FrancophonIA/ELRC3.0 huggingface dataset:
English: Tafinlar is for oral use.
Maltese: Tafinlar huwa għall-użu orali.
English: The efficacy of the combination with trametinib was superior when indirectly compared to dabrafenib monotherapy in Cohort A.
Maltese: L-effikaċja tal-kombinazzjoni ma' trametinib kienet superjuri meta mqabbla indirettament mal-monoterapija b'dabrafenib fil-Grupp A.
English: Cough
Maltese: Mewt
English: No dose modification of trametinib is required when taken in combination with dabrafenib (see section 4.4).
Maltese: Ma hija meħtieġa ebda modifika ta' trametinib meta dan jittieħed flimkien ma' dabrafenib (ara sezzjoni 4.4).
English: Co-administration of repeat doses of dabrafenib 150 mg twice daily and the pH-elevating agent rabeprazole 40 mg once daily resulted in a 3% increase in AUC and a 12% decrease in dabrafenib Cmax.
Maltese: L-għoti flimkien ta' dożi ripetuti ta' dabrafenib 150 mg darbtejn kuljum u s-sustanza li żżid il-pH rabeprazole 40 mg darba kuljum wassal għal żieda ta' 3% fl-AUC u tnaqqis ta' 12% fis-Cmax ta' dabrafenib.
English: • Kidney problems, kidney failure
Maltese: • Problemi fil-kliewi, insuffiċjenza tal-kliewi
English: Primary tumour or tumour from a metastatic site was tested with an investigational use only assay (IUO).
Maltese: Tumur primarju jew tumur minn sit metastatiku kien ittestjat b'analiżi bi skop investigattiv (IUO) biss.
English: A decrease in exposure was observed with repeat dosing, likely due to induction of its own metabolism.
Maltese: Ġie osservat tnaqqis fl-espożizzjoni b'dożaġġ ripetut, probabbilment minħabba l-induzzjoni tal-metaboliżmu tiegħu stess.
English: b This study was designed to support or reject the null hypothesis of OIRR ≤10% (based on historical results) in favour of the alternative hypothesis of OIRR ≥ 30% in BRAF V600E mutation positive subjects.
Maltese: b Dan l-istudju kien maħsub biex isostni jew jirrifjuta l-ipoteżi nulla ta' OIRR ≤ 10 % (ibbażata fuq ir-riżultati tal-passat) favur l-ipoteżi alternattiva ta' OIRR ≥ 30 % f'individwi pożittivi għallmutazzjoni BRAF V600E.
English: The most common adverse reactions (incidence 20%) for dabrafenib in combination with trametinib were: pyrexia, fatigue, nausea, chills, headache, diarrhoea, vomiting, arthralgia and rash.
Maltese: L-aktar reazzjonijiet avversi komuni (inċidenza ta' ≥ 20%) għal dabrafenib flimkien ma' trametinib kienu: deni, għejja, dardir, tertir ta' bard, uġigħ ta' ras, dijarrea, rimettar, artralġja u raxx.
English: In patients treated with dabrafenib in combination with trametinib with suspected ILD or pneumonitis, including patients presenting with new or progressive pulmonary symptoms and findings including cough, dyspnoea, hypoxia, pleural effusion, or infiltrates, pending clinical investigations, please refer to the trametinib SmPC (see section 4.2) for dose modification instructions for trametinib.
Maltese: F'pazjenti kkurati b'dabrafenib flimkien ma' trametinib b'ILD suspettat jew b'pulmonite suspettata, inklużi pazjenti li jippreżentaw sintomi u sejbiet pulmonari ġodda jew progressivi inklużi sogħla, qtugħ ta' nifs, ipoksja, effużjoni plewrali, jew infiltrati, sakemm isiru investigazzjonijiet kliniċi, jekk jogħġbok irreferi għall-SmPC ta' trametinib (ara sezzjoni 4.2) għal struzzjonijiet dwar il-modifika fiddoża ta' trametinib.
English: The IUO is an allele-specific polymerase chain reaction (PCR) assay performed on DNA extracted from formalin-fixed paraffin-embedded (FFPE) tumour tissue.
Maltese: L-IUO hija reazzjoni katina tal-polimerażi (PCR) speċifika għall-allele mwettqa fuq DNA estratt minn tessut ta' tumur inkorporat fil-paraffina mwaħħal mal-formalina (FFPE).
English: From an OS analysis at 5 years, the median OS for the combination arm was approximately 7 months longer than for dabrafenib monotherapy (25.8 months versus 18.7 months) with 5-year survival rates of 32% for the combination versus 27% for dabrafenib monotherapy (Table 6, Figure 1).
Maltese: Skont analiżi tal-OS fil-5 sena, l-OS medjana għall-fergħa tal-kombinazzjoni kienet ta' madwar 7 xhur itwal minn tal-grupp mogħti monoterapija b'dabrafenib (25.8 xhur kontra 18.7 xhur) b'rati ta' sopravivenza fuq 5 snin ta' 32% għall-kombinazzjoni kontra 27% għallmonoterapija b'dabrafenib (Tabella 6, Figura 1).
English: Effect of dabrafenib on other medicinal products
Maltese: Effetti ta' dabrafenib fuq prodotti mediċinali oħra
English: Of the total number of patients in the integrated safety population of dabrafenib monotherapy (n=578), 22% were 65 years of age and older, and 6% were 75 years of age and older.
Maltese: Mill-għadd totali ta' pazjenti fil-popolazzjoni ta' sigurtà integrata ta' monoterapija b'dabrafenib (n=578), 22 % kellhom aktar minn 65 sena, u 6 % kellhom aktar minn 75 sena.
English: • Sore mouth or mouth ulcers, inflammation of mucous membranes
Maltese: • Ħalq misluħ jew ulċeri fil-ħalq, infjammazzjoni tal-membrani mukużi
English: Haemorrhage
Maltese: Iperkeratosi
English: The median DoR and PFS were not yet estimable (Table 15).
Maltese: Id-DoR u l-PFS medjani kienu għadhom ma setgħux jiġu stmati (Tabella 15).
English: Please refer to the trametinib SmPC (see section 4.4).
Maltese: Jekk jogħġbok irreferi għall-SmPC ta' trametinib (ara sezzjoni 4.4).
English: Table 6 Overall Survival results for Study MEK115306 (COMBI-d)
Maltese: Ir-riżultati tas-Sopravivenza Globali għall-Istudju MEK115306 (COMBI-d)
English: In vitro, dabrafenib is a mechanism based inhibitor of CYP3A4.
Maltese: In vitro, dabrafenib huwa inibitur ta' CYP3A4 bbażat fuq il-mekkaniżmu.
English: Seborrhoeic keratosis
Maltese: Keratosi seborrejika
English: Haemorrhagic events, including major haemorrhagic events and fatal haemorrhages, have occurred in patients taking dabrafenib in combination with trametinib.
Maltese: Avvenimenti emorraġiċi, inklużi avvenimenti emorraġiċi ewlenin u emorraġiji fatali, seħħew f'pazjenti li kienu qegħdin jieħdu dabrafenib flimkien ma' trametinib.
English: Number of patients Died (event), n
Maltese: Numru ta' pazjenti Mietu (episodju), n (%)
English: • Cohort B: Combination therapy (dabrafenib 150 mg twice daily and trametinib 2 mg once daily), 59 patients enrolled.
Maltese: • Grupp B: Terapija ta' kombinazzjoni (dabrafenib 150 mg darbtejn kuljum u trametinib 2 mg darba biss), 59 pazjent irreġistrati. 57 pazjent kellhom waħda sa tliet kuri sistemiċi preċedenti għall-mard metastatiku tagħhom.
English: Tafinlar 50 mg hard capsules Tafinlar 75 mg hard capsules dabrafenib
Maltese: Informazzjoni għall-pazjent Tafinlar 50 mg kapsula iebsa Tafinlar 75 mg kapsula iebsa dabrafenib
English: Rash has been observed in about 24% of patients in clinical trials when dabrafenib is used in combination with trametinib (see section 4.8).
Maltese: Ir-raxx kien osservat f'madwar 24% tal-pazjenti fi provi meta dabrafenib jintuża flimkien ma' trametinib(ara sezzjoni 4.8).
English: Fever has been reported in clinical trials with dabrafenib as monotherapy and in combination with trametinib; the incidence and severity of pyrexia are increased with the combination therapy (see section 4.4).
Maltese: Ġie rrapportat deni fi provi kliniċi b'dabrafenib bħala monoterapija u flimkien ma' trametinib; linċidenza u s-severità tad-deni jiżdiedu bit-terapija kkombinata (ara sezzjoni 4.4).
English: • Muscle spasms
Maltese: • awrina skura
English: The metabolism of dabrafenib is primarily mediated by CYP2C8 and CYP3A4 to form hydroxy-dabrafenib, which is further oxidised via CYP3A4 to form carboxy-dabrafenib.
Maltese: Il-metaboliżmu ta' dabrafenib huwa medjat primarjament minn CYP2C8 u CYP3A4 biex jifforma hydroxy-dabrafenib, li huwa ossidizzat ulterjorment permezz ta' CYP3A4 biex jiġi ffurmat carboxydabrafenib. Carboxy-dabrafenib jista' jitneħħielu d-dijossidu tal-karbonju, permezz ta' proċess mhux enzimatiku biex jiġi ffurmat desmethyl-dabrafenib.
English: Activation of MAP-kinase signalling in BRAF wild type cells which are exposed to BRAF inhibitors may lead to increased risk of non-cutaneous malignancies, including those with RAS mutations (see section 4.4).
Maltese: L-attivazzjoni ta' sinjalazzjoni ta' MAP-kinasi f'ċelloli bi BRAF tat-tip selvaġġ esposti għal inibituri ta' BRAF tista' twassal għal żieda fir-riskju ta' tumuri malinni mhux tal-ġilda, inkluż dawk b'mutazzjonijiet RAS (ara sezzjoni 4.4).
English: Intracranial response assessed by the investigator in Cohorts B, C and D were secondary endpoints of the study.
Maltese: Ir-rispons intrakranjali evalwat millinvestigatur f'Koħorti B, Ċ u D kienu endpoints sekondarji fl-istudju.
English: This may lead to increased risk of non-cutaneous malignancies with dabrafenib exposure (see section 4.8) when RAS mutations are present.
Maltese: Dan jista' jwassal għal riskju miżjud ta' malinni mhux kutanji b'esponiment għal dabrafenib (ara sezzjoni 4.8) meta jkunu preżenti mutazzjonijiet RAS.
English: Caution should be exercised and additional International Normalised Ratio (INR) monitoring is recommended when dabrafenib is used concomitantly with warfarin and at discontinuation of dabrafenib (see section 4.5).
Maltese: Għandha tiġi eżerċitata kawtela u huwa rakkomandat li jsir monitoraġġ addizzjonali tal-Proporzjon Normalizzat Internazzjonali (INR) meta dabrafenib jintuża flimkien ma' warfarin u wara waqfien ta' dabrafenib (ara sezzjoni 4.5).
English: Opaque dark pink capsules, approximately 19 mm long, with capsule shell imprinted with “GS LHF” and “75 mg”.
Maltese: Kapsuli opaki ħomor skuri, twal madwar 19 mm, bil-qoxra tal-kapsula stampata b'‘GS LHF' u ‘75 mg'.
English: Two dabrafenib capsule strengths, 50 mg and 75 mg, are available to effectively manage dose modification requirements.
Maltese: Hemm disponibbli żewġ qawwiet tal-kapsuli ta' dabrafenib, 50 mg u 75 mg, biex jimmaniġġjaw b'mod effettiv il-ħtiġijiet tal-modifikazzjoni tad-doża.
English: • Cohort D: patients with BRAFV600D/E/K/R mutant melanoma with symptomatic brain metastases, with or without prior local brain-directed therapy and ECOG performance status of 0 or 1 or 2.
Maltese: • Koħort D: pazjenti b'melanoma għall-mutazzjoni BRAFV600D/E/K/R b'metatesi fil-moħħ asintomatika, li ngħataw minn qabel jew le terapija lokalizzata diretta fil-moħħ u bil-qagħda talpunteġġ ta' prestazzjoni ECOG 0 jew 1 jew 2.
English: No studies have been conducted to investigate the pharmacokinetics of dabrafenib in paediatric patients.
Maltese: Ma sar l-ebda studju biex tiġi investigata l-farmakokinetika ta' dabrafenib f'pazjenti pedjatriċi.
English: The median time to diagnosis of the first occurrence of cuSCC in study MEK115306 was 223 days (range 56 to 510 days) in the combination therapy arm and 60 days (range 9 to 653 days) in the dabrafenib monotherapy arm.
Maltese: Iż-żmien medjan għad-dijanjożi tal-ewwel okkorrenza ta' cuSCC fl-istudju MEK115306 kien ta' 223 jum (medda ta' bejn 56 jum u 510 ijiem) fil-fergħa tat-terapija ta' kombinazzjoni u ta' 60 jum (medda ta' bejn 9 ijiem u 653 jum) filfergħa tal-monoterapija b'dabrafenib.
English: If possible, show them the Tafinlar pack with this leaflet.
Maltese: Jekk ikun possibbli, urihom il-pakkett ta' Tafinlar ma' dan il-fuljett.
English: Median PFS Months (95% CI)
Maltese: PFS Medjana Xhur (95% CI)
English: Patients ≥65 years were more likely to experience SAEs and AEs leading to permanent discontinuation of medicinal product, dose reduction and dose interruption than those <65 years.
Maltese: Il-pazjenti ta' ≥ 65 sena kellhom probabbiltà akbar li jesperjenzaw SAEs u AEs li jwasslu għal twaqqif permanenti ta' prodott mediċinali, tnaqqis tad-doża u interruzzjoni tad-doża minn dawk fl-età ta' < 65 sena.
English: From an OS analysis at 5 years, the median OS for the combination arm was approximately 8 months longer than the median OS for vemurafenib monotherapy (26.0 months versus 17.8 months) with 5-year survival rates of 36% for the combination versus 23% for vemurafenib monotherapy (Table 8, Figure 2).
Maltese: Skont analiżi tal-OS fil-5 sena, l-OS medjana għall-fergħa tal-kombinazzjoni kienet ta' madwar 8 xhur itwal mill-OS medjana għall-monoterapija b'vemurafenib (26.0 xhur kontra 17.8 xhur) b'rati ta' sopravivenza fuq 5 snin ta' 36% għall-kombinazzjoni kontra 23% għallmonoterapija b'vemurafenib (Tabella 8, Figura 2).
English: Of the specimens from the non-clinical and clinical trials (n=876) that were mutation positive by the THxID BRAF assay and subsequently were sequenced using the reference method, the specificity of the assay was 94%.
Maltese: Mill-kampjuni mill-provi kliniċi u mhux kliniċi (n=876) li rriżultaw pożittivi għallmutazzjoni mill-analiżi BRAF THxID u sussegwentement kienu sekwenzjati permezz tal-metodu ta' referenza, l-ispeċifiċità tal-analiżi kienet 94 %.
English: The Kaplan-Meier OS curve appears to stabilise from 3 to 5 years (see Figure 1).
Maltese: Il-kurvatura tal-OS Kaplan-Meier jidher li ssir stabbli minn 3 sa 5 snin (ara Figura 1).
English: • Inflammation of the eye (uveitis, see “Eye problems” earlier in section 4))
Maltese: • Infjammazzjoni tal-għajn (uveite, ara ‘Problemi fl-għajnejn' aktar 'il fuq f'sezzjoni 4))
English: Study MEK116513 was a 2-arm, randomised, open-label, Phase III study comparing dabrafenib and trametinib combination therapy with vemurafenib monotherapy in BRAF V600 mutation-positive unresectable or metastatic melanoma.
Maltese: L-istudju MEK116513 kien studju 2-arm, randomizzat u open-label tal-Fażi III li qabbel it-terapija b'kombinazzjoni ta' dabrafenib u trametinib mal-monoterapija b'vemurafenib f'pazjenti b'melanoma li ma tistax titneħħa b'intervent kirurġiku jew metastatika pożittiva għal mutazzjoni BRAF V600. Lendpoint primarju tal-istudju kien OS b'endpoint sekondarju ewlieni ta' PFS.
English: • Skin effects including cutaneous squamous cell carcinoma (a type of skin cancer), wart-like growths, skin tags, uncontrolled skin growths or lesions (basal cell carcinoma), dry skin, itching or redness of skin, patches of thick, scaly, or crusty skin (actinic keratosis), skin lesions, skin reddening, increased sensitivity of the skin to sun
Maltese: • Effetti tal-ġilda inkluża infezzjoni tal-ġilda (ċellulite), infjammazzjoni tal-follikuli tax-xagħar fil-ġilda, disturbi fid-dwiefer bħal tibdil fil-bażi tad-dwiefer, uġigħ fid-dwiefer, infezzjoni u nefħa tal-cuticle, raxx tal-ġilda bl-infafet mimlija materja, karċinoma taċ-ċelloli skwamużi tal ġilda (tip ta' kanċer tal-ġilda), papilloma (tip ta' tumur tal-ġilda li ġeneralment ma jagħmilx ħsara), tkabbir tal-ġilda bħal felul, żieda fis-sensittività għax-xemx mill-ġilda (ara wkoll "Tibdil fil-ġilda tiegħek" aktar kmieni fis-sezzjoni 4)
English: Patients should be closely monitored when re-starting dabrafenib after an episode of pancreatitis (see section 4.4).
Maltese: Il-pazjenti għandhom jiġu mmonitorjati mill-qrib meta jerġgħu jibdew dabrafenib wara episodju ta' pankreatite (ara sezzjoni 4.4).
English: Patients were stratified by BRAF mutation status (V600E versus V600K) and stage of disease prior to surgery using the American Joint Committee on Cancer (AJCC) 7th edition Melanoma Staging System (by Stage III sub-stage, indicating different levels of lymph node involvement and primary tumour size and ulceration).
Maltese: Il-pazjenti tqassmu skont il-qagħda tal-mutazzjoni BRAF (V600E kontra V600K) u l-istadju tal-marda qabel lintervent kirurġiku permezz tas-seba' edizzjoni tas-Sistema ta' Stadji tal-Melanoma tal-Kumitat Konġunt għall-Kanċer (AJCC) (skont is-sottostadju ta' Stadju III, li jindika livelli differenti ta' involviment tal-għeqiedi limfatiċi u d-daqs u l-ulċerazzjoni tat-tumur ewlieni).
English: Arthralgia
Maltese: Paronikja
English: Chorioretinopathy Retinal detachment Periorbital oedema
Maltese: Korjoretinopatija Distakkament retinali Edema periorbitali
English: Nausea Vomiting Diarrhoea
Maltese: Newtropenija Anemija
English: • eye pain
Maltese: • vista mċajpra
English: Patients with brain metastases (results from the Phase II study (BREAK-MB) BREAK-MB was a multicentre, open-label, two-cohort, Phase II study designed to evaluate the intracranial response of dabrafenib in subjects with histologically confirmed (Stage IV) BRAF-mutation positive (V600E or V600K) melanoma metastatic to the brain.
Maltese: Pazjenti b'metastasi fil-moħħ (riżultati mill-istudju tal-Fażi II (BREAK-MB) BREAK-MB kien studju b'aktar minn ċentru wieħed tal-Fażi II b'tikketta mikxufa u żewġ koorti maħsub biex jevalwa r-rispons intrakranjali ta' dabrafenib f'individwi b'melanoma pożittiva għallmutazzjoni-BRAF (V600E jew V600K) ikkonfermata b'mod istoloġiku (Stadju IV) li hija metastatika għall-moħħ.
English: Intracranial response rate, % (95 % CI)
Maltese: Ir-rata ta' rispons intrakranjali, % (95 % CI)
English: • Swelling of the hands or feet (oedema peripheral)
Maltese: • Nefħa tal-idejn jew tas-saqajn (edema periferali)
English: The median duration of follow-up (time from randomisation to last contact or death) was 2.83 years in the dabrafenib and trametinib combination arm and 2.75 years in the placebo arm.
Maltese: Id-dewmien medju tal-follow-up (żmien mirrandomizzazzjoni sal-aħħar kuntatt jew mewt) kien ta' 2.83 snin fil-grupp mogħti taħlita ta' dabrafenib u trametinib u 2.75 snin fil-grupp mogħti l-plaċebo.
English: The management of adverse reactions may require treatment interruption, dose reduction, or treatment discontinuation (see Tables 1 and 2).
Maltese: L-immaniġġjar ta' reazzjonijiet avversi jista' jeħtieġ li l-kura tiġi interrotta, id-doża titnaqqas, jew li lkura titwaqqaf (ara Tabelli 1 u 2).
English: Therapy with dabrafenib should be interrupted if the patient's temperature is ≥38.5ºC (please refer to Table 2 for dose modification guidance).
Maltese: It-terapija b'dabrafenib għandha tiġi interrotta jekk it-temperatura tal-pazjent tkun ≥ 38.5ºC (jekk jogħġbok irreferi għal Tabella 2 għal gwida dwar il-modifika fid-doża).
English: Patients with LVEF lower than the institutional lower limit of normal were not included in clinical trials with dabrafenib.
Maltese: Pazjenti b'LVEF aktar baxx mill-aktar limitu istituzzjonali baxx tan-normal ma kinux inklużi fil-provi kliniċi b'dabrafenib.
English: Developmental toxicity including embryo-lethality and ventricular septal defects and variation in thymic shape were seen at 300 mg/kg/day, and delayed skeletal development and reduced foetal body weight at ≥20 mg/kg/day (≥0.5 times human clinical exposure based on AUC).
Maltese: Deher effett tossiku fuq liżvilupp li kien jinkludi letalità tal-embriju u difetti fis-septum ventrikolari u varjazzjoni fil-forma tattimu b'dożi ta' 300 mg/kg/jum, u dewmien fl-iżvilupp skeletali u tnaqqis fil-piż tal-ġisem tal-fetu b'doża ta' ≥ 20 mg/kg/jum (≥ 0.5 darbiet l-esponiment kliniku tal-bniedem abbażi tal-AUC).
English: In subjects with BRAF V600 mutation positive melanoma, administration of dabrafenib resulted in inhibition of tumour phosphorylated ERK relative to baseline.
Maltese: F'individwi b'melanoma pożittiva għall-mutazzjoni BRAF V600, l-għoti ta' dabrafenib irriżulta flinibizzjoni ta' tumur ERK fosforilat relattiv għal-linja bażi.
English: Interaction studies have only been performed in adults.
Maltese: Studji ta' interazzjoni twettqu biss fuq l-adulti.
English: The Kaplan-Meier OS curve appears to stabilise from 3 to 5 years (see Figure 2).
Maltese: Il-kurvatura tal-OS Kaplan-Meier jidher li ssir stabbli minn 3 sa 5 snin (ara Figura 2).
English: • some medicines used to treat certain psychiatric conditions, such as haloperidol
Maltese: • xi mediċini użati għall-kura ta' ċerti kundizzjonijiet psikjatriċi, bħal haloperidol
English: Administration of dabrafenib 150 mg twice daily and warfarin resulted in a decrease in AUC of S- and R- warfarin of 37% and 33%, respectively, compared to administration of warfarin alone.
Maltese: L-għoti ta' dabrafenib 150 mg darbtejn kuljum u warfarin irriżulta fi tnaqqis fl-AUC ta' S- u Rwarfarin ta' 37 % u 33 %, rispettivament, meta mqabbel mal-għoti ta' warfarin waħdu.
English: Patients should be routinely monitored for visual signs and symptoms (such as change in vision, photophobia and eye pain) while on therapy.
Maltese: Il-pazjenti għandhom jiġu mmonitorjati ta' spiss għal sinjali viżwali u sintomi (bħal, tibdil fil-vista, fotofobija u uġigħ flgħajnejn) waqt li jkunu fuq it-terapija.
English: Median OS and estimated 1-year, 2-year, 3-year, 4 year and 5-year survival rates are presented in Table 6.
Maltese: L-OS medjana u r-rati ta' sopravivenza stmati għal sena, sentejn, 3 snin, 4 snin u 5 snin huma ppreżentati f'Tabella 6.
English: Please refer to the trametinib SmPC section 4.4 for additional information.
Maltese: Jekk jogħġbok irreferi għal sezzjoni 4.4 talSmPC ta' trametinib għal tagħrif addizzjonali.
English: Dabrafenib was not mutagenic or clastogenic using in vitro tests in bacteria and cultured mammalian cells, and an in vivo rodent micronucleus assay.
Maltese: Dabrafenib ma kienx mutaġeniku jew klastoġeniku meta ntużaw testijiet in vitro f'batterji u kultura ta' ċelloli mammiferi, u assaġġ ta' mikronuklei ta' annimali gerriema in vivo.
English: Cases were managed with excision and did not require treatment modification (see section 4.4).
Maltese: Il-każijiet kienu mmaniġġjati bi qtugħ u ma kinux jeħtieġu modifikazzjoni tal-kura (ara sezzjoni 4.4).
English: Exceptions where dose modifications are necessary for only one of the two treatments are detailed below for pyrexia, uveitis, RAS mutation positive non-cutaneous malignancies (primarily related to dabrafenib), left ventricular ejection fraction (LVEF) reduction, retinal vein occlusion (RVO), retinal pigment epithelial detachment (RPED) and interstitial lung disease (ILD)/pneumonitis (primarily related to trametinib).
Maltese: Jekk iseħħu tossiċitajiet relatati mal-kura meta dabrafenib jintuża flimkien ma' trametinib, mela allura ż-żewġ trattamenti għandu jkollhom id-doża mnaqqsa, interrotta jew imwaqqfa simultanjament. Leċċezzjonijiet, meta jkun hemm bżonn ta' modifika fid-doża għal wieħed biss miż-żewġ trattamenti, huma spjegati fid-dettall hawn taħt għal deni, uveite, tumuri malinni mhux tal-ġilda pożittivi għal mutazzjoni RAS (primarjament b'rabta ma' dabrafenib), tnaqqis tal-frazzjoni tal-ħruġ ventrikolari taxxellug (LVEF), okklużjoni tal-vina retinali (RVO), distakkament epiteljali tal-pigment retinali (RPED) u mard interstizjali tal-pulmun (ILD)/pulmonite (primarjament b'rabta ma' trametinib).
English: Tafinlar 75 mg hard capsules
Maltese: Tafinlar 75 mg kapsuli ibsin
English: (months) Median (95% CI)
Maltese: (xhur) Medju (95 % CI)
English: Median PFS (months) (95% CI) Hazard Ratio (95% CI)
Maltese: Marda progressiva jew mewt, n (%) PFS medja (xhur) (95 % CI) Proporzjon talPeriklu (95 % CI)
English: When dabrafenib is used alone and in combination with trametinib, therapy with dabrafenib should be interrupted if the patient's temperature is ≥38.5
Maltese: It-terapija għandha tiġi interrotta jekk it-temperatura tal-pazjent tkun ≥ 38.5ºC.
English: The majority of patients had a BRAF V600E mutation (91%).
Maltese: Il-biċċa l-kbira tal-pazjenti kellhom mutazzjoni BRAF V600E (91%).
English: Retinal vein occlusion (RVO) and Retinal pigment epithelial detachment (RPED) If patients report new visual disturbances such as diminished central vision, blurred vision, or loss of vision at any time while on combination therapy with dabrafenib and trametinib, please refer to the trametinib SmPC (see section 4.2) for dose modification instructions for trametinib.
Maltese: Okklużjoni tal-vina retinali (RVO - Retinal vein occlusion) u distakkament epiteljali tal-pigment retinali (RPED - Retinal pigment epithelial detachment) Jekk il-pazjenti jirrapportaw disturbi viżivi ġodda bħal vista ċentrali mnaqqsa, viżjoni mċajpra, jew telf fil-vista fi kwalunkwe żmien waqt it-terapija ta' kombinazzjoni b'dabrafenib u trametinib, jekk jogħġbok irreferi għall-SmPC ta' trametinib (ara sezzjoni 4.2) għal struzzjonijiet dwar il-modifika fiddoża ta' trametinib.
English: • some medicines that reduce cholesterol levels, such as atorvastatin and simvastatin
Maltese: • xi mediċini li jbaxxu l-livelli tal-kolesterol, bħal atorvastatin u simvastatin