Poulvac Ilt
Revised: July 2013
AN: 00462/2013
SUMMARY OF PRODUCT CHARACTERISTICS
NAME OF THE IMMUNOLOGICAL VETERINARY MEDICINAL PRODUCT
Poulvac ILT
QUALITATIVE AND QUANTITATIVE COMPOSITION
Qualitative composition
Avian Infectious Laryngotracheitis virus vaccine (live), freeze dried for veterinary use.
Quantitative composition
Active substances: Per dose
1. Freeze dried fraction
Avian Infectious Laryngotracheitis virus, Salsbury strain 146 102.5to 104.3EID50
Excipients
Stabilising medium QS 1 dose
For a full list of excipients, see section 6.1
2. Liquid Diluent
Buffer solution QS 1 dose
PHARMACEUTICAL FORM
Lyophilisate for suspension in the diluent for administration by intraocular route.
CLINICAL PARTICULARS
Target Species
Chickens
Indications for use, specifying the target species
For the prevention of mortality and clinical signs due to infection with avian infectious laryngotracheitis virus. Onset of immunity is 14 days post vaccination. Duration of immunity has not been assessed, however, experience from field use indicates that once vaccinated birds remain immune to avian infectious laryngotracheitis virus infection during entire laying period.
Contra-Indications
Do not vaccinate diseased birds (except in case of an emergency vaccination).
Special Warnings
In order to prevent spread of vaccine strain from vaccinated flocks to non-vaccinated flocks, all non-vaccinated birds present on the farm must be vaccinated at the same time.
Special precautions for use, including special precautions to be taken by the person administering the medicinal product to animals
i. Special precautions for use in animals
Use clean vaccination materials.
Protect the vaccine from exposure to heat and/or direct sunlight.
Avoid contact with disinfectants as this makes the vaccine ineffective.
Prevent spread of vaccine virus from vaccinated flocks to non-vaccinated flocks.
ii. Special precautions to be taken by the person administering the veterinary medicinal product to animals
None
Adverse reactions (frequency and seriousness)
About four days after vaccination, redness and some swelling of the conjunctiva, or laboured breathing may be seen. Under good hygienic conditions, this reaction will not last longer than three days.
Use during pregnancy, lactation or lay
Do not use in laying chickens.
Interactions with other medicinal products and other forms of interaction
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be decided on a case by case basis.
Amounts to be administered and administration route
Vaccine is administered to chickens from 4 weeks of age by eye drop.
1000 doses of freeze dried vaccine must be completely dissolved in 30 ml of the sterile diluent provided and a drop of dispenser calibrated to deliver at least three hundredth of a millilitre per drop must be used.
Remove the rubber stopper from the vaccine vial and add sterile diluent to half fill the vial. Replace the rubber stopper and shake gently so that all the vaccine material is completely dissolved.
Pour the dissolved vaccine into the remaining sterile diluent and shake again until completely mixed. The sterile diluent should be at room temperature when used.
Fit the drop dispenser on the bottle. Hold the bird so that one eye is pointed upwards and allow one drop of vaccine to fall into the eye.
Contact with the disinfectant makes the vaccine ineffective.
Protect the reconstituted vaccine from heat or direct sunlight.
Overdose (symptoms, emergency procedures, antidotes), if necessary
Administration of an overdose does not result in significantly worse adverse reactions to those seen after administration of a single dose.
Withdrawal period
Zero Days
IMMUNOLOGICAL PROPERTIES
To stimulate active immunity against avian laryngotracheitis virus.
ATC Vet code:QI01AD08
PHARMACEUTICAL PARTICULARS
List of excipients
Sucrose
Pharmatone
Dehydrated Non-fat milk
Sodium Glutamate
Phosphate Buffer saline
6.2 Incompatibilities
Do not mix with any other veterinary medicinal product.
6.3 Shelf-life
Vaccine
Shelf-life of the veterinary medicinal product as packaged for sale: 24 months.
Liquid diluent
Shelf-life of the veterinary medicinal product as packaged for sale:: 12 months.
Shelf-life after dilution or reconstitution according to directions: 2 hours.
Special precautions for storage
Store and transport at 2C to 8C.
Protect from light.
Do not freeze.
Nature and composition of immediate packaging
Vial: Type I (Ph.
Eur.) Borosilicate glass bottles. 6 ml capacity
Closure: Type I (Ph. Eur.) bromobutyl rubber stoppers sealed with
aluminium caps.
Pack Sizes: Pack of 10 vials containing 1000 doses.
Diluent:
Vial: (Ph. Eur.) LDPE
Plastic bottles
Closure: Type I (Ph. Eur.) Bromobutyl rubber stoppers sealed with
aluminium caps.
Pack Size: Diluent is supplied in 30 ml LDPE plastic
bottles.
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products, if appropriate
Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant approved for use by the competent authorities.
MARKETING AUTHORISATION HOLDER
Zoetis UK Limited
5thFloor, 6 St. Andrew Street
London
EC4A 3AE
MARKETING AUTHORISATION NUMBER
Vm42058/4106
DATE OF RENEWAL OF THE AUTHORISATION
Date:26 October 2010
DATE OF REVISION OF THE TEXT
Date:July 2013
Approved:
19/07/2013
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