FrancophonIA/ELRC3.0 huggingface dataset:
English: Danofloxacin mesilate
Danish: Danofloxacinmesilat
English: Vétoquinol B.V.
Danish: Vétoquinol N.V.
English: Flumix Poudre A 3 % Flumequine
Danish: Flumix Poudre A 3 % Flumequin
English: Pre-ruminant Cattle
Danish: Præ-drøvtyggende kvæg
English: Danofloxacin 31.73 mg/ml (equivalent to
Danish: Danofloxacin 31,73 mg/ml (svarende til 25 mg/ml
English: Schippers Europe B.V. Bleijenhoek 17
Danish: Schippers Europe B.V.
English: Romania Laboratorios Karizoo, S.A. Polg.
Danish: Rumænien Laboratorios Karizoo, S.A. Polg.
English: VETHELLAS 31 Augoustou 51 41221 Larissa GREECE
Danish: Grækenland VETHELLAS 31 Augoustou 51
English: Rabbits Fur animals
Danish: Kaniner Pelsdyr
English: Strength Pharmaceutical form
Danish: Lægemiddelform Dyreart
English: Intraruminal device Cattle
Danish: Intraruminalt indlæg Kvæg
English: Subcutaneous or intraveneous or intramuscular
Danish: Subkutant eller intravenøst eller intramuskulært
English: Colistin sulphate Oxolinic acid
Danish: Colistinsulfat Oxolinsyre
English: Flumiquil Poudre A 3 % Flumequine
Danish: Flumiquil Poudre A 3 % Flumequin
English: Medicated premix Pigs Chickens
Danish: Medicineret premix Svin Kyllinger
English: Intramuscular
Danish: Intramuskulært
English: Flumesyva Liquid 20% Flumequine
Danish: Flumesyva Liquid 20% Flumequin
English: Romania Dar al Dawa Veterinary & Agricultural Industrial Co. Ltd. Jordan Na`ur 11710
Danish: Rumænien Dar al Dawa Veterinary & Agricultural Industrial Co.
English: Enrofloxacin Colistin sulphate
Danish: Enrofloxacin Colistinsulfat
English: Romania Bayer HealthCare AG Animal Health Division 51368 Leverkusen
Danish: Rumænien Bayer HealthCare AG Animal Health Division 51368 Leverkusen
English: Flumexil 1.5% Flumequine
Danish: Flumexil 1.5% Flumequin
English: Inoxyl Poudre Orale Oxolinic acid 100 mg
Danish: Inoxyl Poudre Orale Oxolinsyre
English: Grounds for amendment of the summary of product characeristics and package leaflet
Danish: Begrundelser for ændring af produktresuméet og indlægssedlen
English: Goats
Danish: Geder
English: Belgium Pfizer Animal Health Benelux Division
Danish: Pfizer Animal Health Benelux Division Pleinlaan 17
English: Medicated premix Pigs Poultry
Danish: Medicineret premix Svin Fjerkræ
English: Romania Laboratorios Hipra, S.A. Avda.
Danish: Rumænien Laboratorios Hipra, S.A. Avda.
English: Cattle Pigs
Danish: Svin Kvæg
English: Romania Vétoquinol Biowet Sp. z o.o.
Danish: Rumænien Vétoquinol Biowet Sp. z o.o.
English: Eurovet Animal Health B.V. Handelsweg 25
Danish: Nederlandene Eurovet Animal Health B.V.
English: 1126 Budapest
Danish: 1126 Budapest HUNGARY
English: Quinocol Oral Solution Enrofloxacin Colistin sulphate
Danish: Quinocol Oral Solution Enrofloxacin Colistinsulfat
English: Quinocol oral solution Enrofloxacin Colistin sulphate
Danish: Quinocol oral solution Enrofloxacin Colistinsulfat
English: Calves Exotic pet animals
Danish: Kalve Eksotiske kæledyr
English: Romania Vétoquinol S. A. Magny Vernois
Danish: Rumænien Vétoquinol S. A. Magny Vernois
English: Ruminating calves
Danish: Drøvtyggende kalve
English: Subcutaneous intravenous
Danish: Subkutant intravenøst
English: Calves Lambs Goatlings Rabbits Fur animals
Danish: Gedekid Kaniner Pelsdyr
English: FLUMISOL 36% Flumequine
Danish: Flumisol 36 % Flumequin
English: Amoxicillin trihydrate Flumequine
Danish: Amoxicillin Flumequin
English: Oily suspension
Danish: Oliesuspension
English: Cattle (suckling calves)
Danish: Kvæg (diende kalve)
English: Enrofloxacin Oxytetracycline hydrochloride Iodoform25 mg/ml
Danish: Enrofloxacin Oxytetracyclinh ydrochlorid Iodoform25 mg/ml
English: Flumiquil 50 % powder Flumequine
Danish: Flumiquil 50 % powder Flumequin
English: Flumequine 10% pulvis Flumequine
Danish: Flumequine 10% pulvis Flumequin
English: Cattle Pigs Poultry Rabbits
Danish: Kvæg Svin Fjerkræ Kaniner
English: Dali Industrial Estate; P.O.
Danish: Dali Industrial Estate; P.O. Box 17020
English: Intravenous, subcutaneous
Danish: Intravenøst, subkutant
English: Cattle Goats Horses Sheep
Danish: Kvæg Geder Heste Får
English: Germany Vétoquinol S. A. Magny Vernois
Danish: Grækenland Vétoquinol S. A. Magny Vernois
English: VETAFLUMINA 5% Flumequine
Danish: VETAFLUMINA 5% Flumequin
English: Subcutaneous, intraveneous
Danish: Subkutant, intravenøst
English: Calves Poultry
Danish: Kalve Kyllinger
English: 1123 Budapest
Danish: 1123 Budapest HUNGARY
English: Flumechina 50% Flumequine
Danish: Flumechina 50% Flumequin
English: Poultry Turkeys
Danish: Kalkuner Kyllinger
English: Germany Bayer Animal Health GmbH 51368 Leverkusen
Danish: Grækenland Bayer Animal Health GmbH 51368 Leverkusen
English: Oxolinic acid 50 g
Danish: Oxolinsyre 100 g
English: Poultry Rabbits
Danish: Fjerkræ Kaniner
English: Poultry Calves Dogs Cats
Danish: Fjerkræ Kalve Hunde Katte
English: Poultry (chicken and turkeys) Pigeons
Danish: Fjerkræ (kyllinger og kalkuner) Duer
English: Amendment to the summary of product characteristics and package leaflet
Danish: Bilag III Ændring af produktresuméet og indlægssedlen
English: FLUMEXIL 5% Flumequine
Danish: FLUMEXIL 5% Flumequin
English: Flumequine 10% WSP Flumequine
Danish: Flumequine 10% WSP Flumequin
English: Flumequinorom 10% Flumequine
Danish: Flumequinorom 10% Flumequin
English: Box 319
Danish: Bruistensingel 310
English: VETAFLUMINA 50% Flumequine
Danish: VETAFLUMINA 50% Flumequin
English: Recommendations for prudent use “Official and local antimicrobial policies should be taken into account when the product is used.” “Whenever possible, quinolones should only be used based on susceptibility testing.” “Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to the quinolones and may decrease the effectiveness of treatment with other (fluoro)quinolones due to the potential for cross resistance.”
Danish: "Brug af lægemidlet, som afviger fra vejledningen i produktresuméet, kan øge prævalensen af bakterier, som er resistente over for quinoloner, og kan mindske effekten af behandling med andre (fluoro)quinoloner på grund af potentialet for krydsresistens."
English: Chickens Cattle
Danish: Kyllinger Kvæg
English: Rabbits Poultry
Danish: Kaniner Fjerkræ
English: Intramuscular, subcutaneous
Danish: Intramuskulært, subkutant
English: Cattle Pigs Dogs Cats
Danish: Kvæg Svin Hunde Katte
English: Calves Pigs
Danish: Kalve Svin
English: Rabbits Dogs Cats Chickens
Danish: Geder Svin Kaniner Hunde Katte Kyllinger
English: Poultry Pigs Cattle
Danish: Fjerkræ Svin Kvæg
English: Germany Medistar Arzneimittel-Vertrieb GmbH
Danish: Medistar ArzneimittelVertrieb GmbH Schäferkampstr.
English: Chickens
Danish: Mink
English: Poultry (chickens and turkeys)
Danish: Fjerkræ (kyllinger og kalkuner)
English: Flumequine 50% WSP Flumequine
Danish: Flumequine 50 % WSP Flumequin
English: Flumequine 50 % WSP Flumequine
Danish: Flumequine 50% WSP Flumequin
English: ENTERFLUME 50% Flumequine
Danish: ENTERFLUME 50% Flumequin
English: Calves Lambs Poultry
Danish: Kalve Lam Fjerkræ
English: Poultry Cattle Rabbits
Danish: Fjerkræ Kvæg Kaniner
English: Intravenous, intramuscular, subcutaneous
Danish: Intravenøst, intramuskulært, subkutant
English: Subcutaneous, intramuscular
Danish: Subkutant, intramuskulært
English: Cattle Pigs Poultry Lambs
Danish: Kvæg Svin Fjerkræ Lam
English: Flumisol 10 % Flumequine
Danish: Flumisol 10 % Flumequin
English: Intravenous, intramuscular
Danish: Intravenøst, intramuskulært
English: Calves Pigs Poultry
Danish: Kalve Svin Fjerkræ
English: Poultry Pigs
Danish: Svin Fjerkræ
English: Pigs Cattle Poultry Fish
Danish: Svin Kvæg Fjerkræ Fisk
English: Poultry (excluding laying)
Danish: Fjerkræ (ekskl.
English: Romania Dopharma Research BV Zalmweg 24
Danish: Rumænien Dopharma Research BV Zalmweg 24
English: Intramuscular, intravenous, subcutaneous
Danish: Intramuskulært, intravenøst, subkutant
English: 2160 Wommelgem BELGIUM
Danish: Lt. Caluwaertstraat 1 2160 Wommelgem BELGIUM
English: Intramuscular, subcutaneous, intravenous
Danish: Intramuskulært, subkutant, intravenøst
English: Flumesol 10% Flumequine
Danish: Flumesol 10% Flumequin
English: FLUMAX 50% Flumequine
Danish: FLUMAX 50% Flumequin
English: Bovine
Danish: Kvæg Kvæg
English: Amoxicillin Flumequine amoxicillin 22,5g/100g flumequine15g/ 100g
Danish: Amoxicillin 22,5 g/100 g
English: Cattle Buffalos Horses Sheep Goats Pigs
Danish: Kvæg Bøfler Heste Får
English: Intramuscular, intravenous, intramuscular
Danish: Intramuskulært, intravenøst, intramuskulært
English: Intramuscular, intravenous
Danish: Intramuskulært, intravenøst
English: Pigs Calves
Danish: Svin Kalve
English: Romania Krka, d. d., Novo mesto Šmarješka cesta 6
Danish: Rumænien Krka, d. d., Novo mesto Šmarješka cesta 6
English: Flumequine 10% Flumequine
Danish: Flumequine 10% Flumequin
English: Cattle Sheep Goats Sows
Danish: Kvæg Geder Får
English: Pigs Lambs
Danish: Smågrise Lam
English: Pigs Dogs Cats
Danish: Hunde Katte
English: Cattle Pigs Poultry
Danish: Kvæg Svin Høner
English: Poultry Pigeons Cats Dogs Cattle Pigs
Danish: Fjerkræ Duer Katte Hunde Kvæg Svin
English: Young poultry (chickens and turkeys)
Danish: Ungfjerkræ (kyllinger og kalkuner)
English: 4.5 Special precautions for use i) Special precautions for use in animals
Danish: 4.5 Særlige forsigtighedsregler vedrørende brugen i) Særlige forsigtighedsregler vedrørende brug til dyr Anbefalinger vedrørende forsigtig brug "Der skal tages højde for officielle og lokale retningslinjer vedrørende antimikrobielle stoffer ved anvendelse af lægemidlet."
English: Cattle Sheep Goats Pigs Poultry Rabbit Fish
Danish: Geder Svin Fjerkræ Kaniner Fisk
English: Horses Rabbits Chickens Dogs
Danish: Smågrise Kaniner Hunde
English: Calves Pigs Poultry Fish
Danish: Kalve Svin Fjerkræ Fisk
English: Pigs Fish
Danish: Svin Fisk
English: Enrofloxacin 2.5%
Danish: Enrofloxacin 2,5 % Oral opløsning
English: Intramuscular, subcutaneous, intramuscular
Danish: Intramuskulært, subkutant, intramuskulært
English: Coophavet S.A.S Saint Herblion, B.P.
Danish: Coophavet S.A.S Saint Herblion, B.P. 7 44153 Ancenis Cedex FRANCE
English: Broilers Rabbits
Danish: Bæverrotter Kaniner
English: Chickens Calves Pigs
Danish: Kyllinger Kalve Svin
English: Chickens Cattle Dogs Cats Pigeons
Danish: Kyllinger Kvæg Hunde Katte Duer
English: Intrauterine tablet
Danish: Opløseligt pulver
English: Cattle Sheep Chickens Hens
Danish: Slagtekyllinger Avlshøns
English: Fattening Chickens Fattening Turkeys
Danish: Kyllinger Kalkuner Duer
English: Pigeons
Danish: Kalkuner
English: Subcutaneous, Intravenous, intramuscular
Danish: Subkutant, intravenøst, Intramuskulært
English: • Fluoroquinolone products “Official and local antimicrobial policies should be taken into account when the product is used.” “Fluoroquinolones should be reserved for the treatment of clinical conditions which have responded poorly, or are expected to respond poorly, to other classes of antimicrobials.” “Whenever possible, fluoroquinolones should only be used based on susceptibility testing.” “Use of the product deviating from the instructions given in the SPC may increase the prevalence of bacteria resistant to the fluoroquinolones and may decrease the effectiveness of treatment with other quinolones due to the potential for cross resistance.”
Danish: "Brug af lægemidlet, som afviger fra vejledningen i produktresuméet, kan øge prævalensen af bakterier, som er resistente over for fluoroquinoloner, og kan mindske effekten af behandling med andre quinoloner på grund af potentialet for krydsresistens."
English: Poultry Pigs Fish
Danish: Fjerkræ Svin Fisk
English: Flumequine 50% Flumequine
Danish: Flumequine 50% Flumequin
English: Birds Pigs Lambs Kids Cattle
Danish: Svin Kvæg Lam Geder Kid
English: Enrofloxacin 0.5%
Danish: Enrofloxacin 0,5 % Oral opløsning
English: Poultry Pigs Lambs Kids Calves
Danish: Fjerkræ Svin Kvæg Lam Kid
English: Cattle Birds
Danish: Kvæg Avlssøer
English: Cattle Pigs Hen
Danish: Kvæg Svin Får
English: Calves Lambs Poultry Fish
Danish: Kalve Lam Fjerkræ Fisk
English: Cattle Buffalos Calves Foals Lambs Kids Pigs Piglets Rabbits Fowl
Danish: Lam Kaniner Svin Fjerkræ Kvæg Pelsdyr
English: Poultry Pigs Dogs Cats
Danish: Fjerkræ Svin Hunde Katte
English: Cattle Goats Horses Sheep Pigs Poultry
Danish: Kyllinger Kalkuner Svin Kvæg Får
English: Poultry Turkey Oral
Danish: Fjerkræ Oralt
English: Denmark Krka, d. d., Novo mesto Šmarješka cesta 6
Danish: Nederlandene Krka, d. d., Novo mesto Šmarješka cesta 6
English: Chickens Pigs
Danish: Kyllinger Svin
English: Fish Pigs Calves Poultry
Danish: Fisk Svin Kalve Fjerkræ
English: Belgium Dopharma Research BV Zalmweg 24
Danish: Nederlandene Dopharma Research BV Zalmweg 24
English: Lambs Rabbits Pigs
Danish: Svin Kaniner
English: Industrial Area Aradippou 7100; P.O.
Danish: Industrial Area Aradippou 7100; P.O. Box 40261 6302 Larnaca
English: Cattle Goats Horses Rabbits Sheep Fish Pigs Poultry
Danish: Geder Svin Heste Kaniner Kyllinger Hunde
English: Flumiquil 50 % Flumequine
Danish: Flumiquil 50 % Flumequin
English: Oxolinic acid 24 g
Danish: Colistinsulfat 12 g
English: Cattle Ovine Pigs Dogs
Danish: Kvæg Smågrise Hunde
English: Poulrty
Danish: æglæggende)
English: Water soluble granules
Danish: Vandopløseligt granulat
English: In addition the Committee notes that the list of products in Annex I does not include all veterinary medicinal products containing quinolones including fluoroquinolones authorised in the EEA-EU, as either some products were not notified to the Agency by the competent national authorities or the information was not received in time to include these products in the current referral.
Danish: Desuden bemærker udvalget, at listen over lægemidler i bilag I ikke indeholder alle veterinærlægemidler, som indeholder quinoloner, inkl.
English: Lithuania Dopharma Research BV Zalmweg 24
Danish: Grækenland Dopharma Research BV Zalmweg 24
English: Danofloxacin 2.5%
Danish: Danofloxacin 2,5 % Injektionsvæske, opløsning
English: London, 22 January 2009 Doc.
Danish: London, den 22. januar 2009 Dok.
English: The Committee also had concerns over what happens to the medicine in the body, how it should be given and how safe it is.
Danish: Udvalget havde også betænkeligheder med hensyn til, hvad der sker med lægemidlet i kroppen, hvordan det skal gives, og hvor sikkert det er.
English: People who have this mutation are more likely to develop cancer.
Danish: Mennesker med denne mutation har større sandsynlighed for at udvikle kræft.
English: The application was at day 179 when the company withdrew.
Danish: Ansøgningsproceduren var ved dag 179, da virksomheden trak sin ansøgning tilbage.
English: What is Advexin?
Danish: Hvad er Advexin?
English: Questions and answers on the withdrawal of the marketing application for Advexin
Danish: Spørgsmål og svar vedrørende tilbagetrækningen af ansøgningen om markedsføringstilladelse for Advexin
English: International non-proprietary name (INN): contusugene ladenovec
Danish: Internationalt fællesnavn (INN): contusugene ladenovec
English: The effects of Advexin were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Advexin blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: The patient received 12 Advexin injections into some of the tumours over a five-month period.
Danish: Patienten fik 12 Advexin-injektioner i nogle af tumorerne i løbet af en periode på fem måneder.
English: Li-Fraumeni cancer can occur in many areas of the body but usually affects the breast, brain, bone or soft tissue (tissue that connects, surrounds and supports other structures in the body).
Danish: Li-Fraumeni kræft kan forekomme mange steder i kroppen, men rammer oftest brystet, hjernen, knoglerne eller bløddele (det væv, der forbinder, omgiver og støtter andre strukturer i kroppen).
English: The effectiveness of the medicine was assessed by using scans to look at how the tumours responded to treatment.
Danish: Lægemidlets virkning blev vurderet ved brug af scanninger for at se, hvordan tumorerne reagerede på behandlingen.
English: This is a type of virus that has been altered genetically so that it can carry a gene into the cells of the body.
Danish: Det er en virustype, som er blevet genetisk ændret, så det kan bære et gen ind i kroppens celler.
English: In addition, the company had not supplied enough evidence to demonstrate that Advexin could be made in a reliable manner, or that it would not be harmful to the environment or to people in close contact with the patient.
Danish: Derudover havde virksomheden ikke fremlagt tilstrækkelig dokumentation til at påvise, at Advexin kunne fremstilles på pålidelig vis, eller at det ikke var skadeligt for miljøet eller for personer i tæt kontakt med patienten.
English: The company also presented the results of a number of small studies looking at the effects of a range of doses of Advexin on different types of cancer.
Danish: Virksomheden fremlagde også resultaterne fra et antal mindre undersøgelser af virkningerne af en række doser af Advexin på forskellige kræfttyper.
English: On 17 December 2008, Gendux Molecular Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Advexin for the treatment of Li-Fraumeni cancer.
Danish: Den 17. december 2008 meddelte Gendux Molecular Limited officielt Udvalget for Humanmedicinske Lægemidler (CHMP), at virksomheden ønskede at trække sin ansøgning om markedsføringstilladelse for Advexin til behandling af Li-Fraumeni kræft tilbage.
English: The virus in Advexin is an ‘adenovirus' that has been engineered so that it cannot make copies of itself and therefore does not cause infections in humans.
Danish: Viruset i Advexin er et ”adenovirus”, der er manipuleret, så det ikke kan lave kopier af sig selv og derfor ikke kan give infektion hos mennesker.
English: The active substance in Advexin, contusugene ladenovec, is a ‘viral vector'.
Danish: Det aktive stof i Advexin, contusugene ladenovec, er en “viral vektor”.
English: What was Advexin expected to be used for?
Danish: Hvad forventedes Advexin anvendt til?
English: Advexin was expected to cure or slow down the disease by restoring the normal protective function of the cells.
Danish: Advexin forventedes at helbrede eller forsinke sygdommen ved at genoprette cellernes normale beskyttende funktion.
English: Advexin was expected to be used to treat Li-Fraumeni cancer in patients from the age of 18 years.
Danish: Advexin forventedes anvendt til behandling af Li-Fraumeni kræft hos patienter over 18 år.
English: The company presented information from a study on one patient with Li-Fraumeni cancer in the lower abdomen, the bones and the brain.
Danish: Virksomheden fremlagde oplysninger fra en undersøgelse af en patient med Li-Fraumeni kræft i nederste del af abdomen, knoglerne og hjernen.
English: Advexin was designated as an orphan medicinal product on 23 October 2006.
Danish: Advexin blev udpeget som lægemiddel til sjældne sygdomme den 23. oktober 2006.
English: How is Advexin expected to work?
Danish: Hvordan forventes Advexin at virke?
English: Based on the review of the data and the company's response to the CHMP list of questions, at the time of the withdrawal, the CHMP had some concerns and was of the provisional opinion that Advexin could not have been approved for the treatment of Li-Fraumeni cancer.
Danish: På baggrund af gennemgangen af dataene og virksomhedens besvarelse af CHMP's liste med spørgsmål på tidspunktet for tilbagetrækningen af ansøgningen havde CHMP visse betænkeligheder og var af den foreløbige opfattelse, at Advexin ikke kunne have været godkendt til behandling af Li-Fraumeni kræft.
English: The CHMP was concerned that there was not enough evidence to show that the injection of Advexin into Li-Fraumeni tumours led to benefits for patients.
Danish: CHMP fandt grund til betænkelighed ved, at der ikke var tilstrækkelig dokumentation for, at injektion af Advexin i Li-Fraumeni-tumorer var til gavn for patienterne.
English: Advexin was expected to be injected directly into the tumours, thus allowing the cancer cells to produce normal p53 protein again.
Danish: Advexin skulle injiceres direkte i tumorerne, således at kræftcellerne igen kunne producere normalt p53-protein.
English: Li-Fraumeni cancer is a type of cancer that occurs in patients with Li-Fraumeni syndrome, a condition where a gene called p53 is defective because of a mutation.
Danish: Li-Fraumeni er en kræfttype, der forekommer hos patienter med Li-Fraumeni syndrom, en tilstand, hvor et gen kaldet p53 er defekt som følge af mutation.
English: The gene carried by the virus in Advexin is the normal (non-defective) p53 gene.
Danish: Genet, som bæres af viruset i Advexin, er det normale (ikke-defekte) p53gen.
English: What are the consequences of the withdrawal for patients undergoing clinical trials or compassionate use programmes with Advexin?
Danish: Hvilke konsekvenser har tilbagetrækningen for patienter, der deltager i kliniske undersøgelser med Advexin eller i programmer for anvendelse af Advexin med særlig udleveringstilladelse?
English: Advexin is a suspension for injection that contains contusugene ladenovec, a genetically modified virus which carries the p53 gene.
Danish: Advexin er en suspension til injektion, som indeholder contusugene ladenovec, et genetisk modificeret virus, der er bærer af p53-genet.
English: The p53 protein, which is produced from the non-defective p53 gene present in the human body, normally contributes to the repair of damaged DNA and causes cell death when the DNA cannot be repaired.
Danish: Det p53-protein, som produceres af det ikke-defekte p53-gen, som optræder i den menneskelige organisme, medvirker normalt til at reparere beskadiget dna og forårsager celledød, når dna'et ikke kan repareres.
English: In Li-Fraumeni cancer, where the p53 gene is defective, the p53 protein does not work properly and the cancer cells can continue to grow and divide.
Danish: Ved Li-Fraumeni kræft, hvor p53-genet er defekt, fungerer p53-proteinet ikke korrekt, og kræftcellerne kan fortsætte med at vokse og dele sig.
English: Because cancer cells contain damaged DNA, the p53 protein either helps to repair the DNA or causes the cells to die.
Danish: Da kræftceller indeholder beskadiget dna, hjælper p53-proteinet enten med at reparere dna'et eller medfører, at cellerne dør.
English: The company did not inform the CHMP whether there were any consequences of the withdrawal for patients in clinical trials or compassionate use programmes with Advexin.
Danish: Virksomheden har ikke meddelt CHMP, hvorvidt tilbagetrækningen vil få konsekvenser for patienter, der deltager i kliniske undersøgelser med Advexin eller i programmer for anvendelse af Advexin med særlig udleveringstilladelse.
English: However these are manageable if the appropriate measures are in place (see below).
Danish: De er imidlertid håndterbare, hvis de er truffet passende foranstaltninger (se nedenfor).
English: B-cell ALL
Danish: B-celle ALL
English: Further information on Kymriah can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information vedrørende Kymriah findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Kymriah
Danish: Andre oplysninger om Kymriah
English: These results were comparable to those from studies of patients receiving standard cancer treatments.
Danish: Disse resultater var sammenlignelige med dem fra studier af patienter, der fik standardbehandlinger for kræft.
English: Serious infections occur in around 3 in 10 DLBCL patients.
Danish: Alvorlige infektioner forekommer hos ca. 3 ud af 10 DLBCL-patienter.
English: Patients should be closely monitored for 10 days after treatment for side effects and are advised to stay close to a specialist hospital for at least 4 weeks after treatment.
Danish: Patienterne bør overvåges nøje i 10 dage efter behandling for bivirkninger, og det tilrådes, at de opholder sig tæt på et specialiseret hospital i mindst 4 uger efter behandlingen.
English: What measures are being taken to ensure the safe and effective use of Kymriah?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Kymriah?