Oralvax HE (Canada)

HEMORRHAGIC ENTERITIS VACCINE

Live Virus

DIRECTIONS FOR USE, READ CAREFULLY

Description

ORALVAX HE vaccine is a live virus vaccine containing a turkey avirulent Type II avian adenovirus of pheasant origin. The virus is grown in the RP-19 cell line and freeze-dried and sealed under vacuum.

Oralvax HE Indications For Use

This product has been shown to be effective for the vaccination of healthy turkeys 6 weeks of age or older against hemorrhagic enteritis. Duration of immunity has not been established. For more information regarding efficacy and safety data, see productdata.aphis.usda.gov.

Preparation Of The 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 TURKEYS SIX 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 turkeys 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 administrations 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.

Oralvax HE Caution

1. VACCINATE ONLY HEALTHY TURKEYS.

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

3. Avoid exposing birds other than turkeys to this vaccine.

4. In outbreak situations, vaccinate healthy birds first progressing toward outbreak areas in order to vaccinate affected birds last.

5. Do not use to vaccinate pheasants.

6. Use entire contents when first opened.

7. Do not vaccinate within 21 days before slaughter.

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

9. Inactivate unused contents before disposal.

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

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

12. Contains gentamicin and amphotericin B as preservatives.

13. 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 birds and the degree of field exposure. Therefore, directions should be followed carefully.

Records

Keep a record of vaccine type, quantity, serial number, expiration date, and place of purchase; the date and time of vaccination; the number, age, breed, and location of the birds; 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, NE68103 USA

VLN 165A/PCN 17E1.20

1 800 211-3573 (USA)

1 866 683-7838 (Canada)

For patent information:

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

367915 R2

CPN: 1208068.6