Fish and Aquatic Conservation


Erythromycin 200 Injectable INAD #12-781

Spawning Fall Chinook Salmon and facilities underwater photography. Pacific Northwest Fisheries. Credit: Ryan Hagerty/USFWS

Summary

ERYMICIN 200 Injection (Erymicin 200) is a solution that contains erythromycin for injection on juvenile and adult Salmonids. Erymicin 200 is only available for purchase through Syndel USA. The primary goal of field studies conducted under INAD #12-781 is to evaluate the efficacy of erythromycin for 1) controlling mortality caused by BKD (causative agent: Renibacterium salmoninarum) in salmonid species; and 2) control the vertical transmission of R. salmoninarum from BKD positive female broodstock to eggs/progeny. Fish treated for controlling mortality can be treated a single time with Erymicin 200 Injection at 10 – 25 mg erythromycin per kilogram (kg) fish body weight. Fish treated to control vertical transmission can be treated 1 to 3 times with Erymicin 200 at 10 – 25 mg erythromycin per kg fish body weight with a minimum injection interval of 21 days. The total dosage will not exceed 75 mg erythromycin per kilogram (kg) fish body weight over 3 injections. Adherence to a 60-day Investigational withdrawal period is required for all fish treated with Erymicin 200 under this INAD. To participate in the INAD Program for Erymicin 200 visit the data collecting site.

Please read the Study Protocol prior to any treatments. It contains the protocol, MSDS, and a copy of the forms to be used as a guide for collecting data that will be entered into the online INAD database. The FDA authorization letter(s) for this INAD is currently only available by emailing Bonnie Johnson .


INAD objective/purpose: Collect supportive and/or pivotal data needed to establish the effectiveness of erythromycin to 1) control mortality caused by bacterial kidney disease (BKD; causative agent: Renibacterium salmoninarum) in salmonid species; and 2) control the vertical transmission of R. salmoninarum from BKD positive female broodstock to eggs/progeny.

Drug Name
Erythromycin (Erymicin 200 Injectable)

Drug Source
Syndel USA
1441 W Smith Rd,
Ferndale, WA 98248 USA

Jason Montgomery
Phone: 800-283-5292
Fax: 360-384-0270
email: jasonm@syndel.com
Website: www.syndel.com

Target pathogen(s): Bacterial kidney disease (BKD; causative agent: Renibacterium salmoninarum)

Method of administration: IM or IP injection only

Treatment dosage:

  • 10 to 25 milligrams (mg) erythromycin per kilogram (kg) fish body weight
  • The total dosage will not exceed 75 mg erythromycin per kilogram (kg) fish body weight over 3 injections.

Treatment regimen:

  • Objective A: single injection with no repetition
  • Objective B: single or multiple injection with a maximum of 3 treatments; injection interval must be a minimum of 21 days.

Investigational Withdrawal period:

  • 60 days
  • No Investigational withdrawal period is required for fish that are not susceptible to legal harvest for a period post-treatment equal to the Investigational withdrawal periods noted above or are illegal for harvest during those same periods.
  • Objective B only: fish treated within 60 days of spawning (i.e. death) may not be used for stream nutrient enhancement programs.

Required test parameters:

  • Investigator must collect mortality data throughout the 5 day pre-treatment, treatment, and 10-day post-treatment period. Investigator should also report general fish behavior and any adverse effects relating to treatment.

Limitations or restrictions on use of drug:

  • Investigator must follow all instructions in the Study Protocol for INAD 12-781 regarding drug acquisition and handling, fish treatment and disposition, and data reporting requirements.
  • Drug discharge must be in compliance with local NPDES permitting requirements.

Required INAD fee: $700/facility/year

AADAP Contact Information:
Ms. Bonnie Johnson, FWS-AADAP
Phone: 406-994-9905
Fax: 406-582-0242
email: bonnie_johnson@fws.gov