Nobilis® IB+ND

INDICATIONS

Nobilis^® IB+ND is a combined inactivated vaccine for the protection of future breeding chickens against Infectious Bronchitis (Massachusetts type) and Newcastle Disease.

COMPOSITION

Each 0,5 mℓ dose of Nobilis^® IB+ND contains immunogenic strains of Infectious Bronchitis virus (Massachusetts type), inducing ≥ 6,0 log₂ HI units and Newcastle Disease virus, containing at least ≥ 50 PD₅₀ units. The viruses have been inactivated with formalin and subsequently suspended in the water phase of a water-in-oil emulsion.

STORAGE INSTRUCTIONS

• Store between 2 °C – 8 °C in a refrigerator.
• Do not freeze.
• Allow the vaccine to gradually reach room temperature (20 °C – 25 °C) prior to use.
• 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.

• Vaccinate healthy chickens only.
• Do not mix Nobilis^® IB+ND with other vaccines or medication.
• Do not over- or under-dose the vaccine.
• 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 inject intravenously.
• Vaccination of chickens in production may lead to a slight drop in egg production.
• In case of accidental self-injection, seek medical advice immediately and show the package insert to the physician.
• 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.
• Do not eat, drink or smoke whilst handling the vaccine.
• It is essential to adhere to the vaccination programme to maintain a satisfactory immune response.
• Do not store partially used containers for future use and use the entire contents once opened.
• Destroy any unused vaccine within 24 hours 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.

Special precautions to be taken by the person administering Nobilis^® IB+ND to animals

To the user

Nobilis® IB+ND contains mineral oil. Accidental injection/self-injection may result in severe pain and swelling, particularly if injected into a joint or finger. In rare cases it could result in the loss of the affected finger if prompt medical attention is not given. If you are accidentally injected with this veterinary medicinal product, seek prompt medical advice, even if only a very small amount is injected, and take this package leaflet with you. If pain persists for more than 12 hours after medical examination, seek medical advice again.

To the physician

Nobilis® IB+ND contains mineral oil. Even if small amounts have been injected, accidental injection with this product can cause intense swelling, 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.

DIRECTIONS FOR USE – USE ONLY AS DIRECTED

Recommended vaccination programme

• Nobilis^® IB+ND should be given to chickens around 16 to 20 weeks of age, but not less than 4 weeks before the expected onset of lay.
• For an optimal booster effect, the chickens must be primed with live vaccines of the separate component strains.
• The best results will be obtained if vaccination with inactivated IB vaccine takes place 6 weeks or more after administering the live vaccine but under no circumstances should it be done earlier than 4 weeks after priming.

DOSAGE AND ADMINISTRATION

• Allow the vaccine to gradually reach room temperature (20 °C – 25 °C) 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.
• Each chicken should be given 0,5 mℓ of the vaccine intramuscularly in the breast muscle or subcutaneously in the back of the neck. (For 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).
• Inject all the chickens in the flock.

IMMUNITY

If priming and subsequent vaccination have been carried out correctly the chickens will develop antibodies at a level which provides protection against Newcastle Disease and production losses caused by serotype Massachusetts of Infectious Bronchitis.

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. This does not constitute permanent tissue damage provided the vaccination has been carried out aseptically.

PRESENTATION

A nearly white homogenous emulsion packed in 500 mℓ bottle containing 1 000 doses.

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

14 June 1999

Zimbabwe Reg. No. E94/80.23.10/9364 Pharmacological classification: 802310 Distribution category: VMGD