1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Paracox-5, Oral suspension

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active substances:

Each 0.004 ml dose of vaccine contains the following numbers ofsporulated oocysts derived from five precocious attenuated lines of coccidia:

Eimeria acervulina HP 500 – 650 oocysts*

Eimeria maxima CP 200 – 260 oocysts*

Eimeria maxima MFP 100 – 130 oocysts*

Eimeria mitis HP 1000 – 1300 oocysts*

Eimeria tenella HP 500 – 650 oocysts*

*According to the in vitro counting procedure of the manufacturer at the time of blending and at release.

For a list of excipients, see section 6.1.

For administration by spray in the hatchery the recommended red foodcolouring agent cochineal E120, should be added to the diluted vaccine to give a concentration in the diluted vaccine of 0.1% w/v, equivalent to 210-280 µg/bird. The purity of the cochineal E120 must be in compliance with Commission Directive 95/45/EC.¹

3. PHARMACEUTICAL FORM

Oral suspension.

4. CLINICAL PARTICULARS

4.1 Target species

Chickens.

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

Immunity begins to develop within 14 days post vaccination and is maintained for at least 40 days post vaccination.

4.3 Contraindications

None.

4.4 Special warnings

Paracox-5 for oral administration by dilution and spraying onto birds in the hatchery in conjunction with added red food colouring agent, or by spraying onto feed or by addition to drinking water, only.

Only vaccinate healthy birds. Do not administer to stressed chicks, e.g. chilled, not feeding or drinking.

Chickens should be strictly floor reared on litter. 'Paracox-5' vaccine contains live coccidia 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 via the litter. Recycling ensures satisfactory flock protection against all the pathogenic species of Eimeria contained in the vaccine.

Measures should be taken to ensure that the bulk diluted vaccine is resuspended at intervals during administration.

Since the protection against coccidial infection following “Paracox-5” administration is enhanced by natural challenge, it should be noted that access to any therapeutic agents having anti-coccidial activity at any time following vaccination may reduce the duration of effective protection. This is important throughout the life of the chicken.

To reduce the chance of coccidial field challenge before the onset of immunity, litter should be removed and chicken housing should be thoroughly cleaned between rearing cycles.

A significant reduction in efficacy may be observed if a red food colouring agent cochineal E120 is not added to the diluted vaccine before administration by hatchery spray. Addition of a red food colouring agent cochineal E120 is only to be employed for hatchery spray administration.

The recommended colouring agent is cochineal E120 and full efficacy of the product may not be achieved if an alternative to cochineal E120 food colouring agent is used.

4.5 Special precautions for use

Special precautions for use in animals

Ensure that all vaccination equipment is thoroughly cleaned before use.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

When spraying the vaccine onto feed or in the hatchery well fitting masks and eye protection should be worn by the operator.

4.6 Adverse reactions (frequency and seriousness)

Mild lesions of e.g. E. acervulina, and E. tenella (lesion scores of +1 or +2 using the numerical ranking system of Johnson and Reid, 1970) have occasionally been discovered in birds 3 to 4 weeks after vaccination. Lesions of this severity will not affect the performance of immune chickens.

4.7 Use during lay

The safety of the veterinary medicinal product has not been established during lay.

4.8 Interaction with other medicinal products and other forms of interaction

Do not administer anticoccidial agents including sulphonamides and antibacterial agents before or after vaccination with Paracox-5.

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.

4.9 Amounts to be administered and administration route

A single dose of Paracox-5 should be administered to chicks either in the hatchery by spray or via feed at one-day-old or at 3 days old via drinking water.

Administration via feed

Sufficient starter feed for the first 24-48h should be laid out on paper or plastic along the floor of the poultry house. Do not administer the vaccine via an automatic feeding machine or place treated feed directly under heating lamps.

Shake the container vigorously for 30 seconds before use, to ensure re-suspension of the oocysts. Dilute Paracox-5 in water at the rate of approximately 5000 doses in up to 3 litres of water and spray evenly over the surface of the feed using a coarse spray. Ensure a controlled, even coverage of the total surface area of the feed available to the chicks. Agitate the applicator reservoir regularly throughout application to avoid settling out of oocysts. Ensure that all available feed is treated and that the total number of doses dispensed matches the number of birds in the house.

Once the vaccine has been diluted for use it should be sprayed onto feed and birds should be placed with access to the feed within two hours.

When the treated allocation of feed has been consumed, routine feeding may continue.

Administration via water

Place chicks in the house at day-old and encourage them to become accustomed to the nipple drinker system. When the chicks are 3 days old the lighting system is turned off for about 7 hours. Raise all drinking lines out of reach of the chicks for about two hours before administration of the vaccine. At the same time the lighting is switched on. Drain each drinking line completely.

Dilute the vaccine to a concentration of 1 dose/2 - 4ml in cold tap water. Calculate the average number of birds per drinking line and calculate the volume of diluted vaccine needed per drinking line at a rate 2 - 4 ml per bird.

Fill each line with diluted vaccine and lower to allow the 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. As the birds drink, keep each line full via its reservoir until all the diluted vaccine prepared for that line has been added. Normal water supply then follows.

It is recommended that before using the vaccine in a facility for the first time, precautions are taken to check that the procedure ensures the drinking lines have been properly primed with Paracox-5, as shown by the appearance of the indicator from nipples at the end the line, before the chicks are allowed to start drinking.

Administration via hatchery spray

Vaccine should be delivered using a dose volume of between 0.21 and 0.28 ml per bird, in a cabinet providing a coarse spray. Determine the delivery capacity of the spray cabinet in terms of the volume delivered per 100 birds. Multiply this volume by 50 to give the total volume of diluted vaccine required for 5,000 doses (or by 10 for 1,000 doses) and add this volume of water to a suitable container (normally between 1.0 and 1.5 litres for 5,000 doses or 200 and 300 ml for 1,000 doses). Uptake of the vaccine by the birds, and therefore the efficacy of the vaccine, is improved if a red food colouring agent is added to the diluted vaccine before administration by spray. Add sufficient red food colouring agent (cochineal E120) to the water to give a concentration of 0.1% w/v.

Shake one 5,000 dose (or 1,000 dose) vial of Paracox-5 vigorously for 30 seconds to ensure resuspension of the oocysts. Add the entire contents of the vial to the diluent and mix thoroughly. Add the diluted vaccine to the applicator reservoir and operate the cabinet to 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 chicks. Agitate the applicator reservoir regularly throughout application to avoid settling out of oocysts. Prepare birds for delivery to rearing accommodation.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

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

4.11 Withdrawal period(s)

Zero days

5. IMMUNOLOGICAL PROPERTIES

ATC Vet Code: QI01AN01

Induces specific immunity to wild strains of these Eimeria species when ingested by chickens.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Phosphate buffered saline

6.2 Incompatibilities

Do not mix with any other veterinary medicinal product.

6.3 Shelf-life

Shelf life of the veterinary medicinal product as packaged for sale: 33 weeks.

Shelf life after first opening the immediate packaging has not been determined. It is therefore recommended that the vaccine is diluted for use immediately after the vial has been opened.

6.4 Special precautions for storage

Store and transport refrigerated (2 °C to 8 °C). Do not freeze. Protect from light.

6.5 Nature and composition of immediate packaging

The containers are 4 ml and 20 ml plastic vials made of clear, colourless PETG (polyethylene terephthalate copolyester) with bromobutyl stoppers and aluminium crimps. The crimp is a 20 mm Flip-Tear-Up made of clear lacquered aluminium with a white polypropylene disc. Vials are packaged in boxes.

5 x 4ml (1000 doses)

5 x 20ml (5000 doses)

Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products

Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant approved for use by the competent authorities.

7. MARKETING AUTHORISATION HOLDER

Intervet UK Ltd Walton Manor Walton Milton Keynes Bucks MK7 7AJ

Intervet Ireland Ltd Magna Drive Magna Business Park Citywest Road Dublin 24

8. MARKETING AUTHORISATION NUMBER(S)

Vm 01708/4552

VPA 10996/215/001

9. DATE OF RENEWAL OF THE AUTHORISATION

17 February 2010

10. DATE OF REVISION OF THE TEXT

August 2010