NOBILIS® GUMBORO INAC.

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

FOR ANIMAL USE ONLY

NOBILIS^® GUMBORO INAC.

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 INSTRUCTIONS

• 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.
• Opened bottles should be used within 3 hours.

WARNINGS

• Withdrawal period: Do not market chickens for slaughter purposes for at least 6 weeks after vaccination.
• Avoid intravenous injection
• Vaccinate healthy chickens only.
• 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.
• Do not over- or under-dose the vaccine.
• Do not use within 2 weeks of antimicrobial treatment.
• Vaccination of chickens in production may lead to a slight drop in egg production.
• 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

• Observe aseptic precautions. Ensure that all vaccination equipment (containers, syringes and needles) is clean and sterile prior to and during use. Use sterile equipment when administering the vaccine.
• Do not use disinfectants or antiseptics to sterilise any equipment.
• It is good vaccination practice when handling the vaccine to avoid contact with the eyes, hands and clothing.
• 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.
• It is essential to adhere to the vaccination program to maintain a satisfactory immune response.

Special precautions to be taken by the person administering Nobilis^® Gumboro Inac to animals

To the user

Nobilis^® Gumboro Inac contains mineral oil. If you are accidentally injected with this vaccine, seek prompt medical advice even if only a very small amount is injected and take the package insert with you to show to the physician. If pain persists for more than 12 hours after medical examination, seek medical advice again.

To the physician

Nobilis^® Gumboro Inac contains mineral oil. Even if small amounts have been injected, this vaccine can cause intense vascular spasm which may, for example result in ischaemic necrosis and even the loss of a digit. Expert, PROMPT, surgical attention is required and may necessitate early incision and irrigation of the injected area, especially where there is involvement of finger pulp or tendon sheaths.

DIRECTIONS FOR USE – USE ONLY AS DIRECTED

Shake well before use and at regular intervals during vaccination.

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                                                 

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                         

MANUFACTURER

Intervet International B.V.

35 Wim de Körverstraat

Boxmeer, The Netherlands

DATE OF PUBLICATION OF THIS PACKAGE INSERT

03 December 2014