FrancophonIA/ELRC3.0 huggingface dataset:
English: Ertugliflozin is a potent, selective, and reversible inhibitor of SGLT2.
Maltese: Ertugliflozin huwa inibitur potenti, selettiv, u riversibbli ta' SGLT2.
English: In the pool of three placebo-controlled clinical trials, female genital mycotic infections (e.g., genital candidiasis, genital infection fungal, vaginal infection, vulvitis, vulvovaginal candidiasis, vulvovaginal mycotic infection, vulvovaginitis) occurred in 9.1%, 12%, and 3.0% of females treated with ertugliflozin 5 mg, ertugliflozin 15 mg, and placebo, respectively.
Maltese: Fil-ġabra ta' tliet provi kliniċi kontrollati bil-plaċebo, infezzjonijiet mikotiċi fil-ġenitali tan-nisa (eż., kandidjasi fil-ġenitali, infezzjoni bil-fungu fil-ġenitali, infezzjoni fil-vaġina, vulvite, kandidjasi filvulva u fil-vaġina, infezzjoni mikotika fil-vulva u fil-vaġina, vulvovaġinite) seħħew f'9.1%, 12%, u 3.0% tan-nisa ttrattati b'ertugliflozin 5 mg, ertugliflozin 15-il mg, u plaċebo, rispettivament.
English: Ertugliflozin and ertugliflozin glucuronides did not inhibit the activity of UGTs 1A6, 1A9 or 2B7 in vitro.
Maltese: Ertugliflozin u l-glukuronidi ta' ertugliflozin ma inibixxewx l-attività ta' UGTs 1A6, 1A9 jew 2B7 in vitro.
English: Renal function and risk of volume depletion should be taken into account (see sections 4.4 and 4.8).
Maltese: Għandhom jitqiesu l-funzjoni talkliewi u r-riskju ta' tnaqqis fil-volum (ara sezzjonijiet 4.4 u 4.8).
English: When ertugliflozin was used as monotherapy, the incidence of hypoglycaemic events in the ertugliflozin groups was 2.6% in both groups and 0.7% in the placebo group.
Maltese: Meta ertugliflozin intuża bħala monoterapija, l-inċidenza ta' avvenimenti ipogliċemiċi fil-gruppi ta' ertugliflozin kienet ta' 2.6% fiż-żewġ gruppi u 0.7% fil-grupp tal-plaċebo.
English: There was no evidence of a mutagenic potential of metformin in the following in vitro tests: Ames test (S. typhimurium), gene mutation test (mouse lymphoma cells), or chromosomal aberrations test (human lymphocytes).
Maltese: Ma kien hemm l-ebda xhieda tal-potenzjal mutaġeniku ta' metformin fit-testijiet in vitro li ġejjin: fittest ta' Ames (S. typhimurium), fit-test ta' mutazzjoni tal-ġeni (ċelluli tal-limfoma tal-ġurdien), jew fittest ta' aberrazzjoni tal-kromosomi (limfoċiti umani).
English: Ertugliflozin does not exhibit time-dependent pharmacokinetics and accumulates in plasma up to 10-40% following multiple dosing.
Maltese: Ertugliflozin ma jurix farmakokinetika li tiddependi mill-ħin u jakkumula fil-plażma sa 10-40% wara għoti ta' ħafna dożi.
English: There were no clinically meaningful differences in the ertugliflozin Cmax values among the different renal function groups.
Maltese: Ma kien hemm l-ebda differenzi ta' importanza klinika fil-valuri tasCmax ta' ertugliflozin fost il-gruppi differenti ta' funzjoni tal-kliewi.
English: Organic cation transporters (OCT) Metformin is a substrate of both transporters OCT1 and OCT2.
Maltese: Trasportaturi katjoniċi organiċi (OCT, organic cation transporters) Metformin huwa sustrat kemm għat-trasportatur OCT1 kif ukoll għal OCT2.
English: Experience in New York Heart Association (NYHA) class I-II is limited, and there is no experience in clinical studies with ertugliflozin in NYHA class III-IV.
Maltese: Esperjenza fil-klassi I-II tal-Assoċjazzjoni tal-Qalb ta' New York (NYHA - New York Heart Association) hija limitata, u ma hemm l-ebda esperjenza fi studji kliniċi b'ertugliflozin filklassi III- IV ta' NYHA.
English: The combination of ertugliflozin 5 or 15 mg and sitagliptin resulted in incremental FPG reductions of 0.46 and 0.65 mmol/l compared to the ertugliflozin alone or 1.02 and 1.28 mmol/l compared to sitagliptin alone, respectively.
Maltese: Il-kombinazzjoni ta' ertugliflozin 5 jew 15-il mg u sitagliptin wasslet għal tnaqqis inkrementali ta' 0.46 u 0.65 mmol/l flFPG meta mqabbla ma' l-ertugliflozin waħdu jew 1.02 u 1.28 mmol/l meta mqabbla ma' sitagliptin waħdu, rispettivament.
English: How to store Segluromet
Maltese: Tiħux Segluromet
English: As add-on to metformin and sitagliptin, ertugliflozin 5 mg and 15 mg resulted in statistically significant placebo-corrected reductions in SBP of 2.9 mmHg and 3.9 mmHg, respectively.
Maltese: Bħala żieda ma' metformin u sitagliptin, ertugliflozin 5 mg u 15-il mg wassal għal tnaqqis sinifikanti b'mod statistiku ikkoreġut bi plaċebo fl-SBP ta' 2.9 mmHg u 3.9 mmHg, rispettivament.
English: In the pool of placebo-controlled studies, the incidence of documented hypoglycaemia was increased for ertugliflozin 5 mg and 15 mg (5.0% and 4.5%) compared to placebo (2.9%).
Maltese: Fil-ġabra ta' studji kkontrollati bil-plaċebo, l-inċidenza ta' ipogliċemija ddokumentata żidedet għal ertugliflozin 5 mg u 15-il mg (5.0% and 4.5%) meta mqabbla mal-plaċebo (2.9%).
English: There is no clinical experience in patients with Child-Pugh class C (severe) hepatic impairment.
Maltese: Ma hemm l-ebda esperjenza klinika f'pazjenti b'indeboliment tal-fwied tal-klassi C ta' Child-Pugh (sever).
English: Infections and infestations Very common
Maltese: Infezzjonijiet u infestazzjonijiet Komuni ħafna
English: Signs of toxicity that were considered adverse were generally observed at exposures greater than or equal to 77 times the human unbound exposure (AUC) at the maximum recommended human dose (MRHD) of 15 mg/day.
Maltese: Sinjali ta' tossiċità li kienu meqjusa avversi kienu ġeneralment osservati f'esponimenti akbar minn jew ekwivalenti għal 77 darba aktar mill-esponiment għallmediċina mhux marbuta fil-bniedem (AUC) ) bid-doża massima rakkomandata għall-bnedmin (MRHD, maximum recommended human dose) ta' 15-il mg/jum.
English: The mean steady-state volume of distribution of ertugliflozin following an intravenous dose is 86 l. Plasma protein binding of ertugliflozin is 93.6% and is independent of ertugliflozin plasma concentrations.
Maltese: L-irbit ta' ertugliflozin mal-proteini tal-plażma huwa 93.6% u huwa indipendenti mill-konċentrazzjonijiet ta' ertugliflozin fil-plażma.
English: Sexual maturation was delayed in both sexes at 250 mg/kg/day (estimated 620 times the MRHD at 15 mg/day, based on AUC).
Maltese: Kien hemm dewmien fil-maturazzjoni sesswali fiż-żewġ sessi biddoża ta' 250 mg/kg/jum (stmata li hija 620 darba aktar mill-MRHD bid-doża ta' 15-il mg/jum, abbażi tal-AUC).
English: The safety of concomitantly administered ertugliflozin and metformin has been evaluated in 1,083 patients with type 2 diabetes mellitus treated for 26 weeks in a pool of two placebo-controlled trials: as ertugliflozin add on therapy to metformin and as ertugliflozin add-on therapy to sitagliptin and metformin (see section 5.1).
Maltese: Is-sigurtà ta' ertugliflozin mogħti flimkien ma' metformin ġiet evalwata f'1,083 pazjent b'dijabete mellitus tat-tip 2 ittrattati għal 26 ġimgħa f'ġabra ta' żewġ provi kkontrollati bil-plaċebo: ertugliflozin bħala terapija miżjuda ma' metformin u ertugliflozin bħala terapija miżjuda ma' sitagliptin u metformin (ara sezzjoni 5.1).
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 talorgani (SOC, system organ class).
English: The primary assessment of safety was conducted in a pool of three 26-week, placebo-controlled trials.
Maltese: Il-valutazzjoni primarja tas-sigurtà saret f'ġabra ta' tliet provi ta' 26 ġimgħa, ikkontrollati bil-plaċebo.
English: In the pool of placebo-controlled studies, the incidence of adverse events related to volume depletion (dehydration, dizziness postural, presyncope, syncope, hypotension, and orthostatic hypotension) was low (< 2%) and not notably different across the ertugliflozin and placebo groups.
Maltese: Fil-ġabra ta' studji kkontrollati bil-plaċebo, linċidenza ta' avvenimenti avversi relatati mat-tnaqqis fil-volum (deidratazzjoni, sturdament meta wieħed iqum bilwieqfa, presinkope, sinkope, pressjoni baxxa, u pressjoni ortostatika baxxa) kienet baxxa (< 2%) u ma kinitx differenti b'mod li seta' jiġi nnutat fil-gruppi kollha ta' ertugliflozin u talplaċebo.
English: The mean age of the patients across these four studies ranged from 55.1 to 59.1 years (range 21 years to 86 years); 15.6% to 29.9% of patients were ≥65 years of age and 0.6% to 3.8% were ≥75 years of age.
Maltese: 6% sa 29.9% tal-pazjenti kellhom età ta' ≥ 65 sena u 0.6% sa 3.8% kellhom età ta' ≥ 75 sena.
English: • liver function test disorders
Maltese: • disturbi fit-testijiet tal-funzjoni tal-fwied
English: The apparent volume of distribution (V/F) of metformin following single oral doses of metformin hydrochloride tablets 850 mg averaged 654 ± 358 l. Metformin is negligibly bound to plasma proteins.
Maltese: Il-volum ta' distribuzzjoni li jidher (V/F) ta' metformin wara doża waħda mill-ħalq ta' pilloli ta' metformin hydrochloride ta' 850 mg kellu medja ta' 654 ± 358 l. Metformin jintrabat b'mod insinifikanti mal-proteini tal-plażma.
English: Long-term treatment with metformin has been associated with a decrease in vitamin B12 absorption, which may very rarely result in clinically significant vitamin B12 deficiency (e.g., megaloblastic anaemia).
Maltese: Trattament fit-tul b'metformin ġie assoċjat ma' tnaqqis fl-assorbiment tal-vitamina B12, li b'mod rari ħafna jista' jwassal għal defiċjenza sinifikanti b'mod kliniku fil-vitamina
English: Least squares means adjusted for treatment, time, prior antihyperglycaemic medication (monotherapy or dual therapy), baseline eGFR (continuous) and the interaction of time by treatment.
Maltese: Medji tal-least squares aġġustati għat-trattament, għall-ħin, għall-mediċina antiipergliċemika preċedenti (monoterapija jew terapija b'żewġ mediċini), għall-eGFR fil-linja bażi (kontinwa) u l-interazzjoni tal-ħin skont it-trattament.
English: Rare cases of DKA, including life-threatening and fatal cases, have been reported in clinical trials and post-marketing in patients treated with sodium glucose co-transporter-2 (SGLT2) inhibitors, and cases have been reported in clinical trials with ertugliflozin.
Maltese: Każijiet rari ta' DKA, inklużi każijiet ta' theddida għall-ħajja u fatali, ġew irrappurtati fi provi kliniċi u wara t-tqegħid fis-suq f'pazjenti ttrattati b'inibituri tal-kotrasportatur 2 tal-glucose u s-sodium (SGLT2, sodium glucose co-transporter-2), u ġew irrappurtati każijiet fi provi kliniċi b'ertugliflozin.
English: In patients at increased risk of further progression of renal impairment and in the elderly, renal function should be assessed more frequently, e.g., every 3-6 months.
Maltese: F'pazjenti b'riskju akbar ta' aktar progressjoni ta' indeboliment tal-kliewi u fl-anzjani, il-funzjoni tal-kliewi għandha tiġi evalwata b'mod aktar frekwenti, eż., kull 3-6 xhur.
English: • reduced body temperature and heartbeat Lactic acidosis is a medical emergency and must be treated in a hospital.
Maltese: • temperatura tal-ġisem u taħbit tal-qalb imnaqqsa Aċidożi lattika hija emerġenza medika u għandha tiġi ttrattata fi sptar.
English: • have kidney problems
Maltese: • għandek problemi tal-kliewi
English: If Fournier's gangrene is suspected, Segluromet should be discontinued and prompt treatment (including antibiotics and surgical debridement) should be instituted.
Maltese: Jekk ikun hemm suspett ta' kankrena ta' Fournier, Segluromet għandu jitwaqqaf u jinbeda trattament fil-pront (li jinkludi antibijotiċi u t-tneħħija kirurġika tal-parti affettwata).
English: In the study of ertugliflozin in combination with metformin in patients with baseline HbA1c from 7.0-10.5%, the placebo-corrected reductions in HbA1c for the subgroup of patients in the study with baseline HbA1c ≥ 9% were 1.31% and 1.43% with ertugliflozin 5 mg and 15 mg, respectively.
Maltese: Fl-istudju ta' ertugliflozin flimkien ma' metformin f'pazjenti b'HbA1c minn 7.0-10.5% fil-linja bażi, it-tnaqqis fl-HbA1c ikkoreġut mill-plaċebo għas-sottogrupp ta' pazjenti fl-istudju b'HbA1c ≥ 9% fillinja bażi kien ta' 1.31% u 1.43% b'ertugliflozin 5 mg u 15-il mg, rispettivament.
English: Elderly patients are more likely to have decreased renal function.
Maltese: Pazjenti anzjani huwa aktar probabbli li jkollhom tnaqqis fil-funzjoni tal-kliewi.
English: Effects of ertugliflozin on the pharmacokinetics of other medicinal products Interaction studies conducted in healthy volunteers suggest that ertugliflozin had no clinically relevant effect on the pharmacokinetics of sitagliptin, metformin, and glimepiride.
Maltese: Effetti ta' ertugliflozin fuq il-farmakokinetika ta' prodotti mediċinali oħra Studji dwar interazzjoni li saru f'voluntiera f'saħħithom jissuġġerixxu li ertugliflozin ma kellu l-ebda effett rilevanti fuq il-farmakokinetika ta' sitagliptin, metformin, u glimepiride.
English: Segluromet 2.5 mg/850 mg film-coated tablets Segluromet 2.5 mg/1,000 mg film-coated tablets Segluromet 7.5 mg/850 mg film-coated tablets Segluromet 7.5 mg/1,000 mg film-coated tablets ertugliflozin/metformin hydrochloride
Maltese: Segluromet 2.5 mg/850 mg pilloli miksija b'rita Segluromet 2.5 mg/1,000 mg pilloli miksija b'rita Segluromet 7.5 mg/850 mg pilloli miksija b'rita Segluromet 7.5 mg/1,000 mg pilloli miksija b'rita ertugliflozin/metformin hydrochloride
English: Table 3: Results at Week 26 from a factorial study with ertugliflozin and sitagliptin as add-on combination therapy with metformin compared to individual components alone*
Maltese: Tabella 3: Riżultati f'Ġimgħa 26 minn studju dwar fatturi b'ertugliflozin u sitagliptin bħala terapiji miżjuda flimkien ma' metformin imqabbla mal-komponenti individwali waħedhom*
English: Effects on bone (shorter femur length, increased trabecular bone in the femur) as well as effects of delayed puberty were observed at an exposure 817 times the MHRD of 15 mg/day based on AUC.
Maltese: Effetti fuq l-għadam (tul iqsar tal-femur, żieda fl-għadam trabekulari fil-femur) kif ukoll effetti ta' ttardjar tal-pubertà ġew osservati b'esponiment ta' 817-il darba aktar mill-MRHD ta' 15-il mg/jum abbażi tal-AUC.
English: Table 4: Results at Week 26 from an add-on study of ertugliflozin in combination with metformin and sitagliptin*
Maltese: Tabella 4: Riżultati f'Ġimgħa 26 minn studju ta' ertugliflozin miżjud flimkien ma' metformin u sitagliptin*
English: • Inhibitors of both OCT1 and OCT2 (such as crizotinib, olaparib) may alter efficacy and renal elimination of metformin.
Maltese: • Inibituri kemm ta' OCT1 kif ukoll ta' OCT2 (bħal crizotinib, olaparib) jistgħu jibdlu l-effikaċja u l-eliminazzjoni ta' metformin mill-kliewi.
English: When ertugliflozin was added to metformin and compared to sulphonylurea, the incidence of hypoglycaemia was higher for the sulphonylurea (27%) compared to ertugliflozin (5.6% and 8.2% for ertugliflozin 5 mg and 15 mg, respectively).
Maltese: Meta ertugliflozin żdied ma' metformin u tqabbel ma' sulphonylurea, l-inċidenza tal-ipogliċemija kienet akbar għas-sulphonylurea (27%) meta mqabbla ma' ertugliflozin (5.6% u 8.2% għal ertugliflozin 5 mg u 15-il mg, rispettivament).
English: Avoid excessive alcohol intake while taking Segluromet since this may increase the risk of lactic acidosis (see section “Warnings and precautions”).
Maltese: Evita konsum eċċessiv ta' alkoħol waqt li tkun qed tieħu Segluromet peress li dan jista' jżid ir-riskju ta' aċidożi lattika (ara s-sezzjoni “Twissijiet u prekawzjonijiet”).
English: • if you are taking certain medicines for the treatment of high blood pressure (ACE inhibitors and angiotensin II receptor antagonists).
Maltese: • jekk inti qed tieħu ċerti mediċini għat-trattament ta' pressjoni għolja (inibituri ta' ACE u antagonisti tar-riċetturi ta' angiotensin II).
English: Suomi/Finland MSD Finland Oy Puh/Tel: + 358 (0)9 804650 info@msd.fi
Maltese: + 358 (0)9 804650 info@msd.fi
English: When used as add-on to metformin, the incidence of hypoglycaemic events was 7.2% in the ertugliflozin 5 mg group, 7.8% in the ertugliflozin 15 mg group and 4.3% in the placebo group.
Maltese: Meta intuża bħala żieda ma' metformin, linċidenza ta' avvenimenti ipogliċemiċi kienet ta' 7.2% fil-grupp ta' ertugliflozin 5 mg, 7.8% fil-grupp ta' ertugliflozin 15-il mg u 4.3% fil-grupp tal-plaċebo.
English: Ertugliflozin was a weak inhibitor of UGTs 1A1 and 1A4 in vitro at higher concentrations that are not clinically relevant.
Maltese: Ertugliflozin kien inibitur dgħajjef ta' UGTs 1A1 u 1A4 in vitro f'konċentrazzjonijiet ogħla li mhumiex rilevanti b'mod kliniku.
English: - Hypersensitivity to the active substances or to any of the excipients listed in section 6.1; - any type of acute metabolic acidosis (such as lactic acidosis, diabetic ketoacidosis [DKA]); - diabetic pre coma;
Maltese: - Sensittività eċċessiva għas-sustanzi attivi jew għal kwalunkwe sustanza mhux attiva elenkata fis-sezzjoni 6.1; - kwalunkwe tip ta' aċidożi metabolika akuta (bħal aċidożi lattika, ketoaċidożi tad-dijabete
English: Segluromet combines two antihyperglycaemic agents with complementary mechanisms of action to improve glycaemic control in patients with type 2 diabetes: ertugliflozin, a SGLT2 inhibitor, and metformin hydrochloride, a member of the biguanide class.
Maltese: Segluromet jikkombina żewġ sustanzi kontra l-ipergliċemija b'mekkaniżmi ta' azzjoni li jikkumplimentaw lil xulxin biex itejbu l-kontroll gliċemiku f'pazjenti b'dijabete tat-tip 2: ertugliflozin, inibitur ta' SGLT2, u metformin hydrochloride, membru tal-klassi tal-biguanide.
English: Ertugliflozin increases the risk of genital mycotic infections.
Maltese: Ertugliflozin iżid ir-riskju ta' infezzjonijiet mikotiċi tal-ġenitali.
English: In the study of patients inadequately controlled on metformin with baseline HbA1c from 7.5-11.0%, among the subgroup of patients with a baseline HbA1c ≥ 10%, the combination of ertugliflozin 5 mg or 15 mg with sitagliptin resulted in reductions of HbA1c of 2.35% and 2.66%, respectively, compared to 2.10%, 1.30%, and 1.82% for ertugliflozin 5 mg, ertugliflozin 15 mg, and sitagliptin alone, respectively.
Maltese: Fl-istudju ta' pazjenti li ma kinux ikkontrollati b'mod adegwat b'metformin b'HbA1c minn 7.5-11.0% fil-linja bażi, fost is-sottogrupp ta' pazjenti b'linja bażi ta' HbA1c ≥ 10%, il-kombinazzjoni ta' ertugliflozin 5 mg jew 15-il mg ma' sitagliptin wasslet għal tnaqqis ta' 2.35% u 2.66% fl-HbA1c, rispettivament, meta mqabbla ma' 2.10%, 1.30%, u 1.82% għal ertugliflozin 5 mg, ertugliflozin 15-il mg, u sitagliptin waħedhom, rispettivament.
English: Active-controlled study of ertugliflozin versus glimepiride as add-on combination therapy with metformin
Maltese: Studju kkontrollat b'mod attiv ta' ertugliflozin versus glimepiride bħala terapija miżjuda flimkien ma'
English: General introduction
Maltese: Introduzzjoni ġenerali
English: Food decreases the extent of and slightly delays the absorption of metformin, as shown by approximately a 40% lower mean peak plasma concentration (Cmax), a 25% lower area under the plasma concentration versus time curve (AUC), and a 35-minute prolongation of time to peak plasma concentration (Tmax) following administration of a single 850-mg tablet of metformin with food, compared to the same tablet strength administered fasting.
Maltese: L-ikel inaqqas kemm metformin jiġi assorbit u jdewwem kemxejn l-assorbiment tiegħu, kif muri blogħla konċentrazzjoni (Cmax) medja fil-plażma ta' madwar 40% inqas, erja taħt il-kurva talkonċentrazzjoni fil-plażma versus ħin (AUC) ta' 25% inqas, u titwil ta' 35 minuta fil-ħin sal-ogħla konċentrazzjoni fil-plażma (Tmax) wara l-għoti ta' pillola waħda ta' 850 mg ta' metformin mal-ikel, mqabbla mal-istess qawwa tal-pillola mogħtija waqt is-sawm.
English: Ertugliflozin and Metformin
Maltese: Ertugliflozin flimkien ma' metformin
English: The major metabolic pathway for ertugliflozin is UGT1A9 and UGT2B7-mediated O-glucuronidation to two glucuronides that are pharmacologically inactive at clinically relevant concentrations.
Maltese: Is-sensiela ta' reazzjonijiet metaboliċi prinċipali għal ertugliflozin hija glukuronidazzjoni O medjata minn UGT1A9 u UGT2B7 għal żewġ glukuronidi li huma farmakoloġikament inattivi f'konċentrazzjonijiet rilevanti b'mod kliniku.
English: In patients with type 2 diabetes treated with ertugliflozin in combination with metformin, clinically meaningful reductions in HbA1c were observed in subgroups defined by age, sex, race, ethnicity, geographic region, baseline BMI, baseline HbA1c, and duration of type 2 diabetes mellitus.
Maltese: F'pazjenti b'dijabete tat-tip 2 ttrattati b'ertugliflozin flimkien ma' metformin, ġie osservat tnaqqis ta' sinifikat kliniku fl-HbA1c f'sottogruppi definiti mill-età, mis-sess, mir-razza, mill-etniċità, mir-reġjun ġeografiku, mill-BMI fil-linja bażi, mill-HbA1c fil-linja bażi u mit-tul ta' żmien b'dijabete tat-tip 2.
English: Therefore, symptomatic hypotension may occur after initiating Segluromet (see section 4.8), particularly in patients with impaired renal function (eGFR less than 60 ml/min/1.73 m or a CrCl less than 60 ml/min), elderly patients (≥ 65 years), patients on diuretics, or patients on anti-hypertensive therapy with a history of hypotension.
Maltese: Għalhekk, tista' sseħħ pressjoni baxxa bis-sintomi wara li jinbeda Segluromet (ara sezzjoni 4.8), b'mod partikolari f'pazjenti b'funzjoni indebolita tal-kliewi (eGFR inqas minn 60 ml/min/1.73 m2 jew CrCl inqas minn 60 ml/min), pazjenti anzjani (≥ 65 sena), pazjenti fuq id-dijuretiċi, jew pazjenti fuq terapija kontra l-ipertensjoni bi storja ta' ipotensjoni.
English: When ertugliflozin was administered to juvenile rats from post-natal day (PND) 21 to PND 90, a period of renal development corresponding to the late second and third trimesters of human pregnancy, increased kidney weights, dilatation of the renal pelvis and tubules, and renal tubular mineralization were seen at an exposure 13 times the maximum clinical dose of 15 mg/day, based on AUC.
Maltese: Meta ertugliflozin ingħata lill-firien żgħażagħ mill-21 jum ta' wara t-twelid (PND, postnatal day) sad90 PND, li huwa perjodu ta' żvilupp tal-kliewi li jaqbel ma' tard fit-tieni u t-tielet trimestri tat-tqala tal-bniedem, dehru żieda fil-piż tal-kliewi, twessigħ tal-pelvi u tat-tubuli tal-kliewi, u mineralizzazzjoni tat-tubuli tal-kliewi b'esponiment 13-il darba aktar mid-doża klinika massima ta' 15-il mg/jum, abbażi tal-AUC.
English: Segluromet should be discontinued when GFR is persistently below 45 ml/min due to a reduction of efficacy.
Maltese: Segluromet għandu jitwaqqaf meta l-GFR tkun b'mod persistenti inqas minn 45 ml/min minħabba tnaqqis fl-effikaċja.
English: • Inhibitors of OCT1 (such as verapamil) may reduce efficacy of metformin.
Maltese: • Inibituri ta' OCT1 (bħal verapamil) jistgħu jnaqqsu l-effikaċja ta' metformin.
English: In patients with decreased renal function, the plasma and blood half-life of metformin is prolonged and the renal clearance is decreased in proportion to the decrease in eGFR (see sections 4.3 and 4.4).
Maltese: F'pazjenti b'funzjoni mnaqqsa tal-kliewi, il-half-life ta' metformin fil-plażma u fid-demm titwal u ttneħħija mill-kliewi tonqos fi proporzjon ma' tnaqqis fl-eGFR (ara sezzjonijiet 4.3 u 4.4).
English: Segluromet 2.5 mg/850 mg film-coated tablets Segluromet 2.5 mg/1,000 mg film-coated tablets Segluromet 7.5 mg/850 mg film-coated tablets Segluromet 7.5 mg/1,000 mg film-coated tablets
Maltese: Segluromet 2.5 mg/850 mg pilloli miksija b'rita Segluromet 2.5 mg/1,000 mg pilloli miksija b'rita Segluromet 7.5 mg/850 mg pilloli miksija b'rita Segluromet 7.5 mg/1,000 mg pilloli miksija b'rita
English: Ertugliflozin did not adversely affect developmental outcomes in rats and rabbits at maternal exposures that were 239 and 1,069 times, respectively, the human exposure at the maximum clinical dose of 15 mg/day, based on AUC.
Maltese: Ertugliflozin ma affettwax b'mod avvers riżultati ta' żvilupp fil-firien u fil-fniek b'esponiment tal-omm li kienu 239 u 1,069 darba, rispettivament, aktar millesponiment tal-bniedem bid-doża klinika massima ta' 15-il mg/jum, abbażi tal-AUC.
English: Diabetic ketoacidosis (ertugliflozin)
Maltese: Ketoaċidożi tad-dijabete (ertugliflozin)