Medication Guide App

Renogen

This page contains information on Renogen for veterinary use.
The information provided typically includes the following:
  • Renogen Indications
  • Warnings and cautions for Renogen
  • Direction and dosage information for Renogen

Renogen

This treatment applies to the following species:
Manufacturer: Novartis (Aqua Div.)

DIRECTIONS FOR USE

RENOGEN INJECTION VACCINE

Presentation:

This vaccine is presented as a lyophilized live culture of a microorganism that shares common antigenic determinants with Renibacterium salmoninarum, and is to be resuspended with sterile diluent before use.

Use:

As an aid in the prevention of Bacterial Kidney Disease caused by Renibacterium salmoninarum in healthy salmonids 10 g or larger.

Directions For Use

A. Resuspension of lyophilized culture

1. Flip off the red 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. Evacuate the syringe.

3. Using the hypodermic syringe provided, withdraw 2 cc 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 Inject the withdrawn sterile diluent into the vial of RENOGEN and shake the vial until the culture is completely dissolved and resuspended in the diluent.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.

Dosage and Administration

To use, fish are anaesthetized until immobilized, and are then injected with 0.1 mL of the vaccine intra-peritoneally along the midline, one fin length ahead of the pelvic fins.

Precautions

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

2. Vaccinate healthy fish only.

3. Use entire contents within 4 hours of resuspension of the culture. Shake well before using.

4. Store package at 2 - 7°C (35 - 45°F). PROTECT FROM LIGHT. DO NOT FREEZE.

5. 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.

6. 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.

7. If accidental injection of the operator occurs, the operator should discontinue activity and seek medical advice.

8. CAUTION! Live microorganism. Any unused vaccine, used containers, and hypodermic syringes should be disposed of by burning.

Package Quantities: One (1) 5 cc glass vial of lyophilized culture, one (1) intravenous bag containing 1,000 mL of sterile diluent, and one (1) 3 cc sterile hypodermic syringe.

Additional Information:

Due to the relationship between water temperature and 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 disease occurs.

Manufacturer: Aqua Health Ltd., Charlottetown, PE, CANADA, C1E 2A7 Can. Vet. Biol. Est. Lic. No. 28

Produced For: Novartis Animal Health US Inc., Larchwood, Iowa, 51241. U.S. Vet. Permit No. 303A

PI-033-0

1 mL live culture

L-033-3

1000 mL sterile diluent

L-034-3

NAC No.: 14970126

NOVARTIS ANIMAL HEALTH
(Aqua Division)

37 McCARVILLE ST., WEST ROYALTY INDUSTRIAL PARK, CHARLOTTETOWN, PE, C1E 2A7
Telephone:   1-902-367-7323
Customer Service:   1-877-544-4966
Technical Service:   1-905-814-0840
Fax:   902-370-3208
Email:   tanya.knudson@novartis.com
Every effort has been made to ensure the accuracy of the Renogen information published above. However, it remains the responsibility of the readers to familiarize themselves with the product information contained on the US product label or package insert.

Copyright © 2014 North American Compendiums. Updated: 2014-09-05

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