Cevac Transmune Lyophilisate for Suspension for Injection with Solvent for Chickens

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Infectious bursal disease virus

Available from:

Ceva Animal Health Ltd

ATC code:

QI01AD09

INN (International Name):

Infectious bursal disease virus

Pharmaceutical form:

Lyophilisate for suspension for injection

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Chickens

Therapeutic area:

Live Viral Vaccine

Authorization status:

Authorized

Authorization date:

2006-10-20

Summary of Product characteristics

Revised: September 2022
AN: 01484/2022
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
CEVAC TRANSMUNE Lyophilisate for Suspension for Injection with Solvent
for Chickens
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of reconstituted vaccine (0.05 ml in-ovo or 0.1 ml
subcutaneous) contains:
ACTIVE SUBSTANCE:
Live attenuated infectious bursal disease (IBD) virus, strain
Winterfield 2512 at least 0.1
CID
50
*
EXCIPIENTS:
BDA (bursal disease antibody)
at least 90 VN titre**
* CID
50
(Chicken Infective Dose 50%)
** VN titre (virus neutralisation titre)
For a full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Lyophilisate for suspension for injection with solvent.
Pale brown lyophilisate for reconstitution with a water-clear,
colourless or a clear red solvent
provided for injection.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Chickens and embryonated chicken eggs.
4.2
INDICATIONS FOR USE SPECIFYING THE TARGET SPECIES
For the active immunisation of 18-day-old embryonated broiler hatching
eggs or 1-day-old
broiler chickens from hens vaccinated against IBD, to reduce
mortality, clinical disease,
weight loss and acute lesions of bursa of Fabricius associated with
infection caused by very
virulent Avian Infectious Bursal Disease (IBD) viruses.
The release of the vaccine virus from the complex (and therefore
immunisation) is
influenced by the natural decline of maternally derived antibodies
(MDA), and has been
found not to occur until MDA has reached relatively low levels.
The onset of clinical protection depends on the initial MDA level. In
vaccinated broilers it is
achieved within 1 day after the first signs of vaccine virus effect in
the bursa of Fabricius.
Revised: September 2022
AN: 01484/2022
Page 2 of 9
Onset of immunity: between 21 and 32 days of age.
Duration of immunity: up to 42 days of age.
The virulent challenge tests conducted to support the claim were
carried out on broilers
having an MDA ELISA titre of 6,000 (1-day-old chicks).
Field trials carri