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Revised: December 2011
AN: 00178/2011
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Porcilis PRRS
Lyophilisate and solvent for suspension for injection for pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Per dose of 2 ml (intramuscular application) or 0.2 ml (intradermal application) of
reconstituted vaccine:
Lyophilisate:
ACTIVE SUBSTANCE:
Live attenuated PRRS virus strain DV: 10
4.0
- 10
6.3
TCID
50
*
Solvent (Diluvac Forte):
ADJUVANT:
dl-
-tocopheryl acetate: 75 mg/ml
For a full list of excipients, see section 6.1.
*
tissue culture infective dose 50 %
3.
PHARMACEUTICAL FORM
Lyophilisate and solvent for suspension for injection.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of clinically healthy pigs in a PRRS virus contaminated
environment, to reduce viraemia caused by infection with European strains of PRRS
virus.
SPECIFIC CLAIMS
For finishing pigs, the effect of the virus on the respiratory system is most relevant.
A significant improvement of rearing results (reduced morbidity due to PRRS
infection, and a better daily growth and feed conversion) until the end of the
fattening period was observed in vaccinated pigs during field trials, particularly in
piglets vaccinated at 6 weeks of age.
For breeding pigs, the effect of the virus on the reproductive system is most
relevant. A significant improvement of the reproductive performance in PRRS virus
contaminated environments and a reduction of transplacental virus trans
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