CEVAC TRANSMUNE LYOPHILISATE FOR SUSPENSION FOR INJECTION WITH SOLVENT FOR CHICKENS
Țară: Irlanda
Limbă: engleză
Sursă: HPRA (Health Products Regulatory Authority)
Caracteristicilor produsului
(SPC)
17-03-2016
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Ingredient activ:
LIVE, ATTENUATED INFECTIOUS BURSAL DISEASE (IBD) VIRUS, STRAIN WINTERFIELD 2512, G-61
Disponibil de la:
Ceva Santé Animale
Codul ATC:
QI01AD09
INN (nume internaţional):
LIVE, ATTENUATED INFECTIOUS BURSAL DISEASE (IBD) VIRUS, STRAIN WINTERFIELD 2512, G-61
Dozare:
Unknown
Forma farmaceutică:
Lyophilisate and solvent for suspension for injection
Tip de prescriptie medicala:
POM
Grupul Terapeutică:
Fowl - Chicken
Zonă Terapeutică:
Avian infectious bursal disease virus vaccine (Gumboro disease)
Indicații terapeutice:
Immunological
Statutul autorizaţiei:
Authorised
Data de autorizare:
2007-11-26
Caracteristicilor produsului
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
CEVAC TRANSMUNE lyophilisate for suspension for injection with solvent for chicken
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One in ovo dose (0.05 ml) or subcutaneous dose (0.1 ml) contains:
Live attenuated IBD virus, strain Winterfield 2512
at least 0.1 CID
50
*
Excipients:
BDA (bursal disease antibody)
at least 90 VN titre**
Other
qs 1 dose
Solvent
qs 1 dose
* 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 solvent provided for injection.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Chickens, 18-day-old embryonated broiler hatching eggs or 1-day-old broiler chickens, from hens vaccinated against
IBD.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the active immunisation of chickens 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. In practice, this is expected to occur between 21
and 32 days of age in target broiler flocks.
Duration of immunity: up to 42 days of age.
The virulent challenges tests conducted to su
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