FrancophonIA/ELRC3.0 huggingface dataset:
English: The composite endpoint of all-cause mortality or first CHF hospitalisation was also significantly reduced with candesartan, HR 0.80 (95%CI: 0.70 to 0.92, p=0.001).
Maltese: Il-punt aħħari mlaqqa' ta' mortalità min kull kawża jew l-ewwel dħul l-isptar minħabba CHF ukoll tnaqqas b'mod sinifikanti b'candesartan, HR 0.80 (95%CI: 0.70 sa 0.92, p=0.001).
English: The estimated absolute bioavailability of the tablet is therefore 14%.
Maltese: Il-bijodisponibbiltà assoluta stmata għall-pillola għalhekk hija ta' 14%.
English: These changes were considered to be caused by the pharmacological action of candesartan.
Maltese: Dawn it-tibdiliet kienu kkunsidrati li ġew ikkawżati mill-azzjoni farmakoloġika ta' candesartan.
English: The CHMP considered that the available clinical data support a dose of candesartan up to 32 mg for the treatment of hypertension.
Maltese: Is-CHMP ikkunsidra li d-dejta klinika disponibbli tappoġġja doża ta' candesartan sa 32 mg għall-kura tal-pressjoni għolja.
English: AstraZeneca AB, Strängnäsvägen 44, S-151 85 Södertälje, Sweden
Maltese: AstraZeneca AB, Strängnäsvägen 44, S-151 85
English: In a pooled analysis of clinical trial data of hypertensive patients, adverse reactions with candesartan cilexetil were defined based on an incidence of adverse events with candesartan cilexetil at least 1% higher than the incidence seen with placebo.
Maltese: F'analiżi pooled ta' dejta minn provi kliniċi fuq pazjenti bi pressjoni għolja, reazzjonijiet avversi b'candesartan cilexetil kienu mfissra fuq bażi ta' inċidenza ta' każijiet avversi mill-anqas 1% ogħla mill-inċidenza li dehret bi plaċebo.
English: Data from in vitro and in vivo mutagenicity testing indicates that candesartan will not exert mutagenic or clastogenic activities under conditions of clinical use.
Maltese: Dejta minn ittestjar in vitro u in vivo għal mutazzjoni fil-ġeni tindika li candesartan ma jagħmilx użu minn attivitajiet mutaġeniċi jew klastoġeniċi fil-kundizzjonijiet tal-użu kliniku.
English: Blopress 16 mg comprimidos
Maltese: Blopress 16 mg comprimidos 16 mg
English: In controlled clinical studies adverse reactions were mild and transient.
Maltese: Fi studji kliniċi kkontrollati reazzjonijiet avversi kienu ħfief u temporanji.
English: In patients whose vascular tone and renal function depend predominantly on the activity of the reninangiotensin-aldosterone system (e.g. patients with severe congestive heart failure or underlying renal disease, including renal artery stenosis), treatment with other medicinal products that affect this system has been associated with acute hypotension, azotaemia, oliguria or, rarely, acute renal failure.
Maltese: F'pazjenti li t-ton vaskulari u l-funzjoni tal-kliewi tagħhom jiddependu l-aktar mill-attività tas-sistema ta' renin-angiotensin-aldosterone (eż. pazjenti b'insuffiċjenza konġestiva tal-qalb qawwija jew meta diġà jkun hemm mard tal-kliewi li jinkludi stenożi tal-arterja renali), il-kura bi prodotti mediċinali oħra li jaffettwaw din is-sistema kienu assoċjati ma' pressjoni baxxa akuta, ażotemija, oligurja jew, b'mod rari, indeboliment akut tal-kliewi.
English: In CHARM-Preserved, no statistically significant reduction was achieved in the composite endpoint of cardiovascular mortality or first CHF hospitalisation, HR 0.89 (95%CI: 0.77 to 1.03, p=0.118).
Maltese: F'CHARM-Preserved, ma nkiseb l-ebda tnaqqis sinifikanti b'mod statistiku mill-punt aħħari mlaqqa' għall-mortalità minn kawżi kardjovaskulari jew l-ewwel dħul l-isptar minħabba CHF, HR 0.89 (95%CI: 0.77 sa 1.03, p=0.118).
English: The CHMP thus considered that although candesartan can be administered with other heart failure treatment (including ACE inhibitors, beta-blockers, diuretics and digitalis or a combination thereof), the association of an ACE inhibitor, a potassium-sparing diuretic and candesartan is not recommended.
Maltese: Is-CHMP ikkunsidra għalhekk li għalkemm candesartan jista' jingħata ma' trattament ieħor għall-kollass tal-qalb (inklużi inibituri ACE, imblukkaturi-beta, dijuretiċi u diġitalis jew kombinazzjoni tagħhom), l-assoċjazzjoni ta' inibitur ACE, dijuretiku ta' potassium sparing u candesartan mhijiex irrakkomandata.
English: Atacand can be administered with other heart failure treatment, including ACE inhibitors, beta-blockers, diuretics and digitalis or a combination of these medicinal products.
Maltese: Atacand jista' jingħata flimkien ma' kuri oħra għal insuffiċjenza tal-qalb, li jinkludu impedituri ta' ACE, imblokkaturi tar-riċetturi beta, dijuetiċi, u digitalis jew taħlita ta' dawn il-prodotti mediċinali.
English: Renal artery stenosis
Maltese: Stenożi tal-arterja tal-kilwa
English: Atacand 32 mg comprimidos
Maltese: Atacand 32 mg comprimidos 32 mg
English: The mean peak serum concentration (Cmax) is reached 3-4 hours following tablet intake.
Maltese: Il-medja tal-ogħla konċentrazzjoni fis-serum (Cmax) tintlaħaq bejn 3-4 sigħat wara li tittieħed il-pillola.
English: • if you are allergic (hypersensitive) to candesartan cilexetil or any of the other ingredients of Atacand (see section 6).
Maltese: • Jekk inti allerġiku (tbati minn sensittivita' eċċessiva) għall-candesartan cilexetil jew sustanzi oħra ta' Atacand (ara sezzjoni 6).
English: Atacand contains lactose.
Maltese: Atacand fih il-lactose.
English: Following an oral dose of
Maltese: Meta tuża mediċini oħra
English: Based on the above the CHMP considers the benefit/risk ratio of Atacand to be favourable and the harmonised PI to be approvable.
Maltese: Fuq il-bażi ta' dan ta' fuq, is-CHMP jikkunsidra l-propozjon benefiċċju/riskju ta' Actand bħala favorevoli u l-PI armonizzat bħala approvabbli.
English: Furthermore, candesartan induced hyperplasia/hypertrophy of the juxtaglomerular cells.
Maltese: Barra dan, candesartan induċa iperplasja/ipertrofija taċ-ċelluli jukstaglomerulari.
English: • if you are more than 3 months pregnant (it is also better to avoid Atacand in early pregnancysee pregnancy section).
Maltese: • Jekk għandek aktar minn 3 xuhur tqala (huwa aħjar illi tevita tieħu Atacand fil-bidu ta' tqala (ara s-sezzjoni fuq tqala)
English: Results from the CHARM programme showed clear benefits with regard to cardiovascular (CV) mortality and morbidity for patients with heart failure on candesartan and concomitant medication.
Maltese: Riżultati mill-programm CHARM urew benefiċċji ċari fir-rigward tal-mortalità u l-morbidità kardjovaskulari (CV) għal pazjenti b'kollass tal-qalb fuq candesartan u medikazzjoni konkomitanti.
English: Greece
Maltese: Maroussi Greece
English: The renal elimination of candesartan is both by glomerular filtration and active tubular secretion.
Maltese: It-tneħħija ta' candesartan mill-kilwa ssir kemm permezz ta' filtrazzjoni glomerulari kif ukoll b'sekrezzjoni tubulari attiva.
English: Important information about some of the ingredients of Atacand Atacand contains lactose which is a type of sugar.
Maltese: Informazzjoni importanti fuq xi sustanzi mhux attivi ta' Atacand Atacand fiħ lactose li huwa tip ta' zokkor.
English: The CHMP considered that the safety information in hypertension and chronic heart failure (CHF) should be presented separately.
Maltese: Is-CHMP ikkunsidra li l-informazzjoni dwar is-sigurtà għal pressjoni għolja u kollass tal-qalb kroniku (CHF) għandha tkun ippreżentata b'mod separat.
English: Of candesartan patients 36.6% (95%CI: 33.7 to 39.7) and of placebo patients 42.7% (95%CI: 39.6 to 45.8) experienced this endpoint, absolute difference 6.0% (95%CI: 10.3 to 1.8).
Maltese: 39.6 sa 45.8) esperjenzaw dan il-punt aħħari, differenza assoluta ta' 6.0% (95%CI: 10.3 sa 1.8).
English: Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded.
Maltese: Evidenza epidemjoloġika rigward riskju ta' teratoġenita wara esponiment għall- impedituri ACE waqt l-ewwel trimestru tat-tqala ma kienx konklussiv; madanakollu żieda żgħira fir-riskju ma tistax tiġi eskluża.
English: Blopress 32 mg comprimidos
Maltese: Blopress 32 mg comprimidos 32 mg
English: Of candesartan patients 33.0% (95%CI: 30.1 to 36.0) and of placebo patients 40.0% (95%CI: 37.0 to 43.1) experienced this endpoint, absolute difference 7.0% (95%CI: 11.2 to 2.8).
Maltese: 37.0 sa 43.1) esperjenzaw dan il-punt aħħari, differenza assoluta ta' 7.0% (95%CI: 11.2 sa 2.8).
English: Aortic and mitral valve stenosis (obstructive hypertrophic cardiomyopathy) As with other vasodilators, special caution is indicated in patients suffering from haemodynamically relevant aortic or mitral valve stenosis, or obstructive hypertrophic cardiomyopathy.
Maltese: Stenożi tal-valv tal-aorta u dak mitrali (kardjomijopatija ipertrofika ostruttiva)
English: Based on available data, including results from the CHARM study programme (Candesartan in Heart Failure: Assessment of Reduction in Mortality and morbidity) which included patients in NYHA functional class II to IV, the Committee noted there is no reason to exclude NYHA class IV patients.
Maltese: Stima ta' Tnaqqis filMortalità u morbidità) li nkludiet pazjenti f'NYHA funzjonali klassi II sa IV, il-Kumitat innota li ma kienx hemm raġuni għalxiex jiġu esklużi pazjenti tal-NYHA klassi IV.
English: In two studies, both including patients with mild to moderate hepatic impairment, there was an increase in the mean AUC of candesartan of approximately 20% in one study and 80% in the other study (see section 4.2).
Maltese: F' żewġ studji, li t-tnejn jinkludu pazjenti b'indeboliment minn ħafif sa moderat tal- fwied, kien hemm żieda fil-medja tal-AUC ta' candesartan ta' bejn wieħed u ieħor 20% fi studju wieħed u 80% fl-istudju l-ieħor (ara sezzjoni 4.2).
English: • Do not use Atacand after the expiry date which is stated on the carton, blister pack or bottle.
Maltese: • Tużax Atacand wara d-data ta' skadenza li tidher fuq il-kartuna, folja jew flixkun.
English: Very rare Dizziness, headache
Maltese: Rari ħafna Iperkalimja, iponatrimija
English: According to a meta-analysis, the average additional effect of a dose increase from 16 mg to 32 mg once daily was small.
Maltese: Skont meta-analiżi, l-effett addizzjonali medju ta' żieda fid-doża minn 16-il mg għal 32 mg darba kuljum kien żgħir.
English: Common Hyperkalaemia
Maltese: GĦAMLA KWALITTATIVA
English: EXPIRY DATE
Maltese: Id-data ta'
English: Patients with intravascular volume depletion
Maltese: Klassi tas-Sistemi u tal-Organi Frekwenza Effetti Mhux Mixtieqa Infezzjonijiet u infestazzjonijiet
English: Patients with primary hyperaldosteronism will not generally respond to antihypertensive medicinal products acting through inhibition of the renin-angiotensin-aldosterone system.
Maltese: Pazjenti b'iperaldosteroniżmu primarju ġeneralment ma jirrispondux għal prodotti mediċinali kontra lpressjoni għolja li jaħdmu permezz ta' impediment fuq is-sistema tar-renin-angiotensin-aldosterone.
English: • treating high blood pressure (hypertension) in adult patients.
Maltese: • Kura ta' pressjoni għolja fid-demm (pressjoni) f' pazjenti adulti
English: • When you are prescribed Atacand, discuss with your doctor before drinking alcohol.
Maltese: • Meta tiġi preskritt Atacand tkellem mat-tabib tiegħek qabel tixrob l-alkoħol.
English: Treatment of adult patients with heart failure and impaired left ventricular systolic function (left ventricular ejection fraction ≤ 40%) as add-on therapy to ACE inhibitors or when ACE inhibitors are not tolerated.
Maltese: Kura ta' pazjenti adulti b'kollass tal-qalb u funzjoni sistolika indebolita tal-ventrikola tax-xellug (frazzjoni ta' tfigħ ventrikolari tax-xellug ≤ 40%) bħala terapija miżjuda għal inibituri ACE jew meta l-inibituri ACE ma jkunux ittollerati.
English: The usual recommended initial dose of Atacand is 4 mg once daily.
Maltese: Id-doża inizjali rrakkmandata normalment ta' Atacand hija ta' 4 mg darba kuljum.
English: Hypertension indication
Maltese: Immaniġġar
English: • The usual dose of Atacand is 8 mg once a day.
Maltese: • Id-doża normali ta' Atacand hija ta' 8 mg darba kuljum.
English: Of candesartan patients 37.9% (95%CI: 35.2 to 40.6) and of placebo patients 42.3% (95%CI: 39.6 to 45.1) experienced this endpoint, absolute difference 4.4% (95%CI: 8.2 to 0.6).
Maltese: 39.6 sa 45.1) esperjenzaw dan il-punt aħħari, differenza assoluta ta' 4.4% (95%CI: 8.2 sa 0.6).
English: Both the mortality and morbidity (CHF hospitalisation) components of these composite endpoints contributed to the favourable effects of candesartan.
Maltese: Kemm il-komponenti ta' mortalità kif ukoll ta' morbidità (dħul l-isptar minnħabba CHF) ta' dawn il-punti aħħarin mlaqqgħin ikkontribwixxew għall-effetti favorevoli ta' candesartan.
English: Treatment of essential hypertension in adults.
Maltese: Kura ta' pressjoni għolja fl-adulti.
English: • Potassium supplements or salt substitutes containing potassium (medicines that increase the amount of potassium in your blood).
Maltese: • Supplimenti ta' potassju jew sostituti tal-melħ li fihom l-potassju (mediċii li jżidu l-ammont ta' potassju fid-demm)
English: The hypertension indication was approved in all member states (MSs).
Maltese: L-indikazzjoni ta' pressjoni għolja ġiet approvata fl-Istati Membri kollha (SM).
English: AstraZeneca AB, S-151 85 Södertälje, Gärtunavägen, Sweden
Maltese: S-151 85, Södertälje Gärtunavägen Sweden
English: Very rare Renal impairment, including renal failure in susceptible patients (see section 4.4)
Maltese: Rari ħafna Indeboliment tal-kliewi, li jinkludi insuffiċjenza tal-kliewi f'pazjenti suxxettibbli (ara sezzjoni 4.4)
English: inhibitors such as enalapril, captopril, lisinopril or ramipril.
Maltese: • Mediċini oħra li jgħinu sabiex titbaxxa l-pressjoni, bħal beta-blokers, diazoxide u impedituri ACE bħal enealapril, captopril, lisinopril jew ramipril
English: Following oral administration, candesartan cilexetil is converted to the active substance candesartan.
Maltese: Sensittività eċċessiva għal candesartan cilexetil jew għal xi sustanzi mhux attivi.
English: Section 4.2 Posology and method of administration
Maltese: Sezzjoni 4.6 Tqala u Treddigħ
English: These events were more common in patients over 70 years of age, diabetics, or subjects who received other medicinal products which affect the renin-angiotensin-aldosterone system, in particular an ACE inhibitor and/or spironolactone.
Maltese: Dawn l-avvenimenti kienu aktar komuni f' pazjenti ta' l-fuq minn 70 sena, dijabetiċi, jew nies li rċievew prodotti mediċinali oħra li jaffetwaw is-sistema ta' renin-angiotensin-aldosterone, partikularment impeditur ACE u/jew spironolactone.
English: In this leaflet:
Maltese: L-indikazzjonijiet mifthema kienu:
English: celecoxib or etoricoxib (medicines to relieve pain and inflammation).
Maltese: Meta tieħu Aacand ma l-ikel u x-xorb (partikularment alkoħol)
English: As with ACE inhibitors, concomitant use of AIIRAs and NSAIDs may lead to an increased risk of worsening of renal function, including possible acute renal failure, and an increase in serum potassium, especially in patients with poor pre-existing renal function.
Maltese: Bħal ma jiġri b'impedituri ta' ACE, l-użu konkomitanti ta' AIIRAs u NSAIDs jista' jwassal għal żieda fir-riskju li l-funzjoni tal-kliewi tmur għall-agħar, inkluż il-possibbiltà ta' insuffiċjenza akuta tal kliewi, u żieda fil-potassju fis-serum, speċjalment f'pazjenti li diġà jkollhom funzjoni tal-kliewidgħajfa.
English: Evaluation of patients with heart failure should include periodic assessments of renal function, especially in elderly patients 75 years or older, and patients with impaired renal function.
Maltese: L-evalwazzjoni ta' pazjenti b'indeboliment tal-qalb għandha tinkludi stimi tal-funzjoni tal-kliewi f'perjodi regolari, speċjalment f'pazjenti anzjani li għandhom 75 sena jew aktar, u f'pazjenti b'indeboliment fil-funzjoni tal-kliewi.
English: There was no evidence of abnormal systemic or target organ toxicity at clinically relevant doses.
Maltese: Ma kien hemm l-ebda evidenza ta' tossiċità sistemika mhux normali jew tal-organi fil-mira b'dożi rilevanti b'mod kliniku.
English: Periodic monitoring of serum creatinine and potassium is recommended (see section 4.4).
Maltese: Monitoraġg f'intervalli perjodiċi tal-krejatinina u l-potassju fis-serum huwa rrakomandat (ara sezzjoni 4.4).
English: Regarding concomitant therapy, according to the ESC heart failure guidelines (ESC HF, 2008), the current standard of care in patients is an adequate dose of a beta-blocker and an ACE inhibitor.
Maltese: Fir-rigward ta' terapija konkomitanti, skont il-linji gwida tal-ESC dwar il-kollass tal-qalb (ESC HF, 2008), l-istandard attwali tal-kura fil-pazjenti hija doża adegwata ta' imblokkatur-beta u inibitur ACE.
English: Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with ACE inhibitors.
Maltese: Żidiet riversibbli fil-konċentrazzjonijiet ta' lithium fis-serum u fit-tossiċità kienu rrappurtati waqt għoti konkomitanti ta' lithium u impedituri ta' ACE.
English: It is rapidly converted to the active substance, candesartan, by ester hydrolysis during absorption from the gastrointestinal tract.
Maltese: Huwa jinbidel malajr fis-sustanza attiva, candesartan, permezz ta' idrolisi tal-ester waqt assorbiment mill-passaġġ gastrointestinali.
English: The CHMP thus endorsed the wording “Essential hypertension”.
Maltese: Is-CHMP għalhekk approva l-kliem “Pressjoni għolja essenzjali”.
English: When candesartan cilexetil is used together with hydrochlorothiazide, the reduction in blood pressure is additive.
Maltese: Meta candesartan cilexetil jintuża flimkien ma' hydrochlorothiazide, it-tnaqqis fil-pressjoni jkun addittiv.
English: In conclusion, based on the assessment of the MAH proposal and responses, and following the discussions of the committee, the CHMP adopted harmonised sets of PI documents for Atacand and associated names.
Maltese: F'konklużjoni, fuq il-bażi tal-istima tal-proposta u t-tweġibiet tal-MAH, u wara d-diskussjonijiet talkumitat, is-CHMP adotta settijiet armonizzati ta' dokumenti PI għal Atacand u l-ismijiet assoċjati.
English: By this definition, the most commonly reported adverse reactions were dizziness/vertigo, headache and respiratory infection.
Maltese: Permezz ta' din id-definizzjoni, l-aktar reazzjonijijet avversi rrappurtati b'mod komuni kienu sturdament/vertiġini, uġigħ ta' ras u infezzjoni fl-apparat tan-nifs.
English: This summary was last updated in 10-2016
Maltese: Dan is-sommarju ġie aġġornat l-aħħar fi: 10-2016.
English: Cystadane contains the active substance betaine anhydrous.
Maltese: Cystadane fih is-sustanza attiva betaine anhydrous.
English: The full EPAR for Cystadane 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: Cystadane is supplied with 3 measuring spoons to measure 100 mg, 150 mg and 1 g of the powder.
Maltese: Cystadane jiġi bi 3 imgħaref tal-kejl biex jitkejlu 100 mg, 150 mg u 1 g tat-trab.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Cystadane can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Maltese: Is-sommarju tal-opinjoni tal-Kumitat għall-Prodotti Mediċinali Orfni għal Cystadane jinstab fis-sit elettroniku tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: Other information about Cystadane
Maltese: Informazzjoni oħra dwar Cystadane
English: This is a summary of the European public assessment report (EPAR) for Cystadane.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Cystadane.
English: This included 202 reports that described the effects of Cystadane, given at a variety of doses, on homocysteine levels in homocystinuria patients of various ages.
Maltese: Din kienet tinkludi 202 rapporti li ddeskrivew l-effetti ta' Cystadane, mogħti f'diversi dożi, fuq il-livelli ta' homocysteine f'pazjenti ta' diversi etajiet b'omoċistinurja.
English: In homocystinuria, betaine reduces homocysteine levels in the blood by transforming homocysteine into the amino acid methionine.
Maltese: Fl-omoċistinurja, betaine jnaqqas il-livelli ta' homocysteine fid-demm billi jittrasforma homocysteine fl-aċidu amminiku methionine.
English: It is used with other treatments, such as vitamin B6 (pyridoxine), vitamin B12 (cobalamin), folate and a special diet.
Maltese: B12 (cobalamin), il-folate u dieta speċjali.
English: Why is Cystadane approved?
Maltese: Għaliex ġie approvat Cystadane?
English: Because the number of patients with homocystinuria is low, the disease is considered ‘rare', and Cystadane was designated an ‘orphan medicine' (a medicine used in rare diseases) on 9 July 2001.
Maltese: Peress li n-numru ta' pazjenti li jbatu minn omoċistinurja huwa baxx, il-marda hija kkunsidrata ‘rari', u Cystadane ġie kklassifikat bħala ‘mediċina orfni' (mediċina li tintuża f'mard rari) fid-9 ta' Lulju 2001.
English: Cystadane betaine anhydrous
Maltese: Sommarju tal-EPAR għall-pubbliku betaine anhydrous
English: The European Commission granted a marketing authorisation valid throughout the European Union for Cystadane on 15 February 2007.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Cystadane fil-15 ta' Frar 2007.
English: The company presented information on Cystadane from the scientific literature.
Maltese: Il-kumpanija ppreżentat informazzjoni dwar Cystadane mid-dokumentazzjoni xjentifika.
English: Betaine is a natural substance that is extracted from sugar beet.
Maltese: Betaine huwa sustanza naturali li hija estratta mill-pitrava taz-zokkor.
English: What are the risks associated with Cystadane?
Maltese: X'inhuma r-riskji assoċjati ma' Cystadane?
English: The standard dose of Cystadane is 100 mg per kilogram of body weight a day, divided into two equal doses.
Maltese: Id-doża standard ta' Cystadane hija 100 mg għal kull kilogramma tal-piż tal-ġisem kuljum, maqsuma f'żewġ dożi ndaqs.
English: Methionine levels should be monitored in patients taking Cystadane, as it might lead to cerebral oedema (swelling in the brain).
Maltese: Il-livelli ta' methionine għandhom jiġu ssorveljati f'pazjenti li jieħdu Cystadane, peress li dan jista' jwassal għal edema ċerebrali (nefħa fil-moħħ).
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that, although there were few systematic studies of Cystadane, the medicine is useful when added to existing treatments for homocystinuria, such as vitamin supplementation and using a special diet.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-Aġenzija ddeċieda li, għalkemm hemm ftit studji sistematiċi ta' Cystadane, il-mediċina hija utli meta tiżdied mal-kuri eżistenti għal omoċistinurja, bħas-supplimentazzjoni tal-vitamina u l-użu ta' dieta speċjali.
English: Most patients were also taking vitamins B6 or B12, or folate.
Maltese: B6 jew B12, jew folate.
English: The Committee noted that Cystadane is not a substitute for other treatments.
Maltese: Il-Kumitat innota li Cystadane mhuwiex sostitut għal kuri oħrajn.
English: For 140 patients, information was also provided on their symptoms, the dose and duration of treatment, and other medicines being taken.
Maltese: Għal 140 pazjent, kienet ukoll ipprovduta informazzjoni dwar is-sintomi tagħhom, id-doża u d-dewmien tal-kura, u mediċini oħra li kienu qed jittieħdu.
English: Cystadane is a medicine used to treat homocystinuria, an inherited disease where the amino acid homocysteine cannot be broken down and therefore builds up in the body.
Maltese: Cystadane huwa mediċina użata biex tikkura l-omoċistinurja, marda li tintiret fejn l-aċidu amminiku homocysteine ma jkunx jista' jitkisser u għalhekk jakkumula fil-ġisem.
English: The Committee decided that Cystadane's benefits outweighed its risks in the adjunctive treatment of homocystinuria, when it is used according to its indication.
Maltese: Il-Kumitat iddeċieda li l-benefiċċji ta' Cystadane huma akbar mir-riskji tiegħu fil-kura aġġuntiva ta' omoċistinurja, meta jintuża skont l-indikazzjoni tiegħu.