar (E172).
English: Vokanamet 50 mg/1000 mg film-coated tablets EU/1/14/918/004 (20 tablets) EU/1/14/918/005 (60 tablets) EU/1/14/918/006 (180 tablets)
Maltese: Vokanamet 50 mg/1000 mg pilloli miksijin b'rita EU/1/14/918/004 (20 pillola) EU/1/14/918/005 (60 pillola) EU/1/14/918/006 (180 pillola s)
English: In patients with a GFR < 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'GFR < 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: 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 4.
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 4.
English: Vokanamet 50 mg/1000 mg film-coated tablets
Maltese: Vokanamet 50 mg/1000 mg pilloli miksijin b'rita
English: Candidal balanitis or balanoposthitis was reported in 4.2% and 3.7% of male patients treated with canagliflozin 100 mg once daily and canagliflozin 300 mg once daily, respectively, compared to 0.6% in placebo-treated male patients.
Maltese: Balanite jew balanopostite kandidjali kienet irrappurata f'4.2% u 3.7% tal-pazjenti rġiel ikkurati b'canagliflozin 100 mg kuljum u canagliflozin 300 mg kuljum, rispettivament, meta mqabbla ma'
English: Alcohol intoxication is associated with an increased risk of lactic acidosis (particularly in cases of fasting, malnutrition, or hepatic impairment) due to the metformin active substance of Vokanamet (see section 4.4).
Maltese: Intossikazzjoni bl-alkoħol hija assoċjata ma' riskju akbar ta' aċidożi lattika (b'mod partikulari f'każijiet ta' sawm, malnutrizzjoni jew indeboliment epatiku) minħabba s-sustanza attiva metformin ta' Vokanamet (ara sezzjoni 4.4).
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 fil-kreatinina tas-serum u fin-nitroġenu tal-urea fid-demm (BUN - blood urea nitrogen) (ara sezzjoni 4.8).
English: Canagliflozin has not been studied in severe renal impairment.
Maltese: Canagliflozin ma ġiex studjat f'indeboliment sever tal-kliewi.
English: Vokanamet 150 mg/1000 mg film-coated tablets Macrogol (3350)
Maltese: Vokanamet 150 mg/1000 mg pilloli miksijin b'rita Macrogol (3350)
English: The prospective randomised (UKPDS) study has established the long-term benefit of intensive blood glucose control in type 2 diabetes.
Maltese: L-istudju randomised prospettiv (UKPDS) stabbilixxa l-benefiċċju fit-tul ta' kontroll intensiv tal glukożju fid-demm f'dijabete tat-tip 2.
English: Vokanamet 50 mg/850 mg film-coated tablets EU/1/14/918/001 (20 tablets) EU/1/14/918/002 (60 tablets) EU/1/14/918/003 (180 tablets)
Maltese: Vokanamet 50 mg/850 mg pilloli miksijin b'rita EU/1/14/918/001 (20 pillola) EU/1/14/918/002 (60 pillola) EU/1/14/918/003 (180 pillola)
English: Special caution should be exercised in situations where renal function may become impaired; for example, when initiating antihypertensive or diuretic therapy and when starting treatment with a non-steroidal antiinflammatory drug (NSAID).
Maltese: Għandu jkun hemm kawtela speċjali f'sitwazzjonijiet fejn il-funzjoni tal-kliewi tista' tiġi indebolita; per eżempju meta tinbeda terapija kontra l-pressjoni għolja jew terapija dijuretika u meta tinbeda kura b'mediċina kontra l-infjammazzjoni li mhix sterojd (NSAID - non-steroidal anti-inflammatory drug).
English: Canagliflozin is an orally-active inhibitor of SGLT2.
Maltese: Canagliflozin m'għandux jintuża.