FrancophonIA/ELRC3.0 huggingface dataset:
English: Each tablet contains 200 mg sotagliflozin.
Maltese: Kull pillola fiha 200 mg sotagliflozin.
English: • rifampicin (an antibiotic used to treat tuberculosis and some other infections).
Maltese: • rifampicin (antibijotiku li jintuża biex tiġi trattata t-tuberekulożi u xi infezzjoniijet oħra).
English: From study 1 and study 2, 278 subjects participated in a blinded continuous glucose monitoring (CGM) sub-study (see Table 5).
Maltese: Mill-istudju 1 u l-istudju 2, 278 individwu pparteċipaw f'sottostudju ta' monitoraġġ kontinwu tal glucose (CGM, continuous glucose monitoring) fejn la l-investigaturi u lanqas l-individwi ma kienu jafu liema sustanza qed tintuża (ara Tabella 5).
English: Exposure of sotagliflozin was evaluated in a dedicated study of subjects with mild (creatinine clearance [CLcr]: 60 to less than 90 mL/min) and moderate (CLcr: 30 to less than 60 mL/min) renal impairment and with normal renal function.
Maltese: (tneħħija tal-kreatinina [CLcr]: 60 sa inqas minn 90 mL/min) u moderat (CLcr: 30 sa inqas minn 60 mL/min) tal-kliewi u b'funzjoni normali tal-kliewi.
English: Film-coated tablet Multipack: 200 (2 packs of 100) film-coated tablets
Maltese: Pillola miksija b'rita Pakkett b'ħafna: 200 (2 pakketti ta' 100) pillola miksijin b'rita
English: Film-coated tablet 10 film-coated tablets 20 film-coated tablets 30 film-coated tablets 60 film-coated tablets 90 film-coated tablets 100 film-coated tablets 180 film-coated tablets
Maltese: Pillola miksija b'rita 10 pilloli miksijin b'rita 20 pillola miksijin b'rita 30 pillola miksijin b'rita 60 pillola miksijin b'rita 90 pillola miksijin b'rita 100 pillola miksijin b'rita 180 pillola miksijin b'rita
English: The apparent volume of distribution of sotagliflozin following administration of a single 400 mg oral dose of [14C]-sotagliflozin was found to be very high with a mean value of 9392 L.
Maltese: Il-volum apparenti ta' distribuzzjoni ta' sotagliflozin wara għoti ta' doża waħda ta' 400 mg sotagliflozin [14C] mill-ħalq insab li kien għoli ħafna b'valur medju ta' 9,392 L.
English: Ketonaemia or Ketonuria
Maltese: Ketonimja jew
English: Other medicines and Zynquista
Maltese: Mediċini oħra u Zynquista
English: The incidence of renal-related events was low and similar across the groups (1.5%, 1.5% and 1.3% for sotagliflozin 200 mg, sotagliflozin 400 mg and placebo).
Maltese: L-inċidenza ta' avvenimenti marbuta mal-kliewi kienet baxxa u tixxiebah fil-gruppi kollha (1.5%, 1.5% u 1.3% għal sotagliflozin 200 mg, sotagliflozin 400 mg u plaċebo).
English: Insulin Insulin + sotagliflozin 200 mg
Maltese: Insulina + sotagliflozin 200 mg
English: Mean increases in serum creatinine from baseline to week 4 was 4.0%, 4.3% and 1.4% for sotagliflozin 200mg, sotagliflozin 400 mg and placebo, respectively.
Maltese: Żidiet medji fil-kreatinina fis-serum mil-linja bażi sa ġimgħa 4 kienu 4.0%, 4.3% u 1.4% għal sotagliflozin 200 mg, sotagliflozin 400 mg u plaċebo, rispettivament.
English: No differences in HbA1c decrease could be detected across subgroups including age, gender, race, geographic region, baseline BMI, age at diagnosis, baseline HbA1c, eGFR, duration of disease and insulin delivery method.
Maltese: Ma setgħu jiġu nnutati l-ebda differenzi fit-tnaqqis fl-HbA1c fis-sottogruppi kollha inklużi l-età, is sess tal-persuna, ir-razza, ir-reġjun ġeografiku, BMI fil-linja bażi, età meta saret id-dijanjosi, HbA1c fil-linja bażi, eGFR, tul ta' żmien tal-marda u metodu ta' għoti tal-insulina.
English: * Defined as an event consistent with hypoglycaemia where the patient required the assistance of another person to recover, lost consciousness, or experienced a seizure (regardless of whether biochemical documentation of a low glucose value was obtained).
Maltese: * Definita bħala avveniment konsistenti ma' ipogliċemija fejn il-pazjent kien jeħtieġ l-assistenza ta' persuna oħra biex jirkupra, intilef minn sensih, jew tatu aċċessjoni (irrispettivament jekk inkisbitx dokumentazzjoni bijokimika ta' valur baxx tal-glucose).
English: Adverse reactions listed below are classified according to frequency and system organ class (SOC).
Maltese: Ir-reazzjonijiet avversi elenkati taħt huma kklassifikati skont il frekwenza u l-klassi tas-sistemi u tal-organi (SOC, system organ class).
English: However, the mechanism behind the limited increase in exposure is not completely elucidated as sotagliflozin and M19 (sotagliflozin 3-O-glucuronide) are characterized as BCRP inhibitors in vitro and M19 also as an inhibitor OATP1B3 and OAT3.
Maltese: Madankollu, l-mekkaniżmu wara ż-żieda limitata fl-esponiment għadu ma nstilitx kompletament minħabba li sotagliflozin u M19 (sotagliflozin 3-O-glucuronide) huma kkaratterizzati bħala inibituri ta' BCRP in vitro u M19 huwa inibitur ta' OATP1B3 u OAT3 ukoll.
English: • Hold Zynquista immediately if patient's BHB level is > 0.6 mmol/L (1+ urine ketone) with symptoms or if BHB > 1.5 mmol/L (2+ urine ketone) with or without symptoms.
Maltese: • Waqqaf Zynquista immedjatament jekk il-livell ta' BHB tal-pazjent jkun > 0.6 mmol/L (keton flawrina 1+) bis-sintomi jew jekk BHB jkun > 1.5 mmol/L (keton fl-awrina 2+) bis-sintomi jew mingħajrhom.
English: • flatulence
Maltese: Plaċebo
English: At week 24, treatment with 200 mg or 400 mg sotagliflozin provided statistically significant reductions in HbA1c (p-value <0.001) compared to insulin alone.
Maltese: F'ġimgħa 24, it-trattament b'200 mg jew 400 mg sotagliflozin ipprovda tnaqqis sinifikanti b'mod statistiku f'HbA1c (valur p <0.
English: The pharmacokinetics (PK) of sotagliflozin has been characterized in healthy subjects and in diabetic patients.
Maltese: Il-farmakokinetika (PK, pharmacokinetics) ta' sotagliflozin ġiet karatterizzata f'individwi f'saħħithom u f'pazjenti dijabetiċi.
English: a Adverse event grouping, including, but not limited to, vulvovaginal mycotic infection, vaginal infection, vulvitis, vulvovaginal candidiasis, genital infection, genital candidiasis, genital infection fungal, vulvovaginitis, urogenital infection fungal.
Maltese: a Grupp tal-avveniment avvers, jinkludi, iżda mhux limitat għal, infezzjoni mikotika fil-vulva u lvaġina, infezzjoni fil-vaġina, vulvite, kandidjasi fil-vulva u l-vaġina, infezzjoni fil-ġenitali, kandidjasi fil-genitali, infezzjoni bil-fungu fil-ġenitali, vulvovaġinite, infezzjoni bil-fungu fl-apparat tal-awrina u fil-ġenitali.
English: The incidence of UTI in female subjects was 12%, 7.0% and 11% and the incidence of UTI in male subjects was 2.3%, 4.0% and 1.8% for sotagliflozin 200 mg, sotagliflozin 400 mg and placebo, respectively.
Maltese: L-inċidenza ta' UTI f'individwi nisa kienet 12%, 7.0% u 11% u l-inċidenza ta' UTI f'individwi rġiel kienet 2.3%, 4.0% u 1.8% għal sotagliflozin 200 mg, sotagliflozin 400 mg u plaċebo, rispettivament.
English: Table 1: Actions to take in case of elevated ketone levels
Maltese: Tabella 1: Azzjonijiet li tieħu f'każ ta' livelli għoljin tal-keton
English: The overall frequency of urinary tract infections reported were 7.1% and 5.5% for sotagliflozin 200 mg and sotagliflozin 400 mg compared to 6.1% for placebo.
Maltese: Il-frekwenza totali rrappurtata ta' infezzjonijiet fl-apparat tal-awrina kienet 7.1% u 5.5% għal sotagliflozin 200 mg u sotagliflozin 400 mg imqabbla ma' 6.1% għall-plaċebo.
English: The PK of sotagliflozin appeared to be dose proportional in the therapeutic dose range of 200 mg to 400 mg QD.
Maltese: Il-PK ta' sotagliflozin dehret li hija fi proporzjon mad-doża fil-firxa tad-doża terapewtika ta' 200 mg sa 400 mg QD.
English: Consistent with the mechanism of SGLT2 inhibition with increased UGE, sotagliflozin increases the risk for genital mycotic infections as reported in clinical trials (see section 4.8).
Maltese: B'konsistenza mal-mekkaniżmu ta' inibizzjoni ta' SGLT2 b'żieda fil-UGE, sotagliflozin iżid ir-riskju ta' infezzjonijiet mikotiċi fil-genitali kif irrappurtat fil-provi kliniċi (ara sezzjoni 4.8).
English: Adverse reactions related to volume depletion (e.g., hypovolemia, blood pressure decreased, blood pressure systolic decreased, dehydration, hypotension, orthostatic hypotension, and syncope) were reported by 2.7%, 1.1% and 1.0% of patients treated with sotagliflozin 200mg, sotagliflozin 400 mg and placebo.
Maltese: Reazzjonijiet avversi marbuta mat-tnaqqis filvolum (eż., tnaqqis fil-volum, tnaqqis fil-pressjoni tad-demm, tnaqqis fil-pressjoni sistolika tad-demm, deidratazzjoni, pressjoni baxxa, pressjoni baxxa meta tqum bilwieqfa, u sinkope) ġew irrappurtati minn 2.7%, 1.1% u 1.0% tal-pazjenti ttrattati b'sotagliflozin 200 mg, b'sotagliflozin 400 mg u bil plaċebo.
English: Stage IV (eGFR ≥15 and <30 mL/min/1.73 m2) sotagliflozin exposures were 1.95 and 2.25 fold higher compared to subjects with normal renal function.
Maltese: Istadju IIIb (eGFR ≥30 u <45 mL/min/1.73 m2) u CKD fl-Istadju IV (eGFR ≥15 u <30 mL/min/1.73 m2) l-esponimenti għal sotagliflozin kienu 1.95 u 2.25 drabi ogħla meta mqabbla ma' individwi b'funzjoni normali tal-kliewi.
English: In study 3 at 24 weeks incidences of severe hypoglycaemia were 2.4% and 3.0% on placebo and sotagliflozin 400 mg, respectively and the reduction in the rate of hypoglycaemic events at 24 weeks (blood glucose ≤3.1 mmol/L) for sotagliflozin 400 mg was 22% (p<0.001) compared to insulin alone.
Maltese: Fi studju 3 f'ġimgħa 24 l-inċidenzi ta' ipogliċemija severa kienu 2.4% u 3.0% fuq plaċebo u sotagliflozin 400 mg, rispettivament u t-tnaqqis fir-rata ta' avvenimenti ta' ipogliċemija f'ġimgħa 24 (glucose fid-demm ≤3.1 mmol/L) għal sotagliflozin 400 mg kien 22% (p<0.001) meta mqabbel mal insulina waħedha.
English: SGLT2 is the predominant transporter responsible for reabsorption of glucose from the glomerular filtrate back into the circulation.
Maltese: SGLT2 huwa t-trasportatur predominanti responsabbli għall-assorbiment mill-ġdid tal-glucose mill-filtrat tal-glomeruli lura għal ġoċ-ċirkulazzjoni.
English: Rate of documented hypoglycaemia† (events per patient year) at thresholds of ≤3.1 or ≤3.9 mmol/L
Maltese: (avvenimenti għal kull sena li l pazjenti damu fuq it-trattament) b'limiti ta' ≤3.1 jew ≤3.9 mmol/L
English: In InTandem1 (study 1) and in InTandem2 (study 2) sotagliflozin was used as add on to optimised insulin and in InTandem3 (Study 3) sotagliflozin was used as add on to any existing insulin regimen in patients not on HbA1c goal.
Maltese: (studju 1) u f'InTandem2 (studju 2) sotagliflozin intuża miżjud mal-aħjar doża tal-insulina u f'InTandem3 (Studju 3) sotagliflozin intuża miżjud ma' kwalunkwe skeda eżistenti tal-insulina f'pazjenti li ma kellhomx l-HbA1c intenzjonat.
English: Sotagliflozin is not recommended in patients with moderate and severe hepatic impairment (see sections 4.4 and 5.2).
Maltese: Sotagliflozin mhuwiex rrakkomandat f'pazjenti b'indeboliment sever tal-fwied (ara sezzjonijiet 4.4 u 5.2).
English: If ketones are high follow instructions given above in Table 1 (see section 4.2).
Maltese: L-azzjonijiet irrakkomandati huma elenkati f'Tabella 1 (ara sezzjoni 4.2).
English: In a fertility study in rats, sotagliflozin had no effect on reproductive performance, fertility, and embryo/fetal viability.
Maltese: Fi studju dwar il-fertilità fil-firien, sotagliflozin ma kellu l-ebda effett fuq il-kapaċità riproduttiva, ilfertilità u l-vijabilità tal-embriju u tal-fetu.
English: Male genital mycotic infections*,b, † urinary tract infections*' †
Maltese: Infezzjonijiet mikotiċi filġenitali fl-irġiel*,b, †
English: Oval, blue, film-coated tablet printed with “2456” on one side in black ink (tablet length: 14.2 mm, tablet width: 8.7 mm).
Maltese: Pillola ovali, blu, miksija b'rita stampata b'“2456” b'linka sewda fuq naħa waħda (tul tal-pillola: 14.2 mm, wisgħa tal-pillola: 8.7 mm).
English: Table 3: Changes from baseline in serum creatinine and eGFR in the pool of two 52-week placebocontrolled studies
Maltese: Tabella 3: Bidliet mil-linja bażi fil-kreatinina fis-serum u l-eGFR f'ġabra ta' żewġ studji ta' 52 ġimgħa ikkontrollai bi plaċebo
English: In a 12 week dose ranging study, consistent with SGLT1 inhibition, placebo corrected change from baseline 2-hour post prandial glucose (PPG), measured after a standardised mixed meal, was reduced by 1.52 mmol/L (p=0.15) and 2.73 mmol/L (p=0.006) in patients taking 200 mg and 400 mg sotagliflozin respectively, which is consistent with SGLT1 inhibition.
Maltese: Tnaqqis fil-glucose wara l-ikel Fi studju ta' 12-il ġimgħa b'firxa ta' dożi, b'konsistenza ma' inibizzjoni ta' SGLT1, bidla mil-linja bażi ta' glucose sagħtejn wara l-ikel (PPG, post prandial glucose) ikkoreġuta bi plaċebo, imkejla wara ikla standard imħallta, tnaqqset b'1.52 mmol/L (p=0.15) u 2.73 mmol/L (p=0.006) f'pazjenti li kienu qed jieħdu 200 mg u 400 mg sotagliflozin rispettivament, li huwa konsistenti ma' inibizzjonijiet ta' SGLT1.
English: Sotagliflozin may increase the risk of hypotension in patients at risk for volume contraction (see section 4.4).
Maltese: Sotagliflozin jista' jżid ir-riskju ta' pressjoni baxxa f'pazjenti li huma f'riskju għal tnaqqis fil volum (ara sezzjoni 4.4).
English: In embryo-fetal development studies in rats and rabbits, sotagliflozin was orally administered at doses up to 350 mg/kg in rats and 200 mg/kg in rabbits.
Maltese: Fl-istudji tal-iżvilupp tal-embriju u tal-fetu fil-firien u l-fniek, sotagliflozin ingħata mill-ħalq b'dożi sa 350 mg/kg fil-firien u 200 mg/kg fil-fniek.
English: The mean eGFR was 92 mL/min/1.73 m2 and 3.3% had eGFR between 45 and 60 mL/min/1.73 m2.
Maltese: Il-medja tal-eGFR kienet 92 mL/min/1.73 m2 u 3.3% kellhom eGFR bejn 45 u 60 mL/min/1.73 m2.
English: In study 3 there was a significant reduction in FPG of 0.79 mmol/L (p<0.001) with sotagliflozin 400 mg at 24 weeks compared to insulin alone.
Maltese: Fl-istudju 3 kien hemm tnaqqis sinifikanti ta' 0.79 mmol/L (p<0.001) fl-FPG b'sotagliflozin 400 mg f'ġimgħa 24 meta mqabbel mal-insulina waħedha.
English: † Defined as a documented SMBG or laboratory blood glucose value below or equal to threshold of 3.1 or 3.9 mmol/L.
Maltese: Definita bħala valur dokumentat ta' SMBG jew ta' glucose fid-demm tal-laboratorju daqs jew anqas millimitu ta' 3.1 jew 3.9 mmol/L.
English: • if you are on caloric restriction, carbohydrate restriction or ketogenic diet
Maltese: • jekk inti qiegħed fuq dieta b'restrizzjoni tal-kaloriji, restrizzjoni tal-karboidrati jew dieta ketoġenika
English: Your doctor may reduce the dose of insulin.
Maltese: - Pazjenti bi ħtieġa żgħira ta' insulina.
English: Diarrhoea, flatulence
Maltese: Infezzjonijiet fl-appart tal-awrina
English: The mean BMI was 30 kg/m2 and 23% of patients had SBP ≥ 130 mmHg.
Maltese: Il-medja tal-BMI kienet 30 kg/m2 u 23% tal-pazjenti kellhom SBP ≥ 130 mmHg.
English: In a 12-week dose ranging study, consistent with SGLT2 inhibition, 24-h placebo corrected change from baseline Urinary Glucose Excretion (UGE) increased by 57.7 grams (p<0.001) and 70.5 grams (p<0.001) in patients with type 1 diabetes taking 200 mg and 400 mg sotagliflozin respectively, which is consistent with SGLT2 inhibition.
Maltese: Fi studju ta' 12-il ġimgħa b'firxa ta' dożi, b'konsistenza ma' inibizzjoni ta' SGLT2, il-bidla fitTneħħija tal-Glucose mal-Awrina (UGE, Urinary Glucose Excretion) f'24 siegħa kkoreġuta bilplaċebo żdiedet b'57.7 grammi (p<0.001) u 70.5 grammi (p<0.
English: Both sotagliflozin and its major human metabolite 3-O-glucuronide (M19), exhibited high binding to human plasma proteins in vitro (fraction unbound approx. 2%) which was not dependent on the concentration of sotagliflozin and M19.
Maltese: Kemm sotagliflozin kif ukoll il-metabolit prinċipali 3-O-glucuronide (M19) fil-bniedem, urew irbit qawwi mal-proteini tal-plasma tal-bniedem in vitro (proporzjon mhux marbut madwar 2%) li ma kienx dipendenti fuq il-konċentrazzjoni ta' sotagliflozin u M19.
English: Table 6: Efficacy results of a 24 week placebo-controlled study of sotagliflozin as add-on to insulin therapy in patients not at HbA1c goal (Study 3):
Maltese: Tabella 6: Riżultati tal-effikaċja tal-istudju ta' 24 ġimgħa ta' sotagliflozin ikkontrollat bi plaċebo bħala terapija miżjuda mat-terapija tal-insulina f'pazjenti li ma kellhomx l-HbA1c intenzjonat (Studju 3):
English: The exposure-adjusted incidence rate was 3.12, 4.19 and 0.21 subjects per 100 patient-years for sotagliflozin 200 mg, sotagliflozin 400 mg and placebo.
Maltese: Ir-rata ta' inċidenza aġġustata għall-esponiment kienet 3.12, 4.19 u 0.21 individwu għal kull 100 pazjent trattat għal sena b'sotagliflozin 200 mg, sotagliflozin 400 mg u plaċebo.
English: Diabetic ketoacidosis*' †
Maltese: Ketoaċidożi tad-dijabete*' †
English: This patient is using ZYNQUISTA for the treatment of Type 1 Diabetes Mellitus (T1DM).
Maltese: Dan il-pazjent qiegħed juża' ZYNQUISTA għat-trattament tad-Dijabete Mellitus tat-Tip 1 (T1DM Type 1, Diabetes Mellitus).
English: The mean eGFR was 92 mL/min/1.73 m2 and 5 % had eGFR between 45 and 60 mL/min/1.73 m2.
Maltese: Il-medja tal-eGFR kienet 92 mL/min/1.73 m2 u 5% kellhom eGFR bejn 45 u 60 mL/min/1.73 m2.
English: In a pre-specified pooled analysis of study 1 and study 2, treatment with sotagliflozin as adjunct to insulin resulted in a reduction of SBP (-0.6 mmHg for placebo, -2.6 mmHg for sotagliflozin 200 mg and -4.1 mmHg for sotagliflozin 400 mg) at week 12.
Maltese: F'ġabra ta' analiżi speċifikata minn qabel ta' studju 1 u studju 2, it-trattament b'sotagliflozin miżjud mal-insulina wassal għal tnaqqis fl-SBP (-0.6 mmHg għall-plaċebo, -2.6 mmHg għal sotagliflozin 200 mg u -4.1 mmHg għal sotagliflozin 400 mg) f'ġimgħa 12.
English: Effects of sotagliflozin on other medicinal products There is an increase in AUC0-inf and Cmax of digoxin (27% and 52% respectively) when coadministered with sotagliflozin 400mg, due to inhibition of P-gp by sotagliflozin.
Maltese: Effetti ta' sotagliflozin fuq prodotti mediċinali oħra Ikun hemm żieda fl-AUC0-inf u fis-Cmax ta' digoxin (27% u 52% rispettivament) meta jingħata flimkien ma' sotagliflozin 400 mg, minħabba inibizzjoni ta' P-gp permezz ta' sotagliflozin.
English: ANNEX II
Maltese: Tabella 4).
English: It cannot be ruled out that sotagliflozin may interact with other sensitive OAT3, OATP- and/or BCRPsubstrates (e.g.: fexofenadine, paclitaxel, bosentan, methotrexate, furosemide, benzylpenicillin) resulting in potentially larger increases of exposure than seen for rosuvastatin.
Maltese: Ma jistax jiġi eskluż li sotagliflozin jista' jkollu interazzjoni ma' sustrati sensittivi oħra ta' OAT3, OATP u/jew BCRP (eż.: fexofenadine, paclitaxel, bosentan, methotrexate, furosemide, benzylpenicillin) li possibbilment iwasslu għal żidiet akbar fl-esponiment minn dak li deher għal rosuvastatin.
English: Unchanged [14C]-sotagliflozin was the predominant radioactive peak detected in faecal extracts representing a mean of 23% of the total administered radioactive dose.
Maltese: Sotagliflozin [14C] mhux mibdul kien l-aktar valur radjuattiv predominanti nnutat fl-ippurgar b'rappreżentazzjoni ta' medja ta' 23% tad-doża radjuattiva totali mogħtija.
English: The mean BMI was 28 kg/m2 and 32% of patients had SBP ≥ 130 mmHg.
Maltese: Il-medja tal-BMI kienet 28 kg/m2 u 32% tal-pazjenti kellhom SBP ≥ 130 mmHg.
English: The patient should be informed: - how to recognize the risk factors which can predispose to ketosis and DKA (including, but not limited to, recent or recurrent history of DKA, missed or reduced insulin doses, decreased caloric intake or severe dehydration, vigorous exercise, intercurrent illness, surgery, alcohol abuse, and in patients using an insulin infusion pump, insulin infusion interruption), - how to recognize DKA signs or symptoms, emphasizing that DKA could occur even when blood glucose levels are below 14 mmol/L (250 mg/dL), - when to discontinue sotagliflozin therapy (see section 4.2), - what actions to take when ketosis/DKA is suspected.
Maltese: Il-pazjent għandu jiġi infurmat: - kif jagħraf il-fatturi ta' riskju li jistgħu jippredisponu għal ketożi u DKA (inklużi, iżda mhux biss, storja riċenti jew rikurrenti ta' DKA, dożi tal-insulina maqbużin jew imnaqqsa, tnaqqis fit-teħid kalorifiku jew deidratazzjoni severa, eżerċizzju qawwi, mard fl-istess waqt, operazzjoni, abbuż tal-alkoħol, u f'pazjenti li jużaw il-pompa għall-infużjoni tal-insulina,
English: Zynquista is indicated as an adjunct to insulin therapy to improve glycaemic control in adults with type 1 diabetes mellitus with a Body Mass Index (BMI) ≥ 27 kg/m2, who have failed to achieve adequate glycaemic control despite optimal insulin therapy.
Maltese: Zynquista huwa indikat biex jiżdied mat-terapija tal-insulina biex itejjeb il-kontroll gliċemiku f'adulti b'dijabete mellitus tat-tip 1 b'Indiċi tal-Massa tal-Ġisem (BMI, Body Mass Index) ≥ 27 kg/m2, li ma rnexxielhomx jiksbu kontroll gliċemiku adegwat minkejja l-aħjar terapija bl-insulina.
English: • The risk of DKA is increased with sotagliflozin treatment.
Maltese: • Ir-riskju ta' DKA jiżdided bi trattament b'sotagliflozin.
English: The mean eGFR was 87 mL/min/1.73 m2 and 5.7% of patients had eGFR between 45 and 60 mL/min/1.73 m2.
Maltese: Il-medja tal-eGFR kienet 87 mL/min/1.73 m2 u 5.7% tal-pazjenti kellhom eGFR bejn 45 u 60 mL/min/1.73 m2.
English: Effects of other medicinal products on sotagliflozin The coadministration of a multiple dosing regimen of rifampicin, an inducer of various UGT and CYP metabolizing enzymes, with a single dose of 400 mg sotagliflozin resulted in a decrease in the AUC0-inf (60%) and Cmax (40%) of sotagliflozin.
Maltese: L-għoti fl-istess waqt ta' skeda ta' għoti ta' ħafna dożi ta' rifampicin, induttur ta' diversi enzimi UGT u CYP li jimmetabolizzaw, ma' doża waħda ta' 400 mg sotagliflozin wasslet għal tnaqqis fl-AUC0-inf (60%) u fis-Cmax (40%) ta' sotagliflozin.
English: In a study with subjects with reduced hepatic function, AUC of sotagliflozin was not increased in mild (Child Pugh A) hepatic impaired subjects, but was increased by ~3 fold in moderate (Child Pugh B) and ~ 6 fold in severe (Child Pugh C) hepatic impaired subjects.
Maltese: Indeboliment tal-fwied Fi studju f'individwi b'funzjoni mnaqqsa tal-fwied, l-AUC ta' sotagliflozin ma żdiditx f'individwi b'indeboliment ħafif (Child Pugh A) tal-fwied, iżda żdiedet bi ~3 drabi aktar b'indeboliment moderat
English: Drug/Laboratory test interference
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: Bolus insulin
Maltese: Insulina tal-bażi
English: In the clinical trials (pool of two 52-week placebo-controlled trials) of sotagliflozin, the incidence of diabetic ketoacidosis (DKA) was higher in the sotagliflozin treatment group compared with the placebo group (see section 4.8).
Maltese: (DKA, diabetic ketoacidosis) kienet ogħla fil-grupp ta' trattament b'sotagliflozin meta mqabbla malgrupp tal-plaċebo (ara sezzjoni 4.8).
English: Prior to launch of Zynquista (sotagliflozin), as an adjunct to insulin therapy to improve glycaemic control in adults with type 1 diabetes mellitus with a Body Mass Index (BMI) ≥ 27 kg/m2, who have failed to achieve adequate glycaemic control despite optimal insulin therapy, in each Member State, the Marketing Authorisation Holder (MAH) must agree the content and format of educational materials for sotagliflozin, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Maltese: f'kull Stat Membru, id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq (MAH, Marketing Authorisation Holder) għandu jaqbel fuq il-kontenut u l-format tal-materjal edukattiv għal sotagliflozin, inklużi l-mezz ta' komunikazzjoni, il-mod ta' distribuzzjoni, u kwalunkwe aspett ieħor tal-programm, mal-Awtorità Nazzjonali Kompetenti.
English: Ketone monitoring during treatment:
Maltese: Monitoraġġ tal-keton matul it-trattament:
English: Each study was of 52 weeks duration, with primary and key secondary endpoints at 24 weeks.
Maltese: Kull studju dam 52 ġimgħa, bl-iskopijiet finali primarji u sekondarji f'ġimgħa 24.
English: LS mean % Difference from insulin alone, adjusted mean [95%CI]
Maltese: medja ta' LS Differenza mill-insulina waħedha, medja ta' LS [95%CI]
English: There is limited experience in clinical trials in patients with moderate and severe hepatic impairment.
Maltese: Hemm esperjenza limitata fi provi kliniċi f'pazjenti b'indeboliment moderat u sever tal-fwied.