Enterisol Salmonella T/C

Company: Boehringer Ingelheim Animal Health

Salmonella Choleraesuis-Typhimurium Vaccine

Avirulent Live Culture

For use in swine only.

This product has been shown to be effective for the vaccination of healthy swine 2 weeks of age or older against Salmonella Choleraesuis and S. Typhimurium. Onset of immunity for the S. Typhimurium fraction is evident within 14 days of vaccination. The duration of immunity has not been determined. For more information regarding efficacy and safety data go to productdata.aphis.usda.gov.

Directions and dosage: Rehydrate the vaccine by adding a portion of the contents of the accompanying diluent to the vaccine vial. Shake well and transfer the reconstituted suspension back into the diluent bottle. Mix with the remaining diluent to complete to a total volume of 200 mL. Shake well. Use entire contents immediately. Administer a single 2 mL dose per pig, either orally or via the drinking water. The need for annual booster vaccinations has not been established for this product; consultation with a veterinarian is recommended.

Vaccination By Oral Drenching

Administer a single 2 mL dose orally.

Vaccination Via The Drinking Water

Conventional water directions (open trough or barrel type [tank] system)

1. Do not reconstitute the vaccine until ready to vaccinate.

2. Do not treat animals with medicated feed containing antimicrobials effective against Salmonella spp. for a minimum of 3 days before and 3 days after the day of vaccination. This will result in a vaccination window totaling 7 days in length.

3. Discontinue sanitizers and disinfectants from drinking water prior to vaccination. Flush watering system with nonchlorinated/nontreated clean water to eliminate any antibacterial agents.

4. Rehydrate the vaccine according to directions above.

5. Add number of doses of vaccine equal to or more than the number of pigs to vaccinate, to the appropriate amount of clean, nontreated drinking water (see Caution section).

6. Final solution containing vaccine should be consumed within 6 hours after reconstituting the vaccine.

Directions For Automatic Watering Systems Equipped With Proportioner

Several types of medicators/proportioners are commercially available.

1. Do not reconstitute the vaccine until ready to vaccinate.

2. Do not treat animals with medicated feed containing antimicrobials effective against Salmonella spp. for a minimum of 3 days before and 3 days after the day of vaccination. This will result in a vaccination window totaling 7 days in length.

3. Provide sufficient watering space so that all pigs can drink within a 6 hour time frame.

4. Discontinue sanitizers and disinfectants from drinking water prior to vaccination. Flush watering system with nontreated, clean water to eliminate any antibacterial agents. (This can be accomplished during pre-measurement of stock solution volume requirement in step 6.)

5. Set proportioner to deliver 1 oz. (30 mL) of vaccine solution per 1 gallon (3.8 liters) of drinking water. Regularly clean proportioners internally to remove antibiotics or other contaminants that may impair vaccine viability. Maintain proportioners to manufacturer’s specifications in order to safeguard accurate vaccine administration.

6. Pre-measure the volume of stock solution required for vaccination during a 6 hour period as follows:

a. Fill a clean bucket or other suitable fluid container with water. Be sure to start with more water than the group of swine is expected to consume in a 6 hour period.

b. Insert proportioner draw tube into the water and ensure that the inlet end rests on the bottom of the container.

c. Adjust valves to start proportioned water flowing into the group of swine scheduled for vaccination.

d. After 6 hours, record the volume of water drawn from the container during this period. This 6 hour disappearance volume will be the total volume of clean water, chlorine neutralizer (step 7c), and vaccine to be used on the day of vaccination.

e. Return water supply flow to normal (bypass the proportioner) until ready to vaccinate.

f. NOTE: it is recommended to conduct this pre-measurement at the same time of day as intended for vaccination.

7. Prepare vaccine stock solution as follows:

a. Reconstitute vaccine according to directions above.

b. Add approximately half of the pre-measured amount of clean, disinfectant-free water to the container to be used for stock solution.

c. To ensure vaccine viability, use one or more Reload Pack (Reload Pack DT or Reload Pack DT 5X), which contain the stabilizer sodium thiosulfate, with any source of drinking and stock solution water. A blue dye is also included to facilitate charging water lines and detection of vaccine-containing water (step 8).

d. Add a number of vaccine doses to the stock solution equal to or greater than the number of pigs to vaccinate. Mix thoroughly.

e. Add clean, disinfectant-free water to bring the total volume of this stock solution to the pre-measured 6 hour volume. Mix thoroughly.

8. Vaccinate pigs using the prepared stock-solution as follows:

a. Insert proportioner draw tube into the vaccine stock solution. Ensure that the inlet end is resting on the bottom of the solution container.

b. Adjust water supply valves to direct water through the proportioner.

c. Charge the main water distribution lines throughout the facility being vaccinated. To do this, drain (bleed) water from the valve or drinker on each main line at the end farthest away from the proportioner.

d. Drain water from each main line until the water appears light blue in color.

e. Pigs should consume the vaccine-containing water within 6 hours after reconstituting the vaccine. Do not medicate or use disinfectants immediately following vaccination.

Enterisol Salmonella T/C Caution

The actual amount of water consumed may vary considerably depending on several factors, including environmental temperature and drinker type. It is recommended to pre-measure the actual stock solution volume requirements the day prior to vaccination, during the planned vaccination time period. This should be done in order to ensure that the vaccine is consumed within the 6 hour recommended time frame.

Incompatibility: Do not treat animals with medicated feed containing antimicrobials effective against Salmonella spp. for a minimum of 3 days before and 3 days after the day of vaccination. This will result in a vaccination window totaling 7 days in length.

Precautions

Store at 35-46°F (2-8°C). Do not freeze. Use entire contents when first opened. Do not vaccinate within 21 days before slaughter. Do not mix with other products, except as specified on the label. Do not use concurrently with antimicrobials effective against Salmonella spp. A minimum antibiotic-free period of 3 days pre- and post-vaccination is recommended. All materials used in administering this vaccine must be free of antimicrobial or disinfectant residue to prevent inactivation. In case of anaphylactoid reaction, administer epinephrine. Vaccinated pigs may intermittently shed the vaccine organism in feces for a minimum of 4 weeks after vaccination. This product has not been tested in pregnant animals. In case of human exposure, contact a physician. Inactivate unused contents before disposal.

ENTERISOL^® is a registered trademark of Boehringer Ingelheim Vetmedica GmbH, used under license.

Boehringer Ingelheim Animal Health USA Inc., St. Joseph, MO 64506

Phone: 1 (888) 637-4251

VLN/PCN 124/19A2.00

175705-03

CPN: 1028301.2