Nobilis Gumboro 228E Data Sheet

Presentation

Lyophilisate for suspension for oral administration.

Live, freeze-dried viral vaccine containing Gumboro disease virus strain 228E  (2 - 3 log₁₀ EID₅₀ per dose).  For reconstitution and administration in the drinking water.

Uses

Dosage and administration

The vaccine should be administered in the drinking water.

Birds, which should be at least 10 days of age, should be given a single vaccination.  The optimum age for vaccination may be calculated using the level of maternal antibody in the chicks at day old (Kouwenhoven’s formula), but normally lies in the range 12-18 days.  Further information is available from Intervet technical staff.

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 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.

Guidelines for broilers
2 litres water per 1000 birds per day of age.

Hence 1000 14 day broilers would require 1000 doses of vaccine to be reconstituted in 28 litres of water. 

Individual flocks may differ but the above will be approximately right for the majority of producers.  If the birds have higher or lower water requirements, adjust the volumes accordingly.

Where the number of birds is between the standard dosages, the next higher dosage should be used.

Administration

Water should be withheld before vaccination.  For recommendations see the paragraph on management below.  Ensure that all reconstituted vaccine is consumed within 1 - 2 hours.  Turn on mains water when all the water containing vaccine 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.  When used in chickens where maternal antibody still exists, the way in which this vaccine is administered is critical.  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. morning time for broilers, 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 of the crop and will be less stressful to the birds.  Performance should therefore be less adversely affected.

For further information on use of a vaccine in specific circumstances or in conjunction with other Intervet vaccines consult Intervet technical staff.

Contra-indications, warnings, etc.

Only healthy animals should be vaccinated.

The vaccine should not be used in birds without maternally derived antibodies.  Spread of the vaccine strain to such birds should be prevented.

The vaccine may cause a transient lymphocyte depletion in the bursa of Fabricius.  This does not result in a significant immunosuppressive effect when used in chickens with maternally derived antibodies (MDA). 

Do not vaccinate birds in lay.

No information is available on the effects of concurrent use of this vaccine with any other and it is therefore recommended that no other vaccine should be administered within 14 days before or after vaccination with the product.

Wash and disinfect hands after use.

Withdrawal period:

Nil. 

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

Pharmaceutical precautions

Store at between +2°C and +8°C.  Protect from light. Do not freeze.

Reconstituted vaccine should be consumed within 2 hours.

Do not mix with any other medicinal product.

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

Legal category

POM-V          

Package quantities

Vials containing 500, 1000, 2500, 5000 or 10000 doses.

Further information

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 compromised 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.

Marketing authorisation number

Vm 01708/4333