FrancophonIA/ELRC3.0 huggingface dataset:
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Solvent for Nobivac Bb
Danish: VETERINÆRLÆGEMIDLETS NAVN Solvens til Nobivac Bb
English: INDICATION Live vaccine against feline upper respiratory tract disease caused by Bordetella bronchiseptica.
Danish: INDIKATION Levende vaccine mod infektion i de øvre luftveje hos katte forårsaget af Bordetella bronchiseptica.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Label for the vaccine vial:
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER Etiket til vaccine hætteglas:
English: 4.2 Indications for use, specifying the target species For active immunisation of cats, of 1 month of age or older to reduce clinical signs of Bordetella bronchiseptica associated upper respiratory tract disease.
Danish: 4.2 Terapeutiske indikationer med angivelse af dyrearter, som lægemidlet er beregnet til Til aktiv immunisering af katte i alderen 1 måned eller ældre for reduktion af kliniske symptomer på infektion i de øvre luftveje forårsaget af Bordetella bronchiseptica.
English: Aseptically reconstitute the freeze-dried vaccine with 0.3 ml of the sterile solvent provided.
Danish: Opløs den frysetørrede vaccine aseptisk i 0,3 ml af den medfølgende sterile solvens.
English: Aseptically reconstitute the lyophilisate with 0.3 ml of the sterile solvent provided.
Danish: Opløs aseptisk lyofilisatet i 0,3 ml af den medfølgende sterile solvens.
English: The onset of immunity was established in 8 week old cats as early as 72 hours after vaccination.
Danish: Immuniteten indtræder allerede 72 timer efter vaccination af 8 uger gamle katte.
English: C. STATEMENT OF THE MRLs
Danish: ANGIVELSE AF MRL-VÆRDIER
English: For active immunisation of cats, of 1 month of age or older, to reduce clinical signs of Bordetella bronchiseptica associated upper respiratory tract disease.
Danish: Til aktiv immunisering af katte i alderen 1 måned eller ældre for reduktion af de kliniske symptomer på infektion i de øvre luftveje forårsaget af Bordetella bronchiseptica.
English: Intervet International B.V. Wim de Körverstraat 35 NL - 5831 AN Boxmeer The Netherlands
Danish: Wim de Körverstraat 35 NL-5831 AN Boxmeer Holland
English: CONTRAINDICATIONS Do not use in pregnant or lactating queens.
Danish: KONTRAINDIKATIONER Må ikke anvendes til drægtige eller diegivende katte.
English: In case of accidental self-administration seek medical advice immediately and show the package leaflet or the label to the physician.
Danish: Hvis man ved et uheld injicerer sig selv søges straks læge, som forevises indlægsseddel eller etiket.
English: QUANTITY OF THE ACTIVE SUBSTANCE(S) 106.3- 108.3 CFU/dose B. bronchiseptica
Danish: MÆNGDEN AF AKTIVT STOF (AKTIVE STOFFER) CFU/dosis af B. bronchiseptica
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Nobivac Bb for cats
Danish: VETERINÆRLÆGEMIDLETS NAVN Nobivac Bb til kat
English: PHARMACEUTICAL FORM Lyophilisate and solvent for suspension.
Danish: LÆGEMIDDELFORM Lyofilisat og solvens, suspension.
English: METHOD AND ROUTE OF ADMINISTRATION For nasal use.
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ(E) Til nasal anvendelse.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Label for the solvent vial:
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER Etiket til solvens hætteglas:
English: 4.8 Interaction with other medicinal products and other forms of interaction
Danish: 4.8 Interaktion med andre lægemidler og andre former for interaktion Der foreligger ingen oplysninger om sikkerhed og virkning ved brug af vaccinen sammen med andre lægemidler til dyr.
English: Pharmacovigilance system
Danish: FARMACEUTISKE OPLYSNINGER
English: 4.7 Use during pregnancy, lactation or lay
Danish: 4.7 Anvendelse under drægtighed, laktation eller æglægning Må ikke anvendes til drægtige eller diegivende katte.
English: A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLER(E) AF DE(T) BIOLOGISK AKTIVE STOF(FER) OG INDEHAVER(E) AF VIRKSOMHEDSGODKENDELSE ANSVARLIG FOR BATCHFRIGIVELSE
English: THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN” Keep out of the reach and sight of children
Danish: TEKSTEN “OPBEVARES UTILGÆNGELIGT FOR BØRN” Opbevares utilgængeligt for børn
English: Plastic box containing 5 vials of 1 dose of lyophilisate and 5 vials of solvent.
Danish: Plastikæske indeholdende 5 hætteglas af 1 dosis lyofilisat og 5 hætteglas med solvens.
English: The vaccine is administered directly from the tip of the syringe onto the opening of the nostril and enters the nasal cavity during inhalation.
Danish: Vaccinen gives fra sprøjtens studs ind i næseborsåbningen og når næsehulen, når katten trækker vejret ind.
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY OR USE
Danish: B. BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN, HERUNDER BEGRÆNSNINGER FOR UDLEVERING OG BRUG
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Nobivac Bb lyophilisate and solvent for suspension for cats
Danish: VETERINÆRLÆGEMIDLETS NAVN Nobivac Bb lyofilisat og solvens, suspension til kat.
English: EXPIRY DATE
Danish: 10. UDLØBSDATO UDL.D.
English: Carton box containing 5 vials of 1 dose of lyophilisate and 5 vials of solvent.
Danish: Karton indeholdende 5 hætteglas af 1 dosis lyofilisat og 5 hætteglas med solvens.
English: SPECIAL WARNING(S), IF NECESSARY Read the package leaflet before use for special warnings for immunocompromised humans.
Danish: Læs inden brug om særlige advarsler for personer med svækket immunforsvar i indlægssedlen.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each dose (0.2 ml) of reconstituted suspension contains: Lyophilisate:
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Hver dosis (0,2 ml) rekonstitueret suspension indeholder: Aktive stoffer: koloni dannende enheder (CFU) af levende Bordetella bronchiseptica bakterie stamme B-C2
English: 4.11 Withdrawal period
Danish: 6.3 Opbevaringstid
English: PACKAGE SIZE 5 unit-dose vials of lyophilisate and 5 vials of solvent.
Danish: PAKNINGSSTØRRELSE 5 én-dosis hætteglas med lyofilisat og 5 hætteglas med solvens.
English: Manufacturers of the biological active substance
Danish: Navn og adresse på fremstilleren (fremstillerne) af de(t) biologisk aktive stof(fer)
English: PACKAGE LEAFLET FOR Nobivac Bb lyophilisate and solvent for suspension for cats
Danish: INDLÆGSSEDDEL Nobivac Bb lyofilisat og solvens, suspension til kat
English: Active substance:
Danish: Pakningsstørrelser:
English: CFU of live Bordetella bronchiseptica bacteria strain B-C2.
Danish: ANGIVELSE AF AKTIVE STOFFER OG ANDRE STOFFER Hver dosis af 0,2 ml indeholder: CFU af levende Bordetella bronchiseptica bakterie stamme B-C2.
English: Presentations:
Danish: INDLÆGSSEDDEL
English: Special precautions for use in animals
Danish: 4.5 Særlige forsigtighedsregler vedrørende brugen Særlige forsigtighedsregler vedrørende brug til dyr Kun raske katte bør vaccineres.
English: 16 March 2015
Danish: Den 16. marts 2015
English: The referral started on 4 June 2014.
Danish: Indbringelsen blev indledt den 4. juni 2014.
English: The final opinion was converted into a Decision by the European Commission on 16 March 2015.
Danish: Den endelige udtalelse blev omarbejdet til en beslutning af Europa-Kommissionen den 16. marts 2015.
English: International non-proprietary name (INN): colistin
Danish: Internationalt fællesnavn (INN): colistin
English: The most common target species are pigs followed by chicken and cattle then other poultry species (e.g. turkeys), horses, rabbits, sheep and goats.
Danish: Den almindeligste måldyreart er svin, efterfulgt af kyllinger og kvæg og derefter andre fjerkræarter (f.eks. kalkuner), heste, kaniner, får og geder.
English: The Committee appointed C. Ibrahim as rapporteur and M. Holzhauser-Alberti as co-rapporteur.
Danish: Som rapportør og medrapportør udpegede udvalget hhv. C. Ibrahim og M. Holzhauser-Alberti.
English: Committee for Medicinal Products for Veterinary Use (CVMP)
Danish: Udvalget for Veterinærlægemidler (CVMP)
English: This group of antibiotics has a polypeptide structure, with mainly bactericidal activity and a medium antibacterial spectrum, which covers Gram-negative microorganisms only.
Danish: Denne gruppe antibiotika har polypeptidstruktur, overvejende baktericid virkning og et middelbredt antibakterielt spektrum alene mod gramnegative mikroorganismer.
English: Colistin sulfate belongs to the polymyxin group of antibiotics.
Danish: Colistinsulfat er et antibiotikum i polymyxingruppen.
English: Based on the evaluation of the currently available data, the CVMP considered that the overall benefitrisk profile for these products remains positive subject to amendments in the product information.
Danish: På grundlag af vurderingen af de foreliggende data fandt CVMP, at det overordnede benefit/risk-forhold fortsat er positivt for disse produkter, forudsat at der ændres i produktinformationen.
English: Veterinary medicinal products containing colistin as a sole active substance for oral administration in food producing animals are widely used in almost all EU Member States.
Danish: Veterinærlægemidler med colistin som eneste aktive stof har i næsten alle EU-medlemsstater udbredt anvendelse til oral administration til fødevareproducerende dyr.
English: The CVMP was requested to give its opinion on the measures that need to be taken in order to ensure the prudent use of colistin in food-producing animals across the EU and to minimise potential risks with the use of the identified products; inter alia whether there is a need to include adequate indications and warnings on prudent use in the product information and/or restrict indications for the identified products taking into account the CVMP revised guideline on the SPC for antimicrobial products (EMEA/CVMP/SAGAM/383441/2005) 2.
Danish: CVMP blev anmodet om at fremsætte en udtalelse om, hvilke foranstaltninger der bør træffes dels for at sikre forsvarlig brug af colistin hos fødevareproducerende dyr i hele EU, dels for at minimere potentielle risici ved brug af de pågældende produkter, herunder, om der bør indsættes passende anvisninger og advarsler om forsvarlig brug i produktinformationen, og/eller om indikationerne for de pågældende produkter bør begrænses i henhold til CVMP's reviderede retningslinjer for produktresuméer for antimikrobielle produkter (EMEA/CVMP/SAGAM/383441/2005)2.
English: On 12 May 2014, the European Commission presented to the Agency a referral notification under Article 35 of Directive 2011/82/EC, regarding veterinary medicinal products containing colistin to be administered orally.
Danish: Den 12. maj 2014 foretog Europa-Kommissionen en indbringelse for agenturet i henhold til artikel 35 i direktiv 2011/82/EF vedrørende veterinærlægemidler indeholdende colistin til oral administration.
English: No written comments on the recommendations and proposed changes in the product information were provided by the applicants and marketing authorisation holders.
Danish: Ansøgerne og markedsføringstilladelsesindehaverne fremsatte ingen skriftlige kommentarer til anbefalingerne og ændringsforslagene til produktinformationen.
English: Therefore, on 11 December 2014 the Committee adopted by consensus a positive opinion, recommending variations to the terms of the marketing authorisations for veterinary medicinal products containing colistin to be administered orally.
Danish: Den 11. december 2014 vedtog udvalget derfor enstemmigt en positiv udtalelse, der anbefaler ændring af betingelserne for markedsføringstilladelserne for veterinærlægemidler indeholdende colistin til oral administration.
English: 1 Article 35 of Directive 2001/82/EC, as amended 2 CVMP revised guideline on the SPC for antimicrobial products (EMEA/CVMP/SAGAM/383441/2005)
Danish: 2 CVMP's reviderede vejledning om produktresuméer for antimikrobielle midler (EMEA/CVMP/SAGAM/383441/2005)
English: Oral colistin formulations including powder, solution, premix, tablets and paste have been authorised, mainly for group and flock treatment for the treatment and prevention of different specified gastrointestinal diseases caused by sensitive Enterobacteriacea species (e.g. Salmonella and Escherichia coli), but marketing authorisations without more specific indications do also exist.
Danish: Orale formuleringer af colistin i form af pulver, opløsning, premix, tabletter og pasta er hovedsagelig godkendt til gruppe- og flokvis behandling og forebyggelse af en række specifikke gastrointestinale sygdomme forårsaget af følsomme Enterobacteriacea-arter (f.eks.
English: Opinion following an Article 351 referral for veterinary medicinal products containing colistin to be administered orally
Danish: Udtalelse efter en artikel 35-indbringelse for veterinærlægemidler indeholdende colistin til oral administration
English: MA (EU) number (Invented) name Strength Pharmaceutical form Route of administration
Danish: MF (EU)-nummer (Særnavn) Navn
English: After mixing, 1 dose (0.5 ml) contains:
Danish: Efter sammenblanding, 1 dosis (0,5 ml) indeholder:
English: A/California/7/2009 (H1N1)v like strain (X-179A) 3.75 micrograms** * propagated in eggs ** haemagglutinin
Danish: A/California/7/2009 (H1N1)v-lignende stamme (X-179A) 3,75 mikrogram** * opformeret i æg ** hæmagglutinin
English: Intramuscular use suspension (H1N1): vial (glass); emulsion (adjuvant): vial (glass)
Danish: Intramuskulær anvendelse suspension (H1N1): hætteglas (glas); emulsion (adjuvans): hætteglas (glas);
English: Packaging Content (concentration) Package size
Danish: Særnavn Styrke Lægemiddelform Indgivelsesvej Emballage Indhold (Koncentration)
English: Cufence must be stored in a refrigerator (between 2ºC and 8ºC).
Danish: Cufence skal opbevares i køleskab (mellem 2 °C og 8 °C).
English: Further information on Cufence can be found on the Agency's website: www.ema.europa.eu/medicines/human/EPAR/cufence
Danish: Yderligere information om Cufence findes på agenturets websted under: www.ema.europa.eu/medicines/human/EPAR/cufence
English: Cufence should be taken on an empty stomach, at least one hour before or two hours after meals.
Danish: Cufence bør indtages på tom mave mindst en time før eller to timer efter et måltid.
English: Other information about Cufence
Danish: Andre oplysninger om Cufence
English: As for all medicines, data on the use of Cufence are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brugen af Cufence løbende overvåget.
English: The recommended daily dose is 4 to 8 capsules in adults, and 2 to 5 capsules in children.
Danish: Den anbefalede daglige dosis er 4-8 kapsler til voksne og 2-5 kapsler til børn.
English: What measures are being taken to ensure the safe and effective use of Cufence?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Cufence?
English: The capsules are taken in 2 to 4 divided doses.
Danish: Kapslerne inddeles i 2 til 4 doser.
English: Trientine has been used for over 30 years to treat patients with Wilson's disease.
Danish: Trientin har været anvendt i over 30 år til at behandle patienter med Wilsons sygdom.
English: Cufence is available as 200 mg capsules.
Danish: Cufence findes som kapsler a 200 mg.
English: Why is Cufence authorised in the EU?
Danish: Hvorfor er Cufence godkendt i EU?
English: The European Medicines Agency therefore decided that Cufence's benefits are greater than its risks and it can be authorised for use in the EU.
Danish: Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved Cufence opvejer risiciene, og at det kan godkendes til anvendelse i EU.
English: Side effects reported with Cufence are carefully evaluated and any necessary action taken to protect patients.
Danish: De indberettede bivirkninger ved Cufence vurderes omhyggeligt, og der tages de nødvendige forholdsregler for at beskytte patienterne.
English: What is Cufence and what is it used for?
Danish: Hvad er Cufence, og hvad anvendes det til?
English: An overview of Cufence and why it is authorised in the EU
Danish: En oversigt over Cufence, og hvorfor det er godkendt i EU
English: Skin rash may affect up to 1 in 100 people.
Danish: Hududslæt kan forekomme hos op til 1 ud af 100 personer.
English: Doses are adjusted according to patient response and levels of copper in the body.
Danish: Doserne justeres i forhold til patientens respons og kobberindholdet i kroppen.
English: A small proportion of patients had deteriorating symptoms: 5% with worsening liver symptoms and 3% with worsening neurological symptoms.
Danish: andel af patienterne havde symptomer på forværring: 5 % med symptomer på forværret leversygdom og 3 % med forværrede neurologiske symptomer.
English: Cufence can only be obtained with a prescription and treatment should be started by a specialist with experience in the management of Wilson's disease.
Danish: Cufence fås kun på recept, og behandling bør indledes af en læge med erfaring i behandling af Wilsons sygdom.
English: The most common side effect with Cufence (which may affect up to 1 in 10 people) is nausea (feeling sick), especially when starting treatment.
Danish: De hyppigste bivirkninger ved Cufence (som kan forekomme hos op til 1 ud af 10 personer) er kvalme, især ved behandlingsstart.
English: What are the risks associated with Cufence?
Danish: Hvilke risici er der forbundet med Cufence?
English: It works by attaching to copper in the body and forming a complex that is then eliminated in the urine and faeces.
Danish: Det virker ved at binde sig til kobber i kroppen og danne et komplekst produkt, som derefter udskilles med urinen og afføringen.
English: Cufence is a medicine used to treat patients aged 5 years and older with Wilson's disease, a genetic condition in which copper absorbed from food builds up in the body, particularly in the liver and the brain, causing damage.
Danish: Cufence er et lægemiddel, der bruges hos patienter i alderen 5 år og opefter som behandling for Wilsons sygdom, en genetisk tilstand, hvor kobber optaget fra fødevarer ophobes i kroppen, især i leveren og hjernen, og forvolder skade.
English: For more information about using Cufence, see the package leaflet or contact your doctor or pharmacist.
Danish: Hvis du ønsker mere information om anvendelsen af Cufence, kan du læse indlægssedlen eller kontakte lægen eller apotekspersonalet.
English: Cufence is used in patients who cannot take D-penicillamine, another medicine for this condition.
Danish: Cufence anvendes hos patienter, der ikke kan tage Dpenicillamin, et andet lægemiddel til behandling af denne tilstand.
English: In a study of medical records of 77 patients treated with trientine for at least six months, symptoms of liver disease improved in almost half (49%) of the patients treated, and neurological symptoms
Danish: I et studie, der omfattede sygejournaler fra 77 patienter, der blev behandlet med trientin i mindst seks måneder, sås en forbedring af symptomerne på leversygdom hos næsten halvdelen (49 %) af de behandlede patienter og en forbedring af de neurologiske symptomer hos 14 % af patienterne.
English: Cufence (trientine dihydrochloride) EMA/410631/2019
Danish: Cufence (trientindihydrochlorid) EMA/325626/2019
English: The active substance in Cufence, trientine, is a chelating agent.
Danish: Det aktive stof i Cufence, trientin, er en chelatdanner.
English: Duodenitis (inflammation of the duodenum, the part of the gut leading out of the stomach) and severe colitis (inflammation in the large bowel causing pain and diarrhoea) have also been reported.
Danish: Duodenitis (betændelse i tolvfingertarmen, den del af tarmen, der støder op til maven) og svær colitis (tyktarmsbetændelse, der giver smerter og diarré) er også blevet indberettet.
English: Cufence (trientine dihydrochloride)
Danish: Cufence (trientindihydrochlorid)
English: In some patients, neurological deterioration can occur at the start of the treatment, with symptoms such as dystonia (involuntary muscle contractions), stiffness, tremor (shaking) and dysarthria (difficulty speaking).
Danish: Hos nogle patienter kan der forekomme neurologisk svækkelse ved behandlingsstart med symptomer som dystoni (ufrivillige muskelsammentrækninger), stivhed, rysten og dysarthri (talebesvær).
English: The safety of Cufence has been shown to be similar to that of other trientine medicines.
Danish: Hvad sikkerheden angår, har Cufence vist sig at svare til andre lægemidler med trientin.
English: Cufence contains the active substance trientine dihydrochloride.
Danish: Cufence indeholder det aktive stof trientindihydrochlorid.
English: For the full list of side effects and restrictions of Cufence, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Cufence fremgår af indlægssedlen.
English: What benefits of Cufence have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Cufence?
English: The active substance in Cufence, trientine, has been shown to improve symptoms of liver and neurological disease in patients with Wilson's disease who could no longer take D-penicillamine.
Danish: Det aktive stof i Cufence, trientin, har vist sig at forbedre symptomer på leversygdom og neurologiske symptomer hos patienter med Wilsons sygdom, som ikke længere kunne tage D-penicillamin.
English: Although Dpenicillamine is the main treatment for this condition, trientine is effective at improving the symptoms of liver and neurological disease in patients who cannot take this medicine.
Danish: Selvom Dpenicillamin er standardbehandling ved denne sygdom, er trientin effektivt til at forbedre symptomerne på leversygdom og neurologiske lidelser hos patienter, der ikke kan tage dette lægemiddel.
English: The company that markets Cufence will conduct a study to further characterise the effectiveness of trientine in the treatment of Wilson's disease, including its effect on the associated liver, neurological or psychiatric symptoms and what the dose should be during early treatment.
Danish: Virksomheden, der markedsfører Cufence, vil gennemføre et studie med henblik på yderligere at redegøre for trientins effektivitet ved Wilsons sygdom, herunder dets indvirkning på de dermed forbundne tilstande, nemlig leversygdom og neurologiske eller psykiatriske lidelser, og med henblik på at fastsætte den dosis, der skal gives ved behandlingens start.
English: How is Cufence used?
Danish: Hvordan anvendes Cufence?
English: How does Cufence work?
Danish: Hvordan virker Cufence?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Cufence have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Cufence.
English: The primary endpoint was OS.
Danish: Det primære endepunkt var OS.
English: requiring urgent treatment);
Danish: som kræver akut behandling)
English: There was no difference in overall survival (OS) seen in either group.
Danish: Der var ingen forskel i overordnet overlevelse (OS) i nogen af grupperne.
English: Improved (< grade 3)
Danish: Forbedret (< grad 3)
English: The treatment will usually be given over a period of approximately 60 minutes.
Danish: Behandlingen vil sædvanligvis blive givet over en periode på ca. 60 minutter.
English: As with all therapeutic proteins, there is potential for immunogenicity.
Danish: Som det er tilfældet med alle terapeutiske proteiner, er der risiko for immunogenicitet.
English: 1 Greater than or equal to grade 3 is defined as severe or life-threatening Special populations
Danish: 1 Større end eller lig med grad 3 defineres som alvorlig eller livstruende Særlige populationer
English: Occurrence of skin symptom(s): ≥ grade 31
Danish: Forekomst af hudsymptom(er): ≥ grad 31
English: It is recommended to maintain this lower infusion rate in all subsequent infusions.
Danish: Det anbefales, at denne lavere infusionshastighed bibeholdes ved alle efterfølgende infusioner.
English: Magnesium repletion is recommended, as appropriate.
Danish: Magnesiumretablering anbefales efter behov.
English: There was an increase in mortality in the panitumumab arm.
Danish: Der var forøget mortalitet i panitumumab-armen.