FrancophonIA/ELRC3.0 huggingface dataset:
English: • Tell your doctor immediately if you have or experience symptoms such as persistent high temperature, severe headache, nausea (feeling sick), tiredness, yellowing of the skin or eyes and vomiting.
Maltese: • Għid lit-tabib tiegħek immedjatament jekk ikollok jew jekk tesperjenza sintomi bħal temperatura għolja persisteni, uġigħ ta' ras sever, nawsja (tħossok ma tiflaħx), għeja, sfura tal-ġilda jew tal għajnejn u rimettar.
English: The company that markets Zinbryta (Biogen Idec Ltd) has already voluntarily requested a withdrawal of the medicine's marketing authorisation and has informed EMA of its intention to stop clinical studies.
Maltese: Il-kumpanija li tqiegħed Zinbryta fis-suq (Biogen Idec Ltd) diġà talbet b'mod volontarju l-irtirar talawtorizzazzjoni għat-tqegħid fis-suq tal-mediċina u infurmat lill-EMA bil-ħsieb tagħha li twaqqaf listudji kliniċi.
English: • If you are in a clinical study with Zinbryta, contact the doctor treating you in the study.
Maltese: • Jekk qed tipparteċipa fi studju kliniku b'Zinbryta, ikkuntattja lit-tabib li jkun qiegħed jikkurak fl istudju.
English: Please tell us what you think about this information by answering a few questions - it will only take a couple of minutes of your time:
Maltese: Jekk jogħġbok għidilna x'taħseb dwar din l-informazzjoni billi twieġeb ftit mistoqsijiet - dan ser jieħu biss ftit minuti mill-ħin tiegħek:
English: Patients stopping treatment must be followed up for at least 6 months (see more details below).
Maltese: Il-pazjenti li jwaqqfu l-kura għandhom jiġu segwiti għal tal-inqas 6 xhur (ara aktar dettalji hawn taħt).
English: A preliminary review of the available evidence indicates that immune reactions observed in the reported cases may be linked to the use of Zinbryta.
Maltese: Reviżjoni preliminari tal-evidenza disponibbli tindika li reazzjonijiet immuni osservati fil-każijiet irrappurtati jistgħu jkunu marbuta mal-użu ta' Zinbryta.
English: Multiple sclerosis medicine Zinbryta suspended in the EU
Maltese: L-EMA tirrakkomanda s-sospensjoni immedjata u l-ġbir lura tal-mediċina tal-isklerożi multipla Zinbryta
English: The review is being carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee responsible for the evaluation of safety issues for human medicines, which will make a set of recommendations.
Maltese: Ir-reviżjoni inizjali qiegħda ssir mill-Kumitat dwar il-Valutazzjoni tar-Riskji tal-Farmakoviġilanza (PRAC), il-Kumitat responsabbli għall-evalwazzjoni ta' kwistjonijiet tas-sigurtà għall-mediċini għall-użu mill-bniedem, li ser jagħmel sett ta' rakkomandazzjonijiet.
English: EMA will complete its in-depth review and make public the final outcome.
Maltese: L-EMA ser tkompli r-reviżjoni tagħha fil-fond u ser tippubblika r-riżultat finali.
English: Zinbryta may also be linked to severe immune reactions affecting several other organs.
Maltese: Zinbryta jista' jkun marbut ukoll ma' reazzjonijiet immuni severi li jaffettwaw bosta organi oħrajn.
English: Following a 2017 review of the medicine's effects on the liver, the use of the medicine was restricted to patients who have tried at least two other disease-modifying treatments and cannot be treated with any other multiple sclerosis treatments.
Maltese: Wara reviżjoni tal2017 tal-effetti tal-mediċina fuq il-fwied, l-użu tal-mediċina ġie ristrett għal pazjenti li ppruvaw talinqas żewġ kuri oħra li jimmodifikaw il-marda u li ma jistgħux jiġu kkurati b'xi kura oħra tal-isklerożi multipla.
English: 19 January 2015
Maltese: 19 ta' Jannar 2015
English: Nasonex and associated names are currently marketed in the following Member States of the EU: Austria, Belgium, Bulgaria, Croatia, Cyprus1, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden and United Kingdom, as well as in Iceland and Norway.
Maltese: Attwalment, Nasonex u ismijiet assoċjati huma kkummerċjalizzati fl-Istati Membri tal-UE li ġejjin: lAwstrija, il-Belġju, il-Bulgarija, il-Kroazja, Ċipru1, ir-Repubblika Ċeka, id-Danimarka, l-Estonja, ilFinlandja, Franza, il-Ġermanja, il-Greċja, l-Ungerija, l-Irlanda, l-Italja, il-Latvja, il-Litwanja, ilLussemburgu, Malta, il-Pajjiżi l-Baxxi, il-Polonja, il-Portugall, ir-Rumanija, ir-Repubblika Slovakka, isSlovenja, Spanja, l-Isvezja u r-Renju Unit, kif ukoll l-Islanda u n-Norveġja.
English: Nasonex contains the active substance mometasone furoate.
Maltese: Nasonex fih is-sustanza attiva mometasone furoate.
English: What is Nasonex?
Maltese: X'inhu Nasonex?
English: The CHMP also harmonised other sections of the SmPC, including sections 4.4 (special warnings and precautions for use), 4.6 (fertility, pregnancy and lactation), 4.8 (side effects) and 5.1 (pharmacodynamic properties).
Maltese: Is-CHMP armonizza wkoll sezzjonijiet oħrajn tal-SmPC, inklużi sezzjonijiet 4.4 (twissija speċjali u prekawzjonijiet għall-użu), 4.6 (fertilità, tqala u treddigħ) u 4.8 (effetti sekondarji) u 5.1 (proprjetajiet farmakodinamiċi).
English: • Treatment of nasal polyps in adults (aged 18 years and older).
Maltese: • Kura ta' polipi nażali f'adulti (ta' 18-il sena ‘l fuq).
English: On 20 November 2014, the European Medicines Agency completed a review of Nasonex and associated names.
Maltese: Fl-20 ta' Novembru 2014, l-Aġenzija Ewropea għall-Mediċini temmet reviżjoni ta' Nasonex u ismijiet assoċati.
English: The company that markets these medicines is Merck Sharp & Dohme.
Maltese: Il-kumpanija li tqiegħed dawn il-mediċini fis-suq hija Merck Sharp & Dohme.
English: The areas harmonised include:
Maltese: Is-sezzjonijiet armonizzati jinkludu:
English: Questions and answers on Nasonex and associated names (mometasone furoate, 50 microgram, nasal spray)
Maltese: (mometasone furoate, 50 mikrogramma, sprej nażali)
English: Why was Nasonex reviewed?
Maltese: Għaliex ġiet rivedut Nasonex?
English: Nasonex is an anti-inflammatory medicine that is used in adults and children from three years of age to treat the symptoms of seasonal allergic or perennial rhinitis (inflammation of the nasal passages caused by occasional or long-term allergy).
Maltese: Nasonex huwa mediċina anti-infjammatorja li tintuża fl-adulti u fit-tfal mill-età ta' tliet snin biex tikkura sintomi ta' rinite allerġika staġjonali jew perennjali (infjammazzjoni tal-passaġġi nażali kkawżata minn allerġija okkażjonali jew fit-tul).
English: • Treatment of symptoms of seasonal allergic or perennial rhinitis in adults and in children aged three and above.
Maltese: • Kura ta' sintomi ta' rinite allerġika staġjonali u perennjali f'adulti u fitfal mill-età ta' tliet snin ‘il fuq.
English: The CHMP, in the light of the data submitted and the scientific discussion within the Committee, was of the opinion that the SmPCs, labelling and package leaflets for Nasonex should be harmonised across the EU.
Maltese: Is-CHMP, fid-dawl tad-data sottomessa u d-diskussjoni xjentifika fil-Kumitat, kien tal-opinjoni li lSmPCs, it-tikkettar u fuljetti ta' tagħrif għal Nasonex għandhom jiġu armonizzati madwar l-UE kollha.
English: Having harmonised the indications, the CHMP also harmonised recommendations on the doses.
Maltese: Wara li armonizza l-indikazzjonijiet, is-CHMP armonizza wkoll ir-rakkomandazzjonijiet fuq id-dożi.
English: 1 Nasonex is marketed in Cyprus under Art.126a of Directive 27/2004 EC, which allows a country to place a product in the market for justified public health reasons for a limited number of years.
Maltese: 1 Nasonex huwa kkummerċjalizzat f'Ċipru skont l-Art.126a tad-Direttiva 27/2004
English: • Patients with known hypersensitivity (allergy) to mometasone furoate or to any other ingredients.
Maltese: • Pazjenti b'ipersensittività (allerġija) magħrufa għal mometasone furoate jew għal xi ingredjenti oħrajn.
English: • Patients who have an untreated and localised infection, such as herpes, affecting the inside of the nose.
Maltese: • Pazjenti li għandhom infezzjoni mhux ikkurata lokalizzata, bħal ħerpes, li taffettwa n-naħa ta'
English: After reviewing the available data supporting the medicine's use, the CHMP agreed that Nasonex can be used for the following:
Maltese: Wara li rreveda d-data disponibbli li tappoġġja l-użu tal-mediċina, is-CHMP qabel li Nasonex jista' jintuża għal dan li ġej:
English: As Nasonex has been authorised in the EU via national procedures, this has led to divergences across Member States in the way the medicine can be used, as seen in differences in the summaries of product characteristics (SmPCs), labelling and package leaflets in the countries where the medicine is marketed.
Maltese: Peress li Nasonex ġie awtorizzat fl-UE permezz ta' proċeduri nazzjonali, dan wassal għal diverġenzi madwar l-Istati Membri fil-mod kif tista' tintuża l-mediċina, kif jidher mid-differenzi fis-Sommarji talKaratteristiċi tal-Prodott (SmPCs - Summaries of Product Characteristics), it-tikkettar u l-fuljetti ta' tagħrif fil-pajjiżi fejn il-mediċina hija fis-suq.
English: • Patients who have recently undergone nose surgery or who have a wound in the nose, because
Maltese: • Pazjenti li riċentament għaddew minn kirurġija tal-imnieħer jew li għandhom xi ġerħa fl-imnieħer,
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that there is a need to harmonise the prescribing information for Nasonex and associated names in the European Union (EU).
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija kkonkluda li jeħtieġ li l-informazzjoni ta' preskrizzjoni għal Nasonex u ismijiet assoċjati fl-Unjoni Ewropea (UE) tiġi armonizzata.
English: In view of this, on 17 September 2013 the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Nasonex in the EU.
Maltese: Fid-dawl ta' dan, fis-17 ta' Settembru 2013, il-Kummissjoni Ewropea rreferiet il-kwistjoni lis-CHMP sabiex jarmonizza l-awtorizzazzjonijiet għat-tqegħid fis-suq għal Nasonex fl-UE.
English: It is available as a nasal spray.
Maltese: Huwa disponibbli bħala sprej nażali.
English: The amended information to doctors and patients is available here.
Maltese: L-informazzjoni emendata għat-tobba u l-pazjenti hija disponibbli hawn.
English: In addition, it is used in adults to treat nasal polyps (growths in the lining of the nose).
Maltese: Barra minn hekk, jintuża f'adulti biex jikkura polipi nażali (tkabbir firrita tal-imnieħer).
English: The CHMP agreed to that Nasonex must not be used in:
Maltese: Mistoqsijiet u tweġibiet fuq Nasonex u ismijiet assoċjati
English: EMA/402904/2016 EMEA/H/C/000780
Maltese: EMEA/H/C/000780
English: The full EPAR for Rasilez 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: It is available as tablets (150 and 300 mg).
Maltese: Jiġi bħala pilloli (150 u 300 mg).
English: This summary was last updated in 06-2016.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'06-2016.
English: The blood pressure was measured in ‘millimetres of mercury' (mmHg).
Maltese: Il-pressjoni tad-demm tkejlet f'‘millimetri ta' merkurju' (mmHG).
English: When the results of the five studies comparing Rasilez taken alone with placebo were looked at together, patients aged under 65 years had an average fall in diastolic blood pressure of 9.0 mmHg after eight weeks of taking 150 mg Rasilez, from an average of 99.4 mmHg at the start of the study.
Maltese: Meta r-riżultati tal-ħames studji li qabblu Rasilez meħud waħdu ma' plaċebo ġew analizzati flimkien, il-pazjenti li kellhom inqas minn 65 sena kellhom tnaqqis medju fil-pressjoni tad-demm dijastolika ta' 9.0 mmHg wara tmien ġimgħat jieħdu 150 mg Rasilez, minn medja ta' 99.4 mmHg fil-bidu tal-istudju.
English: Other information about Rasilez
Maltese: Informazzjoni oħra dwar Rasilez
English: The recommended dose of Rasilez is 150 mg once a day.
Maltese: Id-doża rakkomandata ta' Rasilez hija 150 mg darba kuljum.
English: Rasilez is a medicine that contains the active substance aliskiren.
Maltese: Rasilez hu mediċina li fiha s-sustanza attiva aliskiren.
English: This was compared with a fall of 5.8 mmHg from 99.3 mmHg in the patients taking placebo.
Maltese: Dan tqabbel ma' tnaqqis ta' 5.8 mmHg minn 99.3 mmHg fil-pazjenti li kienu qed jieħdu l-plaċebo.
English: Combination studies looked at Rasilez used with an ACE inhibitor (ramipril), an ARB (valsartan), a beta-blocker (atenolol), a calcium-channel blocker (amlodipine) and a diuretic (hydrochlorothiazide).
Maltese: L-istudji tat-tqabbil eżaminaw lil Rasilez użat flimkien ma' inibitur ACE (ramipril), ma' ARB,(valsartan), ma' beta-blocker (atenolol), u ma' sustanza li timblokka l-kanali tal-kalċju (amlodipina) u sustanza dijuretika (idroklorotijażide).
English: This is a summary of the European public assessment report (EPAR) for Rasilez.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Rasilez.
English: The most common side effects with Rasilez (seen in between 1 and 10 patients in 100) are dizziness, diarrhoea, arthralgia (joint pain) and hyperkalaemia (high blood potassium levels).
Maltese: L-effetti sekondarji l-iktar komuni b'Rasilez (li dehru f'bejn 1 u 10 pazjenti minn kull 100) huma sturdament, dijarrea, artralġija (uġigħ fil-ġogi), iperkaljemija (livelli għoljin ta' potassju fid-demm).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Rasilez on 22 August 2007.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Rasilez valida fl-Unjoni Ewropea kollha fit-22 ta' Awwissu 2007.
English: The active substance in Rasilez, aliskiren, is a renin inhibitor.
Maltese: Is-sustanza attiva f'Rasilez, l-aliskiren, hi inibitur tar-renina.
English: Rasilez has been studied in 14 main studies involving over 10,000 patients with essential hypertension.
Maltese: Rasilez ġie studjat f'14-il studju ewlieni li fihom ħadu sehem iktar minn 10,000 pazjent b'ipertensjoni essenzjali.
English: What is the risk associated with Rasilez?
Maltese: X'inhu r-riskji assoċjati ma' Rasilez?
English: What is Rasilez?
Maltese: X'inhu Rasilez?
English: It blocks the activity of a human enzyme called renin, which is involved in the production of a substance called angiotensin I in the body.
Maltese: Din timblokka l-attività ta' enzima umana magħrufa bħala renina, li hija involuta fil-produzzjoni ta' sustanza msejħa anġjotensina I fil-ġisem.
English: Why has Rasilez been approved?
Maltese: Għaliex ġie approvat Rasilez?
English: How has Rasilez been studied?
Maltese: Kif ġie studjat Rasilez?
English: Rasilez may be taken alone or in combination with other medicines for hypertension, with the exception of ‘angiotensin converting enzyme (ACE) inhibitors' or ‘angiotensin receptor blockers' (ARBs) in patients with diabetes, or moderate or severe kidney impairment.
Maltese: Rasilez jista' jittieħed waħdu jew flimkien ma' mediċina oħra kontra l-ipertensjoni, bl-eċċezzjoni ta' ‘inibituri ta' enzimi li jikkonvertu lanġjotensini (ACE)' jew ‘imblokkaturi tar-riċetturi tal-anġjotensini' (ARBs) f'pazjenti bid-dijabete, jew b'indeboliment tal-kliewi moderat jew sever.
English: Rasilez must also not be taken with ciclosporin, itraconazole or other medicines known as ‘potent P-glycoprotein inhibitors' (such as quinidine).
Maltese: Rasilez lanqas m'għandu jittieħed maċ-ċiklosporina, l-itrakonażol jew mediċini oħra magħrufa bħala ‘inibituri qawwija glikoproteina-P' (bħal quinidine).
English: Angiotensin I is converted into the hormone angiotensin II, which is a powerful vasoconstrictor (a substance that narrows blood vessels).
Maltese: Lanġjotensina I tiġi konvertita fl-ormon anġjotensina II, li huwa vażokostrittur qawwi (sustanza li ddejjaq il-vini).
English: However, in February 2012, following the review of a study called ALTITUDE, the CHMP recommended that Rasilez should not be used together with an ACE inhibitor or ARB in patients with diabetes or with moderate or severe kidney impairment because of an increase in the risk of cardiovascular and kidney problems.
Maltese: Madanakollu, fi Frar 2012, wara rrieżami ta' studju msejjaħ ALTITUDE, is-CHMP irrakkomanda li Rasilez m'għandux jintuża flimkien ma' inibitur ACE jew ma' ARB f'pazjenti bid-dijabete jew b'indeboliment tal-kliewi moderat jew sever minħabba żieda fir-riskju ta' problemi kardjovaskulari u fil-kliewi .
English: Larger falls were seen in patients aged 65 years or over and those taking higher doses of Rasilez.
Maltese: Fil-pazjenti li kellhom 65 sena jew iktar u f'dawk li kienu qed jieħdu dożi ogħla ta' Rasilez kien hemm tnaqqis ikbar.
English: The CHMP noted that Rasilez is effective in reducing blood pressure when used alone or in combination.
Maltese: Is-CHMP innota li Rasilez kien effettiv fit-tnaqqis tal-pressjoni tad-demm meta użat waħdu jew f'kombinazzjoni.
English: This may reduce the risks associated with high blood pressure, such as having a stroke.
Maltese: Dan jista' jnaqqas ir-riskji assoċjati ma' pressjoni tad-demm għolja, bħal puplesija.
English: The dose of Rasilez may be increased to 300 mg once a day in patients whose blood pressure is not adequately controlled.
Maltese: Id-doża ta' Rasilez tista' tiżdied għal 300 mg darba kuljum f'pazjenti li l-pressjoni tad-demm tagħhom ma tkunx tista' tiġi kkontrollata adegwatament.
English: Angina
Maltese: Anġina
English: Heart failure
Maltese: Insuffiċjenza kardijaka
English: This overview was last updated in 11-2018.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'11-2018.
English: Corlentor contains the active substance ivabradine.
Maltese: Corlentor fih is-sustanza attiva ivabradine.
English: Further information on Corlentor can be found on the Agency's website: https://www.ema.europa.eu/en/medicines/human/EPAR/corlentor
Maltese: Aktar informazzjoni fuq Corlentor tinstab fuq is-sit elettroniku talAġenzija: https://www.ema.europa.eu/en/medicines/human/EPAR/corlentor .
English: Other information about Corlentor
Maltese: Informazzjoni oħra dwar Corlentor
English: Corlentor received a marketing authorisation valid throughout the EU on 25 October 2005.
Maltese: Corlentor irċieva awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fil-25 ta' Ottubru 2005.
English: In the context of a procedure under Article 20 of Regulation (EC) No 726/2004.
Maltese: Fil-kuntest ta' proċedura skont l-Artikolu 20 tar-Regolament (KE) Nru 726/2004.
English: It was as effective as atenolol (a beta blocker) in a study of 939 patients and as effective as amlodipine (another medicine used to treat angina) in a study of 1,195 patients.
Maltese: Kienet effikaċji daqs atenolol (imblokkatur tar-riċetturi Beta) fi studju ta' 939 pazjent u effikaċji daqs amlodipine (mediċina oħra li tintuża għall-kura tal-anġina) fi studju ta' 1,195 pazjent.
English: Results showed that Corlentor was more effective than placebo at preventing death due to disease of the heart or blood vessels or hospitalisation due to worsening heart failure: 24.5% (793 out of 3,241) of patients treated with Corlentor died or were hospitalised due to worsening heart failure, compared with 28.7% (937 out of 3,264) of patients receiving placebo.
Maltese: Ir-riżultati wrew li Corlentor kien aktar effikaċi minn plaċebo fil-prevenzjoni tal-mewt minħabba mard fil-qalb jew fil-vini jew dħul fl-isptar minħabba laggravar tal-insuffiċjenza kardijaka: 24.5 % (793 minn 3,241) tal-pazjenti kkurati b'Corlentor mietu jew iddaħħlu l-isptar minħabba aggravar tal-insuffiċjenza kardijaka, meta mqabbla ma' 28.7 % (937 minn 3,264) tal-pazjenti li kienu qed jirċievu plaċebo.
English: Corlentor was compared with placebo in one main study involving over 6,500 patients with long-term moderate to severe heart failure.
Maltese: Corlentor tqabbel ukoll ma' plaċebo fi studju ewlieni wieħed li involva aktar minn 6,500 pazjent b'insuffiċjenza kardijaka fit-tul minn moderata sa gravi.
English: The active substance in Corlentor, ivabradine, works by blocking the ‘If currents' in the sinus node, the ‘pacemaker' for the heart that controls the heart's contractions and regulates the heart rate.
Maltese: Is-sustanza attiva f'Corlentor, ivabradine, taħdem billi timblokka l-”kurrenti If” fin-nodi tas-sinus, il-”pacemaker” tal-qalb li jikkontrolla l-kontrazzjonijiet talqalb u jirregola t-taħbit il-qalb.
English: It also concluded that Corlentor was effective in long-term heart failure with an acceptable safety profile.
Maltese: Ikkonkludiet ukoll li Corlentor kien effikaċi kontra l-insuffiċenza kardijaka fit-tul u li għandu profil ta' sigurtà aċċettabbli.
English: The recommended starting dose is 5 mg twice a day with meals, which the doctor may increase to 7.5 mg twice a day or decrease to 2.5 mg (half a 5-mg tablet) twice a day depending on the patient's heart rate and symptoms.
Maltese: Id-doża inizjali rrakkomandata hija 5 mg darbtejn kuljum mal-ikliet, li t-tabib jista' jżid għal 7.5 mg darbtejn kuljum jew inaqqas għal 2.5 mg (nofs pillola ta' 5 mg) darbtejn kuljum skont ir-rata ta' taħbit tal-qalb tal-pazjent u s-sintomi.
English: As for all medicines, data on the use of Corlentor are continuously monitored.
Maltese: Bħal għall-mediċini kollha, id-data dwar l-użu ta' Corlentor hija ssorveljata kontinwament.
English: Corlentor is available as tablets (5 and 7.5 mg) and it can only be obtained with a prescription.
Maltese: Corlentor jiġi bħala pilloli (5 u 7.5mg) u jista' jinkiseb biss b'riċetta ta' tabib.
English: Bradycardia (slow heart rate) is common (it may affect up to 1 in 10 people).
Maltese: Il-bradikardija (rata ta' taħbit tal-qalb baxxa) hija komuni (tista' taffettwa sa 1 minn 10).
English: What are the risks associated with Corlentor?
Maltese: X'inhuma r-riskji assoċjati ma' Corlentor?
English: Corlentor is a heart medicine used to treat the symptoms of long-term stable angina (pains to the chest, jaw and back, brought on by physical effort) in adults with coronary artery disease (disease of the heart caused by the obstruction of the blood vessels that supply blood to the heart muscle).
Maltese: Corlentor huwa mediċina tal-qalb li tintuża għall-kura tas-sintomi ta' anġina stabbli fit-tul (uġigħ fissider, ix-xedaq u d-dahar, ikkaġunat minn sforzi fiżiċi) f'adulti b'marda tal -arterja koronarja (marda filqalb ikkaġunata minn imblukkar fl-arterji u fil-vini tad-demm li jwasslu d-demm sal-muskolu tal-qalb).
English: Corlentor must not be used in patients who have a resting heart rate below 70 beats per minute, very low blood pressure, various types of heart disorder (including cardiogenic shock, rhythm disorders, heart attack, unstable or acute (sudden) heart failure and unstable angina) or severe liver problems.
Maltese: Corlentor ma għandux jintuża fuq pazjenti li r-rata tat-taħbit tal-qalb tagħhom waqt l-irpoż tkun taħt is-70 taħbita fil-minuta, li jkollhom pressjoni tad-demm baxxa ħafna, diversi tipi ta' disturbi fil-qalb (inklużi xokkijiet kardjoloġiċi, disturbi ritmiċi, attakk tal-qalb, insuffiċjenza kardijaka instabbli jew akuta (għall-għarrieda) u anġina instabbli) jew problemi gravi fil-fwied.
English: A sixth study compared Corlentor with placebo in 19,102 patients with coronary artery disease and without clinical heart failure.
Maltese: Is-sitt studju qabbel lil Corlentor ma' plaċebo f'19,102 pazjenti b'mard tal-arterja koronarja u mingħajr insuffiċjenza kardijaka klinika.
English: The medicine is used in patients who have a normal heart rhythm, and whose heart rate is at least 70 beats per minute.
Maltese: Il-mediċina tintuża f'pazjenti li għandhom ritmu tal-qalb normali u li r-rata ta' taħbit tal-qalb tagħhom hija tal-inqas 70 taħbita fil-minuta.
English: However, a fifth study in 728 patients showed that adding Corlentor to amlodipine did not provide an additional benefit.
Maltese: Madankollu, il-ħames studju f'728 pazjent wera li ż-żieda ta' Corlentor ma' amlodipine ma pprovdietx benefiċċju addizzjonali.