Nobilis® Gumboro 228E

Nobilis^® GUMBORO 228E

Reg. No. G2423 (Act 36/1947)

Namibia Reg. No. V16/24.3/1371 [NS0]

NAFDAC Reg. No. 04-3248

Only for use by or under the supervision of persons registered in terms of or authorised in terms of section 23(1)(c) of the Veterinary and Para-Veterinary Professions Act, 1982 (Act No. 19 of 1982)

INDICATIONS

A freeze-dried vaccine for the active immunisation of chickens against Infectious Bursal Disease (Gumboro).

COMPOSITION

Nobilis^® Gumboro 228E contains 2,0 log₁₀ EID₅₀ of live Gumboro Disease virus strain 228E per dose. The freeze-dried vaccine pellet contains stabilisers and gentamycin.

IMMUNITY

The first signs of the antibody response are observed 1 week after vaccination.

STORAGE

• Store in the dark between 2 ºC and 8 ºC in a refrigerator.
• 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.
• Do not use Nobilis® Gumboro 228E after the expiry date which is stated on the container label.
• After reconstitution: Use within 2 hours.

WARNINGS

• Withdrawal period: Do not slaughter within 21 days after vaccination.
• Vaccinate healthy chickens only.
• Do not use Nobilis^® Gumboro 228E if the contents are brownish and stick to the container, as this indicates that the integrity of the container has been breached.
• Do not use Nobilis^® Gumboro 228E if the spheres keep floating in the water and do not dissolve.
• Do not use Nobilis^® Gumboro 228E if the cup has been opened before.
• Do not use if Nobilis® Gumboro 228E balls have shrunk and/or appear dehydrated.
• Do not use the contents of damaged containers.
• It is advisable to vaccinate all the susceptible chickens on the farm at the same time. If this is not feasible, strict separation of vaccinated and unvaccinated chickens should be done to prevent the spread of the vaccine virus to the unvaccinated chickens.
• Do not mix Nobilis^® Gumboro 228E with other vaccines.
• Do not over- or under-dose the vaccine.
• Do not use within 2 weeks of antimicrobial treatment.
• Do not inject intravenously.
• Do not open and reconstitute the vaccine until ready to start vaccination.
• Ensure that the vaccine medicated water is consumed within 1 to 2 hours.
• Each cup should be used immediately after opening.
• Do not administer Nobilis^® Gumboro 228E 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.
• Do not open and reconstitute the vaccine until ready to start vaccination.
• KEEP OUT OF REACH OF CHILDREN, ANIMALS 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

• Ensure that the drinking water used for the administration of the vaccine is free from chlorine, iron or disinfectants.
• Ensure that the vaccination equipment (spray apparatus, droppers) is clean prior to use.

The spray apparatus should be free from sediments, corrosion and traces of disinfectants. It should be used for vaccination purposes only.

• The reconstituted vaccine should be consumed within 1 to 2 hours (i.e., shelf-life of 2 hours) at a temperature of 25 ºC or lower.
• Wash and disinfect the hands and equipment after vaccination.
• It is good vaccination practice to avoid contact with the eyes, hands and clothing when handling the vaccine.
• Adhere to the vaccination programme to obtain optimum results.
• Do not eat, drink or smoke whilst handling the product.
• Destroy any unused vaccine and dispose of all the empty vaccine containers and disposable equipment after use in accordance with National Environmental Management: Waste Act, 2008 (Act No. 59 of 2008).
• Do not contaminate rivers, dams or any water sources with containers or waste.

DIRECTIONS FOR USE – USE ONLY AS DIRECTED

ADMINISTRATION

• Nobilis^® Gumboro 228E is delivered as a lyophilized spheres in cups.
• The vaccine is administered through the drinking water at 1 dose per chicken.
• Nobilis^® Gumboro 228E should be dissolved in an amount of water, which will be consumed by the chickens within 2 hours.

Preparation and Dosage

Drinking water

• Open the seal on the aluminium cup and pour the vaccine balls directly into the water. Mix the water containing the vaccine well before use.
• After reconstitution, the suspension should be clear.
• Use cool, in cool, clean, non-chlorinated water which is free from iron.
• Ensure the uptake of all vaccine-medicated water within 2 hours. Ensure that there are enough drinkers available to ensure that all chickens have access to vaccine-medicated water within 1 to 2 hours.
• Depending on weather conditions, it may be advisable to deprive the chickens of water 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 litres of water as the age of the chickens in days, to a maximum of 40 litres.
• The vaccine should be given in the early morning, as this is the main drinking period, as well as the cooler 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 chickens between standard dosages, the next higher dose should be chosen.

VACCINATION PROGRAMME

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 chickens can be successfully vaccinated depends on the level of maternally derived antibodies (MDA), 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 to 14.
2. Broilers derived from parent flocks vaccinated with inactivated Gumboro vaccines may be vaccinated from day 14 to 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 to 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 to 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 titer 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.

Vaccination reaction

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

PRESENTATION

Container with sealed aluminum laminate cups containing 1 000, 2 500 or 5 000 doses of freeze-dried spheres.

Not all pack sizes may be marketed.

REGISTRATION HOLDER

Intervet South Africa (Pty) Ltd.

20 Spartan Road, Spartan

1619, RSA

Tel: +27 (0) 11 923 9300

E-mail: msdahza@msd.com

www.msd-animal-health.co.za

DATE OF PUBLICATION OF THIS PACKAGE INSERT

29 November 2021

Zimbabwe Reg. No. 95/80.23.10/9389 Pharmacological classification: 802310 Distribution category: VMGD