NOBILIS® IB Multi+ND

FOR ANIMAL USE ONLY

NOBILIS® IB Multi+ND

Reg. No. G4436 (Act 36/1947)

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

A combined inactivated vaccine for the protection of chickens against Avian Infectious Bronchitis (Massachusetts, D207/274 serotypes) and Newcastle Disease.

The vaccine is recommended for the booster vaccination of layers and breeding stock for protection against the Massachusetts serotype and the D207/D274 serotype (and related serotypes) of Infectious Bronchitis, for use in areas where the IB serotypes which are covered by the vaccine strains are known to be prevalent, and for protection against Newcastle Disease.

In areas where variant serotypes of IB are not present, a Nobilis® vaccine with only the Massachusetts serotype strain as the IB component can be used.  In areas where variant serotypes of IB are known to be prevalent, a Nobilis® vaccine including variant strains of IB should be used.

COMPOSITION

Nobilis® IB Multi+ND contains two immunogenic strains of Infectious Bronchitis virus, (Massachusetts serotype inducing ³ 5,5 log2 VN units and a variant strain belonging to the D207/D274 serotype inducing  ³ 4,0 log2 VN units) and one immunogenic strain of Newcastle Disease virus containing ³ 50 PD50 units.  The viruses have been grown on embryonated eggs and are inactivated with formalin.  Subsequently they have been suspended in the aqueous phase of a water-in-oil emulsion.

STORAGE INSTRUCTION

  • Store between 2 °C – 8 °C in a refrigerator.
  • Do not freeze.
  • Once broached use within 3 hours.
  • Protect from exposure to direct sunlight.

WARNINGS

  • Withdrawal period: Do not slaughter animals for human consumption for at least 21 days after vaccination.
  • Vaccinate healthy chickens only.
  • Do not mix Nobilis® IB Multi+ND with other vaccines or medication.
  • Do not over- or under-dose the vaccine.
  • Do not inject intravenously.
  • In case of accidental self-injection, seek medical advice immediately and show the package insert to the physician.
  • 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 use during laying or within 4 weeks before the onset of the laying period.
  • 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 Multi+ND to animals

To the user

Nobilis® IB Multi+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 Multi+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 Multi+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 and Newcastle Disease.

For priming against IB Massachusetts the following scheme is suggested:

Day-old:            IB Vaccine Nobilis® Strain Ma5 by coarse spray/oculo-nasal method.

Additional priming for the IB variant serotypes:  (IB Multi)

8 to 12 weeks:  Preferably homologous IB Vaccine Nobilis® Strain D274 (serotype D207/D274), or else heterologous IB Vaccine Nobilis® Strain Ma5. Application Method:  preferably oculo-nasal. The spray method can also be used.

The best results will be obtained if vaccination with inactivated vaccine takes place 6 or more weeks after administration of the live primer but in no circumstances should it be done earlier than 4 weeks after priming.

DOSAGE AND ADMINISTRATION

  • Allow the vaccine to gradually reach room temperature (20 ºC – 25 ºC) prior to use.
  • Shake well before use and at regular intervals during the vaccination process.
  • Remove the aluminium overseal and the vaccine is ready for use.
  • Each chicken should be given 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).
  • 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 the serotypes of Infectious Bronchitis covered by the vaccine strains.

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

Type II glass or polyethylene terephthalate (PET) 250 or 500 mℓ vials containing 500 or 1 000 doses respectively. The vials are closed with nitryl rubber stoppers and sealed with a coded aluminium cap.

Not all pack sizes may 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 PACKAGE INSERT

24 July 2020