INNOVAX® ND-IBD

FOR ANIMAL USE ONLY

INNOVAX® ND-IBD

Reg. No. G4375 (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

Innovax® ND-IBD is recommended for active immunisation of 1-day-old chicks:

  • To reduce mortality and clinical signs caused by Newcastle disease (ND) virus,
  • To prevent mortality and to reduce clinical signs and lesions of infectious bursal disease (IBD) virus,
  • To reduce mortality, clinical signs and lesions caused by Marek’s disease (MD) virus.

IMMUNITY

Onset of immunity:                   ND: 4 weeks,

                                                          IBD: 2 weeks,

                                                          MD: 9 days.

Duration of immunity:             ND: 8 weeks,

                                                          IBD: 8 weeks,

                                                          MD: entire risk period.

COMPOSITION

Each 0,2 mℓ dose of reconstituted vaccine contains:

Cell-associated live recombinant turkey herpes virus (strain HVP360), expressing the fusion protein of Newcastle disease virus and the VP2 protein of infectious bursal disease virus: 103,3 – 104,6 PFU1.

1 PFU: plaque forming units.

STORAGE INSTRUCTIONS

  • Ampoules (cell suspension): Store and transport frozen in liquid nitrogen (below -140 °C).
  • Solvent: Store at or below 25 °C.
  • Liquid Nitrogen Container: Store liquid nitrogen container securely in an upright position in a clean, dry and well-ventilated room separated from the hatching/chicken room in the hatchery.
  • In-use shelf-life: 2 hours.
  • Control of correct storage: To allow a check on correct storage and transport, the ampoules are placed upside down in the liquid nitrogen containers. If frozen vaccine is situated in the tip of the ampoule, it indicates that the vaccine has been thawed and must not be used.

WARNINGS

  • Withdrawal period: Do not slaughter chickens for human consumption within 21 days after vaccination.
  • Vaccinate healthy 1-day-old chicks only.
  • As a live vaccine, the vaccine strain is excreted from vaccinated birds and may spread to turkeys. Safety trials have shown that the strain is safe for turkeys. However, precautionary measures should be followed in order to avoid direct or indirect contact between vaccinated chickens and turkeys.
  • Do not mix with any other vaccine, immunological product or medication, except the applicable solvent supplied for use with Innovax® ND-IBD.
  • Safety and efficacy data demonstrate that Innovax® ND-IBD can be administered on the same day, but not mixed with Nobilis® ND Clone 30 (G2466), Nobilis® ND C2 (G2872), Nobilis® IB Ma5 (G2300) or Nobilis® IB 4-91 (G4031). For this associated use, an onset of immunity of 3 weeks (combination with Nobilis® ND Clone 30) and 2 weeks (combination with Nobilis® ND C2), has been demonstrated for Newcastle disease.
  • No information is available on the safety and efficacy of Innovax® ND-IBD when used with any other veterinary medicinal product, except the products mentioned above. A decision to use Innovax® ND-IBD before or after any other veterinary medicinal product therefore needs to be made on a case by case basis by the responsible veterinarian.
  • No information is available on use in laying or breeding birds. Information is only available for broilers.
  • Keep vaccine ampoules frozen in liquid nitrogen until ready to vaccinate.
  • Do not use vaccine that has been thawed other than immediately before use. Refer to STORAGE INSTRUCTIONS.
  • 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 use.
  • Do not contaminate the vaccine with disinfectants or spirits.
  • It is good vaccination practice when handling the vaccine, to avoid contact with the eyes, hands, skin and clothing. Mask and eye protection should be used by the operator.
  • 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 Innovax® ND-IBD to animals

  • Innovax® ND-IBD is a virus suspension packed in glass ampoules and stored in liquid nitrogen.
  • The liquid nitrogen container and vaccine should only be handled by properly trained personnel, taking into consideration the safety precautions for handling liquid nitrogen and materials at very low temperatures. 
  • The handling of liquid nitrogen should take place in a well-ventilated area.
  • Before withdrawing ampoules from the liquid nitrogen canister, protective equipment consisting of gloves, long sleeves and a facemask and goggles should be worn.
  • In case of an accident, to prevent serious wounds by either the liquid nitrogen or the ampoules, when removing an ampoule from the canister, hold palm of gloved hand away from body and face.
  • Care should be exercised to prevent contaminating your hands, eyes and clothing with the suspension.
  • CAUTION: Ampoules have been known to explode on sudden temperature changes. Do not thaw in hot or ice-cold water. For this reason, thaw the ampoules in clean water at

25 °C to 27 °C.

  • In case of accidental self-injection, seek medical advice immediately and show this package leaflet to the physician.

DOSAGE AND DIRECTIONS FOR USE – USE ONLY AS DIRECTED

  • After dilution, administer a single 0,2 mℓ dose of vaccine per chicken by subcutaneous injection in the neck.
  • Use within 2 hours after opening of the ampoule.

Preparation of the vaccine

Disinfect vaccinating equipment by boiling in water for 20 minutes or by autoclaving (15 minutes at 121 °C).

Do not use chemical disinfectants.

The handling of liquid nitrogen should take place in a well-ventilated area.

  1. Use the applicable solvent for the  reconstitution of cell associated poultry vaccines. Use 400 mℓ of solvent for each 2 000 doses of cell suspension or 800 mℓ of solvent for each 4 000 doses of cell suspension.
  2. Preparation of the vaccine must be planned before the ampoules are taken from the liquid nitrogen. The exact amount of vaccine ampoules and amount of solvent needed must be calculated first. There is no information available on the number of doses on the ampoules once they are removed from the cane, so special care must be taken to avoid the mix-up of ampoules with different number of doses and ensure that the applicable solvent is used.
  3. Before withdrawing the ampoules from the liquid nitrogen container, protect hands with gloves, wear long sleeves and use a facemask and goggles. When removing an ampoule from the cane, hold in the palm of a gloved hand away from the body and the face.
  4. When withdrawing a cane of ampoules from the canister in the liquid nitrogen container, expose only the ampoule(s) to be used immediately. It is recommended to handle a maximum of 5 ampoules (from one cane only) at a time. After removing the required ampoule(s), the remaining ampoules should be put back immediately into the canister with the liquid nitrogen.
  5. The content of the ampoule(s) is thawed rapidly by immersing in clean water at 25 °C to 27 °C. Gently swirl the ampoule(s) to disperse the contents. It is important that the suspension, after being thawed, is mixed immediately into the solvent to protect the cells.
  6. Dry the ampoule, then break the ampoule at its neck and immediately proceed as described below.
  7. Gently withdraw the contents of the ampoule into a sterile syringe, mounted with an 18-gauge needle.
  8. Insert the needle through the stopper of the solvent and add the contents of the syringe slowly and gently to the solvent bag. Gently swirl and invert the bag to mix the vaccine.
  9. Withdraw a portion of the solvent into the syringe to rinse the ampoule.
  10. Remove the washing from the ampoule and inject it gently into the solvent bag. Remove the syringe and invert the bag (6 to 8 times) to mix the vaccine.
  11. The vaccine is now ready for use.
  12. Innovax® ND-IBD must be used within 2 hours. Do not store any unused vaccine for future use.

After adding the content of the ampoule to the applicable solvent, the ready to use product is a clear, red coloured suspension for injection.

PRESENTATION

Suspension:

Off-red to red suspension in Type I glass ampoules containing 2 000 or 4 000 doses. Ampoules are stored on a cane and attached to the cane is a coloured clip displaying the dose (2 000 doses: salmon-pink coloured clip, and 4 000 doses: yellow coloured clip).

Solvent:

Clear red solution in a 400 mℓ or 800 mℓ plastic bag.

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

7 October 2019

Botswana Reg. No. BOV2200002 (2 000 doses)

                                BOV2200002A (4 000 doses)     

Schedule: POM