HATCHPAK IB H120, frozen suspension for nebuliser suspension

Country: Ирска

Језик: Енглески

Извор: HPRA (Health Products Regulatory Authority)

Активни састојак:

Live infectious bronchitis virus (H120) component

Доступно од:

Boehringer Ingelheim Vetmedica GmbH

АТЦ код:

QI01AD07

INN (Међународно име):

Live infectious bronchitis virus (H120) component

Дозирање:

.

Фармацеутски облик:

Frozen suspension for nebuliser suspension

Тип рецептора:

POM: Prescription Only Medicine as defined in relevant national legislation

Терапеутска област:

avian infectious bronchitis virus

Статус ауторизације:

Authorised

Датум одобрења:

2013-05-24

Карактеристике производа

Health Products Regulatory Authority
07 December 2018
CRN008MQ5
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
HATCHPAK IB H120, frozen suspension for nebuliser suspension
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
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
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.
Health Products Regulatory Authority
07 December 2018
CRN008MQ5
Page 2 of 6
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.
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
prevent fatal suffocation_._
- Wear protective gloves and spectacles during the ampoule thawing and
opening
operations. Skin contact with liquid nitrogen must be prevented as it
can cause tissue
freezing, resulting in severe burns.
- Open ampoules holdin