Univax-BD

BURSAL DISEASE VACCINE

Live Virus

CAUTION: USE ONLY IN STATES (U.S.) WHERE PERMITTED AND ON PREMISES WITH A HISTORY OF BURSAL DISEASE.

DIRECTIONS FOR USE, READ CAREFULLY

Description

This vaccine is a live virus vaccine containing a carefully selected mild strain of bursal disease virus grown in tissue culture and combined with stabilizing agents. The product is supplied as a lyophilized vaccine contained in vials sealed under vacuum.

Univax-BD Indications For Use

This product has been shown to be effective for the vaccination of healthy 18 to 19 days of age chicken embryos or chickens 1 day of age or chickens 1 week 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

Many factors must be considered in determining the proper vaccination program for a particular farm or poultry operation. To be fully effective, the vaccine must be administered to healthy receptive chickens held in a proper environment under good management. In addition, the response may be modified by the age of the chickens and their immune status. Seldom does one vaccination under field conditions produce complete protection for all individuals, in a given flock. The amount of protection required will vary with the type of operation and the degree of exposure that a flock is likely to encounter. For these reasons a program of periodic revaccination may be required.

Preparation Of The Vaccine

FOR IN OVO OR SUBCUTANEOUS USE

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

1. Do not open and mix the vaccine until ready for use.

2. Mix only one vial at a time and use entire contents within 2 hours.

3. Dilute the vaccine with diluent for administration. Use 100 ml of sterile diluent for each 1,000 doses of vaccine to administer 0.1 ml dose per chicken embryo or use 50 ml for each 1,000 doses of vaccine to administer 0.05 ml per chicken embryo by the in ovo route. Use 200 ml of sterile diluent for each 1,000 doses of vaccine to administer 0.2 ml dose per chicken by the subcutaneous route.

4. Lift top of seal on vaccine vial to expose rubber stopper. Use 10mL syringe mounted with sterile 18 gauge needle to take 5 mL of diluent from diluent bag and transfer to vaccine vial.

5. Vigorously shake vaccine vial with transferred diluent to rehydrate the vaccine.

6. Use same sterile needle and syringe to completely transfer rehydrated vaccine to diluent bag. Rinse syringe and vaccine vial by withdrawing additional diluent from bag and repeat the process.

7. Vigorously shake final rehydrated vaccine for 20-30 seconds to mix thoroughly.

8. The vaccine is now ready for use.

IN OVO OR SUBCUTANEOUS ADMINISTRATION

FOR CHICKENS EMBRYOS 18 TO 19 DAYS OF AGE OR CHICKENS 1 DAY OF AGE

For in ovo administration: inoculate each 18 to 19 day-old chicken embryo with a full dose (0.05 ml or 0.1ml). For subcutaneous administration: inoculate each day-old chicken with a full dose (0.2 ml).

Preparation Of Vaccine

FOR DRINKING WATER 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 ONE WEEK 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.

Univax-BD Caution

1. VACCINATE ONLY HEALTHY CHICKENS.

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

3. Use only in states (U.S.) where permitted and on premises with a history of bursal disease.

4. Use entire contents when first opened.

5. Do not vaccinate within 21 days before slaughter.

6. Store at 2° to 8°C (35° to 46°F). Do not freeze.

7. Inactivate unused contents before disposal.

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

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

10. Contains gentamicin as a preservative.

11. 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 1271.00

1 800 211-3573 (USA)

1 866 683-7838 (CAN)

For patent information:

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

352683-02

CPN: 1047204.5