Porcilis PRRS Lyophilisate and Solvent for Suspension for Injection for Pigs

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: VMD (Veterinary Medicines Directorate)

Δραστική ουσία:

Porcine respiratory and reproductive syndrome virus

Διαθέσιμο από:

MSD Animal Health UK Limited

Φαρμακολογική κατηγορία (ATC):

QI09AD03

INN (Διεθνής Όνομα):

Porcine respiratory and reproductive syndrome virus

Φαρμακοτεχνική μορφή:

Lyophilisate for suspension for injection

Τρόπος διάθεσης:

POM-V - Prescription Only Medicine – Veterinarian

Θεραπευτική ομάδα:

Pigs

Θεραπευτική περιοχή:

Live Viral Vaccine

Καθεστώς αδειοδότησης:

Authorized

Ημερομηνία της άδειας:

2000-09-21

Αρχείο Π.Χ.Π.

Revised: November 2023
AN: 02481/2023
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 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
For the full list of excipients, see section 6.1.
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.
Onset of immunity: 28 days post vaccination.
Revised: November 2023
AN: 02481/2023
Page 2 of 8
Duration of immunity: 24 weeks post vaccination.
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 SPECIES
No data are availab