Enterisol Salmonella T/C FF (Canada)

Company: Boehringer Ingelheim Animal Health

Salmonella Choleraesuis-Typhimurium Vaccine

Avirulent Live Culture

For use in swine only

For use in animals only

Enterisol Salmonella T/C FF Indications

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 established. For more information regarding efficacy and safety data go to productdata.aphis.usda.gov.

Directions and dosage: Plan vaccination timing to allow thawing of the contents of the vaccine vial in a trickling cool water bath until liquid (usually 30-40 minutes). Shake well and use entire contents immediately. Do not thaw vaccine by removing from the freezer the day before use. This will inactivate the vaccine.

Vaccination By Oral Drenching

Administer a single 0.4 mL dose orally.

Vaccination Via The Drinking Water

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

1. Do not thaw vaccine until ready to vaccinate.

2. Remove all medications, sanitizers, and disinfectants from drinking water, and any medicated feeds, for a minimum of 72 hours (3 days) prior to and following vaccination. This will result in a medication-free vaccination window totalling no less than 7 days in length.

3. Flush watering system with nonchlorinated/nontreated clean water to eliminate any antibacterial agents.

4. Thaw vaccine according to directions.

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 thawing of the vaccine.

Directions For Automatic Watering Systems Equipped With Proportioner

Several types of medicators/proportioners are commercially available.

1. Do not thaw vaccine until ready to vaccinate.

2. Remove all medications, sanitizers, and disinfectants from drinking water, and any medicated feeds, for a minimum of 72 hours (3 days) prior to and following vaccination. This will result in a medication-free vaccination window totalling no less than 7 days in length.

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

4. 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 30 mL of vaccine solution per 3.8 litres of 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 a Reload Pack™ DT. Add 1 Reload Pack™ for every 3.8 L of stock solution. Reload Packs™ contain the stabilizer sodium thiosulfate to neutralize chlorine. A blue dye is also included to facilitate charging water lines (step 8). Mix the water and Reload Pack™ thoroughly.

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 FF 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.

Precautions

Store frozen at ≤ -60°C. Do not thaw until immediately prior to use. Shake well before use. Do not mix with other products, except as specified on the label. Use entire contents when first opened. Do not vaccinate within 21 days before slaughter. In case of anaphylactoid reaction, administer epinephrine. This product has not been tested in pregnant animals. In case of human exposure, contact a physician. Inactivate unused contents before disposal. Do not use concurrently with antibiotics, including feed antibiotics. 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. Vaccinated pigs may intermittently shed the vaccine organism in feces for a minimum of 4 weeks after vaccination. There are no known safety risks to humans, but workers should use protective equipment (gloves, mask) while handling the vaccine during administration and while handling farm wastes. Measures to prevent accidental exposure of immunocompromised or vulnerable individuals should be taken. Municipal and provincial regulations, as well as current Best Management Practices, should be strictly followed for appropriate disposal of the waste from vaccinated pigs.

RELOAD PACK™ is a trademark of Boehringer Ingelheim Animal Health USA Inc., used under license.

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

Manufactured by

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

Tel.: 1 (888) 637-4251

VLN/PCN 124/19A2.01

Manufactured for

Boehringer Ingelheim Animal Health Canada Inc., Burlington ON L7L 5H4

CPN: 1182215.0