Clonevac D-78

BURSAL DISEASE VACCINE

Live Virus

Use only in states or countries where permitted and on premises with a history of bursal disease.

DIRECTIONS FOR USE, READ CAREFULLY

This vaccine contains an intermediate strain of Infectious Bursal Disease (IBD) Virus propagated in SPF (Specific Pathogen Free) substrates. This strain was developed from a bursal disease field isolate.

Clonevac D-78 Indications For Use

This product has been shown to be effective for the vaccination of healthy chickens 1 day of age or 2 weeks of age or older against infectious bursal disease. Duration of immunity has not been established. For more information regarding efficacy and safety data, see productdata.aphis.usda.gov.

Vaccination Programs

Immune status, general health, and field exposure to IBD virus must be assessed to develop an effective program. Immunological priming of breeder replacement chickens can be accomplished at 10 to 12 weeks of age, followed by the use of an inactivated vaccine at 18 to 20 weeks of age.

Preparation Of Vaccine

FOR DRINKING WATER OR COARSE SPRAY USE

DO NOT OPEN AND MIX THE VACCINE UNTIL READY TO BEGIN VACCINATION. USE VACCINE IMMEDIATELY AFTER MIXING.

1. Remove the tear-off seal and stopper from the vial containing the lyophilized vaccine.

2. Carefully pour clean, cool, non-chlorinated water into the vaccine vial until the vial is approximately two-thirds full.

3. Insert the rubber stopper and shake vigorously until all material is dissolved.

4. The vaccine is now ready to be applied as per label in accordance with the directions below. For best results, be sure to follow directions carefully!

Drinking Water Administration

FOR CHICKENS TWO WEEKS OF AGE OR OLDER

1. Do not use any disinfectants in the drinking water for 48 hours before vaccinating and 24 hours after vaccination.

2. Withhold water from the chickens until they are thirsty.

3. Calculate the water volume needed so the vaccine will be consumed in approximately 2 hours.

4. Optional: as an aid in preserving the virus, add a vaccine stabilizer to the stock solution or to the tank containing clean, cool, non-chlorinated water. Agitate thoroughly. Follow the manufacturer’s rate of administration and wait time.

5. Add rehydrated vaccine from vial to the water and mix thoroughly.

6. Turn on tank valve or automatic dosing system.

7. Provide as sole source of drinking water until all vaccine-water solution has been consumed.

Coarse Spray Vaccination

FOR CHICKENS ONE DAY OF AGE OR OLDER

Calculate the water volume needed. For example, a machine which dispenses 21 ml to a box of 100 chickens - total volume for 1,000 doses is 210 ml of non-chlorinated water. For coarse spray in chicken houses, follow manufacturer’s direction for the particular spray machine. Add rehydrated vaccine and mix thoroughly.

Clonevac D-78 Caution

1. VACCINATE ONLY HEALTHY CHICKENS.

2. All chickens should be vaccinated at the same time.

3. Use entire contents when first opened.

4. Do not vaccinate within 21 days before slaughter.

5. Store at 2° to 8° C (35° to 46° F).

6. Inactivate unused contents before disposal.

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

8. In case of human exposure, contact a physician.

9. Contains gentamicin as a preservative.

10. FOR ANIMAL USE ONLY.

Notice

This vaccine has undergone rigid potency, safety and purity tests, and meets Merck Animal Health U.S. and local regulatory requirements. It is designed to stimulate effective immunity when used as directed, but the user must be advised that the response to the product depends upon many factors, including, but not limited to, conditions of storage and handling by the user, administration of the vaccine, health and responsiveness of the individual chickens and the degree of field exposure. Therefore, directions should be followed carefully.

Records

Keep a record of vaccine, quantity, serial number, expiration date, and place of purchase; the date and time of vaccination; the number, age, breed, and locations of chickens; names of operators performing the vaccination and any observed reactions.

FEDERAL REGULATIONS PROHIBIT THE REPACKAGING OR SALE OF THE CONTENTS OF THIS CARTON IN FRACTIONAL UNITS. DO NOT ACCEPT IF SEAL IS BROKEN.

Intervet Inc. d/b/a Merck Animal Health, Omaha, NE 68103 USA

VLN 165A/PCN 1271.17

1 800 211-3573 (USA)

1 866 683-7838 (CAN)

For patent information: http://www.merck.com/product/patent/home.html

389210 R5

CPN: 1047315.4