FrancophonIA/ELRC3.0 huggingface dataset:
English: Erbitux is indicated for the treatment of patients with squamous cell cancer of the head and neck
Danish: Erbitux er indiceret til behandling af patienter med planocellulært karcinom i hoved og hals
English: Radiation therapy alone
Danish: Strålebehandling alene
English: Citric acid monohydrate Sodium hydroxide Water for injections
Danish: Citronsyremonohydrat Natriumhydroxid Vand til injektionsvæsker
English: Cetuximab in combination with radiation therapy for locally advanced disease
Danish: Cetuximab i kombination med strålebehandling til lokalt fremskreden sygdom
English: Cetuximab is a chimeric monoclonal IgG1 antibody that is specifically directed against the epidermal growth factor receptor (EGFR).
Danish: Cetuximab er et kimerisk monoklonalt IgG1-antistof specifikt rettet mod den epidermale vækstfaktorreceptor (EGFR).
English: When cetuximab was administered at an initial dose of 400 mg/m 2 body surface area, the mean volume of distribution was approximately equivalent to the vascular space (2.9 L/m 2 with a range of
Danish: Når cetuximab blev givet med en initialdosis på 400 mg/m² legemsoverflade, svarede middelværdien for distributionsvolumen nogenlunde til det vaskulære fordelingsrum (2,9 l/m² med et område på 1,5 til 6,2 l/m²).
English: Do not use this medicine after the expiry date which is stated on the label and the carton after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: 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.
Danish: Populationen med RAS-mutation, der består af disse 65 patienter og 113 patienter med tumorer med KRAS exon 2-mutationer, som blev behandlet, før de indgik i studiet, var begrænset til patienter med mCRC af KRAS exon 2-vildtypen.
English: Severe infusion-related side effects include:
Danish: Svære infusionsrelaterede bivirkninger omfatter:
English: They normally occur during the infusion, within 1 hour afterwards, or sometimes also after this period.
Danish: De opstår som regel under infusionen, inden for 1 time efter eller somme tider også efter denne tidsperiode.
English: MARKETING AUTHORISATION NUMBERS EU/1/04/281/003
Danish: MARKEDSFØRINGSTILLADELSESNUMRE EU/1/04/281/003
English: No other formal interaction studies with cetuximab have been performed in humans.
Danish: Der er ikke foretaget andre særlige interaktionsundersøgelser med cetuximab hos mennesker.
English: In the KRAS wild-type population of the CALGB/SWOG 80405 study (n=1137), superiority of cetuximab plus chemotherapy over bevacizumab plus chemotherapy was not shown based on an interim analysis.
Danish: I KRAS-vildtype-populationen i CALGB/SWOG 80405-studiet (n=1.137) blev det ikke vist, at cetuximab plus kemoterapi var bedre end bevacizumab plus kemoterapi, baseret på en interimanalyse.
English: 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.
Danish: Den kemiske og fysiske stabilitet under brugen af Erbitux 5 mg/ml er påvist i 48 timer ved 25°C, hvis opløsningen forberedes som beskrevet i pkt.
English: Cetuximab binds to the EGFR with an affinity that is approximately 5- to 10-fold higher than that of endogenous ligands.
Danish: Cetuximab binder sig til EGFR med en affinitet, som er cirka 5 til 10 gange højre end kroppens egne ligander.
English: No formal animal studies have been performed to establish the carcinogenic potential of cetuximab or to determine its effects on male and female fertility.
Danish: Der er ikke udført formelle dyrestudier for at fastlægge cetuximabs karcinogenicitet eller for at påvise effekt på fertiliteten hos hanner og hunner.
English: Cetuximab should be used with caution in patients with a history of keratitis, ulcerative keratitis or severe dry eye.
Danish: Cetuximab skal bruges med forsigtighed til patienter med keratitis, ulcerativ keratitis eller alvorlig øjentørhed i anamnesen.
English: Side effects concerning the lungs
Danish: Bivirkninger, der påvirker lungerne
English: • acne-like skin alterations
Danish: • akne-lignende hudforandringer
English: Hypomagnesaemia (see section 4.4).
Danish: Hypomagnesæmi (se pkt.
English: 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.
Danish: Behandlingen i armen med cetuximab omfattede op til 6 cyklusser platinbaseret kemoterapi i kombination med cetuximab efterfulgt af cetuximab som vedligeholdelsesbehandling indtil sygdomsprogression.
English: If interstitial lung disease is diagnosed, cetuximab must be discontinued and the patient be treated appropriately.
Danish: Hvis der diagnosticeres interstitiel lungesygdom, skal behandlingen med cetuximab seponeres og patienten have adækvat behandling.
English: In combination with fluoropyrimidines, the frequency of cardiac ischaemia including myocardial infarction and congestive heart failure as well as the frequency of hand-foot syndrome (palmar-plantar erythrodysaesthesia) were increased compared to that with fluoropyrimidines.
Danish: Ved administration i kombination fluoropyrimidiner steg hyppigheden af kardial iskæmi, herunder myokardieinfarkt og kongestiv hjeteinsufficiens, samt hyppigheden af hånd-fod-syndrom (palmarplantar erytrodysæstesi) sammenlignet med kun fluoropyrimidiner.
English: 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.
Danish: Hvis du bemærker, at hudforandringer bliver værre, skal du omgående kontakte en læge, specielt hvis du også oplever generelle tegn på infektion, såsom feber og træthed.
English: These signs may indicate a skin infection, which may have serious consequences including life-threatening conditions.
Danish: Disse tegn kan tyde på en hudinfektion, som kan have alvorlige konsekvenser for dig, herunder være livstruende.
English: Cetuximab is a chimeric monoclonal IgG1 antibody produced in a mammalian cell line (Sp2/0) by recombinant DNA technology.
Danish: Cetuximab er et kimerisk monoklonalt IgG1 antistof fremstillet i en cellelinje (Sp 2/0) fra pattedyr ved rekombinant DNA-teknologi.
English: The initial dose should be given slowly and speed of infusion must not exceed 5 mg/min (see section 4.4).
Danish: Initialdosis bør gives langsomt, og infusionshastigheden må ikke overstige 5 mg/min (se pkt.
English: Cetuximab has not been studied in patients with pre-existing haematological disorders (see section 4.4).
Danish: Cetuximab er ikke undersøgt hos patienter med allerede eksisterende hæmatologiske forstyrrelser (se pkt.
English: It is recommended to start cetuximab therapy one week before radiation therapy and to continue cetuximab therapy until the end of the radiation therapy period.
Danish: Det anbefales at indlede behandling med cetuximab en uge før strålebehandlingen og at fortsætte behandlingen med cetuximab, indtil strålebehandlingsperioden afsluttes.
English: Your doctor will calculate the correct dose of Erbitux for you because it depends on your body surface area.
Danish: Den korrekte dosis af Erbitux afhænger af legemets overflade.
English: • reduction in the number of white blood cells
Danish: • nedsat antal af hvide blodlegemer.
English: However, in preclinical wound healing models EGFR selective tyrosine kinase inhibitors were shown to retard wound healing.
Danish: I prækliniske sårhelingsmodeller har EGFR-selektive tyrosinkinasehæmmere imidlertid vist sig at forsinke sårheling.
English: They must not be administered earlier than 1 hour after the end of the cetuximab infusion.
Danish: De må ikke indgives tidligere end en time efter afsluttet cetuximab-infusion.
English: 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).
Danish: I kombination med lokal strålebehandling af hoved- og halsområdet var de yderligere bivirkninger dem, som er typiske for strålebehandling (f.eks. mucositis, stråledermatit, dysfagi eller leukopeni, der hovedsageligt optrådte som lymfocytopeni).
English: In these patients, Erbitux is used in combination with radiation therapy or with other anticancer medicines.
Danish: Hos disse patienter anvendes Erbitux i kombination med strålebehandling eller med andre lægemidler mod kræft.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 100 mg/20 mL
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 100 mg/20 ml
English: Severe infusion-related reactions, including anaphylactic reactions, may commonly occur, in some cases with fatal outcome.
Danish: Der kan ofte forekomme svære infusionsrelaterede, herunder anafylaktiske reaktioner, i nogle tilfælde med dødelig udgang.
English: Cetuximab as a single agent or in combination with chemotherapy was investigated in 5 randomised controlled clinical studies and several supportive studies.
Danish: Cetuximab som enkeltstofbehandling eller i kombination med kemoterapi blev undersøgt i 5 randomiserede, kontrollerede, kliniske studier og flere understøttende studier.
English: RAS status was evaluable in tumour samples of 407 KRAS exon 2 wild-type patients reflecting 69% of the overall KRAS exon 2 wild-type patient population (592 patients).
Danish: RAS-status kunne evalueres i tumorprøver fra 407 patienter med KRAS exon 2-vildtypen, hvilket afspejler 69% af den samlede patientpopulation med KRAS exon 2-vildtype (592 patienter).
English: For storage conditions after opening, see section 6.3.
Danish: Opbevaringsforhold efter anbrud, se pkt.
English: Cetuximab pharmacokinetics were studied when cetuximab was administered as monotherapy or in combination with concomitant chemotherapy or radiation therapy in clinical studies.
Danish: Cetuximabs farmakokinetik blev undersøgt, da cetuximab blev indgivet som monoterapi eller i kombination med samtidig kemoterapi eller strålebehandling i kliniske studier.
English: In a randomised controlled clinical study with 424 patients, reporting rates of severe acute radiation dermatitis and mucositis as well as of late radiation-therapy-related events were slightly higher in patients receiving radiation therapy in combination with cetuximab than in those receiving radiation therapy alone.
Danish: I et randomiseret, kontrolleret, klinisk studier med 424 patienter var antallet af svær, akut stråledermatit og mucositis samt af sene rapporterede hændelser, relaterede til strålebehandlingen, let forhøjet hos patienter, som fik strålebehandling i kombination med cetuximab, sammenlignet med dem, som kun fik strålebehandling.
English: 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.
Danish: Hvis du får Erbitux i kombination med anden medicin mod kræft, skal denne medicin tidligst gives 1 time efter afsluttet Erbitux-infusion.
English: Cetuximab in combination with platinum-based chemotherapy in recurrent and/or metastatic disease
Danish: Cetuximab i kombination med platinbaseret kemoterapi ved recidiverende og/eller metastatisk sygdom
English: Tumour samples from approximately 81% of patients were analysed retrospectively for KRAS expression, of which 55% were KRAS wild-type.
Danish: Tumorprøver fra ca. 81% af patienterne blev analyseret retrospektivt for KRAS-ekspression, heraf 55% var KRAS-vildtypen.
English: KRAS wild-type population
Danish: Population med KRAS-vildtype
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/281/003
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/04/281/003
English: The main side effects of Erbitux are infusion-related side effects and side effects concerning the skin: Infusion-related side effects
Danish: De væsentligste bivirkninger ved Erbitux er infusionsrelaterede bivirkninger samt bivirkninger, der påvirker huden:
English: • For administration with a syringe pump: Calculate the required volume of Erbitux.
Danish: • Indgift med sprøjtepumpe: Beregn den nødvendige mængde Erbitux.
English: In combination with platinum-based chemotherapy, the frequency of severe leukopenia or severe neutropenia may be increased, and thus may lead to a higher rate of infectious complications such as febrile neutropenia, pneumonia and sepsis compared to platinum-based chemotherapy alone (see section 4.4).
Danish: I kombination med platinbaseret kemoterapi kan hyppigheden af svær leukopeni eller svær neutropeni være forøget og således resultere i et større antal af infektiøse komplikationer som f.eks. febril neutropeni, lungebetændelse eller sepsis sammenlignet med platinbaseret kemoterapi alene (se pkt.
English: The initial dose is 400 mg cetuximab per m body surface area.
Danish: Den initiale dosis er 400 mg cetuximab per m² legemsoverflade.
English: These side effects normally occur during the infusion, within 1 hour afterwards, or sometimes also after this period.
Danish: Disse bivirkninger forekommer normalt under infusionen, inden for 1 time efter infusionen eller somme tider også efter denne tidsperiode.
English: 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).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med cetuximab i alle undergrupper af den pædiatriske population med kolorektal adenokarcinom, orofaryngeal og laryngeal karcinom samt karcinom i næsen (undtagen nasofaryngeal karcinom og lymfoepiteliom, se pkt.
English: In vitro cetuximab inhibits the production of angiogenic factors by tumour cells and blocks endothelial cell migration.
Danish: In vitro hæmmer cetuximab tumorcellers produktion af angiogene faktorer og blokerer migration af endotelceller.
English: • with polyethylene (PE), ethyl vinyl acetate (EVA) or polyvinyl chloride (PVC) bags,
Danish: • med poser af polyetylen (PE), ethylvinylacetat (EVA) eller polyvinylklorid (PVC),
English: However, dependent on the dose, an increased incidence of abortion was observed (see section 5.3).
Danish: Der blev dog observeret en dosisafhængig stigning af spontan abort (se pkt.
English: • For administration with infusion pump or gravity drip (undiluted): Calculate the required volume of Erbitux.
Danish: • Indgift med infusionspumpe eller almindeligt drop (ufortyndet): Beregn den nødvendige mængde Erbitux.
English: Similarly, the pharmacokinetics of irinotecan were unchanged when cetuximab was co-administered.
Danish: Irinotecans farmakokinetik var også uændret, ved samtidig indgift af cetuximab.
English: Erbitux 5 mg/mL solution for infusion is supplied in vials containing 20 mL or 100 mL.
Danish: Erbitux 5 mg/ml infusionsvæske, opløsning leveres i hætteglas, som indeholder 20 ml eller 100 ml.
English: Connect the infusion line and prime it with Erbitux before starting the infusion.
Danish: Tilslut infusionslinjen og opspæd med Erbitux inden infusionen indledes.
English: Frequency not known:Superinfection of skin lesions*.
Danish: Superinfektion af hudlæsioner*.
English: Tell your doctor if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
Danish: Fortæl altid lægen, hvis du tager anden medicin eller har gjort det for nylig.
English: • The other ingredients are sodium chloride, glycine, polysorbate 80, citric acid monohydrate, sodium hydroxide and water for injections.
Danish: • Øvrige indholdsstoffer: natriumchlorid, glycin, polysorbat 80, citronsyremonohydrat, natriumhydroxid og vand til injektionsvæsker.
English: Erbitux may be administered via a gravity drip, an infusion pump or a syringe pump.
Danish: Erbitux kan indgives med almindeligt drop, infusionspumpe eller sprøjtepumpe.
English: FIRE-3 (First-line combination of cetuximab with FOLFIRI): The FIRE-3 study was a multicentre randomised phase-III study investigating head-to-head 5-FU, folinic acid and irinotecan (FOLFIRI) combined with either cetuximab or bevacizumab in patients with KRAS exon 2 wild-type metastatic colorectal cancer (mCRC).
Danish: FIRE-3 (1. linjebehandling med en kombination af cetuximab og FOLFIRI): FIRE-3 studiet var et randomiseret fase III-multicenterstudie, der undersøgte 5-FU, folinsyre og irinotecan (FOLFIRI) ”head to head”, kombineret med enten cetuximab eller bevacizumab, hos patienter med KRAS exon 2-vildtype metastatisk kolorektal cancer (mCRC).
English: No conclusive data on the neutralising effect of HACAs on cetuximab is available to date.
Danish: Der foreligger til dato ingen afgørende data om den neutraliserende effekt af HACAs på cetuximab.
English: Transfer the Erbitux into a sterile evacuated container or bag.
Danish: Overfør Erbitux til en steril, tom beholder eller pose.
English: Locoregional control months, median (95% CI) Hazard Ratio (95% CI) p-value OS months, median (95% CI) Hazard Ratio (95% CI) p-value median follow-up, months 1-year OS rate, % (95% CI) 2-year OS rate, % (95% CI) 3-year OS rate, % (95% CI) 5-year OS rate, % (95% CI) CI = confidence interval, OS = overall survival time, a '+' denotes that the upper bound limit had not been reached at cut-off
Danish: Locoregional kontrol måneder, median (95% CI) Hazard ratio (95% CI) p-værdi OS måneder, median (95% CI) Hazard ratio (95% CI) p-værdi median opfølgning, måneder 1-års OS-rate, % (95% CI) 2-års OS-rate, % (95% CI) 3-års OS-rate, % (95% CI) 5-års OS-rate, % (95% CI) CI = confidence interval, konfidensinterval, OS = overlevelsestid, et "+" betyder, at den øvre grænse ikke var nået ved "cut-off"
English: Of these, 362 patients received cetuximab and oxaliplatin plus fluoropyrimidines (117 patients OxMdG and 245 patients XELOX) and 367 patients received oxaliplatin plus fluoropyrimidines alone (127 patients OxMdG and 240 patients XELOX).
Danish: 362 af disse patienter fik cetuximab og oxaliplatin plus fluoropyrimidiner (117 patienter OxMdG og 245 patienter XELOX), og 367 patienter fik oxaliplatin plus fluoropyrimidiner alene (127 patienter OxMdG og 240 patienter XELOX).
English: If you receive Erbitux with radiation therapy, some of the side effects you may experience can also be related to this combination, such as:
Danish: Hvis du får Erbitux i kombination med strålebehandling, kan nogle af de bivirkninger, du får, også være forbundet med denne kombination, såsom:
English: Chemotherapy must not be administered earlier than 1 hour after the end of the cetuximab infusion.
Danish: Kemoterapi må ikke indgives tidligere end en time efter afsluttet cetuximab-infusion.
English: When cetuximab is used in combination with chemotherapeutic agents, also refer to their respective product information.
Danish: Når cetuximab anvendes i kombination med kemoterapeutiske stoffer skal de respektive produktresuméer til disse stoffer læses.
English: However, dependent on the dose, an increased incidence of abortion was observed.
Danish: Der blev dog observeret en dosisafhængig stigning af spontan abort.
English: • skin reactions typical for radiation therapy
Danish: • hudreaktioner, som er almindelige som følge af strålebehandlingen
English: • inflammation of the eye lid or the front part of the eye
Danish: • betændelse i øjenlåget eller hornhinden
English: Squamous cell cancer of the head and neck
Danish: Planocellulært karcinom i hoved og hals
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Danish: Du kan finde yderligere oplysninger om Erbitux på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: 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).
Danish: 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).
English: • decrease in blood levels of magnesium
Danish: • fald i indholdet af magnesium i blodet
English: • decrease in blood levels of calcium
Danish: • fald i indholdet af kalcium i blodet
English: Cetuximab in combination with chemotherapy
Danish: Cetuximab i kombination med kemoterapi
English: 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).
Danish: 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.
English: Erbitux is usually infused once a week.
Danish: Erbitux gives normalt som infusion én gang ugentligt.
English: Erbitux is usually infused into a vein (given as a drip) once a week.
Danish: Erbitux gives normalt som infusion i en åre (som drop) en gang ugentligt.
English: Erbitux 5 mg/mL is administered intravenously with an infusion pump, gravity drip or a syringe pump (for handling instructions, see section 6.6).
Danish: Erbitux 5 mg/ml gives intravenøst med en infusionspumpe, almindeligt drop eller en sprøjtepumpe (vedrørende håndtering, se pkt.
English: 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.
Danish: 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.
English: Sodium chloride, glycine, polysorbate 80, citric acid monohydrate, sodium hydroxide, water for injections
Danish: Natriumchlorid, glycin, polysorbat 80, citronsyremonohydrat, natriumhydroxid, vand til injektionsvæsker.
English: • 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.
Danish: • 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.
English: Erbitux may cause side effects concerning the eyes.
Danish: Erbitux kan forårsage bivirkninger fra øjnene.
English: Erbitux may cause infusion-related side effects.
Danish: Erbitux kan give infusionsrelaterede bivirkninger.
English: All subsequent weekly doses are 250 mg cetuximab per m2 each.
Danish: Alle følgende ugentlige doser er på 250 mg cetuximab per m².
English: In vivo cetuximab inhibits expression of angiogenic factors by tumour cells and causes a reduction in tumour neo-vascularisation and metastasis.
Danish: In vivo hæmmer cetuximab tumorcellers angiogene faktorer og fremkalder en reduktion i tumorens neo-vaskularisering og metastasering.
English: Cetuximab blocks binding of endogenous EGFR ligands resulting in inhibition of the function of the receptor.
Danish: Cetuximab blokerer bindingen af kropsegne EGFR-ligander, hvilket hæmmer receptorens funktion.