Innovax-ILT-IBD

1 x 2000 dose
Concentrate and diluent for suspension for injection
OV
SC

Species

Chickens (one day-old chicks and embryonated eggs).

Indications

For active immunisation of one-day-old chicks or 18-19 day-old embryonated eggs:

- to reduce mortality, clinical signs and lesions caused by avian infectious laryngotracheitis (ILT) virus and Marek’s disease (MD) virus.

- to prevent mortality and to reduce clinical signs and lesions caused by infectious bursal disease (IBD) virus.

Onset of immunity: IBD: 3 weeks of age, ILT: 4 weeks of age, MD: 5 days of age.

Duration of immunity: IBD: 100 weeks, ILT: 100 weeks,

MD: entire risk period.

Dose to be administered and administration route

Subcutaneous use or in ovo use.

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 solvent for cell associated poultry vaccines for reconstitution. Reconstitute the vaccine according to the tables below:

For subcutaneous use reconstitute the vaccine according to the table below:

Solvent bag

Number of vaccine ampoules for

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

Bag of 1,200 ml

3 ampoules containing 2,000 doses

Bag of 1,600 ml

4 ampoules containing 2,000 doses

Bag of 1,600 ml

2 ampoules containing 4,000 doses

For in ovo use reconstitute the vaccine according to the table below:

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

Bag of 1,200 ml

12 ampoules containing 2,000 doses

Bag of 1,200 ml

6 ampoules containing 4,000 doses

Bag of 1,600 ml

16 ampoules containing 2,000 doses

Bag of 1,600 ml

8 ampoules containing 4,000 doses

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

2. Preparation of the vaccine shall be planned before the ampoules are taken from the liquid nitrogen and the exact amount of vaccine ampoules and amount of solvent needed shall 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 has to be taken to ensure that the mix-ups of ampoules with different number of doses is avoided and the correct solvent is used.

3. 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.

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 ampoule(s), the remaining ampoules should be put back immediately into the canister in the liquid nitrogen container.

5. The content of the ampoule(s) is thawed rapidly by immersing in clean water at 25 °C – 27 °C. Gently swirl the ampoule(s) to disperse the contents. It is important that the ampoule content, 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.

6. Gently withdraw the contents of the ampoule into a sterile syringe, mounted with an 18-gauge needle.

7. 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.

8. Repeat steps 6 and 7 for additional ampoules, if required.

9. Remove the syringe and invert the bag (6–8 times) to mix the vaccine.

10. The vaccine is now ready for use.

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

When this product is mixed with Nobilis Rismavac, both should be diluted in the same solvent bag in the same way (400 ml of solvent for each 2,000 doses of both products or 800 ml of solvent for each 4,000 doses of both products).

Posology:

Subcutaneous use: one single injection of 0.2 ml per chick. In ovo: one single injection of 0.05 ml per egg.

Administration:

The vaccine is administered by subcutaneous injection in the neck or by in ovo injection. 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).

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 content is situated in the tip of the ampoule this indicates that the content has been thawed and must not be used.

Adverse reactions

None known.

Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or its local representative or the national competent authority via the national reporting system. See also the last section of the package leaflet for respective contact details.

Dispensing

POM-V

References

Leaflet is unavailable
Poultry
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Art. Nr. 01708/5082
PACKAGES
Innovax-ILT-IBD
MSD
1 x 2000 dose
01708/5082
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