Persovac 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:

Ceva Animal Health Ltd

ATC code:

QI09AD03

INN (International Name):

Porcine respiratory and reproductive syndrome virus

Pharmaceutical form:

Lyophilisate and solvent for suspension for injection

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Pigs

Therapeutic area:

Live Viral Vaccine

Authorization status:

Expired

Authorization date:

2020-02-26

Summary of Product characteristics

Issued: February 2020
AN: 00939/2018
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Persovac lyophilisate and solvent for suspension for injection for
pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose (1 ml) contains:
ACTIVE SUBSTANCE:
Live porcine reproductive and respiratory syndrome (PRRS) virus strain
P120: 4.0 –
7.3 log
10
CCID
50
*
*CCID
50
Cell culture infective dose 50%
EXCIPIENT:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lyophilisate and solvent for suspension for injection
Lyophilisate: off-white, homogeneous pellet.
Solvent: clear aqueous solution.
The reconstituted product is a white, opalescent liquid.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs (for fattening)
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of pigs from 3 weeks of age in a PRRS virus
contaminated
environment, in order to reduce viraemia associated with European PRRS
virus
strains (genotype 1) infection.
Onset of immunity: 3 weeks post vaccination
Duration of immunity: 24 weeks post vaccination
In a laboratory trial in seronegative piglets vaccinated at the age of
32 days, a
reduction of titre and overall nasal shedding was observed after a
challenge 5 weeks
after vaccination.
4.3
CONTRAINDICATIONS
Do not use in PRRS naïve herds in which the presence of PRRSV has not
been
established using reliable diagnostic methods.
Do not use in boars producing semen, as PRRS virus can be shed in
semen.
Issued: February 2020
AN: 00939/2018
Page 2 of 5
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Care should be taken to avoid the introduction of the vaccine strain
into an area
where PRRS virus is not already present. The vaccine strain is
excreted and thus
may infect the susceptible pigs in contacts with vaccinated animals
for at least 7
weeks. To avoid this infection, it is advised to vaccinate all target
pigs within a herd
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