Porcilis PRRS lyophilisate and solvent for suspension for injection for pigs

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

Porcine reproductive respiratory syndrome (prrs) virus strain dv live

Disponible desde:

Intervet Ireland Limited

Código ATC:

QI09AD03

Designación común internacional (DCI):

Porcine reproductive respiratory syndrome (prrs) virus strain dv live

Dosis:

.

formulario farmacéutico:

Lyophilisate and solvent for suspension for injection

tipo de receta:

POM: Prescription Only Medicine as defined in relevant national legislation

Grupo terapéutico:

Pigs

Área terapéutica:

porcine reproductive and respiratory syndrome (PRRS) virus

indicaciones terapéuticas:

Immunological - Live Vaccine

Estado de Autorización:

Authorised

Fecha de autorización:

2003-06-06

Ficha técnica

1
September 2021
SUMMARY OF PRODUCT CHARACTERISTICS
2
June 2022
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-
α
-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.
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
3
June 2022
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 prevalence of European PRRS virus has
not b