FrancophonIA/ELRC3.0 huggingface dataset:
English: On 21 July 2011, Hexal AG officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Ibandronic Acid Hexal, for the prevention of skeletal events in patients with breast cancer and bone metastases.
Maltese: Fil-21 ta' Lulju 2011, Hexal AG innotifikat uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) li tixtieq tirtira l-applikazzjoni għal awtorizzazzjoni għat-tqegħid fis-suq għal Ibandronic Acid Hexal għall-prevenzjoni ta' episodji skeletali f'pazjenti b'kanċer tas-sider u b'metastasi fl-għadam.
English: The letter from the company notifying the Agency of the withdrawal of the application is available under the tab ‘All documents'.
Maltese: L-ittra mill-kumpanija li biha nnotifikat lill-Aġenzija bl-irtirar tal-applikazzjoni hija disponibbli taħt it-tab ‘Id-dokumenti kollha'.
English: The evaluation had finished and the CHMP had given a positive opinion.
Maltese: L-evalwazzjoni waslet fi tmiemha u s-CHMP kien ħareġ opinjoni pożittiva.
English: Ibandronic Acid Hexal is a medicine that contains the active substance ibandronic acid.
Maltese: Ibandronic Acid Hexal huwa mediċina li fiha s-sustanza attiva aċidu ibandroniku.
English: Ibandronic Acid Hexal is expected to work in the same way as the reference medicine, Bondronat.
Maltese: Ibandronic Acid Hexal huwa mistenni jaħdem bl-istess mod bħall-mediċina ta' referenza, Bondronat.
English: Ibandronic Acid Hexal was to be used to prevent ‘skeletal events' (fractures [broken bones] or bone complications requiring treatment) in patients with breast cancer and bone metastases (when the cancer has spread to the bone).
Maltese: Ibandronic Acid Hexal kellu jintuża biex jipprevjeni ‘episodji skeletali' (ksur ta' għadam jew kumplikazzjonijiet tal-għadam li jeħtieġu kura) f'pazjenti b'kanċer tas-sider u b'metastasi fl-għadam (meta l-kanċer ikun infirex għall-għadam).
English: The CHMP concluded that, in accordance with EU requirements, Ibandronic Acid Hexal had been shown to have comparable quality and to be bioequivalent to Bondronat.
Maltese: Is-CHMP ikkonkluda li, skont ir-rekwiżiti tal-UE, Ibandronic Acid Hexal intwera li għandu kwalità li tixbah lil dik ta' Bondronat u li huwa bijoekwivalenti.
English: It was to be available as white tablets.
Maltese: Din il-mediċina hija disponibbli bħala pilloli bojod.
English: Therefore, the CHMP's view was that, as for Bondronat, the benefit outweighs the identified risk.
Maltese: Għaldaqstant, il-fehma tas-CHMP kienet li, bħal fil-każ ta' Bondronat, il-benefiċċju huwa akbar mir-riskju identifikat.
English: As the maximum duration of a treatment course with 0.01% w/w estradiol containing medicinal products for topical use is limited to 4 weeks (not repeated use), the MAHs should provide a detailed plan including precise short timelines on the adaptation of the lower pack size (25g) and the withdrawal of the 35g and 50g pack sizes, in all EU member states where they are currently authorised.
Maltese: Peress li l-perjodu massimu tal-kors ta' kura bi prodotti mediċinali għal użu topiku li fihom 0.01% w/w estradiol huwa limitat għal 4 ġimgħat (użu mhux ripetut), l-MAHs għandhom jipprovdu pjan iddettaljat li jinkludi skedi taż-zmien qosra u preċiżi dwar ladattament tal-pakkett ta' daqs iżgħar (25g) u l-irtirar tal-pakketti tad-daqsijiet ta' 35g u 50g, fl-Istati Memri kollha tal-UE fejn huma awtorizzati attwalment.
English: The maximum duration of a treatment course with 0.01% w/w estradiol containing medicinal products for topical use is limited to 4 weeks (not repeated use).
Maltese: Il-perjodu massimu tal-kors ta' kura bi prodotti mediċinali għal użu topiku li fihom 0.01% w/w estradiol huwa limitat għal 4 ġimgħat (użu mhux ripetut).
English: Therefore pack sizes of 100g should be withdrawn from all EU member states where they are currently authorised.
Maltese: Għalhekk, il-pakketti ta' daqs ta' 100g għandhom jiġu rtirati mill-Istati Membri kollha tal-UE fejn huma awtorizzati attwalment.
English: National Competent Authorities of Member States or reference Member States, if applicable, shall ensure that the following conditions are fulfilled by the MAHs:
Maltese: Kundizzjonijiet għall-awtorizzazzjonijiet għat-tqegħid fis-suq L-Awtoritajiet Nazzjonali Kompetenti tal-Istati Membri jew tal-Istati Membri ta' referenza, jekk ikun applikabbli, għandhom jiżguraw li l-MAHs jissodisfaw il-kundizzjonijiet li ġejjin:
English: Conditions to the marketing authorisations
Maltese: Kundizzjonijiet għall-awtorizzazzjonijiet għat-tqegħid fis-suq
English: EU number Invented name
Maltese: Numru ta' l-UE Isem talProdott
English: Oral use blister (PVC/alu)
Maltese: Folja (PVC/Alu)
English: 250 mg Capsule, hard
Maltese: 250 mg Kapsula, iebsa Użu orali
English: capsules
Maltese: 100 kapsuli
English: EU/1/04/289/001
Maltese: EU/1/04/289/001 Angiox
English: Angiox
Maltese: Kunjett
English: 250 mg Powder for concentrate for solution for
Maltese: 250 mg Trab għal konċentrat għal soluzzjoni għal injezzjoni jew infużjoni
English: 10 vials
Maltese: 10 kunjetti t x
English: CrCl < 60 mL/min), (see sections 4.2 and 4.4);
Maltese: CrCl < 60 mL/min), (ara sezzjonijiet 4.2 u 4.4);
English: See section “Operations and X-rays”.
Maltese: Ara s-sezzjoni, “Operazzjonijiet u raġġi X”.
English: Johnson & Johnson România SRL Str. Tipografilor nr. 11-15 Clădirea S-Park, Corp A2, Etaj 5
Maltese: Tipografilor nr. 11-15 Clădirea S-Park, Corp A2, Etaj 5
English: See section “Vokanamet with alcohol”.
Maltese: Ara s-sezzjoni, “Vokanamet mal-alkoħol”.
English: See section “Look out for side effects” and section 4.
Maltese: Ara s-sezzjoni, “Oqgħod attent għal effetti sekondarji” u s sezzjoni 4.
English: • carbamazepine, phenytoin, or phenobarbital (medicines used to control seizures)
Maltese: ● carbamazepine, phenytoin, jew phenobarbital (mediċini li jintużaw biex jikkontrollaw laċċessjonijiet)
English: 1 x 20 film-coated tablets 1 x 60 film-coated tablets 180 (3 x 60) film-coated tablets.
Maltese: 1 x 20 pillola miksija b'rita 1 x 60 pillola miksija b'rita 180 (3 x 60) pillola miksija b'rita.
English: Glimepiride (titrated) + metformin (N = 482)
Maltese: Glimepiride (titrat) + metformin (N=482)
English: • The active substances are canagliflozin and metformin hydrochloride.
Maltese: ● Is-sustanzi attivi huma canagliflozin u metformin hydrochloride.
English: Buckinghamshire HP12 4EG - UK Tel: +44 1494 567 444
Maltese: Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG - UK Tel: +44 1494 567 444
English: d p = 0.013 compared to placebo.
Maltese: d p=0.013 meta mqabbel ma' plaċebo.
English: Rashc, Urticaria not known
Maltese: Raxxc, Urtikarja
English: • rifampicin (an antibiotic used to treat tuberculosis)
Maltese: ● rifampicin (antibijotiku li jintuża biex jikkura t-tuberkulożi)
English: • Moderate and severe renal impairment (patients with eGFR < 60 mL/min/1.73 m2 or
Maltese: ● Indeboliment moderat u qawwi tal-kliewi (pazjenti b'eGFR < 60 mL/min/1.73 m2
English: Effects of canagliflozin on other medicinal products Digoxin
Maltese: Effetti ta' canagliflozin fuq prodotti mediċinali oħra Digoxin
English: • efavirenz or ritonavir (medicines used to treat HIV infection)
Maltese: ● efavirenz jew ritonavir (mediċina li tintuża biex tikkura infezzjoni bl-HIV)
English: Vokanamet with alcohol
Maltese: Vokanamet mal-alkoħol
English: Sitagliptin 100 mg + metformin and sulfonylurea (N=378)
Maltese: Sitagliptin 100 mg + metformin u sulphonylurea (N=378)
English: In in vitro studies, canagliflozin neither inhibited cytochrome P450 CYP1A2, CYP2A6, CYP2C19, CYP2D6, or CYP2E1, CYP2B6, CYP2C8, CYP2C9, nor induced CYP1A2, CYP2C19, CYP2B6,
Maltese: Fi studji in vitro, canagliflozin la inibixxa CYP1A2,CYP2A6, CYP2C19, CYP2D6, jew CYP2E1,
English: The racial distribution of patients who received canagliflozin was 72% White, 16% Asian, 4% Black, and 8% other groups.
Maltese: Id-distribuzzjoni tar-razez talpazjenti li rċevew canagliflozin kienet 72% Bojod, 16% Asjatiċi, 4% Suwed, u 8% gruppi oħra.
English: ● Diabetic ketoacidosis, diabetic pre-coma;
Maltese: ● Ketoaċidożi tad-dijabete, qabel koma tad-dijabete;
English: ● Hypersensitivity to the active substances or any of the excipients (see section 6.1);
Maltese: ● Sensittività eċċessiva għas-sustanzi attivi jew għal kwalunkwe wieћed mill-eċċipjenti (ara sezzjoni 6.1);
English: Gastro-intestinal symptomsb
Maltese: Disturbi gastro-intestinali komuni
English: Following co-administration of canagliflozin with rifampicin (an inducer of various active transporters and drug-metabolising enzymes), 51% and 28% decreases in canagliflozin systemic exposure (area under the curve, AUC) and peak concentration (Cmax) were observed.
Maltese: Wara għoti ta' canagliflozin ma' rifampicin (induttur ta' diversi trasportaturi attivi u enzimi li jimmetabolizzaw il-mediċini), kien osservat tnaqqis ta' 51% u 28% fl-esponiment sistemiku (żona taħt il-kurva, AUC - area under the curve) għal canagliflozin u fl-ogħla konċentrazzjoni (Cmax) ta'
English: 300 mg, respectively, compared to 2.7% for placebo.
Maltese: 100 mg u 300 mg, rispettivament, meta mqabbla ma' 2.7% għall-plaċebo.
English: ● a significant reduction of the absolute risk of overall mortality: metformin 13.5 events/1,000 patient-years versus diet alone 20.6 events/1,000 patient-years, (p=0.011), and versus the combined sulphonylurea and insulin monotherapy groups 18.9 events/1,000 patient-years (p=0.021)
Maltese: ● tnaqqis sinifikanti fir-riskju assolut ta' mortalità totali: metformin 13.5 każ/1,000 sena ta' pazjent versus dieta waħedha 20.6 każ/1,000 sena ta' pazjent, (p=0.011), u versus il-gruppi kkombinati ta' monoterapija b'sulphonylurea u insulina 18.9 każ/1,000 sena ta' pazjent (p=0.021)
English: For patients with an estimated glomerular filtration rate (eGFR) 60 mL/min/1.73 m2 to < 90 mL/min/1.73m2 or creatinine clearance (CrCl) of 60 mL/min to < 90 mL/min, no dose adjustment is needed.
Maltese: Għal pazjenti b'rata stmata ta' filtrazzjoni mill-glomeruli (eGFR - estimated glomerular filtration rate) minn 60 mL/min/1.73 m2 sa < 90 mL/min/1.73 m2 jew tneħħija tal-kreatinina (CrCl - creatinine clearance) minn 60 mL/min sa < 90 mL/min, mhuwa meħtieġ l-ebda aġġustament fid-doża.
English: Consistent with the mechanism of sodium glucose co-transporter 2 (SGLT2) inhibition with increased UGE, vulvovaginal candidiasis in females and balanitis or balanoposthitis in males were reported in clinical trials with canagliflozin (see section 4.8).
Maltese: sodium glukożju co-transporter 2) b'żieda fil-UGE, kienet irrappurtata kandidjasi vulvovaġinali finnisa u balanite jew balanopostite fl-irġiel fi provi kliniċi b'canagliflozin (ara sezzjoni 4.8).
English: • cimetidine (medicine used to treat stomach problems)
Maltese: ● cimetidine (mediċina użata biex tikkura problemi fl-istonku)
English: The primary assessment of safety and tolerability was conducted in a pooled analysis (N = 2,313) of four 26-week placebo-controlled clinical studies (monotherapy and add-on therapy with metformin, metformin and a sulphonylurea, and metformin and pioglitazone).
Maltese: L-istima primarja ta' sigurtà u tollerabbiltà saret f'analiżi kollettiva (n=2,313) ta' erba' studji kliniċi ta' 26 ġimgħa kkontrollati bil-plaċebo (monoterapija u terapija miżjuda ma' metformin, metformin u wieħed mis-sulphonylureas, u metformin u pioglitazone).
English: Gender, race/ethnicity, or body mass index had no clinically meaningful effect on the pharmacokinetics of canagliflozin based on a population pharmacokinetic analysis.
Maltese: Sess, razza/etniċità, jew indiċi tal-massa tal-ġisem ma kellhom l-ebda effett ta' sinifikat kliniku fuq il farmakokinetika ta' canagliflozin imsejsa fuq analiżi farmakokinetika tal-popolazzjoni.
English: Vokanamet must not be used in patients with moderate or severe renal impairment (eGFR < 60 mL/min/1.73m2 or CrCl < 60 mL/min) due to the active substance metformin (see sections 4.3, 4.4 and 5.2).
Maltese: (eGFR < 60 mL/min/1.73m2 jew CrCl < 60 mL/min) minħabba s-sustanza attiva metformin (ara sezzjonijiet 4.3, 4.4 u 5.2).
English: Nervous system disorders common
Maltese: Disturbi fis-sistema nervuża komuni
English: Canagliflozin was studied as dual therapy with metformin, dual therapy with a sulphonylurea, triple therapy with metformin and a sulphonylurea, triple therapy with metformin and pioglitazone, as an add-on therapy with insulin, and as monotherapy (table 3).
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.
English: Placebo + metformin and sulphonylurea (N = 156)
Maltese: metformin u sulphonylurea (N=156)
English: ● a significant reduction of the absolute risk of any diabetesrelated complication in the metformin group (29.8 events/1,000 patient-years) versus diet alone (43.3 events/1,000 patient-years), p=0.0023, and versus the combined sulphonylurea and insulin monotherapy groups (40.1 events/1,000 patientyears), p=0.0034
Maltese: ● tnaqqis sinifikanti fir-riskju assolut ta' kwalunkwe kumplikazzjoni marbuta mad-dijabete filgrupp ta' metformin (29.8 każ/1,000 sena ta' pazjent) versus id-dieta waħedha (43.3 każ/1,000 sena ta' pazjent), p=0.0023, u versus il-gruppi kkombinati ta' monoterapija b'sulphonylurea u insulina (40.1 każ/1,000 sena ta' pazjent), p=0.0034
English: compared to 1.5% for placebo.
Maltese: 1.9% bi plaċebo.
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: Meta canagliflozin żdied ma' terapija blinsulina, kienet osservata ipogliċemija f'49.3%, 48.2%, u 36.8% tal-pazjenti kkurati b'canagliflozin 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: respectively, compared to 0.6% for placebo.
Maltese: rispettivament, meta mqabbla ma' 0.6% għall-plaċebo.
English: • Vokanamet 50 mg/850 mg film-coated tablets (tablets) are pink, capsule-shaped, 20 mm in length, and debossed with “CM” on one side and “358” on the other side.
Maltese: ● Il-pilloli Vokanamet 50 mg/850 mg miksijin b'rita (pilloli) huma roża, forma ta' kapsula, b'tul ta' 20 mm, u mnaqqxa b'“CM” fuq naħa waħda u “358” fuq in-naħa l-oħra.
English: ● in patients already being treated with the combination of canagliflozin and metformin as separate tablets.
Maltese: ● f'pazjenti li diġà qed jiġu kkurati bil-kombinazzjoni ta' canagliflozin u metformin bħala pilloli separati.
English: Titanium dioxide (E171)) Iron oxide yellow (E172) Iron oxide red (E172)
Maltese: Titanium dioxide (E171) Iron oxide isfar (E172)
English: Placebo + insulin (N = 565)
Maltese: insulina (N=565)
English: • Vokanamet 50 mg/1000 mg film-coated tablets (tablets) are beige, capsule-shaped, 21 mm in length, and debossed with “CM” on one side and “551” on the other side.
Maltese: ● Il-pilloli Vokanamet 50 mg/1000 mg miksijin b'rita (pilloli) huma beġ, forma ta' kapsula, b'tul ta' 21 mm, u mnaqqxa b'“CM” fuq naħa waħda u “551” fuq in-naħa l-oħra.
English: ● a significant reduction of the absolute risk of any diabetes-related mortality: metformin 7.5 events/1,000 patient-years, diet alone 12.7 events/1,000 patient-years, p=0.017
Maltese: ● tnaqqis sinifikanti fir-riskju assolut ta' kwalunkwe mortalità marbuta mad-dijabete: metformin 7.5 każ/1,000 sena ta' pazjent, dieta waħedha 12.7 każ/1,000 sena ta' pazjent, p=0.017
English: Placebo (N = 93)
Maltese: (N=93)
English: Table 3: Efficacy results from placebo-controlled clinical studiesa
Maltese: Tabella 3: Riżultati ta' effikaċja minn studji kliniċi kkontrollati bi plaċeboa
English: • Vokanamet 150 mg/1000 mg film-coated tablets (tablets) are purple, capsule-shaped, 22 mm in length, and debossed with “CM” on one side and “611” on the other side.
Maltese: ● Il-pilloli Vokanamet 150 mg/1000 mg miksijin b'rita (pilloli) huma vjola, forma ta' kapsula, b'tul ta' 22 mm, u mnaqqxa b'“CM” fuq naħa waħda u “611” fuq in-naħa l-oħra.
English: For patients with a baseline eGFR 30 mL/min/1.73 m2 to < 60 mL/min/1.73 m2 or CrCl 30 to < 60 mL/min, the incidences were 4.8% on canagliflozin 100 mg once daily and 8.1% on canagliflozin 300 mg once daily compared to 2.6% in the control group.
Maltese: < 60 mL/min/1.73 m2 fil-linja bażi jew CrCl minn 30 sa < 60 mL/min, l-inċidenzi kienu 4.8% fuq canagliflozin 100 mg darba kuljum u 8.1% fuq canagliflozin 300 mg darba kuljum meta mqabbla ma' 2.6% fil-grupp ta' kontroll.
English: Diagnosis
Maltese: Terapija
English: Diagnostic laboratory findings are decreased blood pH, plasma lactate levels above 5 mmol/L, and an increased anion gap and lactate/pyruvate ratio.
Maltese: Sejbiet dijanjostiċi tal-laboratorju huma pH tad-demm imnaqqsa, livelli ta' lactate fil-plażma aktar minn 5 mmol/L, u żieda fl-anion gap u l-proporzjon ta' lactate/pyruvate.
English: 5.2 Pharmacokinetic properties
Maltese: .2 Tagħrif farmakokinetiku VOKANAMET
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: Wara għoti mill-ħalq ta' pillola ta' 850 mg, kien osservat tnaqqis ta' 40% fl-ogħla konċentrazzjonijiet fil-plażma, tnaqqis ta' 25% fl-AUC, u tul ta' 35 minuta aktar fil-ħin biex tintlaħaq l-ogħla konċentrazzjoni fil plażma.
English: Avoid consumption of large amounts of alcohol, or medicines containing alcohol, when taking this medicine.
Maltese: Għandu jiġi evitat il-konsum tal-alkoħol u ta' prodotti mediċinali li fihom l-alkoħol.
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: 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: Fl-analiżi kollettiva tal-erba' istudji ta' 26 ġimgħa kkontrollati bil-plaċebo, l-inċidenza tar reazzjonijiet 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: As Vokanamet contains metformin, therapy must be discontinued 48 hours before elective surgery with general, spinal, or peridural anaesthesia.
Maltese: Kirurġija Minħabba li Vokanamet fih metformin, it-terapija għandha titwaqqaf 48 siegħa qabel kirurġija elettiva b'anestesija ġenerali, fis-sinsla jew peridurali.
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: Placebo + metformin (N=183)
Maltese: metformin (N=183)
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: In a study comparing canagliflozin 300 mg once daily 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 darba kuljum ma' sitagliptin 100 mg darba kuljum 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: • constipation
Maltese: ● stitikezza
English: • Hepatic impairment, acute alcohol intoxication, alcoholism (see sections 4.2 and 4.5).
Maltese: ● Indeboliment tal-fwied, intossikazzjoni akuta bl-alkoħol, alkoħoliżmu (ara sezzjonijiet 4.2 u
English: Vokanamet contains two different active substances, canagliflozin and metformin.
Maltese: X'inhu Vokanamet u għalxiex jintuża Vokanamet fih żewġ sustanzi attivi differenti, canagliflozin u metformin.
English: n Mean percent changes from baseline in serum phosphate were 3.6% and 5.1% for canagliflozin 100 mg and 300 mg,
Maltese: n Bidliet perċentwali medji mil-linja bażi fil-phosphate fis-serum kienu 3.6% u 5.1% għal canagliflozin 100 mg u 300 mg,
English: • an X-ray where you will be injected with a dye.
Maltese: ● se tieħu raġġi X fejn se tiġi injettat b'kulur.
English: ● Hepatic impairment, acute alcohol intoxication, alcoholism (see sections 4.2 and 4.5).
Maltese: deidratazzjoni, infezzjoni qawwija, xokk (ara sezzjoni 4.4);
English: MARKETING AUTHORISATION NUMBER(S) EU/1/14/918/010 (20 tablets) EU/1/14/918/011 (60 tablets) EU/1/14/918/012 (180 tablets)
Maltese: EU/1/14/918/010 (20 pillola) EU/1/14/918/011 (60 pillola) EU/1/14/918/012 (180 pillola)
English: b p < 0.001 compared to placebo.
Maltese: b p<0.001 meta mqabbel ma' plaċebo.
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: UGT2B4*2/*2 carriers.
Maltese: UGT1A9*1/*3 u 18% f'dawk li jkollhom UGT2B4*2/*2.
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: n 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: 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,
English: Therefore, Vokanamet must be discontinued prior to, or at the time of the test and not reinstituted until 48 hours afterwards, and only after renal function has been re-evaluated and found to be normal (see section 4.4).
Maltese: Għalhekk, Vokanamet għandu jitwaqqaf qabel, jew meta jsir it-test u ma jerġax jinbeda sa 48 siegħa wara, u għandu jinbeda biss wara li l-funzjoni tal-kliewi tkun ġiet evalwata mill-ġdid u nstabet li hija normali (ara sezzjoni 4.4).