FrancophonIA/ELRC3.0 huggingface dataset:
English: The safety of concomitantly administered ertugliflozin and sitagliptin has been evaluated in 990 patients with type 2 diabetes mellitus treated for 26 weeks in three studies; a factorial study of ertugliflozin 5 mg or 15 mg in combination with sitagliptin 100 mg once daily compared to the individual components, a placebo-controlled study of ertugliflozin 5 mg or 15 mg as add-on therapy to sitagliptin 100 mg and metformin once daily, and a placebo-controlled study of initial therapy with ertugliflozin 5 mg or 15 mg once daily in combination with sitagliptin 100 mg once daily (see section 5.1).
Maltese: Is-sigurtà ta' ertugliflozin mogħti flimkien ma' sitagliptin ġiet evalwata f'990 pazjent b'dijabete mellitus tat-tip 2 ittrattati għal 26 ġimgħa fi tliet studji; studju dwar fatturi ta' ertugliflozin 5 mg jew 15-il mg flimkien ma' sitagliptin 100 mg darba kuljum imqabbla mal-komponenti individwali, studju kkontrollat bi plaċebo ta' ertugliflozin 5 mg jew 15-il mg bħala terapija miżjuda ma' sitagliptin 100 mg u metformin darba kuljum, u studju kkontrollat bi plaċebo ta' terapija inizjali b'ertugliflozin 5 mg jew 15-il mg darba kuljum flimkien ma' sitagliptin 100 mg darba kuljum (ara sezzjoni 5.1). Linċidenza u t-tip ta' reazzjonijiet avversi f'dawn it-tliet studji kienu simili għar-reazzjonijiet avversi li dehru b'ertugliflozin u huma deskritti hawn taħt f'Tabella 1.
English: Sitagliptin Pharmacokinetic interactions
Maltese: Interazzjonijiet farmakokinetiċi
English: Following administration of 0.25 mg digoxin concomitantly with 100 mg of sitagliptin daily for 10 days, the plasma AUC of digoxin was increased on average by 11% and the plasma Cmax on average by 18%.
Maltese: Wara l-għoti ta' 0.25 mg digoxin flimkien ma' 100 mg ta' sitagliptin kuljum għal 10 ijiem, l-AUC ta' digoxin filplażma żdiedet b'medja ta' 11 %, u s-Cmax fil-plażma b'medja ta' 18 %.
English: Experience in New York Heart Association (NYHA) class I-II is limited, and there is no experience in clinical studies with Steglujan 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'Steglujan fil-klassi III- IV ta' NYHA.
English: Minimal increases in QTc, not considered to be clinically relevant, were observed in one study at a dose of 800 mg sitagliptin.
Maltese: Iż-żidiet minimi fil-QTc, li ma tqisux klinikament rilevanti, kienu osservati fi studju wieħed b'doża ta' 800 mg sitagliptin.
English: The study population included 2,004 patients ≥ 75 years of age and 3,324 patients with renal impairment (eGFR < 60 ml/min/1.73 m
Maltese: Il-popolazzjoni tal-istudju kienet tinkludi 2,004 pazjenti b'età ta' ≥ 75 sena u 3,324 pazjent b'indeboliment tal-kliewi (eGFR < 60 ml/min/1.73 m2).
English: For this reason, it is possible that potent CYP3A4 inhibitors (i.e., ketoconazole, itraconazole, ritonavir, clarithromycin) could alter the pharmacokinetics of sitagliptin in patients with severe renal impairment or ESRD.
Maltese: (jiġifierii.e. ketoconazole, itraconazole, ritonavir, clarithromycin) jistgħu jibdlu l-farmakokinetika ta' sitagliptin f'pazjenti b'indeboliment sever talkliewi jew ESRD.
English: The TECOS was a randomised study in 14,671 patients in the intention-to-treat population with an HbA1c of ≥ 6.5 to 8.0% with established CV disease who received sitagliptin (7,332) 100 mg daily (or 50 mg daily if the baseline eGFR was ≥ 30 and < 50 ml/min/1.73 m2) or placebo (7,339) added to usual care targeting regional standards for HbA1c and CV risk factors.
Maltese: TECOS kien studju arbitrarju f'14,671 pazjent fil-popolazzjoni bl-intenzjoni li tiġi ttrattata b'HbA1c ta' ≥ 6.5 sa 8.0% b'mard CV stabbilit li rċivew sitagliptin (7,332) 100 mg kuljum (jew 50 mg kuljum jekk l-eGFR fil-linja bażi kienet ≥ 30 u < 50 ml/min/1.73 m2) jew plaċebo (7,339) miżjud mal-kura tas-soltu li l-mira tiegħu kienet l-istandards reġjonali għal HbA1c u fatturi ta' riskju CV.
English: In the pool of placebo-controlled studies, the incidence of documented hypoglycemia 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: • when metformin and/or a sulphonylurea (SU) and one of the monocomponents of Steglujan do not provide adequate glycaemic control.
Maltese: • meta metformin u/jew wieħed mis-sulphonylureas (SU) u wieħed mill-monokomponenti ta'
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 (27.2%) meta mqabbla ma' ertugliflozin (5.6% u 8.2% għal ertugliflozin 5 mg u 15-il mg, rispettivament).
English: Table 3: Results at Week 26 from an add-on study of ertugliflozin in combination with metformin and sitagliptin*
Maltese: Tabella 3: Riżultati f'Ġimgħa 26 minn studju ta' ertugliflozin miżjud flimkien ma' metformin u sitagliptin*
English: These included hypoglycaemia (frequency very common with the combination of sulphonylurea and metformin), influenza (common with insulin (with or without metformin)), nausea and vomiting (common with metformin), flatulence (common with metformin or pioglitazone), constipation (common with the combination of sulphonylurea and metformin), peripheral oedema (common with pioglitazone or the combination of pioglitazone and metformin), somnolence and diarrhoea (uncommon with metformin), and dry mouth (uncommon with insulin (with or without metformin)).
Maltese: Dawn kienu jinkludu ipogliċemija (frekwenza komuni ħafna ma' sulphonylurea flimkien ma' metformin), influwenza (komuni bl-insulina (flimkien ma' metformin jew mingħajru)), nawsja u rimettar (komuni ma' metformin), gass (komuni ma' metformin jew pioglitazone), stitikezza (komuni ma' sulphonylurea flimkien ma' metformin), edima periferali (komuni ma' pioglitazone jew ma'
English: • Steglujan lowers blood sugar levels in adult patients (aged 18 years and older) with type 2
Maltese: • Steglujan ibaxxi l-livelli taz-zokkor fid-demm f'pazjenti adulti (li għandhom 18-il sena u aktar)
English: When used in monotherapy, ertugliflozin 5 and 15 mg resulted in statistically significant placebocorrected reductions in 2-hour post-prandial glucose (PPG) of 3.83 and 3.74 mmol/l.
Maltese: Meta ntuża bħala monoterapija, ertugliflozin 5 mg u 15-il mg wassal għal tnaqqis sinifikanti b'mod statistiku kkoreġut mill-plaċebo ta' 3.83 u 3.74 mmol/l fil-glucose ta' wara l-ikel (PPG, post-prandial glucose) wara sagħtejn.
English: Diabetic Ketoacidosis (ertugliflozin)
Maltese: Ketoaċidożi tad-Dijabete (ertugliflozin)
English: Table 2: 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 2: Riżultati f'Ġimgħa 26 minn studju dwar fatturi b'ertugliflozin u sitagliptin bħala terapiji miżjuda flimkien ma' metformin imqabbla mal-komponenti individwali waħedhom*
English: Sitagliptin prevents the hydrolysis of incretin hormones by DPP-4, thereby increasing plasma concentrations of the active forms of GLP-1 and GIP.
Maltese: Sitagliptin jipprevjeni lidrolisi tal-ormoni incretin minn DPP-4, u b'hekk iwassal għal żieda fil-konċentrazzjonijiet tal-forom attivi ta' GLP-1 u GIP fil-plażma.
English: TECOS (trial evaluating cardiovascular outcomes with sitagliptin) The cardiovascular safety study with sitagliptin (TECOS) included 7,332 patients treated with sitagliptin, 100 mg daily (or 50 mg daily if the baseline eGFR was ≥ 30 and < 50 ml/min/1.73 m2), and
Maltese: L-istudju dwar sigurtà kardjovaskulari b'sitagliptin (TECOS) kien jinkludi 7,332 pazjent ittrattati b'sitagliptin, 100 mg kuljum (jew 50 mg kuljum jekk l-eGFR fil-linja bażi kienet ≥ 30 u < 50 mL/min/1.73 m2), u 7,339 pazjent ittrattati bi plaċebo fil-popolazzjoni bl-intenzjoni li tiġi ttrattata.
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'HbA1c ≥ 10% fil-linja bażi, 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: Elderly subjects (65 to 80 years) had approximately 19% higher plasma concentrations of sitagliptin compared to younger subjects.
Maltese: Individwi anzjani (65 sa 80 sena) kellhom konċentrazzjonijiet ta' sitagliptin fil-plażma madwar 19% ogħla mqabbla ma' individwi iżgħar.
English: In vitro data suggest that sitagliptin does not inhibit or induce CYP450 isoenzymes.
Maltese: Data in vitro tissuġġerixxi li sitagliptin la jinibixxi u l-anqas jinduċi l-isoenzimi CYP450.
English: ,a,2
Maltese: Ħakka,2
English: Steglujan 5 mg/100 mg tablets ertugliflozin/sitagliptin
Maltese: Steglujan 5 mg/100 mg pilloli ertugliflozin/sitagliptin
English: The mean age of the patients across these 3 studies ranged from 55.1 to 59.1 years (range 21 years to 85 years).
Maltese: L-età medja tal-pazjenti f'dawn it-3 studji kienet tvarja minn 55.1 sa 59.1 snin (firxa minn 21 sena sa 85 sena).
English: Hypersensitivity to the active substances or to any of the excipients listed in section 6.1.
Maltese: Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe sustanza mhux attiva elenkata fissezzjoni 6.1.
English: Post-marketing reports of serious hypersensitivity reactions in patients treated with sitagliptin have been reported (see section 4.8).
Maltese: Kien hemm rapporti wara t-tqegħid fis-suq ta' reazzjonijiet ta' sensittività eċċessiva serji f'pazjenti ttrattati b'sitagliptin (ara sezzjoni 4.8).
English: Hispanic or Latino patients comprised 15.6% to 36.1% of the population.
Maltese: 6% sa 36.1% tal-popolazzjoni.
English: Across the 3 studies, the racial distribution ranged from 72.9% to 90.4% White, 0.0% to 20.3% Asian, 1.9% to 4.5% Black and 4.8% to 5.4% Other.
Maltese: 3% Asjatiċi, 1.9% sa 4.5% Suwed u 4.8% sa 5.4% Oħrajn.
English: Brown, 12.0 x 7.4 mm, almond-shaped, film-coated tablets debossed with “555” on one side and plain on the other side.
Maltese: Pilloli miksija b'rita, kannella, forma ta' lewża, 12.0 x 7.4 mm, imnaqqxa b'“555” fuq naħa waħda u bla marki fuq in-naħa l-oħra.
English: Cases of inflammation of the pancreas (pancreatitis) have been reported in patients receiving sitagliptin (see section 4).
Maltese: Dawn il-kondizzjonijiet mediċi jistgħu jżidu ċċans li taqbdek pankreatite (ara sezzjoni 4).
English: If Fournier's gangrene is suspected, Steglujan should be discontinued and prompt treatment (including antibiotics and surgical debridement) should be instituted.
Maltese: Jekk ikun hemm suspett ta' kankrena ta' Fournier, Steglujan għandu jitwaqqaf u jinbeda trattament fil-pront (li jinkludi antibijotiċi u t-tneħħija kirurġika tal-parti affettwata).
English: Vulvovaginal pruritus
Maltese: Pemfigojd bulluż
English: Effects of age, body weight, gender and race
Maltese: Effetti tal-età, tal-piż tal-ġisem, tas-sess tal-persuna, u tar-razza
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: Sitagliptin is a member of a class of oral antihyperglycaemic agents called dipeptidyl peptidase 4 (DPP-4) inhibitors.
Maltese: Sitagliptin huwa membru ta' klassi ta' sustanzi kontra l-ipergliċemija li jittieħdu mill-ħalq li jissejħu inibituri ta' dipeptidyl peptidase 4 (DPP-4).
English: Steglujan 15 mg/100 mg
Maltese: Steglujan 15-il mg/100 mg
English: Bullous pemphigoid a, * ,2
Maltese: Uġigħ fid-dahar a,2 Artropatija a,2
English: TECOS Cardiovascular Safety Study
Maltese: L-Istudju ta' Sigurtà Kardjovaskulari TECOS
English: How to store Steglujan 6.
Maltese: Kif taħżen Steglujan 6.
English: Alternative methods should be used to monitor glycaemic control.
Maltese: Steglujan ma jipprovdux kontroll gliċemiku adegwat.
English: Additionally, when added on to background metformin and sitagliptin therapy, ertugliflozin 5 mg and 15 mg resulted in statistically significant placebo subtracted reductions in SBP of 2.9 and 3.9 mmHg, respectively.
Maltese: 15-il mg wassal għal tnaqqis sinifikanti b'mod statistiku fl-SBP imnaqqas mill-plaċebo ta' 2.9 u 3.9 mmHg, rispettivament.
English: Age did not have a clinically meaningful impact on the pharmacokinetics of sitagliptin based on a population pharmacokinetic analysis of Phase 1 and Phase 2 data.
Maltese: L-età ma kellha l-ebda impatt ta' sinifikat kliniku fuq il-farmakokinetika ta' sitagliptin abbażi ta' analiżi farmakokinetika ta' popolazzjoni ta' data ta' Fażi 1 u Fażi 2.
English: • Sitagliptin helps to increase the levels of insulin produced after a meal.
Maltese: • Sitagliptin jgħin biex iżid il-livelli ta' insulina li jipproduċi l-ġisem tiegħek wara ikla.
English: Ertugliflozin 5 mg Ertugliflozin 15 mg Placebo
Maltese: Ertugliflozin 5 mg Ertugliflozin 15-il mg
English: In addition, GLP-1 lowers glucagon secretion from pancreatic alpha cells.
Maltese: Barra dan, GLP-1 inaqqas it-tnixxija ta' glucagon miċ-ċelluli alfa tal-frixa.
English: The efficacy and safety of ertugliflozin in combination with sitagliptin have been studied in 3 multicentre, randomised, double-blind, placebo- and active comparator-controlled, Phase 3 clinical studies involving 1,985 patients with type 2 diabetes.
Maltese: L-effikaċja u s-sigurtà ta' ertugliflozin flimkien ma' sitagliptin ġew studjati fi 3 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 sustanza qed tintuża, li kienu jinvolvu 1,985 pazjent b'dijabete tat-tip 2.
English: These characteristics had no clinically meaningful effect on the pharmacokinetics of sitagliptin based on a composite analysis of Phase 1 pharmacokinetic data and on a population pharmacokinetic analysis of Phase 1 and Phase 2 data.
Maltese: Dawn il-karatteristiċi ma' kellhom l-ebda effett ta' sinifikat kliniku fuq il-farmakokinetika ta' sitagliptin abbażi ta' analiżi komposta ta' data farmakokinetika ta' Fażi 1 u fuq analiżi farmokokinetika ta' popolazzjoni ta' data ta' Fażi 1 u Fażi 2.
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: 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: Incretin hormones, including glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), are released by the intestine throughout the day, and levels are increased in response to a meal.
Maltese: L-ormoni incretins, li jinkludu l-peptide-1 li qisu glucagon (GLP-1, glucagon-like peptide-1), u l-polypeptide insulinotropiku li jiddependi mill-glucose (GIP - glucose-dependent insulinotrophic polypeptide), jintreħew mill intestini matul il-ġurnata, u l-livelli jogħlew b'rispons għal ikla.
English: Steglujan 15 mg/100 mg tablets ertugliflozin/sitagliptin
Maltese: Steglujan 15-il mg/100 mg pilloli ertugliflozin/sitagliptin
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
English: In patients with type 2 diabetes with hyperglycaemia, these changes in insulin and glucagon levels lead to lower haemoglobin A1c (HbA1c) and lower fasting and post-prandial glucose concentrations.
Maltese: F'pazjenti b'dijabete tattip 2 bl-ipergliċemija, dawn il-bidliet fil-livelli tal-insulina u l-glucagon iwasslu għal tnaqqis flemoglobina A1c (HbA1c) u jnaqqsu l-konċentrazzjonijiet ta' glucose waqt is-sawm u wara l-ikel.
English: In Phase 1 multiple-dose studies, there were no dose-related clinical adverse reactions observed with sitagliptin with doses of up to 600 mg per day for periods of up to 10 days and 400 mg per day for periods of up to 28 days.
Maltese: Fi studji ta' Fażi 1 b'ħafna dożi, ma kien hemm l-ebda reazzjonijiet kliniċi avversi marbuta mad-doża osservati b'sitagliptin b'dożi sa 600 mg kuljum għal perjodi sa 10 ijiem u 400 mg kuljum għal perjodi sa 28 jum.
English: Table 4: Results at Week-26 from a combination therapy study of ertugliflozin and sitagliptin*
Maltese: Tabella 4: Riżultati f'Ġimgħa 26 minn studju ta' terapija b'ertugliflozin flimkien ma' sitagliptin*
English: Elderly patients are more likely to have decreased renal function.
Maltese: Pazjenti anzjani huma aktar probabbli li jkollhom tnaqqis fil-funzjoni tal-kliewi.
English: Beige, 12.0 x 7.4 mm, almond-shaped, film-coated tablets debossed with “554” on one side and plain on the other side.
Maltese: Pilloli miksija b'rita, kannella fl-isfar, forma ta' lewża, 12.0 x 7.4 mm, imnaqqxa b'“554” fuq naħa waħda u bla marki fuq in-naħa l-oħra.
English: Further, GLP-1 does not impair the normal glucagon response to hypoglycaemia.
Maltese: Apparti dan, GLP-1 ma jfixkilx irrispons normali tal-glucagon għall-ipogliċemija.
English: Hypoglycaemia has been observed when sitagliptin was used in combination with insulin or a sulphonylurea.
Maltese: Ġiet osservata ipogliċemija meta sitagliptin intuża flimkien ma' insulina jew sulphonylurea.
English: Acute renal failure a,2
Maltese: Insuffiċjenza akuta tal-kliewia,2
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: 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: 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 2).
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 2).
English: Metabolism may play a more significant role in the elimination of sitagliptin in the setting of severe renal impairment or end-stage renal disease (ESRD).
Maltese: Il-metaboliżmu jista' jkolllu rwol aktar sinifikanti fleliminazzjoni ta' sitagliptin fejn ikun hemm indeboliment sever tal-kliewi jew mard tal-kliewi fl-aħħar stadju (ESRD, end-stage renal disease).
English: • Steglujan 15 mg/100 mg film-coated tablets (tablets) are brown, 12.0 x 7.4 mm, almond-shaped,
Maltese: • Il-pilloli miksija b'rita (pilloli) Steglujan 15-il mg/100 mg huma pilloli miksija b'rita, kannella, forma ta' lewża, 12.0 x 7.4 mm, imnaqqxa b'“555” fuq naħa waħda u bla marki fuq in-naħa loħra.
English: • Steglujan can be used instead of taking both ertugliflozin and sitagliptin as separate tablets.
Maltese: • Steglujan jista' jintuża minflok tieħu ertugliflozin u sitagliptin bħala pilloli separati.
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: In a two-day study in healthy subjects, sitagliptin alone increased active GLP-1 concentrations, whereas metformin alone increased active and total GLP-1 concentrations to similar extents.
Maltese: Fi studju ta' jumejn f'individwi f'saħħithom, sitagliptin waħdu żied il-konċentrazzjonijiet ta' GLP-1 attiv, filwaqt li metformin waħdu żied il-konċentrazzjonijiet ta' GLP-1 attiv u totali sa punt simili.
English: The apparent terminal t1/2 following a 100-mg oral dose of sitagliptin was approximately
Maltese: It-t1/2 terminali apparenti wara doża ta' 100 mg sitagliptin mill-ħalq kienet ta' madwar 12.4 sigħat.
English: • stuffy or runny nose and sore throat
Maltese: • tħossok imdardar/ra jew tirremetti
English: The most commonly reported adverse reactions across the clinical program were vulvovaginal mycotic infection and other female genital mycotic infections.
Maltese: L-aktar reazzjonijiet avversi rrappurtati b'mod komuni matul il-programm kliniku kollu kienu infezzjoni mikotika fil-vulva u l-vaġina, u infezzjonijiet mikotiċi oħra fil-ġenitali tan-nisa.
English: The effects of GLP-1 and GIP are glucose-dependent such that when blood glucose concentrations are low, stimulation of insulin release and suppression of glucagon secretion by GLP-1 are not observed.
Maltese: L-effetti ta' GLP-1 u GIP jiddependu mill-glucose b'tali mod li meta l-konċentrazzjonijiet ta' glucose fid-demm ikunu baxxi, lstimuli ta' rilaxx tal-insulina u t-trażżin tat-tnixxija tal-glucagon minn GLP-1, ma jiġux osservati.
English: Sitagliptin accumulates only minimally with multiple doses.
Maltese: Sitagliptin jakkumula biss b'mod minimu b'dożi multipli.
English: Sitagliptin is a potent and highly selective inhibitor of the enzyme DPP-4 and does not inhibit the closely-related enzymes DPP-8 or DPP-9 at therapeutic concentrations.
Maltese: Sitagliptin huwa inibitur qawwi u selettiv ħafna tal-enzima DPP-4 u f'konċentrazzjonijiet terapewtiċi ma jinibixxix l-enzimi DPP-8 jew DPP-9 li huma relatati mill-qrib.
English: Thrombocytopenia
Maltese: Il-Belġju