ReproCyc PRRS EU lyophilisate and solvent for suspension for injection for pigs

Country: Իռլանդիա

language: անգլերեն

source: HPRA (Health Products Regulatory Authority)

active_ingredient:

Live attenuated prrs 94881 virus

MAH:

Boehringer Ingelheim Ltd

ATC_code:

QI09AD03

INN:

Live attenuated prrs 94881 virus

dosage:

.

pharmaceutical_form:

Lyophilisate + solvent for suspension

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_indication:

Immunological - Live Vaccine

authorization_status:

Authorised

authorization_date:

2015-04-02

SPC

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
ReproCyc PRRS EU lyophilisate and solvent for suspension for injection
for pigs.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose (2 ml) contains:
Lyophilisate:
ACTIVE SUBSTANCE
Live attenuated Porcine Respiratory and Reproductive Syndrome Virus
(PRRSV), strain 94881 (genotype 1)
At least: 10
TCID
10
TCID
*Tissue Culture Infectious Dose 50
Solvent:
ADJUVANT
Carbomer: 2.0 mg
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Lyophilisate and solvent for suspension for injection.
Lyophilisate: off-white to milky grey
Solvent: clear, colourless solution
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Pigs (breeding females)
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of breeding females from farms affected with
European (genotype 1) Porcine Reproductive
and Respiratory Syndrome Virus (PRRSV) to reduce the duration of
viraemia, the proportion of viraemic gilts/sows
and viral loads in blood after exposure to PRRSV as shown under
experimental conditions.
Onset of immunity:
4 weeks
Duration of immunity:
17 weeks
Vaccination of breeding females according to the recommended schedule
described in section 4.9 reduces the negative
reproductive disorders associated with PRRSV.
Under experimental challenge conditions a reduction in transplacental
virus transmission after challenge was
additionally demonstrated. In piglets from vaccinated sows, a
reduction in the negative impact of PRRS virus infection
(mortality, clinical signs and weight gain) was also demonstrated
during the first 20 days of life.
3.9
50
-
7.0
50
*
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