Paracox®-5

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 broilers against Eimeria acervulina, E. maxima, E. mitis and

E. tenella.

PRESENTATION

Paracox®-5 is a translucent, aqueous suspension of oocysts derived from 5 precocious lines of coccidia, presented as a live, attenuated oral vaccine.

COMPOSITION

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

E. acervulina HP500650
E. maxima CP200230
E. maxima MFP100130
E. mitis HP          1 0001 300
E. tenella HP500650

STORAGE INSTRUCTIONS

  • Store in a refrigerator between 2 °C and 8 °C.
  • Do not freeze.
  • Protect from light.

WARNINGS

  • TO BE USED FOR THE IMMUNISATION OF BROILERS ONLY.
  • Withdrawal period: None.
  • For oral use only.
  • Vaccinate healthy chickens only.
  • 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 anticoccidial agents including sulphonamides and antibacterial agents having anticoccidial activity (viz. oxytetracycline, chlortetracycline, furazolidone and nitrofurazone).
  • 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.
  • Dispose of any unused vaccine as well as all empty vaccine containers and vaccination equipment according to local waste disposal regulations.
  • 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

  • Since immunity to coccidial infection following Paracox®-5 administration is enhanced by natural challenge, it should be noted that access to any agents having anticoccidial activity at any time following vaccination may reduce the duration of effective immunity.
  • To reduce the chances of coccidial field challenge occurring before the full development of immunity, housing should be thoroughly cleaned between rearing cycles.
  • Partially used containers and diluted vaccine must be discarded immediately as per local waste disposal regulations following 1 vaccination session, as under field conditions it may be difficult to avoid accidental contamination of the vaccine.
  • Use before expiry date on carton.

DIRECTIONS FOR USE – USE ONLY AS DIRECTED

A single dose of Paracox®-5 should be administered to chicks by hatchery spray.

The minimum dose of vaccine is 0,004 mℓ per chick. Each 4 mℓ vial will provide sufficient vaccine for 1 000 chicks, and each 20 mℓ vial will provide sufficient vaccine for 5 000 chicks.

By hatchery spray

Determine the delivery capacity of the Spraycox cabinet or the spray cabinet as recommended by MSD Animal Health, in terms of the volume delivered per 100 chicks.

Dilution of 5 000 dose vial

Multiply the delivery capacity (per 100 chicks) by 50 to give the total volume of diluted vaccine required for 5 000 doses and add this volume of water to a suitable container (normally between 1,0 and 1,5 litres for 5 000 doses).

Delivery capacity of spray cabinet (mℓ) per 100 chicks x 50 (containers of 100 chicks each) = volume of water (mℓ) needed to dilute 1 x 5 000 dose vial.

Dilution of 1 000 dose vial

Multiply the delivery capacity (per 100 chicks) by 10 to give the total volume of diluted vaccine required for 1 000 doses and add this volume of water to a suitable container (normally between 200 and 300 mℓ for 1 000 doses).

Delivery capacity of spray cabinet (mℓ) per 100 chicks x 10 (containers of 100 chicks each) = volume of water (mℓ) needed to dilute 1 x 1 000 dose vial.

Add sufficient red food colourant (such as Cochineal Red) 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 chicks 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. Vaccine should be delivered using a dose volume of between 0,21 and 0,28 mℓ per chick.

Prepare chicks for delivery to rearing accommodation.

PRESENTATION

Vials containing 4 mℓ (1 000 doses) or 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

6 November 2009