Porcilis PRRS Lyophilisate and Solvent for Suspension for Injection for Pigs

Valsts: Lielbritānija

Valoda: angļu

Klimata pārmaiņas: VMD (Veterinary Medicines Directorate)

Aktīvā sastāvdaļa:

Porcine respiratory and reproductive syndrome virus

Pieejams no:

MSD Animal Health UK Limited

ATĶ kods:

QI09AD03

SNN (starptautisko nepatentēto nosaukumu):

Porcine respiratory and reproductive syndrome virus

Zāļu forma:

Lyophilisate for suspension for injection

Receptes veids:

POM-V - Prescription Only Medicine – Veterinarian

Ārstniecības grupa:

Pigs

Ārstniecības joma:

Live Viral Vaccine

Autorizācija statuss:

Authorized

Autorizācija datums:

2000-09-21

Produkta apraksts

Revised: December 2021
AN: 01388/2021 & 01389/2021
Page 1 of 8
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.
Revised: December 2021
AN: 01388/2021 & 01389/2021
Page 2 of 8
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: at least 24 weeks.
4.3
CONTRAINDICATIONS
Do not use in herds where the prevalence of European PRRS virus has
not been
established through reliable diagnostic methods.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECI