FrancophonIA/ELRC3.0 huggingface dataset:
English: System organ class
Maltese: Klassifika tassistemi u talorgani
English: The majority of patients were male (61.6%), and Caucasian (92.5%), and the median age was 54 years (range 26 to 83 years), similarly distributed between the two cohorts.
Maltese: Il-maġġoranza tal-pazjenti kienu rġiel (61.6%), u Kawkasi (92.5%), u l-età medjana kienet ta' 54 sena (firxa 26 sa 83 sena), imqassma b'mod simili bejn iż-żewġ koorti.
English: In a phase III clinical trial (MO25515, N= 3219), a higher incidence of potentiation of radiation toxicity was reported when vemurafenib patients received radiation prior to and during vemurafenib therapy (9.1%) compared to those patients who received radiation and vemurafenib concomitantly (5.2 %) or to those whose radiation treatment was prior to vemurafenib (1.5%).
Maltese: III (MO25515, N= 3219), kienet irrappurtata inċidenza ogħla ta' taħrix tattossiċità tar-radjazzjoni meta pazjenti fuq vemurafenib irċevew radjazzjoni qabel u waqt terapija b'vemurafenib (9.1%) meta mqabbla ma' dawk il-pazjenti li rċevew radjazzjoni u vemurafenib flistess waqt (5.2%) jew ma' dawk li t-trattament bir-radjazzjoni tagħhom kien qabel vemurafenib
English: Drug reaction with eosinophilia and systemic symptoms(1)(2)
Maltese: Reazzjoni għallmediċina b'eosinofilja u sintomi sistemiċi(1)(2)
English: In the non-compartmental analysis, after dosing with 960 mg vemurafenib twice daily the Day 15 / Day 1 ratio ranged from 15- to 17-fold for AUC, and 13to 14-fold for Cmax, yielding AUC0-8h and Cmax of 380.2 ± 143.6 µg⋅h/mL and 56.7 ± 21.8 µg/mL, respectively, under steady-state conditions.
Maltese: F'analiżi mhux kumpartimentali, wara dożaġġ b'960 mg vemurafenib darbtejn kuljum il-proporzjon ta' Ġurnata 15 / Ġurnata 1 varja minn 15 sa 17-il darba għal AUC, u minn 13 sa 14-il darba għal Cmax, li jirriżulta f'AUC0-8h u Cmax ta' 380.2 ± 143.6 µg⋅h/mL u 56.7 ± 21.8 µg/mL, rispettivament, taħt kundizzjonijiet ta' stat fiss.
English: Table 2: Dose modification schedule based on prolongation of the QT interval QTc value
Maltese: Tabella 2: Skeda ta' modifikazzjoni tad-doża bbażata fuq titwil tal-intervall QT Valur QTc
English: In a Phase I trial, asymptomatic grade 3 increases in transaminases (ALT/AST >5 x ULN) and bilirubin (total bilirubin >3x ULN) were reported with concurrent administration of ipilimumab (3 mg/kg) and vemurafenib (960 mg BID or 720 mg BID).
Maltese: Fi prova ta' Fażi I, żidiet mhux sintomatiċi ta' grad 3 fit-transaminases (ALT/AST >5 x ULN) u bilirubin (bilirubin totali >3x ULN) kienu rrappurtati waqt għoti flimkien ma' ipilimumab (3 mg/kg) u vemurafenib (960 mg BID jew 720 mg BID).
English: Nine of the 132 patients enrolled into NP22657 had V600K mutation-positive tumours according to retrospective Sanger sequencing.
Maltese: Disa' minn 132 pazjent irreġistrati f'NP22657 kellhom tumuri pożittivi għall-mutazzjoni V600K skont is-sekwenzjar retrospettiv Sanger.
English: Inhibitory Concentration 50 (nM)
Maltese: 50 (nM)
English: Chronic myelomonocytic leukaemia(2)(4),
Maltese: Lewkimja mijelomonoċitika kronika(2)(4),
English: dacarbazine 75 (22)
Maltese: 30 ta' Diċembru dacarbazine 75 (22)
English: Anticipated frequency in V600 mutation-positive melanoma (t)
Maltese: Frekwenza antiċipata f'melanoma pożittiva għallmutazzjoni V600 (t)
English: ● medicines for heart rhythm problems (e.g. quinidine, amiodarone)
Maltese: • mediċini għal problemi fir-ritmu tal-qalb (eż. quinidine, amiodarone)
English: QT prolongation may lead to an increased risk of ventricular arrhythmias including Torsade de Pointes.
Maltese: Titwil ta' QT jista' jwassal għal żieda fir-riskju ta' arritmija ventrikulari inkluż Torsade de Pointes.
English: ● Fainting sensation.
Maltese: • Sensazzjoni ta' ħass ħażin.
English: In a clinical trial, co-administration of vemurafenib decreased the AUC of midazolam (CYP3A4 substrate) by an average 39% (maximum decrease up to 80%).
Maltese: Fi prova klinika, l-għoti fl-istess ħin ta' vemurafenib naqqas l-AUC ta' midazolam (substrat ta' CYP3A4) b'medja ta' 39% (tnaqqis massimu sa 80%).
English: Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitor, ATC code: L01XE15
Maltese: Sustanzi antineoplastiċi, inibitur tal-proteina kinase, Kodiċi ATC:
English: pancreatic adenocarcinoma
Maltese: adenokarċinoma talfrixa
English: Analysis of centralised ECG data from an open-label uncontrolled phase II QT sub-study in 132 patients dosed with vemurafenib 960 mg twice daily (NP22657) showed an exposure-dependent QTc prolongation.
Maltese: II mhux ikkontrollat u open label fuq 132 pazjent li ngħataw doża ta' 960 mg vemurafenib darbtejn kuljum (NP22657) uriet titwil ta' QTc dipendenti mill-esponiment.
English: Table 8: Overall survival in previously untreated patients with BRAF V600 mutation-positive melanoma by LDH, tumour stage and ECOG status (post hoc analysis, December 20, 2012 cutoff, censored results at time of cross over)
Maltese: Tabella 8: Sopravivienza globali f'pazjenti b'melanoma pożittiva għall-mutazzjoni BRAF V600 skont LDH li ma kinux ittrattati qabel, stadju tat-tumur u stat ECOG (analiżi post hoc, waqfien fl-20 ta' Diċembru 2012, riżultati ċċensurati fil-ħin tal-qlib)
English: Croscarmellose sodium Colloidal anhydrous silica Magnesium stearate Hydroxypropylcellulose
Maltese: Croscarmellose sodium Colloidal anhydrous silica
English: Zelboraf 240 mg film-coated tablets vemurafenib
Maltese: Zelboraf 240 mg Pillola vemurafenib
English: Co-administration of vemurafenib resulted in an 18% increase in AUC of S-warfarin (CYP2C9 substrate).
Maltese: L-għoti fl-istess ħin ta' vemurafenib irriżulta f'żieda ta' 18% fl-AUC ta' S-warfarin (substrat ta' CYP2C9).
English: Caution should be exercised when dosing vemurafenib concurrently with P-gp substrates (e.g. aliskiren, ambrisentan, colchicine, dabigatran etexilate, digoxin, everolimus, fexofenadine, lapatinib, maraviroc, nilotinib, posaconazole, ranolazine, sirolimus, sitagliptin, talinolol, topotecan) and dose reduction of the concomitant medicinal product may be considered, if clinically indicated.
Maltese: Għandu jkun hemm kawtela meta vemurafenib jingħata flimkien ma' substrati ta' P-gp (eż. aliskiren, ambrisentan, colchicine, dabigatran etexilate, digoxin, everolimus, fexofenadine, lapatinib, maraviroc, nilotinib, posaconazole, ranolazine, sirolimus, sitagliptin, talinolol, topotecan) u jekk indikat klinikament jista' jiġi kkunsidrat tnaqqis fid-doża tal-prodott mediċinali mogħti fl-istess waqt.
English: The majority of patients was male (61%), Caucasian (99%), and had stage M1c disease (61%).
Maltese: Il-maġġoranza tal-pazjenti kienu rġiel (61%), Kawkasi (99%), u kellhom marda ta' stadju M1c (61%).
English: A clinical drug interaction study demonstrated that multiple oral doses of vemurafenib (960 mg twice daily) increased the exposure of a single oral dose of the P-gp substrate digoxin, approximately 1.8 and 1.5 fold for digoxin AUClast and Cmax, respectively.
Maltese: Studju kliniku dwar l-interazzjoni tal-mediċina wera li dożi orali multipli ta' vemurafenib (960 mg darbtejn kuljum) żiedu l-esponiment ta' doża orali waħda ta' digoxin li huwa substrat ta' P-gp, b'madwar 1.8 u 1.5 darbiet għall-AUClast u s-Cmax ta' digoxin, rispettivament.
English: Initiation of treatment with vemurafenib is not recommended in patients with QTc>500 milliseconds (ms).
Maltese: Mhux rakkomandat bidu ta' trattament b'vemurafenib f'pazjenti b'QTc>500 millisekonda (ms).
English: Mechanism of action and pharmacodynamic effects Vemurafenib is an inhibitor of BRAF serine-threonine kinase.
Maltese: Mekkaniżmu ta' azzjoni u effetti farmakodinamiċi Vemurafenib huwa inibitur ta' BRAF serine-threonine kinase.
English: ● Rash
Maltese: • Raxx
English: The majority of vemurafenib-related material (94%) was recovered in faeces, and <1% in urine.
Maltese: Il-maġġoranza tal-materjal relatat ma' vemurafenib (94%) kienet irkuprata fl-ippurgar, u <1% fl-awrina.
English: ● Medicines that could be influenced by a protein called P-gp (e.g. aliskiren, colchicine, digoxin, everolimus, fexofenadine) or a protein called BCRP (e.g. methotrexate, mitoxantrone, rosuvastatin).
Maltese: • Mediċini li jistgħu jiġu influwenzati minn proteina msejħa P-gp (eż. aliskiren, colchicine, digoxin, everolimus, fexofenadine) jew minn proteina msejħa BCRP (eż. methotrexate, mitoxantrone, rosuvastatin).
English: Uncommon ≥ 1/1,000 to < 1/100 Rare ≥ 1/10,000 to < 1/1,000
Maltese: Rari ≥ 1/10,000 sa < 1/1,000
English: ● Medicines that influence a protein called P-gp or BCRP (e.g. verapamil, cyclosporine, ritonavir, quinidine, itraconazole, gefitinib).
Maltese: • Mediċini li jinfluwenzaw proteina msejħa P-gp jew BCRP (eż. verapamil, cyclosporine, ritonavir, quinidine, itraconazole, gefitinib).
English: Metabolism and nutrition disorders
Maltese: Disturbi fil metaboliżmu u nnutrizzjoni
English: ● Medicines that strongly inhibit the metabolising protein called CYP3A4 (e.g. ritonavir, saquinavir, telithromycin, ketoconazole, itraconazole, voriconazole, posaconazole, nefazodone, atazanavir)
Maltese: • Mediċini li jinibixxu b'mod qawwi l-proteina metabolizzanti msejħa CYP3A4 (eż. ritonavir, saquinavir, telithromycin, ketoconazole, itraconazole, voriconazole, posaconazole, nefazodone, atazanavir)
English: Patients were randomised to treatment with vemurafenib (960 mg twice daily) or dacarbazine (1000 mg/m2 on day 1 every 3 weeks).
Maltese: Il-pazjent kienu randomised għat-trattament b'vemurafenib (960 mg darbtejn kuljum) jew dacarbazine (1000 mg/m2 fil-jum 1 kull 3 ġimgħat).
English: Consider additional drug level monitoring for P-gp substrate medicinal products with a narrow therapeutic index (NTI) (e.g. digoxin, dabigatran etexilate, aliskiren) (see section 4.4).
Maltese: Ikkunsidra monitoraġġ addizzjonali tal-livell tal-mediċina għal prodotti mediċinali substrati ta' P-gp li għandhom indiċi terapewtiku dejjaq (NTI - narrow therapeutic index) (eż. digoxin, dabigatran etexilate, aliskiren) (ara sezzjoni 4.4).
English: Serum creatinine elevations were mostly mild (>1-1.5x ULN) to moderate (>1.5-3x ULN) and observed to be reversible in nature (see table 4).
Maltese: Żidiet fil-livell tal-kreatinina fis-serum fil-biċċa l-kbira kienu ħfief (>1-1.5x ULN) sa moderati (>1.5-3x ULN) u osservati li jkunu ta' natura riversibbli (ara tabella 4).
English: (y) As of December 30, 2010, a total of 549 patients were evaluable for PFS and 439 patients were evaluable for overall response rate.
Maltese: Sat-30 ta' Diċembru 2010, total ta' 549 pazjent setgħu jiġu evalwati għal PFS u 439 pazjent setgħu jiġu evalwati għar-rata ta' rispons globali.
English: Limited pharmacokinetic data from six adolescent patients aged between 15 and 17 years with stage IIIC or IV BRAF V600 mutation positive melanoma suggest that vemurafenib pharmacokinetic characteristics in adolescents are generally similar to those in adults.
Maltese: Data farmakokinetika limitata minn sitt pazjenti adolexxenti ta' età bejn 15 u 17-il sena b'melanoma ta' stadju IIIC jew IV pożittiva għall-mutazzjoni BRAF V600 tissuġġerixxi li l-karatteristiċi farmakokinetiċi ta' vemurafenib fl-adolexxenti ġeneralment huma simili għal dawk fl-adulti.
English: Severe dermatologic reactions have been reported in patients receiving vemurafenib, including rare cases of Stevens-Johnson syndrome and toxic epidermal necrolysis in the pivotal clinical trial.
Maltese: Fil-prova klinika pivitali, f'pazjenti li kienu qed jirċievu vemurafenib, kienu rrappurtati reazzjonijiet dermatoloġiċi severi inkluż każijiet rari tas-sindrome ta' Stevens-Johnson u nekrolisi tossika talepidermide.
English: With a median follow-up of 12.9 months (range, 0.6 to 20.1), the primary endpoint of confirmed best overall response rate (CR + PR) as assessed by an independent review committee (IRC) was 53% (95% CI: 44%, 62%).
Maltese: B'tul medjan li fih ġie segwit il-pazjent ta' 12.9 xhur (firxa, 0.6 sa 20.1), il-mira primarja tal-aħjar rata ta' rispons globali kkonfermata (CR + PR) kif evalwata minn kumitat ta' rieżami indipendenti (IRC) kienet ta' 53% (CI ta' 95%: 44%, 62%).
English: dacarbazine 122 (36)
Maltese: 31 ta' Marzu dacarbazine 122 (36)
English: 7th nerve paralysis, neuropathy peripheral
Maltese: Paraliżi tas-7 nerv,
English: ● Types of skin cancers (basal cell carcinoma, new primary melanoma)
Maltese: • Tipi ta' kanċers tal-ġilda (karċinoma taċ-ċellula bażali, melanoma primarja ġdida)
English: Best overall confirmed response rate as assessed by independent review committee, number of responders n (%) b Two-sided 95% Clopper-Pearson Confidence Interval (CI) c Duration of response as assessed by an Independent Review Committee d Kaplan-Meier estimate e Assessed by investigator
Maltese: b Intervall ta' Kunfidenza (CI - Confidence Interval) ta' Clopper-Pearson ta' 95% fuq żewġ naħat ċ Dewmien tar-rispons kif evalwat minn Kumitat ta' Rieżami Indipendenti d Stima Kaplan-Meier e Evalwat mill-investigatur
English: Laboratory abnormalities should be managed with dose reduction, treatment interruption or with treatment discontinuation (see sections 4.2 and 4.8).
Maltese: Anormalitajiet tal-laboratorju għandhom jiġu mmaniġġjati permezz ta' tnaqqis fid-doża, interruzzjoni tat-trattament jew permezz ta' twaqqif tat-trattament (ara sezzjonijiet 4.2 u 4.8).
English: It is highly bound to human plasma proteins in vitro (>99%).
Maltese: Proporzjon għoli huwa mwaħħal mal-proteini fil-plażma tal-bniedem in vitro (>99%).
English: Currently available data are described in sections 4.8, 5.1, and 5.2, but no recommendation on a posology can be made.
Maltese: Data disponibbli attwalment hija deskritta fis-sezzjonijiet 4.8, 5.1, u 5.2, iżda ma tista' ssir l-ebda rakkomandazzjoni dwar pożoloġija.
English: Pack-size: 56 x 1 film-coated tablets (7 blisters of 8 x 1 tablet)
Maltese: Daqs tal-pakkett: 56 x pillola miksija b'rita waħda (7 folji ta' 8 x pillola waħda) 6.6 Prekawzjonijiet speċjali għar-rimi
English: Many anticancer medicinal products are substrates of BCRP and therefore there is a theoretical risk for an interaction with vemurafenib.
Maltese: Ħafna prodotti mediċinali kontra l-kanċer huma substrati ta' BCRP u għalhekk hemm riskju teoretiku ta' interazzjoni ma' vemurafenib.
English: Median (months) (95% CI)d
Maltese: Medjan (xhur) (CI ta' 95%)d
English: ● Dizziness
Maltese: • Dijarea
English: Two patients (1.5%) developed treatment-emergent absolute QTc values >500 ms (CTC Grade 3), and only one patient (0.8%) exhibited a QTc change from baseline of >60 ms (see section 4.4).
Maltese: Żewġ pazjenti (1.5%) żviluppaw valuri assoluti ta' QTc li dehru mit-trattament ta' > 500 ms (CTC Grad 3), u pazjent wieħed biss (0.8%) kellu bidla f'QTc millinja bażi ta' > 60 ms (ara sezzjoni 4.4).
English: It cannot be excluded that vemurafenib pharmacokinetics could be affected by such medicines through influence on P-gp (e.g. verapamil, cyclosporine, quinidine) or BCRP (e.g. cyclosporine, gefitinib).
Maltese: Ma jistax jiġi eskluż li l-farmakokinetika ta' vemurafenib tista' tiġi affettwata minn dawn il-mediċini permezz ta' influwenza fuq il-P-gp (eż. verapamil, cyclosporine, quinidine) jew BCRP (eż. cyclosporine, gefitinib).
English: Table 7: Overall survival in previously untreated patients with BRAF V600 mutation-positive melanoma by study cut-off date (N=338 dacarbazine, N=337 vemurafenib) Cut-off dates
Maltese: Tabella 7: Sopravivenza globali f'pazjenti li ma kinux ittrattati qabel b'melanoma pożittiva għall-mutazzjoni BRAF V600 skont id-dati ta' waqfien tal-istudju (N=338 dacarbazine, N=337 vemurafenib)
English: Effects of vemurafenib on Drug Metabolizing Enzymes Results from an in vivo drug-drug interaction study in metastatic melanoma patients demonstrated that vemurafenib is a moderate CYP1A2 inhibitor and a CYP3A4 inducer.
Maltese: Ir-riżultati minn studju in vivo dwar l-interazzjonijiet bejn mediċina u oħra f'pazjenti b'melanoma metastatika wrew li vemurafenib huwa inibitur moderat ta' CYP1A2 u induttur ta' CYP3A4.
English: Management of adverse drug reactions or QTc prolongation may require dose reduction, temporary interruption and/or treatment discontinuation (see tables 1 and 2).
Maltese: Immaniġġar ta' reazzjonijiet avversi tal-mediċina jew titwil ta' QTc jistgħu jeħtieġu tnaqqis fid-doża, interruzzjoni temporanja u/jew twaqqif tat-trattament (ara tabelli 1 u 2).
English: Important information about some of the ingredients of Zelboraf This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodiumfree'.
Maltese: Informazzjoni importanti dwar xi wħud mill-ingredjenti ta' Zelboraf Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull pillola, jiġifieri essenzjalment ‘ħielsa mis-sodium'.
English: The population pharmacokinetic analysis indicated a 17% greater apparent clearance (CL/F) and a 48% greater apparent volume of distribution (V/F) in males than in females.
Maltese: L-analiżi tal-farmakokinetika tal-popolazzjoni indikat tneħħija evidenti (CL/F) ta' 17% akbar u volum ta' distribuzzjoni evidenti (V/F) ta' 48% akbar fl-irġiel milli fin-nisa.
English: ● Medicines that stimulate the metabolising proteins called CYP3A4 or a metabolising process called glucuronidation (e.g. rifampicin, rifabutin, carbamazepine, phenytoin or St John's Wort)
Maltese: • Mediċini li jistimulaw l-proteini metabolizzanti msejħa CYP3A4 jew proċess metabolizzanti msejjaħ glukuronidazzjoni (eż. rifampicin, rifabutin, carbamazepine, phenytoin jew St John's
English: Concomitant administration of strong inducers of CYP3A4, P-gp and glucuronidation (e.g. rifampicin, rifabutin, carbamazepine, phenytoin or St John's Wort [hypericin]) might lead to decreased exposure of vemurafenib and should be avoided when possible (see section 4.5).
Maltese: Effett ta' prodotti mediċinali oħra fuq vemurafenib L-għoti flimkien ta' indutturi qawwija ta' CYP3A4, P-gp u glukuronidazzjoni (eż. rifampicin, rifabutin, carbamazepine, phenytoin jew St John's Wort [hypericin]) jista' jwassal għal tnaqqis flesponiment ta' vemurafenib u għandu jiġi evitat meta possibbli (ara sezzjoni 4.5).
English: PFS - overall Median (months)e
Maltese: PFS - globali
English: DORc in brain (n)
Maltese: ċ fil-moħħ (n)
English: Leukaemia, Pancreatic adenocarcinoma)
Maltese: Mijelomonoċitika Kronika, Adenokarċinoma tal-frixa)
English: Dupuytren's contracture(1)(2)
Maltese: Dupuytren(1)(2)
English: ● Do not take Zelboraf regularly on an empty stomach.
Maltese: • Tiħux Zelboraf b'mod regolari fuq stonku vojt.
English: acute tubular necrosis(1)(2) (h)
Maltese: nekrosi akuta tat tubi ż-żgħar(1)(2) (h)
English: The safety and efficacy of vemurafenib in children less than 18 years old have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' vemurafenib fit-tfal ta' età inqas minn 18-il sena ma ġewx determinati.
English: Vemurafenib might decrease the efficacy of hormonal contraceptives (see section 4.5).
Maltese: Vemurafenib jista' jnaqqas l-effikaċja ta' kontraċettivi ormonali (ara sezzjoni 4.5).
English: Limited data are available in patients with renal impairment.
Maltese: Data limitata hija disponibbli f'pazjenti b'indeboliment renali.
English: It was designed to detect the predominant BRAF V600E mutation with high sensitivity (down to 5% V600E sequence in a background of wild type sequence from FFPE-derived DNA).
Maltese: Kien iddisinjat biex isib l-mutazzjoni BRAF V600E predominanti b'sensittività għolja (sa 5% ta' sekwenza V600E fi sfond ta' sekwenza tat-tip selvaġġ minn DNA derivata minn FFPE).
English: They are available in aluminium perforated unit dose blisters in packs of 56 x 1 tablets.
Maltese: Huma disponibbli f'folji pperforati b'doża waħda magħmula minn aluminju f'pakketti ta' 56 x pillola waħda.
English: Co-administration of vemurafenib increased the plasma exposure (AUC) of caffeine (CYP1A2 substrate) 2.6-fold.
Maltese: L-għoti fl-istess ħin ta' vemurafenib żied l-esponiment fil-plażma (AUC) tal-kafeina (substrat ta' CYP1A2) bi 2.6 darbiet.
English: Drug reaction with eosinophilia and systemic symptoms (DRESS) has been reported in association with vemurafenib in the post-marketing setting (see section 4.8).
Maltese: Reazzjoni tal-mediċina b'eosinofilja u sintomi sistemiċi (DRESS - drug reaction with eosinophilia and systemic symptoms) kienet irrappurtata f'assoċjazzjoni ma' vemurafenib fl-ambjent ta' wara t-tqegħid fis-suq (ara sezzjoni 4.8).
English: ● Cough.
Maltese: • Sogħla.
English: The geometric mean ratios between the fed and fasted states for Cmax and AUC were 2.5 and 4.6 to 5.1 fold, respectively.
Maltese: Il-proporzjonijiet ġeometriċi medji bejn stat wara l-ikel u dak sajjem għal Cmax u l-AUC kienu 2.5 u 4.6 sa 5.1 darbiet, rispettivament.
English: Estimated from 16,403 melanomas with annotated BRAF codon 600 mutations in the public COSMIC database, release 71 (November 2014).
Maltese: Stmata minn 16,403 melanoma b'mutazzjonijiet BRAF fil-kodon 600 annotati fid-database publika COSMIC,
English: Patients with severe renal impairment should be closely monitored (see sections 4.4 and 5.2).
Maltese: Pazjenti b'indeboliment renali sever għandhom jiġu ssorveljati mill-qrib (ara sezzjonijiet 4.4 u 5.2).
English: Zelboraf is an anticancer medicine that contains the active substance vemurafenib.
Maltese: Zelboraf huwa mediċina kontra l-kanċer li fih is-sustanza attiva vemurafenib.
English: Non-censored results at time of cross-over: March 31 2011: HR (95% CI) = 0.47 (0.35, 0.62); October 3 2011: HR (95% CI) = 0.67 (0.54, 0.84); February 1 2012: HR (95% CI) = 0.76 (0.63, 0.93); December 20 2012: HR (95% CI) = 0.79 (0.66, 0.95)
Maltese: HR (CI ta' 95%) = 0.76 (0.63, 0.93); 20 ta' Diċembru 2012:
English: ● Joint or muscle pain, musculoskeletal pain
Maltese: • Uġigħ fil-ġogi jew fil-muskoli, uġigħ muskoluskeletriku
English: A single-arm, multicentre study (N = 146) of vemurafenib was conducted in adult patients with histologically confirmed metastatic melanoma harbouring the BRAF V600 mutation (according to the cobas 4800 BRAF V600 Mutation Test) and with brain metastases.
Maltese: Twettaq studju bi grupp wieħed u b'aktar minn ċentru wieħed (N = 146) ta' vemurafenib f'pazjenti adulti b'melanoma metastatika kkonfermata istoloġikament li għandha l-mutazzjoni BRAF V600 (skont it-Test ta' Mutazzjoni cobas 4800 BRAF V600) u b'metastasi fil-moħħ.
English: Older patients (≥ 65 years) may be more likely to experience adverse reactions, including cuSCC, decreased appetite, and cardiac disorders.
Maltese: Pazjenti ta' età akbar (≥ 65 sena) jistgħu jkunu aktar probabbli li jkollhom esperjenza ta' reazzjonijiet avversi, inkluż cuSCC, tnaqqis fl-aptit, u disturbi fil-qalb.
English: ● A medicine called ipilimumab, another medicine for the treatment of melanoma.
Maltese: • Mediċina msejħa ipilimumab, mediċina oħra għat-trattament tal-melanoma.
English: It cannot be excluded that vemurafenib may increase the exposure of medicines transported by BCRP (e.g. methotrexate, mitoxantrone, rosuvastatin).
Maltese: Ma jistax jiġi eskluż li vemurafenib jista' jżid l-esponiment għall-mediċini trasportati minn BCRP (eż. methotrexate, mitoxantrone, rosuvastatin).
English: The population apparent volume of distribution for vemurafenib in metastatic melanoma patients is estimated to be 91 L (with 64.8% between patient variability).
Maltese: Il-volum ta' distribuzzjoni evidenti tal-popolazzjoni għal vemurafenib f'pazjenti b'melanoma metastatika huwa stmat bħala 91 L (b'64.8% varjabilità bejn il-pazjenti).
English: The majority of the excised lesions reviewed by an independent central dermatopathology laboratory were classified as SCCkeratoacanthoma subtype or with mixed-keratoacanthoma features (52%).
Maltese: Il-maġġoranza tal-leżjonijiet li tneħħew evalwati minn laboratorju dermatopatoloġiku ċentrali indipendenti kienu kklassifikati bħala SCC tas-sottotip keratoakantoma jew b'karatteristiċi ta' keratoakantoma mħallta (52%).
English: ADRs which were reported in melanoma patients are listed below by MedDRA body system organ class, frequency and grade of severity.
Maltese: ADRs li kienu rrappurtati f'pazjenti b'melanoma huma elenkati hawn taħt skont il-klassifika tassistemi u tal-organi tal-ġisem MedDRA, il-frekwenza u l-grad ta' severità.