FrancophonIA/ELRC3.0 huggingface dataset:
English: 1 GS-US-312-0123 a phase 3, randomised, double blind, placebo-controlled study evaluating the efficacy and safety of idelalisib in combination with bendamustine and rituximab for previously untreated CLL GS-US-313-0124 a phase 3, randomised, double blind, placebo-controlled study evaluating the efficacy and safety of idelalisib in combination with rituximab for previously treated iNHL GS-US-313-0125 a phase 3, randomised, double blind, placebo-controlled study evaluating the efficacy and safety of idelalisib in combination with bendamustine and rituximab for previously treated iNHL
Maltese: GS-US-312-0123, studju tal-fażi tlieta, randomizzat, double blind, ikkontrollat bil-plaċebo li jevalwa l-effikaċja u s-sigurtà ta' idelalisib flimkien ma' bendamustine u rituximab għal CLL li qabel ma kienx ikkurat GS-US-313-0124 studju tal-fażi tlieta, randomizzat, double blind, ikkontrollat bil-plaċebo li jevalwa l-effikaċja u s-sigurta ta' idelalisib flimkien ma' rituximab għal iNHL ikkurata qabel
English: On 11 March 2016, pursuant to Article 20 of Regulation (EC) No 726/2004, the European Commission requested the opinion of the Agency on whether the marketing authorisation of Zydelig (idelalisib) should be maintained, varied, suspended or revoked.
Maltese: Fil-11 ta' Marzu 2016, skont l-Artikolu 20 tar-Regolament (KE) Nru 726/2004, il-Kummissjoni Ewropea talbet l-opinjoni tal-Aġenzija dwar jekk l-awtorizzazzjoni għat-tqegħid fis-suq ta' Zydelig (idelalisib) għandhiex tinżamm, tinbidel, tiġi sospiża jew revokata.
English: Regular clinical and laboratory monitoring for cytomegalovirus infection is also recommended in patients with evidence of prior infection.
Maltese: Monitoraġġ kliniku u fil-laboratorju regolari għall-infezzjoni b'cytomegalovirus huwa rrakkomandat ukoll fil-pazjenti b'evidenza ta' infezzjoni preċedenti.
English: • The PRAC reviewed the preliminary data provided by the marketing authorisation holder on the interim results of studies GS-US-312-0123, GS-US-313-0124, GS-US-313-0125 that suggested an increased risk of death and serious infection with idelalisib.
Maltese: • Il-PRAC irrieżamina d-data preliminari pprovduta mid-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq dwar ir-riżultati interim tal-istudji GS-US-312-0123, GS-US-313-0124, GS-US-3130125 li ssuġġeriet żieda akbar fir-riskju ta' mewt u infezzjoni serja b'idelalisib.
English: • The PRAC noted that studies -0123, -0124 and -0125 involved patient groups and treatment combinations different from those of the authorised indications of Zydelig.
Maltese: • Il-PRAC innota li l-istudji -0123, -0124 u -0125 kienu jinvolvu gruppi ta' pazjenti u kombinazzjonijiet ta' kura differenti minn dawk tal-indikazzjonijiet awtorizzati ta' Zydelig.
English: The PRAC also reviewed all the other relevant data presented by the MAH and the views expressed by the oncology scientific advisory group.
Maltese: Il-PRAC eżamina d-data rilevanti kollha l-oħra ppreżentata mill-MAH u l-opinjonijiet espressi mill-grupp xjentifiku konsultattiv dwar l-onkoloġija.
English: The CHMP, as a consequence, considers that the benefit-risk balance of Zydelig (idelalisib) remains favourable subject to the amendments to the product information.
Maltese: Konsegwentement, is-CHMP ikkunsidra li l-bilanċ bejn il-benefiċċju u r-riskju ta' Zydelig (idelalisib) jibqa' favorevoli soġġett għall-emendi fl-informazzjoni tal-prodott.
English: The PRAC concluded that the same risk minimisation measures should be applied.
Maltese: Il-PRAC ikkonkluda li għandhom jiġu applikati l-istess miżuri ta' tnaqqis tar-riskju.
English: The CHMP recently adopted a positive opinion to also authorise the use of idelalisib in CLL in combination with another anti CD20 monoclonal antibody, ofatumumab.
Maltese: Is-CHMP dan l-aħħar adotta opinjoni pożittiva sabiex jawtorizza wkoll l-użu ta' idelalisib f'CLL flimkien ma' antikorp monoklonali ieħor li jaħdem kontra s-CD20, ofatumumab.
English: Idelalisib is known to cause very commonly infections and neutropenia and these risks are reflected in the product information.
Maltese: Idelalisib huwa magħruf li jikkawża infezzjonijiet komuni ħafna u newtropenija u dawn ir-riskji huma riflessi fl-informazzjoni dwar il-prodott.
English: The PRAC considered the new interim safety data and very limited efficacy data from three studies (-0123,0124, -0125), that have been terminated, evaluating the addition of idelalisib to standard therapies in first line CLL and relapsed indolent non-Hodgkin lymphoma (iNHL)/small lymphocytic lymphoma (SLL) as well as the results of all other relevant trials including those that supported the above listed indications.
Maltese: Il-PRAC ikkunsidra d-data interim ġdida dwar is-sigurtà u data limitata ħafna dwar l-effikaċja minn tliet studji (0123, -0124, -0125), li ġew itterminati, filwaqt li evalwa ż-żieda ta' idelalisib mat-terapiji standard għas-CLL tal-ewwel għażla u rikaduti ta' limfoma mhux ta' Hodgkin indolenti (iNHL) /limfoma limfoċitika żgħira (SLL) kif ukoll ir-riżultati tal-provi rilevanti l-oħrajn kollha inklużi dawk li kienu jappoġġjaw l-indikazzjonijiet imsemmija hawn fuq.
English: Zydelig (idelalisib) is a centrally authorised product and is currently indicated in combination with rituximab for the treatment of adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy, or as first line treatment in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy.
Maltese: Zydelig (idelalisib) huwa prodott awtorizzat skont proċedura ċentralizzata u attwalment huwa indikat flimkien ma' rituximab għall-kura ta' pazjenti adulti b'lewkimja limfoċitika kronika (CLL) li tal-anqas ikunu rċevew terapija waħda preċedenti, jew bħala kura tal-ewwel għażla fil-preżenza ta' tħassir ta' 17p jew ta' mutazzjoni ta' TP53 f'pazjenti li l-kimoimmunoterapija mhijiex adatta għalihom.
English: CMV infections were also notably reported in the idelalisib treatment arms, however, in controlled studies where idelalisib was administered in combination with rituximab or ofatumumab and not bendamustine, the reported rate was low.
Maltese: Infezzjonijiet CMV ukoll kienu notevolment irrapportati fil-gruppi tal-kura b'idelalisib, madankollu, fi studji kkontrollati fejn idelalisib ingħata flimkien ma' rituximab jew ofatumumab u mhux bendamustine, ir-rata rrapportata kienet baxxa.
English: Following the same precautionary principle, in view of the limited data available in treatment naïve patients with 17p deletion or TP53 mutation it was also considered that idelalisib in combination with ofatumumab should be only be used first-line in CLL patients with 17p deletion or TP53 mutation who are not eligible for any other therapies.
Maltese: Skont l-istess prinċipju ta' prekawzjoni, fid-dawl tad-data limitata disponibbli f'pazjenti li ma ngħatawx kura bi tħassir ta' 17p jew mutazzjoni ta' TP53, kien ikkunsidrat ukoll li idelalisib flimkien ma' ofatumumab għandu jintuża biss f'pazjenti b'CLL tal-ewwel għażla bi tħassir ta' 17p jew mutazzjoni ta' TP53 li mhumiex eliġibbli għal kwalunkwe terapija oħra.
English: No low-risk population or risk-free period could be identified and the risk may persist after end of therapy, therefore, taking into account current guidelines on PJP prophylaxis and in line with the advice from experts consulted during the review (scientific advisory group [SAG]), the PRAC recommended that PJP prophylaxis should be administered to all patients throughout idelalisib treatment and prolonged afterward for up to 6 months based on clinical judgement.
Maltese: Ma ġiet identifikata ebda popolazzjoni b'riskju baxx jew perjodu mingħajr riskju u r-riskju jista' jkompli wara li tintemm itterapija, u għalhekk, wara li kkunsidra l-linji gwida attwali dwar il-profilassi għall-PJP u f'konformità mal-parir tal-esperti kkonsultati waqt ir-reviżjoni (il-grupp xjentifiku konsultattiv [SAG]), il-PRAC irrakkomanda li l-profilassi għall-PJP għandha tingħata lill-pazjenti kollha tul il-kura kollu b'idelalisib u estiża sa sitt xhur wara skont il-ġudizzju kliniku.
English: On 10 March 2016, the European Commission was informed that an increased risk of death and higher incidence of serious adverse events (SAE) among subjects receiving idelalisib compared to the control groups had been observed in three clinical trials by the independent safety data monitoring group.
Maltese: Fl-10 ta' Marzu 2016, il-Kummissjoni Ewropea ġiet infurmata li fi tliet provi kliniċi, il-grupp Indipendenti ta' Monitoraġġ tas-Sikurezza tad-Data kien osserva riskju akbar ta' mewt u inċidenza ogħla ta' avvenimenti avversi serji (SAE) fost individwi li kienu qed jirċievu idelalisib meta mqabbla mal-gruppi ta' kontroll.
English: In particular an increased incidence of PJP, carrying a high risk of morbidity and mortality, was observed in the idelalisib treatment arms compared to controls in all the studies, and appeared to be significantly lower in patients administered PJP prophylaxis.
Maltese: B'mod partikolari, fil-gruppi ta' kura b'idelalisib ġiet osservata inċidenza ogħla ta' PJP, li ġġorr magħha riskju għoli ta' morbidità u mortalità, meta mqabbla mal-kontrolli fl-istudji kollha, u dehret li kienet konsiderevolment aktar baxxa fil-pazjenti li ngħataw profilassi għall-PJP.
English: If the benefits of resuming idelalisib are judged to outweigh the risks of CMV, consideration should be given to administering pre-emptive CMV therapy.
Maltese: Jekk jitqies li l-benefiċċji li jerġa' jissokta l-kura b'idelalisib huma akbar mir-riskji ta' CMV, għandha tiġi kkunsidrata l-possibbiltà li tingħata terapija preventiva kontra s-CMV.
English: Similarly, in studies -0124 and -0125 idelalisib was not used as monotherapy as currently authorised but in combination with rituximab or rituximab and bendamustine, respectively.
Maltese: Bl-istess mod, fl-istudji -0124 u0125 idelalisib ma ntużax bħala monoterapija kif inhu awtorizzat bħalissa iżda flimkien ma' rituximab jew rituximab u bendamustine, rispettivament.
English: The PRAC considered that further minimisation measures of the known risk of infection related to the use of idelalisib were necessary.
Maltese: Il-PRAC ikkunsidra li kienu meħtieġa miżuri oħrajn ta' tnaqqis tar-riskju magħruf ta' infezzjoni relatat mal-użu ta' idelalisib.
English: The PRAC noted that in study -0123, idelalisib was administered in combination with rituximab and bendamustine (an unauthorised combination) in previously untreated CLL patients with and without 17p deletion/TP53 mutation, which is not the same population as the one in the current CLL indication in first line.
Maltese: Il-PRAC innota li fl-istudju -0123, idelalisib ingħata flimkien ma' rituximab u bendamustine (kombinazzjoni mhux awtorizzata) f'pazjenti li kellhom CLL u li ma kinux ikkurati qabel bi jew mingħajr tħassir ta' 17p jew mutazzjoni ta' TP53, li mhijiex l-istess popolazzjoni bħal dik fl-indikazzjoni attwali tas-CLL tal-ewwel għażla.
English: Nevertheless, as a precaution and in view of the fact that limited data are available in treatment-naïve CLL patients with 17p deletion or TP53 mutation, the PRAC recommended that idelalisib should only be used in this group of patients if they are not eligible for any other therapies.
Maltese: Madankollu, bħala prekawzjoni u fid-dawl tal-fatt li data limitata hija disponibbli f'pazjenti b'CLL li ma ħadux kura bi tħassir ta' 17p jew mutazzjoni ta' TP53, il-PRAC irrakkomanda li idelalisib għandu jintuża biss f'dan il-grupp ta' pazjenti jekk mhumiex eliġibbli għal kwalunkwe terapija oħra.
English: To this effect, the PRAC recommended that treatment with idelalisib should not be initiated in patients with evidence of systemic infections, that patients should be monitored for respiratory symptoms and that they should be administered Pneumocystis jirovecii pneumonia prophylaxis throughout and after idelalisib treatment.
Maltese: B'mod partikolari, il-PRAC irrakkomanda li l-kura ma għandhiex tinbeda f'pazjenti b'evidenza ta' infezzjoni sistemika kontinwa, li l-pazjenti għandhom jiġu mmonitorjati għal sinjali u sintomi respiratorji u għandhom jiġu avżati biex jirrapportaw sintomi respiratorji ġodda minnufih.
English: Menveo is a vaccine.
Maltese: Menveo huwa vaċċin.
English: It contains parts of the bacterium Neisseria meningitidis (N. meningitidis).
Maltese: Fih partijiet tal-batterju Neisseria meningitidis (N. meningitidis).
English: Menveo meningococcal group A, C, W135 and Y conjugate vaccine
Maltese: Menveo grupp meninġokokkali A, C, W135 u Y vaċċin konjugat
English: The European Commission granted a marketing authorisation valid throughout the European Union for Menveo on 15 March 2010.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Menveo valida fl-Unjoni Ewropea kollha fil-15 ta' Marzu 2010.
English: This document is a summary of the European Public Assessment Report (EPAR) for Menveo.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Menveo.
English: Menveo was compared with a similar conjugated vaccine against N. meningitidis.
Maltese: Menveo tqabbel ma' vaċċin simili konjugat kontra l-N. meningitidis.
English: The ability of Menveo to trigger the production of antibodies (immunogenicity) was assessed in a main study involving almost 4,000 participants aged 11 years and above and in a second main study involving almost 3,000 children between two and 10 years old.
Maltese: L-abilità ta' Menveo li jqanqal il-produzzjoni ta' antikorpi (immunoġeniċità) kienet ivvalutata fi studju li involva kważi 4,000 parteċipant minn 11-il sena ‘l fuq u fi studju ewlieni ieħor li involva kważi 3,000 tifel u tifla li kellhom bejn is-sentejn u l-10 snin.
English: This summary was last updated in 09-2015.
Maltese: Dan is-sommarju ġie aġġornat f'09-2015.
English: Menveo is used to protect adults and children from the age of two against invasive disease caused by four groups of the bacterium N. meningitidis (A, C, W135, and Y).
Maltese: Menveo jintuża biex jipproteġi l-adulti u lit-tfal minn sentejn 'il fuq kontra mard invażiv ikkaġunat minn erba' gruppi tal-batterju N. meningitidis (A, C, W-135, u Y).
English: In children between two and 10 years old, the most common side effects were similar and also included sleepiness and irritability.
Maltese: Fit-tfal ta' bejn is-sentejn u l-10 snin, l-effetti sekondarji l-aktar komuni kienu simili u inkludew il-ħedla u l-irritabbiltà.
English: How has Menveo been studied?
Maltese: Kif ġie studjat Menveo?
English: The CHMP noted that five N. meningitidis bacterial groups (A, B, C, W135 and Y) are responsible for invasive disease, and that Menveo provides broader protection than other available vaccines.
Maltese: Is-CHMP innota li ħames gruppi ta' batterju N. meningitidis (A, B, C, W135 u Y) huma responsabbli mill-marda invażiva, u li Menveo jagħti protezzjoni usa' minn vaċċini oħra disponibbli.
English: The most common side effects with Menveo in adults and children from the age of 11 (seen in more than 1 patient in 10) are headache, nausea (feeling sick), malaise (feeling unwell), myalgia (muscle pain), as well as pain, erythema (reddening of the skin) and induration (hardening) at the site of injection.
Maltese: L-effetti sekondarji l-aktar komuni bl-użu ta' Menveo fl-adulti u fit-tfal minn 11-il sena 'l fuq (li dehru f'aktar minn pazjent wieħed minn għaxra) huma wġigħ ta' ras, nawżja (tħossok ma tiflaħx), telqa (ma tħossokx f'sikktek), mijalġja (uġigħ muskolari), kif ukoll uġigħ, eritema (ħmura fil-ġilda) u ebusija fissit tal-injezzjoni.
English: What is the risk associated with Menveo?
Maltese: X'inhu r-riskju assoċjat ma' Menveo?
English: Other information about Menveo
Maltese: Kif jintuża Menveo?
English: The full EPAR for Menveo 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 Għal aktar informazzjoni rigward il-kura b'Menveo, aqra l-fuljett ta' tagħrif (parti wkoll mill-EPAR) jew ikkuntattja lit-tabib jew lill-ispiżjar tiegħek.
English: Why has Menveo been approved?
Maltese: Għaliex ġie approvat Menveo?
English: Menveo is used in people who are at risk of exposure to the bacterium.
Maltese: Menveo jintuża fuq persuni b'riskju ta' esponiment għall-batterju.
English: A risk management plan has been developed to ensure that Menveo is used as safely as possible.
Maltese: Ġie żviluppat pjan ta' ġestjoni tar-riskju biex jiżgura li Menveo jintuża bl-aktar mod sigur possibbli.
English: How is Menveo used?
Maltese: X'inhu Menveo?
English: The results of the main studies showed that Menveo was as effective as the comparator vaccine in stimulating an immune response against all four types of N. meningitidis oligosaccharides in adults and children from the age of two.
Maltese: Ir-riżultati tal-istudji ewlenin urew li Menveo kien effikaċi daqs il-vaċċin komparatur fl-istimulazzjoni ta' rispons immunitarju kontra l-erba' tipi kollha tal-oligosakkaridi tal-N. meningitidis fl-adulti u fladoloxxenti minn sentejn ‘il fuq.
English: The Committee therefore decided that Menveo's benefits are greater than its risks in people who are at risk of exposure to N. meningitidis bacterium, and recommended that it be given marketing authorisation.
Maltese: Għalhekk il-Kumitat iddeċieda li l-benefiċċji ta' Menveo huma akbar mir-riskji tiegħu fir-rigward ta' persuni li jkunu f'riskju li jkunu esposti għall-batterju N. meningitidis, u għaldaqstant irrakkomanda li jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: Menveo is given as a single injection preferably into the shoulder muscle.
Maltese: Menveo jingħata permezz ta' injezzjoni waħda preferibbilment fil-muskolu tal-ispalla.
English: The main measure of effectiveness was whether Menveo was as good as the comparator vaccine at stimulating immune response against the four types of N. meningitidis oligosaccharides.
Maltese: L-għadd ta' persuni li kellhom rispons immunitarju kontra loligosakkaridi kien simili għaż-żewġ vaċċini.
English: Menveo must not be used in people who are hypersensitive (allergic) to the active substances or any of the other ingredients, including diphtheria toxoid.
Maltese: Menveo ma għandux jintuża f'nies li jistgħu jkunu ipersensittivi (allerġiċi) għas-sustanzi attivi jew għal kwalunkwe sustanza oħra tiegħu, fosthom difterija toksojd.
English: What is Menveo used for?
Maltese: Kif jaħdem Menveo?
English: Invasive disease occurs when the bacteria spread through the body causing serious infections such as meningitis (infection of the membranes that surround the brain and spine) and septicaemia (blood infection).
Maltese: Mard invażiv iseħħ meta l-batterji jinfirxu mal-ġisem u jikkawżaw infezzjonijiet serji bħal meninġite (infezzjoni tal-membrani madwar ilmoħħ u l-ispina) u settiċemija (infezzjoni tad-demm).
English: Menveo contains small amounts of oligosaccharides (a type of sugar) extracted from four groups of the N. meningitidis bacterium: A, C, W135 and Y. These have been purified, then ‘conjugated' (attached) to a protein from the bacterium Corynebacterium diphtheriae.
Maltese: Dawn jiġu purifikati u mbagħad konjugati'(imwaħħla) ma' proteina mill-batterju Corynebacterium diphtheriae.
English: The full EPAR for Lacosamide Accord 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: The medicine can only be obtained with a prescription and is available as tablets (50 mg; 100 mg; 150 mg; 200 mg).
Maltese: Il-mediċina tista' tinkiseb biss b'riċetta ta' tabib u tiġi bħala pilloli (50 mg; 100 mg; 150 mg; 200 mg).
English: The active substance in Lacosamide Accord, lacosamide, is an epilepsy medicine.
Maltese: Is-sustanza attiva f'Lacosamide Accord, lacosamide, hija mediċina kontra l-epilessija.
English: Lacosamide Accord contains the active substance lacosamide.
Maltese: Lacosamide Accord fih is-sustanza attiva lacosamide.
English: Other information about Lacosamide Accord
Maltese: Informazzjoni oħra dwar Lacosamide Accord
English: Lacosamide Accord is an epilepsy medicine used to treat partial-onset seizures (epileptic fits starting in one specific part of the brain) in patients with epilepsy aged 16 years or older.
Maltese: Lacosamide Accord huwa mediċina kontra l-epilessija li tintuża biex tikkura attakki ta' puplesija li jevolvu b'mod parzjali (attakki epilettiċi li jibdew minn parti speċifika tal-moħħ) f'pazjenti li jbatu millepilessija u li għandhom minn 16-il sena ‘l fuq.
English: This is a summary of the European public assessment report (EPAR) for Lacosamide Accord.
Maltese: Dan huwa sommarju tar-rappport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Lacosamide Accord.
English: Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicine, Vimpat, and do not need to be repeated for Lacosamide Accord.
Maltese: Diġà saru studji dwar il-benefiċċji u r-riskji tas-sustanza attiva fl-użu approvat mal-mediċina ta' referenza, Vimpat, u ma għandhomx għalfejn jiġu ripetuti għal Lacosamide Accord.
English: There was no need for ‘bioequivalence' studies to investigate whether Lacosamide Accord is absorbed similarly to the reference medicine to produce the same level of the active substance in the blood.
Maltese: Ma kienx hemm bżonn ta' studji ta' "bijoekwivalenza" biex jiġi investigat jekk Lacosamide Accord jiġix assorbit b'mod simili bħall-mediċina ta' referenza biex jipproduċi l-istess livell tas-sustanza attiva fid-demm.
English: The exact way in which lacosamide works is still unclear but it seems to reduce the activity of sodium channels (pores on the surface of nerve cells) that allow electrical impulses to be transmitted between nerve cells.
Maltese: Il-mod eżatt ta' kif taħdem il-lakosamide għadu mhuwiex ċar, iżda jidher li din tnaqqas l-attività tal-kanali tas-sodju (pori fil-wiċċ taċ-ċelloli tannervituri) li jippermettu t-trażmissjoni ta' impulsi elettriċi bejn iċ-ċelloli tan-nervituri.
English: Because Lacosamide Accord is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Minħabba li Lacosamide Accord huwa mediċina ġenerika, il-benefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: The usual starting dose is 50 mg twice a day which may be increased weekly to a maximum dose of 300 mg twice a day if used alone, or 200 mg twice a day if given with other epilepsy medicines.
Maltese: Id-doża tal-bidu tas-soltu hija 50 mg darbtejn kuljum li tista' tiżdied kull ġimgħa għal doża massima ta' 300 mg darbtejn kuljum jekk użata waħidha, jew 200 mg darbtejn kuljum jekk tingħata ma' mediċini
English: Together, these actions may prevent abnormal electrical activity spreading through the brain, reducing the chance of an epileptic fit.
Maltese: Flimkien, dawn l-azzjonijiet jistgħu jipprevjenu l-attività elettrika anormali milli tinfirex mal-moħħ kollu, u b'hekk inaqqsu lpossibbiltà ta' attakk epilettiku.
English: EPAR summary for the public
Maltese: Sommarju tal-EPAR għall-pubbliku lacosamide
English: This means that Lacosamide Accord contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Vimpat.
Maltese: Dan ifisser li Lacosamide Accord fih l-istess sustanza attiva u jaħdem bl-istess mod bħal "mediċina ta' referenza" diġà awtorizzata fl-Unjoni Ewropea (UE) imsejħa Vimpat.
English: This is because the active substance, lacosamide, has been shown to be highly soluble and completely absorbed, meaning that almost 100% of the substance reaches the blood when taken by mouth.
Maltese: Dan għaliex is-sustanza attiva lacosamide, intweriet li hija solubbli ħafna u tiġi assorbita kompletament, li jfisser li kważi 100 % tas-sustanza tasal fid-demm meta tittieħed mill-ħalq.
English: Why is Lacosamide Accord approved?
Maltese: Għaliex ġie approvat Lacosamide Accord?