AviPro IBD Xtreme Lyophilisate for Suspension

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Infectious bursal disease virus

Available from:

Elanco Europe Ltd

ATC code:

QI01AD09

INN (International Name):

Infectious bursal disease virus

Pharmaceutical form:

Oral lyophilisate

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Chickens

Therapeutic area:

Live Viral Vaccine

Authorization status:

Authorized

Authorization date:

2008-05-29

Summary of Product characteristics

Revised: December 2020
AN: 01251/2020
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
AviPro IBD Xtreme
Lyophilisate for suspension
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
1 dose contains 10
1.5
- 10
3.0
EID
50
* live intermediate plus IBD (Infectious Bursal Disease)
virus, strain V217.
*EID
50
= 50 % embryo infective dose: the virus titre required to infect 50 %
of the
inoculated embryos.
Host system: embryonated SPF-hen´s eggs
EXCIPIENT(S):
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Lyophilisate for suspension.
Appearance: rose to red brown lyophilisate
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Chickens (from 7 days old)
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of chickens with maternally derived antibodies
(breakthrough titre:
636) to reduce clinical disease, weight loss and acute lesions of the
bursa of Fabricius
associated with infection caused by very virulent avian Infectious
Bursal Disease (IBD)
viruses.
Onset of protection: 2 weeks.
Duration of immunity: 12 weeks based on serology
4.3
CONTRAINDICATIONS
Do not use in unhealthy birds.
Revised: December 2020
AN: 01251/2020
Page 2 of 5
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
As described under 4.6.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
The vaccine strain may spread to unvaccinated chickens, since it is
excreted via the
faeces for at least 9 days. Avoid spreading to laying hens, birds
approaching lay and
young birds below 7 days of age.
The vaccine should not be used in birds without maternally derived
antibodies. Spread of
the vaccine strain to such birds should be prevented.
This vaccine induces serious and prolonged lesions in the bursa of
Fabricius. It should
therefore only be used to compete with very virulent (vv) IBD virus
infection or to induce
immunity in the face of still high maternally derived antibody (MDA)
levels (breakthrough
ELISA titre 636), where vaccines containing mild an