Nobilis® Gumboro 228E

PACKAGE INSERT

For Animal Use Only

Nobilis^® Gumboro 228E

Only for use by or under the supervision of persons registered in terms of or authorized in terms of section 23(1)(c) of the Veterinary and Para-Veterinary Professions Act, 1982 (Act 19 of 1982)

Reg. No. G 2423 (Act 36/1947)

Nobilis^® Gumboro 228E is a live vaccine for the active immunization of fowls against infectious Bursa Disease (Gumboro).

Storage

• Store in the dark between 2 ºC and 8 ºC. Do not freeze.
• Avoid prolonged or repetitive exposure to high ambient temperatures following withdrawal from the refrigerator prior to use.
• Protect from exposure to direct sunlight.

Composition

Nobilis^® Gumboro 228E is a freeze-dried vaccine containing live Gumboro Disease virus strain 228E in stabiliser.

Contents

Nobilis^® Gumboro 228E contains per dose 2.0 log₁₀ EID₅₀ of live Gumboro Disease virus strain 228E. The vaccine pellet contains stabilisers and gentamycin.

Warnings

• Do not vaccinate within 21 days before slaughter.
• It is advisable to vaccinate all the susceptible fowls on the farm at the same time.
• If this is not feasible, strict separation of vaccinated an unvaccinated fowls should be done to prevent the spread of the vaccine virus to the unvaccinated fowls.
• Destroy any unused, reconstituted vaccine, empty vaccine containers, needles etc. by for instance, burning after completion of the vaccination.
• Do not store partially used vaccine containers for future use.
• Protect the reconstituted vaccine from direct sunlight.
• Do not mix the vaccine with other vaccines.
• Do not administer the vaccine simultaneously with or within 7 days after the vaccination with any other live vaccine.
• Use according to the number of doses as indicated on the label.
• Wash and disinfect the hands and equipment after vaccination.
• Do not open and reconstitute the vaccine until ready to start vaccination.
• Use the vaccine within 2 hours after reconstitution.
• The vaccine should be dissolved in an amount of water, which will be consumed by the fowls within 2 hours.
• Keep out of reach of children and uninformed persons.
• Although this vaccine has been extensively tested under a large variety of conditions, failure thereof may ensue as a result of a wide range of reasons. If this is suspected, seek veterinary advice and notify the registration holder.

Precautions

• Vaccinate healthy fowls only.
• Ensure that the drinking water used for the administration of the vaccine is free from chlorine, iron or disinfectants.
• Ensure that the vaccine-medicated water is consumed within 1 to 2 hours (i.e. shelf-life of 2 hours) at a temperature of 25ºC or lower.
• Each container should be used immediately after opening.
• All containers used for the reconstitution and administration of the vaccine must be clean and free from rust and traces of detergents and disinfectants.
• Do not use the contents of damaged containers.
• It is good vaccination practice to avoid contact with the eyes, hands and clothing when handling the vaccine.

Directions for Use

Use only as directed

Vaccination Program

The vaccine virus strain 228E is a less attenuated intermediate IBDV strain. As a result of this, the virus is capable to break through the maternal immunity at an earlier stage and will spread better through the vaccinated flock.

The age at which the fowls can be successfully vaccinated depends on the level of maternally derived antibodies (MDA) and therefore on the kind of flock and on the way the parent flock had been vaccinated.

Guidelines

1. Broilers derived from parent flocks vaccinated with live Gumboro vaccine only, may be vaccinated from day 7 – 14.

2. Broilers derived from parent flocks vaccinated with inactivated Gumboro vaccines may be vaccinated from day 14 – 17.

3. The vaccination of future laying stock derived from parent flocks vaccinated with live Gumboro vaccines only, should be carried out from day 14 – 21.

4. The vaccination of future laying stock derived from parent flocks vaccinated with live and with inactivated Gumboro vaccines should be carried out from day 21 – 28.

The above presented scheme is based on the fact that at these time periods the MDA levels in that particular progeny have decreased sufficiently (e.g. log2 VN titre between approximately 7.0 and 8.5) to vaccinate them successfully with Nobilis^® Gumboro 228E but are still high enough to protect them against infection with circulating field viruses.

Administration

• The vaccine is administered through the drinking water at one dose per fowl.
• The vaccine should be dissolved in an amount of water, which will be consumed by the fowls within 2 hours.

Preparation and Dosage

Drinking water

The containers of vaccine should be opened under water. Use cool, clean, non-chlorinated water which is free from iron or chlorine.  To stabilize the vaccine virus, the addition of 2g skimmed milk powder per liter of drinking water (0.2%) is recommended. In equal parts of fresh milk and water the virus retains its activity much longer.

Ensure the uptake of all vaccine-medicated water in 2 hours. Ensure that there are enough drinkers available to ensure that all fowls have access to vaccine medicated water within 1 – 2 hours.

Depending on weather conditions, it may be advisable to deprive the fowls of water prior to vaccination. Ensure that the fowls are thirsty by withholding normal water supply from the fowls for one to two hours, depending on the ambient temperature prior to vaccination. A sufficient number of water troughs to provide adequate drinking space are essential. These should be thoroughly cleaned and free from traces of detergents and/or disinfectants. Do not use disinfectants or detergents to clean the troughs.

The quantity of water depends on a large number of factors, including ambient temperature, stocking densities etc. It is advisable to consult water consumption tables. An example of dosing rates is as follows:

Dissolve 1 000 doses in as many liters of water as the age of the fowls in days, to maximum of 40 liters.

The vaccine should be given in the early morning, as this is the main drinking period, as well as the cool period of the day. When vaccinating large flocks, it is advisable to start by dissolving only part of the vaccine. If the vaccine is administered through a central water supply or proportioner, greater care should be taken.

For numbers of fowls between standard dosages, the next higher dose should be chosen.

Immunity

The first signs of the antibody response are observed one week after vaccination.

Vaccination Reaction

Post-vaccination reactions have not been observed after the vaccination of healthy fowls.

Presentation

Vials containing 500, 1 000, 2 000, 2 500, 3 000, 5 000 and 10 000 doses respectively and packed in cardboard boxes of 10 vials per box.

Registration Holder

Intervet South Africa (Pty) Ltd.

20 Spartan Road

Spartan, 1619

RSA

Tel: +27 (0) 11 923 9300

Fax: +27 (0) 11 392 3158

www.msd-animal-health.co.za