NOBILIS GUMBORO 228E

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

GUMBORO DISEASE VIRUS STRAIN 228E LIVE

Available from:

Intervet Ireland Limited

ATC code:

QI01AD09

INN (International Name):

GUMBORO DISEASE VIRUS STRAIN 228E LIVE

Dosage:

%v/v

Pharmaceutical form:

Powder for Oral Solution

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:

2004-11-12

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Nobilis Gumboro 228E.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
per dose (ml)
Live Gumboro virus strain 228E
2.0 log
10
EID
50
*
* EID
50
= Egg Infective dose 50%
EXCIPIENT(S)
For a full list of excipients see section 6.1
3 PHARMACEUTICAL FORM
Powder for Oral Solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Chickens from 10 days of age.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the active immunisation of chickens to reduce mortality, clinical signs and/or lesions of Infectious Bursal Disease
(Gumboro) Infectious Bursal Disease (Gumboro disease).
Onset of immunity: Immunity develops within 7 days.
Duration of immunity: Data from the field shows that broilers are protected throughout the rearing period and breeder
and layers birds are protected at least until the protection is boosted by use of an inactivated vaccine before the onset of
lay.
4.3 CONTRAINDICATIONS
None.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
The vaccine virus may spread and care should be taken to prevent spread of the vaccine strain to non-vaccinated birds.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 30/04/2012_
_CRN 7012195_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Do not use in unhealthy birds. Sick or weak birds will not develop adequate immunity following vaccination.
The properties of the vaccine virus are such that the virus may spread to in-contact birds. Care should be taken to
ensure that the vaccine virus does not spread to unvaccinated birds.
A good immune response is reliant on the reaction of an immunogenic agent and a fully competent immune