Renogen

Company: Elanco (Aqua Health)

ARTHROBACTER VACCINE, LIVE CULTURE

Renogen Indications

This product has been shown to be effective for the vaccination of healthy salmonids 10g or larger against Bacterial Kidney Disease caused by Renibacterium salmoninarum. The duration of immunity of this product has not been determined. For more information regarding efficacy and safety data, see productdata.aphis.usda.gov.

Composition

This vaccine contains a lyophilized live culture of a microorganism that shares common antigenic determinants with Renibacterium salmoninarum.

Dosage and Administration

Anesthetize fish to immobilize and administer a 0.1 mL injection of the resuspended vaccine intraperitoneally one fin length ahead of the pelvic fins along the midline.

A. Resuspension of lyophilized culture

1. Flip off the cap on the vial of RENOGEN lyophilized culture.

2. Using the hypodermic syringe provided, puncture the rubber septum of the RENOGEN vial and withdraw 2 cc of air from the vial into the syringe.

3. Using the hypodermic syringe provided, withdraw 2 mL of sterile diluent from the addition port of the diluent bag.

4. Inject the withdrawn sterile diluent into the vial of RENOGEN and shake the vial until the culture is completely dissolved and resuspended in the diluent.

B. Final formulation of ready-to-use RENOGEN vaccine

1. Insert the hypodermic syringe into the vial of resuspended RENOGEN, invert the vial, and withdraw all of the culture into the syringe.

2. Inject the contents of the syringe into the diluent bag through the addition port. Shake the bag well to ensure complete mixing of the components.

3. Discard the hypodermic syringe in a secure manner to prevent injury. DO NOT REUSE.

4. Remove the product transfer kit from its sterile package. Tear the tab from the spike port of the diluent bag and insert the spike of the transfer kit into the port.

5. Attach the opposite end of the transfer kit to the injection gun.

Vaccination Program: Due to the relationship between water temperature and the onset of immunity, it is recommended that a minimum period of 400 degree-days (number of days multiplied by the mean water temperature for each day in °C during period) is allowed before exposure to the disease agents occurs. This product should be used as part of a comprehensive fish health program in consultation with a licensed veterinarian.

Renogen Caution

1. Shake well before using.

2. Do not mix with other products, except as specified on the label.

3. Store package at 2 - 8°C (35-46° F). DO NOT FREEZE. PROTECT FROM LIGHT.

4. Use entire contents within 4 hours of resuspension of the culture.

5. Vaccinate healthy fish only.

6. Do not vaccinate fish within 60 days of slaughter.

7. It is recommended that antimicrobial drugs not be administered 14 days before or after vaccination. It is recommended that oxytetracycline not be administered 6 weeks before or after vaccination.

8. If accidental injection of the operator occurs, the operator should seek medical attention immediately. In case of human exposure, contact a physician.

9. KEEP OUT OF REACH OF CHILDREN.

10. Live microorganism. Inactivate any unused vaccine, used containers, and hypodermic syringes before disposal.

11. Diagnostic kits which employ the use of polyclonal antiserum against Renibacterium salmoninarum should not be used to screen fish vaccinated with this product for at least 4 weeks after vaccination, since kidney samples from vaccinated fish will yield positive test results.

Package Content:

The box contains the following: One (1) 5 mL glass vial of lyophilized culture, one (1) intravenous bag containing 1000 mL of sterile diluent, one (1) 3 mL sterile hypodermic syringe and a transfer kit.

Manufacturer: Elanco Canada Limited, Charlottetown, PE, Canada

(Can. Vet. Biol. Est. Lic. No. 40)

Distributed in the US by: Elanco US Inc., Fort Dodge IA 50501

(US VPN 303A / PCN 1K11.00) - 1-800-265-5475

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

PA102822X

CPN: 1497012.11