FrancophonIA/ELRC3.0 huggingface dataset:
English: The mean age of patients was 46 years, 8.1% were 65 years or older.
Maltese: L-età medja tal-pazjenti kienet 46 sena, 8.1% kellhom 65 sena jew aktar.
English: • Guidance to the physician for assessing whether the patient is eligible for sotagliflozin prescription, e.g. patient selection criteria including adherence to insulin treatment and insulin thresholds, patient's beta-hydroxybutyrate (BHB) < 0.6 mmol/L or urine ketones < 1+, BMI ≥ 27 kg/m2, absence of DKA risk factors.
Maltese: kriterji tal-għażla tal-pazjent jinkludu li wieħed iżomm mat-trattament tal-insulina u mal-ammonti tal-insulina li inqas minnnhom ma jkunx hemm rispons xieraq, il-beta-hydroxybutyrate (BHB) talpazjent < 0.6 mmol/L jew il-ketoni fl-awrina < 1+, BMI ≥ 27 kg/m2, in-nuqqas ta' fatturi ta' riskju għal DKA.
English: At the end of 24 weeks the reduction in HbA1c was -0.36% and -0.38% and at 52 weeks it was -0.23% and -0.32% with sotagliflozin 200mg and 400 mg, respectively.
Maltese: Fit-tmiem tal-24 ġimgħa it-tnaqqis fl-HbA1c kien -0.36% u -0.38% u fit-52 ġimgħa kien -0.23% u -0.32% b'sotagliflozin 200 mg u 400 mg, rispetttivament.
English: The HbA1c reduction observed in patients with eGFR ≥60 to <90 mL/min/1.73 m2 was comparable to the HbA1c reduction observed in patients with eGFR ≥90 mL/min/1.73 m2.
Maltese: It-tnaqqis flHbA1c osservat f'pazjenti b'eGFR ≥60 sa <90 mL/min/1.73 m2 kien kumparabbli mat-tnaqqis flHbA1c osservat f'pazjenti b'eGFR ≥90 mL/min/1.73 m2.
English: o nausea, vomiting, or abdominal pain o excessive thirst o constantly feeling tired o high levels of ketones in urine tests or beta-hydroxybutyrate (BHB) in blood tests o difficulty breathing/rapid, deep breathing o breath with fruity odour o difficulty paying attention, or confusion o rapid weight loss
Maltese: o nawsja, rimettar, jew uġigħ fl-addome o għatx eċċessiv o tħossok għajjien/a l-ħin kollu o livelli għoljin ta' ketoni fit-testijiet tal-awrina jew beta-hydroxybutyrate (BHB) fit-testijiet taddemm o diffikultà bit-teħid tan-nifs /teħid tan-nifs mgħaġġel, fil-fond o nifs b'riħa ta' frott o diffikultà toqgħod attent/a, jew konfużjoni o telf ta' piż f'daqqa.
English: Sotagliflozin should not be initiated in patients with an eGFR < 60 mL/min and should be discontinued at eGFR persistently below 45 mL/min (see section 4.2 and 4.8).
Maltese: jkun anqas minn 45 mL/min b'mod persistenti (ara sezzjoni 4.2 u 4.8)
English: In the study 48% were male and 92% were White and 84% of randomised patients completed the study.
Maltese: Flistudju 48% kienu rġiel u 92% kienu Bojod u 84% tal-pazjenti magħżula b'mod arbitrarju temmew l istudju.
English: 1 episode in the past 6 months).
Maltese: 65 sena).
English: Beginning 6 weeks prior to randomization, insulin dose was adjusted (optimised) to achieve the following glycaemic goals fasting/preprandial, self-monitored blood glucose (SMBG) 4.4-7.2 mmol/L and 2-hour/peak postprandial SMBG glucose <10 mmol/L.
Maltese: Minn 6 ġimgħat qabel ma l-pazjenti ntagħżlu b'mod arbitrarju, id-doża tal-insulina ġiet aġġustata (ingħatat l-aħjar doża) biex jinkisbu l-iskopijiet ġliċemiċi fi stat ta' sawm/wara l-ikel li ġejjin, glucose fid-demm immonitorjat mill-persuna nnifisha (SMBG, glucose self-monitored blood) 4.4-7.2 mmol/L
English: Discontinuation due to genital mycotic infections occurred in 0%, 0.4% and 0.4% of patients treated with sotagliflozin 200 mg, sotagliflozin 400 mg and placebo, respectively.
Maltese: It-twaqqif minħabba infezzjonijiet mikotiċi fil-ġenitali seħħew f'0%, 0.4% u 0.4% tal-pazjenti ttrattati b'sotagliflozin 200 mg, sotagliflozin 400 mg u plaċebo, rispettivament.
English: Local intestinal inhibition of SGLT1, the major transporter for glucose absorption, delays and reduces glucose absorption in the proximal intestine, resulting in a blunting and delay of postprandial hyperglycaemia.
Maltese: Inibizzjoni lokali fil-musrana ta' SGLT1, it-trasportatur prinċipali għall-assorbiment tal-glucose, idewwem u jnaqqas l-assorbiment tal-glucose fil-musrana prossimali, li jwassal għal dgħufija u dewmien tal-ipergliċemija ta' wara l-ikel.
English: Basal insulin
Maltese: Linja bażi
English: In subjects with renal impairment, exposure to sotagliflozin following a single dose of 400 mg was approximately 1.7 fold higher in subjects with mild and up to 2.7 fold higher in subjects with moderate renal impairment compared to subjects with normal renal function.
Maltese: F'individwi b'indeboliment tal-kliewi, l esponiment għal sotagliflozin wara doża waħda ta' 400 mg kien madwar 1.7 drabi ogħla f'individwi b'indeboliment ħafif u sa 2.7 drabi ogħla f'individwi b'indeboliment moderat tal-kliewi meta mqabbel ma' funzjoni normali tal-kliewi.
English: Study 3 InTandem 3 (study 3) was a 24-week duration study performed on a background of existing insulin regimen in type 1 diabetes patients with screening HbA1c ≥7.0% to ≤11.0%, to evaluate efficacy and safety of sotagliflozin 400 mg once daily versus insulin alone.
Maltese: InTandem 3 (studju 3) kien studju li dam 24 ġimgħa li sar fuq sfond ta' skeda eżistenti ta' insulina f'pazjenti b'dijabete tat-tip 1 b'HbA1c fl-eżami tad-dħul fl-istudju ≥7.0% sa ≤11.0%, biex tiġi evalwata l-effikaċja u s-sigurtà ta' sotagliflozin 400 mg darba kuljum versus insulina waħedha.
English: In the rat study, embryo-lethality, effects on fetal growth along with cardiovascular and skeletal abnormalities were observed at an exposure multiple of 158-times the human exposure at 400 mg/day.
Maltese: Fl-istudju tal-far, ġew osservati mewt tal-embriju, effetti fuq it-tkabbir tal-fetu flimkien ma' anormalitajiet kardjovaskulari u skeletriċi b'esponiment li kien multiplu ta' 158 darba aktar mill-esponiment fil-bniedem bid-doża ta' 400 mg/kuljum.
English: For all patients, it is recommended that ketones should be measured with changes to the normal routine, including reduced carbohydrate intake, intercurrent illness, reductions in total daily insulin dosing, physical activity and stress.
Maltese: huwa rrakkomandat li l-ketoni għandhom jiġu mkejla f'bidliet mir-rutina normali, inklużi tnaqqis fit teħid tal-karboidrati, mard fl-istess ħin, tnaqqis fl-għoti tad-doża totali ta' kuljum tal-insulina, attività fiżika, u stress.
English: Interference with 1,5-anhydroglucitol (1,5-AG) Assay Monitoring glycaemic control with 1,5-AG assay is not recommended as measurements of 1,5-AG are unreliable in assessing glycaemic control in patients taking medicinal products that inhibit SGLT2.
Maltese: Interferenza bejn il-prodott mediċinali/t-test tal-laboratorju Interferenza mal-Assaġġ 1,5-anhydroglucitol (1,5-AG)
English: Pooled analysis of change in SBP in patients with baseline SBP ≥130 mmHg showed greater reduction in SBP at week 12 (-5.4 mmHg for placebo, -9.0 mmHg for sotagliflozin 200 mg and -10.7 mmHg for sotagliflozin 400 mg).
Maltese: Ġabra ta' analiżi ta' bidla fl-SBP f'pazjenti b'SBP ≥130 mmHg fil-linja bażi uriet tnaqqis akbar fl-SBP f'ġimgħa 12 (-5.4 mmHg għall-plaċebo, -9.0 mmHg għal sotagliflozin 200 mg u -10.
English: Baseline, mean in mmHg Change from baseline, LS mean Difference from insulin alone, adjusted mean [95% CI]
Maltese: Linja bażi, medja f'mmHg Bidla mil-linja bażi, medja ta' LS Differenza mill-insulina waħedha, medja aġġustata [95% CI]
English: No developmental toxicity was observed at doses up to 200 mg/kg/day in the rabbit, which was up to 9-times the human exposure at the MRHD.
Maltese: 200 mg/kg/jum fil-fenek, li kienet sa 9 darbiet aktar mill-esponiment uman bl-MRHD.
English: In the broader pool, including all type 1 diabetes mellitus patients in phase 2 and 3 studies, the exposure-adjusted incidence rate was 3.07, 5.29 and 0.76 subjects per 100 patient-years for sotagliflozin 200 mg, sotagliflozin 400 mg and placebo (see section 4.4).
Maltese: Fil-ġabra aktar wiesa', inklużi l-pazjenti kollha b'dijabete tat-tip 1 fl-istudji ta' fażi 2 u 3, ir-rata ta' inċidenza aġġustata għallesponiment kienet 3.07, 5.29 u 0.76 individwu għal kull 100 pazjent trattat għal sena b'sotagliflozin 200 mg, sotagliflozin 400 mg u plaċebo (ara sezzjoni 4.4).
English: Elderly may be at an increased risk of volume depletion (see section 4.2).
Maltese: L-anzjani jistgħu jkunu f'riskju akbar ta' tnaqqis fil-volum (ara sezzjoni 4.2).
English: How to take Zynquista
Maltese: Tiħux Zynquista:
English: Fasting plasma glucose
Maltese: Glucose fil-plasma waqt is-sawm
English: c Adverse events grouping, including dehydration, hypovolaemia, postural dizziness, orthostatic hypotension, hypotension, syncope and presyncope when reported in context of volume depletion.
Maltese: c Grupp tal-avveniment avvers, jinkludi deidratazzjoni, ipovolimja, sturdament skont il-pożizzjoni, pressjoni baxxa mal-waqqaf, pressjoni baxxa, sinkope u presinkope meta rrappurtat fil-kuntest ta' tnaqqis fil-volum.
English: In the study 52% were male and 96.2% were White and 87% of randomised patients completed the study.
Maltese: Flistudju 52% kienu rġiel u 96.2% kienu Bojod u 87% tal-pazjenti magħżula b'mod arbitrarju temmew l istudju.
English: Discontinuation due to genital mycotic infections occurred in 1.2%, 1.1% and 0.8% of patients treated with sotagliflozin 200 mg, sotagliflozin 400 mg and placebo, respectively.
Maltese: It-twaqqif minħabba infezzjonijiet mikotiċi fil-ġenitali seħħ f'1.2%, 1.1% u 0.8% tal-pazjenti ttrattati b'sotagliflozin 200 mg, sotagliflozin 400 mg u plaċebo, rispettivament.
English: Urinary glucose excretion
Maltese: Glucose fl-awrina
English: Urine glucose
Maltese: Użu orali
English: In studies 1 and 2 combined, patient 24-week completion rates were 89.5% among insulin alone patients, and 91.4% and 90.7% among patients receiving 200 mg and 400 mg of sotagliflozin, respectively.
Maltese: Fl-istudji 1 u 2 flimkien, ir-rati ta' pazjenti li temmew l-24 ġimgħa kienu 89.5% fost il-pazjenti li kienu qed jieħdu l-insulina waħedha, u 91.4% u 90.7% fost il-pazjenti li kienu qed jirċievu 200 mg u 400 mg ta' sotagliflozin, rispettivament.
English: Increased urinationd, blood creatinine increased/ glomerular filtration decreased†
Maltese: żieda fil-kreatinina fiddemm/ tnaqqis filfiltrazzjoni mill-glomeruli†
English: Zynquista is used as an addition to insulin treatment in adults with type 1 diabetes with a body mass index (BMI) greater than or equal to 27.
Maltese: Zynquista jintuża miżjud mat-trattament tal-insulina f'adulti bid-dijabete tat-tip 1 b'indiċi tal-massa tal-ġisem (BMI, body mass index) ta' 27 jew aktar.
English: These are the signs and symptoms of diabetic ketoacidosis (see also section 2 under ‘Warnings and precautions'):
Maltese: Dawn huma s-sinjali u s-sintomi ta' ketoaċidożi tad-dijabete (ara wkoll sezzjoni 2 taħt, ‘Twissijiet u prekawzjonijiet'):
English: dAdverse events grouping, including urine output increased, polydipsia, micturition urgency, nocturia, pollakiuria and polyuria eMean percent changes from baseline for sotagliflozin 200 mg and 400 mg versus placebo, respectively, were HDL-C 3.3% and 4.2% versus 0.5%; LDL-C 5.0% and 6.1% versus 3.3%; triglycerides 5.7% and 5.4% versus 2.7%.
Maltese: rispettivament, kienu HDL-C 3.3% u 4.2% versus 0.5%; LDL-C 5.0% u 6.1% versus 3.3%; trigliċeridi 5.7% u 5.4% versus 2.7%. f Il-proporzjon ta' individwi li ssodisfaw il-kriterja li l-ematokrit ikun >50% kien ogħla fil-gruppi ta' sotagliflozin 200 mg u 400 mg (6.7% u 8.2%) meta mqabbel mal-grupp tal-plaċebo (2.7%)
English: • yeast infection (thrush) of the penis (signs may include irritation, itching, unusual discharge or odour)
Maltese: • infezzjoni bil-ħmira (traxx) fil-vaġina (sinjali jistgħu jinkludu irritazzjoni, ħakk, tnixxija jew riħa mhux tas-soltu)
English: Blood ketone body increased, serum lipids increasede, haematocrit increasedf
Maltese: Żieda fil-korpi tal-keton fid-demm, żieda fil-lipidi fis-serume, żieda flematokritf
English: Ketone monitoring during treatment
Maltese: Monitoraġġ tal-keton matul it-trattament
English: INSTRUCTIONS ON USE 16.
Maltese: 6%, u 85.
English: - Patients with elevated ketones levels (BHB reading is greater than 0.6 mmol/L or urine ketones one plus (+)).
Maltese: - Pazjenti b'livelli għoljin ta' ketoni (qari ta' BHB jkun aktar minn 0.6 mmol/L jew ketoni fl-awrina plass wieħed (+)).
English: The CL/F estimated using a population PK, which mostly evaluated T1DM patients, was 239 L/hr.
Maltese: Is-CL/F stmata permezz ta' PK ta' popolazzjoni, li l-parti kbira tagħha stmat pazjenti T1DM, kienet 239 L/siegħa.
English: - More frequent, at least 2 to 4 times per year, renal function monitoring is recommended in patients with an eGFR below 60 mL/min/1.73 m2.
Maltese: - Huwa rrakkomandat monitoraġġ tal-funzjoni tal-kliewi aktar frekwenti, mill-inqas darbtejn sa 4 darbiet fis-sena, f'pazjenti b'eGFR inqas minn 60 mL/min/1.73 m2.
English: The recommended actions are listed in Table 1 (see section 4.2).
Maltese: Tabella 1 f'sezzjoni 4.2).
English: The proportion of patients with A1C <7.0% at 24 weeks was 19.0% for placebo, 35.1% for sotagliflozin 200mg, 40.4% for sotagliflozin 400mg and at 52 weeks was 18.3%, 28.6% and 31.6% for placebo, sotagliflozin 200 mg and 400 mg respectively.
Maltese: 400mg u fit-52 ġimgħa kien 18.3%, 28.6% u 31.6% għal plaċebo, sotagliflozin 200 mg u sotagliflozin 400 mg rispettivament.
English: At Week 24, mean
Maltese: 6 ġimgħat) , medja ta' LS
English: Based on the mode of action of sodium glucose co-transporter 2 (SGLT-2) inhibitors, by increasing urinary glucose excretion (UGE), sotagliflozin induces an osmotic diuresis which may reduce intravascular volume and decrease blood pressure (see sections 4.8 and 5.1).
Maltese: Abbażi tal-mod kif jaħdmu l-inibituri tal-kotrasportatur 2 ta' sodium u glucose (SGLT-2, sodium glucose co-transporter 2), billi jżid it-tneħħija tal-glucose mal-awrina (UGE, urinary glucose excretion), sotagliflozin jinduċi dijuresi osmotika li tista' tnaqqas il-volum intravaskulari u tbaxxi lpressjoni tad-demm (ara sezzjonijiet 4.8 u 5.1).
English: The patient alert card should contain the following key elements:
Maltese: Il-kartuna ta' allert tal-pazjent għandu jkun fiha l-elementi prinċipali li ġejjin:
English: Sotagliflozin causes an osmotic diuresis, which may lead to intravascular volume contraction and adverse reactions related to volume depletion.
Maltese: Sotagliflozin jikkawża dijuresi osmotika, li tista' twassal għal tnaqqis fil-volum intravaskulari u reazzjonijiet avversi marbuta ma' tnaqqis fil-volum.
English: • Signs/symptoms of DKA - if not adequately managed DKA can be severe and fatal.
Maltese: • Sinjali/sintomi ta' DKA - jekk ma tiġix immaniġġjata b'mod xieraq DKA tista' tkun severa u fatali.
English: - When needed to prevent hypoglycaemia, insulin dose reduction should be done cautiously to avoid ketosis and DKA (see section 4.2).
Maltese: - Meta jkun meħtieġ biex tiġi evitata ipogliċemija, it-tnaqqis fid-doża tal-insulina għandu jsir b'kawtela biex tiġi evitata ketożi u DKA (ara sezzjoni 4.2).
English: Fournier´s gangrene has to be treated immediately.
Maltese: Fournier trid tiġi ttrattata immedjatament.
English: The adverse effects on embryo-fetal development at 350 mg/kg/day were associated with maternal toxicity (body weight loss/decreased body weight gain and decreased food consumption during gestation day (GD) 6 to 8).
Maltese: L-effetti avversi fuq l-iżvilupp tal-embriju u tal-fetu bi 350 mg/kg/jum kienu assoċjati ma' tossiċità fl-omm (telf ta' piż tal-ġisem/tnaqqis fiż-żieda fil-piż tal-ġisem u tnaqqis fil-konsum tal-ikel waqt il-jiem (GD, gestation day) 6 sa 8 tat-tqala).
English: In case of conditions that may lead to fluid loss (e.g., gastrointestinal illness), careful monitoring of volume status (e.g., physical examination, blood pressure measurements, laboratory tests including haematocrit) and electrolytes is recommended for patients receiving sotagliflozin.
Maltese: F'każ ta' kondizzjonijiet li jistgħu jwasslu għal telf ta' fluwidu (eż., mard gastrointestinali), huwa rakkomandat monitoraġġ b'attenzjoni tal-istat tal-volum (eż., eżami fiżiku, kejl tal-pressjoni taddemm, testijiet tal-laboratorju inkluż l-ematokrit) u tal-elettroliti għall-pazjenti li jkunu qed jirċievu sotagliflozin.
English: Manufacturer :
Maltese: Manifattur
English: On a background of optimised insulin, the efficacy and safety of sotagliflozin 200 mg or 400 mg once daily versus insulin alone were evaluated in two double-blind, placebo controlled studies (study 1 and 2) performed in 1575 patients with type 1 diabetes on insulin pump or multiple daily injection therapy.
Maltese: Studju 1 u studju 2 Fuq sfond tal-aħjar doża tal-insulina, l-effikaċja u s-sigurtà ta' sotagliflozin 200 mg jew 400 mg darba kuljum versus l-insulina waħedha ġew evalwati f'żewġ studji kkontrollati bi plaċebo (studju 1 u 2) fejn la l-investigaturi u lanqas l-individwi ma kienu jafu liema sustanza qed tintuża, li saru f'1,575 pazjent b'dijabete tat-tip 1 li kienu fuq terapija b'pompa tal-insulina jew ħafna injezzjonijiet kuljum.
English: • Do not start caloric restriction or carbohydrate restriction while treated with sotagliflozin.
Maltese: • Tibdiex restrizzjoni tal-kaloriji jew tal-karboidrati waqt li tkun qed tiġi ttrattat b'sotagliflozin.
English: The median Tmax ranged from 1.25 to 3 hours, over a single-dose range of 400 to 2000 mg.
Maltese: Il-medjan tat-Tmax kien ivarja bejn 1.25 u 3 sigħat, fuq medda ta' doża waħda bejn 400 u 2000 mg.
English: Patients should be monitored for signs and symptoms of hypotension after initiating therapy.
Maltese: Il-pazjenti għandhom jiġu mmonitorjati għal sinjali u sintomi ta' pressjoni baxxa wara li tinbeda t-terapija.
English: The incidence of male genital infections (e.g. balanoposthitis, genital infection fungal) was increased for sotagliflozin 200 mg (3.0%), sotagliflozin 400 mg (6.3%) compared to placebo (1.1%).
Maltese: żdiedet għal sotagliflozin 200 mg (3.0%), sotagliflozin 400 mg (6.3%) meta mqabbla mal-plaċebo
English: Actions
Maltese: (avvenimenti
English: • Patients with euglycaemic DKA should receive glucose, insulin and fluids for DKA management, sotagliflozin should be discontinued.
Maltese: • Pazjenti li jkollhom DKA b'livell normali ta' glucose fid-demm għandhom jirċievu glucose, insulina u fluwidi għall-immaniġġjar tad-DKA, sotagliflozin għandu jitwaqqaf.
English: When sotagliflozin tablets were administered with a high-caloric breakfast, plasma exposure to sotagliflozin as measured by Cmax and AUC0 inf was about 2.5- and 1.5-fold higher, respectively, compared to fasted condition.
Maltese: Meta pilloli ta' sotagliflozin ingħataw ma' kolazzjon b'ħafna kaloriji, l-esponiment għal sotagliflozin fil-plasma kif imkejjel mis-Cmax u l-AUC0 inf kien madwar 2.5 u 1.5 drabi ogħla, rispettivament, meta mqabbel mal-istat ta' sawm.
English: Zynquista is not recommended for children and adolescents under 18 years of age, because it has not been studied in these patients.
Maltese: Zynquista mhuwiex rrakkomandat għal tfal u adolexxenti li għandhom taħt it-18-il sena, minħabba li ma ġiex studjat f'dawn il-pazjenti.
English: Your blood sugar levels may increase when you stop taking Zynquista.
Maltese: Il-livelli taz-zokkor fiddemm tiegħek jistgħu jiżdiedu meta inti tieqaf tieħu Zynquista.
English: Not applicable.
Maltese: Immaniġġjar ta' DKA
English: At week 24, treatment with 400 mg sotagliflozin before the first meal of the day resulted in statistically significant more patients achieving the net benefit primary endpoint (proportion of patients with HbA1c <7.0% at week 24 and no episode of severe hypoglycaemia, and no episode of DKA from randomisation to Week 24) compared with insulin alone (28.6% versus 15.2%) (p-value<0.001) and provided statistically significant mean reductions in HbA1c (p-value <0.001).
Maltese: F'ġimgħa 24, trattament b'400 mg sotagliflozin qabel l-ewwel ikla tal-jum wassal għal numru sinifikanti b'mod statistiku akbar ta' pazjenti jiksbu l-iskop primarju ta' benefiċċju nett (proporzjon ta' pazjenti b'HbA1c <7.0% f'ġimgħa 24 u l-ebda episodju ta' ipogliċemija severa, u l-ebda episodju ta'
English: Difference from insulin alone, LS mean [95%CI]
Maltese: medja ta' LS [95% CI]
English: Component of a multipack, can't be sold separately.
Maltese: Komponent ta' pakkett b'ħafna, ma jistax jinbiegħ separat.
English: Urine laboratory assessments
Maltese: IL-PRODOTT MEDIĊINALI
English: Foot care
Maltese: medja aġġustata
English: In order to avoid hypoglycaemia with the first dose of sotagliflozin a 20% reduction in the first mealtime bolus insulin may be considered.
Maltese: Sabiex tiġi evitata l-ipogliċemija bl-ewwel doża ta' sotagliflozin jista' jitqies tnaqqis ta' 20% fl-ewwel insulina li tingħata f'daqqa waqt l-ikel.
English: Printing ink
Maltese: Kisa tar-rita
English: ≤3.1 mmol/L: 19.0 ≤3.9 mmol/L: 95.6
Maltese: ≤3.9 mmol/L: 95.6
English: Mean duration of diabetes was 20 years, 39% of patients were using insulin pump and 61 % were using non-pump insulin therapy.
Maltese: Medja tat-tul ta' żmien tad-dijabete kienet 20 sena, 39% tal-pazjenti kienu qed jużaw pompa tal-insulina u 61% kienu qed jużaw terapija b'insulina mhux mill-pompa.
English: Genital mycotic infections
Maltese: GĦAMLA FARMAĊEWTIKA
English: Before initiating treatment with sotagliflozin 200 mg and before increasing dose to sotagliflozin 400 mg:
Maltese: Qabel jinbeda t-trattament b'sotagliflozin 200 mg u qabel id-doża tiżdied għal sotagliflozin 400 mg:
English: This card contains important safety information about diabetic ketoacidosis (DKA) ▼This medicinal product is subject to additional monitoring.
Maltese: Dan il-prodott mediċinali huwa suġġett għal monitoraġġ addizzjonali.
English: Fertility
Maltese: FOLJI
English: Renal function abnormalities (increased serum creatinine and decreased eGFR) can occur after initiating sotagliflozin (see section 4.8).
Maltese: Anormalitajiet fil-funzjoni tal-kliewi (żieda fil-kreatinina fis-serum u tnaqqis fl-eGFR) jistgħu jseħħu wara li jinbeda sotagliflozin (ara sezzjoni 4.8).
English: Zynquista 200 mg film-coated tablets sotagliflozin
Maltese: Zynquista 200 mg pilloli miksijin b'rita sotagliflozin
English: Incidence of severe hypoglycaemia (%)* Reduction in risk of severe hypoglycaemia compared to insulin alone (%)
Maltese: Inċidenza ta' ipogliċemija severa (%)* Tnaqqis fir-riskju ta'
English: At week 24 and 52 the change from baseline in creatinine was equal to or less than 0.02 mg/dL for both sotagliflozin 200 and sotagliflozin 400 mg.
Maltese: F'ġimgħa 24 u 52 il-bidla fil-kreatinina mil-linja bażi kienet ta' 0.02 mg/dL jew inqas kemm għal sotagliflozin 200 mg kif ukoll għal sotagliflozin 400 mg.
English: In a rat carcinogenicity study, a statistically significant increase in thyroid follicular cell carcinoma was observed in males at 75 mg/kg/day, approx. 14 times the MRHD, the highest dose evaluated.
Maltese: Fi studju dwar riskju ta' kaġun ta' kanċer fil-far, ġiet osservata żieda sinifikanti b'mod statistiku filkarċinoma taċ-ċellula follikulari tat-tirojde f'irġiel b'75 mg/kg/jum, madwar 14-il darba l-MRHD, logħla doża evalwata.
English: No overall differences in safety were observed with sotagliflozin treatment as compared to insulin alone in subjects with eGFR between 45 and 60 mL/min/1.73 m2.
Maltese: Globalment ma kienu osservati l-ebda differenzi fis-sigurtà bittrattament b'sotagliflozin meta mqabbel mal-insulina waħedha f'individwi b'eGFR bejn 45 u 60 mL/min/1.73 m2.
English: Post-Baseline LS means, LS mean differences, 95% CLs, and p-values for each individual study were obtained from accounting for missing data *p <0.001 † p 0.12 ‡ p=0.034
Maltese: 15.2%) (valur p<0.001) u pprovda tnaqqis medju sinifikanti b'mod statistiku fl-HbA1c (valur p <0.
English: Animal studies have shown that sotagliflozin crosses the placenta.
Maltese: Jekk tieħu aktar pilloli Zynquista milli suppost, kellem tabib jew mur fi sptar immedjatament.
English: Zynquista 200 mg film coated tablets:
Maltese: Zynquista 200 mg pilloli miksija b'rita:
English: Initiation of sotagliflozin is not recommended when eGFR is less than 60 ml/min/1.73 m2 and should be discontinued if eGFR is persistently less than 45 mL/min/1.73 m2 (see sections 4.4 and 4.8).
Maltese: Mhuwiex rakkomandat li jinbeda sotagliflozin meta l-eGFR jkun inqas minn 60 ml/min/1.73 m2 u għandu jitwaqqaf jekk l-eGFR jkun anqas minn 45 mL/min/1.73 m2 b'mod persistenti (ara sezzjonijiet 4.4 u 4.8).