| Objective/purpose: |
Collect
supportive and pivotal data needed to establish the effectiveness
of oxytetracycline (OTC) when fed as a feed additive to 1) control
mortality caused by bacterial diseases in a variety of freshwater and marine fish, and abalone; and
2) mark skeletal tissue of finfish. |
| Drug name: |
Oxytetracycline
dihydrate (Terramycin 200®
for Fish) |
| Source of drug: |
Phibro
Animal Health |
| Address: |
65 Challenger Road
Ridgefield, NJ 07660 |
| Contact: |
Paul Duquette
Phone:
973-575-5255
Fax: 973-575-4354
email: paul.duquette@pahc.com |
| Target
pathogen(s): |
Bacterial
pathogens susceptible to oxytetracycline. |
| Method
of administration: |
Medicated-feed
treatment |
| Treatment
dosage: |
Standard
therapeutic finfish dose: 2.5 - 3.75 g OTC per 100 pounds fish per day.
High therapeutic finfish dose: 10 g OTC per 100 pounds fish body weight per day.
Standard abalone dose: up to 6.0 g OTC per 100 pound abalone body weight per day.
Skeletal marking dose: same as standard or high therapeutic finfish dose.
|
| Treatment
regimen: |
Option
A: standard therapeutic finfish dose; 10-day treatment duration (all salmonids).
Option B: high therapeutic finfish dose; 14-day treatment duration; temp
> 4°C (all finfish).
Option C: standard therapeutic finfish dose; 10-day treatment duration (non-salmonid freshwater and marine fish).
Option D: standard abalone dose; 14-day treatment duration.
Option E: skeletal marking at standard therapeutic dose,
10-day treatment duration; skeletal marking at high therapeutic dose, 14-day treatment duration.
|
| Withdrawal
period: |
Option
A: 21 days;
Option B: 70 days;
Option C: 40 days
Option D: 35 days
Option E (standard dose): 21 days (salmonids);
40 days (non-salmonids).
Option E (high dose): 70 days
(all finfish)
No withdrawal
period is required for treated fish that will not be susceptible
to legal harvest or slaughtered for market for the appropriate
number of days as specified in the Options listed
above. |
| Required
test parameters: |
Investigator
must collect mortality data throughout the 5-day pre-treatment,
treatment, and 21-day post-treatment periods. Investigator should
also report general fish behavior and any possible adverse effects
relating to treatment. |
| Limitations
or restrictions on use: |
Investigator
must follow all instructions in the Study Protocol for INAD
9332 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: |
$400.00
per facility per year |
| AADAP
contact for other information: |
Ms.
Bonnie Johnson, FWS - AADAP
Phone: 406-994-9905
Fax: 406-582-0242
bonnie_johnson@fws.gov |
| Disclaimer: |
Product and company names mentioned in this website, or mentioned in materials accessed via this website, are for informational purposes only. The mention of such does not imply endorsement by the Aquatic Animal Drug Approval Partnership, the U.S. Fish & Wildlife Service or any other organization of the U.S. Government. |
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