Cevac IBD 2512 L Lyophilisate for Oral Suspension for Chickens

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: VMD (Veterinary Medicines Directorate)

Δραστική ουσία:

Infectious bursal disease virus

Διαθέσιμο από:

Ceva Animal Health Ltd

Φαρμακολογική κατηγορία (ATC):

QI01AD09

INN (Διεθνής Όνομα):

Infectious bursal disease virus

Φαρμακοτεχνική μορφή:

Lyophilisate for Oral Suspension

Τρόπος διάθεσης:

POM-V - Prescription Only Medicine – Veterinarian

Θεραπευτική ομάδα:

Chickens

Θεραπευτική περιοχή:

Live Viral Vaccine

Καθεστώς αδειοδότησης:

Authorized

Ημερομηνία της άδειας:

2012-11-07

Αρχείο Π.Χ.Π.

Revised: October 2022
AN: 01549/2022
Page 1 of 6
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 infectious bursal disease (IBD) virus strain, Winterfield 2512,
G-61
2.0 log10 to 3.2
log10 EID50*/dose
* EID50 (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.).
Revised: October 2022
AN: 01549/2022
Page 2 of 6
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.
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
Vaccinate healthy birds only.
It is not recommended to vaccinate birds younger than 10 days of age,
regardless of the
level of maternally derived antibodies (see section 4.9).
The vaccine contains an “intermediate-plus” virus strain, causing
significant
immunosuppressio