CEVAC TRANSMUNE lyophilisate for suspension for injection with solvent for chickens

Država: Irska

Jezik: angleščina

Source: HPRA (Health Products Regulatory Authority)

Aktivna sestavina:

Live, attenuated infectious bursal disease (IBD) virus, strain winterfield 2512, G-61

Dostopno od:

Ceva Santé Animale

Koda artikla:

QI01AD09

INN (mednarodno ime):

Live, attenuated infectious bursal disease (IBD) virus, strain winterfield 2512, G-61

Odmerek:

.

Farmacevtska oblika:

Lyophilisate and solvent for suspension for injection

Tip zastaranja:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapevtska skupina:

Chickens

Terapevtsko območje:

avian infectious bursal disease virus (gumboro disease)

Terapevtske indikacije:

Immunological

Status dovoljenje:

Authorised

Datum dovoljenje:

2007-11-26

Lastnosti izdelka

Health Products Regulatory Authority
03 March 2021
CRN009WH5
Page 1 of 7
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 redsolvent 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.
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).