PM-Onevax-C

PASTEURELLA MULTOCIDA VACCINE

Avirulent Live Culture, Avian Isolate

DIRECTIONS FOR USE, READ CAREFULLY

Wing Web Stick Route

Description

This vaccine is a live bacterial vaccine containing the mild avirulent PM-1 strain of Pasteurella multocida in a freeze-dried preparation sealed under vacuum. The seed culture used to make this vaccine has been laboratory tested for protection in chickens against challenge with the X-73 (Type 1) strain of P. multocida and in turkeys against challenge with the P1059 (Type 3) strain of P. multocida.

PM-Onevax-C Indications For Use

This product has been shown to be effective for the vaccination of healthy chickens 10 to 12 weeks of age against pasteurellosis (fowl cholera) due to Pasteurella multocida Type 1 and turkeys 15 weeks of age or older against pasteurellosis (fowl cholera) due to Pasteurella multocida Type 3. Duration of immunity has not been established. For more information regarding efficacy and safety data, see productdata.aphis.usda.gov.

When To Vaccinate

Chickens: Use by wing web stab to vaccinate chickens 10-12 weeks of age. Historically, a revaccination at 18-20 weeks of age with at least 6 weeks and not more than 10 weeks between vaccinations was recommended for this product. The need for this booster has not been established. Contact your veterinarian or manufacturer for more information on revaccination frequency. Initial vaccination in chickens over 12 weeks of age may be undesirable because larger granulomas may develop at the site of inoculation and this may result in downgrading of carcasses at slaughter.

Turkeys: Use by wing-web stab to vaccinate turkey breeders 15-18 weeks of age. Historically, a revaccination 8 weeks later was recommended for this product. The need for this booster has not been established. Contact your veterinarian or manufacturer for more information on revaccination frequency. Turkey breeders must be vaccinated at least twice with live fowl cholera vaccine via oral route prior to wing-web vaccination. Use of this vaccine in turkeys which have not been orally prevaccinated may cause severe postvaccination reactions, including lameness and death. The interval between the last oral vaccination and the first wing-web vaccination should not exceed 6 weeks.

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 birds held in a proper environment under good management. In addition, the response may be modified by the age of the bird 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 WING-WEB ADMINISTRATION

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 vaccine vial.

2. Remove the seal and stopper from the vial containing the diluent.

3. Hold the diluent bottle firmly in an upright position and insert the shorter end of the transfer tube. Still holding the diluent bottle in an upright position, insert the neck of the vaccine vial over the longer end of the transfer tube. The vaccine vial should snap into position, connecting the two vials securely.

4. Invert the two containers so that the vaccine vial is on the bottom and allow the diluent to flow into the vaccine vial. If the diluent does not flow freely, squeeze the diluent bottle gently and the diluent will flow into the vaccine vial. The vaccine vial should be completely filled with diluent to prevent excess foaming.

5. Hold the joined containers by the ends; shake vigorously until the vaccine plug is completely dissolved.

6. Return the joined containers to their original position (diluent bottle on 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. Be sure all the product is removed from the vaccine vial.

7. Remove the vaccine vial and transfer tube from the neck of the diluent bottle.

8. The vaccine is now ready to use.

9. Wash hands thoroughly after mixing the vaccine.

Wing-web Administration

FOR CHICKENS 10-12 WEEKS OF AGE AND TURKEYS 15 WEEKS OF AGE OR OLDER

1. Vaccination is accomplished by dipping the needle applicator into the mixed vaccine and piercing the webbed portion of the underside of the wing. Avoid piercing through feathers which may wipe off the vaccine and avoid hitting the wing muscle or bone to minimize reaction. The applicator is designed to pick up the proper amount of vaccine on the needles, which is deposited in the tissues when the wing is pierced.

2. Redip the applicator in the vaccine before each application. Excess vaccine adhering to the applicator should be removed by touching the applicator to the inside of the vial.

3. At 5 to 10 days following vaccination, a swelling of the skin (subcutaneous granuloma) will develop on the wing-web at the point of inoculation. The absence of this local reaction may mean that improper vaccination methods were used. Examination for these “takes” at 7 days post-vaccination may be used to assure that proper vaccination has been conducted.

PM-Onevax-C Caution

1. VACCINATE ONLY HEALTHY BIRDS.

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

3. Do not medicate birds with antibacterial drugs 3 days prior to or 5 days after vaccination.

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. 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, quantity, serial number, expiration date, and place of purchase; the date and time of vaccination; the number, age, breed, and locations of 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, NE 68103 USA

VLN 165A/PCN 1871.04

1 800 211-3573 (USA)

1 866 683-7838 (CAN)

For patent information:

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

396403-02

CPN: 1047156.5