FrancophonIA/ELRC3.0 huggingface dataset:
English: A clinical trial of vildagliptin in patients with New York Heart Association NYHA functional class I-III showed that treatment with vildagliptin was not associated with a change in left-ventricular function or worsening of pre-existing congestive heart failure (CHF) versus placebo.
Maltese: Waqt prova klinika b'vildagliptin fost pazjenti bi klassi I-III funzjonali New York Heart Association (NYHA) intwera li trattament b'vildagliptin ma wassalx għal bidla fil-funzjoni tal-ventrikolu taxxellug jew biex tiggrava l-insuffiċjenza konġestiva tal-qalb eżistenti diġà (CHF) meta mqabbel malplaċebo.
English: Table 5 Adverse reactions reported in patients who received Jalra 50 mg twice daily in combination with metformin and a sulphonylurea (N=157)
Maltese: Reazzjonijiet avversi rapportati f'pazjenti li ħadu Jalra 50 mg darbtejn kuljum ma' metformin u xi sulphonylurea (N=157)
English: Placebo-corrected mean change in HbA1c (%) at week 24 (95% CI)
Maltese: Il-bidla aġġustata bil-plaċebo millmedja tal-bidla flHbA1c (%) ma' ġimgħa 24 (95%CI)
English: In a 24-week double-blind controlled trial, vildagliptin (50 mg twice daily) was compared to rosiglitazone (8 mg once daily).
Maltese: Fi prova double-blind kontrollata li damet 24-ġimgħa, vildagliptin (50 mg darbtejn kuljum) kien imqabbel ma' rosiglitazone (8 mg darba kuljum).
English: A multiple-dose, open-label trial was conducted to evaluate the pharmacokinetics of the lower therapeutic dose of vildagliptin (50 mg once daily) in patients with varying degrees of chronic renal impairment defined by creatinine clearance (mild: 50 to <80 ml/min, moderate: 30 to <50 ml/min and severe: <30 ml/min) compared to normal healthy control subjects.
Maltese: Prova open label b'ħafna dożi saret biex tistma l-farmakokinetika tad-doża terapewtika l-baxxa ta' vildagliptin (50 mg darba kuljum) f'pazjenti bi gradi varji ta' indeboliment kroniku tal-kliewi ddefinit permezz tat-tneħħija tal-krejatinina (ħafif: 50 sa <80 ml/min, moderat: 30 sa <50 ml/min u qawwi: <30 ml/min) meta mqabbla ma' individwi normali f'saħħithom bħala kontroll.
English: Table 4 Adverse reactions reported in patients who received Jalra 100 mg daily as monotherapy in double-blind studies (N=1,855)
Maltese: Tabella 4 Reazzjonijiet avversi rrappurtati f'pazjenti li rċievew Jalra 100 mg kuljum bħala monoterapija fi studji double-blind (N=1,855)
English: After 1 year mean reductions in HbA1c were -0.4% with vildagliptin added to metformin and -0.5% with glimepiride added to metformin, from a mean baseline HbA1c of 7.3%.
Maltese: Wara sena t-tnaqqisiet medji ta' HbA1c kienu ta' -0.4% meta vildagliptin kien miżjud ma' metformin u ta' -0.5% meta glimepiride kien miżjud ma' metformin, millinja bażi ta' HBA1c ta' 7.3%.
English: Vildagliptin AUC increased on average 1.4, 1.7 and 2-fold in patients with mild, moderate and severe renal impairment, respectively, compared to normal healthy subjects.
Maltese: L-AUC ta' vildagliptin żdiedet b'medja ta' 1.4, 1.7 u darbtejn aktar f'pazjenti b'indeboliment ħafif, moderat u qawwi tal-kliewi, rispettivament, meta mqabbel ma' individwi normali f'saħħithom.
English: When used as monotherapy, in combination with metformin, in combination with thiazolidinedione, in combination with metformin and a sulphonylurea, or in combination with insulin (with or without metformin), the recommended daily dose of vildagliptin is 100 mg, administered as one dose of 50 mg in the morning and one dose of 50 mg in the evening.
Maltese: Meta jintuża bħala monoterapija, f'kombinazzjoni ma' metformin, f'kombinazzjoni ma' thiazolidinedione, f'kombinazzjoni ma' metformin u xi sulphonylurea, jew f'kombinazzjoni malinsulina (ma' metformin jew mingħajru), id-doża ta' vildagliptin rakkomandata hija ta' 100 mg kuljum mogħtija bħala doża waħda ta' 50 mg filgħodu u doża waħda ta' 50 mg filgħaxija.
English: The incidence of peripheral oedema was lower in the vildagliptin group than in the rosiglitazone group (2.1% vs. 4.1% respectively).
Maltese: L-inċidenza ta' edema periferali kienet aktar baxxa fil-grupp b'vildagliptin milli fil-grupp b'rosiglitazone (2.1% kontra 4.1% rispettivament).
English: The maximum daily dose is 100 mg.
Maltese: Id-doża massima ta' kuljum hija ta' 100 mg.
English: • Store in the original package in order to protect from moisture.
Maltese: • Aħżen fil-pakkett oriġinali sabiex tilqa' mill-umdità.
English: In patients with moderate renal impairment vildagliptin significantly decreased HbA1c compared with placebo (difference of -0.53%) from a mean baseline of 7.9%.
Maltese: F'pazjenti b'indeboliment moderat tal-kliewi vildagliptin naqqas l-HbA1c b'mod sinifikanti meta tqabbel mal-plaċebo (differenza ta' -0.53%) mill-medja tal-linja bażi ta' 7.9%.
English: Clinical experience in patients with NYHA functional class III treated with vildagliptin is still limited and results are inconclusive (see section 5.1).
Maltese: L-esperjenza klinika ma' pazjenti bi klassi funzjonali III NYHA ttrattati b'vildagliptin għadha limitata u r-riżultati mhumiex konklussivi (ara sezzjoni 5.1).
English: As dual oral therapy in combination with - metformin, in patients with insufficient glycaemic control despite maximal tolerated dose of monotherapy with metformin, - a sulphonylurea, in patients with insufficient glycaemic control despite maximal tolerated dose of a sulphonylurea and for whom metformin is inappropriate due to contraindications or intolerance, - a thiazolidinedione, in patients with insufficient glycaemic control and for whom the use of a thiazolidinedione is appropriate.
Maltese: Bħala terapija bi tnejn f'kombinazzjoni ma' - metformin, f'pazjenti li ma jkollhomx kontroll suffiċjenti taz-zokkor fid-demm minkejja li jkunu qed jieħdu l-ogħla doża tollerata ta' metformin waħdu, - sulphonylurea, f'pazjenti li ma jkollhomx kontroll suffiċjenti taz-zokkor fid-demm minkejja li jkunu qed jieħdu l-ogħla doża tollerata ta' sulphonylurea u li ma jistgħux jieħdu metformin minħabba li hu kontra-indikat jew għax ma jittollerawhx, - thiazolidinedione, f'pazjenti li ma jkollhomx kontroll suffiċjenti taz-zokkor fid-demm u għal min l-użu ta' thiazolidinedione huwa adattat.
English: Jalra is not a substitute for insulin in insulin-requiring patients.
Maltese: Jalra mhux sostitut ta' l-insulina f'pazjenti li jeħtieġu l-insulina.
English: In clinical trials, the incidence of hypoglycaemia was common in patients receiving vildagliptin 100 mg daily in combination with metformin (1%) and uncommon in patients receiving placebo + metformin (0.4%).
Maltese: Fi studji kliniċi, l-inċidenza ta' l-ipogliċemija kienet komuni f'pazjenti li kienu qed jirċievu vildagliptin 100 mg kuljum f'kombinazzjoni ma' metformin (1%) u mhux komuni f'pazjenti li kienu qed jirċievu plaċebo + metformin (0.4%).
English: In data from controlled monotherapy and add-on therapy trials of up to 24 weeks in duration, the incidence of ALT or AST elevations  3x ULN (classified as present on at least 2 consecutive measurements or at the final on-treatment visit) was 0.2%, 0.3% and 0.2% for vildagliptin 50 mg once daily, vildagliptin 50 mg twice daily and all comparators, respectively.
Maltese: Minn dejta minn monoterapija kontrollata u provi add-on li damu sa 24 ġimgħa, l-inċidenza ta' żiediet fl-ALT jew AST kienet  3 darbiet ULN (klassifikata bħala preżenti f'mill-anqas 2 kejliet wara xulxin jew fl-aħħar żjara fuq il-kura) kienu 0.2%, 0.3% u 0.2% għal vildagliptin 50 mg kuljum, vildagliptin 50 mg darbtejn kuljum u l-kumparaturi kollha, rispettivament.
English: Overall, vildagliptin improved glycaemic control when given as monotherapy or when used in combination with metformin, a sulphonylurea, and a thiazolidinedione, as measured by clinically relevant reductions in HbA1c from baseline at study endpoint (see Table 8).
Maltese: B'mod ġenerali, vildagliptin tejjeb il-kontroll gliċemiku meta ngħata bħala monoterapija jew meta ntuża f'kombinazzjoni ma' metformin, sulphonylurea u thiazolidinedione kif imkejjel minn tnaqqis klinikament rilevanti fl-HbA1c mil-linja bażi fl-endpoint ta' l-istudju (ara Tabella 8).
English: Administration of vildagliptin with food resulted in a decreased Cmax (19%).
Maltese: L-għotja ta' vildagliptin ma' likel wasslet għal tnaqqis fis-Cmax (19%).
English: Adverse reactions reported in patients who received Jalra in double-blind studies as monotherapy and add-on therapies are listed below for each indication by system organ class and absolute frequency.
Maltese: Reazzjonijiet avversi rrappurtati f'pazjenti li rċievew Jalra fi studji double blind bħala monoterapija u terapiji miżjuda huma elenkati hawn taħt għall-kull indikazzjoni bil-klassi ta' l-organi tas-sistema u frekwenza assoluta.
English: The active substance of Jalra, vildagliptin, belongs to a group of medicines called “oral antidiabetics”.
Maltese: Is-sustanza attiva ta' Jalra, vildagliptin, tagħmel parti minn grupp ta' mediċini li jissejħu “antidijabetiċi orali”.
English: Vildagliptin was removed by haemodialysis to a limited extent (3% over a 3-4 hour haemodialysis session starting 4 hours post dose).
Maltese: Tneħħa biss ammont limitat ta' vildagliptin permezz tad-dijalisi tad-demm (3% f'sessjoni ta' dijalisi tad-demm li damet sejra bejn 3-4 sigħat u li bdiet 4 sigħat wara t-teħid tad-doża).
English: At 400 mg, there were three cases of muscle pain, and individual cases of mild and transient paraesthesia, fever, oedema and a transient increase in lipase levels.
Maltese: B'400 mg, kien hemm tlett każijiet ta' uġigħ fil-muskoli, u każijiet individwali ta' parasteżija ħafifa u mumentanja, deni, edema u żiediet mumentanji fil-livelli ta' lipase.
English: In healthy elderly subjects (≥ 70 years), the overall exposure of vildagliptin (100 mg once daily) was increased by 32%, with an 18% increase in peak plasma concentration as compared to young healthy subjects (18-40 years).
Maltese: F'individwi anzjani (≥ 70 sena) b'saħħithom, l-esponiment globali ta' vildagliptin (100 mg darba kuljum) żdied b'32%, b'żieda ta' 18% ta' l-ogħla konċentrazzjoni fil-plażma meta mqabbel ma' individwi żgħażagħ (18-40 sena) b'saħħithom.
English: Jalra contains lactose (milk sugar).
Maltese: 82 mg lactose (anidru).
English: At 5 mg/kg/day (approximately equivalent to human AUC exposure at the 100 mg dose), only blisters were observed.
Maltese: B'5 mg/kg/jum (kważi daqs l-esponiment AUC fil-bniedem bid-doża ta' 100 mg), dehru biss bżieżaq.
English: The exposure to vildagliptin after a single dose in patients with mild and moderate hepatic impairment was decreased (20% and 8%, respectively), while the exposure to vildagliptin for patients with severe impairment was increased by 22%.
Maltese: L-esponiment għal vildagliptin wara doża waħda f'pazjenti b'indeboliment ħafif u moderat kien imnaqqas (20% u 8%, rispettivament), fil-waqt li l-esponiment għal vildagliptin f'pazjenti b'indeboliment tal-fwied sever kien miżjud b'22%.
English: Table 1 Adverse reactions reported in patients who received Jalra 100 mg daily in combination with metformin in double-blind studies (N=208)
Maltese: Tabella 1 Reazzjonijiet avversi rrappurtati f'pazjenti li rċievew Jalra 100 mg kuljum ma' metformin fi studji double-blind (N=208)
English: The noeffect dose in rats was 25 mg/kg (5-fold human exposure based on AUC) and in mice 750 mg/kg (142fold human exposure).
Maltese: Iddoża mingħajr effett fil-firien kienet 25 mg/kg (5-darbiet l-esponiment fil-bniedem ibbażat fuq l-AUC) u fil-ġrieden 750 mg/kg (142-darba l-esponiment fil-bniedem).
English: In clinical trials, weight did not change from baseline when vildagliptin 100 mg daily was added to metformin (+0.2 kg and -1.0 kg for vildagliptin and placebo, respectively).
Maltese: Fi provi kliniċi, l-piż ma nbidilx mil-linja bażi meta vildagliptin 100 mg kuljum, kien miżjud ma' metformin (+0.2 kg u -1.0 kg għal vildagliptin u plaċebo, rispettivament).
English: Table 3 Adverse reactions reported in patients who received Jalra 100 mg daily in combination with a thiazolidinedione in double-blind studies (N=158)
Maltese: Tabella 3 Reazzjonijiet avversi rrappurtati f'pazjenti li rċievew Jalra 100 mg flimkien ma' thiazolidinedione fi studji double-blind (N=158)
English: In patients with severe renal impairment, vildagliptin significantly decreased HbA1c compared with placebo (difference of -0.56%) from a mean baseline of 7.7%.
Maltese: F'pazjenti b'indeboliment qawwi tal-kliewi, vildagliptin naqqas l-HbA1c b'mod sinifikanti meta tqabbel mal-plaċebo (differenza ta' -0.56%) mill-medja tal-linja bażi ta' 7.7%.
English: In clinical trials, weight did not change from baseline when vildagliptin 50 mg daily was added to glimepiride (-0.1 kg and -0.4 kg for vildagliptin and placebo, respectively).
Maltese: Fi provi kliniċi, il-piż ma nbidilx mil-linja bażi meta vildagliptin 50 mg kien miżjud ma' glimepiride (-0.1 kg u -0.4 kg għal vildagliptin u plaċebo, rispettivament).
English: More than 1,900 patients receiving vildagliptin 50 mg once daily or 100 mg daily were ≥ 65 years.
Maltese: Aktar minn 1,900 pazjent li kienu qed jirċievu vildagliptin 50 mg darba kuljum jew 100 mg kuljum kellhom ≥ 65 sena.
English: Treatment with vildagliptin 50-100 mg daily in patients with type 2 diabetes significantly improved markers of beta cell function including HOMA- (Homeostasis Model Assessment-), proinsulin to insulin ratio and measures of beta cell responsiveness from the frequently-sampled meal tolerance test.
Maltese: Kura b'vildagliptin 50-100 mg kuljum f'pazjenti bid-dijabete tat-tip 2 tejbet b'mod sinifikanti l-markaturi tal-funzjoni taċ-ċelluli beta inkuż HOMA- (Evalwar- tal-Mudell ta' Omejostażi), proporzjon tal-pro-insulina ma' l-insulina u l-kejl ta' kemm juru rispons iċ-ċelluli beta mit-test tattolleranza li jieħu ħafna kampjuni.
English: Since vildagliptin is not a cytochrome P (CYP) 450 enzyme substrate and does not inhibit or induce CYP 450 enzymes, it is not likely to interact with active substances that are substrates, inhibitors or inducers of these enzymes.
Maltese: Peress li vildagliptin mhuwiex sottostrat ta' l-enzima cytochrome P (CYP) 450 u la jinibixxi u l-anqas jinduċi l-enzimi CYP 450, x'aktarx li ma tinteraġġixxix ma' sustanzi attivi li huma sottostrati, inibituri jew indutturi ta' dawn l-enzimi.
English: Other medicines and Jalra
Maltese: Mediċini oħra u Jalra
English: • Do not use any Jalra pack that is damaged or shows signs of tampering.
Maltese: • Tuża l-ebda pakkett ta' Jalra li jkun danneġġjat jew li juri sinjali ta' tbabis.
English: Table 2 Adverse reactions reported in patients who received Jalra 50 mg in combination with a sulphonylurea in double-blind studies (N=170)
Maltese: Tabella 2 Reazzjonijiet avversi rrappurtati f'pazjenti li rċievew Jalra 100 mg kuljum ma' sulphonylurea fi studji double-blind (N=170)
English: Nasopharyngitis Metabolism and nutrition disorders Common
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni Komuni
English: There were more cardiac events in vildagliptin treated patients with NYHA class III heart failure compared to placebo.
Maltese: Kien hemm aktar episodji kardijaċi fost il-pazjenti ttrattati b'vildagliptin u li kellhom insuffiċjenza tal-qalb bi klassi III NYHA mqabbel mal-plaċebo.
English: Pancreatitis
Maltese: Urtikarja
English: Jalra is not recommended for use in children and adolescents (< 18 years).
Maltese: Jalra mhux irrakkomandat għall-użu fi tfal u adolexxenti (< 18-il sena).
English: After two years, mean reduction in HbA1c was -0.5% for vildagliptin and -0.6% for gliclazide, from a mean baseline HBA1c of 8.6%.
Maltese: Wara sentejn, it-tnaqqis medju ta' HbA1c kien ta' -0.5% għal vildagliptin u ta' -0.6% għal gliclazide, mil-linja bażi medja ta' HBA1c ta' 8.6%.
English: Table 6 Adverse reactions reported in patients who received Jalra 100 mg daily in combination with insulin (with or without metformin) in double-blind studies (N=371)
Maltese: Tabella 6 Reazzjonijiet avversi rapportati f'pazjenti li rċevew Jalra 100 mg kuljum f'kombinazzjoni mal-insuluna (bi jew mingħajr metformin) fi studji double blind (N=371)
English: Dizziness, tremor Skin and subcutaneous tissue disorders Common
Maltese: Stitikezza Disturbi muskolu-skeltriċi u tat-tessuti konnettivi
English: White to light yellowish, round (8 mm diameter), flat-faced, bevelled-edge tablet.
Maltese: Pillola bajda tagħti ftit fl-isfar, tonda (8 mm dijametru), wiċċ ċatt, b' xifer imżerżaq.
English: 68.8% and 80.5% of the patients with moderate and severe renal impairment respectively were treated with insulin (mean daily dose of 56 units and 51.6 units respectively) at baseline.
Maltese: 5% tal-pazjenti b'indeboliment moderat u qawwi tal-kliewi rispettivament ġew ikkurati bl-insulina (doża medja ta' 56 unità u 51.6 unità kuljum rispettivament) fil-linja bażi.
English: Vildagliptin significantly decreased HbA1c compared with placebo (difference of 0.6%) from a mean baseline of 7.8% at week 16.
Maltese: Vildagliptin naqqas b'qawwa l-HbA1c mqabbel mal-plaċebo (differenza ta' 0.6%) mill-medja fil-linja bażi ta' 7.8%. fis-16il ġimgħa.
English: In comparative controlled monotherapy studies, hypoglycaemia was uncommon, reported in 0.4% (7 of 1,855) of patients treated with vildagliptin 100 mg daily compared to 0.2% (2 of 1,082) of patients in the groups treated with an active comparator or placebo, with no serious or severe events reported.
Maltese: Fi studji kontrollati b'monoterapija għat-tqabbil, l-ipogliċemija kienet mhux komuni, irrappurtata f'0.4% (7 minn 1,855) tal-pazjenti ikkurati b'vildagliptin 100 mg kuljum imqabbla ma' 0.2% (2 minn 1,082) tal-pazjenti ikkurati fil-gruppi bi plaċebo jew mediċina attiva għat-tqabbil, mingħajr ma ġew rappurtati każijiet serji sew severi.
English: In a 52-week double-blind controlled trial, vildagliptin (50 mg twice daily) reduced baseline HbA1c by -1% compared to -1.6% for metformin (titrated to 2 g/day) statistical non-inferiority was not achieved.
Maltese: Fi prova double-blind kontrollata li damet 52-ġimgħa, vildagliptin (50 mg darbtejn kuljum) naqqas lHbA1c mil-linja bażi b'-1% meta mqabbel ma' -1.6% għal metformin (miżjud għal 2 g/jum) ma nstabx li ma kienx inferjuri b'mod statistiku.
English: Monotherapy placebo controlled studies
Maltese: Studji kontrollati b'monoterapija ta' plaċebo
English: Vildagliptin in combination with metformin and glimepiride significantly decreased HbA1c compared with placebo.The placebo-adjusted mean reduction from a mean baseline HbA1c of 8.8% was -0.76%.
Maltese: It-tnaqqis medju aġġustat għall-plaċebo minn linja ta' riferiment medju għal HbA1c ta' 8.8% kien ta' -0.76%.
English: In clinical trials, weight did not change from baseline when vildagliptin 100 mg daily was administered as monotherapy (-0.3 kg and -1.3 kg for vildagliptin and placebo, respectively).
Maltese: Fi provi kliniċi, il-piż ma nbidilx mil-linja bażi meta vildagliptin 100 mg kuljum ingħata bħala monoterapija (-0.3 kg u -1.3 kg għal vildagliptin u plaċebo rispettivament).
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà Ir-rekwiżiti biex jiġu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont lArtikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikatfuq ilportal elettroniku Ewropew tal-mediċini.
English: In clinical trials, the incidence of hypoglycaemia was uncommon in patients receiving vildagliptin + pioglitazone (0.6%) but common in patients receiving placebo + pioglitazone (1.9%).
Maltese: Fi provi kliniċi, l-inċidenza ta' ipogliċemija ma kienitx komuni f'pazjenti li kienu qed jirċievu vildagliptin flimkien ma' pioglitazone (0.6%) iżda komuni f'pazjenti li kienu qed jirċievu plaċebo flimkien ma' pioglitazone (1.9%).
English: Tablet.
Maltese: U KONTENUT Pillola
English: The plasma protein binding of vildagliptin is low (9.3%) and vildagliptin distributes equally between plasma and red blood cells.
Maltese: Vildagliptin jeħel ftit (9.3%) mal-proteini tal-plażma u vildagliptin jinfirex b'mod ugwali bejn ilplażma u ċ-ċelluli ħomor tad-demm.
English: An increased incidence of wavy ribs was observed in rats in association with reduced maternal body weight parameters, with a no-effect dose of 75 mg/kg (10-fold human exposure).
Maltese: Inċidenza akbar ta' kustilji mbewqa dehret fil-firien b'mod assoċjat ma' tnaqqis fil-parametri tal-piż tal-ġisem ta' l-omm, b'doża mingħajr effett ta' 75 mg/kg (10darbiet l-esponiment fil-bniedem).
English: Mean change from baseline in HbA1c (%) at week 24
Maltese: Il-medja talbidla mil-linja bażi fl-HbA1c (%) ma' ġimgħa 24
English: In clinical trials, the incidence of hypoglycaemia when vildagliptin 50 mg once daily was added to glimepiride was 1.2% versus 0.6% for placebo + glimepiride.
Maltese: Fi provi kliniċi, l-inċdenza ta' ipoglċemija meta vildagliptin 50 mg ingħata darba kuljum flimkien ma' glimepiride kienet ta' 1.2% kontra 0.6% għall-plaċebo flimkien ma' glimepiride.
English: In non-diabetic (normal glycaemic) individuals, vildagliptin does not stimulate insulin secretion or reduce glucose levels.
Maltese: F'individwi mhux dijabetiċi (gliċemija normali), vildagliptin ma jikkawżax stimulazzjoni tas-sekrezzjoni ta' l-insulina jew inaqqas il-livelli ta' glucose.
English: Vildagliptin is also indicated for use in combination with insulin (with or without metformin) when diet and exercise plus a stable dose of insulin do not provide adequate glycaemic control.
Maltese: Vildagliptin huwa wkoll indikat biex jintuża f'kombinazzjoni mal-insulina (ma' metformin jew mingħajru) meta d-dieta u l-eżerċizzju flimkien ma' doża stabbli ta' insulina ma jipprovdux kontroll gliċemiku xieraq.
English: Jalra 50 mg tablets are round, white to light yellowish and flat, with “NVR” on one side and “FB” on the other.
Maltese: Kif jidher Jalra u l-kontenut tal-pakkett Jalra 50 mg pilloli huma tondi, bojod jagħtu fl-isfar ċar u ċatti, b'“NVR” fuq naħa u “FB” fuq l-oħra.
English: DPP-4 inhibition by vildagliptin is not affected by gender.
Maltese: Linibizzjoni ta' DPP-4 minn vildagliptin mhiex effettwata mis-sess.
English: As triple oral therapy in combination with - a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.
Maltese: Bħala terapija bi tlieta f'kombinazzjoni ma' - xi sulphonylurea u metformin meta d-dieta u l-eżerċizzju flimkien ma' terapija doppja b'dawn il-prodotti mediċinali ma jipprovdux kontroll gliċemiku xieraq.
English: In a 13-week toxicology study in cynomolgus monkeys, skin lesions have been recorded at doses ≥ 5 mg/kg/day.
Maltese: Fi studju tossikioloġiku li dam 13-il ġimgħa fuq xadini cynomolgus, leżjonijiet fil-ġilda kienu reġistrati b'dożi ta'≥ 5 mg/kg/jum.
English: The effect of impaired hepatic function on the pharmacokinetics of vildagliptin was studied in patients with mild, moderate and severe hepatic impairment based on the Child-Pugh scores (ranging from 6 for mild to 12 for severe) in comparison with healthy subjects.
Maltese: L-effett ta' indeboliment fil-funzjoni epatika fuq il-farmakokinetika ta' vildagliptin kienet studjata f'pazjenti b'indeboliment tal-fwied ħafif, moderat u sever skond il-punteġġi Child-Pugh (minn 6 għal ħafif sa 12 għal sever) imqabbla ma' individwi b'saħħithom.
English: The maximum change (increase or decrease) in the exposure to vildagliptin is ~30%, which is not considered to be clinically relevant.
Maltese: Il-bidla massima (żieda jew tnaqqis) fl-esponiment għal vildagliptin hija ~30% li mhix meqjusa klinikament rilevanti.
English: Metabolism is the major elimination pathway for vildagliptin in humans, accounting for 69% of the dose.
Maltese: Il-metaboliżmu huwa l-mezz ewlieni ta' l-eliminazzjoni ta' vildagliptin fil-bniedem, li jgħodd għal 69% tad-doża.