Vepured Suspension for Injection for Pigs

Pays: Royaume-Uni

Langue: anglais

Source: VMD (Veterinary Medicines Directorate)

Ingrédients actifs:

Genetically modified recombinant Stx2e antigen

Disponible depuis:

Laboratorios Hipra SA

Code ATC:

QI09AB02

DCI (Dénomination commune internationale):

Genetically modified recombinant Stx2e antigen

forme pharmaceutique:

Suspension for injection

Type d'ordonnance:

POM-V - Prescription Only Medicine – Veterinarian

Groupe thérapeutique:

Pigs

Domaine thérapeutique:

Inactivated Bacterial Vaccine

Statut de autorisation:

Authorized

Date de l'autorisation:

2017-07-18

Résumé des caractéristiques du produit

Renewed Indefinitely: March 2022
AN: 02840/2021
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
VEPURED suspension for injection for pigs
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of 1 ml contains:
ACTIVE SUBSTANCE:
Recombinant verotoxin 2e of _E.
coli_.............................................
RP* ≥ 1.50
* RP – relative potency (ELISA)
ADJUVANTS:
Aluminium hydroxide (Al
3+
) ..........................................................
2.117 mg
DEAE-dextran.................................................................................10
mg.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
Whitish suspension.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Pigs.
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Active immunisation of piglets from 2 days of age to prevent mortality
and reduce
clinical signs of oedema disease (caused by verotoxin 2e produced by
_E. coli_) and to
reduce the loss of daily weight gain during the finishing period in
the face of
infections with verotoxin 2e producing _E. coli _until slaughter from
164 days of age.
Onset of immunity:
21 days after vaccination.
Duration of immunity:
112 days after vaccination.
4.3
CONTRAINDICATIONS
Do not use in cases of hypersensitivity to the active substance, to
the adjuvants or to
any of the excipients.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccinate healthy animals only.
Renewed Indefinitely: March 2022
AN: 02840/2021
Page 2 of 4
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Not applicable.
Special precautions to be taken by the person administering the
veterinary medicinal
product to animals
Not applicable.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
Very common adverse reactions:
- Mild inflammation at the injection site (< 5 cm in diameter) that
typically
resolves within three days post-vaccination without treatment.
- Mild depression during the day of vaccination.
- Temperature rise of maximum 1.1 °