Target species
Chickens.
Indications for use
For active immunisation of one-day-old chicks:
- to prevent mortality and clinical signs and reduce lesions caused by MD virus (including very virulent MD virus), and
- to prevent mortality and clinical signs and lesions caused by IBD (also known as Gumboro disease) virus.
Onset of immunity: MD: 5 days after vaccination. IBD: 14 days after vaccination.
Duration of immunity: MD: A single vaccination is sufficient to provide protection for the entire risk period. IBD: 10 weeks after vaccination.
Contraindications
None.
Special warnings for each target species
Vaccinate healthy animals only.
Chickens with maternally derived antibodies against MD when vaccinated with this veterinary medicinal product, may have a delayed onset of immunity against IBD.
Special precautions for use
Special precautions for use in animals
Apply the usual aseptic precautions to all administration procedures.
As this is a live vaccine, both vaccine strains may be excreted from vaccinated birds. The RN1250 vaccine strain has not been shown to spread in experimental conditions. The vHVT013-69 vaccine strain may be spread to unvaccinated chickens and turkeys. Appropriate veterinary and husbandry measures should be taken to avoid spread of the vaccine strains to unvaccinated chickens, turkeys and other susceptible species.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
Personal protective equipment consisting of gloves, spectacles and boots should be worn when handling the veterinary medicinal product, before withdrawing from liquid nitrogen, during the ampoule thawing and opening operations. Frozen glass ampoules may explode during sudden temperature changes. Store and use liquid nitrogen only in a dry and well-ventilated place. Inhalation of the liquid nitrogen is dangerous.
Adverse reactions (frequency and seriousness)
None.
Use during pregnancy, lactation or lay
This veterinary medicinal product is designed for one-day-old chicks and therefore the safety of the veterinary medicinal product has not been established during lay.
Interaction with other medicinal products and other forms of interaction
No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product. 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.
Preparation of the vaccine suspension:
• Wear protective gloves, spectacles and boots during the ampoule thawing and opening operations. The handling of liquid nitrogen should take place in a well-ventilated area.
• Preparation of the vaccine shall be planned before the ampoules are taken from the liquid nitrogen. The exact amount of vaccine ampoules and amount of solvent needed shall be calculated first according to the table below provided as example:
Solvent bag | Number of vaccine ampoules |
1 bag of 200 ml solvent | 1 ampoule containing 1,000 doses |
1 bag of 400 ml solvent | 2 ampoules containing 1,000 doses or 1 ampoule containing 2,000 doses |
1 bag of 800 ml solvent | 4 ampoules containing 1,000 doses or 2 ampoules containing 2,000 doses or 1 ampoule containing 4,000 doses |
• Remove from the liquid nitrogen container only those ampoules, which are to be used immediately.
• Thaw the contents of the ampoules rapidly by gentle agitation in water at 25 °C-30 °C. The thawing process should not exceed 90 seconds. Proceed immediately to the next step.
• As soon as they are thawed, wipe the ampoules with a clean paper towel and then open them while holding them at arm’s length (in order to prevent injury if any ampoule breaks).
• Select an appropriately sized sterile syringe to withdraw the vaccine from all the ampoules that are thawed, and fit it with a needle of 18 gauge or larger.
• Tear the overpouch on the solvent bag, and then gently insert the syringe needle through the septum of one of the bag connecting tubes and withdraw 2 ml of solvent.
• Then draw up the complete contents of all the thawed ampoules into the syringe. Do this by slowly drawing up the contents from each ampoule by gently tilting the ampoule forward and inserting the needle with the bevel edge facing downwards towards the bottom of the ampoule. Continue until all the vaccine is drawn out of the ampoule.
• Transfer the syringe contents into the solvent bag (do not use the solvent if it is cloudy).
• Gently mix the vaccine in the solvent bag by moving the bag back and forth.
• It is important to rinse the ampoules and ampoule tips. To do this, draw up a small volume of the solvent containing the vaccine into the syringe. Then slowly fill the ampoule bodies and tips with it. Withdraw the content from the ampoule bodies and tips, and inject it back into the solvent bag.
• Repeat this rinsing operation once.
• Repeat the thawing, opening, transfer and rinsing operations for the appropriate number of ampoules to be diluted in the solvent bag.
• The vaccine is ready for use and should be mixed by gentle agitation and used immediately. During vaccination, gently swirl the bag frequently to ensure the vaccine remains homogenously mixed.
• The vaccine is a clear, red-orange coloured suspension for injection to be used within two hours. Do not freeze it under any circumstances. Do not re-use opened containers of vaccine.
Posology:
One single injection of 0.2 ml per one-day-old chick.
Method of administration:
The vaccine must be administered by subcutaneous injection in the neck.
Overdose (symptoms, emergency procedures, antidotes), if necessary
A limited and transient effect on growth was observed when 10-fold maximum release dose was administered to White Leghorn specified pathogen free chickens.
Withdrawal period(s)
Zero days.