Ruvax Vet.

Primær information

  • Handelsnavn:
  • Ruvax Vet. 25 IE/ml injektionsvæske, suspension
  • Dosering:
  • 25 IE/ml
  • Lægemiddelform:
  • injektionsvæske, suspension
  • Brugt til:
  • Dyr
  • Medicin typen:
  • Allopatiske stof

Dokumenter

  • for den brede offentlighed:
  • Oplysningerne indlægssedlen for dette produkt er i øjeblikket ikke tilgængelig, kan du sende en anmodning til vores kundeservice, og vi vil give dig besked, så snart vi er i stand til at opnå det.


    Anmode informationsbrochure for offentligheden.

Lokation

  • Fås i:
  • Ruvax Vet. 25 IE/ml injektionsvæske, suspension
    Danmark
  • Sprog:
  • dansk

Terapeutisk information

  • Terapeutisk gruppe:
  • Svin

Andre oplysninger

Status

  • Kilde:
  • Lægemiddelstyrelsen - Danish Medicines Agency
  • Autorisationsnummer:
  • 14967
  • Sidste ændring:
  • 16-07-2018

Produktresumé

14. juni 2018

PRODUKTRESUMÉ

for

Ruvax Vet., injektionsvæske, suspension

0.

D.SP.NR

8836

1.

VETERINÆRLÆGEMIDLETS NAVN

Ruvax vet.

2.

KVALITATIV OG KVANTITATIV SAMMENSÆTNING

1 dosis (2 ml) indeholder:

Aktivt stof :

Erysipelothrix rhusiopathiae serotype 2 > 1 ELISA U

Adjuvans:

Aluminium hydroxid 4,2 mg

Hjælpestoffer:

Thiomersal 0,2 mg

Natriumclorid 0,15 m til 2 ml

3.

LÆGEMIDDELFORM

Injektionsvæske, suspension

4.

KLINISKE OPLYSNINGER

4.1

Dyrearter

Svin.

4.2

Terapeutiske indikationer

Vaccination mod rødsyge hos svin.

4.3

Kontraindikationer

Ingen kendte.

14967_spc.doc

Side 1 af 3

4.4

Særlige advarsler for hver dyreart

Ingen.

4.5

Særlige forsigtighedsregler vedrørende brugen

Særlige forsigtighedsregler for dyret

Ingen.

Særlige forsigtighedsregler for personer, der administrerer lægemidlet

Ingen.

Andre forsigtighedsregler

Bør omrystes før brug.

4.6

Bivirkninger

Forbigående systemisk reaktion (nedstemthed, temparaturstigning m.v.) kan ses efter

vaccination. Lokal hævelse på injektionsstedet kan forekomme. Vaccinationen kan

medføre hypersensitivitetsreaktioner hos dyr, der er overfølsomme for

rødsygekomponenten.

4.7

Drægtighed, diegivning eller æglægning

Kan anvendes

4.8

Interaktion med andre lægemidler og andre former for interaktion

Ingen kendte.

4.9

Dosering og indgivelsesmåde

Vaccinationsprogram:

Basisvaccination: 2 ml s.c. eller i.m. gentaget efter 4 uger.

Revaccination: Hver 6. måned.

4.10

Overdosering

Ved administration af den dobbelte dosis observeredes ingen særlige symptomer.

4.11

Tilbageholdelsestid

Slagtning: 0 døgn.

5.

FARMAKOLOGISKE OG IMMUNOLOGISKE OPLYSNINGER

Ruvax vet. er en inaktiveret vaccine mod rødsyge hos svin. Vaccinen inducerer immunitet

mod Erysipelothrix rhusiopathiae serotype 1a, 1b og 2 og giver beskyttelse over for de

almindeligt forekommende serotyper og E.rhusiopathiae. Ved vaccination af drægtige søer

opnås passiv immunitet hos afkommet via antistoffer i kolostrum.

14967_spc.doc

Side 2 af 3

6.

FARMACEUTISKE OPLYSNINGER

6.1

Hjælpestoffer

Thiomersal

Natriumchlorid

Renset vand

6.2

Uforligeligheder

Ingen kendte.

6.3

Opbevaringstid

2 år.

Anbrudt flerdosisbeholder skal anvendes inden 24 timer efter anbrud.

6.4

Særlige opbevaringsforhold

Opbevares i køleskab (+2 °C-8 °C).

6.5

Emballage

Hætteglas à 50 ml.

6.6

Særlige forholdsregler ved bortskaffelse af rester af lægemidlet eller affald

Beholder og eventuelt restindhold tilbageleveres til apotek/leverandør eller til kommunal

modtageordning.

7.

INDEHAVER AF MARKEDSFØRINGSTILLADELSEN

Boehringer Ingelheim Animal

Health Nordics A/S

Strødamvej 52

2100 København Ø

8.

MARKEDSFØRINGSTILLADELSESNUMMER

14967.

9.

DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE

23. maj 1996.

10.

DATO FOR ÆNDRING AF TEKSTEN

14. juni 2018

11.

UDLEVERINGSBESTEMMELSE

14967_spc.doc

Side 3 af 3

  • Oplysningerne indlægssedlen for dette produkt er i øjeblikket ikke tilgængelig, kan du sende en anmodning til vores kundeservice, og vi vil give dig besked, så snart vi er i stand til at opnå det.

    Anmode informationsbrochure for offentligheden.



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