FrancophonIA/ELRC3.0 huggingface dataset:
English: The decrease in mean leukocyte count observed in oclacitinib-treated dogs was not progressive, and affected all white blood cell counts (neutrophil, eosinophil and monocyte counts) except lymphocyte counts.
Danish: Faldet i gennemsnitlig leukocyttal, der blev observeret hos oclacitinibbehandlede hunde, var ikke progressivt og påvirkede tælling af alle hvide blodlegemer (neutrofil-, eosinofil- og monocyttal) undtagen lymfocyttal.
English: Oclacitinib tablets were administered to healthy, one year old Beagle dogs twice daily for 6 weeks, followed by once per day for 20 weeks, at 0.6 mg/kg bw, 1.8 mg/kg bw and 3.0 mg/kg bw for a total of 26 weeks.
Danish: Oclacitinib-tabletter blev administreret til raske, et år gamle beaglehunde to gange dagligt i 6 uger, efterfulgt af én gang dagligt i 20 uger, med 0,6 mg/kg kv, 1,8 mg/kg kv og 3,0 mg/kg kv i 26 uger i alt.
English: Shelf life of the veterinary medicinal product as packaged for sale in bottles: 18 months.
Danish: Opbevaringstid for veterinærlægemidlet i HDPE-flaske: 18 måneder.
English: Anorexia
Danish: Opkastning Anorexi
English: Pharmacotherapeutic group: Agents for dermatitis, excluding corticosteroids.
Danish: Farmakoterapeutisk gruppe: Midler til dermatitis, ekskl.
English: ANNEX I 0BSUMMARY OF PRODUCT CHARACTERISTICS
Danish: BILAG I 0BPRODUKTRESUME
English: Each film-coated tablet contains 3.6 mg, 5.4 mg or 16 mg oclacitinib (as oclacitinib maleate).
Danish: Hver filmovertrukket tablet indeholder 3,6 mg, 5,4 mg eller 16 mg oclacitinib som oclacitinibmaleat.
English: The recommended initial dose is 0.4 to 0.6 mg oclacitinib/kg bodyweight, administered orally, twice daily for up to 14 days.
Danish: Den anbefalede, initiale dosis er 0,4 - 0,6 mg oclacitinib/kg kropsvægt, administreret oralt, to gange dagligt i op til 14 dage.
English: Apoquel 16 mg tablets
Danish: Apoquel 16 mg tabletter
English: Furthermore, in cases of allergic dermatitis and atopic dermatitis, it is recommended to investigate and treat complicating factors, such as bacterial, fungal or parasitic infections/infestations (e.g. flea and mange).
Danish: I tilfælde af allergisk dermatitis og atopisk dermatitis anbefales det endvidere at undersøge og behandle komplicerende faktorer, så som bakterie-, svampe- eller parasitære infektioner/infestationer (f.eks. lopper og skab).
English: Clinical observations that were considered likely to be related to oclacitinib treatment included: alopecia (local), papilloma, dermatitis, erythema, abrasions and scabbing/crusts, interdigital "cysts", and oedema of the feet.
Danish: Kliniske observationer, der ansås for at være relateret til oclacitinibbehandling, omfatter: alopeci (lokalt), papilloma, dermatitis, erythema, afskrabninger og sår/sårskorper, interdigitale ”cyster” og ødem af poterne.
English: Any remaining half tablet should be placed back in the opened blister and stored in the original cardboard carton, or in the HDPE bottle (for a maximum of 3 days).
Danish: Resterende halve tabletter bør lægges tilbage enten i det anbrudte blisterkort i den originale æske af karton eller HDPE-flasken, og opbevares i højst 3 dage.
English: The recommended initial dose of Apoquel tablets to be given to the dog is to achieve 0.4 to 0.6 mg oclacitinib/kg bodyweight, administered orally, twice daily for up to 14 days.
Danish: Den anbefalede, initiale dosis af Apoquel tabletter der skal gives til hunden er 0,4 - 0,6 mg oclacitinib/kg kropsvægt, administreret oralt, to gange dagligt i op til 14 dage.
English: For maintenance therapy (after the initial 14 days of treatment), the same dose (0.4 to 0.6 mg oclacitinib/kg bodyweight) should then be administered only once a day.
Danish: Ved vedligeholdelsesbehandling (efter de første 14 dage af behandlingen) bør den samme dosis (0,40,6 mg/kg kropsvægt) kun administreres én gang dagligt.
English: Apoquel 5.4 mg tablets
Danish: Apoquel 5,4 mg tabletter
English: Dermatitis lesions were mostly secondary to the development of interdigital furunculosis on one or more feet during the study with the number and frequency of observations increasing with increasing dose.
Danish: Dermatitislæsioner var hovedsageligt sekundære til udvikling af interdigital furunkolose på en eller flere poter i studieforløbet, med stigende antal og hyppighed af observationer med stigende dosis og var hyppigt forbundet med interdigital furunkolosis.
English: Any remaining half tablet should be stored in the bottle and discarded if not used within 3 days.
Danish: Resterende halve tabletter bør opbevares i flasken og hvis de ikke bliver anvendt, skal de bortskaffes inden for 3 dage.
English: New cutaneous or subcutaneous lumps Weakness (Lethargy) Excessive thirst (Polydipsia)
Danish: Opkastning Manglende eller tab af appetit (Anorexi) Nye kutane eller subkutane knuder Svaghed (Letargi) Overdreven tørst (Polydipsi)
English: EU/2/13/154/001 (1 x 20 tablets, 3.6 mg) EU/2/13/154/007 (1 x 50 tablets, 3.6 mg) EU/2/13/154/002 (1 x 100 tablets, 3.6 mg) EU/2/13/154/010 (20 tablets, 3.6 mg) EU/2/13/154/011 (50 tablets, 3.6 mg) EU/2/13/154/012 (100 tablets, 3.6 mg) EU/2/13/154/003 (1 x 20 tablets, 5.4 mg) EU/2/13/154/008 (1 x 50 tablets, 5.4 mg) EU/2/13/154/004 (1 x 100 tablets, 5.4 mg) EU/2/13/154/013 (20 tablets, 5.4 mg) EU/2/13/154/014 (50 tablets, 5.4 mg) EU/2/13/154/015 (100 tablets, 5.4 mg) EU/2/13/154/005 (1 x 20 tablets, 16 mg) EU/2/13/154/009 (1 x 50 tablets, 16 mg) EU/2/13/154/006 (1 x 100 tablets, 16 mg) EU/2/13/154/016 (20 tablets, 16 mg) EU/2/13/154/017 (50 tablets, 16 mg) EU/2/13/154/018 (100 tablets, 16 mg)
Danish: EU/2/13/154/001 (1 x 20 tabletter, 3,6 mg) EU/2/13/154/007 (1 x 50 tabletter, 3,6 mg) EU/2/13/154/002 (1 x 100 tabletter, 3,6 mg) EU/2/13/154/010 (20 tabletter, 3,6 mg) EU/2/13/154/011 (50 tabletter, 3,6 mg) EU/2/13/154/012 (100 tabletter, 3,6 mg) EU/2/13/154/003 (1 x 20 tabletter, 5,4 mg) EU/2/13/154/008 (1 x 50 tabletter, 5,4 mg) EU/2/13/154/004 (1 x 100 tabletter, 5,4 mg) EU/2/13/154/013 (20 tabletter, 5,4 mg) EU/2/13/154/014 (50 tabletter, 5,4 mg) EU/2/13/154/015 (100 tabletter, 5,4 mg) EU/2/13/154/005 (1 x 20 tabletter, 16 mg) EU/2/13/154/009 (1 x 50 tabletter, 16 mg) EU/2/13/154/006 (1 x 100 tabletter, 16 mg) EU/2/13/154/016 (20 tabletter, 16 mg) EU/2/13/154/017 (50 tabletter, 16 mg) EU/2/13/154/018 (100 tabletter, 16 mg)
English: For maintenance therapy, the same dose (0.4 to 0.6 mg oclacitinib/kg bodyweight) should then be administered only once a day.
Danish: Ved vedligeholdelsesbehandling bør den samme dosis (0,4 - 0,6 mg/kg kropsvægt) kun administreres én gang dagligt.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE CARDBOARD CARTON for Blister
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE ÆSKE AF KARTON (Blisterpakning)
English: EU/2/13/154/010 (20 tablets, 3.6 mg) EU/2/13/154/011 (50 tablets, 3.6 mg) EU/2/13/154/012 (100 tablets, 3.6 mg) EU/2/13/154/013 (20 tablets, 5.4 mg) EU/2/13/154/014 (50 tablets, 5.4 mg) EU/2/13/154/015 (100 tablets, 5.4 mg) EU/2/13/154/016 (20 tablets, 16 mg) EU/2/13/154/017 (50 tablets, 16 mg) EU/2/13/154/018 (100 tablets, 16 mg)
Danish: EU/2/13/154/010 (20 tabletter, 3,6 mg) EU/2/13/154/011 (50 tabletter, 3,6 mg) EU/2/13/154/012 (100 tabletter, 3,6 mg) EU/2/13/154/013 (20 tabletter, 5,4 mg) EU/2/13/154/014 (50 tabletter, 5,4 mg) EU/2/13/154/015 (100 tabletter, 5,4 mg) EU/2/13/154/016 (20 tabletter, 16 mg) EU/2/13/154/017 (50 tabletter, 16 mg) EU/2/13/154/018 (100 tabletter, 16 mg)
English: Apoquel 3.6 mg tablets for dogs.
Danish: Apoquel 3,6 mg tabletter til hunde.
English: Apoquel 16 mg tablets for dogs.
Danish: Apoquel 16 mg tabletter til hunde.
English: EU/2/13/154/001 (1 x 20 tablets, 3.6 mg) EU/2/13/154/007 (1 x 50 tablets, 3.6 mg) EU/2/13/154/002 (1 x 100 tablets, 3.6 mg) EU/2/13/154/003 (1 x 20 tablets, 5.4 mg) EU/2/13/154/008 (1 x 50 tablets, 5.4 mg) EU/2/13/154/004 (1 x 100 tablets, 5.4 mg) EU/2/13/154/005 (1 x 20 tablets, 16 mg) EU/2/13/154/009 (1 x 50 tablets, 16 mg) EU/2/13/154/006 (1 x 100 tablets, 16 mg)
Danish: EU/2/13/154/001 (1 x 20 tabletter, 3,6 mg) EU/2/13/154/007 (1 x 50 tabletter, 3,6 mg) EU/2/13/154/002 (1 x 100 tabletter, 3,6 mg) EU/2/13/154/003 (1 x 20 tabletter, 5,4 mg) EU/2/13/154/008 (1 x 50 tabletter, 5,4 mg) EU/2/13/154/004 (1 x 100 tabletter, 5,4 mg) EU/2/13/154/005 (1 x 20 tabletter, 16 mg) EU/2/13/154/009 (1 x 50 tabletter, 16 mg) EU/2/13/154/006 (1 x 100 tabletter, 16 mg)
English: Any remaining half tablet should be stored in the blister and discarded if not used within 3 days.
Danish: Resterende halve tabletter bør opbevares i blisterpakningen og hvis de ikke bliver anvendt, skal de bortskaffes inden for 3 dage.
English: Given the potential for effects on certain clinicopathological parameters (see section 4.6), periodic monitoring with complete blood counts and serum biochemistry is recommended when dogs are on long-term treatment.
Danish: 4.6) anbefales det regelmæssigt at monitorere med komplet blodtælling og biokemiske parametre i serum ved langtidsbehandling af hunde.
English: Given the potential for effects on certain clinicopathological parameters (see section 6), periodic monitoring with complete blood counts and serum biochemistry is recommended when dogs are on long-term treatment.
Danish: 6) anbefales det regelmæssigt at monitorere med komplet blodtælling og biokemiske parametre i serum ved langtidsbehandling af hunde.
English: Apoquel 5.4 mg tablets for dogs.
Danish: Apoquel 5,4 mg tabletter til hunde.
English: When treating pruritus associated with allergic dermatitis with oclacitinib, investigate and treat any underlying causes (e.g., flea allergic dermatitis, contact dermatitis, food hypersensitivity).
Danish: Ved behandling af pruritus med oclacitinib, i forbindelse med allergisk dermatitis, skal alle tilgrundliggende årsager (f.eks. loppebetinget allergisk dermatitis, kontaktdermatitis, fødemiddelallergi) undersøges og behandles.
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Danish: Særlige forholdsregler der skal træffes af personer, der administrerer lægemidlet til dyr: Vask hænder efter administration.
English: The tablets are breakable along the score line.
Danish: Tabletterne kan deles langs med delekærven.
English: 16 mg oclacitinib per tablet (as oclacitinib maleate).
Danish: 16 mg oclacitinib pr tablet (som oclacitinibmaleat).
English: 5.4 mg oclacitinib per tablet (as oclacitinib maleate).
Danish: 5,4 mg oclacitinib pr tablet (som oclacitinibmaleat).
English: Apoquel 3.6 mg film-coated tablets for dogs Apoquel 5.4 mg film-coated tablets for dogs Apoquel 16 mg film-coated tablets for dogs
Danish: Apoquel 3,6 mg filmovertrukne tabletter til hunde Apoquel 5,4 mg filmovertrukne tabletter til hunde Apoquel 16 mg filmovertrukne tabletter til hunde
English: Apoquel 3.6 mg film-coated tablets for dogs Apoquel 5.4 mg film-coated tablets for dogs Apoquel 16 mg film-coated tablets for dogs oclacitinib
Danish: Apoquel 3,6 mg filmovertrukne tabletter til hunde Apoquel 5,4 mg filmovertrukne tabletter til hunde Apoquel 16 mg filmovertrukne tabletter til hunde oclacitinib
English: PACKAGE LEAFLET: Apoquel 3.6 mg film-coated tablets for dogs Apoquel 5.4 mg film-coated tablets for dogs Apoquel 16 mg film-coated tablets for dogs
Danish: INDLÆGSSEDDEL: Apoquel 3,6 mg filmovertrukne tabletter til hunde Apoquel 5,4 mg filmovertrukne tabletter til hunde Apoquel 16 mg filmovertrukne tabletter til hunde
English: 3.6 mg oclacitinib per tablet (as oclacitinib maleate).
Danish: 3,6 mg oclacitinib pr tablet (som oclacitinibmaleat).
English: Wash hands after administration.
Danish: Særlige forsigtighedsregler for personer, som indgiver lægemidlet til dyr: Vask hænder efter administration.
English: The CHMP reviewed all the data available for each of the four sites concerned.
Danish: CHMP gennemgik alle de tilgængelige data for hvert af de fire pågældende produktionssteder.
English: A harmonised European approach to supply has been in place since identification of the concern at Castlebar and the article 31 procedure remains ongoing pending resolution of the outstanding issues.
Danish: Der har eksisteret en harmoniseret europæisk tilgang til leveringen, siden problemet blev identificeret i Castlebar, og proceduren i henhold til artikel 31 fortsætter, indtil de udestående spørgsmål er blevet løst.
English: Furthermore, the opinion on the Castlebar site cannot be finalised at this stage as issues remained for resolution by the marketing authorisation holder.
Danish: Desuden kan udtalelsen om Castlebar-produktionsstedet endnu ikke færdiggøres på nuværende tidspunkt, eftersom der stadig er spørgsmål, som indehaveren af markedsføringstilladelsen ikke har løst.
English: Overall summary of the scientific evaluation on the inclusion of additional sites into the existing licenses of dialysis solutions (Dianeal, Extraneal and Nutrineal) produced by Baxter group of companies and associated companies (see Annex I)
Danish: Samlet resumé af den videnskabelige vurdering af medtagelsen af yderligere produktionssteder i de eksisterende tilladelser for dialysevæsker (Dianeal, Extraneal og Nutrineal) fremstillet af Baxter-koncernen og tilknyttede virksomheder (se bilag I)
English: - All drug substances should be supported by active substance master files or appropriate data and comply with Ph Eur requirements.
Danish: - Alle lægemiddelstoffer skal støttes af master files eller passende data om de aktive stoffer og være i overensstemmelse med kravene i Den Europæiske Farmakopé.
English: the CHMP recommends the variation to the terms of the marketing authorisations concerning the addition of three manufacturing sites (Canada, Turkey and Poland) and for which the relevant amendments to sections of the summaries of product characteristics and package leaflets are set out in Annex III for dialysis solutions produced by Baxter group of companies and associated companies (see Annex I).
Danish: anbefaler CHMP ændringen af betingelserne for markedsføringstilladelserne, hvad angår tilføjelsen af tre produktionssteder (Canada, Polen og Tyrkiet), og for hvilke de relevante ændringer af punkterne i produktresuméerne og indlægssedlerne fremgår af bilag III for dialysevæsker fremstillet af Baxterkoncernen og tilknyttede virksomheder (se bilag I).
English: At this stage of the article 31 review procedure, sufficient data is available to recommend the variation to the marketing authorisations consisting in the inclusion of Canada, Poland and Turkey as additional manufacturing sites, as no major quality issues were identified at these sites.
Danish: På dette stadium af vurderingsproceduren i henhold til artikel 31 er der tilstrækkelige data tilgængelige til at anbefale en ændring af markedsføringstilladelserne, der består i medtagelsen af Canada, Polen og Tyrkiet som yderligere produktionssteder, eftersom der ikke blev identificeret nogen større kvalitetsproblemer på disse produktionssteder.
English: In light of the current uncertainty over the root cause and the future re-instatement of supply from Castlebar, the addition of manufacturing sites to the marketing authorisations aimed at mitigating future supply problems arising for PD solutions in Europe, ensuring that sufficient PD solutions are available.
Danish: I lyset af den nuværende usikkerhed omkring hovedårsagen og den kommende genoptagelse af levering fra Castlebar tog tilføjelsen af produktionssteder i markedsføringstilladelserne sigte på at afhjælpe kommende leveringsproblemer for PD-væsker i Europa ved at sikre, at der er tilstrækkeligt med PDvæsker tilgængelige.
English: Grounds for the addition of three manufacturing sites to the marketing authorisations and amendment of the summaries of product characteristics and package leaflets
Danish: Begrundelser for tilføjelsen af tre produktionssteder til markedsføringstilladelserne og ændring af produktresuméerne og indlægssedlerne
English: • The CHMP considers that sufficient quality data is available to recommend the inclusion of manufacturing sites located in Canada, Poland and Turkey into the existing marketing authorisations for peritoneal dialysis solutions.
Danish: • CHMP er af den opfattelse, at der er tilstrækkelige kvalitetsdata tilgængelige til at anbefale medtagelsen af produktionssteder i Canada, Polen og Tyrkiet i de eksisterende markedsføringstilladelser for peritonealdialysevæsker.
English: • The CHMP considered the referral under Article 31 of Directive 2001/83/EC, as amended, for dialysis solutions produced at Castlebar by Baxter group of companies and associated companies.
Danish: • CHMP behandlede indbringelsen i henhold til artikel 31 i direktiv 2001/83/EF, med senere ændringer, for dialysevæsker fremstillet i Castlebar af Baxter-koncernen og tilknyttede virksomheder.
English: An article 31 referral procedure of Directive 2001/83/EC, as amended was initiated by the European Commission (EC) following reports of out-of-specifications results for endotoxins in dialysis solutions produced at Castlebar by Baxter group of companies and associated companies.
Danish: Europa-Kommissionen indledte en indbringelsesprocedure i henhold til artikel 31 i direktiv 2001/83/EF, med senere ændringer, efter rapporterne om resultater uden for specifikationsområdet for endotoksiner i dialysevæsker fremstillet i Castlebar af Baxter-koncernen og tilknyttede virksomheder.
English: Therefore, without prejudice to the ongoing article 31 procedure, the CHMP considers that sufficient information is available to issue a first opinion for this Article 31 procedure recommending the addition of Canada, Poland and Turkey manufacturing sites to the existing PD solutions' marketing authorisations, subject to conditions set out in the Annex IV.
Danish: Med forbehold af den igangværende procedure i henhold til artikel 31 er CHMP af den opfattelse, at der er tilstrækkeligt med information tilgængelig til at afgive den første udtalelse i denne procedure i henhold til artikel 31, hvor det anbefales, at produktionsstederne i Canada, Polen og Tyrkiet medtages i de eksisterende markedsføringstilladelser for PD-væsker på de betingelser, der fremgår af bilag IV.
English: Scientific conclusions and grounds for the addition of three manufacturing sites to the marketing authorisations and amendment of the summaries of product characteristics and package leaflets presented by the EMA
Danish: Bilag II Videnskabelige konklusioner og begrundelser for tilføjelsen af tre produktionssteder til markedsføringstilladelserne og ændring af produktresuméerne og indlægssedlerne fremlagt af EMA
English: Presently, the information available on the USA site is insufficient to conclude on its addition, pending the outcome of a recent inspection carried out at this site.
Danish: Som det er nu, er den tilgængelige information om USA-produktionsstedet utilstrækkelig til at konkludere, at det skal medtages.
English: EU/1/15/1048/001 Cotellic
Danish: EU/1/15/1048/001
English: Blister (PVC/PVDC) 63 (3 x 21) tablets
Danish: 63 (3 x 21) tabletter
English: MA (EU) number (Invented) name Strength Pharmaceutical Form Route of Administration
Danish: (Særnavn) Navn Styrke
English: Immediate Packaging Pack size
Danish: Lægemiddelform Administration Emballage
English: Oral use
Danish: Pakningsstørrelse
English: This summary was last updated on 16/09/2010.
Danish: Dette sammendrag blev sidst ajourført i 16/09/2010.
English: Direct therapeutic benefit
Danish: Direkte terapeutiske fordele
English: • for the consumer: all components have been investigated and no risk for the consumer has been identified.
Danish: • For forbrugeren: Alle komponenter er blevet undersøgt, og der er ikke blevet identificeret nogen risiko for forbrugeren.
English: The risk using this inactivated vaccine can be classified as minimal.
Danish: Risikoen forbundet med anvendelse af denne inaktiverede vaccine kan klassificeres som minimal.
English: Overall, the safety of this vaccine has been well documented and reported for the target animals, the user, the consumer and the environment.
Danish: Samlet set er vaccinens sikkerhed veldokumenteret og rapporteret for måldyrene, brugerne, forbrugerne og miljøet.
English: The European Commission granted a marketing authorisation valid throughout the European Union, for RHINISENG to Laboratorios Hipra S.A. on 16/09/2010.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for RHINISENG til Laboratorios Hipra, S.A. den 16/09/2010.
English: Main potential risks for the vaccine as such:
Danish: De vigtigste potentielle risici forbundet med vaccinen:
English: • for the environment: no risk identified from the use of this inactivated vaccine
Danish: • For miljøet: Der er ikke blevet identificeret nogen risiko ved brugen af denne inaktiverede vaccine.
English: The safety of RHINISENG was demonstrated in several well conducted and reported laboratory and field studies.
Danish: Sikkerheden ved RHINISENG blev påvist i en række velgennemførte og rapporterede laboratorie- og feltundersøgelser.
English: Other information about RHINISENG:
Danish: Andre oplysninger om RHINISENG:
English: RHINISENG is a vaccine against a bacterial disease.
Danish: RHINISENG er en vaccine mod en bakteriel sygdom.
English: These antibodies are then transferred to the piglets via the colostrum they receive.
Danish: Disse antistoffer overføres derefter til smågrisene gennem den kolostrum, de indtager.
English: When it is given to sows, the animal's immune system (their natural defence mechanism) learns how to make antibodies (a special type of protein) to fight the disease.
Danish: Når en so vaccineres, lærer dyrets immunsystem (dets naturlige forsvarsmekanisme) at danne antistoffer (en særlig type protein) til at bekæmpe sygdommen.
English: • for the user: accidental self-injection is the only identified risk and an appropriate warning has been included in the SPC to reflect the (small) risk.
Danish: • For brugeren: Utilsigtet selvindgivelse er den eneste identificerede risiko, og der er medtaget en passende advarsel om denne (mindre) risiko i produktresuméet.
English: The field efficacy results supported those obtained from the laboratory studies.
Danish: Resultaterne af feltundersøgelserne af lægemidlets virkning understøttede resultaterne fra laboratorieundersøgelserne.
English: The benefit-risk balance may be found in the scientific discussion module of this EPAR.
Danish: Risk-benefit-forholdet fremgår af afsnittet om den videnskabelige drøftelse i denne EPAR.
English: Results demonstrated that the vaccination of sows, gilts and boars according to the vaccination programme did not provoke unacceptable local or systemic reactions after vaccination and no significant differences in reproductive parameters between vaccinated and placebo-treated animals were recorded either.
Danish: Resultaterne påviste, at vaccination af søer, gylter og orner i henhold til vaccinationsprogrammet ikke fremkaldte uacceptable lokale eller systemiske reaktioner efter vaccination, og der blev heller ikke registreret nogen signifikante forskelle mellem reproduktionsparametrene hos henholdsvis vaccinerede dyr og dyr behandlet med placebo.
English: • for the target animal: there are mild and transitory local reactions at the injection site, resolving within few days and a transiently elevated body temperature within acceptable limits.
Danish: • For måldyret: Der kan på injektionsstedet forekomme milde, forbigående lokale reaktioner, som forsvinder i løbet af få dage, samt forbigående forøgelse af legemstemperaturen inden for acceptable grænser.
English: This is reflected in the relevant sections of the SPC.
Danish: Dette afspejles i de relevante afsnit i produktresuméet.
English: In the future, if the sows are exposed to the above mentioned bacteria, the immune system will be able to make those antibodies quicker and this will help their piglets to fight the disease and its after effects such as weight loss.
Danish: Hvis søerne på et senere tidspunkt eksponeres for ovennævnte bakterier, vil deres immunsystem være i stand til hurtigere at danne antistofferne, hvilket vil hjælpe smågrisene med at bekæmpe sygdommen og eftervirkningerne heraf, såsom vægttab.