Coliprotec F4 (Canada)

Escherichia Coli Vaccine

Avirulent Live Culture

Lyophilized

FOR ORAL USE ONLY IN SWINE

Coliprotec F4 Indications

This product has been shown to be effective for vaccination of healthy pigs of 17 days of age or older against diarrhea due to K88 (F4)-positive Escherichia coli. For more information regarding efficacy and safety data, see productdata.aphis.usda.gov.

Precautions

- Store refrigerated at 2-8°C (35-46°F). Do not freeze.

- For oral administration only.

- Materials and water used for the preparation and administration of the vaccine must be free of antibiotic, detergent and disinfectant residue to prevent inactivation of Coliprotec F4.

- Do not administer antibiotics or other live vaccines for a minimum of 3 days prior to and after vaccination.

- Withdraw antibiotics and disinfectants from drinking water for a minimum of 3 days prior to and after vaccination.

- Use entire content when first opened.

- The solution containing the vaccine should be used within 4 hours of preparation.

- Do not vaccinate within 21 days before slaughter.

- Burn the vial and all unused content.

Warning

Anaphylactic reactions may occur. Use epinephrine as antidote. Dispose unused product and empty containers according to local waste disposal requirements.

Coliprotec F4 Dosage And Administration

The Coliprotec F4 vaccine is administered orally using one dose per pig. Three methods of administration are recommended: 1) Individual oral drench, 2) Conventional drinking water systems (bowls, tanks) and 3) Automatic medicator (proportioner, dosing pump) watering system. In case of concerns about the presence of disinfectant residues in the drinking water, it is recommended to add skimmed milk powder as a stabilizer into the drinking water prior to adding the vaccine. The final concentration of the skimmed milk powder should be 5 g / liter.

Directions For Administration

Individual oral drench

Do not open or rehydrate the lyophilized vaccine until use. Water used for rehydration or for administration of the vaccine must be free of antibiotic, detergent and disinfectant residue to prevent inactivation of the vaccine. Withdraw antibiotics and disinfectants from drinking water for a minimum of 3 days prior to and after vaccination. Rehydrate the lyophilized bacterial culture in the vial using approximately 10 mL (200-dose format or less) or 20 mL (format of more than 200 doses) of water. Shake well. Transfer the vaccine to a sterile graduated container. Rinse the bottle with another 10 mL of water and transfer to the same container. Dilute the vaccine in the container using water to obtain a final volume of 3 mL per dose. Shake well. Using a syringe or a drencher, administer a single oral 3 mL dose of the vaccine preparation per pig.

Conventional drinking water system (bowls, tanks)

Do not open or rehydrate the lyophilized vaccine until use. Water used for rehydration or for administration of the vaccine must be free of antibiotic, detergent and disinfectant residue to prevent inactivation of the vaccine. Withdraw antibiotics and disinfectants from drinking water for a minimum of 3 days prior to and after vaccination. Flush the watering system with untreated water. Withhold water for 1 to 2 hours immediately before vaccination. Ensure that pigs have easy access to water over a period of 4 hours by providing adequate watering space.

On the day prior to vaccination, at the time of the day scheduled for the vaccination and after the pigs have been deprived of water for a period of 1 to 2 hours, determine the volume (mL) of water consumed within 4 hours by the number of pigs to be vaccinated. If the information is not available, please refer to the reference table below. Rehydrate the lyophilized bacterial culture in the vial using approximately 10 mL (200-dose format or less) or 20 mL (format of more than 200 doses) of water. Shake well. Transfer the vaccine to a sterile graduated container. Rinse the vial with another 10 mL of water and transfer to the same graduated container. Dilute the vaccine with the determined volume of water. Add the vaccine solution to the drinking water bowls or tanks for the pigs to be vaccinated. The solution containing the vaccine should be consumed within 4 hours.

Automatic medicator watering system (proportioner, dosing pump)

Do not open or rehydrate the lyophilized vaccine until use. Water used for rehydration or for administration of the vaccine must be free of antibiotic, detergent and disinfectant residue to prevent inactivation of the vaccine. Withdraw antibiotics and disinfectants from drinking water for a minimum of 3 days prior to and after vaccination. Flush the watering system and the proportioner with untreated water. Withhold water for 1 to 2 hours immediately before vaccination. Ensure that pigs have easy access to water over a period of 4 hours by providing adequate watering space.

On the day prior to vaccination, at the time of the day scheduled for the vaccination and after the pigs have been deprived of water for a period of 1 to 2 hours, determine the volume of stock solution to be prepared for the number of pigs to be vaccinated. In order to do so, pre-fill the proportioner container with a known volume of water and determine the volume (mL) used within 4 hours by the number of pigs to be vaccinated. If the information is not available, please refer to the reference table below. Select the volume of the proportioner for 30.0 mL of stock solution per 4 liters of water (1 oz per gallon or 1:128).

Preparation of the vaccine stock solution: Use the number of doses equal to the number of pigs to be vaccinated. Rehydrate the lyophilized bacterial culture in the vial using approximately 10 mL (200-dose format or less) or 20 mL (format of more than 200 doses) of water. Shake well. Transfer the vaccine to the proportioner container. Rinse the vial with another 10 mL of water and transfer to the same container. Add the volume of water to reach the determined volume of stock solution. Mix well. Insert the tube of the proportioner into the vaccine stock solution and open the water system. The solution containing the vaccine should be consumed within 4 hours.

Reference Table For Water Consumption

Water consumption is affected by environmental temperature, management conditions, and the age of pigs. The following table serves as a guideline.

¹Proportioner set at 30 mL per 4 liters (1 oz per gallon or 1:128)

Manufactured for:

Elanco Canada Limited, 1919 Minnesota Court, Suite 401, Mississauga, Ontario L5N 0C9 Canada

1-800-265-5475

Manufactured by:

Diamond Animal Health, Inc., 2538 S.E. 43rd Street, Des Moines, IA 50327 U.S.A.

VLN/PCN: 213/1551.02

Coliprotec, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates.

©2022 Elanco or its affiliates.

02342

PA103586X

CPN: 1231169.2