FrancophonIA/ELRC3.0 huggingface dataset:
English: Drug-drug interaction studies with digoxin (P-glycoprotein substrate) and warfarin (CYP2C9 substrate) in healthy subjects have shown no clinically relevant pharmacokinetic interactions after coadministration with vildagliptin.
Maltese: Studji kliniċi ta' interazzjoni bejn il-mediċini li saru b'digoxin (sottostrat ta' glikoproteina-P) u warfarin (sottostrat ta' CYP2C9) f'individwi b'saħħithom ma wrew l-ebda interazzjonijiet farmakokinetiċi klinikament rilevanti wara li ngħataw flimkien ma' vildagliptin.
English: Table 4 Adverse reactions reported in patients who received vildagliptin 100 mg daily as monotherapy in double-blind studies (N=1855)
Maltese: Tabella 4 Reazzjonijiet avversi rrappurtati f'pazjenti li rċevew vildagliptin 100 mg kuljum bħala monoterapija fi studji double-blind (N=1855)
English: EU/1/08/483/001-006 EU/1/08/483/013-015 EU/1/08/483/019-024 EU/1/08/483/031-033
Maltese: EU/1/08/483/031-033
English: Film-coated tablet
Maltese: Karatteristiċi fil-pazjenti
English: Ethnic group: Limited data suggest that race does not have any major influence on vildagliptin pharmacokinetics.
Maltese: Dejta limitata tindika li r-razza mgħandhiex influwenza maġġuri fuq il-farmakokinetika ta' vildagliptin.
English: Vildagliptin added to patients whose glycaemic control was not satisfactory despite treatment with metformin monotherapy resulted after 6-month treatment in additional statistically significant mean reductions in HbA1c compared to placebo (between group differences of -0.7% to -1.1% for vildagliptin 50 mg and 100 mg, respectively).
Maltese: Meta vildagliptin kien miżjud f'pazjenti li l-kontroll gliċemiku tagħhom ma kienx sodisfaċenti minkejja kura b'monoterpija ta' metformin irriżulta li wara 6 xhur ta' kura kien hemm żieda statistikament sinifikanti fil-medja ta' tnaqqis ta' HbA1c meta mqabbel mal-plaċebo (differenzi bejn ilgruppi ta' -0.7% sa' -1.1% għal vildagliptin 50 mg u 100 mg rispettivament).
English: Bioequivalence has been demonstrated between Zomarist at three dose strengths (50 mg/500 mg, 50 mg/850 mg and 50 mg/1000 mg) versus free combination of vildagliptin and metformin hydrochloride tablets at the corresponding doses.
Maltese: Intweriet bioekwivalenza mejn Zomarist fi tlett qawwiet ta' dożi (50 mg/500 mg, 50 mg/850 mg u 50 mg/1000 mg), kontra kombinazzjoni ħielsa ta' pilloli ta' vildagliptin u metformin hydrochloride bid-dożi li jikkorrispondu għalihom.
English: Metformin is contraindicated in patients with GFR <30 ml/min and should be temporarily discontinued in the presence of conditions that alter renal function (see section 4.3).
Maltese: Metformin huwa kontraindikat f'pazjenti b'GFR < 30 mL/min u għandu jitwaqqaf temporanjament filpreżenza ta' kundizzjonijiet li jibdlu l-funzjoni renali (ara sezzjoni 4.3).
English: The incidence of hypoglycaemia was lower in the vildagliptin group than in the placebo group (22.9% vs. 29.6%).
Maltese: L-inċidenza ta' ipogliċemija kienet aktar baxxa fil-grupp ta' vildagliptin milli fil-grupp tal-plaċebo (22.9% kontra 29.6%).
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: Fil-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: Table 1 Adverse reactions reported in patients who received vildagliptin 100 mg daily as add-on therapy to metformin compared to placebo plus metformin in double-blind studies (N=208)
Maltese: Tabella 1 Reazzjonijiet avversi rrappurtati f'pazjenti li rċevew vildagliptin 100 mg kuljum bħala terapija li ġiet miżjuda ma' metformin meta mqabbla ma' plaċebo ma' metformin fi studji double-blind (N=208)
English: Nasopharyngitis Metabolism and nutrition disorders Uncommon
Maltese: Disturbi fil-metaboliżmu u n-nutrizzjoni Rari ħafna
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini: http://www.ema.europa.eu
English: Vildagliptin Information regarding overdose with vildagliptin is limited.
Maltese: Informazzjoni dwar doża eċċessiva b'vildagliptin hija limitata.
English: An increased incidence of mammary adenocarcinomas and haemangiosarcomas was observed with a no-effect dose of 500 mg/kg (59-fold human exposure) and 100 mg/kg (16-fold human exposure), respectively.
Maltese: Żieda fl-adenokanċeromi tal-mammarji u haemangiosrcomas dehru b'doża mingħajr effett ta' 500 mg/kg (59 darba l-esponiment fil-bniedem) u 100 mg/kg (16-il darba lesponiment fil-bniedem), rispettivament.
English: Hepatic impairment: In subjects with mild, moderate or severe hepatic impairment (Child-Pugh A-C) there were no clinically significant changes (maximum ~30%) in exposure to vildagliptin.
Maltese: F'individwi b'indeboliment epatiku ħafif, moderat jew sever (Child-Pugh A-C) ma kienx hemm bidliet klinikament sinifikanti (massimu ~30%) fl-esponiment għal vildagliptin.
English: Following administration of a dose of 850 mg, the plasma peak concentration was 40% lower, AUC was decreased by 25% and time to peak plasma concentration was prolonged by 35 minutes.
Maltese: Wara li tingħata doża ta' 850 mg, l-ogħla konċentrazzjoni fil-plażma kienet 40% aktar baxxa, AUC kien imnaqqas b'25% u l-ħin sabiex inkisbet l-ogħla konċentrazzjoni fil-plażma ittawlet b'35 minuta.
English: In the overall population, the placebo-adjusted mean reduction from a mean baseline HbA1c 8.8% was -0.72%.
Maltese: Fil-popolazzjoni globali, it-tnaqqis medju aġġustat għal plaċebo minn linja ta' riferiment medju għal ta' 8.8% ta' HbA1c kien ta' -0.72%.
English: Adverse reactions reported in patients who received vildagliptin in double-blind studies as monotherapy and add-on therapies are listed below by system organ class and absolute frequency.
Maltese: Reazzjonijiet avversi rrappurtati f'pazjenti li rċevew vildagliptin fi studji double-blind bħala monoterapija u terapiji miżjuda huma elenkati hawn taħt skont il-klassi tas-sistema ta' l-organi u frekwenza assoluta.
English: In vitro studies demonstrated that vildagliptin does not inhibit/induce CYP 450 enzymes.
Maltese: Studji in vitro wrew li vildagliptin ma jimpedixxix/jinduċix l-enzimi CYP 450.
English: Polychlorotrifluoroethylene (PCTFE)/PVC/Alu blister Available in packs containing 10, 30, 60, 120, 180 or 360 film-coated tablets and in multi-packs containing 120 (2 packs of 60), 180 (3 packs of 60) or 360 (6 packs of 60) film-coated tablets.
Maltese: Polychlorotrifluoroethylene (PCTFE)/PVC/Alu folja Jiġi f'pakketti li jkun fihom 10, 30, 60, 120, 180 jew 360 pillola miksija b'rita u f'pakketti b'ħafna li fihom 120 (2 pakketti ta' 60), 180 (3 pakketti ta' 60) jew 360 (6 pakketti ta' 60) pilloli miksija b'rita.
English: Table 3 Adverse reactions reported in patients who received vildagliptin 100 mg daily in combination with insulin (with or without metformin) in double-blind studies (N=371)
Maltese: Tabella 3 Reazzjonijiet avversi rapportati f'pazjenti li rċevew vildagliptin 100 mg kuljum f'kombinazzjoni mal-insuluna (bi jew mingħajr metformin) fi studji double blind (N=371)
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: Zomarist 50 mg/850 mg film-coated tablets vildagliptin/metformin hydrochloride
Maltese: Zomarist 50 mg/850 mg pilloli miksija b'rita vildagliptin/metformin hydrochloride
English: Zomarist with alcohol
Maltese: Zomarist ma' alkoħol
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' cytochrome P (CYP) 450 u la jimpedixxi u lanqas jinduċi l-enzimi CYP 450, x'aktarx li ma jinteraġixxix mas-sustanzi attivi li huma sottostrati, impedituri jew indutturi ta' dawn l-enzimi.
English: Nervous system disorders Common
Maltese: Tnaqqis taz-zokkor fid-demm Disturbi fis-sistema nervuża Komuni
English: The decrease in HbA1c observed in patients with a baseline ≥10.0% was greater.
Maltese: It-tnaqqis ta' HbA1c osservat f'pazjenti b'linja bażi ≥10.0% kien akbar.
English: See section 4
Maltese: Dublin 4
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 ħfief u mumentanji ta' parasteżija, deni, edema u żieda mumentanja tal-livelli tal-lipase.
English: Hepatic impairment (see sections 4.2, 4.4 and 4.8) Acute alcohol intoxication, alcoholism Breast-feeding (see section 4.6)
Maltese: Indeboliment tal-fwied (ara sezzjonijiet 4.2, 4.4 u 4.8).
English: In a 52-week trial, vildagliptin (50 mg twice daily) was compared to gliclazide (mean daily dose: 229.5 mg) in patients inadequately controlled with metformin (metformin dose at baseline 1928 mg/day).
Maltese: Waqt prova li damet għaddejja 52 ġimgħa, vildagliptin (50 mg darbtejn kuljum) tqabbel ma' gliclazide (id-doża medja ta' kuljum: 229.5 mg) f'pazjenti kkontrollati mhux kif jixraq b'metformin (id-doża ta' metformin fil-linja bażi ta' 1928 mg kuljum).
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 ekwivalenti għall-esponiment AUC fil-bniedem b'doża ta' 100 mg), dehru biss nfatet.
English: WIN MEDICA ΦΑΡΜΑΚΕΥΤΙΚΗ A.E. Tηλ: +30 210 74 88 821
Maltese: Tηλ: +30 210 74 88 821
English: Zomarist 50 mg/1000 mg film-coated tablets vildagliptin/metformin hydrochloride
Maltese: Zomarist 50 mg/1000 mg pilloli miksija b'rita vildagliptin/metformin hydrochloride
English: Mean reductions from baseline HbA1c of 8.4% were -0.9% with vildagliptin added to metformin and -1.0% with pioglitazone added to metformin.
Maltese: It-tnaqqisiet fil-medja mil-linja bażi fl-HbA1c ta' 8.4% kienu ta' -0.9% meta vildagliptin kien miżjud ma' metformin u ta' -1.0% meta pioglitazone kien miżjud ma' metformin.
English: Angiotensin converting enzyme (ACE) inhibitors may decrease the blood glucose levels.
Maltese: Impedituri ta' angiotensin converting enzyme (ACE) jistgħu jnaqqsu l-livelli tal-glucose fid-demm.
English: Gender: No clinically relevant differences in the pharmacokinetics of vildagliptin were observed between male and female healthy subjects within a wide range of age and body mass index (BMI).
Maltese: Ma dehrux differenzi klinikament rilevanti bejn il-farmakokinetika ta' vildagliptin fl-irġiel u nnisa b'saħħithom f'medda wiesa' ta' etajiet u indiċi tal-massa tal-ġisem (BMI).
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 jistimulax it-tnixxija tal-insulina jew inaqqas livelli ta' glucose.
English: In a 13-week toxicology study in cynomolgus monkeys, skin lesions have been recorded at doses ≥ 5 mg/kg/day.
Maltese: Fi studju tossikoloġiku ta' 13-il ġimgħa f'xadini cynomolgus, feriti fil-ġilda kienu reġistrati b'dożi ta' ≥ 5 mg/kg/jum.
English: Age: 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 b'saħħithom anzjani (≥ 70 sena), l-esponiment globali ta' vildagliptin (100 mg darba kuljum) żdied b'32%, b'żieda ta' 18% fl-ogħla konċentrazzjoni fl-plażma meta mqabbla ma' individwi b'saħħithom żgħażagħ (18-40 sena).
English: In another 24-week study in patients with more advanced type 2 diabetes not adequately controlled on insulin (short and longer acting, average insulin dose 80 IU/day), the mean reduction in HbA1c when vildagliptin (50 mg twice daily) was added to insulin was statistically significantly greater than with placebo plus insulin (0.5% vs. 0.2%).
Maltese: Fi studju ieħor ta' 24 ġimgħa fuq pazjenti li għandhom dijabete avvanzata ta' tip 2 mhix adegwatament ikkontrollata bl-insulina (li taġixxi fuq perjodu qasir jew itwal, doża medja tal-insulina ta' 80 IU/jum) it-tnaqqis medju f'HbA1c meta vildagliptin (50 mg darbtejn kuljum) kien miżjud mal-insulina kien statistikament ogħla b'mod sinifikanti mill-plaċebo u l-insulina (0.5% kontra 0.2%).
English: Zomarist is not recommended for use in children and adolescents (< 18 years).
Maltese: Zomarist mhux irrakkomandat għall-użu fit-tfal u adolexxenti (< 18-il sena).
English: Film-coated tablet.
Maltese: Ma ġewx identifikati metaboliti fil-bnedmin.
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 b'dijabete tat-tip 2 tejjeb b'mod sinifikanti l-markaturi tal-funzjoni taċ-ċelluli beta inklużi HOMA-β (Stima tal-Mudell B'Omeostażi-β), proporzjoni tal-proinsulina mal-insulina u kejl tar-risponsittività taċ-ċelluli beta mit-testijiet tat-tolleranza għall-ikel li jiġu kampjunati spissi.
English: Zomarist 50 mg/850 mg film-coated tablets Zomarist 50 mg/1000 mg film-coated tablets
Maltese: Zomarist 50 mg/850 mg pilloli miksija b'rita Zomarist 50 mg/1000 mg pilloli miksija b'rita
English: Children and adolescents The use of Zomarist in children and adolescents up to 18 years of age is not recommended.
Maltese: Tfal u adolexxenti L-użu ta' Zomarist fi tfal u adolexxenti ta' età ta' sa 18-il sena mhux rakkomandat.
English: A 24-week randomised, double-blind, placebo-controlled trial was conducted in 449 patients to evaluate the efficacy and safety of vildagliptin (50 mg twice daily) in combination with a stable dose of basal or premixed insulin (mean daily dose 41 units), with concomitant use of metformin (N=276) or without concomitant metformin (N=173).
Maltese: Saret prova double-blind u każwali ta' 24 ġimgħa bil-plaċebo bħala kontroll fuq 449 pazjent sabiex tiġi evalwata l-effikaċja u s-sigurtà ta' vildaglipdin (50 mg darbtejn kuljum) f'kombinazzjoni ma' doża fissa ta' insulina bażilari jew mħallta minn qabel (doża medja ta' kuljum 41 unità), bl-użu fl-istess ħin ta' metformin (N=276) jew mingħajr l-użu fl-istess ħin ta' metformin (N=173).
English: Table 6 Post-marketing adverse reactions
Maltese: Wara t-tqegħid fis-suq Tabella 6 Reazzjonijiet avversi wara t-tqegħid fis-suq
English: As with other oral antidiabetic medicinal products the hypoglycaemic effect of vildagliptin may be reduced by certain active substances, including thiazides, corticosteroids, thyroid products and sympathomimetics.
Maltese: Bħal prodotti mediċinali kontra d-dijabete oħrajn li jittieħdu mill-ħalq l-effet ipogliċemiku ta' vildagliptin jista' jitnaqqas minn ċerti sustanzi attivi, li jinkludu thiazides, corticosteroids, prodotti tattirodje u simpatomimetiċi.
English: Vildagliptin is not metabolised by CYP 450 enzymes to any quantifiable extent, and accordingly the metabolic clearance of vildagliptin is not anticipated to be affected by comedications that are CYP 450 inhibitors and/or inducers.
Maltese: Vildagliptin ma jiġix metabolizzat mill-enzimi CYP 450 b'ammont li jista' jiġi kwantifikat, u b'hekk it-tneħħija metabolika ta' vildagliptin mhux mistennija li tiġi effettwata meta tingħata ma' mediċini oħrajn li huma impedituri u/jew indutturi tas-CYP 450.
English: A 24-week randomised, double-blind, placebo-controlled trial was conducted in 318 patients to evaluate the efficacy and safety of vildagliptin (50 mg twice daily) in combination with metformin (≥1500 mg daily) and glimepiride (≥4 mg daily).
Maltese: Saret prova double-blind u każwali ta' 24 ġimgħa bil-plaċebo bħala kontroll fuq 318-il pazjent sabiex tiġi evalwata l-effikaċja u s-sigurtà ta' vildagliptin (50 mg darbtejn kuljum) f'kombinazzjoni ma' metformin (≥1500 mg kuljum) u glimepiride (≥4 mg kuljum).
English: • Uncommon (may affect up to 1 in 100 people): joint pain, tiredness, constipation, swollen hands, ankle or feet (oedema).
Maltese: • Mhux komuni (jistgħu jaffettwaw sa persuna waħda minn kull 100): uġigħ fil-ġogi, għeja, stitikezza, idejn, għaksa jew saqajn minfuħin (edema).
English: Rare cases of hepatic dysfunction (including hepatitis) have been reported with vildagliptin.
Maltese: Każijiet rari ta' funzjoni mhux normali tal-fwied (inkluża l-epatite) kienu rrappurtati b'vildagliptin.
English: Upper respiratory tract infection
Maltese: Disturbi gastro-intestinali
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: Ir-rekwiżiti biex jiġu ppreżentati ta 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 ppubblikat fuq ilportal elettroniku Ewropew tal-mediċini.
English: The administration of vildagliptin results in a rapid and complete inhibition of DPP-4 activity resulting in increased fasting and postprandial endogenous levels of the incretin hormones GLP-1 and GIP.
Maltese: L-għoti ta' vildagliptin iwassal għall-impediment mgħaġġel u komplet tal-attività tad-DPP-4 li twassal għal żieda fil-livelli endoġeni ta' waqt is-sawm u wara l-ikel tal-ormoni inkretin GLP-1 u GIP.
English: A study in healthy volunteers showed that cimetidine, administered as 400 mg twice daily, increased metformin systemic exposure (AUC) by 50%.
Maltese: Studju f'voluntiera b'saħħithom wera li cimetidine, mogħti bħala 400 mg darbtejn kuljum, żied lesponiment għal metformin (AUC) b'50%.
English: Symptoms of lactic acidosis include: - vomiting - stomach ache (abdominal pain) - muscle cramps - a general feeling of not being well with severe tiredness - difficulty in breathing - reduced body temperature and heartbeat
Maltese: Sintomi ta' aċidożi lattika jinkludu: - rimettar - uġigħ fl-istonku (uġigħ addominali) - bugħawwieġ fil-muskoli - sensazzjoni ġenerali li ma tiflaħx flimkien ma' għeja severa - diffikultà biex tieħu n-nifs - temperatura tal-ġisem u taħbit tal-qalb imnaqqsa
English: 10 film-coated tablets 30 film-coated tablets 60 film-coated tablets 120 film-coated tablets 180 film-coated tablets 360 film-coated tablets
Maltese: 10 pilloli miksija b'rita 30 pillola miksija b'rita 60 pillola miksija b'rita 120 pillola miksija b'rita 180 pillola miksija b'rita 360 pillola miksija b'rita
English: However, bioequivalence of Zomarist with co-administered vildagliptin and metformin has been demonstrated (see section 5.2).
Maltese: Madankollu, il-bioekwivalenza ta'Zomarist meta ngħata flimkien ma' vildagliptin u metformin ġiet murija (ara sezzjoni 5.2).
English: Pharmacotherapeutic group: Drugs used in diabetes, combinations of oral blood glucose lowering drugs, ATC code: A10BD08
Maltese: Mediċini li jintużaw fid-dijabete, kombinazzjonijiet ta' mediċini li jbaxxu l-glucose fid-demm, Kodiċi ATC:
English: Each tablet contains 50 mg vildagliptin and 850 mg metformin hydrochloride (corresponding to 660 mg of metformin).
Maltese: Kull pillola fiha 50 mg vildagliptin u 850 mg metformin hydrochloride (jikkorrispondi għal 660 mg metformin).
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: Id-doża mingħajr effett filfirien kienet 25 mg/kg (5-darbiet l-esponiment fil-bniedem ibbażat fuq l-AUC) u fil-ġrieden 750 mg/kg (142-darbiet l-esponiment fil-bniedem).
English: • Common (may affect up to 1 in 10 people): dizziness, headache, trembling that cannot be controlled, metallic taste, low blood glucose.
Maltese: • Komuni (jistgħu jaffettwaw sa persuna waħda minn kull 10): sturdament, uġigħ ta' ras, tregħid li ma jkunx jista' jiġi kkontrollat, togħma ta'metall, glucose fid-demm baxx.
English: Zomarist 50 mg/850 mg film-coated tablets Zomarist 50 mg/1000 mg film-coated tablets vildagliptin/metformin hydrochloride
Maltese: Informazzjoni għall-utent Zomarist 50 mg/850 mg pilloli miksija b'rita Zomarist 50 mg/1000 mg pilloli miksija b'rita vildagliptin/metformin hydrochloride
English: A meta-analysis of independently and prospectively adjudicated cardiovascular events from 37 phase III and IV monotherapy and combination therapy clinical studies of up to more than 2 years duration (mean exposure 50 weeks for vildagliptin and 49 weeks for comparators) was performed and showed that vildagliptin treatment was not associated with an increase in cardiovascular risk versus comparators.
Maltese: III u IV b'monoterapija u terapija kkombinata li damu għaddejjin sa aktar minn sentejn (esponiment medju ta' 50 ġimgħa għal vildagliptin u 49 weeks għas-sustanzi ta' paragun) li wriet li trattament b'vildagliptin ma kienx assoċjat ma' żieda fir-riksju kardovaskulari mqabbel malkomparaturi.
English: Each tablet contains 50 mg vildagliptin and 1000 mg metformin hydrochloride (corresponding to 780 mg of metformin).
Maltese: Kull pillola fiha 50 mg vildagliptin u 1000 mg metformin hydrochloride (jikkorrispondi għal 780 mg metformin).
English: If no adequate strength of Zomarist is available, individual monocomponents should be used instead of the fixed dose combination.
Maltese: Jekk ma tkunx disponibbli qawwa adegwata ta' Zomarist, għandhom jiġu użati monokomponenti individwali minflok il-kombinazzjoni ta' doża fissa.
English: Zomarist 50 mg/1000 mg film-coated tablets are dark yellow, oval tablets with “NVR” on one side and “FLO” on the other.
Maltese: Zomarist 50 mg/1000 mg pilloli miksija b'rita huma pilloli sofor skuri, ovali b'“NVR” fuq naħa waħda u “FLO” fuq l-oħra.
English: Metformin may exert its glucose-lowering effect via three mechanisms: - by reduction of hepatic glucose production through inhibition of gluconeogenesis and glycogenolysis; - in muscle, by modestly increasing insulin sensitivity, improving peripheral glucose uptake and utilisation; - by delaying intestinal glucose absorption.
Maltese: Metformin jista' jeżerċita l-effett tiegħu li jnaqqas il-glucose permezz ta' tlett mekkaniżmi: - billi jnaqqas il-produzzjoni tal-glucose mill-fwied billi jimpedixxi l-glukoneoġenesi u glyjkoġenoliżi; - fil-muskoli, billi jżid b'mod modest is-sensittività għall-insulina, u b'hekk itejjeb ir-risorbiment tal-glucose periferali u l-użu tiegħu; - billi jittardja l-assorbiment tal-glucose mill-imsaren.
English: After intravenous administration to healthy subjects, the total plasma and renal clearances of vildagliptin are 41 and 13 l/h, respectively.
Maltese: Wara l-għotja minn ġol-vina lill-individwi b'saħħithom, it-tneħħija totali ta' vildagliptin mill-plażma u mill-kliewi huma 41 u 13 l/h, rispettivament.