FrancophonIA/ELRC3.0 huggingface dataset:
English: It should be kept in mind that the post-partum is a vulnerable period with background risks of hypertension, convulsions, pre-eclampsia, psychiatric events and cardiovascular/cerebrovascular and thrombotic events.
Maltese: Wieħed għandu jżomm f'moħħu li ż-żmien ta' wara t-tqala huwa perjodu vulnerabbli b'riskji ġenerali ta', pressjoni għolja, aċċessjonijiet, pre-eklampsja, avvenimenti psikjatriċi, u avvenimenti kardjovaskulari/ċerebrovaskulari u trombotiċi.
English: This information can be coordinated at individual Member States level.
Maltese: Din l-informazzjoni tista' tiġi kkoordinata f'livell ta' Stati Membri individwali.
English: In light of the above, and given the widespread use of bromocriptine in lactation inhibition, the ANSM considered that the benefit/risk ratio of bromocriptine-containing products in this indication is unfavourable and that it is in the interest of the Union to refer the bromocriptine-containing medicinal products for oral use indicated in post-partum inhibition of lactation to the PRAC and requested in July 2013 that it gives a recommendation under Article 31 of Directive 2001/83/EC, on whether marketing authorisations of these products should be maintained, varied, suspended or withdrawn.
Maltese: Fid-dawl ta' dan ta' hawn fuq, u minħabba l-użu mifrux ta' bromocriptine f'inibizzjoni ta' treddigħ, lANSM ikkunsidra l-proporzjon tal-benefiċċju/riskju ta' prodotti mediċinali li fihom bromocroptine f'dan l-użu bħala li mhuwiex favorevoli u li huwa fl-interess tal-Unjoni li tirreferi prodotti mediċnali li fihom bromocriptine għal użu orali indikati f'inibizzjoni ta' treddigħ wara t-tqala lill-PRAC u talab f'Lulju 2013 li jagħti rakkomandazzjoni skont l-Artikolu 31 tad-Direttiva 2001/83/KE, fuq jekk l-awtorizzazzjonijiet għat-tqegħid fis-suq ta' dawn il-prodotti għandhomx jinżammu, jinbidlu, jiġu sospiżi jew irtirati.
English: • Finally, for the bromocriptine-containing medicinal products for oral use in the post-partum inhibition of lactation with the strengths of 5 mg and 10 mg, the PRAC is of the opinion that the benefit does not outweigh the risks of misuse and medication error and therefore recommended this indication to be deleted.
Maltese: • Finalment, għal prodotti mediċnali li fihom bromocriptine għal użu mill-ħalq f'inibizzjoni ta' treddigħ wara t-tqala b'dożi ta' 5 mg u 10 mg, il-PRAC huwa tal-opinjoni li l-benefiċċju ma jegħlibx ir-riskji ta' użu ħażin u żball terapewtiku u għalhekk irrakkomanda li dan l-użu jitħassar.
English: In some studies bromocriptine was associated with higher incidence of rebound phenomenon compared to cabergoline (in one study), and similar to lisuride or non-ergot dopamine agonist.
Maltese: F'xi studji, bromocriptine ġie assoċjat ma' inċidenza ogħla ta' fenomenu ta' rikaduta meta mqabbel ma' cabergoline (fi studju wieħed), u simili għal lisuride jew agonist ta' dopamina mhux ergot.
English: Finally, the PRAC considered that, to avoid medication errors or misuse, the indication for inhibition of post-partum lactation, should be removed from the product information of the 5 mg and 10 mg strengths.
Maltese: Finalment, il-PRAC ikkunsidra li, biex jiġu evitati żbalji terapewtiċi jew użu ħażin, l-użu għal inibizzjoni ta' treddigħ wara t-tqala, għandu jitneħħa mill-informazzjoni tal-prodott tad-dożi 5 mg u 10 mg.
English: • In addition, the PRAC recommended all strengths of these products to be contraindicated in patients with uncontrolled hypertension, hypertensive disorders of pregnancy (including eclampsia, pre-eclampsia or pregnancy-induced hypertension), hypertension post-partum and puerperium as well as in patients with a history of coronary artery disease or other severe cardiovascular conditions, or symptoms/history of severe psychiatric disorders;
Maltese: • Barra minn hekk, il-PRAC irrakkomanda li d-dożi kollha ta' dawn il-prodotti jiġu kontraindikati f'pazjenti bi pressjoni għolja mhux ikkontrollata, disturbi ta' pressjoni għolja tat-tqala (inklużi eklampsja, pre-eklampsja jew pressjoni għolja minħabba tqala), pressjoni għolja wara t-tqala u filpweperju, u pazjenti bi storja ta' mard tal-arterji koronarji jew kundizzjonijiet kardjovaskulari severi oħrajn, jew sintomi/storja ta' disturbi psikjatriċi severi;
English: Clinical studies and published literature supported the use of bromocriptine in prevention or suppression of physiological lactation in post-partum.
Maltese: Studji kliniċi u letteratura ppubblikata appoġġjaw l-użu ta' bromocriptine fil-prevenzjoni jew trażżin ta' espressjoni tal-ħalib fiżjoloġiku wara t-tqala.
English: Based on a case report, it was recommended that familial history of preeclampsia should be included as a contraindication of bromocriptine in post-partum and for blood pressure to be closely monitored, especially in case of headaches (Makdassi, 1991).
Maltese: Abbażi ta' rapport ta' każ, kien rakkomandat li l-istorja familjali preeklampsja għandha tiġi inkluża bħala kontraużu ta' bromocriptine wara t-tqala u li l-pressjoni għolja tiġi ssorveljata mill-qrib, speċjalment f'każijiet ta' uġigħ ta' ras (Makdassi, 1991).
English: The PRAC, as a consequence, concluded that the benefit-risk balance of oral bromocriptine-containing medicinal products in the post-partum inhibition of lactation identified in Annex I remains favourable, subject to the agreed changes to the product information including restrictions and warnings.
Maltese: Il-PRAC, b'konsegwenza ta' dan, ikkonkluda li l-bilanċ bejn benefiċċju u riskju ta' prodotti mediċinali li fihom bromocriptine għal inibizzjoni ta' treddigħ wara t-tqala identifikat f'Anness I jibqa' favorevoli, soġġett għal tibdiliet fl-informazzjoni tal-prodott inklużi restrizzjonijiet u twissijiet.
English: In the European Union (EU) it is also used to treat other conditions, such as hyperprolactinaemia and Parkinson's disease; however these indications are not in the scope of this European review.
Maltese: Fl-Unjoni Ewropea (UE) jintuża wkoll biex jikkura kundizzjonijiet oħrajn, bħal iperprolaktinemija u l-marda ta' Parkinson; madankollu dawn l-indikazzjonijiet mhumiex fil-mira ta' din ir-reviżjoni Ewropea.
English: The study observing the risks of hypertension found that while bromocriptine did not appear to increase the risk of inducing post-partum hypertension, it may aggravate already existing pregnancy-induced hypertension.
Maltese: L-istudju li osserva r-riskji ta' pressjoni għolja sab li filwaqt li bromocriptine ma deherx li jżid ir-riskju li jikkaġuna pressjoni għolja wara t-tqala, jista' jiggrava pressjoni għolja eżistenti minħabba t-tqala.
English: Grounds for the PRAC recommendation
Maltese: Raġunijiet għar-rakkomandazzjoni tal-PRAC
English: Following the assessment of the relevant data, the PRAC recommended not to use bromocriptine for the routine suppression of lactation or for the relief of symptoms of post-partum pain and engorgement which can be adequately treated with non-pharmacological intervention (such as firm breast support, ice application) and/or simple analgesics.
Maltese: Wara evalwazzjoni tad-dejta relevanti, il-PRAC irrakkomanda li bromocriptine ma jintużax għat-trażżin ta' rutina ta' treddigħ jew għall-eżenzjoni ta' sintomi ta' uġigħ jew konġestjoni ta' wara t-twala li jistgħu jiġu kkurati b'mod xieraq b'intervent mhux farmakoloġiku (bħal appoġġ sod mas-sider, applikazzjoni ta' silġ) u/jew analġeżiċi sempliċi.
English: Although some factors suggested causality of the events to bromocriptine, independent risk factors for these types of events are present in the post-partum period.
Maltese: Għalkemm xi fatturi ssuġġerew il-kawżalità tal-avvenimenti għal bromocriptine, fatturi ta' riskju indipendenti għal dawn it-tipi ta' avvenimenti huma preżenti fil-perjodu ta' wara t-tqala.
English: The PRAC was of the opinion that this potential risk could be mitigated through limiting the use of bromocriptine to circumstances where breastfeeding is not possible due to medical reasons (such as intrapartum loss, neonatal death, HIV infection of the mother) and inclusion of contraindications, warning and precautions in the product information, as it is already the case in some Member States.
Maltese: Il-PRAC kien tal-opinjoni li dan ir-riskju potenzjali jista' jitnaqqas billi jiġi ristrett l-użu ta' bromocriptine għal ċirkostanzi fejn treddigħ mhuwiex possibbli minħabba raġunijiet mediċi (bħal telf waqt it-tqala, mewt tat-tarbija mattwelid, infezzjoni tal-HIV tal-omm) u inklużjoni ta' kontraindikazzjonijiet, twissijiet u prekawzjonijiet flinformazzjoni tal-prodott, kif inhu diġà l-każ f'xi Stati Membri.
English: Concomitantly, in France, following a first national pharmacovigilance survey that showed that cardiovascular adverse drug reactions (ADRs) accounted for an important proportion of the AEs reported, the summary of product characteristics (SmPC) had been reinforced with respect to these ADRs.
Maltese: Fl-istess żmien, fi Franza, wara l-ewwel stħarriġ nazzjonali ta' farmakoviġilanza li wera li reazzjonijiet tal-mediċini avversi (ADRs) kardjovaskulari jammontaw għal proporzjon importanti tal-AEs rappurtati, is-sommarju tal-karatteristiċi tal-prodott (SmPC) ġew rinfurzati fir-rigward ta' dawn l-ADRs.
English: With regards to off label use and misuse, while high rates were reported in the French surveys, the analysis of the safety database of the MAH of the originator covering the period since the first marketing authorisation, focused on the dose and treatment duration, retrieved much lower rates (4.2% and 4.7% respectively).
Maltese: Fir-rigward ta' użu off label u użu ħażin, filwaqt li fl-istħarriġ Franċiż ġew irrappurtati rati għoljin, lanaliżi tad-database tas-sigurtà tal-MAH tal-oriġnatur li kopriet il-perjodu mill-ewwel awtorizzazzjoni għat-tqegħid fis-suq, kisbet rati ħafna iktar baxxi (4,2% u 4.7% rispettivament).
English: In addition, the PRAC was of the view that the contra-indication in patients with uncontrolled hypertension, hypertensive disorders of pregnancy (including eclampsia, pre-eclampsia or pregnancyinduced hypertension), hypertension post-partum and in the puerperium, and patients with a history of coronary artery disease or other severe cardiovascular conditions, or symptoms/history of severe psychiatric disorders, already partially in place in most member states should be implemented across all Member States.
Maltese: Barra minn hekk, il-PRAC kien tal-fehma li l-kontraindikazzjonijiet f'pazjenti bi pressjoni għolja mhux ikkontrollata, disturbi ta' pressjoni għolja tat-tqala (inklużi eklampsja, pre-eklampsja jew pressjoni għolja minħabba tqala), pressjoni għolja wara t-tqala u fil-pwerperju, u pazjenti bi storja ta' mard talarterji koronarji jew kundizzjonijiet kardjovaskulari severi oħrajn, jew sintomi/storja ta' disturbi psikjatriċi severi, diġà parzjalment stabbiliti f'ħafna mill-Istati Membri għandhom jiġu implimentati madwar l-Istati Membri kollha.
English: Based on the available data the PRAC could not exclude a causality between the use of bromocriptine and cardiovascular, neurovascular and psychiatric events; these are already included in many PI for these products.
Maltese: Abbażi tad-dejta disponibbli, il-PRAC ma setax jeskludi kawżalità bejn l-użu ta' bromocriptine u avvenimenti karjovaskulari, newrovaskulari u psikjatriċi; dawn diġà huma inklużi f'ħafna mill-PI ta' dawn il-prodotti.
English: The PRAC recommended that blood pressure should be closely monitored, especially during the first days of therapy and a warning advising to discontinue treatment in case of hypertension, suggestive chest pain, severe, progressive, or unremitting headache (with or without visual disturbances), or evidence of central nervous system toxicity, and that this should be reflected in the product information.
Maltese: Il-PRAC irrakkomanda li l-pressjoni għolja għandha tiġi sorveljata mill-qrib, speċjalment waqt l-ewwel ġranet ta' terapija u għandha toħroġ twissija li tirrakkomanda li ma tibqax tingħata l-kura f'każ ta' pressjoni għolja, uġigħ suġġestiv fis-sider, uġigħ ta' ras sever, progressiv jew bla waqfien (bi jew mingħajr disturbi viżwali), jew evidenza ta' tossiċità fis-sistema nervuża ċentrali, u li dan għandu jiġi rifless fl-informazzjoni tal-prodott.
English: Based on these conclusions, the PRAC concluded that the benefit-risk balance of bromocriptinecontaining medicinal products remains favourable subject to changes to the product information, including agreed restrictions and warnings.
Maltese: Abbażi ta' dawn il-konklużjonijiet, il-PRAC ikkonkluda li l-bilanċ bejn benefiċċu u riskju ta' prodotti mediċinali li fihom bromocriptine jibqa' wieħed favorevoli soġġett għal tibdiliet fl-informazzjoni talprodott, inklużi restrizzjonijiet u twissijiet miftehma.
English: The PRAC reviewed the safety results from all clinical studies conducted as part of the initial development plan and noted that no cardiovascular, neurological or psychiatric adverse events in association with post-partum administration of bromocriptine were observed.
Maltese: Il-PRAC irreveda r-riżultati ta' sigurtà mill-istudji kliniċi kollha li twettqu bħala parti mill-pjan ta' żvilupp inizjali u nnota li ma ġie osservat ebda avveniment avvers kardjovaskulari, newroloġiku jew psikjatriku b'rabta ma' amministrazzjoni wara t-tqala ta' bromocriptine.
English: Eucreas with alcohol
Maltese: Eucreas ma' alkoħol
English: Eucreas is not a substitute for insulin.
Maltese: Eucreas mhux sostitut għall-insulina.
English: The composite endpoint of adjudicated major adverse cardiovascular events (MACE) including acute myocardial infarction, stroke or cardiovascular death was similar for vildagliptin versus combined active and placebo comparators [Mantel-Haenszel risk ratio (M-H RR) 0.82 (95% CI 0.61-1.11)].
Maltese: L-endpoint kompost ta' avvenimenti kardjovaskulari avversi ewlenin (MACE - major adverse cardiovascular events) aġġudikati inkluż infart mijokardijaku akut, puplesija jew mewt kardjovaskulari kien simili għal vildagliptin kontra komparaturi attivi u tal-plaċebo kkombinati [ilproporzjon tar-riskju Mantel-Haenszel (M-H RR - Mantel-Haenszel risk ratio) ta' 0.82 (CI ta' 95% 0.61-1.11)].
English: EU/1/07/425/007-012 EU/1/07/425/016-018 EU/1/07/425/025-030 EU/1/07/425/034-036
Maltese: EU/1/07/425/007-012 EU/1/07/425/016-018
English: Other medicines and Eucreas
Maltese: Mediċini oħra u Eucreas
English: There have been no therapeutic clinical trials conducted with Eucreas.
Maltese: Ma sarux provi kliniċi terapewtiċi b'Eucreas.
English: Vildagliptin/metformin 50 mg/1000 mg twice daily reduced HbA1c by -1.82% ,vildagliptin/metformin 50 mg/500 mg twice daily by -1.61%, metformin 1000 mg twice daily by -1.36% and vildagliptin 50 mg twice daily by -1.09% from a mean baseline HbA1c of 8.6%.
Maltese: Doża ta' 50 mg/1000 mg vildagliptin/metformin darbtejn kuljum naqqset l-HbA1c b'-1.82%, doża ta' 50 mg/500 mg vildagliptin/metformin darbtejn kuljum naqqsitu b'-1.61%, 1000 mg metformin darbtejn kuljum naqqsuh b'-1.36% u 50 mg vildagliptin darbtejn kuljum naqqsuh b'-1.09% mill-medja tal-linja bażi ta' HbA1c ta' 8.6%.
English: Eucreas should not be used in patients with hepatic impairment, including those with pre-treatment alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 times the upper limit of normal (ULN) (see sections 4.3, 4.4 and 4.8).
Maltese: Eucreas m'għandux jintuża f'pazjenti b'indeboliment tal-fwied, inklużi pazjenti li jkollhom alanine aminotransferase (ALT) jew aspartate aminotransferase (AST) qabel il-kura > 3 darbiet il-limitu ta' fuq tan-normal (ULN) (ara sezzjonijiet 4.3, 4.4 u 4.8).
English: Analysis of the results for overweight patients treated with metformin after failure of diet alone showed: - a significant reduction in the absolute risk of any diabetes-related complication in the metformin group (29.8 events/1,000 patient-years) versus diet alone (43.3 events/1,000 patientyears), p=0.0023, and versus the combined sulphonylurea and insulin monotherapy groups (40.1 events/1,000 patient-years), p=0.0034; - a significant reduction in the absolute risk of diabetes-related mortality: metformin 7.5 events/1,000 patient-years, diet alone 12.7 events/1,000 patient-years, p=0.017; - a significant reduction in the absolute risk of overall mortality: metformin 13.5 events/1,000 patient-years versus diet alone 20.6 events/1,000 patient-years (p=0.011), and versus the combined sulphonylurea and insulin monotherapy groups 18.9 events/1,000 patientyears (p=0.021); - a significant reduction in the absolute risk of myocardial infarction: metformin 11 events/1,000 patient-years, diet alone 18 events/1,000 patient-years (p=0.01).
Maltese: Analiżi tar-riżultati għallpażjenti li għandhom piż eċċessiv li ġew ikkurati b'metformin wara li d-dieta waħidha falliet uriet: - tnaqqis sinifikanti fir-riskju assolut ta' kwalunkwe kumplikazzjoni relatata mad-dijabete filgrupp fuq metformin (29.8 każijiet/1,000 sena tal-pazjent) kontra d-dieta waħidha (43.3 każijiet/1,000 sena tal-pazjent), p=0.0023, u kontra l-gruppi b'sulphonylurea kombinata u monoterapija bl-insulina (40.1 każijiet/1,000 sena tal-pazjent), p=0.0034; - tnaqqis sinifikanti fir-riskju assolut ta' mortalità relatata mad-dijabete: metformin 7.5 każijiet/1,000 sena tal-pazjent, dieta waħidha 12.7 każijiet/1,000 sena tal-pazjent, p=0.017; - tnaqqis sinifikanti fir-riskju assolut ta' mortalità: metformin 13.5 każijiet/1,000 sena tal-pazjent kontra dieta waħidha 20.6 każijiet/1,000 sena tal-pazjent (p=0.011), u kontra l-gruppi b'sulphonylurea kombinata u monoterapija bl-insulina 18.9 każijiet/1,000 sena tal-pazjent (p=0.021); - tnaqqis sinifikanti fir-riskju assolut ta' infart mijokardijaku: metformin 11-il każ/1,000 sena talpazjent, dieta waħidha 18-il każ/1,000 sena tal-pazjent (p=0.01).
English: Adults with normal renal function (GFR ≥ 90 ml/min) The dose of antihyperglycaemic therapy with Eucreas should be individualised on the basis of the patient's current regimen, effectiveness and tolerability while not exceeding the maximum recommended daily dose of 100 mg vildagliptin.
Maltese: Adulti b'funzjoni renali normali (GFR ≥ 90 mL/min) Id-doża ta' terapija anti-ipergliċemika b'Eucreas għandha tiġi individwalizzata abbażi tal-programm ta' kura attwali tal-pazjent, l-effettività u t-tollerabilità waqt li ma taqbiżx id-doża massima rakkomandata ta' kuljum ta' 100 mg vildagliptin.
English: The rate and extent of absorption of metformin from Eucreas 50 mg/1000 mg were decreased when given with food as reflected by the decrease in Cmax by 26%, AUC by 7% and delayed Tmax (2.0 to 4.0 h).
Maltese: Ir-rata u l-grad ta' assorbiment ta' metformin milEucreas 50 mg/1000 mg kienu mnaqqsa meta mogħtija ma' l-ikel bi tnaqqis fis-Cmax b'26%, AUC b'7% u Tmax ittardjat (2.0 sa 4.0 h).
English: Eucreas combines two antihyperglycaemic agents with complimentary mechanisms of action to improve glycaemic control in patients with type 2 diabetes: vildagliptin, a member of the islet enhancer class, and metformin hydrochloride, a member of the biguanide class.
Maltese: Eucreas jikkombina żewġ aġenti kontra l-ipergliċemija b'mekkaniżmu ta' azzjoni kumplimentari sabiex jitjieb il-kontroll ta' pazjenti bid-dijabete tat-tip 2: vildagliptin, membru tal-klassi li jtejjeb lislet, u metformin hydrochloride, membru tal-klassi biguanide.
English: Date of first authorisation: 14 November 2007 Date of latest renewal: 23 July 2012
Maltese: Data tal-aħħar tiġdid: 23 Lulju 2012
English: The active substances of Eucreas, vildagliptin and metformin, belong to a group of medicines called “oral antidiabetics”.
Maltese: Is-sustanzi attivi ta' Eucreas, vildagliptin u metformin, jagħmlu parti minn grupp ta' mediċini li jissejħu “antidijabetiċi orali”.
English: EU/1/07/425/001-006 EU/1/07/425/013-015 EU/1/07/425/019-024 EU/1/07/425/031-033
Maltese: EU/1/07/425/019-024
English: What Eucreas contains - The active substances are vildagliptin and metformin hydrochloride.
Maltese: X'fih Eucreas - Is-sustanzi attivi huma vildagliptin u metformin hydrochloride.
English: Bioequivalence has been demonstrated between Eucreas 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 Eucreas 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: - Do not use Eucreas if you are pregnant or breast-feeding (see also “Do not take Eucreas”).
Maltese: - Tużax Eucreas jekk tqila jew qed tredda' (ara wkoll “Tiħux Eucreas”).
English: Eucreas 50 mg/850 mg film-coated tablets vildagliptin/metformin hydrochloride
Maltese: Eucreas 50 mg/850 mg pilloli miksija b'rita vildagliptin/metformin hydrochloride
English: As metformin is excreted via the kidney, and elderly patients have a tendency to decreased renal function, elderly patients taking Eucreas should have their renal function monitored regularly (see sections 4.4 and 5.2).
Maltese: Peress illi metformin jitneħħa mill-kilwa, u pazjenti anzjani għandhom it-tendenza li jkollhom funzjoni renali mnaqsa, pazjenti anzjani li jkunu qed jieħdu Eucreas għandu jkollhom il-funzjoni renali immonitorata b'mod regolari (ara sezzjonijiet 4.4 u 5.2).
English: Metformin is a biguanide with antihyperglycaemic effects, lowering both basal and postprandial plasma glucose.
Maltese: Metformin huwa biguanide b'effetti kontra l-ipergliċemija, jnaqqas kemm il-glucose fil-plasma basiku kif ukoll dak ta' wara l-ikel.
English: Eucreas 50 mg/1000 mg film-coated tablets vildagliptin/metformin hydrochloride
Maltese: Eucreas 50 mg/1000 mg pilloli miksija b'rita vildagliptin/metformin hydrochloride
English: Children and adolescents The use of Eucreas in children and adolescents up to 18 years of age is not recommended.
Maltese: Tfal u adolexxenti L-użu ta' Eucreas fi tfal u adolexxenti ta' età ta' sa 18-il sena mhux rakkomandat.
English: 60 film-coated tablets.
Maltese: Ma ġewx identifikati metaboliti fil-bnedmin.
English: However, bioequivalence of Eucreas with co-administered vildagliptin and metformin has been demonstrated (see section 5.2).
Maltese: Madankollu, il-bioekwivalenza ta'Eucreas meta ngħata flimkien ma' vildagliptin u metformin ġiet murija (ara sezzjoni 5.2).
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 talfunzjoni taċ-ċelluli beta inklużi HOMA-β (Stima tal-Mudell B'Omeostażi-β), proporzjoni talproinsulina ma' l-insulina u kejl tar-risponsittività taċ-ċelluli beta mit-testijiet tat-tolleranza għall-ikel li jiġu kampjunati spissi.
English: Eucreas is indicated in the treatment of type 2 diabetes mellitus: - Eucreas is indicated in the treatment of adult patients who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone or who are already treated with the combination of vildagliptin and metformin as separate tablets.
Maltese: Eucreas huwa indikat għall-kura ta' dijabete mellitus tat-tip 2: - Eucreas huwa indikat għall-kura ta' pazjenti adulti li ma jistgħux jiksbu kontroll gliċemiku xieraq bl-ogħla doża li jifilħu ta' metformin li jittieħed mill-ħalq waħdu jew li diġà qed jiġu kkurati b'taħlita ta' vildagliptin u metformin bħala pilloli separati.
English: Eucreas 50 mg/850 mg film-coated tablets Eucreas 50 mg/1000 mg film-coated tablets
Maltese: Eucreas 50 mg/850 mg pilloli miksija b'rita Eucreas 50 mg/1000 mg pilloli miksija b'rita
English: - Eucreas is indicated in combination with a sulphonylurea (i.e. triple combination therapy) as an adjunct to diet and exercise in adult patients inadequately controlled with metformin and a sulphonylurea.
Maltese: - Eucreas huwa indikat biex jingħata flimkien ma' sulphonylurea (i.e terapija ta' kombinazzjoni tripla) bħala aġġunt għad-dieta u l-eżerċizzju f'pazjenti adulti li mhux qed jiġu kkontrollati b'mod adegwat b'metformin u b'sulphonylurea.