natgillin/translations-raw huggingface dataset:
Når cetuximab anvendes i kombination med kemoterapeutiske stoffer skal de respektive produktresuméer til disse stoffer læses. 
When cetuximab is used in combination with chemotherapeutic agents, also refer to their respective product information.
Der blev dog observeret en dosisafhængig stigning af spontan abort. 
However, dependent on the dose, an increased incidence of abortion was observed.
• hudreaktioner, som er almindelige som følge af strålebehandlingen 
• skin reactions typical for radiation therapy
• betændelse i øjenlåget eller hornhinden 
• inflammation of the eye lid or the front part of the eye
Planocellulært karcinom i hoved og hals 
Squamous cell cancer of the head and neck
Du kan finde yderligere oplysninger om Erbitux på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu. 
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
I populationen med KRAS-mutationen fik 297 patienter cetuximab og oxaliplatin plus fluoropyrimidiner (101 patienter OxMdG og 196 patienter XELOX), og 268 patienter fik oxaliplatin plus fluoropyrimidiner alene (78 patienter OxMdG og 190 patienter XELOX). 
Of the KRAS mutant population, 297 patients received cetuximab and oxaliplatin plus fluoropyrimidines (101 patients OxMdG and 196 patients XELOX) and 268 patients received oxaliplatin plus fluoropyrimidines alone (78 patients OxMdG and 190 patients XELOX).
• fald i indholdet af magnesium i blodet 
• decrease in blood levels of magnesium
• fald i indholdet af kalcium i blodet 
• decrease in blood levels of calcium
Cetuximab i kombination med kemoterapi 
Cetuximab in combination with chemotherapy
Kombination af Erbitux og oxaliplatin-holdig kemoterapi er kontraindiceret til patienter med metastatisk kolorektal cancer (mCRC) med RAS-mutation og til patienter med mCRC med ukendt RAS-status (se også pkt. 
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).
Erbitux gives normalt som infusion én gang ugentligt. 
Erbitux is usually infused once a week.
Erbitux gives normalt som infusion i en åre (som drop) en gang ugentligt. 
Erbitux is usually infused into a vein (given as a drip) once a week.
Erbitux 5 mg/ml gives intravenøst med en infusionspumpe, almindeligt drop eller en sprøjtepumpe (vedrørende håndtering, se pkt. 
Erbitux 5 mg/mL is administered intravenously with an infusion pump, gravity drip or a syringe pump (for handling instructions, see section 6.6).
Der skal anvendes en separat infusionslinje til infusionen, og linjen skal gennemskylles med sterilt natriumchlorid 9 mg/ml (0,9%) injektionsopløsning i slutningen af infusionen. 
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.
Natriumchlorid, glycin, polysorbat 80, citronsyremonohydrat, natriumhydroxid, vand til injektionsvæsker. 
Sodium chloride, glycine, polysorbate 80, citric acid monohydrate, sodium hydroxide, water for injections
• Indgift med infusionspumpe eller almindeligt drop (fortyndet med steril natriumchlorid 9 mg/ml (0,9%) opløsning): Tag en infusionspose af passende størrelse med steril natriumchlorid 9 mg/ml (0,9%) opløsning. 
• For administration with infusion pump or gravity drip (diluted with sterile sodium chloride 9 mg/mL (0.9%) solution): Take an infusion bag of adequate size of sterile sodium chloride 9 mg/mL (0.9%) solution.
Erbitux kan forårsage bivirkninger fra øjnene. 
Erbitux may cause side effects concerning the eyes.
Erbitux kan give infusionsrelaterede bivirkninger. 
Erbitux may cause infusion-related side effects.
Alle følgende ugentlige doser er på 250 mg cetuximab per m². 
All subsequent weekly doses are 250 mg cetuximab per m2 each.
In vivo hæmmer cetuximab tumorcellers angiogene faktorer og fremkalder en reduktion i tumorens neo-vaskularisering og metastasering. 
In vivo cetuximab inhibits expression of angiogenic factors by tumour cells and causes a reduction in tumour neo-vascularisation and metastasis.
Cetuximab blokerer bindingen af kropsegne EGFR-ligander, hvilket hæmmer receptorens funktion. 
Cetuximab blocks binding of endogenous EGFR ligands resulting in inhibition of the function of the receptor.
• EMR 62 202-006: Dette randomiserede studie sammenlignede kombinationen af cetuximab og strålebehandling (211 patienter) med strålebehandling alene (213 patienter) hos patienter med lokalt fremskreden planocellulært karcinom i hoved og hals. 
• EMR 62 202-006: This randomised study compared the combination of cetuximab and radiation therapy (211 patients) with radiation therapy alone (213 patients) in patients with locally advanced squamous cell cancer of the head and neck.
5.1 for yderligere oplysninger. 
For details, see section 5.1.
Dato for første markedsføringstilladelse: 29/06/2004 
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 29/06/2004
Erbitux er indiceret til behandling af patienter med metastatisk kolorektal cancer af RAS-vildtypen, som udviser epidermale vækstfaktorreceptorer (EGFR) 
Erbitux is indicated for the treatment of patients with epidermal growth factor receptor (EGFR)expressing, RAS wild-type metastatic colorectal cancer
• trombocyttal < 100.000/mm³ 
• platelet count < 100000/mm³
Erbitux indeholder cetuximab, som er et monoklonalt antistof. 
Erbitux contains cetuximab, a monoclonal antibody.
• med infusionssæt af polyetylen (PE), polyuretan (PUR), ethylvinylacetat (EVA), termoplastisk polyolefin (TP) eller polyvinylklorid (PVC), 
• with polyethylene (PE), polyurethane (PUR), ethyl vinyl acetate (EVA), polyolefine thermoplastic (TP) or polyvinyl chloride (PVC) infusion sets,
Hvis du får Erbitux i kombination med anden medicin mod kræft, herunder fluoropyrimidiner, kan det være mere sandsynligt, at du oplever hjerteproblemer, som kan blive livstruende. 
If you receive Erbitux in combination with other anticancer medicines, including fluoropyrimidines, it may be more likely that you experience heart problems which may be life-threatening.
Første dosis (400 mg/m² legemsoverflade) gives som infusion over en periode på cirka 2 timer med en infusionshastighed, der ikke overstiger 5 mg/min. 
The first dose (400 mg/m² body surface area) is infused over a period of approximately 2 hours with an infusion rate not faster than 5 mg/min.
Træk den nødvendige mængde Erbitux op fra et hætteglas. 
Draw up the required volume of Erbitux from a vial.
Population med RAS-vildtype 
RAS wild-type population
Erbitux indeholder: 
What Erbitux contains
De efterfølgende doser (250 mg/m² legemsoverflade) gives som infusion i løbet af cirka 1 time med en infusionshastighed, der ikke overstiger 10 mg/min. 
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.
Hudreaktioner*. 
Skin reactions*.
Overfør Erbitux til den klargjorte infusionspose. 
Transfer the Erbitux into the prepared infusion bag.
Hos patienter med lokalt-fremskreden planocellulært karcinom i hoved og hals anvendes cetuximab samtidig med strålebehandling. 
In patients with locally advanced squamous cell cancer of the head and neck, cetuximab is used concomitantly with radiation therapy.
Bivirkninger, der påvirker huden 
Side effects concerning the skin
Reaktionerne ses hovedsageligt som akne-lignende udslæt og/eller mindre hyppigt som pruritus, tør hud, afskalning, hypertrichose eller neglelidelser (f.eks. paronychia). 
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).
Gentag proceduren, til den beregnede mængde er nået. 
Repeat this procedure until the calculated volume has been reached.
Hvis du får Erbitux i kombination med anden medicin mod kræft, kan nogle af de bivirkninger, du måske får, også skyldes kombinationen eller den anden medicin. 
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.
KVALITATIV OG KVANTITATIV SAMMENSÆTNING En ml infusionsvæske, opløsning indeholder 5 mg cetuximab. 
QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of solution for infusion contains 5 mg cetuximab.
Svære infusionsrelaterede reaktioner i nogle tilfælde med dødelig udgang (se pkt. 
Severe infusion-related reactions, in some cases with fatal outcome (see section 4.4); fatigue.
Brug af anden medicin sammen med Erbitux 
Other medicines and Erbitux
Tilslut infusionslinjen og opspæd med fortyndet Erbitux, før infusionen indledes. 
Connect the infusion line and prime it with the diluted Erbitux before starting the infusion.
I såvel in vitro- som in vivo-analyser hæmmer cetuximab formeringen og fremkalder apoptose hos humane tumorceller med EGFR. 
In both in vitro and in vivo assays, cetuximab inhibits the proliferation and induces apoptosis of human tumour cells that express EGFR.
Hazard ratio (95% CI) p-værdi 
Hazard Ratio (95% CI) p-value
Efter sygdomsprogression blev der hos 50% af patienterne i den behandlingsarm, der kun fik irinotecan, indledt behandling med midler rettet mod EGFR. 
Following disease progression, treatment with EGFR-targeting agents was initiated in 50% of patients in the irinotecan-alone arm.
Hos patienter med metastatisk kolorektal cancer anvendes cetuximab i kombination med kemoterapi eller som enkeltstofbehandling (se pkt. 
In patients with metastatic colorectal cancer, cetuximab is used in combination with chemotherapy or as a single agent (see section 5.1).
Hos patienter med recidiverende og/eller metastatisk planocellulært karcinom i hoved og hals anvendes cetuximab i kombination med platinbaseret kemoterapi efterfulgt af cetuximab som vedligeholdelsesbehandling indtil sygdomsprogression (se pkt. 
In patients with recurrent and/or metastatic squamous cell cancer of the head and neck, cetuximab is used in combination with platinum-based chemotherapy followed by cetuximab as maintenance therapy until disease progression (see section 5.1).
Sæt en passende kanyle på en steril sprøjte af passende størrelse (minimum 50 ml). 
Take an appropriate sterile syringe (minimum 50 mL) and attach a suitable needle.
• blodpropper i lungerne 
• blood clots in the lungs
Hvis du får Erbitux i kombination med en anden slags medicin mod kræft, som indeholder fluoropyrimidiner, er det mere sandsynligt at du får følgende bivirkninger af denne medicin: 
If you receive Erbitux in combination with an anticancer medicine containing fluoropyrimidines, it is more likely that you experience the following side effects of this other medicine:
Almindelig (≥ 1/100 til < 1/10) 
Common ( 1/100 to < 1/10)
Aseptisk meningitis. 
Frequency not known: Aseptic meningitis.
Gentag om nødvendigt proceduren, til den beregnede mængde er infunderet. 
If necessary, repeat this procedure until the calculated volume has been infused.
Sygdomme i åndedrætsorganer 
Respiratory disorders
Population med KRAS-mutation 
KRAS mutant population
Pakning med 1 hætteglas. 
Pack size of 1 vial.
Cetuximab bør ikke anvendes til behandling af patienter med kolorektal cancer, hvis tumorer har RAS-mutationer, eller til patienter med en ukendt RAS-status i tumorer. 
Colorectal cancer patients with RAS mutated tumours Cetuximab should not be used in the treatment of colorectal cancer patients whose tumours have RAS mutations or for whom RAS tumour status is unknown.
Til vurdering af RAS-status blev andre mutationer end dem på exon 2 i KRAS-genet bestemt ud fra alle evaluerbare tumorprøver inden for populationen med KRAS exon 2-vildtypen (65 %). 
For the assessment of the RAS status, mutations other than those on exon 2 of the KRAS gene were determined from all evaluable tumour samples within the KRAS exon 2 wild-type population (65%).
For vurderingen af RAS-status blev andre mutationer end dem på exon 2 i KRAS-genet bestemt ud fra alle evaluerbare tumorprøver inden for populationen med KRAS exon 2-vildtypen. 
For the assessment of the RAS status, mutations other than those on exon 2 of the KRAS gene were determined from all evaluable tumour samples within the KRAS exon 2 wild-type population.
Cirka 15 ud af 100 patienter kan få svære hudreaktioner. 
In about 15 out of 100 patients these skin reactions are likely to be severe.
4.4); mucositis, i nogle tilfælde alvorlig. 
Mild or moderate infusion-related reactions (see section 4.4); mucositis, in some cases severe.
Der er ikke foretaget toksicitetsstudier med samtidig indgift af cetuximab og kemoterapeutika. 
Toxicity studies with co-administration of cetuximab and chemotherapeutic agents have not been performed.
Anvend almindeligt drop eller infusionspumpe til indgift. 
Use a gravity drip or an infusion pump for administration.
Cetuximab blev initieret en uge før strålebehandlingen og givet i doserne beskrevet under pkt. 
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.
Patienter, der i henhold til tumorstatus, Karnofsky-performance-status (KPS) og alder, havde en god prognose, havde større gavn af behandlingen, når cetuximab blev givet sammen med platinbaseret kemoterapi. 
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.
• øget mængde af visse leverenzymer i blodet 
• increase in blood levels of certain liver enzymes
Tilslut infusionslinjen til sprøjten, og start infusionen efter at have opspædet linjen med Erbitux eller steril natriumchlorid 9 mg/ml (0,9%) opløsning. 
Connect the infusion line to the syringe and start the infusion after priming the line with Erbitux or sterile sodium chloride 9 mg/mL (0.9%) solution.
Dehydrering, især som følge af diaré eller mucositis; hypokalcæmi (se pkt. 
Dehydration, in particular secondary to diarrhoea or mucositis; hypocalcaemia (see section 4.4); anorexia which may lead to weight decrease.
Sjælden (≥ 1/10.000 til < 1/1.000) 
Rare ( 1/10,000 to < 1/1,000)
Hvis du får Erbitux i kombination med andre lægemidler mod kræft, herunder platin, er der større sandsynlighed for, at antallet af de hvide blodlegemer i dit blod er formindsket. 
If you receive Erbitux in combination with anticancer medicines including platinum, it is more likely that your white blood cell count may be reduced.
Hvert hætteglas med 100 ml indeholder 500 mg cetuximab (5 mg/ml). 
Each vial of 100 mL contains 500 mg cetuximab (5 mg/mL).
CI = konfidensinterval, OxMdG = oxaliplatin plus 5-FU/FA-infusion, OS = overlevelsestid, PFS = progressionsfri overlevelsestid 
CI = confidence interval, OxMdG = oxaliplatin plus infusional 5-FU/FA, OS = overall survival time, PFS = progression-free survival time
Population med RAS-mutation 
RAS mutant population
I opfølgningsbehandlingen fik dog næsten 50% af patienterne fra armen med cetuximab-monoterapi en kombination af cetuximab og irinotecan efter progression af sygdommen, hvilket kan have påvirket den samlede overlevelsestid. 
In the randomised trial, the improvement in overall survival time did not reach statistical significance; however, in the follow-up treatment, nearly 50% of the patients of the cetuximab alone arm received a combination of cetuximab and irinotecan after progression of disease, which may have influenced overall survival time.
1 hætteglas med 100 mg/20 ml 
1 vial of 100 mg/20 mL
Patienter, der i henhold til tumorstatus, Karnofsky-performance-status (KPS) og alder, havde en god prognose, havde større gavn af behandlingen, når cetuximab blev givet sammen med strålebehandling. 
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 radiation therapy.
Studiedata viser, at det er højst usandsynligt, at patienter med metatastisk kolorektal cancer og aktiverende RAS-mutationer vil få gavn af behandling med cetuximab eller en kombination af cetuximab og kemoterapi. 
Study data demonstrate that patients with metastatic colorectal cancer and activating RAS mutations are highly unlikely to benefit from treatment with cetuximab or a combination of cetuximab and chemotherapy and as add-on to FOLFOX4 a significant negative effect on progression-free survival time (PFS) was shown.
FOLFOX4 Cetuximab plus FOLFOX4 
Cetuximab plus FOLFOX4
• CA225025: Dette randomiserede studie med patienter med metastatisk kolorektal cancer, som tidligere havde fået behandling med oxaliplatin, irinotecan plus fluoropyrimidin for metastatisk sygdom, sammenlignede kombinationen af cetuximab som enkeltstof sammen med "bedste understøttende pleje" ("best supportive care", BSC) (287 patienter) med "bedste understøttende pleje" alene (285 patienter). 
• CA225025: This randomised study in patients with metastatic colorectal cancer who had received prior oxaliplatin-, irinotecan- and fluoropyrimidine-based treatment for metastatic disease compared the addition of cetuximab as a single agent to best supportive care (BSC) (287 patients) with best supportive care (285 patients).
Cetuximab som enkeltstof 
Cetuximab as a single agent
Oddsrate (95% CI) p-værdi 
Odds Ratio (95% CI) p-value
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert hætteglas med 20 ml indeholder 100 mg cetuximab (5 mg/ml). 
STATEMENT OF ACTIVE SUBSTANCE(S) Each vial of 20 mL contains 100 mg cetuximab (5 mg/mL).
Indstil og kontroller hastigheden som forklaret under pkt. 
Set and control the rate as explained in section 4.2.
OS måneder, median (95% CI) Hazard ratio (95% CI) p-værdi PFS måned, median (95% CI) Hazard ratio (95% CI) p-værdi ORR % (95% CI) p-værdi CI = confidence interval, konfidensinterval, CTX = platinbaseret kemoterapi, ORR = objektiv responsrate, OS = overlevelsestid, PFS = progressionsfri overlevelsestid 
OS months, median (95% CI) Hazard Ratio (95% CI) p-value PFS months, median (95% CI) Hazard Ratio (95% CI) p-value ORR % (95% CI) p-value CI = confidence interval, CTX = platinum-based chemotherapy, ORR = objective response rate, OS = overall survival time, PFS = progression-free survival time
Erbitux kan forårsage bivirkninger, der påvirker huden. 
Erbitux may cause side effects concerning the skin.
Erbitux 5 mg/ml infusionsvæske, opløsning Cetuximab 
Erbitux 5 mg/mL solution for infusion Cetuximab
BSC Cetuximab plus BSC BSC 
Cetuximab plus BSC
De væsentligste fund i toksicitetsstudier med Cynomolgusaber (et studie med kronisk toksicitet og et studie om embryo-føtal udvikling) var dosisafhængige hudreaktioner, der startede ved dosisniveauer, som svarede til dem, der blev anvendt hos mennesker. 
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).
Disse omfatter symptomer som feber, kulderystelser, svimmelhed eller dyspnø og forekommer tidsmæssigt i tæt tilknytning til især den første infusion med cetuximab. 
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.
Gentag proceduren, til den beregnede mængde er infunderet. 
Repeat this procedure until the calculated volume has been infused.
stop infusionen omgående og behandl symptomer intensivt. 
stop infusion immediately, treat symptoms vigorously and contraindicate further use of cetuximab
Ved samtidig behandling med andre kemoterapeutiske stoffer henvises der til produktinformationen til disse lægemidler angående doseringen eller de anbefalede dosisændringer. 
For the dosage or recommended dose modifications of concomitantly used chemotherapeutic agents, refer to the product information for these medicinal products.
Dette kan medføre efterfølgende komplikationer, f.eks. cellulitis, erysipelas eller, potentielt med dødeligt udfald, staphylococcal scalded skin syndrome (SSSS), nekrotiserende fasciitis eller sepsis. 
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, necrotising fasciitis or sepsis.
Andelen af patienter i patientpopulationen med tumorer af KRASvildtypen, som kunne vurderes med hensyn til KRAS-status, var 58%. 
The proportion of patients with KRAS wild-type tumours from the patient population evaluable for KRAS status comprised 58%.
Dette kan især være tilfældet, hvis du får hudreaktioner, betændelse i slimhinderne i mave-tarm-kanalen eller i munden eller får diaré. 
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.
Forbehandling 
Pre-treatment
Ikke almindelig (≥ 1/1.000 til < 1/100) 
Uncommon ( 1/1,000 to < 1/100)
FREMSTILLERENS BATCHNUMMER Batch 
BATCH NUMBER BN
• blodpropper i blodårerne i benene 
• blood clots in the veins of the legs
LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Erbitux 5 mg/ml infusionsvæske, opløsning Cetuximab 
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Erbitux 5 mg/mL solution for infusion
• CA225006: Dette randomiserede studie med patienter med metastatisk kolorektal cancer, som tidligere havde fået behandling med oxaliplatin plus fluoropyrimidin for metastatisk sygdom, sammenlignede kombinationen af cetuximab og irinotecan (648 patienter) med irinotecan alene (650 patienter). 
• CA225006: This randomised study in patients with metastatic colorectal cancer who had received initial combination treatment with oxaliplatin plus fluoropyrimidine for metastatic disease compared the combination of cetuximab and irinotecan (648 patients) with irinotecan alone (650 patients).
1 hætteglas med 500 mg/100 ml 
1 vial of 500 mg/100 mL
4 for detaljer, da nogle hudreaktioner kan have alvorlige konsekvenser for dig, herunder være livstruende. 
Please also read 'Side effects concerning the skin' in section 4 for details, as some skin reactions may have serious consequences for you, including life-threatening conditions.
Andelen af patienter i patientpopulationen med tumorer af KRAS-vildtypen, som kunne vurderes mht. KRAS-status, var 57%. 
The proportion of patients with KRAS wild-type tumours from the patient population evaluable for KRAS status comprised 57%.
• EMR 62 202-002: Dette randomiserede studie med patienter med recidiverende og/eller metastatisk planocellulært karcinom i hoved og hals, som ikke tidligere havde fået kemoterapi for denne sygdom, sammenlignede kombinationen af cetuximab og cisplatin eller carboplatin plus 5-fluoruracil som infusion (222 patienter) med samme kemoterapi alene (220 patienter). 
• EMR 62 202-002: 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).
Sæt en passende kanyle på en steril sprøjte af passende størrelse. 
Take an appropriate sterile syringe and attach a suitable needle.
BSC = bedste understøttende pleje (best supportive care,), CI = confidence interval, konfidensinterval, ORR = objective response rate (patienter med komplet respons eller delvis respons), OS = overlevelsestid, PFS = progressionsfri overlevelsestid 
(95% CI) p-value BSC = best supportive care, CI = confidence interval, ORR = objective response rate (patients with complete response or partial response), OS = overall survival time, PFS = progression-free survival time
Hvert hætteglas med 20 ml indeholder 100 mg cetuximab. 
Each vial of 20 mL contains 100 mg cetuximab.