FrancophonIA/ELRC3.0 huggingface dataset:
English: In another clinical trial, vemurafenib increased Cmax and AUC of a single 2 mg dose of tizanidine (CYP1A2 substrate) approximately 2.2-fold and 4.7-fold, respectively.
Maltese: 2 mg ta' tizanidine (substrat ta' CYP1A2) b'madwar 2.2 darbiet u 4.7 darbiet, rispettivament.
English: Although transient tumour regressions were seen, the best overall response rate (BORR) was 0% (95% CI: 0%, 46%) based on confirmed responses.
Maltese: Għalkemm kienu osservati rigressjonijiet temporanji tat-tumur, abbażi ta' risponsi kkonfermati l-aħjar rata ta' rispons globali (BORR - best overall response rate) kienet ta' 0% (CI ta' 95%: 0%, 46%).
English: There are only limited data available in patients with severe renal impairment (see section 5.2).
Maltese: Hemm biss data limitata disponibbli f'pazjenti b'indeboliment renali sever (ara sezzjoni 5.2).
English: A phase II single-arm, multi-centre, multinational study was conducted in 132 patients who had BRAF V600E mutation-positive metastatic melanoma according to the cobas 4800 BRAF V600 Mutation Test and had received at least one prior therapy.
Maltese: II bi grupp wieħed, b'aktar minn ċentru wieħed, multinazzjonali f'132 pazjent li kellhom melanoma metastatika pożittiva għall-mutazzjoni BRAF V600E skont it-Test ta' Mutazzjoni cobas 4800 BRAF V600 u li kienu rċevew mill-inqas terapija waħda qabel.
English: A total of 57 patients out of 673 whose tumours were analysed retrospectively by sequencing were reported to have BRAF V600K mutation-positive melanoma in NO25026.
Maltese: Total ta' 57 pazjent minn 673 li kellhom it-tumuri tagħhom analizzati b'mod retrospettiv permezz ta' sekwenzjar kienu rrappurtati li kellhom melanoma pożittiva għall-mutazzjoni BRAF V600K f'NO25026.
English: PHARMACEUTICAL FORM AND CONTENTS 56 x 1 film-coated tablets
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 56 x pillola miksija b'rita waħda
English: Fatigue, pyrexia, oedema peripheral, asthenia
Maltese: Għeja, deni, edima periferali, astenja
English: Variability in exposure may also occur due to differences in gastro-intestinal fluid content, volumes, pH, motility and transition time and bile composition.
Maltese: Varjabilità fl-esponiment tista' sseħħ ukoll minħabba differenzi fil-kontenut tal-fluwidu gastrointestinali, il-volumi, il-pH, il-motilità u l-ħin ta' tranżizzjoni u l-kompożizzjoni tal-bili.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 17 February 2012
Maltese: 9 DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 17 ta' Frar 2012
English: Serious hypersensitivity reactions, including anaphylaxis have been reported in association with vemurafenib (see sections 4.3 and 4.8).
Maltese: Reazzjonijiet ta' sensittività eċċessiva serji, inkluż anafilassi kienu rrappurtati f'assoċjazzjoni ma' vemurafenib (ara sezzjonijiet 4.3 u 4.8).
English: New primary melanomas have been reported in clinical trials.
Maltese: Melanomi primarji ġodda kienu rrappurtati fi provi kliniċi.
English: Vemurafenib should be used with caution in combination with strong inhibitors of CYP3A4, glucuronidation and/or transport proteins (e.g. ritonavir, saquinavir, telithromycin, ketoconazole, itraconazole, voriconazole, posaconazole, nefazodone, atazanavir).
Maltese: Vemurafenib għandu jintuża b'attenzjoni flimkien ma' inibituri qawwija ta' CYP3A4, glukuronidazzjoni u/jew proteini ta' trasport (eż. ritonavir, saquinavir, telithromycin, ketoconazole, itraconazole, voriconazole, posaconazole, nefazodone, atazanavir).
English: Concomitant use of vemurafenib with agents metabolized by CYP1A2 with narrow therapeutic windows (e.g. agomelatine, alosetron, duloxetine, melatonin, ramelteon, tacrine, tizanidine, theophylline) is not recommended.
Maltese: L-użu fl-istess ħin ta' vemurafenib ma' sustanzi mmetabolizzati minn CYP1A2 b'indiċi terapewtiku dejjaq (eż. agomelatine, alosetron, duloxetine, melatonin, ramelteon, tacrine, tizanidine, theophylline) mhuwiex rakkomandat.
English: • ≥ 2x ULN ALP (without other cause for ALP elevation)
Maltese: • ≥ 2x ULN ALP (mingħajr kawża oħra għal żieda f'ALP)
English: The bioavailability at steady state ranged between 32 and 115% (mean 64%) relative to an intravenous microdose, in a phase I study with uncontrolled food conditions in 4 patients with BRAF V600 positive malignancies.
Maltese: Il-bijodisponibilità fi stat fiss varjat bejn 32 u 115% (medja ta' 64%) meta mqabbla ma' mikrodoża filvini, fi studju ta' fażi I b'kundizzjonijiet ta' ikel mhux ikkontrollati f'4 pazjenti b'tumuri malinni pożittivi għal BRAF V600.
English: Photosensitivity reaction, actinic keratosis, rash, rash maculo-papular, pruritus, hyperkeratosis, erythema, palmarplantar erythrodysaesthesia syndrome, alopecia, dry skin, sunburn
Maltese: Reazzjoni ta' fotosensittività, raxx, raxx makulopapulari, ħakk, iperkeratosi, eritema, sindrome ta' eritrodisestesija palmari-plantari, alopeċja, ġilda xotta, ħruq ikkawżat mix-xemx
English: Exercise caution and consider additional INR (international normalized ratio) monitoring when vemurafenib is used concomitantly with warfarin (see section 4.4).
Maltese: Uża l-kawtela u kkunsidra monitoraġġ addizzjonali ta' INR (international normalized ratio, proporzjon normalizzat internazzjonali) meta vemurafenib jintuża fl-istess ħin ma' warfarin (ara sezzjoni 4.4).
English: Uveitis,
Maltese: Korriment,
English: dacarbazine 175 (52)
Maltese: 3 ta' Ottubru dacarbazine 175 (52)
English: Most patients were male (56%) and Caucasian (99%), the median age was 54 years (24% were ≥ 65 years), all patients had ECOG performance status of 0 or 1, and the majority of patients had stage M1c disease (65%).
Maltese: Il-biċċa lkbira tal-pazjenti kienu rġiel (56%) u Kawkasi (99%), l-età medjana kienet ta' 54 sena (24% kellhom ≥ 65 sena), il-pazjenti kollha kellhom stat ta' prestazzjoni ECOG ta' 0 jew 1, u l-maġġoranza tal-pazjenti kellhom marda ta' stadju M1c (65%).
English: December 20,
Maltese: 20 ta' Diċembru 2012
English: Vemurafenib was shown to be phototoxic, in vitro, on cultured murine fibroblasts after UVA irradiation, but not in vivo in a rat study at doses up to 450 mg/kg/day (at exposures below the anticipated clinical exposure (based on AUC comparison).
Maltese: Fi studju fuq il-firien vemurafenib intwera li huwa fototossiku in vitro, fuq fibroblasti mill-ġrieden ikkultivati wara irradjazzjoni b'UVA, iżda mhux in vivo f'dożi sa 450 mg/kg/jum (f'esponimenti inqas mill-esponiment kliniku mistenni (ibbażat fuq paragun tal-AUC).
English: In the population pharmacokinetic analysis using data from clinical trials in patients with metastatic melanoma, mild and moderate renal impairment did not influence the apparent clearance of vemurafenib (creatinine clearance >40 ml/min).
Maltese: Fl-analiżi tal-farmakokinetika tal-popolazzjoni bl-użu ta' data minn provi kliniċi f'pazjenti b'melanoma metastatika, indeboliment renali ħafif u moderat ma influwenzax it-tneħħija evidenti ta' vemurafenib (tneħħija ta' kreatinina >40 ml/min).
English: Dose reduction of the concomitant CYP1A2 substrate drug may be considered, if clinically indicated.
Maltese: It-tnaqqis fid-doża tal-mediċina substrat ta' CYP1A2 li tingħata fl-istess ħin jista' jiġi kkunsidrat, jekk ikun indikat klinikament.
English: How to take Zelboraf
Maltese: Trattament ta' radjazzjoni
English: Results from the phase II study (MO25743) in patients with brain metastases
Maltese: Riżultati mill-istudju ta' fażi II (MO25743) f'pazjenti b'metastasi fil-moħħ
English: Effects of vemurafenib on drug transport systems In vitro studies have demonstrated that vemurafenib is an inhibitor of the efflux transporters P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP).
Maltese: P-glycoprotein) u l-proteina ta' reżistenza għall-kanċer tas-sider (BCRP - breast cancer resistance protein).
English: Table 9: Overall response rate and progression-free survival in previously untreated patients with BRAF V600 mutation-positive melanoma vemurafenib dacarbazine p-value (x)
Maltese: Rata ta' rispons globali u sopravivenza mingħajr progressjoni f'pazjenti b'melanoma pożittiva għall-mutazzjoni BRAF V600 li ma kinux ittrattati qabel vemurafenib dacarbazine valur p (x)
English: The most common adverse drug reactions (ADR) of any grade (> 30%) reported with vemurafenib include arthralgia, fatigue, rash, photosensitivity reaction, alopecia, nausea diarrhea, headache,
Maltese: L-aktar reazzjonijiet avversi tal-mediċina (ADR - adverse drug reactions) komuni ta' kwalunkwe grad (> 30%) irrappurtati b'vemurafenib jinkludu artralġja, għeja, raxx, reazzjoni ta' fotosensittività, alopeċja, dardir, dijarea, uġigħ ta' ras, ħakk, rimettar, papilloma tal-ġilda u iperkeratożi.
English: For photosensitivity grade 2 (intolerable) or greater, dose modifications are recommended (see section
Maltese: Għal fotosensittività ta' grad 2 (intollerabbli) jew akbar, huma rakkomandati modifikazzjonijiet fiddoża (ara sezzjoni 4.2).
English: The median age was 52 years with 19% of patients being older than 65 years.
Maltese: L-età medjana kienet ta' 52 sena b'19% tal-pazjenti kellhom aktar minn 65 sena.
English: ● Inflammation of the eye (uveitis)
Maltese: • Infjammazzjoni tal-għajn (uveite)
English: Mild induction of CYP2B6 by vemurafenib was noted in vitro at a vemurafenib concentration of 10 µM.
Maltese: Kienet innotata induzzjoni ħafifa ta' CYP2B6 ikkawżata minn vemurafenib in vitro f'konċentrazzjoni ta' vemurafenib ta' 10 μM.
English: Unexplained abdominal pain should be promptly investigated (including measurement of serum amylase and lipase).
Maltese: Uġigħ addominali inspjegabbli għandu jiġi investigat minnufih (inkluż kejl ta' amylase u lipase fis-serum).
English: ● Changes in electrical activity of the heart (QT prolongation)
Maltese: • Bidliet fl-attività elettrika tal-qalb (titwil ta' QT)
English: If during treatment the QTc exceeds 500 ms, vemurafenib treatment should be temporarily interrupted, electrolyte abnormalities (including magnesium) should be corrected, and cardiac risk factors for QT prolongation (e.g. congestive heart failure, bradyarrhythmias) should be controlled.
Maltese: Jekk matul it-trattament QTc jaqbeż 500 ms, it-trattament b'vemurafenib għandu jiġi temporanjament interrott, anormalitajiet fl-elettroliti (inkluż magnesium) għandhom jiġu kkoreġuti, u fatturi ta' riskju tal-qalb għal titwil ta' QT (eż. insuffiċjenza konġestiva tal-qalb, bradiarritmija) għandhom jiġu kkontrollati.
English: Renal toxicity, ranging from serum creatinine elevations to acute interstitial nephritis and acute tubular necrosis, has been reported with vemurafenib.
Maltese: Tossiċità renali, li tvarja minn żidiet fil-livell tal-kreatinina fis-serum sa nefrite akuta tal-interstizju u nekrosi akuta tat-tubi ż-żgħar, ġiet irrappurtata b'vemurafenib.
English: Change ≥ 1 grade from baseline to any grade Change ≥ 1 grade from baseline to grade 3 or higher
Maltese: Bidla ta' ≥ grad 1 mil-linja bażi għal kwalunkwe grad Bidla ta' ≥ grad 1 mil-linja bażi għal grad 3 jew ogħla
English: Co-administration of itraconazole, a strong CYP3A4/Pgp inhibitor, increased steady state vemurafenib AUC by approximately 40%.
Maltese: L-għoti fl-istess waqt ta' itraconazole, inibitur qawwi ta' CYP3A4/Pgp, żied l-AUC ta' vemurafenib fi stat fiss b'madwar 40%.
English: Secondary objectives included an evaluation of the efficacy of vemurafenib using BORR in the brain of previously treated patients, duration of response (DOR), progression-free survival (PFS) and overall survival (OS) in patients with melanoma metastatic to the brain (see table 10).
Maltese: Oġġettivi sekondarji kienu jinkludu evalwazzjoni tal-effikaċja ta' vemurafenib bl-użu ta' BORR filmoħħ ta' pazjenti ttrattati qabel, tul tar-rispons (DOR - duration of response), sopravivenza mingħajr progressjoni (PFS - progression-free survival) u sopravivenza globali (OS - overall survival) f'pazjenti b'melanoma b'metastasi fil-moħħ (ara tabella 10).
English: In a clinical study, co-administration of a single dose 960 mg of vemurafenib with rifampicin, significantly decreased the plasma exposure of vemurafenib by approximately 40%.
Maltese: Fi studju kliniku, l-għoti ta' doża waħda ta' 960 mg ta' vemurafenib flimkien ma' rifampicin, naqqas b'mod sinifikanti l-esponiment fil-plażma għal vemurafenib b'madwar 40%.
English: Potentiation of radiation treatment toxicity has been reported in patients receiving vemurafenib (see sections 4.4 and 4.8).
Maltese: Taħrix tat-tossiċità ta' trattament ta' radjazzjoni kien irrappurtat f'pazjenti li kienu qed jirċievu vemurafenib (ara sezzjonijiet 4.4 u 4.8).
English: There were no increases to Grade 4 ALT, alkaline phosphatase or bilirubin.
Maltese: Ma kien hemm l-ebda żieda għal ALT, alkaline phosphatase jew bilirubin ta' Grad 4.
English: Vemurafenib is for oral use.
Maltese: Sejjaħ tabib immedjatament.
English: The in vivo relevance of this finding is unknown, but a risk for a clinically relevant effect on concomitantly administered CYP2C8 substrates cannot be excluded.
Maltese: Ir-rilevanza in vivo ta' din is-sejba mhijiex magħrufa, iżda riskju ta' effett klinikament rilevanti fuq substrati ta' CYP2C8 mogħtija fl-istess waqt ma jistax jiġi eskluż.
English: Taking your tablets
Maltese: DATA TA' SKADENZA
English: ● Use an appropriate method of contraception during your treatment and for at least 6 months after the end of your treatment.
Maltese: • Uża metodu xieraq ta' kontraċezzjoni waqt it-trattament tiegħek u għal mill-inqas 6 xhur wara t-tmiem tat-trattament tiegħek.
English: 2nd occurrence of any grade 2 or 3 AE or persistence after treatment interruption
Maltese: It-tieni okkorrenza ta' kwalunkwe AE ta' grad 2 jew 3 jew persistenza wara interruzzjoni tat-trattament
English: Stop taking Zelboraf and talk to your doctor immediately if you get a skin rash with any of the following symptoms: blisters on your skin, blisters or sores in your mouth, peeling of your skin, fever, redness or swelling of your face, hands, or soles of your feet.
Maltese: Waqqaf Zelboraf u kellem lit-tabib tiegħek minnufih jekk ikollok raxx fil-ġilda flimkien ma' xi wieħed mis-sintomi li ġejjin: infafet fil-ġilda tiegħek, infafet jew feriti f'ħalqek, tqaxxir tal-ġilda, deni, ħmura jew nefħa fil-wiċċ, fl-idejn, jew fil-qiegħ tas-saqajn.
English: • To grade 3
Maltese: • Għal grad 3
English: a in brain
Maltese: U LUŻU
English: Each film-coated tablet contains 240 milligrams (mg) of vemurafenib (as a co-precipitate of vemurafenib and hypromellose acetate succinate).
Maltese: Kull pillola fiha 240 mg ta' vemurafenib (bħala kopreċipitat ta' vemurafenib u hypromellose acetate succinate).
English: No signs of genotoxicity were identified in in vitro assays (bacterial mutation [AMES Assay], human lymphocyte chromosome aberration) nor in the in vivo rat bone marrow micronucleus test conducted with vemurafenib.
Maltese: Ma kinux identifikati sinjali ta' ġenotossiċità f'analiżi in vitro (mutazzjoni fil-batterja [analiżi AMES], aberrazzjoni fil-kromożomi tal-limfoċiti tal-bniedem) u lanqas fit-test tal-mikronukleu tal-mudullun tal-far in vivo mwettqa b'vemurafenib.
English: The population elimination half-life estimated by the population PK analysis for vemurafenib is 51.6 hours (the 5th and 95th percentile range of the individual half-life estimates is 29.8 - 119.5 hours).
Maltese: Il-half-life tal-eliminazzjoni talpopolazzjoni stmata mill-analiżi tal-PK tal-popolazzjoni għal vemurafenib hija ta' 51.6 sigħat (firxa tal-5 u l-95 perċentil tal-istimi tal-half-life individwali hija ta' 29.8 - 119.5 sigħat).
English: Cutaneous squamous cell carcinoma (d) (cuSCC)
Maltese: SCC tal-ġilda (d), keratoakantoma,
English: Amongst these patients, 3 had a PR, 3 had SD, 2 had PD and one was not evaluable.
Maltese: Fost dawn il-pazjenti, 3 kellhom PR, 3 kellhom SD, 2 kellhom PD u wieħed ma setax jiġi evalwat.
English: Serious allergic reactions
Maltese: Reazzjonijiet allerġiċi serji
English: The efficacy and safety of vemurafenib in patients with tumours expressing rare BRAF V600 mutations other than V600E and V600K have not been convincingly established (see section 5.1).
Maltese: L-effikaċja u s-sigurtà ta' vemurafenib f'pazjenti b'tumuri li għandhom mutazzjonijiet BRAF V600 rari minbarra V600E u V600K ma ġewx stabbiliti b'mod konvinċenti (ara sezzjoni 5.1).
English: (95% CI)d
Maltese: (CI ta' 95%)
English: • ≥ 3x ULN ALT with simultaneous elevation of bilirubin concentration > 2x ULN
Maltese: ALT b'żieda fl-istess waqt tal-konċentrazzjoni tal-bilirubina għal > 2x ULN
English: • Problem with the nerves that can produce pain, loss of sensation and/or muscle weakness
Maltese: • Problema bin-nervituri li tista' tipproduċi wġigħ, telf ta' sensazzjoni u/jew dgħufija fil-muskoli
English: ● Medicines that are mainly eliminated by metabolising proteins called CYP1A2 (e.g caffeine, olanzapine, theophylline), CYP3A4 (e.g. some oral contraceptives) or called CYP2C8.
Maltese: • Mediċini li fil-biċċa l-kbira huma eliminati permezz tal-proteini metabolizzanti msejħa CYP1A2 (eż. kafeina, olanzapine, theophylline), CYP3A4
English: In the phase II and phase III clinical trials, eligible patients were identified using a real-time polymerase chain reaction assay (the cobas 4800 BRAF V600 Mutation Test).
Maltese: III, pazjenti eliġibbli kienu identifikati bl-użu ta' assaġġ ta' reazzjoni tal-katina polymerase fil-ħin reali (Test ta' Mutazzjoni cobas 4800 BRAF V600).
English: Cutaneous Squamous Cell Carcinoma (cuSCC)
Maltese: • Tip ta' kanċer tal-ġilda (karċinoma taċ-ċellula skwamuża fil-ġilda)
English: A total of 146 patients were enrolled.
Maltese: Kienu rreġistrati total ta' 146 pazjent.
English: BORR
Maltese: LOTT
English: The population apparent clearance of vemurafenib in patients with metastatic melanoma is estimated to be 29.3 L/day (with 31.9% between patient variability).
Maltese: It-tneħħija evidenti tal-popolazzjoni għal vemurafenib f'pazjenti b'melanoma metastatika hija stmata bħala 29.3 L/jum (b'varjabilità ta' 31.9% bejn il-pazjenti).
English: Mild to severe photosensitivity was reported in patients who received vemurafenib in clinical studies (see section 4.8).
Maltese: Fotosensittività ħafifa sa severa kienet irrappurtata f'pazjenti li rċevew vemurafenib fi studji kliniċi (ara sezzjoni 4.8).
English: Vemurafenib is absorbed with a median Tmax of approximately 4 hours following a single 960 mg dose (four 240 mg tablets).
Maltese: Id-doża rakkomandata ta' vemurafenib hija ta' 960 mg (4 pilloli ta' 240 mg) darbtejn kuljum
English: The co-primary efficacy endpoints of the study were overall survival (OS) and progression-free survival (PFS).
Maltese: Il-miri tal-effikaċja koprimarji tal-istudju kienu sopravivenza globali (OS - overall survival) u sopravivenza mingħajr progressjoni (PFS - progressionfree survival).
English: Within each frequency grouping, ADRs are presented in order of decreasing severity and were reported using NCI-CTCAE v 4.0 (common toxicity criteria) for assessment of toxicity.
Maltese: F'kull grupp ta' frekwenza, l-ADRs huma mniżżla skont is-severità tagħhom, bl-aktar serji jitniżżlu lewwel u kienu rrappurtati bl-użu ta' NCI-CTCAE v 4.0 (kriterji ta' tossiċità komuni) għallvalutazzjoni tat-tossiċità.
English: Biliary excretion appears to be another important elimination pathway.
Maltese: Tneħħija mill-marrara tidher li hija mezz ieħor importanti ta' eliminazzjoni.
English: Data are insufficient to determine the effect of metabolic or excretory hepatic impairment on vemurafenib pharmacokinetics (see sections 4.2 and
Maltese: Mhix disponibbli data adegwata biex jiġi ddeterminat l-effett ta' indeboliment epatiku metaboliku jew ta' tneħħija fuq ilfarmakokinetika ta' vemurafenib (ara sezzjonijiet 4.2 u 4.4).
English: It is currently unknown whether vemurafenib at a plasma level of 100 µM observed in patients at steady state (approximately 50 µg/ml) may decrease plasma concentrations of concomitantly administered CYP2B6 substrates, such as bupropion.
Maltese: Bħalissa mhux magħruf jekk vemurafenib f'livell fil-plażma ta' 100 µM osservat f'pazjenti fi stat fiss (madwar 50 µg/ml) jistax inaqqas il-konċentrazzjonijiet fil-plażma ta' substrati ta' CYP2B6 mogħtija fl-istess waqt, bħal bupropion.
English: Dose reduction and/or additional drug level monitoring for P-gp substrate medicinal products with narrow therapeutic index (NTI) (e.g. digoxin, dabigatran etexilate, aliskiren) may be considered if these medicinal products are used concomitantly with vemurafenib (see section 4.5).
Maltese: Jistgħu jiġu kkunsidrati tnaqqis fid-doża u/jew monitoraġġ addizzjonali tal-livell tal-medicina għal prodotti mediċinali substrati ta' P-gp li għandhom indiċi terapewtiku dejjaq (NTI - narrow therapeutic index) (eż. digoxin, dabigatran etexilate, aliskiren) jekk dawn il-prodotti mediċinali jintużaw flimkien ma' vemurafenib (ara sezzjoni 4.5).
English: Resume dosing at 720 mg twice daily (or 480 mg twice daily if the dose has already been lowered).
Maltese: Erġa' ibda d-dożaġġ b'720 mg darbtejn kuljum (jew 480 mg darbtejn kuljum jekk diġà tnaqqset id-doża).
English: Do not use Zelboraf after the expiry date which is stated on the carton and the blister after EXP.
Maltese: Tużax Zelboraf wara d-data ta' meta tiskadi li tidher fuq il-kartuna u l-folja wara EXP.
English: Arthralgia, myalgia, pain in extremity, musculoskeletal pain, back pain
Maltese: Artralġja, majalġja, uġigħ flestremitajiet, uġigħ muskoluskeletriku,
English: In the event the patient develops Cutaneous Squamous Cell Carcinoma (cuSCC), it is recommended to continue the treatment without modifying the dose of vemurafenib (see sections 4.4 and 4.8).
Maltese: Karċinoma taċ-Ċellula Skwamuża fil-Ġilda (cuSCC), huwa rakkomandat li t-trattament jitkompla mingħajr modifikazzjoni fid-doża ta' vemurafenib (ara sezzjonijiet 4.4 u 4.8).
English: This inhibitory effect was confirmed in the ERK phosphorylation and cellular anti-proliferation assays in available melanoma cell lines expressing V600-mutant BRAF.
Maltese: Dan l-effett inibitorju kien ikkonfermat fl-analiżi tal-fosforilazzjoni ta' ERK u antiproliferazzjoni ċellulari f'razez ta' ċelluli ta' melanoma disponibbli li għandhom BRAF V600-mutant.
English: During clinical trials with vemurafenib, grade 3 adverse reactions reported more frequently in females than males were rash, arthralgia and photosensitivity.
Maltese: Waqt provi kliniċi b'vemurafenib, reazzjonijiet avversi ta' grad 3 irrappurtati b'mod aktar frekwenti fin-nisa milli fl-irġiel kienu raxx, artralġja u fotosensittività.
English: Table 1: Dose modification schedule based on the grade of any Adverse Events (AEs)
Maltese: Tabella 1: Skeda ta' modifikazzjoni tad-doża bbażata fuq il-grad ta' kwalunkwe Avvenimenti
English: Dupuytren's contracture and plantar fascial fibromatosis Dupuytren's contracture and plantar fascial fibromatosis have been reported with vemurafenib.
Maltese: Kontrazzjoni ta' Dupuytren u fibromatosi tal-faxxa plantari Kontrazzjoni ta' Dupuytren u fibromatosi tal-faxxa plantari ġew irrappurtati b'vemurafenib.
English: Conjugation metabolites (glucuronidation and glycosylation) were also identified in humans.
Maltese: Fil-bnedmin kienu identifikati wkoll metaboliti ta' konjugazzjoni (glukuronidazzjoni u glikosilazzjoni).
English: Vemurafenib is indicated in monotherapy for the treatment of adult patients with BRAF V600 mutation-positive unresectable or metastatic melanoma (see section 5.1).
Maltese: Vemurafenib huwa indikat bħala monoterapija għat-trattament ta' pazjenti adulti b'melanoma li ma tistax titneħħa jew metastatika pożittiva għall-mutazzjoni BRAF V600 (ara sezzjoni 5.1).
English: NAME OF THE MEDICINAL PRODUCT Zelboraf 240 mg film-coated tablets vemurafenib
Maltese: Informazzjoni għall-utent Zelboraf 240 mg pilloli miksija b'rita vemurafenib
English: Severe hypersensitivity reactions may include Stevens-Johnson syndrome, generalised rash, erythema or hypotension.
Maltese: Reazzjonijiet ta' sensittività eċċessiva severi jistgħu jinkludu s-sindrome ta' StevensJohnson, raxx ġeneralizzat, eritema jew pressjoni baxxa.