FrancophonIA/ELRC3.0 huggingface dataset:
English: • 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.
Danish: • 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.
English: For details, see section 5.1.
Danish: 5.1 for yderligere oplysninger.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 29/06/2004
Danish: Dato for første markedsføringstilladelse: 29/06/2004
English: Erbitux is indicated for the treatment of patients with epidermal growth factor receptor (EGFR)expressing, RAS wild-type metastatic colorectal cancer
Danish: Erbitux er indiceret til behandling af patienter med metastatisk kolorektal cancer af RAS-vildtypen, som udviser epidermale vækstfaktorreceptorer (EGFR)
English: • platelet count < 100000/mm³
Danish: • trombocyttal < 100.000/mm³
English: Erbitux contains cetuximab, a monoclonal antibody.
Danish: Erbitux indeholder cetuximab, som er et monoklonalt antistof.
English: • with polyethylene (PE), polyurethane (PUR), ethyl vinyl acetate (EVA), polyolefine thermoplastic (TP) or polyvinyl chloride (PVC) infusion sets,
Danish: • med infusionssæt af polyetylen (PE), polyuretan (PUR), ethylvinylacetat (EVA), termoplastisk polyolefin (TP) eller polyvinylklorid (PVC),
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: Draw up the required volume of Erbitux from a vial.
Danish: Træk den nødvendige mængde Erbitux op fra et hætteglas.
English: RAS wild-type population
Danish: Population med RAS-vildtype
English: What Erbitux contains
Danish: Erbitux indeholder:
English: 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.
Danish: 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.
English: Skin reactions*.
Danish: Hudreaktioner*.
English: Transfer the Erbitux into the prepared infusion bag.
Danish: Overfør Erbitux til den klargjorte infusionspose.
English: In patients with locally advanced squamous cell cancer of the head and neck, cetuximab is used concomitantly with radiation therapy.
Danish: Hos patienter med lokalt-fremskreden planocellulært karcinom i hoved og hals anvendes cetuximab samtidig med strålebehandling.
English: Side effects concerning the skin
Danish: Bivirkninger, der påvirker huden
English: 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).
Danish: Reaktionerne ses hovedsageligt som akne-lignende udslæt og/eller mindre hyppigt som pruritus, tør hud, afskalning, hypertrichose eller neglelidelser (f.eks. paronychia).
English: Repeat this procedure until the calculated volume has been reached.
Danish: Gentag proceduren, til den beregnede mængde er nået.
English: 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.
Danish: 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.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of solution for infusion contains 5 mg cetuximab.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING En ml infusionsvæske, opløsning indeholder 5 mg cetuximab.
English: Severe infusion-related reactions, in some cases with fatal outcome (see section 4.4); fatigue.
Danish: Svære infusionsrelaterede reaktioner i nogle tilfælde med dødelig udgang (se pkt.
English: Other medicines and Erbitux
Danish: Brug af anden medicin sammen med Erbitux
English: Connect the infusion line and prime it with the diluted Erbitux before starting the infusion.
Danish: Tilslut infusionslinjen og opspæd med fortyndet Erbitux, før infusionen indledes.
English: In both in vitro and in vivo assays, cetuximab inhibits the proliferation and induces apoptosis of human tumour cells that express EGFR.
Danish: I såvel in vitro- som in vivo-analyser hæmmer cetuximab formeringen og fremkalder apoptose hos humane tumorceller med EGFR.
English: Hazard Ratio (95% CI) p-value
Danish: Hazard ratio (95% CI) p-værdi
English: Following disease progression, treatment with EGFR-targeting agents was initiated in 50% of patients in the irinotecan-alone arm.
Danish: Efter sygdomsprogression blev der hos 50% af patienterne i den behandlingsarm, der kun fik irinotecan, indledt behandling med midler rettet mod EGFR.
English: In patients with metastatic colorectal cancer, cetuximab is used in combination with chemotherapy or as a single agent (see section 5.1).
Danish: Hos patienter med metastatisk kolorektal cancer anvendes cetuximab i kombination med kemoterapi eller som enkeltstofbehandling (se pkt.
English: 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).
Danish: 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.
English: Take an appropriate sterile syringe (minimum 50 mL) and attach a suitable needle.
Danish: Sæt en passende kanyle på en steril sprøjte af passende størrelse (minimum 50 ml).
English: • blood clots in the lungs
Danish: • blodpropper i lungerne
English: 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:
Danish: 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:
English: Common ( 1/100 to < 1/10)
Danish: Almindelig (≥ 1/100 til < 1/10)
English: Frequency not known: Aseptic meningitis.
Danish: Aseptisk meningitis.
English: If necessary, repeat this procedure until the calculated volume has been infused.
Danish: Gentag om nødvendigt proceduren, til den beregnede mængde er infunderet.
English: Respiratory disorders
Danish: Sygdomme i åndedrætsorganer
English: KRAS mutant population
Danish: Population med KRAS-mutation
English: Pack size of 1 vial.
Danish: Pakning med 1 hætteglas.
English: 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.
Danish: 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.
English: 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%).
Danish: 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 %).
English: 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.
Danish: 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.
English: In about 15 out of 100 patients these skin reactions are likely to be severe.
Danish: Cirka 15 ud af 100 patienter kan få svære hudreaktioner.
English: Mild or moderate infusion-related reactions (see section 4.4); mucositis, in some cases severe.
Danish: 4.4); mucositis, i nogle tilfælde alvorlig.
English: Toxicity studies with co-administration of cetuximab and chemotherapeutic agents have not been performed.
Danish: Der er ikke foretaget toksicitetsstudier med samtidig indgift af cetuximab og kemoterapeutika.
English: Use a gravity drip or an infusion pump for administration.
Danish: Anvend almindeligt drop eller infusionspumpe til indgift.
English: 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.
Danish: Cetuximab blev initieret en uge før strålebehandlingen og givet i doserne beskrevet under pkt.
English: 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.
Danish: 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.
English: • increase in blood levels of certain liver enzymes
Danish: • øget mængde af visse leverenzymer i blodet
English: 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.
Danish: Tilslut infusionslinjen til sprøjten, og start infusionen efter at have opspædet linjen med Erbitux eller steril natriumchlorid 9 mg/ml (0,9%) opløsning.
English: Dehydration, in particular secondary to diarrhoea or mucositis; hypocalcaemia (see section 4.4); anorexia which may lead to weight decrease.
Danish: Dehydrering, især som følge af diaré eller mucositis; hypokalcæmi (se pkt.
English: Rare ( 1/10,000 to < 1/1,000)
Danish: Sjælden (≥ 1/10.000 til < 1/1.000)
English: If you receive Erbitux in combination with anticancer medicines including platinum, it is more likely that your white blood cell count may be reduced.
Danish: 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.
English: Each vial of 100 mL contains 500 mg cetuximab (5 mg/mL).
Danish: Hvert hætteglas med 100 ml indeholder 500 mg cetuximab (5 mg/ml).
English: CI = confidence interval, OxMdG = oxaliplatin plus infusional 5-FU/FA, OS = overall survival time, PFS = progression-free survival time
Danish: CI = konfidensinterval, OxMdG = oxaliplatin plus 5-FU/FA-infusion, OS = overlevelsestid, PFS = progressionsfri overlevelsestid
English: RAS mutant population
Danish: Population med RAS-mutation
English: 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.
Danish: 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.
English: 1 vial of 100 mg/20 mL
Danish: 1 hætteglas med 100 mg/20 ml
English: 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.
Danish: 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.
English: 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.
Danish: 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.
English: Cetuximab plus FOLFOX4
Danish: FOLFOX4 Cetuximab plus FOLFOX4
English: • 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).
Danish: • 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).
English: Cetuximab as a single agent
Danish: Cetuximab som enkeltstof
English: Odds Ratio (95% CI) p-value
Danish: Oddsrate (95% CI) p-værdi
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each vial of 20 mL contains 100 mg cetuximab (5 mg/mL).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert hætteglas med 20 ml indeholder 100 mg cetuximab (5 mg/ml).
English: Set and control the rate as explained in section 4.2.
Danish: Indstil og kontroller hastigheden som forklaret under pkt.
English: 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
Danish: 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
English: Erbitux may cause side effects concerning the skin.
Danish: Erbitux kan forårsage bivirkninger, der påvirker huden.
English: Erbitux 5 mg/mL solution for infusion Cetuximab
Danish: Erbitux 5 mg/ml infusionsvæske, opløsning Cetuximab
English: Cetuximab plus BSC
Danish: BSC Cetuximab plus BSC BSC
English: 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).
Danish: 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.
English: 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.
Danish: Disse omfatter symptomer som feber, kulderystelser, svimmelhed eller dyspnø og forekommer tidsmæssigt i tæt tilknytning til især den første infusion med cetuximab.
English: Repeat this procedure until the calculated volume has been infused.
Danish: Gentag proceduren, til den beregnede mængde er infunderet.
English: stop infusion immediately, treat symptoms vigorously and contraindicate further use of cetuximab
Danish: stop infusionen omgående og behandl symptomer intensivt.
English: For the dosage or recommended dose modifications of concomitantly used chemotherapeutic agents, refer to the product information for these medicinal products.
Danish: Ved samtidig behandling med andre kemoterapeutiske stoffer henvises der til produktinformationen til disse lægemidler angående doseringen eller de anbefalede dosisændringer.
English: 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.
Danish: Dette kan medføre efterfølgende komplikationer, f.eks. cellulitis, erysipelas eller, potentielt med dødeligt udfald, staphylococcal scalded skin syndrome (SSSS), nekrotiserende fasciitis eller sepsis.
English: The proportion of patients with KRAS wild-type tumours from the patient population evaluable for KRAS status comprised 58%.
Danish: Andelen af patienter i patientpopulationen med tumorer af KRASvildtypen, som kunne vurderes med hensyn til KRAS-status, var 58%.
English: 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.
Danish: Dette kan især være tilfældet, hvis du får hudreaktioner, betændelse i slimhinderne i mave-tarm-kanalen eller i munden eller får diaré.
English: Pre-treatment
Danish: Forbehandling
English: Uncommon ( 1/1,000 to < 1/100)
Danish: Ikke almindelig (≥ 1/1.000 til < 1/100)
English: BATCH NUMBER BN
Danish: FREMSTILLERENS BATCHNUMMER Batch
English: • blood clots in the veins of the legs
Danish: • blodpropper i blodårerne i benene
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Erbitux 5 mg/mL solution for infusion
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Erbitux 5 mg/ml infusionsvæske, opløsning Cetuximab
English: • 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).
Danish: • 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).
English: 1 vial of 500 mg/100 mL
Danish: 1 hætteglas med 500 mg/100 ml
English: 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.
Danish: 4 for detaljer, da nogle hudreaktioner kan have alvorlige konsekvenser for dig, herunder være livstruende.
English: The proportion of patients with KRAS wild-type tumours from the patient population evaluable for KRAS status comprised 57%.
Danish: Andelen af patienter i patientpopulationen med tumorer af KRAS-vildtypen, som kunne vurderes mht. KRAS-status, var 57%.
English: • 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).
Danish: • 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).
English: Take an appropriate sterile syringe and attach a suitable needle.
Danish: Sæt en passende kanyle på en steril sprøjte af passende størrelse.
English: (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
Danish: 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
English: Each vial of 20 mL contains 100 mg cetuximab.
Danish: Hvert hætteglas med 20 ml indeholder 100 mg cetuximab.
English: OS months, median (95% CI) Hazard Ratio (95% CI) p-value PFS months, median (95% CI)
Danish: OS måneder, median (95% CI) Hazard ratio (95% CI) p-værdi PFS måneder, median (95% CI)
English: • EMR 62 202-007: This randomised study in patients with metastatic colorectal cancer after failure of irinotecan-based treatment for metastatic disease as the last treatment before study entry compared the combination of cetuximab and irinotecan (218 patients) with cetuximab monotherapy (111 patients).
Danish: • EMR 62 202-007: Dette randomiserede studie med patienter med metastatisk kolorektal cancer, som havde fået virkningsløs, irinotecan-baseret behandling for metastatisk sygdom som sidste behandling inden tilmelding til studiet, sammenlignede kombinationen af cetuximab og irinotecan (218 patienter) med cetuximab-monoterapi (111 patienter).
English: NAME OF THE MEDICINAL PRODUCT Erbitux 5 mg/mL solution for infusion Cetuximab
Danish: LÆGEMIDLETS NAVN Erbitux 5 mg/ml infusionsvæske, opløsning Cetuximab
English: FIRE-3, an investigator-sponsored clinical phase-III study, compared the treatment of FOLFIRI in combination with either cetuximab or bevacizumab in the first-line treatment of patients with KRAS exon 2 wild-type mCRC.
Danish: FOLFIRI i kombination med enten cetuximab eller bevacizumab som 1. linjebehandling af patienter med mCRC af KRAS exon 2-vildtypen.
English: The proportion of patients with KRAS wild-type tumours from the patient population evaluable for KRAS status comprised 63%.
Danish: Andelen af patienter i patientpopulationen, som havde tumorer af KRAS-vildtypen, og som kunne vurderes mht. KRAS-status, var 63%.
English: • metastatic cancer of the large intestine.
Danish: • Metastatisk tyktarmskræft.
English: NAME OF THE MEDICINAL PRODUCT Erbitux 5 mg/mL solution for infusion
Danish: LÆGEMIDLETS NAVN Erbitux 5 mg/ml infusionsvæske, opløsning
English: Each mL of the solution for infusion contains 5 mg cetuximab.
Danish: 1 ml infusionsvæske, opløsning indeholder 5 mg cetuximab.
English: • EMR 62 202-013: This randomised study in patients with metastatic colorectal cancer who had not received prior treatment for metastatic disease compared the combination of cetuximab and irinotecan plus infusional 5-fluorouracil/folinic acid (FOLFIRI) (599 patients) to the same chemotherapy alone (599 patients).
Danish: • EMR 62 202-013: Dette randomiserede studie med patienter med metastatisk kolorektal cancer, som ikke tidligere havde fået behandling for metastatisk sygdom, sammenlignede kombinationen af cetuximab og irinotecan plus 5-fluoruracil/folinsyre-infusion (FOLFIRI) (599 patienter) med den samme kemoterapibehandling uden cetuximab (599 patienter).