FrancophonIA/ELRC3.0 huggingface dataset:
English: The pharmacovigilance data evaluated by the Dutch competent regulatory authority that resulted in its intention to vary the authorisations is a published suspected adverse reaction (SAR) in a human being, reporting cardiovascular and central nervous system effects over a period of 3 days after accidental selfinjection of Sedivet (Reference: Hoyer, Mark J. Alpha2-agonisten, alledaagse verdovingsmiddelen in de diergeneeskunde praktijk, maar verre van ongevaarlijk - de gevolgen van een accidentele zelfinjectie.
Danish: De oplysninger vedrørende lægemiddelovervågning, som den nederlandske myndighed evaluerede, og som resulterede i, at denne myndighed ønskede at ændre tilladelserne, er en ifølge de offentliggjorte oplysninger formodet bivirkning hos en person, der meldte om effekter i hjerte-/karsystemet og centralnervesystemet over en periode på tre dage efter ved et uheld at have injiceret sig selv med Sedivet (reference: Hoyer, Mark J. Alpha2-agonisten, alledaagse verdovingsmiddelen in de diergeneeskunde praktijk, maar verre van ongevaarlijk - de gevolgen van een accidentele zelfinjectie.
English: The MAHs were invited to comment and submit any counterproposals by 16 September 2008.
Danish: Indehaverne af markedsføringstilladelserne blev anmodet om at kommentere og indsende eventuelle modforslag senest den 16. september 2008.
English: The CVMP considered published data on the effects of xylazine hydrochloride on intrauterine pressure in the cow, the oxytocic effect of xylazine on the canine uterus, effects of detomidine, romifidine and xylazine on intrauterine pressure and sedation in horses, and the effects of xylazine on intrauterine pressure, uterine blood flow, maternal and foetal cardiovascular and pulmonary function in pregnant goats.
Danish: Udvalget vurderede de offentliggjorte oplysninger om virkningerne af xylazin hydrochlorid på det intrauterine tryk hos køer, den oxytociske virkning af xylazin på uterus hos hunde, virkninger af detomidin, romifin og xylazin på det intrauterine tryk og sedation af heste og virkningerne af xylazin på det intrauterine tryk, blodgennemstrømningen i uterus og den kardiovaskulære og pulmonære funktion på mor og foster hos drægtige geder.
English: Equi Products Holland BV, Hermelijnkoog 44, 1822 CB Alkmaar, THE NETHERLANDS
Danish: Equi Products Holland BV, Hermelijnkoog 44, 1822 CB Alkmaar, NEDERLANDENE
English: In another reproductive study when dexmedetomidine was administered subcutaneously to pregnant rats from gestation day 16 through nursing, it caused lower pup weights at 8 and 32 µg/kg as well as foetal and embryocidal toxicity of second generation offspring at a dose of 32 µg/kg.
Danish: I en anden reproduktionsundersøgelse, hvor dexmedetomidin blev indgivet subkutant til gravide rotter fra dag 16 af graviditeten til og med diegivning, medførte dette lavere fødselsvægt ved 8 og 32 µg/kg samt føtal og embryocidal toksicitet i andengenerationsafkom ved en dosis på 32 µg/kg.
English: Pfizer Co. Ltd., 1123 Budapest, Alkotás u. 53, HUNGARY
Danish: Pfizer Co. Ltd., 1123 Budapest Alkotás u. 53, UNGARN
English: Bayer BV Animal Health, Postbus 80, 3640 AB Mijdrecht, THE NETHERLANDS
Danish: Bayer BV Animal Health, Postboks 80, 3640 AB Mijdrecht, NEDERLANDENE
English: Boehringer Ingelheim, Postbus 8037, 1802 KA Alkmaar, THE NETHERLANDS
Danish: Boehringer Ingelheim, Postboks 8037, 1802 KA Alkmaar, NEDERLANDENE
English: The Products listed in Annex I are approved in various MS for use via the parental route, containing alpha2adrenoreceptor agonists romifidine, xylazine, detomidine, medetomidine.
Danish: Lægemidlerne i bilag I er godkendt i forskellige medlemslande til brug via parenteral indgivelsesvej og indeholder alfa2-adrenoreptor agonisterne romifidin, xylazin, detomidin, medetomidin.
English: Medetomidine, structurally related to detomidine, at an intravenous dose 0.67 µg/kg bw caused hypotension and sedation that lasted for at least 8 hours, as reported in the MRL Summary Report for detomidine.
Danish: Ved en intravenøs dosis på 0,67 µg/kg kropsvægt medførte medetomidin, der strukturelt er relateret til detomidin, hypotension og sedation af otte timers varighed, hvilket også er anført i de sammenfattende rapporter om maksimalgrænseværdier for detomidin.
English: In the Summary of Product Characteristics (SPC) for a medicinal product for use in humans, Catapresan, containing the alpha2-adrenoreceptor agonist clonidine (injectable and tablets), the dermal adverse reactions after an unknown route of exposure are listed as skin-rash, urticaria, pruritus, and hairloss with an incidence rate of 1/100 - 1/10000 in patients.
Danish: I produktresuméet (SPC) for et humanmedicinsk lægemiddel, Catapresan, indeholdende alfa2-adrenoreceptor agonisten klonidin (til injektion og i tabletform), blev følgende bivirkninger nævnt for huden efter ukendt eksponeringsmåde: hududslæt, urticaria, pruritus samt hårtab i forholdet 1/100 - 1/10000.
English: Kepro BV, Maadgenburgstraat 38, 7421 ZE Deventer, THE NETHERLANDS
Danish: Kepro BV, Maadgenburgstraat 38, 7421 ZE Deventer, NEDERLANDENE
English: In conclusion, the precautionary measures should be reflected in the product literature of the concerned veterinary medicinal products containing alpha2-adrenoreceptor agonists.
Danish: Disse forebyggende foranstaltninger skal derfor afspejles i produktdokumentationen for de pågældende veterinærlægemidler indeholdende alfa-2-adrenoreceptor antagonister.
English: CEVA Santé BV, Tiendweg 8c, 2671 SB Naaldwijk, THE NETHERLANDS
Danish: CEVA Santé BV, Tiendweg 8c, 2671 SB Naaldwijk, NEDERLANDENE
English: Bayer Hungária Ltd., 1123 Budapest, Alkotás u. 50, HUNGARY
Danish: Bayer Hungária Ltd., 1123 Budapest Alkotás u. 50, UNGARN
English: It was concluded that systemic effects after dermal exposure could not be excluded.
Danish: Det blev konkluderet, at det ikke kan udelukkes, at der kan være systemiske virkninger efter hudkontakt.
English: The CVMP concluded that these scientific recommendations concerning the precautionary measures apply also to other injectable products containing alpha2-adrenoreceptor agonists.
Danish: Udvalget konkluderede, at de faglige anbefalinger vedrørende forebyggende foranstaltningerne også gælder for andre produkter til injektion indeholdende alfa-2-adrenoreceptor antagonister.
English: Orion Corporation, Box 65, 02101 Esbo, FINLAND
Danish: Orion Corporation, Postboks 65, 02101 Esbo, FINLAND
English: The CVMP considered publicly available data on systemic toxicity after ocular exposure to xylazine hydrochloride in a human; corneal toxicity of xylazine and clonidine, in combination with ketamine, in the rat; and acute reversible cataract induced by xylazine and by ketamine-xylazine anesthesia in rats and mice.
Danish: Udvalget vurderede de offentligt tilgængelige oplysninger om systemisk toksicitet efter øjeneksponering med xylazin hydrochlorid for mennesker, toksicitet i hornhinden som følge af xylazin og klonidin i kombination med ketamin hos rotter samt akut reversibel katarakt som følge af xylazin og ketamin-xylazin anæstesi hos rotter og mus.
English: The MAHs were invited to comment and justify any counterproposals by 16 October 2006.
Danish: Indehaverne af markedsføringstilladelserne blev bedt om at fremsætte bemærkninger og redegøre for eventuelle modforslag senest den 16. oktober 2006.
English: Pfizer Animal Health BV, Postbus 37, 2900 AA Capell a/d Ijssel, THE NETHERLANDS
Danish: Pfizer Animal Health BV, Postboks 37, 2900 AA Capell a/d Ijssel, NEDERLANDENE
English: Ventricular arrhythmias are stated to have been reported, probably after accidental self-injection, but such was not reported in the published report on the human adverse reaction (Hoyer, M.J., 2006).
Danish: Der angives at foreligge indberetninger om ventrikulær arytmi, formentlig efter selvinjektion ved et uheld, men dette var ikke med i den offentliggjorte rapport om bivirkninger hos mennesker (Hoyer, M.J., 2006).
English: Globalmed Ltd, Ground Floor, 134 Church Hill, Loughton, Essex IG10 1LH, UNITED KINGDOM
Danish: Ground Floor 134 Church Hill, Loughton, Essex IG10 1LH, STORBRITANNIEN
English: Following consideration of the data available, the CVMP agreed on the relevance of this precautionary measure, recommending the following:
Danish: På grundlag af de foreliggende oplysninger blev udvalget enigt om relevansen af denne foranstaltning og fremsatte denne anbefaling:
English: In addition, the following information concerning human adverse reactions was considered by the CVMP:
Danish: Udvalget vurderede desuden også følgende oplysninger om bivirkninger hos mennesker:
English: In the rat study, a NOEL of 0.1 mg/kg bw/day was based on foetal and maternal toxicity and teratogenicity.
Danish: I rotteundersøgelsen var den dosis, som medførte dødelighed, 0,1 mg/kg kropsvægt baseret på føtal og maternel toksicitet og teratogenicitet.
English: Boehringer Ingelheim España S.A., Prat de la Riva s/n., 08190 Sant Cugat del Valles.
Danish: Boehringer Ingelheim España S.A., Prat de la Riva s/n. 08190 Sant Cugat del Valles, Barcelona, SPANIEN
English: The CVMP considered information provided by one MAH concerning the product's characteristics in relation to sensitisation and contact dermatitis.
Danish: Udvalget behandlede også de oplysninger, som en af indehaverne af markedsføringstilladelsen anførte om produktresuméet i relation til overfølsomhed og kontaktdermatitis.
English: Quvera Ltd, Unit 8, Brember Road, Harrow, Middlesex HA2 8AX, UNITED KINGDOM
Danish: Unit 8, Brember Road, Harrow, Middlesex HA2 8AX, STORBRITANNIEN
English: Therefore, the CVMP concluded upon the following recommendation:
Danish: Udvalget vedtog derfor følgende anbefaling:
English: The NOEL was 0.5 mg/kg bw/day based on maternal toxicity.
Danish: Dosen, som medførte dødelighed, var 0,5 mg/kg kropsvægt baseret på maternel toksicitet.
English: Country Product invented name
Danish: Land Lægemidlets særnavn
English: Bayer HealthCare AG, Animal Health Division, 51368, Leverkusen, GERMANY
Danish: Bayer HealthCare AG, Animal Health Division, 51368, Leverkusen, TYSKLAND
English: Novivet BV, Albert Cuyplaan 2B, 7482 JA Haaksbergen, THE NETHERLANDS
Danish: Novivet BV, Albert Cuyplaan 2B, 7482 JA Haaksbergen, NEDERLANDENE
English: The competent regulatory authority for medicinal products for veterinary use of the Netherlands College Ter Beoordeling van Geneesmiddelen (Medicines Evaluation Board) Bureau Diergeneesmiddelen, notified the EMEA on 21 August 2006 in accordance with Article 78(1) of Directive 2001/82/EC, as amended by Directive 2004/28/EC, of its intention to vary 21 marketing authorisations These authorisations are for veterinary medicinal products containing an alpha2-adrenoreceptor agonist (romifidine, xylazine, detomidine or medetomidine) as the active substance and approved for use via a parenteral (injectable) route.
Danish: Den kompetente offentlige myndighed for veterinærmedicinske lægemidler i Nederlandene, College Ter Beoordeling van Geneesmiddelen (Medicines Evaluation Board) Bureau Diergeneesmiddelen, underrettede den 21. august 2006 i henhold til artikel 78, stk. 1, i direktiv 2001/82/EF, senere ændret ved direktiv 2004/28/EF, EMEA om, at den havde til hensigt at ændre 21 markedsføringstilladelser.
English: The pharmacovigilance data evaluated included the published suspected adverse reaction (SAR) in a human being, reporting cardiovascular and central nervous system effects (Hoyer, M.J., 2006).
Danish: De evaluerede oplysninger i forbindelse med lægemiddelovervågningen omfattede den ifølge de offentliggjorte oplysninger formodede bivirkning hos en person, som meldte om effekter i hjerte/karsystemet og centralnervesystemet (Hoyer, M.J., 2006).
English: Wirtz Farma BV, Albert Cuyplaan 2B, 7482 JA Haaksbergen, THE NETHERLANDS
Danish: Wirtz Farma BV, Albert Cuyplaan 2B, 7482 JA Haaksbergen, NEDERLANDENE
English: The information on the approved United States New Drug Application (NDA) label for Precedex was considered, stating that dexmedetomidine should be used during pregnancy only if the potential benefits justify the potential risk to the foetus.
Danish: Heraf fremgår det, at dexmedetomidin kun må bruges af gravide, hvis de fordele, der kan være, opvejer risikoen for fostret.
English: NRP/VFP-00544-05 Alfasan International B.V., Kuipersweg 9, P.O.
Danish: NRP/VFP-00544-05 Alfasan International B.V.
English: NRP/VFP-01453-07 Alfasan International B.V., Kuipersweg 9, P.O.
Danish: NRP/VFP-01453-07 Alfasan International B.V.
English: Box 65, 02201 Espoo, FINLAND
Danish: Orion oyj, Postboks 65, 02201 Espoo, FINLAND
English: Bayer Vital Gmbh, 51368 Leverkusen, GERMANY
Danish: Bayer, Vital GmbH, 51368 Leverkusen, TYSKLAND
English: ALFASAN INTERNATIONAL B.V. Kuipersweg 9, 3449 Ja Woerden, THE NETHERLANDS
Danish: ALFASAN INTERNATIONAL B.V., Kuipersweg 9, 3449 - Ja Woerden, NEDERLANDENE
English: The CVMP further considered proprietary data provided by another MAH concerning three of the products.
Danish: Udvalget behandlede desuden allerede eksisterende oplysninger, som en anden indehaver af en markedsføringstilladelse fremlagde om tre af lægemidlerne.
English: Having considered the matter, the CVMP concluded on the following recommendation:
Danish: Efter at have overvejet spørgsmålet vedtog udvalget følgende anbefalinger:
English: No information on the risks for pregnant women was available in the reported human adverse reaction (Hoyer, M.J., 2006).
Danish: Der forelå ingen oplysninger om risici for gravide kvinder i forbindelse med de indberettede bivirkninger hos mennesker (Hoyer, M.J., 2006).
English: 323-03-8/01-42 VET4VET, Gerbičeva 50, 1000 Ljubljana, SLOVENIA
Danish: VET4VET, Gerbičeva 50, 1000 Ljubljana, SLOVENIEN
English: In the case of accidental contact of the product with eyes, rinse abundantly with fresh water.
Danish: Kommer lægemidlet ved et uheld i kontakt med øjnene, skylles øjnene omgående med rigelige mængder ferskvand.
English: Medetomidine
Danish: Medetomidin
English: Chanelle Pharmaceuticals Manufacturing Ltd., Dublin Road, Loughrea Co. Galway, IRELAND
Danish: Chanelle Pharmaceuticals Manufacturing Ltd., Dublin Road, Loughrea Co., Galway, IRLAND
English: Chanelle Pharmaceuticals Manufacturing Ltd., Loughrea, Co. Galway, IRELAND
Danish: Chanelle Pharmaceuticals Manufacturing Ltd., Loughrea, Co. Galway, IRLAND
English: Detomidine
Danish: Detomidin
English: Boehringer Ingelheim Ltd, Ellesfield Avenue Bracknell, Berkshire RG12 8YS, UNITED KINGDOM
Danish: Boehringer Ingelheim Ltd, Ellesfield Avenue Bracknell Berkshire RG12 8YS, IRLAND
English: Alfasan Nederland BV, Postbus 78, 3440 AB Woerden, THE NETHERLANDS
Danish: Alfasan Nederland BV, Postboks 78, 3440 AB Woerden, NEDERLANDENE
English: Orion Corporation Orion Pharma, Tengstromink 8, Box 65, Turku 20101, FINLAND
Danish: Orion Corporation Orion Pharma, Tengstromink 8, Postboks 65, Turku, FIN-20101, FINLAND
English: Marketing Authorisation number Marketing Authorisation Holder
Danish: Markedsføringstilladelsens nummer
English: 0205IS0127F012 SCS BOEHRINGER INGELHEIM COMM.V, Vesalius Science Park, Avenue, Ariane, 16, 1200 Bruxelles, BELGIUM
Danish: SCS BOEHRINGER INGELHEIM COMM.V, Vesalius Science Park, Avenue Ariane 16, 1200 Bruxelles, BELGIEN
English: 0187IS0155F012 BAYER N.V., Louizalaan 143, 1050 Brussel, BELGIUM
Danish: BAYER N.V., Louizalaan 143, 1050 Bruxelles, BELGIEN
English: Having considered the data and the comments from the MAHs, the CVMP agreed on the following recommendation:
Danish: På grundlag af de indsendte oplysninger og bemærkningerne fra indehaverne af markedsføringstilladelserne vedtog udvalget følgende anbefaling:
English: Romifidine Chlorhydrate
Danish: Romifidin chlorhydrat
English: ADVICE TO DOCTORS: <The substance> is an alpha2-adrenoreceptor agonist whose toxicity may cause clinical effects including sedation, respiratory depression and coma, bradycardia and hypotension and hyperglycaemia.
Danish: RÅD TIL LÆGER: Stoffet er en alfa2-adrenoreceptor agonist, der kan være så giftigt, at det medfører kliniske virkninger, herunder sedation, svækket åndedræt og koma, bradykardi samt hypotension og hyperglykæmi.
English: Orion Corporation Orion Pharma, Tengstromink 8, Box 65, Turku, 0101, FINLAND
Danish: Orion Pharma, Tengstromink 8, Postboks 65, Turku, FIN-0101, FINLAND
English: No information on eye exposure was available in the reported human adverse reaction (Hoyer, M.J., 2006).
Danish: Der forelå ingen oplysninger om øjeneksponering i de indberettede bivirkninger hos mennesker (Hoyer, M.J., 2006).
English: <The substance> is an alpha2-adrenoreceptor agonist, symptoms after absorption may involve clinical effects including dose-dependent sedation, respiratory depression, bradycardia, hypotension, a dry mouth, and hyperglycaemia.
Danish: Stoffet er en alfa2-adrenoreceptor agonist, hvor symptomer efter absorbering kan omfatte kliniske virkninger, herunder dosisrelateret sedation, svækket åndedræt og koma, bradykardi, hypotension, mundtørhed og hyperglykæmi.
English: 0419IS0001F012 PFIZER ANIMAL HEALTH S.A. Rue Laid Burniat 1, 1348 Louvain La Neuve, BELGIUM
Danish: PFIZER ANIMAL HEALTH S.A., Rue Laid Burniat 1, 1348 Louvain La Neuve, BELGIEN
English: Advice to doctors: <The substance> is an alpha2-adrenoreceptor agonist, symptoms after absorption may involve clinical effects including dose-dependent sedation, respiratory depression, bradycardia, hypotension, a dry mouth, and hyperglycaemia.
Danish: Råd til læger: Stoffet er en alfa2-adrenoreceptor agonist, hvor symptomer efter absorbering kan omfatte kliniske virkninger, herunder dosisrelateret sedation, svækket åndedræt og koma, bradykardi, hypotension, mundtørhed og hyperglykæmi.
English: UK Domosedan 10 mg/ml Injection
Danish: UK Domosedan 10 mg/ml Injection Detomidin hydrochlorid
English: Marketing
Danish: Markedsføringstilladelsens
English: Boehringer Ingelheim Ltd, Ellesfield, Avenue Bracknell, Berkshire RG12 8YS, UNITED KINGDOM
Danish: Ellesfield, Avenue Bracknell, Berkshire RG12 8YS, DET FORENEDE KONGERIGE
English: 46335/ 06-12-00 PFIZER HELLAS
Danish: 0419IS0003F012
English: Detomidine chlorhydrate
Danish: Detomidin chlorhydrat
English: Box 78, NL-3440 AB Woerden, THE NETHERLANDS
Danish: Kuipersweg 9, Postboks 78, 3440 AB Woerden, NEDERLANDENE
English: Romifidine hydrochloride
Danish: Romifidin hydrochlorid
English: Detomodine hydrochloride
Danish: Detomidin hydrochlorid
English: Medetomidine Chlorhydrate
Danish: Medetomidin chlorhydrat
English: Boehringer Ingelheim Vetmedica GmbH, Binger Strasse 173, 55216 Ingelheim am Rhein, GERMANY
Danish: BOEHRINGER INGELHEIM VETMEDICA GMBH, Binger Strasse 173, 55216 Ingelheim am Rhein, TYSKLAND
English: IT Rompum 2%
Danish: IT Rompun 2%
English: Boehringer Ingelheim Vetmedica GmbH, Binger Str. 173, 55218 Ingelheim, GERMANY
Danish: Boehringer Ingelheim Vetmedica GmbH, Binger Str. 173, 55218 Ingelheim, TYSKLAND
English: 11188/30-03-99 FARMAZAC SYNVET
Danish: 0187IS0120F012
English: IT Rompum
Danish: IT Rompun
English: No information on skin exposure was available in the reported human adverse reaction (Hoyer, M.J., 2006).
Danish: Der forelå ingen oplysninger om hudeksponering i de indberettede bivirkninger hos mennesker (Hoyer, M.J.,
English: Medetomodine hydrochloride
Danish: Xylazin hydrochlorid
English: 19605/23-06-93 ALAPIS
Danish: 96/730/96-C
English: 44613/22-11-00 BOEHRINGER INGELHEIM VETMEDICA GMBH., GERMANY
Danish: BOEHRINGER INGELHEIM VETMEDICA GMBH., TYSKLAND
English: Country
Danish: ALAPIS
English: Duration of immunity: at least 6 months.
Danish: Beskyttelsens varighed: mindst 6 måneder.
English: The efficacy of the vaccine was demonstrated in laboratory studies.
Danish: Vaccinens virkning er påvist i laboratorieundersøgelser.
English: Do not touch!
Danish: Undgå berøring!
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label and cardboard after EXP.
Danish: Brug ikke dette veterinærlægemiddel efter den udløbsdato, der står på etiketten og kartonnen efter EXP.
English: Interaction with other medicinal products and other forms of interaction: Not known.
Danish: Interaktion med andre lægemidler og andre former for interaktion: Ingen kendte.
English: 17493 Greifswald - Insel Riems Germany
Danish: 17493 Greifswald - Insel Riems Tyskland
English: Finally, the pseudogen located between the G - and L-gene has been deleted.
Danish: Endelig er pseudogenet, placeret mellem G- og L-genet blevet slettet.
English: Restricted to duly designated competent authorities.
Danish: Begrænset til behørigt udpegede kompetente myndigheder.
English: Oxytetracycline hydrochloride (may be added as biomarker if requested by authorities)
Danish: Oxytetracyclinhydrochlorid (kan tilsættes som biomarkør, hvis dette kræves af myndighederne)
English: It is recommended to wear disposable rubber gloves when handling and distributing baits.
Danish: Det anbefales, at der anvendes gummihandsker under håndtering og distribution af lokkemaden.
English: In case of contact of the vaccine fluid, immediately remove it by thoroughly rinsing with water and soap.
Danish: I tilfælde af kontakt med vaccinevæsken skal denne øjeblikkeligt fjernes ved at vaske grundigt med vand og sæbe.
English: A higher distribution density is recommended in areas with a high population density of foxes/raccoon dogs.
Danish: En højere distributionstæthed anbefales i områder med en høj populationstæthed af ræve/mårhunde.
English: Pregnancy and lactation: Can be used during pregnancy.
Danish: Drægtighed og laktation: Kan anvendes under drægtighed.
English: The distribution rate depends on the topography, on the population density of the target species and on the epizootiological situation.
Danish: Distributionskvoten afhænger af den stedlige topografi, af dyrearternes populationstæthed og af den epizootiologiske situation.
English: Proposed first aid measures immediately after direct human exposure to the vaccine fluid should follow the recommendations of the WHO as outlined in the “WHO Guide for Rabies Pre- and PostExposure Prophylaxis (PEP) in Humans”.
Danish: Foreslåede førstehjælpsforanstaltninger umiddelbart efter direkte human eksponering for vaccinevæsken skal følge anbefalingerne fra WHO som beskrevet i “WHO Guide for Rabies Pre- and Post-Exposure Prophylaxis (PEP) in Humans” (WHO's guide vedrørende rabiesprofylakse hos mennesker før og efter eksponering).
English: Therefore the recommendations / request of the duly designated competent authority are followed concerning distribution rate, vaccination area, distribution/baiting method and other local/areal conditions as specified by the competent authority.
Danish: Derfor skal den behørigt udpegede kompetente myndigheds anbefalinger/krav vedrørende distributionskvote, vaccinationsområde, distributions-/administrationsmetode og andre lokale/områdebetingede betingelser, som angivet af den kompetente myndighed, følges.
English: No field studies were conducted.
Danish: Der er ikke udført feltundersøgelser.
English: a) the administration of the product to animals will interfere with the implementation of a national programmes for the diagnosis, control or eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals.
Danish: a) at behandling af dyr med veterinærlægemidlet griber forstyrrende ind i gennemførelsen af et nationalt program til diagnosticering, bekæmpelse eller udryddelse af sygdomme hos dyr eller gør det vanskeligt at bekræfte, at levende dyr eller levnedsmidler eller andre produkter hidrørende fra behandlede dyr ikke er kontamineret,
English: The administration of the vaccine at 10 times the recommended dose induced no undesirable effects.
Danish: Indgivelse af vaccinen i mængder på 10 gange den anbefalede dosis fremkaldte ikke nogen bivirkninger.
English: To protect regions which are free of rabies, baiting may be carried out to create a vaccination belt or in the form of spot vaccinations.
Danish: For at beskytte regioner, der er fri for rabies, kan der udlægges lokkemad for at skabe et vaccinationsbælte eller i form af spotvaccinationer.
English: Store and transport frozen, below -15 °C.
Danish: Opbevares og transporteres nedfrosset, under -15°C.
English: Distribution of baits manually or by air.
Danish: Lokkemaden distribueres manuelt eller fra luften.