FrancophonIA/ELRC3.0 huggingface dataset:
English: Only one patient among the 54 in whom the effectiveness of Savene could be measured had tissue damage requiring surgery.
Maltese: Pazjent wieħed biss minn 54 li fihom setgħet tiġi mkejla l-effikaċja ta' Savene kellu ħsara fit-tessut li kellha bżonn operazzjoni.
English: What is Savene?
Maltese: Kif jaħdem Savene?
English: Dexrazoxane has been in use since the 1990s as a medicine to help prevent the cardiomyopathy (harm to the heart muscle) associated with the use of anthracyclines.
Maltese: Dexrazoxane ilu jintuża mis-snin 90 bħala mediċina li tgħin fil-prevenzjoni ta' kardjomijapatija (ħsara lill-muskolu tal-qalb) assoċjata mal-użu tal-anthrcyclines.
English: Anthracycline extravasation is a condition that can currently be managed using various methods, but for which there is no standard authorised treatment.
Maltese: L-ekstravażjoni ta' anthracycline hija kundizzjoni li bħalissa tista' tkun immaniġjata b'diversi metodi, iżda li għaliha ma hemmx kura standard awtorizzata.
English: Why has Savene been approved?
Maltese: Għaliex ġie approvat Savene?
English: Savene is a powder and diluent that are made up into a solution for infusion (drip into a vein).
Maltese: Savene huwa trab u dilwent li jsiru soluzzjoni għal infużjoni (dripp ġol-vina).
English: The CHMP concluded that Savene had shown its ability to treat anthracycline extravasation, allowing patients to continue their anticancer treatment.
Maltese: Is-CHMP ikkonkluda li Savene wera l-kapaċità li jikkura l-ekstravażjoni ta' anthracycline, u jippermetti lill-pazjenti li jkomplu bil-kura kontra l-kanċer.
English: Patients will be monitored for these side effects before, during and after treatment.
Maltese: Ilpazjenti għandhom jiġu kkontrollati għal dawn l-effetti sekondarji qabel, waqt u wara t-trattament.
English: Extravasation happens when an anticancer medicine that is normally injected into a vein leaks or is accidentally injected in the tissue surrounding the vein, where it can cause serious damage.
Maltese: Lekstravażjoni sseħħ meta mediċina kontra l-kanċer li normalment tiġi injettata fil-vini tqattar fuq jew tiġi injettata bi żball fit-tessut ta' madwar il-vina, fejn tista' tikkawża ħsara serja.
English: The first infusion of Savene is given as soon as possible after the accident, and no later than six hours after it happened.
Maltese: L-ewwel infużjoni ta' Savene tingħata mill-aktar fis possibbli wara l-inċident, u mhux aktar tard minn sitt sigħat wara li jseħħ.
English: Enzepi is available as capsules (5,000; 10,000; 25,000 and 40,000 units).
Maltese: Enzepi huwa disponibblii bħala kapsuli (unitajiet ta' 5,000; 10,000; 25,000 and 40,000).
English: The full EPAR for Enzepi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Enzepi.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Enzepi.
English: In one main study involving 96 patients, treatment with Enzepi led to the absorption of 84% of the fats consumed by patient over 72 hours compared with 85% absorption with the already authorised medicine.
Maltese: Fi studju ewlieni wieħed li involva 96 pazjent, il-kura b'Enzepi wasslet għallassorbiment ta' 84% tax-xaħmijiet ikkunsmati minn pazjent tul 72 siegħa meta mqabbla ma' assorbiment ta' 85% bil-mediċina diġà awtorizzata.
English: Other information about Enzepi
Maltese: Informazzjoni oħra dwar Enzepi
English: Enzepi pancreas powder
Maltese: Enzepi trab tal-frixa
English: The most important serious side effects observed with all pancreatic enzyme medicines are anaphylactic (allergic) reactions and fibrosing colonopathy (scarring and thickening of the bowel wall).
Maltese: Laktar effetti sekondarji serji importanti osservati bil-mediċini tal-enzima tal-frixa kollha huma reazzjonijiet anafilattiċi (allerġiċi) u kolonopatija fibrosanti (trobbija ta' qoxra u ħxuna tal-ħajt talmusrana).
English: The most common side effects with Enzepi (which may affect more than 1 in 100 people) are effects on the gut (abdominal pain, bloating, diarrhoea, vomiting, constipation and nausea) and headache.
Maltese: L-effetti sekondarji l-aktar komuni b'Enzepi (li jistgħu jaffettwaw aktar minn persuna minn kull 100) huma effetti fuq il-musrana (uġigħ addominali, nefħa, dijarea, rimettar, stitikezza u dardir) u uġigħ ta' ras.
English: Why is Enzepi approved?
Maltese: Għaliex ġie approvat Enzepi?
English: In clinical trials most side effects were mild to moderate in severity.
Maltese: Fil-provi kliniċi, ħafna mill-effetti sekondarji kienu minn ħfief sa moderati fis-severità tagħhom.
English: In terms of safety, Enzepi's side effects are comparable to other marketed products.
Maltese: F'termini ta' sigurtà, l-effetti sekondarji ta' Enzepi huma komparabbli ma' prodotti oħrajn imqiegħda fis-suq.
English: Pancreas enzymes are needed to digest fats, carbohydrates and proteins.
Maltese: Din fiha enzimi li jgħinu fid-diġestjoni tax-xaħmijiet, tal-karboidrati u tal-proteini.
English: What are the risks associated with Enzepi?
Maltese: X'inhuma r-riskji assoċjati ma' Enzepi?
English: The CHMP considered that the use of pancreas powder to treat pancreatic insufficiency has been well established in medical practice for more than 20 years.
Maltese: Ic-CHMP qies li l-użu tat-trab tal-frixa sabiex jikkura l-insuffiċjenza tal-frixa huwa stabbilit sew filprattika medika għal aktar minn 20 sena.
English: How does Enzepi work?
Maltese: Kif jintuża Enzepi?
English: Enzepi is a medicine used to treat adults and children whose pancreas does not produce enough enzymes (a condition known as pancreatic insufficiency) due to cystic fibrosis or other conditions such as pancreatic cancer.
Maltese: Enzepi huwa mediċina użata sabiex tikkura l-adulti u t-tfal li l-frixa tagħhom ma tipproduċix biżżejjed enzimi (kundizzjoni magħrufa bħala insuffiċjenza tal-frixa) minħabba l-fibrożi ċistika jew kundizzjonijiet oħra bħall-kanċer tal-frixa.
English: The active substance in Enzepi is pancreas powder which is obtained from pig pancreas.
Maltese: Enzepi intwera li hu effettiv bħall-mediċina diġà magħrufa mqiegħda fis-suq.
English: Enzepi has been shown to be as effective as an already authorised medicine containing pancreas powder and used in pancreatic insufficiency.
Maltese: Enzepi ntwera li hu effettiv bħala mediċina diġà awtroizzata li fiha t-trab tal-frixa u użata għallinsuffiċjenza tal-frixa.
English: For patients who cannot swallow capsules, the capsules may be opened and the content mixed with a small amount of acidic food such as fruit puree which should be swallowed immediately without chewing.
Maltese: Għal pazjenti li ma jistgħux jibilgħu kapsuli, il-kapsuli jistgħu jinfetħu u l-kontenut jitħallat ma' ammont żgħir ta' ikel aċidiku bħall-puree tal-frott li għandu jinbela minnufih mingħajr ma jintmagħad.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Enzepi's benefits are greater than its risks and recommended that it be approved for use in the EU.
Maltese: Il-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) iddeċieda li l-benefiċċji ta' Enzepi huma akbar mir-riskji tiegħu u rrakkomanda li jkun approvat għall-użu fl-UE.
English: How is Enzepi used?
Maltese: Kif jaħdem Enzepi?
English: a) Grade 1:
Maltese: a) Grad 1:
English: Merck Healthcare KGaA Frankfurter Straße 250 64293 Darmstadt Germany
Maltese: Merck Healthcare KGaA Frankfurter Straße 250 64293 Darmstadt Il-Ġermanja
English: Gustav Mahlerplein 102 1082 MA Amsterdam The Netherlands
Maltese: Gustav Mahlerplein 102 1082 MA Amsterdam in-Netherlands
English: Blepharitis; keratitis.
Maltese: Blefarite; keratite.
English: Date of latest renewal: 29/06/2009
Maltese: Data tal-aħħar tiġdid: 29/06/2009
English: Variable/ statistic
Maltese: Varjabbli/statistika
English: • The active substance is cetuximab.
Maltese: • Is-sustanza attiva hi cetuximab.
English: The recommended infusion period is 120 minutes.
Maltese: Il-perijodu rrakkomandat tal-infużjoni hu ta' 120 minuta.
English: Stevens-Johnson syndrome/toxic epidermal necrolysis.
Maltese: Sindrome Stevens-Johnson/Nekroli żi epidermali tossika
English: Hypomagnesaemia (see section 4.4).
Maltese: Ipomanjesemija (ara sezzjni 4.4).
English: Increase in liver enzyme levels (ASAT, ALAT, AP).
Maltese: Żieda fil-livelli tal-enzimi tal-fwied (ASAT, ALAT, AP).
English: RAS wild-type population
Maltese: Popolazzjoni RAS wild-type
English: Keep this leaflet.
Maltese: Meninġite asettika.
English: The majority of patients included had an ECOG performance status of ≤ 1.
Maltese: Il-maġġoranza ta' pazjenti inklużi kellhom stat ta' prestazzjoni ECOG ta' ≤ 1.
English: • with polyethylene (PE), ethyl vinyl acetate (EVA) or polyvinyl chloride (PVC) bags,
Maltese: • ma' boroż tal-polyethylene (PE), ethyl vinyl acetate (EVA) jew polyvinyl chloride (PVC),
English: Boehringer Ingelheim Pharma GmbH & Co KG Birkendorfer Str. 65
Maltese: Boehringer Ingelheim Pharma GmbH & Co
English: Diarrhoea; nausea; vomiting.
Maltese: Dijarea; nawseja; rimettar.
English: Deep vein thrombosis.
Maltese: Trombożi profonda tal-vini.
English: • decrease in blood levels of magnesium
Maltese: • tnaqqis fil-livelli fid-demm ta' magnesium
English: Pack size of 1 vial.
Maltese: Kull pakkett fih 1 kunjett.
English: Erbitux 5 mg/mL is compatible
Maltese: Erbitux 5 mg/mL hu kompatibbli
English: Rare ( 1/10,000 to < 1/1,000)
Maltese: Rari (≥ 1/10,000 sa < 1/1,000)
English: KRAS wild-type population
Maltese: Popolazzjoni KRAS wild-type
English: The KRAS exon 2 status was recognised as predictive factor for the treatment with cetuximab in 4 of the randomised controlled studies (EMR 62 202-013, EMR 62 202-047, CA225006, and CA225025).
Maltese: L-istat ta' ġene KRAS exon 2 kien rikonoxxut bħala fattur li jbassar għall-kura b'cetuximab f'4 millistudji randomised ikkontrollati (EMR 62 202-013, EMR 62 202-047, CA225006, u CA225025).
English: KRAS mutant population
Maltese: Popolazzjoni KRAS mutant
English: Sodium chloride, glycine, polysorbate 80, citric acid monohydrate, sodium hydroxide, water for injections
Maltese: Sodium chloride, glycine, polysorbate 80, citric acid monohydrate, sodium hydroxide, ilma għallinjezzjoni
English: • Risk Management Plan (RMP)
Maltese: • Pjan tal-Ġestjoni tar-riskju (RMP)
English: RAS mutant population
Maltese: Popolazzjoni RAS mutant
English: Bevacizumab plus FOLFIRI
Maltese: Bevacizumab flimkien ma' FOLFIRI
English: KRAS mutational status was available for 2072 patients.
Maltese: Listat tal-mutazzjoni KRAS kien disponibbli għal 2,072 pazjent.
English: Take an appropriate sterile syringe (minimum 50 mL) and attach a suitable needle.
Maltese: Uża siringa sterili adattata (minimu ta' 50 mL) u waħħal labra adattata.
English: Electrolyte disturbances
Maltese: Disturbi fl-elektroliti
English: Erbitux 5 mg/mL is chemically and physically stable for up to 48 hours at 25°C, if the solution is prepared as described hereafter.
Maltese: Erbitux 5 mg/mL hu kimikament u fiżikament stabbli sa 48 siegħa f'temperatura ta' 25°C, jekk issoluzzjoni tkun ppreparata kif deskritt hawn taħt.
English: The development of human anti-chimeric antibodies (HACA) is a class effect of monoclonal chimeric antibodies.
Maltese: L-iżvilupp ta' human anti-chimeric antibodies (HACA) (antikorpi anti-kimeriċi umani) hu effett ta' klassi ta' antikorpi kimeriċi monoklonali.
English: 20 mL or 100 mL of solution in a vial (Type I glass) with a stopper (halobutyl rubber) and a seal (aluminium/polypropylen).
Maltese: 20 mL jew 100 mL ta' soluzzjoni f'kunjett (ħġieġ ta' Tip I) b'tapp (lastku tal-halobutyl) u siġill (aluminju/polypropylen).
English: Erbitux 5 mg/mL is administered intravenously with an infusion pump, gravity drip or a syringe pump (for handling instructions, see section 6.6).
Maltese: Erbitux 5 mg/mL jingħata minn ġol-vina b'pompa tal-infużjoni, gravity drip jew pompa tas-siringa (għal istruzzjonijiet fuq l-amministrazzjoni ara sezzjoni 6.6).
English: RAS status was evaluable in tumour samples of 407 KRAS exon 2 wild-type patients reflecting 69% of the overall KRAS exon 2 wild-type patient population (592 patients).
Maltese: L-istat RAS kien evalwabbli f'kampjuni ta' tumuri ta' 407 pazjenti bi KRAS exon 2 wild-type li jirriflettu 69% tal-popolazzjoni globali ta' pazjenti bi KRAS exon 2 wild-type (592 pazjent).
English: Erbitux contains cetuximab, a monoclonal antibody.
Maltese: Erbitux fih cetuximab, antikorp monoklonali.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 29/06/2004
Maltese: DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Data tal-ewwel awtorizzazzjoni: 29/06/2004
English: The mean Cmax ( standard deviation) was 18555 microgram per mL.
Maltese: Il-medja tas-Cmax (± devjazzjoni standard) kienet ta' 185±55 mikrogrammi f'kull 1 mL.
English: • For administration with infusion pump or gravity drip (diluted with sterile sodium chloride 9 mg/mL (0.9%) solution): Take an infusion bag of adequate size of sterile sodium chloride 9 mg/mL (0.9%) solution.
Maltese: • Biex tagħti l-infużjoni bil-pompa jew bi gravity drip (dilwita b'soluzzjoni sterili ta' sodium chloride 9 mg/mL (0.9%)): Uża borża ta' l-infużjoni ta' daqs adegwat ta' soluzzjoni sterili ta' sodium chloride 9 mg/mL (0.9%).
English: Mean peak cetuximab concentrations were 155.8 microgram per mL in week 3 and 151.6 microgram per mL in week 8, whereas the corresponding mean trough concentrations were 41.3 and 55.4 microgram per mL, respectively.
Maltese: 8 mikrogrammi f'kull 1 mL f'ġimgħa 3, u 151.6 mikrogrammi f'kull 1 mL f'ġimgħa 8, filwaqt li l-medja talkonċentrazzjonijiet l-iktar baxxi kienet ta' 41.3 u 55.4 mikrogrammi f'kull 1 mL, rispettivament.
English: • as a single agent in patients who have failed oxaliplatin- and irinotecan-based therapy and who are intolerant to irinotecan.
Maltese: • bħala mediċina waħidha f'pazjenti li ma rnexxewx b'terapija bbażata fuq oxaliplatin u irinotecan, u li huma intolleranti għal irinotecan.
English: From the KRAS evaluated population 64% of the patients (192) had KRAS wildtype tumours and 108 patients KRAS mutations.
Maltese: Mill-popolazzjoni ta' KRAS li ġiet evalwata, 64% tal-pazjenti (192) kellhom tumuri ta' KRAS wild type u 108 pazjenti kellhom mutazzjonijiet ta' KRAS.
English: Erbitux 5 mg/mL solution for infusion Cetuximab
Maltese: Erbitux 5 mg/mL soluzzjoni għall-infużjoni Cetuximab
English: Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies, ATC code: L01XC06
Maltese: Mediċini antineoplastiċi, antikorpi monoklonali, Kodiċi ATC:
English: 1082 MA Amsterdam The Netherlands
Maltese: Merck Europe B.V. 1082 MA Amsterdam in-Netherlands
English: Overall, measurable HACA titres were noted in 3.4% of the patients studied, with incidences ranging from 0% to 9.6% in the target indication studies.
Maltese: Globalment, livelli ta' HACA li jistgħu jitkejlu, kienu osservati f'3.4% tal-pazjenti li kienu studjati, b'inċidenzi li jvarjaw minn 0% sa 9.6% fl-istudji tal-indikazzjoni fil-mira.
English: Of the KRAS mutant population, 297 patients received cetuximab and oxaliplatin plus fluoropyrimidines (101 patients OxMdG and 196 patients XELOX) and 268 patients received oxaliplatin plus fluoropyrimidines alone (78 patients OxMdG and 190 patients XELOX).
Maltese: Mill-popolazzjoni mutanti ta' KRAS, 297 pazjent rċivew cetuximab u oxaliplatin flimkien ma' fluoropyrimidines waħidhom (101 pazjent OXMdG u 196 pazjent XELOX) u 268 pazjent irċivew oxaliplatin ma' fluoropyrimidines waħidhom (78 pazjent OxMdG u 190 pazjent XELOX).
English: • in first-line in combination with FOLFOX,
Maltese: • flimkien ma' kura primarja b'FOLFOX,
English: Cetuximab plus FOLFOX4
Maltese: Cetuximab flimkien ma' FOLFOX4
English: Common ( 1/100 to < 1/10)
Maltese: Komuni (≥ 1/100 sa < 1/10)
English: • decrease in blood levels of calcium
Maltese: • tnaqqis fil-livelli fid-demm tal-calcium
English: Erbitux is used to treat two different types of cancer:
Maltese: Erbitux jintuża għall-kura ta' żewġ tipi differenti ta' kanċer:
English: Cardiovascular disorders
Maltese: Disturbi gastro-intestinali
English: Hazard Ratio (95% CI) p-value
Maltese: Proporzjon ta' periklu (95% CI) p-value
English: Uncommon ( 1/1,000 to < 1/100)
Maltese: Mhux komuni (≥ 1/1,000 sa < 1/100)
English: In the overall population, irrespective of KRAS status, the results reported for cetuximab plus irinotecan (648 patients) vs. irinotecan alone (650 patients) were: median overall survival time (OS) 10.71 vs. 9.99 months (HR 0.98), median progression free survival time (PFS) 4.0 vs. 2.6 months (HR 0.69), and objective response rate (ORR) 16.4% vs. 4.2%.
Maltese: 71 vs 9.99 xhur (HR 0.98) żmien medjan ta' sopravivenza globali mingħajr progressjoni (PFS) 4.0 kontra 2.6 xhur (HR 0.69), u rata ta' rispons oġġettiv (ORR): 16.4% kontra 4.2%.
English: In addition, cetuximab was investigated in combination with chemotherapy in an investigator-initiated randomised controlled phase-III study (COIN, COntinuous chemotherapy plus cetuximab or INtermittent chemotherapy).
Maltese: III randomised, ikkontrollat, mibdi mill-investigatur (COIN, COntinuous chemotherapy plus cetuximab or INtermittent chemotherapy - kimoterapija kontinwa jew kimoterapija intermittenti).
English: 1 vial of 100 mg/20 mL
Maltese: INDIVIDWALI 100 mg/20 mL
English: Each vial of 100 mL contains 500 mg cetuximab (5 mg/mL).
Maltese: Kull kunjett ta' 100 mL fih 500 mg ta' cetuximab (5 mg/mL).
English: Of these, 362 patients received cetuximab and oxaliplatin plus fluoropyrimidines (117 patients OxMdG and 245 patients XELOX) and 367 patients received oxaliplatin plus fluoropyrimidines alone (127 patients OxMdG and 240 patients XELOX).
Maltese: Minn dawn, 362 pazjent irċivew cetuximab u oxaliplatin flimkien ma' fluoropyrimidines (117-il pazjent OxMdG u 245 pazjent XELOX) u 367 pazjent irċivew oxaliplatin flimkien ma' fluoropyrimidines waħdu (127 pazjent OxMdG u 240 pazjent XELOX).
English: Mutations of RAS genes at certain hot-spots on exons 2, 3 and 4 result in constitutive activation of RAS proteins independently of EGFR signalling.
Maltese: RAS f'ċerti hot-spots fuq exons 2, 3 u 4 jirriżultaw f'attivazzjoni kostituttiva ta' proteini RAS, indipendentement mis-senjalazzjoni ta' EGFR.
English: Cetuximab is a chimeric monoclonal IgG1 antibody produced in a mammalian cell line (Sp2/0) by recombinant DNA technology.
Maltese: IgG1 prodott f'razza ta' ċelluli mammiferi (Sp2/0) minn teknoloġija DNA rikombinanti.
English: For storage conditions after opening, see section 6.3.
Maltese: Għall-kondizzjonijiet ta' ħażna wara l-ftuħ, ara sezzjoni 6.3.
English: In very rare cases (may affect up to 1 in 10,000 people) patients may experience blistering or peeling of the skin, which may indicate a severe skin reaction called “Stevens-Johnson syndrome”.
Maltese: F'każijiet rari ħafna (li jistgħu jaffettwaw sa persuna 1 f'kull 10,000 persuni) il-pazjenti jista' jkollhom infafet jew tqaxxir tal-ġilda, li jista' jindika reazzjoni severa tal-ġilda msejħa “sindrome ta' StevensJohnson”.
English: Tumour samples from approximately 81% of patients were analysed retrospectively for KRAS expression.
Maltese: Kampjuni tat-tumuri minn madwar 81% talpazjenti ġew analizzati b'mod retrospettiv għall-espressjoni ta' KRAS.
English: According to clinical practice guidelines prophylactic use of oral tetracyclines (6 - 8 weeks) and topical application of 1% hydrocortisone cream with moisturiser should be considered.
Maltese: Skont il-linji gwida tal-prattika klinika, l-użu profilattiku ta' tetracyclines orali (6-8 ġimgħat) u l-applikazzjoni topika ta' krema hydrocortisone 1% ma' moisturizer għandha tiġi kkunsidrata.
English: What Erbitux is
Maltese: Tużax Erbitux
English: Erbitux may be administered via a gravity drip, an infusion pump or a syringe pump.
Maltese: Erbitux jista' jingħata permezz ta' gravity drip, pompa ta' l-infużjoni jew pompa tas-siringa.
English: Pulmonary embolism; interstitial lung disease, which may be fatal (see section 4.4).
Maltese: Emboliżmu pulmonari; mard interstizzjali tal-pulmun, li jista' jkun fatali (ara sezzjoni 4.4).
English: • in combination with irinotecan-based chemotherapy,
Maltese: • flimkien ma' kimoterapija bbażata fuq irinotecan,
English: Similar findings were also reported when cetuximab was given as add-on to XELOX in combination with bevacizumab (CAIRO2).
Maltese: Riżultati simili ġew irrappurtati wkoll meta cetuximab ingħata bħala mediċina addizzjonali ma' XELOX flimkien ma' bevacizumab (CAIRO2).
English: Further post-hoc analyses were performed for studies EMR 62 202-013 and EMR 62 202-047, where also mutations on RAS genes (NRAS and KRAS) other than KRAS exon 2 have been determined.
Maltese: EMR 62 202-013 u EMR 62 202-047, fejn ġew determinati wkoll mutazzjonijiet fuq il-ġeni RAS (NRAS u KRAS) minbarra KRAS exon 2.
English: Overall, no clinically relevant difference between genders was observed.
Maltese: Globalment, l-ebda differenza klinikament rilevanti bejn is-sessi ma kienet osservata.
English: The infusion rate must not exceed 10 mg/min.
Maltese: Ir-rata tal-infużjoni ma tridx taqbeż 10 mg/min.
English: In the KRAS wild-type population of the CALGB/SWOG 80405 study (n=1137), superiority of cetuximab plus chemotherapy over bevacizumab plus chemotherapy was not shown based on an interim analysis.
Maltese: Fil-popolazzjoni KRAS wild-type tal-istudju CALGB/SWOG 80405 (n=1,137), is-superjorità ta' cetuximab flimkien ma' kimoterapija fuq bevacizumab flimkien ma' kimoterapija ma ntwerietx ibbażat fuq analiżi interim.
English: Mutational status should be determined by an experienced laboratory using validated test methods for detection of KRAS and NRAS (exons 2, 3, and 4) mutations (see section 4.4 and 5.1).
Maltese: L-istat tal-mutazzjoni għandu jiġi determinat minn laboratorju b'esperjenza permezz ta' metodi vverifikati ta' test għall-identifikazzjoni tal-mutazzjonijiet (exons 2, 3, u 4) ta' KRAS u NRAS (ara sezzjoni 4.4 u 5.1).
English: In a study of cetuximab administered in combination with irinotecan, the mean cetuximab trough levels were 50.0 microgram per mL in week 12 and 49.4 microgram per mL in week 36.
Maltese: Fi studju dwar cetuximab mogħti flimkien ma' irinotecan, il-medja tal-inqas livelli ta' cetuximab kienet ta' 50.0 mikrogrammi f'kull 1 mL f'ġimgħa 12 u 49.4 mikrogrammi f'kull 1 mL f'ġimgħa 36.
English: 1 vial of 500 mg/100 mL
Maltese: 1 kunjett ta' 500 mg/100 mL.
English: Transfer the Erbitux into the prepared infusion bag.
Maltese: Ittrasferixxi Erbitux ġol-borża ppreparata ta' l-infużjoni.
English: Other medicines and Erbitux
Maltese: Mediċini oħra u Erbitux
English: Tumour samples from approximately 81% of patients were analysed retrospectively for KRAS expression, of which 55% were KRAS wild-type.
Maltese: Kampjuni ta' tumuri minn madwar 81% tal-pazjenti ġew analizzati b'mod retrospettiv għallespressjoni ta' KRAS, li minnhom 55% kienu KRAS wild-type.
English: Cetuximab is a chimeric monoclonal IgG1 antibody that is specifically directed against the epidermal growth factor receptor (EGFR).
Maltese: IgG1 li hu speċifikament immirat kontra l-fattur tattkabbir epidermali (epidermal growth factor receptor - EGFR).
English: OS months, median (95% CI) Hazard Ratio (95% CI) p-value PFS months, median (95% CI) Hazard Ratio (95% CI) p-value ORR % (95% CI) p-value CI = confidence interval, CTX = platinum-based chemotherapy, ORR = objective response rate, OS = overall survival time, PFS = progression-free survival time
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 % (95% CI) valur p CI = intervall tal-kunfidenza, CTX = kimoterapija bbażata fuq il-platinum, ORR = rata ta' rispons oġġettiv, OS = żmien totali ta' sopravivenza, PFS = żmien ta' sopravivenza mingħajr progressjoni
English: Of these, 342 patients had RAS wild-type tumours while RAS mutations were identified in 65 patients.
Maltese: Minn dawn, 342 pazjent kellhom tumuri RAS wild-type filwaqt li mutazzjonijiet RAS ġew identifikati f'65 pazjent.