Lyophilisate for oral or oculo-nasal suspension for chickens.

Presentation

Freeze-dried vaccine containing >3.0 log ₁₀EID₅₀ live Avian Infectious Bronchitis virus strain IB H120 per dose.

To stimulate active immunity against the Massachusetts type of Infectious Bronchitis virus.

Uses

For the active primary immunisation of chickens from day-old, to reduce mortality and clinical signs resulting from infection with Infectious Bronchitis of the Massachusetts serotype.

Onset of immunity:       at latest 3 weeks (based upon vaccination-challenge interval tested; this period may be shorter but this has not been investigated).

Duration of immunity:            at least 6 weeks.

Dosage and administration

The vaccine can be administered to 1-day old chicks and older chickens by coarse spray or by the intranasal/ocular route of administration.  The vaccine can be administered to 7-day and older chicks by drinking water.

Drinking water:

When administering the vaccine by drinking water use cool, clean water supplemented with 2 gram of skimmed milk powder or 50 ml of liquid skimmed milk per litre to dissolve the vaccine, as it is known that this will make the virus retain its activity.

Reconstitution of vaccine:

The vaccine is presented in vials under vacuum.  Measure the correct volume of water for the number of birds to be vaccinated (see below) and open the correct number of vials of vaccine under the surface of the water.  All containers used should be clean and free from any traces of detergent or disinfectant. Mix thoroughly with a clean stirrer, ensuring that all vials used are emptied.  Offer to birds immediately.

Use clean cold water, in which chlorine or metals can neither be tasted nor smelled.  Where water sanitisers are used consult Intervet technical staff.  Chlorine at levels as low as 1 ppm is known to have a detrimental effect on vaccine virus stability, therefore the use of liquid skimmed milk is recommended to prolong the life of the virus.  This may be added to the water at the rate of 500 ml (approximately 1 pint) per 10 litres of water. After mixing well, the solution should be allowed to stand for 15-30 minutes before adding the vaccine.  Only skimmed milk should be used, as the fat in whole milk may block the automatic drinking systems as well as reduce vaccine virus efficacy.

Volumes of water for reconstitution of vaccine: 

The volume of water for reconstitution depends on the age of the birds and the management practice.

Simple drinking troughs and fountains:

The following are guidelines:

1000 doses per litre per age in days up to a volume of 20 litres per 1000 doses.

For heavy breeds, or in hot weather, the quantity of water may be increased up to 30 litres per 1000 doses. Where the number of birds is between the standard dosages, the next higher dosage should be used.

Nipple Drinkers:

Drinker line management is known to have a significant effect on the viability of live vaccine virus.  The vaccine virus can deteriorate very rapidly and it is essential to ensure that all birds received the correct dose. Special care should be observed concerning the method of administration. For example, small header tanks may require recharging with medicated water several times during a 1‑2 hour period.

Administration:

Water should be withheld before vaccination.  For recommendations see below under “Management”.  Ensure that all medicated water is consumed within 1 - 2 hours.  Turn on mains water when all the vaccine water has been consumed. Always make sure that there is food available when vaccinating.  Birds will not drink if they have no food to eat.

Management:

Great care should be taken to ensure that all birds receive a full dose of vaccine when the product is administered.  The following points have been found to improve vaccine "take":

1        Water withholding should be kept to a minimum. Approximately half an hour is all that is required if the following management techniques are used.

2        Try to vaccinate at a time when birds are likely to be drinking, e.g. when food is in the food tracks.

3        Turn the lights down low when the water is turned off.  For bell drinkers, go round the house emptying and cleaning the drinkers during the half-hour lights low period.  Mix up the vaccine according to the recommendations, and towards the end of the half-hour water withholding period, go round all the drinkers filling each with water containing vaccine.  Leave the house and turn the light up.  The increased light intensity will stimulate the birds to look for water and food.  Therefore, it is important that food is available or the birds will not be interested in drinking.  In some cases, it helps to run food tracks at the time the light intensity is increased.

For nipple lines a substantial volume of residual water may remain in the lines after the half-hour water withholding/dark period. It is advisable to drain the lines and prime with vaccine loaded water before allowing the birds to have access to the drinker lines.  Mix up the vaccine and apply to the header tank(s). Calculate the volume of water that is left in the tank below the outlet valve and make sure you add extra vaccine to this volume of water.  For example, if 10 litres remain below the outlet pipe and you are using 10 litres/1000 birds to vaccinate, add one extra vial of vaccine when mixing up vaccine for that tank.  The use of this extra vaccine is important.

4        Once the vaccine has been consumed, resume management practices as normal. This approach to vaccination will ensure a more even vaccination and will be less stressful to the birds.  Performance should therefore be less adversely affected.

Spray vaccination of day- old chicks: 

This technique has been developed for use in day-old birds, and is normally required for emergency use only.  Only spray apparatus approved by Intervet UK Ltd should be used and it is advisable to consult the technical staff of the distributors before using this technique.

Eye- or nose-drop administration:

Reconstitute the vaccine with the appropriate amount of a suitable diluent and administer by means of the standardised dropper. One drop should be applied into one nostril or one eye. Ensure that the nasal drop is inhaled before freeing the bird.

For eye- or nose-drop administration Nobilis Diluent Oculo Nasal (Vm 01708/4502), is available in a dropper in two dosage forms (1000 and 2500 doses).

Vaccination programme:

The optimal time and method of administration depend largely upon the local situation.

Contra-indications, warnings, etc.

Do not vaccinate unhealthy birds. Sick or weak birds will not develop adequate immunity following vaccination.

The reaction seen after primary vaccination is mild and takes the form of slight respiratory symptoms 4-7 days later.  These symptoms normally disappear within 2 weeks.

After administration of an overdose similar effects as with a single dose may be expected.

In young birds the intensity of the reaction produced by the vaccine and also the degree of immunity will vary.  This variation is related to the presence and amount of maternal antibodies to IB in the chicken and also the general health and condition of the birds. Thus, hygiene and management are particularly important in the post‑vaccination period.

Antibiotic medication: When stocks are known to be infected with mycoplasma or there is a history of other infections, e.g. E. coli, it is suggested that antibiotics are administered to reduce the level of infection. The antibiotic manufacturer’s recommendations should be followed at all times.

A good immune response is reliant on the reaction of an immunogenic agent and a fully competent immune system.  Immunogenicity of the vaccine antigen will be reduced by poor storage or inappropriate administration. Immunocompetence of the animal may be comprised by a variety of factors including poor health, nutritional status, genetic factors, concurrent drug therapy and stress. Under certain conditions, for example extreme disease pressure and variant challenge, fully immune birds may succumb to disease. Therefore, successful vaccination may not be synonymous with full protection in the face of a disease challenge.

Under normal conditions, the vaccine is not recommended for use in laying birds.

No information is available on the safety and efficacy from the concurrent use of this vaccine with any other except the live Newcastle disease (strain C2 and strain Clone 30) vaccines and live rhinotracheitis (strain 11/94) vaccines by Intervet. Infectious bursal disease vaccine (strain D78) can be given 7 days after Nobilis IB H 120.

Vaccines which target non respiratory diseases (such as Marek’s disease vaccines) may be administered with Nobilis IB H120 provided that each of the vaccines is administered using the recommended route and the recommended doses.

It is recommended that no other vaccine should be administered within 14 days before or after vaccination with the product. 

Do not mix with any other medicinal product.

The vaccine virus may spread to unvaccinated birds. 

Primary vaccination of fully susceptible laying hens with Nobilis IB H120 might cause a slight fall in egg production.

Operator warnings:

Wash and disinfect hands after use.

When spraying the vaccine, to avoid hay-fever like reactions in some individuals, well fitting masks to appropriate EU standards or better, and eye protection to appropriate EU standards must be worn by the operator and staff.

Withdrawal period:

Zero days.

FOR ANIMAL TREATMENT ONLY.  KEEP OUT OF THE REACH AND SIGHT OF CHILDREN.

Pharmaceutical precautions

Store at between +2°C and +8°C.  Do not freeze.  Protect from light.  Keep the container in the outer carton.

Reconstituted vaccine should be used within 2 hours.

Disposal advice:

Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant approved for use by the competent authorities.

Legal category

POM-VPS                              To be supplied only on veterinary prescription.

Package quantities

Box with 1 or 10 glass vials (type II or type I Ph.Eur.) closed with a halogenobutyl rubber stopper and sealed with a colour-coded aluminium cap, containing 500, 1000, 2500, 5000 or 10,000 doses.  Not all presentations may be marketed.

Further information

Nil.

Marketing Authorisation number

Vm 01708/4284

Marketing Authorisation holder

Intervet UK Ltd

Walton Manor,

Walton

Milton Keynes

Bucks, MK7 7AJ

Distributed in Northern Ireland by:

Intervet Ireland Ltd.

Magna Drive

Magna Business Park

Citywest Road

Dublin 24

Date of text preparation

September 2007.

|Item code: 010008.