natgillin/translations-raw huggingface dataset:
In particular, in these patients negative effects on progression-free survival (PFS) and overall survival (OS) were seen as add-on to FOLFOX4 (see section 5.1). 
Zlasti pri teh bolnikih so opazili negativen vpliv na čas preživetja brez napredovanja bolezni (PFS, progression-free survival time) in na celokupno preživetje (OS, overall survival) pri dodajanju zdravila k FOLFOX4 (glejte poglavje 5.1).
Infusion-related, including anaphylactic, reactions 
Reakcije, povezane z infundiranjem, vključno z anafilaktičnimi
• in combination with radiation therapy for locally advanced disease, 
• v kombinaciji z radioterapijo za lokalno napredovalo bolezen;
The 5 randomised studies investigated a total of 3734 patients with metastatic colorectal cancer, in whom EGFR expression was detectable and who had an ECOG performance status of ≤ 2. 
Pet randomiziranih študij je preučilo skupno število 3734 bolnikov z metastatskim kolorektalnim rakom, pri katerih je bila ugotovljena ekspresija EGFR in pri katerih je bil indeks zmogljivosti ECOG ≤ 2.
• acne-like skin alterations 
• aknam podobne kožne spremembe
What Erbitux is and what it is used for What you need to know before you use Erbitux How to use Erbitux 
Kaj je zdravilo Erbitux in za kaj ga uporabljamo Kaj morate vedeti, preden boste uporabili zdravilo Erbitux Kako uporabljati zdravilo Erbitux Možni neželeni učinki
Of these, 342 patients had RAS wild-type tumours while RAS mutations were identified in 65 patients. 
342 od teh bolnikov je imelo tumorje z nemutiranim tipom RAS, pri 65 bolnikih pa so ugotovili mutacije RAS.
If necessary, repeat this procedure until the calculated volume has been infused. 
Po potrebi ponovite ta postopek, dokler ne bo infundiran ves izračunani volumen.
Some of these reactions may be anaphylactic or anaphylactoid in nature or represent a cytokine release syndrome (CRS). 
Nekatere od teh reakcij imajo lahko anafilaktični ali anafilaktoidni značaj ali predstavljajo sindrom sproščanja citokinov (CRS, cytokine release syndrome).
With the second and third occurrences of severe skin reactions, cetuximab therapy must again be interrupted. 
Ob drugem ali tretjem pojavu hude kožne reakcije morate spet prekiniti terapijo s cetuksimabom.
Other medicines and Erbitux 
Druga zdravila in zdravilo Erbitux
More than 80 out of 100 patients are likely to experience side effects involving the skin. 
Pri več kot 80 od 100 bolnikov obstaja verjetnost, da bodo imeli neželene učinke, povezane s kožo.
Cetuximab has not been studied in patients with pre-existing haematological disorders (see section 4.4). 
Cetuksimaba niso raziskovali pri bolnikih z obstoječimi hematološkimi motnjami (glejte poglavje 4.4).
A formal interaction study showed that the pharmacokinetic characteristics of cetuximab remain unaltered after co-administration of a single dose of irinotecan (350 mg/m2 body surface area). 
Formalna študija medsebojnega delovanja z drugimi zdravili je pokazala, da ostanejo farmakokinetične značilnosti cetuksimaba nespremenjene po sočasni uporabi enkratnega odmerka irinotekana (350 mg/m² telesne površine).
Erbitux is indicated for the treatment of patients with squamous cell cancer of the head and neck 
Zdravilo Erbitux je indicirano za zdravljenje bolnikov z rakom skvamoznih celic glave in vratu
Patients presenting with signs and symptoms suggestive of keratitis such as acute or worsening: eye inflammation, lacrimation, light sensitivity, blurred vision, eye pain and/or red eye should be referred promptly to an ophthalmology specialist. 
Bolnike z znaki in simptomi, ki bi vzbujali sum na keratitis, kot je akutni pojav ali poslabšanje: vnetja očesa, solzenja, občutljivosti na svetlobo, zamegljenega vida, bolečine v očesu in/ali pordelosti očesa, je treba takoj napotiti k specialistu oftalmologu.
In particular a negative effect of cetuximab add-on in the RAS mutant population was observed. 
Opazili so zlasti negativni učinek dodajanja cetuksimaba pri populaciji z mutacijo RAS.
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. 
Če zdravilo Erbitux prejemate v kombinaciji z drugimi zdravili proti raku, je treba ta zdravila vzeti vsaj eno uro po koncu infuzije zdravila Erbitux.
Not all vial sizes may be marketed. 
Na trgu morda ni vseh navedenih pakiranj vial.
A diagnostic assay (EGFR pharmDx) was used for immunohistochemical detection of EGFR expression in tumour material. 
Diagnostični test za EGFR (EGFR pharmDx) je bil uporabljen za imunohistokemično ugotavljanje ekspresije EGFR v tumorskem tkivu.
• reduction in the number of white blood cells 
• zmanjšanje števila belih krvnih telesc
Since Erbitux is only compatible with sterile sodium chloride 9 mg/mL (0.9%) solution for injection, it must not be mixed with other intravenously applied medicinal products. 
Ker je zdravilo Erbitux združljivo samo s sterilno raztopino natrijevega klorida 9 mg/ml (0,9%) za injiciranje, ga ne smete mešati z drugimi zdravili za intravensko uporabo.
Severe infusion-related reactions, in some cases with fatal outcome (see section 4.4); fatigue. 
hude reakcije, povezane z infundiranjem, v nekaterih primerih s smrtnim izidom (glejte poglavje 4.4); utrujenost.
Approximately 75% of the patients with metastatic colorectal cancer screened for clinical studies had an EGFR-expressing tumour and were therefore considered eligible for cetuximab treatment. 
Približno 75% bolnikov z metastatskim kolorektalnim rakom, pri katerih so opravili presejalni test za klinično študijo, je imelo tumor z ekspresijo EGFR, in so bili torej primerni za zdravljenje s cetuksimabom.
• drying out which may be due to diarrhoea or reduced fluid intake 
• izguba tekočine, ki je lahko posledica driske ali zmanjšanega vnosa tekočine
Erbitux 5 mg/mL must be prepared as follows: 
Zdravilo Erbitux 5 mg/ml mora biti pripravljeno, kot sledi:
Only patients with adequate renal and hepatic function have been investigated to date (serum creatinine  1.5fold, transaminases  5fold and bilirubin  1.5fold the upper limit of normal). 
Doslej so bili v študije vključeni le bolniki s primernim delovanjem jeter in ledvic (vrednost serumskega kreatinina ≤ 1,5-kratna zgornja meja normalnih vrednosti, transaminaze ≤ 5-kratna zgornja meja normalnih vrednosti in bilirubin ≤ 1,5-kratna zgornja meja normalnih vrednosti).
If the patient experiences a mild or moderate infusion-related reaction, the infusion rate may be decreased. 
Če pri bolniku nastopi blaga ali zmerna reakcija, povezana z infundiranjem, lahko zmanjšate hitrost infundiranja.
• metastatic cancer of the large intestine. 
• Metastatskega raka debelega črevesa.
Erbitux 5 mg/mL is chemically and physically stable for up to 48 hours at 25°C, if the solution is prepared as described hereafter. 
Zdravilo Erbitux 5 mg/ml je kemično in fizikalno stabilno do 48 ur pri temperaturi 25 °C, če je raztopina pripravljena, kot je opisano v nadaljevanju.
Skin reactions may develop in more than 80% of patients and mainly present as acne-like rash and/or, less frequently, as pruritus, dry skin, desquamation, hypertrichosis, or nail disorders (e.g. paronychia). 
Kožne reakcije se lahko pojavijo pri več kot 80% bolnikov, nastopijo pa v obliki aknam podobnega izpuščaja in/ali (manj pogosto) v obliki pruritusa, suhe kože, deskvamacije, hipertrihoze ali bolezni nohtov (npr. paronihija).
Transfer the Erbitux into the prepared infusion bag. 
Prenesite zdravilo Erbitux v pripravljeno vrečko za infundiranje.
If you notice symptoms such as occurrence or worsening of breathing difficulties, speak to a doctor immediately, especially if you also experience cough or fever. 
Če opazite simptome kot je pojav ali poslabšanje težav pri dihanju, se nemudoma pogovorite z zdravnikom, zlasti, če ob tem tudi kašljate ali imate povišano telesno temperaturo.
In a phase-I study in paediatric patients (1-18 years) with refractory solid tumours, cetuximab was administered in combination with irinotecan. 
V študiji faze I pri pediatričnih bolnikih (1-18 let) z refraktornimi solidnimi tumorji so cetuksimab dajali v kombinaciji z irinotekanom.
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. 
Če opazite, da se stanje prizadetih mest na koži poslabša, se nemudoma pogovorite z zdravnikom, zlasti če imate tudi splošne znake okužbe, kot sta zvišana telesna temperatura in utrujenost.
Further post-hoc analyses were performed for studies EMR 62 202-013 and EMR 62 202-047, where also mutations on RAS genes (NRAS and KRAS) other than KRAS exon 2 have been determined. 
Opravljene so bile nadaljnje post-hoc analize v študijah EMR 62 202-013 in EMR 62 202-047, s katerimi so bile poleg mutacij na eksonu 2 gena KRAS določene tudi druge mutacije na genih RAS (NRAS in KRAS).
Calculate the required volume of Erbitux. 
Izračunajte potreben volumen zdravila Erbitux.
20 mL or 100 mL of solution in a vial (Type I glass) with a stopper (halobutyl rubber) and a seal (aluminium/polypropylen). 
20 ml ali 100 ml raztopine v viali (iz stekla tipa I) z zamaškom (halobutilna guma) in zaporko (iz aluminija/polipropilena).
Diarrhoea; nausea; vomiting. 
driska; navzea; bruhanje.
Combination treatment 
Kombinirano zdravljenje
Skin reactions are very common and treatment interruption or discontinuation may be required. 
Zaradi kožnih reakcij, ki so zelo pogoste, bo morda treba prekiniti ali ukiniti zdravljenje.
These side effects may have serious consequences, in rare cases including life-threatening conditions, and require immediate attention. 
Taki neželeni učinki imajo lahko resne posledice, v redkih primerih so lahko smrtno nevarni in zahtevajo takojšnjo pomoč.
Cetuximab is a chimeric monoclonal IgG1 antibody that is specifically directed against the epidermal growth factor receptor (EGFR). 
Cetuksimab je himerno monoklonsko IgG1 protitelo, ki je specifično usmerjeno proti receptorju za epidermalni rastni faktor (EGFR).
In combination with local radiation therapy of the head and neck area, additional undesirable effects were those typical of radiation therapy (such as mucositis, radiation dermatitis, dysphagia or leukopenia, mainly presenting as lymphocytopenia). 
V kombinaciji z lokalno radioterapijo glave in vratu so se pojavili dodatni neželeni učinki, značilni za radioterapijo (na primer mukozitis, radiacijski dermatitis, disfagija ali levkopenija, ki se pretežno kaže kot limfocitopenija).
In patients with locally advanced squamous cell cancer of the head and neck, cetuximab is used concomitantly with radiation therapy. 
Pri bolnikih z lokalno napredovalim rakom skvamoznih celic glave in vratu se cetuksimab uporablja sočasno z radioterapijo.
Erbitux is usually infused once a week. 
Zdravilo Erbitux se navadno infundira enkrat na teden.
What you need to know before you use Erbitux 
Kaj moratevedeti, preden boste uporabili zdravilo Erbitux
Anaphylactic reactions may occur as early as within a few minutes of the first infusion e.g. due to preformed IgE antibodies cross-reacting with cetuximab. 
Anafilaktične reakcije se lahko pojavijo že nekaj minut po prvem infundiranju, npr. zaradi navzkrižne reakcije obstoječih protiteles IgE s cetuksimabom.
Only patients with adequate renal and hepatic function have been investigated to date (see section 4.4). 
Doslej so bili v študije vključeni le bolniki s primernim delovanjem jeter in ledvic (glejte poglavje 4.4).
• increase in blood levels of certain liver enzymes 
• zvišanje ravni nekaterih jetrnih encimov v krvi
In tumours, activation of RAS by EGFR contributes to EGFR-mediated increased proliferation, survival and the production of pro-angiogenic factors. 
Pri tumorjih aktivacija RAS, ki jo sproži faktor EGFR, povzroči povečano proliferacijo, ki jo povzroča faktor EGFR, preživetje in tvorbo proangiogenetskih faktorjev.
The risk for anaphylactic reactions is much increased in patients with a history of allergy to red meat or tick bites or positive results of tests for IgE antibodies against cetuximab (α-1-3-galactose). 
Tveganje za anafilaktične reakcije se močno poveča pri bolnikih z anamnezo alergij na rdeče meso ali ugrize klopa ali s pozitivnimi rezultati testov za protitelesa za IgE proti cetuksimabu (α-1-3-galaktoza).
Careful monitoring is recommended in such patients, in particular in those who experience skin lesions, mucositis or diarrhoea that may facilitate the occurrence of infections (see section 4.8). 
Takšne bolnike je treba skrbno nadzorovati, zlasti tiste, pri katerih se pojavijo kožne lezije, mukozitis ali driska, ki lahko omogočijo pojav okužb (glejte poglavje 4.8).
The protein product of the proto-oncogene RAS (rat sarcoma) is a central down-stream signaltransducer of EGFR. 
Beljakovinski produkt protoonkogenega RAS (podganji sarkom) je osrednji prevodnik signala faktorja EGFR po signalni poti navzdol.
Cetuximab as a single agent or in combination with chemotherapy was investigated in 5 randomised controlled clinical studies and several supportive studies. 
Cetuksimab kot samostojno zdravilo ali v kombinaciji s kemoterapijo so preučevali v petih randomiziranih, nadzorovanih kliničnih študijah in več podpornih študijah.
The risk for secondary infections (mainly bacterial) is increased and cases of staphylococcal scalded skin syndrome, necrotising fasciitis and sepsis, in some cases with fatal outcome, have been reported (see section 4.8). 
Tveganje za sekundarne okužbe (v glavnem bakterijske) je večje in poročali so o primerih stafilokoknega sindroma luščenja kože, nekrotizirajočega fasciitisa in sepse, ki so bili v nekaterih primerih smrtni (glejte poglavje 4.8).
• with polypropylene (PP) syringes for syringe pump. 
• s polipropilenskimi (PP) brizgami za črpalko za brizgo.
The RAS mutant population comprises these 65 patients together with 113 patients with KRAS exon 2 mutant tumours treated before study enrolment was restricted to patients with KRAS exon 2 wild-type mCRC. 
Populacijo z mutacijo RAS je sestavljalo teh 65 bolnikov skupaj s 113 bolniki s tumorji z mutiranim tipom KRAS (eksona 2), ki so se zdravili, preden je bila vključitev v študijo omejena na bolnike z mCRC z nemutiranim tipom KRAS (eksona 2).
No formal animal studies have been performed to establish the carcinogenic potential of cetuximab or to determine its effects on male and female fertility. 
Formalne študije pri živalih za ugotavljanje kancerogenosti cetuksimaba, določanje njegovih učinkov na plodnost pri moških ali ženskah, niso bile opravljene.
Each subsequent dose (250 mg/m² body surface area) is infused in approximately 1 hour with an infusion rate not faster than 10 mg/min. 
Vsak naslednji odmerek (250 mg/m² telesne površine) se infundira približno 1 uro s hitrostjo infundiranja, ki ni hitrejša kot 10 mg/min.
The majority of patients included had an ECOG performance status of ≤ 1. 
Pri večini vključenih bolnikov je bil indeks zmogljivosti ≤ 1.
There were significant dose reductions and delays of capecitabine or oxaliplatin administration mainly due to higher frequency of diarrhoea in the cetuximab containing arm. 
Prišlo je do pomembnega zmanjšanja odmerkov in zakasnitve pri dajanju kapecitabina ali oksaliplatina, predvsem zaradi višje pogostnosti driske v skupini, ki je prejemala cetuksimab.
Take an appropriate sterile syringe and attach a suitable needle. 
Vzemite ustrezno sterilno brizgo in nanjo pritrdite primerno iglo.
The initial dose is 400 mg cetuximab per m body surface area. 
Začetni odmerek je 400 mg cetuksimaba na m² telesne površine.
Cetuximab is a chimeric monoclonal IgG1 antibody produced in a mammalian cell line (Sp2/0) by recombinant DNA technology. 
Cetuksimab je himerno monoklonsko IgG1 protitelo, izdelano v sesalski celični liniji (Sp2/0) z uporabo tehnologije rekombinantne DNA.
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. 
Srednja največja koncentracija cetuksimaba je bila 155,8 mikrograma/ml v 3. tednu in 151,6 mikrograma/ml v 8. tednu, ustrezna srednja najmanjša koncentracija pa je bila 41,3 mikrograma/ml in 55,4 mikrograma/ml.
What Erbitux is and what it is used for 
Kaj je zdravilo Erbitux in za kaj ga uporabljamo
Your doctor will decide whether such pre-treatment is necessary for subsequent doses. 
Vaš zdravnik se bo odločil, ali je taka premedikacija potrebna tudi pri naslednjih odmerkih.
In time related endpoints no trends indicating clinical benefit could be shown for patients who received cetuximab in combination with the XELOX regimen. 
Pri od časa odvisnih končnih rezultatih študije ni bilo trendov, ki bi kazali na to, da so imeli bolniki, ki so prejemali cetuksimab v kombinaciji z režimom XELOX, klinične koristi.
Similar findings were also reported when cetuximab was given as add-on to XELOX in combination with bevacizumab (CAIRO2). 
O podobnih izsledkih so poročali tudi, ko so cetuksimab dajali kot dodatno zdravilo k zdravilu XELOX v kombinaciji z bevacizumabom (CAIRO2).
A tumour was considered to be EGFR-expressing, if one stained cell could be identified. 
Šteli so, da tumor izraža EGFR, če so našli eno obarvano celico.
Mild or moderate infusion-related reactions (see section 4.4); mucositis, in some cases severe. 
blage ali zmerne reakcije, povezane z infundiranjem (glejte poglavje 4.4); mukozitis, v nekaterih primerih resen.
• as a single agent in patients who have failed oxaliplatin- and irinotecan-based therapy and who are intolerant to irinotecan. 
• kot samostojno zdravilo pri bolnikih, pri katerih zdravljenje z oksaliplatinom in zdravljenje na osnovi irinotekana ni bilo uspešno in pri bolnikih, ki ne prenašajo irinotekana.
From the KRAS evaluated population 64% of the patients (192) had KRAS wildtype tumours and 108 patients KRAS mutations. 
Iz populacije, pri katerih so ocenili tip KRAS, je imelo 64 % bolnikov (192) tumorje nemutiranega tipa KRAS in 108 bolnikov mutacije tipa KRAS.
Cetuximab should be used with caution in patients with a history of keratitis, ulcerative keratitis or severe dry eye. 
Cetuksimab je treba uporabljati previdno pri bolnikih z anamnezo keratitisa, ulcerativnega keratitisa ali zelo suhih oči.
Erbitux 5 mg/mL is administered intravenously with an infusion pump, gravity drip or a syringe pump (for handling instructions, see section 6.6). 
Zdravilo Erbitux 5 mg/ml se daje z intravensko infuzijo, in sicer z infuzijsko črpalko, težnostno kapalno infuzijo ali črpalko za brizgo (za navodila za pripravo glejte poglavje 6.6).
When prescribing cetuximab, the cardiovascular and performance status of the patients and concomitant administration of cardiotoxic compounds such as fluoropyrimidines should be taken into account. 
Pri predpisovanju cetuksimaba je treba upoštevati kardiovaskularno stanje in indeks zmogljivosti bolnika in sočasno dajanje kardiotoksičnih učinkovin kot so fluoropirimidini.
• loss of appetite, leading to weight decrease 
• izguba teka, kar povzroči zmanjšanje telesne mase
MARKETING AUTHORISATION NUMBERS EU/1/04/281/003 
ŠTEVILKE DOVOLJENJ ZA PROMET Z ZDRAVILOM EU/1/04/281/003
Your doctor may consider reducing the infusion rate of Erbitux to manage these symptoms. 
Zdravnik vam bo po potrebi zmanjšal hitrost infuzije zdravila Erbitux, da bi ublažil te simptome.
The European Medicines Agency has waived the obligation to submit the results of studies with cetuximab in all subsets of the paediatric population in the indications adenocarcinoma of the colon and rectum and oropharyngeal, laryngeal or nasal epithelial carcinoma (excluding nasopharyngeal carcinoma or lymphoepithelioma, see section 4.2 for information on paediatric use). 
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij s cetuksimabom za vse podskupine pediatrične populacije za indikacije adenokcarcinoma debelega črevesa in danke ter za karcinom orofaringealnega, laringealnega ali nazalnega epitelija (razen nazofaringealnega karcinoma ali limfoepitelioma; za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
However, in preclinical wound healing models EGFR selective tyrosine kinase inhibitors were shown to retard wound healing. 
V predkliničnih modelih celjenja ran pa se je izkazalo, da za EGFR selektivni zaviralci tirozinske kinaze upočasnijo celjenje ran.
There is no relevant use of cetuximab in the paediatric population in the granted indications. 
Cetuksimab ni namenjen za uporabo pri pediatrični populaciji za odobrene indikacije.
Immunohistochemical detection of EGFR expression was not performed since more than 90% of patients with squamous cell cancer of the head and neck have tumours that express EGFR. 
Imunohistokemičnega določanja ekspresije EGFR niso izvajali, ker se EGFR izraža v tumorjih pri več kot 90% bolnikih z rakom skvamoznih celic glave in vratu.
Do not use Erbitux 
Ne uporabljajte zdravila Erbitux
Erbitux is contraindicated in patients with known severe (grade 3 or 4) hypersensitivity reactions to cetuximab. 
Zdravilo Erbitux je kontraindicirano pri bolnikih z znano hudo preobčutljivostno reakcijo (3. ali 4. stopnje) na cetuksimab.
• in first-line in combination with FOLFOX, 
• kot primarno zdravljenje v kombinaciji s FOLFOX;
Cetuximab was started one week before radiation therapy and administered at the doses described in section 4.2 until the end of the radiation therapy period. 
Cetuksimab so začeli dajati en teden pred radioterapijo in so ga dajali do konca obdobja radioterapije, v odmerkih opisanih v poglavju 4.2.
Headache. 
glavobol.
Cetuximab binds to the epidermal growth factor receptor (EGFR), an antigen on the surface of certain cancer cells. 
Cetuksimab se veže na receptor za epidermalni rastni faktor (EGFR, epidermal growth factor receptor), antigen na površini nekaterih rakavih celic.
Frequency not known: Aseptic meningitis. 
aseptični meningitis.
Mild or moderate infusion-related reactions are very common comprising symptoms such as fever, chills, dizziness, or dyspnoea that occur in a close temporal relationship mainly to the first cetuximab infusion. 
Zelo pogoste so blage ali zmerne reakcije, povezane z infundiranjem, ki vključujejo simptome, kot so zvišana telesna temperatura, mrzlica, omotica ali dispneja, ki se pojavijo časovno zelo povezano zlasti s prvim infundiranjem cetuksimaba.
Patients who receive cetuximab in combination with platinum-based chemotherapy are at an increased risk for the occurrence of severe neutropenia, which may lead to subsequent infectious complications such as febrile neutropenia, pneumonia or sepsis. 
Pri bolnikih, ki prejemajo cetuksimab v kombinaciji s kemoterapijo na osnovi platine, obstaja večje tveganje za pojav hude nevtropenije, ki lahko povzroči nadaljnje zaplete zaradi okužb, kot je febrilna nevtropenija, pljučnica ali sepsa.
Toxicity studies with co-administration of cetuximab and chemotherapeutic agents have not been performed. 
Študije toksičnosti pri sočasni uporabi cetuksimaba in kemoterapevtikov niso bile opravljene.
If you receive Erbitux in combination with radiation therapy, treatment with Erbitux is usually started one week before radiation therapy. 
Če zdravilo Erbitux prejemate v kombinaciji z obsevanjem, se zdravljenje z zdravilom Erbitux navadno začne en teden pred obsevanjem.
• 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) 
• rdečica in otekanje dlani ali podplatov, ki lahko povzroči luščenje kože (sindrom dlani in stopal)
The combination of Erbitux with oxaliplatin-containing chemotherapy is contraindicated for patients with mutant RAS metastatic colorectal cancer (mCRC) or for whom RAS mCRC status is unknown (see also section 4.4). 
Kombinacija zdravila Erbitux s kemoterapijo, ki vsebuje oksaliplatin, je kontraindicirana pri bolnikih z metastatskim kolorektalnim rakom (mCRC, metastatic colorectal cancer) z mutiranim tipom RAS ali kadar mCRC status RAS ni znan (glejte tudi poglavje 4.4).