HIPRAGUMBORO-G97

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

Live Infectious Bursal Disease Virus, strain GM97

Tilgjengelig fra:

Laboratorios Hipra S.A.

ATC-kode:

QI01AD09

INN (International Name):

Live Infectious Bursal Disease Virus, strain GM97

Dosering :

.

Legemiddelform:

Lyophilisate for oculonasal suspension/use in drinking water

Resept typen:

POM: Prescription Only Medicine as defined in relevant national legislation

Terapeutisk gruppe:

Chickens

Terapeutisk område:

avian infectious bursal disease virus (gumboro disease)

Indikasjoner:

Immunological - Live Vaccine

Autorisasjon status:

Authorised

Autorisasjon dato:

2015-05-29

Preparatomtale

Health Products Regulatory Authority
10 December 2019
CRN009DWR
Page 1 of 4
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
HIPRAGUMBORO-G97
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Composition per dose:
ACTIVE SUBSTANCE:
- Live Infectious Bursal Disease Virus, strain GM97: 10
2
- 10
3
EID
50
(embryo infective dose 50%).
EXCIPIENTS AND ADJUVANTS WHERE KNOWLEDGE OF THIS IS ESSENTIAL FOR THE
SAFE ADMINISTRATION OF THE MEDICINAL PRODUCT:
None.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Lyophilisate for oral suspension.
Appearance: reddish tablet.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Species: Chickens.
Category: Broilers.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of broilers with insignificant levels of
maternally derived antibodies (ELISA of 500 or below) to reduce
mortality, clinical signs and bursal lesions of Gumboro disease. Such
birds can be vaccinated from one day of age. The onset of
immunity is 14 days post vaccination and the duration 43 days post
vaccination.
4.3 CONTRAINDICATIONS
Do not vaccinate sick birds.
Do not use in infected flocks showing clinical signs.
Since no studies to demonstrate the safety of this vaccine when it is
administered to layers and breeders have been carried out,
its use is not recommended for these categories of the target species
(see section 4.7).
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Use only in flocks with low levels of maternal antibodies (mean ELISA
titres ≤500). The optimum day of vaccination of broilers
with maternal antibodies is calculated according to the
Kouwenhoven’s formula (see section 4.9 posology).
Due to its residual pathogenicity to the bursa the vaccine should be
used only in areas contaminated with vvIBDV, except for
infected flocks showing clinical signs.
See section 4.3.
Health Products Regulatory Authority
10 December 2019
CRN009DWR
Page 2 of 4
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
- Do not use water with chlorine