CEVAC IBD 2512 L LYOPHILISATE FOR ORAL SUSPENSION FOR CHICKENS

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

LIVE INFECTIOUS BURSAL DISEASE (IBD) VIRUS STRAIN, WINTERFIELD 2512, G-61

Available from:

Ceva Santé Animale

ATC code:

QI01AD09

INN (International Name):

LIVE INFECTIOUS BURSAL DISEASE (IBD) VIRUS STRAIN, WINTERFIELD 2512, G-61

Dosage:

min. 2.0

Pharmaceutical form:

Lyophilisate for suspension

Prescription type:

POM

Therapeutic group:

Fowl - Chicken

Therapeutic area:

Avian infectious bursal disease virus vaccine (Gumboro disease)

Therapeutic indications:

Immunological - Live Vaccine

Authorization status:

Authorised

Authorization date:

2012-12-14

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Cevac IBD 2512 L lyophilisate for oral suspension for chickens
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
One dose contains:
ACTIVE SUBSTANCE:
Live avian infectious bursal disease (IBD) virus, strain Winterfield
2512, G-61
2.0 log
10
to 3.2 log
10
EID
50
*/dose
* EID
50
– embryo infectious dose 50%
EXCIPIENTS:
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Lyophilisate for oral suspension.
Blue freeze-dried powder.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Chickens (broilers)
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the active immunization of broiler chickens from 10 days of age
with maternally-derived antibodies against avian
infectious bursal disease (IBD, Gumboro disease), to reduce mortality,
clinical symptoms, weight loss and acute lesions
in bursa of Fabricius, caused by very virulent infectious bursal
disease virus.
Onset of immunity: 14 days post-vaccination.
Duration of immunity: 27 days post-vaccination.
4.3 CONTRAINDICATIONS
Do not use in infected flocks with clinical symptoms.
Do not use for immunisation of flocks without maternally derived
antibodies (MDA). (See section 4.5.).
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
The vaccine contains an “intermediate-plus” virus strain that is
known to cause immunosuppression and bursal damage
when inoculated into birds without MDA (see sections 4.5, 4.6 and 5.).
Consequently, the vaccine is only indicated for
immunisation of chicken having maternal antibodies and exposed to very
virulent IBD virus strains.
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