Ingelvac PRRSFLEX EU lyophilisate and solvent for suspension for injection for pigs

País: Irlanda

Idioma: anglès

Font: HPRA (Health Products Regulatory Authority)

ingredients actius:

Attenuated prrs 94881 virus

Disponible des:

Boehringer Ingelheim Vetmedica GmbH

Codi ATC:

QI09AD03

Designació comuna internacional (DCI):

Attenuated prrs 94881 virus

Dosis:

104.4 - 106.6 tissue culture infective dose 50% / 1 millilitre

formulario farmacéutico:

Lyophilisate and solvent for suspension for injection

tipo de receta:

POM: Prescription Only Medicine as defined in relevant national legislation

Área terapéutica:

porcine reproductive and respiratory syndrome (PRRS) virus

Estat d'Autorització:

Authorised

Data d'autorització:

2015-04-02

Fitxa tècnica

1
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Ingelvac PRRSFLEX EU lyophilisate and Ingelvac PRRSFLEX EU solvent for
suspension for
injection for pigs
(BE, CY, DE, EL, FR, IT, LU)
Ingelvac PRRSFLEX EU lyophilisate and solvent for suspension for
injection for pigs
(AT, BG, CS, EE, ES, HR, HU, IE, LI, 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 (1 ml) contains:
ACTIVE SUBSTANCE
Lyophilisate:
Live attenuated Porcine Reproductive and Respiratory Syndrome Virus
(PRRSV), strain 94881
(genotype 1): 10
4.4
-10
6.6
TCID
50
*
* Tissue Culture Infectious Dose 50%
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 clinically healthy pigs from 17 days of age
until the end of fattening and
older from farms affected with European (genotype 1) Porcine
Reproductive and Respiratory
Syndrome Virus (PRRSV) to reduce virus load in blood in seropositive
animals under field conditions.
Under experimental challenge conditions in which only seronegative
animals were included, it was
demonstrated that vaccination reduces lung lesions, virus load in
blood and lung tissues as well as
negative effects of infection on daily weight gain. A significant
reduction of the respiratory clinical
signs could additionally be demonstrated at the onset of immunity.
Onset of immunity:
3 weeks
Duration of immunity:
26 weeks
4.3
CONTRAINDICATIONS
Do not use in known cases of hypersensitivity to the active substance
or to any of the excipients.
2
Do not use in breeding animals.
Do not use in PRRS naïve herds in which the presence of PRRSV has not
been established using
reliable diagnostic methods.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy ani