FrancophonIA/ELRC3.0 huggingface dataset:
English: The safety of encorafenib (300 mg orally once daily) in combination with binimetinib (45 mg orally twice daily) was evaluated in 257 patients with BRAF V600 mutant unresectable or metastatic melanoma (hereafter referred to as the Combo 300 population), based on the Phase III study (CMEK162B2301, Part 2).
Maltese: Is-sigurtà ta' encorafenib (300 mg oralment darba kuljum) flimkien ma' binimetinib (45 mg oralment darbtejn kuljum) ġiet evalwata f'257 pazjent b'melanoma mutanti tal-BRAF V600 (minn hawn 'il quddiem imsejħa l-popolazzjoni raggruppata Combo 300) li ma tistax titneħħa, jew metastatika, fuq ilbażi tal-Istudju tal-Fażi II (CMEK162B2301, Parti 2).
English: Dry skin* Pruritus* Alopecia*
Maltese: Newropatija periferali* Sturdament*
English: In the pooled Combo 450 population, mild, mostly Grade 1, asymptomatic blood creatinine elevation was noted in 6.2% (17/274) of patients treated with the Combo 450 mg.
Maltese: Fil-popolazzjoni raggruppata Combo 450, elevazzjoni asintomatika ħafifa, primarjament tal-Grad 1, fil-kreatinina fid-demm ġiet osservata f'6.2% (17/274) tal-pazjenti ttrattati bil-Combo 450 mg. Linċidenza tal-elevazzjoni tal-Grad 3 jew 4 kienet ta' 0.7% (2/274).
English: Haemorrhagei Hypertension *
Maltese: Artralġja* Mijalġjag
English: HRa (95% CI) (vs Vem)
Maltese: HRa (95% CI) (vs Vem) Valur p nominali HRa (95% CI) (vs Vem)
English: While encorafenib is a relatively potent reversible inhibitor of UGT1A1, no differences in binimetinib exposure have been observed clinically when binimetinib was co-administered with encorafenib.
Maltese: Filwaqt li encorafenib hu inibitur riversibbli relattivament potenti ta' UGT1A1, klinikament ma ġiet osservata ebda differenza fl-esponiment ta' binimetinib meta binimetinib ġie koamministrat ma'
English: It should be considered to permanently discontinue encorafenib.
Maltese: Jekk binimetinib jitwaqqaf b'mod permanenti, encorafenib għandu jitwaqqaf.
English: The median duration of exposure was 11.7 months in patients treated with Combo 450, 7.1 months in patients treated with Enco 300 and 6.2 months in patients treated with vemurafenib.
Maltese: Id-durata medjana ta' esponiment kienet ta' 11.7-il xahar f'pazjenti ttrattati b'Combo 450, 7.1 xhur f'pazjenti ttrattati b'Enco 300 u 6.2 xhur f'pazjenti ttrattati b'vemurafenib.
English: Bleeding problems: Braftovi can cause serious bleeding problems.
Maltese: Braftovi jista' jikkawża problemi serji ta' fsada.
English: Birth control medicines containing hormones (such as pills, injections, patches, implants and certain intrauterine devices (IUDs) that release hormones) may not work as well as expected while you are taking Braftovi.
Maltese: Mediċini li jikkontrollaw il-fertilità li fihom l-ormoni (bħal pilloli, injezzjonijiet, faxex li jkun fihom il-mediċina, impjanti u ċerti apparati li jitpoġġew fl-utru (IUDs) li jirrilaxxaw l-ormoni) jistgħu ma jaħdmux tajjeb daqs kemm ikun mistenni waqt li tkun qed tieħu Braftovi.
English: How to store Braftovi
Maltese: X'fih Braftovi
English: Other major metabolic pathways involved hydroxylation, carbamate hydrolysis, indirect glucuronidation and glucose conjugate formation.
Maltese: Mogħdijiet metaboliċi ewlenin oħrajn involvew l-idrossilazzjoni, l-idroliżi tal-karbamat, il-glukuronidazzjoni indiretta u l-formazzjoni tal-konjugati tal-glukożju.
English: In Study CMEK162B2301-Part 2, in the Combo 300 arm, fatigue was observed in 33.5% (86/257) of patients with 1.6% (4/257) Grade 3-4 events.
Maltese: Fi Studju CMEK162B2301-Parti 2, fil-parti tal-istudju Combo 300, l-għeja ġiet osservata fi 33.5% (86/257) tal-pazjenti, b'1.6% (4/257) b'avvenimenti ta' Grad 3-4.
English: New primary malignancies, cutaneous and non-cutaneous, have been observed in patients treated with BRAF inhibitors and can occur when encorafenib is administered (see section 4.8).
Maltese: Malinni primarji ġodda, kutanji u mhux kutanji, ġew osservati f'pazjenti ttrattati b'inibituri tal-BRAF u jistgħu jseħħu meta jiġi amministrat encorafenib (ara sezzjoni 4.8).
English: In Study CMEK162B2301-Part 2, in the Combo 300 arm, haemorrhagic events were observed in 6.6% (17/257) of patients and were Grade 3-4 in 1.6% (4/257) of patients.
Maltese: Fi studju CMEK162B2301-Parti 2, fil-parti tal-istudju Combo 300, avvenimenti emorraġiċi ġew osservati fi 6.6% (17/257) tal-pazjenti, b'1.6% (4/257) tal-pazjenti b'avvenimenti ta' Grad 3-4.
English: Ocular toxicities
Maltese: GĦAMLA FARMAĊEWTIKA
English: The safety of encorafenib in combination with binimetinib has not been established in patients with a baseline LVEF that is either below 50% or below the institutional lower limits of normal.
Maltese: Is-sikurezza ta' encorafenib flimkien ma' binimetinib ma ġietx stabbilita f'pazjenti b'LVEF fil-linja bażi li hi anqas minn 50% jew anqas mil-limiti inferjuri istituzzjonali tan-normal.
English: Additionally, the combination of encorafenib and binimetinib prevented the emergence of resistance in BRAFV600E mutant human melanoma xenografts in vivo.
Maltese: Barra minn hekk, l-għoti flimkien ta' encorafenib u binimetinib ipprevjeniet l-emerġenza ta' reżistenza f'xenografts tal-melanoma mutanti tal-bniedem tal-BRAFV600E in vivo.
English: In Study CMEK162B2301-Part 2, in the Combo 300 arm, RPED was observed in 12.5% (32/257) of patients with 0.4% (1/257) Grade 4 event.
Maltese: Fi Studju CMEK162B2301-Parti 2, fil-parti tal-istudju Combo 300, RPED ġie osservat fi 12.5% (32/257) tal-pazjenti, b'0.4% (1/257) b'avveniment ta' Grad 4.
English: Ophthalmic lesions were partially reversible and consisted of a separation or detachment in the retina between the outer rods and cones layer and retinal pigmented epithelium at the central macula at the fovea.
Maltese: Il-leżjonijiet oftalmiċi kienu parzjalment riversibbli u kienu jikkonsistu f'separazzjoni jew f'distakkament retinali bejn is-saff estern tal-vireg u tal-koni u l-epitelju pigmentat retinali fil-makula ċentrali fil-fovea.
English: Encorafenib in combination with binimetinib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation (see sections 4.4 and 5.1).
Maltese: Encorafenib għandu jintuża b'attenzjoni f'pazjenti b'indeboliment renali sever (ara sezzjonijiet 4.4 u 5.2).
English: The occurrence of QTc prolongation can be managed with dose reduction, interruption or discontinuation with correction of abnormal electrolytes and control of risk factors (see section 4.2).
Maltese: L-okkorrenza ta' titwil tal-QTc tista' tiġi ġestita bi tnaqqis, b'interruzzjoni jew b'waqfien tad-doża b'korrezzjoni tal-elettroliti anormali u b'kontroll tal-fatturi ta' riskju (ara sezzjoni 4.2).
English: In the pooled Combo 450 population, headache occurred in 21.5% (59/274) of patients, including Grade 3 in 1.5% (4/274) of patients.
Maltese: Fil-popolazzjoni raggruppata Combo 450, l-uġigħ ta' ras seħħ f'21.5% (59/274) tal-pazjenti, li jinkludi Grad 3 irrappurtat f'1.5% (4/274) tal-pazjenti.
English: Therefore, concomitant administration of encorafenib with strong CYP3A4 inhibitors should be avoided (due to increased encorafenib exposure and potential increase in toxicity, see section 5.2).
Maltese: għandha tiġi evitata (minħabba ż-żieda fl-esponiment ta' encorafenib u ż-żieda potenzjali fit-tossiċità, ara sezzjoni 5.2).
English: Facial paresis was generally reversible and led to treatment discontinuation in 0.9% (2/217).
Maltese: Il-pareżi tal-wiċċ kienet ġeneralment riversibbli u wasslet għall-waqfien tat-trattament f'0.9% (2/217).
English: Braftovi 50 mg hard capsules Each hard capsule contains 50 mg of encorafenib.
Maltese: Braftovi 50 mg kapsuli iebsin Kull kapsula iebsa fiha 50 mg encorafenib.
English: Do not have grapefruit juice during your treatment with Braftovi.
Maltese: Tiħux meraq tal-grapefruit waqt it-trattament tiegħek b'Braftovi.
English: Read the package leaflet before use.
Maltese: Ixrob ħafna fluwidi matul ittrattament.
English: The median time to onset of the first event of cuSCC (all grades) was 6.5 months (range 1.0 to 22.8 months).
Maltese: Iż-żmien medjan sal-bidu tal-ewwel avveniment ta' cuSCC (il-gradi kollha) kien ta' 6.5 xhur (medda ta' xahar (1) sa 22.8 xahar).
English: Pancreatitis led to dose interruption or adjustment in (0.4 %) 1/274 of patients.
Maltese: L-interruzzjoni tad-doża jew il-modifika fid-doża kienu rrapportati f'0.4% (1/274) tal-pazjenti.
English: Braftovi 75 mg hard capsules Each hard capsule contains 75 mg of encorafenib.
Maltese: Braftovi 75 mg kapsuli iebsin Kull kapsula iebsa fiha 75 mg encorafenib.
English: 1st dose reduction 300 mg once daily 2nd dose reduction 200 mg once daily Subsequent modification
Maltese: Tnaqqis tal-ewwel doża 300 mg darba kuljum Tnaqqis tat-tieni doża 200 mg darba kuljum
English: Flesh coloured opaque cap and white opaque body, printed with a stylised “A” on the cap and “LGX 75mg” on the body.
Maltese: ” A ” distinta fuq l-għatu u “LGX 75mg ”fuq il korp.
English: LVD was reported when encorafenib is used in combination with binimetinib (see section 4.8 of binimetinib SmPC).
Maltese: LVD ġiet irrapportata meta encorafenib jintuża flimkien ma' binimetinib (ara sezzjoni 4.8 tal-SmPC ta' binimetinib).
English: Moderate CYP3A4 inhibitors should be co-administered with caution.
Maltese: L-inibituri moderati ta' CYP3A4 għandhom jiġu koamministrati b'attenzjoni.
English: cuSCCa
Maltese: Kolitek
English: - Liver problems: Braftovi can cause abnormal blood tests related to how your liver works (raised levels of liver enzymes).
Maltese: - Problemi fil-kliewi: Braftovi jista' jbiddel l-attività tal-kliewi tiegħek (ta' spiss testijiet taddemm anormali, aktar rari deidratazzjoni u remettar).
English: There are no clinical data with encorafenib in patients with severe renal impairment.
Maltese: Ma hemm ebda data klinika b'encorafenib f'pazjenti b'indeboliment renali sever.
English: In Study CMEK162B2301-Part 2, in the Combo 300 arm, nausea was observed in 27.2% (70/257) of patients and was Grade 3 in 1.6% (4/257) of patients.
Maltese: Fi Studju CMEK162B2301-Parti 2, fil-parti tal-istudju Combo 300, in-nawsja ġiet osservata fi 27.2% (70/257) tal-pazjenti, u kien ta' Grad 3 f'1.6% (4/257) tal-pazjenti.
English: Vomiting occurred in 15.2% (39/257) of patients with Grade 3 reported in 0.4% (1/257) of patients.
Maltese: 2% (39/257) tal-pazjenti, bi Grad 3 irrappurtat f'0.4% (1/257) tal-pazjenti.
English: A thorough QT study to evaluate the QT prolongation potential of encorafenib has not been conducted.
Maltese: Ma sarx studju dettaljat tal-QT biex jiġi evalwat il-potenzjal ta' titwil tal-QT ta' encorafenib.
English: The most common AEs reported with a higher incidence in patients aged ≥ 65 years compared to patients aged < 65 years included diarrhoea, pruritus, GGT and blood phosphatase alkaline elevation.
Maltese: pazjenti li kellhom < 65 sena kienu jinkludu dijarea, prurite, żieda fil-GGT u fil-fosfatażi alkalina tad demm.
English: At the recommended dose (n = 274) in patients with unresectable or metastatic melanoma, the most common adverse reactions (>25%) occurring in patients treated with encorafenib administered with binimetinib were fatigue, nausea, diarrhoea, vomiting, retinal detachment, abdominal pain, arthralgia, blood CK increased and myalgia.
Maltese: Bid-doża rakkomandata (n = 274) f'pazjenti b'melanoma li ma tistax titneħħa jew metastatika, l-aktar reazzjonijiet avversi komuni (>25 %) li seħħew f'pazjenti ttrattati b'encorafenib amministrata flimkien ma' binimetinib kienu għeja, nawsja, dijarea, remettar, distakkament retinali, uġigħ fl-addome, artralġja, żieda tas-CK fid-demm u mijalġija.
English: Effect of encorafenib on binimetinib
Maltese: Doża ta' encorafenib meta jintuża flimkien ma' binimetinib
English: Encorafenib suppresses the RAF/MEK/ERK pathway in tumour cells expressing several mutated forms of BRAF kinase (V600E, D and K).
Maltese: Encorafenib irażżan il-mogħdija tal-RAF/tal-MEK/tal-ERK f'ċelloli tattumur li jesprimu diversi forom mutati tal-kinasi tal-BRAF (V600E, D u K). Speċifikament, encorafenib jinibixxi tkabbir in vitro u in vivo taċ-ċelloli tal-melanoma mutanti tal-BRAFV600E, D u K.
English: • If not improved, encorafenib should be permanently discontinued.
Maltese: • Encorafenib għandu jitwaqqaf b'mod permanenti.
English: PPES led to discontinuation in 4.1% (9/217) of patients and to dose interruption or dose modification in 23.0% (50/217) of patients.
Maltese: (9/217) tal-pazjenti u għal interruzzjoni tad-doża jew għal modifika tad-doża fi 23.0% (50/217) tal pazjenti.
English: Part 2 of Study CMEK162B2301 was designed to assess the contribution of binimetinib to the encorafenib and binimetinib combination.
Maltese: Parti 2 tal-Istudju CMEK162B2301 kienet mfassla biex tevalwa l-kontribuzzjoni ta' binimetinib għallgħoti flimkien ta' encorafenib u binimetinib.
English: In the pooled encorafenib 300 population, photosensitivity was reported in 4.1% (9/217) of patients.
Maltese: Fil-popolazzjoni raggruppata encorafenib 300, is-sensittività għad-dawl kienet irrapportata f'4.1% (9/217) tal-pazjenti.
English: In vitro experiments indicate encorafenib is a relatively potent reversible inhibitor of UGT1A1, CYP2B6, CYP2C9 and CYP3A4/5, as well as a time-dependent inhibitor of CYP3A4.
Maltese: ta' CYP2B6, ta' CYP2C9 u ta' CYP3A4/5, kif ukoll inibitur dipendenti fuq iż-żmien ta' CYP3A4.
English: A risk to the newborns/infants cannot be excluded.
Maltese: Ir-riskju gћat-trabi tat-twelid/trabi mhux eskluż.
English: Inhibition of P-gp is unlikely to result in a clinically important increase in encorafenib concentrations as encorafenib exhibits high intrinsic permeability.
Maltese: Hu improbabbli li l inibizzjoni tal-P-gp tirriżulta f'żieda klinikament importanti fil-konċentrazzjonijiet ta' encorafenib peress li encorafenib jesibixxi permeabilità intrinsika għolja.
English: When encorafenib was used at a dose of 300 mg once daily in combination with binimetinib 45 mg twice daily (Combo 300) in study CMEK162B2301-Part 2, the frequency category was lower compared to the pooled Combo 450 population for the following adverse reactions: anemia, peripheral neuropathy, haemorrhage, hypertension, pruritus (common); and colitis, increased amylase and increased lipase (uncommon).
Maltese: Meta encorafenib intuża f'doża ta' 300 mg darba kuljum flimkien ma' binimetinib 45 mg darbtejn kuljum (Combo 300) fi studju CMEK162B2301-Parti 2, il-kategorija ta' frekwenza kienet aktar baxxa meta mqabbla mal-popolazzjoni raggruppata ta' Combo 450 għar-reazzjonijiet avversi li ġejjin:
English: These melanomas are usually removed by surgery and treatment with Braftovi (and binimetinib) can continue without interruption.
Maltese: Dawn il-melanomi normalment jitneħħew b'kirurġija u t-trattament bi Braftovi (u b'binimetinib) ikun jista' jitkompla mingħajr interruzzjoni.
English: The median (range) encorafenib terminal half-life (T1/2) was 6.32 h (3.74 to 8.09 h).
Maltese: 6.32 sigħat (3.74 sa 8.09 sigħat).
English: BRAF mutation testing
Maltese: Ittestjar għall-mutazzjoni tal-BRAF
English: Muscular disorders/Myalgial Pain in extremity Back pain
Maltese: Artralġja* Disturbi muskolari/Mijalġjal
English: Since encorafenib is moderately bound to plasma proteins, haemodialysis is likely to be ineffective in the treatment of overdose with encorafenib.
Maltese: Peress li encorafenib jaqbad b'mod moderat mal-proteini tal-plażma, l-emodijalisi aktarx li tkun ineffettiva fit-trattament ta' doża eċċessiva ta' encorafenib.
English: Recommended dose modifications for encorafenib (used in combination with binimetinib) for selected adverse reactions Severity of adverse reactiona Encorafenib
Maltese: Ħielsa minn progressjoni ta' sopravivenza u riżultati tar-rispons ġenerali kkonfermat (reviżjoni ċentrali indipendenti) Encorafenib + binimetinib
English: Rhabdomyolysis
Maltese: Encorafenib
English: If encorafenib is temporarily interrupted (see Table 2), binimetinib should be interrupted.
Maltese: Jekk encorafenib jitwaqqaf b'mod temporanju (ara t-Tabella 2), binimetinib għandu jkun interrott.
English: Cutaneous squamous cell carcinoma
Maltese: Karċinoma taċ-ċelloli tat-tip skwamuż tal-ġilda
English: Encorafenib is both an inhibitor and inducer of CYP3A4.
Maltese: L-użu konkomitanti ma' aġenti li huma substrati ta' CYP3A4
English: The data suggest that hepatic uptake transporters are not involved in encorafenib distribution into primary human hepatocytes.
Maltese: Id-data tissuġġerixxi li t-trasportaturi tat-teħid epatiku mhumiex involuti fid-distribuzzjoni ta' encorafenib fl-epatoċiti umani primarji.
English: Tell your doctor if you have had a different type of cancer than melanoma, as Braftovi may worsen certain other types of cancers.
Maltese: Kellem lit-tabib tiegħek jekk kellek tip differenti ta' kanċer minbarra l-melanoma, peress li Braftovi jista' jaggrava ċerti tipi ta' kanċers oħra.
English: The most common adverse reactions (>25%) occurring in patients treated with encorafenib 300 mg administered with binimetinib were fatigue, nausea and diarrhoea.
Maltese: L-aktar avvenimenti avversi komuni (>25%) li seħħew f'pazjenti ttrattati b'encorafenib 300 mg mogħti flimkien ma' binimetinib kienu għeja, nawsja u dijarea.
English: Encorafenib potentially inhibits a number of transporters.
Maltese: Encorafenib potenzjalment jinibixxi numru ta' trasportaturi.
English: Dose interruption or dose modification occurred in 1.1% (3/274) of patients.
Maltese: Interruzzjoni tad-doża jew modifika tad-doża seħħew f'1.1% (3/274) tal-pazjenti.
English: An evaluation of change over time in score yielded the same trend for EORTC QLQ-C30 and at all visit for FACT-M.
Maltese: Evalwazzjoni tat-tibdil maż-żmien fil-punteġġ rendiet l-istess xejra għall-EORTC QLQC30 u fiż-żjarat kollha għall-FACT-M).
English: Closer monitoring of encorafenib related toxicities in patients with mild hepatic impairment is recommended, including clinical examination and liver function tests, with assessment of ECGs as clinically appropriate during treatment.
Maltese: Hu rakkomandat monitoraġġ aktar mill-qrib ta' tossiċitajiet relatati ma' encorafenib f'pazjenti b'indeboliment epatiku ħafif li jinkludi eżaminazzjoni klinika u testijiet tal-funzjoni tal-fwied, b'evalwazzjoni ta' ECGs kif ikun klinikament xieraq matul it-trattament.
English: Eye problems: Braftovi, when taken with binimetinib, can cause serious eye problems such as fluid to leak under the retina in the eye, leading to detachment of different layers in the eye (retinal epithelial pigmental detachment).
Maltese: Braftovi, meta jittieħed ma' binimetinib, jista' jikkawża problemi serji fl għajnejn bħal tnixxija ta' fluwidi taħt ir-retina fl-għajn, li twassal għal distakkament ta' saffi differenti fl-għajn (distakkament pigmentali retinali epiteljali).
English: Pruritus*
Maltese: Dijarea*
English: Encorafenib in combination with binimetinib in patients with brain metastases There are limited efficacy data with the combination of encorafenib and binimetinib in patients with a BRAF V600 mutant melanoma which have metastasised to the brain (see section 5.1).
Maltese: Encorafenib flimkien ma' binimetinib f'pazjenti b'metastażijiet fil-moħħ Hemm data limitata dwar l-effikaċja bl-għoti ta' encorafenib flimkien ma' binimetinib f'pazjenti b'melanoma mutanti tal-BRAF V600 li kellhom metastażi fil-moħħ (ara sezzjoni 5.1).
English: The encorafenib single agent (300 mg orally once daily) safety profile is based on data from 217 patients with unresectable or metastatic BRAF V600-mutant melanoma (hereafter referred to as the pooled encorafenib 300 population).
Maltese: Il-profil tas-sigurtà ta' encorafenib bħala aġent uniku (300 mg b'mod orali darba kuljum) hu bbażat fuq data minn 217-il pazjent b'melanoma tal-BRAF V600 (minn hawn 'il quddiem imsejħa lpopolazzjoni raggruppata ta' encorafenib 300) li ma tistax titneħħa mutanti jew metastatika.
English: Following a single oral dose of 100 mg [14C] encorafenib in healthy subjects, radioactivity was eliminated equally in both the faeces and urine (mean of 47.2%).
Maltese: Wara doża orali waħda ta' 100 mg [14C] encorafenib f'individwi b'saħħithom, ir-radjuattività ġiet eliminata indaqs kemm fl-ippurgar kif ukoll fl-awrina (medja ta' 47.2%).
English: Braftovi 50 mg hard capsules
Maltese: Braftovi 50 mg kapsuli iebsin
English: Braftovi 75 mg hard capsules
Maltese: Braftovi 75 mg kapsuli iebsin
English: Co-administration of moderate (diltiazem) and strong (posaconazole) CYP3A4 inhibitors with single doses of encorafenib in healthy volunteers resulted in a 2 and 3-fold increase in the area under the concentration-time curve (AUC), respectively and in 44.6% and 68.3% increase in maximum encorafenib concentration (Cmax) respectively.
Maltese: Il-koamministrazjoni ta' inibituri ta' CYP3A4 moderati (diltiazem) u b'saħħithom (posaconazole) b'dożi uniċi ta' encorafenib f'voluntiera b'saħħithom wasslet għal żieda tripla jew doppja fl esponiment ġenerali fl-erja taħt il-kurva ta' konċentrazzjoni u żmien (AUC), rispettivament u f'
English: Survival at 24 months (95% CI)
Maltese: Sopravivenza wara 24 xahar (95% CI)
English: The median duration of treatment was longer for Combo 300 vs Enco 300, 52.1 weeks vs 31.5 weeks.
Maltese: It-tul medju tat-trattament kien itwal għal Combo 300 vs Enco 300, 52.1 gimgħa vs
English: Constipation occurred in 24.1% (66/274) of patients and was Grade 1 or 2.
Maltese: Stitikezza seħħet f'24.1% (66/274) tal-pazjenti u kienet tal-Grad 1 jew 2.
English: Vomiting* Constipation Abdominal pain* Diarrhoea*
Maltese: - problemi fil-vista tiegħek (indeboliment tal-vista) - uġigħ fl-istonku - dijarea
English: For additional information on warnings and precautions associated with binimetinib treatment, see section 4.4 of binimetinib SmPC.
Maltese: Għal informazzjoni addizzjonali dwar twissijiet u prekawzjonijiet assoċjati mat-trattament b'binimetinib, ara sezzjoni 4.4 tal-SmPC ta' binimetinib.
English: Ocular toxicities including uveitis, iritis and iridocyclitis can occur when encorafenib is administered.
Maltese: Jekk ikun possibbli, urihom dan il-fuljett u l-pakkett tal-mediċina.
English: In particular, tell your doctor if you are taking anything in this list or any other medicines: - some medicines to treat fungal infections (such as itraconazole, posaconazole, fluconazole) - some medicines to treat bacterial infections (such as rifampicin, clarithromycin, telithromycin,
Maltese: - xi mediċini għall-kura ta' infezzjonijiet fungali (bħal itraconazole, posaconazole, fluconazole)
English: Uveitis including iritis and iridocyclitis
Maltese: - stitikezza - raxx ta' diversi tipi fuq il-ġilda
English: Contact your doctor straightaway if you become pregnant while taking Braftovi.
Maltese: Dan għaliex dan jista' jżid l-effetti sekondarji ta' Braftovi.
English: Observed cases of renal failure including acute kidney injury and renal impairment were generally associated with vomiting and dehydration.
Maltese: Każijiet osservati ta' insuffiċjenza renali li tinkludi korriment akut tal-kliewi u indeboliment renali ġeneralment ġew assoċjati ma' remettar u ma' deidratazzjoni.
English: Encorafenib N=194 (Enco300)
Maltese: Encorafenib N = 194
English: CK elevation and rhabdomyolysis
Maltese: - Is-sustanzi l-oħra huma:
English: Concomitant agents that are substrates of UGT1A1 (e.g. raltegravir, atorvastatin, dolutegravir) may have increased exposure and should be therefore administered with caution.
Maltese: Filwaqt li binimetinib hu substrat ta' UGT1A1, dan ma ssirlux estrazzjoni tal-musrana, u għalhekk ma hi mistennija ebda DDI ma' encorafenib.
English: Effect of CYP enzymes on encorafenib
Maltese: L-effett ta' enzimi ta' CYP fuq encorafenib
English: In Study CMEK162B2301-Part 2, in the Combo 300 arm, headache was reported in 12.1% (31/257) of patients and was Grade 3 in 0.4% (1/257) of patients.
Maltese: Fi Studju CMEK162B2301-Parti 2, fil-parti tal-istudju Combo 300, l-uġigħ ta' ras ġie osservat fi 12.1% (31/257) tal-pazjenti, u kien ta' Grad 3 f'0.4% (1/257) tal-pazjenti.
English: INSTRUCTIONS ON USE
Maltese: matul it-trattament.
English: Basal cell carcinoma* Skin papilloma*
Maltese: Karċinoma taċ-ċelloli bażali*
English: There are insufficient data to evaluate potential differences in the exposure of encorafenib by race or ethnicity.
Maltese: Ma hemmx biżżejjed data biex jiġu evalwati d-differenzi potenzjali fl-esponiment ta' encorafenib skont ir-razza jew l-etniċità.