GALLIVAC IB88

Ülke: İrlanda

Dil: İngilizce

Kaynak: HPRA (Health Products Regulatory Authority)

Aktif bileşen:

INFECTIOUS BRONCHITIS CORONAVIRUS, STRAIN CR88121 LIVE ATTENUATED

Mevcut itibaren:

Merial Animal Health Limited

ATC kodu:

QI01AD07

INN (International Adı):

INFECTIOUS BRONCHITIS CORONAVIRUS, STRAIN CR88121 LIVE ATTENUATED

Doz:

4.0-5.3

Farmasötik formu:

Powder for suspension for nebulization

Reçete türü:

POM

Terapötik grubu:

Fowl - Chicken

Terapötik alanı:

Avian infectious bronchitis virus vaccine

Terapötik endikasyonlar:

Immunological - Live Vaccine

Yetkilendirme durumu:

Authorised

Yetkilendirme tarihi:

2003-06-23

Ürün özellikleri

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
GALLIVAC IB88.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each dose of reconstituted vaccine contains:
Attenuated Infectious Bronchitis coronavirus, strain CR88121 (793B), at least 4.0 log
10
EID
50
Excipient q.s. 1 dose
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for nebuliser suspension.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Broiler chickens from 14 days of age.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
Reduces clinical signs and lesions of respiratory disease caused by the coronavirus variant, strain CR88 (793B) in
broiler chickens.
Immunity has been demonstrated 17 days after vaccination, and the duration of immunity is at least 5 weeks.
4.3 CONTRAINDICATIONS
In the absence of trial data, furure layers or breeders and chickens in lay must not be vaccinated.
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Gallivac IB88 vaccination does not replace the vaccination schedule against classical Infectious Bronchitis.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 15/06/2012_
_CRN 7012796_
_page number: 1_
4.5 SPECIAL PRECAUTIONS FOR USE
SPECIAL PRECAUTIONS FOR USE IN ANIMALS
Only healthy birds should be vaccinated.
The vaccine virus can spread to non-vaccinated birds, but no trend towards reversion to virulence was demonstrated in
laboratory trials. Nevertheless, care should be taken to prevent spread of vaccine virus to susceptible birds such as
replacement layers and young birds.
SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO THE ANIMALS
Care should be taken during reconstitution and administration of the vaccine. The operator�