Enterisol SC-54

Salmonella Choleraesuis Vaccine, Avirulent Live Culture

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Enterisol SC-54 Indications

For intranasal or water administration in healthy swine one day of age or older as an aid in the prevention of salmonellosis caused by Salmonella choleraesuis var. kunzendorf.

Recommended for use only in healthy, susceptible swine, per label directions.

Directions

Administration And Dosage

Rehydrate the vaccine by adding the full contents of the accompanying sterile diluent to the vaccine vial. Shake well and use immediately. Rehydrate only with the diluent provided; do not mix with other materials.

Intranasal Vaccination

Fill syringe with reconstituted vaccine. Place cannula on the syringe tip and administer a single 2 mL dose intranasally to swine one day of age or older. Administer the complete 2 mL dose to each pig vaccinated. Efficacy and safety of the vaccine at other than the dose or routes prescribed on the label is unknown, and therefore, not recommended and not USDA approved.

Vaccination via the drinking water:

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. 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 totaling no less than 7 days in length.

3. Provide sufficient watering space so that all pigs can drink within a 4 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 1 oz. (30 mL) of vaccine solution per 128 oz. (1 gallon, or 3.8 liters) of drinking water. Regularly clean proportioner internally to remove antibiotics or other contaminants that may impair vaccine viability. Maintain proportioner according to manufacturer’s specifications in order to safeguard accurate vaccine administration.

6. Pre-measure the volume of stock solution required for vaccination during a 4 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 4 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 4 hours, record the volume of water drawn from the container during this period. This 4 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 Ready Pack™ DT (or Reload Pack™ DT if reusing a Ready Pack or other clean container). Use the appropriately sized (1 to 2 gallon) Ready Pack for your stock solution volume, or add 1 Reload Pack for every 1 gallon of stock solution. Ready and 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 Ready Pack or 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 4 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 4 hours after reconstituting the vaccine. Do not medicate or use disinfectants immediately following vaccination.

Directions for open trough or barrel type (tank) system

1. Do not reconstitute the 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 totaling no less than 7 days in length.

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

4. Reconstitute 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 4 hours after reconstitution of the vaccine.

Enterisol SC-54 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 4 hour recommended time frame.

Incompatibility

All materials used in administration of this vaccine must be free of antibiotic and disinfectant residue to prevent vaccine inactivation and reduce product efficacy. A 7-day minimum medication-free period (including feed and water antibiotics) is required (3 days pre-vaccination through 3 days post-vaccination). If possible, a longer medication-free period is recommended.

Storage

Store refrigerated at a temperature between 35-45°F (2-7°C). Do not freeze. After reconstitution, mix gently until contents are completely dissolved. Use entire contents immediately.

Withdrawal Period

Vaccinated pigs are not to be harvested for human consumption within 21 days after vaccination.

Disposal

Burn vaccine container and all unused contents by a procedure allowed by local, state, and Federal regulations.

Additional Information For Veterinarians

Many factors must be considered in determining a sound Salmonella choleraesuis vaccination program for a particular farm. To be most effective, the vaccine must be administered properly to healthy animals maintained in a proper environment under good management. Stressed or immunosuppressed pigs should not be vaccinated as the efficacy of the vaccine in these animals is unknown. The level of individual animal and herd immunity required will vary with management practices, the degree of exposure to Salmonella, and the level of susceptibility of each animal. The vaccination program must be carefully planned and implemented in collaboration with the herd veterinarian following label and insert indications and precautions.

Pigs vaccinated intranasally at 3 weeks of age demonstrated a duration of immunity through at least 20 weeks post vaccination. The duration of immunity for pigs vaccinated intranasally at less than 3 weeks of age has not been determined.

Two field studies were conducted representing more than 50,000 total pigs. Non-vaccinated pigs and pigs vaccinated per label instructions via the drinking water when placed in the finishing barn (approximately 60 pounds body weight) were compared for prevalence of Salmonella at slaughter. Contrasted with non-vaccinated pigs, vaccinated pigs had a significantly (p <0.05) lower prevalence of Salmonella detected by culture of ileocecal lymph nodes collected at slaughter. In a clinical challenge study, pigs vaccinated intranasally with Enterisol^® SC-54 (n=20) and non-vaccinated controls (n=10) were challenged with virulent Salmonella Typhimurium 2 weeks post vaccination. During the subsequent 14 days the challenge control pigs shed S. Typhimurium, which was isolated from 18.0% of daily fecal samples from individual study pigs. Vaccination with Enterisol^® SC-54 significantly (p<0.05) reduced fecal shedding of S. Typhimurium. Only 7.5% of fecal samples from vaccinates were culture positive, a 2.4 fold reduction versus non-vaccinated controls.

Previous Or Active salmonella Or Other Infection

The effect of concurrent or previous infections at or around the time of vaccination on the efficacy of this vaccine in reducing or modifying salmonellosis in pigs is not known.

Enterisol^® is a registered trademark of Boehringer Ingelheim Vetmedica, Inc.

© 2012 Boehringer Ingelheim Vetmedica, Inc. All Rights Reserved.

Boehringer Ingelheim Vetmedica, Inc., St. Joseph, MO 64506 USA

Phone: 800-325-9167

U.S. Veterinary License No. 124

CPN: 1028043.3