qanastek/EMEA-V3 huggingface dataset:
This randomised study in patients with recurrent and/ or metastatic squamous cell cancer of the head and neck who had not received prior chemotherapy for this disease compared the combination of cetuximab and cisplatin or carboplatin plus infusional 5-fluorouracil (222 patients) to the same chemotherapy alone (220 patients).
Dan l- istudju randomised f’ pazjenti b’ kanċer taċ- ċelluli skwamużi fir- ras u fl- għonq, rikorrenti u/ jew metastatiku, li ma kinux irċivew kimoterapija fil- passat għal din il- marda, qabbel il- kumbinazzjoni ta ’ cetuximab u cisplatin jew carboplatin flimkien ma ’ 5- fluorouracil infużjonali (222 pazjent) ma ’ l- istess kimoterapija waħidha (220 pazjent).
Treatment in the cetuximab arm consisted of up to 6 cycles of platinum-based chemotherapy in combination with cetuximab followed by cetuximab as maintenance therapy until disease progression.
Il- kura fil- parti ta ’ l- istudju dwar cetuximab kienet tikkonsisti f’ sa 6 ċikli ta ’ kimoterapija bbażata fuq il- platinum flimkien ma ’ cetuximab segwita minn cetuximab bħala kura tal- manteniment sal- progressjoni tal- marda.
The efficacy data generated in this study are summarised in the table below:
12 L- informazzjoni dwar l- effikaċja li ħarġet minn dan l- istudju hi deskritta fil- qosor fit- tabella hawn taħt:
Cetuximab + CTX
Cetuximab flimkien ma ’ CTX
months, median (95% CI) Hazard Ratio (95% CI) p-value PFS
xhur, medjan (95% CI) Proporzjon ta ’ riskju (95% CI)
10.1 (8.6, 11.2)
10. 1 (8. 6, 11. 2)
0.797
0. 797
(0.644, 0.986) 0.0362
(0. 644, 0. 986)
7.4 (6.4, 8.3)
valur p PFS
months, median (95% CI) Hazard Ratio (95% CI) p-value ORR
xhur, medjan (95% CI) Proporzjon ta ’ riskju (95% CI)
5.6 (5.0, 6.0)
5. 6 (5. 0, 6. 0)
0.538
0. 538
(0.431, 0.672) < 0.0001
(0. 431, 0. 672)
3.3 (2.9, 4.3)
valur p ORR
% (95% CI) p-value
% (95% CI) valur p
35.6 (29.3, 42.3)
35. 6 (29. 3, 42. 3)
19.5 (14.5, 25.4)
19. 5 (14. 5, 25. 4)
CI = confidence interval, CTX = platinum-based chemotherapy, ORR = objective response rate, OS = overall survival time, PFS = progression-free survival time
CI = intervall tal- kunfidenza, CTX = kimoterapija bbażata fuq il- platinum, ORR = rata ta ’ rispons oġġettiv, OS = żmien totali ta ’ sopravivenza, PFS = żmien ta ’ sopravivenza mingħajr progressjoni
Patients with a good prognosis as indicated by tumour stage, Karnofsky performance status (KPS) and age had a more pronounced benefit, when cetuximab was added to platinum-based chemotherapy.
Pazjenti bi pronjosi tajba kif indikat minn- fażi tat- tumur, l- istat tal- prestazzjoni ta ’ Karnofsky (KPS) u l- età, kellhom benefiċċju iktar prominenti meta cetuximab żdied mat- terapija bbażata fuq il- kimoterapija.
In contrast to progression free survival time, no benefit in overall survival time could be demonstrated in patients with KPS ≤ 80 who were 65 years of age or older.
B’ kuntrast mas- sopravivenza mingħajr progressjoni, ma seta ’ jintwera l- ebda benefiċċju fiż- żmien totali ta ’ sopravivenza f’ pazjenti b’ KPS ta ’ ≤ 80 li kellhom 65 sena jew aktar.
12 5.2 Pharmacokinetic properties
5. 2 Tagħrif farmakokinetiku
Cetuximab pharmacokinetics were studied when cetuximab was administered as monotherapy or in combination with concomitant chemotherapy or radiation therapy in clinical studies.
Il- farmakokinetika ta ’ cetuximab ġiet studjata meta cetuximab ingħata bħala monoterapija jew flimkien ma ’ kimoterapija fl- istess ħin jew ma ’ terapija bir- raġġi fi studji kliniċi.
Intravenous infusions of cetuximab exhibited dose-dependent pharmacokinetics at weekly doses ranging from 5 to 500 mg/ m² body surface area.
Infużjonijiet ġol- vina ta ’ cetuximab urew riżultati farmakokinetiċi li kienu jiddependu mid- dożi li jingħataw ta ’ kull ġimgħa, li varjaw minn 5 sa 500 mg/ m² ta ’ erja tas- superfiċje tal- ġisem.
When cetuximab was administered at an initial dose of 400 mg/ m² body surface area, the mean volume of distribution was approximately equivalent to the vascular space (2.9 l/ m² with a range of 1.5 to 6.2 l/ m²).
Meta cetuximab ingħata f’ doża tal- bidu ta ’ 400 mg/ m² ta ’ erja tas- superfiċje tal- ġisem, il- medja tal- volum tad- distribuzzjoni kienet bejn wieħed u ieħor ekwivalenti għall- ispazju vaskulari (2. 9 l/ m² b’ medda ta ’ 1. 5 sa 6. 2 l/ m²).
The mean Cmax (± standard deviation) was 185±55 microgram per ml.
Il- medja tas- Cmax (± devjazzjoni standard) kienet ta ’ 185±55 mikrogrammi f’ kull 1 ml.
The mean clearance was 0.022 l/ h per m² body surface area.
Il- medja tal- eliminazzjoni kienet ta ’ 0. 022 l/ siegħa għal kull 1 m² ta ’ erja tas- superfiċje tal- ġisem.
Cetuximab has a long elimination half-life with values ranging from 70 to 100 hours at the target dose.
Cetuximab għandu half- life twila ta ’ l- eliminazzjoni b’ valuri li jvarjaw minn 70 sa 100 siegħa fid- doża mistennija.
Cetuximab serum concentrations reached stable levels after three weeks of cetuximab monotherapy.
Il- konċentrazzjonijiet ta ’ cetuximab fis- serum laħqu livelli stabbli wara tliet ġimgħat ta ’ monoterapija b’ cetuximab.
Mean peak cetuximab concentrations were 155.8 microgram per ml in week 3 and 151.6 microgram per ml in week 8, whereas the corresponding mean trough concentrations were 41.3 and 55.4 microgram per ml, respectively.
Il- medja tal- konċentrazzjonijiet massimi ta ’ cetuximab kienet ta ’ 155. 8 mikrogrammi f’ kull 1 ml f’ ġimgħa 3, u 151. 6 mikrogrammi f’ kull 1 ml f’ ġimgħa 8, filwaqt li l- medja tal- konċentrazzjonijiet l- iktar baxxi kienet ta ’ 41. 3 u 55. 4 mikrogrammi f’ kull 1 ml, rispettivament.
In a study of cetuximab administered in combination with irinotecan, the mean cetuximab trough levels were 50.0 microgram per ml in week 12 and 49.4 microgram per ml in week 36.
Fi studju dwar cetuximab mogħti flimkien ma ’ irinotecan, il- medja ta ’ l- inqas livelli ta ’ cetuximab kienet ta ’ 50. 0 mikrogrammi f’ kull 1 ml f’ ġimgħa 12 u 49. 4 mikrogrammi f’ kull 1 ml f’ ġimgħa 36.
Several pathways have been described that may contribute to the metabolism of antibodies.
Ġew deskritti diversi rotot li jistgħu jikkontribwixxu għall- metaboliżmu ta ’ l- antikorpi.
All of these pathways involve the biodegradation of the antibody to smaller molecules, i. e. small peptides or amino acids.
Dawn il- linji kollha jinvolvu l- bijodegradazzjoni ta ’ l- antikorp għal molekuli iżgħar, jiġifieri peptides żgħar jew amino acids.
Pharmacokinetics in special populations
13 Farmakokinetika fi gruppi speċjali
An integrated analysis across all clinical studies showed that the pharmacokinetic characteristics of cetuximab are not influenced by race, age, gender, renal or hepatic status.
Analiżi integrata li tħaddan l- istudji kliniċi kollha uriet li l- karatteristiċi farmakokinetiċi ta ’ cetuximab mhumiex influwenzati mir- razza, l- età, is- sess, jew l- istat tal- kliewi jew tal- fwied.
Dose-dependent skin alterations, starting at dose levels equivalent to those used in humans, were the major findings observed in toxicity studies with Cynomolgus monkeys (a chronic repeat-dose toxicity study and an embryo-foetal development study).
Bidliet fil- ġilda li jiddependu mid- doża, li jibdew f’ livelli ta ’ doża li huma ekwivalenti għal dawk li jintużaw fil- bnedmin, kienu s- sejbiet importanti osservati fl- istudji dwar l- effett tossiku li saru fuq xadini tar- razza Cynomolgus (studju dwar l- effett tossiku minn dożi ripetuti u studju dwar l- iżvilupp embrijo- fetali.
An embryo-foetal toxicity study in Cynomolgus monkeys revealed no signs of teratogenicity.
Studju dwar it- tossiċità embrijo- fetali f’ xadini tar- razza Cynomolgus ma żvela l- ebda sinjali ta ’ teratoġeniċità.
However, dependent on the dose, an increased incidence of abortion was observed.
Madankollu, skond id- doża, kienet osservata żieda fl- inċidenza ta ’ abort.
Non-clinical data on genotoxicity and local tolerance including accidental administration by routes other than the intended infusion revealed no special hazard for humans.
Informazzjoni mhix klinika dwar l- effett tossiku fuq il- ġeni u tolleranza lokali li tinkludi l- għoti bla ħsieb minn rotot oħrajn li ma kienux dawk intenzjonati għall- infużjoni, ma wrew l- ebda periklu speċjali għall- bnedmin.
No formal animal studies have been performed to establish the carcinogenic potential of cetuximab or to determine its effects on male and female fertility.
Ma saru l- ebda studji formali fuq annimali biex jistabbilixxu l- potenzjal karċinoġeniku ta ’ cetuximab jew biex jiddeterminaw l- effetti tiegħu fuq il- fertilità maskili u femminili.
Toxicity studies with co-administration of cetuximab and chemotherapeutic agents have not been performed.
Ma saru l- ebda studji dwar it- tossiċità bl- għoti flimkien ta ’ cetuximab u mediċini kemoterapewtiċi.
No non-clinical data on the effect of cetuximab on wound healing are available to date.
S’ issa m’ hemm l- ebda informazzjoni mhux klinika fuq l- effett ta ’ cetuximab fuq il- fejqan tal- feriti.
However, in preclinical wound healing models EGFR selective tyrosine kinase inhibitors were shown to retard wound healing.
Madankollu, f’ mudelli ta ’ qabel l- użu kliniku dwar il- fejqan tal- feriti, intwera li inibituri kinase tyrosine selettivi EGFR ifixklu l- fejqan tal- feriti.
Sodium dihydrogen phosphate Disodium phosphate Sodium chloride Water for injections
Sodium dihydrogen phosphate Disodium phosphate Sodium chloride Water for injections
A separate infusion line must be used.
Għandha tintuża linja separata ta ’ l- infużjoni.
Chemical and physical in-use stability of Erbitux 2 mg/ ml has been demonstrated for 20 hours at 25ºC.
14 L- istabbiltà kimika u l- istabbiltà fiżika waqt l- użu ta ’ Erbitux 2 mg/ ml ma nbidletx tul 20 siegħa f’ temperatura ta ’ 25ºC.
Erbitux does not contain any antimicrobial preservative or bacteriostatic agent.
Erbitux ma fih l- ebda sustanza preservattiva jew batterjostatika kontra l- mikrobi.
From a microbiological point of view, the product shall be used immediately after opening.
Mill- aspett mikrobijoloġiku, il- prodott għandu jintuża immedjatament wara li jinfetaħ.
If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8ºC, unless opening has taken place in controlled and validated aseptic conditions.
Jekk ma jintużax immedjatament, iż- żmien tal- ħażna waqt l- użu u l- kundizzjonijiet ta ’ qabel l- użu huma r- responsabbiltà ta ’ min qed jużah, u normalment ma jkunx iżjed minn 24 siegħa f’ temperatura ta ’ 2 sa 8°C, ħlief jekk il- ftuħ ikun sar f’ kundizzjonijiet asettiċi kkontrollati u vverifikati.
Store in a refrigerator (2°C - 8°C).
Aħżen fi friġġ (2°C - 8°C).
For storage conditions after opening, see section 6.3.
Għall- kundizzjonijiet ta ’ ħażna wara li jinfetaħ, ara sezzjoni 6. 3.
50 ml of solution in a vial (Type I glass) with a stopper (teflon-coated bromobutyl rubber) and a seal (aluminium).
50 ml ta ’ soluzzjoni f’ kunjett (ħġieġ ta ’ Tip I) b’ tapp (tal- lastku bromobutyl miksi bit- teflon) u siġill (aluminju).
Pack size of 1.
Daqs tal- pakkett ta ’ 1.
Erbitux may be administered via a gravity drip, an infusion pump or a syringe pump.
Erbitux jista ’ jingħata permezz ta ’ gravity drip, pompa ta ’ l- infużjoni jew pompa tas- siringa.
A separate infusion line must be used for the infusion, and the line must be flushed with sterile sodium chloride 9 mg/ ml (0.9%) solution for injection at the end of infusion.
Linja separata ta ’ l- infużjoni trid tintuża għall- infużjoni, u l- linja trid titlaħlaħ fit- tmiem ta 'l- infużjoni b’ sodium chloride 9 mg/ ml (0. 9%) soluzzjoni sterili għall- injezzjoni.
Erbitux 2 mg/ ml is a colourless solution that may contain product-related whitish and amorphous visible particles.
Erbitux 2 mg/ ml hu soluzzjoni bla kulur li jista ’ jkun fiha frak viżibbli marbuta mal- prodott li huma bojod u bla sura.
These particles do not affect the quality of the product.
Dawn il- frak ma jaffettwawx il- kwalità tal- prodott.
Nevertheless, the solution must be filtered with an in-line filter of 0.2 micrometer or 0.22 micrometer nominal pore size during administration.
Madankollu, is- soluzzjoni trid tkun iffiltrata permezz ta ’ filtru in- line 0. 2 mikrometri jew 0. 22 mikrometri daqs nominali tal- pori matul l- għoti.
14 Erbitux 2 mg/ ml is compatible • with polyethylene, ethyl vinyl acetate or polyvinyl chloride bags, • with polyethylene, ethyl vinyl acetate, polyvinyl chloride, polybutadiene or polyurethane infusion sets, • with polyethersulfone, polyamide or polysulfone in-line filters.
Erbitux 2 mg/ ml hu kompatibbli • ma ’ boroż tal- polyethylene, ethyl vinyl acetate jew polyvinyl chloride, • ma ’ settijiet ta ’ l- infużjoni tal- polyethylene, ethyl vinyl acetate, polyvinyl chloride, polybutadiene jew polyurethane, • ma ’ filtri in- line tal- polyethersulfone, polyamide jew polysulfone.
Care must be taken to ensure aseptic handling when preparing the infusion.
Għandha tingħata attenzjoni biex jiġi żgurat l- immaniġġjar asettiku meta tipprepara l- infużjoni.
Erbitux 2 mg/ ml must be prepared as follows:
Erbitux 2 mg/ ml għandu jkun ippreparat kif ġej:
• In-line filtration with an infusion pump or gravity drip:
• Filtrazzjoni in- line b’ pompa ta ’ l- infużjoni jew gravity drip:
Take an appropriate sterile syringe (minimum 50 ml) and attach a suitable needle.
Uża siringa sterili adattata (minimu ta ’ 50 ml) u waħħal labra adattata.
Draw up the required volume of Erbitux from a vial.
Iġbed il- volum meħtieġ ta ’ Erbitux minn kunjett.
Transfer the Erbitux into a sterile evacuated container or bag.
Ittrasferixxi Erbitux ġo kontenitur jew borża vojta sterili.
Repeat this procedure until the calculated volume has been reached.
Irrepeti din il- proċedura sakemm ikollok il- volum li trid.
Insert a suitable in-line filter into the infusion line and prime it with Erbitux or sterile sodium chloride 9 mg/ ml (0.9%) solution before starting the infusion.
Daħħal filtru in- line adattat ġol- linja ta ’ l- infużjoni u imliha (prime it) b’ Erbitux jew b’ soluzzjoni sterili ta ’ sodium chloride 9 mg/ ml (0. 9%) qabel ma ’ tibda l- infużjoni.
Use a gravity drip or an infusion pump for administration.
Uża gravity drip jew pompa ta ’ l- infużjoni biex tagħti l- mediċina.
Set and control the rate as explained in section 4.2.
Issettja u ikkontrolla r- rata kif spjegat f’ sezzjoni 4. 2.
• In-line filtration with a syringe pump:
15 • Filtrazzjoni in- line b’ pompa tas- siringa:
Remove the needle and put the syringe into the syringe pump.
Neħħi l- labra u poġġi s- siringa ġol- pompa tas- siringa.
Take a suitable in-line filter and connect it to the application set.
Ħu filtru in- line u waħħlu mas- sett ta ’ l- għoti.
Connect the infusion line to the syringe, set and control the rate as explained in section 4.2 and start the infusion after priming the line with Erbitux or sterile sodium chloride 9 mg/ ml (0.9%) solution.
Waħħal il- linja ta ’ l- infużjoni mas- siringa, issettja u ikkontrolla r- rata kif spjegat f’ sezzjoni 4. 2 u ibda l- infużjoni wara li tagħmel priming tal- linja b’ Erbitux jew b’ soluzzjoni sterili ta ’ sodium chloride 9 mg/ ml (0. 9%).
Repeat this procedure until the calculated volume has been infused.
Irrepeti din il- proċedura sakemm jingħata il- volum ikkalkulat.
Filters may occasionally clog up during the infusion.
Il- filtri kultant jistgħu jinstaddu waqt l- infużjoni.
If there is evidence of filter clogging, the filter must be replaced.
Jekk jiġri hekk, il- filtru għandu jinbidel.
Merck KGaA, 64271 Darmstadt, Germany
Merck KGaA, 64271 Darmstadt, Ġermanja
Erbitux 5 mg/ ml solution for infusion
Erbitux 5 mg/ ml soluzzjoni għall- infużjoni
Each ml of solution for infusion contains 5 mg cetuximab.
Kull 1 ml ta ’ soluzzjoni għall- infużjoni fih 5 mg ta ’ cetuximab.
Each vial contains 10 ml, 20 ml, 50 ml or 100 ml.
Kull kunjett fih 10 ml, 20 ml, 50 ml jew 100 ml.
Erbitux 5 mg/ ml is a colourless solution.
Erbitux 5 mg/ ml hu soluzzjoni bla kulur.
16 Colorectal cancer
17 Kanċer tal- kolon u tar- rektum
Erbitux 5 mg/ ml is administered intravenously with an infusion pump, gravity drip or a syringe pump (for handling instructions, see section 6.6).
Erbitux 5 mg/ ml jingħata minn ġol- vina b’ pompa ta ’ l- infużjoni, gravity drip jew pompa tas- siringa (għal struzzjonijiet dwar l- immaniġġjar ara sezzjoni 6. 6).
For the initial dose, the recommended infusion period is 120 minutes.
Għad- doża tal- bidu, il- perijodu rrakkomandat ta ’ l- infużjoni hu ta ’ 120 minuta.
For the subsequent weekly doses, the recommended infusion period is 60 minutes.
Għad- dożi sussegwenti ta ’ kull ġimgħa, il- perijodu rrakkomandat ta ’ l- infużjoni hu ta ’ 60 minuta.
The maximum infusion rate must not exceed 10 mg/ min.
Ir- rata massima ta ’ l- infużjoni ma tridx taqbeż 10 mg/ min.
17 4.4 Special warnings and precautions for use
18 4. 4 Twissijiet speċjali u prekawzjonijiet għall- użu
18 Neutropenia and related infectious complications
19 In- newtropenja u kumplikazzjonijiet infettivi marbuta magħha.
It is strongly recommended that Erbitux be given during pregnancy or to any woman not employing adequate contraception only if the potential benefit justifies a potential risk to the foetus.
20 Hu rrakkomandat bil- qawwa li Erbitux jingħata biss matul it- tqala jew lil kwalunkwe mara li ma tkunx qed tuża kontraċezzjoni adegwata jekk il- benefiċċju potenzjali jiġġustifika r- riskju potenzjali lill- fetu.
19 It is recommended that women do not breast-feed during treatment with Erbitux and for 2 months after the last dose, because it is not known whether cetuximab is excreted in breast milk.
Hu rrakkomandat li n- nisa ma jreddgħux matul il- kura b’ Erbitux u għal xahrejn wara l- aħħar doża, għax mhux magħruf jekk cetuximab jgħaddix fil- ħalib tas- sider.
Skin and subcutaneous tissue disorders
21 Disturbi fil- ġilda u fit- tessuti ta ’ taħt il- ġilda
20 Metabolism and nutrition disorders
Disturbi fil- metaboliżmu
Skin reactions
22 Reazzjonijiet tal- ġilda
21 Skin lesions induced by cetuximab may predispose patients to superinfections (e. g. with S. aureus), which may lead to subsequent complications, e. g. cellulitis, erysipelas, or, potentially with fatal outcome, staphylococcal scalded skin syndrome or sepsis.
Leżjonijiet fil- ġilda kkaġunati minn cetuximab jistgħu jippredisponu lill- pazjenti għal superinfezzjonijiet (eż. b’ S. aureus), li jistgħu jinfexxu f’ kumplikazzjonijiet oħra, eż. ċellulite, erysipelas, jew, potenzjalment b’ riżultat fatali, is- sindrome ta ’ ġilda mismuta bi staphylococcus jew b’ xi mikrobu ieħor.
Mechanism of action
23 Mekkaniżmu ta ’ kif jaħdem
22 Cetuximab does not bind to other receptors belonging to the HER family.
Cetuximab ma jeħilx ma ’ riċetturi oħrajn li jappartienu għall- familja HER.
In metastatic colorectal cancer, the incidence of KRAS mutations is in the range of 30 - 50%.
24 F’ kanċer metastatiku tal- kolon u tar- rektum, l- inċidenza ta ’ mutazzjonijiet tal- ġene KRAS hi fil- medda ta ’ 30 - 50%.
23 Cetuximab in combination with chemotherapy
Cetuximab flimkien mal- kimoterapija
The efficacy data generated in this study are summarised in the table below:
25 L- informazzjoni dwar l- effikaċja li ħarġet minn dan l- istudju hi deskritta fil- qosor fit- tabella hawn taħt:
24 A significant difference in overall survival time could not be shown in this study.
Differenza sinifikanti fiż- żmien totali ta ’ sopravivenza ma setgħetx tintwera f’ dan l- istudju.
Addition of cetuximab to best supportive care reduced the overall risk of death in the overall study population by 23% and the overall risk of disease progression by 32%.
26 Iż- żieda ta ’ cetuximab ma ’ l- aħjar kura ta ’ appoġġ naqqset ir- riskju totali ta ’ mewt fil- popolazzjoni totali ta ’ l- istudju bi 23% u riskju totali tal- progressjoni tal- marda bi 32%.
25 The efficacy data generated in this study are summarised in the table below:
L- informazzjoni dwar l- effikaċja li ħarġet minn dan l- istudju hi deskritta fil- qosor fit- tabella hawn taħt:
The efficacy data generated in this study are summarised in the table below:
27 L- informazzjoni dwar l- effikaċja li ħarġet minn dan l- istudju hi deskritta fil- qosor fit- tabella hawn taħt:
26 5.2 Pharmacokinetic properties
5. 2 Tagħrif farmakokinetiku
Pharmacokinetics in special populations
28 Farmakokinetika fi gruppi speċjali
Sodium chloride Glycine Polysorbate 80 Citric acid monohydrate Sodium hydroxide Water for injections
Sodium chloride Glycine Polysorbate 80 Citric acid monohydrate Sodium hydroxide Water for injections
6.3 Shelf life
29 6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
Chemical and physical in-use stability of Erbitux 5 mg/ ml has been demonstrated for 48 hours at 25ºC, if the solution is prepared as described in section 6.6.
L- istabbiltà kimika u l- istabbiltà fiżika waqt l- użu ta ’ Erbitux 5 mg/ ml ma nbidletx tul 48 siegħa f’ temperatura ta ’ 25°C, jekk is- soluzzjoni tkun ippreparata kif deskritt f’ sezzjoni 6. 6.
10 ml, 20 ml, 50 ml or 100 ml of solution in a vial (Type I glass) with a stopper (flurotec-coated bromobutyl rubber) and a seal (aluminium/ polypropylen).
10 ml, 20 ml, 50 ml jew 100 ml ta ’ soluzzjoni f’ kunjett (ħġieġ ta ’ Tip I) b’ tapp (tal- lastku bromobutyl miksi bil- flurotec) u siġill (aluminju/ polypropylen).
Not all vial sizes may be marketed.
Jista ’ jkun li mhux il- kunjetti tad- daqsijiet kollha jkunu għall- skop kummerċjali.
28 Erbitux 5 mg/ ml is compatible • with polyethylene (PE), ethyl vinyl acetate (EVA) or polyvinyl chloride (PVC) bags, • with polyethylene (PE), polyurethane (PUR), ethyl vinyl acetate (EVA), polyolefine thermoplastic (TP) or polyvinyl chloride (PVC) infusion sets, • with polypropylene (PP) syringes for syringe pump.
Erbitux 5 mg/ ml hu kompatibbli • ma ’ boroż tal- polyethylene (PE), ethyl vinyl acetate (EVA) jew polyvinyl chloride (PVC), • ma ’ settijiet ta ’ l- infużjoni tal- polyethylene (PE), polyurethane (PUR), ethyl vinyl acetate (EVA), polyolefine thermoplastic (TP) jew polyvinyl chloride (PVC), • ma ’ siringi tal- polypropylene (PP) għall- pompa tas- siringa.
Erbitux 5 mg/ ml must be prepared as follows:
Erbitux 5 mg/ ml għandu jkun ippreparat kif ġej:
• For administration with infusion pump or gravity drip (diluted with sterile sodium chloride 9 mg/ ml (0.9%) solution):
• Biex tagħti l- infużjoni bil- pompa jew bi gravity drip (dilwita b’ soluzzjoni sterili ta ’ sodium chloride 9 mg/ ml (0. 9%)):
Take an infusion bag of adequate size of sterile sodium chloride 9 mg/ ml (0.9%) solution.
Uża borża ta ’ l- infużjoni ta ’ daqs adegwat ta ’ soluzzjoni sterili ta ’ sodium chloride 9 mg/ ml (0. 9%).
Calculate the required volume of Erbitux.
Ikkalkula l- volum meħtieġ ta ’ Erbitux.
Remove an adequate volume of the sodium chloride solution from the infusion bag, using an appropriate sterile syringe with a suitable needle.
Neħħi volum adegwat tas- soluzzjoni ta ’ sodium chloride mill- borża ta ’ l- infużjoni, billi tuża siringa sterili adattata ma ’ labra adattata.
Take an appropriate sterile syringe and attach a suitable needle.
Uża siringa sterili adattata u waħħal labra adattata.
Transfer the Erbitux into the prepared infusion bag.
Ittrasferixxi Erbitux ġol- borża ppreparata ta ’ l- infużjoni.
Connect the infusion line and prime it with the diluted Erbitux before starting the infusion.
Waħħal il- linja ta ’ l- infużjoni u imliha (prime it) b’ Erbitux dilwit qabel ma ’ tibda l- infużjoni.
• For administration with infusion pump or gravity drip (undiluted):
30 • Biex tagħti l- infużjoni bil- pompa jew bi gravity drip (mhux dilwit):
Connect the infusion line and prime it with Erbitux before starting the infusion.
Waħħal il- linja ta ’ l- infużjoni u imliha (prime it) b’ Erbitux qabel ma ’ tibda l- infużjoni.
• For administration with a syringe pump:
• Meta tuża pompa tas- siringa:
Connect the infusion line to the syringe, set and control the rate as explained in section 4.2 and start the infusion after priming the line with Erbitux or sterile sodium chloride 9 mg/ ml (0.9%) solution.
Waħħal il- linja ta ’ l- infużjoni mas- siringa, mas- sett u ikkontrolla r- rata tal- infużjoni kif spjegat f’ sezzjoni 4. 2 u ibda l- infużjoni wara li tagħmel priming tal- linja b’ Erbitux jew b’ soluzzjoni sterili ta ’ sodium chloride 9 mg/ ml (0. 9%).
If necessary, repeat this procedure until the calculated volume has been infused.
Jekk ikun meħtieġ, irrepeti din il- proċedura sakemm jingħata l- volum ikkalkulat.
31 A.
31 ANNESS II
MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTURI TAS- SUSTANZA BIJOLOĠIKA ATTIVA U DETENTUR TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- HRUĠ TAL- LOTT
Name and address of the manufacturers of the biological active substance
KUNDIZZJONIJIET TA 'L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
Merck KGaA Frankfurter Straße 250 64293 Darmstadt Germany
Merck KGaA Frankfurter Straße 250 64293 Darmstadt Ġermanja
65 88397 Biberach Germany
65 88397 Biberach Ġermanja
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FUQ IL- FORNIMENT U L- UŻU • IMPOSTI FUQ ID- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
Summary of Product Characteristics, section 4.2).
Sommarju tal - Karatteristiċi tal- Prodott, sezzjoni 4. 2).
• CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FIR- RIGWARD TA ’ L- UŻU • MINGĦAJR PERIKLU U EFFETTIV TAL- PRODOTT MEDIĊINALI
• OTHER CONDITIONS
KUNDIZZJONIJIET OĦRA •
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 9.0 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 dwar l- Immaniġġjar tar- Riskju Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq jikkommetti ruħu li jwettaq l- istudji u attivitajiet addizzjonali ta ’ farmakoviġilanza deskritti fil- Pjan tal- Farmakoviġilanza kif miftehma f’ verżjoni 9. 0 tal- Pjan dwar l- Immaniġġjar tar- Riskju (RMP) ippreżentat fil- modulu 1. 8. 2. tal- Applikazzjoni ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq u kwalunkwe aġġornamenti sussegwenti tal- RMP mifthema mill- CHMP.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Skond il- Linja Gwida CHPM dwar is- Sistemi ta ’ l- Immaniġġjar tar- Riskju għal prodotti mediċinali għall- użu uman, l- RMP aġġornat għandu jkun sottomess fl- istess ħin mar- Rapport Perjodiku dwar l- Aġġornament tas- Sigurtà (PSUR) li jmiss.
32 In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
33 Barra minn hekk, għandu jkun sottomess RMP aġġornat: • Meta wieħed jirċievi informazzjoni ġdida li tista ’ teffetwa l- ispeċifikazzjoni tas- Sigurta` kurrenti, il- Pjan ta ’ Farmakoviġilanza jew attivitajiet li jnaqqsu r- riskji • Fi żmien 60 jum minn meta jintlaħaq punt importanti (ta ’ Farmakoviġilanza jew tnaqqis ta ’ riskju) • Fuq talba tal- EMEA.
34 A.
34 ANNESS III
35 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
TIKKETTA
1 ml contains 2 mg cetuximab.
1 ml fih 2 mg ta ’ cetuximab.
Sodium dihydrogen phosphate, disodium phosphate, sodium chloride, water for injections
Sodium dihydrogen phosphate, disodium phosphate, sodium chloride, ilma għall- injezzjoni
Solution for infusion, 1 vial of 50 ml
Soluzzjoni għall- infużjoni, 1 kunjett ta ’ 50 ml
Administer via in-line filtration.
Agħti permezz ta ’ filtrazzjoni in- line.
37 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
38 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Cetuximab Intravenous use.
Cetuximab Użu għal ġol- vini.
38 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
39 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
1 ml contains 5 mg cetuximab.
1 ml fih 5 mg ta ’ cetuximab.
Sodium chloride, glycine, polysorbate 80, citric acid monohydrate, sodium hydroxide, water for injections
Sodium chloride, glycine, polysorbate 80, citric acid monohydrate, sodium hydroxide, ilma għall- injezzjoni
Solution for infusion, 1 vial of 10 ml
Soluzzjoni għall- infużjoni, 1 kunjett ta ’ 10 ml
40 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
41 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
Solution for infusion, 1 vial of 20 ml
Soluzzjoni għall- infużjoni, 1 kunjett ta ’ 20 ml
43 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
44 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
44 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
45 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
46 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
47 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
47 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
48 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Solution for infusion, 1 vial of 100 ml
Soluzzjoni għall- infużjoni, 1 kunjett ta ’ 100 ml
49 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
50 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
51 PACKAGE LEAFLET:
FULJETT TA ’ TAGĦRIF
Erbitux 2 mg/ ml solution for infusion Cetuximab
Erbitux 2 mg/ ml soluzzjoni għall- infużjoni Cetuximab
You may need to read it again. • If you have any further questions, ask your doctor. • If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Jista ’ jkollok bżonn terġa ’ taqrah. • Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib 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 Erbitux is and what it is used for 2.
X’ inhu Erbitux u għalxiex jintuża 2.
Before you use Erbitux 3.
Qabel ma tuża Erbitux 3.
How to use Erbitux 4.
Kif għandek tuża Erbitux 4.
How to store Erbitux 6.
Kif taħżen Erbitux 6.
WHAT ERBITUX IS AND WHAT IT IS USED FOR
X’ INHU ERBITUX U GĦALXIEX JINTUŻA
What Erbitux is
X’ inhu Erbitux
Erbitux contains cetuximab, a monoclonal antibody.
Erbitux fih cetuximab, antikorp monoklonali.
Monoclonal antibodies are proteins that specifically recognise and bind to other unique proteins called antigens.
Antikorpi monoklonali huma proteini li speċifikament jagħrfu u jeħlu ma ’ proteini uniċi oħrajn imsejħa antiġeni.
Cetuximab binds to the epidermal growth factor receptor (EGFR), an antigen on the surface of certain cancer cells.
Cetuximab jeħel ma ’ l- epidermal growth factor receptor (EGFR), antiġen li jinsab fil- wiċċ ta ’ ċerti ċelluli tal- kanċer.
As a result of this binding, the cancer cell can no longer receive the messages it needs for growth, progression and metastasis.
Bħala riżultat ta ’ dan it- twaħħil, iċ- ċellula tal- kanċer ma tkunx tista ’ tirċievi iżjed il- messaġġi li għandha bżonn għat- tkabbir, il- progressjoni u l- metastasi.
What Erbitux is used for
Għalxiex jintuża Erbitux
Erbitux is used to treat two different types of cancer:
Erbitux jintuża għall- kura ta ’ żewġ tipi differenti ta ’ kanċer:
• metastatic cancer of the large intestine.
• kanċer metastatiku tal- musrana l- kbira.
In these patients, Erbitux is used alone or in combination with other anticancer medicines.
F’ dawn il- pazjenti, Erbitux jintuża waħdu jew flimkien ma ’ mediċini oħrajn kontra l- kanċer.
• squamous cell cancer of the head and neck.
• kanċer taċ- ċelluli skwamużi fir- ras u fl- għonq.
In these patients, Erbitux is used in combination with radiation therapy or with other anticancer medicines.
F’ dawn il- pazjenti, Erbitux jintuża flimkien ma ’ terapija bir- raġġi jew flimkien ma ’ mediċini oħrajn kontra l- kanċer.
BEFORE YOU USE ERBITUX
QABEL MA TUŻA ERBITUX
Do not use Erbitux Do not use Erbitux if you have ever had a severe hypersensitivity (allergic) reaction to cetuximab.
Tużax Erbitux Tużax Erbitux jekk xi darba kellek sensittività eċċessiva severa (jiġifieri kont allerġiku/ a) għal cetuximab.
52 Take special care with Erbitux Erbitux may cause infusion-related side effects.
53 Oqgħod attent ħafna b ’ Erbitux Erbitux jista ’ jikkawża effetti sekondarji marbuta ma ’ l- infużjoni.
Such reactions may be allergic in nature.
Dawn ir- reazzjonijiet jistgħu jkunu allerġiċi fin- natura tagħhom.
Please read'Infusion-related side effects' in section 4 for details, as they may have serious consequences for you, including life-threatening conditions.
Jekk jogħġbok aqra ‘ Effetti sekondarji marbuta ma ’ l- infużjoni ’ f’ sezzjoni 4 għad- dettalji, għax dawn jista ’ jkollhom konsegwenzi serji fuqek, li jinkludu kundizzjonijiet li huma ta ’ periklu għall- ħajja.
These side effects normally occur during the infusion, within 1 hour afterwards, or sometimes also after this period.
Dawn l- effetti sekondarji normalment iseħħu waqt l- infużjoni, fi żmien siegħa wara l- infużjoni, jew xi kultant ukoll iktar tard.
To recognise early signs of such effects, your condition will be checked regularly while you receive each infusion of Erbitux and for at least 1 hour afterwards.
Biex tagħraf is- sinjali tal- bidu ta ’ effetti bħal dawn, il- kundizzjoni tiegħek ser tkun iċċekkjata regolarment kull darba li tingħata infużjoni ta ’ Erbitux, u għal mill- inqas siegħa wara.
If you receive Erbitux in combination with anticancer medicines including platinum, it is more likely that your white blood cell count may be reduced.
Jekk tirċievi Erbitux flimkien ma ’ mediċini kontra l- kanċer li jinkludu l- platinum, x’ aktarx li jkun iktar possibbli li l- għadd taċ- ċelluli tad- demm bojod tiegħek jista ’ jonqos.
Your doctor will therefore monitor your blood and general condition for signs of infection (see also'Side effects in combination with other anticancer treatments' in section 4).
It- tabib tiegħek għalhekk ser jimmonitorja d- demm u kundizzjoni ġenerali tiegħek għal sinjali ta ’ infezzjoni (ara wkoll ‘ Effetti sekondarji flimkien ma ’ kuri oħrajn kontra l- kanċer ’ f’ sezzjoni 4).
Using other medicines Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Meta tuża mediċini oħra Jekk jogħġbok għid lit- tabib tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
Pregnancy Tell your doctor if you are pregnant or if you are not using reliable contraception (speak to your doctor if you are not sure).
Tqala Għid lit- tabib tiegħek jekk inti tqila jew jekk m’ intix tuża kontraċezzjoni affidabbli (kellem lit- tabib tiegħek jekk m’ intix ċerta).
Your doctor will then discuss with you the risks and benefits of using Erbitux in these situations.
It- tabib tiegħek ser jiddiskuti miegħek ir- riskji u l- benefiċċji ta ’ l- użu ta ’ Erbitux waqt it- tqala f’ dawn is- sitwazzjonijiet.
Breast-feeding Do not breast-feed your baby during the period over which you are being treated with Erbitux and for two months after the last dose.
Treddigħ Treddax lit- tarbija tiegħek matul il- perijodu li fih tkun qed tiġi kkurata b’ Erbitux, u għal xahrejn wara l- aħħar doża.
Driving and using machines Do not drive or use any tools or machines if you experience treatment-related symptoms that affect your ability to concentrate and react.
Sewqan u tħaddim ta ’ magni Issuqx u m’ għandekx tagħmel użu minn għodda jew tħaddem magni jekk ikollok sintomi marbuta mal- kura li jaffettwaw il- ħila tiegħek li tikkonċentra u tirreaġixxi.
HOW TO USE ERBITUX
KIF GĦANDEK TUŻA ERBITUX
A doctor experienced in the use of anticancer medicines will supervise your Erbitux therapy.
Tabib b’ esperjenza fl- użu ta ’ mediċini kontra l- kanċer ser jissorvelja t- terapija tiegħek b’ Erbitux.
During each infusion and for at least 1 hour afterwards, your condition will be checked regularly for early signs of a possible infusion-related side effect.
Waqt kull infużjoni u għal mill- inqas siegħa wara, il- kundizzjoni tiegħek ser tkun iċċekkjata regolarment għal sinjali bikrin ta ’ effett sekondarju marbut ma ’ l- infużjoni.
Pre-treatment
Qabel il- kura
Before the first dose, you will receive an antiallergic medicine in order to reduce the risk of an allergic reaction.
Qabel l- ewwel doża, inti ser tirċievi mediċina kontra l- allerġija sabiex tnaqqas ir- riskju ta ’ reazzjoni allerġika.
Your doctor will decide whether such pre-treatment is necessary for subsequent doses.
It- tabib tiegħek ser jiddeċiedi jekk din il- kura preventiva hix meħtieġa għal dożi sussegwenti.
Dosage and administration
Dożaġġ u kif jingħata
Erbitux is usually infused into a vein (given as a drip) once a week.
Erbitux normalment jingħata bħala infużjoni ġo vina (mogħti bħala dripp) darba f’ ġimgħa.
Your doctor will calculate the correct dose of Erbitux for you because it depends on your body surface area.
It- tabib tiegħek ser jikkalkula d- doża ta ’ Erbitux li għandek bżonn, għax din tiddependi fuq l- erja tas- superfiċje ta ’ ġismek.
The first dose (400 mg/ m² body surface area) is infused over a period of approximately 2 hours.
L- ewwel doża (400 mg/ m² ta ’ erja tas- superfiċje tal- ġisem) hi nfuża fuq perijodu ta ’ madwar sagħtejn.
Each subsequent dose (250 mg/ m²) is infused in approximately 1 hour.
Kull doża sussegwenti (250 mg/ m²) hi nfuża f’ madwar siegħa.
Erbitux must not be infused more rapidly than 10 mg/ min.
Erbitux m’ għandux ikun infuż b’ rata ta ’ iktar minn 10 mg/ min.
Detailed instructions for your doctor or your nurse on how to prepare the Erbitux infusion are included at the end of this package leaflet (see'Handling instructions').
54 Struzzjonijiet dettaljati għat- tabib jew in- ners tiegħek dwar kif għandhom jippreparaw l- infużjoni b’ Erbitux huma inklużi fit- tmiem ta ’ dan fuljett ta ’ tagħrif (ara ‘ Struzzjonijiet dwar l- immaniġġjar ’).
53 Duration of treatment
Tul tal- kura
Erbitux is usually infused once a week.
Erbitux normalment jingħata bħala infużjoni darba f’ ġimgħa.
The duration of treatment may vary depending on your disease as well as from person to person and your doctor will therefore discuss with you how long you will receive Erbitux.
It- tul ta ’ żmien tal- kura jista ’ jvarja, u dan jiddependi fuq il- marda tiegħek kif ukoll ivarja minn persuna għall- oħra, u għalhekk it- tabib tiegħek ser jiddiskuti miegħek it- tul ta ’ żmien kemm ser iddum tirċievi Erbitux.
Combination with other anticancer treatments
L- għoti ma ’ kuri oħrajn kontra l- kanċer
If you receive Erbitux in combination with other anticancer medicines, these medicines must be administered at least 1 hour after the end of the Erbitux infusion.
Jekk inti tirċievi Erbitux flimkien ma ’ mediċini oħrajn kontra l- kanċer, dawn il- mediċini jridu jingħataw mill- inqas siegħa wara t- tmiem ta ’ l- infużjoni b’ Erbitux.
If you receive Erbitux in combination with radiation therapy, treatment with Erbitux is usually started one week before radiation therapy.
Jekk tirċievi Erbitux flimkien ma ’ terapija bir- raġġi, il- kura b’ Erbitux normalment tinbeda ġimgħa qabel it- terapija bir- raġġi.
Like all medicines, Erbitux can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Erbitux jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
The main side effects of Erbitux are infusion-related side effects and side effects concerning the skin:
L- effetti sekondarji ewlenin ta ’ Erbitux huma effetti sekondarji marbuta ma ’ l- infużjoni u effetti sekondarji li jikkonċernaw l- ġilda:
Infusion-related side effects
Effetti sekondarji marbuta ma ’ l- infużjoni
More than 10 out of 100 patients are likely to experience infusion-related side effects; in more than 1 out of 100 patients these side effects are likely to be severe.
Iktar minn 10 minn kull 100 pazjent x’ aktarx li ser ikollhom effetti sekondarji marbuta ma ’ l- infużjoni; f’ iktar minn 1 minn kull 100 pazjent, dawn l- effetti sekondarji x’ aktarx li ser ikunu severi.
They normally occur during the infusion, within 1 hour afterwards, or sometimes also after this period.
Dawn normalment iseħħu waqt l- infużjoni, jew fi żmien siegħa wara l- infużjoni, jew xi kultant ukoll iktar tard.
Mild or moderate infusion-related side effects include: • fever • chills • dizziness • breathing difficulties If such symptoms occur, please inform your doctor as soon as possible.
Effetti ħfief jew moderati marbuta ma ’ l- infużjoni jinkludu: • deni • tertir ta ’ bard • sturdament • diffikultajiet biex tieħu n- nifs Jekk dawn is- sintomi jseħħu, jekk jogħġbok informa lit- tabib tiegħek kemm jista ’ jkun malajr.
Your doctor may consider reducing the infusion rate of Erbitux to manage these symptoms.
It- tabib tiegħek jista ’ jaħseb biex inaqqas ir- rata ta ’ l- infużjoni ta ’ Erbitux biex jikkontrolla dawn is- sintomi.
Severe infusion-related side effects include: • severe breathing difficulties which develop rapidly • hives • fainting • chest pain (a symptom of side effects on your heart) If such symptoms occur, speak to a doctor immediately.
Effetti sekondarji severi marbuta ma ’ l- infużjoni jinkludu: • diffikultajiet severi biex tieħu n- nifs li jiżviluppaw malajr • urtikarja • ħass ħażin • uġigħ fis- sider (sintomi ta ’ effetti sekondarji fuq qalbek) Jekk dawn is- sintomi jseħħu, kellem lil tabib immedjatament.
These side effects may have serious consequences, in rare cases including life-threatening conditions, and require immediate attention.
Dawn l- effetti sekondarji jista ’ jkollhom konsegwenzi serji, li f’ każijiet rari jinkludu kundizzjonijiet ta ’ periklu għall- ħajja, u jeħtieġu attenzjoni immedjata.
Treatment with Erbitux must then be stopped.
Il- kura b’ Erbitux għandha mbagħad titwaqqaf.
Side effects concerning the skin
55 Effetti sekondarji li jikkonċernaw il- ġilda
More than 80 out of 100 patients are likely to experience side effects involving the skin.
Iktar minn 80 minn kull 100 pazjent x’ aktarx li ser ikollhom effetti sekondarji fil- ġilda.
In about 15 out of 100 patients these skin reactions are likely to be severe.
F’ madwar 15 minn kull 100 pazjent, dawn ir- reazzjonijiet tal- ġilda x’ aktarx li ser ikunu severi.
Most of these side effects develop within the first three weeks of treatment.
Il- biċċa l- kbira ta ’ dawn l- effetti sekondarji jiżviluppaw matul l- ewwel tliet ġimgħat tal- kura.
They usually disappear over time after the end of Erbitux therapy.
Dawn normalment jgħibu maż- żmien wara t- tmiem tat- terapija b’ Erbitux.
54 Main side effects concerning the skin include: • acne-like skin alterations • itching • dry skin • scaling • excessive growth of hair • nail disorders, for example inflammation of the nail bed
Effetti sekondarji ewlenin li jikkonċernaw il- ġilda jinkludu: • bidliet fil- ġilda qishom akne • ħakk • ġilda xotta • ġilda li titqaxxar • tkabbir eċċessiv ta ’ xagħar • disturbi fid- dwiefer, per eżempju infjammazzjoni fil- bażi tad- difer
If you notice extensive skin alterations, please inform your doctor as soon as possible because the Erbitux dose or the time between infusions may need to be changed.
Jekk tinnota tibdil estensiv tal- ġilda, jekk jogħġbok informa lit- tabib tiegħek kemm jista ’ jkun malajr, minħabba li d- doża ta ’ Erbitux jew il- ħin bejn l- infużjonijiet jista ’ jkollhom jinbidlu.
Your doctor will decide whether treatment has to be stopped if skin reactions reappear after several dose reductions.
It- tabib tiegħek ser jiddeċiedi jekk il- kura għandhiex titwaqqaf jekk ir- reazzjonijiet tal- ġilda jitfaċċaw mill- ġdid wara tnaqqis ripetut fid- doża.
If you notice that already affected areas of your skin get worse, speak to a doctor immediately, especially if you also experience general signs of infection such as fever and tiredness.
Jekk tinnota li l- partijiet tal- ġilda tiegħek li huma diġà affettwati jmorru għall- agħar, kellem lil tabib immedjatament, speċjalment jekk flimkien magħhom, ikollok ukoll sinjali ġenerali ta ’ infezzjoni, bħal deni u għeja.
These signs may indicate a skin infection, which may have serious consequences including life-threatening conditions.
Dawn is- sinjali jistgħu jindikaw infezzjoni tal- ġilda, li jista ’ jkollha konsegwenzi serji li jinkludu kundizzjonijiet ta ’ periklu għall- ħajja.
Very common side effects (may occur in more than 10 out of 100 patients) • inflammation of the lining of the intestine, mouth, and nose which may lead to nose bleeding in some patients • decrease in blood levels of magnesium • increase in blood levels of certain liver enzymes
Effetti sekondarji komuni ħafna (li jistgħu jseħħu f’ iktar minn 10 minn kull 100 pazjent) • infjammazzjoni tal- kisja ta ’ l- imsaren, tal- ħalq, u ta ’ l- imnieħer li jistgħu jwasslu għal ħruġ ta ’ demm mill- imnieħer f’ xi pazjenti • tnaqqis fil- livelli fid- demm ta ’ magnesium • żieda fil- livelli fid- demm ta ’ ċerti enzimi tal- fwied
Common side effects (may occur in more than 1 out of 100 patients) • headache • tiredness • irritation and redness of the eye • diarrhoea • drying out which may be due to diarrhoea or reduced fluid intake • feeling sick • vomiting • loss of appetite, leading to weight decrease • decrease in blood levels of calcium
Effetti sekondarji komuni (li jistgħu jseħħu f’ iktar minn 1 minn kull 100 pazjent) • uġigħ ta ’ ras • għeja • irritazzjoni u ħmura ta 'l- għajnejn • dijarea • nuqqas ta ’ likwidu f’ ġismek li jista ’ jkun minħabba d- dijarea jew minħabba nuqqas ta ’ teħid ta ’ fluwidu • tħossok imdardar • rimettar • telf ta ’ aptit, li jwassal għal tnaqqis fil- piż • tnaqqis fil- livelli fid- demm tal- calcium
Uncommon side effects (may occur in less than 1 out of 100 patients) • blood clots in the veins of the legs • blood clots in the lungs • inflammation of the eye lid or the front part of the eye
Effetti sekondarji mhux komuni (li jistgħu jseħħu f’ inqas minn 1 minn kull 100 pazjent) • emboli tad- demm fil- vini tar- riġlejn • emboli tad- demm fil- pulmuni • infjammazzjoni ta ’ tebqet il- għajnejn jew tal- parti ta ’ quddiem ta ’ l- għajn (kornea)
Side effects in combination with other anticancer treatments
Effetti sekondarji flimkien ma ’ kuri oħrajn kontra l- kanċer
If you receive Erbitux in combination with other anticancer medicines, some of the side effects you may experience can also be related to the combination or the other medicines.
Jekk tirċievi Erbitux flimkien ma ’ mediċini oħrajn kontra l- kancer, xi wħud mill- effetti sekondarji li jista ’ jkollok, jistgħu jkunu marbuta wkoll ma ’ din il- kumbinazzjoni tal- mediċina jew mal- mediċini oħrajn.
Therefore, please make sure that you also read the package leaflet for the other medicines.
Għalhekk, jekk jogħġbok aċċerta ruħek li taqra wkoll il- fuljett ta ’ tagħrif għall- mediċini oħrajn.
If you receive Erbitux in combination with anticancer medicines including platinum, it is more likely that your white blood cell count may be reduced.
56 Jekk tirċievi Erbitux flimkien ma ’ mediċini kontra l- kanċer li jinkludu l- platinum, x’ aktarx li jkun iktar possibbli li l- għadd taċ- ċelluli tad- demm bojod tiegħek jista ’ jonqos.
This may lead to infectious complications including life-threatening conditions, especially if you experience skin reactions, inflammation of the lining of the intestine and mouth or diarrhoea.
Dan jista ’ jwassal għal kumplikazzjonijiet infettivi li jinkludu kundizzjonijiet ta ’ periklu għall- ħajja, speċjalment jekk ikollok reazzjonijiet tal- ġilda, infjammazzjoni tal- kisja tal- imsaren u l- ħalq jew dijarea.
Therefore, if you experience general signs of infection such as fever and tiredness, please speak to a doctor immediately.
Għalhekk, jekk ikollok sinjali ġenerali ta ’ infezzjoni bħal deni u għeja, jekk jogħġbok kellem lil tabib immedjatament.
55 If you receive Erbitux in combination with an anticancer medicine containing 5-fluorouracil, it is more likely that you experience the following side effects of this other medicine: • chest pain • heart attack • heart failure • redness and swelling of the palms of the hands or the soles of the feet which may cause the skin to peel (hand-foot syndrome)
Jekk tirċievi Erbitux flimkien ma ’ mediċina kontra l- kanċer li jkun fiha 5- fluorouracil, x’ aktarx li ser ikollok dawn l- effetti sekondarji li ġejjin ta ’ din il- mediċina l- oħra: • uġigħ fis- sider • attakk tal- qalb • insuffiċjenza tal- qalb • ħmura u nefħa tal- kefef ta ’ l- idejn jew fil- qiegħ tas- saqajn li jistgħu jikkawżaw il- ġilda li titqaxxar (sindrome ta ’ l- idejn- saqajn)