FrancophonIA/ELRC3.0 huggingface dataset:
English: With haemodialysis, use of alternative waste nitrogen excretion pathways (sodium phenylbutyrate, sodium benzoate and sodium phenylacetate), dietary protein restriction, and, in some cases, essential amino acid supplementation, the survival rate in new-borns diagnosed after birth (but within the first month of life) increased to almost 80 % with most deaths occurring during an episode of acute hyperammonaemic encephalopathy.
Maltese: Meta tittieħed oralment, il-granijiet għandhom jitħalltu ma' ikliet solidi (bħal patata maxx jew purè tat-tuffieħ) jew ikliet likwidi (bħal ilma, meraq tat-tuffieħ, meraq tal-larinġ jew formoli għat-trabi ħielsa mill-proteina).
English: Further information on Tracleer can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: Aktar informazzjoni dwar Tracleer tinstab fis-sit web tal-Aġenzija: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Tracleer contains the active substance bosentan.
Maltese: Tracleer fih is-sustanza attiva bosentan.
English: This medicine overview was last updated in 10-2019.
Maltese: Din il-ħarsa ġenerali ġiet aġġornata l-aħħar f'10-2019.
English: It is available as film-coated tablets (62.5 mg; 125 mg) and as dispersible tablets (32 mg).
Maltese: Jiġi bħala pilloli miksijin b'rita (62.5 mg; 125 mg) u bħala pilloli li jdubu (32 mg).
English: The PAH can be:
Maltese: Il-PAH tista' tkun:
English: Other information about Tracleer
Maltese: Informazzjoni oħra dwar Tracleer
English: Tracleer received a marketing authorisation valid throughout the EU on 15 May 2002.
Maltese: Tracleer ingħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fil-15 ta' Mejju 2002.
English: The ‘class' reflects the severity of the disease: ‘class III' PAH involves marked limitation of physical activity.
Maltese: Il-“klassi” tirrifletti l-gravità tal-marda: il-PAH tal-"klassi III" tinvolvi limitazzjoni ċara ta' attività fiżika.
English: Treatment of PAH
Maltese: Il-kura tal-PAH
English: The active substance in Tracleer, bosentan, blocks a naturally occurring hormone called endothelin-1 (ET-1), which causes blood vessels to narrow.
Maltese: Is-sustanza attiva fi Tracleer, il-bosentan, timblokka ormon li jseħħ naturali msejjaħ endotelin-1 (ET1), li jikkawża tidjiq fil-vażi.
English: • primary (with no identified cause or inherited);
Maltese: • primarja (bl-ebda kawża identifikata jew li tkun intirtet);
English: Two additional studies looked at the effects of Tracleer dispersible tablets in children: the first study included 36 children with PAH aged between 2 and 11 years, while the second study included 64 children with PAH aged from 3 months up to 11 years.
Maltese: Żewġ studji addizzjonali ħarsu lejn l-effetti tal-pilloli Tracleer li jdubu fit-tfal: l-ewwel studju inkluda 36 tifel u tifla bil-PAH li l-età tagħhom kienet bejn is-sentejn u l-11-il sena, filwaqt li t-tieni studju inkluda 64 tifel u tifla bil-PAH kellhom minn tliet xhur sa 11-il sena.
English: In a study in 185 patients with class II disease the distance the patients could walk over 6 minutes was similar in the Tracleer and placebo groups.
Maltese: Fi studju f'185 pazjent b'marda tal-klassi II, id-distanza li l-pazjenti setgħu jimxu tul 6 minuti kienet simili għall-gruppi ta' Tracleer u tal-plaċebo.
English: In adults, it should be started at a dose of 62.5 mg twice a day for four weeks and then increased to the usual dose of 125 mg twice a day.
Maltese: Fl-adulti, għandu jinbeda b'doża ta' 62.5 mg darbtejn kuljum għal erba' ġimgħat, u din tiżdied għad-doża normali ta' 125 mg darbtejn kuljum.
English: Why has Tracleer been approved?
Maltese: Għaliex Tracleer ġie approvat?
English: Similar results were seen in a study in 54 adults with class III PAH that was associated with congenital heart defects.
Maltese: Riżultati simili dehru fi studju f'54 adult bil-PAH tal-klassi III li kienet assoċjata ma' difetti tal-qalb konġenitali.
English: • caused by congenital (inborn) heart defects with shunts (abnormal passageways) causing abnormal flow of blood through the heart and lungs.
Maltese: • ikkawżata minn difetti konġenitali (titwieled bihom) tal-qalb b'shunts (passaġġi anormali) li jikkawżaw fluss anormali tad-demm mill-qalb u l-pulmun.
English: • caused by scleroderma (also called systemic sclerosis, a disease where there is abnormal growth of the connective tissue that supports the skin and other organs);
Maltese: • ikkawżata minn skleroderma (imsejħa wkoll sklerożi sistemika, marda fejn ikun hemm tkabbir anormali tat-tessut konnettiv li jappoġġa l-ġilda u organi oħrajn);
English: What are the risks associated with Tracleer?
Maltese: X'inhuma r-riskji assoċjati ma' Tracleer?
English: In the larger study patients were able to walk 44 metres further.
Maltese: Fl-istudju akbar il-pazjenti setgħu jimxu 44 metru aktar.
English: This is based on two studies in a total of 245 adults with class III or IV disease that was either primary or caused by scleroderma.
Maltese: Dan huwa bbażat fuq żewġ studji f'total ta' 245 adult b'marda tal-klassi III jew IV li kienet primarja jew ikkawżata minn skleroderma.
English: Tracleer was more effective than placebo at reducing the development of new digital ulcers based on two studies in a total of 312 adults.
Maltese: Tracleer kien iktar effettiv minn plaċebo fit-tnaqqis tal-iżvilupp ta' ulċeri ġodda fuq is-swaba', ibbażat fuq żewġ studji f'total ta' 312-il adult.
English: PAH is abnormally high blood pressure in the arteries of the lungs.
Maltese: IlPAH hija pressjoni tad-demm anormalment għolja fl-arterji tal-pulmuni.
English: As for all medicines, data on the use of Tracleer are continuously monitored.
Maltese: Bħal fil-każ tal-mediċini kollha, id-data dwar l-użu ta' Tracleer hija ssorveljata kontinwament.
English: In PAH, Tracleer film-coated tablets added to patient's current therapy was more effective than placebo (a dummy treatment) in improving the distance patients could walk in 6 minutes (a way of measuring exercise capacity) after 16 weeks of treatment.
Maltese: Fil-PAH, iż-żieda ta' pilloli Tracleer miksijin b'rita fit-terapija attwali tal-pazjent kienet iktar effettiva minn plaċebo (kura finta) sabiex ittejjeb id-distanza li l-pazjenti setgħu jimxu f'6 minuti (mezz biex titkejjel il-kapaċità tal-eżerċizzju) wara 16-il ġimgħa ta' kura.
English: ‘Class II' involves slight limitation of physical activity.
Maltese: II" tinvolvi limitazzjoni ħafifa tal-attività fiżika.
English: 1 year and older, the recommended starting and maintenance dose is 2 mg per kilogram body weight twice a day.
Maltese: Fit-tfal bil-PAH fl'età ta' sena u aktar, id-doża rakkomandata tal-bidu u tal-manteniment hija ta' 2 mg għal kull kilogramm tal-piż tal-ġisem darbtejn kuljum.
English: The most common side effects with Tracleer (which may affect more than 1 in 10 people) are headache, fluid retention, anaemia (low levels of haemoglobin, the protein in red blood cells that carries oxygen around the body) and abnormal results of blood tests to check the liver.
Maltese: L-effetti sekondarji l-aktar komuni bi Tracleer (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 10) huma wġigħ ta' ras, żamma ta' fluwidi, anemija (livelli baxxi ta' emoglobina, il-proteina f'ċelloli ħomor tad-demm li ġġorr l-ossiġnu madwar il-ġisem) u riżultati anormali ta' testijiet tad-demm biex jiġi kontrollat il-fwied.
English: However, Tracleer decreased the resistance to blood flow by 23%, indicating a widening of the blood vessels, compared with placebo after 6 months of treatment.
Maltese: Madankollu, Tracleer naqqas ir-reżistenza tal-fluss taddemm bi 23 %, u dan jindika twessigħ tal-vażi, meta mqabbel mal-plaċebo wara 6 xhur ta' kura.
English: Tracleer is used to treat patients with class III pulmonary arterial hypertension (PAH) to improve exercise capacity (the ability to carry out physical activity) and reduce symptoms.
Maltese: Tracleer jintuża għall-kura ta' pazjenti b'ipertensjoni arterjali pulmonari (PAH) tal-klassi
English: The company that makes Tracleer will provide a patient alert card to remind patients of the need for regular blood tests for liver function and to use effective contraception to avoid pregnancy.
Maltese: Il-kumpanija li tipproduċi Tracleer se tipprovdi kard ta' twissija tal-pazjenti biex tfakkar lill-pazjenti dwar il-ħtieġa għal testijiet tad-demm regolari għall-funzjoni tal-fwied u biex tintuża kontraċezzjoni effettiva biex tiġi evita t-tqala.
English: Side effects reported with Tracleer are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati bi Tracleer huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: In the first study, patients taking Tracleer had an average of 1.4 new digital ulcers after 16 weeks, compared with 2.7 in the patients taking placebo.
Maltese: Fl-ewwel studju, il-pazjenti li kienu qed jieħdu Tracleer kellhom medja ta' 1.4 ulċeri ġodda fuq is-swaba' wara 16-il ġimgħa, meta mqabbla ma' 2.7 fil-pazjenti li kienu qed jieħdu plaċebo.
English: Treatment of systemic sclerosis with digital ulcers
Maltese: Kura ta' sklerożi sistemika b'ulċeri fuq is-swaba'
English: Tracleer must not be used in patients who have certain liver problems, who are pregnant or could become pregnant and who are not using reliable contraceptive methods or who are taking ciclosporin (a medicine that acts on the immune system).
Maltese: Tracleer m'għandux jintuża f'pazjenti li jkollhom ċerti problemi tal-fwied, f'nisa li jkunu tqal jew li jistgħu joħorġu tqal u li ma jkunux qed jużaw metodi ta' kontraċezzjoni affidabbli jew li qed jieħdu ciclosporin (mediċina li taħdem fuq is-sistema immunitarja).
English: Tracleer is given to reduce the number of new digital ulcers.
Maltese: Tracleer jingħata sabiex inaqqas in-numru ta' ulċeri ġodda fis-swaba'.
English: What measures are being taken to ensure the safe and effective use of Tracleer?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Tracleer?
English: Improvements were also seen in a study of 19 children aged between 3 and 15 years taking the filmcoated tablets.
Maltese: Intwera wkoll titjib fi studju ta' 19-il tifel u tifla ta' bejn it-3 snin u l-15-il sena li kienu qed jieħdu pilloli miksijin b'rita.
English: In patients with systemic sclerosis and digital ulcer disease, there is narrowing of the blood vessels of the fingers and toes leading to ulcers.
Maltese: F'pazjenti bi sklerożi sistemika u b'marda tal-ulċeri fuq is-swaba', hemm tidjieq fil-vażi tas-swaba' talidejn u tas-saqajn li jwassal għall-ulċeri.
English: Tracleer can also be used in adults with systemic sclerosis in whom poor blood circulation caused by the disease has led to the development of digital ulcers (sores on the fingers and toes).
Maltese: Tracleer jista' jintuża wkoll f'adulti bi sklerożi sistemika li fihom, iċ-ċirkolazzjoni tad-demm dgħajfa kkawżata bil-marda wasslet għall-iżvilupp ta' "ulċeri fuq is-swaba'” (feriti fuq is-swaba' tal-idejn u tassaqajn).
English: For the full list of side effects Tracleer, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji rrappurtati bi Tracleer, ara l-fuljett ta' tagħrif.
English: 14 August 2015 EMA/465403/2015
Maltese: EMA/465403/2015
English: • A study in 2013 by Brown et al. showed that 15% of the mothers were unable to use the autoinjector successfully in their children.
Maltese: • Studju fl-2013 minn Brown et al. wera li 15% tal-ommijiet ma kinux kapaċi jużaw l-awtoinjettur fuq it-tfal tagħhom b'suċċess.
English: The CHMP opinion was forwarded to the European Commission, which issued a final legally binding decision applicable in all EU Member States on 14/08/2015.
Maltese: L-opinjoni tas-CHMP intbagħtet lill-Kummissjoni Ewropea, li ħarġet deċiżjoni finali legalment vinkolanti applikabbli fl-Istati Membri tal-UE kollha fi 14/08/2015.
English: The review looked at data from several studies including:
Maltese: Ir-rieżami eżamina data minn diversi studji inklużi:
English: J Allergy Clin Immunol 101(1 Pt 1): 33-37.
Maltese: "Epinephrine absorption in children with a history of anaphylaxis." J Allergy Clin Immunol 101(1 Pt 1): 33-37.
English: J Allergy Clin Immunol 108(5): 871-873.
Maltese: "Epinephrine absorption in adults: intramuscular versus subcutaneous injection." J Allergy Clin Immunol 108(5): 871-873.
English: Contact our press officer Monika Benstetter
Maltese: Ikkuntattja l-uffiċjal tal-istampa tagħna Monika Benstetter
English: Simons, F. E., X. Gu, et al. (2001).
Maltese: Simons, F. E., X.
English: • The companies that market adrenaline auto-injectors have been asked to carry out a pharmacokinetic/pharmacodynamic study to better understand how adrenaline penetrates body tissues when given through an auto-injector.
Maltese: • Il-kumpaniji li jqiegħdu l-awtoinjetturi tal-adrenalina fis-suq intalbu jwettqu studju farmakokinetiku/farmakodinamiku biex jinftiehem aħjar kif l-adrenalina tippenetra t-tessuti talġisem meta tingħata permezz ta' awtoinjettur.
English: • Adrenaline auto-injectors are used to treat severe allergic reactions, while the patient awaits emergency medical assistance.
Maltese: • L-awtoinjetturi tal-adrenalina jintużaw fil-kura ta' reazzjonijiet allerġiċi severi, waqt li l-pazjent jistenna l-assistenza medika ta' emerġenza.
English: Ann Allergy Asthma Immunol 94(5): 539
Maltese: "Adequacy of the epinephrine autoinjector needle length in delivering epinephrine to the intramuscular tissues." Ann Allergy Asthma Immunol 94(5): 539
English: The review was carried out by the Committee for Medicinal Products for Human Use (CHMP), responsible for questions concerning medicines for human use, which has adopted the Agency's final opinion.
Maltese: Ir-rieżami twettaq mill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP), responsabbli mill-mistoqsijiet dwar mediċini għall-użu mill-bniedem, li adotta l-opinjoni finali tal-Aġenzija.
English: Adrenaline auto-injectors are potentially life-saving treatments for anaphylaxis (severe allergic reactions) while the patient waits for emergency medical assistance.
Maltese: L-awtoinjetturi tal-adrenalina huma kuri li potenzjalment isalvaw il-ħajja għal anafilassi (reazzjonijiet allerġiċi severi) waqt li l-pazjent jistenna assistenza medika ta' emerġenza.
English: The review of adrenaline auto-injectors was initiated at the request of the United Kingdom in April 2014, under Article 31 of Directive 2001/83/EC.
Maltese: Ir-rieżami tal-awtoinjetturi tal-adrenalina nbeda fuq talba tar-Renju Unit f'April 2014, skont lArtikolu 31 tad-Direttiva 2001/83/KE.
English: This followed a national review of all adrenaline autoinjector products approved in the UK, which concluded that there was no robust evidence that the devices deliver adrenaline into a muscle for all patients.
Maltese: Dan sar wara rieżami nazzjonali tal-prodotti kollha ta' awtoinjetturi tal-adrenalina approvati fir-Renju Unit, li kkonkluda li ma kienx hemm evidenza robusta li lapparat jagħti l-adrenalina ġo muskolu tal-pazjenti kollha.
English: On 25 June 2015, the European Medicines Agency (EMA) recommended several measures, including the introduction of more effective educational material, to ensure that patients and carers use adrenaline auto-injectors successfully.
Maltese: Fil-25 ta' Ġunju 2015, l-Aġenzija Ewropea għall-Mediċini (EMA) irrakkomandat diversi miżuri, inkluż lintroduzzjoni ta' materjal edukattiv iktar effikaċi, biex tiżgura li l-pazjenti u min jieħu ħsiebom jużaw lawtoinjetturi tal-adrenalina b'suċċess.
English: However, the CHMP noted that several factors may affect whether adrenaline is actually delivered into a muscle; these include needle length, the thickness of fat under the skin, the way the auto-injector works (e.g. if it is spring loaded or not), the angle at which the device is placed on the skin and the force used to activate the device as well as how well the user follows the instructions for injection.
Maltese: L-informazzjoni dwar il-prodott tal-awtoinjetturi tal-adrenalina ġiet aġġornata wkoll b'iktar twissijiet u prekawzjonijiet, inkluż rakkomandazzjoni li l-pazjenti għandhom jingħataw riċetta ta' tabib għal żewġ awtoinjetturi li għandhom iġorru magħhom dejjem u rakkomandazzjoni għall-membri tal-familja, min jieħu ħsieb il-pazjent jew għalliema li għandhom jitħarrġu dwar kif għandhom jużaw l-awtoinjettur.
English: • It is likely that your doctor will recommend that you carry 2 injectors, in case a second dose is needed while you wait for emergency assistance.
Maltese: • Huwa probabbli li t-tabib tiegħek ser jirrakkomanda li ġġorr żewġ injetturi, f'każ li jkollok bżonn ittieni doża waqt li tistenna l-assistenza ta' emerġenza.
English: The CHMP concluded that training of the user is of paramount importance.
Maltese: Is-CHMP ikkonkluda li t-taħriġ tal-utent huwa ta' importanza kbira.
English: • Several factors may affect whether adrenaline reaches the muscle layer.
Maltese: • Diversi fatturi jistgħu jaffettwaw jekk l-adrenalina tasalx sas-saff tal-muskoli.
English: Having assessed all the available data, EMA's Committee for Medicinal Products for Human Use (CHMP) acknowledged that giving the medicine by injection into the muscle is the preferred way to obtain a rapid response in anaphylaxis.
Maltese: Wara li vvaluta d-data disponibbli kollha, il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) tal-EMA għaraf li l-għoti tal-mediċina b'injezzjoni ġol-muskolu huwa l-mod preferut ta' kif jinkiseb rispons rapidu f'anafilassi.
English: Adrenaline (epinephrine) auto-injectors are given to people who are at risk of anaphylaxis (severe allergic reaction) or have had a previous episode of anaphylaxis, to use as a first-aid measure in case of emergencies while waiting for emergency medical assistance.
Maltese: L-awtoinjetturi tal-adrenalina (epinephrine) jingħataw lil persuni li huma f'riskju ta' anafilassi (reazzjoni allerġika severa) jew li kellhom xi episodju preċedenti ta' anafilassi, biex jintużaw bħala miżura talewwel għajnuna f'każ ta' emerġenza waqt li jistennew assistenza medika ta' emerġenza.
English: The CHMP also concluded that further data should be generated to better understand how adrenaline penetrates body tissues when given with each of the different auto-injectors.
Maltese: Is-CHMP ikkonkluda wkoll li għandha tiġi ġġenerata iktar data biex jinftiehem aħjar kif l-adrenalina tippenetra it-tessuti tal-ġisem meta tingħata b'kull wieħed mill-awtoinjetturi differenti.
English: EMA/230377/2010 EMEA/H/C/466
Maltese: EMEA/H/C/466
English: Onsenal is a medicine that contains the active substance celecoxib.
Maltese: Onsenal huwa mediċina li fiha s-sustanza attiva celecoxib.
English: In adults, Onsenal had reduced the average number of polyps by 28% after six months, while the number had fallen by 5% in the patients taking placebo.
Maltese: F'adulti, Onsenal naqqas innumru medju ta' polipi bi 28% wara sitt xhur, filwaqt li n-numru naqas b'5% fil-pazjenti ttrattati bilplaċebo.
English: The maximum recommended daily dose of Onsenal is 800 mg.
Maltese: Id-doża massima ta' kuljum ta' Onsenal hija 800 mg.
English: The active substance in Onsenal, celecoxib, is a ‘non-steroidal anti-inflammatory drug' (NSAID) that belongs to the group ‘cyclo-oxygenase 2 (COX-2) inhibitors'.
Maltese: Is-sustanza attiva f'Onsenal, celecoxib, hija mediċina antinfjammatorja mhux sterojdali (NSAID) li tappartjeni għall-grupp 'inibituri taċ-ċiklossiġenażi-2 (COX2)'.
English: This document is a summary of the European Public Assessment Report (EPAR) for Onsenal.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Onsenal.
English: COX-2 is found at high levels in adenomatous colorectal polyps.
Maltese: Il-COX-2 jinsab f'livelli għoljin fil-polipi adenomatużi kolorettali.
English: Onsenal is used to reduce the number of polyps in patients with familial adenomatous polyposis (FAP).
Maltese: Onsenal jintuża biex inaqqas l-għadd ta' qarnit fil-poliposi adenomatuża familjali (FAP).
English: Because the number of patients with FAP is low, the disease is considered ‘rare', and Onsenal was designated an ‘orphan medicine' (a medicine used in rare diseases) on 20 November 2001.
Maltese: Billi l-għadd ta' pazjenti bl-FAP huwa wieħed żgħir, il-marda hija kkunsidrata ‘rari', u Onsenal kien ikklassifikat bħala ‘mediċina orfni' (mediċina għal mardiet rari) fil-20 ta' Novembru 2001.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Onsenal is available
Maltese: Is-sommarju tal-opinjoni tal-Kumitat għall-Prodotti Mediċinali Orfni għal Onsenal huwa disponibbli hawn.
English: How does Onsenal work?
Maltese: X'inhu Onsenal?
English: Onsenal at a dose of 400 mg twice a day was more effective than placebo.
Maltese: Onsenal f'doża ta' 400 mg darbtejn kuljum kien iktar effikaċi mill-plaċebo.
English: Onsenal has been authorised under ‘exceptional circumstances'.
Maltese: Onsenal ġie awtorizzat f''Ċirkostanzi Eċċezzjonali'.
English: The usual medical care for FAP
Maltese: Il-kura medika normali għallpazjenti bl-FAP għandha titkompla.
English: It blocks the COX-2 enzyme, resulting in a reduction in the production of prostaglandins, substances that are involved in processes such as inflammation and the activity of smooth muscle (muscle that performs automatic tasks such as the opening and closing of blood vessels).
Maltese: Is-sustanza timblokka l-enzima COX-2 bil-konsegwenza li tnaqqas il-produzzjoni ta' prostaglandini, sustanzi involuti fil-proċessi bħallinfjammazzjoni u l-attività tal-muskolatura lixxa (muskoli li jwettqu funzjonijiet awtomatiċi bħall-ftuħ u l-għeluq tal-arterji u tal-vini).
English: Onsenal has been studied in one main study involving 83 adults (aged 18 years or over) with FAP, in which two doses of Onsenal were compared with placebo (a dummy treatment).
Maltese: Onsenal ġie eżaminat fi studju ewlieni wieħed li involva 83 adult (minn 18-il sena ‘'l fuq) bl-FAP, li fih żewġ dożi ta' Onsenal tqabblu ma' plaċebo (trattament finta).
English: The European Commission granted a marketing authorisation valid throughout the European Union for Onsenal on 17 October 2003.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha, għal Onsenal fis-17 ta' Ottubru 2003.
English: An additional study looked at the effects of Onsenal in 18 patients aged 10 to 14 years with FAP.
Maltese: Onsenal naqqas ukoll l-għadd ta' qarnit f'pazjenti bejn l-10 u l-14-il sena bl-FAP.
English: What is the risk associated with Onsenal?
Maltese: X'inhu r-riskju assoċjat ma' Onsenal?
English: This is a genetic disease that causes ‘adenomatous intestinal polyps', growths that project from the lining of the colon or rectum (large intestine).
Maltese: Din hija marda ġenetika li tikkawża ‘qarnit adenomatuż intestinali', strutturi li jisporġu 'l barra mill-kisi tal-kolon jew tar-rektum (l-intestina l-kbira).
English: The recommended dose of Onsenal is 400 mg twice a day with food.
Maltese: Id-doża rakkomandata f'Onsenal hija 400 mg darbtejn kuljum ma' l-ikel.
English: The CHMP decided that Onsenal's benefits are greater than its risks but noted that no effect of Onsenal on the risk of developing cancer of the intestine had been shown.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' Onsenal huma ikbar mir-riskji tiegħu iżda nnota li ma deher eba effett ta' Onsenal li jpoġġi fir-riskju l-iżvilupp ta' kanċer tal-intestin.
English: For the full list of restrictions, see the
Maltese: Għal-lista sħiħa ta' restrizzjonijiet, ara l-Fuljett ta' Tagħrif.
English: Onsenal should not be used in people who may be hypersensitive (allergic) to celecoxib, to any of the other ingredients, or to sulphonamides (such as some antibiotics).
Maltese: Onsenal ma għandux jintuża minn persuni li jista' jkunu ipersensittivi (allerġiċi) għal celecoxib, kwalunkwe mill-ingredjenti l-oħra, jew għas-sulfonamidi (bħal xi antibijotiċi).