Porcilis PRRS Lyophilisate and Solvent for Suspension for Injection for Pigs

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Porcine respiratory and reproductive syndrome virus

Available from:

MSD Animal Health UK Limited

ATC code:

QI09AD03

INN (International Name):

Porcine respiratory and reproductive syndrome virus

Pharmaceutical form:

Lyophilisate for suspension for injection

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Pigs

Therapeutic area:

Live Viral Vaccine

Authorization status:

Authorized

Authorization date:

2000-09-21

Summary of Product characteristics

Revised: September 2023
AN: 00878/2022
Page 1 of 9
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 injection) 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
*
*
tissue culture infective dose 50 %
Solvent:
ADJUVANT:
dl-

-tocopheryl acetate: 75 mg/ml
EXCIPIENTS:
QUALITATIVE COMPOSITION OF EXCIPIENTS AND OTHER
CONSTITUENTS
_Lyophilisate:_
culture medium
chemically defined stabiliser CD#279 (patented)
_Solvent:_
polysorbate 80
sodium chloride
potassium dihydrogen phosphate
disodium phosphate dihydrate
simethicone
water for injection
Lyophilisate: light yellow to white cake.
Solvent: white solution.
Revised: September 2023
AN: 00878/2022
Page 2 of 9
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Pigs.
3.2
INDICATIONS FOR USE FOR EACH 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.
Onset of immunity: 28 days post vaccination.
Duration of immunity: 24 weeks post vaccination.
3.3
CONTRAINDICATIONS
Do not use in herds where the preva