AviPro IBD Xtreme Lyophilisate for Suspension

البلد: المملكة المتحدة

اللغة: الإنجليزية

المصدر: VMD (Veterinary Medicines Directorate)

العنصر النشط:

Infectious bursal disease virus

متاح من:

Elanco Europe Ltd

ATC رمز:

QI01AD09

INN (الاسم الدولي):

Infectious bursal disease virus

الشكل الصيدلاني:

Oral lyophilisate

نوع الوصفة الطبية :

POM-V - Prescription Only Medicine – Veterinarian

المجموعة العلاجية:

Chickens

المجال العلاجي:

Live Viral Vaccine

الوضع إذن:

Authorized

تاريخ الترخيص:

2008-05-29

خصائص المنتج

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