FrancophonIA/ELRC3.0 huggingface dataset:
English: In dogs, when cefovecin was administered as a single subcutaneous dose of 8 mg/kg bodyweight, absorption was rapid and extensive; peak plasma concentration at 6 hours was 120 µg/ml and bioavailability approximately 99 %.
Danish: Hos hunde var absorptionen hurtig og fuldstændig når cefovecin blev givet som en enkelt subkutan dosis på 8 mg/kg legemsvægt; maksimal plasmakoncentration ved 6 timer var 120 µg/ml og biotilgængeligheden omkring 99 %.
English: Anaerobic bacteria such as Bacteroides spp.
Danish: Anaerobe bakterier som Bacteroides og Fusobacterium spp.
English: Fourteen days after administration, the mean cefovecin concentration in plasma was 5.6 μg/ml.
Danish: Fjorten dage efter administrationen var middel cefovecin koncentrationen i plasma 5,6 µg/ml.
English: WITHDRAWAL PERIOD(S) Not applicable.
Danish: 10. TILBAGEHOLDELSESTID Ikke relevant.
English: Powder and solvent for solution for injection.
Danish: Pulver og solvens til injektionsvæske, opløsning.
English: Discard date:
Danish: Kasseres dato:
English: Do not use in cases of hypersensitivity to cephalosporin or penicillin antibiotics.
Danish: Bør ikke anvendes i tilfælde af overfølsomhed over for cephalosporin eller penicillin.
English: EXPIRY DATE EXP:
Danish: 10. UDLØBSDATO EXP:
English: The product is available in a single pack of either 5 ml or 23 ml, composed of a vial containing the freezedried powder, and a second vial containing the diluent.
Danish: Præparatet findes i en enkeltpakning bestående af enten et 5 ml eller 23 ml hætteglas med det frysetørrede pulver og et andet hætteglas med solvens.
English: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Danish: Ikke anvendte veterinærlægemidler, samt affald heraf bør destrueres i henhold til lokale retningslinjer.
English: When applying a proposed microbiological breakpoint of I ≤ 4 µg/ml, cefovecin resistance in S. pseudintermedius and beta-haemolytic Streptococci isolates was less than 0.02 % and 3.4 % in Prevotella intermedia isolates.
Danish: Cefovecin resistens hos S. pseudintermedius og beta-haemolytiske Streptococcus isolater var mindre end 0,02 % og 3,4 % hos Prevotella intermedia-isolater når der blev anvendt et foreslået mikrobiologisk breakpoint for I ≤ 4 µg/ml.
English: The percentage of cefovecin resistant isolates in coagulase negative Staphylococcus spp.
Danish: Procentdelen af cefovecinresistente isolater af koagulasenegative Staphylococcus spp.
English: EXP: {mm/yyyy}
Danish: EXP:
English: Powder: Type I glass vial of either 5 ml or 23 ml with butyl rubber stopper sealed with an aluminium flip-off seal.
Danish: Pulver: Type I glas hætteglas enten 5 ml eller 23 ml med butyl gummiprop, forseglet med aluminiumshætte.
English: Type I glass vial of either 10 ml or 19 ml with chlorobutyl rubber stopper sealed with an aluminium flipoff seal.
Danish: Type I glas hætteglas enten 10 ml eller 19 ml med chlorobutyl gummiprop, forseglet med aluminiumshætte.
English: SPECIAL STORAGE PRECAUTIONS Keep out of the sight and reach of children.
Danish: EVENTUELLE SÆRLIGE FORHOLDSREGLER VEDRØRENDE OPBEVARING Opbevares utilgængeligt for børn.
English: TARGET SPECIES Dogs and cats.
Danish: DYREARTER Hund og kat.
English: The fundamental requirement of the treatment of periodontal disease is mechanical and/or surgical intervention by the veterinarian.
Danish: Et mekanisk og/eller operativt indgreb gennemført af dyrlægen er det basale krav for behandlingen af en sygdom i tandkødet.
English: A single subcutaneous injection of 8 mg/kg bodyweight (1 ml per 10 kg bodyweight).
Danish: En enkelt subkutan injektion med 8 mg/kg legemsvægt (1 ml pr. 10 kg legemsvægt).
English: Repeated dosing (eight administrations) in 14-day intervals at five times the recommended dose was tolerated well in young dogs.
Danish: Gentagen dosering (otte administrationer) med 14 dages mellemrum ved fem gange den anbefalede dosis til unge hunde tåltes udmærket.
English: 852 mg cefovecin (as sodium salt)
Danish: Aktivt stof: 852 mg cefovecin (som natriumsalt)
English: QUANTITY OF OTHER SUBSTANCES 13 mg/ml benzyl alcohol in water for injections.
Danish: MÆNGDEN AF ANDRE STOFFER 13 mg/ml benzylalkohol i vand til injektionsvæsker
English: Repeated dosing (eight administrations) in 14-day intervals at five times the recommended dose was tolerated well in young cats.
Danish: Gentagen dosering (otte administrationer) med 14 dages intervaller ved fem gange den anbefalede dosis til unge katte tåltes udmærket.
English: Active substance:
Danish: Hjælpestoffer:
English: In addition, cefovecin exhibits in-vitro activity against Escherichia coli which is associated with canine and feline urinary tract infections.
Danish: Yderligere viser cefovecin in vitro aktivitet mod Escherichia coli, som findes ved urinvejsinfektioner hos hunde og katte.
English: Methyl parahydroxybenzoate (E218) Propyl parahydroxybenzoate (E216) Benzyl alcohol
Danish: Methylparahydroxybenzoat (E218) Propylparahydroxybenzoat (E216) Benzylalkohol
English: Cefovecin exhibits in-vitro activity against Staphylococcus pseudintermedius and Pasteurella multocida which are associated with canine and feline skin infections.
Danish: Cefovecin viser in vitro aktivitet mod Staphylococcus pseudintermedius og Pasteurella multocida i forbindelse med hudinfektioner hos hunde og katte.
English: 7.67 mg methyl parahydroxybenzoate (E218) 0.85 mg propyl parahydroxybenzoate (E216)
Danish: 7,67 mg methylparahydroxybenzoat (E218) 0,85 mg propylparahydroxybenzoat (E216)
English: Urinary tract infections in dogs and cats: A single subcutaneous injection of 8 mg/kg bodyweight (1 ml per 10 kg bodyweight).
Danish: Urinvejsinfektioner hos hunde og katte: En enkelt subkutan injektion med 8 mg/kg legemsvægt (1 ml pr. 10 kg legemsvægt).
English: SPECIAL WARNING(S)
Danish: SÆRLIGE ADVARSLER
English: Severe infections of the gingival and periodontal tissues in dogs: A single subcutaneous injection of 8 mg/kg bodyweight (1 ml per 10 kg bodyweight).
Danish: Alvorlige infektioner i tandkødet og det parodontale væv hos hunde: En enkelt subkutan injektion på 8 mg/kg legemsvægt (1 ml per 10 kg legemsvægt).
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” For animal treatment only.
Danish: TEKSTEN ”TIL DYR” Til dyr.
English: (2003 survey)
Danish: (Undersøgelse i
English: Pack size: 1 vial of powder and 1 vial of diluent.
Danish: Pakningsstørrelse: 1 hætteglas med pulver og 1 hætteglas med solvens.
English: Cefovecin exhibits in vitro activity against Staphylococcus pseudintermedius and Pasteurella multocida which are associated with canine and feline skin infections.
Danish: Cefovecin har in vitro aktivitet mod Staphylococcus pseudintermedius og Pasteurella multocida, som ses i forbindelse med hudinfektioner hos hunde og katte.
English: For the treatment of skin and soft tissue abscesses and wounds associated with Pasteurella multocida, Fusobacterium spp., Bacteroides spp., Prevotella oralis, β haemolytic Streptococci and/or Staphylococcus pseudintermedius.
Danish: Til behandling af bylder og sår i hud og bindevæv forårsaget af Pasteurella multocida, Fusobacterium spp., Bacteroides spp., Prevotella oralis, beta-haemolytiske Streptococci og/eller Staphylococcus pseudintermedius.
English: Animal Weight (Dogs and Cats) Volume to be Administered 2.5 kg
Danish: Dyrets vægt (Hunde og Katte)
English: 19.17 mg methyl parahydroxybenzoate (E218) 2.13 mg propyl parahydroxybenzoate (E216)
Danish: 19,17 mg methylparahydroxybenzoat (E218) 2,13 mg propylparahydroxybenzoat (E216)
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION Dogs and cats: 8 mg cefovecin/kg body weight (1 ml/10 kg body weight).
Danish: Hunde og katte: 8 mg cefovecin/kg legemsvægt (1 ml/10 kg legemsvægt).
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL (5 ml LYOPHILISED POWDER VIAL)
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER ETIKET (5 ml HÆTTEGLAS MED LYOFILISERET PULVER)
English: For the treatment of skin and soft tissue infections including pyoderma, wounds and abscesses associated with Staphylococcus pseudintermedius, β haemolytic Streptococci, Escherichia coli and/or Pasteurella multocida.
Danish: Til behandling af hud og bindevævsinfektioner inklusive pyodermi, sår og abscesser forårsaget af Staphylococcus pseudintermedius, beta-haemolytiske Streptococci, Escherichia coli og/eller Pasteurella multocida.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL (23 ml LYOPHILISED POWDER VIAL)
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER ETIKET (23 ml HÆTTEGLAS MED FRYSETØRRET PULVER)
English: If you know you are allergic to penicillins or cephalosporins, avoid contact with contaminated litter.
Danish: Undgå kontakt med forurenet affald hvis du ved, at du er allergisk over for penicilliner eller cephalosporiner.
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” For animal treatment only
Danish: TEKSTEN “TIL DYR” Til dyr.
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Convenia 80 mg/ml powder for solution for injection for dogs and cats
Danish: VETERINÆRLÆGEMIDLETS NAVN Convenia 80 mg/ml pulver til injektionsvæske, opløsning til hunde og katte
English: ROUTE(S) OF ADMINISTRATION For subcutaneous use.
Danish: INDGIVELSESVEJ(E) Til subkutan injektion.
English: Dosing Table
Danish: Doseringstabel
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each 23 ml vial of lyophilised powder contains: Active substance:
Danish: Hvert 23 ml hætteglas med lyofiliseret pulver indeholder:
English: (See also Section 12 ‘Special Warnings - For the animal'.)
Danish: 12, Special forholdsregler til brug hos dyr.)
English: 10.8 ml water for injections
Danish: 13 mg/ml benzylalkohol 10,8 ml vand til injektionsvæsker
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Convenia 80 mg/ml powder and solvent for solution for injection for dogs and cats
Danish: VETERINÆRLÆGEMIDLETS NAVN Convenia 80 mg/ml pulver og solvens til injektionsvæske, opløsning til hunde og katte
English: and Porphyromonas spp.
Danish: og Porhyromonas spp.
English: Each 19 ml vial of diluent contains:
Danish: Hvert 19 ml hætteglas med solvens indeholder:
English: Each 10 ml vial of diluent contains:
Danish: Hvert 10 ml hætteglas med solvens indeholder:
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Veterinary medicinal product subject to prescription.
Danish: B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG
English: For use only for the following infections requiring prolonged treatment.
Danish: 4.2 Terapeutiske indikationer med angivelse af dyrearter, som lægemidlet er beregnet til Kun til anvendelse ved følgende infektioner, der kræver langtidsbehandling.
English: For animal treatment only.
Danish: Til dyr.
English: PACKAGE LEAFLET: Convenia 80 mg/ml powder and solvent for solution for injection for dogs and cats
Danish: INDLÆGSSEDDEL Convenia 80 mg/ml pulver og solvens til injektionsvæske, opløsning til hunde og katte
English: field isolates.
Danish: Antal isolater
English: 1.8 mg/ml methyl parahydroxybenzoate (E218) 0.2 mg/ml propyl parahydroxybenzoate (E216) 12.3 mg/ml benzyl alcohol
Danish: Efter opløsning ifølge anvisning på etiketten indeholder injektionsvæsken: 80,0 mg/ml cefovecin (som natriumsalt) 1,8 mg/ml methylparahydroxybenzoat (E218) 0,2 mg/ml propylparahydroxybenzoat (E216) 12,3 mg/ml benzylalkohol
English: Excipients:
Danish: feltisolater.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL (10 ml DILUENT VIAL)
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER ETIKET (10 ml HÆTTEGLAS MED SOLVENS)
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL (19 ml DILUENT VIAL)
Danish: MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER ETIKET (19 ml HÆTTEGLAS MED SOLVENS)
English: Dog Cat Pasteurella multocida Dog Cat
Danish: Pasteurella multocida
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Convenia 80 mg/ml powder and solvent for solution for injection for dogs and cats cefovecin
Danish: Convenia 80 mg/ml pulver og solvens til injektionsvæske, opløsning til hunde og katte cefovecin
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE OUTER CARTON (CONTAINING LYOPHILISED POWDER VIAL AND DILUENT VIAL) 23 ml Vial - 5 ml Vial
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDERKARTON (INDEHOLDENDE HÆTTEGLAS MED FRYSETØRRET PULVER OG HÆTTEGLAS MED SOLVENS)
English: Sodium citrate
Danish: Natriumcitrat
English: Other information about Varuby
Danish: Andre oplysninger om Varuby
English: The full EPAR for Varuby can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Varuby findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: By blocking the receptors, Varuby can prevent this effect.
Danish: Ved at blokere for receptorerne kan Varuby forebygge denne virkning.
English: This is a summary of the European public assessment report (EPAR) for Varuby.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Varuby.
English: Varuby contains the active substance rolapitant.
Danish: Varuby indeholder det aktive stof rolapitant.
English: The most common side effects with Varuby (which may affect between 1 and 2 people in 100) are tiredness and headache.
Danish: De hyppigste bivirkninger ved Varuby (som kan forekomme hos mellem 1 og 2 ud af 100 personer) er træthed og hovedpine.
English: What measures are being taken to ensure the safe and effective use of Varuby?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Varuby?
English: What is Varuby and what is it used for?
Danish: Hvad er Varuby, og hvad anvendes det til?
English: Why is Varuby approved?
Danish: Hvorfor blev Varuby godkendt?
English: Overall, therefore, Varuby's benefits are greater than its risks and it has been recommended for approval for use in the EU.
Danish: Overordnet set opvejer fordelene ved Varuby risiciene, og det anbefales, at det godkendes til anvendelse i EU.
English: The active substance in Varuby, rolapitant, works by blocking neurokinin-1 (NK1) receptors.
Danish: Det aktive stof i Varuby, rolapitant, virker ved at blokere neurokinin-1-receptorerne (NK1receptorerne).
English: There was no delayed nausea and vomiting in 71% of patients given Varuby (475 of 666) compared with 62% of those given placebo (410 of 666).
Danish: Der var ingen forsinket kvalme eller opkastning hos 71 % af de patienter, der fik Varuby (475 ud af 666) sammenlignet med 62 % af dem, der fik placebo (410 ud af 666).
English: In both studies, one involving 532 patients and the other involving 555 patients, participants also received dexamethasone and granisetron (a 5-HT3 receptor antagonist).
Danish: I begge undersøgelser, hvoraf den ene omfattede 532 patienter, og den anden 555 patienter, modtog deltagerne også dexamethason og granisetron (en 5-HT3-receptorantagonist).
English: It is not intended to provide practical advice on how to use Varuby.
Danish: Det er ikke en praktisk vejledning i, hvordan Varuby bør anvendes.
English: What are the risks associated with Varuby?
Danish: Hvilke risici er der forbundet med Varuby?
English: Chemotherapy can release a substance in the body (substance P) which attaches to these receptors and stimulates delayed nausea and vomiting.
Danish: Kemoterapi kan udløse et stof i kroppen (stof P), der binder sig til disse receptorer og stimulerer forsinket kvalme og opkastning.
English: Varuby is given with dexamethasone and a 5-HT3 receptor antagonist (two other types of medicine to prevent nausea and vomiting) but how these are given depends on the type of chemotherapy.
Danish: Varuby gives med dexamethason og en 5-HT3-receptorantagonist (to andre typer af lægemidler til forebyggelse af kvalme og opkastning), men hvordan disse gives afhænger af typen af kemoterapi.
English: Varuby was also more effective than placebo in a third main study when used with dexamethasone and granisetron in patients given moderately emetogenic chemotherapy.
Danish: Varuby var også mere effektivt end placebo i en tredje hovedundersøgelse, hvor det blev brugt sammen med dexamethason og granisetron hos patienter, der fik moderat emetogen kemoterapi.
English: Adding the results from both studies together, there was no nausea and vomiting in the period from 24 to 120 hours after chemotherapy in 71% of patients (382 out of 535) given Varuby, while the figure with placebo was 60% (322 out of 535 patients).
Danish: Af resultaterne af begge undersøgelser fremgik det, at der ikke forekom kvalme eller opkastning i 24-120 timer efter kemoterapi hos 71 % af de patienter (382 ud af 535), der fik Varuby, mens tallet for placebo var 60 % (322 ud af 535 patienter).
English: For more information about treatment with Varuby, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Varuby, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: For further information, see the summary of product characteristics (also part of the EPAR).
Danish: De nærmere oplysninger fremgår af produktresuméet (også en del af denne EPAR).
English: Patients taking Varuby must not take St John's wort (a herbal medicine for mild depression) as this can reduce the effect of Varuby.
Danish: Patienter, der tager Varuby, må ikke tage perikon (et urtepræparat mod mild depression), da dette kan nedsætte virkningen af Varuby.
English: In two main studies, Varuby was more effective than placebo (a dummy treatment) in preventing delayed nausea and vomiting after highly emetogenic chemotherapy.
Danish: I to hovedundersøgelser var Varuby mere effektivt end placebo (en uvirksom behandling) til at forebygge forsinket kvalme og opkastning efter svært emetogen kemoterapi.
English: Varuby acts against delayed nausea and vomiting (when the symptoms occur 24 hours or more after the cancer treatment) and is given with other medicines that help control more immediate nausea and vomiting.
Danish: Varuby virker mod forsinket kvalme og opkastning (når symptomerne optræder 24 timer eller derover efter kræftbehandlingen) og gives med andre lægemidler, der medvirker til at bekæmpe mere akut kvalme og opkastning.
English: For the full list of all side effects and restrictions with Varuby, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Varuby fremgår af indlægssedlen.
English: Varuby produced an improvement in the control of delayed nausea and vomiting when added to other standard treatments.
Danish: Varuby medførte en bedre håndtering af forsinket kvalme og opkastning, når det blev brugt som tillægsbehandling til andre standardlægemidler.
English: In addition, any side effects were manageable and were similar to those usually observed with medicines for nausea and vomiting.
Danish: Dertil kommer, at bivirkningerne var overskuelige og svarede til dem, der normalt opstår ved brug af lægemidler mod kvalme og opkastning.
English: For practical information about using Varuby, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Varuby, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Varuby is a medicine used to prevent nausea (feeling sick) and vomiting in adult cancer patients who are receiving chemotherapy (medicines to treat cancer).
Danish: Varuby er et lægemiddel, der anvendes til at forebygge kvalme og opkastning hos voksne kræftpatienter, som modtager kemoterapi (lægemidler til behandling for kræft).
English: When given with medicines that work by other mechanisms to prevent immediate nausea and vomiting, Varuby can help provide prolonged control against these symptoms after chemotherapy.
Danish: Når det gives sammen med lægemidler, der ved hjælp af andre mekanismer modvirker akut kvalme og opkastning, kan Varuby bidrage til langvarigt at begrænse disse symptomer efter kemoterapi.
English: Different chemotherapy medicines produce different degrees of nausea and vomiting, and Varuby is used in patients receiving highly or moderately emetogenic (vomit-inducing) chemotherapy.
Danish: Forskellige kemoterapilægemidler medfører forskellige grader af kvalme og opkastning, og Varuby bruges hos patienter, der får kemoterapi, der er emetogen (opkastningsinducerende) i moderat eller svær grad.
English: What benefits of Varuby have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Varuby?
English: How is Varuby used?
Danish: Hvordan anvendes Varuby?
English: How does Varuby work?
Danish: Hvordan virker Varuby?
English: Although a number of medicines are approved in the EU for management of chemotherapy-associated nausea and vomiting significant numbers of patients still experience it, and management of nausea in particular remains a challenge.
Danish: Selvom flere lægemidler er godkendt i EU til at behandle kemoterapiinduceret kvalme og opkastning, lider et betydeligt antal patienter stadigvæk under følgevirkningerne af kemoterapi.
English: Two tablets are swallowed on the first day of each cycle of chemotherapy, 2 hours or less before chemotherapy starts.
Danish: Varuby udleveres kun efter recept og fås som tabletter a 90 mg. To tabletter sluges på den første dag i hver kemoterapicyklus, højst 2 timer før kemoterapien påbegyndes.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Varuby have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Varuby.
English: London, 14 July 2008 EMEA/CHMP/151554/2008
Danish: London, den 14. juli 2008 EMEA/CHMP/151554/2008
English: Article 29(4) of Directive 2001/83/EC, as amended.
Danish: Artikel 29, stk. 4, i direktiv 2001/83/EF, med senere ændringer.
English: The final opinion was converted into a Decision by the European Commission on 11 July 2008.
Danish: Den endelige udtalelse blev konverteret til en afgørelse truffet af Europa-Kommissionen den 11. juli 2008.
English: The Mutual Recognition Procedure started on 2 May 2007.
Danish: Den gensidige anerkendelsesprocedure blev indledt den 2. maj 2007.
English: Repeat use: Austria, Bulgaria, Cyprus, Spain, France, Italy, Malta and Portugal
Danish: Gentagen brug: Østrig, Bulgarien, Cypern, Spanien, Frankrig, Italien, Malta og Portugal.
English: The arbitration procedure started on 15 November 2007 with the adoption of a list of questions.
Danish: Voldgiftsproceduren blev indledt den 15. november 2007 med vedtagelse af en liste med spørgsmål.
English: The Marketing Authorisation Holder provided written explanations on 16 January 2008.
Danish: Indehaveren af markedsføringstilladelsen fremsendte skriftlige redegørelser den 16. januar 2008.
English: The United Kingdom referred the reasons of disagreement to the EMEA on 25 October 2007.
Danish: De britiske registreringsmyndigheder indbragte grundene til uenigheden for EMEA den 25. oktober 2007.
English: The Rapporteur was Dr Ian Hudson and Co-Rapporteur was Dr Pierre Demolis.
Danish: Den udpegede rapportør og medrapportør var henholdsvis dr. Ian Hudson og dr. Pierre Demolis.
English: A positive opinion was adopted by consensus on 19 March
Danish: Udvalget vedtog en positiv udtalelse ved konsensus den 19. marts 2008.
English: The Reference Member State was United Kingdom and the Concerned Member States were: First wave: Belgium, Czech Republic, Denmark, Estonia, Finland, Germany, Greece, Hungary, Iceland, Ireland, Latvia, Lithuania, Luxembourg, The Netherlands, Norway, Poland, Slovak Republic, Slovenia and Sweden
Danish: Første fase: Belgien, Den Tjekkiske Republik, Danmark, Estland, Finland, Tyskland, Grækenland, Ungarn, Island, Irland, Letland, Litauen, Luxembourg, Nederlandene, Norge, Polen, Den Slovakiske Republik, Slovenien og Sverige