ENTEROVAX®

FOR ANIMAL USE ONLY

Tenosynovitis Vaccine, Modified Live Virus

Reg. No. G3615 (Act 36/1947)

Namibia Reg. No. V07/24.3/739 NS0

INDICATIONS

For use in healthy chickens as an aid in the control and prevention of reo virus induced tenosynovitis (viral arthritis).

COMPOSITION

Contains a modified live avian reo virus 1133 TC/C6 strain in a freeze-dried preparation sealed under vacuum and preserved with gentamycin.

STORAGE

• Store between 2 °C and 7 °C.
• Do not freeze.
• Protect from light.

WARNINGS

• Withdrawal period: Do not slaughter chickens for human consumption within 21 days after vaccination.
• Do not administer this vaccine to breeders 18 weeks of age or older, as the vaccine virus will be shed in the eggs.
• Vaccinate healthy chickens only.
• Do not spill or spatter the vaccine.
• Do not dilute the vaccine or otherwise stretch the dosage.
• Use entire contents of vial when first opened.
• 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 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

• Do not administer this product by injection.
• Do not administer using an automatic eye drop vaccinator to day-old chicks.
• Do not mix Enterovax^® with other vaccines.
• Observe aseptic precautions. Ensure that all vaccination equipment is clean and sterile prior to use.
• It is good vaccination practice when handling or reconstituting vaccine to avoid contact with the eyes, hands and clothing.
• Wash hands thoroughly after using the vaccine.

DIRECTIONS FOR USE – USE ONLY AS DIRECTED

WHEN TO VACCINATE

Spray method: 1 day of age.

Drinking water method: 1 week of age or older.

PREPARATION OF THE VACCINE

Spray method

• Do not open and mix the vaccine until ready to use.
• Open only 1 vial at a time and use entire contents within 2 hours.
• Remove the tear-off aluminium seal and stopper from the bottle containing the freeze-dried vaccine.
• Remove the tear-off aluminium seal and stopper from the diluent bottle. Insert the long end of adapter into the diluent bottle.
• Hold the diluent bottle firmly in an upright position and insert the vaccine vial on the adapter of the diluent bottle. The neck of the vaccine vial should snap into position and should be seated securely on the adapter of the diluent bottle.
• Invert the 2 containers so that the vaccine vial is at the bottom and allow the diluent to flow into the vaccine vial. If the diluent does not flow freely, gently tap or squeeze the bottle and release to draw the diluent into the vaccine container. The vaccine vial should be completely filled with the diluent to prevent excess foaming.
• Hold the joined containers by the ends and shake until the vaccine plug is completely dissolved.
• Return the joined containers to their original position (diluent bottle at the bottom). Allow the vaccine to flow into the diluent bottle. If the vaccine does not flow into the diluent bottle, tap or squeeze the diluent bottle gently and release to draw the vaccine into the diluent bottle. Ensure entire contents are removed from the vaccine vial.
• Remove the vaccine vial and adapter from the neck of the diluent bottle.
• The vaccine is now ready for use.

Drinking water method

• Do not open and mix the vaccine until ready for use.
• Mix only 1 vial at a time and use entire contents within 1 hour.
• Remove the tear-off aluminium seal from the vaccine vial without disturbing the rubber stopper.
• Use cool, clean, non-chlorinated water.
• Holding the vial submerged in a bucket of water, lift the lip of the rubber stopper so that the water is sucked into the vial.
• Reseat the stopper and shake the vial to thoroughly dissolve the vaccine. The vaccine is now ready for use.

HOW TO VACCINATE

Spray method

• Use this method to vaccinate day-old chicks. Proper coarse spray application of this vaccine is best accomplished through use of a clean spray cabinet, adjusted to deliver approximately 7 mℓ per 100 chicks.
• Rehydrate the vaccine according to the above instructions “Preparation of the vaccine – Spray method”.
• Further dilute each 1 000 doses of vaccine to 70 mℓ, each 2 500 doses of vaccine to

175 mℓ, or each 5 000 doses of vaccine to 350 mℓ using clean, cool, non-chlorinated water.

• Following the spray cabinet directions, adjust the cabinet so that 100 chicks are sprayed with 7 mℓ of the diluted vaccine over a 2 second period.

Drinking water method

• Do not mix the vaccine into the drinking water until ready for use.
• Withhold water for 1 to 2 hours, depending on the ambient temperature, before vaccinating, to ensure that chickens are thirsty. Thoroughly clean and rinse all watering containers so that no residual disinfectants remain.
• Dilute the vaccine immediately before use with cool, clean, non-chlorinated water.
• Add the rehydrated vaccine to water as follows and mix thoroughly;

Each 1 000 chickens (1 week or older) – 10 ℓ.

• Distribute diluted vaccine so that all chickens are able to drink within 1 hour.
• The diluted vaccine should be the sole source of drinking water until completely consumed.
• Avoid placing water in direct sunlight.

PRESENTATION

Cartons containing 10 x 1 000, 10 x 2 500 and 10 x 5 000 dose vials.

 REGISTRATION HOLDER                              MANUFACTURER

Intervet South Africa (Pty) Ltd.                           Intervet Inc.

Spartanweg 20, Spartan                                    21401 West Center Road

1619, RSA                                                          Elkhorn, Nebraska

Tel: +27 (0) 11 923 9300                                    68022 USA

Faks: +27 (0) 11 392 3158                                

www.msd-animal-health.co.za

DATE OF PUBLICATION OF THIS PACKAGE INSERT

18 February 2010