FrancophonIA/ELRC3.0 huggingface dataset:
English: The company that markets Ilaris will provide doctors who will use Ilaris with educational material containing the prescribing information, the patient reminder card and information for doctors containing important safety information about Ilaris, including precautions to be taken when using the medicine.
Maltese: Il-kumpanija li tqiegħed Ilaris fis-suq ser tipprovdi lit-tobba li ser jużaw Ilaris b'materjal edukattiv li jkun fih l-informazzjoni dwar il-preskrizzjoni, il-kard ta' tfakkira tal-pazjent u informazzjoni għat-tobba dwar is-sigurtà ta' Ilaris, inklużi l-prekawzjonijiet li jridu jittieħdu meta tintuża l-mediċina.
English: In one of the studies, none of the patients with CAPS who received Ilaris during the 24-week treatment period had a relapse, compared with 81% of patients who received placebo (a dummy treatment).
Maltese: Ilaris matul il-perjodu ta' 24 ġimgħa ta' kura ma reġgħet feġġitlu l-marda, meta mqabbla ma' 81% tal-pazjenti li ħadu l-plaċebo (kura finta).
English: For information on doses and dose adjustments, see the summary of product characteristics (also part of the EPAR).
Maltese: Għal aktar informazzjoni dwar dożi u aġġustamenti fid-doża, ara s-sommarju tal-karatteristiċi tal-prodott (parti wkoll mill-EPAR).
English: Bemfola follitropin alfa
Maltese: Follitropin alfa
English: The full EPAR and risk management plan summary for Bemfola can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Why is Bemfola approved?
Maltese: Għal xiex ġie approvat Bemfola?
English: • women with severe deficiency (very low levels) of luteinising hormone (LH) and follicle stimulating hormone (FSH).
Maltese: • in-nisa b'defiċjenza severa (livelli baxxi ħafna) ta' ormon luteinizzanti (LH) u ormon follikulu stimulanti (FSH).
English: Bemfola has been shown to be comparable to the reference medicine, GONAL-f.
Maltese: Bemfola ntwera li huwa paragunabbli mal-mediċina ta' referenza, GONAL-f.
English: Bemfola is a medicine that contains the active substance follitropin alfa.
Maltese: Bemfola huwa mediċina li fiha s-sustanza attiva follitropin alfa.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Bemfola on 27 March 2014.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Bemfola fis-27 ta' Marzu 2014.
English: The active substance in Bemfola, follitropin alfa, is a copy of the natural hormone FSH.
Maltese: Is-sustanza attiva f'Bemfola, il-follitropin alfa, hija kopja tal-ormon naturali
English: The follitropin alfa in Bemfola, as well as in the reference product GONAL-f, is produced by a method known as ‘recombinant DNA technology': it is made by cells into which a gene (DNA) has been introduced, which makes them able to produce human FSH.
Maltese: Il-follitropin alfa f'Bemfola, kif ukoll fil-prodott ta' referenza GONAL-f, huwa prodott b'metodu magħruf bħala ‘teknoloġija rikombinanti tadDNA': isir minn ċelloli li jkun ġie introdott fihom ġene (DNA) li jagħmilhom kapaċi jipproduċu l-FSH uman.
English: Other information about Bemfola
Maltese: Bemfola
English: The most common side effects with Bemfola (which may affect more than 1 in 10 people) are reactions at the injection site (pain, redness, bruising, swelling or irritation).
Maltese: L-effetti sekondarji l-aktar komuni b'Bemfola (li jistgħu jaffettwaw lil aktar minn persuna 1 minn kull 10) huma reazzjonijiet fis-sit tal-injezzjoni (uġigħ, ħmura, tbenġil, nefħa jew irritazzjoni).
English: • women who are undergoing assisted reproductive techniques (fertility treatment) such as in vitro fertilisation.
Maltese: • in-nisa li jkunu għaddejjin minn tekniki riproduttivi assistiti (kura tal-fertilità) bħal fertilizzazzjoni in vitro.
English: Bemfola is a ‘biosimilar medicine'.
Maltese: Bemfola huwa ‘mediċina bijosimili'.
English: This is a summary of the European public assessment report (EPAR) for Bemfola.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Bemfola.
English: Bemfola must not be used in people who are hypersensitive (allergic) to follitropin alfa, FSH, or any of the other ingredients.
Maltese: Bemfola ma jistax jintuża f'nies li huma ipersensittivi (allerġiċi) għal follitropin alfa, FSH, jew kwalunkwe sustanza oħra tiegħu.
English: What are the risks associated with Bemfola?
Maltese: X'inhuma r-riskji assoċjati ma' Bemfola?
English: In the body, FSH controls reproductive function: in women, it stimulates the production of eggs in the ovaries; in men, it stimulates the production of sperm in the testicles.
Maltese: Fil-ġisem, l-FSH jikkontrolla l-funzjoni riproduttiva: fin-nisa, jistimula l-produzzjoni ta' bajd fl-ovarji; fl-irġiel, jistimula lproduzzjoni ta' sperma fit-testikoli.
English: • men who have hypogonadotrophic hypogonadism (a rare hormone deficiency disease).
Maltese: • l-irġiel li għandhom ipogonadiżmu ipogonadotrofiku (marda ta' defiċjenza ta' ormon rari).
English: Bemfola was compared with GONAL-f in one main study involving 372 women who were undergoing assisted reproductive techniques.
Maltese: 372 mara li kienu għaddejjin minn tekniki riproduttivi assistiti.
English: Bemfola is used together with human chorionic gonadotrophin (hCG) therapy to stimulate sperm production.
Maltese: Bemfola jintuża flimkien ma' terapija ta' gonadotrofina korjonika umana (hCG) biex jistimula l-produzzjoni tal-isperma.
English: A risk management plan has been developed to ensure that Bemfola is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiżgura li Bemfola jintuża bl-aktar mod sigur possibbli.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements for biosimilar medicines, Bemfola has been shown to have a comparable quality, safety and effectiveness to GONAL-f.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija ddeċieda li, skont irrekwiżiti tal-UE għall-mediċini bijosimili, Bemfola ntwera li għandu kwalità, sigurtà u effikaċja paragunabbli għal GONAL-f.
English: Therefore, the CHMP's view was that, as for GONAL-f, the benefits of Bemfola outweigh the identified risks.
Maltese: Għaldaqstant, il-fehma tas-CHMP kienet li, bħal fil-każ ta' GONAL-f, ilbenefiċċji ta' Bemfola huma akbar mir-riskji identifikati.
English: The study showed that Bemfola was as effective as GONAL-f at stimulating the ovaries during assisted reproductive techniques, as an average of 11 eggs were retrieved with both medicines.
Maltese: L-istudju wera li Bemfola kien effikaċi daqs GONAL-f fl-istimulazzjoni tal-ovarji matul it-tekniki riproduttivi assistiti, peress li bħala medja ġew irkuprati 11-il bajda biż-żewġ mediċini.
English: This means that Bemfola is similar to a biological medicine (also known as the ‘reference medicine') that is already authorised in the European Union (EU).
Maltese: Dan ifisser li Bemfola huwa simili għal mediċina bijoloġika (magħrufa wkoll bħala ‘mediċina ta' referenza') li diġà hija awtorizzata fl-Unjoni Ewropea (UE).
English: It must not be used in patients with tumours of the pituitary gland or hypothalamus, or cancer of the breast, womb or ovary.
Maltese: Ma għandux jintuża f'pazjenti b'tumuri tal-glandola pitwitarja jew l-ipotalamu, jew kanċer tas-sider, il-ġuf jew l-ovarji.
English: How is Bemfola used?
Maltese: Kif jaħdem Bemfola?
English: • women who do not produce eggs and who do not respond to treatment with clomiphene citrate (another medicine that stimulates the ovaries to produce eggs);
Maltese: • in-nisa li ma jipproduċux il-bajd u li ma jirrispondux għal kura b'clomiphene citrate (mediċina oħra li tistimula l-ovarji biex jipproduċu l-bajd);
English: In women, ovarian cysts (sacs of fluid within the ovaries) and headache are also seen in more than 1 patient in 10.
Maltese: Fin-nisa, huma osservati wkoll ċisti fl-ovarji (boroż ta' fluwidu fl-ovarji) u uġigħ ta' ras f'aktar minn pazjent 1 minn kull 10.
English: The reference medicine for Bemfola is GONAL-f. For more information on biosimilar medicines, see the question-and-answer document here.
Maltese: Għal aktar tagħrif dwar il-mediċini bijosimili, ara ddokument ta' mistoqsijiet u tweġibiet hawnhekk.
English: It is available as ‘orodispersible' tablets (5, 10, 15 and 20 mg).
Maltese: Jiġi bħala pilloli (5, 10, 15 u 20 mg).
English: The full EPAR for Zyprexa Velotab can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Zyprexa Velotab olanzapine
Maltese: Zyprexa Velotab olanzapina
English: The active substance in Zyprexa Velotab, olanzapine, is an antipsychotic medicine.
Maltese: Is-sustanza attiva f'Zyprexa Velotab, l-olanzapina, hija mediċina antipsikotika.
English: The recommended starting dose of Zyprexa Velotab depends on the disease being treated: 10 mg per day is used in schizophrenia and in the prevention of manic episodes, and 15 mg per day in the treatment of manic episodes, unless it is used with other medicines, in which case the starting dose can be 10 mg per day.
Maltese: Doża ta' 10 mg kuljum tintuża għall-iskiżofrenija u fil-prevenzjoni ta' episodji manijaċi, u 15 mg kuljum fit-trattament ta' episodji manijaċi, sakemm ma tintużax ma' mediċini oħra, f'liema każ id-doża inizjali tista' tkun ta' 10 mg kuljum.
English: This is a summary of the European public assessment report (EPAR) for Zyprexa Velotab.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Zyprexa Velotab.
English: Zyprexa Velotab is a medicine that contains the active substance olanzapine.
Maltese: Zyprexa Velotab huwa mediċina li fiha s-sustanza attiva olanzapina.
English: It is thought that olanzapine's beneficial effect is due to it blocking receptors for the neurotransmitters 5-hydroxytrypamine (also called serotonin) and dopamine.
Maltese: Hu maħsub li l-effett benefiku tal-olanzapina huwa dovut għall-imblokkar tar-riċetturi għan-newrotrażmettituri 5-idrossitriptamina (5-hydroxytrypamine, imsejħa wkoll serotonina) u dopamina.
English: Zyprexa Velotab was as effective as the medicines that it was compared with for the treatment of adults with schizophrenia, the treatment of moderate to severe manic episodes in adults, and the prevention of recurrence in adults with bipolar disorder.
Maltese: Zyprexa Velotab kien effettiv daqs il-mediċini li tqabbel magħhom għat-trattament ta' adulti bliskiżofrenija, għat-trattament ta' episodji manijaċi minn moderati sa severi f'adulti, u dawk li ma jħallux pazjenti b'diżordni bipolari jirkadu.
English: Zyprexa Velotab is also used to treat moderate to severe manic episodes (extremely high mood) in adults.
Maltese: Zyprexa Velotab jintuża wkoll fil-kura ta' episodji manijaċi moderati sa severi (burdata tajba b'mod estrem) f'adulti.
English: The most common side effects with Zyprexa Velotab (seen in more than 1 patient in 10) are somnolence (sleepiness), weight gain, orthostatic hypotension (sudden drop in blood pressure on standing up) and raised levels of prolactin (a hormone).
Maltese: L-effetti sekondarji l-aktar komuni b'Zyprexa Velotab (li dehru f'iktar minn pazjent wieħed minn kull 10) huma somnolenza (ngħas), żieda fil-piż, ipotensjoni ortostatika (il-pressjoni tad-demm titbaxxa f'daqqa mal-qawmien bil-wieqfa) u żieda fil-livelli tal-prolaktin (ormon).
English: Zyprexa Velotab contains the same active substance as another medicine called Zyprexa that has been authorised in the European Union (EU) since 1996.
Maltese: Zyprexa Velota fih l-istess sustanza attiva bħal mediċina oħra msejħa Zyprexa li ilha awtorizzata flUnjoni Ewropea (UE) mill-1996.
English: Like Zyprexa, Zyprexa Velotab was more effective at improving symptoms than placebo (a dummy treatment).
Maltese: Bħal Zyprexa, Zyprexa Velotab kien iktar effettiv mill-plaċebo (trattament finta) fit-titjib tas-sintomi.
English: What is Zyprexa Velotab?
Maltese: Kif jintuża Zyprexa Velotab?
English: For the full list of all side effects reported with Zyprexa Velotab, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji kollha rrappurtati b'Zyprexa Velotab, ara l-fuljett ta' tagħrif.
English: Why has Zyprexa Velotab been approved?
Maltese: Għaliex ġie approvat Zyprexa Velotab?
English: Patients over 65 years of age and patients who have reduced liver or kidney function may need a lower starting dose of 5 mg per day.
Maltese: Pazjenti li jkollhom iktar minn 65 sena u pazjenti li jkollhom problemi fil-fwied jew fil-kliewi tagħhom jista' jkollhom bżonn ta' doża inizjali iktar baxxa ta' 5 mg kuljum.
English: The CHMP decided that Zyprexa Velotab's benefits are greater than its risks and recommended that Zyprexa Velotab be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Zyprexa Velotab huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: How has Zyprexa Velotab been studied?
Maltese: Kif ġie studjat Zyprexa Velotab?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Zyprexa Velotab on 3 February 2000.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Zyprexa Velotab fit-3 ta' Frar 2000.
English: Other information about Zyprexa Velotab
Maltese: Aktar tagħrif dwar Zyprexa Velotab
English: Ref. EMEA/530964/2007
Maltese: EMEA/560498/2007
English: International non-proprietary name (INN): natalizumab
Maltese: Denominazzjoni Komuni Internazzjonali (INN - International non-Proprietary Name): natalizumab
English: The active substance in Natalizumab Elan Pharma, natalizumab, is a monoclonal antibody.
Maltese: Is-sustanza attiva f'Natalizumab Elan Pharma, natalizumab, hija antikorp monoklonali.
English: The company that applied for authorisation is Elan Pharma International Ltd.
Maltese: Il-kumpanija li applikat għall-awtorizzazzjoni hija Elan Pharma International Ltd.
English: It contains the active substance natalizumab.
Maltese: Huwa fih is-sustanza attiva natalizumab.
English: The active substance in Natalizumab Elan Pharma, natalizumab, has been available in the European Union for the treatment of multiple sclerosis since 2006 as TYSABRI.
Maltese: Is-sustanza attiva f'Natalizumab Elan Pharma, natalizumab, ilha preżenti fl-Unjoni Ewropea għallkura ta' sklerosi multipla bħala TYSABRI mill-2006.
English: The effects of Natalizumab Elan Pharma were tested in two main studies involving a total of 905 patients with moderate to severe Crohn's disease.
Maltese: L-effetti ta' Natalizumab Elan Pharma kienu ittestjati f'żewġ studji ewlenin li involvew total ta' 905 pazjenti b'marda ta' Crohn moderata sa severa.
English: Natalizumab has been designed to bind to specific types of integrin (α4β1 and α4β7 integrins), proteins found on the surface of most leucocytes (the white cells in the blood that are involved in the inflammation process).
Maltese: Natalizumab ġie iddisinnjat biex jorbot ma' tipi speċifiċi ta' integrin (integrini α4β1 u α4β7), proteini li jinsabu fuq il-wiċċ tal-parti kbira tallewkoċiti (iċ-ċelloli bojod fid-demm li huma involuti fil-proċess ta' l-infjammazzjoni).
English: The CHMP also had concerns over the safety of Natalizumab Elan Pharma in patients with Crohn's disease, because of a risk of serious infections, including the brain infection progressive multifocal leucoencephalopathy (PML).
Maltese: Is-CHMP ukoll kellu tħassib fuq is-sigurtà ta' Natalizumab Elan Pharma f'pazjenti bil-marda ta' Crohn, minħabba riskju ta' infezzjonijiet serji, inklużi l-infezzjoni tal-moħħ lewkoenkefalopatija multifokali progressiva (PML).
English: Natalizumab Elan Pharma was expected to be used to treat moderate to severe, active Crohn's disease, a disease causing inflammation of the gut.
Maltese: Natalizumab Elan Pharma kien mistenni li jintuża biex jikkura marda ta' Crohn attiva, moderata sa severa, marda li tikkaġuna infjammazzjoni tal-musrana.
English: Natalizumab Elan Pharma is a concentrated solution that is diluted to make a solution for infusion (drip into a vein).
Maltese: Natalizumab Elan Pharma huwa soluzzjoni ikkonċentrata li hija dilwita biex tagħmel soluzzjoni għal infużjoni (drip ġol-vina).
English: In July 2007, the CHMP was concerned that there was insufficient evidence to show the effectiveness of Natalizumab Elan Pharma.
Maltese: Fl-Lulju 2007, is-CHMP kien imħasseb li ma kienx hemm biżżejjed evidenza li turi l-effikaċja ta' Natalizumab Elan Pharma.
English: What is happening for TYSABRI for the treatment of multiple sclerosis?
Maltese: X'qed jiġri għal TYSABRI għal kura ta' sklerożi multipla?
English: There was also insufficient evidence of maintenance of the medicine's effects.
Maltese: Lanqas ma kien hemm evidenza biżżejjed tal-manteniment ta' leffetti tal-mediċina.
English: What were the major concerns that led the CHMP to recommend the refusal of the marketing authorisation?
Maltese: X'kienu t-tħassib maġġuri li wasslu lis-CHMP biex tirrakkomanda r-rifjut ta' l-awtorizzazzjoni għat-tqegħid fis-suq?
English: On 19 July 2007, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Natalizumab Elan Pharma concentrate for solution for infusion, intended for the treatment of Crohn's disease.
Maltese: Fis-17 ta' Lulju 2007, il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) adotta opinjoni negattiva u rrakomanda li ma tingħatax l-awtorizzazzjoni għat-tqegħid fis-suq għal prodott mediċinali Natalizumab Elan Pharma konċentrat għal soluzzjoni għal infużjoni, intenzjonat għall-kura tal-marda ta' Crohn.
English: The 354 patients who responded to treatment with Natalizumab Elan Pharma then went on to enter the second study, in which the effects of Natalizumab Elan Pharma in maintaining the response to treatment were compared with those of placebo.
Maltese: It-354 pazjent li irreaġġixxew għal kura b'Natalizumab Elan Pharma imbagħad baqgħu sejrin biex jidħlu fit-tieni studju, fejn l-effetti ta' Natalizumab Elan Pharma f'li jmantni ir-reazzjoni għal kura kienu mqabbla ma' dawk ta' plaċebo.
English: A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and bind to a specific structure (called an antigen) that is found on certain cells in the body.
Maltese: Antikorp monoklonali huwa antikorp (tip ta' proteina) li ġie iddisinnjat biex jagħraf u jorbot ma' struttura speċifika (imsejħa antiġen) li tinsab fuq ċerti ċelloli tal-ġisem.
English: The first study compared the effects of starting treatment with Natalizumab Elan Pharma with that of placebo (a dummy treatment) in all 905 patients.
Maltese: L-ewwel studju qabbel l-effetti tal-bidu ta' kura b'Natalizumab Elan Pharma ma' dak ta' plaċebo (kura finta) fid-905 pazjenti kollha.
English: What is Natalizumab Elan Pharma?
Maltese: X'inhu Natalizumab Elan Pharma?
English: What was Natalizumab Elan Pharma expected to be used for?
Maltese: Għal x'hiex kien mistenni li jintuża Natalizumab Elan Pharma?
English: The main measure of effectiveness was the proportion of patients whose symptoms improved after 10 weeks.
Maltese: Il-miżura ewlenija ta' l-effikaċja kienet il-proporzjon ta' pazjenti li s-sintomi tagħhom tjiebu wara 10 ġimgħat.
English: By blocking the α4β7 integrin, natalizumab was expected to prevent the leucocytes from attaching to the surface of cells within the gut.
Maltese: Billi jimblokka l-integrin α4β7, natalizumab kien mistenni li jimpedixxi l-lewkoċiti milli jeħlu malwiċċ ta' ċelloli ġewwa l-musrana.
English: The company informed the CHMP that there are no clinical trials or compassionate use programmes using Natalizumab Elan Pharma ongoing in the European Union for the treatment of Crohn's disease.
Maltese: Il-kumpanija infurmat lis-CHMP li bħalissa, fl-Unjoni Ewropea, m'hija qegħda ssir l-ebda prova klinika u m'huwa qed isir l-ebda programm ta' użu ta' kompassjoni li juża Natalizumab Elan Pharma għall-kura tal-marda ta' Crohn.
English: The effects of Natalizumab Elan Pharma were first tested in experimental models before being studied in humans.
Maltese: L-effetti ta' Natalizumab Elan Pharma kienu l-ewwel ittestjati f'mudelli sperimentali qabel ma ġew studjati fil-bnedmin.
English: In the study of patients starting treatment with Natalizumab Elan Pharma, the effects of the medicine were modest.
Maltese: Fl-istudju ta' pazjenti li qed jibdew kura b'Natalizumab Elan Pharma, leffetti tal-mediċina kienu modesti.
English: Magyarország Egis Gyógyszergyár Zrt.
Maltese: Egis Gyógyszergyár Zrt.
English: See section 2, Do not take Velmetia.
Maltese: Ara sezzjoni 2, Tiħux Velmetia.
English: Pierre Fabre Médicament Tél: +33 (0) 1 49 10 80 00
Maltese: Tél: +33 (0) 1 49 10 80 00
English: Velmetia with alcohol
Maltese: Velmetia ma' alkoħol
English: Velmetia combines two antihyperglycaemic medicinal products with complementary mechanisms of action to improve glycaemic control in patients with type 2 diabetes: sitagliptin phosphate, a dipeptidyl peptidase 4 (DPP-4) inhibitor, and metformin hydrochloride, a member of the biguanide class.
Maltese: Velmetia jikkumbina żewġ prodotti mediċinali kontra l-ipergliċemija b'mekkaniżmi ta' azzjoni kumplimentari biex jitjieb il-kontroll gliċemiku f'pazjenti b'dijabete tip 2: sitagliptin phosphate, li hu impeditur dipeptidyl peptidase 4 (DPP-4), u metformin hydrochloride, li hu membru tal-klassi biguanide.
English: Analysis of the results for overweight patients treated with metformin after failure of diet alone showed: - a significant reduction of 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 patient--years), 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 of the absolute risk of any 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 of 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 patient-years (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: - tnaqqis sinifikanti fir-riskju assolut ta' kwalunkwe kumplikazzjoni relatata mad-dijabete filgrupp ta' metformin (29.8 episodju/1,000 pazjenti-snin) kontra dieta waħidha (43.3 episodju/1,000 pazjenti-snin), p=0.0023, u kontra l-gruppi ta' monoterapija ta' kumbinazzjoni ta' sulphonylurea u insulina (40.1 episodju/1,000 pazjenti-snin), p=0.0034 - tnaqqis sinifikanti fir-riskju assolut ta' kwalunkwe mortalità relatata mad-dijabete: metformin 7.5 episodji/1,000 pazjenti-snin, dieta waħidha 12.7-il episodju /1,000 pazjenti-snin, p=0.017 - tnaqqis sinifikanti fir-riskju assolut ta' mortalità totali: metformin 13.5-il episodju/1,000 pazjenti-snin kontra dieta waħidha 20.6 episodju/1,000 pazjenti-snin, (p=0.011), u kontra l-gruppi ta' monoterapija ta' kumbinazzjoni ta' sulphonylurea u insulina 18.9-il episodju/1,000 pazjenti-snin (p=0.021) - tnaqqis sinifikanti fir-riskju assolut ta' infart majokardjali: metformin 11-il episodju/1,000 pazjenti-snin, dieta waħidha 18-il episodju/1,000 pazjenti-snin, (p=0.01).