Mycovac-L

MYCOPLASMA GALLISEPTICUM VACCINE

Live Culture

DIRECTIONS FOR USE, READ CAREFULLY

Description

This vaccine is a live vaccine, prepared from the Intervet 6/85 strain of Mycoplasma gallisepticum in a freeze dried preparation sealed under vacuum. The 6/85 strain is unique in that it is highly immunogenic for chickens and non-pathogenic for turkeys, does not readily spread to adjacent houses of chickens and is biologically stable. This vaccine has been propagated under exacting standards. The immunizing capability of this vaccine has been proven by various procedures including the Master Seed Immunogenicity Test.

Mycovac-L Indications For Use

This product has been shown to be effective for the vaccination of healthy chickens 6 weeks of age or older against M. gallisepticum. 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 Vaccine

FOR 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!

Coarse Spray Administration

FOR CHICKENS SIX WEEKS 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 2,000 doses is 420 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.

Mycovac-L Caution

1. VACCINATE ONLY HEALTHY CHICKENS.

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

3. Do not medicate chickens with antibacterial drugs five days prior to or after vaccination.

4. The 6/85 strain of MG is not pathogenic for turkeys, but care should be taken in the application of the vaccine and handling of the chickens so as to maintain very tight disease security.

5. This vaccine should not be administered within two weeks of any live Newcastle, bronchitis or laryngotracheitis vaccination.

6. Do not administer this vaccine within four weeks of onset of egg production or after egg production has begun.

7. Use entire contents when first opened.

8. Do not vaccinate within 21 days before slaughter.

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

10. Inactivate unused contents before disposal.

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

12. This vaccine is to be used only in states where its usage is permitted and is to be used in compliance with applicable state and federal regulations.

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

14. 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 1751.01

1 800 211-3573 (USA)

1 866 683-7838 (Canada)

For patent information:

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

383899-09

CPN: 1047336.3