FrancophonIA/ELRC3.0 huggingface dataset:
English: Other conditions with stimulation of the renin-angiotensin-aldosterone system In patients whose vascular tone and renal function depend predominantly on the activity of the renin-angiotensin-aldosterone system (e.g. patients with severe congestive heart failure or underlying renal disease, including renal artery stenosis), treatment with medicinal products that affect this system has been associated with acute hypotension, hyperazotaemia, oliguria, or rarely acute renal failure (see section 4.8).
Maltese: Kundizzjonijiet oħrajn bl-istimulazzjoni tas-sistema renin-angiotensin-aldosterone F'pazjenti fejn it-ton vaskulari u l-funzjoni renali jiddependu b'mod predominanti fuq l-attività tassistema renin-angiotensin-aldosterone (eż. pazjenti b'insuffiċjenza konġestiva severa tal-qalb jew li għandhom mard prinċipali renali, li jinkludi stenosi tal-arterja renali), il-kura bi prodotti mediċinali oħrajn li jaffettwaw din is-sistema kienet assoċjata ma' pressjoni baxxa ħafna akuta, iperażotemija, oligurja, jew, b'mod rari, ma' insuffiċjenza renali akuta (ara sezzjoni 4.8).
English: An increase in cholesterol and triglyceride levels has been associated with thiazide diuretic therapy; however, at the 12.5 mg dose contained in Tolucombi, minimal or no effects were reported.
Maltese: Żieda fil-livelli tal-kolesterol u tat-trigliċeridi kienet assoċjata ma' terapija dijuretika b'thiazide; madankollu, bid-doża ta' 12.5 mg li hemm f'Tolucombi, effetti minimi kienu rrappurtati, jew l-ebda effett.
English: Common side effects (may affect up to 1 in 10 people): Dizziness.
Maltese: Effetti sekondarji komuni (jistgħu jaffettwaw sa persuna 1 f'10): Sturdament.
English: - Medicines that may increase blood potassium levels such as potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, ACE inhibitors, cyclosporin (an immunosuppressant drug) and other medicinal products such as heparin sodium (an anticoagulant).
Maltese: - Mediċini li jistgħu jżidu l-livelli tal-potassium fid-demm bħal dijuretiċi li ma jipproduċux potassium, supplimenti tal-potassium, sostituti tal-melħ li jkun fihom il-potassium, inibituri ta' ACE, cyclosporin (mediċina immunosoppressanti) u prodotti mediċinali oħrajn bħal heparin sodium (antikoagulant).
English: - Cholestasis and biliary obstructive disorders.
Maltese: - Kolestasi u mard ostruttiv tal-marrara.
English: Serious angioedema may occur rarely (≥1/10,000 to <1/1,000).
Maltese: Effetti sekondarji rar ħafna (jistgħu jaffettwaw sa persuna 1 f'10,000)
English: Cytotoxic agents (e.g. cyclophosphamide, methotrexate) Thiazides may reduce the renal excretion of cytotoxic medicinal products and potentiate their myelosuppressive effects.
Maltese: Mediċini ċitotossiċi (eż. cyclophosphamide, methotrexate) Thiazides jistgħu jnaqqsu t-tneħħija renali ta' prodotti mediċinali ċitotossiċi u jsaħħu l-effetti majelosuppressivi tagħhom.
English: In a typical study in patients with a mean creatinine clearance of 90 ml/min the elimination half-life of hydrochlorothiazide was increased.
Maltese: Fi studju tipiku f'pazjenti b'medja ta' tneħħija tal-kreatinina ta' 90 ml/min, il-half-life tal-eliminazzjoni ta' hydrochlorothiazide żdiedet.
English: Tolucombi 40 mg/12.5 mg tablets:
Maltese: Tolucombi 40 mg/12.5 mg pilloli
English: Tolucombi 40 mg/12.5 mg tablets Each tablet contains 40 mg telmisartan and 12.5 mg hydrochlorothiazide.
Maltese: Tolucombi 40 mg/12.5 mg pilloli Kull pillola fiha 40 mg ta' telmisartan u 12.5 mg ta' hydrochlorothiazide.
English: Gastrointestinal disorders Common:
Maltese: Disturbi vaskulari Mhux komuni:
English: - Medicines for the treatment of diabetes (insulins or oral agents such as metformin).
Maltese: - Mediċini għall-kura tad-dijabete (insulini jew mediċini orali bħal metformin).
English: Arthralgia, muscle cramps, pain in limb
Maltese: Suffejra epatoċellulari, suffejra kolestatika
English: Tolucombi 80 mg/12.5 mg tablets Each tablet contains 80 mg telmisartan and 12.5 mg hydrochlorothiazide.
Maltese: Tolucombi 80 mg/12.5 mg pilloli Kull pillola fiha 80 mg ta' telmisartan u 12.5 mg ta' hydrochlorothiazide.
English: Adverse reactions reported in all clinical trials and occurring more frequently (p ≤0.05) with telmisartan plus hydrochlorothiazide than with placebo are shown below according to system organ class.
Maltese: Reazzjonijiet avversi rrappurtati fil-provi kliniċi kollha u li seħħew b'mod iktar frekwenti (p 0.05) meta ngħata telmisartan flimkien ma' hydrochlorothiazide milli meta ngħata l-plaċebo, qed jintwerew hawn taħt skond il-klassi tas-sistema tal-organi.
English: White to yellowish white on one side and yellow marbled on the opposite side of two-layer biconvex oval tablet, tablet dimensions 18 mm x 9 mm.
Maltese: Bajda għal safrani abjad u safrani irħamat fuq in-naħa opposta ta' pillola fuq żewġ saffi ovali mżaqqa, dimensjonijiet tal-pillola 18 mm x 9 mm.
English: - Amantadine (medicine used to treat Parkinson's disease and also used to treat or prevent certain illnesses caused by viruses).
Maltese: - Amantadine (mediċina użata biex tikkura l-marda ta' Parkinson u tintuża wkoll bix tikkura jew tipprevjeni ċertu mard ikkawżat mill-viruses).
English: Tolucombi is also available at the dose strengths 40 mg/12.5 mg and 80 mg/12.5 mg.
Maltese: Tolucombi hu disponibbli wkoll f'dożi b'qawwa ta' 40 mg/12.5 mg u 80 mg/12.5 mg.
English: Tolucombi is a combination of two active substances, telmisartan and hydrochlorothiazide in one tablet.
Maltese: Tolucombi hu taħlita ta' żewġ sustanzi attivi, telmisartan u hydrochlorothiazide f'pillola waħda.
English: Not known: Anorexia, appetite decreased, electrolyte imbalance, hypercholesterolaemia, hyperglycaemia, hypovolaemia
Maltese: Anoreksja, tnaqqis fl-aptit, żbilanċ fl-elettroliti, iperkolesterolemija, ipergliċemija, ipovolemija
English: Investigations Not known: Triglycerides increased
Maltese: Żieda fit-triglycerides
English: Tolucombi 40 mg/12.5 mg contains 147.04 mg sorbitol in each tablet, which is equivalent to 5 mg/kg/day, if the body weight is 29.8 kg.
Maltese: Tolucombi 40 mg/12.5 mg fih 147.04 mg sorbitol f'kull pillola, li hu ekwivalenti għal 5 mg/kg/jum jekk il-piż tal-ġisem ikun 29.8 kg.
English: 80 mg/25 mg tablets: White to yellowish white on one side and yellow marbled on the opposite side of two-layer biconvex oval tablet, tablet dimensions 18 mm x 9 mm.
Maltese: Bojod għal safrani fl-abjad u safrani irħamat fuq in-naħa opposta ta' pillola fuq żewġ saffi ovali mżaqqa, dimensjonijiet tal-pillola 18 mm x 9 mm.
English: Side effects of unknown frequency (frequency cannot be estimated from the available data):
Maltese: Effetti sekondarji ta' frekwenza mhux magħrufa (il-frekwenza ma tistax tiġi stmata mit-tagħrif disponibbli):
English: Conversely, due to the antagonism of the angiotensin II (AT1) receptors by the telmisartan component of Tolucombi, hyperkalaemia might occur.
Maltese: Għal kuntrarju, minħabba l-antaġoniżmu tar-riċetturi ta' angiotensin II (AT1) mill-komponent ta' telmisartan ta' Tolucombi, tista' sseħħ l-iperkalemija.
English: This applies especially to the medicines listed below taken at the same time with Tolucombi:
Maltese: Mediċini oħra u Tolucombi:
English: Hydrochlorothiazide: Following oral administration of Tolucombi peak concentrations of hydrochlorothiazide are reached in approximately 1.0 - 3.0 hours after dosing.
Maltese: Wara l-għoti ta' Tolucombi mill-ħalq, il-konċentrazzjonijiet massimi ta' hydrochlorothiazide jintlaħqu wara madwar 1.0 - 3.0 sigħat wara d-dożaġġ.
English: Toxicological findings also well known from preclinical studies with angiotensin converting enzyme inhibitors and angiotensin II receptor antagonists were: a reduction of red cell parameters (erythrocytes, haemoglobin, haematocrit), changes of renal haemodynamics (increased blood urea nitrogen and creatinine), increased plasma renin activity, hypertrophy/hyperplasia of the juxtaglomerular cells and gastric mucosal injury.
Maltese: Ir-riżultati tossikoloġiċi magħrufa sew minn studji li kienu saru qabel l-użu kliniku b'inibituri talenzimi li jibdlu l-angiotensin u b' antagonisti tar-riċetturi ta' angiotensin II kienu: tnaqqis fil-parametri taċ-ċelluli l-ħomor (eritroċiti, emoglobina, ematokrit), bidliet tal-emodinamika renali (żieda finnitroġenu tal-urea fid-demm u kreatinina), żieda fl-attività tar-renin fil-plażma, ipertrofija/iperplasija taċ-ċelluli juxtaglomerulari, u ħsara mukożali gastrika.
English: Tolucombi 80 mg/12.5 mg contains 294.08 mg sorbitol in each tablet, which is equivalent to 5 mg/kg/day, if the body weight is 58.8 kg.
Maltese: Tolucombi 80 mg/12.5 mg fih 294.08 mg sorbitol f'kull pillola, li hu ekwivalenti għal 5 mg/kg/jum jekk il-piż tal-ġisem ikun 58.8 kg.
English: Stomach discomfort
Maltese: Disturbi gastro-intestinali
English: - Renal artery stenosis (narrowing of the blood vessels to one or both kidneys).
Maltese: - Stenosi tal-arterji renali (tidjiq tal-vini/arterji lejn kilwa waħda jew lejn iż-żewġ kliewi).
English: Overdose with hydrochlorothiazide is associated with electrolyte depletion (hypokalaemia, hypochloraemia) and hypovolaemia resulting from excessive diuresis.
Maltese: Doża eċċessiva b'hydrochlorothiazide hi marbuta ma' tnaqqis fl-elettroliti (ipokalemija, ipokloremija) u ipovolemija li tirriżulta minn dijuresi eċċessiva.
English: Abdominal pain, constipation,dyspepsia, vomiting, gastritis
Maltese: Anemija aplastika, anemija emolitika, insuffiċjenza filfunzjoni tal-mudullun, lewkopenija, newtropenija, agranuloċitosi
English: Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin converting enzyme inhibitors.
Maltese: Żidiet riversibbli fil-konċentrazzjonijiet ta' lithium fis-serum u t-tossiċità kienu rrappurtati bl-għoti flimkien ta' lithium ma' inibituri tal-enzimi li jibdlu l-angiotensin.
English: Adverse reactions known to occur with each component given singly but which have not been seen in clinical trials may occur during treatment with Tolucombi.
Maltese: Reazzjonijiet avversi li huma magħrufa li jseħħu meta kull komponent jingħata waħdu, iżda li ma kinux osservati fil-provi kliniċi, jistgħu jseħħu matul ilkura b'Tolucombi.
English: Other medicines and Tolucombi
Maltese: Kif taħżen Tolucombi
English: Hepatic function abnormal / liver disorder
Maltese: Funzjoni epatika anormali/disturb fil-fwied
English: BLISTER
Maltese: SIBT
English: White to almost white or pinkish white on one side and pink marbled on the opposite side of two-layer biconvex oval tablet, tablet dimensions 15 mm x 7 mm.
Maltese: Bojod għal kważi bojod jew bojod fir-roża fuq naħa waħda u roża irħamata fuq in-naħa opposta ta' pillola fuq żewġ saffi ovali mżaqqa, bid-dimensjonijiet tal-pillola 15 mm x 7 mm.
English: - Anti-cholinergic medicines (medicines used to treat a variety of disorders such as gastrointestinal cramps, urinary bladder spasm, asthma, motion sickness, muscular spasms, Parkinson's disease and as an aid to anaesthesia) such as atropine and biperiden.
Maltese: - Supplimenti tal-calcium u/jew supplimenti ta' vitamina D. - Mediċini antikolinerġiċi (mediċini użati biex jikkuraw varjetà ta' disturbi bħal bugħawwieġ gastrointestinali, spażmu tal-bużżieqa tal-awrina, ażżma, dardir waqt il-moviment/ivvjaġġar, spażmi muskolari, il-marda tal-Parkinson u bħala għajnuna meta tingħata l-anestesija) bħal atropine u biperiden.
English: Presumably through blockade of the renin-angiotensin-aldosterone system, co-administration of telmisartan tends to reverse the potassium loss associated with these diuretics.
Maltese: Hu maħsub li permezz ta' imblokk tas-sistema renin-angiotensin-aldosterone, l-għoti ta' telmisartan fl-istess waqt għandu tendenza li jreġġa' lura t-telf tal-potassium assoċjat ma' dawn id-dijuretiċi.
English: Psychiatric disorders Uncommon: Anxiety Rare:
Maltese: Infezzjonijiet u infestazzjonijiet Mhux komuni: Rari:
English: SUN
Maltese: Deni
English: Anticholinergic agents (e.g. atropine, biperiden) may increase the bioavailability of thiazide-type diuretics by decreasing gastrointestinal motility and stomach emptying rate.
Maltese: Mediċini anti-kolinerġiċi (eż. atropine u biperiden) jistgħu jżidu l-bijodisponibilità ta' dijuretiċi tat-tip thiazide billi jnaqqsu moviment spontanju gastrointestinali u r-rata tat-tbattil tal-istonku.
English: - Medicines that are affected by changes of the blood potassium level such as heart medicines (e.g. digoxin) or medicines to control the rhythm of your heart (e.g. quinidine, disopyramide, amiodarone, sotalol), medicines used for mental disorders (e.g. thioridazine, chlorpromazine, levomepromazine) and other medicines such as certain antibiotics (e.g. sparfloxacine, pentamidine) or certain medicines to treat allergic reactions (e.g. terfenadine).
Maltese: - Mediċini li huma affettwati minn tibdil tal-livell tal-potassium fid-demm bħal mediċini tal-qalb (eż. digoxin) jew mediċini biex jikkontrollaw ir-ritmu tal-qalb tiegħek (eż. quinidine, disopyramide, amiodarone, sotalol), mediċini użati għal disturbi mentali (eż. thioridazine, chlorpromazine, levomepromazine) u mediċini oħrajn bħal ċerti antibijotiċi (eż. sparfloxacine, pentamidine) jew ċerti mediċini għall-kura ta' reazzjonijiet allerġiċi (eż. terfenadine).
English: Experience with Tolucombi is modest in the patients with mild to moderate renal impairment, therefore periodic monitoring of potassium, creatinine and uric acid serum levels is recommended.
Maltese: L-esperjenza b'Tolucombi hi modesta f'dawk il-pazjenti b'indeboliment renali minn ħafif sa moderat, u għalhekk, monitoraġġ pejodiku tal-livelli tal-potassium, tal-kreatinina u tal-uric acid serum hu rakkomandat.
English: Eczema, drug eruption, toxic skin eruption
Maltese: Ekżema, eruzzjoni minħabba l-mediċina, eruzzjoni tossika talġilda
English: - Telmisartan belongs to a group of medicines called angiotensin II receptor antagonists.
Maltese: TWISSIJA SPEĊJALI LI L-PRODOTT MEDIĊINALI GĦANDU JINŻAMM
English: Potassium-sparing diuretics, potassium supplements or potassium-containing salt substitutes should be co-administered cautiously with Tolucombi (see section 4.5).
Maltese: Dijuretiċi potassium-sparing, supplimenti tal-potassium jew sostituti tal-potassium li fihom il-melħ, għandhom jingħataw blattenzjoni flimkien ma' Tolucombi (ara sezzjoni 4.5).
English: Interstitial lung disease
Maltese: Disturbi fis-sistema endokrinarja
English: Ref.: EMEA/CHMP/746208/2009
Maltese: EMEA/CHMP/78791/2010
English: London, 19 November 2009 Doc.
Maltese: Londra, 19 ta' Novembru 2009 Dok. ta' Ref:.
English: International non-proprietary name (INN): bevacizumab
Maltese: Isem internazzjonali komuni (INN): bevacizumab
English: The active substance in Avastin, bevacizumab, is a monoclonal antibody.
Maltese: Is-sustanza attiva f'Avastin, bevacizumab, hija antikorp monoklonali.
English: On 19 November 2009, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of a change to the marketing authorisation for the medicinal product Avastin.
Maltese: Fid-19 ta' Novembru 2009, il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) adotta opinjoni negattiva, fejn irrakkomanda r-rifjut ta' modifika fl-awtorizzazzjoni għat-tqegħid fissuq għall-prodott mediċinali Avastin.
English: The company that applied for the change to the authorisation is Roche Registration Limited.
Maltese: Il-kumpanija li applikat għat-tibdil fl-awtorizzazzjoni hija Roche Registration Limited.
English: A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen) that is found in the body.
Maltese: Antikorp monoklonali huwa antikorp (tip ta' proteina) li huwa mfassal biex jagħraf u jeħel ma' struttura speċifika (magħrufa bħala antiġene) li tinstab fil-ġisem.
English: It may request a re-examination of the opinion within 15 days of receipt of notification of this negative opinion.
Maltese: Din tista' titlob eżami mill-ġdid tal-opinjoni fi żmien 15-il jum minn meta tkun irċiviet in-notifika ta' din l-opinjoni negattiva.
English: There were two main measures of effectiveness: the number of patients whose tumours had responded to treatment ; and ‘progressionfree survival' (the number of patients who were still alive and whose disease had not got worse) after six months of treatment.
Maltese: Hemm żewġ modi ta' kejl ta' effikaċja: in-numru ta' pazjenti li t-tumuri tagħhom irrispondew għat-trattament; u kellhom 'sopravivenza mingħajr progressjoni' (in-numru ta' pazjenti li għadhom ħajjin u li l-marda ma marritx għall-agħar) wara sitt xhur mit-trattament.
English: Avastin has been authorised since January 2005.
Maltese: Avastin ġie awtorizzat minn Jannar 2005.
English: Bevacizumab has been designed to attach to vascular endothelial growth factor (VEGF), a protein that circulates in the blood and makes blood vessels grow.
Maltese: Bevacizumab inħoloq biex jeħel mal-fattur tat-tkabbir tal-endotelju vaskulari (vascular endothelial growth factor, VEGF), proteina li tiċċirkola fid-demm u tkabbar larterji u l-vini.
English: What is happening with Avastin for the treatment of colorectal, breast, lung and kidney cancer?
Maltese: X'qed jiġri b'Avastin għat-trattament tal-kanċer kolorektali, tas-sider, tal-pulmun u tal-kliewi?
English: Avastin was to be used in on its own or in combination with irinotecan (another anticancer medicine).
Maltese: Avastin kellu jintuża waħdu jew f'kumbinazzjoni ma' irinotecan (mediċina oħra kontra l-kanċer).
English: What was Avastin expected to be used for?
Maltese: Għal xiex kien mistenni li jintuża Avastin?
English: Therefore, at that point in time, the CHMP was of the opinion that the balance of benefits and risks of Avastin in the treatment of glioblastoma after relapse could not be established.
Maltese: Għalhekk, f'dan il-waqt, is-CHMP kienet tal-opinjoni li l-bilanċ bejn il-benefiċċji u r-riskji ta' Avastin fit-trattament tal-glioblastoma wara rikaduta ma jistax jiġi stabbilit.
English: The company presented the results of one main study involving 167 patients with glioblastoma that had come back after one or two previous courses of treatment.
Maltese: Il-kumpanija ppreżentat ir-riżultati tal-istudju prinċipali tagħha li jinvolvi 167 pazjent bil-glioblastoma li ġie lura wara kors jew tnejn ta' trattament preċedenti.
English: It is already used in combination with other medicines to treat cancer of the colon or rectum (large intestine), breast cancer, non-small cell lung cancer and kidney cancer.
Maltese: Diġa' jintuża f'kumbinazzjoni ma' mediċini oħrajn sabiex jittratta l-kanċer tal-kolon jew tar-rektum (musrana l-kbira), kanċer tas-sider, kanċer tal-pulmun mhux b'ċelloli żgħar u kanċer tal-kliewi.
English: Avastin is a concentrate that is made up into a solution for infusion (drip into a vein).
Maltese: Avastin huwa konċentrat li jitħallat biex isir soluzzjoni għall-infużjoni (dripp fil-vina).
English: It contains the active substance bevacizumab.
Maltese: Huwa fih issustanza attiva bevacizumab.
English: There are no consequences on the use of Avastin in its authorised indications, for which the balance of benefits and risks remains unchanged.
Maltese: Ma hemm l-ebda konsegwenza fuq l-użu ta' Avastin fl-indikazzjoni awtorizzata, fejn il-bilanċ bejn il benefiċċji u r-riskji jibqa' invarjat.
English: Questions and answers on the recommendation for the refusal of a change to the marketing authorisation for Avastin
Maltese: Mistoqsija u tweġiba dwar l-irtirar tal-applikazzjoni għal modifika fl-awtorizzazzjoni għat-tqegħid fis-suq għal Avastin
English: The change concerned an extension of indication to add the treatment of glioblastoma after relapse.
Maltese: It-tibdil jikkonċerna estensjoni tal-indikazzjoni ta' żjieda tattrattament tal-glioblastoma wara r-rikaduta.
English: In glioblastoma, Avastin is expected to work in the same way as it does in its existing indications.
Maltese: F'glioblastoma, Avastin huwa mistenni li jaħdem bl-istess mod meta jkun hemm l-indikazzjonijiet eżistenti.
English: The full EPAR for Lixiana 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: Lixiana edoxaban
Maltese: -moħħ tnaqqset meta mqabbel ma
English: The usual dose is 60 mg once a day.
Maltese: Id-doża normali hija 60 mg darba kuljum.
English: This is a summary of the European public assessment report (EPAR) for Lixiana.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Lixiana.
English: When another recommended definition of the type of stroke was used, embolism or stroke due to blood clots was seen in 143 patients given Lixiana (0.9%) and 157 given warfarin (1%).
Maltese: Meta ntużat definizzjoni rrakkomandata oħra tat-tip ta' puplesija, kien osservat emoboliżmu jew puplesija minħabba emboli tad-demm f'143 pazjent li ngħataw Lixiana (0.9%) u 157 li ngħataw warfarin (1%).
English: The active substance in Lixiana, edoxaban, is a ‘factor Xa inhibitor'.
Maltese: Is-sustanza attiva f'Lixiana, l-edoksaban, hija ‘inibitur tal-fattur Xa'.
English: This means that it blocks factor Xa, an enzyme that is involved in the production of thrombin.
Maltese: Dan ifisser li din timblokka l-fattur Xa, enzima involuta fil-produzzjoni tat-trombina.
English: Lixiana contains the active substance edoxaban.
Maltese: Lixiana fih is-sustanza attiva edoksaban.
English: What are the risks associated with Lixiana?
Maltese: X'inhuma r-riskji assoċjati ma' Lixiana?
English: Lixiana is available as tablets (15, 30 and 60 mg) and can only be obtained with a prescription.
Maltese: Lixiana jiġi f'pilloli (15, 30 u 60 mg) u jista' jinkiseb biss b'riċetta ta' tabib.
English: Lixiana is an anticoagulant medicine (a medicine that prevents blood clotting) used in adults:
Maltese: Lixiana huwa mediċina antikoagulanti (mediċina li tipprevjeni t-tagħqid tad-demm) li jintuża fl-adulti:
English: Lixiana has been shown to be as effective as the standard anticoagulant warfarin in preventing stroke and systemic embolism in patients with atrial fibrillation.
Maltese: Lixiana ntwera li huwa effikaċi daqs l-antikoagulant standard warfarin biex jipprevjeni puplesija u emboliżmu sistemiku f'pazjenti b'fibrillazzjoni atrijali.
English: A first systemic embolism or stroke occurred in 182 patients given standard doses of Lixiana and in 232 of those given warfarin, corresponding to annual rates for these events of around 1.2% and 1.5% respectively.
Maltese: L-ewwel emboliżmu sistemiku jew puplesija seħħet f'182 pazjent li ngħataw dożi standard ta' Lixiana u f'232 ta' dawk li ngħataw warfarin, li jikkorrispondu għal rati annwali għal dawn l-avveniment ta' madwar 1.2% u 1.5% rispettivament.
English: Further episodes were seen in 130 of 4,118 patients given edoxaban (3.2%) and in 146 of 4,122 given warfarin (3.5%).
Maltese: '146 minn 4,122 li ngħataw warfarina (3.5% ).
English: Why is Lixiana approved?
Maltese: Għaliex ġie approvat Lixiana?
English: In the treatment and prevention of blood clots in patients with DVT or pulmonary embolism, Lixiana was also found to be as effective as warfarin, in a study involving over 8,200 patients.
Maltese: Fil-kura u l-prevenzjoni tal-emboli tad-demm f'pazjenti b'DVT jew emboliżmu pulmonari, Lixiana nstab ukoll li huwa effikaċi daqs warfarin, fi studju li involva aktar minn 8,200 pazjent.
English: Other common side effects are anaemia (low levels of red blood cells), rash, itching, headache, dizziness, belly pain and abnormal results in tests of liver function.
Maltese: ' tkun severa jew saħ anemija (livelli baxxi ta mor tad-demm), raxx, ħakk, uġigħ ta' ras, sturdament, uġigħ ta' żaqq u riżultati anomali fit-testijiet tal-funzjoni tal-fwied.
English: There was a trend for better results in patients with reduced kidney function than those whose kidney function was normal.
Maltese: -funzjoni tal-kliewi minn ħal riżultati a dawk li l-funzjoni tal-kliewi tagħhom kienet normali.
English: The effects were studied in one main study, which involved over 21,000 patients for an average of 2.5 years.
Maltese: L-effetti ġew studjati fi studju wieħed ewlieni, li involva aktar minn 21,000 pazjent għal medja ta' sentejn u nofs.