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

Land: Írland

Tungumál: enska

Heimild: HPRA (Health Products Regulatory Authority)

Virkt innihaldsefni:

Live attenuated prrs 94881 virus

Fáanlegur frá:

Boehringer Ingelheim Vetmedica GmbH

ATC númer:

QI09AD03

INN (Alþjóðlegt nafn):

Live attenuated prrs 94881 virus

Skammtar:

.

Lyfjaform:

Lyophilisate and solvent for suspension for injection

Gerð lyfseðils:

POM: Prescription Only Medicine as defined in relevant national legislation

Lækningarsvæði:

porcine reproductive and respiratory syndrome (PRRS) virus

Leyfisstaða:

Authorised

Leyfisdagur:

2015-04-02

Vara einkenni

1
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
ReproCyc PRRS EU lyophilisate and ImpranFLEX solvent for suspension
for injection for pigs
(BE, CY, DE, EL, FR, LU)
ReproCyc PRRS EU lyophilisate and solvent for suspension for injection
for pigs
(AT, BG, CZ, EE, ES, HR, HU, IE, LI, LT, LV, NL, PL, PT, RO, SI, SK,
UK)
ReproCyc PRRS EU lyophilisate and ReproCyc PRRS EU solvent for
suspension for injection for pigs
(IT)
The name [the product] will be used in the Product Information
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose (2 ml) contains:
ACTIVE SUBSTANCE
Lyophilisate:
Live attenuated Porcine Reproductive and Respiratory Syndrome Virus
(PRRSV), strain 94881
(genotype 1): 10
3.9
-10
7.0
TCID
50
*
*Tissue Culture Infectious Dose 50%
ADJUVANT
Solvent:
Carbomer: 2.0 mg
EXCIPIENTS:
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
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
2
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.
4.3
CONTRAINDICATIONS
Do not use in case of hypersensitivity to the active substance