Nobilis® Reo+IB+G+ND

INDICATIONS

Nobilis^® Reo+IB+G+ND is a combined, inactivated vaccine for chickens and is recommended for the booster vaccination of breeding stock for protection against Infectious Bronchitis and Newcastle Disease and for the immunisation against Reo virus infection and Infectious Bursal Disease virus to protect the offspring against Reo virus infections and Gumboro Disease by maternal antibodies for at least the first weeks of life.

COMPOSITION

Each dose of Nobilis^® Reo+IB+G+ND contains inactivated Infectious Bronchitis virus Massachusetts serotype strain 41 inducing ≥ 6,0 log₂ HI units, Newcastle Disease virus Clone 30 ≥ 50 PD₅₀ units, Gumboro virus strain D78 inducing ≥ 14,5 log₂ VN units and Reo virus strains 1733 and 2408 inducing ≥ 7,4 log₂ ELISA units. The viruses were grown in embryonated eggs or on CEF or Vero Cell cultures, inactivated with formalin and subsequently suspended in the aqueous phase of an oil adjuvant emulsion.

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 the Massachusetts serotype of Infectious Bronchitis.

Under normal field situations, the offspring hatched at any stage of the laying period will have sufficient maternal antibodies to protect them against disease caused by Gumboro infections and Reo infections during the first weeks of life.

STORAGE INSTRUCTIONS

• Store between 2 °C and 8 °C 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.
• After broaching the bottle, use within 3 hours.

WARNINGS

• Withdrawal period: Do not market chickens for slaughter purposes for at least 6 weeks after vaccination.
• Vaccinate healthy chickens only.
• Avoid intravenous injection.
• Do not mix Nobilis^® Reo+IB+G+ND with other vaccines.
• Vaccination of chickens in production may lead to a slight decrease in egg production.
• In case of accidental self-injection, seek medical advice immediately and show this package leaflet to the physician.
• Do not store partially used vaccine vials for future use and use the entire contents once opened.
• 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.
• 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.

Special precautions to be taken by the person administering Nobilis^® Reo+IB+G+ND to chickens

To the user

Nobilis^® Reo+IB+G+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^® Reo+IB+G+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 a tendon.

DIRECTIONS FOR USE – USE ONLY AS DIRECTED

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

RECOMMENDED VACCINATION PROGRAMME

Nobilis^® Reo+IB+G+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 against Infectious Bronchitis, Newcastle Disease, Avian Reo virus infection and Infectious Bursal Disease.

The best results will be obtained if vaccination with an 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 injected with 0,5 mℓ of the vaccine intramuscularly into the thigh or breast muscle, or subcutaneously into the lower part 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.
• 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.

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

A homogenous white to nearly white water-in-oil emulsion, packed in a hydrolytical, Type ll glass or PET bottle, closed with a nitryl rubber stopper and sealed with a coded aluminium cap. Each bottle contains 500 mℓ, sufficient for 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

20 January 2015

Zimbabwe Reg. No. 96/80.23.17/9437 Pharmacological classification: 802310 Distribution category: VMGD