FrancophonIA/ELRC3.0 huggingface dataset:
English: ORR (%)
Maltese: ORR (%) (CI ta' 95%)
English: Mutational status should be determined by an experienced laboratory using validated test methods for detection of KRAS (exons 2, 3, and 4) and NRAS (exons 2, 3, and 4) mutations.
Maltese: L-istat ta' mutazzjoni għandu jiġi determinat minn laboratorju b'esperjenza, billi jintużaw metodi ta' testijiet ivvalidati biex jiġu identifikati mutazzjonijiet ta' KRAS (exons 2, 3 u 4) u NRAS (exons 2, 3 u 4).
English: FOLFIRI (months) Median (95% CI)
Maltese: FOLFIRI (xhur) Medjan (CI ta' 95%)
English: The incidence of BRAF exon 15 mutation in the wild-type KRAS (exon 2) population was approximately 8%.
Maltese: L-inċidenza ta' mutazzjoni ta' BRAF exon 15 filpopolazzjoni bi KRAS tat-tip salvaġġ (exon 2) kienet madwar 8%.
English: Dermatological reactions (including nail effects), observed in patients treated with Vectibix or other EGFR inhibitors, are known to be associated with the pharmacologic effects of therapy.
Maltese: Reazzjonijiet dermatoloġiċi (inkluż effetti fuq id-dwiefer), osservati f'pazjenti ttrattati b'Vectibix jew b'inibituri ta' EGFR oħra, huma magħrufa li huma assoċjati mal-effetti farmakoloġiċi tat-terapija.
English: Wild-type KRAS (exon 2) population
Maltese: Populazzjoni bi KRAS tat-tip salvaġġ (exon 2)
English: Wild-type RAS population PFS
Maltese: Popolazzjoni b'RAS tat-tip salvaġġ PFS
English: Each vial contains 400 mg of panitumumab.
Maltese: Kull kunjett fih 400 mg ta' panitumumab.
English: Skin necrosis4
Maltese: Nekrosi fil-ġilda4
English: The final concentration should not exceed 10 mg/mL.
Maltese: Il-konċentrazzjoni finali m'għandiex taqbeż 10 mg/ml.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of concentrate contains 20 mg panitumumab.
Maltese: U KWANTITATTIVA Kull mL ta' konċentrat fih 20 mg panitumumab.
English: Skin rash and diarrhoea were the major findings observed in repeat-dose toxicity studies of up to 26 weeks duration in cynomolgus monkeys.
Maltese: Raxx fil-ġilda u dijarea kienu s-sejbiet maġġuri osservati fi studji dwar l-effett tossiku minn dożi ripetuti li damu sa 26 ġimgħa f'xadini cynomolgus.
English: The study was prospectively analysed by tumour KRAS (exon 2) status which was evaluable in 93% of the patients.
Maltese: L-istudju kien analizzat b'mod prospettiv skont l-istat ta' KRAS (exon 2) tat-tumur li seta' jiġi evalwat fi 93% tal-pazjenti.
English: A shortened progression-free survival and overall survival time were observed in a clinical study in patients with mutant RAS tumours who received panitumumab and FOLFOX (see sections 4.4 and 5.1).
Maltese: Kienu osservati sopravivenza mingħajr progressjoni u żmien ta' sopravivenza globali mqassra fi studju kliniku f'pazjenti b'tumuri b'RAS mutant li rċevew panitumumab u FOLFOX (ara sezzjonijiet 4.4 u 5.1).
English: Severe diarrhoea (NCI-CTC grade 3 and 4) was reported in 2% of patients treated with Vectibix as a monotherapy and in 16% of patients treated with Vectibix in combination with chemotherapy.
Maltese: Dijarea severa (NCI-CTC grad 3 u 4) kienet irrappurtata fi 2% tal-pazjenti ttrattati b'Vectibix bħala monoterapija u f'16% tal-pazjenti ttrattati b'Vectibix flimkien ma' kimoterapija.
English: The incidence of these additional RAS mutations in the wild-type KRAS exon 2 population was approximately 16%.
Maltese: L-indiċenza ta' dawn il-mutazjonijiet addizjonali ta' RAS fil-popolazzjoni bi KRAS tat-tip salvaġġ exon 2 kienet madwar 16%.
English: Gastro-oesophageal reflux disease
Maltese: Disturbi gastro-intestinali
English: Dermatological reactions (including nail effects), observed in patients treated with Vectibix or other EGFR inhibitors, are known to be associated with the pharmacologic effects of therapy (with crossreference to sections 4.2 and 4.8).
Maltese: Reazzjonijiet dermatoloġiċi (inkluż effetti fuq id-dwiefer), osservati f'pazjenti ttrattati b'Vectibix jew b'inibituri oħra ta' EGFR, huma magħrufa li huma assoċjati mal-effetti farmakoloġiċi tat-terapija (b'referenza inkroċjata għal sezzjonijiet 4.2 u 4.8).
English: Data on the development of anti-panitumumab antibodies has been evaluated using two different screening immunoassays for the detection of binding anti-panitumumab antibodies (an ELISA which detects high-affinity antibodies, and a Biosensor Immunoassay which detects both high and low-affinity antibodies).
Maltese: Dejta dwar l-iżvilupp ta' antikorpi anti-panitumumab ġiet stmata bl-użu ta' żewġ immunoassays differenti ta' ttestjar għas-sejba ta' antikorpi anti-panitumumab li jeħlu (ELISA li ssib antikorpi b'affinità għolja, u Biosensor Immunoassay li jsib antikorpi b'affinità kemm għolja kif ukoll baxxa).
English: Progressively decreasing serum magnesium levels leading to severe (grade 4) hypomagnesaemia have been observed in some patients.
Maltese: F'xi pazjenti kien osservat tnaqqis progressiv fil-livelli ta' magnesium fis-serum li jwassal għallipomanjesimja severa (grad 4).
English: Each vial contains either 100 mg of panitumumab in 5 mL, or 400 mg of panitumumab in 20 mL.
Maltese: Kull kunjett fih 100 mg ta' panitumumab f'5 mL, jew 400 mg ta' panitumumab f'20 mL.
English: No overall differences in safety or efficacy were observed in elderly patients (≥ 65 years of age) treated with Vectibix monotherapy.
Maltese: Ma kienux osservati differenzi globali fis-sigurtà jew fl-effikaċja f'pazjenti anzjani (età ta' ≥ 65 sena) ittrattati b'Vectibix bħala monoterapija.
English: KRAS and NRAS genes encode small, GTP-binding proteins involved in signal transduction.
Maltese: Il-ġeni KRAS u NRAS għandhom kowd għal proteini żgħar li jeħlu ma' GTP involuti fit-transduzzjoni tas-sinjal.
English: Administration of Vectibix
Maltese: Kif gћandek tuża Vectibix
English: First-line combination with bevacizumab and oxaliplatin or irinotecan-based chemotherapy
Maltese: Ikkombinat ma' bevacizumab u kimoterapija bbażata fuq oxaliplatin jew irinotecan bħala trattament tal-ewwel għażla
English: Eyelid irritation
Maltese: Reazzjonijiet allerġiċi
English: • spreading infection below the skin (cellulitis); hair follicle inflammation (folliculitis); localised infection; skin rash with pus-filled blisters (rash pustular); urinary tract infection;
Maltese: • infezzjoni taħt il-ġilda li tinfirex (ċellulite); infjammazzjoni tal-follikuli tax-xagħar (follikulite); infezzjoni lokalizzata; raxx fil-ġilda b'infafet mimlija bil-materja (raxx pastulari); infezzjoni flappartat tal-awrina;
English: • chest pain; pain; chills; pain in the extremity; immune reaction (hypersensitivity); rapid heart rate (tachycardia);
Maltese: • uġigħ fis-sider; uġigħ; sirdat; uġigħ fl-estremitajiet; reazzjoni immuni (sensittività eċċessiva); rata ta' taħbit tal-qalb mgħaġġla (takikardija);
English: The efficacy of Vectibix in second-line in combination with irinotecan, 5-fluorouracil (5-FU) and leucovorin (FOLFIRI) was evaluated in a randomised, controlled trial of 1,186 patients with mCRC with the primary endpoints of OS and PFS. Other key endpoints included the ORR, time to response, TTP, and duration of response.
Maltese: L-effikaċja ta' Vectibix bħala trattament tat-tieni għażla flimkien ma' irinotecan, 5-fluorouracil (5-FU) u leucovorin (FOLFIRI) kienet evalwata fi prova randomised u kkontrollata ta' 1,186 pazjent b'mCRC b'punti finali primarji ta' OS u PFS.
English: The efficacy of Vectibix in first-line in combination with FOLFIRI was evaluated in a single-arm study of 154 patients with the primary endpoint of objective response rate (ORR).
Maltese: L-effikaċja ta' Vectibix bħala trattament tal-ewwel għażla flimkien ma' FOLFIRI kienet evalwata fi studju bi grupp wieħed ta' 154 pazjent b'punt finali primarju ta' rata ta' rispons oġġettiv (ORRobjective response rate).
English: A predefined retrospective subset analysis of 586 patients of the 597 patients with wild-type KRAS (exon 2) mCRC was performed, where tumour samples from these patients were tested for additional RAS and BRAF mutations as previously described.
Maltese: Twettqet analiżi retrospettiva definita minn qabel ta' sottogrupp ta' 586 pazjent minn 597 pazjent b'mCRC bi KRAS tat-tip salvaġġ (exon 2), fejn kampjuni tat-tumur minn dawn il-pazjenti kienu ttestjati għall-mutazzjonijiet addizzjonali ta' RAS u BRAF kif deskritt qabel.
English: Doses higher than 1,000 mg should be infused over approximately 90 minutes.
Maltese: Dożi akbar minn 1,000 mg għandhom jiġu infużi fuq madwar 90 minuta.
English: Dermatitis acneiform Rash
Maltese: Dermatite tixbaħ lill-akne Raxx
English: Clinical efficacy as monotherapy
Maltese: Effikaċja klinika bħala monoterapija
English: If Vectibix is to be used in combination with FOLFOX then it is recommended that mutational status be determined by a laboratory that participates in a RAS External Quality Assurance programme or wild-type status be confirmed in a duplicate test.
Maltese: Jekk Vectibix se jintuża flimkien ma' FOLFOX huwa rakkomandat li l-istat ta' mutazzjoni jiġi determinat minn laboratorju li jipparteċipa fi programm Estern ta' Assigurazzjoni tal-Kwalità ta' RAS jew li l-istat tat-tip salvaġġ jiġi kkonfermat f'test duplikat.
English: Vectibix must be administered using a low protein binding 0.2 or 0.22 micrometre in-line filter, through a peripheral line or indwelling catheter.
Maltese: Vectibix għandu jingħata bl-użu ta' filtru fil-pajp tad-dripp ta' 0.2 jew 0.22 mikrometru, li jeħel b'mod baxx mal-proteini, minn ġo pajp periferali jew kateter minn ġewwa.
English: Life-threatening and fatal infectious complications including necrotising fasciitis and sepsis have been observed in patients treated with Vectibix (see section 4.4).
Maltese: Komplikazzjonijiet infettivi ta' periklu għall-ħajja u fatali inklużi faxxite b'nekrosi u sepsi kienu osservati f'pazjenti ttrattati b'Vectibix (ara sezzjoni 4.4).
English: Dilute in a total volume of 100 mL.
Maltese: Iddilwixxi f'volum totali ta' 100 mL.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Vectibix 20 mg/ml sterile concentrate panitumumab
Maltese: Vectibix 20 mg/mL konċentrat għal soluzzjoni għall-infużjoni panitumumab
English: < 1% as detected by the acid-dissociation ELISA and 3.8% as detected by the Biacore assay;
Maltese: • L-inċidenza ta' antikopri li jeħlu (minbarra pazjenti pożittivi b'mod temporanju u qabel id-doża) kienet ta' < 1% kif osservata permezz ta' acid-dissociation ELISA u ta' 3.8% kif osservata permezz tal-analiżi Biacore;
English: EGFR has been implicated in the control of prenatal development and may be essential for normal organogenesis, proliferation, and differentiation in the developing embryo.
Maltese: EGFR kien implikat fil-kontroll tal-iżvilupp ta' qabel it-twelid u jista' jkun essenzjali għall-organoġenesi, proliferazzjoni, u divrenzjar normali fl-embriju li qed jiżviluppa.
English: • hair loss (alopecia); mouth ulcers and cold sores (stomatitis); inflammation of the mouth
Maltese: • telf ta' xagħar (alopeċja); ulċeri fil-ħalq u ponot tad-deni (stomatite); infjammazzjoni tal-ħalq
English: A greater frequency of pulmonary embolism, infections (predominantly of dermatologic origin), diarrhoea, electrolyte imbalances, nausea, vomiting and dehydration was also observed in the treatment arms using Vectibix in combination with bevacizumab and chemotherapy.
Maltese: Kienet osservata wkoll frekwenza ogħla ta' emboliżmu pulmonari, infezzjonijiet (l-aktar ta' oriġini dermatoloġika), dijarea, sbilanċ fl-elettroliti, tqalligħ, rimettar u deidratazzjoni, fil-gruppi ta' trattament li kienu qed jużaw Vectibix flimkien ma' bevacizumab u kimoterapija.
English: Patients were randomised 1:1 to receive Vectibix at a dose of 6 mg/kg given once every two weeks plus best supportive care (not including chemotherapy) (BSC) or BSC alone.
Maltese: Il-pazjenti kienu randomised 1:1 biex jirċievu Vectibix b'doża ta' 6 mg/kg mogħti darba kull ġimagħtejn flimkien mal-aqwa kura ta' appoġġ (kimoterapija mhux inkluża) (BSC - best supportive care) jew BSC waħedha.
English: Across monotherapy and combination mCRC clinical studies (n = 2,224), infusion-related reactions (occurring within 24 hours of any infusion), which may include symptoms/signs such as chills, fever or dyspnoea, were reported in approximately 5% of Vectibix-treated patients, of which 1% were severe (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 kwalunkwe infużjoni), li jistgħu jinkludu sintomi/sinjali bħal tertir, deni jew qtugħ ta' nifs, kienu rrappurtati f'madwar 5% tal-pazjenti ttrattati b'Vectibix, li minnhom 1% kienu severi (NCI-CTC grad 3 u grad 4).
English: Vectibix is used in the treatment of metastatic colorectal cancer (cancer of the bowel) for adult patients with a certain type of tumour known as a “Wild-type RAS tumour”.
Maltese: Vectibix jintuża fit-trattament ta' kanċer metastatiku tal-kolorektum (kanċer tal-musrana) għallpazjenti adulti b'ċertu tip ta' tumur magħruf bħala “Tumur b'RAS tat-tip salvaġġ”.
English: Vectibix must be administered as an intravenous infusion via an infusion pump, using a low protein binding 0.2 or 0.22 micrometre in-line filter, through a peripheral line or indwelling catheter.
Maltese: Vectibix għandu jingħata bħala infużjoni fil-vini permezz ta' pompa tal-infużjoni, bl-użu ta' filtru filpajp tad-dripp ta' 0.2 jew 0.22 mikrometru, li jeħel b'mod baxx mal-proteini, minn ġo pajp periferali jew kateter minn ġewwa.
English: The data in the table below describe adverse reactions reported from clinical studies in patients with mCRC who received panitumumab as a single agent or in combination with chemotherapy (n = 2,224) and spontaneous reporting.
Maltese: Id-dejta fit-tabella taħt tiddeskrivi reazzjonijiet avversi rrappurtati minn studji kliniċi f'pazjenti b'mCRC li rċevew panitumumab bħala sustanza waħedha jew flimkien ma' kimoterapija (n = 2,224) u rappurtar spontanju.
English: • dry mouth; indigestion (dyspepsia); rectal bleeding (rectal haemorrhage); lip inflammation (cheilitis); heartburn (gastroesophageal reflux);
Maltese: • ħalq xott; indiġestjoni (dispepsja); fsada mir-rektum (emorraġija mir-rektum); infjammazzjoni tax-xufftejn (kelite); ħruq ta' stonku (rifluss gastro-esofagali);
English: Hirsutism Ingrowing nail Onycholysis
Maltese: Ż-ŻGĦAR EWLENIN TIKKETTA TAL-KUNJETT
English: Dermatologic related reactions, a pharmacologic effect observed with epidermal growth factor receptor (EGFR) inhibitors, are experienced with nearly all patients (approximately 94%) treated with Vectibix.
Maltese: Reazzjonijiet relatati mal-ġilda, effett farmakoloġiku osservat b'inibituri tar-riċettur tal-fattur tattkabbir epidermali (EGFR - epidermal growth factor receptor), jinħassu minn kważi l-pazjenti kollha (madwar 94%) ittrattati b'Vectibix.
English: Patients with a history of, or evidence of, interstitial pneumonitis or pulmonary fibrosis were excluded from clinical studies.
Maltese: Pazjenti b'passat ta', jew evidenza ta' pulmonite tal-interstizju jew fibrożi pulmonari kienu esklużi minn studji kliniċi.
English: Vectibix should be diluted in sodium chloride 9 mg/mL (0.9%) solution for injection by healthcare professional using aseptic technique.
Maltese: Vectibix għandu jiġi dilwit f'soluzzjoni għallinjezzjoni ta' 9 mg/mL (0.9%) sodium chloride minn professjonist tal-kura tas-saħħa permezz ta' teknika asettika.
English: In combination with irinotecan- or oxaliplatin-based chemotherapy:
Maltese: Flimkien ma' kimoterapija bbażata fuq irinotecan jew oxaliplatin:
English: 20 mL of concentrate for solution for infusion.
Maltese: 20 mL ta' konċentrat għal soluzzjoni għall-infużjoni.
English: In the event of acute onset or worsening pulmonary symptoms, Vectibix treatment should be interrupted and a prompt investigation of these symptoms should occur.
Maltese: F'każ ta' bidu akut jew irkadar ta' sintomi pulmonari, it-trattament b'Vectibix għandu jitwaqqaf temporanjament u għandu jkun hemm investigazzjoni immedjata ta' dawn is-sintomi.
English: Onychoclasis
Maltese: Uġigħ
English: 4 Ulcerative keratitis, skin necrosis, Stevens-Johnson syndrome and toxic epidermal necrolysis are panitumumab ADRs that were reported in the post-marketing setting.
Maltese: Keratite ulċerattiva, nekrosi fil-ġilda, sindrome ta' Stevens-Johnson u nekrolisi tossika tal-epidermide huma ADRs ta' panitumumab li kienu rrappurtati fl-ambjent ta' wara t-tqegħid fis-suq.
English: • headache; dizziness; anxiety.
Maltese: • uġigħ ta' ras; sturdament; ansjetà.
English: Type I glass vial with an elastomeric stopper, aluminium seal and flip-off plastic cap. One vial contains either 100 mg of panitumumab in 5 mL, or 400 mg panitumumab in 20 mL of concentrate for solution for infusion.
Maltese: Kunjett wieħed fih jew 100 mg panitumumab f'5 mL, jew 400 mg panitumumab f'20 mL ta' konċentrat għal soluzzjoni għall-infużjoni.
English: Your doctor may decide to reduce the rate of your infusion or discontinue your treatment with Vectibix.
Maltese: Is-sejba ta' formazzjoni ta' antikorpi hija dipendenti fuq is-sensittività u l-ispeċifiċità tal-analiżi.
English: Mucosal inflammation Oedema peripheral
Maltese: Infjammazzjoni fil-mukuża Edima periferali
English: This medicine contains 3.45 mg sodium (main component of cooking/table salt) in each mL unit.
Maltese: Dan il-mediċina fiha 3.45 mg sodium (il-komponent prinċipali tal-melħ tat-tisjir/li jintuża mal-ikel) f'kull unità ta' mL.
English: A predefined retrospective subset analysis of 143 patients of the 154 patients with wild-type KRAS (exon 2) mCRC was performed, where tumour samples from these patients were tested for additional RAS mutations.
Maltese: Twettqet analiżi retrospettiva definita minn qabel ta' sottogrupp ta' 143 pazjent minn 154 pazjent b'mCRC bi KRAS tat-tip salvaġġ (exon 2), fejn kampjuni tat-tumur minn dawn il-pazjenti kienu ttestjati għall-mutazzjonijiet addizzjonali ta' RAS.
English: • skin ulcer; scab; excess hair growth (hypertrichosis); redness and swelling of palms of hands or soles of feet (hand-foot syndrome); excess sweating (hyperhidrosis); skin reaction (dermatitis);
Maltese: • ulċera fil-ġilda; qoxra; tkabbir eċċessiv ta' xagħar (ipertrikożi); ħmura u nefħa tal-pali tal-idejn u tal-qiegħ tas-saqajn (sindrome tal-id u tas-sieq); għaraq żejjed (iperidrożi); reazzjoni tal-ġilda (dermatite);
English: A high incidence of severe diarrhoea was observed when panitumumab was administered in combination with IFL (see section 4.4), and increased toxicity and deaths were seen when panitumumab was combined with bevacizumab and chemotherapy (see sections 4.4 and 5.1).
Maltese: Kienet osservata inċidenza għolja ta' dijarea severa meta panitumumab ingħata flimkien ma' IFL (ara sezzjoni 4.4), u kienet osservata żieda fit-tossiċità u fl-imwiet meta panitumumab ingħata flimkien ma' bevacizumab u kimoterapija (ara sezzjonijiet 4.4 u 5.1).
English: Across all clinical trials, skin reactions occurred in approximately 94% of patients receiving Vectibix as monotherapy or in combination with chemotherapy (n = 2,224).
Maltese: Fil-provi kliniċi kollha, reazzjonijiet fil-ġilda seħħew f'madwar 94% tal-pazjenti li kienu qed jirċievu Vectibix bħala monoterapija jew flimkien ma' kimoterapija (n = 2,224).
English: The efficacy of Vectibix was also evaluated in an open-label trial in patients with wild-type KRAS (exon 2) mCRC.
Maltese: L-effikaċja ta' Vectibix kienet evalwata wkoll fi prova open-label, f'pazjenti b'mCRC bi KRAS tat-tip salvaġġ (exon 2).
English: Dyspnoea Cough
Maltese: Ġilda xotta
English: The fatal event occurred after re-exposure following a prior episode of angioedema; both episodes occurred greater than 24 hours after administration (see sections 4.3 and 4.4).
Maltese: L-avveniment fatali seħħ wara esponiment mill-ġdid wara episodju minn qabel ta' anġjoedima; iż-żewġ episodji seħħew aktar minn 24 siegħa wara l-għoti (ara sezzjonijiet 4.3 u 4.4).
English: • keratitis (inflammation of the front part of the eye (cornea));
Maltese: • keratite (infjammazzjoni tal-parti ta' quddiem tal-għajn (kornea));
English: Doses higher than 1,000 mg should be infused over approximately 90 minutes (for handling instructions, see section 6.6).
Maltese: Dożi akbar minn 1,000 mg għandhom jiġu infużi fuq madwar 90 minuta (għal istruzzjonijiet fuq l-immaniġġjar, ara sezzjoni 6.6).
English: Life-threatening and fatal infectious complications including necrotising fasciitis and sepsis have been observed in patients treated with Vectibix.
Maltese: Komplikazzjonijiet infettivi ta' periklu għall-ħajja u fatali inklużi faxxite b'nekrosi u sepsi kienu osservati f'pazjenti ttrattati b'Vectibix.
English: Treatment and management of dermatologic reactions should be based on severity and may include a moisturiser, sun screen (SPF > 15 UVA and UVB), and topical steroid cream (not stronger than 1% hydrocortisone) applied to affected areas, and/or oral antibiotics (e.g. doxycycline).
Maltese: It-trattament u l-immaniġġjar ta' reazzjonijiet dermatoloġiċi għandu jkun ibbażat fuq is-severità u jista' jinkludi krema għall-ġilda xotta, krema ta' protezzjoni mix-xemx (SPF ta' > 15 UVA u UVB), u krema sterojda topika (mhux aktar qawwija minn 1% hydrocortisone) applikati fuq il-partijiet affettwati, u/jew antibijotiċi orali (eż. doxycycline).
English: • ulcerative keratitis (a serious condition of ulceration of the front part of the eye (cornea)
Maltese: • keratite ulċerattiva (kondizzjoni serja b'ulċerazzjoni fil-parti ta' quddiem tal-għajn (kornea) li teħtieġ trattament urġenti);
English: Vectibix contains the active substance panitumumab, which belongs to a group of medicines called monoclonal antibodies.
Maltese: Vectibix fih is-sustanza attiva panitumumab, li tagħmel parti minn grupp ta' mediċini msejħa antikorpi monoklonali.
English: EGFR promotes cell growth in normal epithelial tissues, including the skin and hair follicle, and is expressed on a variety of tumour cells.
Maltese: EGFR jippromwovi tkabbir taċ-ċelluli f'tessuti tal-epitelju normali, inkluż il-follikuli tal-ġilda u tax-xagħar, u jiġi espress fuq varjetà ta' ċelluli tat-tumur.
English: Colourless, pH 5.6 to 6.0 solution that may contain translucent to white, visible amorphous, proteinaceous panitumumab particles.
Maltese: Soluzzjoni bla kulur, b'pH bejn 5.6 u 6.0 li jista' jkun fiha frak ta' panitumumab, trasluċidi sa bojod, ta' dehra amorfa, magħmula minn proteini.
English: In patients with a history of interstitial pneumonitis or pulmonary fibrosis, the benefits of therapy with panitumumab versus the risk of pulmonary complications must be carefully considered.
Maltese: F'pazjenti b'passat ta' pulmonite tal-interstizju jew fibrożi pulmonari, il-benefiċċji ta' terapija b'panitumumab kontra r-riskju ta' komplikazzjonijiet pulmonari għandhom jiġu kkunsidrati b'attenzjoni.
English: However, at doses above 2 mg/kg, the AUC of panitumumab increases in an approximately dose-proportional manner.
Maltese: Madankollu, b'dożi ta' aktar minn 2 mg/kg, l-AUC ta' panitumumab bejn wieħed u ieħor tiżdied b'mod proporzjonali mad-doża.
English: Seek medical attention immediately if you experience symptoms of an allergic reaction to Vectibix, including but not limited to difficulty breathing, chest tightness, a sensation of choking, dizziness, or fainting.
Maltese: Fittex attenzjoni medika minnufih jekk ikollok sintomi ta' reazzjoni allerġika għal Vectibix, inkluż iżda mhux limitat għal diffikultà biex tieħu nifs, tagħfis fissider, sensazzjoni li qed tifga, sturdament jew ħass ħażin.
English: • No evidence of an altered safety profile was found in patients who tested positive for antibodies to Vectibix.
Maltese: • Ma nstabet l-ebda evidenza ta' bidla fil-profil ta' sigurtà f'pazjenti li kienu pożittivi għallantikorpi kontra Vectibix.
English: For clinical management of dermatological reactions, including dose modification recommendations, see section 4.4.
Maltese: Għall-immaniġġjar kliniku ta' reazzjonijiet dermatoloġiċi, inkluż rakkomandazzjonijiet għallmodifikazzjoni fid-doża, ara sezzjoni 4.4.