Renogen (Canada)

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 Health)

ARTHROBACTER SP. NOV., LIVE CULTURE

with Sterile Diluent

BACTERIAL KIDNEY DISEASE VACCINE.

FOR VETERINARY USE ONLY

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 cap on the vial of RENOGEN® lyophilized culture.

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

3. Inject the withdrawn sterile diluent into the vial of RENOGEN® and shake the vial until the culture is completely dissolved and resuspended in the diluent.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 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, anaesthetize fish until immobilized and inject with 0.1 mL of the vaccine intraperitoneally along the ventral midline, one fin length cranial to 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 - 8°C (35-46°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 immediately.

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

Package Quantities:

The box contains the following: One (1) 5 cc glass vial of lyophilized culture, one (1) intravenous bag containing 1,000 mL of sterile diluent, one (1) 3 cc sterile hypodermic syringe and a transfer kit.

Further 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 agents occurs.

KEEP OUT OF REACH OF CHILDREN

Renogen is a Registered Trademark of Novartis AG, Basel, Switzerland.

Manufacturer: Novartis Animal Health Canada, Inc., Charlottetown, PE, CANADA - 1-800-387-6325

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

Manufacturer: Novartis Animal Health Canada, Inc., Charlottetown, PE, Canada, C1E 2A7

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

PI-015-3

1 mL live culture

L-016-2

1000 mL sterile diluent

L-015-3

1000 mL container

L-019-1

NAC No.: 1235007.8

NOVARTIS ANIMAL HEALTH CANADA, INC.
(Aqua Health Business)

37 MCCARVILLE ST., WEST ROYALTY INDUSTRIAL PARK, CHARLOTTETOWN, PE, C1E 2A7
Telephone:   1-902-367-7374
Customer Service:   1-877-544-4966
Sales and Technical Information:   1-800-387-6325
Fax:   902-370-3208
Email:   christa.macdonald@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 Canadian product label or package insert.

Copyright © 2014 North American Compendiums. Updated: 2014-12-03

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