FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Danish: Der kan opstå anafylaktiske reaktioner så hurtigt som inden for få minutter af den første infusion f.eks. på grund af allerede dannede IgE-antistoffer, der krydsreagerer med cetuximab.
English: If a diagnosis of ulcerative keratitis is confirmed, treatment with cetuximab should be interrupted or discontinued.
Danish: Hvis en diagnose på ulcerativ keratitis bekræftes, skal behandlingen med cetuximab afbrydes eller seponeres.
English: With respect to the KRAS status, tumour samples were only available from 23% of the patients (300 of 1298).
Danish: Med hensyn til KRAS-status var tumorprøver kun tilgængelige fra 23% af patienterne (300 ud af 1.298).
English: More than 10 out of 100 patients are likely to experience infusion-related side effects; in more than 1 out of 100 patients these side effects are likely to be severe.
Danish: Hos mere end 10 ud af 100 patienter kan der forekomme infusionsrelaterede bivirkninger; hos mere end 1 ud af 100 patienter kan disse bivirkninger være svære.
English: Headache.
Danish: Hovedpine.
English: Main side effects concerning the skin include:
Danish: De væsentligste bivirkninger vedrørende huden omfatter:
English: An embryo-foetal toxicity study in Cynomolgus monkeys revealed no signs of teratogenicity.
Danish: Et embryo-føtalt toksicitetsstudie med Cynomolgusaber påviste ingen tegn på teratogenicitet.
English: Mild or moderate infusion-related side effects include:
Danish: Lette eller moderate infusionsrelaterede bivirkninger omfatter:
English: Calculate the required volume of Erbitux.
Danish: Beregn den nødvendige mængde Erbitux.
English: Hypocalcaemia may also occur; in particular in combination with platinum-based chemotherapy the frequency of severe hypocalcaemia may be increased.
Danish: Der kan ligeledes opstå hypokalcæmi; det er især i kombination med platinbaseret kemoterapi, at hyppigheden af svær hypokalcæmi kan være forøget.
English: 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).
Danish: Kun patienter med den fornødne nyre- og leverfunktion er undersøgt til dato (serumkreatinin ≤ 1,5 gang, aminotransferaser ≤ 5 gange og bilirubin ≤ 1,5 gang den normale øverste grænse).
English: If severe skin reactions occur a fourth time or do not resolve to grade 2 during interruption of treatment, permanent discontinuation of cetuximab treatment is required.
Danish: Hvis der forekommer svære hudreaktioner en fjerde gang, eller reaktionen ikke falder til grad 2 under afbrydelse af behandlingen, er det nødvendigt at stoppe behandlingen med cetuximab permanent.
English: Main adverse reactions of cetuximab are skin reactions which may become severe, especially in combination with chemotherapy.
Danish: Cetuximabs væsentligste bivirkninger er hudreaktioner, som kan blive alvorlige, især ved kombination med kemoterapi.
English: Your doctor will discuss with you whether you may need any particular supervision (see also 'Side effects in combination with other anticancer treatments' in section 4).
Danish: Lægen vil diskutere med dig om du har behov for nogen speciel form for overvågning (se også "Bivirkninger i kombination med andre behandlinger mod kræft" under pkt.
English: The RAS mutant population consists of patients with known KRAS exon 2 mutations as well as additionally identified RAS mutations.
Danish: Populationen med RAS-mutationen består af patienter med kendte KRAS exon 2-mutationer såvel som yderligere identificerede RAS-mutationer.
English: Approximately 15% of the skin reactions are severe, including single cases of skin necrosis.
Danish: Omkring 15% af hudreaktionerne er svære, herunder enkelte tilfælde af hudnekrose.
English: Your doctor will decide whether treatment has to be stopped if skin reactions reappear after several dose reductions.
Danish: Lægen vil afgøre, om behandlingen skal stoppes, hvis hudreaktionerne kommer igen, efter at dosis er blevet nedsat flere gange.
English: • 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)
Danish: • rødme eller hævelse af håndflader og fodsåler som kan få huden til at skalle (hånd-fod-syndrom)
English: Before initiation of combination treatment, contraindications for concomitantly used chemotherapeutic agents or radiation therapy must be considered.
Danish: Før kombinationsbehandlingen indledes, skal kontraindikationerne for de samtidigt anvendte kemoterapeutiske stoffer og for strålebehandling tages i betragtning.
English: Combination with other anticancer treatments
Danish: Kombination med andre behandlinger mod kræft
English: 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.
Danish: Erbitux 5 mg/ml er kemisk og fysisk stabilt i op til 48 timer ved 25°C, hvis opløsningen forberedes som beskrevet herunder.
English: It is recommended that cetuximab treatment be continued until progression of the underlying disease.
Danish: Det anbefales at fortsætte behandlingen med cetuximab, til den tilgrundliggende sygdom udvikler sig.
English: Medium to high-potency topical corticosteroids or oral tetracyclines have been used for the treatment of skin reactions.
Danish: Middelstærkt til stærkt virkende topikale kortikosteroider eller orale tetracykliner er blevet anvendt til behandling af hudreaktioner.
English: These side effects may have serious consequences, in rare cases including life-threatening conditions, and require immediate attention.
Danish: Disse bivirkninger kan have alvorlige følger, i sjældne tilfælde kan de være livstruende og kræve øjeblikkelig behandling.
English: Detailed instructions for your doctor or your nurse on how to prepare the Erbitux infusion are included at the end of this package leaflet (see 'Handling instructions').
Danish: I slutningen af denne indlægsseddel findes der detaljerede instruktioner til lægen eller sygeplejersken om, hvordan Erbitux-infusionen forberedes (se "Håndteringsinstruktioner").
English: There is limited experience in the use of cetuximab in combination with radiation therapy in colorectal cancer.
Danish: Der er begrænsede erfaringer med brugen af cetuximab i kombination med strålebehandling af kolorektal cancer.
English: In uncommon cases (may affect up to 1 in 100 people) patients may experience an inflammation of the lungs (called interstitial lung disease), which may have serious consequences including lifethreatening conditions.
Danish: Patienter kan i ikke almindelige tilfælde (kan forekomme hos op til 1 ud af 100 personer) få en inflammation (betændelse) i lungerne (kaldes interstitiel lungesygdom), som kan få alvorlige konsekvenser, herunder være livstruende.
English: 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.
Danish: Cirka 75% af patienterne med metastatisk kolorektal cancer, som blev screenet til kliniske studier, havde en tumor med EGFR og blev derfor betragtet som egnede til behandling med cetuximab.
English: More than 80 out of 100 patients are likely to experience side effects involving the skin.
Danish: Hos mere end 80 ud af 100 patienter kan der forekomme bivirkninger, som påvirker huden.
English: • in combination with platinum-based chemotherapy for recurrent and/or metastatic disease.
Danish: • i kombination med platinbaseret kemoterapi til recidiverende og/eller metastatisk sygdom.
English: A diagnostic assay (EGFR pharmDx) was used for immunohistochemical detection of EGFR expression in tumour material.
Danish: En diagnostisk analyse (EGFR pharmDx) blev anvendt til immunohistokemisk påvisning af EGFR i tumormateriale.
English: The mean Cmax ( standard deviation) was 18555 microgram per mL.
Danish: Middelværdien for Cmax (± standardafvigelsen) var 185±55 µg/ml.
English: If you experience these symptoms, please speak to a doctor immediately, because these signs may have serious consequences including life-threatening conditions.
Danish: Hvis du får disse symptomer, skal du omgående kontakte en læge, da disse tegn kan have alvorlige konsekvenser for dig, herunder være livstruende.
English: To recognise early signs of such effects, your condition will be checked regularly while you receive each infusion of Erbitux and for at least 1 hour afterwards.
Danish: For at konstatere tidlige tegn på bivirkninger vil din helbredstilstand blive kontrolleret regelmæssigt under hver infusion af Erbitux og i mindst en time derefter.
English: Occurrence of a severe infusion-related reaction requires immediate and permanent discontinuation of cetuximab therapy and may necessitate emergency treatment.
Danish: Svære infusionsrelaterede reaktioner kræver omgående og vedvarende seponering af cetuximab og kan kræve akutbehandling.
English: In a phase-I study in paediatric patients (1-18 years) with refractory solid tumours, cetuximab was administered in combination with irinotecan.
Danish: I et fase I-studie med pædiatriske patienter (1-18 år) med refraktære solide tumorer blev cetuximab givet i kombination med irinotecan.
English: • leukocyte count < 3000/mm³
Danish: • leukocyttal < 3.000/mm³
English: The majority of skin reactions develop within the first three weeks of therapy.
Danish: De fleste hudreaktioner udvikles inden for de tre første uger af behandlingen.
English: Electrolyte repletion is recommended, as appropriate.
Danish: Mætning med elektrolytter anbefales efter behov.
English: 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.
Danish: Da Erbitux kun er foreneligt med steril natriumchlorid 9 mg/ml (0,9%) opløsning til injektion, må det ikke blandes med andre lægemidler, som gives intravenøst.
English: 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.
Danish: Middel peak-koncentrationer for cetuximab var 155,8 µg/ml i uge 3 og 151,6 µg/ml i uge 8, hvorimod de tilsvarende middeltal for laveste koncentrationer var hhv. 41,3 og 55,4 µg/ml.
English: Side effects in combination with other anticancer treatments
Danish: Bivirkninger i kombination med andre behandlinger mod kræft
English: Your doctor will therefore monitor your blood and general condition for signs of infection (see also 'Side effects in combination with other anticancer treatments' in section 4).
Danish: Derfor vil lægen undersøge dit blod og overvåge dig for tegn på infektioner (se også "Bivirkninger i kombination med andre behandlinger mod kræft" under pkt.
English: Cetuximab binds to the epidermal growth factor receptor (EGFR), an antigen on the surface of certain cancer cells.
Danish: Cetuximab binder sig til den epidermale vækstfaktorreceptor (EGFR), som er et antigen på overfladen af visse kræftceller.
English: Cetuximab serum concentrations reached stable levels after three weeks of cetuximab monotherapy.
Danish: Cetuximabs serumkoncentrationer nåede et stabilt niveau efter tre uger med cetuximab monoterapi.
English: 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.
Danish: De 5 randomiserede studier undersøgte i alt 3.734 patienter med metastatisk kolorektal cancer og påvist EGFR-ekspression og med en ECOG-performancestatus på ≤ 2.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER HÆTTEGLAS ETIKET
English: The development of human anti-chimeric antibodies (HACA) is a class effect of monoclonal chimeric antibodies.
Danish: Udviklingen af humane anti-kimeriske antistoffer (human anti-chimeric antibodies, HACA) er en effekt i klassen af monoklonale, kimeriske antistoffer.
English: Erbitux is contraindicated in patients with known severe (grade 3 or 4) hypersensitivity reactions to cetuximab.
Danish: Erbitux er kontraindiceret hos patienter med kendte, svære (grad 3 eller 4) overfølsomhedsreaktioner over for cetuximab.
English: Further post-hoc analyses on mutations on RAS genes other than KRAS exon 2 have been evaluated.
Danish: Yderligere post-hoc-analyser af andre mutationer på RAS-gener end KRAS exon 2 er blevet evalueret.
English: 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).
Danish: Risikoen for anafylaktiske reaktioner er meget højere hos patienter med en anamnese med allergi over for rødt kød eller skovflåtbid eller positive resultater af test for IgE-antistoffer mod cetuximab (α-1-3-galactose).
English: In very rare cases (may affect up to 1 in 10,000 people) patients may experience blistering or peeling of the skin, which may indicate a severe skin reaction called “Stevens-Johnson syndrome”.
Danish: Patienter kan i meget sjældne tilfælde (kan forekomme hos op til 1 ud af 10.000 personer) få blæredannelse eller hudafskalning, der kan være tegn på en alvorlig hudreaktion kaldet "StevensJohnsons syndrom".
English: Prior to the first infusion, patients must receive premedication with an antihistamine and a corticosteroid at least 1 hour prior to administration of cetuximab.
Danish: Før den første infusion af cetuximab skal patienterne præmedicineres med et antihistamin og et kortikosteroid mindst 1 time før administration.
English: In these patients, Erbitux is used alone or in combination with other anticancer medicines.
Danish: Hos disse patienter anvendes Erbitux alene eller i kombination med andre lægemidler mod kræft.
English: There is limited experience with single doses higher than 400 mg/m2 body surface area to date or weekly administrations of doses higher than 250 mg/m 2 body surface area.
Danish: Der er begrænsede erfaringer med enkeltdoser højere end 400 mg/m² legemsoverflade eller ugentlige administrationer af doser på mere end 250 mg/m² legemsoverflade.
English: In particular a negative effect of cetuximab add-on in the RAS mutant population was observed.
Danish: Der blev især observeret en negativ virkning ved tillæg af cetuximab i populationen med RASmutationen.
English: Pulmonary embolism; interstitial lung disease, which may be fatal (see section 4.4).
Danish: Lungeemboli; interstitiel lungesygdom, som kan være dødelig (se pkt.
English: EGFR signalling pathways are involved in the control of cell survival, cell cycle progression, angiogenesis, cell migration and cellular invasion/metastasis.
Danish: EGFR-signalbaner er involverede i kontrollen af cellernes overlevelse, udvikling i cellecyklus, angiogenese, cellemigration og celleinfiltration/metastaser.
English: In the overall population, irrespective of KRAS status, the results reported for cetuximab plus irinotecan (648 patients) vs. irinotecan alone (650 patients) were: median overall survival time (OS) 10.71 vs. 9.99 months (HR 0.98), median progression free survival time (PFS) 4.0 vs. 2.6 months (HR 0.69), and objective response rate (ORR) 16.4% vs. 4.2%.
Danish: I den samlede population, uanset KRAS-status, var resultaterne rapporteret for cetuximab plus irinotecan (648 patienter) vs. irinotecan alene (650 patienter): median samlet overlevelsestid (OS) 10,71 vs. 9,99 måneder (Hazard ratio 0,98), median progressionsfri overlevelsestid (PFS) 4,0 vs. 2,6 måneder (HR 0,69), og objektiv responsrate (ORR) 16,4% vs. 4,2%.
English: Hypomagnesaemia is reversible following discontinuation of cetuximab.
Danish: Hypomagnesæmi er reversibelt efter ophør med cetuximab.
English: Cetuximab also targets cytotoxic immune effector cells towards EGFRexpressing tumour cells (antibody dependent cell-mediated cytotoxicity, ADCC).
Danish: Cetuximab påvirker også cytotoksiske immun-effektorceller mod tumorceller med EGFR (antibody dependent cell-mediated cytotoxicity, ADCC).
English: In addition, significantly fewer patients treated with cetuximab received second-line therapy.
Danish: Desuden fik signifikant færre patienter behandlet med cetuximab anden-linjebehandling.
English: 20 mL or 100 mL of solution in a vial (Type I glass) with a stopper (halobutyl rubber) and a seal (aluminium/polypropylen).
Danish: 20 ml og 100 ml opløsning i et hætteglas (Type I glas) med en prop (halobutylgummi) og en forsegling (aluminium/polypropylen).
English: 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).
Danish: Risikoen for sekundære infektioner (hovedsageligt bakterielle) er øget, og tilfælde af staphylococcal scalded skin syndrome, nekrotiserende fasciitis og sepsis, i nogle tilfælde med dødelig udgang, er blevet rapporteret (se pkt.
English: 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.
Danish: Der blev ikke foretaget immunohistokemisk påvisning af EGFR-ekspression, da mere end 90% af patienterne med planocellulært karcinom i hoved og hals havde tumorer, som var EGFR-positive.
English: Not all vial sizes may be marketed.
Danish: Begge størrelser på hætteglas er ikke nødvendigvis markedsført.
English: If you receive Erbitux in combination with radiation therapy, treatment with Erbitux is usually started one week before radiation therapy.
Danish: Hvis du får Erbitux i kombination med strålebehandling, indledes behandlingen med Erbitux som regel en uge før strålebehandlingen.
English: Mutational status should be determined by an experienced laboratory using validated test methods for detection of KRAS and NRAS (exons 2, 3, and 4) mutations (see section 4.4 and 5.1).
Danish: Mutationsstatus skal bestemmes af et erfarent laboratorium med validerede testmetoder til påvisning af KRAS- og NRAS-mutationer (exon 2, 3 og 4) (se pkt.
English: Erbitux 5 mg/mL is compatible
Danish: Erbitux 5 mg/ml er foreneligt
English: 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.
Danish: Hvis du bemærker symptomer, såsom vejrtrækningsbesvær eller forværring af vejrtrækningsbesvær, skal du omgående kontakte din læge, især hvis du også hoster eller har feber.
English: In time related endpoints no trends indicating clinical benefit could be shown for patients who received cetuximab in combination with the XELOX regimen.
Danish: Der kunne ikke vises nogen tendenser, der indikerede klinisk fordel i tidsrelaterede endepunkter for patienter, der fik cetuximab i kombination med XELOX-regimet.
English: 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.
Danish: Patienter, som får cetuximab i kombination med platinbaseret kemoterapi, har en øget risiko for at der opstår svær neutropeni, hvilket kan resultere i efterfølgende infektiøse komplikationer som f.eks. febril neutropeni, lungebetændelse eller sepsis.
English: Limited observations in animals are indicative of a placental transfer of cetuximab, and other IgG1 antibodies have been found to cross the placental barrier.
Danish: Begrænsede observationer hos dyr tyder på, at cetuximab passerer placentabarrieren, og det er konstateret, at andre IgG1-antistoffer passerer placentabarrieren.
English: Intravenous infusions of cetuximab exhibited dose-dependent pharmacokinetics at weekly doses ranging from 5 to 500 mg/m body surface area.
Danish: Intravenøse infusioner med cetuximab udviste dosisafhængig farmakokinetik ved ugentlige doser fra 5 til 500 mg/m² legemsoverflade.
English: 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).
Danish: En særlig interaktionsundersøgelse viste, at cetuximabs farmakokinetiske egenskaber ikke ændres efter samtidig indgift af en enkelt dosis irinotecan (350 mg/m² legemsoverflade).
English: Remove an adequate volume of the sodium chloride solution from the infusion bag, using an appropriate sterile syringe with a suitable needle.
Danish: Udtag en tilstrækkelig mængde af natriumchloridopløsningen fra infusionsposen ved hjælp af en egnet steril sprøjte med en kanyle af passende størrelse.
English: 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).
Danish: Der blev især observeret negative virkninger hos disse patienter med hensyn til progressionsfri overlevelse (PFS) og samlet overlevelse (OS), når cetuximab blev givet som tillæg til FOLFOX4 (se pkt.
English: What you need to know before you use Erbitux
Danish: Det skal du vide, før du får Erbitux
English: 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).
Danish: En tæt monitorering af sådanne patienter anbefales; herunder især de patienter, som får hudlæsioner, mucositis eller diaré, hvilket kan øge risikoen for at der opstår infektioner (se pkt.
English: Tumour samples from approximately 81% of patients were analysed retrospectively for KRAS expression.
Danish: Tumorprøver fra ca. 81% af patienterne blev analyseret retrospektivt for KRAS-ekspression.
English: From the KRAS evaluated population 64% of the patients (192) had KRAS wildtype tumours and 108 patients KRAS mutations.
Danish: I den KRAS-evaluerede population havde 64% af patienterne (192) KRASvildtypetumorer, og 108 patienter havde KRAS-mutationer.
English: Colourless solution.
Danish: Farveløs opløsning.
English: In addition, cetuximab was investigated in combination with chemotherapy in an investigator-initiated randomised controlled phase-III study (COIN, COntinuous chemotherapy plus cetuximab or INtermittent chemotherapy).
Danish: Cetuximab blev desuden undersøgt i kombination med kemoterapi i et investigator-indledt, randomiseret, kontrolleret fase III-studie (COIN, COntinuous chemotherapy plus cetuximab or INtermittent chemotherapy).
English: With the second and third occurrences of severe skin reactions, cetuximab therapy must again be interrupted.
Danish: Anden og tredje gang, der forekommer svære hudreaktioner, skal behandlingen med cetuximab igen afbrydes.
English: 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.
Danish: Når cetuximab ordineres, skal der tages hensyn til patienternes kardiovaskulære status, performance-status og samtidig indgivelse af kardiotoksiske stoffer, såsom fluoropyrimidiner.
English: In tumours, activation of RAS by EGFR contributes to EGFR-mediated increased proliferation, survival and the production of pro-angiogenic factors.
Danish: I tumorer bidrager aktivering af RAS via EGFR til EGFR-medieret øget celleproliferation, celleoverlevelse og produktion af pro-angiogene faktorer.
English: There are no data on the effect of cetuximab on human fertility.
Danish: Der er ingen data for cetuximabs virkning på human fertilitet.
English: In a study of cetuximab administered in combination with irinotecan, the mean cetuximab trough levels were 50.0 microgram per mL in week 12 and 49.4 microgram per mL in week 36.
Danish: I et studie hvor der blev givet cetuximab i kombination med irinotecan, var middeltallet for de laveste værdier for cetuximab 50,0 µg/ml i uge 12 og 49,4 µg/ml i uge 36.