Poulvac Bursaplex

Directions For Use

Bursal Disease Vaccine

Live Virus

This product has been shown to be effective for the vaccination of healthy chickens 1 day of age and older or 18- to 19-day-old embryonated chicken eggs against infectious bursal disease. Duration of immunity has not been established. For more information regarding efficacy and safety data, go to productdata.aphis.usda.gov.

It is essential that the birds be maintained under good environmental conditions and that exposure to disease viruses be reduced as much as possible. Bursaplex is a virus-antibody complex vaccine that contains a live strain of bursal disease virus of chicken embryo origin in conjunction with bursal disease antiserum.

Poulvac Bursaplex Cautions

Use only in localities where permitted.

Use only in flocks with a history of infectious bursal disease.

This vaccine may be combined only with Zoetis Inc.’s Marek’s Disease Vaccine, Serotypes 2 and 3, Live Virus.

Keep out of reach of children.

Rehydration of Vaccine

1. Dilute the vaccine only as directed while observing aseptic technique and precautions for safe handling.

2. For each 1,000 doses of vaccine to be administered by subcutaneous injection, use 200 mL of sterile diluent.

3. For each 4,000 doses of vaccine to be administered in ovo, at 0.05 mL/egg (50 μL/egg), use 200 mL of sterile diluent.

4. Using a 20-mL sterile syringe and an 18-gauge x 1.5” needle, rehydrate only the vials of vaccine that are to be used immediately.

5. Aseptically transfer enough diluent to the vial containing the lyophilized virus to fill it about 3/4 full. Shake the contents gently until the vaccine is evenly suspended.

6. Aseptically remove the virus suspension from the vial and combine into the remaining diluent. Thoroughly mix the vaccine and diluent by massaging and inverting. Use immediately.

In Ovo Administration

Before initiating in ovo vaccination, carefully read and follow the Embrex^® Inovoject^® System operator’s manual. Failure to follow instructions may result in personal injury and embryonic morbidity/mortality. Only healthy embryonated eggs should be vaccinated.

1. Sanitize the Embrex Inovoject System before and after use.

2. Inject a 0.05-mL dose into each embryonated egg.

3. Use the entire contents of the vaccine container within one hour after mixing.

Subcutaneous Injection Method

Important: Sterilize vaccinating equipment by autoclaving 15 minutes at 121°C or by boiling in water for 20 minutes. Never allow any chemical disinfectant to come in contact with vaccinating equipment.

1. Use a sterile automatic syringe with a 20-22 gauge, 3/8-1/2” needle, set to accurately deliver 0.2 mL. Check accuracy of delivery several times throughout vaccination.

2. Hold the chicken by the back of the neck, just below the head. The skin in this area is raised by gently pinching with the thumb and forefinger. Insert the needle beneath the skin directing it away from the head. Inject 0.2 mL per chick and avoid hitting muscles and bones in the neck.

3. Use entire contents of the vaccine within one hour of mixing.

Precautions

Store at 2°-8°C. Prolonged exposure to higher temperatures and/or direct sunlight may adversely affect potency. Do not freeze.

Use entire contents when first opened.

Inactivate unused contents before disposal.

Do not vaccinate within 21 days before slaughter.

Contains gentamicin as a preservative.

Do not mix with other products, except as specified on the label.

In case of human exposure, contact a physician.

Do not vaccinate diseased embryonated eggs or birds.

Administer a full dose to each embryonated egg or to each bird.

Exposure to disease must be minimized as much as possible.

For veterinary use only.

Notice: Bursaplex has met the regulations of the USDA in regard to safety, purity, potency, and the capability to protect normally susceptible chickens. This vaccine has been tested by the Master Seed immunogenicity test for efficacy.

The ability of this vaccine to produce satisfactory results may depend on many factors, including but not limited to conditions of storage and handling by the user; administration of the vaccine; health and responsiveness of individual chickens; and the degree of exposure. Therefore, directions for use should be followed carefully. The use of this vaccine is subject to applicable state and federal laws and regulations.

This vaccine in non-returnable

Technical inquiries should be directed to Zoetis Inc. Veterinary Services, (888) 963-8471.

VLN 190/PCN 1271.0A

Zoetis Inc., Kalamazoo, MI 49007, USA

40039215

Presentation: 8,000 doses.

CPN: 3690381.2