Ingelvac PRRSFLEX EU Lyophilisate and Solvent for Suspension for Injection for Pigs

Land: Vereinigtes Königreich

Sprache: Englisch

Quelle: VMD (Veterinary Medicines Directorate)

Wirkstoff:

Porcine respiratory and reproductive syndrome virus

Verfügbar ab:

Boehringer Ingelheim Limited

ATC-Code:

QI09AD03

INN (Internationale Bezeichnung):

Porcine respiratory and reproductive syndrome virus

Darreichungsform:

Lyophilisate for suspension for injection

Verschreibungstyp:

POM-V - Prescription Only Medicine – Veterinarian

Therapiegruppe:

Pigs

Therapiebereich:

Live Viral Vaccine

Berechtigungsstatus:

Authorized

Berechtigungsdatum:

2015-03-26

Fachinformation

Revised: September 2015
AN: 00499/2015
SUMMARY OF PRODUCT CHARACTERISTICS
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, LI, LU)
Ingelvac PRRSFLEX 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 (1 ml) contains:
Lyophilisate:
ACTIVE SUBSTANCE
Live attenuated Porcine Respiratory and Reproductive Syndrome Virus
(PRRSV), strain 94881 (genotype 1)
At least: 10
4.4
TCID
50
-10
6.6
TCID
50*
*Tissue Culture Infectious Dose 50
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 (from 17 days of age until the end of fattening)
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of clinically healthy pigs at 17 days of age
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
additionaly be demonstrated at the onset of immunity.
Page 1 of 5
Onset of immunity:3 weeks
Duration of immunity:
26 weeks
4.3
CONTRAINDICATIONS
Do not use in case of hypersensitivity to the active substance or to
any of the
excipients.
Do not use in breeding animals.
Do not use in PRRS naïve herds in which the presence of PRRSV has not
been
established
using