AviPro IBD Xtreme Lyophilisate for Suspension

দেশ: যুক্তরাজ্য

ভাষা: ইংরেজি

সূত্র: VMD (Veterinary Medicines Directorate)

সক্রিয় উপাদান:

Infectious bursal disease virus

থেকে পাওয়া:

Lohmann Animal Health GmbH

এটিসি কোড:

QI01AD09

INN (আন্তর্জাতিক নাম):

Infectious bursal disease virus

ফার্মাসিউটিকাল ফর্ম:

Oral lyophilisate

প্রেসক্রিপশন টাইপ:

POM-V - Prescription Only Medicine – Veterinarian

থেরাপিউটিক গ্রুপ:

Chickens

থেরাপিউটিক এলাকা:

Live Viral Vaccine

অনুমোদন অবস্থা:

Authorized

অনুমোদন তারিখ:

2008-05-29

পণ্য বৈশিষ্ট্য

Revised: March 2015
AN: 00880/2014
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
AviPro IBD Xtreme
(alternative FR: AviPro IBD X, ES: AviPro IBDX, HU: AviPro IBD X
vakcina A.U.V.)
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.
4.4
SPECIAL WARNINGS FOR EACH TARGET SPECIES
As described under 4.6.
Page 1 of 5
Revised: March 2015
AN: 00880/2014
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 (b