HATCHPAK IB H120 NEO Effervescent Tablet for Oculonasal Suspension for Chickens

国家: 英国

语言: 英文

来源: VMD (Veterinary Medicines Directorate)

有效成分:

Infectious bronchitis virus

可用日期:

Boehringer Ingelheim Animal Health UK Ltd

ATC代码:

QI01AD07

INN（国际名称）:

Infectious bronchitis virus

药物剂型:

Effervescent tablet

处方类型:

POM-V - Prescription Only Medicine – Veterinarian

治疗组:

Chickens

治疗领域:

Live Viral Vaccine

授权状态:

Authorized

授权日期:

2017-01-30

产品特点

Revised: March 2023
AN: 00862/2022
Page 1 of 6
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
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.
Revised: March 2023
AN: 00862/2022
Page 2 of 6
3.4
SPECIAL WARNINGS
Vaccinate healthy animals only.
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 respiratory distress or any general sign bet