HATCHPAK IB H120 NEO effervescent tablet for nebuliser suspension for chickens

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Live avian infectious bronchitis virus (strain h120)

Available from:

Merial Animal Health Limited

ATC code:

QI01AD07

INN (International Name):

Live avian infectious bronchitis virus (strain h120)

Dosage:

.

Pharmaceutical form:

Effervescent tablet

Prescription type:

POM: Prescription Only Medicine as defined in relevant national legislation

Therapeutic group:

Chickens

Therapeutic area:

avian infectious bronchitis virus

Therapeutic indications:

Immunological - Live Vaccine

Authorization status:

Authorised

Authorization date:

2017-02-10

Summary of Product characteristics

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
HATCHPAK IB H120 NEO effervescent tablet for nebuliser suspension for
chickens
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
EACH DOSE CONTAINS:
ACTIVE SUBSTANCE:
Live Infectious Bronchitis virus, H120
strain........................... 3.7 to 4.7 log10 EID
50
(*)
(*) EID
50
: 50 per cent egg infective doses
EXCIPIENT(S):
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Effervescent tablet for nebuliser suspension.
Orange mottled, round tablet.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
One day old chickens.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
In one
day-old chickens:
active
immunisation against
Infectious
Bronchitis
in order
to reduce
infection with
Massachusetts serotype of Infectious Bronchitis virus.
Onset of immunity: 21 days
Duration of immunity: 6 weeks after a single administration.
4.3 CONTRAINDICATIONS
None.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Vaccine viruses can spread to unvaccinated birds.
Infection of unvaccinated chickens with the vaccine virus from
vaccinated birds does not cause any signs of disease.
Reversion to virulence trials carried out in the laboratory have
shown that the vaccine viruses do not acquire any pathogenic
characteristics after at least 5 passages in chickens.
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