FrancophonIA/ELRC3.0 huggingface dataset:
English: Plasma Cmax and AUC of ertugliflozin increase in a dose-proportional manner following single doses from 0.5 mg to 300 mg and following multiple doses from 1 mg to 100 mg.
Maltese: Is-Cmax u l-AUC ta' ertugliflozin fil-plażma jiżdiedu b'mod fi proporzjon mad-doża wara dożi waħdiet minn 0.5 mg sa 300 mg u wara ħafna dożi minn 1 mg sa 100 mg.
English: Merck Sharp & Dohme (Sweden) AB Tfn: + 46 (0)77 570 04 88 medicinskinfo@merck.com
Maltese: Tfn: + 46 (0)77 570 04 88 medicinskinfo@merck.com
English: Microscopic changes related to glucosuria and/or calciuria observed only in rodents included dilatation of renal tubules, hypertrophy of zona glomerulosa in adrenal glands (rats), and increased trabecular bone (rats).
Maltese: Bidliet mikroskopiċi marbuta ma' glukosurja u/jew kalċjurja osservati biss fl-annimali gerriema kienu jinkludu twessigħ tat-tubuli tal-kliewi, ipertrofija taż-żona glomerulosa fil-glandoli adrenali (firien), u żieda fl-għadam trabekulari (firien).
English: Blood creatinine increased/Glomerular filtration rate decreased and renal-related events (ertugliflozin)
Maltese: Żieda ta' kreatinina fid-demm/Tnaqqis fir-rata ta' filtrazzjoni mill-glomeruli u avvenimenti marbuta mal-kliewi (ertugliflozin)
English: Results in the in vivo mouse micronucleus test were also negative.
Maltese: Riżultati fit-test tal-mikronukleju tal-ġurdien in vivo kienu negattivi wkoll.
English: Patients should be alerted to the risk of hypoglycaemia when Segluromet is used in combination 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: Il-pazjenti għandhom jiġu mwissija dwar ir-riskju ta' ipogliċemija meta Segluromet jintuża flimkien mal-insulina jew ma' sustanza li tikkawża t-tnixxija tal-insulina u dwar ir-riskju ogħla ta' reazzjonijiet avversi marbuta ma' tnaqqis fil-volum, bħal ma huwa sturdament meta wieħed iqum bilwieqfa (ara sezzjonijiet 4.2, 4.4, u 4.8).
English: Name and address of the manufacturer(s) responsible for batch release Merck Sharp & Dohme B.V.
Maltese: Isem u indirizz tal-manifattur(i) responsabbli għall-ħruġ tal-lott Merck Sharp & Dohme B.V.
English: Long-term carcinogenicity studies have been performed in rats (dosing duration of 104 weeks) and mice (dosing duration of 91 weeks) at doses up to and including 900 mg/kg/day and 1,500 mg/kg/day, respectively.
Maltese: Saru studji fit-tul dwar karċinoġeniċità fil-firien (tul ta' żmien tal-għoti tad-dożi ta' 104 ġimgħat) u lġrieden (tul ta' żmien tal-għoti tad-dożi ta' 91 ġimgħa) b'dożi sa u inkluż 900 mg/kg/jum u 1,500 mg/kg/jum, rispettivament.
English: In the same pool, male genital mycotic infections (e.g., balanitis candida, balanoposthitis, genital infection, genital infection fungal) occurred in 3.7%, 4.2%, and 0.4% of males treated with ertugliflozin 5 mg, ertugliflozin 15 mg, and placebo, respectively.
Maltese: Fl-istess ġabra ta' provi, infezzjonijiet mikotiċi fil-ġenitali tal-irġiel (eż., kandida balanite, balanopostite, infezzjoni fil-ġenitali, infezzjoni bil-fungu fil-ġenitali) seħħew fi 3.7%, 4.2%, u 0.4% tal-irġiel ittrattati b'ertugliflozin 5 mg, ertugliflozin 15-il mg, u plaċebo, rispettivament.
English: Pharmacokinetic drug interaction studies with Segluromet have not been performed; however, such studies have been conducted with ertugliflozin and metformin, the individual active substances of Segluromet.
Maltese: Ma sarux studji farmakokinetiċi dwar interazzjonijiet tal-mediċina b'Segluromet; madankollu, dawn listudji saru b'ertugliflozin u metformin, is-sustanzi attivi individwali ta' Segluromet.
English: In the pre- and post-natal development study, decreased post-natal growth and development were observed in rats administered ertugliflozin gestation day 6 through lactation day 21 at ≥ 100 mg/kg/day (estimated 239 times the human exposure at the maximum clinical dose of 15 mg/day, based on AUC).
Maltese: Fl-istudju dwar l-iżvilupp ta' qabel u wara t-twelid, ġie osservat tnaqqis fit-tkabbir u fl-iżvilupp ta' wara t-twelid fil-firien li ngħataw ertugliflozin minn jum 6 tat-tqala sa jum 21 tat-treddigħ bid-doża ta' ≥ 100 mg/kg/jum (stmata li hija 239 darba aktar mill-esponiment uman bid-doża massima klinika ta' 15-il mg/jum, abbażi tal-AUC).
English: Hispanic or Latino patients comprised 15.6% to 34.5% of the population.
Maltese: 6% sa 34.5% tal-popolazzjoni.
English: In a 52-week, active-controlled study versus glimepiride, reductions from baseline in SBP were 2.2 mmHg and 3.8 mmHg for ertugliflozin 5 mg and 15 mg, respectively, while subjects treated with glimepiride had an increase in SBP from baseline of 1.0 mmHg.
Maltese: Fi studju ta' 52 ġimgħa ikkontrollat b'mod attiv versus glimepiride, tnaqqis mil-linja bażi fl-SBP kien 2.2 mmHg u 3.8 mmHg għal ertugliflozin 5 mg u 15-il mg rispettivament, filwaqt li individwi ttrattati b'glimepiride kellhom żieda fl-SBP mil-linja bażi ta' 1.0 mmHg.
English: Maximum daily dose is 2,000 mg.
Maltese: 2,000 mg.
English: Diagnostic laboratory findings are decreased blood pH (< 7.35), increased plasma lactate levels (> 5 mmol/l) and an increased anion gap and lactate/pyruvate ratio.
Maltese: Sejbiet dijanjostiċi tal-laboratorju huma tnaqqis fil-pH tad-demm (< 7.35), żieda fil-livelli ta' lactate fil-plażma (>5 mmol/l) u żieda fl-anion gap u lproporzjon ta' lactate/pyruvate.
English: Blood pressure
Maltese: Health) Limited
English: Multiple-dose administration of rifampin (a UGT and CYP inducer) decreases ertugliflozin AUC and Cmax by 39% and 15%, respectively.
Maltese: L-għoti ta' ħafna dożi ta' rifampin (induttur ta' UGT u CYP) inaqqas l-AUC u s-Cmax ta' ertugliflozin b'39% u 15%, rispettivament.
English: The incidence of urinary tract infections was not notably different in the ertugliflozin 5 mg and 15 mg groups (4.0% and 4.1%) and the placebo group (3.9%).
Maltese: L-inċidenza ta' infezzjonijiet fl-apparat tal-awrina ma kinitx differenti b'mod notevoli filgruppi ta' ertugliflozin 5 mg u 15-il mg (4.0% u 4.1%) u fil-grupp tal-plaċebo (3.9%).
English: Maximum daily dose is 3,000 mg.
Maltese: 3,000 mg.
English: Table 2: Results at Week 26 from a placebo-controlled study for ertugliflozin used in combination with metformin*
Maltese: Tabella 2: Riżultati f'Ġimgħa 26 minn studju kkontrollat bil-plaċebo ta' ertugliflozin użat flimkien ma' metformin*
English: • The active substances are ertugliflozin and metformin.
Maltese: • Is-sustanzi attivi huma ertugliflozin u metformin.
English: • stomach ache
Maltese: • ħass ħażin
English: Vulvovaginal pruritus
Maltese: Popolazzjoni pedjatrika
English: In a Phase 1 clinical pharmacology study in patients with type 2 diabetes and mild, moderate, or severe renal impairment (as determined by eGFR), following a single-dose administration of 15 mg ertugliflozin, the mean increases in AUC of ertugliflozin were ≤ 1.7-fold, compared to subjects with normal renal function.
Maltese: Fi studju farmakoloġiku kliniku ta' Fażi 1 f'pazjenti b'dijabete tat-tip 2 u indeboliment ħafif, moderat jew sever tal-kliewi (skont kif iddeterminat mill-eGFR), wara għoti ta' doża waħda ta' 15-il mg ertugliflozin, il-medja taż-żieda fl-AUC ta' ertugliflozin kienet ≤1.7 drabi aktar meta mqabbla ma' individwi b'funzjoni normali tal-kliewi.
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 millfiltrat tal-glomeruli lura għal ġoċ-ċirkolazzjoni.
English: The efficacy of ertugliflozin 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' ertugliflozin tiddependi 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: • blood tests may show changes related to kidney function (such as ‘creatinine')
Maltese: • testijiet tad-demm jistgħu juru bidliet marbuta mal-funzjoni tal-kliewi (bħal ‘kreatinina')
English: Studies using single oral doses of metformin hydrochloride tablets 500 mg to 1,500 mg, and 850 mg to 2,550 mg, indicate that there is a lack of dose proportionality with increasing doses, which is due to decreased absorption rather than an alteration in elimination.
Maltese: Studji bl-użu ta' dożi waħdiet ta' pilloli ta' metformin hydrochloride ta' 500 mg sa 1,500 mg, u 850 mg sa 2,550 mg mill-ħalq, jindikaw li hemm nuqqas ta' proporzjonalità mad-doża meta d-dożi jiżdiedu, li huwa minħabba tnaqqis fl-assorbiment aktar milli bidla fleliminazzjoni.
English: Necrotising fasciitis of the perineum (Fournier's gangrene) Post-marketing cases of necrotising fasciitis of the perineum, (also known as Fournier's gangrene), have been reported in female and male patients taking SGLT2 inhibitors.
Maltese: Fasciitis nekrotika tal-perineum (kankrena ta' Fournier) Każijiet wara t-tqegħid fis-suq ta' fasciitis nekrotika tal-perineum, (magħrufa wkoll bħala kankrena ta' Fournier), ġew irrappurtati f'pazjenti nisa u rġiel li kienu qed jieħdu inibituri SGLT2.
English: The proportion of subjects having any occurrence of BUN values ≥ 50% increase and value >ULN was numerically higher in the ertugliflozin 5 mg group and higher in the 15 mg group (7.9% and 9.8%, respectively) relative to the placebo group (5.1%).
Maltese: à Il-proporzjon ta' individwi li kellhom kwalunkwe okkorrenza ta' żieda ≥ 50% fil-valuri BUN u valuri >ULN kienu numerikament ogħla fil-grupp ta' ertugliflozin 5 mg u ogħla fil-grupp ta' 15-il mg (7.9% u 9.8%, rispettivament) relattiv għall-grupp tal-plaċebo (5.1%).
English: Increases in serum creatinine and decreases in eGFR were greater in patients with moderate renal impairment (see section 4.8).
Maltese: Żidiet fil-kreatinina fis-serum u tnaqqis fl-eGFR kienu akbar f'pazjenti b'indeboliment moderat tal-kliewi (ara sezzjoni 4.8).
English: BLISTER FOR SEGLUROMET 7.5 mg/850 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Segluromet 7.5 mg/850 mg
English: The AUC of ertugliflozin decreased by approximately 13%, and Cmax decreased by approximately 21% compared to subjects with normal hepatic function.
Maltese: L-AUC ta' ertugliflozin naqset b'madwar 13%, u s-Cmax naqset b'madwar 21% meta mqabbla ma' individwi b'funzjoni normali tal-fwied.
English: • take other diabetes medicines; you are more likely to get low blood sugar with certain medicines.
Maltese: • tieħu mediċini oħra tad-dijabete; huwa iżjed probabbli li inti jkollok zokkor baxx fid-demm b'ċerti mediċini.
English: 0.5% for ertugliflozin 5 mg, ertugliflozin 15 mg, and the comparator group and for subjects with eGFR 45 to < 60 mL/min/1.73 m2, the incidence was 6.4%, 3.7%, and 0% respectively.
Maltese: F'individwi b'eGFR < 60 mL/min/1.73 m2, l-inċidenza kienet 5.1%, 2.6%, u 0.5% għal ertugliflozin 5 mg, ertugliflozin 15-il mg, u fil-grupp ta' paragun u għal individwi b'eGFR 45 sa < 60 mL/min/1.73 m2, l-inċidenza kienet 6.4%, 3.7%, u 0% rispettivament.
English: Patients with type 2 diabetes inadequately controlled on metformin monotherapy (≥ 1,500 mg/day) were randomised to one of five active-treatment arms: ertugliflozin 5 mg or 15 mg, sitagliptin 100 mg, or sitagliptin 100 mg in combination with 5 mg or 15 mg ertugliflozin administered once daily in addition to continuation of background metformin therapy (see Table 3).
Maltese: Pazjenti b'dijabete tat-tip 2 li ma kinux ikkontrollati b'mod adegwat b'monoterapija ta' metformin (≥ 1,500 mg/jum) intagħżlu b'mod arbitrarju għal wieħed minn ħames gruppi ta' trattament attiv: ertugliflozin 5 mg jew 15-il mg, sitagliptin 100 mg, jew sitagliptin 100 mg flimkien ma' 5 mg jew 15-il mg ertugliflozin mogħtija darba kuljum flimkien mat-tkomplija tat-terapija fl-isfond b'metformin (ara Tabella 3).
English: Low blood sugar (hypoglycaemia; common)
Maltese: Zokkor baxx fid-demm (ipogliċemija; komuni)
English: BLISTER FOR SEGLUROMET 7.5 mg/1000 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Segluromet 7.5 mg/1000 mg
English: Dose-response modelling indicates that ertugliflozin 5 mg and 15 mg result in near maximal urinary glucose excretion (UGE) in patients with type 2 diabetes mellitus, providing 87% and 96% of maximal inhibition, respectively.
Maltese: Immudellar tar-rispons skont id-doża jindika li ertugliflozin 5 mg u 15-il mg iwasslu għal tneħħija kważi massima tal-glucose fl-awrina (UGE, urinary glucose excretion) f'pazjenti b'dijabete mellitus tat-tip 2, billi jipprovdu 87% u 96% tal-inibizzjoni massima, rispettivament.
English: Overall, ertugliflozin is unlikely to affect the pharmacokinetics of concurrently administered drugs eliminated by these enzymes.
Maltese: Globalment, ertugliflozin mhux probabbli li jaffettwa l-farmakokinetika ta' mediċini mogħtija flimkien miegħu li jiġu eliminati minn dawn l-enzimi.
English: In trials with SGLT2 inhibitors, patients with a history of genital mycotic infections and uncircumcised males were more likely to develop genital mycotic infections (see section 4.8).
Maltese: Fi provi b'inibituri ta' SGLT2, pazjenti bi storja ta' infezzjonijiet mikotiċi tal-ġenitali u rġiel li ma kellhomx ċirkonċiżjoni kellhom probabbiltà akbar li jiżviluppaw infezzjonijiet mikotiċi tal-ġenitali (ara sezzjoni 4.8).
English: Renal-related adverse reactions (e.g., acute kidney injury, renal impairment, acute prerenal failure) may occur in patients treated with ertugliflozin, particularly in patients with moderate renal impairment where the incidence of renal-related adverse reactions was 2.5%, 1.3%, and 0.6% in patients treated with ertugliflozin 5 mg, ertugliflozin 15 mg, and placebo, respectively.
Maltese: Reazzjonijiet avversi marbuta mal-kliewi (eż., ħsara akuta fil-kliewi, indeboliment tal-kliewi, stat ta' qabel insuffiċjenza akuta tal-kliewi) jistgħu jseħħu f'pazjenti ttrattati b'ertugliflozin, b'mod partikolari f'pazjenti b'indeboliment moderat tal-kliewi fejn l-inċidenza ta' reazzjonijiet avversi marbuta malkliewi kienet 2.5%, 1.3%, u 0.6% f'pazjenti ttrattati b'ertugliflozin 5 mg, ertugliflozin 15-il mg, u plaċebo, rispettivament.
English: The efficacy and safety of ertugliflozin in combination with metformin have been studied in 4 multi-centre, randomised, double-blind, placebo- and active comparator-controlled, Phase 3 clinical studies involving 3,643 patients with type 2 diabetes.
Maltese: L-effikaċja u s-sigurtà ta' ertugliflozin flimkien ma' metformin ġew studjati f'4 studji kliniċi, ta' Fażi 3, b'ħafna ċentri, arbitrarji, ikkontrollati bil-plaċebo u b'sustanza attiva ta' paragun fejn la linvestigaturi u lanqas l-individwi ma kienu jafu liema sstanza qed tintuża li kienu jinvolvu 3,643 pazjent b'dijabete tat-tip 2.
English: BLISTER FOR SEGLUROMET 2.5 mg/850 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Segluromet 2.5 mg/850 mg
English: Pink, 19.1 x 10.6 mm oval, film-coated tablet debossed with “2.5/1000” on one side and plain on the other side.
Maltese: Pillola miksija b'rita, roża, ovali, 19.1 x 10.6 mm, imnaqqxa b'“2.5/1000” fuq naħa waħda u bla marki fuq in-naħa l-oħra.
English: Maximum daily dose is 1,000 mg.
Maltese: 1,000 mg.
English: Dark brown, 18 x 10 mm oval, film-coated tablet debossed with “7.5/850” on one side and plain on the other side.
Maltese: Pillola miksija b'rita, kannella skura, ovali, 18 x 10 mm, imnaqqxa b'“7.5/850” fuq naħa waħda u bla marki fuq in-naħa l-oħra.
English: Ertugliflozin 15 mg
Maltese: Ertugliflozin 15-il mg
English: Before initiating ertugliflozin/metformin, consider factors in the patient history that may increase the risk for amputation.
Maltese: Qabel ma tibda ertugliflozin/metformin, qis fatturi fl-istorja tal-pazjent li jistgħu jżidu r-riskju ta' amputazzjoni.
English: Segluromet 2.5 mg/850 mg film-coated tablets EU/1/18/1265/001
Maltese: Pilloli Segluromet 2.5 mg/850 mg miksija b'rita EU/1/18/1265/001
English: If no adequate strength of Segluromet is available, individual monocomponents should be used instead of the fixed-dose combination.
Maltese: Jekk ma tkunx disponibbli qawwa adegwata ta' Segluromet, għandhom jiġu użati monokomponenti individwali minflok il-kombinazzjoni ta' doża fissa.
English: BLISTER FOR SEGLUROMET 2.5 mg/1000 mg
Maltese: INFORMAZZJONI BIL-BRAILLE Segluromet 2.5 mg/1000 mg
English: • vaginal itching
Maltese: • għatx eċċessiv
English: Segluromet 7.5 mg/1,000 mg film-coated tablets EU/1/18/1265/022
Maltese: Pilloli Segluromet 7.5 mg/1,000 mg miksija b'rita EU/1/18/1265/022
English: Skin and subcutaneous tissue disorders Very rare
Maltese: Disturbi fil-fwied u fil-marrara Rari ħafna
English: The blood-to-plasma concentration ratio of ertugliflozin is 0.66.
Maltese: Il-proporzjon tal-konċentrazzjoni ta' ertugliflozin fid-demm mal-plażma huwa 0.66.
English: Segluromet 7.5 mg/850 mg film-coated tablets EU/1/18/1265/015
Maltese: Pilloli Segluromet 7.5 mg/850 mg miksija b'rita EU/1/18/1265/015
English: Least squares means adjusted for treatment, time, prior antihyperglycaemic medication (metformin monotherapy or metformin + another AHA), baseline eGFR (continuous), menopausal status randomisation stratum (men, premenopausal women, women who are perimenopausal or < 3 years postmenopausal, women who are  3 years postmenopausal) and the interaction of time by treatment.
Maltese: Medji tal-least squares aġġustati għat-trattament, għall-ħin, għall-mediċina antiipergliċemika preċedenti (monoterapija b'metformin jew metformin + AHA ieħor), għall-eGFR fil-linja bażi (kontinwa), għall-istrat tal-għażla arbitrarja tal-istat tal-menopawsa (irġiel, nisa qabel il-menopawsa, nisa li qegħdin viċin il-menopawsa jew < 3 snin wara l-menopawsa, nisa ≥ 3 snin wara l-menopawsa) u l-interazzjoni tal-ħin skont it-trattament. ‡ p≤ 0.001 imqabbel mal-plaċebo. § p< 0.001 imqabbel mal-plaċebo (ibbażat fuq il-paraguni aġġustati tal-proporzjon ta' probabbiltà minn mudell ta' rigressjoni loġistika bl-użu ta' imputazzjoni multipla għal valuri neqsin tad-data).
English: Genital mycotic infections (ertugliflozin)
Maltese: Infezzjonijiet mikotiċi fil-ġenitali (ertugliflozin)
English: Segluromet 2.5 mg/1,000 mg film-coated tablets EU/1/18/1265/008
Maltese: Pilloli Segluromet 2.5 mg/1,000 mg miksija b'rita EU/1/18/1265/008
English: • Segluromet lowers blood sugar levels in adult patients (aged 18 years and older) with type 2
Maltese: • Segluromet ibaxxi l-livelli taz-zokkor fid-demm f'pazjenti adulti (li għandhom 18-il sena u aktar) li għandhom dijabete tat-tip 2.
English: How to take Segluromet 4.
Maltese: Kif għandek tieħu Segluromet 4.
English: Ertugliflozin as add-on combination therapy with metformin and sitagliptin A total of 463 patients with type 2 diabetes inadequately controlled on metformin (≥ 1,500 mg/day) and sitagliptin 100 mg once daily participated in a randomised, double-blind, multi-centre, 26-week, placebo-controlled study to evaluate the efficacy and safety of ertugliflozin.
Maltese: Ertugliflozin bħala terapija miżjuda flimkien ma' metformin u sitagliptin Total ta' 463 pazjent b'dijabete tat-tip 2 li ma kinux ikkontrollati b'mod adegwat b'metformin (≥ 1,500 mg/jum) u sitagliptin 100 mg darba kuljum ipparteċipaw fi studju ta' 26 ġimgħa, arbitrarju b'ħafna ċentri, ikkontrollat bi plaċebo, fejn la l-investigaturi u lanqas l-individwi ma kienu jafu liema sustanza qed tintuża, biex jevalwa l-effikaċja u s-sigurtà ta' ertugliflozin.
English: 56 film-coated tablets
Maltese: Valutazzjonijiet tal-awrina fil-laboratorju
English: • if you have uncontrolled diabetes, with, for example, severe hyperglycaemia (high blood glucose), nausea, vomiting, diarrhoea, rapid weight loss, lactic acidosis (see “Risk of lactic acidosis” below) or ketoacidosis.
Maltese: • jekk għandek dijabete mhux ikkontrollata, pereżempju b'ipergliċemija severa (glucose għoli fiddemm), dardir, rimettar, dijarea, telf mgħaġġel fil-piż, aċidożi lattika (ara “Riskju ta' aċidożi lattika” hawn taħt) jew ketoaċidożi.
English: Metformin is dialyzable with a clearance of up to 170 ml/min under good haemodynamic conditions.
Maltese: Metformin jitneħħa bid-dijalisi bi tneħħija sa 170 ml/min f'kundizzjonijiet emodinamiċi favorevoli.
English: The plasma protein binding of ertugliflozin was unaffected in patients with moderate hepatic impairment.
Maltese: L-irbit ta' ertugliflozin mal-proteini tal-plasma ma ġiex affettwat f'pazjenti b'indeboliment moderat tal-fwied.
English: Steady-state is reached after 4 to 6 days of once-daily dosing with ertugliflozin.
Maltese: L-istat fiss intlaħaq wara 4 sa 6 ijiem ta' għoti ta' doża ta' ertugliflozin darba kuljum.
English: Segluromet 2.5 mg/1000 mg tablets ertugliflozin/metformin hydrochloride
Maltese: Segluromet 2.5 mg/1000 mg pilloli ertugliflozin/metformin hydrochloride
English: o Each Segluromet 7.5 mg/850 mg film-coated tablet contains 7.5 mg ertugliflozin (as ertugliflozin L-pyroglutamic acid) and 850 mg of metformin hydrochloride.
Maltese: o Kull pillola miksija b'rita ta' Segluromet 7.5 mg/850 mg fiha 7.5 mg ertugliflozin (bħala ertugliflozin L-pyroglutamic acid) u 850 mg ta' metformin hydrochloride.
English: Segluromet 7.5 mg/1000 mg tablets ertugliflozin/metformin hydrochloride
Maltese: Segluromet 7.5 mg/1000 mg pilloli ertugliflozin/metformin hydrochloride
English: Overall, ertugliflozin is unlikely to affect the pharmacokinetics of concurrently administered medications that are substrates of these transporters.
Maltese: Globalment, ertugliflozin mhux probabbli li jaffettwa l-farmakokinetika ta' mediċini mogħtija flimkien miegħu li huma sustrati ta' dawn ittrasportaturi.
English: Repeat-dose oral toxicity studies were conducted in mice, rats, and dogs for up to 13, 26, and 39 weeks, respectively.
Maltese: Studji dwar tossiċità minn għoti ta' dożi ripetuti mill-ħalq saru fil-ġrieden, fil-firien, u fil-klieb sa 13, 26, u 39 ġimgħa, rispettivament.
English: Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilisation.
Maltese: Metformin inaqqas il-produzzjoni tal-glucose fil-fwied, inaqqas l-assorbiment tal-glucose mill-musrana, u jtejjeb is-sensittività għall-insulina billi jżid lassorbiment u l-użu tal-glucose periferali.
English: Patients who may be at higher risk of DKA include patients with a low beta-cell function reserve (e.g., type 2 diabetes patients with low C-peptide or latent autoimmune diabetes in adults (LADA) or patients with a history of pancreatitis), patients with conditions that lead to restricted food intake or severe dehydration, patients for whom insulin doses are reduced and patients with increased insulin requirements due to acute medical illness, surgery, or alcohol abuse.
Maltese: Pazjenti li jistgħu jkunu f'riskju akbar ta' DKA jinkludu pazjenti b'riserva baxxa ta' funzjoni taċċelluli beta (eż., pazjenti b'dijabete tat-tip 2 b'peptide C baxx jew dijabete awtoimmuni latenti fl-adulti (LADA, latent autoimmune diabetes in adults) jew pazjenti bi storja ta' pankreatite), pazjenti b'kondizzjonijiet li jwasslu għal teħid ristrett ta' ikel jew deidratazzjoni severa, pazjenti li jitnaqqsulhom id-dożi tal-insulina u pazjenti b'żieda fil-ħtieġa tal-insulina minħabba mard mediku akut, operazzjoni jew abbuż tal-alkoħol.
English: Segluromet 7.5 mg/850 mg tablets ertugliflozin/metformin hydrochloride
Maltese: Segluromet 7.5 mg/850 mg pilloli ertugliflozin/metformin hydrochloride
English: Ertugliflozin may increase the risk of hypoglycaemia when used in combination with insulin and/or an insulin secretagogue.
Maltese: Ertugliflozin jista' jżid ir-riskju ta' ipogliċemija meta jintuża flimkien mal-insulina u/jew ma' sustanza li tikkawża t-tnixxija tal-insulina.
English: Patients [N (%)] with HbA1c < 7% Body Weight (kg)
Maltese: Differenza minn glimepiride (medja tal-LS†, CI ta' 95%) Pazjenti [N (%)] b'HbA1c < 7% Piż tal-Ġisem (kg)
English: Segluromet 2.5 mg/850 mg tablets ertugliflozin/metformin hydrochloride
Maltese: Segluromet 2.5 mg/850 mg pilloli ertugliflozin/metformin hydrochloride