FrancophonIA/ELRC3.0 huggingface dataset:
English: Both types of tablets will be available for some time, which will allow doctors to switch patients from dispersible tablets to film-coated tablets.
Maltese: Tista' faċilment issir distinzjoni bejn iż-żewġ tipi ta' pilloli.
English: Does not contain lactose
Maltese: Ma fihx lattożju
English: Educational material will be given to patients and healthcare professionals using Exjade (deferasirox), following the introduction of a film-coated tablet to the already authorised dispersible tablet.
Maltese: Ser jingħata materjal edukattiv lil pazjenti u professjonisti tal-kura tas-saħħa li jużaw Exjade (deferasirox), wara l-introduzzjoni ta' pillola miksija b'rita mal-pillola li tinħall diġà awtorizzata.
English: • Exjade dispersible tablets will not be available in the future.
Maltese: • Il-pilloli Exjade li jinħallu mhux ser ikunu disponibbli fil-futur.
English: • Whereas the dispersible tablets have to be taken on an empty stomach 30 minutes before food, the film-coated tablets can be taken on an empty stomach or with a light meal.
Maltese: • Filwaqt li l-pilloli li jinħallu għandhom jittieħdu fuq stonku vojt 30 minuta qabel l-ikel, il-pilloli miksijin b'rita jistgħu jittieħdu fuq stonku vojt jew ma' ikla ħafifa.
English: When to take tablets
Maltese: Meta għandek tieħu l-pilloli
English: Healthcare professionals will be notified of the planned date for removing the dispersible tablets from the market.
Maltese: Il-professjonisti tal-kura tas-saħħa sejrin jiġu nnotifikati dwar id-data ppjanata għat-tneħħija tal-pilloli li jinħallu mis-suq.
English: Exjade is a medicine used to treat chronic iron overload (an excess of iron in the body) in patients with beta thalassemia or other blood disorders in which patients do not have enough normal haemoglobin in the blood.
Maltese: Exjade huwa mediċina li jintuża sabiex jikkura l-akkumulu kroniku ta' ħadid (eċċess ta' ħadid fil-ġisem) f'pazjenti li jbatu mill-beta talassemija jew minn disturbi tad-demm oħrajn fejn il-pazjenti m'għandhomx biżżejjed emoglobina normali fid-demm.
English: National Competent Authorities of Member State(s) or Reference Member State(s) if applicable, shall ensure that the following conditions are fulfilled by the MAH(s):
Maltese: L-Awtoritajiet Nazzjonali Kompetenti tal-Istat(i) Membru/i jew tal-Istat(i) Membru/i ta' Referenza jekk applikabbli, għandhom jassiguraw li l-MAH(s) jissodisfaw il-kondizzjonijiet li ġejjin:
English: The MAHs should identify a specific patient population for which the benefits of the product outweigh the risk.
Maltese: Il-MAHs għandhom jidentifikaw popolazzjoni speċifika ta' pazjenti li għaliha l-benefiċċji tal-prodott jegħlbu r-riskji.
English: The full EPAR for CoAprovel 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: CoAprovel irbesartan / hydrochlorothiazide
Maltese: CoAprovel irbesartan/idroklorotijażide (hydrochlorothiazide)
English: The most common side effects with CoAprovel (seen in between 1 and 10 patients in 100) are dizziness, nausea (feeling sick) or vomiting, abnormal urination, fatigue (tiredness), and increases in blood urea nitrogen (BUN, a breakdown product of protein), creatinine (a breakdown product of muscle) and creatine kinase (an enzyme found in muscle).
Maltese: L-iktar effett sekondarju komuni ma' CoAprovel (li deher f'bejn pazjent 1 u 10 minn 100) huma listurdament, nawżea (dardir) jew remettar, produzzjoni anomala ta' awrina, għeja, u żidiet fil-livelli ta' nitroġenu fl-urea tad-demm (BUN, prodott ta' skart tal-proteini), kreatinina (prodott tat-tkissir talmuskoli) u kreatina kinażi (creatine kinase - enzima li tinsab fil-muskoli).
English: It is available as tablets (150 mg or 300 mg irbesartan and 12.5 mg hydrochlorothiazide; 300 mg irbesartan and 25 mg hydrochlorothiazide).
Maltese: Jiġi bħala pilloli (150 mg jew 300 mg irbesartan u 12.5 mg idroklorotijażide; 300 mg irbesartan u 25 mg idroklorotijażide).
English: This is a summary of the European public assessment report (EPAR) for CoAprovel.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal CoAprovel.
English: Irbesartan on its own has been approved in the European Union (EU) since 1997 under the names Karvea and Aprovel.
Maltese: L-irbesartan waħdu ilu approvat fl-Unjoni Ewropea (UE) sa mill-1997 taħt l-ismijiet Karvea u Aprovel.
English: The European Commission granted a marketing authorisation valid throughout the EU for CoAprovel on 15 October 1998.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha għal CoAprovel fil15 ta' Ottubru 1998.
English: CoAprovel contains two active substances, irbesartan and hydrochlorothiazide.
Maltese: CoAprovel fih żewġ sustanzi attivi, l-irbesartan u l-idroklorotijażide.
English: What is the risk associated with CoAprovel?
Maltese: Għal xiex jintuża CoAprovel?
English: CoAprovel must also not be used in patients who have severe liver, kidney or bile problems, blood potassium levels that are too low or blood calcium levels that are too high.
Maltese: CoAprovel lanqas ma għandu jintuża f'pazjenti li jkollhom problemi gravi fil-fwied, filkliewi jew fis-sistema biljari, livelli baxxi wisq ta' potassju, u livelli għoljin wisq ta' kalċju.
English: What benefit has CoAprovel shown during the studies?
Maltese: Liema benefiċċju wera CoAprovel waqt l-istudji mwettqa?
English: CoAprovel is a medicine that contains two active substances, irbesartan and hydrochlorothiazide.
Maltese: CoAprovel huwa mediċina li fiha żewġ sustanzi attivi, l-irbesartan u l-idroklorotijażide.
English: How has CoAprovel been studied?
Maltese: Kif ġie studjat CoAprovel?
English: CoAprovel must not be used in people who are hypersensitive (allergic) to irbesartan, hydrochlorothiazide, sulfonamides, or any of the other ingredients.
Maltese: CoAprovel ma għandux jintuża f'persuni li jistgħu jkunu ipersensittivi (allerġiċi) għal irbesartan, għallidroklorotijażide, għas-sulfonamidi, jew għal kwalunkwe ingredjent ieħor.
English: The CHMP decided that CoAprovel's benefits are greater than its risks and recommended that it be given marketing authorisation.
Maltese: Is-CHMP iddeċieda li l-benefiċċji ta' CoAprovel huma akbar mir-riskji tiegħu u rrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: What is CoAprovel?
Maltese: X'inhu CoAprovel?
English: The studies of Karvea/Aprovel used with hydrochlorothiazide as separate tablets were used to support the use of CoAprovel.
Maltese: L-istudji ta' Karvea/Aprovel użat mal-idroklorotijażide bħala pilloli separati ntużaw b'appoġġ għall-użu ta' CoAprovel.
English: CoAprovel in combination with aliskiren-containing medicines (used to treat essential hypertension) must not be used in patients with diabetes, or moderate or severe kidney impairment.
Maltese: CoAprovel ma għandux jintuża flimkien ma' mediċini li fihom l-aliskiren (użat fil-kura tal-ipertensjoni essenzjali) f'pazjenti bid-dijabete, jew insuffiċjenza moderata jew gravi fil-kliewi.
English: For the full list of all side effects reported with CoAprovel, see the package leaflet.
Maltese: Għal-lista sħiħa ta' effetti sekondarji rrappurati ma' CoAprovel, ara l-fuljett ta' tagħrif.
English: CoAprovel may be added to some other treatments for hypertension.
Maltese: CoAprovel jista' jiżdied ma' trattamenti oħra għall-ipertensjoni.
English: 25 October 2013 EMA/652753/2013
Maltese: 18 ta' Diċembru 2013 EMA/27446/2014
English: − Ancillary treatment of Raynaud's syndrome;
Maltese: − Kura anċillari tas-sindromu ta' Raynaud;
English: − Acute retinopathies of vascular origin;
Maltese: − Retinopatiji akuti ta' oriġini vaskulari;
English: − Ancillary treatment of intermittent claudication in symptomatic peripheral arterial occlusive disease (PAOD Stage II);
Maltese: − Kura anċillari ta' klawdikazzjoni intermittenti f'mard okklussiv arterjali periferali sintomatiku (PAOD fi Stadju II);
English: − Orthostatic hypotension;
Maltese: − Ipotensjoni ortostatika
English: • The available efficacy data for the described indications were considered to be very limited.
Maltese: • Id-dejta disponibbli dwar l-effikaċja għall-indikazzjonijiet deskritti kienet meqjusa limitata ħafna.
English: • Fibrosis was most frequently reported with dihydroergotamine, including retroperitoneal, cardiac, pulmonary and pleural fibrosis.
Maltese: • Il-fibrożi kienet irrapportata aktar frekwenti b'dihydroergotamine, inkluż fibrożi retroperitonali, kardijaka, pulmonari u plewrali.
English: The review of ergot derivatives was initiated on 18 January 2012 at the request of France, under Article 31 of Directive 2001/83/EC.
Maltese: Ir-reviżjoni tad-derivati tal-ergotina nbdiet fit-18 ta' Jannar 2012 fuq talba ta' Franza, skont lArtikolu 31 tad-Direttiva 2001/83/KE.
English: Five ergot derivatives were considered in the CHMP review: dihydroergocristine, dihydroergotamine, dihydroergotoxine, nicergoline and the combination of dihydroergocryptine with caffeine.
Maltese: Ħames derivati tal-ergotina kienu kkunsidrati fir-reviżjoni tas-CHMP: dihydroergocristine, dihydroergotamine, dihydroergotoxine, nicergoline u l-kombinazzjoni ta' dihydroergocryptine malkaffeina.
English: Several cases of ergotism or symptoms potentially related to ergotism (including severe cases of symptoms of constriction of peripheral blood vessels) were also identified with the other ergot derivatives.
Maltese: Diversi każijiet ta' ergotiżmu jew sintomi potenzjalment relatati mal-ergotiżmu (inklużi każijiet serji ta' sintomi ta' kostrizzjoni tal-vażi periferali tad-demm) ġew identifikati wkoll bid-derivati l-oħra tal-ergotina.
English: In addition, scientific advisory groups held in December 2012 and October 2013 did not consider there was evidence of a therapeutic need for ergot derivatives in the indications covered by the review.
Maltese: Barra minn hekk, il-gruppi konsultattivi xjentifiċi li tlaqqgħu f'Diċembru 2012 u f'Ottubru 2013 ma qisux li kien hemm evidenza ta' ħtieġa terapewtika għad-derivati tal-ergotina fl-indikazzjonijiet koperti mir-reviżjoni.
English: The CHMP noted that there is a plausible mechanism by which ergot-derivatives could cause fibrosis and ergotism.
Maltese: Is-CHMP innota li hemm mekkaniżmu plawsibbli li bih id-derivati tal-ergotina jistgħu jikkawżaw fibrożi u ergotiżmu.
English: • Patients currently taking these medicines for any of the above indications should have their treatment reviewed at a routine (non-urgent) medical appointment.
Maltese: • Pazjenti li attwalment qed jieħdu dawn il-mediċini għal xi waħda mill-indikazzjonijiet ta' hawn fuq għandu jkollhom il-kura tagħhom riveduta waqt appuntament mediku ta' rutina (mhux urġenti).
English: They have also been used for treating chronic pathological cognitive and neurosensorial impairment (problems with memory and sensation) and for preventing migraine headaches.
Maltese: Intużaw ukoll għall-kura ta' indeboliment konjittiv u newrosensorjali patoloġiku kroniku (problemi bil-memorja u s-sensazzjoni) u għall-prevenzjoni tal-uġigħ ta' ras talemigranja.
English: • Medicines containing substances known as ergot derivatives can have serious side effects, called fibrosis and ergotism.
Maltese: • Mediċini li fihom sustanzi magħrufa bħala derivati tal-ergotina jista' jkollhom effetti sekondarji serji, magħrufa bħala fibrożi u ergotiżmu.
English: • Healthcare professionals should stop prescribing medicines containing dihydroergocristine, dihydroergotamine, dihydroergotoxine, nicergoline or a combination of dihydroergocryptine with caffeine, for any of the following indications:
Maltese: • Il-professjonisti tal-kura tas-saħħa għandhom jieqfu jippreskrivu mediċini li fihom dihydroergocristine, dihydroergotamine, dihydroergotoxine, nicergoline jew kombinazzjoni ta' dihydroergocryptine mal-kaffeina, għal xi waħda minn dawn l-indikazzjonijiet:
English: Certain ergot derivatives have been used to treat conditions usually affecting elderly patients, such as peripheral arterial occlusive disease (PAOD, where the body's large arteries become obstructed) causing pain when walking, and Raynaud's syndrome (where the blood supply is blocked to the extremities, usually the fingers and toes), as well as eyesight disturbances due to blood circulation problems.
Maltese: Ċerti derivati tal-ergotina ntużaw biex jittrattaw kondizzjonijiet li normalment jaffettwaw pazjenti anzjani, bħal mard okklussiv arterjali periferali (PAOD, fejn l-arterji l-kbar tal-ġisem jiġu mblukkati) li jikkawża uġigħ waqt il-mixi, u s-sindromu ta' Raynaud (fejn il-provvista tad-demm lejn l-estremitajiet tiġi mblukkata, normalment is-swaba' tal-idejn u s-saqajn), kif ukoll disturbi fil-vista minħabba problemi fiċċirkolazzjoni tad-demm.
English: • Some ergot derivatives are approved in some EU Member States for use in other therapeutic indications, including other circulatory disorders, treatment of dementia (including Alzheimer's disease) and treatment of acute migraine.
Maltese: • Xi derivati tal-ergotina huma approvati f'xi Stati Membri tal-UE għall-użu f'indikazzjonijiet terapewtiċi oħra, inklużi disturbi ċirkolatorji oħra, il-kura tad-dimenzja (inkluż il-marda ta' Alzheimer) u l-kura ta' emigranja akuta.
English: Ergot derivatives are substances derived from a group of fungi commonly known as ergot.
Maltese: Derivati tal-ergotina huma sustanzi li ġejjin minn grupp ta' fungi magħrufin b'mod komuni bħala ergotina.
English: • Cases of ergotism or potentially related symptoms were most frequently reported with dihydroergotamine.
Maltese: • Każijiet ta' ergotiżmu jew sintomi potenzjalment relatati ġew irrapportati b'mod aktar frekwenti b'dihydroergotamine.
English: The severity of such adverse effects and their possible fatal outcome was underlined.
Maltese: Is-severità ta' dawn l-effetti avversi u l-eżitu fatali possibbli tagħhom kienu enfasizzati.
English: The review was initiated due to concerns identified by the French National Agency for the Safety of Medicine and Health Products (ANSM) in a national pharmacovigilance review in 2011.
Maltese: Ir-reviżjoni nbdiet minħabba tħassib identifikat mill-Aġenzija Nazzjonali Franċiża għasSigurtà tal-Mediċini u l-Prodotti tas-Saħħa (ANSM) f'reviżjoni nazzjonali tal-farmakoviġilanza fl-2011.
English: This is based on a review of data showing an increased risk of fibrosis (formation of excess connective tissue that can damage organs and body structures) and ergotism (symptoms of ergot poisoning, such as spasms and obstructed blood circulation) with these medicines.
Maltese: Dan huwa bbażat fuq reviżjoni ta' dejta li turi żieda fir-riskju ta' fibrożi (formazzjoni ta' tessut konnettiv żejjed li jista' jagħmel ħsara lill-organi u lill-istrutturi tal-ġisem) u ergotiżmu (sintomi ta' avvelenament bl-ergotina, bħal spażmi u ostruzzjoni fiċ-ċirkolazzjoni tad-demm) b'dawn il-mediċini.
English: The varying affinity for serotoninergic receptors of the different ergot derivatives, and the therapeutic doses used, may explain the differences observed in reporting frequencies for the fibrotic reactions.
Maltese: L-affinità varjabbli tad-derivati differenti tal-ergotina għar-riċetturi serotonerġiċi, u ddożi terapewtiċi użati, jistgħu jispjegaw id-differenzi osservati fil-frekwenzi ta' rapportar tarreazzjonijiet fibrotiċi.
English: The European Commission has already endorsed the CHMP opinion for 4 other ergot derivatives (dihydroergocristine, dihydroergotamine, nicergoline dihydroergocryptine), adopting a final legally binding decision on 27 September 2013.
Maltese: Il-Kummissjoni Ewropea approvat l-opinjoni tas-CHMP għal dihydroergocristine, dihydroergotamine, nicergoline u dihydroergocryptine fis-27 ta' Settembru 2013 u l-opinjoni tas-CHMP għal dihydroergotoxine fit-18 ta' Diċembru 2013.
English: The pharmaceutical forms and the approved indications, strengths and doses vary in different EU countries.
Maltese: Il-forom farmaċewtiċi u l-indikazzjonijiet, qawwiet u dożi approvati jvarjaw f'pajjiżi differenti tal-UE.
English: • You should make a non-urgent appointment with your doctor if you are taking a medicine containing any of these substances: dihydroergocristine, dihydroergotamine, dihydroergotoxine, nicergoline or a combination of dihydroergocryptine with caffeine.
Maltese: • Għandek tagħmel appuntament mhux urġenti mat-tabib tiegħek jekk qed tieħu mediċina li fiha xi sustanza minn dawn li ġejjin: dihydroergocristine, dihydroergotamine, dihydroergotoxine, nicergoline jew kombinazzjoni ta' dihydroergocryptine mal-kaffeina.
English: In the EU, medicines containing ergot derivatives have been authorised by national procedures and have been marketed under various trade names.
Maltese: Fl-UE, mediċini li fihom derivati tal-ergotina ġew awtorizzati permezz ta' proċeduri nazzjonali u tqiegħdu fis-suq taħt ismijiet kummerċjali differenti.
English: In its review, the CHMP considered all available data on the benefits and risks of ergot derivatives, including data from clinical studies, post-marketing safety reports and the published literature.
Maltese: Fir-reviżjoni tiegħu, is-CHMP ikkunsidra d-dejta kollha disponibbli dwar il-benefiċċji u r-riskji ta' derivati tal-ergotina, inkluża dejta minn studji kliniċi, rapporti tas-sigurtà wara t-tqegħid fis-suq u l-letteratura ppubblikata.
English: In some EU countries, certain ergot derivatives are also authorised for other indications not covered by the CHMP review, including other circulatory disorders, treatment of dementia (including Alzheimer's disease) and treatment of acute migraine.
Maltese: F'xi pajjiżi tal-UE, ċerti derivati tal-ergotina huma wkoll awtorizzati għal indikazzjonijiet oħra li mhumiex koperti mir-reviżjoni tas-CHMP, inklużi disturbi ċirkolatorji oħra, il-kura tad-dimenzja (inkluż il-marda ta' Alzheimer) u l-kura ta' emigranja akuta.
English: The CHMP opinion follows a review of available safety and efficacy data on ergot derivatives in the above indications, including clinical studies, post-marketing data in Europe and the published literature:
Maltese: L-opinjoni tas-CHMP issegwi reviżjoni tad-dejta disponibbli dwar is-sigurtà u l-effikaċja ta' derivati talergotina fl-indikazzjonijiet ta' hawn fuq, inklużi studji kliniċi, dejta wara t-tqegħid fis-suq fl-Ewropa u lletteratura ppubblikata:
English: Patients were young (mean age 41 years-old), with a short time to onset after starting dihydroergotamine (less than 2 months, mean: 2 days).
Maltese: Il-pazjenti kienu żgħar (età medja ta' 41 sena), bi żmien qasir għall-bidu tagħhom wara li nbeda dihydroergotamine (anqas minn xahrejn, medja: jumejn).
English: As a result, they should no longer be used in the EU to treat a number of conditions involving blood circulation problems (that usually affect elderly patients) or problems with memory and sensation, or to prevent migraine headaches, as the risks outweigh the benefits.
Maltese: B'riżultat ta' dan, m'għandhomx jibqgħu jintużaw fl-UE biex jittrattaw għadd ta' kondizzjonijiet li jinvolvu problemi fiċ-ċirkolazzjoni tad-demm (li normalment jaffettwaw pazjenti anzjani) jew problemi bil-memorja u s-sensazzjoni, jew għallprevenzjoni ta' uġigħ ta' ras tal-emigranja, peress li r-riskji huma akbar mill-benefiċċji.
English: Restrictions on use of medicines containing ergot derivatives
Maltese: Restrizzjonijiet dwar l-użu ta' mediċini li fihom derivati tal-ergotina
English: The CHMP noted the difficulty of diagnosing fibrosis (due to delayed onset of symptoms) and the probability of under-reporting of fibrotic reactions.
Maltese: Is-CHMP innota d-diffikultà biex issir dijanjosi ta' fibrożi (minħabba li s-sintomi jdumu biex jidhru) u l-probabbiltà ta' nuqqas ta' rappurtar ta' reazzjonijiet fibrotiċi.
English: CHMP confirms its recommendations for dihydroergotoxine following a reexamination
Maltese: Aktar dwar il-proċedura
English: • Ergot derivatives are recognised as being capable of inducing fibrosis, in particular heart valve fibrosis, through serotoninergic receptor activation, which is extensively described in the literature.
Maltese: • Derivattivi tal-ergotina huma rikonoxxuti li kapaċi jinduċu fibrożi, b'mod partikolari, fibrożi tal-valvi tal-qalb, permezz tal-attivazzjoni tar-riċetturi serotonerġiċi, li ġiet deskritta b'mod estensiv filletteratura.
English: There were fewer reports of fibrotic reactions with the other ergot derivatives.
Maltese: Kien hemm anqas rapporti ta' reazzjonijiet fibrotiċi bid-derivati l oħra tal-ergotina.
English: − Ancillary treatment of visual acuity decrease and visual field disturbances presumably of vascular origin;
Maltese: − Kura anċillari ta' tnaqqis fil-preċiżjoni viżwali u disturbi fil-kamp viżiv preżumibbilment ta'
English: These medicines should no longer be used to treat several conditions involving blood circulation problems or problems with memory and sensation, or to prevent migraine headaches, since the risks are greater than the benefits in these indications.
Maltese: Dawn il-mediċini m'għandhomx jibqgħu jintużaw għall-kura ta' diversi kondizzjonijiet li jinvolvu problemi fiċ-ċirkolazzjoni tad-demm jew problemi bil-memorja u s-sensazzjoni, jew għall-prevenzjoni ta' uġigħ ta' ras talemigranja, peress li r-riskji huma akbar mill-benefiċċji f'dawn l-indikazzjonijiet.
English: Invented Name
Maltese: Numru ta' l-EU Isem inventat
English: 7 vials + 7 pre-filled syringes + 14 injection needles + 14 alcohol swabs
Maltese: Mnejn jingħata Il-pakkett
English: It is available as tablets (500 mg) and capsules (250 mg).
Maltese: Huwa disponibbli bħala pilloli (500 mg) u kapsuli (250 mg).
English: The full EPAR for Myclausen 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: Myclausen is a ‘generic medicine'.
Maltese: Myclausen huwa ‘mediċina ġenerika'.
English: Myclausen mycophenolate mofetil
Maltese: Myclausen mikofonelat mofetil (mycophenolate mofetil)
English: Other information about Myclausen:
Maltese: Informazzjoni oħra dwar Myclausen:
English: The European Commission granted a marketing authorisation valid throughout the EU for Myclausen on 7 October 2010.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha għal Myclausen fis7 ta' Ottubru 2010.
English: The active substance in Myclausen, mycophenolate mofetil, is an immunosuppressive medicine.
Maltese: Is-sustanza attiva f'Myclausen, il-mikofenolat mofetil, hija mediċina immunosuppressiva.
English: This document is a summary of the European public assessment report (EPAR) for Myclausen.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Myclausen.
English: What are the benefit and risk of Myclausen?
Maltese: X'inhuma l-benefiċċju u r-riskju ta' Myclausen?
English: Myclausen is a medicine that contains the active substance mycophenolate mofetil.
Maltese: Myclausen huwa mediċina li fiha s-sustanza attiva mikofonelat mofetil.
English: For liver transplants in adults, mycophenolate mofetil should be given as an infusion (drip into a vein) for the first four days after the transplant, before the patient is switched to Myclausen 1.5 g twice a day as soon as it can be tolerated.
Maltese: Għal trapjanti tal-fwied fl-adulti, il-mikofonelat mofetil għandu jingħata bħala infużjoni (dripp fil-vina) għall-ewwel erbat ijiem wara t-trapjant, qabel ma l-pazjent jibda jingħata Myclausen 1.5 g darbtejn kuljum hekk kif dan ikun jista' jiġi tollerat.
English: The CHMP concluded that, in accordance with EU requirements, Myclausen has been shown to have comparable quality and to be bioequivalent to Cellcept.
Maltese: Is-CHMP ikkonkluda li, f'konformità mar-rekwiżiti tal-UE, Myclausen wera li għandu kwalità komparabbli u li huwa bijoekwivalenti ma' Cellcept.
English: Because Myclausen is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Cellcept.
Maltese: Peress li Myclausen huwa mediċina ġenerika, l-istudji fil-pazjenti kienu limitati għal testijiet li jiddeterminaw il-bijoekwivalenza tiegħu għall-mediċina ta' referenza, Cellcept.