FrancophonIA/ELRC3.0 huggingface dataset:
English: The review of Procoralan/Corlentor was initiated on 8 May 2014 at the request of the European Commission, under Article 20 of Regulation (EC) No 726/2004.
Maltese: Ir-reviżjoni ta' Procoralan/Corlentor inbdiet fit-8 ta' Mejju 2014 fuq talba tal-Kummissjoni Ewropea, skont l-Arikolu 20 tar-Regolament (KE) Nru 726/2004.
English: • The risk of developing atrial fibrillation is increased in patients treated with Corlentor/Procoralan.
Maltese: • Ir-riskju ta' żvilupp ta' fibrillazzjoni atrijali jiżdied f'pazjenti kkurati b'Corlentor/Procoralan.
English: The review of Corlentor/Procoralan was first carried out by the EMA's Pharmacovigilance Risk Assessment Committee (PRAC).
Maltese: Ir-reviżjoni ta' Corlentor/Procoralan twettqet l-ewwel mill-Kumitat għall-Evalwazzjoni tar-Riskji filqasam tal-Farmakoviġilanza (PRAC) tal-EMA.
English: • The starting dose of Corlentor/Procoralan should not exceed 5 mg twice daily and the maintenance dose of Corlentor/Procoralan should not exceed 7.5 mg twice daily.
Maltese: • Id-doża inizjali ta' Corlentor/Procoralan ma għandhiex taqbeż 5 mg darbtejn kuljum u d-doża ta' manteniment ta' Corlentor/Procoralan ma għandhiex taqbeż 7.5 mg darbtejn kuljum.
English: • In the symptomatic treatment of patients with chronic stable angina, Corlentor/Procoralan should only be started if the patient's resting heart rate is above or equal to 70 beats per minute (bpm).
Maltese: • Fil-kura sintomatika ta' pazjenti b'anġina kronika stabbli, Corlentor/Procoralan għandu jinbeda biss jekk ir-rata tal-qalb tal-pazjent fil-mistrieħ hija daqs jew iktar minn 70 taħbita fil-minuta (bpm).
English: • The concomitant use of Corlentor/Procoralan with verapamil or diltiazem is now contraindicated.
Maltese: • L-użu ta' Corlentor/Procoralan flimkien ma' verapamil jew diltiazem issa huwa kontraindikat.
English: These recommendations are based on the EMA's review of the final data from the SIGNIFY study1, which showed that in a subgroup of patients who had symptomatic angina there was a small but significant increase in the combined risk of cardiovascular death or non-fatal heart attack with Corlentor/Procoralan compared with placebo (3.4% vs 2.9% yearly incidence rates).
Maltese: Dawn ir-rakkomandazzjonijiet huma abbażi tar-reviżjoni tal-EMA tad-data finali minn studju tasSIGNIFY1, li wera li f'sottogrupp ta' pazjenti li kellhom anġina sintomatika kien hemm żieda żgħira iżda sinifikanti fir-riskju kkombinat ta' mewt kardjovaskulari jew attakk tal-qalb mhux fatali b'Corlentor/Procoralan meta mqabbel mal-plaċebo (3.4% vs 2.9% rati ta' inċidenza annwali).
English: In its evaluation the EMA also assessed additional data on the safety and effectiveness of Corlentor/Procoralan which showed that the risk of atrial fibrillation is increased in patients treated with Corlentor/Procoralan compared with controls (4.9% vs 4.1%).
Maltese: Fl-evalwazzjoni tagħha, l-EMA evalwat ukoll data addizzjonali fuq is-sigurtà u l-effikaċja ta' Corlentor/Procoralan li wriet li r-riskju ta' fibrillazzjoni atrijali jiżdied f'pazjenti kkurati b'Corlentor/Procoralan meta mqabbel mal-kontrolli (4.9% vs 4.1%).
English: • Corlentor/Procoralan is a medicine used to treat symptoms of angina (chest pain due to problems with the blood flow to the heart) and to treat heart failure.
Maltese: • Corlentor/Procoralan huwa mediċina li tintuża fil-kura ta' sintomi ta' anġina (uġigħ fis-sider minħabba problemi biċ-ċirkolazzjoni għall-qalb) u biex tikkura insuffiċjenza kardijaka.
English: Regular monitoring for the occurrence of atrial fibrillation is recommended.
Maltese: Huwa rrakkomandat monitoraġġ regolari għall-okkorrenza ta' fibrillazzjoni atrijali.
English: • The data from SIGNIFY did not demonstrate a beneficial effect for Corlentor/Procoralan on cardiovascular outcomes in coronary artery patients without clinical heart failure.
Maltese: • Id-data minn SIGNIFY ma wrietx effett benefiċċjali għal Corlentor/Procoralan fuq riżultati kardjovaskulari f'pazjenti tal-arterja koronarja li ma għandhomx insuffiċjenza klinika tal-qalb.
English: • Prior to starting treatment or when considering titration, serial heart rate measurements, ECG, or ambulatory 24-hour monitoring should be considered when determining the heart rate.
Maltese: • Qabel tinbeda l-kura jew meta tiġi kkunsidrata t-titrazzjoni, għandu jiġi kkunsidrat kejl tar-rata tattaħbit tal-qalb serjali, ECG, jew monitoraġġ ambulatorju għal 24 siegħa biex tiġi ddeterminata rrata tat-taħbit tal-qalb.
English: Patients in the SIGNIFY study were started on a higher than recommended dose of Corlentor/Procoralan and received up to 10 mg twice a day, which is higher than the currently authorised maximum daily dose (7.5 mg twice a day).
Maltese: Il-pazjenti fl-istudju SIGNIFY inbdew fuq doża ogħla milli huwa rakkomandat ta' Corlentor/Procoralan u rċevew sa 10 mg dartbejn kuljum, li huwa ogħla mid-doża massima ta' kuljum li hija attwalment awtorizzata (7.5 mg darbtejn kuljum).
English: However, the Agency reiterated that the starting dose for angina should not exceed 5 mg twice a day and that the maximum dose should not exceed 7.5 mg twice a day.
Maltese: Madankollu, l-Aġenzija tenniet li d-doża inizjali għal anġina ma għandhiex taqbeż 5 mg darbtejn kuljum u li d-doża massima ma għandhiex taqbeż 7.5 mg darbtejn kuljum.
English: Corlentor/Procoralan is used to treat symptoms of long-term stable angina (chest pain due to problems with the blood flow to the heart) in adults with coronary heart disease (disease of the heart caused by the obstruction of the blood vessels that supply blood to the heart muscle) who have a normal heart rhythm.
Maltese: Corlentor/Procoralan jintuża għall-kura ta' sintomi ta' anġina stabbli fit-tul (uġigħ fis-sider minħabba problemi biċ-ċirkolazzjoni tad-demm għall-qalb) f'adulti b'mard tal-qalb koronarju (mard tal-qalb ikkawżat minn imblukkar tal-vini li jissupplixxu d-demm għall-muskolu tal-qalb) li għandhom ritmu talqalb normali. Corlentor/Procoralan jintuża wkoll f'pazjenti b'insuffiċjenza kardijaka fit-tul (meta l-qalb ma tkunx tista' tippompja biżżejjed demm għall-bqija tal-ġisem).
English: Other recommendations are that doctors must not prescribe Corlentor/Procoralan together with the medicines verapamil or diltiazem that reduce the heart rate, and that they should monitor their patients for atrial fibrillation (irregular rapid contractions of the upper chambers of the heart).
Maltese: Rakkomandazzjonijiet oħrajn huma li t-tobba ma jagħtux riċetta għal Corlentor/Procoralan flimkien mal-mediċini verapamil jew diltiazem li jnaqqsu r-rata tal-qalb, u li għandhom jimmonitorjaw ilpazjenti tagħhom għal fibrillazzjoni atrijali (kontrazzjonijiet mgħaġġla irregolari tal-kompartimenti superjuri tal-qalb).
English: Corlentor/Procoralan is used to treat symptoms of angina (chest pain due to problems with the blood flow to the heart) and to treat heart failure.
Maltese: Corlentor/Procoralan jintuża biex jikkura s-sintomi ta' anġina (uġigħ fissider minħabba problemi biċ-ċirkolazzjoni tad-demm għall-qalb) u biex jikkura insuffiċjenza kardijaka.
English: In addition, discontinuation should be considered if the improvement is only limited and if there is no clinically relevant reduction in resting heart rate within 3 months.
Maltese: Barra minn hekk, għandu jiġi kkunsidrat it-twaqqif tiegħu jekk it-titjib huwa biss limitat u jekk ma jkunx hemm tnaqqis klinikament relevanti fir-rata tal-qalb fil-mistrieħ fi żmien 3 xhur.
English: • As Corlentor/Procoralan could cause irregular rapid contractions of the upper chambers of the heart (a condition known as atrial fibrillation) your doctor will monitor your heart function regularly and will reconsider treatment if atrial fibrillation develops.
Maltese: • Minħabba li Corlentor/Procoralan jista' jikkawża kontrazzjonijiet mgħaġġla irregolari talkompartimenti superjuri tal-qalb (kundizzjoni magħrufa bħala fibrillazzjoni atrijali) it-tabib tiegħek sejjer jimmonitorja l-funzjoni ta' qalbek b'mod regolari u sejjer jikkunsidra mill-ġdid il-kura jekk tiżviluppa fibrillazzjoni atrijali.
English: • Corlentor/Procoralan should be discontinued if the symptoms of angina do not improve within 3 months.
Maltese: • Corlentor/Procoralan għandu jitwaqqaf jekk is-sintomi ta' anġina ma jitjibux fi żmien 3 xhur.
English: Because of a small but significant increase of the combined risk of cardiovascular death, myocardial infarction and heart failure seen in patients with symptomatic angina in the SIGNIFY study, recommendations have been issued to reduce this risk.
Maltese: Minħabba żieda żgħira iżda sinifikanti tar-riskju kkombinat tas-saħħa kardjovaskulari, infart mijokardjali u insuffiċjenza kardijaka li dehret f'pazjenti b'anġina sintomatika fl-istudju SIGNIFY, inħarġu rakkomandazzjonijiet biex dan ir-riskju jitnaqqas.
English: • Corlentor/Procoralan must not be used together with the medicines verapamil or diltiazem which reduce the heart rate.
Maltese: • Corlentor/Procoralan ma għandux jintuża flimkien mal-mediċini verapamil jew diltiazem li jnaqqsu r-rata tal-qalb.
English: The PRAC recommendations were then sent to the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which adopted the Agency's final opinion.
Maltese: Ir-rakkomandazzjonijiet tal-PRAC imbagħad intbagħtu lillKumitat għall-Prodotti Mediċinali għall-Użu mill-Bnedmin (CHMP), responsabbli mill-mistoqsijiet li jikkonċernaw mediċini għall-użu mill-bnedmin, li adotta l-opinjoni finali tal-Aġenzija.
English: Because Corlentor/Procoralan has not been shown to provide benefits such as reducing the risk of heart attack or cardiovascular death (death due to heart problems), the medicine should only be used to alleviate symptoms of angina.
Maltese: Minħabba li Corlentor/Procoralan ma ntweriex li jipprovdi benefiċċji bħal tnaqqis tar-riskju ta' attakk tal-qalb jew ta' mewt kardjovaskulari (mewt minħabba problemi tal-qalb), il-mediċina għandha tintuża biss biex isserraħ minn sintomi ta' anġina.
English: • The benefit-risk balance of Corlentor/Procoralan remains positive for its authorised indications.
Maltese: • Il-bilanċ bejn il-benefiċċjuu r-riskju ta' Corlentor/Procoralan jibqa' pożittiv għall-użu awtorizzat tiegħu.
English: 1.0 ml (50 mg/ml) 12 (3 x 4) pre-filled pens (multipack)
Maltese: 12 (3 x 4)-il pinna mimlija għal-lest (pakkett multiplu)
English: Pack size bottle (HDPE)
Maltese: 112-il pillola flixkun (HDPE)
English: MA (EU) number (Invented) name
Maltese: Numru tal-MA Isem (ivvintat) Qawwa Għamla farmaċewtika
English: II.
Maltese: I.
English: Section 4.3 - Contraindication
Maltese: Sezzjoni 4.3 - Kontraindikazzjonijiet
English: Other medicines and X
Maltese: Mediċini oħra u X
English: Section 5.1 - Pharmacodynamic properties
Maltese: Sezzjoni 5.1 - Proprjetajiet farmakodinamici
English: “Dual blockade of the renin-angiotensin-aldosterone system (RAAS)
Maltese: “Imblokk doppju tas-sistema renin-angiotensin-aldosterone:
English: Do not <take> <use> X <:>
Maltese: <Tiħux> <Tużax> X <:>
English: Section 1.
Maltese: Sezzjoni 1.
English: Section 2.
Maltese: Sezzjoni 2.
English: or - an angiotensin II receptor blocker such as valsartan, telmisartan, irbesartan.”
Maltese: jew - imblokkatur tar-riċetturi ta' angiotensin II bħal valsartan, telmisartan, irbesartan.”
English: For products containing the angiotensin-converting enzyme inhibitors (ACE-inhibitors) benazepril, captopril, cilazapril, delapril, enalapril, fosinopril, imidapril, lisinopril, moexipril, perindopril, quinapril, ramipril, spirapril, trandolapril and zofenopril, the existing product information shall be amended (insertion, replacement or deletion of the text as appropriate) to reflect the agreed wording as provided below
Maltese: Għal prodotti li fihom l-inibituri tal-enzima li tibdel angiotensin (inibituri ta' ACE) benazepril, captopril, cilazapril, delapril, enalapril, fosinopril, imidapril, lisinopril, moexipril, perindopril, quinapril, ramipril, spirapril, trandolapril u zofenopril, l-informazzjoni eżistenti tal-prodott għandha tiġi emendata (inserzjoni, sostituzzjoni jew tħassir tal-kitba kif xieraq) biex tirrifletti l-kitba miftiehma kif deskritt hawn taħt
English: - aliskiren
Maltese: (RAAS)
English: potassium) in your blood at regular intervals.
Maltese: elettroliti (eż. potassium) fid-demm tiegħek f'intervalli regolari.
English: ALTITUDE (Aliskiren Trial in Type 2 Diabetes Using Cardiovascular and Renal Disease Endpoints) was a study designed to test the benefit of adding aliskiren to a standard therapy of an ACE-inhibitor or an angiotensin II receptor blocker in patients with type 2 diabetes mellitus and chronic kidney disease, cardiovascular disease, or both.
Maltese: ALTITUDE (Aliskiren Trial in Type 2 Diabetes Using Cardiovascular and Renal Disease Endpoints) kien studju maħsub biex jittestja l-benefiċċju li jiżdied aliskiren ma' terapija standard ta' inibitur ta' ACE jew imblokkatur tar-riċetturi ta' angiotensin II f'pazjenti b'dijabete mellitus tip 2 u mard kroniku tal-kliewi, mard kardjovaskulari, jew it-tnejn.
English: “Two large randomised, controlled trials (ONTARGET (ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial) and VA NEPHRON-D (The Veterans Affairs Nephropathy in Diabetes)) have examined the use of the combination of an ACE-inhibitor with an angiotensin II receptor blocker.
Maltese: “Żewġ provi kbar, ikkontrollati, li fihom il-parteċipanti ntgħażlu b'mod każwali (ONTARGET (ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial) u VA NEPHRON-D (The Veterans Affairs Nephropathy in Diabetes)) eżaminaw l-użu tal kombinazzjoni ta' inibitur ta' ACE flimkien ma' imblokkatur tar-riċetturi ta' angiotensin II.
English: For products containing the angiotensin II receptor blockers azilsartan, eprosartan, irbesartan, losartan, olmesartan and telmisartan, the existing product information shall be amended (insertion, replacement or deletion of the text as appropriate) to reflect the agreed wording as provided below
Maltese: Għal prodotti li fihom l-imblokkaturi tar-riċetturi ta' angiotensin II azilsartan, eprosartan, irbesartan, losartan, olmesartan u telmisartan, l-informazzjoni eżistenti tal-prodott għandha tiġi emendata (inserzjoni, sostituzzjoni jew tħassir tal-kitba kif xieraq) biex tirrifletti l-kitba miftiehma kif deskritt hawn taħt
English: • if you are taking an ACE-inhibitor together with a medicine which belongs to the class of medicines known as mineralocorticoid receptors antagonists (MRA).
Maltese: • jekk qed tieħu inibitur ta' ACE flimkien ma' mediċina li tappartjeni għall-klassi ta' mediċini magħrufa bħala antagonisti tar-riċetturi mineralokortikojdi (MRA).
English: Section 4.1 - Therapeutic indications
Maltese: Sezzjoni 4.1 - Indikazzjonijiet terapewtiċi
English: VA NEPHRON-D was a study in patients with type 2 diabetes mellitus and diabetic nephropathy.
Maltese: VA NEPHRON-D kien studju li twettaq f'pazjenti b'dijabete mellitus tip 2 u nefropatija dijabetika.
English: “Clinical trial data has shown that dual blockade of the renin-angiotensin-aldosterone system (RAAS) through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is associated with a higher frequency of adverse events such as hypotension, stroke, hyperkalaemia and decreased renal function (including acute renal failure) compared to the use of a single RAAS-acting agent (see sections 4.3, 4.4 and 5.1).”
Maltese: “Dejta minn provi kliniċi wriet li imblokk doppju tas-sistema renin-angiotensin-aldosterone (RAAS) permezz tal-użu kombinat ta' inibituri ta' ACE, imblokkaturi tar-riċetturi ta' angiotensin II jew aliskiren, hu assoċjat ma' frekwenza ogħla ta' avvenimenti avversi bħal pressjoni baxxa, puplesija, iperkalimja u tnaqqis fil-funzjoni tal-kliewi (li jinkludi insuffiċjenza akuta tal-kliewi) meta mqabbel mal-użu ta' sustanza waħda li taġixxi fuq RAAS (ara sezzjonijiet 4.3, 4.4 u 5.1).”
English: “The concomitant use of [Product name] with aliskiren-containing products is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) (see sections 4.5 and
Maltese: “L-użu fl-istess ħin ta' [Isem tal-prodott] ma' prodotti li jkun fihom aliskiren hu kontraindikat f'pazjenti b'dijabete mellitus jew indeboliment tal-kliewi (GFR < 60 ml/min/1.73 m2) (ara sezzjonijiet 4.5 u 5.1).”
English: The combination of an ACE-inhibitor, a potassium-sparing diuretic and [Product name] is not recommended and should be considered only after careful evaluation of the potential benefits and risks (see sections 4.4, 4.8 and 5.1).”
Maltese: Il-kombinazzjoni ta' inibitur ta' ACE, dijuretiċi li ma jipproduċux tnixxija tal-potassium fl-awrina u [Isem tal-prodott] mhijiex rakkomandata u għandha tiġi kkunsidrata biss wara evalwazzjoni bir-reqqa tal-benefiċċji u r-riskji potenzjali (ara sezzjonijiet 4.4, 4.8 u 5.1).”
English: Triple combination of an ACE-inhibitor, a mineralocorticoid receptor antagonist and candesartan is also not recommended.
Maltese: Il-kombinazzjoni tripla ta' inibitur ta' ACE, antagonist tar-riċetturi mineralokortikojdi u candesartan ukoll mhijiex rakkomandata.
English: Triple combination of an ACE-inhibitor, a mineralocorticoid receptor antagonist and valsartan is also not recommended.
Maltese: Il-kombinazzjoni tripla ta' inibitur ta' ACE, antagonist tar-riċetturi mineralokortikojdi u valsartan ukoll mhijiex rakkomandata.
English: Section 4.2 - Posology and method of administration
Maltese: Sezzjoni 4.2 - Pożoloġija u metodu ta' kif għandu jingħata
English: • “if you have diabetes mellitus or impaired kidney function and you are treated with either of the following classes of medicines used to treat high blood pressure: - an ACE-inhibitor such as enalapril, lisinopril, ramipril.
Maltese: • “jekk qed tieħu xi waħda minn dawn il-klassijiet ta' mediċini li ġejjin li jintużaw għal kura ta' pressjoni tad-demm għolja: - inibitur ta' ACE bħal enalapril, lisinopril, ramipril.
English: Dual blockade of RAAS through the combined use of ACE-inhibitors, angiotensin II receptor blockers or aliskiren is therefore not recommended (see sections 4.5 and 5.1).
Maltese: Imblokk doppju ta' RAAS permezz tal-użu kombinat ta' inibituri ta' ACE, imblokkaturi tar-riċetturi ta' angiotensin II jew aliskiren għalhekk mhuwiex rakkomandat (ara sezzjonijiet 4.5 u 5.1).
English: Package leaflet
Maltese: Twissijiet u prekawzjonijiet
English: “The treatment of adult patients with heart failure and impaired left ventricular systolic function (left ventricular ejection fraction ≤ 40%) when ACE-inhibitors are not tolerated or as add-on therapy to ACE-inhibitors in patients with symptomatic heart failure, despite optimal therapy, when mineralocorticoid receptor antagonists are not tolerated (see sections 4.2, 4.4, 4.5 and 5.1)”.
Maltese: Flimkien ma' dan, l-indikazzjoni ta' insuffiċjenza tal-qalb eżistenti għandha tiġi riveduta kif ġej: “Il-kura ta' pazjenti adulti b'insuffiċjenza tal-qalb u funzjoni sistolika tal-ventriklu tax-xellug indebolita (porzjon ta' tfigħ 'il barra mill-ventriklu tax-xellug ta' ≤ 40%) meta inibituri ta' ACE ma jkunux ittollerati jew bħala terapija addizzjonali ma' inibituri ta' ACE f'pazjenti b'insuffiċjenza tal-qalb sintomatika, minkejja l-għoti tal-aħjar terapija, meta antagonisti tar-riċetturi mineralokortikojdi ma jkunux ittollerati (ara sezzjonijiet 4.2, 4.4, 4.5 u 5.1)”.
English: In patients with heart failure, the triple combination of an ACE-inhibitor, a beta blocker and [Product name] has not shown any clinical benefit (see section 5.1).
Maltese: F'pazjenti b'insuffiċjenza tal-qalb, il-kombinazzjoni tripla ta' inibitur ta' ACE, inibitur tar-riċetturi beta u [Isem tal-prodott] ma wriet l-ebda benefiċċju kliniku (ara sezzjoni 5.1).
English: [Product name] may be co-administered with an ACE-inhibitor in patients with symptomatic heart failure despite optimal standard heart failure therapy when mineralocorticoid receptor antagonists are not tolerated.
Maltese: [Isem tal-prodott] jista' jingħata flimkien ma' inibitur ta' ACE f'pazjenti insuffiċjenza tal-qalb sintomatika minkejja l-għoti tal-aħjar terapija standard kontra l-insuffiċjenza talqalb meta antagonisti tar-riċetturi mineralokortikojdi ma jkunux ittollerati.
English: • - if you are being treated with an ACE-inhibitor together with certain other medicines to treat your heart failure, which are known as mineralocorticoid receptors antagonists (MRA) (for example spironolactone, eplerenone) or betablockers (for example metoprolol).
Maltese: • - jekk qed tiġi kkurat b'inibitur ta' ACE flimkien ma' ċerti mediċini oħrajn biex jikkuraw linsuffiċjenza tal-qalb tiegħek, li huma magħrufa bħala antagonisti tar-riċetturi mineralokortikojdi (MRA) (pereżempju spironolactone, eplerenone) jew imblokkaturi tarriċetturi beta (pereżempju metoprolol).
English: The following wording should be added in the “Posology in Heart Failure” section:
Maltese: Il-kitba li ġejja għandha tiġi inkorporata fis-sezzjoni “Insuffiċjenza tal-qalb”:
English: “X can be used to treat adult heart failure patients with reduced heart muscle function when Angiotensin Converting Enzyme (ACE) inhibitors cannot be used or in addition to ACE-inhibitors when symptoms persist despite treatment and mineralocorticoid receptor antagonists (MRA) cannot be used.
Maltese: “X jista' jintuża għal kura ta' pazjenti adulti b'insuffiċjenza tal-qalb b'funzjoni mnaqqsa tal-muskoli talqalb meta inibituri tal-Enzima Li Tibdel Angiotensin (ACE) ma jkunux jistgħu jintużaw, jew flimkien ma' inibituri ta' ACE meta s-sintomi jippersistu minkejja l-kura, u antagonisti tar-riċetturi mineralokortikojdi (MRA) ma jkunux jistgħu jintużaw.
English: “If you are taking an angiotensin II receptor blocker (ARB) or an ACE-inhibitor, (see also information under the headings “Do not <take> <use> X” and “Warnings and precautions”)”
Maltese: “Jekk qed tieħu imblokkatur tar-riċetturi ta' angiotensin II (ARB) jew inibitur ta' ACE (ara wkoll l informazzjoni taħt l-intestaturi “Tiħux> <Tużax> X” u “Twissijiet u prekawzjonijiet”)”
English: (ACE-inhibitors and MRAs are medicines used to treat heart failure).”
Maltese: (Inibituri ta' ACE u MRAs huma mediċini li jintużaw għal kura ta' insuffiċjenza tal-qalb).
English: Treatment of adult patients with symptomatic heart failure when ACE-inhibitors are not tolerated or in beta-blocker intolerant patients as add-on therapy to ACE-inhibitors when mineralocorticoid receptor antagonists cannot be used (see sections 4.2, 4.4, 4.5 and 5.1).”
Maltese: Il-kura ta' pazjenti adulti b'insuffiċjenza tal-qalb sintomatika meta inibituri ta' ACE ma jkunux ittollerati jew f'pazjent li ma jittollerawx imblokkaturi tar-riċetturi beta bħala terapija addizzjonali ma' inibituri ta' ACE meta antagonisti tar-riċetturi mineralokortikojdi ma jkunux jistgħu jintużaw (ara sezzjonijiet 4.2, 4.4, 4.5 u 5.1).”
English: However, the triple combination of an ACE-inhibitor, valsartan and a beta blocker or a potassium-sparing diuretic is not recommended (see sections 4.4 and 5.1).
Maltese: Madankollu, il-kombinazzjoni tripla ta' inibitur ta' ACE, valsartan u imblokkatur tar-riċetturi beta jew dijuretiku li ma jipproduċix potassium mhijiex rakkomandata (ara sezzjonijiet 4.4 u 5.1).
English: “Your doctor may need to change your dose and/or to take other precautions: If you are taking an angiotensin II receptor blocker (ARB) or aliskiren (see also information under the headings “Do not <take> <use> X” and “Warnings and precautions”)”
Maltese: Jekk qed tieħu imblokkatur tar-riċetturi ta' angiotensin II (ARB) jew aliskiren (ara wkoll l-informazzjoni taħt l-intestaturi “Tiħux> <Tużax> X” u “Twissijiet u prekawzjonijiet”)”
English: Talk to your doctor <or> <pharmacist> <or nurse> before <taking> <using> X
Maltese: Kellem <lit-tabib> <jew> <l-ispiżjar> <jew l-infermier> tiegħek qabel <tieħu> <tuża> X
English: If you are taking an ACE-inhibitor or aliskiren (see also information under the headings “Do not <take> <use> X” and “Warnings and precautions”)
Maltese: Jekk qed tieħu inibitur ta' ACE jew aliskiren (ara wkoll l-informazzjoni taħt l-intestaturi “Tiħux> <Tużax> X” u “Twissijiet u prekawzjonijiet”)”
English: See also information under the heading “Do not <take> <use> X””
Maltese: Ara wkoll l-informazzjoni taħt l-intestatura “Tiħux> <Tużax> X””