Nobilis® IB+ND+EDS

Nobilis® IB+ND+EDS is a combined inactivated vaccine for the protection of layers and breeders against Egg Drop Syndrome ’76 and for the booster vaccination of breeding chickens against Newcastle Disease and Massachusetts types of Infectious Bronchitis.

FOR ANIMAL USE ONLY

NOBILIS® IB+ND+EDS

Reg. No. G2613 (Act 36/1947)

NAFDAC Reg. No. 04-3250

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+ND+EDS is a combined inactivated vaccine for the protection of layers and breeders against Egg Drop Syndrome ’76 and for the booster vaccination of breeding chickens against Newcastle Disease and Massachusetts types of Infectious Bronchitis.

COMPOSITION

Each 0,5 mℓ dose of Nobilis® IB+ND+EDS contains immunogenic strains of Infectious Bronchitis virus serotype Massachusetts, inducing ≥ 6,0 log2 HI units, Newcastle Disease virus, containing

≥ 50 PD50 units, and Egg Drop Syndrome ’76 virus BC strain 14, inducing ≥ 6,5 log2 HI units. The viruses have been inactivated with formalin and subsequently suspended in the water phase of a water-in-oil emulsion.

IMMUNITY

If priming and subsequent vaccination have been carried out correctly the chickens will develop antibodies at a level which provides protection against Egg Drop Syndrome ’76, Newcastle Disease and production losses caused by the Massachusetts serotype of Infectious Bronchitis.

STORAGE INSTRUCTIONS

  • Store between 2 °C to 8 °C in a refrigerator.
  • Do not freeze.
  • Protect from light.
  • Avoid prolonged or repetitive exposure to high ambient temperatures following withdrawal from the refrigerator prior to use.
  • 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.
  • Ensure that chickens marketed do not have swellings at the vaccination site, as this may result in the condemnation of the chickens.
  • Vaccination of chickens in production may lead to a slight drop in egg production.
  • Do not mix Nobilis® IB+ND+EDS with other vaccines.
  • Do not inject intravenously.
  • In case of accidental self-injection may lead to severe local allergic reaction. Consult and inform the physician that the vaccine contains a mineral oil.
  • 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.
  • 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®IB+ND+EDS to animals

To the user

Nobilis®IB+ND+EDS 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+EDS 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 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 ºC to 25 ºC) prior to use.
  • Remove the aluminum over seal and the vaccine is ready for use.
  • Inject all the chickens in the flock.

Recommended Vaccination Programme

Nobilis®IB+ND+EDS 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 and Newcastle Disease.

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.

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 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

14 June 1999

Zimbabwe Reg. No. E2017/80.23.17/9755
Pharmacological classification: 80.23.17
Distribution category: PP Vet