Chickens.

For the active immunisation of healthy chickens to reduce infection and clinical signs of coccidiosis caused by Eimeria acervulina, E.brunetti, E. maxima, E. mitis, E. necatrix, E. praecox, and E. tenella.

Onset of immunity: begins to develop within 10 days post vaccination

Duration of immunity: at least 36 weeks when birds are housed in conditions that permit oocyst recycling.

For the active immunisation of chickens against coccidiosis caused by Eimeria acervulina, E. brunetti, E. maxima, E. mitis, E. necatrix, E. praecox, and E. tenella:

-to reduce oocyst excretion for E. acervulina, E. brunetti, E. maxima, E. necatrix, E. praecox and E. tenella.

-to reduce loss in weight gain for E. acervulina, E. brunetti, E. mitis, E. necatrix, E. praecox and E. tenella.

Onset of immunity: 21 days post vaccination

Duration of immunity 10 weeks

None.

Vaccinate healthy animals only.

Food and water provided at any stage before or after vaccination must be free from anticoccidial agents including sulphonamides and antibacterial agents having anticoccidial activity.

The vaccine contains live coccidian oocysts and is dependent upon replication of the vaccinal lines within the host for development of protection.

It is common to find oocysts in the gastrointestinal tract of vaccinated birds from 1-3 weeks or more after vaccination. These oocysts are most likely to be vaccinal oocysts which recycle in the birds/litter. This ensures satisfactory flock protection against all the pathogenic strains of the same species of Eimeria that are contained in the vaccine.

Chickens should be healthy and reared on floor with litter. Litter should be removed, and chicken housing thoroughly cleaned and disinfected between rearing cycles, to minimize carry over to the next flock. This will reduce the chances of a coccidial field challenge occurring before the development of adequate flock protection. Particular care should be taken to ensure that all chicks take water when vaccinated by pipeline nipples at day-old. Ensure that all vaccination equipment is thoroughly cleaned before use.

Do not administer to dry drinkers.

In any animal population there may be a small number of individuals which fail to respond fully to vaccination. Successful vaccination depends upon correct administration of the vaccine together with the animal’s ability to respond. This can be influenced by such factors as genetic constitution, intercurrent infection, age, the presence of maternally derived antibodies, nutritional status, concurrent drug therapy and stress.

For administration by spray-on-chickens the vaccine should be diluted using “Solvent for spray-on-chickens”.

Wash hands immediately after use.

Personal protection equipment consisting of masks and eye protection should be worn when spraying the vaccine.

Mild lesions e.g. E. acervulina, E. necatrix and E. tenella [lesion score of +1 or +2 using the numerical ranking system of Johnson and Reid (1970)] have commonly been discovered in birds 3-4 weeks after vaccination in laboratory studies. Lesions of this severity will not affect the performance of chickens.

The frequency of adverse reactions is defined using the following convention:

- Very common (more than 1 in 10 animals treated displaying adverse

reaction(s))

- Common (more than 1 but less than 10 animals in 100 animals treated)

- Uncommon (more than 1 but less than 10 animals in 1,000 animals treated)

- Rare (more than 1 but less than 10 animals in 10,000 animals treated)

- Very rare (less than 1 animal in 10,000 animals treated, including isolated

reports).

Do not use in birds in lay.

Since the protection against coccidial infection following vaccine administration is enhanced by natural challenge, it should be noted that access to any therapeutic agents having anticoccidial activity at any time following vaccination may reduce the duration of effective protection. This is particularly important in the four weeks following vaccination.

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.

For oral administration to chickens by spray-on-feed, by spray-on-chickens, or in drinking water. A single dose of vaccine (0.004 ml undiluted vaccine) should be administered to chickens between day-old and 9 days of age, inclusive.

Shake the container vigorously for 30 seconds before use, to ensure homogeneous suspension of the oocysts.

a) in drinking water

The product may be administered in water via line drinkers from first placement of the chicks at 1 day of age, provided that a procedure is used that ensures consumption of the vaccinated water evenly by all chicks, avoiding settlement of oocysts. For example, the following methods have been shown to be successful:

The vaccine should be diluted to a concentration of 1 dose per 2 ml in cold tap water. Care should be taken to empty the vial completely by rinsing in the water used to dilute the vaccine, and the diluted vaccine should be well stirred immediately before use. Calculate the total volume of water in the drinker system to be used, the average number of birds per drinking line and therefore the number of drinker lines and volume of diluted vaccine required. For static drinker lines, it is recommended that birds should be thirsted for 1-2 hours prior to administration. Each line should be drained and primed under gravity with diluted vaccine immediately before allowing birds access to the nipples. An initial charge (about 1 litre) of an indicator (e.g. milk) can be used to show when the line has been filled to the end and can be closed without wasting vaccine. Turn on the mains water supply when all of the diluted vaccine has been consumed. For drinker lines temporarily connected up to a re-circulating system, it is recommended that vaccine dilution be carried out in a temporary reservoir incorporated within the circulation system, ensuring that the contents remain well mixed at all times. In order to mix the oocysts evenly, the diluted vaccine should be allowed to re-circulate through the drinker lines before the birds are allowed to drink.

The above examples are intended as a guide to illustrate the principles that should be followed in adapting a particular pipeline drinker system.

Due to the difficulties associated with getting very young birds to drink from nipple drinkers, particular care should be taken to ensure that chicks of 1-3 days old take sufficient water for vaccine uptake when vaccinated using this method.

Alternatively, vaccination using supplementary drinkers between 5-9 days may be preferred. Occasionally on farms using nipple lines, supplementary drinkers are provided for the first 4-5 days. These may be fount-type drinkers or small bell-type drinkers which are automatically fed from the nipple line. If each supplementary drinker of this type is fed individually from the line, then the method of vaccination is essentially similar to bell-type drinkers. If, however, these drinkers are fed in sequence from a single nipple, one may encounter problems of air-locks after this type of drinker has been disconnected in order to deprive the birds of water for the 1-2 hours before vaccination. In this case it may be more appropriate to make an initial dilution of vaccine in a suitable container, e.g. a watering can, and pour the diluted vaccine into each drinker, as for individual founts.

IMPORTANT

The vaccine should not be administered into the main header tank of the watering system. The dilution of vaccine would be too high and the oocysts would not remain in suspension.

a) On feed

A method of application should be chosen that ensures rapid, even coverage of the total surface area of the feed available to the chicks. The vaccine may be sprayed, using a coarse spray, diluted in water. The vaccine should be diluted to a concentration of 1 dose per 0.4 ml (1,000 doses of Paracox-8 added to 400 ml of water,5,000 doses of Paracox-8 added to 2 litres of water). Care should be taken to empty the vial completely by rinsing it in the water used to dilute the vaccine and to ensure that the applicator reservoir is agitated regularly throughout application to avoid settling out of oocysts.

b) Spray-on-chickens

Vaccine should be delivered using a dose volume of 0.21 ml of diluted vaccine per bird using a coarse spray. Determine the delivery capacity of the spray device in terms of the volume delivered per 100 birds. Multiply this volume by 50 to give the total volume of diluted vaccine required for 5000 doses (or by 10 for 1,000 doses).

For the preparation of 5000 doses diluted vaccine, a total of 0.21 × 5000 = 1050 ml diluted vaccine is needed and is divided over the vaccine, solvent and water as below:

1. 20 ml Paracox-8 vaccine (1 vial)

2. 500 ml Solvent (1 bottle)

3. Fill up to 1,050 ml with tap water

i.e. for the preparation of 1,000 doses diluted vaccine, a total of 0.21 × 1,000 = 210 ml diluted vaccine is needed and is divided over the vaccine, solvent and water as below:

1. 4 ml Paracox-8 vaccine (1 vial)

2. 100 ml Solvent (1 bottle)

3. Fill up to 210 ml with tap water

The solvent contains a red colouring agent and xanthan gum, both of which are included for better uptake. Water used for vaccine dilution should be fresh, cool and free of pollution. Use clean containers for vaccine preparation. Shake the 5,000-dose (or 1,000-dose) vial of Paracox-8 vigorously for 30 seconds to ensure re-suspension of the oocysts. Empty the content of the vial completely by rinsing with a small quantity of the water used to dilute the vaccine. Empty the content of the solvent bottle completely by rinsing with the remaining amount of water and mix to a uniform solution. Add the vaccine solution to the solvent solution and mix thoroughly. Add the diluted vaccine to the applicator reservoir and spray evenly over the birds using a coarse spray. Ensure a controlled, even coverage of the total internal surface area of the box containing the chickens. Leave the birds in the box for at least 30 minutes in a well-lighted area to allow time for the birds to preen.

Severe overdose (× 5 or more) may lead to a temporary reduction in daily live weight gain.

Zero days.