Nobilis® ND Clone 30

A live freeze-dried vaccine to prevent Newcastle Disease in chickens. It is administered via coarse spray or eye drop method.

FOR ANIMAL USE ONLY

NOBILIS® ND CLONE 30

Reg. No. G2466 (Act 36/1947)

Namibia Reg. No. V98/24.3/672 [NS0]

NAFDAC Reg. No.: 04-3252

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

INDICATIONS

A live freeze-dried vaccine to prevent Newcastle Disease in chickens. It is administered via coarse spray or eye drop method.

COMPOSITION

Nobilis® ND Clone 30 contains a live freeze-dried vaccine virus strain Clone 30.

Each dose contains at least 106 EID50 of the Newcastle Disease vaccine virus strain Clone 30. The vaccine pellet contains stabilisers and gentamycin sulphate.

STORAGE INSTRUCTIONS

  • Store in the dark between 2 ºC and 8 ºC. Do not freeze.
  • Avoid prolonged or repetitive exposure to high ambient temperatures following withdrawal from the refrigerator prior to use.
  • Protect from direct sunlight.
  • After reconstitution: Use within 2 hours

WARNINGS

  • Withdrawal period: Do not vaccinate within 21 days of slaughter.
  • Do not administer the vaccine simultaneously with or within 7 days after the vaccination with any other live vaccine.
  • It is advisable to vaccinate all the 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 the vaccine virus to the non-vaccinated chickens.
  • Protect the reconstituted vaccine from direct sunlight.
  • Do not mix Nobilis® ND Clone 30 with other vaccines.
  • Wash and disinfect hands and equipment after vaccinating.
  • Use according to the number of doses as indicated on the label.
  • Do not store partially used vaccine 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).
  • 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

  • Vaccinate healthy chickens only.
  • If the spray method is used for the administration of the vaccine, ensure that there is no chlorine, iron or disinfectants in the water.
  • If the spray method is used ensure that the spray apparatus is free from sediments, corrosion and traces of disinfectants.
  • Each vial should be used immediately after opening.
  • 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.
  • It is good vaccination practice to avoid contact with the eyes, hands and clothing when handling the vaccine.

DIRECTIONS FOR USE – USE ONLY AS DIRECTED

ADMINISTRATION

The vaccine may be administered by coarse spray or eye drop installation. (For eye drop application, the Intervet Diluent Oculo-Nasal may be used.)

The vaccine may be delivered as a lyophilised pellet in a glass vial or as lyophilised spheres in cups.

Spray Method

  • Nobilis® ND Clone 30 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.
  • The spray apparatus should be free from sediments, corrosion and traces of disinfectants (preferably to be used for vaccination purposes only).
  • The vaccine medicated water should be spread 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.
  • Dissolve 1 000 doses in 1 ℓ of water and set the nozzle to produce fine droplets falling like fine rain. (Aerosol generators should be used only when this is known to be safe in chickens).

Eye Drop Application

  • Dissolve the vaccine in physiological saline solution or the Intervet Diluent Oculo-Nasal may be used.
  • Administer by means of a standardised dropper (usually 30 mℓ per 1 000 doses).
  • A single drop should be applied from a height of a few centimeters onto 1 eye. The eye drop should be allowed to spread across the surface of the eye.
  • The diluent contains a dye (patent blue) which allows an easy check on the correct vaccination.
  • Do not release the chickens until a swallowing motion is noticed.

VACCINATION PROGRAMME

The optimum time and method of administration depends largely upon the local situation. Therefore, the advice of a veterinary surgeon should be sought. The vaccine is safe to use from day 1 of age onwards.

IMMUNITY AND VACCINATION REACTION

Duration and intensity of the vaccination reaction and the establishment of a solid immunity are generally dependent on the health and condition of the chickens. Hygiene and management are also important in the post vaccination period.

An adequate immunity against Newcastle Disease will last for approximately 6 weeks. In areas where Newcastle Disease is endemic (high risk areas) a secondvaccination with Nobilis® ND Clone 30 should be given within approximately 2 to 4 weeks after the first. Consult your veterinarian. Emergency vaccination during the laying period may be accompanied by a transient drop in egg production.

PRESENTATION

Boxes with type I glass vials each containing a freeze-dried pellet of 1 000, 2 500, and 5 000 doses containing 1, 2 or 10 vials. The vial is closed with a halogenobutyl rubber stopper and sealed with an aluminium cap.

Boxes with sealed aluminium laminate cups containing the lyophilised products in 1 000, 2 500,

5 000 or 10 000 doses.

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 THIS PACKAGE INSERT

29 November 2021

Zimbabwe Reg. No. E94/80.23.10/9363
Veterinary Classification: 802310
Distribution Category: V.M.G.D