POULVAC IBMM + ARK – POWDER FOR NEBULISER SOLUTION FOR BROILER CHICKENS

Land: Irland

Sprog: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

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Hent Produktets egenskaber (SPC)
29-01-2016

Aktiv bestanddel:

AVIAN INFECTIOUS BRONCHITIS VIRUS STRAIN MASSACHUSETTS 1263, AVIAN INFECTIOUS BRONCHITIS VIRUS STRAIN ARKANSAS 3168

Tilgængelig fra:

Zoetis Ireland Limited

ATC-kode:

QI01AD07

INN (International Name):

AVIAN INFECTIOUS BRONCHITIS VIRUS STRAIN MASSACHUSETTS 1263, AVIAN INFECTIOUS BRONCHITIS VIRUS STRAIN ARKANSAS 3168

Dosering:

Unknown

Lægemiddelform:

Powder for nebuliser solution

Recept type:

POM

Terapeutisk gruppe:

Fowl - Chicken

Terapeutisk område:

Avian infectious bronchitis virus vaccine

Terapeutiske indikationer:

Immunological - Live Vaccine

Autorisation status:

Authorised

Autorisation dato:

2013-12-09

Produktets egenskaber

                                SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE VETERINARY MEDICINAL PRODUCT
POULVAC IBMM + ARK – Powder for nebuliser solution for broiler chickens.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
3 PHARMACEUTICAL FORM
Powder for nebuliser solution.
4 CLINICAL PARTICULARS
4.1 TARGET SPECIES
Broiler chickens.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For the active immunisation of chickens to reduce the severity of upper respiratory tract infections caused
by Massachusetts and 793/B/91-type strains of Avian Infectious Bronchitis virus.
The onset of immunity is from three weeks post vaccination and lasts for six weeks post vaccination.
Protection has also been demonstrated in the presence of maternally derived antibody.
4.3 CONTRAINDICATIONS
Do not use in unhealthy birds. Do not re-vaccinate birds.
Do not use during the laying period or in birds intended for laying or breeding.
Spray vaccination should not be used if an intercurrent infection is suspected.
Quantitative composition
ACTIVE SUBSTANCES:
GLOBAL AMOUNT PER DOSE
Avian Infectious Bronchitis Virus
10
3.3
EID
50
*
(Strain Massachusetts1263 and Strain Arkansas 3168)
*EID
50
: Embryo infective dose 50%
EXCIPIENTS:
For a full list of excipients, see section 6.1.
HEALTH PRODUCTS REGULATORY AUTHORITY
________________________________________________________________________________________________________________________
_Date Printed 07/01/2016_
_CRN 7022521_
_page number: 1_
4.4 SPECIAL WARNINGS FOR EACH TARGET SPECIES
Infectious Bronchitis virus strains Massachusetts and Arkansas may spread to in contact birds. The duration of spreading
of the vaccine virus is for up to 30 days following vaccination.
It is recommended that all chickens on a site be vaccinated with this product.
Do not use on mixed sites of broilers and breeders.
4.5 SPECIAL PREC
                                
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