Aquavac-COL

Company: Intervet/Merck Animal Health

FLAVOBACTERIUM COLUMNARE VACCINE

Avirulent Live Culture

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Description

AQUAVAC-COL contains an avirulent strain of Flavobacterium columnare, as a frozen preparation. AQUAVAC-COL is administered to fish as a timed bath treatment. AQUAVAC-COL has been shown to provide significant protection from disease and mortality when vaccinated fish are challenged with common virulent wild-type isolates of F. columnare.

Aquavac-COL Indications For Use

The vaccine is indicated as an aid in the prevention of columnaris disease in catfish and largemouth bass due to F. columnare infection. Vaccinate healthy catfish at 7 days post-hatch or older. Vaccinate healthy largemouth bass at 11 days post-hatch or older. Fish should be healthy and free of disease at the time of vaccination. Sick or weak fish may not develop adequate immunity. For maximum benefit, fish should be vaccinated for a minimum of two minutes at least 14 days prior to anticipated exposure to columnaris disease. Vaccination is not recommended when water temperatures are below 21° C (70° F) or above 29° C (85° F).

Vaccination Programs

AQUAVAC-COL is intended for use in a comprehensive program of fish health management program and producers are encouraged to consult with their veterinarian or other fish health professionals before use. AQUAVAC-COL can be applied by immersion at any time during the production cycle. AQUAVAC-COL is easily administered at any time fish are being handled and can be integrated into routine fish handling practices such as grading, inventorying, sorting, splitting, hauling, moving or ponding. For catfish, the most common application is a bath treatment of 7 days post-hatch fry in a transport tank before stocking fish into nursery or fingerling ponds.

Dosage

Each vial of AQUAVAC-COL is sufficient to vaccinate 100,000 catfish or largemouth bass fry in 5 gallons of water. When applied to catfish fry at 7 days of age posthatch, the number of fish per weight (13,000 fish per pound or 29 fish/gram or 812 fish per ounce) needs to be determined in order to calculate the proper dosage of the vaccine. Similar calculations can be used to determine the number of largemouth bass fry at 11 days of age post-hatch to be vaccinated. The following table should be used to determine the proper dosage when vaccinating fry.

When vaccinating older catfish, each ten-pack of AQUAVAC-COL vaccine is sufficient to vaccinate 75 pounds of fish in 50 gallons of water as described in “Administration”. The following table can be used to help determine the proper dosage and use of AQUAVAC-COL.

ADMINISTRATION

Prior to vaccination, ensure that all nets, buckets, tanks and other equipment are thoroughly cleaned and properly disinfected and rinsed prior to use. Ensure that all troughs or hauling tanks have been cleaned and flushed free of any excess feces or feed. To reduce stress, it is recommended that the fish not be fed for 3 to 4 hours prior to vaccination. Use standard methods to determine the total weight of each group of fish to be vaccinated.

Caution: Because the dosage of AQUAVAC-COL is based on total fish weight, it is important that the biomass of fish be inventoried as accurately as possible immediately prior to vaccination to ensure full efficacy of the vaccine. Refer to Table A or Table B as guidelines to determine the amount of vaccine and volume of water needed for vaccinating each group of fish.

AQUAVAC-COL should be kept frozen at or below - 60° C (- 76° F). If stored frozen at - 20° C (- 4° F) (non-frost-free freezer), the product must be used within 7 days or discarded. Caution: Do not thaw AQUAVAC-COL until immediately prior to use.

Tank Vaccination during transport

1. Calculate the water volume of transport tank and determine the volume of water for vaccination based on guidelines in Table A or Table B. Fill the transport tank with clean water to this level.

2. Turn on oxygen to transport tank. Ensure the air stones are all working and adequate oxygenation is being provided to all areas of the tank.

3. Add fish to be vaccinated to the transport tank.

4. Thaw the number of vials of vaccine needed by placing vials into a 79° F waterbath.

5. Immediately add thawed vaccine to transport tank, pouring evenly across the surface of the tank. Mix gently but thoroughly.

6. Wait at least two minutes.

7. After two minutes, fill the transport tank with at least an equal amount of water and do not dilute further for at least 15 minutes. Haul to the nursery or fingerling pond for stocking. The usual precautions must be taken to ensure fish in the transport tank are properly tempered to the pond water temperature before discharge.

8. Discharge fish and vaccine solution into pond and observe for any signs of stress.

9. Begin feeding as usual.

Storage Conditions

AQUAVAC-COL should be stored frozen at or below - 60° C (- 76° F) prior to use. If AQUAVAC-COL is stored frozen at - 20°C (- 4°F) (non-frost-free freezer), the product must be used within 7 days or discarded. Once AQUAVAC- COL has been thawed, it must be used immediately. At no time should AQUAVAC- COL be exposed to direct sunlight or excessive heat above ambient air or water temperatures.

PRECAUTIONS AND WARNINGS

1. VACCINATE ONLY HEALTHY FISH. DO NOT VACCINATE WITHIN 21 DAYS BEFORE HARVEST. Although disease may not be evident, concurrent disease and adverse environmental conditions may cause complications or reduce effectiveness of AQUAVAC-COL vaccine.

2. WITHHOLD ALL CHEMICAL OR ANTIBIOTIC TREATMENTS in the water or feed for 3 days before and 5 days after vaccination.

3. USE AQUAVAC-COL VACCINE IMMEDIATELY FOLLOWING THAWING.

4. DO NOT ATTEMPT TO STORE OR REUSE THE VACCINE ONCE IT HAS BEEN THAWED. Each vial of AQUAVAC-COL vaccine is designed and intended for use in a single application.

5. DILUTE AQUAVAC-COL VACCINE ONLY AS DIRECTED. Any changes in the recommended dilution rate may cause the product to become ineffective.

6. ENSURE ACCURACY OF INVENTORIES PRIOR TO VACCINATION. Because the dosage of AQUAVAC-COL is based on total fish weight, it is important that the fish be inventoried as accurately as possible immediately prior to vaccination to ensure full efficacy and safety of the vaccine.

7. DO NOT ATTEMPT TO VACCINATE MORE FISH THAN DIRECTED OR OTHERWISE CHANGE THE DOSAGE OF AQUAVAC-COL. To do so can cause the product to become ineffective.

8. USE THE ENTIRE CONTENTS OF EACH VIAL WHEN FIRST THAWED AND OPENED.

9. WHEN VACCINATION HAS BEEN COMPLETED, BURN ALL CONTAINERS AND ANY UNUSED CONTENTS.

10. AVOID CONTACT OF OPEN WOUNDS WITH THE VACCINE. WASH HANDS THOROUGHLY AFTER USING THE VACCINE.

11. ANY ADVERSE OR UNUSUAL EFFECTS ASSOCIATED WITH THE USE OF AQUAVAC-COL SHOULD BE IMMEDIATELY REPORTED TO CUSTOMER SERVICE: 1-800-521-5767.

12. AQUAVAC-COL IS INTENDED FOR USE IN ANIMALS ONLY.

Notice

AQUAVAC-COL has undergone rigid potency, safety and purity tests, and meets Intervet Inc. and USDA 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 fish, environmental conditions following vaccination and the severity and timing of field exposure to F. columnare and columnaris disease following vaccination. Therefore, directions should be followed carefully to ensure safe use and optimum performance.

AQUAVAC-COL is not hazardous when used according to directions and poses no known human health risk for healthy individuals. A material safety data sheet (MSDS) is available upon request. This and any other consumer information can be obtained by Customer Service at 1-800-521-5767.

Records

The user is advised to keep a written record of vaccination including vaccine, quantity, serial number, expiration date, and place of purchase; the date and time of vaccination; the breed, lot number, pond number, population, age, average size and total weight of fish vaccinated; names of operators administering the vaccine; water temperature and environmental conditions as well as observations on the general health of the animals at the time of vaccination; and any unusual reactions or conditions observed.

The use of this vaccine is subject to applicable federal, state and local laws and regulations.

USE ONLY AS DIRECTED

STORE VACCINE FROZEN AT OR BELOW - 60° C (- 76° F)

IF STORED FROZEN AT 20° C (- 4° F) (NON-FROST-FREE FREEZER), THE PRODUCT MUST BE USED WITHIN 7 DAYS OR DISCARDED.

DO NOT EXPOSE TO EXCESSIVE HEAT

THIS PRODUCT IS NON-RETURNABLE

QUALITY Tested for Purity, Potency, and Safety

Federal Regulations prohibit the repackaging or sale of the contents of this carton in fractional units. Do not accept if seal is broken or tampered with. Use only where permitted.

FOR VETERINARY USE ONLY

Intervet Inc., Omaha, NE 68103, USA

U.S. Veterinary License No. 165A

1-800-521-5767

U.S. Patent Nos. 6,881,412 & 6,991,793

039943-05

CPN: 10474472