Poulvac IB Primer

Country: United Kingdom

Language: English

Source: VMD (Veterinary Medicines Directorate)

Active ingredient:

Infectious bronchitis virus

Available from:

Zoetis UK Limited

ATC code:

QI01AD07

INN (International Name):

Infectious bronchitis virus

Pharmaceutical form:

Oral solution

Prescription type:

POM-V - Prescription Only Medicine – Veterinarian

Therapeutic group:

Chickens

Therapeutic area:

Live Viral Vaccine

Authorization status:

Authorized

Authorization date:

2005-04-15

Summary of Product characteristics

Revised: August 2020
AN: 00620/2020
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Poulvac IB Primer
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Avian infectious bronchitis vaccine (live), freeze-dried.
QUANTITATIVE COMPOSITION
Active Ingredients
Per dose
Infectious bronchitis virus strain H120
10
3.0
– 10
5.4
EID
50
Infectious bronchitis virus strain D274 clone
10
3.0
– 10
5.4
EID
50
Excipients
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Oral solution _or_ spray solution after reconstitution of the
freeze-dried
vaccine in water.
4.
CLINICAL PARTICULARS
4.1
TARGET SPECIES
Chickens from one day of age.
4.2 INDICATIONS FOR USE, SPECIFYING THE TARGET SPECIES
For active immunisation of chickens to reduce upper respiratory tract
infections caused by strains of the Massachusetts serotype and Dutch
variant strains D207/D274.
The onset of immunity is from 27 days post vaccination.
Protection of chicks will be of approximately 16 weeks duration at
which age the chickens may be vaccinated with an appropriate
inactivated IBV vaccine product.
4.3
CONTRAINDICATIONS
Do not use in sick chickens.
Refer to sections 4.4 and 4.7.
Revised: August 2020
AN: 00620/2020
Page 2 of 6
4.4 SPECIAL WARNINGS
It is accepted that spray administration offers benefits over water
administration in terms of ease of application and percentage of birds
vaccinated.
Nevertheless,
greater
secondary
problems
may
result
under certain management conditions. Spray vaccination should not be
used if intercurrent infection is suspected. It is important to
consult your
veterinary adviser or Zoetis technical staff before using the spray
technique.
Efficacy against infectious bronchitis caused by the 4/91 (793B) UK
variant IB strain has not been demonstrated.
Maternally derived antibody (MDA) can interfere with the development
of active immunity. Where it is likely that recent field infection or
vaccination of the parent flock has stimulated a high antibody titre
and
consequently a high le