| Objective/purpose: |
Collect scientific data necessary to support pivotal efficacy trials to further establish the effectiveness of OTC to control bacterial diseases of marine penaeid shrimp species that occur under a variety of environmental conditions and over a range of temperatures. |
| 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
webpage: http://www.phibroah.com/ |
| Target
pathogen(s): |
Bacterial
shrimp pathogens susceptible to oxytetracycline. |
| Method
of administration: |
Medicated-feed
treatment |
| Treatment
dosage: |
4.5 g oxytetracycline per kg of feed
|
| Treatment
regimen: |
Medicated feed will be administered as a single treatment regimen, to be fed to satiation daily for 14 days.
A new treatment regimen may be initiated no sooner than five (5) days after the last treatment regimen has ended.
|
| Withdrawal
period: |
2 days
No withdrawal
period is required for treated shrimp what will be rendered. |
| Required
test parameters: |
Source data must be collected for at least 5 days before treatment, during treatment, and for at least 20 days after the treatment period (i.e., the post-treatment period) has ended.
Collection of this data is critically important. Samples of hepatopancreas or other typically affected tissue will be removed from groups of representative shrimp and tested by bacteriological, serological, or other methods to determine the presence of target pathogens.
Investigator should
also report general shrimp 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
8069 regarding drug acquisition and handling, shrimp treatment
and disposition, and data reporting requirements.
Drug discharge
must be in compliance with local NPDES permitting requirements.
T200 will be administered as a single treatment regimen. A new treatment regimen may be initiated no sooner than five (5) days after the last treatment regimen ended. |
| 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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