FrancophonIA/ELRC3.0 huggingface dataset:
English: The average molecular weight of Refixia is approximately 98 kDa and the molecular weight of the protein moiety alone is 56 kDa.
Danish: Den gennemsnitlige molekylevægt af Refixia er cirka 98 kDa, og molekylevægten af proteinmolekyledelen alene er 56 kDa. Ved aktivering af Refixia fraspaltes aktiveringspeptidet, herunder 40 kDa polyethylenglycol-molekyledelen, og det native aktiverede faktor IX-molekyle bliver tilbage.
English: After reconstitution, 1 ml of Refixia contains approximately 500 IU nonacog beta pegol.
Danish: Efter rekonstitution indeholder 1 ml Refixia cirka 500 IE nonacog betapegol.
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1000 IU
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 1000 IE
English: STATEMENT OF ACTIVE SUBSTANCE Powder: 500 IU nonacog beta pegol (approx. 125 IU/ml after reconstitution),
Danish: ANGIVELSE AF AKTIVT STOF Pulver: 500 IE nonacog betapegol (ca. 125 IE/ml efter opblanding)
English: If you are not sure if either of the above applies to you, talk to your doctor before using this medicine.
Danish: Kontakt lægen, før du bruger dette lægemiddel, hvis du er usikker på, om noget af ovenstående gælder for dig.
English: The use of Refixia in children below 12 years is not indicated.
Danish: Refixia er ikke indiceret hos børn under 12 år.
English: • Turn over the protective cap, and snap the vial adapter onto the vial.
Danish: • Vend beskyttelseshætten, og klik hætteglasadapteren fast på hætteglasset.
English: Overall haemostatic efficacy
Danish: Samlet hæmostatisk virkning
English: Excipient with known effect Less than 1 mmol sodium (23 mg) per vial.
Danish: Hjælpestof, som behandleren skal være opmærksom på 1 hætteglas indeholder mindre end 1 mmol natrium (23 mg).
English: After reconstitution, 1 ml of Refixia contains approximately 250 IU nonacog beta pegol.
Danish: Efter rekonstitution indeholder 1 ml Refixia cirka 250 IE nonacog betapegol.
English: Instructions on how to use Refixia
Danish: Brugervejledning til Refixia
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 2000 IU
Danish: INDHOLD ANGIVET SOM VÆGT, VOLUMEN ELLER ANTAL DOSER 2000 IE
English: STATEMENT OF ACTIVE SUBSTANCE Powder: 1000 IU nonacog beta pegol (approx. 250 IU/ml after reconstitution),
Danish: ANGIVELSE AF AKTIVT STOF Pulver: 1000 IE nonacog betapegol (ca. 250 IE/ml efter opblanding)
English: Do not freeze reconstituted Refixia solution or store it in syringes.
Danish: Opblandet Refixia injektionsvæske må ikke fryses eller opbevares i sprøjter.
English: Keep reconstituted Refixia solution out of direct light.
Danish: Opblandet Refixia injektionsvæske må ikke opbevares i direkte lys.
English: Do not use solutions that are cloudy or have deposits.
Danish: Brug ikke injektionsvæsker, der er uklare eller har bundfald.
English: STATEMENT OF ACTIVE SUBSTANCE Powder: 2000 IU nonacog beta pegol (approx. 500 IU/ml after reconstitution),
Danish: ANGIVELSE AF AKTIVT STOF Pulver: 2000 IE nonacog betapegol (ca. 500 IE/ml efter opblanding)
English: Use of a reference laboratory is recommended when a chromogenic assay or a qualified one-stage clotting assay is not available locally.
Danish: Hvis en kromogenanalyse eller en kvalificeret 1-trins-koagulationsanalyse ikke er tilgængelig lokalt, anbefales det at anvende et referencelaboratorium.
English: Chemical and physical in-use stability have been demonstrated for 24 hours stored in a refrigerator
Danish: Efter rekonstitution Der er påvist kemisk og fysisk stabilitet i 24 timer ved opbevaring i køleskab (2°C - 8°C) og i 4 timer ved stuetemperatur (≤ 30°C).
English: Refixia 2000 IU powder and solvent for solution for injection Each vial contains nominally 2000 IU nonacog beta pegol*.
Danish: Refixia 2000 IE pulver og solvens til injektionsvæske, opløsning Hvert hætteglas indeholder nominelt 2000 IE nonacog betapegol*.
English: 18-65 years
Danish: 18-65 år N=20
English: NAME OF THE MEDICINAL PRODUCT Refixia 2000 IU powder and solvent for solution for injection nonacog beta pegol (recombinant coagulation factor IX)
Danish: Refixia 2000 IE pulver og solvens til injektionsvæske, opløsning nonacog betapegol (rekombinant koagulationsfaktor IX)
English: Refixia 500 IU powder and solvent for solution for injection Each vial contains nominally 500 IU nonacog beta pegol*.
Danish: Refixia 500 IE pulver og solvens til injektionsvæske, opløsning Hvert hætteglas indeholder nominelt 500 IE nonacog betapegol*.
English: The use of Refixia in children below 12 years is not indicated (see section 4.2 for information on paediatric use).
Danish: Refixia er ikke indiceret hos børn under 12 år (se pkt.
English: If the plastic cap is loose or missing, do not use the vial.
Danish: Brug ikke hætteglasset, hvis plastikhætten mangler eller sidder løst.
English: NAME OF THE MEDICINAL PRODUCT Refixia 1000 IU powder and solvent for solution for injection nonacog beta pegol (recombinant coagulation factor IX)
Danish: Refixia 1000 IE pulver og solvens til injektionsvæske, opløsning nonacog betapegol (rekombinant koagulationsfaktor IX)
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Refixia 2000 IU powder for solution for injection nonacog beta pegol
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ Refixia 2000 IE pulver til injektionsvæske, opløsning nonacog betapegol i.v.
English: NAME OF THE MEDICINAL PRODUCT Refixia 500 IU powder and solvent for solution for injection nonacog beta pegol (recombinant coagulation factor IX)
Danish: Refixia 500 IE pulver og solvens til injektionsvæske, opløsning nonacog betapegol (rekombinant koagulationsfaktor IX)
English: Pivotal trial
Danish: Pivotalt studie
English: • Screw the pre-filled syringe securely onto the vial adapter until resistance is felt.
Danish: • Skru den fyldte sprøjte fast på hætteglasadapteren, indtil der mærkes modstand.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Refixia 500 IU powder for solution for injection nonacog beta pegol
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ Refixia 500 IE pulver til injektionsvæske, opløsning nonacog betapegol i.v.
English: • rash, hives, weals or itching
Danish: • udslæt, nældefeber, hævelse eller kløe
English: Refixia 1000 IU powder and solvent for solution for injection Each vial contains nominally 1000 IU nonacog beta pegol*.
Danish: Refixia 1000 IE pulver og solvens til injektionsvæske, opløsning Hvert hætteglas indeholder nominelt 1000 IE nonacog betapegol*.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION Refixia 1000 IU powder for solution for injection nonacog beta pegol
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ Refixia 1000 IE pulver til injektionsvæske, opløsning nonacog betapegol i.v.
English: • Pull the plunger rod slightly downwards to draw the reconstituted solution into the syringe.
Danish: • Træk stempelstangen en smule tilbage for at trække injektionsvæsken ind i sprøjten.
English: Dosing recommendations
Danish: Doseringsanbefaling
English: Syringe cap
Danish: Fyldt sprøjte
English: What Refixia is and what it is used for What you need to know before you use Refixia How to use Refixia
Danish: Det skal du vide, før du begynder at bruge Refixia Sådan skal du bruge Refixia Bivirkninger
English: What Refixia looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: 0-6 years
Danish: ≥18 år
English: MARKETING AUTHORISATION NUMBERS EU/1/17/1193/001
Danish: MARKEDSFØRINGSTILLADELSESNUMRE EU/1/17/1193/001
English: MARKETING AUTHORISATION NUMBER EU/1/17/1193/002
Danish: MARKEDSFØRINGSTILLADELSESNUMMER EU/1/17/1193/002
English: MARKETING AUTHORISATION NUMBER EU/1/17/1193/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER EU/1/17/1193/001
English: MARKETING AUTHORISATION NUMBER EU/1/17/1193/003
Danish: MARKEDSFØRINGSTILLADELSESNUMMER EU/1/17/1193/003
English: Attach the plunger rod and the syringe
Danish: Klargøring af hætteglas og sprøjte
English: not use the pre-filled syringe.
Danish: Brug ikke den fyldte sprøjte, hvis sprøjtehætten er løs eller mangler.
English: MA (EU) Number Invented name
Danish: MF (EU)-nummer Særnavn Styrke
English: 1 to 10 sterile tubes with 1 prefilled syringe each +1 indwelling cannula or 1 filter stem per prefilled syringe
Danish: 1 til 10 sterile rør hvert med 1 fyldt sprøjte + 1 fastliggende kanyle eller 1 filterskaft pr. fyldt sprøjte
English: 1 to10 sterile tubes with up to 2 applicators each + 1 syringe per applicator
Danish: 1 til 10 sterile rør hvert med op til 2 applikatorer + 1 sprøjte pr. applikator
English: Milk: 72 hours
Danish: Mælk: 72 timer
English: Assessment of the efficacy of the products for the other approved indications remains unchanged.
Danish: Vurderingen af produkternes virkning ved de øvrige godkendte indikationer er uændret.
English: Not authorised for use in horses producing milk for human consumption.
Danish: Ikke godkendt til brug til heste, der producerer mælk til konsum.
English: Delete, where applicable, “in cases of shock in horses”.
Danish: Slet, hvor det er relevant ”i tilfælde af shock hos heste”.
English: According to the current product information for Dexadreson, treatment may be repeated after 24-48 hours.
Danish: I henhold til den gældende produktinformation for Dexadreson kan behandlingen gentages efter 24-48 timer.
English: Kidney and liver were the tissues where the marker residue persisted longest.
Danish: Nyrerne og leveren var de væv, hvor restmarkøren persisterede længst.
English: 192 07 Sollentuna SWEDEN
Danish: 192 07 Sollentuna SVERIGE
English: Therefore it was considered appropriate to use the alternative method in order to establish a withdrawal period for cattle tissues.
Danish: Det blev derfor anset for hensigtsmæssigt at anvende den alternative metode til fastsættelse af en tilbageholdelsestid for væv fra kvæg.
English: Consequently Germany considered that it is in the interest of consumer safety to evaluate the adequacy of the meat withdrawal periods in cattle and horses and the milk withdrawal periods in cattle.
Danish: Tyskland fandt derfor, at det er i forbrugersikkerhedens interesse at vurdere tilstrækkeligheden af tilbageholdelsestiderne for kød hos kvæg og heste og for mælk fra kvæg.
English: Therefore, on 22 August 2012, Germany presented to the Agency a referral notification under Article 35 of Directive 2001/82/EC for Dexadreson 2 mg/ml and associated names, and generic products thereof.
Danish: Den 22. august 2012 indbragte Tyskland derfor sagen for agenturet i henhold til artikel 35 i direktiv 2001/82/EF, for Dexadreson, 2 mg/ml, og relaterede navne samt tilsvarende generiske produkter.
English: All studies were conducted at a single dose of 0.06 mg/kg body weight.
Danish: Alle undersøgelserne blev udført med en enkelt dosis på 0,06 mg/kg kropsvægt.
English: 88326 Aulendorf GERMANY
Danish: 88326 Aulendorf TYSKLAND
English: Meat and offal: 8 days
Danish: Slagtning: 8 dage
English: Reus-Vinyols, Km 4,1 43330 Riudoms, Tarragona SPAIN
Danish: Reus-Vinyols, Km 4,1 43330 Riudoms, Tarragona SPANIEN
English: List of the names, pharmaceutical forms, strengths of the veterinary medicinal products, animal species, applicants/marketing authorisation holders in the Member States
Danish: Liste over navne, lægemiddelformer, styrker af de veterinære lægemidler, dyrearter, indehavere af markedsføringstilladelser i medlemsstaterne
English: One of the studies on residue depletion in cattle tissues was not conducted over a sufficiently long period of time and was therefore not considered suitable to derive a valid withdrawal periods in cattle meat and offal.
Danish: En af undersøgelserne af restkoncentrationer i væv fra kvæg strakte sig ikke over tilstrækkelig lang tid og blev derfor ikke anset for fyldestgørende til at udlede en gyldig tilbageholdelsestid for kød og indmad fra kvæg.
English: Rue Olivier De Serres Angers Technopole 49071 Beaucouze Cedex FRANCE
Danish: Rue Olivier De Serres Angers Technopole 49071 Beaucouze Cedex FRANKRIG
English: United Kingdom Intervet UK Ltd Walton Manor, Walton Milton Keynes MK7 7AJ UNITED KINGDOM
Danish: Storbritannien Intervet UK Ltd Walton Manor, Walton Milton Keynes MK7 7AJ STORBRITANNIEN
English: Intervet GmbH Siemensstraße 107 AT-1210 Wien AUSTRIA
Danish: Intervet GmbH Siemensstraße 107 AT-1210 Wien ØSTRIG
English: D-85716 Unterschleißheim GERMANY
Danish: D-85716 Unterschleißheim TYSKLAND
English: Further to this restriction the CVMP concluded that the single administration of the concerned products does not have an impact on their clinical efficacy.
Danish: I forbindelse med denne begrænsning konkluderede CVMP, at enkeltdosisanvendelse af de pågældende produkter er uden betydning for deres kliniske virkning.
English: Therefore the CVMP considered that the indication for treatment of shock in horses should be removed from the product information;
Danish: CVMP fandt derfor, at indikationen behandling af shock hos heste bør udgå af produktinformationen,
English: 4941 VX Raamsdonksveer THE NETHERLANDS
Danish: 4941 VX Raamsdonksveer HOLLAND
English: Overall summary of the scientific evaluation of Dexadreson 2 mg/ml and associated names, and generic products thereof (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af Dexadreson, 2 mg/ml, og relaterede navne samt tilsvarende generiske produkter (se bilag I)
English: Cattle, horses
Danish: Kvæg og heste
English: Withdrawal periods for the minor species horse can be based on comparison of pharmacokinetic data, indicating that depletion of the substance in horses is not slower than in cattle.
Danish: Tilbageholdelsestider for den mindre betydningsfulde dyreart hest kan baseres på en sammenligning af farmakokinetiske data, som tyder på, at depletionen af stoffet i heste ikke er langsommere end i kvæg.
English: Three residue depletion studies in cattle have been provided, two studies on residue depletion in cattle tissues and one study on residue depletion in milk.
Danish: Der er udført tre restkoncentrationsundersøgelser hos kvæg, heraf to undersøgelser af væv og én undersøgelse af mælk.
English: Applicant/marketing authorisation holder
Danish: Indehaver af markedsføringstilladelsen
English: The benefit-risk balance for the products concerned remains positive subject to amendments in the product information.
Danish: Konklusioner vedrørende benefit/risk-forholdet Benefit/risk-forholdet for de omhandlede produkter er fortsat positivt under forudsætning af ændringer i produktinformationen.
English: Dexamethasone is a long acting synthetic glucocorticoid used as anti-inflammatory, anti-allergic and gluconeogenetic agent for administration to agricultural and domestic animals.
Danish: Dexamethason er et langtidsvirkende syntetisk glukokortikoid, der anvendes som antiinflammatorisk, antiallergisk og glukoneogenetisk middel til landdyr og andre husdyr.
English: Delete, where applicable, all references for repeat treatment in cattle and horses and treatment in cases of shock in horses.
Danish: Slet alle henvisninger til gentagen behandling hos kvæg og heste og behandling i tilfælde af shock hos heste, hvor det er relevant.
English: The other study was considered valid, however, the data set obtained from it did not allow the use of the statistical approach for the determination of withdrawal periods in accordance with the CVMP note for guidance: approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95)2 as statistical criteria for the linear regression analysis were not fulfilled.
Danish: Den anden undersøgelse blev imidlertid anset for gyldig, men dataene gjorde det ikke muligt at anvende den statistiske tilgang til fastsættelse af tilbageholdelsestider i overensstemmelse med CVMP's vejledning: tilgang til harmonisering af tilbageholdelsestider (EMEA/CVMP/036/95)2, da de statistiske kriterier for lineær regressionsanalyse ikke var opfyldt.
English: 5830 AB Boxmeer THE NETHERLANDS
Danish: 5830 AB Boxmeer HOLLAND
English: DOSAGES FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Danish: DOSERING FOR HVER DYREART, ANVENDELSESMÅDE OG INDGIVELSESVEJ(E)
English: The residue depletion study in milk was considered acceptable, but the recommended method for the calculation of a milk withdrawal period according to the CVMP note for guidance for the determination of withdrawal periods in milk (EMEA/CVMP/473/98)3 - the Time to safe concentration (TTSC) methodcannot be used due to the insufficient number of animals included in the study.
Danish: Restkoncentrationsundersøgelsen i mælk kunne godtages, men den anbefalede metode til beregning af en tilbageholdelsestid for mælk i henhold til CVMP's vejledning om fastsættelse af tilbageholdelsestider i mælk (EMEA/CVMP/473/98)3 - metoden Tid til sikker koncentration (TTSC) - kan ikke anvendes på grund af det utilstrækkelige antal dyr i undersøgelsen.
English: The veterinary medicinal products Dexadreson 2 mg/ml and its associated names and generic products are solutions for injection which contain 2 mg dexamethasone per ml.
Danish: Veterinærlægemidlerne Dexadreson, 2 mg/ml, og relaterede navne og tilsvarende generiske produkter er injektionsvæsker, opløsning, der indeholder dexamethason, 2 mg/ml.
English: • the CVMP considered that the overall benefit-risk balance is positive for Dexadreson 2 mg/ml and associated names, and generic products thereof subject to amendments in the product information; the CVMP has recommended variations of the marketing authorisations for Dexadreson 2 mg/ml and associated names, and generic products thereof (see annex I) in order to amend the summaries of product characteristics, labelling and package leaflets in line with recommended changes in the product information as set out in annex III.
Danish: • CVMP anså det overordnede benefit/risk-forhold for at være positivt for Dexadreson, 2 mg/ml, og relaterede navne samt tilsvarende generiske produkter under forudsætning af ændringer i produktinformationen, anbefalede CVMP ændring af markedsføringstilladelserne for Dexadreson, 2 mg/ml, og relaterede navne samt de tilsvarende generiske produkter (se bilag I), idet produktresuméerne, etiketteringen og indlægssedlerne ændres i henhold til de anbefalede ændringer af produktinformationen, der fremgår af bilag III.
English: Quality, target animals safety, user safety and environmental risk have not been assessed in this referral procedure.
Danish: Denne henvisningsprocedure omfatter ikke kvalitet, sikkerhed for måldyrearten, brugersikkerhed eller miljørisiko.
English: No residue depletion data are available in horses for the single or repeat dose treatment.
Danish: Der forelå ingen restkoncentrationsdata for heste ved enkeltdosis eller ved gentagen dosering.
English: Six days after administration the residue concentrations were
Danish: 6 dage efter administration var restkoncentrationerne under MRL-værdierne i nyrer og lever.
English: The marketing authorisation holders agreed to remove the advice on repeat dose treatment in horses from the product information.
Danish: Indehaverne af markedsføringstilladelse indvilligede i at fjerne anvisningerne i produktresuméet om behandling med gentagne doser til heste.
English: • In the absence of residue depletion or pharmacokinetic data for the higher dosages recommended for the indication concerning treatment of shock in horses, no safe withdrawal period for these dosages can be set for Dexadreson 2 mg/ml and associated names, and generic products thereof.
Danish: • i mangel af restkoncentrationsdata og farmakokinetiske data for de højere doseringer, der anbefales til behandling af shock hos heste, kan der ikke fastsættes en sikker tilbageholdelsestid for disse doseringer af Dexadreson, 2 mg/ml, og relaterede navne samt tilsvarende generiske produkter.
English: Intervet International B.V. Wim de Körverstraat 35 5831, AN Boxmeer THE NETHERLANDS
Danish: Wim de Körverstraat 35 5831, AN Boxmeer HOLLAND
English: No safe withdrawal period for these dosages can be set and the CVMP considered that the shock indication should be withdrawn from the product information of Dexadreson and its generic products, where applicable.
Danish: For disse doseringer kan der ikke fastsættes en sikker tilbageholdelsestid, og CVMP fandt, at indikationen shock bør udgå af produktinformationen for Dexadreson og eventuelle tilsvarende generiske produkter.
English: Germany noted that Dexadreson 2 mg/ml and its associated names has different withdrawal periods in cattle (meat and milk) and horses (meat) established by the Member States across the EU/EEA.
Danish: Tyskland konstaterede, at de fastsatte tilbageholdelsestider for kvæg (kød og mælk) og heste (kød) er forskellige i forskellige medlemsstater i EU/EØS.
English: In the absence of residue depletion data at the maximum intended dose and further to the concerns expressed above, the marketing authorisation holders agreed to remove the advice on repeat dose treatment after 24-48 hours in cattle from the product information.
Danish: I mangel af restkoncentrationsdata ved den maksimale påtænkte dosis og som følge af ovennævnte betænkeligheder indvilligede indehaveren af markedsføringstilladelsen i at fjerne anvisningerne i produktinformationen om gentagelse af dosis efter 24-28 timer hos kvæg.
English: No residue depletion or pharmacokinetic data are available for the much higher dosages recommended for the treatment of shock in horses.
Danish: Der forelå ingen restkoncentrationsdata ved de langt højere anbefalede doser til behandling af shock hos heste.
English: VICH GL48: Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: marker residue depletion studies to establish product withdrawal periods (EMA/CVMP/VICH/463199/2009)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/04/WC500105052.pdf 2 CVMP note for guidance: approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004428.pdf below the MRL values in kidney and liver.
Danish: VICH GL48: Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: marker residue depletion studies to establish product withdrawal periods (EMA/CVMP/VICH/463199/2009)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/04/WC500105052.pdf 2 CVMP note for guidance: approach towards harmonisation of withdrawal periods (EMEA/CVMP/036/95)http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/10/WC500004428.pdf nødvendigt med en maksimal sikkerhedsmargin på 30 %, hvilket fører til en tilbageholdelsestid på 8 dage for enkeltdosisbehandling med 0,06 mg dexamethason/kg kropsvægt.
English: Therefore a 20% safety span was applied to the observed period of 60 hours, resulting in a withdrawal period of 72 hours, i.e. 3 days, in milk from cows treated at a single dose of 0.06 mg dexamethasone per kg body weight.
Danish: Der blev derfor tillagt en sikkerhedsmargin på 20 % til den iagttagne periode på 60 timer, resulterende i en tilbageholdelsestid på 72 timer, dvs. 3 dage, for mælk fra køer behandlet med en enkelt dosis på 0,06 mg dexamethason/kg kropsvægt.
English: As there were no residue depletion data with the recommended repeat dose treatment in cattle and horses, the CVMP concluded that the advice on repeat dose treatment in cattle and horses should be removed from the product information.
Danish: Da der ikke forelå restkoncentrationsdata ved den anbefalede gentagne dosering til kvæg og heste, konkluderede CVMP, at anvisningen om gentagen dosering til kvæg og heste bør udgå af produktinformationen.
English: • On the basis of the residue depletion data in cattle and the pharmacokinetic data in horses submitted by the marketing authorisation holders for Dexadreson 2 mg/ml and associated names, and generic products thereof, the CVMP considered that withdrawal periods of 8 days for cattle meat and offal, 72 hours for cattle milk and 8 days for horse meat and offal were safe;
Danish: • efter gennemgang af de restkoncentrationsdata for kvæg og farmakokinetiske data for heste, der er forelagt af markedsføringstilladelsesindehaverne for Dexadreson, 2 mg/ml, og relaterede navne samt de tilsvarende generiske produkter fandt CVMP, at tilbageholdelsestiderne på 8 dage for kød og indmad fra kvæg, 72 timer for mælk fra kvæg og 8 dage for kød og indmad fra heste var sikre,