FrancophonIA/ELRC3.0 huggingface dataset:
English: In study MN302 leflunomide was significantly less effective than methotrexate.
Maltese: Fl-istudju MN302 leflunomide kien b'mod sinifikanti inqas effettiv minn methotrexate.
English: A tuberculin reaction test should be considered for those patients with other tuberculosis risk factors.
Maltese: Test għar-reazzjoni ta' tuberculin għandu jiġi kkonsidrat għal dawk il-pazjenti b'fatturi oħra ta' riskju għal tuberkolosi.
English: - Severe sometimes life-threatening reactions (Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme).
Maltese: Stevens-Johnson, nekrolisi epidermali tossika, eritema multiforme).
English: - Hedache.
Maltese: - Ħakk.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar dan il-prodott tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini (EMA):http://www.ema.europa.eu/
English: HDPE containers: Do not store above 30°C.
Maltese: Taħżinx f'temperatura 'l fuq minn 30°C.
English: In female mice an increased incidence, dose-dependent, of bronchiolo-alveolar adenomas and carcinomas of the lung was noted.
Maltese: Fil-ġrieden nisa, kien hemm żieda fl-inċidenza ta' adenomi u kanċer tal-pulmun tat-tip bronkjolo-alvejolari, li kienu ddeterminati mid-doża użata.
English: • Pregnant women, or women of childbearing potential who are not using reliable contraception during treatment with leflunomide and thereafter as long as the plasma levels of the active metabolite are above 0.02 mg/l (see section 4.6).
Maltese: • Nisa tqal b'tarbija, jew nisa li jinsabu fl-età li jista' jkollhom it-tfal u mhux qegħdin jużaw kontraċettivi effettivi waqt il-kura b'leflunomide, u wara, sakemm il-livelli fil-plażma tal prodott jibqgħu ikunu aktar minn 0.02 mg/l (ara sezzjoni 4.6).
English: • In rheumatoid arthritis: leflunomide therapy is usually started with a loading dose of 100 mg once daily for 3 days.
Maltese: Normalment, it-terapija b'leflunomide tibda b'doża ta' kkargar ta' 100 mg darba kuljum għal 3 ijiem.
English: - Skin sensation, i.e. burning, prickling, itching, or tingling (paraesthesia).
Maltese: - Sensazzjoni tal-ġilda, i.e.ħruq, tingiż, ħakk, jew tnemnim (paraestesija).
English: Medicinal product subject to medical prescription.
Maltese: U EFFETTIV TAL-PRODOTT MEDIĊINALI
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON/BOTTLE PACK
Maltese: KARTUNA TA' BARRA/PAKKETT TAL-FLIXKUN
English: To minimise any possible risk, men wishing to father a child should consider discontinuing use of leflunomide and taking colestyramine 8 g 3 times daily for 11 days or 50 g of activated powdered charcoal 4 times daily for 11 days.
Maltese: leflunomide u jieħdu 8 g 3 darbiet kuljum ta' colestyramine għal 11-il jum jew 50 g ta' trab ta' charcoal attivat 4 darbiet kuljum għal 11-il jum.
English: The efficacy of leflunomide in the treatment of rheumatoid arthritis was demonstrated in 4 controlled trials (1 in phase II and 3 in phase III).
Maltese: Artrite rewmatojdi L-effikaċja ta' leflunomide fil-kura tal-artrite rewmatojde ntweriet f'4 provi kkontrollati (1 fil-fażi II u
English: - An increase in some liver test results.
Maltese: DATA TA' REVIŻJONI TAT-TEST
English: Leflunomide Teva 10 mg film-coated tablets leflunomide
Maltese: Leflunomide Teva 10 mg pilloli miksija b'rita leflunomide
English: The MAH shall perform the pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in the RMP presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates of the RMP agreed by the Committee for Medicinal Products for Human Use (CHMP).
Maltese: farmakovigilanza kif deskritt fil-Pjan ta' Farmakoviġilanza kif inhu maqbul fil-RMP ppreżentat f'Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti tal-RMP kif maqbul mill-Kumitat għall-Prodotti Mediċinali għall-Użu millBniedem (CHMP).
English: - Severe liver damage (i.e. liver failure, liver necrosis), which may be fatal.
Maltese: - Infjammazzjoni tal-pulmun (mard interstizzjali tal-pulmun), li jista' jkun fatali.
English: Leflunomide was studied in a single multicenter, randomized, double-blind, active-controlled trial in 94 patients (47 per arm) with polyarticular course juvenile rheumatoid arthritis.
Maltese: ikkontrollata b'mod attiv f'94 pazjent (47 kull driegħ) b'kors poliartikulari ta' artrite rewmatojdi ġovanili.
English: Repeated oral administration of leflunomide to mice for up to 3 months, to rats and dogs for up to 6 months and to monkeys for up to 1 month's duration revealed that the major target organs for toxicity were bone marrow, blood, gastrointestinal tract, skin, spleen, thymus and lymph nodes.
Maltese: It-teħid orali u repetut ta' leflunomide fil-ġrieden għal perijodu sa 3 xhur, filfirien u l-klieb għal perijodu sa 6 xhur, u fix-xadini għal-perijodu ta' xahar, żvela li l-organi maġġuri milquta mit-tossiċità kienu l-mudullun, id-demm, il-passaġġ gastrointestinali, il-ġilda, il-milsa, it-timu u l-glandoli limfatiċi.
English: • Each Leflunomide Teva 20 mg film-coated tablet contains 20 mg of leflunomide.
Maltese: • Kull pillola miksija b'rita ta' Leflunomide Teva 20 mg fiha 20 mg ta' leflunomide.
English: The metabolic biotransformation of leflunomide to A771726 and subsequent metabolism of A771726 is not controlled by a single enzyme and has been shown to occur in microsomal and cytosolic cellular fractions.
Maltese: A771726, u l-metaboliżmu sussegwenti ta' A771726, mhumiex ikkontrollat b'enżima waħda, u ntwera li dan jiġri fil-mikrożomi u l-likwidu taċ-ċitoplażma fil-frazzjonijiet ċellulari.
English: Folate supplementation was optional and only used in 10 % of patients.
Maltese: It-teħid addizzjonali ta' folate ma kienx obbligatorju u ntuża biss minn 10% tal-pazjenti.
English: - A cough or breathing problems as these may indicate inflammation of the lung (interstitial lung disease).
Maltese: - Jekk qatt kellek it-tuberkulosi jew disturbi ta' l-Interstitium tal-Pulmun (marda fil-pulmun).
English: Colestyramine given orally at a dose of 8 g three times a day for 24 hours to three healthy volunteers decreased plasma levels of A771726 by approximately 40 % in 24 hours and by 49 % to
Maltese: Meta colestyramine ingħata mill-ħalq f'doża ta' 8 g tliet darbiet kuljum għal 24 siegħa lil tliet voluntieri b'saħħithom, il-livelli ta' A771726 fil-plażma tnaqqsu b'madwar 40% f'24
English: An in vivo interaction study with cimetidine (non-specific cytochrome P450 inhibitor) has demonstrated a lack of a significant interaction.
Maltese: cytochrome P450) wera li ma kienx hemm interazzjoni sinifikanti.
English: Immune system disorders severe anaphylactic/anaphylactoid reactions, vasculitis, including cutaneous hypokalaemia, hyperlipidemia, hypophosphataemia paraesthesia, headache, dizziness, peripheral neuropathy
Maltese: Disturbi tas-sistema nervuża paraestesija, uġigħ ta' ras, sturdament, newropatija periferika
English: agranulocytosis
Maltese: FARMAĊEWTIKU
English: EU/1/11/675/005 100 film-coated tablets
Maltese: EU/1/11/675/006-010
English: cutaneous lupus erythematosus, pustular psoriasis or worsening psoriasis Musculoskeletal and connective tissue disorders
Maltese: Mhux magħruf lupus eritematożu kutanju, psorijażi pustulari jew il-psorijażi tmur għall-agħar Disturbi muskoloskeletriċi u tat-tessut konnettiv
English: Pack sizes of 30 and 100 film-coated tablets.
Maltese: Daqsijiet tal-pakkett ta' 30 u 100 pillola miksija b'rita.
English: For ALT (SGPT) elevations between 2- and 3-fold the upper limit of normal, dose reduction from 20 mg to 10 mg may be considered and monitoring must be performed weekly.
Maltese: għandu jiġi kkonsidrat li d-doża titnaqqas minn 20 mg sa 10 mg u monitoraġġ isir kull ġimgħa.
English: Alanine aminotransferase (ALT) or serum glutamopyruvate transferase (SGPT) and a complete blood cell count, including a differential white blood cell count and a platelet count, must be checked simultaneously and with the same frequency:
Maltese: Alanine aminotransferase (ALT) jew glutamopyruvate transferase fis-serum (SGPT) u għadd sħiħ taċ-ċelluli tad-demm, li jinkludi l-għadd divrenzjali ta' ċelluli bojod tad-demm u l-għadd ta' plejtlits, għandhom jiġu ċċekjati u bl-istess frekwenza:
English: Pregnancy
Maltese: pankreatite
English: • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being
Maltese: • Fiż-żmien 60 jum minn meta jintlaħaq għan importanti (farmakoviġilanza jew minimizzazzjoni tar-riskju);
English: A771726 plasma levels can be expected to be above 0.02 mg/l for a prolonged period.
Maltese: Il-livelli fil-plażma ta' A771726 huma mistennija li jkunu 'l fuq minn 0.02 mg/l għal żmien twil.
English: In clinical trials no safety problems were observed when leflunomide and NSAIDs metabolised by CYP2C9 were co-administered.
Maltese: Iddiskuti mat-tabib tiegħek sabiex tara jekk xi mediċina li qed tieħu titkissirx b'CYP2C9.
English: Leflunomide Teva 20 mg film-coated tablets
Maltese: IL-PRODOTT MEDIĊINALI Leflunomide Teva 20 mg pilloli miksija b'rita
English: The use of leflunomide with antimalarials used in rheumatic diseases (e.g. chloroquine and hydroxychloroquine), intramuscular or oral gold, D-penicillamine, azathioprine and other immunosuppressive agents including Tumour Necrosis Factor alpha-Inhibitors has not been adequately studied up to now in randomised trials (with the exception of methotrexate, see section 4.5).
Maltese: 5.3 Tagħrif ta' qabel l-użu kliniku dwar is-sigurtà Leflunomide, li ngħata oralment u fil-kavita tal-peritonew, kien studjat mill-aspett ta' tossiċità akuta fil-ġrieden u l-firien.
English: What Leflunomide Teva looks like and contents of the pack Leflunomide Teva 10 mg film-coated tablets are white, round film-coated tablets, engraved with “10” on one side and “L” on the other.
Maltese: Kif jidher Leflunomide Teva u l-kontenut tal-pakkett Il-pilloli miksija b'rita ta' Leflunomide Teva 10 mg huma bojod, tondi u fuqhom hemm intaljat fuqhom “10” fuq naħa waħda u “L” fuq naħa oħra.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
Maltese: Sommarju tal-profil tas-sigurtà
English: 14C-leflunomide in three healthy volunteers, no unchanged leflunomide was detected in plasma, urine or faeces.
Maltese: Fi studju b'14C-leflunomide radjutikkettat fi tliet voluntieri b'saħħithom, ma ġie intraċċat ebda leflunomide mhux mibdul fil-plażma, l-urina jew l-ippurgar.
English: Physicians and patients should be made aware that there is an ad hoc advisory service available to provide information on leflunomide plasma
Maltese: L-ispeċjalisti u l-pazjenti għandhom jiġu mgħarrfa li hemm disponibbli servizz ta' konsulenza ad hoc li jagħti informazzjoni dwar l-ittestjar fil-laboratorju tal-livell ta' leflunomide fil-plażma.
English: In vivo, it is rapidly and almost completely metabolised to A771726 which is active in vitro, and is presumed to be responsible for the therapeutic effect.
Maltese: In vivo, huwa metaboliżżat malajr u kważi kompletament għal A771726, li huwa attiv in vitro,u li huwa preżunt li jikkawża l-effett terapewtiku.
English: However, the minor metabolite TFMA (4-trifluoromethylaniline) caused clastogenicity and point mutations in vitro, whilst insufficient information was available on its potential to exert this effect in vivo.
Maltese: Madanakollu, il-prodott metaboliku minuri TFMA (4-trifluoromethylaniline) ikkaġuna clastoġeniċità u mutazzjonijiet tal-punt in vitro, filwaqt li ma kienx hemm biżżejjed tagħrif biex tixhet dawl biex dan l-effett ikun jista' jsir in vivo.
English: - Inflammation of the lung (interstitial lung disease), which may be fatal.
Maltese: - Disturb tad-demm - Infjammazzjoni tal-pulmun (mard interstizzjali tal-pulmun), li jista' jkun fatali.
English: NAME OF THE MEDICINAL PRODUCT Leflunomide Teva 10 mg film-coated tablets
Maltese: Kull pillola miksija b'rita fiha 10 mg ta' leflunomide
English: Leflunomide Teva passes into breast milk.
Maltese: - Din il-mediċina ġiet mogħtija lilek biss.
English: For women receiving leflunomide treatment and who wish to become pregnant, one of the following procedures is recommended in order to ascertain that the foetus is not exposed to toxic concentrations of A771726 (target concentration below 0.02 mg/l):
Maltese: Għan-nisa li qed jieħdu l-kura b'leflunomide u li jixtiequ joħorġu tqal, waħda minn dawn il-proċeduri hija irrakkomandata biex jiżguraw li l-fetu ma jkunx espost għal livelli tossiċi ta' l-A771726 (il-mira tal-livell huwa inqas minn 0.02 mg/l):
English: At steady state plasma levels accumulate about 33- to 35-fold compared with single dose.
Maltese: Fi stat stabbli, il-livelli fil-plażma jakkumulaw għal madwar 33 sa 35 darba meta mqabbla ma' doża waħda.
English: mild allergic reactions severe anaphylactic/anaphylactoid reactions, vasculitis, including cutaneous hypokalaemia, hyperlipidemia, hypophosphataemia paraesthesia, headache, dizziness, peripheral neuropathy
Maltese: reazzjonijiet severi anafilattiċi jew reazzjonijiet anafilattojdi, vaskulite, li tinkludi l-vaskulitenekrotika tal-ġilda Disturbi fil-metaboliżmu u n-nutrizzjoni Komuni:
English: UAB “Sicor Biotech” Tel: +370 5 266 02 03 Luxembourg/Luxemburg Teva Pharma Belgium S.A. Tél/Tel: +32 3 820 73 73 Magyarország Teva Magyarország Zrt Tel.: +36 1 288 64 00
Maltese: Minħabba l-ħalf-life twila ħafna ta' A771726 (madwar ġimagħtejn), doża inizjali ta' 100 mg għal 3 ijiem kienet użata fl-istudji kliniċi sabiex tiffaċilita l-kisba ta' malajr ta' livelli fi stadju-fiss ta' A771726.
English: All leflunomide patients in the phase III trials used an initial dose of 100 mg for 3 days.
Maltese: III inbdew fuq doża inizjali ta' 100 mg għal tliet ijiem.
English: - If you have a serious infection.
Maltese: Infezzjonijiet u Infestazzjonijiet
English: Risk Management Plan (RMP)
Maltese: METODU U MOD(I) TA' AMMINISTRAZZJONI
English: OTHER SPECIAL WARNING(S), IF NECESSARY
Maltese: MANIFATTUR(I) RESPONSABBLI
English: Leflunomide Teva is not recommended for use in patients below 18 years since efficacy and safety in juvenile rheumatoid arthritis (JRA) have not been established (see sections 5.1 and 5.2).
Maltese: Leflunomide Teva mhux rakkomandat għall-użu f'pazjenti li għadhom m'għalqux 18-il sena peress li l-effikaċja u s-sigurtà tal-artrite rewmatojdi ġovanili (juvenile rheumatoid arthritis (JRA)) għadha ma ġietx stabbilita (ara sezzjonijiet 5.1 u 5.2).
English: United Kingdom
Maltese: Česká republika
English: NAME OF THE MEDICINAL PRODUCT Leflunomide Teva 20 mg film-coated tablets
Maltese: TAL-PRODOTT MEDIĊINALI Leflunomide Teva 20 mg pilloli miksija b'rita leflunomide
English: • Each Leflunomide Teva 10 mg film-coated tablet contains 10 mg of leflunomide.
Maltese: • Kull pillola miksija b'rita ta' Leflunomide Teva 10 mg fiha 10 mg ta' leflunomide.
English: Leflunomide is a disease-modifying anti-rheumatic agent with antiproliferative properties.
Maltese: Leflunomide huwa sustanza b'karatteristiċi antiproliferattivi li jaġixxi bħala prodott antirewmatoloġiku.
English: The duration may be modified depending on clinical or laboratory variables.
Maltese: żmien jista' jkun modifikat skont il-varjabbli kliniċi u dawk tal-laboratorju.
English: The MAH must ensure that the system of pharmacovigilance, as presented in Module 1.8.1. of the Marketing Authorisation, is in place and functioning before and whilst the medicinal product is on the market.
Maltese: farmakoviġilanza ppreżentata f'Modulu 1.8.1 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq tkun fis-seħħ u tiffunzjona qabel u waqt li l-prodott mediċinali jkun fis-suq.
English: increased hair loss, eczema, rash (including maculopapular rash), pruritus, dry skin
Maltese: żieda fit-twaqqigħ tax-xagħar, ekżema, raxx (li jinkludi raxx makulopapulari), ħakk, ġilda xotta
English: • every 8 weeks thereafter (see section 4.4).
Maltese: • kull 8 ġimgħata wara dan (ara sezzjoni 4.4).
English: EU/1/11/675/007 100 film-coated tablets
Maltese: EU/1/11/675/006 30 pillola miksija b'rita EU/1/11/675/007 100 pillola miksija b'rita
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.
Maltese: Pazjenti bi problemi rari u ereditarji f'intolleranza għall-galaktosju, in-nuqqas ta' Lapp lactase jew il-malassorbiment ta' glukosju-galattosju m'għandhomx jieħdu dan il-prodott mediċinali.
English: Leflunomide was administered as a single oral 100 mg dose to 3 haemodialysis patients and 3 patients on continuous peritoneal dialysis (CAPD).
Maltese: 3 pazjenti oħra fuq id-dijaliżi kontinwa mill-peritonew (CAPD).
English: Studies with both hemodialysis and CAPD (chronic ambulatory peritoneal dialysis) indicate that A771726, the primary metabolite of leflunomide, is not dialysable.
Maltese: F'dawn l-istudji, l-effett kliniku kien relatat sew mal-livell ta' A771726 fil-plażma u mad-doża ta' kuljum ta' leflunomide.
English: Thus, the overall incidence of infections can increase (in particular of rhinitis, bronchitis and pneumonia).
Maltese: Għalhekk, l-inċidenza totali ta'infezzjonijiet tista' tiżdied (partikolarment ir-rinite, il-bronkite u l-pulmonite).
English: Elimination of A771726 is slow and characterised by an apparent clearance of about 31 ml/hr.
Maltese: L-eliminazzjoni ta' A771726 issir bil-mod u hija ikkaratterizzata bit-tneħħija apparenti ta' madwar 31 ml fis-siegħa.
English: The active metabolite of leflunomide, A771726 is suspected to cause serious birth defects when administered during pregnancy.
Maltese: Il-prodott metaboliku attiv ta' leflunomide A771726 huwa maħsub li jista' jagħmel difetti serji tat-twelid meta jingħata waqt it-tqala.
English: The recommended maintenance dose is leflunomide 10 mg to 20 mg once daily depending on the severity (activity) of the disease.
Maltese: Id-doża rakkomandata ta' leflunomide hi ta' 10 mg sa 20 mg darba kuljum skont is-severità (lattività) tal-marda.
English: Leflunomide Teva is contraindicated in pregnancy (see section 4.3).
Maltese: F'każijiet bħal dawn l-espożizzjoni mill-ġdid ta' leflunomide huwa kontraindikat (ara sezzjoni 4.3).
English: EU/1/11/675/002 100 film-coated tablets
Maltese: EU/1/11/675/001 30 pillola miksija b'rita EU/1/11/675/002 100 pillola miksija b'rita
English: The Physician Leaflet should contain the following key messages:
Maltese: Disturbi fil-ġilda u tat-tessut ta' taħt il-ġilda Komuni:
English: Other symptoms that affect the entire body include loss of appetite, fever, loss of energy and anemia (lack of red blood cells).
Maltese: Sintomi oħra li jistgħu jeffettwaw il-ġisem kollu huma n-nuqqas t'aptit, id-deni, nuqqas ta' enerġija u anemija (nuqqas taċ-ċelluli ħomor tad-demm).
English: Blisters: Do not store above 25°C.
Maltese: Taħżinx f'temperatura 'l fuq minn 25°C.
English: • The identified risk of synergistic hepato- or haematotoxicity associated with combination therapy with another Disease-Modifying Antirheumatic Drug (e.g. methotrexate).
Maltese: • Ir-riskju magħruf li jekk tittieħed fl-istess ħin ma' mediċina oħra Antirewmatika li Timmodifika l-Kura (eż.methotrexate), l-epato jew l-ematotossiċità assoċjata ma' din it-terapija kkombinata hija sinerġistika.
English: Leflunomide Teva 10 mg film-coated tablets
Maltese: Leflunomide Teva 10 mg pilloli miksija b'rita
English: neutropenia or thrombocytopenia due to causes other than rheumatoid arthritis.
Maltese: - Infertilità riversibbli tar-raġel.
English: White, round film-coated tablets, engraved with “10” on one side and “L” on the other.
Maltese: Pilloli miksija b'rita bojod u tondi li fuqhom hemm intaljat “10” fuq naħa waħda u “L” fuq in-naħa l-oħra.
English: Entresto is available as tablets (24 mg sacubitril / 26 mg valsartan, 49 mg sacubitril / 51 mg valsartan, and 97 mg sacubitril / 103 mg valsartan).
Maltese: Entresto huwa disponibbli bħala pilloli (24 mg sacubitril / 26 mg valsartan, 49 mg sacubitril / 51 mg valsartan, u 97 mg sacubitril / 103 mg valsartan).
English: Other information about Entresto
Maltese: Informazzjoni oħra dwar Entresto
English: The full EPAR and risk management plan summary for Entresto 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: Entresto sacubitril / valsartan
Maltese: Sommarju tal-EPAR għall-pubbliku sacubitril / valsartan
English: Why is Entresto approved?
Maltese: Għaliex ġiet approvat Entresto?
English: The study was stopped early because there was compelling evidence that Entresto was more effective than enalapril.
Maltese: L-istudju twaqqaf qabel għax kien hemm evidenza konvinċenti li Entresto kien aktar effikaċi minn enalapril.
English: This is a summary of the European public assessment report (EPAR) for Entresto.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Entresto.
English: What are the risks associated with Entresto?
Maltese: X'inhuma r-riskji assoċjati ma' Entresto?
English: The two active substances in Entresto, sacubitril and valsartan, work in different ways.
Maltese: Iż-żewġ sustanzi attivi f'Entresto, sacubitril u valsartan, jaħdmu b'modi differenti.
English: In the group treated with Entresto, 21.8% (914 of 4,187) patients either died as a result of heart and circulation problems or were admitted to hospital with heart failure compared to 26.5% (1,117 of 4,212) patients treated with enalapril.
Maltese: Fil-grupp ikkurat b'Entresto, 21.8% (914 minn 4,187) tal-pazjenti mietu jew bħala riżultat ta' problemi tal-qalb u taċ-ċirkolazzjoni jew iddaħħlu lisptar b'insuffiċjenza tal-qalb meta mqabbel ma' 26.
English: The recommended starting dose is one tablet of Entresto 49 mg / 51 mg twice a day and the dose is then doubled after 2 to 4 weeks to 97 mg / 103 mg twice a day.
Maltese: Id-doża rakkomandata tal-bidu hija ta' pillola waħda ta' Entresto 49 mg / 51 mg darbtejn kuljum u d-doża mbagħad tiġi rduppjata wara ġimagħtejn sa 4 ġimgħat għal 97 mg / 103 mg darbtejn kuljum.
English: Sacubitril blocks the breakdown of natriuretic peptides produced in the body.
Maltese: Sacubitril jimblokka t-tkissir tal-peptidi natrijuretiċi prodotti fil-ġisem.
English: Valsartan, one of the active substances in the medicine, is well established for the treatment of high blood pressure and heart failure; its side effects are well known.
Maltese: Valsartan, wieħed mis-sustanzi attivi fil-mediċina, huwa stabbilit sew għall-kura ta' pressjoni għolja tad-demm u insuffiċjenza tal-qalb; l-effetti sekondarji tiegħu huma magħrufin sew.
English: A potentially severe side effect, angioedema (rapid swelling of deeper skin tissues as well as the tissues around the throat, causing breathing difficulty), can occur uncommonly (affecting fewer than 1 in 100 people).
Maltese: Effett sekondarju potenzjalment sever, anġjoedema (nefħa mgħaġġla ta' tessuti tal-ġilda aktar fil-fond kif ukoll tat-tessuti madwar il-gerżuma, li jikkawżaw diffikultà fit-teħid tan-nifs), jista' jseħħ b'mod mhux komuni (jaffettwa anqas minn 1 minn kull 100 persuna).
English: Entresto is a heart medicine that contains the active substances sacubitril and valsartan.
Maltese: Entresto huwa mediċina tal-qalb li fiha s-sustanzi attivi sacubitril u valsartan.
English: A risk management plan has been developed to ensure that Entresto is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiġi żgurat li Entresto jintuża bl-aktar mod sigur possibbli.
English: For further information, see the summary of product characteristic (also part of the EPAR).
Maltese: Għal aktar informazzjoni, ara s-sommarju tal-karatteristiċi tal-prodott (parti wkoll mill-EPAR).
English: It is used in adults with long-term heart failure who have symptoms of the disease.
Maltese: Dan jintuża f'adulti li jbatu minn insuffiċjenza tal-qalb fit-tul li għandhom sintomi tal-marda.
English: For the full list of restrictions see the package leaflet.
Maltese: Għal-lista sħiħa ta' restrizzjonijiet, ara l-fuljett ta' tagħrif.
English: How does Entresto work?
Maltese: Kif jaħdem Entresto?