HATCHPAK IB H120, FROZEN SUSPENSION FOR NEBULISER
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
20-04-2024
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Active ingredient:
LIVE INFECTIOUS BRONCHITIS VIRUS (H120) COMPONENT
Available from:
Merial Animal Health Limited
ATC code:
QI01AD07
INN (International Name):
LIVE INFECTIOUS BRONCHITIS VIRUS (H120) COMPONENT
Dosage:
3.7 to 4.7
Pharmaceutical form:
Frozen suspension for nebuliser suspension
Prescription type:
POM
Therapeutic group:
Fowl - Chicken
Therapeutic area:
Avian infectious bronchitis virus vaccine
Therapeutic indications:
Immunological - Live Vaccine
Authorization status:
Authorised
Authorization date:
2013-05-24
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
HATCHPAK IB H120, frozen suspension for nebuliser suspension.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Frozen suspension for nebuliser suspension. Yellow.
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
Massuchusetts 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.
PER ONE RECONSTITUTED DOSE:
ACTIVE SUBSTANCES:
Live Infectious Bronchitis virus, H120 strain 3.7 to 4.7 log
10
EID
50*
EXCIPIENT(S):
For a full list of excipients, see section 6.1.
* 50 per cent egg infective doses
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 27/05/2013_
_CRN 7014050_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Vaccinate healthy birds only.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS
_-_
Care should be taken when handling the vaccine preparation. The cold gas must not be breathed. The
manipulation should take place only in well ventilated place to preve
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