Poulvac Ibmm + Ark Vaccine
Country: Italy
Language: English
Source: HMA (Heads of Medicines Agencies)
Summary of Product characteristics
(SPC)
10-05-2013
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Active ingredient:
Infectious Bronchitis Virus 0
Available from:
Fort Dodge Animal Health
Pharmaceutical form:
Suspension for injection
Therapeutic area:
Chicken
Authorization date:
2011-09-15
Summary of Product characteristics
Revised: July 2013
AN: 00938/2012
Page 1 of 5
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
QUANTITATIVE COMPOSITION
Active Substances:
Global Amount per Dose
Avian Infectious Bronchitis Virus
(Strain Massachusetts1263 and
Strain Arkansas 3168)
10
3.3
EID
50
*
*EID
50
: Embryo infective dose 50%
Excipients:
For a full list of excipients, see section 6.1.
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.
Revised: July 2013
AN: 00938/2012
Page 2 of 5
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.
4.4 SPECIAL WARNINGS
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
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