NOBILIS® GUMBORO INAC.

FOR ANIMAL USE ONLY

Reg. No. G2562 (Act 36/1947)

INDICATIONS

Nobilis® Gumboro Inac. is an inactivated vaccine recommended for the booster vaccination of breeding stock against Infectious Bursal Disease in order to protect the offspring of vaccinated chickens against Gumboro disease.

COMPOSITION

Each 0,5 mℓ dose of Nobilis® Gumboro Inac. vaccine contains Gumboro virus strain D78 inducing ≥ 14,5 log2 VN units. The virus was grown on Vero Cell cultures, was inactivated with formalin and subsequently suspended in the aqueous phase of an oil adjuvant emulsion.

STORAGE

  • Store in the dark between 2 °C and 8 °C.
  • 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.

WARNINGS

  • Withdrawal period: Do not market chickens for slaughter purposes for at least 6 weeks after vaccination.
  • Avoid intravenous injection.
  • Ensure that chickens marketed do not have swellings at the site of vaccine administration, as this may result in the condemnation of the chickens.
  • Do not mix Nobilis® Gumboro Inac. with other vaccines.
  • Vaccination of chickens in production may lead to a slight drop in egg production.
  • Accidental self-vaccination may lead to severe local allergic reaction. Consult a physician informing him/her that the vaccine contains a mineral oil.
  • Opened bottles should be used within 3 hours. Do not store partially used containers for future use and use the entire contents once opened.
  • Destroy any unused vaccine as well as all vaccine containers and vaccination equipment according to local waste disposal regulations.
  • KEEP OUT OF REACH OF CHILDREN, UNINFORMED PERSONS AND ANIMALS.
  • 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 chickens only.
  • Observe aseptic precautions. Ensure that all vaccination equipment (needles, syringes, etc.) is clean and sterile prior to and during use.
  • It is essential to adhere to the vaccination program to maintain a satisfactory immune response.
  • It is good vaccination practice when handling the vaccine to avoid contact with the eyes, hands and clothing.

DIRECTIONS FOR USE – USE ONLY AS DIRECTED

Shake well before use and at regular intervals during the vaccination process.

RECOMMENDED VACCINATION PROGRAMME

Nobilis® Gumboro Inac. should be given to chickens around 16 to 20 weeks of age, but not less than 4 weeks before the onset of lay.

For an optimal booster effect, the chickens must be primed with a live vaccine against Infectious Bursal Disease.

The best results will be obtained if vaccination with inactivated vaccine takes place 6 or more weeks after administration of the live primer, but under no circumstances should it be done earlier than 4 weeks after priming.

DOSAGE AND ADMINISTRATION

  • Each chicken should be given 0,5 mℓ of the vaccine intramuscularly into the thigh or breast muscle or subcutaneously into the back of the neck. (Administration via intramuscular injection into the breast muscle, the needle should be pointed in the direction of the chicken’s head to prevent the needle from entering the body cavity.).
  • Allow the vaccine to gradually reach room temperature (20 ºC to 25 ºC) prior to use.
  • Shake well before use and at regular intervals during the vaccination process.
  • Remove the aluminium over seal and the vaccine is ready for use.
  • Inject all the chickens in the flock.

IMMUNITY

When the priming and subsequent vaccination have been carried out correctly the offspring hatched at any stage of the laying period will, under normal field situations, have sufficient maternal antibodies to protect them against disease caused by Gumboro infections during the first week of life.

VACCINATION REACTIONS

In healthy chickens, no clinical reaction to the vaccination will be observed. For some weeks after vaccination a slight swelling may be felt at the site of the vaccination. Local tissue reactions may occur.

PRESENTATION

Bottles containing 500 mℓ sufficient for 1 000 doses packed in a cardboard box.

REGISTRATION HOLDER                                        MANUFACTURER

Intervet South Africa (Pty) Ltd.                                    Intervet International B.V.

20 Spartan Road, Spartan                                           35 Wim de Körverstraat

1619, RSA                                                                   Boxmeer, The Netherlands

Tel: +27 (0) 11 923 9300

Fax: +27 (0) 11 392 3158

www.msd-animal-health.co.za                                              

DATE OF PUBLICATION OF THIS PACKAGE INSERT

03 December 2014