Revised: April 2010
AN: 00022/2010
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Poulvac i-IB, ND, EDS, IBD, SHS.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Qualitative composition
Combined infectious bronchitis virus vaccine (inactivated); Newcastle
disease virus vaccine (inactivated); egg drop syndrome virus vaccine
(inactivated); infectious bursal disease virus vaccine (inactivated);
swollen head syndrome virus vaccine (inactivated).
Quantitative composition
Active Substances:
Inactivated Infectious Bronchitis virus, strain M41
ELISA titer
Inactivated Newcastle Disease virus, strain Ulster
Inactivated Egg Drop Syndrome virus ‘76, strain A127
titer
Inactivated Infectious Bursal Disease virus, strain Lukert
ELISA titer
Inactivated Swollen Head Syndrome virus, clone 19
ELISA titer
*PD50 = 50% protective dose
Adjuvants
Marcol 52
Arlacel 83V
Tween 80V
Excipients:
Thimerosal 1% solution
Formaldehyde
3.
PHARMACEUTICAL FORM
Milky coloured water in oil emulsion for injection.
4.
CLINICAL PARTICULARS
4.1
Target Species
Chicken (Layer and breeder).
Per 0.5 ml dose
 5.32 log2
 50 *PD50
≥ 7.13 log2 HI
≥ 9.99 log2
≥ 9.62 log2
Per 0.5 ml dose
239 mg
23 mg
0.004 ml
40 - 60µg
< 0.05%
Revised: April 2010
AN: 00022/2010
4.2
Indications for use specifying the target species
For active (re-) immunisation of layer and breeder chickens to reduce
the egg drop due to Infectious Bronchitis virus (Massachusetts serotype)
infection; to reduce the mortality, clinical signs and/or lesions due to
Newcastle Disease virus; to reduce the egg drop due to Egg Drop
Syndrome virus ’76; and to reduce the egg drop due to Swollen Head
Syndrome virus.
For passive immunisation of progeny of layer and breeder chickens
against Infectious Bursal Disease virus to reduce mortality, clinical signs
and/or lesions due to the disease.
Chickens should preferably be primed with live vaccines containing the
following antigens: IB, ND, IBD and SHS.
Onset and Duration of immunity:
Infectious Bronchitis virus:
Onset: 4 weeks after vaccination with inactivated vaccine alone and 2
weeks after vaccination if first primed with live vaccine.
Duration of immunity is a minimum of 38 weeks after vaccination based
on serology.
Newcastle Disease virus:
Onset: 2 weeks after vaccination.
Duration of immunity is a minimum of 38 weeks after vaccination based
on serology.
Egg Drop Syndrome virus:
Onset: 4 weeks after vaccination
Duration of immunity is a minimum of 38 weeks after vaccination, this is
based on challenge at 32 weeks post vaccination and serology up to 38
weeks after vaccination.
Infectious Bursal Disease virus:
Onset: Parent flocks are able to transfer the passive immunity to the
progeny 4 weeks after vaccination with inactivated vaccine alone and 2
weeks after vaccination if primed with live vaccine.
Parent flocks are able to transfer the passive immunity to the progeny for
at least 38 weeks after vaccination. This is based on challenge at 32
weeks post vaccination and serology up to 38 weeks after vaccination.
Progeny of the vaccinated layers and breeders were protected against
IBD virus during the first three weeks after hatching.
Swollen Head Syndrome virus:
Onset: 3 weeks after vaccination if first primed with live vaccine.
Duration of immunity is 13 weeks as demonstrated by challenge with
protection expected to last for a minimum of 38 weeks post vaccination
based on serology.
4.3
None
Contraindications
Revised: April 2010
AN: 00022/2010
4.4
Special warnings
Vaccinate only healthy birds.
4.5
Special precautions for use
i. Special precautions for use in animals
Avoid stress in the birds around the time of vaccination.
ii. Special precautions to be taken by the person administering the
veterinary medicinal product to animals
To the user:
This product contains mineral oil (light liquid paraffin). Accidental
injection/self injection may result in severe pain and swelling,
particularly if injected into a joint or finger, and in rare cases could result
in the loss of the affected finger if prompt medical attention is not given.
If you are accidentally injected with this product, seek prompt medical
advice even if only a very small amount is injected and take the
package insert with you. If pain persists for more than 12 hours after
medical examination, seek medical advice again.
To the physician:
This product contains mineral oil (light liquid paraffin). Even if small
amounts have been injected, accidental injection with this product can
cause intense swelling, which may, for example, result in ischaemic
necrosis and even the loss of a digit. Expert, PROMPT, surgical
attention is required and may necessitate early incision and irrigation of
the injected area, especially where there is involvement of finger pulp or
tendon.
4.6
Adverse reactions (frequency and seriousness)
Mild aseptic inflammatory reaction may occur at the site of injection
which may persist for at least 10 days.
4.7
Use during pregnancy, lactation or lay
Do not use in birds in lay or within 4 weeks before the onset of laying
period.
4.8
Interactions with other medicinal products and other forms
of interaction
No information is available on the safety and efficacy from the
concurrent use of this vaccine with any other. It is therefore
recommended that no other vaccines should be administered within 14
days before or after vaccination with the product.
Revised: April 2010
AN: 00022/2010
4.9
Amounts to be administered and administration route
Vaccination Schedule
One full dose of 0.5 ml of the vaccine is administered by intramuscular
injection in layer and breeder chickens at 12 weeks of age or older, at
least 4 weeks before the start of laying. Chickens should preferably be
primed with live vaccines containing the following antigens: IB, ND, IBD
and SHS.
4.10
Overdose (symptoms, emergency procedures, antidotes), if
necessary
Administration of a twofold overdose does not increase the reactions.
4.11
Withdrawal period(s)
Zero hours/days
5.
IMMUNOLOGICAL PROPERTIES
Poulvac i-IB, ND, EDS, IBD, SHS stimulates active immunity against
Infectious Bronchitis (IB) virus (Massachusetts serotype), Newcastle
Disease (ND) virus, Egg Drop Syndrome virus ’76 (EDS) and Swollen
Head Syndrome (SHS) virus. It also stimulates active immunity in the
parent birds in order to provide passive immunity to the progeny against
Infectious Bursal Disease (IBD) virus.
ATCVet code:
6.
QI01AA07
PHARMACEUTICAL PARTICULARS
6.1
List of excipients
Disodium phosphate dehydrate
Potassium dihydrogen Phosphate
Sodium chloride
6.2
Incompatibilities
Do not mix with any other vaccine/immunological product.
6.3
Shelf life
The shelf life is 12 months for the unopened product.
The contents of the bottle should be used within 6 hours after broaching
the container.
Revised: April 2010
AN: 00022/2010
6.4
Special precautions for storage
Store and transport refrigerated (2°C - 8°C).
Protect from light.
Do not freeze.
6.5
Nature and composition of immediate packaging
500 ml of vaccine emulsion in individual high density polyethylene vials
containing 1000 doses, closed with a rubber stopper and aluminium
cap.
Pack size: Packs with 1 x 1000 dose and 10 x 1000 dose vials.
6.6
Special precautions for the disposal of unused veterinary
medicinal product or waste materials derived from the use
of such products
Any unused vaccine or waste material should be disposed of in
accordance with local requirements.
7.
MARKETING AUTHORISATION HOLDER
Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
8.
MARKETING AUTHORISATION NUMBERS
Vm 00057/4383
9.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
11 May 2006
10.
DATE OF REVISION OF THE TEXT
April 2010