natgillin/translations-raw huggingface dataset:
Der er ikke blevet fremsendt data for kyllinger, men indehaveren af markedsføringstilladelsen indsendte som støtte den nyligt indbragte sag i henhold til artikel 35 om alle styrker af vandopløselige pulvere og orale opløsninger, som indeholder doxycyclinhyclat indiceret til anvendelse hos fjerkræ og beregnet til indgivelse via drikkevandet (EMEA/V/A/047).
No data have been provided for chickens, however the Marketing Authorisation Holder submitted in support of the recent Article 35 referral for all strengths of water soluble powders and oral solutions containing doxycycline hyclate indicated for use in poultry and intended for administration via the drinking water (EMEA/V/A/047).
Må ikke kombineres med bakteriocide antibiotika f.eks. penicilliner eller cefalosporiner.
Do not combine with antibiotics that are bacteriocidal e.g. penicillins or cephalosporins.
Doxycyclin tilhører gruppen af tetracyclinantibiotika.
Doxycycline belongs to the group of the tetracycline antibiotics.
Kartonæske til 10 x 100 gram alufoliebreve med etiket til breve med 100 gram og indlægsseddel
Carton box for the 10x100 grams Alufoil sachets with label for 100 gram sachets and leaflet
Det virker ved at hæmme proteinsyntesen i bakteriecellen.
It exerts its action by inhibiting the protein synthesis of the bacterial cell.
I tilfælde af allergi over for antibiotika af tetracyclin-klassen skal der udvises særlig forsigtighed under håndteringen af dette produkt og den medicinerede opløsning.
If you know you are allergic to the tetracycline class of antibiotics, special care should be taken when handling this product or the medicated solution.
ANDRE OPLYSNINGER Pakningsstørrelser: 100 g, 10 x 100 g, 250 g, 500 g og 1 kg Ikke alle pakningsstørrelser er nødvendigvis markedsført.
OTHER INFORMATION Pack sizes: 100g, 10x 100g, 250g, 500g and 1 kg Not all pack sizes may be marketed.
Poser med 100 g, 250 g, 500 g og 1 kg og 10 x 100 g i æske af karton.
Sachets of 100g, 250g, 500g and 1 kg and 10x 100g in a carton box.
Der var tidligere blevet fremsendt data som en del af den nyligt indbragte sag i henhold til artikel 35 om alle styrker af vandopløselige pulvere og orale opløsninger, som indeholder doxycyclinhyclat indiceret til anvendelse hos fjerkræ, og beregnet til indgivelse via drikkevandet (EMEA/V/A/047).
Data had previously been submitted as part of the recent Article 35 referral for all strengths of water soluble powders and oral solutions containing doxycycline hyclate indicated for use in poultry and intended for administration via the drinking water (EMEA/V/A/047).
Efter administration af doxycyclinhyclat til kyllinger med en faktisk dosis på 21 mg/kg kropsvægt opnåedes middel plasmakoncentrationer over 1 µg/ml i løbet af 6 timer, og som varede i 6 timer efter seponering af medicineringen.
Following administration of doxycycline hyclate at an actual dose of 21 mg/kg body weight to chickens mean plasma concentrations above 1 µg/ml were reached within 6 hours and lasted for 6 hours after cessation of medication.
Når svin indgives 12,5 mg doxycyclinhyclat/kg kropsvægt/dag i 8 dage, vil en tilbageholdelsestid på 4 dage garantere forbrugersikkerheden.
When pigs are administered 12.5 mg doxycycline hyclate/kg bw/day for 8 days; meat withdrawal periods of 4 days will ensure consumer safety.
Kyllinger: Benyttes i flokke med klinisk sygdom til reduktion af mortalitet, morbiditet og kliniske symptomer samt til reduktion af læsioner på grund af pasteurellose forårsaget af Pasteurella multocida eller til at reducere morbiditet og læsioner i tilfælde af luftvejsinfektioner forårsaget af Ornithobacterium rhinotracheale (ORT).
Chickens: Where clinical disease is present in the flock, to reduce mortality, morbidity, and clinical signs and to reduce lesions due to Pasteurellosis caused by Pasteurella multocida or to reduce morbidity and lesions in respiratory infections caused by Ornithobacterium rhinotracheale (ORT).
PAKNINGSSTØRRELSE 100 gram
PACKAGE SIZE 100 gram
Efter administration af doxycyclinhyclat med en faktisk dosis på 10 mg/kg kropsvægt lå steady state-koncentrationen i området fra 0,75 til 0,93 µg/g mellem 12 og 96 timer efter påbegyndelse af medicineringen.
Following administration of doxycycline hyclate at an actual dose of 10 mg/kg body weight steady state plasma concentrations ranged from 0.75 to 0.93 µg/g between 12 and 96 hours after start of medication.
Tetracycliner har et bredt aktivitetsspektrum, som hæmmer Gram-positive og Gram-negative bakterier, mycoplasmer, chlamydiae, rickettsier og visse protozoer.
Tetracyclines have broad spectrum activity inhibiting Gram-positive and Gram-negative bacteria, mycoplasmas, chlamydiae, rickettsias and some protozoa.
500 mg svarende til 433 mg doxycyclin 433 mg corresponding to 500 mg doxycycline hyclate
500 mg corresponding to 433 mg doxycycline 433 mg corresponding to 500 mg doxycycline hyclate
Doxycyclin er et halvsyntetisk antibiotikum af tetracyclintypen.
Doxycycline is a semi-synthetic tetracycline antibiotic.
Nedsat akkumulering af tetracycliner (nedsat permeabilitet af bakteriens cellevæg og aktivt effluks), proteinbeskyttelse af det bakterielle ribosom, enzymatisk inaktivering af antibiotikummets og rRNA-mutationer (som forhindrer tetracyclin i at binde sig til ribosomet).
Four resistance mechanisms acquired by microorganisms against tetracyclines in general have been reported: Decreased accumulation of tetracyclines (decreased permeability of the bacterial cell wall and active efflux), protein protection of the bacterial ribosome, enzymatic inactivation of the antibiotic and rRNA mutations (preventing the tetracycline binding to ribosome).
Lægemiddel-form Dyrearter
Animal species
Det Forenede Kongerige
UK
Optagelsen af doxycyclin kan reduceres ved tilstedeværelse af store mængder calcium, jern, magnesium eller aluminium i foderet.
Absorption of doxycycline can be decreased in the presence of high quantities of calcium, iron, magnesium or aluminium in the diet. Do not administered together with antacids, kaolin and iron preparations.
4.4 Særlige advarsler for hver enkelt dyreart, som lægemidlet er beregnet til
4.4 Special warning for each target species.
Eurovet Animal Health B.V., P.O. 179,
Hungary Eurovet Animal Health B.V., P.O. 179,
• Kyllinger (slagtekyllinger, unghøns, avlshøns):10 mg doxycyclinhyclat pr. kg kropsvægt pr. dag i 3 til 4 dage til behandling af infektioner forårsaget af P. multocida, og 20 mg doxycyclinhyclat pr. kg kropsvægt pr. dag i 3 til 4 dage til behandling af infektioner forårsaget af O.
• Chickens (broiler, pullet, breeder): 10 mg doxycycline hyclate per kg body weight per day for 3-4 days for the treatment of infections caused by P. multocida and 20 mg doxycycline hyclate per kg body weight per day for 3-4 days for the treatment of infections caused by
- Kød og indvolde: 12 dage efter en dosering på 20 mg/kg kropsvægt i 4 dage.
- Meat and offal: 12 days, following a dose rate of 20 mg/kg body weight for 4 days.
Særlige forsigtighedsregler vedrørende brug til dyr På grund af bakteriernes forventelige varierende følsomhed (tidsmæssig, geografisk) over for doxycyclin, hvor særligt A. pleuropneumoniae og O. rhinotracheale kan udvise forskelle i følsomheden fra et land til et andet og endog fra en gård til en anden, anbefales det at udføre bakteriologisk prøvetagning og følsomhedstestning.
Due to likely variability (time, geographical) in susceptibility of bacteria for doxycycline, especially susceptibility of A. pleuropneumoniae and O. rhinotracheale may differ from country to country and even farm to farm, bacteriological sampling and susceptibility testing are recommended.
29 , 475-485 3 Bousquet E., Morvan H., AitkenI., Morgan J.H.(1997), Comparative in vitro activity of doxycycline and oxytetracycline against porcine respiratory pathogens, Veterinary Record, July 12, 141(2), p. 37-40
(1997), Comparative in vitro activity of doxycycline and oxytetracycline against porcine respiratory pathogens, Veterinary Record, July 12, 141(2), p. 37-40
12,5 mg doxycyclinhyclat (25 mg produkt) per kg kropsvægt per dag i 4 på hinanden følgende dage.
12.5 mg doxycycline hyclate (25 mg product) per kg body weight per day for 4 consecutive days.
F. J. Angulo et al., Evidence of an Association Between Use of Anti-microbial Agents in Food Animals and Anti-microbial Resistance Among Bacteria Isolated from Humans and the Human Health Consequences of Such Resistance, J. Vet. Med.. 5 De Jong et al.: A pan-European survey of antimicrobial susceptibility towards human-use antimicrobial drugs among zoonotic and commensal bacteria isolated from healthy food producing animals.
F. J. Angulo et al., Evidence of an Association Between Use of Anti-microbial Agents in Food Animals and Antimicrobial Resistance Among Bacteria Isolated from Humans and the Human Health Consequences of Such Resistance, J. Vet. Med.. 51: 374 - 379
LÆGEMIDDELFORM Gult pulver til brug i drikkevand.
PHARMACEUTICAL FORM Yellow powder for use in drinking water.
LÆGEMIDDELFORM Gult, krystallinsk pulver til brug i drikkevand.
PHARMACEUTICAL FORM Yellow crystalline powder for use in drinking water.
6.4 Særlige opbevaringsforhold
6.4 Storage precautions
Svin og kyllinger (slagtekyllinger, unghøns, avlshøns).
Pigs and chickens (broiler, pullet, breeder).
Restkoncentrationsdataene for kyllingekød for begge doseringer (10 mg doxycyclinhyclat pr. kg kropsvægt pr. dag i 4 dage og 20 mg doxycyclinhyclat pr. kg kropsvægt pr. dag i 4 dage) blev fremsendt.
The chicken meat residue depletion data for both dosing regimens (10 mg doxycycline hyclate per kg body weight per day for 4 days and 20 mg doxycycline hyclate per kg body weight per day for 4 days) were submitted.
Kyllinger: - Kød og indvolde: 3 dage efter en dosering på 10 mg/kg kropsvægt i 4 dage.
Chickens: - Meat and offal: 3 days, following a dose rate of 10 mg/kg body weight for 4 days.
Svin: Til behandling af de kliniske symptomer i forbindelse med luftvejsinfektioner hos svin forårsaget af Actinobacillus pleuropneumoniae, Pasteurella multocida og Mycoplasma hyopneumoniae, der er følsomme over for doxycyclin.
Pigs: For the treatment of the clinical signs associated with porcine respiratory disease caused by Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae susceptible to doxycycline.
DYREARTER Svin og kyllinger (slagtekyllinger, unghøns, avlshøns).
TARGET SPECIES Pigs and chickens (broiler, pullet, breeder).
• Svin:12,5 mg doxycyclinhyclat (25 mg lægemiddel) pr. kg kropsvægt pr. dag i 4 på hinanden følgende dage.
• Pigs: 12.5 mg doxycycline hyclate (25 mg product) per kg body weight per day for 4
Hvis der opstår symptomer som f.eks. hududslæt efter eksponering, skal der straks søges lægehjælp.
If you develop symptoms following exposure such as skin rash, you should seek medical advice and show this warning to the physician.
Doxycyclinhyclat FR: Doxycycline Hjælpestoffer:
Doxycycline hyclate France: Doxycycline Excipients
En tilbageholdelsestid for kyllingekød på 3 dage, når kyllingerne behandles med 10 mg doxycyclinhyclat/kg kropsvægt/dag i 4 dage, og en tilbageholdelsestid på 12 dage, når kyllingerne behandles med 20 mg doxycyclinhyclat/kg kropsvægt/dag i 4 dage kan accepteres.
A chicken meat withdrawal period of 3 days when chickens are treated with 10 mg doxycycline hyclate/kg bw/day for 4 days; and a meat withdrawal period of 12 days when the chicken are treated with 20 mg doxycycline hyclate/kg bw/day for 4 days can be accepted.
MARKEDSFØRINGSTILLADELSENS NUMMER Udfyldes nationalt
MARKETING AUTHORISATION NUMBER To be completed nationally
PAKNINGSSTØRRELSE 10 x 100 gram
PACKAGE SIZE 10x100 gram
10 mg doxycyclinhyclat (20 mg produkt) per kg kropsvægt per dag i 3-4 på hinanden følgende dage i tilfælde af infektion forårsaget af P. multocida og
10 mg doxycycline hyclate (20 mg product) per kg body weight per day for 3-4 consecutive days in case of infections caused by P. multocida and
Desuden blev en tilbageholdelsestid for kyllingekød på 12 dage efter en dosis på 20 mg doxycyclinhyclat pr. kg kropsvægt pr. dag i 4 dage anset for at være acceptabel.
In addition a chicken meat withdrawal period of 12 days following a dose rate of 20 mg doxycycline hyclate per kg body weight per day for 4 days was considered acceptable.
20 mg doxycyclinhyclat (40 mg produkt) per kg kropsvægt per dag i 3-4 på hinanden følgende dage i tilfælde af infektion forårsaget af O. rhinotracheale.
20 mg doxycycline hyclate (40 mg product) per kg body weight per day for 3-4 consecutive days in case of infections caused by O. rhinotracheale.
Doxycyclin udskilles primært med fæces.
Doxycycline is primarily excreted with the faeces.
En tilbageholdelsestid for kyllingekød på 3 dage efter en dosis på 10 mg doxycyclinhyclat pr. kg kropsvægt pr. dag i 4 dage blev anset for at være acceptabel.
A chicken meat withdrawal period of 3 days following a dose rate of 10 mg doxycycline hyclate per kg body weight per day for 4 days was considered acceptable.
På grund af dets høje lipidopløselighed udviser doxycyclin en god vævspenetration.
Because doxycycline is highly lipid soluble, it has a good tissue penetration.
Svin, Kyllinger (non-egg laying)
Powder for use in drinking water pigs, chickens (non-egg laying)
DATO FOR SENESTE GODKENDELSE AF INDLÆGSSEDLEN Udfyldes nationalt
DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED To be completed nationally
Gnmsnt.
Chickens
• Kyllinger (slagtekyllinger, unghøns, avlshøns): Når der er klinisk sygdom i flokken, for at nedbringe dødelighed, morbiditet og kliniske tegn, og for at nedbringe læsioner på grund af
• Chickens (broiler, pullet, breeder): Where clinical disease is present in the flock, to reduce mortality, morbidity and clinical signs and to reduce lesions due to Pasteurella multocida or to reduce morbidity and lesions in respiratory infections caused by O. rhinotracheale.
Særligt kan A. pleuropneumoniae udvise forskelle i følsomheden fra et land til et andet og endog fra en gård til en anden.
In pig pathogens resistance against doxycycline may also vary; especially susceptibility figures of A. pleuropneumoniae may differ from country to country and even farm to farm.
OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE OPLYSNINGER, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE INDLÆGSSEDDEL
PARTICULARS TO APPEAR ON THE OUTER PACKAGE IMMEDIATE PACKAGE
Handelsweg 25, NL-5531 AE Bladel, The Netherlands
NL-5531 AE Bladel,
Vinsyre
LEAFLET
Vurdering af benefit/risk-forholdet
Evaluation of the Benefit-risk balance
• Dosering;
• Target species;
Soludox, 500 mg/g, Water Soluble Powder for Svin
Soludox, 500 mg/g, Water Soluble Powder for Pigs
Til brugeren
Applicant/
Benefit/risk-vurdering
Benefit Risk assessment
Svin Kyllinger
Pigs Chickens
Restkoncentrationsdataene for svinekød blev indsendt, og disse understøttede en tilbageholdelsestid på 4 dage, når svin indgives 12,5 mg doxycyclinhyclat/kg kropsvægt/dag i op til 8 dage.
The pig meat residue depletion data was made available and supported a meat withdrawal period of 4 days when pigs are administered 12.5 mg doxycycline hyclate/kg body weight/day for up to 8 days.
Restkoncentrationsdata for kyllinger understøtter en tilbageholdelsestid på 3 dage, når kyllinger indgives 10 mg doxycyclinhyclat/kg kropsvægt/dag i 4 dage.
Residue depletion data in chickens support a meat withdrawal period of 3 days when chickens are administered at 10 mg doxycycline hyclate/kg body weight/day for 4 days.
Restkoncentrationsdata hos kyllinger understøtter en tilbageholdelsestid på 12 dage, når kyllinger indgives 20 mg doxycyclinhyclat/kg kropsvægt/dag i 4 dage.
Residue depletion data in chickens support a meat withdrawal period of 12 days when chickens are administered at 20 mg doxycycline hyclate/kg body weight/day for 4 days.
INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Udfyldes nationalt
MARKETING AUTHORISATION HOLDER To be completed nationally
Restkoncentrationsdata hos svin understøtter en tilbageholdelsestid på 4 dage, når svin indgives 12,5 mg doxycyclinhyclat/kg kropsvægt/dag i op til 8 dage.
Residue depletion data in pigs support a meat withdrawal period of 4 days when pigs are administered at 12.5 mg doxycycline hyclate/kg body weight/day for up to 8 days.
Bilag III Produktresumé, etikettering, indlægsseddel
Summary of product characteristics, labelling and package leaflet
FR: Soludox 433 mg/g powder for use in drinking water for pigs and chickens Doxycycline
France only: Soludox 433 mg/g powder for use in drinking water for pigs and chickens Doxycycline
FR: Soludox 433 mg/g powder for use in drinking water for pigs and chickens Doxycycline.
France only: Soludox 433 mg/g powder for use in drinking water for pigs and chickens Doxycycline.
Handelsveg 25 - PO Box 179, 5530 AD Bladel
Lithuania Eurovet Animal Health B.V. Handelsveg 25 - PO Box 179, 5530 AD Bladel
DATO FOR SENESTE GODKENDELSE AF TEKSTEN Skal udfyldes
DATE ON WHICH THE TEXT WAS LAST APPROVED To be completed nationally
Soludox 500 mg/g powder for use in drinking water for Kyllinger
Soludox 500 mg/g powder for use in drinking water for chickens
Doxycyclinhyclat 500 mg, svarende til 433 mg doxycyclin.
Doxycycline hyclate 500 mg, corresponding to 433 mg doxycycline France: Doxycycline 433 mg, corresponding to 500 mg doxycycline hyclate
Soludox 500 mg/g powder for use in drinking water for Svin
Soludox 500 mg/g powder for use in drinking water for pigs
Soludox 433 mg/g powder for use in drinking water for pigs and chickens (France only)
NAME OF THE VETERINARY MEDICINAL PRODUCT Soludox 500 mg/g powder for use in drinking water for pigs and chickens Soludox 433 mg/g powder for use in drinking water for pigs and chickens (France only)
Soludox 500 mg/g pulver til brug i drikkevand til svin og kyllinger.
Soludox 500 mg/g powder for use in drinking water for pigs and chickens Doxycycline hyclate.
Eurovet Animal Health B.V.
Poland Eurovet Animal Health B.V., Handelsweg 25,
SÆRLIG(E) ADVARSEL/ADVARSLER
SPECIAL WARNING(S), IF NECESSARY
• Dyrearter, som lægemidlet er beregnet til;
• Amounts to be administered;
Erbitux har været godkendt siden juni 2004.
Erbitux has been authorised since June 2004.
Det anvendes allerede til behandling af følgende kræftformer:
It is already used to treat the following types of cancer:
I disse ‘undergruppeanalyser' blev det tilstræbt at identificere en gruppe af patienter, som ville drage fordel af behandlingen.
These ‘subgroup analyses' attempted to identify a group of patients that would benefit from treatment.
Som følge heraf kan tumorcellerne ikke længere modtage de signaler, der får dem til at vokse, udvikle sig og spredes.
As a result, the tumour cells can no longer receive the messages needed for growth, progression and spread.
‘Metastatisk' betyder, at kræften har spredt sig til andre dele af kroppen
‘Metastatic' means that the cancer has spread to other parts of the body;
CHMP var også betænkelig ved uoverensstemmelserne i undersøgelsesresultaterne mellem de to vigtigste målestokke for effekt.
The CHMP was also concerned over discrepancies in the studies' findings between the two main measures of effectiveness.
Virksomheden fremlagde resultaterne af to hovedundersøgelser, som omfattede i alt 1 801 voksne med fremskreden, metastatisk eller recidiverende ikke-småcellet lungekræft, der ikke tidligere var blevet behandlet.
The company presented the results of two main studies involving a total of 1,801 adults with advanced, metastatic or recurrent non-small cell lung cancer who had not been treated before.
I november 2009 efter revurderingen tilføjede CHMP en yderligere betænkelighed ved de måder, hvorpå resultaterne af undersøgelserne var blevet analyseret, efter at de var afsluttet.
In November 2009, following the re-examination, the CHMP added a further concern over the ways in which the studies' results were analysed after they can been completed.
Det primære effektmål var, hvor længe patienterne overlevede, og hvor længe de levede, uden at kræften forværredes.
The main measures of effectiveness were how long the patientssurvived and how long they lived without their cancer getting worse.
Spørgsmål og svar vedrørende anbefalingen af afslag på ansøgningen om ændring af markedsføringstilladelsen for Erbitux cetuximab
Questions and answers on the recommendation for the refusal of a change to the marketing authorisation for Erbitux cetuximab
Det får ingen konsekvenser for anvendelse af Erbitux til de godkendte indikationer, for hvilke benefit/risk-forholdet forbliver uændret.
There are no consequences on the use of Erbitux in its authorised indications, for which the balance of benefits and risks remains unchanged.
Ændringen vedrørte en udvidelse af indikationen til også at omfatte behandling af ikke-småcellet lungekræft.
The change concerned an extension of indication to add the treatment of non-small cell lung cancer.
Til lungekræft forventedes Erbitux at virke på samme måde, som det virker ved de nuværende indikationer.
In lung cancer, Erbitux is expected to work in the same way as it does in its existing indications.
Det skulle have været anvendt til patienter, som ikke tidligere var blevet behandlet, hvor tumorcellerne havde et overfladeprotein kaldet epidermal vækstfaktorreceptor (EGFR).
It was to be used in patients who had not been treated before, when the tumour cells had a protein on their surface called epidermal growth factor receptor (EGFR).
Et monoklonalt antistof er en type protein, der er opbygget, så det genkender og binder sig til en bestemt struktur (kaldet et antigen) i kroppen.
A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and attach to a specific structure (called an antigen) in the body.
Hvad sker der med Erbitux til behandling af kræft i colon eller rectum og kræft i hoved og hals?
What is happening with Erbitux for the treatment of cancer of the colon or rectum and cancers of the head and neck?
Hvad forventedes Erbitux anvendt til?
What was Erbitux expected to be used for?
I juli 2009 fandt CHMP grund til betænkelighed ved, at fordelene ved at tilføje Erbitux til standard platinbaseret kemoterapi var beskedne med hensyn til overlevelsestider, og at lægemidlet ikke havde en overbevisende effekt på, hvor lang tid patienterne levede, uden at deres kræft forværredes.
In July 2009, the CHMP was concerned that the benefits of adding Erbitux to standard platinum-based chemotherapy were modest in terms of survival times, and that the medicine did not have a convincing effect on how long patients lived without their cancer getting worse.
• metastatisk kræft i colon eller rectum (tyktarmen).
• metastatic cancer of the colon or rectum (large intestine).
Erbitux forventedes også anvendt til behandling af ‘ikke-småcellet' lungekræft, som var fremskreden (var begyndt at sprede sig) eller metastatisk.
Erbitux was also expected to be used to treat ‘non-small cell' lung cancer that was advanced (had started to spread) or metastatic.
Disse former for kræft angriber cellerne i mund- og halsslimhinden eller i organer såsom larynx (strubehovedet).
These types of cancer affect the cells of the lining of the mouth or the throat, or of organs such as the larynx (voice box).
CHMP var derfor af den opfattelse, at fordelene ved Erbitux til behandling af ikke-småcellet lungekræft ikke opvejede risiciene.
Therefore, the CHMP was of the opinion that the benefits of Erbitux in the treatment of non-small cell lung cancer did not outweigh its risks.
Den 23. juli 2009 vedtog Udvalget for Humanmedicinske Lægemidler (CHMP) en negativ udtalelse, der anbefalede afslag på ansøgning om ændring af markedsføringstilladelsen for lægemidlet Erbitux.
On 23 July 2009, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of a change to the marketing authorisation for the medicinal product Erbitux.
Der blev iagttages svære bivirkninger hos visse lungekræftpatienter, som fik Erbitux - disse svarede til de bivirkninger, der kunne observeres hos patienter behandlet med Erbitux for andre former for kræft.
Severe side effects were seen in some lung cancer patients who received Erbitux - these were similar to the side effects seen in patients treated with Erbitux for other types of cancer.