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

Šalis: Didžioji Britanija

kalba: anglų

Šaltinis: VMD (Veterinary Medicines Directorate)

Veiklioji medžiaga:

Porcine respiratory and reproductive syndrome virus

Prieinama:

Boehringer Ingelheim Animal Health UK Ltd

ATC kodas:

QI09AD03

INN (Tarptautinis Pavadinimas):

Porcine respiratory and reproductive syndrome virus

Vaisto forma:

Lyophilisate and solvent for suspension for injection

Recepto tipas:

POM-V - Prescription Only Medicine – Veterinarian

Farmakoterapinė grupė:

Pigs

Gydymo sritis:

Live Viral Vaccine

Autorizacija statusas:

Authorized

Leidimo data:

2015-03-26

Prekės savybės

Revised: March 2022
AN: 01473/2021 and 01474/2021
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Ingelvac PRRSFLEX EU lyophilisate and solvent for suspension for
injection for pigs
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
Revised: March 2022
AN: 01473/2021 and 01474/2021
Page 2 of 6
4.3
CONTRAINDICATIONS
Do not use in known cases 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 reliable diagnostic methods.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
Do not use in boars producing semen for n