Hipragumboro CW Lyophilisate for use in drinking water

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Avian infectious bursal disease virus, live

Available from:

Laboratorios Hipra S.A.

ATC code:

QI01AD09

INN (International Name):

Avian infectious bursal disease virus, live

Dosage:

.

Pharmaceutical form:

Lyophilisate for use in drinking water

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic area:

avian infectious bursal disease virus (gumboro disease)

Authorization status:

Authorised

Authorization date:

2018-12-07

Summary of Product characteristics

1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
HIPRAGUMBORO CW Lyophilisate for use in drinking water.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
EACH DOSE CONTAINS:
ACTIVE SUBSTANCE:
Live attenuated infectious bursal disease virus, strain
CH/80…………….. 10
3.5
– 10
5.5
CCID
50
*
*cell culture infective dose 50 %.
EXCIPIENT:
QUALITATIVE
COMPOSITION OF EXCIPIENTS AND
OTHER CONSTITUENTS
Disodium phosphate dodecahydrate
Potassium dihydrogen phosphate
Povidone
Potassium chloride
Sodium chloride
Sucrose
Monosodium glutamate
Water for injections
Lyophilisate: Brown freeze-dried lyophilisate.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
Chickens.
3.2
INDICATIONS FOR USE FOR EACH TARGET SPECIES
For active immunisation of chicken (broilers) with maternally derived
antibodies (MDA ELISA
breakthrough titre of 115) to prevent clinical signs and to reduce
loss of weight and bursal damage
caused by Gumboro Disease.
Onset of immunity: 14 days post vaccination.
Duration of immunity: 30 days post vaccination.
3.3
CONTRAINDICATIONS
None.
3.4
SPECIAL WARNINGS
Vaccinate healthy animals only.
The optimal day of vaccination is calculated according to the
Deventer’s formula, applying an ELISA
titre of 115 as the MDA breakthrough titre.
3.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the target species:
Vaccinated chickens may excrete the vaccine strain up to 10 days
following vaccination. During this
time, the vaccine strain can spread to unvaccinated chicken.
Appropriate veterinary and husbandry measures should be taken to avoid
spread of the vaccine strain to
susceptible species.
The vaccine should not be used in birds without maternally derived
antibodies (MDA).
Special precautions to be taken by the person administering the
veterinary medicinal product to animals:
Personal protective equipment consisting of impervious gloves should
be worn when handling the
veterinary medicinal product.
Wash and disinfect hands and equipment after use.
In case of accidental ingestion, contact with the eyes, or spillage
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