Nobilis® Newcavac

Nobilis® Newcavac is an inactivated vaccine recommended for the booster vaccination of primed layers and breeding chickens for protection against Newcastle Disease.

NOBILIS® NEWCAVAC

Reg. No. G2757 (Act 36/1947)

Namibia Reg. No. V05/23.3/456 NS0

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® Newcavac is an inactivated vaccine recommended for the booster vaccination of primed layers and breeding chickens for protection against Newcastle Disease.

IMMUNITY

When priming and subsequent vaccination have been carried out correctly, the chickens will develop antibodies at a level which provides protection against Newcastle Disease.

COMPOSITION

Each 0,5 mℓ dose of Nobilis® Newcavac contains ≥ 50 PD50 units of the inactivated Newcastle Disease virus Clone 30. The virus is inactivated with formalin and suspended in the aqueous phase of a water-in-oil emulsion.

STORAGE INSTRUCTIONS

  • Store between 2 °C and 8 °C in a refrigerator.
  • Do not freeze.
  • Protect from exposure to direct sunlight.
  • Avoid prolonged or repetitive exposure to high ambient temperatures following withdrawal from the refrigerator prior to use.

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® Newcavac with other vaccines.
  • Ensure that chickens marketed do not have swellings at the site of vaccine administration, as this may result in the condemnation of the chickens.
  • Vaccination of chickens in production may lead to a slight decrease in egg production.
  • Do not store partially used containers for future use and use entire contents when opened.  
  • Accidental self-vaccination may lead to a severe local allergic reaction. Consult a physician informing him/her 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 vaccination equipment (needles, syringes, etc.) is clean and sterile before and during use.
  • Ensure that all equipment is kept clean and sterile during vaccination.
  • It is essential to adhere to the vaccination programme to maintain a satisfactory immune response.
  • 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.
  • 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® Newcavac to chickens

To the user

Nobilis® Newcavac contains mineral oil. Accidental 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 vaccine, 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® Newcavac 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

Allow the vaccine to gradually reach room temperature (20 °C to 25 °C) prior to use.

Shake the bottle well and at regular intervals during use.

Remove the aluminium seal and the vaccine is ready for use.

Inject all the chickens in the flock.

Recommended Vaccination Programme

Primed chickens should be vaccinated with Nobilis® Newcavac around 16 to 20 weeks, but not less than 4 weeks before the expected onset of lay. For an optimal booster effect, the chickens must be primed with live vaccine against Newcastle Disease.

The best results are obtained if the vaccination with the inactivated vaccine takes place 6 or more weeks after the 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 given 0,5 mℓ of Nobilis® Newcavac intramuscularly in breast muscle or subcutaneously in the lower part of the neck.

(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).

ADVERSE REACTIONS

In healthy chickens, no clinical reaction 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 27 March 2003

Zimbabwe Reg. No. E 91/80.23.10/9288
Veterinary Classification: 802310
Distribution Category: V.M.G.D