Nobilis® IB+G+ND

Nobilis® IB+G+ND is a combined inactivated vaccine for primed chickens and is recommended for the protection of the progeny of primed breeders during the first week of life against Infectious Bursal Disease (Gumboro), and for the booster vaccination of future layers and breeders against Infectious Bronchitis and Newcastle Disease.


FOR ANIMAL USE ONLY

Reg. No. G2696 (Act 36/1947)

Namibia Reg. No. V05/24.3/460 [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 19 of 1982).

Newcastle disease is a controlled disease in terms of the Animal Diseases Act (Act 35/1984). The occurrence or suspicion of this disease must be reported to the responsible state veterinarian immediately.

INDICATIONS

Nobilis® IB+G+ND is a combined inactivated vaccine for primed chickens and is recommended for the protection of the progeny of primed breeders during the first weeks of life against Infectious Bursal Disease (Gumboro) and for the booster vaccination of future layers and breeders against the Massachusetts serotype of Infectious Bronchitis and Newcastle Disease.

COMPOSITION

Each dose of Nobilis® IB+G+ND contains inactivated Infectious Bronchitis virus Massachusetts serotype strain M41 inducing ≥ 6,0 log2 HI units, inactivated Newcastle Disease virus Clone 30 ≥ 50 PD50 units and inactivated Infectious Bursal Disease (Gumboro) inducing ≥ 14,5 log2 VN units. The viruses were grown in embryonated eggs 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 Infectious Bursal disease (Gumboro) 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.
  • Once the bottle is opened, use the contents 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.
  • Ensure that chickens marketed do not have swellings at the injection site, as this may result in the condemnation of the chickens.
  • Do not mix Nobilis® IB+G+ND with any other vaccines.
  • Vaccination of chickens in production may lead to a slight drop in egg production.
  • Accidental self-injection may lead to a severe local allergic reaction. Consult a physician and show this package leaflet, since this vaccine contains a mineral oil.
  • Do not store partially used containers 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 (needles, syringes, etc.) is clean and sterile prior to and during use. Use sterile equipment when administering the vaccine.
  • It is essential to adhere to the vaccination program to maintain a satisfactory immune response.
  • Do not eat, drink, or smoke whilst handling the vaccine.
  • It is good vaccination practice, when handling the vaccine, to avoid contact with the eyes, hands and clothing.
  • Wear protective clothing, masks, gloves etc. according to hazard standards.
  • Destroy any unused vaccine and dispose of all the vaccine containers and disposable equipment after use in accordance with National Environmental Management: Waste Act, 2008 (Act No. 59 of 2008).

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

To the user

Nobilis® 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® 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.

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. For 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 °C to 25 °C) prior to use.
  • Remove the aluminium overseal and the vaccine is ready for use.
  • Vaccinate all the chickens in the flock.

Recommended Vaccination Programme

  • Nobilis® IB+G+ND should be administered 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 Bronchitis, Newcastle Disease and 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 vaccination be done earlier than 4 weeks after priming.

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 damage of the tissue provided that the vaccination has been carried out aseptically.

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.

Not all pack sizes may necessarily be 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

03 December 2014