Target Species:
Chickens (one-day-old chicks and embryonated eggs).
Indications for use:
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.
Contraindications:
None.
Special warnings for each target species:
Vaccinate healthy animals only.
Special precautions for use:
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 have to be followed in order to avoid direct or indirect contact between vaccinated chickens and turkeys.
Operator warnings:
The handling of liquid nitrogen should take place in a well-ventilated area.
Innovax-ILT-IBD 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 ampoule content. 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 – 27 °C.
Adverse Reactions:
None known.
Use during pregnancy or lactation:
Laying birds:
The safety of the veterinary medicinal product has not been established during lay.
Interactions:
Safety and efficacy data are available which demonstrate that the vaccine Innovax-ILT-IBD can be mixed in the same solvent and administered by either in ovo or subcutaneous route with Nobilis Rismavac.
Safety and efficacy data are available which demonstrate that this vaccine can be administered to one-day-old chicks on the same day but not mixed with Nobilis ND Clone 30 or Nobilis ND C2 or Nobilis IB Ma5 or Nobilis IB 4-91. For such associated uses, an onset of immunity of 3 weeks has been demonstrated for ND and IB.
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except the products mentioned above. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Amounts 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 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 |
Bag of 1,200 ml solvent | 3 ampoules containing 2,000 doses |
Bag of 1,600 ml solvent | 4 ampoules containing 2,000 doses |
Bag of 1,600 ml solvent | 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 solvent | 12 ampoules containing 2,000 doses |
Bag of 1,200 ml solvent | 6 ampoules containing 4,000 doses |
Bag of 1,600 ml solvent | 16 ampoules containing 2,000 doses |
Bag of 1,600 ml solvent | 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.
1Preparation 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.
2Before 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.
3When 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.
4The 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.
5Dry the ampoule, then break the ampoule at its neck and immediately proceed as described below.
6Gently withdraw the contents of the ampoule into a sterile syringe, mounted with an 18-gauge needle.
7Insert 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.
8Repeat steps 6 and 7 for additional ampoules, if required.
9Remove the syringe and invert the bag (6 – 8 times) to mix the vaccine.
10The 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).
Overdose:
No symptoms were observed after the administration of a 10-fold dose of vaccine.
Withdrawal periods:
Zero days.