UNISTRAIN PRRS lyophilisate and solvent for suspension for injection for pigs

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Live attenuated prrsv, strain vp-046 bis

Available from:

Laboratorios Hipra S.A.

ATC code:

QI09AD03

INN (International Name):

Live attenuated prrsv, strain vp-046 bis

Dosage:

10(3.5) - 10(5.5) cell culture infective dose 50/dose

Pharmaceutical form:

Lyophilisate and solvent for suspension for injection

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Pigs

Therapeutic area:

porcine reproductive and respiratory syndrome (PRRS) virus

Therapeutic indications:

Immunological - Live Vaccine

Authorization status:

Authorised

Authorization date:

2013-03-01

Summary of Product characteristics

Health Products Regulatory Authority
31 January 2022
CRN00C90R
Page 1 of 7
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.
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.
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 reduction