HATCHPAK IB H120, FROZEN SUSPENSION FOR NEBULISER

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

LIVE INFECTIOUS BRONCHITIS VIRUS (H120) COMPONENT

Disponibil de la:

Merial Animal Health Limited

Codul ATC:

QI01AD07

INN (nume internaţional):

LIVE INFECTIOUS BRONCHITIS VIRUS (H120) COMPONENT

Dozare:

3.7 to 4.7

Forma farmaceutică:

Frozen suspension for nebuliser suspension

Tip de prescriptie medicala:

POM

Grupul Terapeutică:

Fowl - Chicken

Zonă Terapeutică:

Avian infectious bronchitis virus vaccine

Indicații terapeutice:

Immunological - Live Vaccine

Statutul autorizaţiei:

Authorised

Data de autorizare:

2013-05-24

Caracteristicilor produsului

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
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_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