Paracox®-5 - MSD Animal Health South Africa

For the active immunisation of broilers against Eimeria acervulina, E. maxima, E. mitis and E. tenella.

FOR ANIMAL USE ONLY

PARACOX^®-5

Reg. No. G2817 (Act 36/1947)

Attenuated Oral Coccidiosis Vaccine for Chickens

This vaccine may only be used by, or under the supervision of persons registered in terms of, or authorised in terms of section 23 (1) (c) of the Veterinary and Para-Veterinary Professions Act, 1982 (Act No. 19 of 1982).

INDICATIONS

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

Immunity begins to develop within 14 days post vaccination and is maintained for at least 42 days post vaccination.

COMPOSITION

Each 0,004 mℓ dose of vaccine contains the following numbers of sporulated oocysts derived from precocious lines of coccidia:

E. acervulina HP ≥ 500

E. maxima CP ≥ 200

E. maxima MFP ≥ 100

E. mitis HP ≥ 1 000

E. tenella HP ≥ 500

STORAGE INSTRUCTIONS

Store between 2 °C and 8 °C in a refrigerator.
Do not freeze.
Protect from light.
Do not store partially used containers for future use.

WARNINGS

Withdrawal period: Do not slaughter chickens for human consumption within 21 days of vaccination.
Vaccinate healthy chickens only.
TO BE USED FOR THE IMMUNISATION OF BROILERS ONLY.
Do not use in layers or breeders in lay.
For oral use only.
Do not administer to stressed or unhealthy chickens, e.g., chilled, not eating or drinking.
Do not mix Paracox®-5 with any other veterinary medicinal product.
Do not over- or underdose the vaccine.
For administration by spray on chickens, a red food colourant agent (Cochineal E120) should be added to the diluted vaccine.
For the spray-on-chicken method of administration, a significant reduction in efficacy may be observed if diluted in tap water without red colourant. The purity of Cochineal E120 must be in compliance with Commission Directive 95/45/EC.
Chickens should be strictly floor reared to have access to their droppings, as reinfection is required to induce immunity.
Since the protection against coccidial infection follow Paracox®-5 administration is enhanced by natural challenge, it should be noted that access to any therapeutic agents having anti-coccidial activity during the 4 weeks following vaccination, will affect the efficacy of the vaccine.
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 (viz., oxytetracycline, chlortetracycline, furazolidone and nitrofurazone).
Measures should be taken to ensure an even distribution of oocysts in the diluted vaccine suspension during the entire administration period.
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 growing cycles.
Freezing this vaccine will inactivate it. Do not under any circumstances use this vaccine if it has been frozen.
The vaccine will not actively immunise avian species other than the chickens against coccidiosis nor will it confer immunity against Eimeria spp. other than those contained in the vaccine.
No information is available on the safety and efficacy of Paracox®-5 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.
KEEP OUT OF REACH OF CHILDREN, UNINFORMED PERSONS AND ANIMALS.
Although this vaccine has been extensively tested under a wide variety of conditions, failure thereof may ensue as a result of a wide range of reasons. If this is suspected, seek veterinary advice and notify the registration holder.

PRECAUTIONS

Special precautions for use in chickens

Ensure that all vaccination equipment is thoroughly cleaned before use.

Special precautions to be taken by the person administering Paracox®-5 to chickens

Do not use disinfectants or antiseptics to sterilise any equipment or drinking water equipment.
Operators should wear appropriate protective equipment, e.g., gloves, well-fitting masks and eye protection when administering the vaccine via spray.
Wash hands before and immediately after use.
Avoid contact of the product with skin, eyes and mouth.
Do not eat, drink or smoke whilst handling the product.
Use entire contents when the container is first opened and do not store unused containers for future use.
Partially used containers, diluted vaccine and vaccination equipment must be discarded immediately as per National Environmental Management: Waste Act, 2008 (Act No. 59 of 2008) following one vaccination session, as under field conditions, it may be difficult to avoid accidental contamination of the vaccine.
Do not contaminate rivers, dams or any water sources with containers or waste.
Adhere to the vaccination programme to obtain optimum results.

USE DURING LAY

The safety of the vaccine during lay has not been established.

DIRECTIONS FOR USE – USE ONLY AS DIRECTED

A single dose of Paracox^®-5 should be administered to chicks from 1 day of age by spray-on-feed, spray-on-chickens, or at 5 days old via drinking water.

Chickens should be floor reared on litter.

Administration via feed

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

Shake the vaccine vial vigorously for ≥ 30 seconds before use to resuspend the oocysts.

Dilute Paracox®-5 in water at the rate of approximately 5 000 doses in up to 3 ℓ of water.

Shake well and ensure an even distribution of oocysts in the suspension throughout the application period.

Ensure a controlled, even coverage of the total surface area of the feed available to the chickens using a coarse spray. Ensure that all available feed is treated and that the total number of doses dispensed matches the number of chickens in the house. Chickens should be placed with access to the feed within 2 hours. When the treated feed has been consumed, routine feeding may continue.

Administration via water

Place chickens in the house at day-old and encourage them to become accustomed to the drinking system. When the chickens are 5 days old, the lighting system is turned off for about 7 hours. Raise all drinking lines out of reach of the chickens for about 2 hours before administration of the vaccine. At the same time, the lighting is switched on. Drain each drinking line completely. Bell drinkers can also be used effectively.

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

Fill each line with diluted vaccine and lower to allow the chickens access to the drinking system. An initial charge (about 1 ℓ) 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 chickens 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 drinkers at the end of the line, before the chickens are allowed to start drinking.

Administration via spray-on-chickens

For administration by spray-on-chickens, red food colouring agent (Cochineal E120) should be added to the diluted vaccine.

Red food colouring agent (Cochineal E120)

Vaccine should be delivered using a dose volume of between 0,21 and 0,28 mℓ diluted vaccine per chicken using a course spray. Determine the delivery capacity of the spray device in terms of the volume delivered per 100 chickens. 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 ℓ for 5 000 doses or 200 and 300 mℓ for 1 000 doses).

Uptake of the vaccine by the chickens, 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, equivalent to 210 to 280 μg per chicken.

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 water and mix thoroughly. Add the diluted vaccine to the applicator reservoir and operate the cabinet to spray evenly over the chickens 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 the oocysts. Leave the chickens in the box for at least 30 minutes in a well-lighted area to allow time for the birds to preen.

PRESENTATION

Paracox®-5 is a translucent, aqueous suspension presented in PETG vials closed with bromobutyl rubber stoppesr and sealed with aluminium caps, packed in cartons.

5 x 4 mℓ (1 000 doses) or 5 x 20 mℓ (5 000 doses).

REGISTRATION HOLDER

Intervet South Africa (Pty) Ltd.

20 Spartan Road, Spartan

1619, RSA

Tel: +27 (0) 11 923 9300

E-mail: msdahza@msd.com

www.msd-animal-health.co.za

DATE OF PUBLICATION OF THIS PACKAGE INSERT 30 June 2022