HIPRAGUMBORO-G97
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
13-06-2015
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Active ingredient:
LIVE INFECTIOUS BURSAL DISEASE VIRUS, STRAIN GM97
Available from:
Laboratorios Hipra S.A.
ATC code:
QI01AD09
INN (International Name):
LIVE INFECTIOUS BURSAL DISEASE VIRUS, STRAIN GM97
Dosage:
Unknown
Pharmaceutical form:
Lyophilisate for suspension
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:
2015-05-29
Summary of Product characteristics
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).
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 29/05/2015_
_CRN 7019891_
_page number: 1_
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 res
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