FrancophonIA/ELRC3.0 huggingface dataset:
English: New-born infants exposed to antipsychotics (including aripiprazole) during the third trimester of pregnancy are at risk of adverse reactions including extrapyramidal and/or withdrawal symptoms that may vary in severity and duration following delivery.
Maltese: Trabi li għadhom kif twieldu li kienu esposti għal antipsikotiċi (li jinkludu aripiprazole) waqt it-tielet trimestru ta' tqala huma f'riskju ta' reazzjonijiet avversi li jinkludu sintomi ekstrapiramidali u/jew sintomi ta' meta jitwaqqfu mediċini jew drogi li jivvizzjaw li jistgħu jvarjaw fis-severità u tul ta' żmien wara t-twelid.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer label (with blue box) - Multipack 400 mg
Maltese: Kartuna ta' barra (bil-kaxxa blu) - Pakkett multiplu 400 mg
English: • seizure (fits)
Maltese: • infjammazzjoni tal-fwied
English: Therefore, Abilify Maintena is non-inferior to aripiprazole oral tablets 10-30 mg.
Maltese: Għalhekk, Abilify Maintena mhuwiex inferjuri għall-pilloli orali ta' aripiprazole ta' 10-30 mg.
English: Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection in pre-filled syringe Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection in pre-filled syringe aripiprazole
Maltese: Abilify Maintena 300 mg trab u solvent għal suspensjoni għall-injezzjoni li terħi l-mediċina bil-mod f'siringa mimlija għal-lest Abilify Maintena 400 mg trab u solvent għal suspensjoni għall-injezzjoni li terħi l-mediċina bil-mod f'siringa mimlija għal-lest aripiprazole
English: Psychiatric disorders
Maltese: Anoreksja Iponatremija
English: In clinical trials, uncommon cases of seizure were reported during treatment with aripiprazole.
Maltese: Ħsibijiet u mġieba suwiċidali ġew irrappurtati waqt trattament b'aripiprazole.
English: The concomitant use of CYP3A4 inducers with Abilify Maintena should be avoided because the blood levels of aripiprazole are decreased and may be below the effective levels.
Maltese: L-użu fl-istess waqt ta' indutturi ta' CYP3A4 ma' Abilify Maintena għandu jiġi evitat minħabba li l-livelli ta' aripiprazole fid-demm jonqsu u jistgħu jkunu taħt il-livelli effettivi.
English: Close supervision of high risk patients should accompany antipsychotic treatment.
Maltese: Għandu dejjem ikun hemm superviżjoni mill-qrib ta' pazjenti li jkunu f'riskju għoli waqt trattament antipsikotiku.
English: With intramuscular injection, however an inflammatory response was seen at the injection site, and consisted of granulomatous inflammation, foci (deposited drug), cellular infiltrates, oedema (swelling) and, in monkeys, fibrosis.
Maltese: Madanakollu, b'injezzjoni ġol-muskoli deher rispons infjammatorju fis-sit tal-injezzjoni, li kien jikkonsisti f'infjammazzjoni granulomatuża, foci (mediċina depożitata), infiltrati ċellulari, edima
English: • extreme restlesness and restless legs
Maltese: • irrikwitezza estrema u riġlejn irrikweti
English: Taking into account the PRAC Assessment Report on the PSUR(s) for aripiprazole, the scientific conclusions of CHMP are as follows:
Maltese: Meta jiġi kkunsidrat ir-Rapport ta' Valutazzjoni tal-PRAC dwar il-PSUR(s) għal aripiprazole, ilkonklużjonijiet xjentifiċi tas-CHMP huma kif ġej:
English: What you need to know before you are given Abilify Maintena Do not use Abilify Maintena:
Maltese: X'għandek tkun taf qabel ma tingħata Abilify Maintena Tużax Abilify Maintena:
English: Six-hundred and sixty two patients eligible for the 38-week Double-blind, Active-controlled Phase were randomly assigned in a 2:2:1 ratio to double-blind treatment to one of 3 treatment groups: 1) Abilify Maintena 2) the stabilisation dose of oral aripiprazole 10-30 mg, or 3) aripiprazole LongActing Injectable 50 mg/25 mg.
Maltese: Sitt mija u tnejn u sittin pazjent eliġibbli għal Fażi Double-blind ikkontrollata b'mod Attiv ta' 38 ġimgħa kienu assenjati b'mod każwali fi proporzjon ta' 2:2:1 għal trattament double-blind għal wieħed minn 3 gruppi ta' trattament:
English: Muscle rigidity Muscle spasms Muscle twitching Muscle tightness Myalgia
Maltese: It-titrazzjoni tad-doża ta' dan il-prodott mediċinali mhix meħtieġa.
English: • stomach discomfort
Maltese: • diffikultà biex tibla'
English: If there are adverse reactions with the 400 mg dosage, reduction of the dose to 300 mg once monthly should be considered.
Maltese: Jekk ikun hemm reazzjonijiet avversi bid-doża ta' 400 mg, għandu jiġi kkunsidrat tnaqqis tad-doża għal 300 mg darba fix-xahar.
English: Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection in pre-filled syringe aripiprazole
Maltese: Abilify Maintena 400 mg trab u solvent għal suspensjoni għall-injezzjoni li terħi l-mediċina bil-mod aripiprazole
English: Strong CYP2D6 and strong CYP3A4 inhibitors
Maltese: Meta impedituri dgħajfa ta' CYP3A4
English: Gluteal injections should be alternated between the two gluteal muscles.
Maltese: L-injezzjonijiet gluteali għandhom jiġu alternati bejn iż-żewġ muskoli gluteali.
English: • allergic reaction (e.g. swelling in the mouth, tongue, face and throat, itching, hives), rash
Maltese: • reazzjoni allerġika (eż., nefħa fil-ħalq, fl-ilsien, fil-wiċċ u fil-griżmejn, ħakk, ħorriqija), raxx
English: Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection in pre-filled syringe aripiprazole
Maltese: Abilify Maintena 300 mg trab u solvent għal suspensjoni għall-injezzjoni li terħi l-mediċina bil-mod aripiprazole
English: Since patients treated with antipsychotics often present with acquired risk factors for VTE, all possible risk factors for VTE should be identified before and during treatment with aripiprazole and preventive measures undertaken (see section 4.8).
Maltese: Billi pazjenti kkurati b'mediċini antipsikotiċi ta' spiss ikollhom diġà minn qabel fatturi ta' riskju għal VTE, il-fatturi kollha possibbli ta' riskju għal VTE għandhom jiġu identifikati qabel u matul il-kura b'aripiprazole u għandhom jittieħdu miżuri ta' prevenzjoni (ara sezzjoni 4.8).
English: Step 3: Injection procedure a) Twist and pull off Over-cap and Tip-cap.
Maltese: Stadju 2: Rikostituzzjoni tat-trab a) Imbotta l-virga tal-planġer bil-mod sabiex tqabbad il-kamini.
English: The occurrence of suicidal behaviour is inherent in psychotic illnesses, and in some cases has been reported early after initiation or switch of antipsychotic treatment, including treatment with aripiprazole (see section 4.8).
Maltese: Suwiċidalità Il-fatt li sseħħ imġieba suwiċidali hija inerenti f'mard psikotiku, u f'xi każijiet ġiet irrapurtata kmieni wara l-bidu ta' kura antipsikotika jew meta saret bidla fil-kura antipsikotika, inkluż trattament b'aripiprazole (ara sezzjoni 4.8).
English: • heart problems including torsades de pointes, stopping of the heart, irregularities in heart rhythm that may be due to abnormal nerve impulses in the heart, abnormal readings during heart examination (ECG) QT prolongation
Maltese: • disturbi fit-tħaddid • problemi tal-qalb li jinkludu torsades de pointes, il-qalb tieqaf, irregolaritajiet fi-ritmu tal-qalb li jistgħu jkunu dovuti għal impulsi abnormali tan-nerv fil-qalb/riżultati abnormali waqt l-eżami tal-qalb (ECG) titwil tal-QT
English: Visually confirm that the needle is fully engaged into the needle protection sheath, and discard.
Maltese: Dawn jistgħu jkunu sinjali ta' kondizzjoni msejħa “diskineżja tardiva”.
English: Abilify Maintena 300 mg Vial
Maltese: Abilify Maintena Kunjett ta' 300 mg
English: Aripiprazole Long-Acting Injectable 50 mg/25 mg (n = 131)
Maltese: Aripiprazole 50 mg/25 mg li Jiġi
English: Thrombocytopenia Neutrophil count decreased White blood cell count decreased
Maltese: Taħżinx is-suspensjoni rikostitwita fis-siringa.
English: The results of analysis of the primary efficacy endpoint, the estimated proportion of patients experiencing impending relapse by end of Week 26 of the Double-blind, Active-controlled Phase, showed that Abilify Maintena 400 mg/300 mg is non-inferior to aripiprazole oral tablets 10-30 mg.
Maltese: Ir-riżultati ta' analiżi tal-punt aħħari ta' effikaċja prinċipali, il-proporzjon ta' pazjenti stmati li jesperjenzaw rikaduta imminenti sa tmiem il-Ġimgħa 26 tal-Fażi Double-blind, ikkontrollata b'mod attiv, urew li Abilify Maintena 400 mg/300 mg ‘mhux inferjuri' għal pilloli orali ta' aripiprazole
English: In the Double-blind Placebo-controlled Phase of the 52-week trial, from baseline to last visit there was a mean decrease in prolactin levels in Abilify Maintena (−0.38 ng/ml) compared with a mean increase in placebo (1.67 ng/ml).
Maltese: 38 ng/ml) meta mqabbel ma' żieda medja fil-grupp tal-plaċebo (1.67 ng/ml).
English: Deltoid muscle administration
Maltese: Għoti fil-muskoli tad-deltojdi
English: • experience a combination of fever, sweating, faster breathing, muscle stiffness and drowsiness or sleepiness (may be signs of neuroleptic malignant syndrome)
Maltese: • esperjenza ta' kombinazzjoni ta' deni, għorieq, tieħu nifs mgħaġġel, ebusija muskolari, u ħedla jew ngħas (jistgħu jkunu sinjali ta' sindrome malinn newrolettiku)
English: Pathological gambling and other impulse control disorders Pathological gambling, hypersexuality, compulsive shopping and binge or compulsive eating can occur in patients treated with aripiprazole (see section 4.4).
Maltese: Logħob tal-ażżard patoloġiku u disturbi oħra tal-kontroll tal-impuls Logħob tal-ażżard patoloġiku, ipersesswalità, xiri kompulsiv u teħid ta' ikel bla rażan u kompulsiv jistgħu jseħħu f'pazjenti trattati b'aripiprazole (ara sezzjoni 4.4).
English: The reconstituted medicine is a white to off-white, fluid suspension.
Maltese: Ilmediċina rrikostitwita hija suspensjoni fluwida, minn bajda sa offwajt.
English: Discard
Maltese: Dardir
English: Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection
Maltese: Abilify Maintena 300 mg trab u solvent għal suspensjoni għall-injezzjoni li terħi l-mediċina bil-mod Abilify Maintena 400 mg trab u solvent għal suspensjoni għall-injezzjoni li terħi l-mediċina bil-mod
English: Seizure
Maltese: Suffejra
English: The recommended needle for deltoid administration is a 25 mm (1 inch), 23 gauge hypodermic safety needle; for obese patients, a 38 mm (1.5 inch), 22 gauge hypodermic safety needle should be used.
Maltese: 25 mm (pulzier) 23 gejġ, waħda 38 mm (pulzier u nofs) 22 gejġ u waħda ta' 51 mm (żewġ pulzieri)
English: • panic reaction
Maltese: • reazzjoni ta' paniku
English: Each single pack containing one pre-filled syringe, and three hypodermic safety needles: one 25 mm (1 inch) 23 gauge, one 38 mm (1.5 inch) 22 gauge and one 51 mm (2 inch) 21 gauge.
Maltese: Il-labra rrakkomandata għall-għoti fid-deltojde għandha tkun labra ipodermika ta' sigurtà ta' 25 mm (pulzier), 23 gejġ; għal pazjenti obeżi, għandha tintuża labra ipodermika ta' sigurtà ta' 38 mm (pulzier u nofs), 22 gejġ.
English: In the placebo group 39.6 % of the patients had progressed to impending relapse, whilst in the Abilify Maintena group impending relapse occurred in 10 % of the patients; thus patients in the placebo group had a 5.03-fold greater risk of experiencing impending relapse.
Maltese: għalhekk pazjenti fil-grupp tal-plaċebo kellhom riskju ta' 5.03 darba aktar li jesperjenzaw rikaduta imminenti.
English: Urinary retention Urinary incontinence
Maltese: Żamma tal-awrina, Inkontinenza tal-awrina
English: Fall: Although the available data did not provide sufficient evidence to support a clear causal relationship between aripiprazole and this ADR, 507 cases have been identified reporting 518 events of Fall associated with Abilify.
Maltese: Għalkemm it-tagħrif disponibbli ma pprovdiex biżżejjed provi biex isostni relazzjoni każwali ċara bejn aripiprazole u din ir-reazzjoni avversa għall-mediċina, 507 każijiet ġew identifikati li rraportaw 518-il każ ta' Waqgħa assoċjata ma' Abilify.
English: In clinical trials of one year or less duration, there were uncommon reports of treatment emergent dyskinesia during treatment with aripiprazole.
Maltese: Fi provi kliniċi li damu sena jew inqas, kien hemm rapporti mhux komuni li waqt it-trattament b'aripiprazole l-pazjent żviluppa diskajneżja.
English: Elderly patients with dementia-related psychosis
Maltese: Pazjenti anzjani bi psikosi relatata ma' dimenzja
English: Extrapyramidal disorder Akathisia Tremor
Maltese: Diskajneżja tardiva Parkinsoniżmu Disturb taċ-ċaqlieq
English: Action
Maltese: Akatisja
English: • uncontrollable twitching, jerking or writhing movements
Maltese: • movimenti tal-muskoli li inti ma tistax tikkontrolla bħal titkerrah, tfaqqa' xofftejk u movimenti tal-ilsien.
English: • difficulty in passing urine
Maltese: • livelli mnaqqsa jew ogħla fid-demm tal-ormon prolaktin
English: Dysphoria Sleep disorder Bruxism
Maltese: Disturbi taddemm u tassistema limfatika
English: Renal impairment
Maltese: Mhux obeżi
English: Aripiprazole has minor to moderate influence on the ability to drive and use machines due to potential nervous system and visual effects, such as sedation, somnolence, syncope, vision blurred, diplopia (see section 4.8).
Maltese: Aripiprazole ma xekkilx il-fertilità abbażi ta' dejta minn studji ta' tossiċità riproduttiva. 4.7 Effetti fuq il-ħila biex issuq u tħaddem magni Aripiprazole għandu effett żgħir sa effett moderat fuq il-ħila biex issuq u tħaddem magni minħabba l-possibbiltà ta' effetti fuq is-sistema nervuża u effetti viżwali, bħal sedazzjoni, ħedla, sinkope, vista mċajpra, diplopja (ara sezzjoni 4.8).
English: Pancreatitis Dysphagia
Maltese: Ketoaċidożi dijabetika
English: Pathological gambling and other impulse control disorders
Maltese: Disturbi tal-kontroll tal-impuls
English: Blood prolactin decreased Hyperprolactinaemia
Maltese: Iperkolesterolemija Iperinsulinemija Iperlipidemija
English: Each pre-filled syringe contains 400 mg aripiprazole.
Maltese: Kull siringa mimlija għal-lest fiha 400 mg aripiperazole.
English: In a short-term (12-week), randomised, double-blind, placebo-controlled trial with Abilify Maintena 400 mg/300 mg treated subjects the symptoms which had at least twice the incidence of placebo were increased weight and akathisia.
Maltese: Fi prova każwali, double-blind, bil-plaċebo bħala kontroll ta' terminu ta' żmien qasir (12-il ġimgħa) fuq individwi ttrattati b'Abilify Maintena 400 mg/300 mg is-sintomi li kellhom tal-anqas id-doppju tal inċidenza tal-plaċebo kienu żieda fil-piż u akatisja.
English: If you miss an injection of Abilify Maintena
Maltese: L-inċidenzi ta' pazjenti fuq Abilify
English: Hypersensitivity reactions, characterised by allergic symptoms, may occur with aripiprazole (see section 4.8).
Maltese: Tnaqqis fid-doża jew waqfien tal-prodott mediċinali għandu jiġi kkonsidrat jekk il-pazjent jiżviluppa dawn ix-xenqat (ara sezzjoni 4.8).
English: After oral administration of aripiprazole, there are no differences in the pharmacokinetics of aripiprazole between healthy elderly and younger adult subjects.
Maltese: Wara l-għoti orali ta' aripiprazole, ma kienx hemm differenzi fil-farmakokinetika ta' aripiprazole bejn individwi anzjani f'saħħithom u individwi adulti iżgħar.
English: Weight
Maltese: Obeżi
English: • certain medicines to treat HIV infection (such as efavirenz, nevirapine, and protease inhibitors e.g. indinavir, ritonavir)
Maltese: • ċerti mediċini biex jittrattaw infezzjoni ta' HIV (bħal efavirenz, nevirapine, u impedituri ta'
English: Twist + Pull Off
Maltese: Tlegħib Disgewżja
English: • muscle stiffness
Maltese: • ebusija tal-muskoli
English: Ensure the needle is firmly seated on the needle protection device with a push and clockwise twist and then pull the needle cap straight away from the needle.
Maltese: Tqala Ma sarux studji xierqa u kkontrollati tajjeb, ta' aripiprazole fin-nisa tqal.
English: Mekinist is available as tablets (0.5 and 2 mg).
Maltese: Mekinist jiġi bħala pilloli (0.5 u 2 mg).
English: Further information on Mekinist 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: Mekinist contains the active substance trametinib.
Maltese: Mekinist fih is-sustanza attiva trametinib.
English: Other information about Mekinist
Maltese: Informazzjoni oħra dwar Mekinist
English: Mekinist received a marketing authorisation valid throughout the EU on 30 June 2014.
Maltese: Mekinist ingħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fit-30 ta' Ġunju 2014.
English: Some 40% of patients treated with the combination either died or had their disease come back after an average of about 3.5 years compared with 59% of patients receiving placebo.
Maltese: Madwar 40% tal-pazjenti li ngħataw il-kura bil-kombinazzjoni, mietu jew reġgħet ħarġitilhom il-marda wara medja ta' madwar 3.5 snin meta mqabbla ma' 59% tal-pazjenti li ngħataw plaċebo.
English: • advanced (stage III) melanoma after surgery for it. Mekinist is used in combination with dabrafenib;
Maltese: • melanoma avvanzata (stadju III) wara l-kirurġija għalih. Mekinist jintuża flimkien ma' dabrafenib;
English: Patients given the combination lived on average 25.6 months versus 18 months with vemurafenib.
Maltese: Il-pazjenti li ngħataw il-kombinazzjoni għexu bħala medja 25.6 xhur meta mqabbla ma' 18-il xahar b'vemurafenib.
English: In melanoma and non-small cell lung cancer with the BRAF V600 mutation, an abnormal form of the protein BRAF is present, which switches on another protein called MEK involved in stimulating cell division.
Maltese: Fil-melanoma u fil-kanċer tal-pulmun mhux b'ċelloli żgħar b'mutazzjoni BRAF V600, hija preżenti forma anormali tal-proteina BRAF, li tattiva proteina oħra msejħa MEK involuta fl-istimulazzjoni tad-diviżjoni taċ-ċelloli.
English: It is used in combination with dabrafenib.
Maltese: Jintuża flimkien ma' dabrafenib.
English: The most common side effects with Mekinist (which may affect more than 1 in 5 people) are rash, diarrhoea, tiredness, peripheral oedema (swelling, especially of ankles and feet), nausea and acneiform dermatitis (acne-like inflammation of the skin).
Maltese: L-effetti sekondarji l-aktar komuni b'Mekinist (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 5) huma raxx, dijarea, għeja, edema periferali (nefħa, speċjalment fl-għekiesi u s-saqajn), nawsja u dermatite akneiforma (infjammazzjoni tal-ġilda li tixbaħ l-akne).
English: Mekinist is used on its own or in combination with another cancer medicine, dabrafenib;
Maltese: Mekinist jintuża waħdu jew flimkien ma' mediċina oħra ta' kontra l-kanċer, dabrafenib;
English: The use of Mekinist and dabrafenib led to a response in over 60% of the patients, compared with 23% of patients using dabrafenib alone.
Maltese: L-użu ta' Mekinist u dabrafenib wassal għal rispons f'aktar minn 60% tal-pazjenti, meta mqabbel ma' 23% tal-pazjenti li użaw dabrafenib waħdu.
English: • melanoma (a skin cancer) that has spread or cannot be removed surgically.
Maltese: • melanoma (kanċer tal-ġilda) li tkun infirxet u li ma tistax titneħħa kirurġikament.
English: In a study involving 870 patients with stage III melanoma that had been removed surgically, the combination of Mekinist and dabrafenib given for 1 year was compared with placebo (a dummy treatment).
Maltese: Fi studju li involva 870 pazjent b'melanoma fi stadju III li kienet tneħħiet kirurġikament, ilkombinazzjoni ta' Mekinist u dabrafenib mogħtija għal sena tqabblet ma' plaċebo (kura finta).
English: As for all medicines, data on the use of Mekinist are continuously monitored.
Maltese: Bħal għall-mediċini kollha, id-data dwar l-użu ta' Mekinist hija ssorveljata kontinwament.
English: When Mekinist is taken in combination with dabrafenib the most common side effects (which may affect more than 1 in 5 people) are fever, tiredness, nausea, chills, headache, diarrhoea, vomiting, joint pain and rash.
Maltese: Meta Mekinist jittieħed flimkien ma' dabrafenib, l-effetti sekondarji l-aktar komuni (li jistgħu jaffettwaw aktar minn persuna 1 minn kull 5) huma deni, għeja, nawsja, tertir, uġigħ ta' ras, dijarea, rimettar, uġigħ fil-ġogi u raxx.
English: Patients given the combination lived for 11 months without their disease worsening compared with 8.8 months for those given dabrafenib alone.
Maltese: Il-pazjenti li ngħataw il-kombinazzjoni għexu għal 11-il xahar mingħajr ma l-marda tagħhom marret għall-agħar, meta mqabbla ma' 8.8 xhur għal dawk li ngħataw dabrafenib biss.
English: Mekinist is a cancer medicine used to treat adults whose cancer cells have a specific genetic mutation (change) in their genes called 'BRAF V600'.
Maltese: Mekinist huwa mediċina ta' kontra l-kanċer li jintuża għall-kura ta' adulti li ċ-ċelloli tal-kanċer tagħhom għandhom mutazzjoni ġenetika speċifika (bidla) fil-ġeni tagħhom msejħa ‘BRAF V600'.
English: In a second study involving 704 patients, Mekinist with dabrafenib was compared with another medicine for melanoma, vemurafenib.
Maltese: Fit-tieni studju li involva 704 pazjenti, Mekinist ma' dabrafenib tqabbel ma' mediċina oħra għall-melanoma, vemurafenib.
English: Patients taking Mekinist lived on average for 4.8 months before their disease getting worse, compared with 1.5 months for patients given dacarbazine or paclitaxel.
Maltese: Il-pazjenti li ħadu Mekinist għexu bħala medja għal 4.8 xhur qabel ma l-marda tagħhom marret għall-agħar, meta mqabbla ma' 1.5 xhur għal pazjenti li ngħataw dacarbazine jew paclitaxel.
English: What are the risks associated with Mekinist?
Maltese: X'inhuma r-riskji assoċjati ma' Mekinist?
English: In one study, 423 patients were given either the combination or dabrafenib alone.
Maltese: Fi studju wieħed, 423 pazjent ingħataw jew il-kombinazzjoni jew dabrafenib waħdu.
English: What measures are being taken to ensure the safe and effective use of Mekinist?
Maltese: X'miżuri qegħdin jittieħdu biex jiġi żgurat l-użu sigur u effettiv ta' Mekinist?
English: How is Mekinist used?
Maltese: Kif jaħdem Mekinist?
English: Mekinist was more effective than the cancer medicines dacarbazine or paclitaxel at controlling melanoma that had spread to other parts of the body or could not be removed surgically.
Maltese: Mekinist kien aktar effettiv mill-mediċini ta' kontra l-kanċer dacarbazine jew paclitaxel fil-kontroll talmelanoma li nfirxet f'partijiet oħrajn tal-ġisem jew li ma setgħetx titneħħa b'kirurġija.
English: Mekinist has been studied in patients whose cancer had the BRAF V600 mutation.
Maltese: Mekinist ġie studjat f'pazjenti li l-kanċer tagħhom kellu l-mutazzjoni BRAF V600.
English: For the full list of side effects and restrictions of Mekinist, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet ta' Mekinist, ara l-fuljett ta' tagħrif.
English: The active substance in Mekinist, trametinib, works by blocking MEK and by preventing its activation by BRAF, thereby slowing down the growth and spread of the cancer.
Maltese: Is-sustanza attiva f'Mekinist, it-trametinib, taħdem billi timblokka l-MEK u billi tevita l-attivazzjoni tagħha minn BRAF, b'hekk jitnaqqsu t-tkabbir u t-tifrix tal-kanċer.
English: The European Medicines Agency decided that Mekinist's benefits in cancers that carry the BRAF V600 mutation are greater than its risks and it can be authorised for use in the EU.
Maltese: L-Aġenzija Ewropea għall-Mediċini ddeċidiet li l-benefiċċji ta' Mekinist f'kanċers li jkollhom il-mutazzjoni BRAF V600 huma akbar mir-riskji tiegħu u li jista' jiġi awtorizzat għall-użu fl-UE.
English: Mekinist can be continued for as long as the patient benefits from it. After surgery for advanced melanoma, treatment is normally continued for 12 months unless the disease comes back.
Maltese: Wara kirurġija għallmelanoma avvanzata, normalment il-kura tibqa' għaddejja għal 12-il xahar sakemm ma terġax titfaċċa l-marda.
English: What benefits of Mekinist have been shown in studies?
Maltese: X'inhuma l-benefiċċji ta' Mekinist li ħarġu mill-istudji?