qanastek/EMEA-V3 huggingface dataset:
Heart (no effects were found to be common); uncommon: disturbed nerve signals in the heart (first degree), fast heart beat, problems with the electrical rhythm of the heart (long QT); rare: heartbeat irregularity/ disturbed heart-chamber contractions (cardiac flutter, atrial fibrillation), problems with the electrical rhythm of the heart (ST segment/ T wave abnormalities), chest pain, slow heart beat, palpitations.
Qalb (ma nstabu l- ebda effetti li kienu komuni); mhux komuni: disturb fis- sinjali tan- nervaturi tal - qalb (ta ’ l- ewwel grad), taħbit tal- qalb mgħaġġel, problemi bir- ritmu elettriku tal- qalb (QT mtawwal); rari: irregolarità fit- taħbit tal- qalb, kontrazzjonijiet anormali tal- kompartimenti tal- qalb (taħbit tal- qalb irregolari, fibrillazzjoni atrijali), problemi bir- ritmu elettriku tal- qalb (abnormalitajiet fis- segment ST/ mewġa T), uġigħ fis- sider, taħbit tal- qalb bil- mod, palpitazzjonijiet.
Blood vessels, common: warm feeling (vasodilatation) including flushing; uncommon: high blood pressure, swelling and clotting in a vein, peripheral coldness; rare: allergy-like reaction, thickening of the arteries due to cholesterol deposits; low blood pressure.
21 Vini u arterji, komuni: tħoss is- sħana (vażodilatazzjoni) inkluż fwawar; mhux komuni: pressjoni tad - demm għolja, nefħa u tagħqid tad- demm f’ vina, kesħa periferika; rari: reazzjoni qisha allerġika, arterji li jeħxienu minħabba depożiti ta ’ kolesterol; pressjoni tad- demm baxxa.
Respiratory system (no effects were found to be common); uncommon: shortness of breath, cough; rare: shallow breathing.
Sistema respiratorja (ma nstabu l- ebda effetti li kienu komuni); mhux komuni: qtugħ ta ’ nifs, sogħla; rari: tnaqqis fir- respirazzjoni.
Digestive system, common: nausea; uncommon: vomiting, attempting to vomit, diarrhoea, stomach discomfort, stomach pain, pain in the throat, indigestion, dry mouth, wind, decreased feeling or sensitivity of the lips, increased production of saliva, anal itching.
Sistema digestiva, komuni: dardir; mhux komuni: rimettar, tipprova tirremetti, dijarrea, skonfort fl - istonku, uġigħ fl- istonku, uġigħ fil- griżmejn, indiġestjoni, ħalq xott, gass, nuqqas fis- sens tal- mess jew fis- sensittività tax- xufftejn, żieda fil- produzzjoni tal- bżieq, ħakk fl- anus
Skin common: itching; uncommon: hives, reddening of the skin, rash, sweating increased; rare: face swelling, sweatiness.
Ġilda, komuni: ħakk; mhux komuni: urtikarja, ħmura tal- ġilda, raxx, żieda fil- produzzjoni ta ’ l - għaraq; rari: nefħa fil- wiċċ, tidlik tal- ġilda minħabba l- għaraq.
Muscles and bones (no effects were found to be common); uncommon: muscle cramps, muscle spasms, neck pain, pain in limb; rare: muscle tightness, sensation of heaviness.
Muskoli u għadam (ma nstabu l- ebda effetti li kienu komuni); mhux komuni: bugħawwieġ fil - muskoli, spażmi tal- muskoli, uġigħ fl- għonq, uġigħ fir- riġlejn jew fid- dirgħajn; rari: tħoss il- muskoli miġbudin, sensazzjoni ta ’ toqol.
Kidneys and urinary tract (no effects were found to be common); uncommon: blood in the urine, proteins in the urine, sugar in the urine; rare: urge to pass urine, kidney pain, passing urine frequently.
Kliewi u s- sistema urinarja (ma nstabu l- ebda effetti li kienu komuni); mhux komuni: demm fl - awrina, proteini fl- awrina, zokkor fl- awrina; rari: impuls qawwi biex tagħmel l- awrina, uġigħ fil - kliewi, tagħmel l- awrina ta ’ spiss.
20 Sex organs (no effects were found to be common); uncommon: genital itching, genital burning sensation; rare: pelvic pain.
Organi sesswali (ma nstabu l- ebda effetti li kienu komuni); mhux komuni: ħakk ġenitali, sensazzjoni ta ’ ħruq ġenitali; rari: uġigħ pelviku.
General disorders and administration site conditions, common: feeling cold; uncommon: pain, chest pain, fatigue, feeling abnormal, groin pain, feeling hot, injection site pain, injection site coldness, reddening of skin at the injection site; rare: fever, shivering, weakness, chest pressure sensation, injection site blood clot, injection site bruising, injection site inflammation, injection site burning, fluid escaping from injection site into the surrounding tissue, injection site bleeding, injection site itching, sensation of pressure.
Disturbi ġenerali u kundizzjonijiet minn fejn jingħata, komuni: tħoss il- bard; mhux komuni: uġigħ, uġigħ fis- sider, għeja, tħossok anormali, uġigħ fil- groin, tħoss is- sħana, uġigħ fis- sit ta ’ l- injezzjoni, tħoss il- bard fis- sit ta ’ l- injezzjoni, ħmura fis- sit ta ’ l- injezzjoni; rari: deni, tertir, debbulizza, sensazzjoni ta ’ pressjoni fis- sider, tagħqid tad- demm fis- sit ta ’ l- injezzjoni, tbenġil fis- sit ta ’ l - injezzjoni, infjammazzjoni fis- sit ta ’ l- injezzjoni, ħruq fis- sit ta ’ l- injezzjoni, fluwidu li joħroġ mis- sit ta ’ l- injezzjoni, ħruġ ta ’ demm fis- sit ta ’ l- injezzjoni, ħakk fis- sit ta ’ l- injezzjoni, sensazzjoni ta ’ pressjoni.
Injury and poisoning (no effects were found to be common or uncommon); rare: phantom limb pain.
Korriment u avvelenament (ma nstabu l- ebda effetti li kienu komuni jew mhux komuni); rari: uġigħ fantażma fir- riġlejn jew fid- dirgħajn.
As with other intravenous contrast agents, VASOVIST can be associated with allergy-like reactions (anaphylactoid / hypersensitivity reactions) characterised by skin reactions, breathing difficulties and/ or heart/ pulse-rate/ blood pressure disturbances which may lead to consciousness disorders (cutaneous or respiratory reactions, and / or cardiovascular manifestations which may lead to shock).
Bħal mediċini tal- kuntrast oħrajn li jingħataw ġol- vini, VASOVIST jista ’ jkun assoċjat ma ’ reazzjonijiet bħal dawk ta ’ l- allerġija (reazzjonijiet anafilattojdi / minħabba sensittività eċċessiva) li huma kkaratterizzati minn reazzjonijiet fil- ġilda, diffikultajiet respiratorji u/ jew disturbi kardjovaskulari/ rata tal- polz/ pressjoni tad- demm li jistgħu jwasslu għal disturbi li fihom iħossok ħażin (reazzjonijiet tal- ġilda jew respiratorji, u/ jew manifestazzjonijiet kardjovaskulari li jistgħu jwasslu għal xokk).
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or radiologist.
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 jew radjologu tiegħek.
HOW TO STORE VASOVIST
KIF TAĦŻEN VASOVIST
Keep the injection vial in its outer carton in order to protect from light.
Żomm il- kunjett ta ’ l- injezzjoni fil- kartuna ta ’ barra tiegħu biex tilqa ’ mid- dawl.
Do not use VASOVIST after the expiry date which is stated on the label.
Tużax VASOVIST wara d- data ta ’ skadenza li tidher fuq it- tikketta.
Do not use Vasovist if you notice severe discolouration, the occurrence of particulate matter or a defective container.
Tużax Vasovist jekk tinnota telf sever ta ’ kulur, d- dehra ta ’ partiċelli frak jew kontenitur difettuż.
Medicines should not be disposed of via wastewater or household waste.
22 Il- mediċini m’ għandhomx jintremew ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
What VASOVIST contains
X’ fih VASOVIST:
- The active substance is gadofosveset trisodium 244 mg/ millilitre corresponding to 0.25
- Is- sustanza attiva hija gadofosveset trisodium 244 mg/ millilitre li jikkorrespondi għal 0. 25
mmol/ millilitre 10 ml solution contain 2.44 g, 15 ml solution contain 3.66 g and 20 ml solution contain 4.88 g of gadofosveset trisodium in a vial.
mmol/ millilitru 10 ml ta ’ soluzzjoni fiha 2. 44 g, 15 ml ta ’ soluzzjoni fiha 3. 66 g u 20 ml ta ’ soluzzjoni fiha 4. 88 g ta ’ gadofosveset trisodium f’ kunjett.
- The other ingredients are fosveset, sodium hydroxide, hydrochloric acid, and water for injections.
- Is- sustanzi l- oħra huma fosveset, sodium hydroxide, hydrochloric acid, u ilma għall- injezzjonijiet.
What VASOVIST looks like and contents of the pack
Id- Dehra ta ’ VASOVIST u l- kontenuti tal- pakkett:
Vasovist is a clear, colourless to pale yellow liquid.
Vasovist huwa likwidu ċar, bla kulur għal isfar ċar.
The contents of the packs are:
Il- kontenut tal- pakketti huma:
1, 5 or 10 injection vials with 10 ml solution for injection (in 10-ml glass vial) 1, 5 or 10 injection vials with 15 ml solution for injection (in 20-ml glass vial) 1, 5 or 10 injection vials with 20 ml solution for injection (in 20-ml glass vial)
1, 5 jew 10 kunjett għall- injezzjoni b ’ 10 ml ta ’ soluzzjoni għall- injezzjoni (f’ kunjett tal- ħġieġ ta ’ 10 - ml) 1, 5 jew 10 kunjett għall- injezzjoni b ’ 15 ml ta ’ soluzzjoni għall- injezzjoni (f’ kunjett tal- ħġieġ ta ’ 20 - ml) 1, 5 jew 10 kunjett għall- injezzjoni b ’ 20 ml ta ’ soluzzjoni għall- injezzjoni (f’ kunjett tal- ħġieġ ta ’ 20 - ml)
21 Not all pack sizes may be marketed.
Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għall- skop kummerċjali.
Deutschland Bayer Vital GmbH Tel: + 49 (0)214-30 513 48
23 Bayer Vital GmbH Tel: + 49 (0) 214- 30 513 48
Norge Bayer AS Tlf: + 47 24 11 18 00
Bayer AS Tlf: + 47 24 11 18 00
As there is a possibility that NSF may occur with VASOVIST, it should therefore only be used in these patients after careful risk/ benefit assessment, and if the diagnostic information cannot be obtained by other means.
24 Billi hemm possibbiltà li l- NSF tista ’ sseħħ b’ Vasovist, għalhekkdan għandu jintuża biss f’ dawn il - pazjenti wara li ssir analiżi bir- reqqa tar- riskju/ benefiċċju u jekk informazzjoni dianjostika ma tistax tinkiseb bl- ebda mezz ieħor.
Haemodialysis shortly after VASOVIST administration in patients currently receiving haemodialysis may be useful at removing VASOVIST from the body.
Emodijaliżi ftit wara għoti ta ’ Vasovist f’ pazjenti li bħalissa qed jirċievu emodijaliżi tista ’ tkun utli biex tneħħi Vasovist mill- ġisem.
VASOVIST is supplied ready to use as a clear, colourless to pale yellow aqueous solution.
VASOVIST huwa pprovdut lest għall- użu bħala soluzzjoni ċara, bla kulur sa safra ċara.
Vials containing VASOVIST are not intended for the withdrawal of multiple doses.
Kunjetti li fihom VASOVIST mhumiex intenzjonati għal ġbid ta ’ dożi multipli.
The rubber stopper should never be pierced more than once.
It- tapp tal- lastku m’ għandu qatt jittaqqab aktar minn darba.
After withdrawal of the solution from the vial, this medicinal product should be used immediately.
Wara li s- soluzzjoni tinġibed mill- kunjett, dan il- prodott mediċinali għandu jintuża minnufih.
Any remaining solution not used in one examination must be discarded.
Kull sustanza tal- kuntrast li ma tintużax f’ eżami wieħed għandha tintrema.
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR)
RAPPORT PUBBLIKU EWROPEW TAL- VALUTAZZJONI (EPAR)
This document is a summary of the European Public Assessment Report (EPAR).
Dan id- dokument huwa sommarju tar- Rapport Pubbliku Ewropew tal- Valutazzjoni.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
L- għan tiegħu huwa li jispjega kif il- valutazzjoni mwettqa mill- Kumitat għall- Prodotti Mediċinali għal Użu Veterinarju (CVMP) abbażi tad- dokumentazzjoni pprovduta, wasslet għar - rakkomandazzjonijiet fuq il- kundizzjonijiet tal- użu.
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Jekk teħtieġ iktar informazzjoni dwar il- kundizzjoni medika jew it- trattament mediku tal- annimal tiegħek, ikkuntattja lill- veterinarju tiegħek.
What is Vectibix?
X’ inhu Vectibix?
Vectibix is a concentrate that is made up into a solution for infusion (drip into a vein).
Vectibix huwa konċentrat li jitħallat f’ soluzzjoni għal infużjoni (drip ġol- vina).
It contains the active substance panitumumab.
Huwa fih is- sustanza attiva panitumumab.
What is Vectibix used for?
Għal xiex jintuża Vectibix?
Vectibix is used to treat metastatic carcinoma of the colon or rectum.
Vectibix jintuża biex jikkura karċinoma metastatika tal- kolon jew tar- rektum.
This is cancer of the lower intestine (large bowel) that has spread to other parts of the body.
Dan huwa kanċer tal - musrana tan- naħa t’ isfel (musrana l- kbira) li jkun infirex għal partijiet oħra tal- ġisem.
KRAS is a gene that, when mutated in tumour cells, stimulates tumour growth.
Vectibix jintuża waħdu f’ pazjenti li ċ- ċelloli tat- tumur tagħhom għandhom proteina fuq il- wiċċ tagħhom imsejħa riċettur tal- fattur tal- iżvilupp epidermiku (EGFR) u li fih ‘ KRAS ’ mhux mutat. ‘ KRAS ’ huwa ġene li, meta ssir mutazzjoni fiċ- ċelloli tat- tumur, jistimula l- iżvilupp tat- tumur.
Vectibix is used after treatment with combinations of anticancer medicines that include a ‘ fluoropyrimidine’ (such as 5-fluorouracil), oxaliplatin and irinotecan has stopped working.
Vectibix jintuża wara li kura b’ kumbinazzjonijiet ta ’ mediċini kontra l- kanċer li jinkludu l - ‘ fluworopirimidina ’ (fluoropyrimidine, bħal ma huwa 5- fluorouracil), oxaliplatin u irinotecan tkun waqfet taħdem.
How is Vectibix used?
Kif jintuża Vectibix?
Treatment with Vectibix should be supervised by a doctor who has experience in the use of anticancer therapy.
Il- kura b’ Vectibix għandha tkun sorveljata minn tabib li għandu esperjenza fl- użu ta ’ terapija kontra l - kanċer.
It should only be started once detection of non-mutated KRAS has been performed by an experienced laboratory using a reliable method.
Għandu jinbeda meta ssir is- sejba ta ’ ‘ KRAS ’ mhux mutat minn laboratorju b’ esperjenza permezz tal- użu ta ’ metodu affidabbli.
The recommended dose of Vectibix is 6 mg per kilogram body weight given once every two weeks as an infusion.
Id- doża rrakkomandata ta ’ Vectibix hija 6 mg kull kilogramm tal- piż tal- ġisem mogħtija darba kull ġimagħtejn bħala infużjoni.
The recommended infusion time is around 60 minutes, but larger doses may need 90 minutes.
Il- ħin tal- infużjoni rakkomandat huwa madwar 60 minuta, iżda dożi aktar qawwija jeħtieġu 90 minuta.
How does Vectibix work?
Kif jaħdem Vectibix?
The active substance in Vectibix, panitumumab, is a monoclonal antibody.
Is- sustanza attiva f’ Vectibix, panitumumab, hija antikorp monoklonali.
A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and bind to a specific structure (called an antigen) that is found on certain cells in the body.
Antikorp monoklonali huwa antikorp (tip ta ’ proteina) li ġie ddisinjat biex jagħraf u jorbot ma ’ struttura speċifika (imsejħa antiġene) li tinsab fuq ċerti ċelloli fil- ġisem.
Panitumumab has been designed to bind to EGFR, which can be found on the surface of certain cells, including cells in some tumours.
Panitumumab ġie ddisinjat biex jorbot ma ’ EGFR, li jista ’ jinstab fuq il- wiċċ ta ’ ċerti ċelloli, inklużi ċelloli f’ xi tumuri.
As a result of this binding, these tumour cells can no longer receive the messages transmitted via EGFR that they need for growth, progression and spreading (metastasis).
Bħala riżultat ta ’ dan l- irbit, dawn iċ- ċelloli tat- tumur ma jistgħux aktar jirċievu l - messaġġi li jeħtieġu għall- iżvilupp, progress u tixrid (metastażi) trasmessi permezz ta ’ EGFR.
Panitumumab does not seem to work in tumour cells that contain mutated KRAS.
Panitumumab ma jidhirx li jaħdem f’ ċelloli tat- tumur li fihom KRAS mutat.
This is because their growth is not controlled by signals transmitted via EGFR and they continue to grow even when the EGFR is blocked.
Dan minħabba li l -
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. iżvilupp tagħhom mhuwiex ikkontrollat minn sinjali trasmessi permezz ta ’ EGFR u huma jkomplu jikbru anke meta EGFR huwa mblokkat.
How has Vectibix been studied?
Kif ġie studjat Vectibix?
The effects of Vectibix were first tested in experimental models before being studied in humans.
L- effetti ta ’ Vectibix kienu l- ewwel ittestjati f’ mudelli sperimentali qabel ma ġew studjati fil- bnedmin.
Vectibix has been studied in one main study involving a total of 463 patients with colon and rectum cancer whose disease had got worse during or after previous treatment that included a fluoropyrimidine, oxaliplatin and irinotecan.
Vectibix ġie studjat fi studju wieħed ewlieni li involva total ta ’ 463 pazjent b’ kanċer tal- kolon u tar - rektum li l- marda tagħhom kienet marret għal agħar waqt jew wara kura ta ’ qabel li kienet tinkludi l - fluworopirimidina, oxaliplatin u irinotecan.
The effects of Vectibix in addition to ‘ best supportive care’ were compared with those of best supportive care alone.
L- effetti ta ’ Vectibix flimkien ma ’ ‘ l- aqwa kura ta ’ appoġġ ’ kienu mqabbla ma ’ dawk tal- aqwa kura ta ’ appoġġ waħidha.
Best supportive care is any medicines or techniques to help patients, such as antibiotics, painkillers, transfusions and surgery, but not other anticancer medicines.
L- aqwa kura ta ’ appoġġ hija kwalunkwe mediċini jew tekniki li jgħinu lill- pazjent, bħalma huma l- antibijotiċi, il- pilloli li jtaffu l - uġigħ, trasfużjonijiet u interventi kirurġiċi, iżda mhux mediċini oħra għal kontra l- kanċer.
The main measure of effectiveness was the time taken before the disease started to get worse or the patient died.
Il- kejl ewlieni tal- effikaċja kien iż- żmien li jgħaddi qabel il- marda bdiet sejra għall- agħar jew il- pazjent miet.
The results of the study were analysed separately in 243 patients whose tumours contained KRAS that had not mutated and in 184 patients in whom the KRAS gene contained a mutation.
Ir- riżultati tal- istudju kienu analizzati separatament f’ 243 pazjent li t- tumuri tagħhom kien fihom KRAS mhux mutat u f’ 184 pazjent li fihom il- ġene KRAS kien fih mutazzjoni.
What benefit has Vectibix shown during the studies?
X’ benefiċċju wera Vectibix waqt l- istudji?
In the patients with non-mutated KRAS in their tumours, Vectibix prolonged the time until the disease got worse or the patient died: this took an average of 12.3 weeks in the patients who took Vectibix in addition to best supportive care, compared with 7.3 weeks in those who received best supportive care alone.
F’ pazjenti bi KRAS mhux mutat fit- tumuri tagħhom, Vectibix tawwal iż- żmien sakemm il- marda marret għall- agħar jew sakemm il- pazjent miet: dan ħa medja ta ’ 12. 3 ġimgħat fil- pazjenti li ħadu Vectibix flimkien mal- aqwa kura ta ’ appoġġ, meta mqabbel ma ’ 7. 3 ġimgħat f’ dawk li rċevew l- aqwa kura ta ’ appoġġ waħidha.
In contrast, there was no effect of Vectibix in the patients with mutated KRAS in their tumours, with an average time of around 7.3 weeks until disease progression or death in both groups of patients.
B’ kuntrast, ma kien hemm l- ebda effett ta ’ Vectibix fil- pazjenti bi KRAS mutat fit- tumuri tagħhom, bi żmien medju ta ’ madwar 7. 3 ġimgħat sal- progressjoni tal- marda jew mewt fiż- żewġ gruppi ta ’ pazjenti.
What is the risk associated with Vectibix?
X’ inhu r- riskju assoċjat ma ’ Vectibix?
Around 90% of patients receiving Vectibix have side effects affecting the skin, although most of these are mild or moderate.
Madwar 90% ta ’ pazjenti li qed jirċievu Vectibix għandhom effetti sekondarji li jaffettwaw il- ġilda, għalkemm il- parti l- kbira ta ’ dawn huma ħfief jew moderati.
The most common side effects with Vectibix (seen in more than 1 patient in 10) are rash, erythema (redness of the skin), skin exfoliation (skin flaking), pruritus (itching), dry skin, skin fissures (cracks in the skin), paronychia (nail bed infection), diarrhoea, fatigue (tiredness), nausea (feeling sick), vomiting, dyspnoea (difficulty breathing) and cough.
L- aktar effetti sekondarji komuni b ’ Vectibix (li dehru f’ aktar minn pazjent 1 minn kull 10) huma raxx, eritema (ħmura tal- ġilda), esfoljazzjoni tal- ġilda (ġilda li titqarqaċ u titfarfar), ħakk, ġilda xotta, qsim fil- ġilda (xquq fil- ġilda), paronikija (infjamamzzjoni viċin tad- difer), dijarrea, għeja kbira, nawżea (dardir), rimettar, dispnea (diffikultà fit- teħid tan- nifs) u sogħla.
For the full list of all side effects reported with Vectibix, see the Package Leaflet.
Għal- lista sħiħa tal- effetti sekondarji kollha rrapportati b’ Vectibix, ara l- Fuljett ta ’ Tagħrif.
Vectibix should not be used in people who may be hypersensitive (allergic) to panitumumab or any of the other ingredients.
Vectibix m’ għandux jintuża f’ nies li jistgħu jkunu sensittivi żżejjed (allerġiċi) għal panitumumab jew għal kwalunkwe sustanza oħra tiegħu.
It should also not be used in patients with interstitial pneumonitis or pulmonary fibrosis (lung diseases).
M’ għandux jintuża wkoll f’ pazjenti bi pnewmonite interstizjali jew fibrożi pulmonari (mard tal- pulmun).
Why has Vectibix been approved?
Għaliex ġie approvat Vectibix?
The Committee for Medicinal Products for Human Use (CHMP) concluded that Vectibix’ s benefits are greater than its risks as monotherapy for the treatment of patients with EGFR expressing metastatic colorectal carcinoma with non-mutated (wild-type) KRAS after failure of fluoropyrimidine-, oxaliplatin- and irinotecan-containing chemotherapy regimens.
Il- Kumitat għall- Prodotti Mediċinali għal Użu mill- Bniedem (CHMP) ikkonkluda li l- benefiċċji ta ’ Vectibix huma akbar mir- riskji tiegħu bħala monoterapija għall- kura ta ’ pazjenti b’ karċinoma kolorettali li tesprimi EGFR bi KRAS mhux mutat (tip salvaġġ) wara falliment ta ’ reġim ta ’ kimoterapija li fihom il- fluworopirimidina, oxaliplatin u irinotecan.
The Committee recommended that Vectibix be given marketing authorisation.
Il- Kumitat irrakkomanda li Vectibix jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Vectibix has been given ‘ Conditional Approval’.
Vectibix ingħata ‘ Approvazzjoni Kundizzjonali ’.
This means that there is more evidence to come about the medicine, in particular its safety and effectiveness in patients whose tumours contain non-mutated KRAS.
Dan ifisser li għad hemm aktar evidenza x’ tasal dwar il- mediċina, partikolarment fir- rigward tas- sigurtà u l- effikaċja f’ pazjenti li t- tumuri tagħhom fihom KRAS mhux mutat.
Every year, the European Medicines Agency (EMEA) will review any new information that may become available and this summary will be updated as necessary.
Kull sena, l- Aġenzija Ewropea għall- Mediċini (EMEA) tirrevedi kwalunkwe tagħrif ġdid li jista ’ jsir disponibbli u dan is- sommarju jiġi aġġornat skont il- ħtieġa.
What information is still awaited for Vectibix?
X’ tagħrif għadu mistenni għal Vectibix?
The company that makes Vectibix will supply the results of additional studies looking at the safety and effectiveness of the medicine in patients with colorectal cancer with and without mutated KRAS, as well as at the quality of life in patients receiving it.
Il- kumpanija li tipproduċi Vectibix se tipprovdi r- riżultati ta ’ studji addizzjonali li eżaminaw is- sigurtà u l- effikaċja tal- mediċina f’ pazjenti b’ kanċer kolorettali bi jew mingħajr KRAS mutat, kif ukoll lejn il - kwalità ta ’ ħajja f’ pazjenti li qed jirċevuh.
These include studies looking at the use of Vectibix in combination with other medicines, both in patients whose disease has been treated before and in patients who have not received any previous treatment for their cancer, as well as a study to confirm the effectiveness of Vectibix, given on its own, in its approved use.
Dawn jinkludu studji li eżaminaw l- użu ta ’ Vectibix f’ kumbinazzjoni ma ’ mediċini oħra, kemm f’ pazjenti li l- marda tagħhom diġà ġiet ikkurata u f’ pazjenti li qabel ma kienu rċevew l- ebda kura għall- kanċer tagħhom, kif ukoll studju li jikkonferma l- effikaċja ta ’ Vectibix, meta jingħata waħdu, fl- użu approvat tiegħu.
Other information about Vectibix:
Tagħrif ieħor dwar Vectibix:
The European Commission granted a marketing authorisation valid throughout the European Union for Vectibix to Amgen Europe B. V. on 3 December 2007.
Il- Kummissjoni Ewropea tat l- awtorizzazzjoni għat- tqegħid fis- suq għal Vectibix valida fl- Unjoni Ewropea kollha lil Amgen Europe B. V. fit- 3 ta ’ Diċembru 2007.
The full EPAR for Vectibix can be found here.
2/ 3 L- EPAR sħiħa għal Vectibix jista ’ jiġi kkonsultat hawn.
Pharmaceutical
Għamla
Route of
Mnjen jingħata
Strength
Isem Ivvintat
Concentrate for solution for infusion
Konċentrat għal soluzzjoni għall - injezzjoni
Vial (glass)
Użu għal ġol- vini Kunjett (ħġieġ)
Vectibix 20 mg/ ml concentrate for solution for infusion.
Vectibix 20 mg/ ml konċentrat għal soluzzjoni għall- infużjoni.
Each ml of concentrate contains 20 mg panitumumab.
Kull ml ta ’ konċentrat fih 20 mg panitumumab.
Each vial contains either 100 mg of panitumumab in 5 ml, 200 mg in 10 ml, or 400 mg in 20 ml.
Kull kunjett fih 100 mg ta ’ panitumumab f’ 5 ml, 200 mg f’ 10 ml, jew 400 mg f’ 20 ml.
When prepared according to the instructions given in section 6.6, the final panitumumab concentration should not exceed 10 mg/ ml.
Meta jiġi ppreparat skond l- istruzzjonijiet mogħtija f’ sezzjoni 6. 6, il- konċentrazzjoni finali ta ’ panitumumab m’ għandiex taqbeż 10 mg/ ml.
Panitumumab is a human monoclonal IgG2 antibody produced in a mammalian cell line (CHO) by recombinant DNA technology.
Panitumumab huwa antikorp IgG2 monoklonali uman prodott f’ razza ta ’ ċelluli mammiferi (CHO) permezz ta ’ teknoloġija rikombinanti tad- DNA.
Each ml of concentrate contains 0.150 mmol sodium, which is 3.45 mg sodium.
Kull ml ta ’ konċentrat fih 0. 150 mmol ta ’ sodju, li huwa 3. 45 mg ta ’ sodium.
Colourless solution that may contain visible amorphous panitumumab particles.
Soluzzjoni bla kulur li jista ’ jkun fiha frak amorfu ta ’ panitumumab li jidher.
Vectibix is indicated as monotherapy for the treatment of patients with EGFR expressing metastatic colorectal carcinoma with non-mutated (wild-type) KRAS after failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens.
Vectibix huwa indikat bħala monoterapija għall- kura ta ’ pazjenti b’ karċinoma metastatika tal - kolorektum li għandu EGFR u b’ KRAS mhux mutant (tip salvaġġ) wara falliment ta ’ korsijiet ta ’ kimoterapija li fihom fluoropyrimidine, oxaliplatin u irinotecan.
Vectibix treatment should be supervised by a physician experienced in the use of anti-cancer therapy.
Kura ta ’ Vectibix għandha tiġi sorveljata minn tabib b’ esperjenza fl- użu ta ’ terapija kontra l- kanċer.
Detection of non-mutated KRAS expression should be performed by an experienced laboratory using a validated test method.
Is- sejba ta ’ l- espressjoni ta ’ KRAS mhux mutant għandha ssir minn laboratorju b’ esperjenza bl- użu ta ’ metodu ta ’ analiżi validat.
The recommended dose of Vectibix is 6 mg/ kg of bodyweight given once every two weeks.
Id- doża rakkomandata ta ’ Vectibix hija 6 mg/ kg tal- piż tal- ġisem mogħtija darba kull ġimagħtejn.
Prior to infusion, Vectibix should be diluted in 0.9% sodium chloride injection to a final concentration not to exceed 10 mg/ ml (for preparation instructions see section 6.6).
Qabel l- infużjoni, Vectibix għandu jiġi dilwit f’ injezzjoni ta ’ 0. 9% sodium chloride sa konċentrazzjoni finali li ma taqbisx 10 mg/ ml (għal struzzjonijiet dwar il- preparazzjoni ara sezzjoni 6. 6).
Vectibix must be administered as an intravenous (IV) infusion via an infusion pump, using a low protein binding 0.2 or 0.22 micrometer in-line filter, through a peripheral line or indwelling catheter.
Vectibix għandu jingħata bħala infużjoni ġol- vini (IV) permezz ta ’ pompa ta ’ l- infużjoni, bl- użu ta ’ filtru tal- 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.
The recommended infusion time is approximately 60 minutes.
Il- ħin rakkomandat ta ’ l- infużjoni huwa ta ’ madwar 60 minuta.
Doses higher than 1000 mg should be infused over approximately 90 minutes (for handling instructions, see section 6.6).
Dożijiet akbar minn 1000 mg għandhom jiġu infużi fuq madwar 90 minuta (għal struzzjonijiet ta ’ mmaniġġjar, ara sezzjoni 6. 6).
The infusion line should be flushed with sodium chloride solution before and after Vectibix administration to avoid mixing with other medicinal products or IV solutions.
Il- pajp ta ’ l- infużjoni għandu jitlaħlaħ b’ soluzzjoni ta ’ sodium chloride qabel u wara l- għoti ta ’ Vectibix biex jiġi evitat taħlit ma ’ prodotti mediċinali jew soluzzjonijiet IV.
2 Special populations
2 Tagħtix bħala IV push jew bolus.
The safety and efficacy of Vectibix have not been studied in patients with renal or hepatic impairment.
Is- sigurtà u l- effikaċja ta ’ Vectibix ma ġewx studjati f’ pazjenti b’ indeboliment renali jew epatiku.
Dose adjustment is not required in the elderly.
M’ hemmx bżonn ta ’ aġġustament fid- doża fl- anzjani.
In clinical studies no overall differences in safety or efficacy were observed between patients aged ≥ 65 years and younger patients.
Fi studji kliniċi ma kienet osservata l- ebda differenza globali fis- sigurtà u fl- effikaċja bejn pazjenti b’ età ≥ 65 sena u pazjenti iżgħar.
There is no experience in children and Vectibix should not be used in those patients less than 18 years of age.
M’ hemmx esperjenza dwar l- użu fit- tfal u Vectibix m’ għandux jintuża f’ dawk il- pazjenti taħt l- età ta ’ 18- il sena.
Patients with interstitial pneumonitis or pulmonary fibrosis (see Section 4.4).
Pazjenti b’ pulmonite ta ’ l- interstizju jew fibrosi pulmonari (ara Sezzjoni 4. 4).
Dermatologic related reactions, a pharmacologic effect observed with epidermal growth factor receptor (EGFR) inhibitors, are experienced with nearly all patients (approximately 90%) treated with Vectibix (see section 4.8), the majority are mild to moderate in nature.
Reazzjonijiet relatati mal- ġilda, effett farmakoloġiku osservat b’ inibituri tar- riċettur tal- fattur tat - tkabbir epidermali (EGFR), jinħassu minn kważi l- pazjenti kollha (madwar 90%) ikkurati b’ Vectibix (ara sezzjoni 4. 8), il- maġġoranza huma ħafif sa moderati fin- natura tagħhom.
If a patient develops dermatologic reactions that are grade 3 (NCI-CTC/ CTCAE) or higher, or that are considered intolerable, temporarily withhold Vectibix administration until the reactions have improved (≤ grade 2).
Jekk pazjent jiżviluppa reazzjonijiet dermatoloġiċi li huma ta ’ grad 3 (NCI- CTC/ CTCAE) jew akbar, jew li huma kkunsidrati ntollerabbli, l- għoti ta ’ Vectibix għandu jiġi mwaqqaf temporanjament sakemm ir- reazzjonijiet jitjiebu (≤ grad 2).
Once improved to ≤ grade 2, reinstate Vectibix administration at 50% of the original dose.
Ladarba jitjiebu sa ≤ grad 2, l- għoti ta ’ Vectibix għandu jerġa ’ jinbeda b’ 50% tad- doża oriġinali.
If reactions do not recur, escalate the dose of Vectibix by 25% increments until the recommended dose is reached.
Jekk ir- reazzjonijiet ma jerġux iseħħu, d- doża ta ’ Vectibix għandha tiżdied b’ inkrementi ta ’ 25% sakemm tintlaħaq id- doża rakkomandata.
If reactions do not resolve (to ≤ grade 2) after withholding 1 or 2 doses of Vectibix, or if reactions recur or become intolerable at 50% of the original dose, the use of Vectibix should be permanently discontinued.
Jekk ir- reazzjonijiet ma jfiequx (sa ≤ grad 2) wara li jinżammu doża jew tnejn ta ’ Vectibix, jew jekk ir- reazzjonijiet jerġu jseħħu jew jekk isiru ntollerabbli b’ 50% tad- doża oriġinali, l- użu ta ’ Vectibix għandu jitwaqqaf għal kollox.
In clinical studies, subsequent to the development of severe dermatological reactions (including stomatitis), infectious complications including sepsis, in rare cases leading to death, and local abscesses requiring incisions and drainage were reported.
Fi studji kliniċi, wara l- iżvilupp ta ’ reazzjonijiet dermatoloġiċi severi (inkluż stomatite), kienu rrappurtati kumplikazzjonijiet infettivi inkluż sepsi, li f’ każijiet rari wasslu għall- mewt, u axxessi lokali li kien jinħtieġilhom li jinqasmu u jitnaddfu.
Patients who have severe dermatologic reactions or who develop worsening reactions whilst receiving Vectibix should be monitored for the development of inflammatory or infectious sequelae, and appropriate treatment promptly initiated.
Pazjenti li jkollhom reazzjonijiet dermatoloġiċi severi jew li jiżviluppaw reazzjonijiet li jmorru għall- agħar waqt li qed jirċievu Vectibix għandhom jiġu sorveljati għall- iżvilupp ta ’ sintomi nfjammatorji jew infettivi, u għandha tinbeda kura xierqa minnufiħ.
It is recommended that patients wear sunscreen and hats and limit sun exposure whilst receiving Vectibix and experiencing rash/ dermatological toxicities, as sunlight can exacerbate any skin reactions that may occur.
Huwa rakkomandat li l- pazjenti japplikaw krema ta ’ protezzjoni mix- xemx u jilbsu kpiepel u jillimitaw l- espożizzjoni għax- xemx waqt li qed jirċievu Vectibix u jesperjenzaw raxx/ tossiċitajiet dermatoloġiċi, minħabba li d- dawl tax- xemx jista ’ jaggrava kull reazzjoni tal- ġilda li jista ’ jkun hemm.
Pulmonary complications
Kumplikazzjonijiet pulmonari
Patients with a history of, or evidence of, interstitial pneumonitis or pulmonary fibrosis were excluded from clinical studies.
Pazjenti b’ passat ta ’, jew evidenza ta ’ pulmonite ta ’ l- interstizju jew fibrosi pulmonari kienu esklużi minn studji kliniċi.
As Interstitial Lung Disease (ILD) has been observed with EGFR inhibitors, in the event of acute onset or worsening pulmonary symptoms, Vectibix treatment should be interrupted and a prompt investigation of these symptoms should occur.
Minħabba li Marda ta ’ l- Interstizju tal- Pulmun (ILD) kienet osservata b’ inibituri EGFR, f’ każ ta ’ bidu akut jew irkadar ta ’ sintomi pulmonari, kura b’ Vectibix għandha titwaqqaf u għandu jkun hemm investigazzjoni immedjata ta ’ dawn is- sintomi.
If pneumonitis or lung infiltrates are diagnosed, Vectibix should be discontinued and the patient should be treated appropriately.
Jekk ikun hemm dijanjosi ta ’ pulmonite jew ta ’ infiltrati fil- pulmun, Vectibix għandu jitwaqqaf u l- pazjent għandu jiġi kkurat b’ mod xieraq.
Progressively decreasing serum magnesium levels leading to severe (grade 4) hypomagnesaemia have been observed in some patients.
F’ xi pazjenti kien osservat tnaqqis progressiv fil- livelli ta ’ magnesium fis- serum li jwassal għall - ipomanjesimja severa (grad 4).
Patients should be periodically monitored for hypomagnesaemia and accompanying hypocalcaemia prior to initiating Vectibix treatment, and periodically thereafter for up to 8 weeks after the completion of treatment (see section 4.8).
3 perjodikament sa 8 ġimgħat wara li tispiċċa l- kura (ara sezzjoni 4. 8).
Magnesium repletion is recommended, as appropriate.
Forniment ta ’ magnesium huwa rrakkomandat skond il- ħtieġa.
3 Other electrolyte disturbances, including hypokalaemia, have also been observed.
Kien osservat ukoll disturbi oħra fl- elektroliti, inkluż ipokalimja.
Repletion of these electrolytes is also recommended, as appropriate.
Forniment ta ’ dawn l- elektroliti wkoll huwa rrakkomandat skond il- ħtieġa.
This medicinal product contains 0.150 mmol sodium (which is 3.45 mg sodium) per ml of concentrate.
Dan il- prodott mediċinali fih 0. 150 mmol sodium (li huwa 3. 45 mg sodium) kull ml ta ’ konċentrat.
To be taken into consideration by patients on a controlled sodium diet.
Għandu jittieħed f’ konsiderazzjoni minn pazjenti fuq dieta kkontrollata ta ’ sodium.
Vectibix in combination with IFL
Vectibix flimkien ma ’ IFL
Patients receiving Vectibix in combination with the IFL regimen [bolus 5-fluorouracil (500 mg/ m2), leucovorin (20 mg/ m2) and irinotecan (125 mg/ m2)] experienced a high incidence of severe diarrhoea (see section 4.8), therefore administration of Vectibix in combination with IFL should be avoided (see section 4.5).
Pazjenti li qed jirċievu Vectibix flimkien ma ’ kors IFL [bolus 5- fluorouracil (500 mg/ m2), leucovorin (20 mg/ m2) u irinotecan (125 mg/ m2)] kellhom esperjenza ta ’ inċidenza għolja ta ’ dijarea severa (ara sezzjoni 4. 8), għalhekk l- għoti ta ’ Vectibix flimkien ma ’ IFL għandha tiġi evitata (ara sezzjoni 4. 5).
Vectibix in combination with bevacizumab and chemotherapy regimens
Vectibix flimkien ma ’ bevacizumab u korsijiet kimoterapewtiċi
A randomized, open-label, multicentre study of 1,053 patients evaluated the efficacy of bevacizumab and oxaliplatin- or irinotecan-containing chemotherapeutic regimens with and without Vectibix in the first-line treatment of metastatic colorectal cancer.
Studju randomized, open- label, b’ ħafna ċentri ta ’ 1, 053 pazjent ivvaluta l- effikaċja ta ’ bevacizumab u korsijiet kimoterapewtiċi li fihom oxaliplatin jew irinotecan bi u bla Vectibix fil- kura preferita ta ’ kanċer metastatiku tal- kolorektum.
In an interim analysis based on 947 randomized patients, shortened progression free survival time and increased deaths were observed in the patients receiving Vectibix in combination with bevacizumab and chemotherapy.
F’ analiżi interim ibbażat fuq 947 pazjent randomized, kienu osservati tqassir fit- tul ta ’ sopravivenza mingħajr progressjoni u żieda fl- imwiet f’ pazjenti li kienu qed jirċievu Vectibix flimkien ma ’ bevacizumab u kimoterapija.
A greater frequency of pulmonary embolism, infections (predominantly of dermatologic origin), diarrhoea, and dehydration was also observed in the treatment arms using Vectibix in combination with bevacizumab and chemotherapy.
Kienet osservata wkoll frekwenza ogħla ta ’ emboliżmu pulmonari, infezzjonijiet (l- aktar ta ’ oriġini dermatoloġika), dijarea, u deidrazzjoni, fil - gruppi ta ’ kura li kienu qed jużaw Vectibix flimkien ma ’ bevacizumab u kimoterapija.
Therefore administration of Vectibix in combination with bevacizumab containing chemotherapy combinations should be avoided (see section 4.5 and section 5.1).
Għalhekk, l - għoti ta ’ Vectibix flimkien ma ’ taħlitiet ta ’ kimoterapija li fihom bevacizumab għandu jiġi evitat (ara sezzjoni 4. 5 u sezzjoni 5. 1).
Concomitant use of Vectibix and IFL or bevacizumab and chemotherapy combinations is not recommended (see sections 4.4 and 4.8).
L- użu fl- istess ħin ta ’ Vectibix u IFL jew taħlitiet ta ’ kimoterapija li fihom bevacizumab mhux rakkomandat (ara sezzjonijiet 4. 4 u 4. 8).
Increased deaths were observed when panitumumab was administered in combination with bevacizumab and chemotherapy combinations (see section 4.4).
Żieda fl- imwiet kienet osservata meta panitumumab ingħata flimkien ma ’ bevacizumab u taħlitiet ta ’ kimoterapija (ara sezzjoni 4. 4).
There are no adequate data from the use of Vectibix in pregnant women.
M’ hemmx tgħarif biżżejjed dwar l- użu ta ’ Vectibix waqt it- tqala.
The potential risk for humans is unknown.
Studji fuq bhejjem urew ħsara fuq is - sistema riproduttiva (ara sezzjoni 5. 3).
EGFR has been implicated in the control of prenatal development and may be essential for normal organogenesis, proliferation, and differentiation in the developing embryo.
Mhux magħruf ir- riskju potenzjali fuq in- nies. EGFR kien implikat fil- kontroll ta ’ l- iżvilupp ta ’ qabel it- twelid u jista ’ jkun essenzjali għall- organoġenesi, proliferazzjoni, u divrenzjar normali fl- embriju li qed jiżviluppa.
Therefore, Vectibix has the potential to cause foetal harm when administered to pregnant women.
Għalhekk, Vectibix għandu l - potenzjal li jikkawża ħsara lill- fetu meta mogħti lil nisa tqal.
Human IgG is known to cross the placental barrier, and panitumumab may therefore be transmitted from the mother to the developing foetus.
IgG uman huwa magħruf li jgħaddi mill- barriera tal- plaċenta, u għalhekk panitumumab jista ’ jgħaddi mill- omm għall- fetu li qed jiżviluppa.
In women of childbearing potential, appropriate contraceptive measures must be used during treatment with Vectibix, and for 6 months following the last dose.
F’ nisa b’ potenzjal li jista ’ jkollhom it- tfal, miżuri kontraċettivi xierqa għandhom jintużaw waqt kura b’ Vectibix, u għal 6 xhur wara l- aħħar doża.
If Vectibix is used during pregnancy or if the patient becomes pregnant while receiving this medicinal product, she should be advised of the potential risk for loss of the pregnancy or potential hazard to the foetus.
Jekk Vectibix jintuża waqt it- tqala jew jekk il- pazjenta toħroġ tqila waqt li qed tirċievi dan il- prodott mediċinali, hija għandha tiġi avżata dwar ir- riskju potenzjali għat- telf tat- tqala jew dwar il- periklu potenzjali għall - fetu.
4 infant after ingestion is unknown.
4 Treddigħ
It is recommended that women do not breast feed during treatment with Vectibix and for 3 months after the last dose.
Huwa rakkomandat li nisa ma jreddgħux waqt kura b’ Vectibix u għal 3 xhur wara l- aħħar doża.
Animal studies have shown reversible effects on the menstrual cycle and reduced female fertility in monkeys (see Section 5.3).
Studji fil- bħejjem wrew effetti riversibbli fuq iċ- ċiklu menstrwali u tnaqqis fil- fertilità femminili fix - xadini (ara Sezzjoni 5. 3).
Panitumumab may impact the ability of a woman to become pregnant.
Panitumumab jista ’ jaffettwa l- ħila ta ’ mara li tinqabad tqila.
If patients experience treatment-related symptoms affecting their vision and/ or ability to concentrate and react, it is recommended that they do not drive or use machines until the effect subsides.
Jekk pazjenti jesperjenzaw sintomi relatati mal- kura li jaffettwaw il- vista tagħhom u/ jew l- ħila biex tikkonċentra u tirreaġixxi, huwa rakkomandat li ma jsuqux jew iħaddmu magni sakemm l- effeti jtaffu.
Based on an analysis of all patients receiving Vectibix monotherapy (n = 920), the most commonly reported adverse reactions are skin reactions occurring in approximately 90% of patients.
Ibbażat fuq analiżi tal- pazjenti kollha li rċevew monoterapija b’ Vectibix (N = 920), l- aktar reazzjonijiet avversi rrappurtati b’ mod komuni huma reazzjonijiet fil- ġilda li seħħew f’ madwar 90% tal- pazjenti.
These reactions are related to the pharmacologic effects of Vectibix, and the majority are mild to moderate in nature with approximately 10% severe (grade 3 or higher, NCI-CTC).
Dawn ir- reazzjonijet huma relatati ma ’ l- effetti farmakoloġiċi ta ’ Vectibix, u l - maġġoranza huma ħfief sa moderati fin- natura tagħhom, b’ madwar 10% severi (grad 3 jew ogħla, NCI- CTC).
Except where indicated, the data describe adverse reactions reported from clinical studies in patients with metastatic colorectal carcinoma who received panitumumab as a single agent:
Minbarra meta indikat, it- tagħrif jiddeskrivi reazzjonijiet avversi rrappurtati minn studji kliniċi f’ pazjenti b’ karċinoma metastatika tal- kolorektum li rċevew panitumumab bħala sustanza waħedha:
MedDRA Organ System Skin and subcutaneous tissue disorders
Sistema ta ’ l- Organi MedDRA Disturbi fil- ġilda u fit- tessuti ta ’ taħt il - ġilda
Frequency Very common (≥ 1/ 10)
Frekwenza Komuni ħafna (≥ 1/ 10)
Undesirable Effect Rash Erythaema Skin exfoliation Pruritus Dry skin Skin fissures Paronychia
Effett mhux mixtieq Raxx Eritema Ġilda titqaxxar Ħakk Ġilda xotta Qsim fil- ġilda Paronikja
Gastrointestinal disorders General disorders and administrative site conditions
Disturbi gastro- intestinali Disturbi ġenerali u kondizzjonijiet ta 'mnejn jingħata
Diarrhoea Fatigue
Dijarea Għeja
General disorders and administrative site conditions Metabolism and nutrition disorders
Disturbi ġenerali u kondizzjonijiet ta 'mnejn jingħata Disturbi fil- metaboliżmu u n- nutrizzjoni
Infusion reactions (pyrexia, chills) Hypomagnesaemia Hypocalcaemia Hypokalaemia Dehydration
Reazzjonijiet għall- infużjoni (deni, tertir) Ipomanjesimja Ipokalċimja Ipokalemja Deidrazzjoni
Nausea Vomiting
Tqalligħ Rimettar
Respiratory, thoracic and mediastinal disorders Nervous system disorders Eye disorders
Disturbi respiratorji, toraċiċi u medjastinali Disturbi fis- sistema nervuża
Dyspnoea Cough Headache Conjunctivitis Growth of eyelashes Increased lacrimation Ocular hyperaemia Dry eye Eye pruritus
Qtugħ ta ’ nifs Sogħla Uġigħ ta ’ ras
5 MedDRA Organ System Skin and subcutaneous tissue disorders
5 Sistema ta ’ l- Organi MedDRA Disturbi fl- għajnejn
Undesirable Effect Stomatitis Mucosal inflammation Onycholysis Hypertrichosis Alopecia Nasal dryness Dry mouth
Stomatite Infjammazjoni tal- mukosa Onikolisi Ipertrikożi Alopeċja Mnieħer xott Ħalq xott
Pulmonary embolism
Emboliżmu pulmonari
The safety profile of panitumumab in patients whose tumour express KRAS wild-type (n = 123) was generally consistent with overall mCRC monotherapy set described above.
Il- profil ta ’ sigurtà ta ’ panitumumab f’ pazjenti li t- tumur tagħhom għandu KRAS tat- tip salvaġġ (n = 123) ġeneralment kien konsistenti mas- sett globali ta ’ monoterapija mCRC deskritt fuq.
The only differences were that nausea, vomiting, dyspnoea and cough were reported as very common (≥ 1/ 10) in the KRAS wild-type arm whereas these adverse drug reactions were reported as common (≥ 1/ 100 to < 1/ 10) in the overall mCRC monotherapy population.
L- uniċi differenzi kienu li tqalligħ, rimettar, qtugħ ta ’ nifs u sogħla kienu rrappurtati bħala komuni ħafna (≥ 1/ 10) fil- grupp bi KRAS tat- tip salvaġġ filwaqt li dawn ir- reazzjonijiet avversi tal- mediċina kienu rrappurtati bħala komuni (≥ 1/ 100 sa < 1/ 10) fil- popolazzjoni golabli ta ’ monoterapija mCRC.
Diarrhoea when reported was mainly mild or moderate in severity.
Dijarea meta rrappurtata ġeneralment kienet ta ’ severità ħafifa jew moderata.
Two percent of patients with KRAS wild-type had diarrhoea reported as severe.
Tnejn fil- mija tal - pazjenti bi KRAS tat- tip salvaġġ kellhom dijarea rrappurtata bħala severa.
In clinical trials potential infusion reactions (occurring within 24 hours of the first dose) which may include symptoms/ signs such as chills, fever, or dyspnoea, were reported in 2% of Vectibix treated patients, of which < 1% were severe (grade 3).
Fi provi kliniċi reazzjonijiet potenzjali għall- infużjoni (li jseħħu fi żmien 24 siegħa mill- ewwel doża) li jistgħu jinkludu sintomi/ sinjali bħal tertir, deni, jew qtugħ ta ’ nifs, kienu rrappurtati fi 2% tal - pazjenti kkurati b’ Vectibix, li minnhom < 1% kienu severi (grad 3).
No patients had life-threatening (grade 4) or fatal (grade 5) infusion reactions to Vectibix.
L- ebda pazjent ma kellu reazzjonijiet ta ’ l- infużjoni għal Vectibix ta ’ periklu għall- ħajja (grad 4) jew fatali (grad 5).
Most of the symptoms of potential infusion reactions were mild in intensity, resolved without treatment, were isolated occurrences and did not require alteration or interruption of Vectibix administration.
Il- biċċa l - kbira tas- sintomi ta ’ reazzjonijiet potenzjali għall- infużjoni kienu ta ’ intensità ħafifa, fiequ mingħajr kura, kienu episodji iżolati u ma kienux jinħtieġu tibdil jew twaqqif ta ’ l- għoti ta ’ Vectibix.
Skin rash most commonly occurred on the face, upper chest, and back, but could extend to the extremities.
Raxx fil- ġilda seħħ l- aktar komuni fil- wiċċ, fil- parti ta ’ fuq tas- sider, u d- dahar, iżda jista ’ jestendi għall- estremitajiet.
Subsequent to the development of severe skin and subcutaneous reactions, infectious complications including sepsis, in rare cases leading to death, and local abscesses requiring incisions and drainage were reported.
Wara l- iżvilupp ta ’ reazzjonijiet fil- ġilda u fit- tessuti ta ’ taħt il- ġilda severi, kumplikazzjonijiet infettivi inkluż sepsi, li f’ każijiet rari jwassal għall- mewt, u axxessi lokali li jinħtieġu qsim u tindif kienu rrappurtati.
The median time to first symptom of dermatologic reaction was 10 days, and the median time to resolution after the last dose of Vectibix was 28 days.
Il- ħin medjan sa ’ l- ewwel sintomu ta ’ reazzjoni dermatoloġika kien ta ’ 10 ijiem, u l- ħin medjan sal- fejqan wara l- aħħar doża ta ’ Vectibix kien ta ’ 28 ġurnata.
Paronychial inflammation was associated with swelling of the lateral nail folds of the toes and fingers.
Infjammazzjoni paronikjali kienet assoċjata ma ’ nefħa tat- tinja laterali tad- dwiefer tas- swaba tas - saqajn u tal- idejn.
Doses up to 9 mg/ kg have been tested in clinical trials.
4. 9 Doża eċċessiva
There have been reports of overdose at doses up to approximately twice the recommended therapeutic dose.
Kien hemm rapporti ta ’ doża eċċessiva f’ dożi sa madwar id- doppju tad- doża terapewtika rakkomandata.
Adverse events observed included skin toxicity, diarrhoea, dehydration and fatigue and were consistent with the safety profile at the recommended dose.
Episodji avversi osservati inkludew tossiċità fil- ġilda, dijarea, deidrazzjoni u għeja u kienu konsistenti mal- profil tas- sigurtà fid- doża rakkomandata.
Antineoplastic agents, monoclonal antibodies, ATC code:
Sustanzi antineoplastiċi, antikorpi monoklonali, Kodiċi ATC:
6 Mechanism of action
Mekkaniżmu ta ’ azzjoni
Panitumumab is a recombinant, fully human IgG2 monoclonal antibody that binds with high affinity and specificity to the human EGFR.
Panitumumab huwa antikorp rikombinanti, monoklonali IgG2 kompletament uman u li jeħel b’ affinità u speċifiċità ogħlja ma ’ EGFR uman.