INNOVAX®-ND

Learn more about Infectious Bursal Disease affecting poultry flocks by visiting our dedicated website here.

INDICATIONS

Innovax^®-ND is recommended for the active immunisation of healthy 18-day-old chicken embryos by the in ovo route or for 1-day-old chickens by the subcutaneous route as an aid in the prevention of Marek’s disease and Newcastle disease.

IMMUNITY

For Marek’s disease onset of immunity has been demonstrated after 5 days following vaccination and duration of immunity will last for the entire risk period.

For Newcastle disease, onset of immunity has been demonstrated after 2 weeks following vaccination, reaching full immunity at 4 weeks. Duration of immunity has been demonstrated for at least 60 weeks after a single vaccination. In case of high Newcastle disease infection pressure, it may be recommended to use, in addition to Innovax^®-ND,a live Newcastle disease vaccine like Nobilis^® ND C2 (G2872) or Nobilis^® ND Clone 30 (G2466) for vaccination of day-old chickens.

COMPOSITION

Each dose contains at least 1 810 PFU of live turkey herpes virus strain HVT/NDV-F. The vaccine contains traces of gentamycin sulphate.

STORAGE

Ampoules: Store in a filled liquid nitrogen container, < -100 °C.

Nobilis^® Diluent CA: Store at room temperature between 15 °C and 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.

WARNINGS

• Withdrawal period: Do not slaughter chickens for human consumption until 21 days after vaccination.
• Do not mix any substance, vaccine or medication other than Nobilis^® Diluent CA, Nobilis^® Rismavac (G2444) (Rispens CVI988), Nobilis^® ND C2 (G2872), Nobilis^® ND Clone 30 (G2466), or Bursal disease vaccine 89/03, with this vaccine.
• Keep vaccine ampoule frozen in liquid nitrogen until ready to vaccinate.
• Do not use vaccine that has been thawed other than immediately before use. 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 this indicates that the vaccine has been thawed and must not be used.
• No information is available on the safety and efficacy from the concurrent use with other vaccines, except MSD Animal Health’s Nobilis^® Rismavac (G2444), Nobilis^® ND C2 (G2872) or Nobilis^® ND Clone 30 (G2466) with this vaccine.
• Do not use in conjunction with another vaccine containing a classical HVT strain or any other HVT recombinant vaccine.
• Do not vaccinate clinically ill or stressed birds.
• Innovax^®-ND is not indicated for use in lay.
• 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.
• Observe aseptic precautions. Ensure that all vaccination equipment (needles, syringes, etc.) are clean and sterile before use.
• The liquid nitrogen container and vaccine should be handled only by properly trained personnel, taking into consideration the safety precautions for handling liquid nitrogen and materials at a very low temperature.
• Do not contaminate with disinfectant 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.
• In case of accidental self-injection, consult a medical practitioner and show this package insert.
• Do not eat, drink or smoke while handling this vaccine.
• Wash hands thoroughly after use.
• Dispose of any unused vaccine as well as all empty vaccine containers and vaccination equipment in accordance with the National Environmental Management: Waste Act, 2008 (Act No. 59 of 2008).

DOSAGE AND DIRECTIONS FOR USE – USE ONLY AS DIRECTED

Each chicken should receive 1 dose of vaccine.

Preparation of the vaccine

STERILISE VACCINATING EQUIPMENT BY BOILING IN WATER FOR 20 MINUTES OR BY AUTOCLAVING (15 MINUTES AT 121 °C). DO NOT USE CHEMICAL DISINFECTANTS.

1. Use Nobilis^® Diluent CA for reconstitution of the single or combined cell-associated Marek vaccines. For subcutaneous injection, use 200 mℓ Nobilis^® Diluent CA for each

1 000 doses of vaccine to inject 0,2 mℓ per chicken. For in ovo vaccination of eggs use 500 mℓ Nobilis^® Diluent CA for each 10 000 doses of vaccine to inject 0,05 mℓ per egg.

The diluent must be clear, red coloured, without sediment and at room temperature between 15 °C and 25 °C at the time of mixing.

• Before withdrawing vaccine from the liquid nitrogen container, protect hands with gloves, wear long sleeves and use a face mask or goggles. When removing an ampoule from the strip, hold palm of gloved hand away from body and face. Check the containers routinely to ensure that adequate liquid nitrogen levels are maintained in order to cover the vaccine.
• When withdrawing a strip of ampoules from the canister in the liquid nitrogen container, expose only the ampoule(s) to be used immediately. We recommend handling only a maximum of 5 ampoules (1 strip) at a time. After removing the ampoule(s), the remaining ampoules should be replaced immediately in the canister of the liquid nitrogen container.
• The content of the ampoule(s) is thawed rapidly by immersing in clean water between 25 °C and 27 °C. Gently swirl the ampoule(s) to disperse contents. It is important that the vaccine, after being thawed, is mixed as soon as possible into the diluent to protect the cells. Dry the ampoule, then break the ampoule at its neck and immediately proceed as below.
• Gently draw contents of the ampoule into a sterile syringe, mounted with an 18 gauge needle.
• Insert the needle through the stopper of the diluent bag/vial and add slowly and gently the content of the syringe to the diluent. Gently swirl and invert the bag/vial to mix the vaccine. Withdraw a portion of the diluent into the syringe to rinse the ampoule. Remove the contents from the ampoule and inject gently into the diluent bag/vial. Remove the syringe and invert the bag/vial 6 to 8 times to mix the vaccine.
• The vaccine is now ready for use.

Method of vaccination

The vaccine is administered via injection. For subcutaneous vaccination, 0,2 mℓ per chick is injected in the neck.

For in ovo vaccination, eggs are injected on the 18^th day of the embryo development using 0,05 mℓ per egg.

The bag/vial of vaccine should be swirled gently and frequently during vaccination. It should be stored on crushed ice if not used immediately. Entire contents of the bag/vial must be used within 2 hours after mixing. After that, any remaining vaccine should be discarded according to local waste disposal regulations.

PRESENTATION

Type I cryogenic ampoules containing the cell suspension. The ampoules are flame sealed. Ampoules contain2 000 or 4000 doses.

Nobilis^® Diluent CA is supplied separately in multilayer plastic (MLP) bags in 400 mℓ and

800 mℓ.

REGISTRATION HOLDER                                       MANUFACTURER

Intervet South Africa (Pty) Ltd.                            Intervet Inc.

20 Spartan Road                                                         29160 Intervet Lane

Spartan 1619, RSA                                                      Millsboro

Tel: +27 (0) 11 923 9300                                           Delaware 19966-0318 USA

E-mail: msdahza@msd.com

www.msd-animal-health.co.za

DATE OF PUBLICATION OF PACKAGE INSERT 30 August 2018