FrancophonIA/ELRC3.0 huggingface dataset:
English: The adverse events were generally benign in nature, and mostly restricted to the gastrointestinal tract (such as abdominal pain and nausea) or related to the occurrence of skin efflorescences.
Maltese: L-avvenimenti avversi kienu ġeneralment beninni fin-natura tagħhom, u ħafna drabi ristretti għall-apparat gastrointestinali (bħal uġigħ addominali u nawżja) jew relatati mal-okkorrenza tat-twarrid tal-ġilda.
English: The CHMP was of the opinion that a significant number of adverse events would have been expected to be reported in this study due to the underlying disease regardless of the safety profile of Symbioflor 2.
Maltese: Is-CHMP kien tal-fehma li kien mistenni li jiġi rrappurtat numru kbir ta' avvenimenti avversi f'dan listudju minħabba l-marda sottostanti irrispettivament mill-profil tas-sigurtà ta' Symbioflor 2.
English: The CHMP noted that in the clinical development program no data were available for treatment beyond 8 weeks.
Maltese: Is-CHMP innota li fil-programm ta' żvilupp kliniku ma kien hemm l-ebda data disponibbli għal kura wara 8 ġimgħat.
English: In the absence of a run-in phase and specific inclusion criteria, there was also insufficient assurance that the patient population suffered from IBS.
Maltese: Fin-nuqqas ta' fażi preklinika u kriterji ta' inklużjoni speċifiċi, kien hemm ukoll assigurazzjoni insuffiċjenti li lpopolazzjoni tal-pazjenti sofriet minn IBS.
English: The CHMP recommends amendments to the product information and in view of the limitations of the currently available efficacy data for Symbioflor2 in the treatment of irritable bowel syndrome (IBS), the CHMP is of the view that a post-authorisation efficacy study should be conducted.
Maltese: Is-CHMP jirrakkomanda emendi fl-informazzjoni dwar il-prodott u fid-dawl tal-limitazzjonijiet tad-data tal-effikaċja disponibbli bħalissa għal Symbioflor 2 fil-kura ta' sindrome talmusrana irritabbli (IBS), is-CHMP huwa tal-fehma li għandu jsir studju dwar l-effikaċja ta' wara lawtorizzazzjoni.
English: The evaluation of the results was descriptive and thus did not allow establishing whether the differences in efficacy between Symbioflor 2 and placebo were statistically different and clinically meaningful.
Maltese: Il-valutazzjoni tar-riżultati kienet deskrittiva u għalhekk ma ppermettietx li jiġi stabbilit jekk id-differenzi fl-effikaċja bejn Symbioflor 2 u l-plaċebo kinix statistikament differenti u klinikament sinifikanti.
English: • The CHMP also noted that results of the observational study in children older than 4 years with IBS suggested a possible efficacy of Symbioflor 2.
Maltese: • Is-CHMP innota wkoll li r-riżultati tal-istudju ta' osservazzjoni fi tfal ikbar minn 4 snin b'IBS issuġġerew effikaċja possibbli ta' Symbioflor 2.
English: The CHMP acknowledged the MAH's proposal to delete this indication as, in the absence of any data to support the treatment of functional gastrointestinal disorders, a positive benefit-risk balance of Symbioflor 2 could not be established;
Maltese: Is-CHMP irrikonoxxa li l-proposta tal-MAH li jneħħi din l-indikazzjoni peress li, fin-nuqqas ta xi data li tappoġġa l-kura ta disturbi gastrointestinali funzjonali, ma setax jiġi stabbilit bilanċ bejn il-bilanċ bejn il-benefiċċju u r-riskju pożittiv ta Symbioflor 2;
English: In addition, the CHMP noted that data generated in study S2 have not established the long term efficacy of Symbioflor 2 beyond 8 weeks of treatment.
Maltese: Barra minn hekk, is-CHMP innota li data ġġenerata fl-istudju S2 ma stabbilixiex l-effikaċja fit-tul ta' Symbioflor 2 wara 8 ġimgħat ta' kura.
English: Two reports in support of the claimed indication in the treatment of irritable bowel syndrome (IBS) were submitted in the context of this referral procedure:
Maltese: Fil-kuntest ta' din il-proċedura ta' riferiment ġew ippreżentati żewġ rapporti biex jappoġġjaw lindikazzjoni ddikjarata fil-kura ta' sindrome tal-musrana irritabbli (IBS, irritable bowel syndrome):
English: Data were not controlled and did thus not account for the contribution of spontaneous fluctuations of IBS symptoms or for a placebo response in the assessment of the benefit-risk of Symbioflor 2.
Maltese: Id-data ma kinitx ikkontrollata u għalhekk ma kopritx il-kontribut ta' flutwazzjonijiet spontanji ta' sintomi tal-IBS jew għal rispons tal-plaċebo f'valutazzjoni tal-benefiċċju u r-riskju ta' Symbioflor 2.
English: In summary, in the absence of valid statistical evaluation and given the risk of bias and the paucity of elements contributing to support the robustness and the strength of the results (the evidence being based on a single pivotal trial), the CHMP was not able to confidently draw a conclusion with regards to the efficacy of Symbioflor 2 in IBS or a sub-type of IBS.
Maltese: Fil-qosor, fin-nuqqas ta' valutazzjoni statistika valida u minħabba r-riskju ta' preġudizzju u linsuffiċjenza tal-elementi li jikkontribwixxu għall-appoġġ tar-robustezza u l-qawwa tar-riżultati (levidenza bbażata fuq prova pivotali waħda), is-CHMP ma setax jagħmel konklużjoni b'fiduċja firrigward tal-effikaċja ta' Symbioflor 2 fl-IBS jew f'sottotip tal-IBS.
English: The full EPAR for Iscover can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Maltese: L-EPAR sħiħ ta' Iscover jinsab fis-sit elettroniku tal-Aġenzija ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: Iscover clopidogrel
Maltese: Iscover klopidogrel
English: In CAPRIE, there were 939 events in the Iscover group, and 1,020 in the aspirin group.
Maltese: Fl-istudju CAPRIE kien hemm 939 każ fil-grupp ta' Iscover u 1,020 fil-grupp tal-aspirina.
English: The most common side effects with Iscover (seen in between 1 and 10 patients in 100) are haematoma (a collection of blood under the skin), epistaxis (nosebleeds), gastrointestinal haemorrhage (bleeding in the stomach or gut), diarrhoea, abdominal pain (stomach ache), dyspepsia (heartburn), bruising and bleeding where the skin is punctured.
Maltese: L-iktar effetti sekondarji komuni bl-użu ta' Iscover (li dehru f'bejn 1 u 10 pazjenti minn kull 100) huma ematoma (ġbir ta' demm taħt il-ġilda), epistassi (fġir tal-imnieħer), emorraġija gastrointestinali (ħruġ ta' demm fiż-żaqq jew fil-musrana), dijarrea, uġigħ addominali (fiż-żaqq), dispepsija (indiġestjoni), tbenġil u ħruġ ta' demm minn fejn il-ġilda tkun ittaqqbet.
English: Iscover is a medicine that contains the active substance clopidogrel.
Maltese: Iscover huwa mediċina li fiha s-sustanza attiva klopidogrel.
English: This is a summary of the European public assessment report (EPAR) for Iscover.
Maltese: Dan id-dokument huwa sommarju tar-Rapport Pubbliku Ewropew ta' Valutazzjoni (EPAR) għal Iscover.
English: In ST segment elevation myocardial infarction, fewer patients on Iscover had events than patients on placebo (262 against 377 in the CLARITY study, and 2,121 against 2,310 in the COMMIT study).
Maltese: Fir-rigward ta' każi ta' infart mijokardiku b'elevazzjoni tas-segment ST, l-għadd ta' pazjenti li ngħataw Iscover u li għaddew minn avvenimenti iskemiki kien inqas mill-għadd tal-pazjenti li ngħataw plaċebo (262 u 377 rispettivament fl-istudju CLARITY, u 2,121 u 2,310 rispettivament fl-istudju COMMIT).
English: The active substance in Iscover, clopidogrel, is an inhibitor of platelet aggregation.
Maltese: Is-sustanza attiva f'Iscover, jiġifieri l-klopidogrel, hija inibitur tal-aggregazzjoni tal-pjastrini.
English: Iscover was more effective than aspirin at preventing new ischaemic events.
Maltese: Iscover kien iktar effikaċi mill-aspirina fil-prevenzjoni ta' avvenimenti iskemiċi.
English: Iscover is used to prevent problems caused by blood clots in adults who have:
Maltese: Iscover jintuża biex jipprevjeni problemi kkawżati minn emboli f'adulti li:
English: The standard dose of Iscover is one 75-mg tablet once a day.
Maltese: Id-doża standard ta' Iscover hija pillola waħda ta' 75-mg kuljum.
English: What is the risk associated with Iscover?
Maltese: X'inhuma r-riskji assoċjati ma' Iscover?
English: In atrial fibrillation, Iscover has been compared with placebo (both taken together with aspirin) in one main study involving around 7,500 patients who had at least one risk factor for vascular events and who could not take vitamin K antagonist therapy.
Maltese: Fl-istudju dwar il-fibrillazzjoni atrijali Iscover tqabbel ma' plaċebo (meħud kemm mal-aspirina u kemm mingħajrha) matul studju wieħed li involva madwar 7,500 pazjent li kellhom tal-inqas fattur wieħed ta' riskju li jgħaddu minn avvenimenti vaskulari u li ma setgħetx issirilhom terapija bl-għoti tal-antagonisti tal-vitamina K.
English: In the study in atrial fibrillation patients, Iscover taken together with aspirin reduced the risk of new events by 11% compared with placebo taken with aspirin, with the largest reduction (28%) seen for stroke.
Maltese: Fl-istudju fuq pazjenti b'fibrillazzjoni atrijali, it-teħid ta' Iscover flimkien mal-aspirina naqqas ir-riskju ta' avveniment iskemiku ġdid bi 11% apparagun mat-teħid ta' plaċebo ma' aspirina.
English: Iscover as an anticoagulant has been compared with aspirin in a study called CAPRIE including around 19,000 patients who had recently had a heart attack or an ischaemic stroke, or who had established peripheral artery disease.
Maltese: Iscover, bħala antikoagulant, tqabbel mal-aspirina fi studju msejjaħ CAPRIE, li inkluda madwar 19,000 pazjent li riċentement kienu sofrew attakk tal-qalb jew puplesija iskemika, jew li kienet ħarġitilhom xi marda fl-arterji periferiċi.
English: In acute coronary syndrome, Iscover has been compared with placebo (a dummy treatment) in one study involving over 12,000 patients with non-ST segment elevation, 2,172 of whom had a stent inserted during the study (CURE study, lasting up to a year).
Maltese: Fl-istħarriġ tas-sindromu koronarju akut, Iscover tqabbel ma' plaċebo (trattament finta) fi studju wieħed li involva 'l fuq minn 12,000 pazjent b'sindromu mingħajr l-elevazzjoni tas-segment ST, li fosthom kien hemm 2,171 pazjent li waqt l-istudju ddaħħlilhom stent (l-istudju CURE, li dam mhux aktar minn sena).
English: In acute coronary syndrome and atrial fibrillation, Iscover is used together with aspirin, the dose of which should not be higher than 100 mg.
Maltese: Fil-każi ta' sindromu koronarju akut u ta' fibrillazzjoni atrijali, Iscover jittieħed flimkien ma' aspirina u f'dal-każi d-doża m'għandhiex taqbeż il-100 mg.
English: Iscover is converted into its active form in the body.
Maltese: Il-konverżjoni ta' Iscover fil-forma attiva tiegħu ssir fil-ġisem.
English: What is Iscover?
Maltese: X'inhu Iscover?
English: Iscover has also been compared with placebo in two studies involving patients with ST segment elevation: CLARITY, which involved over 3,000 patients and lasted for up to eight days; and COMMIT, which involved almost 46,000 patients and in which the patients received Iscover with or without metoprolol (another medicine used for heart problems or high blood pressure) for up to four weeks.
Maltese: Iscover tqabbel ukoll ma' plaċebo f'żewġ studji li involvew pazjenti b'elevazzjoni tassegment ST: L-istudju CLARITY involva madwar 3,000 pazjent u dam madwar tmint ijiem, mentri listudju COMMIT involva madwar 46,000 pazjent li ngħataw Iscover kemm bil-metoprolol (mediċina oħra użata għall-problemi fil-qalb jew għall-pressjoni għolja) u kemm mingħajrha tul erba' ġimgħat.
English: This showed that Iscover reduces the risk of an event.
Maltese: Dan wera li Iscover inaqqas ir-riskju ta' avvenimenti bħal dawn.
English: Why has Iscover been approved?
Maltese: Għaliex ġie approvat Iscover?
English: How has Iscover been studied?
Maltese: Kif ġie studjat Iscover?
English: It contains inactivated (killed) whole virus of two equine influenza (flu) strains (‘A/equine-2/South Africa/4/03' and ‘A/equine-2/Newmarket/2/93') and tetanus toxoid (chemically inactivated toxin from the tetanus bacterium).
Maltese: Fih virus sħiħ diżattivat (maqtul) ta' żewġ razez tal-influwenza ekwina (‘A/equine-2/South Africa/4/03' u ‘A/equine-2/Newmarket/2/93') u tossojde tat-tetnu (tossin diżattivat kimikament mill-batterju tat-tetnu).
English: The European Commission granted a marketing authorisation valid throughout the European Union, for Equilis Prequenza Te on 8 July 2005.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq valida fl-Unjoni Ewropea kollha għal Equilis Prequenza Te fit-8 ta' Lulju 2005.
English: Tetanus is an acute, often fatal disease caused by the toxin (poison) produced by the bacterium Clostridium tetani.
Maltese: It-tetnu huwa marda akuta, ħafna drabi fatali kkawżata mit-tossin (velenu) prodott mill-batterju Clostridium tetani.
English: The duration of protection was five months after primary vaccination and 12 months after the first revaccination for equine influenza and 17 months after primary vaccination and 24 months after the first revaccination for tetanus.
Maltese: It-tul tal-protezzjoni kienet ħames xhur wara t-tilqima primarja u 12-il xahar wara lewwel tilqima mill-ġdid għall-influwenza ekwina u 17-il xahar wara t-tilqima primarja u 24 xahar wara l-ewwel tilqima mill-ġdid tat-tetnu.
English: The main measure of effectiveness of Equilis Prequenza Te against equine influenza was the production of protective levels of antibodies against the influenza components.
Maltese: Il-kejl ewlieni tal-effikaċja ta' Equilis Prequenza Te kontra l-influwenza ekwina kien il-produzzjoni ta' livelli protettivi ta' antikorpi kontra l-komponenti tal-influwenza.
English: The disease, which usually originates from contaminated wounds, is characterised by overall rigidity (stiffness) and convulsive spasms of the muscles.
Maltese: Ilmarda, li ġeneralment toriġina minn ġrieħi kontaminati, hija kkaratterizzata minn riġidità (ebusija) ġenerali u spażmi konvulsivi tal-muskoli.
English: For ethical reasons no challenge (infection) experiment was performed against tetanus.
Maltese: Għal raġunijiet etiċi ma sar l-ebda esperiment ta' sfida (infezzjoni) kontra t-tetnu.
English: The studies showed that Equilis Prequenza Te is an effective vaccine against equine influenza to reduce clinical signs and virus excretion after infection, and against tetanus to prevent mortality, in horses from 6 months of age.
Maltese: L-istudji wrew li Equilis Prequenza Te huwa vaċċin effettiv kontra l-influwenza ekwina biex inaqqas issinjali kliniċi u l-eskrezzjoni tal-virus wara l-infezzjoni, u kontra t-tetnu biex jipprevjeni l-mortalità, fiżżwiemel ta' 6 xhur jew aktar.
English: Equine influenza and tetanus vaccine
Maltese: Vaċċin contra l-influwenza ekwina u t-tetnu
English: Equilis Prequenza Te is a vaccine for use in horses.
Maltese: Equilis Prequenza Te huwa vaċċin għall-użu fiż-żwiemel.
English: The vaccine also stimulates protection against tetanus to prevent mortality.
Maltese: Il-vaċċin jistimula wkoll il-protezzjoni kontra t-tetnu biex inaqqs il-mortalità.
English: Other information about Equilis Prequenza Te:
Maltese: Tagħrif ieħor dwar Equilis Prequenza Te:
English: Horses developed protective levels of antibodies two weeks after primary vaccination.
Maltese: Iż-żwiemel żviluppaw livelli protettivi ta' antikorpi ġimagħtejn wara ttilqima primarja.
English: Regarding tetanus, the main measure of effectiveness was the production of protective levels of antibodies against tetanus toxoid.
Maltese: Fir-rigward tat-tetnu, il-kejl ewlieni taleffikaċja kien il-produzzjoni ta' livelli protettivi ta' antikorpi kontra t-tossojde tat-tetnu.
English: The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Equilis Prequenza Te exceeded the risks for the approved indications and the Committee recommended that Equilis Prequenza Te be given a marketing authorisation.
Maltese: ll-Kumitat għall-Prodotti Mediċinali għall-Użu Veterinarju (CVMP) ikkonkluda li l-benefiċċji ta' Equilis Prequenza Te huma akbar mir-riskji tiegħu għall-indikazzjonijiet approvati u l-Kumitat irrakkomanda li Equilis Prequenza Te jingħata awtorizzazzjoni għat-tqegħid fis-suq.
English: Why has Equilis Prequenza Te been approved?
Maltese: Għaliex ġie approvat Equilis Prequenza Te?
English: The vaccine reduces the signs of equine influenza and the excretion (shedding) of the virus after infection.
Maltese: Il-vaċċin inaqqas is-sinjali tal-influwenza ekwina u tal-eskrezzjoni (tneħħija) tal-virus wara linfezzjoni.
English: What is Equilis Prequenza Te?
Maltese: X'hinu Equilis Prequenza Te?
English: What is the risk associated with Equilis Prequenza Te?
Maltese: X'inhu r-riskju assoċjat ma' Equilis Prequenza Te?
English: Equilis Prequenza Te contains inactivated whole virus of the influenza strains against which the vaccine is indicated.
Maltese: Equilis Prequenza Te fih virus sħiħ diżattivat tar-razez tal-influwenza li l-vaċċin hu indikat kontrihom.
English: Equilis Prequenza Te is used to vaccinate horses from six months of age against equine influenza and tetanus.
Maltese: Equilis Prequenza Te jintuża fit-tilqim taż-żwiemel mill-età ta' sitt xhur kontra l-influwenza ekwina u ttetnu.
English: In the future, the immune system will be able to produce antibodies more quickly when it is exposed to these virus strains or to the unmodified toxin.
Maltese: Fil-futur, is-sistema immunitarja tkun kapaċi tipproduċi l-antikorpi iktar malajr meta tkun esposta għal dawn ir-razez ta' virusis jew għat-tossin mhux modifikat.
English: Pain at the injection site can occur rarely.
Maltese: Jista' jkun hemm uġigħ fis-sit tal-injezzjoni, iżda dan huwa rari.
English: The current formulation of Equine Prequenza Te has been shown to produce similar results to those shown in the initial studies.
Maltese: L-għamla attwali ta' Equine Prequenza Te ntweriet li tipproduċi riżultati simili għal dawk murija flistudji inizjali
English: What benefit has Equilis Prequenza Te shown during the studies?
Maltese: X' benefiċċju wera Equilis Prequenza Te matul l-istudji?
English: The safety of the initial formulation of Equilis Prequenza Te was studied in several studies under laboratory and field conditions in a large number of horses, from 2 months of age.
Maltese: Is-sigurtà tal-għamla inizjali ta' Equilis Prequenza Te ġiet studjata f'diversi studji f'kundizzjonijiet ta' laboratorju u fuq il-post f'għadd kbir ta' żwiemel, mill-età ta' xahrejn.
English: ITT = Intent to Treat; PFS = Progression-free survival; CI = confidence interval.
Maltese: PFS = Sopravivenza mingħajr progressjoni; CI = intervall ta' fiduċja.
English: and BRF115532 (n=1,076)
Maltese: BRF115532 (n=1,076)
English: 09400, Aranda de Duero
Maltese: Extremadura, 3 09400, Aranda de Duero Burgos
English: 1/10,000 to <1/1,000
Maltese:  1/10,000 sa < 1/1,000
English: Extremadura, 3, 09400, Aranda De Duero, Burgos, Spain Novartis Pharmaceuticals UK Limited, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, United Kingdom
Maltese: Extremadura, 3, 09400, Aranda De Duero, Burgos, Spanja Novartis Pharmaceuticals UK Limited, Frimley Business Park, Frimley, Camberley, Surrey GU16 7SR, Ir-Renju Unit
English: Determination of BRAF mutation status
Maltese: Determinazzjoni ta' status ta' mutazzjoni BRAF
English: Chemotherapy a
Maltese: Kemoterapija a
English: Grade 2-3 RPED
Maltese: RPED ta' Grad 2-3
English: a, BRF113928,
Maltese: a, BRF113928, u
English: Trametinib plasma IV clearance is 3.21 L/hr.
Maltese: Eliminazzjoni ta' trametinib mill-plasma b'IV hija 3.21 L/hr.
English: Binding of trametinib to human plasma proteins is 97.4%.
Maltese: L-irbit ta' trametinib mal-proteini umani huwa 97.4%.
English: System Organ Class
Maltese: Sistema ta' Klassifika talOrgani
English: 7 tablets 30 tablets
Maltese: 30 pillola
English: ≥1/100 to <1/10
Maltese: ≥ 1/100 sa < 1/10
English: NE2 (8.3, NE) NE (6.9, NE)
Maltese: (8.3, NE) NE (6.9, NE)
English: The deacetylation is mediated by the carboxyl-esterases 1b, 1c and 2, with possible contributions by other hydrolytic enzymes.
Maltese: Id-deaċetilitazzjoni hija medjata minn carboxyl-esterases 1b, 1c u 2, b'kontribuzzjonijiet possibbliminn enzimi idrolitiċi oħrajn.
English: Do not take Mekinist:
Maltese: Tiħux Mekinist:
English: N Events Median, months (95% CI) NA (46.9, NA)
Maltese: N Avvenimenti Medju, xhur (95% CI) NA (46.9, NA)
English: Palmar-plantar erythrodysaesthesia syndrome
Maltese: Sindrome ta' eritrodisaestesija palmar-plantar
English: Chemotherapy (n=108)
Maltese: Kemoterapija (n=108)
English: Hypersensitivity a
Maltese: Sensittività eċċessiva a
English: Table 4 Adverse reactions reported in the integrated safety population of trametinib monotherapy (n=329)
Maltese: Tabella 4 Reazzjonijiet avversi rrapportati fil-popolazzjoni ta' sigurtà integrata ta' monoterapija b'trametinib (n = 329)
English: - The active substance is trametinib.
Maltese: - Is-sustanza attiva hija trametinib.
English: Grade 1 RPED
Maltese: RPED ta' Grad 1
English: Table 12 Survival data from the primary and post-hoc analyses
Maltese: Tabella 12 Dejta tas-sopravivenza mill-analiżi primarja u post-hoc
English: Deep vein thrombosis (DVT)/Pulmonary embolism (PE)
Maltese: Trombożi tal-vini fondi (DVT)/Emboliżmu pulmonari (PE)
English: 30 days at no more than 30ºC.
Maltese: Flixkun miftuħ 30 jum u mhux aktar minn 30ºC.
English: Kaplan-Meier curves of investigator-assessed OS (post-hoc analysis 20 May 2013) is presented in Figure 3.
Maltese: Kaplan-Meier tal-OS ivvalutatata mill-investigatur (analiżi post-hoc 20 ta' Mejju, 2013) hija ppreżentata fil-Figura 3.
English:  Read the information “Possible serious side effects” in section 4 of this leaflet.
Maltese:  Aqra l-informazzjoni ‘Effetti sekondarji serji possibbli ‘ f'sezzjoni 4 ta' dan il-fuljett.
English: Trametinib is not a substrate of CYP enzymes or of the transporters BCRP, OATP1B1, OATP1B3, OATP2B1, OCT1, MRP2, and MATE1.
Maltese: Trametinib mhux substrat tal-enzimi CYP jew tat-trasportaturi BCRP, OATP1B1, OATP1B3, OATP2B1, OCT1, MRP2 u MATE1.
English: Chemotherapy (n=108) Trametinib (n=214)
Maltese: Kemoterapija (n=108) Trametinib (n=214)
English: MEK proteins are components of the extracellular signal-related kinase (ERK) pathway.
Maltese: Proteini MEK huma komponenti talmogħdija tal-kinase relatata mas-sinjal ekstraċellulari (ERK).
English: Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitor, ATC code: L01XE25
Maltese: Aġenti antineoplastiċi, inibitur tal-proteina kinase, Kodiċi ATC:
English: Malignant melanoma, metastatic malignant melanoma, and superficial spreading melanoma Stage III e Includes drug hypersensitivity f
Maltese: Melanoma malinni, melanoma malinni metastatika, u melanoma superfiċjali fi Stadju III li tinfirex e Tinkludi sensittività eċċessiva għall-mediċina f
English: Fatal intracranial haemorrhages occurred in the integrated safety population of trametinib in combination with dabrafenib in <1% (8/1076) of patients.
Maltese: Emorraġiji intrakranjali fatali seħħew filpopolazzjoni ta' sigurtà integrata ta' trametinib flimkien ma' dabrafenib f'<1% (8/1076) tal-pazjenti.
English: Based on in vitro studies, trametinib is not an inhibitor of CYP1A2, CYP2A6, CYP2B6, CYP2D6 and CYP3A4.
Maltese: Abbażi ta' studji in vitro, trametinib mhuwiex inibitur ta' CYP1A2, CYP2A6, CYP2B6, CYP2D6 u CYP3A4.
English: The deacetylated metabolite was further metabolised by glucuronidation.
Maltese: Il-metabolit deacetylated kien metabolizzat aktar b' glukuronidazzjoni.
English: Erythema, generalised erythema i Muscle spasms, musculoskeletal stiffness
Maltese: Eritema, eritema ġeneralizzata i Spażmi tal-muskoli, ebusija muskoloskeletrali
English: Safety data in patients ≥75 years is limited (see section 4.8).
Maltese: Dejta ta' sigurtà f'pazjenti ≥ 75 sena hija limitata (ara sezzjoni 4.8).
English: ORR, DoR and PFS were also assessed by an Independent Review Committee (IRC) as a sensitivity analysis.
Maltese: Indipendenti (Independent Review Committee - IRC) bħala analiżi tas-sensittività.
English: * The intensity of clinical adverse reactions graded by the Common Terminology Criteria for Adverse Events v4.0 (CTC-AE)
Maltese: * L-intensità ta' reazzjonijiet kliniċi avversi gradati mill-Kriterji ta' Terminoloġija Komuni għal Avvenimenti Avversi v4.0
English: Mekinist 2 mg film-coated tablets EU/1/14/931/005
Maltese: Mekinist 2 mg pilloli miksijin b'rita EU/1/14/931/005