FrancophonIA/ELRC3.0 huggingface dataset:
English: As monotherapy:
Maltese: Bħala monoterapija:
English: Non-serious cases of keratitis have been observed in 0.3% of clinical trial patients.
Maltese: Każijiet mhux serji ta' keratite kienu osservati f'0.3% tal-pazjenti fil-provi kliniċi.
English: Patients receiving Vectibix in combination with the IFL regimen [bolus 5-fluorouracil (500 mg/m2), leucovorin (20 mg/m2) and irinotecan (125 mg/m2)] experienced a high incidence of severe diarrhoea (see section 4.8).
Maltese: Pazjenti li jkunu qed jirċievu Vectibix flimkien ma' kors ta' IFL [5-fluorouracil (500 mg/m2) bħala bolus, leucovorin (20 mg/m2) u irinotecan (125 mg/m2)] kellhom esperjenza ta' inċidenza għolja ta' dijarea severa (ara sezzjoni 4.8).
English: In the final analysis, the hazard ratio for PFS was 1.27 (95% CI: 1.06, 1.52).
Maltese: Fl-analiżi finali, ilproporzjon ta' periklu għal PFS kien ta' 1.27 (CI ta' 95%: 1.06, 1.52).
English: Panitumumab + FOLFIRI Wild-type RAS (n = 69)
Maltese: RAS tat-tip salvaġġ (n = 69)
English: METHOD OF ADMINISTRATION
Maltese: Technology Way
English: Moreover, panitumumab treatment was associated with improved PFS compared to BSC in patients with wild-type RAS tumours (HR = 0.38 [95% CI: 0.27, 0.56]), but not in patients with tumours harbouring a RAS mutation (HR = 0.98 [95% CI: 0.73, 1.31]).
Maltese: Barra dan, it-trattament b'panitumumab kien assoċjat ma' PFS imtejba meta mqabbla ma' BSC f'pazjenti b'tumuri b'RAS tattip salvaġġ (HR = 0.38 [CI ta' 95%: 0.27, 0.56]), iżda mhux f'pazjenti b'tumuri li fihom mutazzjoni ta' RAS (HR = 0.98 [CI ta' 95%: 0.73, 1.31]).
English: Uncommon (≥ 1/1,000 to
Maltese: Mhux komuni (≥ 1/1,000 sa < 1/100)
English: Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies, ATC code: L01XC08
Maltese: Sustanzi antineoplastiċi, antikorpi monoklonali, Kodiċi ATC:
English: Each mL of concentrate contains 0.150 mmol sodium, which is 3.45 mg sodium.
Maltese: Kull mL ta' konċentrat fih 0.150 mmol ta' sodium, li huwa ekwivalenti għal 3.45 mg ta' sodium.
English: Adverse events observed included skin toxicity, diarrhoea, dehydration and fatigue and were consistent with the safety profile at the recommended dose.
Maltese: Avvenimenti avversi osservati nkludew tossiċità fil-ġilda, dijarea, deidratazzjoni u għeja u kienu konsistenti mal-profil tas-sigurtà bid-doża rakkomandata.
English: However, infusion reactions were more frequent with cetuximab (13% versus 3%) but electrolyte disturbances were more frequent with panitumumab, especially hypomagnesaemia (29% versus 19%).
Maltese: Madankollu, reazzjonijiet għall-infużjoni kienu aktar frekwenti b'cetuximab (13% kontra 3%) iżda disturbi fl-elettroliti kienu aktar frekwenti b'panitumumab, speċjalment ipomanjesimja (29% kontra 19%).
English: CI = confidence interval a In patients that crossed over to panitumumab after progression on BSC alone (95% CI)
Maltese: CI = intervall ta' kunfidenza a F'pazjenti li qalbu għal panitumumab wara progressjoni fuq BSC waħedha (CI ta' 95%)
English: 427 (92%) patients were evaluable for KRAS status of which 184 had mutations.
Maltese: 427 (92%) pazjent setgħu jiġu evalwati għall-istat ta' KRAS u fosthom 184 kellhom mutazzjonijiet.
English: Vectibix is indicated for the treatment of adult patients with wild-type RAS metastatic colorectal cancer (mCRC):
Maltese: Vectibix huwa indikat għat-trattament ta' pazjenti adulti b'kanċer metastatiku tal-kolorektum (mCRC - metastatic colorectal cancer) b'RAS tat-tip salvaġġ:
English: For the mutant KRAS subset, the hazard ratio for PFS was 1.25 with 95% CI: 0.91-1.71.
Maltese: Għas-sottogrupp ta' KRAS mutant, il-proporzjon ta' periklu għal PFS kien ta' 1.25 b'CI ta' 95%: 0.91-1.71.
English: Vectibix plus BSC (n = 124)
Maltese: Vectibix flimkien ma' BSC (n = 124)
English: A predefined retrospective subset analysis of 641 patients of the 656 patients with wild-type KRAS (exon 2) mCRC was performed.
Maltese: Twettqet analiżi retrospettiva definita minn qabel ta' sottogrupp ta' 641 pazjent minn 656 pazjent b'mCRC bi KRAS tat-tip salvaġġ (exon 2).
English: A shortened progression-free survival (PFS) and overall survival (OS) time were observed in patients with mutant KRAS (exon 2) tumours and additional RAS mutations (KRAS [exons 3 and 4] or NRAS [exons 2, 3, 4]) who received panitumumab in combination with infusional 5-fluorouracil, leucovorin, and oxaliplatin (FOLFOX) versus FOLFOX alone (see section 5.1).
Maltese: Kienu osservati sopravivenza mingħajr progressjoni (PFS - progression-free survival) u żmien ta' sopravivenza globali (OS - overall survival) imqassra f'pazjenti b'tumuri bi KRAS mutant (exon 2) u mutazzjonijiet addizzjonali ta' RAS (KRAS [exons 3 u 4] jew NRAS [exons 2, 3, 4]) li rċevew panitumumab flimkien ma' infużjoni ta' 5-fluorouracil, leucovorin, and oxaliplatin (FOLFOX) kontra FOLFOX waħdu (ara sezzjoni 5.1).
English: Continuing infusion at 60% of original dose
Maltese: Kompli l-infużjoni bi 60% tad-doża oriġinali
English: Toxic epidermal necrolysis4
Maltese: Nekrolisi tossika talepidermide4
English: Continuing infusion at 80% of original dose
Maltese: Kompli l-infużjoni bi 80% tad-doża oriġinali
English: Panitumumab is a fully human monoclonal IgG2 antibody produced in a mammalian cell line (CHO) by recombinant DNA technology.
Maltese: IgG2 kompletament uman magħmul f'razza ta' ċelluli mammiferi (CHO - mammalian cell line) permezz ta' teknoloġija tat-tfassil tad-DNA.
English: Difference (months)
Maltese: Differenza (xhur)
English: There have been reports of overdose at doses up to approximately twice the recommended therapeutic dose (12 mg/kg).
Maltese: Kien hemm rapporti ta' doża eċċessiva b'dożi sa madwar id-doppju tad-doża terapewtika rakkomandata (12 mg/kg).
English: 1 See section “Description of selected adverse reactions” below 2 See section 4.4 Infusion-related reactions
Maltese: 1 Ara s-sezzjoni “Deskrizzjoni ta' reazzjonijiet avversi magħżula” hawn taħt 2 Ara sezzjoni 4.4
English: • The incidence of binding antibodies (excluding predose positive patients) was 1% as detected by the acid-dissociation ELISA and < 1% as detected by the Biacore assay;
Maltese: • L-inċidenza ta' antikopri li jeħlu (minbarra pazjenti pożittivi qabel id-doża) kienet ta' 1% kif osservata permezz ta' acid-dissociation ELISA u ta' < 1% kif osservata permezz tal-analiżi Biacore;
English: As with all therapeutic proteins, there is potential for immunogenicity.
Maltese: Bħal bil-proteini terapewtiċi kollha, hemm potenzjal ta' immunoġeniċità.
English: Vectibix plus BSC (n = 84)
Maltese: Vectibix flimkien ma' BSC (n = 84)
English: A multinational, randomised, controlled trial was conducted in 463 patients with EGFR-expressing metastatic carcinoma of the colon or rectum after confirmed failure of oxaliplatin and irinotecancontaining regimens.
Maltese: Prova multinazzjonali, randomised u kkontrollata twettqet f'463 pazjent b'karċinoma metastatika talkolon jew tar-rektum, li għandha EGFR wara falliment ikkonfermat ta' korsijiet li fihom oxaliplatin u irinotecan.
English: Results suggest that age (21-88), gender, race, hepatic function, renal function, chemotherapeutic agents, and EGFR membrane staining intensity (1+, 2+, 3+) in tumour cells had no apparent impact on the pharmacokinetics of panitumumab.
Maltese: Riżultati jissuġġerixxu li l-età (21-88), sess, razza, funzjoni epatika, funzjoni renali, sustanzi kimoterapewtiċi, u l-intensità li biha tittebba' l-membrana ta' EGFR (1+, 2+, 3+) fiċ-ċelluli tat-tumur ma kellhom l-ebda impatt apparenti fuq il-farmakokinetika ta' panitumumab.
English: The study was retrospectively analysed by wild-type KRAS (exon 2) status versus mutant KRAS (exon 2) status.
Maltese: L-istudju kien analizzat b'mod retrospettiv skont l-istat ta' KRAS (exon 2) tat-tip salvaġġ kontra l-istat ta' KRAS (exon 2) mutant.
English: Rash pustular Cellulitis1
Maltese: Raxx bil-ponot bil-materja Ċellulite1
English: The elimination half-life was approximately 7.5 days (range: 3.6 to 10.9 days).
Maltese: Il-half-life tal-eliminazzjoni kienet madwar 7.5 ijiem (firxa: 3.6 sa 10.
English: The recommended dose of Vectibix is 6 mg/kg (milligrams per kilogram of body weight) given once every two weeks.
Maltese: Id-doża rakkomandata ta' Vectibix hija 6 mg/kg (milligrammi kull kilogramma ta' piż tal-ġisem) mogħtija darba kull ġimagħtejn.
English: Panitumumab treatment was discontinued due to a statistically significant reduction in PFS in patients receiving panitumumab observed in an interim analysis.
Maltese: Trattament b'panitumumab twaqqaf minħabba tnaqqis statistikament sinifikanti f'PFS f'pazjenti li kienu qed jirċievu panitumumab osservat f'analiżi interim.
English: However, an increased number of serious adverse events were reported in elderly patients treated with Vectibix in combination with FOLFIRI (45% versus 32%) or FOLFOX (52% versus 37%) chemotherapy compared to chemotherapy alone (see section 4.4).
Maltese: Madankollu, numru akbar ta' avvenimenti avversi serji kienu rrappurtati f'pazjenti anzjani ttrattati b'Vectibix flimkien ma' kimoterapija FOLFIRI (45% kontra 32%) jew FOLFOX (52% kontra 37%) meta mqabbel ma' kimoterapija waħedha (ara sezzjoni 4.4).
English: Mutant KRAS (exon 2) population
Maltese: Popolazzjoni bi KRAS mutant (exon 2)
English: Panitumumab is a recombinant, fully human IgG2 monoclonal antibody that binds with high affinity and specificity to the human EGFR.
Maltese: Panitumumab huwa antikorp monoklonali rikombinanti, IgG2 kompletament uman li jeħel b'affinità u speċifiċità għolja ma' EGFR uman.
English: In the post-marketing setting, rare cases of skin necrosis, Stevens-Johnson syndrome and toxic epidermal necrolysis (see section 4.4) have been reported.
Maltese: Fl-ambjent ta' wara t-tqegħid fis-suq, kienu rrappurtati każijiet rari ta' nekrosi fil-ġilda, sindrome ta' Stevens-Johnson u nekrolisi tossika tal-epidermide (ara sezzjoni 4.4).
English: Following the recommended dose regimen (6 mg/kg given once every 2 weeks as a 1-hour infusion), panitumumab concentrations reached steady-state levels by the third infusion with mean (± Standard Deviation [SD]) peak and trough concentrations of 213 ± 59 and 39 ± 14 mcg/mL, respectively.
Maltese: Wara l-kors ta' doża rakkomandata (6 mg/kg mogħtija darba kull ġimagħtejn bħala infużjoni fuq medda ta' siegħa), il-konċentrazzjonijiet ta' panitumumab laħqu livelli fissi mat-tielet infużjoni b'konċentrazzjonijiet massimi u minimi medji (± Standard Deviation [SD]) ta' 213 ± 59 u 39 ± 14 mcg/mL, rispettivament.
English: Combination with FOLFIRI
Maltese: Ikkombinat ma' FOLFIRI
English: • The other ingredients are sodium chloride, sodium acetate trihydrate, acetic acid (glacial) and water for injections.
Maltese: • Is-sustanzi l-oħra huma sodium chloride, sodium acetate trihydrate, acetic acid (glacial) u ilma għall-injezzjonijiet.
English: PHARMACEUTICAL FORM AND CONTENTS 5 mL of concentrate for solution for infusion.
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT 5 mL ta' konċentrat għal soluzzjoni għall-infużjoni.
English: No incompatibilities have been observed between Vectibix and sodium chloride 9 mg/mL (0.9%) solution for injection in polyvinyl chloride bags or polyolefin bags.
Maltese: Ma kienu osservati l-ebda inkompatibilitajiet bejn Vectibix u soluzzjoni għall-injezzjoni ta' 9 mg/mL (0.9%) sodium chloride f'boroż tal-polyvinyl chloride jew tal-polyolefin.
English: Anaphylactic reaction2
Maltese: Reazzjoni anafilattika2
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 100 mg/5 ml
Maltese: INDIVIDWALI 100 mg/5 mL
English: • eye inflammation (conjunctivitis);
Maltese: • infjammazzjoni fl-għajn (konġuntivite);
English: A population pharmacokinetic analysis was performed to explore the potential effects of selected covariates on panitumumab pharmacokinetics.
Maltese: Twettqet analiżi farmakokinetika tal-popolazzjoni biex tesplora l-effetti potenzjali ta' kovarjanti magħżula fuq il-farmakokinetika ta' panitumumab.
English: Following a single-dose administration of panitumumab as a 1-hour infusion, the area under the concentration-time curve (AUC) increased in a greater than dose-proportional manner and clearance (CL) of panitumumab decreased from 30.6 to 4.6 mL/day/kg as the dose increased from 0.75 to 9 mg/kg.
Maltese: Wara l-għoti ta' doża waħda ta' panitumumab bħala infużjoni fuq medda ta' siegħa, l-erja taħt il-kurva tal-konċentrazzjoni-ħin (AUC - area under the concentration-time curve) żdiedet b'mod akbar minn dak proporzjonali mad-doża u t-tneħħija (CL - clearance) ta' panitumumab naqset minn 30.6 għal 4.6 mL/jum/kg kif id-doża żdiedet minn 0.75 għal 9 mg/kg.
English: This medicinal product contains 3.45 mg sodium per mL, equivalent to 0.017% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Maltese: Dan il-prodott mediċinali fih 3.45 mg sodium f'kull mL, ekwivalenti għal 0.017% tal-ammont massimu rakkomandat mill-WHO ta' 2 g sodium li għandu jittieħed kuljum minn adult.
English: For clinical management of infusion-related reactions, see section 4.4.
Maltese: Għall-immaniġġjar kliniku ta' reazzjonijiet relatati mal-infużjoni, ara sezzjoni 4.4.
English: • inability to sleep (insomnia);
Maltese: • diffikultà biex torqod (insomnija);
English: A trend for OS favouring the control arm was observed in the wild-type KRAS subset of the oxaliplatin cohort (hazard ratio = 1.89; 95% CI: 1.30, 2.75).
Maltese: Kienet osservata tendenza għal OS li tiffavorixxi l-grupp ta' kontroll fis-sottogrupp ta' KRAS tat-tip salvaġġ tal-ko-orti ta' oxaliplatin (proporzjon ta' periklu = 1.89; CI ta' 95%: 1.30, 2.75).
English: In the post-marketing setting, serious infusion-related reactions have been reported, including rare post-marketing reports with a fatal outcome.
Maltese: Fl-ambjent ta' wara t-tqegħid fis-suq, kienu rrappurtati reazzjonijiet serji relatati mal-infużjoni, inklużi rapporti rari wara t-tqegħid fis-suq b'riżultat fatali.
English: Dose regulation
Maltese: Regolazzjoni tad-doża
English: • inflammation of the lungs (interstitial lung disease).
Maltese: • infjammazzjoni tal-pulmuni (marda tal-interstizju tal-pulmun).
English: Severe (NCI-CTC grade 3) skin reactions were reported in 23% and life-threatening (NCI-CTC grade 4) skin reactions in < 1% of patients who received Vectibix monotherapy and in combination with chemotherapy (n = 2,224) (see section 4.8).
Maltese: Reazzjonijiet severi (NCI-CTC grad 3) tal-ġilda kienu rrappurtati fi 23% u reazzjonijiet tal-ġilda ta' periklu għall-ħajja (NCI-CTC grad 4) kienu rrappurtati f'< 1% talpazjenti li rċevew Vectibix bħala monoterapija flimkien ma' kimoterapija (n = 2,224) (ara sezzjoni 4.8).
English: The efficacy of Vectibix as monotherapy in patients with metastatic colorectal cancer (mCRC) who had disease progression during or after prior chemotherapy was studied in open-label, single-arm trials (585 patients) and in two randomised controlled trials versus best supportive care (463 patients) and versus cetuximab (1,010 patients).
Maltese: L-effikaċja ta' Vectibix bħala monoterapija f'pazjenti b'kanċer metastatiku tal-kolorektum (mCRCmetastatic colorectal cancer) li kellhom progressjoni tal-marda waqt jew wara kimoterapija minn qabel kienet studjata fi provi open-label, bi grupp wieħed (585 pazjent) u f'żewġ provi randomised u kkontrollati kontra l-aqwa kura ta' appoġġ (463 pazjent) u kontra cetuximab (1,010 pazjenti).
English: Across monotherapy and combination mCRC clinical studies (n = 2,224), infusion-related reactions (occurring within 24 hours of an infusion) were reported in Vectibix-treated patients, including severe infusion-related reactions (NCI-CTC grade 3 and grade 4).
Maltese: Tul l-istudji kliniċi dwar monoterapija u trattament ikkombinat għal mCRC (n = 2,224), reazzjonijiet relatati mal-infużjoni (li jseħħu fi żmien 24 siegħa wara infużjoni) kienu rrappurtati f'pazjenti ttrattati b'Vectibix, inklużi reazzjonijiet severi relatati mal-infużjoni (NCI-CTC grad 3 u grad 4).
English: For these ADRs the maximum frequency category was estimated from the upper limit of 95% confidence interval for the point estimate based on regulatory guidelines for estimation of the frequency of adverse reactions from spontaneous reporting.
Maltese: Għal dawn l-ADRs il-kategorija ta' frekwenza massima ġiet stmata mil-limitu ta' fuq tal-intervall ta' kunfidenza ta' 95% għall-istima tal-punt ibbażata fuq linji gwida regolatorji għall-istima tal-frekwenza ta' reazzjonijiet avversi minn rappurtar spontanju.
English: Doses higher than 1,000 mg should be diluted in 150 mL sodium chloride 9 mg/mL (0.9%) solution for injection (see section 4.2).
Maltese: Dożi ogħla minn 1,000 mg għandhom jiġu dilwiti f'150 mL ta' soluzzjoni għall-injezzjoni ta' 9 mg/mL (0.9%) sodium chloride (ara sezzjoni 4.2).
English: Electrolyte disturbances
Maltese: Disturbi fl-elettroliti
English: Formal male fertility studies have not been conducted; however, microscopic evaluation of male reproductive organs from repeat-dose toxicity studies in cynomolgus monkeys at doses up to approximately 5-fold the human dose on a mg/kg basis, revealed no differences compared to control male monkeys.
Maltese: Ma sarux studji formali dwar il-fertilità fl-irġiel; madankollu, evalwazzjoni mikroskopika tal-organi riproduttivi maskili minn studji dwar l-effett tossiku minn dożi ripetuti f'xadini cynomolgus b'dożi sa madwar 5 darbiet id-doża umana fuq bażi ta' mg/kg, ma wriet l-ebda differenza meta mqabbla ma' xadini maskili ta' kontroll.
English: The incidence of these additional RAS mutations (KRAS exons 3, 4 and NRAS exons 2, 3, 4) in the wild-type KRAS (exon 2) population was approximately 19%.
Maltese: L-inċidenza ta' dawn ilmutazzjonijiet addizzjonali ta' RAS (KRAS exons 3, 4 u NRAS exons 2, 3, 4) fil-popolazzjoni bi KRAS tat-tip salvaġġ (exon 2) kienet madwar 19%.
English: Continuing infusion at 100% of original dose
Maltese: Kompli l-infużjoni b'100% tad-doża oriġinali
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/423/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/07/423/001
English: Vectibix does not contain any antimicrobial preservative or bacteriostatic agent.
Maltese: Vectibix ma fih l-ebda preservattiv kontra l-mikrobi jew sustanza batterjostatika.
English: Median (months) (95% CI) Hazard ratio (95% CI) ORR n (%) (95% CI) Odds ratio (95% CI)
Maltese: ORR n (%) (CI ta' 95%) Proporzjon ta' probabbiltà (CI ta' 95%)
English: Prior to infusion, Vectibix should be diluted in sodium chloride 9 mg/mL (0.9%) solution for injection to a final concentration not to exceed 10 mg/mL (for preparation instructions see section 6.6).
Maltese: Qabel l-infużjoni, Vectibix għandu jiġi dilwit f'soluzzjoni għall-injezzjoni ta' 9 mg/mL (0.9%) sodium chloride għal konċentrazzjoni finali li ma taqbiżx 10 mg/mL (għal istruzzjonijiet fuq il-preparazzjoni ara sezzjoni 6.6).
English: Severe (NCI-CTC grade 3) skin reactions were reported in 23% and life-threatening (NCI-CTC grade 4) skin reactions in < 1% of patients.
Maltese: Reazzjonijiet severi fil-ġilda (NCI-CTC grad 3) kienu rrappurtati fi 23% u reazzjonijiet filġilda ta' periklu għall-ħajja (NCI-CTC grad 4) f'< 1% tal-pazjenti.
English: This is equivalent to 0.017% of the recommended maximum daily dietary intake of sodium for an adult.
Maltese: Dan huwa ekwivalenti għal 0.017% tal-ammont massimu rakkomandat ta' sodium li ghandu jittieħed kuljum mad-dieta minn adult.
English: 3 See section 4.4 Pulmonary complications
Maltese: 3 Ara sezzjoni 4.4
English: Rare cases of Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported in patients treated with Vectibix in the post-marketing setting.
Maltese: Każijiet rari tas-sindrome ta' Stevens-Johnson u nekrolisi tossika tal-epidermide ġew irrappurtati f'pazjenti ttrattati b'Vectibix fl-ambjent ta' wara ttqegħid fis-suq.
English: Other electrolyte disturbances, including hypokalaemia, have also been observed.
Maltese: Kienu osservati wkoll disturbi oħra fl-elettroliti, inkluż ipokalimja.
English: Tumour samples obtained from the primary resection of colorectal cancer were analysed for the presence of the seven most common activating mutations in the codon 12 and 13 of the KRAS gene.
Maltese: Kampjuni tat-tumur miksuba minn tneħħija primarja ta' kanċer tal-kolorektum kienu analizzati għall-preżenza tas-seba' mutazzjonijiet attivanti l-aktar komuni fil-kodon 12 u 13 tal-ġene KRAS.
English: • Compared with patients who did not develop antibodies, no relationship between the presence of anti-panitumumab antibodies and pharmacokinetics, efficacy and safety has been observed.
Maltese: • Mqabbel mal-pazjenti li ma żviluppawx antikorpi, ma kienet osservata l-ebda relazzjoni bejn ilpreżenza ta' antikorpi anti-panitumumab u l-farmakokinetika, l-effikaċja u s-sigurtà.
English: Doses higher than 1,000 mg should be diluted in 150 mL sodium chloride 9 mg/mL (0.9%) solution for injection.
Maltese: Dożi ogħla minn 1,000 mg għandhom jiġu dilwiti f'150 mL ta' soluzzjoni għall-injezzjoni ta' 9 mg/mL (0.9%) sodium chloride.
English: In the post-marketing setting, serious cases of keratitis and ulcerative keratitis have been rarely reported (see section 4.4).
Maltese: Fl-ambjent ta' wara t-tqegħid fis-suq, każijiet serji ta' keratite u keratite ulċerattiva rari kienu rrappurtati (ara sezzjoni 4.4).
English: The study was prospectively analysed by tumour KRAS (exon 2) status which was evaluable in 91% of the patients.
Maltese: L-istudju kien analizzat b'mod prospettiv skont l-istat ta' KRAS (exon 2) tattumur li seta' jiġi evalwat f'91% tal-pazjenti.
English: Data from an interaction study involving Vectibix and irinotecan in patients with mCRC indicated that the pharmacokinetics of irinotecan and its active metabolite, SN-38, are not altered when the medicinal products are co-administered.
Maltese: Dejta minn studju ta' interazzjoni li kien jinvolvi Vectibix u irinotecan f'pazjenti b'mCRC tindika li lfarmakokinetika ta' irinotecan u l-metabolit attiv tiegħu, SN-38, ma tinbidilx meta l-prodotti mediċinali jingħataw flimkien.
English: Other medicines and Vectibix
Maltese: Mediċini oħra u Vectibix
English: The efficacy of Vectibix in combination with oxaliplatin, 5-fluorouracil (5-FU), and leucovorin (FOLFOX) was evaluated in a randomised, controlled trial of 1,183 patients with mCRC with the primary endpoint of PFS. Other key endpoints included the OS, ORR, time to response, time to progression (TTP), and duration of response.
Maltese: L-effikaċja ta' Vectibix flimkien ma' oxaliplatin, 5-fluorouracil (5-FU), u leucovorin (FOLFOX) kienet evalwata fi prova randomised, ikkontrollata ta' 1,183 pazjent b'mCRC b'punt finali primarju ta' PFS.
English: Interstitial lung disease3
Maltese: Marda tal-interstizju tal-pulmun3
English: • Each mL of concentrate contains 20 mg panitumumab.
Maltese: • Kull mL ta' konċentrat fih 20 mg panitumumab.
English: Rash maculo-papular Skin lesion
Maltese: Raxx makulo-papulari Leżjoni fil-ġilda Tossiċità tal-ġilda Qoxra
English: RAS mutational status should be determined using a validated test method by an experienced laboratory (see section 4.2).
Maltese: L-istat ta' mutazzjoni ta' RAS għandu jiġi determinat minn laboratorju b'esperjenza bl-użu ta' metodu ta' ttestjar validat (ara sezzjoni 4.2).
English: In an exploratory analysis of banked tumour specimens from this study, 11 of 72 patients (15%) with wild-type RAS tumours receiving panitumumab had an objective response compared to only 1 of 95 patients (1%) with mutant RAS tumour status.
Maltese: F'analiżi esploratorja ta' kampjuni arkivjati tat-tumur minn dan l-istudju, 11 minn 72 pazjent (15%) b'tumuri b'RAS tat-tip salvaġġ li kienu qed jirċievu panitumumab kellhom rispons oġġettiv meta mqabbla ma' 1 biss minn 95 pazjent (1%) b'tumur bi stat ta' RAS mutant.
English: Infusion-related reaction1
Maltese: Reazzjoni relatata malinfużjoni1
English: Vectibix plus FOLFIRI (months) Median (95% CI)
Maltese: Vectibix flimkien ma' FOLFIRI (xhur) Medjan (CI ta' 95%)
English: Skin-related reactions are likely to occur in approximately 94 out of 100 people who take Vectibix and are usually mild to moderate.
Maltese: Reazzjonijiet relatati mal-ġilda x'aktarx li jseħħu f'madwar 94 minn kull 100 persuna li jieħdu Vectibix u ġeneralment huma ħfief sa moderati.
English: Median overall survival was 19.4 (95% CI: 18.4, 20.8) and 24.5 (95% CI: 20.4, 24.5) in the panitumumab arm and the non-panitumumab arm.
Maltese: (CI ta' 95%: 18.4, 20.8) u 24.5