Introduction

Company name: Fort Dodge Animal Health

Address: Flanders Road

Hedge End

Southampton SO30 4QH

Telephone: 01489 781711

Fax: 01489 788306

Presentation

A freeze-dried pellet or powder containing infectious bronchitis vaccine (living) modified Massachusetts 1263 strain and Arkansas 3168 strain at ≥ 103.3 EID50 per dose.

Uses

For the active immunisation of broiler chickens to reduce the severity of upper respiratory tract infections caused by Massachusetts and 793/B/91-type strains of Avian Infectious Bronchitis virus.

The onset of immunity is from three weeks post vaccination and lasts for at least six weeks post vaccination.

Dosage and administration

Coarse spray vaccination from one day of age.

Coarse Spray

This vaccine has been used in most types of spray equipment, hand-sprayers (eg ASL Polyspray 2), knapsack sprayers (e.g. Birchmeyer with 0.55 or 1.6 mm spray nozzle, Gloria with 1.0 mm nozzle) or automatic spraying equipment (e.g. Birmex). The apparatus should be set to deliver a coarse spray (droplet size of 80-160 microns), allowing a dose at 0.5 ml per bird.

The vaccine should be reconstituted with water of good quality at room temperature e.g. deionised water or good quality drinking water.

The vaccine should be dissolved as follows:

Remove the aluminium seal from the vaccine vial. To dissolve the vaccine pellet, the rubber stopper should then be removed whilst the vial is immersed in a plastic measuring jug containing one 0.5 litre of clean cool water. Half fill the vial with water, replace the stopper and shake to dissolve any remaining vaccine.

The vaccine concentrate should then be added to the water in the jug, mixed well and transferred to the sprayer tank and thoroughly mixed.

For the 1,000 dose vial a total amount of 0.5 L water should be used.

For the 5,000 dose vial a total amount of 2.5 L water is required and for the 10,000 dose vial a total amount of 5 L water should be used.

The chickens should be sprayed in chick boxes or carton rings in the house to avoid loss of the vaccine virus.

Contra-indications, warnings, etc

FOR ANIMAL TREATMENT ONLY

Do not vaccinate disease birds. Do not re-vaccinate birds.

Do not use during the laying period or in birds for laying or breeding. Spray vaccination should not be used if an intercurrent infection is suspected.

Use reconstituted vaccine within 2 hours.

A slight transient respiratory reaction, including gasping, snicking and raling, may be observed at a rate approximately 10% of vaccinated birds for approximately three days.

No information is available on the safety and the efficacy from the concurrent use of this vaccine with any other.

Infectious Bronchitis virus strains Massachusetts and Arkansas may spread to in contact birds. The duration of spreading of the vaccine virus is for up to 30 days following vaccination. It is recommended that all birds on a site be vaccinated with this product. Do not use on mixed sites of broilers and breeders.

The product should only be used where it has been established that 793/B/91 like infectious bronchitis serotypes are epidemiologically relevant in the area.

Care should be taken to avoid spread of the vaccine virus from vaccinates to pheasants. When administering vaccine operators must protect eyes and nose by wearing goggles and a mask. A helmet with filtered air circulation may be used instead of goggles and mask.

Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant in accordance with national requirements.

Withdrawal period: zero days.

Pharmaceutical precautions

Store and transport in the dark at +2°C to +8°C. Keep out of reach of children.

Legal category

POM-V

Packaging Quantities

1,000, 5,000 and 10,000 dose vials, in protective outer packs containing 10 vials.

Not all pack sizes may be marketed.

Marketing authorisation number

Vm 01596/4262.