Nobilis® Gumboro D78

Learn more about Gumboro disease by visiting our dedicated website here.

FOR ANIMAL USE ONLY

NOBILIS^® GUMBORO D78

Reg. No. G2483 (Act 36/1947)

Namibia Reg. No. V98/24.3/667 [NS0]

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

Nobilis^® Gumboro D78 is a live, freeze-dried vaccine for the immunisation of chickens against Infectious Bursal Disease (Gumboro).

COMPOSITION

Nobilis^® Gumboro D78 is a live freeze-dried vaccine containing live Infectious Bursal Disease (Gumboro) virus strain D78 with stabilisers. Each dose contains at least 4,0 log₁₀ TCID₅₀ of Infectious Bursal Disease (Gumboro) virus strain D78. The freeze-dried vaccine pellet contains stabilisers and gentamycin.

IMMUNITY

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

STORAGE INSTRUCTIONS

• 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 D78 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.
• 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 use Nobilis® Gumboro D78 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 D78 if the spheres keep floating in the water and do not dissolve.
• Do not use Nobilis® Gumboro D78 if the cup has been opened before.
• Do not use if Nobilis® Gumboro D78 balls have shrunk and/or appear dehydrated.
• Do not mix Nobilis® Gumboro D78 with other vaccines or other immunological products. 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.
• Use according to the number of doses as indicated on the label.
• 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

At least 4,0 log₁₀ TCID₅₀ per chicken by drinking water, spray or oculo/nasal instillation.

The volume used for application depends on the way of administration.

The vaccine is delivered as a lyophilised spheres in cups.

A. Spray method

• The content of the cup(s) should be poured into water. Mix the water containing vaccine well before use.
• The vaccine should be dissolved in water in a quantity of 1 000 doses/ℓ of water.
• The spraying equipment must only be used for vaccination purposes and must be free of sediment, rust and traces of disinfectants.
• The vaccine should be dissolved in cool, clean, non-chlorinated water which is free from iron.
• The vaccine-medicated water should be spread evenly over the correct number of chickens, at 30 to 40 cm, preferably when chickens are sitting together in dim light.

B.  Intranasal/eye drop instillation

• Open the seal on the aluminium cup and empty the vaccine via the funnel into physiological saline solution or Intervet Oculo/Nasal diluent.
• Administer the vaccine by means of a standardised dropper (usually 30 mℓ/1 000 doses). One drop should be applied from a height of a few centimetres onto one nostril or one eye. As an eye drop application, the drop should be allowed to spread evenly across the surface of the eye.
• Do not release the chicken until a swallowing motion is noticed.
• The Intervet Oculo/Nasal diluent is commercially available in South Africa and may be used instead of a physiological saline solution.
• For numbers of chickens between standard dosages, the next higher dosage should be chosen.

C.  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.
• The vaccine should be dissolved in an amount of water, which will be consumed by the chickens within approximately 2 hours.
• Nobilis® Gumboro D78 should be dissolved in cool, clean, non-chlorinated water which is free from iron.
• Depending on the weather conditions, it may be advisable to deprive the birds 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 to be used 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.

• Nobilis® Gumboro D78 should be given in the early morning as this is the main drinking period, as well as the cooler period of the day.
• 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 dosage should be chosen.

VACCINATION PROGRAMME

• Nobilis^® Gumboro D78 may be administered to chickens between 7 to 28 days of age.  Strain D78 is effective in the face of the maternally derived antibody level usually existing in flocks between 7 to 28 days of age. The optimum time of vaccination depends on the height of the maternally derived antibody level. In case the antibody level is very variable it is advised to vaccinate the chickens twice with an interval of 1 week.
• Nobilis^® Gumboro D78 may be safely administered to day-old chicks with no or a low level of maternal antibodies.
• The optimum time and method of administration depends largely upon the local situation. Therefore, the advice of a veterinary surgeon should be sought.

Vaccination Reaction

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

PRESENTATION

Containers with 6 or 12 sealed aluminium laminate cups containing 1 000, 2 500 or 5 000 doses of lyophilised sphereons.

Not all pack sizes are necessarily 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

20 July 2022