FrancophonIA/ELRC3.0 huggingface dataset:
English: The Marketing Authorisation Holder (MAH) shall ensure that, at launch, all physicians who are expected to prescribe/use NovoSeven are provided with an Educational pack containing the following:
Maltese: Id-Detentur ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq (MAH) għandu jassigura li ma' lintroduzzjoni tal-prodott fis-suq, it-tobba kollha li huma mistennija li jordnaw/jużaw NovoSeven għandhom jiġu pprovduti b'pakkett Edukattiv li jkun fih dan li ġej:
English: The Marketing Authorisation Holder must implement this educational plan nationally, prior to marketing, and as agreed with the competent authorities in the Member States.
Maltese: Id-Detentur ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq għandu jwettaq dan il-pjan edukattiv fuq skala nazzjonali qabel ma l-prodott jitqiegħed fis-suq u kif miftiehem ma' l-awtoritajiet kompetenti fl-Istati Membri.
English: ANNEX CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
Maltese: ANNESS KUNDIZZJONIJIET JEW RESTRIZZJONIJIET LI GĦANDHOM JIĠU MWETTQA MILLISTATI
English: The physician information pack should contain the following:
Maltese: Il-pakkett ta' informazzjoni għat-tabib għandu jkollu dan li ġej:
English: • Clear demarcation of the new formulation of NovoSeven from original NovoSeven, with clear descriptions of any differences in the vial sizes, colour codes and dosing and reconstitution instructions
Maltese: b'deskrizzjonijiet ċari ta' kull differenza fid-daqsijiet tal-kunjetti, kodiċi ta' kuluri u dożaġġ u istruzzjonijiet ta' rikostituzzjoni.
English: CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
Maltese: KUNDIZZJONIJIET JEW RESTRIZZJONIJIET LI GĦANDHOM JIĠU MWETTQA
English: The absolute bioavailability is 85%.
Maltese: Il-biodisponibilità assoluta hija 85%.
English: “EXP”.
Maltese: “EXP/JIS”.
English: Linearity/non-linearity
Maltese: Linearità/ nuqqas ta' linearità
English: D-90429 Nürnberg Germany
Maltese: D-90429 Nürnberg Il-Ġermanja
English: Elderly (≥ 65 years)
Maltese: Anzjani (≥ 65 sena)
English: The mean volume of distribution (Vd) ranged between 63-276 litres.
Maltese: Il-medja tal-volum tad-distribuzzjoni (Vd) kella medda ta' bejn 63-276 litru.
English: Zomarist is not a substitute for insulin.
Maltese: Zomarist mhux sostitut għall-insulina.
English: - The other ingredients are: Hydroxypropylcellulose, magnesium stearate, hypromellose, titanium dioxide (E 171), yellow iron oxide (E 172), macrogol 4000 and talc.
Maltese: - Is-sustanzi l-oħra huma Hydroxypropylcellulose, magnesium stearate, hypromellose, titanium dioxide (E 171), yellow iron oxide (E 172), macrogol 4000 u talc.
English: EU/1/08/483/007-012 EU/1/08/483/016-018 EU/1/08/483/025-030 EU/1/08/483/034-036
Maltese: EU/1/08/483/007-012 EU/1/08/483/016-018 EU/1/08/483/025-030
English: Metformin is eliminated by renal excretion.
Maltese: Metformin jiġi eliminat permezz ta' tneħħija renali.
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% intervall ta' kunfidenza ta' 0.61-1.11)].
English: Infections and infestations Very rare
Maltese: Infezzjonijiet u infestazzjonijiet Rari ħafna
English: Metformin is contraindicated.
Maltese: Metformin huwa kontraindikat
English: Assessment of each individual MACE component showed no increased risk (similar M-H RR).
Maltese: Valutazzjoni ta' kull komponent individwali ta' MACE ma wriet l-ebda żieda fir-riskju (M-H RR simili).
English: Therefore, vildagliptin is not likely to affect metabolic clearance of co-medications metabolised by CYP 1A2, CYP 2C8, CYP 2C9, CYP 2C19, CYP 2D6, CYP 2E1 or CYP 3A4/5.
Maltese: Għalhekk, vildagliptin x'aktarx li ma jeffettwax it-tneħħija metabolika ta' dawn il-medikamenti li jingħataw flimkien li huma metabolizzati permezz ta' CYP 1A2, CYP 2C8, CYP 2C9, CYP 2C19, CYP 2D6, CYP 2E1 jew CYP 3A4/5.
English: Combination with a sulphonylurea
Maltese: Kombinazzjoni ma' xi sulphonylurea
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: • Uncommon: diarrhoea, flatulence.
Maltese: • Mhux komuni: dijarea, gass.
English: Combination with insulin
Maltese: Kombinazzjoni mal-insulina
English: Vildagliptin, a member of the islet enhancer class, is a potent and selective dipeptidyl-peptidase-4 (DPP-4) inhibitor.
Maltese: Vildagliptin, membru tal-klassi li jtejjeb l-islet, huwa impeditur qawwi u silettiv ta' dipeptidylpeptidase-4 (DPP-4).
English: At 600 mg, one subject experienced oedema of the feet and hands, and increases in creatine phosphokinase (CPK), AST, C-reactive protein (CRP) and myoglobin levels.
Maltese: B'600 mg, individwu wieħed kellu edema ta' l-idejn u tas-saqajn, u żiediet fil-creatine phosphokinase (CPK), AST, proteina reattiva-C (CRP) u fil-livelli talmajoglobina.
English: Renal impairment: In subjects with mild, moderate, or severe renal impairment, systemic exposure to vildagliptin was increased (Cmax 8-66%; AUC 32-134%) and total body clearance was reduced compared to subjects with normal renal function.
Maltese: F'individwi b'indeboliment renali ħafif, moderat, jew sever, l-esponiment sistemiku għal vildagliptin żdiedet (Cmax 8-66%, AUC 32-134%) u t-tneħħija totali mill-ġisem tnaqqset meta mqabbla ma' individwi b'funzjoni renali normali.
English: The incidence of hypoglycaemia was similar in both treatment groups (14.0% in the vildagliptin group vs 16.4% in the placebo group).
Maltese: L-inċidenza ta' ipogliċemija kienet simili fiż-żewġ gruppi ta' trattament (14.0% fil-grupp ta' vildagliptin kontra 16.4% fil-grupp tal-plaċebo).
English: A MACE occurred in 83 out of 9,599 (0.86%) vildagliptin-treated patients and in 85 out of 7,102 (1.20%) comparator-treated patients.
Maltese: MACE seħħew fi 83 minn 9,599 (0.86%) pazjent ittrattati b'vildagliptin u f'85 minn 7,102 (1.20%) pazjent ittrattati b'sustanza ta' paragun.
English: Vildagliptin acts primarily by inhibiting DPP-4, the enzyme responsible for the degradation of the incretin hormones GLP-1 (glucagon-like peptide-1) and GIP (glucose-dependent insulinotropic polypeptide).
Maltese: Vildagliptin jaħdem l-aktar billi jinibixxi DPP-4, l-enzima responsabbli għad-degradazzjoni ta' lormoni incretin GLP-1 (peptajd-1 li jixbah lil glucagon) u GIP (polipeptajd insulinotropiku li jiddependi fuq il-glucose).
English: The incidence of hypoglycaemia was significantly lower in the vildagliptin group (1.7%) than in the glimepiride group (16.2%).
Maltese: L-inċidenza ta' ipogliċemija kienet ħafna anqas fil-grupp mogħti vildagliptin (1.7%) milli fil-grupp mogħti glimepiride (16.2%).
English: Hepatitis (reversible upon discontinuation of the medicinal product) Abnormal liver function tests (reversible upon discontinuation of the medicinal product)
Maltese: Epatite (riversibbli mat-twaqqif tal-prodott mediċinali) Testijiet mhux normali tal-funzjoni tal-fwied (riversibbli mat-twaqqif tal-prodott mediċinali)
English: Elimination Following oral administration of [
Maltese: Eliminazzjoni Wara li ngħata vildagliptin [
English: Zomarist 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: Zomarist 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: Table 5 Adverse reactions for metformin component
Maltese: Reazzjonijiet avversi għall-komponent metformin
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 għall-pażjenti 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 fil-grupp 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 tal-pazjent, dieta waħidha 18 il każ/1,000 sena tal-pazjent (p=0.01).
English: The rate and extent of absorption of metformin from Zomarist 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 milZomarist 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: After 1 year, mean reductions in HbA1c were -0.81% with vildagliptin added to metformin (mean baseline HbA1c 8.4%) and -0.85% with gliclazide added to metformin (mean baseline HbA1c 8.5%); statistical non-inferiority was achieved (95% CI -0.11 - 0.20).
Maltese: Wara sena, tnaqqisiet medji ta' HbA1c kienu ta' -0.81% meta vildagliptin kien miżjud ma' metformin (linja bażi medja ta' HbA1c ta' 8.4%) u ta' -0.85% meta gliclazide kien miżjud ma' metformin (linja bażi medja ta' HbA1c ta' 8.5%); ma nstabx li kienu inferjuri b'mod statistiku (95% CI -0.11 - 0.20).
English: The incidence of hypoglycaemia was common in both treatment groups (5.1% for the vildagliptin + metformin + glimepiride group versus 1.9% for the placebo + metformin + glimepiride group).
Maltese: L-inċidenza ta' ipogliċemija kienet komuni fiż-żewġ gruppi ta' kura (5.1% għall-grupp ta' vildagliptin + metformin + glimepride kontra 1.9% għall-grupp tal-plaċebo + metformin + glimpride).
English: Body weight change with vildagliptin was -0.2 kg vs +1.6 kg with glimepiride.
Maltese: Il-bidla fil-piż b'vildagliptin kienet ta' -0.2 kg kontra +1.6 kg b'glimepiride.
English: The incidence of hypoglycaemia in the overall population was 8.4% and 7.2% in the vildagliptin and placebo groups, respectively.
Maltese: L-inċidenza ta' ipogliċemija fil-popolazzjoni globali kienet ta' 8.4% u 7.2% fil-gruppi ta' vildagliptin u plaċebo, rispettivament.
English: Adults with normal renal function (GFR ≥ 90 ml/min) The dose of antihyperglycaemic therapy with Zomarist 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'Zomarist 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: Date of first authorisation: 01 December 2008 Date of latest renewal: 31 July 2013
Maltese: Data tal-aħħar tiġdid: 31 Lulju 2013
English: The proportion of patients who achieved a decrease in HbA1c of ≥ 0.7% from baseline was statistically significantly higher in both vildagliptin plus metformin groups (46% and 60%, respectively) versus the metformin plus placebo group (20%).
Maltese: Il-proporzjon ta' pazjenti li kisbu tnaqqis fl- HbA1c ta' ≥ 0.7% mil-linja bażi kien ogħla statistikament sinifikanti kemm filgruppi ta' vildagliptin ma' metformin (46% u 60%, rispettivament) kontra l-grupp ta' metformin malplaċebo (20%).
English: Confirmed heart failure (HF) events defined as HF requiring hospitalisation or new onset of HF were reported in 41 (0.43%) vildagliptin-treated patients and 32 (0.45%) comparator-treated patients with M-H RR 1.08 (95% CI 0.68-1.70).
Maltese: Avvenimenti ta' insuffiċjenza tal-qalb (HF - heart failure) ikkonfermata definiti bħala HF li teħtieġ dħul l-isptar jew bidu ġdid ta' HF kienu rrappurtati f'41 (0.43%) pazjent ittrattati b'vildagliptin u 32 (0.45%) pazjent ittrattati b'sustanza ta' paragun b'M-H RR ta' 1.08 (CI ta' 95% 0.68-1.70).
English: Metformin stimulates intracellular glycogen synthesis by acting on glycogen synthase and increases the transport capacity of specific types of membrane glucose transporters (GLUT-1 and GLUT-4).
Maltese: Metformin jistimula is-sintesi ta' glycogen fiċ-ċelluli billi jaħdem fuq glycogen synthase u jżid il-ħila ta' trasport ta' ċerti tipi ta' trasportaturi ta' glucose fil-membrana (GLUT-1 u GLUT-4).
English: The mean volume of distribution of vildagliptin at steady-state after intravenous administration (Vss) is 71 litres, suggesting extravascular distribution.
Maltese: Il-medja tal-volum tad-distribuzzjoni ta' vildagliptin fi stat-fiss wara li jingħata minn ġol-vina (Vss) hija 71 litru, li jindika distribuzzjoni ekstravaskulari.
English: Frequencies are defined as 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-frekwenzi huma definiti bħala 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: Vildagliptin was not mutagenic in conventional in vitro and in vivo tests for genotoxicity.
Maltese: Vildagliptin ma kienx mutaġeniku f'testijiet konvenzjonali in vitro u in vivo għall-ġenotossiċità.
English: Medical attention may be necessary.
Maltese: Jista' jkun hemm bżonn ta' attenzjoni medika.
English: Maximal daily dose is 50 mg.
Maltese: Id-doża massima ta' kuljum hi ta' 50 mg.
English: PA/Alu/PVC/Alu 2 years PCTFE/PVC/Alu 18 months
Maltese: PCTFE/PVC/Alu 18-il xahar
English: The major metabolite (LAY 151) is pharmacologically inactive and is the hydrolysis product of the cyano moiety, accounting for 57% of the dose, followed by the amide hydrolysis product (4% of dose).
Maltese: Il-metabolu ewlieni (LAY 151) mhuwiex attiv mill-lat farmakoloġiku u huwa l-prodott ta' l-idroliżi tal-parti cyano, li tgħodd 57% tad-doża, segwita mill-prodott ta' l-isdroliżi ta' l-amide (4% tad-doża).
English: Renal clearance of metformin is > 400 ml/min, indicating that metformin is eliminated by glomerular filtration and tubular secretion.
Maltese: It-tneħħija renali ta' metformin hija > 400 ml/min, li jindika li metformin jiġi eliminat permezz ta' filtrazzjoni mill-glomeruli u skrezzjoni mit-tubi.
English: The clinical relevance of this decrease is unknown.
Maltese: Ir-rilevanza klinika ta' dan it-tnaqqis mhux magħrufa.
English: In patients at increased risk of further progression of renal impairment and in the elderly, renal function should be assessed more frequently, e.g. every 3-6 months.
Maltese: F'pazjenti b'riskju akbar ta' aktar progressjoni ta' indeboliment renali u flanzjani, il-funzjoni renali għandha tkun evalwata b'mod aktar frekwenti, eż. kull 3-6 xhur.
English: Zomarist 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: Zomarist 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: Headache, chills
Maltese: Dijarea, gass
English: Glucocorticoids, beta-2-agonists, and diuretics have intrinsic hyperglycaemic activity.
Maltese: Glukokortikojdi, agonisti tat-tip beta-2, u dijuretiċi għandhom attività ipergliċemika minnhom infushom.
English: Multipack: 360 (6 packs of 60) film-coated tablets.
Maltese: Pakkett b'ħafna: 360 (6 pakketti ta' 60) pilloli miksija b'rita.
English: It is assumed that the pharmacokinetics of metformin absorption are non-linear.
Maltese: Huwa assumat li l-farmakokinetika ta' l-assorbiment ta' metformin mhix linjari.
English: The active substances of Zomarist, vildagliptin and metformin, belong to a group of medicines called “oral antidiabetics”.
Maltese: Is-sustanzi attivi ta' Zomarist, vildagliptin u metformin, jagħmlu parti minn grupp ta' mediċini li jissejħu “antidijabetiċi orali”.
English: Necrotic lesions of the tail were observed at ≥ 80 mg/kg/day.
Maltese: Feriti nekrotiċi tad-denb dehru b'≥ 80 mg/kg/jum..
English: Multipack: 120 (2 packs of 60) film-coated tablets.
Maltese: Pakkett b'ħafna: 120 (2 pakketti ta' 60) pilloli miksija b'rita.
English: Nausea, gastro-oesophageal reflux disease
Maltese: Tqalligħ, mard ta' rifluss gastro-esofaġeali
English: Table 2 Adverse reactions reported in patients who received vildagliptin 50 mg twice daily in combination with metformin and a sulphonylurea (N=157)
Maltese: Tabella 2 Reazzjonijiet avversi rapportati f'pazjenti li ħadu vildagliptin 50 mg darbtejn kuljum ma' metformin u xi sulphonylurea (N=157)
English: 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: As metformin is excreted via the kidney, and elderly patients have a tendency to decreased renal function, elderly patients taking Zomarist should have their renal function monitored regularly (see sections 4.4 and 5.2).
Maltese: Peress illi metformin jiġi eliminat mill-kilwa, u pazjenti anzjani għandhom it-tendenza li jkollhom funzjoni renali mnaqsa, pazjenti anzjani li jkunu qed jieħdu Zomarist għandu jkollhom il-funzjoni renali immonitorata b'mod regolari (ara sezzjonijiet 4.4 u 5.2).
English: Diagnostic laboratory findings are decreased blood pH (< 7.35), increased plasma lactate levels (> 5 mmol/l) and an increased anion gap and lactate/pyruvate ratio.
Maltese: Sejbiet dijanjostiċi tal-laboratorju huma tnaqqis fil-pH tad-demm (< 7.35), żieda fil-livelli ta' lactate fil-plażma (>5 mmol/l) u żieda fl-anion gap u l-proporzjon ta' lactate/pyruvate.
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, il-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: Multipack: 180 (3 packs of 60) film-coated tablets.
Maltese: Pakkett b'ħafna: 180 (3 pakketti ta' 60) pilloli miksija b'rita.
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: Urticaria Exfoliative and bullous skin lesions, including bullous pemphigoid
Maltese: Urtikarja Leżjonijiet fil-ġilda esfoljattivi u bl-infafet, inkluż pemphigoid bl-infafet
English: • Very rare (may affect up to 1 in 10,000 people): sore throat, runny nose, fever; signs of a high level of lactic acid in the blood (known as lactic acidosis) such as drowsiness or dizziness, severe nausea or vomiting, abdominal pain, irregular heart beat or deep, rapid breathing; redness of the skin, itching; decreased vitamin B12 levels (paleness, tiredness, mental symptoms such as confusion or memory disturbances).
Maltese: • Rari ħafna (jistgħu jaffettwaw sa persuna waħda minn kull 10,000): grieżem misluħin, imnieħer iqattar, deni; sinjali ta' livell għoli ta' aċidu lattiku fid-demm (magħruf bħala aċidożi lattika) bħal tħeddil jew sturdament, dardir qawwi jew rimettar, uġigħ addominali, qalb tħabbat irregolari jew profonda, tieħu n-nifs bil-għaġġla; ħmura tal-ġilda, ħakk; tnaqqis fil-livelli ta' vitamina
English: There were no withdrawals due to adverse reactions reported in the vildagliptin + metformin + glimepiride treatment group versus 0.6% in the placebo + metformin + glimepiride treatment group.
Maltese: Ma kienx hemm reazzjonijiet ta' tiżmim minħabba reazzjonijiet avversi rapportati fil-grupp ta' trattament ta' vildagliptin + metformin + glimepiride meta mqabbel ma' 0.6% fil-grupp ta' trattament bi plaċebo + metformin + glimepride.
English: What Zomarist contains - The active substances are vildagliptin and metformin hydrochloride.
Maltese: X'fih Zomarist - Is-sustanzi attivi huma vildagliptin u metformin hydrochloride.
English: Other medicines and Zomarist
Maltese: Mediċini oħra u Zomarist
English: The following statements reflect the information available on the individual active substances.
Maltese: Id-dikjarazzjonijiet li ġejjin jirriflettu l-informazzjoni disponibbli fuq is-sustanzi attivi individwali.
English: In a clinical trial of 2 years' duration, vildagliptin (50 mg twice daily) was compared to glimepiride (up to 6 mg/day - mean dose at 2 years: 4.6 mg) in patients treated with metformin (mean daily dose: 1894 mg).
Maltese: Waqt prova klinika li damet għaddejja sentejn, vildagliptin (50 mg darbtejn kuljum) tqabbel ma' glimepiride (sa 6 mg kuljum - doża medja fl-aħħar tas-sentejn: 4.6 mg) f'pazjenti kkurati b'metformin (doża medja kuljum: 1894 mg).