Nobilis® ILT

Nobilis® ILT is a live attenuated vaccine for the prevention and emergency vaccination of chickens against Infectious Laryngotracheitis via eye drop administration.

FOR ANIMAL USE ONLY

NOBILIS® ILT

Reg. No. G2450 (Act 36/1947)

Namibia Reg. No. V98/24.3/675 [NS0]

INDICATIONS

Nobilis® ILT is a live attenuated vaccine for the prevention and emergency vaccination of chickens against Infectious Laryngotracheitis via eye drop administration.

COMPOSITION

Each dose of Nobilis® ILT contains a freeze-dried chicken embryo propagated culture of a modified strain of Infectious Laryngotracheitis virus.

CONTENTS

Each dose contains at least 2,5 log10 EID50 of live Infectious Laryngotracheitis virus Serva strain with stabilisers.

IMMUNITY

The vaccine has been prepared from a special strain, modified to allow eye drop administration from the first vaccination onwards. Vaccination by this method produces early immunity (4 to 5 days post vaccination) which will last for about 1 year if the chickens are vaccinated in accordance with the below vaccination programme.

STORAGE INSTRUCTIONS

  • Store in a refrigerator at 2 °C – 8 °C.
  • Do not freeze.
  • Avoid prolonged or repetitive exposure to high ambient temperatures.
  • Protect from exposure to direct sunlight.
  • Solvent: May be stored at room temperature (20 °C – 25 °C).

WARNINGS

  • Withdrawal period: Do not slaughter chickens for human consumption within 21 days after vaccination.
  • 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 unvaccinated chickens should be done to prevent the spread of the vaccine virus to the unvaccinated chickens.
  • Vaccinate healthy chickens only.
  • Do not mix Nobilis® ILT with other vaccines.
  • The vaccine should not be administered simultaneously with or within 14 days after vaccination with other live vaccines.
  • Do not over- or under-dose the vaccine.
  • Use according to the number of doses as indicated on the label.
  • Do not inject intravenously.
  • In case of accidental self-injection, seek medical advice immediately and show the package insert to the physician.
  • Vaccination may cause a slight transient conjunctivitis in some chickens.
  • All reconstituted vaccine should be used within 2 hours after reconstitution.
  • 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.
  • It is good vaccination practice, when handling the vaccine, to avoid contact with the eyes, hands and clothing.
  • Adhere to the vaccination programme to obtain optimum results.
  • Each vial should be used immediately after opening.
  • Keep the bottle inverted, i.e., in a vertical position, to ensure the correct droplet size and to avoid loss of vaccine.
  • Do not eat, drink or smoke whilst handling the vaccine.
  • Destroy any unused vaccine and dispose of all 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

The vaccine is administered via eye drop administration.

PREPARATION OF THE VACCINE SOLUTION

  • Open the vaccine and diluent vials.
  • Connect the vials by using the plastic connector tube.
  • Shake the connected vials until the vaccine is dissolved.
  • Remove the small vial, transfer the liquid into the plastic vial and affix the dropper.
  • On no account should the vaccine be exposed to direct sunlight.

DOSAGE AND ADMINISTRATION

  • Instill 1 drop into an eye of each chicken.
  • Allow the drop to spread across the surface of the eye. Do not release the chicken until a swallowing motion is noticed.
  • Keep the dropper bottle inverted, in a vertical position, to ensure correct droplet size and to avoid loss of vaccine.
  • Note: Once dissolved, the vaccine is very vulnerable. All the vaccine should be used within 2 hours of reconstitution.

VACCINATION PROGRAMME

It is recommended to vaccinate susceptible chickens at the age of 4 to 6 weeks and to revaccinate at 14 to 16 weeks of age.

In emergency cases, the chickens may be vaccinated earlier, but should then always be revaccinated 1 month before the start of the laying period, also by eye drop administration.

PRESENTATION

Cardboard boxes containing 10 vials of 1 000 or 2 500 doses each.

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 THE PACKAGE INSERT

21 January 1998