Nobilis Gumboro D78 lyophilisate for use in drinking water for chickens

देश: आयरलैंड

भाषा: अंग्रेज़ी

स्रोत: HPRA (Health Products Regulatory Authority)

सक्रिय संघटक:

Gumboro disease virus strain D78

थमां उपलब्ध:

Intervet Ireland Limited

ए.टी.सी कोड:

QI01AD09

INN (इंटरनेशनल नाम):

Gumboro disease virus strain D78

डोज़:

.

फार्मास्यूटिकल फॉर्म:

Lyophilisate for oculonasal suspension/use in drinking water

प्रिस्क्रिप्शन प्रकार:

POM: Prescription Only Medicine as defined in relevant national legislation

चिकित्सीय समूह:

Chickens

चिकित्सीय क्षेत्र:

avian infectious bursal disease virus (gumboro disease)

चिकित्सीय संकेत:

Immunological - Live Vaccine

प्राधिकरण का दर्जा:

Authorised

प्राधिकरण की तारीख:

2003-04-04

उत्पाद विशेषताएं

Health Products Regulatory Authority
05 April 2018
CRN000W0H
Page 1 of 6
1
NAME OF THE VETERINARY MEDICINAL PRODUCT
Nobilis Gumboro D78 live
lyophilisate for use in drinking water for chickens
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
ACTIVE SUBSTANCE:
PER DOSE
Live Gumboro disease virus, (strain D78)
≥10
4.0
TCID
50
EXCIPIENTS:
For a full list of excipients see section 6.1.
3
PHARMACEUTICAL FORM
Lyophilisate for
use in drinking water.
Vials: light brown/reddish brown-coloured pellet.
Cups: light brown/reddish brown, predominantly spherical shaped.
4
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Chickens from 14 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).
Onset of immunity: 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
Vaccinate healthy animals only.
It is only necessary to apply the vaccine once to susceptible birds
and this should be
done as early as possible from 14 days of age. In the field, maternal
antibodies will
exist in the majority of chicks, therefore vaccination before 17 days
for broiler-type
birds and 21 days for replacement layers is not normally recommended
where parent
birds have been injected with an inactivated Gumboro vaccine.
Health Products Regulatory Authority
05 April 2018
CRN000W0H
Page 2 of 6
The properties of D78 are such that the vaccine virus will spread to
in-contact birds
and vaccine virus may increase in virulence on bird to bird passage.
A good immune response is reliant on the reaction of an immunogenic
agent and a
fully competent immune system. Immunogenicity of the vaccine antigen
will be
reduced by poor storage or inappropriate administration.
Immuno-