FrancophonIA/ELRC3.0 huggingface dataset:
English: Frequency categories are defined according to the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Maltese: Il-kategoriji ta' frekwenza huma definiti skont il-konvenzjoni li ġejja: komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100), rari (≥ 1/10,000 sa < 1/1,000), rari ħafna (< 1/10,000), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Packs of 14, 28, 30, 84, 90 and 98 film-coated tablets in non-perforated blisters.
Maltese: Pakketti ta' 14, 28, 30, 84, 90 u 98 pillola miksija b'rita f'folji mingħajr sarbut toqob.
English: • Steglatro 5 mg film-coated tablets (tablets) are pink, 6.4 x 6.6 mm, triangular-shaped, with
Maltese: • Il-pilloli miksija b'rita (pilloli) Steglatro 5 mg huma roża, 6.4 x 6.6 mm, forma trijagolari,
English: The racial distribution was 76.8% White, 13.3% Asian, 5.0% Black and 4.8% other.
Maltese: Id-distribuzzjoni tar-razez kienet 76.8% Bojod, 13.3% Asjatiċi, 5.0% Suwed u 4.8% oħrajn.
English: Patients [N (%)] with HbA1c <7% Body Weight (kg)
Maltese: Pazjenti [N (%)] b'HbA1c <7% Piż tal-ġisem (kg)
English: Mean percent changes from baseline for ertugliflozin 5 mg and 15 mg versus placebo, respectively, were LDL-C 5.8% and 8.4% versus 3.2%; total cholesterol 2.8% and 5.7% versus 1.1%; however, HDL-C 6.2% and 7.6% versus 1.9%.
Maltese: Bidliet perċentwali medji mil-linja bażi għal ertugliflozin 5 mg u 15-il mg versus plaċebo, rispettivament, kienu LDL-C 5.8% u 8.4% versus 3.2%; kolesterol totali 2.8% u 5.7% versus 1.1%; madankollu, HDL-C 6.2% u 7.6% versus 1.9%.
English: Efficacy in patients with baseline HbA1c ≥ 8%
Maltese: Effikaċja f'pazjenti b'HbA1c ≥ 8% fil-linja bażi
English: Coadministration of simvastatin with ertugliflozin resulted in a 24% and 19% increase in AUC and Cmax of simvastatin, respectively, and 30% and 16% increase in AUC and Cmax of simvastatin acid, respectively.
Maltese: L-għoti ta' simvastatin flimkien ma' ertugliflozin wassal għal żieda ta' 24% u 19% fl-AUC u s-Cmax ta' simvastatin, rispettivament, u żieda ta' 30% u 16% fl-AUC u s-Cmax tal-aċidu ta' simvastatin, rispettivament.
English: (For study results with respect to combinations and effects on glycaemic control see sections 4.4, 4.5, and 5.1.)
Maltese: (Għal riżultati tal-istudji dwar kombinazzjonijiet u effetti fuq il-kontroll gliċemiku ara sezzjonijiet 4.4, 4.5, u 5.1.)
English: EU/1/18/1267/007 (14 film-coated tablets) EU/1/18/1267/008 (28 film-coated tablets) EU/1/18/1267/009 (30 film-coated tablets) EU/1/18/1267/010 (30x1 film-coated tablets) EU/1/18/1267/011 (84 film-coated tablets) EU/1/18/1267/012 (90 film-coated tablets) EU/1/18/1267/014 (98 film-coated tablets)
Maltese: EU/1/18/1267/007 (14-il pillola miksija b'rita) EU/1/18/1267/008 (28 pillola miksija b'rita) EU/1/18/1267/009 (30 pillola miksija b'rita) EU/1/18/1267/010 (30x1 pillola miksija b'rita) EU/1/18/1267/011 (84 pillola miksija b'rita) EU/1/18/1267/012 (90 pillola miksija b'rita) EU/1/18/1267/014 (98 pillola miksija b'rita)
English: Ertugliflozin 15 mg + Sitagliptin
Maltese: Ertugliflozin 15-il mg + Sitagliptin
English: The mean daily dose of glimepiride was 3.0 mg (see Table 4).
Maltese: Iddoża medja ta' kuljum ta' glimepiride kienet 3.0 mg (Ara Tabella 4.)
English: • The other ingredients are: o Tablet core: microcrystalline cellulose (E460), lactose monohydrate (see section 2), sodium starch glycolate (Type A), magnesium stearate (E470b).
Maltese: o Qalba tal-pillola: microcrystalline cellulose (E460), lactose monohydrate (ara sezzjoni 2), sodium starch glycolate (Type A), magnesium stearate (E470b).
English: “701” on one side and plain on the other side.
Maltese: b'“701” fuq naħa waħda u mingħajr marki fuq in-naħa l-oħra.
English: Do not take Steglatro
Maltese: Tiħux Steglatro
English: Pink, 6.4 x 6.6 mm, triangular-shaped, film-coated tablets debossed with “701” on one side and plain on the other side.
Maltese: Pilloli miksija b'rita, roża, 6.4 x 6.6 mm, b'forma trijangolari, imnaqqxa b'“701” fuq naħa waħda u bla marki fuq in-naħa l-oħra.
English: Across the clinical program, ketoacidosis was identified in 3 of 3,409 (0.1%) ertugliflozin-treated patients and 0.0% of comparator-treated patients (see section 4.4).
Maltese: Matul il-programm kliniku, ketoaċidożi ġiet identifikata fi 3 minn 3,409 (0.1%) pazjenti ttrattati b'ertugliflozin u 0.0% tal-pazjenti ttrattati b'sustanza ta' paragun (ara sezzjoni 4.4).
English: In a subsequent analysis excluding those subjects who used the prohibited medication, ertugliflozin 5 mg and 15 mg were associated with placebo-corrected reductions in HbA1c of -0.14 (-0.36, 0.08) and -0.33 (-0.55, -0.11)
Maltese: F'analiżi sussegwenti li eskludiet dawk lindividwi li wżaw il-medikazzjoni pprojbita, ertugliflozin 5 mg u 15-il mg ġew assoċjati ma' tnaqqis fl-HbA1c ikkoreġut mill-plaċebo ta' -0.14 (-0.36, 0.08) u -0.33 (-0.55, -0.11).
English: Table 2: Results at Week 26 from a placebo-controlled monotherapy study of Steglatro*
Maltese: Tabella 2: Riżultati f'Ġimgħa 26 minn studju ikkontrollat bil-plaċebo ta' monoterapija b'Steglatro*
English: For ertugliflozin 5 mg and 15 mg, the statistically significant placebo-corrected reductions in SBP ranged from 2.9 mmHg to 3.7 mmHg and 1.7 mmHg to 4.5 mmHg, respectively.
Maltese: Għal ertugliflozin 5 mg u 15-il mg, it-tnaqqis sinifikanti b'mod statistiku kkoreġut bil-plaċebo fl-SBP kien ivarja minn 2.9 mmHg sa 3.7 mmHg u 1.7 mmHg sa 4.5 mmHg, rispettivament.
English: The pack sizes are 14, 28, 30, 84, 90 and 98 filmcoated tablets in non-perforated blisters and 30x1 film-coated tablets in perforated unit dose blisters.
Maltese: Id-daqsijiet tal-pakketti huma 14, 28, 30, 84, 90 u 98 pillola miksija b'rita f'folji mingħajr sarbut toqob u 30x1 pillola miksija b'rita f'folji mtaqbin b'sarbut toqob biex tinqata' doża waħda.
English: EU/1/18/1267/001 (14 film-coated tablets) EU/1/18/1267/002 (28 film-coated tablets) EU/1/18/1267/003 (30 film-coated tablets) EU/1/18/1267/004 (30x1 film-coated tablets) EU/1/18/1267/005 (84 film-coated tablets) EU/1/18/1267/006 (90 film-coated tablets) EU/1/18/1267/013 (98 film-coated tablets)
Maltese: EU/1/18/1267/002 (28 pillola miksija b'rita) EU/1/18/1267/003 (30 pillola miksija b'rita) EU/1/18/1267/004 (30x1 pillola miksija b'rita) EU/1/18/1267/005 (84 pillola miksija b'rita)
English: 14 film-coated tablets 28 film-coated tablets 30 film-coated tablets 30x1 film-coated tablets 84 film-coated tablets 90 film-coated tablets 98 film-coated tablets
Maltese: 14-il pillola miksija b'rita 28 pillola miksija b'rita 30 pillola miksija b'rita 30x1 pillola miksija b'rita 84 pillola miksija b'rita 90 pillola miksija b'rita 98 pillola miksija b'rita
English: Red, 9.0 x 9.4 mm, triangular-shaped, film-coated tablets debossed with “702” on one side and plain on the other side.
Maltese: x 9.4 mm, b'forma trijangolari, imnaqqxa b'“702” fuq naħa waħda u bla marki fuq in-naħa l-oħra.
English: Patients [N (%)] with HbA1c < 7% 66 (26.4) Body Weight (kg)
Maltese: (medja tal-LS†, CI ta' 95%) Pazjenti [N (%)] b'HbA1c < 7% 66 (26.4) Piż tal-Ġisem (kg)
English: Patients had an average age of 57.8 years (range 21 years to 87 years), with 25.8% of patients ≥ 65 years of age and 4.5% ≥ 75 years of age.
Maltese: Il-pazjenti kellhom età medja ta' 57.8 snin (firxa minn 21 sena sa 87 sena), b'25.8% tal-pazjenti b'età ≥ 65 sena u 4.5% b'età ≥ 75 sena.
English: Pharmacologically-mediated effects were observed in juvenile rats (see section 5.3).
Maltese: Effetti medjati b'mod farmakoloġiku ġew osservati f'firien żgħażagħ (ara sezzjoni 5.3).
English: Steglatro contains lactose
Maltese: Steglatro fih lactose
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' metformin
English: Steglatro is a member of a group of medicines called sodium glucose co-transporter-2 (SGLT2) inhibitors.
Maltese: Steglatro huwa membru ta' grupp ta' mediċini msejħa inibituri tal-kotrasportatur 2 tas-sodium u lglucose (SGLT2, sodium glucose co-transporter-2).
English: In the monotherapy study, ertugliflozin 5 and 15 mg resulted in statistically significant placebocorrected reductions in 2-hour PPG of 3.83 and 3.74 mmol/l.
Maltese: Fl-istudju ta' 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-PPG wara sagħtejn.
English: Patients with rare hereditary problems of galactose intolerance, total lactase deficiency, or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Pazjenti li għandhom problemi ereditarji rari ta' intolleranza għall-galactose, nuqqas totali ta' lactase, jew malassorbiment tal-glucose-galactose m'għandhomx jieħdu dan il-prodott mediċinali.
English: The tablets contain lactose monohydrate.
Maltese: Lactose monohydrate
English: The placebo-corrected reductions of ertugliflozin 5 or 15 mg in combination with sitagliptin were 2.16 and 2.56 mmol/l.
Maltese: It-tnaqqis ta' ertugliflozin 5 jew 15-il mg flimkien ma' sitagliptin ikkoreġut millplaċebo kien 2.16 u 2.56 mmol/l.
English: In three placebo-controlled studies, ertugliflozin resulted in statistically significant reductions in FPG.
Maltese: Fi tliet studji kontrollati bil-plaċebo, ertugliflozin wassal għal tnaqqis sinifikanti b'mod statistiku flFPG.
English: Most toxicity was consistent with pharmacology related to urinary glucose loss and included decreased body weight and body fat, increased food consumption, diarrhoea, dehydration, decreased serum glucose and increases in other serum parameters reflective of increased protein metabolism, gluconeogenesis and electrolyte imbalances, and urinary changes such as polyuria, glucosuria, and calciuria.
Maltese: Il-biċċa l-kbira tat-tossiċità kienet konsistenti ma' farmakoloġija marbuta mat-telf tal-glucose fl-awrina u kienet tinkludi tnaqqis fil-piż u fix-xaħam tal-ġisem, żieda fil-konsum tal-ikel, dijarea, deidratazzjoni, tnaqqis fil-glucose fis-serum u żidiet f'parametri oħra tas-serum li jirriflettu żieda fil-metaboliżmu tal-proteina, glukoneoġenesi u żbilanċ flelettroliti, u bidliet fl-awrina bħal poliurja, glukosurja, u kalċjurja.
English: The combination of ertugliflozin 5 or 15 mg and sitagliptin resulted in incremental FPG reductions of 0.46 to 0.65 mmol/l compared to the ertugliflozin alone or 1.02 to 1.28 mmol/l compared to sitagliptin alone.
Maltese: Il-kombinazzjoni ta' ertugliflozin 5 jew 15-il mg u sitagliptin wasslet għal tnaqqis inkrementali fl-FPG ta' 0.46 sa 0.65 mmol/l meta mqabbla ma' ertugliflozin waħdu jew 1.02 sa 1.28 mmol/l meta mqabbla ma' sitagliptin waħdu.
English: The efficacy and safety of ertugliflozin have been studied in 7 multi-centre, randomised, double-blind, placebo- or active comparator-controlled, Phase 3 clinical studies involving 4,863 patients with type 2 diabetes, including a study of 468 patients with moderate renal impairment.
Maltese: L-effikaċja u s-sigurtà ta' ertugliflozin ġew studjati f'7 studji kliniċi, ta' Fażi 3, b'ħafna ċentri, arbitrarji, ikkontrollati bil-plaċebo jew b'sustanza attiva ta' paragun, fejn la l-investigaturi u lanqas lindividwi ma kienu jafu liema sustanza qed tintuża, li kienu jinvolvu 4,863 pazjent b'dijabete tat-tip 2, inkluż studju ta' 468 pazjent b'indeboliment moderat tal-kliewi.
English: Necrotising fasciitis of the perineum (Fournier's gangrene)*
Maltese: Fasciitis nekrotika tal-perineum (Kankrena ta'
English: “702” on one side and plain on the other side.
Maltese: b'“702” fuq naħa waħda u mingħajr marki fuq in-naħa l-oħra.
English: • in addition to other medicinal products for the treatment of diabetes.
Maltese: • flimkien ma' prodotti mediċinali oħra għat-trattament tad-dijabete.
English: Ertugliflozin has been studied as monotherapy and in combination with metformin and/or a dipeptidyl peptidase 4 (DPP-4) inhibitor.
Maltese: Ertugliflozin ġie studjat bħala monoterapija u flimkien ma' metformin u/jew inibitur ta' dipeptidyl peptidase 4 (DPP-4).
English: Pharmacotherapeutic group: Drugs used in diabetes, Sodium glucose co-transporter 2 (SGLT2) inhibitors, ATC code: A10BK04.
Maltese: Mediċini li jintużaw fid-dijabete, inibituri tal-kotrasportatur 2 ta' sodium u glucose (SGLT2), Kodiċi ATC:
English: The efficacy of ertugliflozin was also assessed separately in a dedicated study of diabetic patients with moderate renal impairment (468 patients with eGFR ≥ 30 to < 60 ml/min/1.73 m
Maltese: L-effikaċja ta' ertugliflozin ġiet evalwata wkoll b'mod separat fi studju apposta ta' pazjenti dijabetiċi b'indeboliment moderat tal-kliewi (468 pazjent b'eGFR ≥ 30 sa < 60 ml/min/1.73 m2).
English: Steglatro 5 mg Steglatro 15 mg Glimepiride
Maltese: Steglatro 5 mg Steglatro 15-il mg Glimepiride
English: Steglatro 15 mg + Sitagliptin 100 mg
Maltese: Steglatro 15-il mg + Sitagliptin 100 mg
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: Initiation of this medicinal product is not recommended in patients with an estimated glomerular filtration rate (eGFR) less than 60 ml/min/1.73 m2 or CrCl less than 60 ml/min (see section 4.4).
Maltese: Dan il-prodott mediċinali mhuwiex rakkomandat li jinbeda f'pazjenti bi stima tar-rata ta' filtrazzjoni mill-glomeruli (eGFR, estimated glomerular filtration rate) inqas minn 60 ml/min/1.73 m2 jew CrCl inqas minn 60 ml/min (ara sezzjoni 4.4).
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 MRHD 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: ¶, Haemoglobin increased
Maltese: (imsejħa emoglobina)
English: Steglatro 5 mg tablets ertugliflozin
Maltese: Steglatro 5 mg pilloli ertugliflozin
English: If Fournier's gangrene is suspected, Steglatro should be discontinued and prompt treatment (including antibiotics and surgical debridement) should be instituted.
Maltese: Jekk ikun hemm suspett ta' kankrena ta' Fournier, Steglatro għandu jitwaqqaf u jinbeda trattament fil-pront (li jinkludi antibijotiċi u t-tneħħija kirurġika tal-parti affettwata).
English: Excipient(s) with known effect Each tablet contains 28 mg of lactose (as monohydrate).
Maltese: Kull pillola fiha 28 mg ta' lactose (bħala monohydrate).
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 talkliewi, ipertrofija taż-żona glomerulosa fil-glandoli adrenali (firien), u żieda fl-għadam trabekulari (firien).
English: Ertugliflozin is expected to have diminished efficacy in elderly patients with renal impairment (see sections 4.2 and 4.8).
Maltese: Ertugliflozin huwa mistenni li jkollu effikaċja mnaqqsa f'pazjenti anzjani b'indeboliment tal-kliewi (ara sezzjonijiet 4.2 u 4.8).
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% 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 fuq metformin b'HbA1c minn 7.511.0% 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 fl-HbA1c ta' 2.35% u 2.66% meta mqabbel ma' 2.10%, 1.30%, u 1.82% għal ertugliflozin 5 mg, ertugliflozin 15-il mg u sitagliptin waħedhom, rispettivament.
English: • Steglatro 15 mg film-coated tablets (tablets) are red, 9.0 x 9.4 mm, triangular-shaped, with
Maltese: • Il-pilloli miksija b'rita (pilloli) Steglatro 15-il mg huma ħomor, 9.0
English: Difference from placebo (LS mean
Maltese: Differenza mill-plaċebo (medja tal-LS†, CI ta'
English: Steglatro 5 mg Steglatro 15 mg
Maltese: Steglatro 5 mg Steglatro 15-il mg
English: In the study of ertugliflozin added-on to 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 and 15 mg, respectively.
Maltese: Fl-istudju ta' ertugliflozin miżjud ma' metformin f'pazjenti b'HbA1c minn 7.0-10.5% fil-linja bażi, ittnaqqis fl-HbA1c ikkoreġut mill-plaċebo għas-sottogrupp ta' pazjenti fl-istudju b'HbA1c ≥ 9% fillinja bażi kien 1.31% u 1.43% b'ertugliflozin 5 mg u ertugliflozin 15-il mg, rispettivament.
English: When ertugliflozin was administered to juvenile rats from postnatal 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: Tel: 0800 9999 000 (+ 31 23 515 3153) medicalinfo.nl@merck.com
Maltese: Nederland Merck Sharp & Dohme B.V. Tel: 0800 9999 000 (+ 31 23 515 3153) medicalinfo.nl@merck.com
English: In patients with type 2 diabetes treated with ertugliflozin, 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, ġie osservat tnaqqis ta' sinifikat kliniku flHbA1c f'sottogruppi definiti mill-età, mis-sess, mir-razza, mill-etniċità, mir-reġjun ġeografiku, millBMI fil-linja bażi, mill-HbA1c fil-linja bażi u mit-tul ta' żmien b'dijabete tat-tip 2.
English: Only 1.5% of the administered dose was excreted as unchanged ertugliflozin in urine and 34% as unchanged ertugliflozin in faeces, which is likely due to biliary excretion of glucuronide metabolites and subsequent hydrolysis to parent.
Maltese: 1.5% biss mid-doża mogħtija tneħħa bħala ertugliflozin mhux mibdul fl-awrina u 34% bħala ertugliflozin mhux mibdul fl-ippurgar, li x'aktarx huwa minħabba tneħħija tal-metaboliti glukuronidi mill-bila u idrolisi sussegwenti lillmediċina oriġinali.
English: In three 26-week, placebo-controlled studies, ertugliflozin reduced systolic blood pressure (SBP).
Maltese: Fi tliet studji ta' 26 ġimgħa, ikkontrollati bil-plaċebo, ertugliflozin naqqas il-pressjoni sistolika taddemm (SBP, systolic blood pressure).
English: Pool of placebo-controlled trials evaluating Steglatro 5 mg and 15 mg The primary assessment of safety was conducted in a pool of three 26-week, placebo-controlled trials.
Maltese: Ġabra ta' provi kkontrollati bil-plaċebo li vvalutaw Steglatro 5 mg u 15-il mg Il-valutazzjoni primarja tas-sigurtà saret f'ġabra ta' tliet provi ta' 26 ġimgħa, ikkontrollati bil-plaċebo.
English: Steglatro 15 mg tablets ertugliflozin
Maltese: Steglatro 15-il mg pilloli ertugliflozin
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 tal-kliewi u r-riskju ta' tnaqqis fil-volum (ara sezzjonijiet 4.4 u 4.8).
English: In the pre- and postnatal development study, decreased postnatal 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: Vulvovaginal mycotic infection and other female genital mycotic infections*
Maltese: Infezzjoni mikotika fil-vulva u fil-vaġina u infezzjonijiet mikotiċi oħra fil-ġenitali tan-nisa*,†
English: Table 4: Results at Week 52 from an active-controlled study comparing Steglatro to glimepiride as add-on therapy in patients inadequately controlled on metformin*
Maltese: Tabella 4: Riżultati f'Ġimgħa 52 minn studju ikkontrollat b'mod attiv li qabbel Steglatro ma' glimepiride bħala terapija miżjuda f'pazjenti li ma kinux ikkontrollati b'mod adegwat b'metformin*
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: 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 individiwi ttrattati b'glimepiride kellhom żieda fl-SBP mil-linja bażi ta' 1.0 mmHg.
English: Hypoglycaemia*
Maltese: Ipogiċemija*,†
English: Excipient(s) with known effect Each tablet contains 85 mg of lactose (as monohydrate).
Maltese: Kull pillola fiha 85 mg ta' lactose (bħala monohydrate).
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 5).
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 5).