FrancophonIA/ELRC3.0 huggingface dataset:
English: The 5 randomised studies investigated a total of 3734 patients with metastatic colorectal cancer, in whom EGFR expression was detectable and who had an ECOG performance status of ≤ 2.
Maltese: Il-5 studji randomised investigaw total ta' 3,734 pazjent b'kanċer metastatiku tal-kolon u tar-rektum, li fihom, l-espressjoni EGFR kienet osservata u li kellhom stat ta' prestazzjoni ECOG ta' ≤ 2.
English: Only patients with adequate renal and hepatic function have been investigated to date (serum creatinine  1.5fold, transaminases  5fold and bilirubin  1.5fold the upper limit of normal).
Maltese: Pazjenti li kellhom funzjoni adegwata tal-kliewi u tal-fwied biss kienu investigati s'issa (krejatinina tas-serum ≤ 1.5 darba iktar, transaminases ≤ 5 darbiet iktar u bilirubina ≤ 1.5 darba iktar mil-Limitu ta' Fuq tan-Normal (Upper Limit of Normal - ULN)).
English: Frequency not known (cannot be estimated from the available data) An asterisk (*) indicates that additional information on the respective undesirable effect is provided below the table.
Maltese: Asterisk (*) tindika li informazzjoni addizzjonali dwar l-effett mhux mixtieq rispettiv hi pprovduta fittabella t'hawn taħt.
English: • with polypropylene (PP) syringes for syringe pump.
Maltese: • ma' siringi tal-polypropylene (PP) għall-pompa tas-siringa.
English: • The other ingredients are sodium chloride, glycine, polysorbate 80, citric acid monohydrate, sodium hydroxide and water for injections.
Maltese: • Is-sustanzi mhux attivi l-oħra huma sodium chloride, glycine, polysorbate 80, citric acid monohydrate, sodium hydroxide u ilma għall-injezzjonijiet.
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/.
Maltese: Informazzjoni ddettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini: http://www.ema.europa.eu/.
English: Cetuximab plus FOLFIRI
Maltese: Cetuximab flimkien mal-kimoterapija
English: Current data on the development of HACAs is limited.
Maltese: Informazzjoni kurrenti fuq l-iżvilupp ta' HACA hi limitata.
English: The pharmacokinetic results were comparable to those in adults.
Maltese: Ir-riżultati farmakokinetiċi kienu komparabbli ma' dawk f'persuni adulti.
English: Only in study EMR 62 202-007, a post-hoc analysis was not possible.
Maltese: Kien biss fi studju EMR 62 202-007 li analiżi post-hoc ma kinitx possibbli.
English: Pharmacokinetics in special populations
Maltese: Farmakokinetika fi gruppi speċjali
English: The RAS mutant population consists of patients with known KRAS exon 2 mutations as well as additionally identified RAS mutations.
Maltese: RAS tikkonsisti minn pazjenti b'mutazzjonijiet KRAS exon 2 magħrufa kif ukoll b'mutazzjonijiet RAS addizzjonali identifikati.
English: FIRE-3 (First-line combination of cetuximab with FOLFIRI): The FIRE-3 study was a multicentre randomised phase-III study investigating head-to-head 5-FU, folinic acid and irinotecan (FOLFIRI) combined with either cetuximab or bevacizumab in patients with KRAS exon 2 wild-type metastatic colorectal cancer (mCRC).
Maltese: III, li fih il-parteċipanti ntgħażlu b'mod każwali, li investiga 5-FU, folinic acid u irinotecan (FOLFIRI) direttament kontra xulxin flimkien ma' jew cetuximab jew bevacizumab f'pazjenti b'kanċer metastatiku tal-kolon u tar-rektum (mCRC) KRAS exon 2 wild-type.
English: Cetuximab binds to the epidermal growth factor receptor (EGFR), an antigen on the surface of certain cancer cells.
Maltese: Cetuximab jeħel ma' l-epidermal growth factor receptor (EGFR), antiġen li jinsab fil-wiċċ ta' ċerti ċelluli tal-kanċer.
English: If a patient experiences an intolerable or severe skin reaction ( grade 3; Common Terminology Criteria for Adverse Events, CTCAE), cetuximab therapy must be interrupted.
Maltese: Jekk pazjent ikollu reazzjoni intollerabbli jew severa tal-ġilda (≥ grad 3; Kriterji Komuni tatTerminoloġija għal Avvenimenti Avversi, CTCAE), it-terapija b'cetuximab għandha tieqaf.
English: OS months, median (95% CI) Hazard Ratio (95% CI) p-value PFS months, median (95% CI) Hazard Ratio (95% CI) p-value ORR
Maltese: OS xhur, medjan (95% CI) Proporzjon ta' periklu (95% CI) valur p PFS xhur, medjan (95% CI) Proporzjon ta' periklu (95% CI) valur p ORR
English: Transfer the Erbitux into a sterile evacuated container or bag.
Maltese: Ittrasferixxi Erbitux ġo kontenitur jew borża vojta sterili.
English: In some studies association with age ≥ 65 years or performance status has been observed.
Maltese: F'xi studji kienet osservata rabta ma' età ta' ≥ 65 sena jew ma' stat ta' prestazzjoni.
English: OS months, median (95% CI) Hazard Ratio (95% CI) p-value PFS months, median (95% CI)
Maltese: OS xhur, medjan (95% CI) Proporzjon ta' periklu (95% CI) valur p PFS xhur, medjan (95% CI)
English: MARKETING AUTHORISATION NUMBERS EU/1/04/281/003
Maltese: NUMRI TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/04/281/003
English: CI = confidence interval, OxMdG = oxaliplatin plus infusional 5-FU/FA, OS = overall survival time, PFS = progression-free survival time
Maltese: CI = intervall tal-kunfidenza, OxMdG = oxaliplatin flimkien ma' 5-FU/FA infużjonali, OS = żmien globali ta' sopravivenza, PFS = żmien ta' sopravivenza mingħajr progressjoni
English: Cetuximab in combination with chemotherapy
Maltese: Cetuximab hu antikorp kimeriku monoklonali
English: Headache.
Maltese: Konġuntivite.
English: Results from clinical studies show a negative benefit-risk balance in tumours with RAS mutations.
Maltese: Riżultati minn studji kliniċi juru bilanċ negattiv bejn il-benefiċċju u r-riskju f'tumuri b'mutazzjonijiet RAS.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial of 20 mL contains 100 mg cetuximab (5 mg/mL).
Maltese: Kull kunjett ta' 20 mL fih 100 mg ta' cetuximab (5 mg/mL).
English: continue slow infusion under close supervision b) Grade 2:
Maltese: kompli l-infużjoni bil-mod taħt superviżjoni mill-qrib b) Grad 2:
English: Cetuximab plus BSC
Maltese: BSC Cetuximab flimkien ma' BSC
English: A diagnostic assay (EGFR pharmDx) was used for immunohistochemical detection of EGFR expression in tumour material.
Maltese: Assaġġ dijanjostiku (EGFR pharmDx) intuża għall-iskoperta immunoistokimika tal-espressjoni EGFR f'materjal tat-tumur.
English: In clinical studies with doses up to 700 mg/m 2 given every 2 weeks the safety profile was consistent with that described in section 4.8.
Maltese: Fi studji kliniċi b'dożi sa 700 mg/m² mogħtija kull ġimagħtejn, il-profil tas-sigurtà kien konsistenti ma' dak deskritt f'sezzjoni 4.8.
English: Erbitux 5 mg/mL solution for infusion is supplied in vials containing 20 mL or 100 mL.
Maltese: Erbitux 5 mg/mL soluzzjoni għall-infużjoni hu fornut f'kunjetti li fihom 20 mL jew 100 mL.
English: • tiredness
Maltese: • urtikarja
English: Erbitux does not contain any antimicrobial preservative or bacteriostatic agent.
Maltese: Erbitux ma fih l-ebda sustanza preservattiva jew batterjostatika kontra l-mikrobi.
English: continue slow infusion and immediately administer treatment for symptoms c) Grade 3 and 4:
Maltese: kompli l-infużjoni bil-mod u agħti kura għas-sintomi mill-ewwel c) Grad 3 u 4:
English: • with polyethylene (PE), polyurethane (PUR), ethyl vinyl acetate (EVA), polyolefine thermoplastic (TP) or polyvinyl chloride (PVC) infusion sets,
Maltese: (EVA), polyolefine thermoplastic (TP) jew polyvinyl chloride (PVC),
English: The protein product of the proto-oncogene RAS (rat sarcoma) is a central down-stream signaltransducer of EGFR.
Maltese: Il-prodott tal-proteina tal-proto-oncogene RAS (rat sarcoma) hi central down-stream signaltransducer ta' EGFR. Fit-tumuri, l-attivazzjoni tal-ġene RAS minn EGFR tikkontribwixxi għal żieda fil-proliferazzjoni medjata minn EGFR, fis-sopravivenza u fil-produzzjoni ta' fatturi pro-anġjoġeniċi.
English: • EMR 62 202-047: This randomised study in patients with metastatic colorectal cancer who had not received prior treatment for metastatic disease compared the combination of cetuximab and oxaliplatin plus continuous infusional 5-fluorouracil/folinic acid (FOLFOX4) (169 patients) to the same chemotherapy alone (168 patients).
Maltese: Dan l-istudju randomised f'pazjenti b'kanċer metastatiku tal-kolon u tarrektum li ma kinux irċivew kura fil-passat għal mard metastatiku, qabbel il-kumbinazzjoni ta' cetuximab u oxaliplatin flimkien mal-infużjoni kontinwa ta' 5-fluorouracil/folinic acid (FOLFOX4) (169 pazjent) mal-istess kimoterapija waħidha (168 pazjenti).
English: The main undesirable effects of cetuximab are skin reactions, which occur in more than 80% of patients, hypomagnesaemia which occurs in more than 10% of patients and infusion-related reactions, which occur with mild to moderate symptoms in more than 10% of patients and with severe symptoms in more than 1% of patients.
Maltese: L-effetti primarji mhux mixtieqa ta' cetuximab huma reazzjonijiet tal-ġilda, li jseħħu f'iktar minn 80% tal-pazjenti, ipomanjesemija li sseħħ f'iktar minn 10% tal-pazjenti u reazzjonijiet marbuta ma' linfużjoni, li jseħħu b'sintomi minn ħfief sa moderati f'iktar minn 10% tal-pazjenti u b'sintomi severi f'iktar minn 1% tal-pazjenti.
English: • EMR 62 202-013: This randomised study in patients with metastatic colorectal cancer who had not received prior treatment for metastatic disease compared the combination of cetuximab and irinotecan plus infusional 5-fluorouracil/folinic acid (FOLFIRI) (599 patients) to the same chemotherapy alone (599 patients).
Maltese: Dan l-istudju randomised f'pazjenti b'kanċer metastatiku tal-kolon u tarrektum li ma kinux irċivew kura fil-passat għal marda metastatika qabbel il-kumbinazzjoni ta' cetuximab u irinotecan flimkien ma' 5-fluorouracil/folinic acid (FOLFIRI) infużjonali (599 pazjent) ma' l-istess kimoterapija waħidha (599 pazjenti).
English: Odds Ratio (95% CI) p-value
Maltese: Proporzjon ta' periklu (95% CI) valur p
English: For the assessment of the RAS status, mutations other than those on exon 2 of the KRAS gene were determined from all evaluable tumour samples within the KRAS exon 2 wild-type population (65%).
Maltese: Għall-evalwazzjoni tal-istat ta' RAS, ġew determinati mutazzjonijiet oħrajn minbarra dawk fuq exon 2 tal-ġene KRAS mill-kampjuni kollha tat-tumur evalwabbli fil-popolazzjoni KRAS exon 2 wild-type (65%).
English: • skin reactions typical for radiation therapy
Maltese: • reazzjonijiet tal-ġilda li huma tipiċi għat-terapija bir-raġġi
English: The risk for secondary infections (mainly bacterial) is increased and cases of staphylococcal scalded skin syndrome, necrotising fasciitis and sepsis, in some cases with fatal outcome, have been reported (see section 4.8).
Maltese: Ir-riskju għal infezzjonijiet sekondarji (primarjament batterjali) jiżdied u każijiet tas-sindrome ta' ġilda mismuta bi staphylococcus, faxxite b'nekrosi u sepsi, f'xi każijiet b'riżultat fatali, ġew irrappurtati (ara sezzjoni 4.8).
English: When cetuximab was administered at an initial dose of 400 mg/m 2 body surface area, the mean volume of distribution was approximately equivalent to the vascular space (2.9 L/m 2 with a range of
Maltese: Meta cetuximab ingħata f'doża tal-bidu ta' 400 mg/m² ta' erja tas-superfiċje tal-ġisem, il-medja talvolum tad-distribuzzjoni kienet bejn wieħed u ieħor ekwivalenti għall-ispazju vaskulari (2.9 L/m² b'medda ta' 1.5 sa 6.2 L/m²).
English: In rare cases, angina pectoris, myocardial infarction or cardiac arrest have been observed.
Maltese: F'każijiet rari, anġina pectoris, infart mijokardijaku jew waqfien kardijaku kienu osservati.
English: In combination with fluoropyrimidines, the frequency of cardiac ischaemia including myocardial infarction and congestive heart failure as well as the frequency of hand-foot syndrome (palmar-plantar erythrodysaesthesia) were increased compared to that with fluoropyrimidines.
Maltese: Flimkien ma' fluoropyrimidines, il-frekwenza ta' iskemija kardijaka li tinkludi infart mijokardijaku u kollass konġestiv kardijaku, kif ukoll il-frekwenza tas-sindrome tal-idejn u r-riġlejn (palmar-plantar erythrodysaesthesia) żdiedet meta mqabbla ma' dik bi fluoropyrimidines.
English: In a randomised controlled clinical study with 424 patients, reporting rates of severe acute radiation dermatitis and mucositis as well as of late radiation-therapy-related events were slightly higher in patients receiving radiation therapy in combination with cetuximab than in those receiving radiation therapy alone.
Maltese: Fi studju kliniku randomised fuq 424 pazjent, instab li r-rati ta' dermatite akuta u severa minħabba r-raġġi u mukożite, kif ukoll ta' avvenimenti li seħħew wara ċertu żmien marbuta mat-terapija bir-raġġi, kienu ftit ogħla f'pazjenti li kienu qed jirċievu t-terapija bir-raġġi flimkien ma' cetuximab, milli f'dawk li kienu qed jirċievu tterapija bir-raġġi biss.
English: A separate infusion line must be used for the infusion, and the line must be flushed with sterile sodium chloride 9 mg/mL (0.9%) solution for injection at the end of infusion.
Maltese: Linja separata ta' l-infużjoni trid tintuża għall-infużjoni, u l-linja trid titlaħlaħ fit-tmiem ta' l-infużjoni b'sodium chloride 9 mg/mL (0.9%) soluzzjoni sterili għall-injezzjoni.
English: An embryo-foetal toxicity study in Cynomolgus monkeys revealed no signs of teratogenicity.
Maltese: Studju dwar it-tossiċità embrijo-fetali f'xadini tar-razza Cynomolgus ma żvela l-ebda sinjali ta' teratoġeniċità.
English: There is limited experience with single doses higher than 400 mg/m2 body surface area to date or weekly administrations of doses higher than 250 mg/m 2 body surface area.
Maltese: Hemm esperjenza limitata b'dożi waħidhom ogħla minn 400 mg/m² ta' erja tas-superfiċje tal-ġisem s'íssa jew l-għoti kull ġimgħa ta' dożi ogħla minn 250 mg/m² ta' erja tas-superfiċje tal-ġisem.
English: Cetuximab plus OxMdG
Maltese: Cetuximab flimkien ma' OxMdG
English: Dehydration, in particular secondary to diarrhoea or mucositis; hypocalcaemia (see section 4.4); anorexia which may lead to weight decrease.
Maltese: Deidrazzjoni, b'mod partikulari li tkun sekondarja għad-dijarea jew mukożite; ipokalċimja (ara sezzjoni 4.4); anoreksja li tista' twassal għal tnaqqis fil-piż.
English: No clinical benefit could be demonstrated in patients with KPS ≤ 80 who were 65 years of age or older.
Maltese: L-ebda benefiċċju kliniku ma deher f'pazjenti b'KPS ta' ≤ 80 li kellhom 65 sena jew iktar.
English: Radiation therapy + cetuximab
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: FIRE-3, an investigator-sponsored clinical phase-III study, compared the treatment of FOLFIRI in combination with either cetuximab or bevacizumab in the first-line treatment of patients with KRAS exon 2 wild-type mCRC.
Maltese: III, sponsorjat mill-investigatur, qabbel il-kura b'FOLFIRI flimkien jew ma' cetuximab jew ma' bevacizumab fil-kura primarja ta' pazjenti bi KRAS exon 2 wild-type mCRC.
English: In combination with local radiation therapy of the head and neck area, additional undesirable effects were those typical of radiation therapy (such as mucositis, radiation dermatitis, dysphagia or leukopenia, mainly presenting as lymphocytopenia).
Maltese: Flimkien mat-terapija lokali bir-raġġi taż-żona tar-ras u tal-għonq, effetti addizzjonali mhux mixtieqa kienu dawk tipiċi tat-terapija bir-raġġi (bħal mukożite, dermatite minħabba r-radjazzjoni, disfaġja jew lewkopenja, primarjament li tidher bħala limfoċitopenja).
English: It allows continued monitoring of the benefit/risk balance of the medicinal product.
Maltese: Għaldaqstant, il-bilanċ tal-benefiċċju/riskju għadu mhux magħruf.
English: Each subsequent dose (250 mg/m² body surface area) is infused in approximately 1 hour with an infusion rate not faster than 10 mg/min.
Maltese: Kull doża sussegwenti (250 mg/m² ta' erja tassuperfiċje tal-ġisem) hi infuża f'madwar siegħa b'rata ta' infużjoni ta' mhux aktar minn 10 mg/min.
English: Cetuximab + CTX (N=222)
Maltese: IgE kontra cetuximab (α-1-3-galactose).
English: Patients with a good prognosis as indicated by tumour stage, Karnofsky performance status (KPS) and age had a more pronounced benefit, when cetuximab was added to radiation therapy.
Maltese: Pazjenti bi pronjosi tajba kif indikat minn fażi tat-tumur, l-istat tal-prestazzjoni ta' Karnofsky (KPS) u l-età, kellhom benefiċċju iktar ċar meta cetuximab żdied mat-terapija bir-raġġi.
English: Colourless solution.
Maltese: Soluzzjoni bla kulur.
English: Mild or moderate infusion-related reactions (see section 4.4); mucositis, in some cases severe.
Maltese: Reazzjonijiet ħfief jew moderati marbuta ma' l-infużjonijiet (ara sezzjoni 4.4); mukożite, f'xi każijiet severa.
English: EGFR activates proteins called RAS. RAS proteins play an important role in the EGFR pathway -a complex signalling cascade which is involved in the development and progression of cancer.
Maltese: Il-proteini RAS għandhom rwol importanti fil-passaġġ EGFR - kaskata ta' kumplessi li tibgħat il-messaġġi li hi involuta fl-iżvilupp u l-progressjoni tal-kanċer.
English: • COIN: This was an open-label, 3-arm, randomised study in 2445 patients with inoperable metastatic or locoregional colorectal cancer who had not received prior treatment for metastatic disease and compared oxaliplatin plus fluoropyrimidines (infusional 5-fluorouracil/folinic acid [OxMdG] or capecitabine [XELOX]) in combination with cetuximab to the same chemotherapy regimen alone.
Maltese: Dan kien studju randomised, open-label, li kien fih tliet partijiet, li sar fuq 2,445 pazjent b'kanċer metastatiku jew lokoreġjonali tal-kolon u tar-rektum li ma setax jiġi operat, u li ma kienu rċivew l-ebda kura fil-passat għal mard metastatiku, li qabbel oxaliplatin flimkien ma' fluoropyrimidines (5-fluorouracil/folinic acid [OxMdG] jew capecitabine [XELOX]) infużjonali) flimkien ma' cetuximab mal-istess kors ta' kura waħdu.
English: CRS is normally most severe in relation to the first infusion.
Maltese: CRS hija normalment aktar severa fir-rigward tal-ewwel infużjoni.
English: Erbitux is contraindicated in patients with known severe (grade 3 or 4) hypersensitivity reactions to cetuximab.
Maltese: Erbitux hu kontraindikat f'pazjenti li għandhom reazzjonijiet severi ta' sensittività eċċessiva (grad 3 jew 4) għal cetuximab li jafu bihom.
English: The proportion of patients with KRAS wild-type tumours from the patient population evaluable for KRAS status comprised 58%.
Maltese: Il-proporzjon ta' pazjenti b'tumuri wild-type ġene KRAS mill-popolazzjoni ta' pazjenti li setgħu jkunu evalwati għall-istat KRAS kien ta' 58%.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 100 mg/20 mL
Maltese: U KONTENUT Soluzzjoni għall-infużjoni 1 kunjett ta' 100 mg/20 mL.
English: More than 80 out of 100 patients are likely to experience side effects involving the skin.
Maltese: Iktar minn 80 minn kull 100 pazjent x'aktarx li ser ikollhom effetti sekondarji fil-ġilda.
English: All of these pathways involve the biodegradation of the antibody to smaller molecules, i.e. small peptides or amino acids.
Maltese: Dawn il-linji kollha jinvolvu l-bijodegradazzjoni tal-antikorp għal molekuli iżgħar, jiġifieri peptides żgħar jew amino acids.
English: Patients with a good prognosis as indicated by tumour stage, Karnofsky performance status (KPS) and age had a more pronounced benefit, when cetuximab was added to platinum-based chemotherapy.
Maltese: Pazjenti bi pronjosi tajba kif indikat minn-fażi tat-tumur, l-istat tal-prestazzjoni ta' Karnofsky (KPS) u l-età, kellhom benefiċċju iktar prominenti meta cetuximab żdied mat-terapija bbażata fuq il-kimoterapija.
English: Skin lesions induced by cetuximab may predispose patients to superinfections (e.g. with S. aureus), which may lead to subsequent complications, e.g. cellulitis, erysipelas, or, potentially with fatal outcome, staphylococcal scalded skin syndrome, necrotising fasciitis or sepsis.
Maltese: Leżjonijiet fil-ġilda kkaġunati minn cetuximab jistgħu jippredisponu lill-pazjenti għal superinfezzjonijiet (eż. b'S. aureus), li jistgħu jinfexxu f'kumplikazzjonijiet oħra, eż. ċellulite, erysipelas, jew, potenzjalment b'riżultat fatali, is-sindrome ta' ġilda mismuta bi staphylococcus, faxxite b'nekrosi jew b'xi mikrobu ieħor.
English: Skin reactions*.
Maltese: Reazzjonijiet tal-ġilda*.
English: • EMR 62 202-007: This randomised study in patients with metastatic colorectal cancer after failure of irinotecan-based treatment for metastatic disease as the last treatment before study entry compared the combination of cetuximab and irinotecan (218 patients) with cetuximab monotherapy (111 patients).
Maltese: Dan l-istudju randomised f'pazjenti b'kanċer metastatiku tal-kolon u tarrektum wara li l-kura għall-mard metastatiku bbażata fuq irinotecan ma tkunx irnexxiet, bħala laħħar kura qabel ma pazjent ikun irreġistrat fl-istudju, qabbel il-kumbinazzjoni ta' cetuximab u irinotecan (218-il pazjent) mal-monoterapija b'cetuximab (111-il pazjent).
English: Severe infusion-related side effects include:
Maltese: Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata Komuni ħafna:
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of solution for infusion contains 5 mg cetuximab.
Maltese: U KWANTITATTIVA Kull 1 mL ta' soluzzjoni għall-infużjoni fih 5 mg ta' cetuximab.
English: Monoclonal antibodies are proteins that specifically recognise and bind to other unique proteins called antigens.
Maltese: Antikorpi monoklonali huma proteini li speċifikament jagħrfu u jeħlu ma' proteini uniċi oħrajn imsejħa antiġeni.
English: The proportion of patients with KRAS wild-type tumours from the patient population evaluable for KRAS status comprised 57%.
Maltese: Il-proporzjon ta' pazjenti b'tumuri wild-type ġene KRAS mill-popolazzjoni ta' pazjenti li setgħu jkunu evalwati għall-istat KRAS kien ta' 57%.
English: Connect the infusion line to the syringe and start the infusion after priming the line with Erbitux or sterile sodium chloride 9 mg/mL (0.9%) solution.
Maltese: Waħħal il-linja ta' l-infużjoni mas-siringa u ibda linfużjoni wara li tagħmel priming tal-linja b'Erbitux jew b'soluzzjoni sterili ta' sodium chloride 9 mg/mL (0.9%).
English: Cetuximab also targets cytotoxic immune effector cells towards EGFRexpressing tumour cells (antibody dependent cell-mediated cytotoxicity, ADCC).
Maltese: Flimkien ma' dan, jikkaġuna l-assimilazzjoni ta' EGFR, li tista' twassal biex titrażżan ilfunzjoni ta' EGFR. Cetuximab għandu fil-mira wkoll iċ-ċelluli effector immuni ċitotossiċi lejn ċelluli tat-tumur li jesprimu EGFR (antibody dependent cell-mediated cytotoxicity, ADCC).
English: In patients with recurrent and/or metastatic squamous cell cancer of the head and neck, cetuximab is used in combination with platinum-based chemotherapy followed by cetuximab as maintenance therapy until disease progression (see section 5.1).
Maltese: F'pazjenti b'kanċer metastatiku tal-kolon u tar-rektum, cetuximab jintuża flimkien mal-kimoterapija jew bħala mediċina waħidha (ara sezzjoni 5.1).
English: Pre-treatment
Maltese: TAL-PRODOTT
English: A formal interaction study showed that the pharmacokinetic characteristics of cetuximab remain unaltered after co-administration of a single dose of irinotecan (350 mg/m2 body surface area).
Maltese: Studju formali dwar l-interazzjoni wera li l-karatteristiċi farmakokinetiċi ta' cetuximab jibqgħu l-istess wara l-għoti flimkien ta' doża waħda ta' irinotecan (350 mg/m² ta' erja tas-superfiċje tal-ġisem).
English: Treatment may only be resumed at a lower dose level (200 mg/m² after the second occurrence and 150 mg/m² after the third occurrence), if the reaction has resolved to grade 2.
Maltese: Il-kura tkun tista' titkompla biss b'doża iktar baxxa (200 mg/m² wara t-tieni okkorrenza, u b'150 mg/m² wara t-tielet okkorrenza), jekk ir-reazzjoni tkun tjiebet għal grad 2.
English: Intravenous infusions of cetuximab exhibited dose-dependent pharmacokinetics at weekly doses ranging from 5 to 500 mg/m body surface area.
Maltese: Infużjonijiet ġolvina ta' cetuximab urew riżultati farmakokinetiċi li kienu jiddependu mid-dożi li jingħataw ta' kull ġimgħa, li varjaw minn 5 sa 500 mg/m² ta' erja tas-superfiċje tal-ġisem.