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:

Boehringer Ingelheim Vetmedica GmbH

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 area:

avian infectious bronchitis virus

Authorization status:

Authorised

Authorization date:

2017-02-10

Summary of Product characteristics

2
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
HATCHPAK IB H120 NEO effervescent tablet for oculonasal suspension for
chickens
(FR, BE, CY, DE, EL, ES, IE, IT, NL, SI, UK(NI))
HATCHPAK IB H120 effervescent tablet for oculonasal suspension
(FI, IS, SE, DK)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
EACH DOSE CONTAINS:
ACTIVE SUBSTANCE:
Live Infectious Bronchitis virus, H120 strain
.................................................... 3.7 to 4.7 log
10
EID
50
(*)
(*) EID
50
: 50 per cent egg infective dose
EXCIPIENTS:
QUALITATIVE COMPOSITION
_Citric acid, anhydrous _
_Sodium hydrogen carbonate _
_Magnesium stearate _
_Sunset Yellow FCF (E 110) _
_Casein hydrolysate _
_D-Mannitol _
_Sodium hydroxide _
Orange mottled, round tablet.
3.
CLINICAL INFORMATION
3.1
TARGET SPECIES
One-day-old chickens.
3.2
INDICATIONS FOR USE FOR EACH 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.
3.3
CONTRAINDICATIONS
None.
3.4
SPECIAL WARNINGS
Vaccinate healthy animals only.
3
3.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for safe use in the 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.
Special precautions to be taken by the person administering the
veterinary medicinal product to
animals:
Wear respiratory and eye protection during spraying.
Wash and disinfect hands and equipment after vaccinating.
Special precautions for the protection of the environment:
Not applicable.
3.6
ADVERSE EVENTS
One-day-old chickens:
Very common
(> 1 animal / 10 animals treated):
Bronchial rales*
* not associated with respirato