natgillin/translations-raw huggingface dataset:
Hos patienter med metastatisk kolorektal cancer anvendes cetuximab i kombination med kemoterapi eller som enkeltstofbehandling (se pkt.
In patients with metastatic colorectal cancer, cetuximab is used in combination with chemotherapy or as a single agent (see section 5.1).
Hos patienter med recidiverende og/eller metastatisk planocellulært karcinom i hoved og hals anvendes cetuximab i kombination med platinbaseret kemoterapi efterfulgt af cetuximab som vedligeholdelsesbehandling indtil sygdomsprogression (se pkt.
In patients with recurrent and/or metastatic squamous cell cancer of the head and neck, cetuximab is used in combination with platinum-based chemotherapy followed by cetuximab as maintenance therapy until disease progression (see section 5.1).
Sæt en passende kanyle på en steril sprøjte af passende størrelse (minimum 50 ml).
Take an appropriate sterile syringe (minimum 50 mL) and attach a suitable needle.
• blodpropper i lungerne
• blood clots in the lungs
Hvis du får Erbitux i kombination med en anden slags medicin mod kræft, som indeholder fluoropyrimidiner, er det mere sandsynligt at du får følgende bivirkninger af denne medicin:
If you receive Erbitux in combination with an anticancer medicine containing fluoropyrimidines, it is more likely that you experience the following side effects of this other medicine:
Almindelig (≥ 1/100 til < 1/10)
Common ( 1/100 to < 1/10)
Aseptisk meningitis.
Frequency not known: Aseptic meningitis.
Gentag om nødvendigt proceduren, til den beregnede mængde er infunderet.
If necessary, repeat this procedure until the calculated volume has been infused.
Sygdomme i åndedrætsorganer
Respiratory disorders
Population med KRAS-mutation
KRAS mutant population
Pakning med 1 hætteglas.
Pack size of 1 vial.
Cetuximab bør ikke anvendes til behandling af patienter med kolorektal cancer, hvis tumorer har RAS-mutationer, eller til patienter med en ukendt RAS-status i tumorer.
Colorectal cancer patients with RAS mutated tumours Cetuximab should not be used in the treatment of colorectal cancer patients whose tumours have RAS mutations or for whom RAS tumour status is unknown.
Til vurdering af RAS-status blev andre mutationer end dem på exon 2 i KRAS-genet bestemt ud fra alle evaluerbare tumorprøver inden for populationen med KRAS exon 2-vildtypen (65 %).
For the assessment of the RAS status, mutations other than those on exon 2 of the KRAS gene were determined from all evaluable tumour samples within the KRAS exon 2 wild-type population (65%).
For vurderingen af RAS-status blev andre mutationer end dem på exon 2 i KRAS-genet bestemt ud fra alle evaluerbare tumorprøver inden for populationen med KRAS exon 2-vildtypen.
For the assessment of the RAS status, mutations other than those on exon 2 of the KRAS gene were determined from all evaluable tumour samples within the KRAS exon 2 wild-type population.
Cirka 15 ud af 100 patienter kan få svære hudreaktioner.
In about 15 out of 100 patients these skin reactions are likely to be severe.
4.4); mucositis, i nogle tilfælde alvorlig.
Mild or moderate infusion-related reactions (see section 4.4); mucositis, in some cases severe.
Der er ikke foretaget toksicitetsstudier med samtidig indgift af cetuximab og kemoterapeutika.
Toxicity studies with co-administration of cetuximab and chemotherapeutic agents have not been performed.
Anvend almindeligt drop eller infusionspumpe til indgift.
Use a gravity drip or an infusion pump for administration.
Cetuximab blev initieret en uge før strålebehandlingen og givet i doserne beskrevet under pkt.
Cetuximab was started one week before radiation therapy and administered at the doses described in section 4.2 until the end of the radiation therapy period.
Patienter, der i henhold til tumorstatus, Karnofsky-performance-status (KPS) og alder, havde en god prognose, havde større gavn af behandlingen, når cetuximab blev givet sammen med platinbaseret kemoterapi.
Patients with a good prognosis as indicated by tumour stage, Karnofsky performance status (KPS) and age had a more pronounced benefit, when cetuximab was added to platinum-based chemotherapy.
• øget mængde af visse leverenzymer i blodet
• increase in blood levels of certain liver enzymes
Tilslut infusionslinjen til sprøjten, og start infusionen efter at have opspædet linjen med Erbitux eller steril natriumchlorid 9 mg/ml (0,9%) opløsning.
Connect the infusion line to the syringe and start the infusion after priming the line with Erbitux or sterile sodium chloride 9 mg/mL (0.9%) solution.
Dehydrering, især som følge af diaré eller mucositis; hypokalcæmi (se pkt.
Dehydration, in particular secondary to diarrhoea or mucositis; hypocalcaemia (see section 4.4); anorexia which may lead to weight decrease.
Sjælden (≥ 1/10.000 til < 1/1.000)
Rare ( 1/10,000 to < 1/1,000)
Hvis du får Erbitux i kombination med andre lægemidler mod kræft, herunder platin, er der større sandsynlighed for, at antallet af de hvide blodlegemer i dit blod er formindsket.
If you receive Erbitux in combination with anticancer medicines including platinum, it is more likely that your white blood cell count may be reduced.
Hvert hætteglas med 100 ml indeholder 500 mg cetuximab (5 mg/ml).
Each vial of 100 mL contains 500 mg cetuximab (5 mg/mL).
CI = konfidensinterval, OxMdG = oxaliplatin plus 5-FU/FA-infusion, OS = overlevelsestid, PFS = progressionsfri overlevelsestid
CI = confidence interval, OxMdG = oxaliplatin plus infusional 5-FU/FA, OS = overall survival time, PFS = progression-free survival time
Population med RAS-mutation
RAS mutant population
I opfølgningsbehandlingen fik dog næsten 50% af patienterne fra armen med cetuximab-monoterapi en kombination af cetuximab og irinotecan efter progression af sygdommen, hvilket kan have påvirket den samlede overlevelsestid.
In the randomised trial, the improvement in overall survival time did not reach statistical significance; however, in the follow-up treatment, nearly 50% of the patients of the cetuximab alone arm received a combination of cetuximab and irinotecan after progression of disease, which may have influenced overall survival time.
1 hætteglas med 100 mg/20 ml
1 vial of 100 mg/20 mL
Patienter, der i henhold til tumorstatus, Karnofsky-performance-status (KPS) og alder, havde en god prognose, havde større gavn af behandlingen, når cetuximab blev givet sammen med strålebehandling.
Patients with a good prognosis as indicated by tumour stage, Karnofsky performance status (KPS) and age had a more pronounced benefit, when cetuximab was added to radiation therapy.
Studiedata viser, at det er højst usandsynligt, at patienter med metatastisk kolorektal cancer og aktiverende RAS-mutationer vil få gavn af behandling med cetuximab eller en kombination af cetuximab og kemoterapi.
Study data demonstrate that patients with metastatic colorectal cancer and activating RAS mutations are highly unlikely to benefit from treatment with cetuximab or a combination of cetuximab and chemotherapy and as add-on to FOLFOX4 a significant negative effect on progression-free survival time (PFS) was shown.
FOLFOX4 Cetuximab plus FOLFOX4
Cetuximab plus FOLFOX4
• CA225025: Dette randomiserede studie med patienter med metastatisk kolorektal cancer, som tidligere havde fået behandling med oxaliplatin, irinotecan plus fluoropyrimidin for metastatisk sygdom, sammenlignede kombinationen af cetuximab som enkeltstof sammen med "bedste understøttende pleje" ("best supportive care", BSC) (287 patienter) med "bedste understøttende pleje" alene (285 patienter).
• CA225025: This randomised study in patients with metastatic colorectal cancer who had received prior oxaliplatin-, irinotecan- and fluoropyrimidine-based treatment for metastatic disease compared the addition of cetuximab as a single agent to best supportive care (BSC) (287 patients) with best supportive care (285 patients).
Cetuximab som enkeltstof
Cetuximab as a single agent
Oddsrate (95% CI) p-værdi
Odds Ratio (95% CI) p-value
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hvert hætteglas med 20 ml indeholder 100 mg cetuximab (5 mg/ml).
STATEMENT OF ACTIVE SUBSTANCE(S) Each vial of 20 mL contains 100 mg cetuximab (5 mg/mL).
Indstil og kontroller hastigheden som forklaret under pkt.
Set and control the rate as explained in section 4.2.
OS måneder, median (95% CI) Hazard ratio (95% CI) p-værdi PFS måned, median (95% CI) Hazard ratio (95% CI) p-værdi ORR % (95% CI) p-værdi CI = confidence interval, konfidensinterval, CTX = platinbaseret kemoterapi, ORR = objektiv responsrate, OS = overlevelsestid, PFS = progressionsfri overlevelsestid
OS months, median (95% CI) Hazard Ratio (95% CI) p-value PFS months, median (95% CI) Hazard Ratio (95% CI) p-value ORR % (95% CI) p-value CI = confidence interval, CTX = platinum-based chemotherapy, ORR = objective response rate, OS = overall survival time, PFS = progression-free survival time
Erbitux kan forårsage bivirkninger, der påvirker huden.
Erbitux may cause side effects concerning the skin.
Erbitux 5 mg/ml infusionsvæske, opløsning Cetuximab
Erbitux 5 mg/mL solution for infusion Cetuximab
BSC Cetuximab plus BSC BSC
Cetuximab plus BSC
De væsentligste fund i toksicitetsstudier med Cynomolgusaber (et studie med kronisk toksicitet og et studie om embryo-føtal udvikling) var dosisafhængige hudreaktioner, der startede ved dosisniveauer, som svarede til dem, der blev anvendt hos mennesker.
Dose-dependent skin alterations, starting at dose levels equivalent to those used in humans, were the major findings observed in toxicity studies with Cynomolgus monkeys (a chronic repeat-dose toxicity study and an embryo-foetal development study).
Disse omfatter symptomer som feber, kulderystelser, svimmelhed eller dyspnø og forekommer tidsmæssigt i tæt tilknytning til især den første infusion med cetuximab.
Mild or moderate infusion-related reactions are very common comprising symptoms such as fever, chills, dizziness, or dyspnoea that occur in a close temporal relationship mainly to the first cetuximab infusion.
Gentag proceduren, til den beregnede mængde er infunderet.
Repeat this procedure until the calculated volume has been infused.
stop infusionen omgående og behandl symptomer intensivt.
stop infusion immediately, treat symptoms vigorously and contraindicate further use of cetuximab
Ved samtidig behandling med andre kemoterapeutiske stoffer henvises der til produktinformationen til disse lægemidler angående doseringen eller de anbefalede dosisændringer.
For the dosage or recommended dose modifications of concomitantly used chemotherapeutic agents, refer to the product information for these medicinal products.
Dette kan medføre efterfølgende komplikationer, f.eks. cellulitis, erysipelas eller, potentielt med dødeligt udfald, staphylococcal scalded skin syndrome (SSSS), nekrotiserende fasciitis eller sepsis.
Skin lesions induced by cetuximab may predispose patients to superinfections (e.g. with S. aureus), which may lead to subsequent complications, e.g. cellulitis, erysipelas, or, potentially with fatal outcome, staphylococcal scalded skin syndrome, necrotising fasciitis or sepsis.
Andelen af patienter i patientpopulationen med tumorer af KRASvildtypen, som kunne vurderes med hensyn til KRAS-status, var 58%.
The proportion of patients with KRAS wild-type tumours from the patient population evaluable for KRAS status comprised 58%.
Dette kan især være tilfældet, hvis du får hudreaktioner, betændelse i slimhinderne i mave-tarm-kanalen eller i munden eller får diaré.
This may lead to infectious complications including life-threatening conditions, especially if you experience skin reactions, inflammation of the lining of the intestine and mouth or diarrhoea.
Forbehandling
Pre-treatment
Ikke almindelig (≥ 1/1.000 til < 1/100)
Uncommon ( 1/1,000 to < 1/100)
FREMSTILLERENS BATCHNUMMER Batch
BATCH NUMBER BN
• blodpropper i blodårerne i benene
• blood clots in the veins of the legs
LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Erbitux 5 mg/ml infusionsvæske, opløsning Cetuximab
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Erbitux 5 mg/mL solution for infusion
• CA225006: Dette randomiserede studie med patienter med metastatisk kolorektal cancer, som tidligere havde fået behandling med oxaliplatin plus fluoropyrimidin for metastatisk sygdom, sammenlignede kombinationen af cetuximab og irinotecan (648 patienter) med irinotecan alene (650 patienter).
• CA225006: This randomised study in patients with metastatic colorectal cancer who had received initial combination treatment with oxaliplatin plus fluoropyrimidine for metastatic disease compared the combination of cetuximab and irinotecan (648 patients) with irinotecan alone (650 patients).
1 hætteglas med 500 mg/100 ml
1 vial of 500 mg/100 mL
4 for detaljer, da nogle hudreaktioner kan have alvorlige konsekvenser for dig, herunder være livstruende.
Please also read 'Side effects concerning the skin' in section 4 for details, as some skin reactions may have serious consequences for you, including life-threatening conditions.
Andelen af patienter i patientpopulationen med tumorer af KRAS-vildtypen, som kunne vurderes mht. KRAS-status, var 57%.
The proportion of patients with KRAS wild-type tumours from the patient population evaluable for KRAS status comprised 57%.
• EMR 62 202-002: Dette randomiserede studie med patienter med recidiverende og/eller metastatisk planocellulært karcinom i hoved og hals, som ikke tidligere havde fået kemoterapi for denne sygdom, sammenlignede kombinationen af cetuximab og cisplatin eller carboplatin plus 5-fluoruracil som infusion (222 patienter) med samme kemoterapi alene (220 patienter).
• EMR 62 202-002: This randomised study in patients with recurrent and/or metastatic squamous cell cancer of the head and neck who had not received prior chemotherapy for this disease compared the combination of cetuximab and cisplatin or carboplatin plus infusional 5-fluorouracil (222 patients) to the same chemotherapy alone (220 patients).
Sæt en passende kanyle på en steril sprøjte af passende størrelse.
Take an appropriate sterile syringe and attach a suitable needle.
BSC = bedste understøttende pleje (best supportive care,), CI = confidence interval, konfidensinterval, ORR = objective response rate (patienter med komplet respons eller delvis respons), OS = overlevelsestid, PFS = progressionsfri overlevelsestid
(95% CI) p-value BSC = best supportive care, CI = confidence interval, ORR = objective response rate (patients with complete response or partial response), OS = overall survival time, PFS = progression-free survival time
Hvert hætteglas med 20 ml indeholder 100 mg cetuximab.
Each vial of 20 mL contains 100 mg cetuximab.
OS måneder, median (95% CI) Hazard ratio (95% CI) p-værdi PFS måneder, median (95% CI)
OS months, median (95% CI) Hazard Ratio (95% CI) p-value PFS months, median (95% CI)
• 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).
• 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).
LÆGEMIDLETS NAVN Erbitux 5 mg/ml infusionsvæske, opløsning Cetuximab
NAME OF THE MEDICINAL PRODUCT Erbitux 5 mg/mL solution for infusion Cetuximab
FOLFIRI i kombination med enten cetuximab eller bevacizumab som 1. linjebehandling af patienter med mCRC af KRAS exon 2-vildtypen.
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.
Andelen af patienter i patientpopulationen, som havde tumorer af KRAS-vildtypen, og som kunne vurderes mht. KRAS-status, var 63%.
The proportion of patients with KRAS wild-type tumours from the patient population evaluable for KRAS status comprised 63%.
• Metastatisk tyktarmskræft.
• metastatic cancer of the large intestine.
LÆGEMIDLETS NAVN Erbitux 5 mg/ml infusionsvæske, opløsning
NAME OF THE MEDICINAL PRODUCT Erbitux 5 mg/mL solution for infusion
1 ml infusionsvæske, opløsning indeholder 5 mg cetuximab.
Each mL of the solution for infusion contains 5 mg cetuximab.
• 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).
• 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).
CI = confidence interval, konfidensinterval, FOLFIRI irinotecan plus 5-FU/FA-infusion, ORR = objective response rate (patienter med komplet respons eller delvis respons), OS = overlevelsestid, PFS = progressionsfri overlevelsestid
CI = confidence interval, FOLFIRI = irinotecan plus infusional 5-FU/FA, ORR = objective response rate (patients with complete response or partial response), OS = overall survival time, PFS = progression-free survival time
• EMR 62 202-047: Dette randomiserede studie med patienter med metastatisk kolorektal cancer, som ikke tidligere havde fået behandling for metastatisk sygdom, sammenlignede kombinationen af cetuximab og oxaliplatin plus kontinuerlig 5-fluoruracil/folinsyre-infusion (FOLFOX4) (169 patienter) med den samme kemoterapibehandling uden cetuximab (168 patienter).
• EMR 62 202-047: This randomised study in patients with metastatic colorectal cancer who had not received prior treatment for metastatic disease compared the combination of cetuximab and oxaliplatin plus continuous infusional 5-fluorouracil/folinic acid (FOLFOX4) (169 patients) to the same chemotherapy alone (168 patients).
• neglesygdomme, f.eks.betændelse i negleroden
• nail disorders, for example inflammation of the nail bed
Hvert hætteglas med 100 ml indeholder 500 mg cetuximab.
Each vial of 100 mL contains 500 mg cetuximab.
OS måneder, median (95% CI) Hazard ratio (95% CI) p-værdi PFS måneder, median (95% CI) Hazard ratio (95% CI) p-værdi Bedste samlede responsrate
OS months, median (95% CI) Hazard Ratio (95% CI) p-value PFS months, median (95% CI) Hazard Ratio (95% CI) p-value Best overall response rate
OS måneder, median (95% CI) Hazard ratio (95% CI) p-værdi PFS måneder, median (95% CI) Hazard ratio (95% CI) p-værdi ORR
OS months, median (95% CI) Hazard Ratio (95% CI) p-value PFS months, median (95% CI) Hazard Ratio (95% CI) p-value ORR
Sådan får du Erbitux
How to store Erbitux
Håndteringsinstruktioner
Handling instructions
Der findes til dato ingen prækliniske data om af cetuximabs virkning på sårheling.
No non-clinical data on the effect of cetuximab on wound healing are available to date.
4.4 og 5.1).
1.5 to 6.2 L/m2).
• COIN: Dette var et randomiseret, 3-armet, open-label studie med 2.445 patienter med inoperabel metastatisk eller locoregional kolorektal cancer, som ikke tidligere havde fået behandling for metastatisk sygdom.
• COIN: This was an open-label, 3-arm, randomised study in 2445 patients with inoperable metastatic or locoregional colorectal cancer who had not received prior treatment for metastatic disease and compared oxaliplatin plus fluoropyrimidines (infusional 5-fluorouracil/folinic acid [OxMdG] or capecitabine [XELOX]) in combination with cetuximab to the same chemotherapy regimen alone.
• hjertestop
• heart failure
Derfor skal du omgående tale med lægen, hvis du får generelle tegn på infektion, som f.eks. feber og træthed.
Therefore, if you experience general signs of infection such as fever and tiredness, please speak to a doctor immediately.
4 for at få yderligere oplysninger, da disse bivirkninger kan have alvorlige konsekvenser for dig og endda være livstruende.
Please read 'Infusion-related side effects' in section 4 for details, as they may have serious consequences for you, including life-threatening conditions.
Variabel/statistik Strålebehandling plus cetuximab
Radiation therapy + cetuximab
Oversigt over indlægssedlen Virkning og anvendelse Det skal du vide, før du fårbrugeErbitux Sådan fårduErbitux
What Erbitux is and what it is used for What you need to know before you use Erbitux How to use Erbitux
• skaldende hud
• chest pain
• betændelse i tarmens og mundhulens slimhinder
• inflammation of the lining of the intestine and mouth
(95% CI) Oddsrate (95% CI) p-værdi CI = confidence interval, konfidensinterval, FOLFOX4 = oxaliplatin plus kontinuerlig 5-FU/FA-infusion, ORR = objective response rate (patienter med komplet respons eller delvis respons), OS = overlevelsestid, PFS = progressionsfri overlevelsestid, NE = kan ikke estimeres
CI = confidence interval, FOLFOX4 = oxaliplatin plus continuous infusional 5-FU/FA, ORR = objective response rate (patients with complete response or partial response), OS = overall survival time, PFS = progression-free survival time, NE = not estimable
• kløe
• chills
4.4), heler hudreaktionerne generelt uden mén efter nogen tid, når behandlingen ophører.
They generally resolve, without sequelae, over time following cessation of treatment if the recommended adjustments in dose regimen are followed (see section 4.4).
Hudreaktioner
Skin reactions
MA (EU)-nummer
MA (EU) number (Invented) name
1 fyldt pen + 7 NovoFine Plus nåle
1 pre-filled pen + 7 NovoFine Plus needles
1 fyldt pen + 7 NovoTwist nåle
1 pre-filled pen + 7 NovoTwist needles
1 fyldt pen + 7 NovoFine nåle
1 pre-filled pen + 7 NovoFine needles
Disse forbehold blev rejst over for ansøgeren under proceduren, men blev aldrig tilfredsstillende besvaret.
These concerns were raised with the applicant during the procedure but were never adequately addressed.
Ansøgeren henviste specifikt til CHMP´s fire indledende hovedgrunde til afslag:
The applicant addressed specifically the CHMP´s four initial principal grounds for refusal:
Samlet resumé af den videnskabelige vurdering af Qsiva
Overall summary of the scientific evaluation of Qsiva
I det andet år sås imidlertid ikke yderligere vægttab, snarere en gennemsnitlig vægtforøgelse i alle grupper.
However, no additional weight loss was seen in the second year, rather there was a mean weight gain in all groups.
Lægemidlets samlede kvalitet blev anset for acceptabel af CHMP.
The overall quality of the medicinal product was considered acceptable by the CHMP.
Det er kun godkendt til kortvarig behandling (under 3 måneder), og dets langsigtede kardiale toksicitet er ukendt.
It is only being approved for short term periods of treatment (less than three months) and its long term cardiac toxicity is unknown.
The CHMP behandlede følgende punkter:
The CHMP considered the following:
• Kvalitetsspørgsmål
• Quality issues
og eftersom sikkerheden af ovennævnte lægemiddel ikke var tilfredsstillende godtgjort, forelagde ansøgeren en detaljeret begrundelse for fornyet overvejelse af begrundelsen for afslaget.
as the safety of the above mentioned medicinal product was not sufficiently demonstrated, the applicant submitted detailed grounds for the re-examination of the grounds for refusal.
CHMP anbefalede derfor afslag på ansøgning om udstedelse af markedsføringstilladelse for Qsiva.
Therefore, the CHMP has recommended the refusal of the granting of the marketing authorisation for Qsiva.
Begrundelse for fornyet overvejelse
Grounds for re-examination
Derudover blev det foreslået at foretage en undersøgelse af patientregistrering og medicinforbrug med løbende evaluering af effektiviteten af disse foranstaltninger.
In addition, patient registry and drug utilization study was proposed to be conducted to repeatedly evaluate the effectiveness of these measures.