Active substance

Avian encephalomyelitis virus (strain 1143 Calnek) (attenuated)

ATC code

QI01AD02 Avian encephalomyelitis

QI01AD Live viral vaccines

QI01A Immunologicals for domestic fowl

QI01 Immunologicals for aves

QI Immunologicals

Species

Chickens

Indications

For the active immunisation of future layers and breeding chickens from 14 weeks of age against avian encephalomyelitis, to induce passive immunity in young chickens against infection with avian encephalomyelitis virus.

Onset of immunity: 10 weeks demonstrated by challenge of progeny.

Duration of immunity: 39 weeks demonstrated by challenge of progeny.

Dose to be administered and administration route

For administration via drinking water.

One vaccine dose per animal aged 14 weeks and older. All animals of the population must be vaccinated.

The vaccine should be dissolved in the amount of drinking water consumed by the animals within 2 hours. The vaccine must be administered to the drinkers immediately after dissolution so that it is consumed by the animals within 2 hours at most after dilution.

To ensure the vaccine is consumed quickly, drinking water should be withheld from the animals for 1 – 2 hours prior to vaccination. It must be ensured that all animals have adequate access to the vaccine suspension but not have access to normal drinking water until the vaccine has been consumed.

Method of administration

Administration via drinking water

- Determine the required number of vaccine doses and the quantity of water (see below).

- Use the total contents of the vaccine bottles per one chicken house or drinker systems.

- All equipment used for vaccination (lines, hoses, drinkers etc.) should be thoroughly cleaned and must be free from residues of cleaning agents and disinfectants.

- Use only cool, clean, and fresh water, preferably free of chlorine and metal ions. Skimmed milk powder (2 – 4 g/litre water) or skimmed milk (20 – 40 ml/litre water) can improve the quality of the drinking water and prolong the activity of the vaccine; however, this supplement should be added to the water 10 minutes before adding the vaccine.

- Open the vaccine bottle under water and dilute its contents. Ensure that any remaining vaccine is completely emptied by rinsing the bottle and rubber stopper with water.

- Lines filled with water must be emptied before administering the vaccine suspension.

Add the diluted vaccine suspension to cold, fresh water such that, as a rule of thumb, 1,000 vaccine doses are dissolved in one litre of water per age in days for 1,000 chickens, e. g. 10 litres would be required for 1,000 chickens aged 10 days old.

Under hot climatic conditions and for heavy breeds, this amount may be increased to a maximum of 40 litres per 1,000 animals. In case of doubt, the daily water consumption should be determined before vaccination.

To reduce the risk of infection before the onset of immunity, the litter should be removed, and the chicken house cleaned between treatment cycles in the breeding unit.

Adverse reactions

None known.

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See the package leaflet for respective contact details.

Dispensing

POM-V - Prescription Only Medicine – Veterinarian

SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

AviPro AE suspension for use in drinking water

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each dose contains:

Active substance:

Avian encephalomyelitis virus, strain 1143 Calnek, live 10^3.0 - 10^4.5 EID₅₀*

*EID₅₀ = 50% embryo infective dose: the viral titre required to induce an infection in 50% of embryos inoculated with the virus.

Excipients:

Qualitative composition of excipients and other constituents

Disodium hydrogen phosphate

Lactose monohydrate

Potassium dihydrogen phosphate

Skimmed milk powder

Water for injections

Appearance: yellow-brownish liquid.

3. CLINICAL INFORMATION

3.1 Target species

Chickens

3.2 Indications for use for each target species

For the active immunisation of future layers and breeding chickens from 14 weeks of age against avian encephalomyelitis, to induce passive immunity in young chickens against infection with avian encephalomyelitis virus.

Onset of immunity: 10 weeks demonstrated by challenge of progeny.

Duration of immunity: 39 weeks demonstrated by challenge of progeny.

3.3 Contraindications

None.

3.4 Special warnings

Vaccinate healthy animals only.

Eggs of vaccinated breeding birds may be used for breeding purposes not earlier than 4 weeks after vaccination.

3.5 Special precautions for use

Special precautions for safe use in the target species:

The vaccine virus is able to spread horizontally from vaccinated to non-vaccinated chickens. Avian encephalomyelitis virus can naturally infect partridges, turkeys, pheasants, and pigeons.

Appropriate veterinary and husbandry measures should be taken to avoid spread of the vaccine strain to non-vaccinated chickens, partridges, turkeys, pheasants, pigeons, and other susceptible species. All animals in the population must be vaccinated at the same time. To avoid additional stress for the vaccinated animals, no other immunisation should be performed for two weeks before and after the vaccination against avian encephalomyelitis.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

Personal protective equipment consisting of gloves should be worn when handling the veterinary medicinal product.

Special precautions for the protection of the environment:

Not applicable.

3.6 Adverse events

None known.

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See the package leaflet for respective contact details.

3.7 Use during pregnancy, lactation or lay

Laying birds:

Do not use in birds in lay or breeding birds and within 4 weeks before the start of the laying period.

3.8 Interaction 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 made on a case-bycase basis.

3.9 Administration routes and dosage

For administration via drinking water.

One vaccine dose per animal aged 14 weeks and older. All animals of the population must be vaccinated.

The vaccine should be dissolved in the amount of drinking water consumed by the animals within 2 hours. The vaccine must be administered to the drinkers immediately after dissolution so that it is consumed by the animals within 2 hours at most after dilution.

To ensure the vaccine is consumed quickly, drinking water should be withheld from the animals for 1 – 2 hours prior to vaccination. It must be ensured that all animals have adequate access to the vaccine suspension but not have access to normal drinking water until the vaccine has been consumed.

Method of administration