BadgerBCG

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Mycobacterium bovis subsp. bovis

Available from:

Animal and Plant Health Agency

ATC code:

QI20XE01

INN (International Name):

Mycobacterium bovis subsp. bovis

Pharmaceutical form:

Lyophilisate and solvent for suspension for injection

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Badger

Therapeutic area:

Live Bacterial Vaccine

Authorization status:

Authorized

Authorization date:

2010-03-24

Summary of Product characteristics

Revised: October 2020
AN: 00027/2020
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
BadgerBCG
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
LYOPHILISED VACCINE:
Active substance:
_Mycobacterium bovis_ Bacille Calmette Guérin (BCG)
Danish Strain 1331
2-8 × 10
6
colony
forming units (cfu)
DILUENT:
Sauton diluent
1 mL
For full list of excipients, see Section 6.1.
3.
PHARMACEUTICAL FORM
Lyophilisate and solvent for suspension for injection.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Eurasian Badgers (_Meles meles_)
4.2
INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the active immunisation of badgers to reduce lesions of
tuberculosis caused
by _Mycobacterium bovis_.
For use in badgers from the age at which they emerge from the sett.
Onset of immunity is 17 weeks. This is a Limited Marketing
Authorisation.
Duration of immunity is unknown.
However, annual vaccination on a population basis is recommended in
view of
the estimated 30% rate of turnover including new cubs and badger
movement.
4.3
CONTRAINDICATIONS
None
4.4
SPECIAL WARNINGS
None
Revised: October 2020
AN: 00027/2020
Page 2 of 5
4.5
SPECIAL PRECAUTIONS FOR USE
i.
Special precautions for use in animals
None
ii.
Special precautions to be taken by the person administering the
veterinary
medicinal product to animals
BadgerBCG should not be handled by persons receiving systemic
corticosteroids or immunosuppressive treatment including radiotherapy,
those suffering from malignant conditions (e.g., lymphoma, leukaemia,
Hodgkin’s disease or other tumours of the reticulo-endothelial
system),
those with primary or secondary immunodeficiencies, those with HIV-
infection. The reaction to self injection and infection with Bacille
Calmette
Guérin (BCG) may be exaggerated in these persons, and a generalised
BCG-infection is possible.
In case of accidental self-injection, seek medical advice immediately
and
show the package leaflet or the label to the physician.
To the physician:
BadgerBCG is a 1ml dose of the identical AJ