| Objective/purpose: |
Collect
supportive and pivotal data needed to establish the effectiveness
of oxytetracycline (OTC) immersion therapy to control mortality
caused by certain bacterial diseases. |
| Drug name: |
Terramycin-343® |
| Source of drug: |
Pfizer,
Inc. |
| Address: |
Pfizer Animal Health
700 Portage Road
RIC-190-43
Kalamazoo, MI 49001-0199
|
| Contact: |
Dr. Mark Subramanyam
Phone:
269-833-3388
Fax: 269-833-2707
Email: mark.subramanyam@pfizer.com
|
| Target
pathogen(s): |
Bacterial
pathogens susceptible to oxytetracycline. |
| Method
of administration: |
Immersion
treatment |
| Treatment
dosage: |
Options
A & B: single treatment of 20 milligrams OTC per liter
Options C & D: up to multiple treatments at 20 milligrams OTC per liter |
| Treatment
regimen: |
Option
A: 1-hour treatment for salmonids
Option B: 1-hour treatment for various cool and warmwater fish
Option C: 1-hour treatment on 1 to 4 consecutive days for salmonids
Option D: 1-hour treatment on 1 to 4 consecutive days for various cool and warmwater fish |
| Withdrawal
period: |
Options
A & B: 21 days. No withdrawal period is required for fish that will not be catchable for 21 or more days after release, or are illegal for harvest.
Options C & D: 60 days. No withdrawal period is required for fish that will not be catchable for 60 or more days after release, or are illegal for harvest. |
| Required
test parameters: |
Investigator
must collect mortality data throughout the 5-day pretreatment,
treatment, and 30-day posttreatment periods. Investigator should
also report general fish behavior and any adverse effects relating
to treatment. |
| Limitations
or restrictions on use: |
Investigator
must follow all instructions in the Study Protocol for INAD
9033 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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