PARACOX®-8

FOR ANIMAL USE ONLY

PARACOX^®-8

Reg. No. G1994 (Act 36/1947)

Namibia Reg. No. V01/24.3/517 [NS0]

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 19 of 1982).

INDICATIONS

For the active immunisation of 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.

Immunity begins to develop within 10 days post vaccination and is maintained for at least 36 weeks post vaccination, when chickens are housed in conditions that permit oocyst recycling.

COMPOSITION

Paracox^®-8 is a translucent, viscous suspension of oocysts derived from 8 precocious lines of coccidia, presented as a live, attenuated, oral vaccine.

Each 0,004 mℓ dose of vaccine contains the following numbers of live sporulated oocysts:

                        E. acervulina HP         ≥ 500

                        E. brunetti HP             ≥ 100

                        E. maxima CP             ≥ 200  

                        E. maxima MFP          ≥ 100

                        E. mitis HP                  ≥ 1 000

                        E. necatrix HP             ≥ 500

                        E. praecox HP            ≥ 100

                        E. tenella HP               ≥ 500

STORAGE

Paracox^®-8:

• Store between 2 ºC and 8 ºC.
• Do not freeze.
• Protect from light.
• Do not store partially used containers for future use.

Solvent: Solvent for Spray-on-Chickens:

• Store between 2 °C and 25 °C.
• 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.
• Do not administer to laying hens.
• Do not administer to stressed chickens, e.g., chilled, not eating or drinking.
• Do not administer any form of anti-coccidial or sulphonamides in conjunction with this vaccine.
• Do not mix Paracox^®-8 with any other vaccine or medication except the solvent recommended for use for spray administration.
• Do not over- or underdose the vaccine.
• For administration by spray-on-chickens, a red food colouring agent should be added to the diluted vaccine, or the vaccine should be diluted using the solvent: Solvent for Spray-on-Chickens. For the spray-on-chicken method of administration, a significant reduction in efficacy may be observed if diluted in tap water only.
• 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 following Paracox^®-8 administration is enhanced by natural challenge, it should be noted that access to any therapeutic agents having anti-coccidial activity, before or after vaccination, will affect the efficacy of the vaccine. This is particularly important in the 4 weeks following vaccination.
• 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.
• Paracox^®-8 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 chickens from 1 to 3 weeks or more after vaccination. These oocysts are most likely to be vaccinal oocysts which recycle in the chickens/litter. This ensures satisfactory flock protection.
• In any animal population, there may be a small number of individuals which fail to respond fully to vaccination. Successful vaccination depends upon correct storage and administration of the vaccine and the ability of the animal to respond. This can be influenced by such factors as genetic constitution, intercurrent infection, age, nutritional status, concurrent drug therapy and stress.
• No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal products. 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.
• Freezing this vaccine will inactivate it. Do not under any circumstances use this vaccine if it has been frozen.
• Food and water provided at any stage before or after vaccination must be free from anti-coccidial agents, including sulphonamides as well as antibacterial agents that have anti-coccidial activity (viz. oxytetracycline, chlortetracycline, furazolidone, or nitrofurazone).
• The vaccine will not actively immunise avian species other than the chicken against coccidiosis.
• Use before the expiry date indicated on the carton.
• KEEP OUT OF REACH OF CHILDREN, UNINFORMED PERSONS AND ANIMALS.
• Although this vaccine has been extensively tested under a large 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.
• Measures should be taken to ensure an even distribution of oocysts in the diluted vaccine suspension during the entire administration period.

Special precautions to be taken by the person administering Paracox^®-8 to chickens

• Observe aseptic precautions. Ensure that all vaccination equipment (containers, syringes and needles) is clean and sterile prior to use and during use.
• 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 spraying.
• 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 the entire contents when the container is first opened and do not store unused containers for future use.
• Destroy any unused vaccine and dispose of all the vaccine containers and disposable equipment after use in accordance with National Environmental Management: Waste Act, 2008 (Act No. 59 of 2008).
• Do not contaminate rivers, dams or any water sources with containers or waste.
• Adhere to the vaccination programme to obtain optimum results.

DOSAGE AND Directions for USE – Use only as directed

Dosage

For oral administration to chickens from 1 day of age in drinking water or by spray-on-chickens.

A single dose of vaccine should be administered to chickens between 1-day-old and 9 days of age.

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

Advice on correct administration

• Administration via drinking water

Font type drinkers (manually filled)

Paracox^®-8 may be administered into individual drinkers. This method is not suited to day-old chickens.

The appropriate amount of vaccine for delivery into each drinker is calculated as follows:

Total number of chickens per house (or pen)

___________________________________      X 0,004 = Amount of vaccine (mℓ) per drinker

Total number of drinkers per house (or pen)

Remove drinkers up to 2 hours before vaccination. Ensure that drinkers are clean. Ensure that drinkers are filled with water and replaced immediately before delivery of an appropriate volume of vaccine. As a guide to the number of drinkers required at vaccination, there should be approximately 0,25 to 1,00 cm drinker space per chicken.

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.

• Administration via spray-on-chickens

For administration by spray-on-chickens, red food colouring agent (Cochineal E120) should be added to the diluted vaccine, or the vaccine should be diluted using the recommended solvent: Solvent for Spray-on Chickens. The solvent contains a red colouring agent and xanthan gum, both of which are included for better uptake.

a)  Solvent for Spray-on-Chickens

Vaccine should be delivered using a dose volume of 0,21 mℓ of diluted vaccine per chicken using a coarse 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).

I.e., for the preparation of 5 000 doses diluted vaccine, a total of 0,21 x 5 000 = 1 050 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 x 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 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 chickens using a coarse spray. Ensure a controlled, even coverage of the total internal surface area of the box containing the chickens. Leave the chickens in the box for at least 30 minutes in a well-lighted area to allow time for the chickens to preen.

b)  Red food colouring agent (E120)

Vaccine should be delivered using a dose volume of 0,21 and 0,28 mℓ of diluted vaccine per chicken using a coarse spray. Determine the delivery capacity of the spray cabinet 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 litres 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. The purity of the Cochineal E120 must be in compliance with Commission Directive 95/45/EC.

Shake one 5 000 dose (or 1 000 dose) vial vigorously for 30 seconds to 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 chickens. Agitate the applicator reservoir regularly throughout application to avoid settling out of oocysts. Leave the chickens in the box for at least 30 minutes in a well-lighted area to allow time for the chickens to preen.

PRESENTATION

Paracox^®-8: 4 mℓ (1 000 doses) and 20 mℓ (5 000 doses), colourless PETG vials with bromobutyl stoppers and aluminium crimps. Vials are packaged in cardboard boxes.

Solvent for Spray-on-Chickens: For administration by spray-on-chickens, Solvent for spray-on-chickens can be used to dilute the vaccine (100 mℓ solvent for 1 000 doses, 500 mℓ for 5 000 doses). The containers are 100 mℓ and 500 mℓ plastic bottles closed with a rubber stopper and sealed with an aluminium cap.

The Solvent for Spray-on-Chickens is sold as a separate unit.

Not all pack sizes may necessarily be marketed.

REGISTRATION HOLDER                                   

Intervet South Africa (Pty) Ltd.                              

20 Spartan Road, Spartan                                     

1619, RSA                                                              

Tel: +27 (0) 11 923 9300                                       

Fax: +27 (0) 11 392 3158                                      

www.msd-animal-health.co.za

DATE OF PUBLICATION OF THIS PACKAGE INSERT

28 April 2022

Zimbabwe Reg. No. 94/80.23.17/9372 Pharmacological classification: 802317 Distribution category: VMGD