ReproCyc PRRS EU Lyophilisate and Solvent for Suspension for Injection for Pigs

País: Regne Unit

Idioma: anglès

Font: VMD (Veterinary Medicines Directorate)

ingredients actius:

Porcine respiratory and reproductive syndrome virus

Disponible des:

Boehringer Ingelheim Limited

Codi ATC:

QI09AD03

Designació comuna internacional (DCI):

Porcine respiratory and reproductive syndrome virus

formulario farmacéutico:

Lyophilisate for suspension for injection

tipo de receta:

POM-V - Prescription Only Medicine – Veterinarian

Grupo terapéutico:

Pigs

Área terapéutica:

Live Viral Vaccine

Estat d'Autorització:

Authorized

Data d'autorització:

2015-03-26

Fitxa tècnica

Revised: March 2017
AN: 00665/2016
SUMMARY OF PRODUCT CHARACTERISTICS
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, IT, LI, LU)
ReproCyc PRRS EU lyophilisate and solvent for suspension for injection
for pigs
(AT, BG, CZ, EE, ES, HR, HU, IE, LT, LV, NL, PL, PT, RO, SI, SK, UK)
The name [the product] will be used in the Product Information
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
3.9
TCID
50-
10
7.0
TCID
50*
*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
Page 1 of 6
Revised: March 2017
AN: 00665/2016
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.
4.3
CONTRAINDICATIONS
Do not use in case of hype