qanastek/EMEA-V3 huggingface dataset:
EGFR is a transmembrane glycoprotein that is a member of a subfamily of type I receptor tyrosine kinases including EGFR (HER1/ c-ErbB-1), HER2, HER3, and HER4.
EGFR hija glikoproteina transmembranja li hija membru tas - sottofamilja ta ’ kinases tyrosine tar- riċettur tat- tip I inkluż EGFR (HER1/ c- ErbB- 1), HER2, HER3, u HER4.
EGFR promotes cell growth in normal epithelial tissues, including the skin and hair follicle, and is expressed on a variety of tumour cells.
EGFR jippromwovi tkabbir taċ- ċellula f’ tessuti ta ’ l- epitilju normali, inkluż l- follikulu tal- ġilda u tax- xagħar, u jiġi espress fuq varjetà ta ’ ċelluli tat- tumur.
Panitumumab binds to the ligand binding domain of EGFR and inhibits receptor autophosphorylation induced by all known EGFR ligands.
Panitumumab jeħel mal- parti ta ’ EGFR li teħel mal- ligand u jinibixxi awtofosforilizazzjoni tar- riċettur indott mil- ligandi ta ’ EGFR magħrufa kollha.
Binding of panitumumab to EGFR results in internalisation of the receptor, inhibition of cell growth, induction of apoptosis, and decreased interleukin 8 and vascular endothelial growth factor production.
It- twaħħil ta ’ panitumumab ma ’ EGFR jirriżulta f’ internalizazzjoni tar- riċettur, inibizzjoni tat- tkabbir taċ- ċellula, induzzjoni ta ’ apoptożi, u tnaqqis fil - produzzjoni ta ’ interleukin 8 u tal- fattur ta ’ tkabbir tal- endotilju vaskulari.
The KRAS (Kirsten rat sarcoma 2 viral oncogene homologue) gene encodes a small, GTP-binding protein involved in signal transduction.
Il- ġene KRAS (Kirsten rat sarcoma 2 viral oncogene homologue) tieħu ħsieb proteina żgħira li teħel ma ’ GTP involuta fit- transduzzjoni tas- sinjal.
A variety of stimuli, including that from the EGFR activates KRAS which in turn stimulates other intracellular proteins to promote cell proliferation, cell survival and angiogenesis.
Varjetà ta ’ stimuli, inkluż dak minn EGFR jattiva KRAS li mbagħad tistimula proteini intraċellulari oħra biex jippromwovu l- proliferazzjoni taċ- ċelluli, sopravivenza taċ- ċelluli u anġjoġenesi.
Activating mutations in the KRAS gene occur frequently in a variety human tumours and have been implicated in both oncogenesis and tumour progression.
Mutazzjonijiet li jattivaw fil- ġene KRAS iseħħu b’ mod frekwenti f’ varjetà ta ’ tumuri umani u ġew implikati kemm f’ onkoġenesi kif ukoll fil- progressjoni tat- tumur.
In vitro assays and in vivo animal studies have shown that panitumumab inhibits the growth and survival of tumour cells expressing EGFR.
Analiżi in vitro u studji fl- annimali in vivo wrew li panitumumab jinibixxi t- tkabbir u s- sopravivenza ta ’ ċelluli tat- tumur li għandhom EGFR.
No anti-tumour effects of panitumumab were observed in human tumour xenografts lacking EGFR expression.
L- ebda effetti kontra t- tumur ta ’ panitumumab ma ġew osservati f’ xenografts ta ’ tumur uman li ma fihomx EGFR.
The addition of panitumumab to radiation, chemotherapy and/ or other targeted therapeutic agents, in animal studies resulted in an increase in anti-tumour effects compared to radiation, chemotherapy or targeted therapeutic agents alone.
Iż- żieda ta ’ panitumumab mar- radjazzjoni, kimoterapija u/ jew sustanzi terapewtiċi mmirati oħrajn, fi studji fl- annimali rriżulta f’ żieda fl- effetti kontra t- tumur meta mqabbel mar- radjazzjoni, kimoterapija jew sustanzi terapewtiċi mmirati waħedhom.
Data on the development of anti-panitumumab antibodies has been evaluated using two different immunoassays (an ELISA which detects high-affinity antibodies, and a Biosensor Immunoassay which detects both high and low-affinity antibodies), results from these assays indicated that the overall incidence of a post-dose anti-panitumumab antibody response was low.
Tagħrif dwar l- iżvilupp ta ’ antikorpi anti- panitumumab ġie stmat bl- użu ta ’ żewġ immunoassays differenti (ELISA li ssib antikorpi b’ affinità għolja, u Biosensor Immunoassay li jsib antikorpi b’ affinità kemm għolja kif ukoll baxxa), riżultati minn dawn l- analiżi ndikaw li l- inċidenza globali tar - rispons ta ’ l- antikorpi anti- panitumumab wara doża kienet baxxa.
Pre-dose antibodies were detected in 5 of 636 patients (< 1%) and 16/ 635 patients (2.5%) tested by the ELISA and Biosensor Immunoassay respectively.
Antikorpi ta ’ qabel id- doża kienu osservati f’ 5 minn 636 pazjent (< 1%) u 16/ 635 pazjent (2. 5%) ittestjati b’ ELISA u b’ Biosensor Immunoassay rispettivament.
Post-dose neutralising antibodies were detected in 1 of 447 patients (0.2%) and 7 of 447 patients (1.6%) tested by the ELISA and Biosensor Immunoassay respectively.
Antikorpi newtralizzanti ta ’ wara d- doża nstabu f’ 1 minn 447 pazjent (0. 2%) u 7 minn 447 pazjent (1. 6%) ittestjati bl- ELISA u b’ Biosensor Immunoassay rispettivament.
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.
Mqabbel mal- pazjenti li ma żviluppawx antikorpi, ma kienet osservata l- ebda relazzjoni bejn il - preżenza ta ’ antikorpi anti- panitumumab u l- farmakokinetika, l- effikaċja u s- sigurtà.
The detection of antibody formation is dependent on the sensitivity and specificity of the assay.
Is- sejba ta ’ formazzjoni ta ’ antikorpi hija dipendenti fuq is- sensittività u l- ispeċifiċità ta ’ l- analiżi.
The observed incidence of antibody positivity in an assay may be influenced by several factors including sample handling, concomitant medications and underlying disease, therefore, comparison of the incidence of antibodies to other products may be misleading.
L - inċidenza osservata tal- pożitività għal antikorpi f’ analiżi tista ’ tkun influwenzata minn bosta fatturi inkluż l- immaniġġjar tal- kampjun, medikazzjonijiet fl- istess waqt u mard li jkun hemm minn qabel, għalhekk, il- paragun ta ’ l- inċidenza ta ’ l- antikorpi ma ’ prodotti oħra tista ’ tqarraq.
Clinical efficacy
7 Effikaċja klinika
The efficacy of Vectibix in patients with metastatic colorectal cancer (mCRC) who had disease progression during or after prior chemotherapy was studied in a randomised controlled trial (463 patients) and open-label, single-arm trials (384 patients).
L- effikaċja ta ’ Vectibix f’ pazjenti b’ kanċer metastatiku tal- kolorektum (mCRC) li kellhom progressjoni tal- marda waqt jew wara kimoterapija minn qabel kienet studjata fi prova randomised u kkontrollata (463 pazjent) u fi provi open- label u bi grupp wieħed (384 pazjent).
The safety of Vectibix in patients with mCRC who received at least one dose of Vectibix was evaluated in 920 patients.
Is- sigurtà ta ’ Vectibix f’ pazjenti b’ mCRC li rċevew minn ta ’ l- inqas doża waħda ta ’ Vectibix kienet stmata f’ 920 pazjent.
Additional studies were performed with Vectibix as a single agent in patients with other solid tumours and in combination with chemotherapy with and without bevacizumab in patients with mCRC or in combination with chemotherapy in patients with non-small cell lung cancer.
Studji oħrajn twettqu b’ Vectibix bħala sustanża waħedha f’ pazjenti b’ tumuri solidi oħra u flimkien ma ’ kimoterapija bi jew bla bevacizumab f’ pazjenti b’ mCRC jew flimkien ma ’ kimoterapija f’ pazjenti b’ kanċer fil- pulmun mhux taċ- ċelluli żgħar.
7 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 irinotecan- containing regimens.
Prova multinazzjonali, randomised u kkontrollata twettqet f’ 463 pazjent b’ karċinoma metastatika tal - kolon jew tar- rektum, li għandha EGFR wara falliment konfermat ta ’ korsijiet li fihom oxaliplatin u irinotecan.
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.
Pazjenti kienu randomised 1: 1 biex jirċievu Vectibix f’ doża ta ’ 6 mg/ kg mogħti darba kull ġimagħtejn flimkien ma ’ l- aqwa kura ta ’ support (kimoterapija mhux inkluża) (BSC) jew BSC waħdu.
Patients were treated until disease progression or unacceptable toxicity occurred.
Pazjenti kienu kkurati sakemm kien hemm progressjoni tal- marda jew tossiċità mhux aċċettabli.
Upon disease progression BSC alone patients were eligible to crossover to a companion study and receive Vectibix at a dose of 6 mg/ kg given once every two weeks.
Mal - progressjoni tal- marda pazjenti fuq BSC waħdu kienu eliġibbli biex jinqalbu għal studju sieħeb u jirċievu Vectibix f’ doża ta ’ 6 mg/ kg mogħti darba kull ġimagħtejn.
Of 463 patients, 63% were male.
Minn 463 pazjent, 63% keinu rġiel.
The median age was 62 years (range 27 to 83), and 99% were Caucasian.
L- età medjana kienet 62 sena (firxa 27 sa 83), u 99% kienu Kawkasi.
Three hundred and ninety-six (86%) patients had a baseline ECOG Performance Status of 0 or 1.
Tliet mija u sitta u disgħin (86%) pazjent kellhom ECOG Performance Status fil- linja bażi ta ’ 0 jew 1.
Sixty-seven percent of patients had colon cancer and 33% had rectal cancer.
Sebgħa u sittin fil- mija tal- pazjenti kellhom kanċer tal- kolon u 33% kellhom kanċer tar - rektum.
The primary endpoint was progression-free survival (PFS).
Il- mira primarja kienet sopravivenza mingħajr progressjoni (PFS).
In an analysis adjusting for potential bias from unscheduled assessments, the rate of disease progression or death in patients who received Vectibix was reduced by 40% relative to patients that received BSC [Hazard Ratio = 0.60, (95% CI 0.49, 0.74), stratified log-rank p < 0.0001].
F’ analiżi li aġġustat għal mejla potenzjali minn valutazzjonijiet mhux ipprogrammati, ir- rata tal- progressjoni tal- marda jew tal- mewt f’ pazjenti li rċevew Vectibix naqset b’ 40% relattiv għall- pazjenti li rċevew BSC [Proporzjon ta ’ Periklu = 0. 60, (95% CI 0. 49, 0. 74), log- rank stratifikata p < 0. 0001].
There was no difference seen in median PFS times as more than 50% of patients progressed in both treatment groups before the first scheduled visit.
Ma dehret l- ebda differenza fil - ħinijiet tal- PFS medjan minħabba li aktar minn 50% ta ’ pazjenti pprogredixxu fiż- żewġ grupp ta ’ kura qabel l- ewwel vista pprogrammata.
The progression-free survival rates at the first scheduled visit (week 8) were 45.5% on Vectibix plus BSC and 24.6% on BSC alone, a difference of 20.9% [95% CI:
Ir- rati ta ’ sopravvivenza mingħajr progressjoni fl- ewwel vista pprogrammata (ġimgħa numru 8) kienu 45. 5% fuq Vectibix ma ’ BSC u 24. 6% fuq BSC waħdu, differenza ta ’ 20. 9% [95% CI:
12.4, 29.4].
12. 4, 29. 4].
No difference was seen in overall survival.
Ma dehret l- edba differenza fis- sopravvivenza globali.
This may be due to patients receiving panitumumab after progression among those randomized to BSC.
Dan jista ’ jkun minħabba pazjenti li qed jirċievu panitumumab wara progressjoni fost dawk randomized għal BSC.
Tumour response according to modified-RECIST criteria was determined by central review.
Rispons tat- tumur skond kriterju RECIST modifikat kien iddeterminat permezz ta ’ analiżi ċentrali.
Overall, 9.5% [95% CI:
Globalment, 9. 5% [95% CI:
6.1, 14.1] Vectibix plus BSC patients, and 0% [95% CI:
6. 1, 14. 1] tal- pazjenti b’ Vectibix flimkien ma ’ BSC, u 0% [95% CI:
0.0, 1.6] BSC alone patients had a confirmed objective response (partial response), with stable disease in 26% and 10% patients, respectively.
0. 0, 1. 6] tal- pazjenti b’ BSC waħdu kellhom rispons oġġettiv konfermat (rispons parzjali), b’ marda stabbli f’ 26% u 10% tal- pazjenti, rispettivament.
Among the 176 patients who received Vectibix after progression on BSC alone, the response rate (investigator assessment) was 11.4% (95% CI:
Fost 176 pazjent li rċevew Vectibix wara progressjoni fuq BSC waħdu, ir- rata ta ’ rispons (stima ta ’ l- investigatur) kienet 11. 4% (95% CI:
7.1, 17.0).
7. 1, 17. 0).
100%
8 PFS – Pazjenti kollha 100%
90%
Medjan 90%
Median
Episodji / N (%) Medianf’ Ġimgħat
80%
Treatment Group Events / N (%) in Weeks 80% Vectibix + BSC 193 / 231 (84))
Events / N (%) in Weeks 193 / 231 (84) 8.0
193/ 231 (84
BSC Alone
BSC Alone BSC Waħdu
208 / 232 (90) 8.0
208 / 232 (90)) 208/ 232 (90
(95% CI:
Proporzjon ta ’ Periklu= 0. 60 50% (95% CI:
0.49, 0.74) Stratified log-rank test p < 0.0001
0. 49, 0. 74) 40% Analiżi ta ’ log- rank stratifikat p < 0. 0001 30%
8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 38 40 42 44 46 48 50 52 Weeks
8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 38 40 42 44 46 48 50 52 Weeks
BSC Alone
Vectibix + BSC BSC BSC Alone
Unscheduled tumour assessments were moved to the nearest scheduled timepoint
Analiżi tat- tumur mhux ipprogrammati tmexxew għall- eqreb punt ta ’ iprogrammat
The relationship between KRAS mutation status determined in archived paraffin embedded tumour tissue and clinical outcome was evaluated in a retrospective analysis.
Ir- relazzjoni bejn l- istat ta ’ mutazzjoni KRAS iddeterminat minn tessut tat- tumur arkivjat mqiegħed fil - paraffin u r- riżultat kliniku kienu stmati f’ analiżi retrospettiva.
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 (Gly12Asp, Gly12Ala, Gly12Val, Gly12Ser, Gly12Arg, Gly12Cys, and Gly13Asp) of the KRAS gene by using an
Kampjuni tat- tumur miksuba minn tneħħija primarja ta ’ kanċer tal- kolon jew tar- rektum kienu analizzati għall- preżenza tas- seba ’ mutazzjonijiet attivanti l- aktar komuni fil- kodon 12 u 13 (Gly12Asp, Gly12Ala, Gly12Val, Gly12Ser, Gly12Arg, Gly12Cys, u Gly13Asp) tal- ġene KRAS permezz ta ’ reazzjoni tal- katina polymerase speċifika għal allele.
427 (92%) patients were evaluable for KRAS status of which 184 had mutations.
427 (92%) pazjent kienu vvalutabli għall- istat KRAS fost liema 184 kellhom mutazzjonijiet.
In an analysis adjusting for potential bias from unscheduled assessments the hazard ratio for PFS was 0.49 (95% CI:
F’ analiżi li aġġustat għal mejla potenzjali minn valutazzjonijiet mhux ipprogrammati, il- proporzjon ta ’ periklu għal PFS kien 0. 49 (95% CI:
0.37-0.65) in favour of panitumumab in the KRAS wild-type group and 1.07 (95% CI:
0. 37- 0. 65) favur panitumumab fil- grupp b’ KRAS tat- tip salvaġġ u 1. 07 (95% CI:
0.77-1.48) in the KRAS mutant group.
0. 77- 1. 48) fil- grupp b’ KRAS mutant.
The difference in median PFS in the KRAS wild-type group was 8 weeks.
Id- differenza fil- medjan ta ’ PFS fil- grupp b’ KRAS tat- tip selvaġġ kienet ta ’ 8 ġimgħat.
The progression-free survival rates at the first scheduled visit (week 8) in the KRAS wild-type group were 59.7% on Vectibix plus BSC and 21.0% on BSC alone, a difference of 38.7% [95% CI:
Ir- rati ta ’ sopravvivenza mingħajr progressjoni fl- ewwel vista pprogrammata (ġimgħa numru 8) fil - grupp b’ KRAS tat- tip salvaġġ kienu 59. 7% fuq Vectibix ma ’ BSC u 21. 0% fuq BSC waħdu, differenza ta ’ 38. 7% [95% CI:
27.4, 50.0].
27. 4, 50. 0].
The difference in median PFS in the KRAS mutant group was 0 weeks.
Id- differenza fil- medjan ta ’ PFS fil- grupp b’ KRAS mutant kien ta ’ 0 ġimgħat.
The progression-free survival rates at the first scheduled visit (week 8) in the KRAS mutant group were 21.4% on Vectibix plus BSC and 28.0% on BSC alone, a difference of -6.6% [95% CI: -19.0, 5.9].
Ir- rati ta ’ sopravvivenza mingħajr progressjoni fl- ewwel vista pprogrammata (ġimgħa numru 8) fil- grupp b’ KRAS mutant kienu 21. 4% fuq Vectibix ma ’ BSC u 28. 0% fuq BSC waħdu, differenza ta ’ - 6. 6% [95% CI: - 19. 0, 5. 9].
There were no differences in overall survival seen in either group.
Ma kien hemm l- edba differenzi fis- sopravvivenza globali fl- ebda grupp.
In the KRAS wild-type group the response rate was 17% for panitumumab and 0% for BSC.
Fil- grupp ta ’ KRAS tat- tip salvaġġ ir- rata ta ’ rispons kienet 17% għal panitumumab u 0% għal BSC.
In the KRAS mutant group there were no responses in either treatment arm.
Fil- grupp bi KRAS mutant ma ’ kien hemm rispons fl- ebda grupp ta ’ kura.
Stable disease rates in the KRAS wild-type group were 34% for panitumumab and 12% for BSC.
Ir- rati stabbli tal - marda fil- grupp bi KRAS tat- tip salvaġġ kienu 34% għal panitumumab u 12% għal BSC.
The stable disease rates in the KRAS mutant group were 12% for panitumumab and 8% for BSC.
Ir- rati stabbli tal- marda fil- grupp bi KRAS mutant kienu 12% għal panitumumab u 8% għal BSC.
Response rate (investigator assessment) in patients that crossed over to panitumumab after progression on BSC alone was 22% (95% CI:
Ir- rati ta ’ rispons (stima ta ’ l- investigatur) f’ pazjenti li qalbu għal panitumumab wara progrssjoni fuq BSC waħdu kienu 22% (95% CI:
14.0, 31.9) for those with KRAS wild-type tumours and 0% (95% CI:
14. 0, 31. 9) għal dawk b’ tumuri KRAS tat- tip salvaġġ u 0% (95% CI:
0.0, 4.3) for those with mutant KRAS tumours.
0. 0, 4. 3) għal dawk b’ tumuri KRAS mutant.
PFS – Patients with mutant and wild type KRAS Wild Type KRAS
9 PFS – Pazjenti bi KRAS mutant u tat- tip salvaġġ
100%
Treatment Group 100%
Treatment Group
Vectibix + BSC
Median
Events / N (%) 115 / 124 ((93)) 115/ 124 93
Events / N (%) in Weeks
in Weeks
70%
80% 70%
Hazard ratio = 0.49
Proporzjon ta ’ Periklu= 0. 49 Hazard ratio = 0. 49
0.37, 0.65) Stratified log-rank test p < 0.0001 60%
0. 37, Stratified log- rank test p < 0. 0001 Proporzjon Bla Episodji
50%
60% 50%
0%
0% Ġimgħat Subjects at risk:
Subjects at risk:
Individwi f’ riskju:
8 10 12 14 16 18 20 22 24 26 28 30 32 34
8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 38 40 42 44 46 48 50 52 Weeks
36 38 40 42 44 46 48 50 52 Weeks
Vectibix+BSC Vectibix + BSC BSC Waħdu
Unscheduled tumour assessments were moved to the nearest scheduled timepoint
Analiżi tat- tumur mhux ipprogrammati tmexxew għall- eqreb punt iprogrammat
100%
KRAS Mutant Medjan Episodji / N (%) Median f’ Ġimgħat Treatmentta ’ Kura Grupp Group 100% Events / N (%) in Weeks Vectibix + BSC 76 // 84 (90))
76 / 84 (90)
76 84 (90
BSC Alone
BSC Waħdu BSC Alone
95 / 100 (95)
95 / 100 (95) 100 (95)
Proportion Event-Free
0. 77, 1. 48) Proportion Episodji
70%
60%
0%
0% Ġimgħat
16 18 20 22 24 26 28 30 32
8 10 12 14 16 18 20 22 24 26 28 30 32 34 36 38 40 42 44 46 48 50 52 Weeks
34 36 38 40 42 44 46 48 50 52 Weeks
Individwi f’ riskju:
The PACCE study:
L- istudju PACCE:
In this randomised, open label, controlled clinical trial, chemotherapy (oxaliplatin or irinotecan) and bevacizumab were given with and without panitumumab in the first line treatment of patients with metastatic colorectal cancer.
F’ din il- prova randomised, open label u kkontrollata, kimoterapija (oxaliplatin jew irinotecan) u bevacizumab ingħataw ma ’ jew mingħajr panitumumab fil- kura ppreferita ta ’ pazjenti b’ kanċer metastatiku tal- kolorektum.
Panitumumab treatment was discontinued due to a statistically significant reduction in PFS in patients receiving panitumumab observed in an interim analysis.
Kura b’ panitumumab twaqqfet minħabba tnaqqis statistikament sinifikanti f’ PFS f’ pazjenti li qed jirċievu panitumumab osservat f’ analiżi interim.
The hazard ratio for PFS was 1.44 (95% CI:
Il- proporzjon ta ’ periklu għal PFS kien 1. 44 (95% CI:
1.13, 1.85).
1. 13, 1. 85).
Median PFS was 8.8 (95% CI:
Il- medjan ta ’ PFS kien 8. 8 (95% CI:
8.3, 9.5) and 10.5 (95% CI 9.4, 12.0) months in the panitumumab and the non-panitumumab arm, respectively.
Kien
There was an increase in mortality in the Vectibix arm.
10 hemm żieda fil- mortalità fil- grupp b’ Vectibix.
The hazard ratio for overall survival was 1.56 (95% CI:
Il- proporzjon ta ’ periklu għas- sopravvivenza globali kien 1. 56 (95% CI:
1.11, 2.17).
1. 11, 2. 17).
Median overall survival was 18.4 (95% CI:
Il- medjan tas- sopravvivenza globali kien 18. 4 (95% CI:
13.8, not estimable) in the panitumumab arm and not estimable in the non-panitumumab arm.
13. 8, ma jistax jiġi stmat) fil- grupp b’ panitumumab u ma setax jiġi stmat fil- grupp mhux b’ panitumumab.
This medicinal product has been authorised under a “ conditional approval” scheme.
Dan il- prodott mediċinali kien awtorizzat taħt skema ta ’ ‘ approvazzjoni b’ kondizzjoni ’.
This means that further evidence on this medicinal product is awaited, in particular data are required to confirm the effect in patients with wild-type KRAS tumours which is currently supported by a retrospective analysis.
Dan ifisser li għad trid tingħata aktar evidenza dwar dan il- prodott mediċinali, speċjalment tagħrif huwa meħtieġ biex jikkonferma l- effett f’ pazjenti b’ tumuri b’ KRAS tat- tip salvaġġ li bħalissa huwa msaħħaħ minn analiżi retrospettiva.
Further evidence is also awaited regarding the effect of panitumumab in combination with chemotherapy on PFS in patients with wild-type KRAS tumours.
Aktar evidenza hija wkoll mistennijja dwar l- effett ta ’ panitumumab flimkien ma ’ kimoterapija fuq PFS f’ pazjenti b’ tumuri KRAS tat- tip salvaġġ.
Studies investigating this effect are currently ongoing.
Studji li qed jinvestigaw dan l- effett għadhom għaddejjin.
The European Medicines Agency (EMEA) will review new information on the product every year and this SPC will be updated as necessary.
L- Aġenzija Ewropeja dwar il- Mediċini (EMEA) ser tirrevedi l- informazzjoni ġdida dwar il- prodott kull sena u ser taġġorna dan is- Sommarju tal - Karatteristiċi tal- Prodott, skond il- bżonn.
Vectibix administered as a single agent or in combination with chemotherapy exhibits nonlinear pharmacokinetics.
Vectibix mogħti bħala sustanza waħedha jew flimkien ma ’ kimoterapija juri farmakokinetika mhux lineari.
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.
Wara l- għoti ta ’ doża waħda ta ’ panitumumab bħala infużjoni fuq medda ta ’ siegħa, l- erja taħt il- kurva tal- konċentrazzjoni- ħin (AUC) żdiedet b’ mod akbar minn dak proporzjonali mad- doża u t- tneħħija (CL) ta ’ panitumumab naqset minn 30. 6 għal 4. 6 ml/ ġurnata/ kg kif id- doża żdiedet minn 0. 75 għal 9 mg/ kg.
However, at doses above 2 mg/ kg, the AUC of panitumumab increases in an approximately dose-proportional manner.
Madanakollu, f’ dożi ta ’ aktar minn 2 mg/ kg, l- AUC ta ’ panitumumab bejn wieħed u ieħor tiżdied b’ mod proporzjonali mad- doża.
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 (± SD) peak and trough concentrations of 213 ± 59 and 39 ± 14 mcg/ ml, respectively.
Wara l- kors ta ’ dożaġġ rakkomandat (6 mg/ kg mogħti darba kull ġimagħtejn bħala infużjoni fuq medda ta ’ siegħa), konċentrazzjonijiet ta ’ panitumumab laħqu livelli fissi mat- tielet infużjoni b’ konċentrazzjonijiet massimi u minimi medji (± SD) ta ’ 213 ± 59 u 39 ± 14 mcg/ ml, rispettivament.
The mean (± SD) AUC0-tau and CL were 1306 ± 374 mcg• day/ ml and 4.9 ± 1.4 ml/ kg/ day, respectively.
L- AUC0- tau medja (± SD) u CL kienu 1306 ± 374 mcg• jum/ ml u 4. 9 ± 1. 4 ml/ kg/ jum, rispettivament.
The elimination half-life was approximately 7.5 days (range:
Il- half- life ta ’ l- eliminazzjoni kienet madwar 7. 5 ijiem (firxa:
3.6 to 10.9 days).
3. 6 to 10. 9 ijiem).
10 A population pharmacokinetic analysis was performed to explore the potential effects of selected covariates on panitumumab pharmacokinetics.
Twettqet analiżi farmakokinetika tal- popolazzjoni biex tesplora l- effetti potenzjali ta ’ kovarjanti magħżula fuq il- farmakokinetika ta ’ panitumumab.
Results suggest that age, gender, tumour type, race, hepatic function, renal function, chemotherapeutic agents, and EGFR expression in tumour cells had no apparent impact on the pharmacokinetics of panitumumab.
Riżultati jissuġġerixxu li l- età, sess, tip ta ’ tumur, razza, funzjoni epatika, funzjoni renali, aġenti kimoterapewtiċi, u espressjoni ta ’ EGFR fiċ- ċelluli tat - tumur ma kellhom l- ebda impatt apparenti fuq il- farmakokinetika ta ’ panitumumab.
No clinical studies have been conducted to examine the pharmacokinetics of panitumumab in patients with renal or hepatic impairment.
Ma saru l- ebda studji kliniċi biex jeżaminaw il- farmakokinetika ta ’ panitumumab f’ pazjenti b’ indeboliment renali jew epatiku.
No age-related differences in pharmacokinetics of panitumumab were observed in clinical studies in patients 26 to 85 years of age.
Ma kienet osservata l- ebda differenza relatata ma ’ l- età fil - farmakokinetika ta ’ panitumumab fi studji kliniċi f’ pazjenti b’ età minn 26 sa 85 sena.
Adverse reactions seen in animals at exposure levels similar to clinical exposure levels and with possible relevance to clinical use were as follows:
Reazzjonijiet avversi li dehru f’ annimali f’ livelli ta ’ esponiment simili għall- livelli ta ’ esponiment kliniċi u li jista 'jkollhom rilevanza għall- użu kliniku, kienu kif spjegat:
Skin rash and diarrhoea were the major findings observed in repeat-dose toxicity studies of up to 26 weeks duration in cynomolgus monkeys.
Raxx fil- ġilda u dijarea kienu s- sejbiet magġuri osservati fi studji ta ’ tossiċità b’ doża ripetuta li damu sa 26 ġimgħa f’ xadini cynomolgus.
These findings were observed at doses approximately equivalent to the recommended human dose and were reversible upon termination of administration of panitumumab.
Dawn is- sejbiet kienu osservati f’ dożi ekwivalenti għal madwar id- doża rakkomandata fil- bniedem u kienu riversibbli mal- waqfien ta ’ l- għoti ta ’ panitumumab.
The skin rash and diarrhoea observed in monkeys are considered related to the pharmacological action of panitumumab and are consistent with the toxicities observed with other anti-EGFR inhibitors.
Ir - raxx fil- ġilda u d- dijarea osservati fix- xadini huma kkunsidrati bħala relatati ma ’ l- azzjoni farmakoloġika ta ’ panitumumab u huma konsistenti mat- tossiċitajiet osservati b’ inibituri anti- EGFR oħra.
Studies to evaluate the mutagenic and carcinogenic potential of panitumumab have not been performed.
Ma twettqux studji biex jivvalutaw l- potenzjal mutaġeniku u karċinoġeniku ta ’ panitumumab.
Animal studies are insufficient with respect to embryo-foetal development since foetal panitumumab exposure levels were not examined.
Studji fl- annimali mhumiex biżżejjed fir- rigward ta ’ l- iżvilupp tal- embriju- fetu minħabba li ma kienux eżaminati l- livelli ta ’ esponiment ta ’ panitumumab tal- fetu.
Panitumumab has been shown to cause foetal abortions and/ or foetal deaths in cynomolgus monkeys when administered during the period of organogenesis at doses approximately equivalent to the recommended human dose.
Panitumumab intwera li jikkawża aborti tal- fetu u/ jew mwiet tal- fetu f’ xadini cynomolgus meta ingħata waqt il- perjodu ta ’ organoġenesi f’ dożi ekwivalenti għal madwar id- doża rakkomandata fil- bniedem.
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.
11 Ma sarux studji formali fuq il- fertilità fl- irġiel; iżda, evalwazzjoni mikroskopika ta ’ l- organi riproduttivi ta ’ l- irġiel minn studji ta ’ tossiċità b’ dożi ripetuti f’ xadini cynomolgus f’ 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.
Fertility studies conducted in female cynomolgus monkeys showed that panitumumab may produce prolonged menstrual cycle and/ or amenorrhea and reduced pregnancy rate which occurred at all doses evaluated.
Studji fuq il- fertilità li twettqu f’ xadini cynomolgus femminili wrew li panitumumab jista ’ jipproduċi ċiklu menstrwali mtawwal u/ jew amenorreja u rata ta ’ tqala mnaqqsa li seħħew bid- dożi kollha evalwati.
No pre- and post-natal development animal studies have been conducted with panitumumab.
Ma sarux studji dwar l- iżvilupp ta ’ qabel u wara t- twelid fl- annimali b’ panitumumab.
All patients should be advised regarding the potential risk of panitumumab on pre- and post-natal development prior to initiation of Vectibix therapy.
Il- pazjenti kollha għandhom ikunu avżati dwar ir- riskju potenzjali ta ’ panitumumab fuq l- iżvilupp ta ’ qabel u wara t- twelid qabel tinbeda terapija b’ Vectibix.
Sodium chloride Sodium acetate trihydrate Acetic acid, glacial (for pH-adjustment) Water for injection.
Sodium chloride Sodium acetate trihydrate Acetic acid, glacial (għall- aġġustament tal- pH) Ilma għall- injezzjonijiet.
Vectibix does not contain any antimicrobial preservative or bacteriostatic agent.
Vectibix ma fih l- ebda preservattiv kontra l- mikrobi jew sustanza batterjostatika.
The product should be used immediately after dilution.
Il- prodott għandu jintuża minnufih wara d- dilwazzjoni.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and should be no longer than 24 hours at 2°C to 8°C.
Jekk ma jintużax minnufih, il- perijodu ta ’ ħażna waqt l- użu u l - kondizzjonijiet tal- ħażna qabel l- użu huma r- responsabbiltà ta ’ min qed jagħmel użu minnu u m’ għandhomx ikunu aktar minn 24 siegħa f’ temperatura ta ’ 2oC sa 8oC
Single-use vial (type I glass) with an elastomeric stopper, aluminium seal and flip-off plastic cap.
Kunjett għal użu ta ’ darba (ħġieġ tat- tip I) b’ tapp elastomeriku, siġill ta ’ l- aluminju u għatu flip- off tal - plastik.
One vial contains:
Kunjett wieħed fiħ:
100 mg of panitumumab in 5 ml, 200 mg panitumumab in 10 ml, or 400 mg panitumumab in 20 ml of concentrate for solution for infusion.
100 mg panitumumab f’ 5 ml, 200 mg panitumumab f’ 10 ml, jew 400 mg panitumumab f’ 20 ml ta ’ konċentrat għal soluzzjoni għall- infużjoni.
Pack of 1 vial containing 5 ml.
Pakkett ta ’ kunjett wieħed li fiħ 5 ml.
Pack of 1 vial containing 10 ml.
Pakkett ta ’ kunjett wieħed li fiħ 10 ml.
Pack of 1 vial containing 20 ml.
Pakkett ta ’ kunjett wieħed li fiħ 20 ml.
Vectibix should be diluted in 0.9% sodium chloride injection by healthcare professional using aseptic technique.
Vectibix għandu jiġi dilwit f’ injezzjoni ta ’ 0. 9% sodium chloride minn professjonist fil- qasam tas - saħħa permezz ta ’ teknika asettika.
Do not shake or vigorously agitate the vial.
Tħawwadx jew iċċaqlaqx b’ mod vigoruż il- kunjett.
Withdraw the necessary amount of Vectibix for a dose of 6 mg/ kg.
Iġbed l - ammont neċessarju ta ’ Vectibix għal doża ta ’ 6 mg/ kg.
Dilute in a total volume of 100 ml.
Iddilwixxi f’ volum totali ta ’ 100 ml.
The final concentration should not exceed 10 mg/ ml.
Il - konċentrazzjoni finali m’ għandiex taqbeż 10 mg/ ml.
Doses higher than 1000 mg should be diluted in 150 ml 0.9% sodium chloride injection (see section 4.2).
Dożijiet ogħla minn 1000 mg għandhom jiġu dilwiti f’ 150 ml ta ’ injezzjoni ta ’ 0. 9% sodium chloride (ara sezzjoni 4. 2).
The diluted solution should be mixed by gentle inversion, do not shake.
Is- soluzzjoni dilwita għandha titħallat billi tinqaleb ta ’ taħt fuq b’ mod ġentili, tħawwadx.
No incompatibilities have been observed between Vectibix and 0.9% sodium chloride injection in polyvinyl chloride bags or polyolefin bags.
Ma kienu osservati l- ebda inkompatibilitajiet bejn Vectibix u injezzjoni ta ’ 0. 9% sodium chloride f’ boroż ta ’ polyvinyl chloride jew ta ’ polyolefin.
Detailed information on this medicine is available on the website of the European Medicines Agency (EMEA) http: / /www. emea. europa. eu/
Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il- Mediċini (EMEA) http: // www. emea. europa. eu /.
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR TAS- SUSTANZA BIJOLOĠIKA ATTIVA U DETENTUR (I) TA ’ L - AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL - LOTT
6701 Kaiser Drive Fremont, CA 94555 USA
Isem u indirizz tal- manifattur tas- sustanza bijologika attiva Amgen Inc 6701 Kaiser Drive Fremont, CA 94555 USA
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 3 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Sistema ta ’ farmakoviġilanza Id- Detentur ta ’ L- Awtorizzazzjoni għat- tqegħid fis- Suq għandu jiżgura li s- sistema ta ’ farmakoviġilanza, kif deskritta fil- verżjoni 3 ta ’ Modulu 1. 8. 1 ta ’ l- Applikazzjoni għall - Awtorizzazzjoni għat- tqegħid fis- Suq, hija implimentata u qed tiffunzjona qabel u waqt li l- prodott jitqiegħed fis- suq.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 3 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Pjan għall- Immanniġġjar ta ’ Riskji Id- Detentur ta ’ L- Awtorizzazzjoni għat- Tqegħid fis- Suq jwiegħed li jwettaq l- istudji u l- attivitajiet ta ’ farmakoviġilanza oħrajn dettaljati fil- Pjan ta ’ Farmakoviġilanza kif miftiehem f’ verżjoni 3 tal- Pjan għall- Immaniġġjar ta ’ Riskji (RMP) ippresentat f’ Modulu 1. 8. 2 ta ’ l- Applikazzjoni għall - Awtorizzazzjoni għat- tqegħid fis- Suq u kull aġġornament sussegwenti ta ’ RMP miftiehem mis - CHMP.
15 C.
15 Ċ.
The Marketing Authorisation Holder shall complete the following programme of studies within the specified time frame, the results of which shall form the basis of the annual reassessment of the benefit/ risk profile: • To ensure the availability of KRAS test kit by 30 November 2007 • To provide a Statistical Analysis Plan describing the analysis of wild-type KRAS subpopulation for 20050181 and 20050203 studies.
Id- Detentur ta ’ L- Awtorizzazzjoni għat- tqegħid fis- Suq għandu jtemm il- programm ta 'studji li ġejjin fiż- żmien speċifikat, u r- riżultati ta' dawn l- istudji għandhom iservu ta 'bażi għall- istima tal- profil bejn il- benefiċċju/ riskju li ssir kull sena: • Jassigura d- disponibbilità tas- sett ta ’ analiżi għal KRAS sa 30 ta ’ Novembru 2007 • Jipprovdi Pjan ta ’ Analiżi Statistika li tiddeskrivi l- analiżi tas- sottopopolazzjoni b’ KRAS tat- tip salvaġġ għall- istudji 20050181 u 20050203.
Vectibix 20 mg/ ml concentrate for solution for infusion Panitumumab
Vectibix 20 mg/ ml konċentrat għal soluzzjoni għall- infużjoni Panitumumab
Each vial contains 100 mg of panitumumab.
Kull kunjett fiħ 100 mg ta ’ panitumumab.
Each vial contains 200 mg panitumumab.
Kull kunjett fiħ 200 mg panitumumab.
Each vial contains 400 mg panitumumab.
Kull kunjett fiħ 400 mg panitumumab.
Sodium chloride, sodium acetate trihydrate, acetic acid (glacial), water for injections
Sodium chloride, sodium acetate trihydrate, acetic acid (glacial), ilma għall- injezzjonijiet
5 ml of concentrate for solution for infusion.
5 ml ta ’ konċentrat għal soluzzjoni għall- infużjoni.
10 ml of concentrate for solution for infusion.
10 ml ta ’ konċentrat għal soluzzjoni għall- infużjoni.
20 ml of concentrate for solution for infusion.
20 ml ta ’ konċentrat għal soluzzjoni għall- infużjoni.
Vectibix will only be administered by a health care professional and is not required to have Braille on the packaging (EC Guidance concerning the Braille requirements for labelling and the package leaflet [Article 56a of Directive 2001/ 83/ EC as amended]).
Vectibix jingħata biss minn professjonist fil- qasam tas- saħħa u mhux meħtieġ li jkollu Braille fuq il - pakkett (Gwida ta ’ l- EC dwar il- ħtieġijiet tal- Braille fuq it- tikketta u l- fulejtt ta ’ tagħrif [Artiklu 56a ta ’ Direttiva 2001/ 83/ EC kif emendata]).
Vectibix 20 mg/ ml sterile concentrate Panitumumab IV
Vectibix 20 mg/ ml konċentrat sterili Panitumumab
Vectibix 20 mg/ ml concentrate for solution for infusion panitumumab
Vectibix 20 mg/ ml konċentrat għal soluzzjoni għall- infużjoni panitumumab
It may harm them, even if their symptoms are the same as yours. • If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Tista ’ tagħmlilhom il- ħsara, anki jekk ikollhom l- istess sintomi bħal tiegħek. • Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib tiegħek.
What Vectibix is and what it is used for 2.
X’ inhu Vectibix u għalxiex jintuża 2.
Before you use Vectibix 3.
Qabel ma tuża Vectibix 3.
How to use Vectibix 4.
Kif għandek tuża Vectibix 4.
How to store Vectibix 6.
Kif taħżen Vectibix 6.
WHAT VECTIBIX IS AND WHAT IT IS USED FOR
X’ INHU VECTIBIX U GĦALXIEX JINTUŻA
Vectibix is used in the treatment of metastatic colorectal carcinoma (cancer of the bowel) after failure of chemotherapy (medicines used to treat cancer) treatment.
Vectibix jintuża fil- kura ta ’ karċinoma metastatika tal- kolorektum (kanċer tal- musrana) wara falliment ta ’ kura b’ kimoterapija (mediċini wżati għall- kura tal- kanċer).
Vectibix is for use in adults 18 years and over.
Vectibix huwa għall- użu f’ adulti b’ età ta ’ 18- il sena jew aktar.
Vectibix contains the active substance panitumumab, which belongs to a group of medicines called monoclonal antibodies.
Vectibix fiħ is- sustanza attiva panitumumab, li tagħmel parti minn grupp ta ’ mediċini msejjħa antikorpi monoklonali.
Monoclonal antibodies are proteins, which specifically recognise and attach (bind) to other unique proteins in the body.
Antikorpi monoklonali huma proteini, li speċifikament jgħarfu u jeħlu (jingħaqdu) ma ’ proteini oħra uniċi fil- ġisem.
Panitumumab recognises and binds specifically to a protein known as epidermal growth factor receptor (EGFR), which is found on the surface of some cancer cells.
Panitumumab jagħraf u jeħel speċifikament ma ’ proteina magħrufa bħala riċettur tal- fattur tat- tkabbir epidermali (EGFR), li tinsab fuq il- wiċċ ta ’ ċertu ċelluli tal- kanċer.
When growth factors (other body proteins) attach to the EGFR, the cancer cell is stimulated to grow and divide.
Meta fatturi tat- tkabbir (proteini oħra tal- ġisem) jeħlu mal- EGFR, iċ- ċellula tal- kanċer hija stimulata biex tikber u tiddividi.
Panitumumab binds onto the EGFR and prevents the cancer cell from receiving the messages it needs for growth and division.
Panitumumab jeħel mal- EGFR u jipprevjeni ċ- ċellula tal- kanċer milli tirċievi l- messaġġi li għandha bżonn biex tikber u tiddividi.
BEFORE YOU USE VECTIBIX
QABEL MA TUŻA VECTIBIX
Do not use Vectibix
Tużax Vectibix
• if you are allergic (hypersensitive) to panitumumab or any of the other ingredients of Vectibix.
• jekk inti allerġiku/ a (tbagħti minn sensittività eċċessiva) għal panitumumab jew sustanzi oħra ta ’ Vectibix
Take special care with Vectibix
Oqgħod attent ħafna b’ Vectibix
Before starting treatment with Vectibix, please tell your doctor or nurse if you:
Qabel tibda l- kura b’ Vectibix, jekk jogħġbok għid lit- tabib jew ners tiegħek jekk int:
• have previously had or have evidence of interstitial pneumonitis (swelling of the lungs causing coughing and difficulty breathing) or pulmonary fibrosis (scarring and thickening in the lungs with shortness of breath);
• kellek minn qabel jew għandek evidenza ta ’ pulmonite ta ’ l- interstizju (nefħa fil- pulmun li tikkawża sogħla u diffikultà biex tieħu nifs) jew fibrożi pulmonari (ċikatriċii u tħaxxin tal - pulmun bi qtugħ ta ’ nifs);
23 Your doctor will check your blood levels of several substances such as magnesium, and other electrolyte levels such as calcium and potassium in your blood before you start Vectibix treatment.
23 It- tabib tiegħek se jiċċekkja il- livelli fid- demm tiegħek ta ’ diversi sustanzi bħal magnesium, u l- livelli fid- demm tiegħek ta ’ elektroliti oħra bħal calcium u potassium qabel tibda l- kura b’ Vectibix.
If these levels are too low, your doctor may prescribe you appropriate supplements.
Jekk dawn il- livelli huma baxxi ħafna, t- tabib tiegħek jista ’ jippreskrivilek supplimenti xierqa.
During treatment with Vectibix
Waqt kura b’ Vectibix
You may experience dermatologic toxicities (skin reactions), if these worsen or become intolerable please tell your doctor or nurse immediately.
Jista ’ jkollok esperjenza ta ’ tossiċitajiet dermatoloġiċi (reazzjonijiet fil- ġilda), jekk dawn imorru għall - agħar jew isiru intollerabbli jekk jogħġbok għid lit- tabib jew lin- ners tiegħek minnufiħ.
It is recommended that you limit sun exposure whilst receiving Vectibix and if you are experiencing skin reactions as sunlight can worsen these.
Huwa rakkomandat li tillimita l- esponiment tiegħek għax- xemx waqt li qed tirċievi Vectibix u jekk qed ikollok esperjenza ta ’ reazzjonijiet fil- ġilda għax id- dawl tax- xemx jista ’ jagħmilhom agħar.
Wear sunscreen and a hat if you are going to be exposed to sunlight.
Applika krema ta ’ protezzjoni mix- xemx u ilbes kappell jekk ser tkun espost għax- xemx.
Your doctor will ask you to come in for tests to monitor hypomagnesaemia (low magnesium levels in the blood) and hypocalcaemia (low calcium levels in the blood) periodically during your treatment, and for up to 8 weeks after you have finished your treatment.
It- tabib tiegħek se jgħidlek tagħmel xi testijiet biex jissorvelja l- ipomanjesimja (livelli baxxi ta ’ magnesium fid- demm) u l- ipokalċimja (livelli baxxi ta ’ calcium fid- demm) perjodikament waqt il - kura tiegħek, u sa 8 ġimgħat wara li tkun spiċċajt il- kura tiegħek.
Vectibix has not been tested in pregnant women.
Vectibix ma ġiex ittestjat f’ nisa tqal.
It is important to tell your doctor if you are pregnant; think you may be pregnant; or plan to get pregnant.
Huwa mportanti li tgħid lit- tabib tiegħek jekk inti tqila; taħseb li tista ’ tkun tqila; jew qed tippjana li toħroġ tqila.
Vectibix could affect your ability to stay pregnant.
Vectibix jista ’ jaffettwa l- ħila tiegħek biex tibqa ’ tqila.
If you are a woman of child bearing potential, you should use suitable methods of contraception during treatment with Vectibix and for 6 months after the last dose.
Jekk inti mara li jista ’ jkollok it- tfal, għandek tuża metodi xierqa ta ’ kontraċezzjoni waqt kura b’ Vectibix u għal 6 xhur wara l- aħħar doża.
Do not breast-feed your baby during treatment with Vectibix and for 3 months after the last dose.
Treddax lit- tarbija tiegħek waqt kura b’ Vectibix u għal 3 xhur wara l- aħħar doża.
You should speak with your doctor before driving or using machines, as some side effects may impair your ability to do so safely.
Għandek tkellem lit- tabib tiegħek qabel issuq jew tħaddem magni, għax xi effetti sekondarji jistgħu jnaqqsu l- ħila tiegħek biex tagħmel dan b’ mod sikur.
HOW TO USE VECTIBIX
KIF GĦANDEK TUŻA VECTIBIX
Vectibix will be administered in a healthcare facility under the supervision of a doctor experienced in the use of anti-cancer medicines.
Vectibix ser jingħata f’ faċilità tal- qasam tas- saħħa taħt is- superviżjoni ta ’ tabib b’ esperjenza fl- użu ta ’ mediċini kontra l- kanċer.
Vectibix is administered intravenously (into a vein) with an infusion pump (a device that gives a slow injection).
Vectibix jingħata b’ mod intravenuż (ġo vina) b’ pompa ta ’ l- infużjoni (apparat li jagħti injezzjoni bil - mod).
The recommended dose of Vectibix is 6 mg/ kg (milligrams per kilogram of body weight) given once every two weeks.
Id- doża rakkomandata ta ’ Vectibix hija 6 mg/ kg (milligrammi kull kilogramma ta ’ piż tal- ġisem) mogħtija darba kull ġimagħtejn.
The treatment will usually be given over a period of approximately 60 minutes.
Il- kura normalment tingħata fuq perjodu ta ’ madwar 60 minuta.
Like all medicines, Vectibix can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Vectibix jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
24 Very common side effects (seen in more than 1 in 10 people who take Vectibix) were: • pruritis (itching); erythaema (redness of skin); rash; skin exfoliation (flaking skin); dry skin; skin fissures (cracks in the skin); • paronychia (infection of a nail bed); • diarrhoea; • fatigue (extreme tiredness); • nausea and vomiting; • cough; dyspnoea (breathing difficulties).
Effetti sekondarji komuni ħafna (osservati f’ aktar minn 1 kull 10 persuni li jieħdu Vectibix) kienu: • prurite (ħakk); eritema (ħmura tal- ġilda); raxx; ġilda titqaxxar (taqa ’ qxur qxur); ġilda xotta; qsim fil- ġilda (xquq fil- ġilda); • paronikja (infezzjoni taħt id- difer); • dijarea; • għeja (għeja estrema); • Tqalligħ u rimettar; • sogħla; qtugħ ta ’ nifs (diffikultajiet biex tieħu n- nifs).
Common side effects (seen in more than 1, but less than 10 in 100 people taking Vectibix) were: • infusion type reactions (which may include signs and symptoms such as chills; and/ or pyrexia (fever or high temperature); • hypomagnesaemia (low magnesium levels in the blood); • hypocalcaemia (low calcium levels in the blood); • hypokalaemia (low potassium levels in the blood); • dehydration; • headache; • conjunctivitis (eye inflammation); growth of eyelashes and increased lacrimation (flow of tears); ocular hyperaemia (redness of the eye); dry eye; eye pruritus (itchy eyes); • pulmonary embolism (blood clot in the lung); • stomatitis (mouth ulcers and cold sores); mucosal inflammation (inflammation of the mouth); dry mouth; • onycholysis (loosening of the nails); • hypertrichosis (excess hair growth); alopecia (hair loss); • nasal dryness.
Effetti sekondarji komuni (osservati f’ aktar minn 1, iżda inqas minn 10 f’ kull 100 persuna li jieħdu Vectibix) kienu: • reazzjonijiet tat- tip ta ’ l- infużjoni (li jistgħu jinkludu sinjali u sintomi bħal tertir; u/ jew pirexja (deni jew temperatura għolja); • ipomanjesimja (livelli baxxi ta ’ manjesju fid- demm); • ipokalċimja (livelli baxxi ta ’ kalċju fid- demm); • ipokalimja (livelli baxxi ta ’ potassju fid- demm); • deidrazzjoni; • uġigħ ta ’ ras; • konġuntivite (infjammazzjoni ta ’ l- għajn); tkabbir tax- xagħar ta ’ l- għajnejn u żieda fit- tixrid ta ’ dmugħ (tnixxija ta ’ dmugħ); iperimja ta ’ l- għajn (ħmura ta ’ l- għajn); għajn tinħass xotta; ħakk fl- għajn (għajnejn jieklu); • emboliżmu pulmonari (biċċa demm magħqud fil- pulmun); • stomatite (ulċeri fil- ħalq u feriti tar- riħ); infjammazzjoni tal- mukoża (infjammazzjoni tal- ħalq); ħalq xott; • onikożi (jillaxkaw id- dwiefer); • ipertrikożi (tkabbir żejjed tax- xagħar); alopeċja (telf ta ’ xagħar); • imnieħer xott.
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib tiegħek.
Important information about some of the ingredients of Vectibix
Tagħrif importanti dwar uħud mis- sustanzi ta ’ Vectibix
This medicinal product contains 0.150 mmol sodium (which is 3.45 mg sodium) per ml of concentrate.
Dan il- prodott mediċinali fiħ 0. 150 mmol sodju (li huwa 3. 45 mg sodju) kull ml ta ’ konċentrat.
To be taken into consideration by patients on a controlled sodium diet.
Għandu jittieħed f’ kunsiderazzjoni minn pazjenti fuq dieta ta ’ sodju kkontrollat.
HOW TO STORE VECTIBIX
KIF TAĦŻEN VECTIBIX
Vectibix will be stored in the healthcare facility where it is used.
Vectibix se jinħażen f’ faċilità tal- qasam tas- saħħa fejn jintuża.
Do not use Vectibix after the expiry date which is stated on the label and carton after EXP.
Tużax Vectibix wara d- data ta ’ skadenza li tidher fuq it- tikketta u l- kartuna wara JIS.
These measures will help to protect the environment.
Id- data ta ’ skadenza tirreferi għall- aħħar ġurnata ta ’ dak ix- xahar.
25 6.
25 Il- mediċini m’ għandhomx jintremew ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
What Vectibix contains
X’ fih Vectibix:
The active substance is panitumumab 20 mg/ ml.
Is- sustanza attiva hi panitumumab 20 mg/ ml.
The other ingredients of Vectibix are sodium chloride, sodium acetate trihydrate, acetic acid (glacial) and water for injections.
Is- sustanzi l- oħra huma sodium chloride, sodium acetate trihydrate, acetic acid (glacial) u ilma għall - injezzjonijiet.
What Vectibix looks like and contents of the pack
Id- Dehra ta ’ Vectibix u l- kontenuti tal- pakkett:
Vectibix is a colourless liquid that may contain visible particles and is supplied in a vial.
Vectibix huwa likwidu bla kulur li jista ’ jkun fiħ frak li jidher u huwa disponibbli f’ kunjett.
Each pack contains one vial of either 5 ml, 10 ml or 20 ml of concentrate.
Kull pakkett fiħ kunjett wieħed ta ’ 5 ml, 10 ml jew 20 ml ta ’ konċentrat.
Norge Amgen AB Tel: +47 23308000
Norge Deutschland Amgen AB AMGEN GmbH Tel: +47 23308000 Tel: +49 (0) 89 1490960
Ελλάδα Amgen Ελλάς Φαρμακευτικά ΕΠΕ.
26 Polska Ελλάδα Amgen Sp. z o. o.