HATCHPAK IB H120 NEO Effervescent Tablet for Oculonasal Suspension for Chickens

Country: Միացյալ Թագավորություն

language: անգլերեն

source: VMD (Veterinary Medicines Directorate)

active_ingredient:

Infectious bronchitis virus

MAH:

Boehringer Ingelheim Animal Health UK Ltd

ATC_code:

QI01AD07

INN:

Infectious bronchitis virus

pharmaceutical_form:

Effervescent tablet

prescription_type:

POM-V - Prescription Only Medicine – Veterinarian

therapeutic_group:

Chickens

therapeutic_area:

Live Viral Vaccine

authorization_status:

Authorized

authorization_date:

2017-01-30

SPC

Revised: March 2023
AN: 00871/2022
Page 1 of 5
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
HATCHPAK IB H120 NEO effervescent tablet for oculonasal suspension for
chickens
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
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
Vaccinate healthy animals only.
Revised: March 2023
AN: 00871/2022
Page 2 of 5
4.5
SPECIAL PRECAUTIONS FOR USE
Special precautions for use in animals
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.
4.6
ADVERSE REACTIONS (FREQUENCY AND SERIOUSNESS)
One-day-old chickens:
Very common
(> 1 animal / 10 animals treated):
Bronchial rales*
*not associated with respiratory distress or any general sign, are
very common
b