UNISTRAIN PRRS LYOPHILISATE AND SOLVENT FOR SUSPENSION FOR INJECTION FOR PIGS

Country: Իռլանդիա

language: անգլերեն

source: HPRA (Health Products Regulatory Authority)

active_ingredient:

LIVE ATTENUATED PRRSV, STRAIN VP-046 BIS

MAH:

Laboratorios Hipra S.A.

ATC_code:

QI09AD03

INN:

LIVE ATTENUATED PRRSV, STRAIN VP-046 BIS

dosage:

10(3.5) -

pharmaceutical_form:

Lyophilisate and solvent for suspension for injection

prescription_type:

POM

therapeutic_group:

Porcine

therapeutic_area:

Porcine reproductive and respiratory syndrome (PRRS) virus vaccine

therapeutic_indication:

Immunological - Live Vaccine

authorization_status:

Authorised

authorization_date:

2013-03-01

SPC

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 of 2 ml contains:
Freeze-dried powder:
Active substance:
Live attenuated Porcine reproductive and respiratory syndrome virus (PRRSV), strain VP-046 BIS
………………………………………………………....……………………….… 103.5-105.5 CCID50
(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 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. The onset of immunity is 30 days after vaccination and the duration of immunity is 16
weeks demonstrated by challenge.
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 th