Unistrain 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:

Laboratorios Hipra SA

ATC code:

QI09AD03

INN (International Name):

Porcine respiratory and reproductive syndrome virus

Pharmaceutical form:

Lyophilisate and solvent for solution for injection

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Pigs

Therapeutic area:

Live Viral Vaccine

Authorization status:

Authorized

Authorization date:

2013-03-06

Summary of Product characteristics

Revised: February 2022
AN: 00003/2021 & 00004/2021
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Unistrain PRRS lyophilisate and solvent for suspension for injection
for pigs.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose contains:
Freeze-dried powder:
Active substance:
Live attenuated Porcine reproductive and respiratory syndrome virus
(PRRSV),
strain VP-046 BIS
………………………………………………………………….…
10
3.5
-10
5.5
CCID
50
(_cell culture infectious dose_)
Solvent:
Phosphate buffer solution.
Excipients:
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lyophilisate and solvent for suspension for injection.
Lyophilisate: white to yellowish powder.
Solvent: Homogeneous-clear solution.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Breeding females: For active immunisation of breeding females from
farms
affected with European PRRS virus to reduce reproductive disorders,
incidence
and duration of viraemia, transplacental virus transmission, virus
tissue load and
clinical signs in the offspring associated with infection with strains
of PRRS virus.
Under laboratory conditions, vaccination of females reduced the
negative impact
of PRRS virus infection on piglet performance (mortality and weight
gain) within
the first 28 days of life.
Onset of immunity: 30 days after vaccination.
Revised: February 2022
AN: 00003/2021 & 00004/2021
Page 2 of 9
Duration of immunity: 16 weeks after vaccination.
Pigs from 4 weeks of age: For active immunisation of pigs from farms
affected
with European PRRS virus to reduce clinical signs associated with a
PRRS virus
infection, the incidence and duration of viraemia and the duration of
virus
shedding by infected animals. Under experimental conditions, it was
demonstrated that vaccination reduces the virus tissue load in the
lungs. Under
field conditions, where a PRRSV infection occurred during the
fattening period, a
reduc