Nobilis® ND C2

Nobilis® ND C2 is a live freeze-dried vaccine, indicated for the primary vaccination of chickens at 1 day of age or older against Newcastle Disease.

FOR ANIMAL USE ONLY

NOBILIS® ND C2

Reg. No. G2872 (Act 36/1947)

Namibia Reg. No. V05/24.3/455 [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® ND C2 is a live freeze-dried vaccine, indicated for the primary vaccination of chickens at 1-day of age or older against Newcastle Disease.

IMMUNITY

Duration and intensity of the immune reaction and the establishment of a solid immunity are dependent on the possible presence of maternal antibodies and in general on the health and condition of the chickens. Hygiene and management are also important in the post-vaccination period.

COMPOSITION

Each dose of Nobilis® ND C2 contains at least 106 EID50 of live, attenuated Newcastle Disease virus (NDV) strain C2. The virus is propagated in specific pathogen free eggs.

STORAGE INSTRUCTIONS

  • Store in the dark, between 2 °C and 8 °C.
  • 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 reconstitution: Use within 3 hours.

WARNINGS

  • Withdrawal period: Do not slaughter chickens for human consumption within 21 days after vaccination.
  • Vaccinate healthy chickens only.
  • Do not inject intravenously.
  • Do not mix Nobilis® ND C2 with any other vaccines.
  • Accidental contact of Nobilis® ND C2 with human eyes could lead to transient conjunctivitis.
  • Immunisation with Nobilis® ND C2 alone will not provide sufficient protection against virulent Newcastle Disease.
  • Nobilis® ND C2 should be used as a primary vaccination in 1-day-old chickens to reduce the severity of reactions experienced when more virulent Newcastle Disease vaccine strains are subsequently used.
  • It is advisable to vaccinate all susceptible chickens on the farm at the same time. If this is not feasible, strict separation of vaccinated and non-vaccinated chickens should be done to prevent the spread of Nobilis® ND C2 virus to the unvaccinated chickens.
  • Protect the reconstituted vaccine from direct sunlight.
  • 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 is clean and sterile prior to and during use.
  • Use according to the number of doses as indicated on the label.
  • Use the entire contents of vaccine container once opened.
  • In case of the product presented in cups, do not use the product if the contents are brownish and stick to the container, as this indicates that the integrity of the container has been breached.
  • If the spray method is used for the administration of Nobilis® ND C2, ensure that there is no iron, chlorine or disinfectants in the water.
  • All containers used for reconstitution and administration of Nobilis® ND C2, must be clean and free from rust and traces of detergents and disinfectants.
  • Do not use the contents of damaged vaccine containers.
  • It is good vaccination practice when handling vaccines to avoid contact with the eyes, hands and clothing.
  • Wash and disinfect hands and equipment after vaccination.
  • Do not store partially used containers for future use.
  • 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.

DIRECTIONS FOR USE – USE ONLY AS DIRECTED

Do not open and reconstitute Nobilis® ND C2 until ready to start vaccination.

ADMINISTRATION

Nobilis® ND C2 may be administered by spray or eye drop application. Administer 1 dose of at least 106 EID50 per chicken.

The vaccine may be delivered as a freeze-dried cake in a glass vial or as freeze-dried spheres in cups. 

  1. Spray Method
  2. Nobilis® ND C2 should be dissolved in cool, clean, non-chlorinated water which is free from iron. The vials of freeze-dried vaccine should be opened under water, or the content of the cup(s) should be poured into water. In both cases, mix the water containing the vaccine well before use. After reconstitution, the suspension should be clear. The volume of diluent for reconstitution should be sufficient to ensure an even distribution when sprayed onto the birds. This will vary according to the age of the birds being vaccinated and the management system.
  3. The spray apparatus should be free from sediments, corrosion and traces of disinfectants (dedicated for use for vaccination purposes only).
  4. The vaccine medicated water should be sprayed evenly over the correct number of chickens, at a distance of 30 to 40 cm, preferably when the chickens are sitting together in dim light.
  5. Dissolve 1 000 doses per 250 mℓ to 500 mℓ of water and set the nozzle to produce fine droplets falling like fine rain.
  6. Eye Drop Application
  7. Dissolve Nobilis® ND C2 in Diluent Oculo-Nasal (or physiological saline solution) and administer by means of standardised dropper (usually 30 mℓ per 1 000 doses).
  8. The drop should be allowed to spread evenly across the surface of the eye.
  9. The diluent contains a dye (patent blue) which allows an easy check on the correct vaccination.
  10. Do not release the chicken until a swallowing motion is noticed.

VACCINATION PROGRAMME

Nobilis® ND C2 is safe for use as a primary vaccination from 1-day of age onwards.

The optimum time and method of the first administration and revaccination with a secondary vaccine depends largely upon the local situation. Therefore, the advice of a veterinarian should be sought.

PRESENTATION

Carton box with Type I glass vials each containing 1 000, 2 500, or 10 000 doses of freeze-dried pellets.

PET-tray with sealed aluminium laminate cups containing 1 000, 2 500 or 10 000 doses of freeze-dried sphereons.

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 PACKAGE INSERT

23 March 2022

Zimbabwe Reg. No. E2013/80.23.17/9680
Pharmacological classification: 802310
Distribution category: VMGD