FrancophonIA/ELRC3.0 huggingface dataset:
English: Other information about Rolufta Ellipta
Maltese: Informazzjoni oħra dwar Rolufta Ellipta
English: How is Rolufta Ellipta used?
Maltese: Kif jaħdem Rolufta Ellipta?
English: Rolufta Ellipta is used for maintenance (regular) treatment.
Maltese: Rolufta Ellipta jintuża għallkura ta' manutenzjoni (regolari).
English: How does Rolufta Ellipta work?
Maltese: Kif jintuża Rolufta Ellipta?
English: As for all medicines, data on the use of Rolufta Ellipta are continuously monitored.
Maltese: Bħal għall-mediċini kollha, id-data dwar l-użu ta' Rolufta Ellipta hija ssorveljata kontinwament.
English: For the full list of side effects and restrictions with Rolufta Ellipta, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet kollha b'Rolufta Ellipta, ara l-fuljett ta' tagħrif.
English: In the study comparing Rolufta Ellipta with tiotropium, FEV1 improvements over 24 weeks were similar for both medicines.
Maltese: Fl-istudju li qabbel Rolufta Ellipta ma' tiotropium, it-titjib fil-FEV1 fuq 24 ġimgħa kien simili għaż-żewġ mediċini.
English: This authorisation was based on the authorisation granted to Incruse Ellipta in 2014 (‘informed consent').
Maltese: Din l-awtorizzazzjoni kienet ibbażata fuq l-awtorizzazzjoni mogħtija għal Incruse Ellipta fl-2014 (“kunsens infurmat”).
English: Further information on Translarna 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: Translarna has been given ‘conditional authorisation'.
Maltese: Translarna ngħata "awtorizzazzjoni kondizzjonali".
English: Other information about Translarna
Maltese: Informazzjoni oħra dwar Translarna
English: Translarna received a conditional marketing authorisation valid throughout the EU on 31 July 2014.
Maltese: Translarna rċieva awtorizzazzjoni kondizzjonali għat-tqegħid fis-suq valida fl-UE kollha fil31 ta' Lulju 2014.
English: Duchenne muscular dystrophy is rare, and Translarna was designated an ‘orphan medicine' (a medicine used in rare diseases) on 27 May 2005.
Maltese: Distrofija muskolari Duchenne hija rari, u Translarna ġie denominat bħala ‘mediċina orfni' (mediċina li tintuża f'mard rari) fis-27 ta' Mejju 2005.
English: Translarna is available as granules (125, 250 and 1,000 mg) to be taken by mouth after mixing them with liquid or semi-solid food (such as yogurt).
Maltese: Translarna jiġi bħala granuli (125, 250 u 1,000 mg) li għandhom jittieħdu mill-ħalq wara li jitħalltu ma' likwidu jew ma' ikel semisolidu (bħal jogurt).
English: Translarna is taken three times a day, and the recommended dose is 10 mg/kg (10 mg per kilogram body weight) in the morning, 10 mg/kg at midday and 20 mg/kg in the evening (making a total daily dose of 40 mg/kg).
Maltese: Translarna jittieħed tliet darbiet kuljum, u d-doża rakkomandata hija ta' 10 mg/kg (10 mg għal kull kilogramma ta' piż tal-ġisem) filgħodu, 10 mg/kg f'nofsinhar u 20 mg/kg filgħaxija (li jagħmlu doża totali ta' 40 mg/kg).
English: Translarna seemed effective on an assessment of physical activity in 12 patients when compared with past records of 11 patients of similar age who had not been treated with Translarna.
Maltese: Translarna deher effettiv wara valutazzjoni tal-attività fiżika fi 12-il pazjent meta tqabbel ma' rekords fil-passat ta' 11-il pazjent ta' età simili li ma kinux ġew ikkurati b'Translarna.
English: Translarna is for use in patients whose disease is due to the presence of certain defects (called nonsense mutations) in the dystrophin gene which prematurely stop the production of a normal dystrophin protein, leading to a shortened dystrophin protein that does not function properly.
Maltese: Translarna jintuża f'pazjenti li l-marda tagħhom hija minħabba l-preżenza ta' ċerti difetti (imsejħin mutazzjonijiet nonsens) fil-ġene distrofin li jwaqqfu b'mod prematur il-produzzjoni ta' proteina distrofin normali, li twassal għal proteina distrofin imqassra li ma taħdimx sew.
English: What are the risks associated with Translarna?
Maltese: X'inhuma r-riskji assoċjati ma' Translarna?
English: What information is still awaited for Translarna?
Maltese: Liema informazzjoni għadha mistennija għal Translarna?
English: In one main study, involving 174 patients aged 5 to 20 years with Duchenne muscular dystrophy who were able to walk, two doses of Translarna (40 mg/kg daily and 80 mg/kg daily) were compared with placebo (a dummy treatment).
Maltese: Fi studju ewlieni wieħed, li involva 174 pazjent ta' bejn 5 u 20 sena b'distrofija muskolari Duchenne li setgħu jimxu, żewġ dożi ta' Translarna (40 mg/kg kuljum u 80 mg/kg kuljum) tqabblu ma' plaċebo (kura finta).
English: As for all medicines, data on the use of Translarna are continuously monitored.
Maltese: Bħal għall-mediċini kollha, id-data dwar l-użu ta' Translarna hija ssorveljata kontinwament.
English: No improvement was seen with the higher dose (80 mg/kg daily).
Maltese: Ma deher l-ebda titjib bid-doża ogħla (80 mg/kg kuljum).
English: Although an initial analysis of the results of all the data from the study did not show a significant difference in the distances patients in the Translarna and placebo groups could walk, further analyses indicated that walking ability worsened to a lesser extent with 40 mg/kg daily Translarna than with placebo: after 48 weeks of treatment patients receiving 40 mg/kg daily Translarna could walk on average 32 metres more than those given placebo.
Maltese: Għalkemm analiżi inizjali tar-riżultati tad-data kollha mill-istudju ma wriet l-ebda differenza sinifikanti fid-distanzi li pazjenti fil-gruppi ta' Translarna u plaċebo setgħu jimxu, analiżi ulterjuri indikaw li labbiltà tal-mixi naqset fuq livell inqas b'40 mg/kg ta' Translarna kuljum milli bi plaċebo: wara 48 ġimgħa ta' kura, il-pazjenti li ngħataw 40 mg/kg ta' Translarna kuljum setgħu jimxu medja ta' 32 metru iktar minn dawk li ngħataw il-plaċebo.
English: How is Translarna used?
Maltese: Translarna?
English: Patients with Duchenne muscular dystrophy lack normal dystrophin, a protein found in muscles.
Maltese: Il-pazjenti b'distrofija muskolari Duchenne għandhom nuqqas ta' distrofin normali, proteina li tinstab fil-muskoli.
English: Translarna can only be obtained with a prescription and treatment should be started by a specialist doctor experienced in the management of Duchenne/Becker muscular dystrophy.
Maltese: Translarna jista' jinkiseb biss b'riċetta ta' tabib u l-kura għandha tinbeda minn tabib speċjalista b'esperjenza fil-ġestjoni ta' distrofija muskolari Duchenne/Becker.
English: A further study in 230 patients aged 7 to 14 years with worsening walking ability was completed after initial approval, but its results were considered inconclusive.
Maltese: Studju ieħor f'230 pazjent ta' bejn 7 sa 14-il sena b'abbiltà tal-mixi li kienet qiegħda taggrava tlesta wara approvazzjoni inizjali, iżda r-riżultati tiegħu tqiesu inkonklużivi.
English: The most common side effects with Translarna (which may affect more than 5 in 100 people) are vomiting, diarrhoea, nausea (feeling sick), headache, stomach ache and flatulence.
Maltese: L-effetti sekondarji l-aktar komuni bi Translarna (li jistgħu jaffettwaw aktar minn 5 persuni minn kull 100) huma rimettar, dijarea, nawsja (tħossok ma tiflaħx), uġigħ ta' ras, uġigħ fl-istonku u flatulenza.
English: Translarna is used in the small group of patients whose disease is caused by a specific genetic defect (called a ‘nonsense mutation') in the dystrophin gene.
Maltese: Translarna jintuża fil-grupp żgħir ta' pazjenti li l-marda tagħhom hija kkawżata minn difett ġenetiku speċifiku (imsejjaħ ‘mutazzjoni nonsens') fil-ġene distrofin.
English: Duchenne muscular dystrophy is a genetic disease that gradually causes weakness and loss of muscle function.
Maltese: Distrofija muskolari Duchenne hija marda ġenetika li gradwalment tikkawża dgħufija u telf tal-funzjoni tal-muskoli.
English: For the full list of side effects and restrictions of Translarna, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet ta' Translarna, ara l-fuljett ta' tagħrif.
English: Translarna must not be used at the same time as aminoglycoside antibiotics given by injection or infusion (drip) into a vein.
Maltese: Translarna m'għandux jintuża fl-istess ħin ma' antibijotiċi ta' aminoglikosid li jingħataw permezz ta' injezzjoni jew infużjoni (dripp) ġo vina.
English: A small study in children aged 2 to 5 years with Duchenne muscular dystrophy found that the usual dose of Translarna 40 mg/kg daily was sufficient.
Maltese: Studju żgħir fi tfal ta' bejn sentejn sa 5 snin b'distrofija muskolari Duchenne sab li d-doża tas-soltu ta' Translarna 40 mg/kg kuljum kienet biżżejjed.
English: Side effects reported with Translarna are carefully evaluated and any necessary action taken to protect patients.
Maltese: L-effetti sekondarji rrappurtati bi Translarna huma evalwati bir-reqqa u kull azzjoni meħtieġa hi meħuda biex tipproteġi lill-pazjenti.
English: Since Translarna has been given conditional authorisation, the company that markets it will provide results of a new study comparing Translarna with placebo in order to confirm its effectiveness and safety.
Maltese: Minħabba li Translarna ngħata awtorizzazzjoni kondizzjonali, il-kumpanija li tqiegħdu fis-suq ser tipprovdi riżultati ta' studju ġdid li jqabbel Translarna ma' plaċebo sabiex tiġi kkonfermata l-effikaċja u s-sigurtà tiegħu.
English: Duchenne muscular dystrophy can be caused by a number of genetic abnormalities.
Maltese: Distrofija muskolari Duchenne tista' tiġi kkawżata minn numru ta' anormalitajiet ġenetiċi.
English: How does Translarna work?
Maltese: Kif jaħdem Translarna?
English: Because this protein helps to protect muscles from injury as muscles contract and relax, in patients with Duchenne muscular dystrophy the muscles become damaged and eventually stop working.
Maltese: Minħabba li din il-proteina tgħin biex tipproteġi l-muskoli minn korriment waqt li l-muskoli jikkontrattaw u jirrilassaw, f'pazjenti b'distrofija muskolari Duchenne, il-muskoli ssirilhom il-ħsara u eventwalment jieqfu jaħdmu.
English: Translarna is a medicine that is used to treat patients aged 2 years and older with Duchenne muscular dystrophy who are able to walk.
Maltese: Translarna huwa mediċina li tintuża biex tikkura pazjenti li għandhom sentejn u aktar b'distrofija muskolari Duchenne, u li jistgħu jimxu.
English: The maximum single dose is 200 mg.
Maltese: Doża waħda massima hija 200 mg.
English: EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR) RAPTIVA
Maltese: RAPPORT TA' VALUTAZZJONI PUBBLIKA EWROPEA (EPAR) RAPTIVA
English: Medicinal product no longer authorise©EMEA 2007
Maltese: Prodott mediċinali li m'għadux awtorizza©EMEA 2007
English: The active substance in Raptiva, efalizumab, is a monoclonal antibody.
Maltese: Is-sustanza attiva f'Raptiva, efalizumab, hija antikorp monoklonali.
English: How has Raptiva been studied?
Maltese: Kif ġiet studjata Raptiva?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Raptiva to Serono Europe Ltd. on 20 September 2004.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Raptiva valida għall-Unjoni Ewropea kollha lil Serono Europe Ltd. fl-20 ta' Settembru 2004.
English: It contains the active
Maltese: Hija fiha s-sustanza attiva
English: The most common side effects with Raptiva (seen in more than 1 patient in 10) are mild to moderate flu-like symptoms including headache, fever, chills, nausea (feeling sick), myalgia (muscle pain), and leucocytosis and lymphocytosis (increased white blood cell counts).
Maltese: L-aktar effetti sekondarji komuni b'Raptiva (dehru f'aktar minn pazjent 1 f'kull 10) huma sintomi ta' influwenza ħfief għal moderati inklużi uġigħ ta' ras, deni, tertir, nawżja (dardir), majalġja (uġigħ filmuskoli), u lewkoċitożi u limfoċitożi (żieda fl-għadd taċ-ċelloli bojod tad-demm).
English: In the fifth study, overall, 166 (31%) of the 529 patients receiving Raptiva responded to treatment, compared with 11 (4%) of the 264 receiving placebo.
Maltese: Bħala total, fil-ħames studju, 166 (31%) mill-529-il pazjent li kienu qed jirċievu Raptiva irrispondew għal kura, meta mqabbla ma' 11 (4%) tal-264 li kienu qed jirċievu plaċebo.
English: It is used in patients who have failed to respond to or cannot take other systemic (whole-body) treatments for psoriasis, including ciclosporin, methotrexate and PUVA (psoralen ultraviolet-A).
Maltese: Hija tintuża f'pazjenti li naqsu milli jirrispondu jew li ma jistgħux jieħdu trattamenti sistemiċi (għall-ġisem kollu) oħra għall-psorjasi, inklużi ciclosporin, methotrexate u PUVA (psoralen ultraviolet-A).
English: Therefore, the Committee decided that Raptiva's benefits are greater than its risks for the treatment of adult patients with moderate to severe chronic plaque psoriasis who have failed to respond to, or who have a contra-indication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA.
Maltese: Għaldaqstant, il-Kumitat iddeċieda li l-benefiċċji ta' Raptiva huma akbar mir-riskji tagħha għal kura ta' pazjenti adulti bi psorjasi tal-plakek kronika, severa jew moderata li naqsu milli jirrispondu għal, jew li għandhom kontra-indikazzjoni għal, jew li mhumiex tolleranti għal terapiji sistemiċi oħra inklużi ciclosporin, methotrexate u PUVA.
English: The medicine can only be obtained with a prescription.
Maltese: Prodott mediċinali li m'għadux awtorizzat
English: Raptiva was more effective than placebo at improving the symptoms of psoriasis.
Maltese: Raptiva kienet aktar effettiva minn plaċebo biex ittejjeb is-sintomi ta' psorjasi.
English: It is given as a 12-week course, with a first dose of 0.7 mg per kilogram body weight followed by weekly injections of 1.0 mg/kg.
Maltese: Hija tingħata bħala kors ta' 12-il ġimgħa, bl-ewwel doża ta' 0.7 mg għal kull kilogramm ta piż korporali segwita minn injezzjonijiet ta' kull ġimgħa ta' 1.0 mg/kg.
English: Raptiva has been studied in five main studies involving over 3,000 patients with moderate to severe plaque psoriasis.
Maltese: Raptiva ġiet studjata f'ħames studji ewlenin li jinvolu aktar minn 3,000 pazjent bi psorjasi tal-plakek moderata għal severa.
English: Looking at the results of the first four studies taken together, 320 (26%) of the 1,213 patients receiving 1.0 mg/kg Raptiva per week responded to treatment, compared with 25 (4%) of the 715 receiving placebo.
Maltese: F'ħarsa lejn ir-riżultati ta' l-ewwel erba' studji meħudin flimkien, 320 (26%) mill-1,213-il pazjent li kienu qed jirċievu 1.0 mg/kg Raptiva kull ġimgħa irrispondew għal kura, meta mqabbla ma' 25 (4%) tas-715 li kienu qed jirċievu plaċebo.
English: What benefit has Raptiva shown during the studies?
Maltese: X'benefiċċju uriet Raptiva waqt l-istudji?
English: Raptiva is used for the treatment of adults with moderate to severe chronic (long-term) plaque psoriasis (a disease causing red, scaly patches on the skin).
Maltese: Raptiva tintuża fil-kura ta' adulti bi psorjasi tal-plakek (marda li tikkaġuna rqajja' ħomor bil-qxur fuq il-ġilda).
English: PUVA is a type of treatment where the patient receives a medicine containing a compound called a ‘psoralen' before being exposed to ultraviolet
Maltese: PUVA huwa tip ta' trattament fejn il-pazjent jirċievi mediċina li fiha taħlita msejħa ‘psoralen' qabel ma jkun espost għal dawl ultravjola.
English: Efalizumab has been designed to bind to part of a protein called LFA-1 on the surface of lymphocytes, a type of white blood cell that is involved in the inflammation process.
Maltese: Efalizumab ġie mfassal biex jorbot ma' parti ta' proteina msejħa LFA-1 fuq il-wiċċ tal-limfoċiti, tip ta' ċellola bajda tad-demm li hija involuta fil-proċess ta' linfjammazzjoni.
English: As LFA-1 is important in helping the lymphocytes to stick to cells in the skin, efalizumab reduces the inflammation in the skin that causes psoriasis.
Maltese: Peress li LFA-1 hija importanti sabiex tgħin il-limfoċiti jeħlu maċ-ċelloli fil-ġilda, efalizumab inaqqas l-infjammazzjoni li tikkaġuna psorjasi fil-ġilda.
English: A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and bind to a specific structure (called an antigen) that is found on the surface of cells in the body.
Maltese: Antikorp monoklonali huwa antikorp (tip ta' proteina) li ġie mfassal biex jagħraf u jorbot ma' struttura speċifika (imsejħa antiġen) li tinsab fuq il-wiċċ ta' ċelloli fil-ġisem.
English: Raptiva is a powder and solvent that are made up into a solution for injection.
Maltese: Raptiva hija trab u solvent li titħallat f'soluzzjoni għall-injezzjoni.
English: For the full list of all side effects reported with Raptiva, see the Package Leaflet.
Maltese: Għal-lista sħiħa ta' l-effetti sekondarji kollha irrapportati b'Raptiva, ara l-Fuljett ta' Tagħrif.
English: The studies included patients who had not taken other treatments for psoriasis in the past, as well as those who had taken other treatments.
Maltese: L-istudji inkludew pazjenti li ma kienux ħadu kuri oħra għal psorjasi fil-passat, kif ukoll dawk li kienu ħadu kuri oħra.
English: The full EPAR for Exforge HCT 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: amlodipine / valsartan / hydrochlorothiazide
Maltese: amlodipina / valsartan / idroklorotijażide
English: Amlodipine is a ‘calcium channel blocker'.
Maltese: L-amlodipina “timblokka l-kanali tal-kalċju”.
English: This summary was last updated in 09-2013.
Maltese: Dan is-sommarju ġie aġġornat l-aħħar f'09-2013.
English: It is available as tablets containing amlodipine, valsartan and hydrochlorothiazide in the following amounts: 5/160/12.5 mg, 10/160/12.5 mg, 5/160/25 mg, 10/160/25 mg and 10/320/25 mg.
Maltese: Jiġi bħala pilloli li jkun fihom l-amlodipina, il-valsartan u l-idroklorotijażide fl-ammonti li ġejjin: 5/160/12.5 mg, 10/160/12.5 mg, 5/160/25 mg; 10/160/25 mg u 10/320/25 mg.
English: The daily dose of Exforge HCT should not exceed 10 mg of amlodipine, 320 mg of valsartan and 25 mg of hydrochlorothiazide.
Maltese: Id-doża ta' kuljum ta' Exforge HCT ma għandhiex taqbeż l-10 mg amlodipina, 320 mg valsartan u 25 mg idroklorotijażide.
English: The average reduction in blood pressure was around 39.7/24.7 mmHg in patients taking Exforge HCT compared with 32/19.7 mmHg, 33.5/21.5 mmHg and 31.5/19.5 mmHg in patients taking valsartan/hydrochlorothiazide, valsartan/amlodipine and hydrochlorothiazide/amlodipine combinations, respectively.
Maltese: It-tnaqqis medju fil-pressjoni tad-demm kien madwar 39.7/24.7 mmHg f'pazjenti li kienu fuq Exforge HCT meta mqabbel ma' 32/19.7 mmHg, 33.5/21.5 mmHg u 31.5/19.5 mmHg f'pazjenti li kienu qegħdin jieħdu valsartan/idroklorotijażide, valsartan/amlodipina u idroklorotijażide/amlodipina rispettivament.
English: This is a summary of the European public assessment report (EPAR) for Exforge HCT.
Maltese: Dan id-dokument huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Exforge HCT.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Exforge HCT on 16 October 2009.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Exforge HCT valida fl-Unjoni Ewropea kollha fis-16 ta' Ottubru 2009.
English: The most common side effects with Exforge HCT (seen in between 1 and 10 patients in 100) are hypokalaemia (low blood potassium levels), dizziness, headache, hypotension (low blood pressure), dyspepsia (heartburn), pollakiuria (abnormally frequent urination), fatigue (tiredness) and oedema (fluid retention).
Maltese: L-effetti sekondarji l-aktar komuni b'Exforge HCT (li dehru f'madwar pazjent 1 u 10 pazjenti f'100) huma ipokaljemija (livelli baxxi ta' potassju fid-demm), sturdament, uġigħ ta' ras, ipotensjoni (pressjoni tad-demm baxxa), dispepsija (qrusa tal-istonku), pollakjurija (frekwenza anormali talawrina), għejja u edema (żamma tal-fluwidi).
English: Exforge HCT is a medicine that contains three active substances, amlodipine, valsartan and hydrochlorothiazide.
Maltese: Exforge HCT huwa mediċina li fiha t-tliet sustanzi attivi, l-amlodipina, il-valsartan u l-idroklorotijażide.
English: In addition, one main study was carried out in 2,271 patients with moderate to severe hypertension with the highest strength of Exforge HCT (320 mg valsartan, 10 mg amlodipine and 25 mg hydrochlorothiazide).
Maltese: Barra minn hekk, sar studju ewlieni f'2,271 pazjent b'ipertensjoni minn moderata għal gravi bl-ogħla konċentrazzjoni ta' Exforge HCT (320 mg valsartan, 10 mg amlodipina u 25 mg idroklorotijażide).
English: Angiotensin II is a powerful vasoconstrictor (a substance that narrows blood vessels).
Maltese: II huwa vażokostrittur qawwi (sustanza li traqqaq larterji u l-vini).
English: Finally, Exforge HCT must not be used in patients with hypokalaemia (low blood potassium levels), hyponatraemia (low blood sodium levels) and hypercalcaemia (high blood calcium levels) that do not respond to treatment and in patients with hyperuricaemia (high blood levels of uric acid) that causes symptoms.
Maltese: Fl-aħħar nett, Exforge HCT ma jistax jintuża f'pazjenti b'ipokaljemija (livelli baxxi ta' potassju fid-demm), iponatremija (livelli baxxi ta' sodju fid-demm) u iperkalċemija (livelli għoljin tal-kalċju fid-demm) li ma jirrispondux għall-kura u f'pazjenti b'iperuriċemija (livelli għoljin ta' aċtu uriku fid-demm) li tikkawża s-sintomi.
English: Exforge HCT must not be used in people who are hypersensitive (allergic) to the active substances, to other sulfonamides, to dihydropyridine derivatives or to any of the other ingredients in Exforge HCT.
Maltese: Exforge HCT ma għandux jintuża f'nies li jistgħu jkunu ipersensittivi (allerġiċi) għas-sustanzi attivi, għal sulfonamidi oħra, għal derivattivi diidropiridiniċi jew għal kwalunkwe ingredjent ieħor f'Exforge HCT.
English: What is the risk associated with Exforge HCT?
Maltese: X'inhu r-riskju assoċjat ma' Exforge HCT?
English: It blocks special channels on the surface of cells called calcium channels, through which calcium ions normally enter the cells.
Maltese: Din timblokka l-kanali speċjali preżenti fuq il-wiċċ taċċelluli magħrufa bħala kanali tal-kalċju, li minnhom normalment il-joni tal-kalċju jidħlu fiċ-ċelluli.
English: The three active substances in Exforge HCT are anti-hypertensive medicines that are already in use in the European Union (EU).
Maltese: It-tliet sustanzi attivi f'Exforge HCT huma mediċini antiipertensivi li diġà qegħdin jintużaw fl-Unjoni Ewropea (UE).
English: Exforge HCT is taken by mouth as one tablet once a day, at the same time of the day and preferably in the morning.
Maltese: Exforge HCT jittieħed oralment bħala pillola waħda darba kuljum,fl-istess ħin tal-jum u preferibbilment filgħodu.
English: What is Exforge HCT?
Maltese: Kif jaħdem Exforge HCT?
English: For the full list of all side effects reported with Exforge HCT, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji rrappurtati b'Exforge HCT, ara l-fuljett ta' tagħrif.
English: Why has Exforge HCT been approved?
Maltese: Għaliex ġie approvat Exforge HCT?
English: The CHMP noted that patients already taking the three active substances would be more likely to comply with their treatment if prescribed Exforge HCT which combines the three substances in a single tablet.
Maltese: Il-kura bl-ogħla konċentrazzjoni ta' Exforge HCT kienet iktar effettiva minn kombinazzjonijiet li kien fihom tnejn biss mis-sustanzi attivi fil-kura tal-ipertensjoni.
English: How has Exforge HCT been studied?
Maltese: Kif ġie studjat Exforge HCT?
English: The CHMP therefore decided that Exforge HCT's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Għaldaqstant is-CHMP iddeċieda li l-benefiċċji ta' Exforge HCT huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: Valsartan is an ‘angiotensin II receptor antagonist', which means that it blocks the action of a body hormone called angiotensin II.
Maltese: Il-valsartan hu 'antagonist tar-riċetturi tal-anġjotensina