1 Target species
Chickens.
2 Indications for use for each target species
Active immunisation of chickens to reduce the detrimental effect caused by virulent avian metapneumovirus on the ciliary activity, which may be manifested in respiratory clinical signs.
Onset of immunity: 3 weeks post vaccination
Duration of immunity: 9 weeks post vaccination
3 Contraindications
None.
4 Special warnings
Vaccinate healthy animals only.
5 Special precautions for use
Special precautions for safe use in the target species:
Vaccinated chickens may excrete the vaccine strain at least 21 days following vaccination. During this time, the contact of immunosuppressed and unvaccinated chickens and turkeys with vaccinated chickens should be avoided.
Naïve chickens and turkeys in contact with vaccinated chickens have not shown clinical signs under experimental conditions.
Appropriate veterinary and husbandry measures should be taken to avoid spread of the vaccine strain to susceptible species.
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. For spray administration it is recommended to wear a protective face shield.
The vaccine strain can be found in the environment at least for 21 days. Personnel involved in attending vaccinated chickens should follow general hygiene principles (changing clothes, wearing gloves, cleaning and disinfection of boots) and take particular care in handling animal waste and bedding materials from recently vaccinated chickens.
Special precautions for the protection of the environment:
Not applicable.
6 Adverse events
None.
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 its local representative or the national competent authority via the national reporting system. See the package leaflet for respective contact details.
7 Use during pregnancy, lactation or lay
Laying birds:
The safety of RESPIVAC aMPV has been demonstrated during lay.
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 by case basis.
9 Administration routes and dosage
Oculonasal use (by coarse spray administration) or use in drinking water.
Vaccination schedule
One dose of vaccine should be applied by oculonasal use (by coarse spray administration) or via drinking water. Spray can be used from 1 day of age and drinking water from 7 days of age.
For prolonged immunity, chickens can be vaccinated every 9 weeks. The veterinarian should determine the optimum vaccination schedule according to the local epidemiological situation.
Vaccine preparation
Use clean vaccination equipment.
Calculate the number of vials of vaccine required and the volume of water needed to vaccinate all the birds.
For spray administration the recommended volume of water for one dose of vaccine is between 0.14 and 1 ml.
For use in drinking water, the adequate volume is that which can be ingested within 2 hours at most, keeping in mind the age of the birds. If in doubt, measure water intake the day before administering the vaccine.
The final volume of vaccine needed will depend on the number of birds to be vaccinated.
Fill half of the calculated volume of clean, fresh, antiseptic and disinfectant free water (or a lower volume when using half is not feasible) into a clean container in which the vaccine vials can be submerged. The size of the container and the volume of water initially used should be appropriate to achieve a complete reconstitution of all vials that are required for vaccination. Remove the caps from each of the vaccine vials, submerge each one individually and remove the stopper. Shake gently until the lyophilisate is completely dissolved and dilute the resulting suspension. Once empty, the vials should be rinsed a couple of times to ensure the complete reconstitution of the vaccine.
The reconstituted vaccine is a clear, colourless suspension.
Application via oculonasal use (by coarse spray method)
Turn off ventilation during vaccination and up to 15 minutes after vaccination.
The spray applicator should be free from sediments and corrosion traces or disinfectants.
For the adjustment up to the final calculated volume, transfer the reconstituted vaccine into a container containing the remaining volume of water needed for preparation of the vaccine suspension. Fill the spray applicator with the vaccine suspension. Make sure that birds are uniformly distributed during spraying.
The vaccine should be sprayed evenly over the appropriate number of chickens at a distance of 30-40 cm. Vaccination is recommended assuring a droplet size of ≥ 120 μm.
Application via drinking water
Water should be withheld for 1-2 hours prior vaccination, depending on the environmental conditions, to increase the thirst of the birds to ensure that all reconstituted vaccine is consumed within 2 hours.
Confirm that all elements for the drinking equipment are thoroughly clean and free of any trace of antiseptics or disinfectants.
For the adjustment up to the final calculated volume, transfer the reconstituted vaccine into a container containing the remaining volume of water needed for preparation of the vaccine suspension. Transfer the vaccine suspension to the drinking equipment.
10 Symptoms of overdose (and where applicable, emergency procedures and antidotes)
No adverse reactions have been observed after the administration of a 10-fold maximum dose of the vaccine.
11 Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance.
Any person intending to manufacture, import, possess, distribute, sell, supply and use this veterinary medicinal product must first consult the relevant Member State’s competent authority on the current vaccination policies, as these activities may be prohibited in a Member State on the whole or part of its territory pursuant to national legislation.
12 Withdrawal periods
Zero days.