FrancophonIA/ELRC3.0 huggingface dataset:
English: If you have heart problems, your doctor will discuss with you whether you can receive Erbitux in combination with other anticancer medicines, especially if you are 65 years of age or older.
Danish: Hvis du har hjerteproblemer, vil din læge drøfte med dig, om du kan få Erbitux i kombination med anden medicin mod kræft, især hvis du er 65 år eller ældre.
English: If such symptoms occur, please inform your doctor as soon as possible.
Danish: Hvis disse symptomer opstår, skal du kontakte lægen så hurtigt som muligt.
English: Cetuximab has not been studied in patients presenting with one or more of the following laboratory parameters:
Danish: Cetuximab er ikke undersøgt hos patienter med en eller flere af følgende laboratorieparametre:
English: A cytokine release syndrome (CRS) typically occurs within one hour after infusion and is less commonly associated with bronchospasm and urticaria.
Danish: Et cytokinfrigivelsessyndrom (CRS) opstår typisk inden for en time efter infusion og er mindre hyppigt forbundet med bronkospasme og urticaria.
English: The first dose should be administered slowly and the speed must not exceed 5 mg/min whilst all vital signs are closely monitored for at least two hours.
Danish: Den første dosis bør administreres langsomt, og hastigheden må ikke overstige 5 mg/min, mens alle vitale tegn monitoreres nøje i mindst to timer.
English: If the severe skin reaction occurred for the first time, treatment may be resumed without any change in dose level.
Danish: Første gang den svære hudreaktion optræder, kan behandlingen genoptages uden ændring i dosisniveau.
English: • in combination with irinotecan-based chemotherapy,
Danish: • i kombination med irinotecanbaseret kemoterapi,
English: Animal data revealed no evidence of teratogenicity.
Danish: Data fra dyrestudier gav ikke bevis på teratogenicitet.
English: The efficacy data generated in this study are summarised in the table below:
Danish: Studiets effektdata er resumeret i nedenstående tabel:
English: Treatment may only be resumed if the reaction has resolved to grade 2.
Danish: Behandlingen må først genoptages, når reaktionen er faldet til grad 2.
English: The third experimental arm used an intermittent OxMdG or XELOX regimen without cetuximab.
Danish: Den tredje eksperimentelle arm brugte et intermitterende OxMdG- eller XELOX-regime uden cetuximab.
English: Your doctor will discuss with you whether you may need any preventive measures or early treatment.
Danish: Din læge vil diskutere med dig, om du har behov for forebyggende eller tidlig behandling.
English: Most of these side effects develop within the first three weeks of treatment.
Danish: De fleste bivirkninger udvikles inden for behandlingens tre første uger.
English: These reactions are commonly associated with bronchospasm and urticaria.
Danish: Disse reaktioner er ofte forbundet med bronkospasme og urticaria.
English: • loss of appetite, leading to weight decrease
Danish: • manglende appetit, som medfører vægttab
English: continue slow infusion and immediately administer treatment for symptoms c) Grade 3 and 4:
Danish: fortsæt langsom infusion og behandl omgående symptomer c) Grad 3 og 4:
English: However, in this study no positive effects on PFS or OS were demonstrated in patients with KRAS wild-type tumours, either.
Danish: I denne undersøgelse blev der dog heller ikke vist nogen positive virkninger på PFS eller OS hos patienter med tumorer af KRAS-vildtypen.
English: Erbitux must be administered under the supervision of a physician experienced in the use of antineoplastic medicinal products.
Danish: Erbitux skal indgives under opsyn af en læge med erfaring i brug af antineoplastiske lægemidler.
English: Your doctor may consider reducing the infusion rate of Erbitux to manage these symptoms.
Danish: Lægen vil måske overveje at nedsætte infusionshastigheden af Erbitux for at håndtere disse symptomer.
English: Mutations of RAS genes at certain hot-spots on exons 2, 3 and 4 result in constitutive activation of RAS proteins independently of EGFR signalling.
Danish: Mutationer af RAS-generne ved visse hotspots på exon 2, 3 og 4 resulterer i konstitutiv aktivering af RAS-proteiner uafhængigt af EGFR-signalering.
English: • a certain type of cancer of the head and neck (squamous cell cancer).
Danish: • En særlig type kræft i hoved og hals (pladecellekræft).
English: In all studies, cetuximab was administered as described in section 4.2.
Danish: Cetuximab blev i alle studier administreret som beskrevet i afsnit 4.2.
English: Treatment may only be resumed at a lower dose level (200 mg/m² after the second occurrence and 150 mg/m² after the third occurrence), if the reaction has resolved to grade 2.
Danish: Behandlingen må kun genoptages på et lavere dosisniveau (200 mg/m² efter anden forekomst og 150 mg/m² efter tredje forekomst), hvis reaktionen er faldet til grad 2.
English: No dose adjustment is required in older people, but the experience is limited in patients 75 years of age and above.
Danish: Der kræves ingen dosisjustering hos ældre patienter, men erfaringer hos patienter over 75 år er begrænsede.
English: You are more likely to experience severe allergic reactions if you are allergic to red meat, tick bites or had positive results for certain antibodies (seen in a test).
Danish: Du har større sandsynlighed for at opleve alvorlige allergiske reaktioner, hvis du er allergisk over for rødt kød, skovflåtbid eller havde positive resultater for visse antistoffer (set i en test).
English: Deep vein thrombosis.
Danish: Dyb venetrombose.
English: If patients experience treatment-related symptoms affecting their ability to concentrate and react, it is recommended that they do not drive or use machines until the effect subsides.
Danish: Hvis patienter får behandlingsrelaterede symptomer, som påvirker deres koncentrations- og reaktionsevne, frarådes det, at de fører motorkøretøj eller betjener maskiner, før effekten tager af.
English: Results from clinical studies show a negative benefit-risk balance in tumours with RAS mutations.
Danish: Resultater fra kliniske undersøgelser viser en negativt risk/benefit-balance i tumorer med RAS-mutationer.
English: If during the first infusion, an infusion-related reaction occurs within the first 15 minutes, the infusion should be stopped.
Danish: Hvis en infusionsrelateret reaktion opstår inden for de første 15 minutter af den første infusion, skal infusionen stoppes.
English: If you notice other extensive skin alterations, please inform your doctor as soon as possible because the Erbitux dose or the time between infusions may need to be changed.
Danish: Hvis du bemærker andre udbredte hudforandringer, skal du kontakte lægen så hurtigt som muligt, da det kan være nødvendigt at ændre dosis af Erbitux eller tidsrummet mellem infusionerne.
English: EGFR activates proteins called RAS. RAS proteins play an important role in the EGFR pathway -a complex signalling cascade which is involved in the development and progression of cancer.
Danish: EGFR aktiverer proteiner kaldet RAS. RAS-proteiner spiller en vigtig rolle i EGFR-vejen -en kompleks kaskade af signaler, som er involveret i udvikling ogforværring af kræft.
English: Remove the needle and put the syringe into the syringe pump.
Danish: Fjern kanylen og sæt sprøjten i sprøjtepumpen.
English: Your doctor will decide whether such pre-treatment is necessary for subsequent doses.
Danish: Lægen vil afgøre, om denne forbehandling er nødvendig ved efterfølgende doser.
English: Progressively decreasing serum magnesium levels occur frequently and may lead to severe hypomagnesaemia.
Danish: Der forekommer hyppigt tiltagende fald i magnesiumniveauerne i serum, hvilket kan føre til svær hypomagnesæmi.
English: Cetuximab has a long elimination half-life with values ranging from 70 to 100 hours at the target dose.
Danish: Cetuximab har en lang eliminations-halveringstid med værdier fra 70 til 100 timer ved måldosis.
English: The infusion rate must not exceed 10 mg/min.
Danish: Infusionshastigheden må ikke overstige 10 mg/min.
English: If the patient experiences a mild or moderate infusion-related reaction, the infusion rate may be decreased.
Danish: Hvis patienten får en let eller moderat infusionsrelateret reaktion, kan infusionshastigheden nedsættes.
English: • in first-line in combination with FOLFOX,
Danish: • som 1. linjebehandling i kombination med FOLFOX,
English: The efficacy data on the OxMdG regimen generated in this study are summarised in the table below:
Danish: Studiets effektdata på OxMdG-regimet er resumeret i nedenstående tabel:
English: Symptoms may include bronchospasm, urticaria, increase or decrease in blood pressure, loss of consciousness or shock.
Danish: Symptomer kan omfatte bronkospasme, urticaria, stigning eller fald i blodtrykket, bevidstløshed eller shock.
English: Skin reactions are very common and treatment interruption or discontinuation may be required.
Danish: Hudreaktioner er meget almindelige, og afbrydelse eller seponering af behandlingen kan være nødvendig.
English: In the event of symptoms (such as dyspnoea, cough, fever) or radiographic findings suggestive of ILD, prompt diagnostic investigation should occur.
Danish: I tilfælde af symptomer (såsom dyspnø, hoste, feber) eller radiografiske fund, der tyder på ILD, bør der straks udføres diagnostiske undersøgelser.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Danish: Indehaveren af markedsføringstilladelsen skal udføre de påkrævede aktiviteter og foranstaltninger vedrørende lægemiddelovervågning, som er beskrevet i i den godkendte RMP, der fremgår af modul 1.8.2 i markedsføringstilladelsen, og enhver efterfølgende godkendt opdatering af RMP.
English: Close monitoring is required during the infusion and for at least 1 hour after the end of the infusion.
Danish: Tæt monitorering er nødvendig under infusionen, og i mindst en time efter infusionen er afsluttet.
English: • inflammation of the lining of the intestine, mouth, and nose (in some cases severe), which may lead to nose bleeding in some patients
Danish: • betændelse i slimhinderne i tarmene, munden og næsen (i nogle tilfælde alvorlig), som kan medføre næseblødning hos visse patienter.
English: Please tell your doctor, if you have acute or worsening eye problems such as blurred vision, eye pain, red eyes and/or severe dry eye, if you have had such problems in the past or if you use contact lenses.
Danish: Fortæl lægen, hvis du får akutte eller forværrede øjenproblemer, såsom sløret syn, øjensmerter, røde øjne og/eller meget tørre øjne, hvis du har haft sådanne problemer tidligere, eller hvis du bruger kontaktlinser.
English: Combination treatment
Danish: Kombinationsbehandling
English: Side effects of which the frequency is not known (cannot be estimated from the available data) • inflammation of the lining of the brain (aseptic meningitis)
Danish: Bivirkninger, hvor hyppigheden ikke er kendt (kan ikke vurderes ud fra tilgængelige data) • Hjernehindebetændelse (aseptisk meningitis)
English: During each infusion and for at least 1 hour afterwards, your condition will be checked regularly for early signs of a possible infusion-related side effect.
Danish: Under hver infusion og i mindst 1 time derefter bliver din helbredstilstand kontrolleret regelmæssigt for en eventuel infusionsrelateret bivirkning.
English: Symptoms may occur during the first infusion and for up to several hours afterwards or with subsequent infusions.
Danish: Symptomerne kan opstå under og i op til flere timer efter den første infusion eller ved efterfølgende infusioner.
English: The use of cetuximab in combination with chemo-radiotherapy has so far not been adequately investigated.
Danish: Brug af cetuximab i kombination med kemo-stråleterapi er til dato ikke undersøgt tilstrækkeligt.
English: The efficacy of cetuximab in paediatric patients below the age of 18 years has not been established.
Danish: Cetuximabs virkning hos pædiatriske patienter under 18 år er ikke klarlagt.
English: Infusion-related, including anaphylactic, reactions
Danish: Infusionsrelaterede, herunder anafylaktiske reaktioner
English: If a patient experiences an intolerable or severe skin reaction ( grade 3; Common Terminology Criteria for Adverse Events, CTCAE), cetuximab therapy must be interrupted.
Danish: Hvis en patient får en intolerabel eller svær hudreaktion (≥ grad 3, Common Terminology Criteria for Adverse Events, CTCAE), skal behandlingen med cetuximab afbrydes.
English: Pharmacotherapeutic group: Antineoplastic agents, monoclonal antibodies, ATC code: L01XC06
Danish: Farmakoterapeutisk klassifikation: Antineoplastiske stoffer, monoklonale antistoffer, ATC-kode: L01XC06
English: It is recommended that women do not breast-feed during treatment with Erbitux and for 2 months after the last dose, because it is not known whether cetuximab is excreted in breast milk.
Danish: Kvinder frarådes at amme under behandling med Erbitux og i 2 måneder efter sidste dosis, da det ikke vides, om cetuximab udskilles i modermælk.
English: Erbitux does not contain any antimicrobial preservative or bacteriostatic agent.
Danish: Erbitux indeholder ikke noget antimikrobielt konserveringsmiddel eller bakteriehæmmende stof.
English: Effects on male and female fertility have not been evaluated within formal animal studies (see section 5.3).
Danish: Virkningen på fertilitet hos hanner og hunner er ikke blevet evalueret i formelle dyrestudier (se pkt.
English: Only patients with adequate renal and hepatic function have been investigated to date (see section 4.4).
Danish: Kun patienter med den fornødne nyre- og leverfunktion er undersøgt til dato (se pkt.
English: The mean clearance was 0.022 L/h per m² body surface area.
Danish: Middelclearance var 0,022 l/h per m² legemsoverflade.
English: An integrated analysis across all clinical studies showed that the pharmacokinetic characteristics of cetuximab are not influenced by race, age, gender, renal or hepatic status.
Danish: En integreret analyse på tværs af alle kliniske studier viste, at cetuximabs farmakokinetiske karakteristika ikke påvirkes af race, alder, køn, eller nyrernes eller leverens tilstand.
English: Do not use Erbitux if you have ever had a severe hypersensitivity (allergic) reaction to cetuximab.
Danish: Brug ikke Erbitux, hvis du har haft svære overfølsomheds- (allergiske) reaktioner over for cetuximab.
English: A tumour was considered to be EGFR-expressing, if one stained cell could be identified.
Danish: En tumor blev betragtet som EGFR-positiv, hvis der kunne identificeres en enkelt, farvet celle.
English: Of these, 342 patients had RAS wild-type tumours while RAS mutations were identified in 65 patients.
Danish: Ud af disse havde 342 patienter tumorer af RAS-vildtypen, mens RAS-mutationer blev identificeret hos 65 patienter.
English: • irritation and redness of the eye
Danish: • irritation og røde øjne
English: In contrast to progression free survival time, no benefit in overall survival time could be demonstrated in patients with KPS ≤ 80 who were 65 years of age or older.
Danish: I modsætning til den progressionsfrie overlevelsestid kunne der i den samlede overlevelsetid ikke dokumenteres nogen fordel hos patienter med KPS ≤ 80, som var 65 år eller ældre.
English: The main undesirable effects of cetuximab are skin reactions, which occur in more than 80% of patients, hypomagnesaemia which occurs in more than 10% of patients and infusion-related reactions, which occur with mild to moderate symptoms in more than 10% of patients and with severe symptoms in more than 1% of patients.
Danish: De hovedsagelige bivirkninger af cetuximab er hudreaktioner, som forekommer hos mere end 80% af patienterne, hypomagnesæmi, som forekommer hos mere end 10% af patienterne og infusionsrelaterede reaktioner, som forekommer med lette eller moderate symptomer hos mere end 10% af patienterne og med svære symptomer hos mere end 1% af patienterne.
English: • with polypropylene (PP) syringes for syringe pump.
Danish: • med sprøjter af polypropylen (PP) til sprøjtepumpe.
English: Before starting treatment for metastatic cancer of the large intestine your doctor will test your cancer cells if they contain the normal (wild-type) or mutant form of RAS. You must not receive Erbitux in combination with other anticancer treatment containing oxaliplatin if your cancer cells contain the mutant form of RAS.
Danish: Før du begynder behandling mod metastatisk tyktarmskræft, vil din læge undersøge dine kræftceller for at se, om de indeholder den normale (vildtype) eller den muterede form af RAS. Du må ikke få Erbitux i kombination med oxaliplatinholdig behandling mod kræft, hvis dine kræftceller indeholder den muteredeform af RAS.
English: A doctor experienced in the use of anticancer medicines will supervise your Erbitux therapy.
Danish: En læge, som har erfaring med anvendelsen af lægemidler til behandling af cancer, vil overvåge din behandling med Erbitux.
English: Conjunctivitis.
Danish: Konjunktivitis.
English: Similar findings were also reported when cetuximab was given as add-on to XELOX in combination with bevacizumab (CAIRO2).
Danish: Der blev også rapporteret om lignende fund, når cetuximab blev givet som tillæg til XELOX i kombination med bevacizumab (CAIRO2).
English: Further post-hoc analyses were performed for studies EMR 62 202-013 and EMR 62 202-047, where also mutations on RAS genes (NRAS and KRAS) other than KRAS exon 2 have been determined.
Danish: Yderligere post-hoc-analyser blev udført for studierne EMR 62 202-013 og EMR 62 202-047, hvor også andre mutationer på RAS-gener (NRAS og KRAS) end KRAS exon 2 er blevet bestemt.
English: An increased frequency of severe and sometimes fatal cardiovascular events and treatment emergent deaths has been observed in the treatment of non-small cell lung cancer, squamous cell carcinoma of the head and neck and colorectal carcinoma.
Danish: En forøget hyppighed af alvorlige og somme tider letale kardiovaskulære hændelser og dødsfald under behandlingen er blevet observeret under behandling af ikke-småcellet lungecancer, planocellulært karcinom i hoved og hals og kolorektalt karcinom.
English: In clinical studies with doses up to 700 mg/m 2 given every 2 weeks the safety profile was consistent with that described in section 4.8.
Danish: I kliniske studier med doser på op til 700 mg/m² givet hver anden uge var sikkerhedsprofilen overensstemmende med den, som beskrives i pkt.
English: Determination of serum electrolyte levels is recommended prior to and periodically during cetuximab treatment.
Danish: Det anbefales, at elektrolytniveauerne i serum bestemmes forud for og med jævne mellemrum under cetuximab-behandlingen.
English: In rare cases, angina pectoris, myocardial infarction or cardiac arrest have been observed.
Danish: I sjældne er der observeret angina pectoris, myokardieinfarkt eller hjertestop.
English: The efficacy and safety of cetuximab have not been documented in patients with tumours where EGFR was not detected.
Danish: Cetuximabs effekt og sikkerhed er ikke dokumenteret hos patienter med tumorer, hvor EGFR ikke blev påvist.
English: There were significant dose reductions and delays of capecitabine or oxaliplatin administration mainly due to higher frequency of diarrhoea in the cetuximab containing arm.
Danish: Der var signifikante dosisreduktioner og udskydelser af administration af capecitabin eller oxaliplatin, hvilket hovedsageligt skyldtes højere hyppighed af diarré i armen indeholdende cetuximab.
English: • in combination with radiation therapy for locally advanced disease,
Danish: • i kombination med strålebehandling ved lokalt fremskreden sygdom,
English: Cetuximab does not bind to other receptors belonging to the HER family.
Danish: Cetuximab binder sig ikke til andre receptorer i HER-familien.
English: Confounding or contributing factors, such as concomitant chemotherapy known to be associated with ILD, and pre-existing pulmonary diseases were frequent in fatal cases.
Danish: Konfunderende eller medvirkende faktorer, såsom samtidig kemoterapi, der vides at være forbundet med ILD og allerede eksisterende lungesygdomme, var hyppige i de dødelige tilfælde.
English: Special attention is recommended for patients with reduced performance status and pre-existing cardiopulmonary disease.
Danish: Det anbefales at udvise særlig opmærksomhed over for patienter med nedsat kapacitet og allerede eksisterende hjertelungesygdom.
English: Erbitux 5 mg/mL must be prepared as follows:
Danish: Erbitux 5 mg/ml skal forberedes som følger:
English: No clinical benefit could be demonstrated in patients with KPS ≤ 80 who were 65 years of age or older.
Danish: Der kunne ikke dokumenteres nogen fordel hos patienter med KPS ≤ 80, som var 65 år eller ældre.
English: There is no relevant use of cetuximab in the paediatric population in the granted indications.
Danish: Det er ikke relevant at anvende cetuximab hos den pædiatriske population til de godkendte indikationer.
English: Care must be taken to ensure aseptic handling when preparing the infusion.
Danish: Man skal sørge for aseptisk håndtering, mens infusionen forberedes.
English: In combination with capecitabine and oxaliplatin (XELOX) the frequency of severe diarrhoea may be increased.
Danish: I kombination med capecitabin og oxaliplatin (XELOX) kan hyppigheden af svær diarré være øget.
English: • as a single agent in patients who have failed oxaliplatin- and irinotecan-based therapy and who are intolerant to irinotecan.
Danish: • som enkeltstofbehandling til patienter, som har gennemgået en virkningsløs oxaliplatin- og irinotecan-baseret behandling og ikke tåler irinotecan.
English: It is recommended to maintain this lower infusion rate in all subsequent infusions.
Danish: Det anbefales, at infusionshastigheden holdes på det lave niveau ved alle følgende infusioner.
English: The KRAS exon 2 status was recognised as predictive factor for the treatment with cetuximab in 4 of the randomised controlled studies (EMR 62 202-013, EMR 62 202-047, CA225006, and CA225025).
Danish: KRAS exon 2-status blev påvist som prædiktiv faktor for behandling med cetuximab i 4 af de randomiserede, kontrollerede studier (EMR 62 202-013, EMR 62 202-047, CA225006, and CA225025).
English: Patients presenting with signs and symptoms suggestive of keratitis such as acute or worsening: eye inflammation, lacrimation, light sensitivity, blurred vision, eye pain and/or red eye should be referred promptly to an ophthalmology specialist.
Danish: Patienter med tegn og symptomer, der tyder på keratitis, f.eks. akut eller forværring af: øjeninflammation, tåresekretion, lysfølsomhed, sløret syn, øjensmerter og/eller røde øjne skal straks henvises til en oftalmolog.
English: Some of these reactions may be anaphylactic or anaphylactoid in nature or represent a cytokine release syndrome (CRS).
Danish: Nogle af disse reaktioner kan være anafylaktiske eller anafylaktoide af natur eller udgøre et cytokinfrigivelsessyndrom (CRS).
English: • absolute neutrophil count < 1500/mm³
Danish: • absolut neutrofiltal < 1.500/mm³
English: Do not use Erbitux
Danish: Brug ikke Erbitux
English: • The active substance is cetuximab.
Danish: • Aktivt stof: cetuximab.
English: The combination of cetuximab with irinotecan compared to cetuximab alone reduced the overall risk of disease progression by 46% and significantly increased objective response rate.
Danish: Kombinationen af cetuximab med irinotecan sammenlignet med cetuximab-monoterapi reducerede den samlede risiko for sygdomsudvikling med 46% og øgede den objektive responsrate væsentligt.
English: The appearance of HACA did not correlate with the occurrence of hypersensitivity reactions or any other undesirable effect to cetuximab.
Danish: Forekomsten af HACA faldt ikke sammen med forekomsten af overfølsomhedsreaktioner eller andre bivirkninger af cetuximab.
English: In all indications, Erbitux is administered once a week.
Danish: Ved alle indikationer indgives Erbitux en gang ugentligt.