Porcilis PRRS Lyophilisate and Solvent for Suspension for Injection for Pigs

Pays: Royaume-Uni

Langue: anglais

Source: VMD (Veterinary Medicines Directorate)

Ingrédients actifs:

Porcine respiratory and reproductive syndrome virus

Disponible depuis:

Intervet International BV

Code ATC:

QI09AD03

DCI (Dénomination commune internationale):

Porcine respiratory and reproductive syndrome virus

forme pharmaceutique:

Lyophilisate for suspension for injection

Type d'ordonnance:

POM-V - Prescription Only Medicine – Veterinarian

Groupe thérapeutique:

Pigs

Domaine thérapeutique:

Live Viral Vaccine

Statut de autorisation:

Authorized

Date de l'autorisation:

2000-09-21

Résumé des caractéristiques du produit

Revised: July 2020
AN: 01503/2019
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
Each dose of 2 ml (intramuscular application) or 0.2 ml (intradermal
application) of
reconstituted vaccine contains:
Lyophilisate:
ACTIVE SUBSTANCE:
Live attenuated PRRS virus strain DV: 10
4.0
- 10
6.3
TCID
50
*
Solvent:
ADJUVANT:
dl-

-tocopheryl acetate: 75 mg/ml
For the full list of excipients, see section 6.1.
*
tissue culture infective dose 50 %
3.
PHARMACEUTICAL FORM
Lyophilisate and solvent for suspension for injection.
Lyophilisate: light yellow to white cake.
Solvent: white solution.
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 transmission
after challenge was
observed in vaccinated pigs.
The interest of vaccination with Porcilis PRRS lies in obtaining a
homogeneous and high
immune status against PRRS virus in a herd.
Page 1 of 7
Revised: July 2020
AN: 01503/2019
Onset of immunity: 28 days post vaccination.
Duration of immunity: at least 24 weeks.
4.3
CONTRAINDICATIONS
Do not use in herds where the prevalence of European PRRS virus has
not been
estab