UNISTRAIN PRRS LYOPHILISATE AND SOLVENT FOR SUSPENSION FOR INJECTION FOR PIGS
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
30-12-2016
Some documents for this product are not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain them.
Send request.
Send request.
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) -
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 indications:
Immunological - Live Vaccine
Authorization status:
Authorised
Authorization date:
2013-03-01
Summary of Product characteristics
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
Read the complete document
