INNOVAX® ND-ILT

FOR ANIMAL USE ONLY

Innovax^® ND-ILT is a cell-associated live recombinant turkey herpesvirus (HVT) expressing the fusion protein of Newcastle Disease virus and the gD and gI glycoproteins of Infectious Laryngotracheitis virus.

INDICATIONS

Innovax^® ND-ILT induces active immunity against Newcastle Disease (ND), Infectious Laryngotracheitis (ILT) and Marek’s Disease (MD) in chickens. It is indicated for the active immunisation of 1-day-old chicks or embryonated chicken eggs to:

–         Reduce mortality and clinical signs caused by Newcastle Disease virus.

–         Reduce mortality, clinical signs and lesions caused by avian Infectious Laryngotracheitis virus and Marek’s Disease virus.

IMMUNITY

Onset of immunity:             ND: 4 weeks,

ILT: 4 weeks,

MD: 9 days.

Duration of immunity:         ND: 62 weeks,

ILT: 62 weeks,

MD: entire risk period.

COMPOSITION

Each dose of reconstituted vaccine (0,2 mℓ for subcutaneous use or 0,05 mℓ for in ovo use) contains:

Active substance:

Cell-associated live recombinant turkey herpesvirus (strain HVT/NDV/ILT), expressing the fusion protein of Newcastle Disease virus and the glycoproteins gD and gI of Infectious Laryngotracheitis virus: 10^3,3 to 10^4,3 PFU¹.

¹PFU – Plaque Forming Units

Excipients:

Bovine serum, dimethyl sulfoxide, veggie medium.

STORAGE INSTRUCTION

• Ampoule (cell concentrate): 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.
• Do not use Innovax^® ND-ILT after the expiry date stated on the label.
• Shelf-life after reconstitution to directions: 2 hours.
• Do not store partially used containers for future use.
• To allow a check on correct storage and transport, the ampoules are placed upside down in the liquid nitrogen containers. If frozen suspension is situated in the tip of the ampoule, this indicates that the suspension has been thawed and must not be used.

WARNINGS

• Withdrawal period: Do not slaughter chickens for human consumption for at least 21 days after vaccination.
• Vaccinate healthy chickens only.
• Do not mix Innovax^® ND-ILT with any other vaccine or medication except for the products mentioned under “Interaction with other medicinal products and other forms of interaction”.
• Do not use Innovax^® ND-ILT within 2 weeks of antimicrobial treatment.
• Do not over- or under-dose the vaccine.
• Ensure that marketed animals do not have local reactions (swellings) at the site of vaccine administration, or elevated temperature reactions (fever), as this may result in the condemnation of the carcasses.
• May not be used in chickens in lay.
• Do not inject intravenously.
• Do not store partially used containers for future use and use the entire contents when opened.
• Accidental self-injection could lead to a severe allergic reaction. Consult a physician and provide him/her with the package insert.
• 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. Use sterile equipment when administering the vaccine.
• Do not use disinfectants or antiseptics to sterilise any equipment.
• Wear protective clothing, masks, gloves, boots, etc. according to hazard standards.
• Avoid contact of the product with skin, eyes and mouth.
• Do not eat, drink or smoke while handling this product.
• Use entire contents when the ampoule is first opened and do not store unused ampoules for future use.
• Adhere to the vaccination programme to obtain optimum results.
• Do not dispose via wastewater or household waste. Destroy any unused vaccine and dispose of all the 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 for use in chickens

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.

Special precautions to be taken by the person administering Innovax^® ND-ILT to chickens

The handling of liquid nitrogen should take place in a well-ventilated area. Innovax^® ND-ILT is a virus suspension packed in glass ampoules and stored in liquid nitrogen. Before withdrawing ampoules from the liquid nitrogen canister, protective equipment consisting of gloves, long sleeves and a facemask or 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. For this reason, thaw the ampoules in clean water at 25 °C to 27 °C. Do not thaw in hot or ice-cold water.

Interaction with other medicinal products and other forms of interaction

Safety and efficacy data are available which demonstrate that the vaccine can be mixed in the same solvent and administered by the subcutaneous route with Nobilis^® Rismavac (G2444). For this mixed use, an onset of immunity of 5 days has been demonstrated for MD.

Safety and efficacy data are available which demonstrates that Nobilis^® ND Clone 30 (G2466) or Nobilis^® ND C2 (G2872) can be administered (by spray) in 1-day-old chicks vaccinated either by the subcutaneous or in ovo route with Innovax^® ND-ILT. For this associated use, an onset of immunity of 2 weeks has been demonstrated for ND.

Safety and efficacy data are available which demonstrate that Nobilis^® IB Ma5 (G2300) or Nobilis^® IB 4-91 (G4031) can be administered (by spray) in 1-day-old chicks vaccinated either by the subcutaneous or in ovo route with Innovax^® ND-ILT.

No information is available on the safety and efficacy of Innovax^® ND-ILT when used with any other veterinary medicinal product except the products mentioned above. A decision to use Innovax^® ND-ILT  before or after any other veterinary product therefore needs to be made on a case-by-case basis.

Incompatibilities

Do not mix with any other veterinary medicinal product except the solvent (Nobilis^® Diluent CA) supplied for use with the veterinary medicinal product or Nobilis^® Rismavac (G2444).

DOSAGE AND DIRECTIONS FOR USE – USE ONLY AS DIRECTED

Dosage, route and method of administration

The vaccination programme consists of a single dose administered via subcutaneous injection to 1-day-old chicks, or in ovo injection to embryonated chicken eggs.

After dilution, administer a single dose of 0,2 mℓ vaccine per chicken by subcutaneous injection in the neck or one dose of 0,05 mℓ per egg by in ovo injection.

Advice on correct administration

The bag of vaccine should be gently swirled frequently during vaccination to guarantee that the vaccine suspension remains homogenous and that the correct vaccine virus titre is administered (e.g., during long vaccination sessions).

Preparation of the vaccine

The usual aseptic precautions should be applied to all preparation and administration procedures. The handling of liquid nitrogen should take place in a well-ventilated area.

1. Use the solvent for reconstitution. Reconstitute the vaccine according to the tables below:

For subcutaneous use:

Solvent Bag	Number of vaccine ampoules for subcutaneous use
Bag of 400 mℓ solvent	1 ampoule containing 2 000 doses
Bag of 800 mℓ solvent	2 ampoules containing 2 000 doses
Bag of 800 mℓ solvent	1 ampoule containing 4 000 doses

For in ovo use:

Solvent Bag	Number of vaccine ampoules for in ovo use
Bag of 400 mℓ solvent	4 ampoules containing 2 000 doses
Bag of 400 mℓ solvent	2 ampoules containing 4 000 doses
Bag of 800 mℓ solvent	8 ampoules containing 2 000 doses
Bag of 800 mℓ solvent	4 ampoules containing 4 000 doses

The solvent must be clear, red coloured, without sediment and at room temperature (15 °C to 25 °C) at the time of mixing.

• Preparation of the vaccine must be planned before the ampoules are taken from the liquid nitrogen and 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 ampoule once they are removed from the cane, so special care has to be taken to ensure that the mix-up of ampoules with different number of doses is avoided and the correct solvent is used.
• Before withdrawing the ampoules from the liquid nitrogen container, protect hands with gloves, wear long sleeves and use a facemask or goggles. When removing an ampoule from the cane, hold in the palm of a gloved hand away from the body and the face.
• 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 ampoule(s), the remaining ampoules should be put back immediately into the canister in the liquid nitrogen container.
• 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.

Dry the ampoule, then break the ampoule at its neck and immediately proceed as described below.

• Gently withdraw the contents of the ampoule into a sterile syringe, mounted with an 18-gauge needle.
• Insert the needle through the stopper of the solvent bag and add slowly and gently the contents of the syringe to the solvent. Gently swirl and invert the bag to mix the vaccine. Withdraw a portion of the solvent into the syringe to rinse the ampoule. 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.
• The vaccine is now ready to use.
• After adding the content of the ampoule to the solvent, the ready to use product is a clear, red coloured suspension for injection.

PRESENTATION

Cell concentrate: Off-red to red cell concentrate in Type I glass ampoule of 2 mℓ 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 multilayer plastic bag of 400 mℓ and 800 mℓ.

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

MANUFACTURER                                            

Intervet International BV,                                   

Ambachtstraat 4                                              

3732 CN De Bilt                                                

The Netherlands                                              

DATE OF PUBLICATION OF PACKAGE INSERT

11 March 2022