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NADA Number: 038-439

Proprietary Name Terramycin® 200 for Fish
Sponsor Phibro Animal Health Corp.
Sponsor Address GlenPointe Centre East, 3d floor
300 Frank W. Burr Blvd., suite 21
Teaneck, NJ    07666
USA
Ingredients Oxytetracycline Dihydrate
Species (Class) CRUSTACEANS (Lobster)
FISH (FRESHWATER-REARED ONCORHYNCHUS MYKISS)
FISH (SALMONIDS)
FISH (FRESHWATER-REARED SALMONIDS)
FISH (Catfish, reared)
FISH (Pacific salmon, reared)
Routes of Administration ORAL, IN FEED
Dosage Form TYPE A MEDICATED ARTICLE
Dispensing Status OTC
Exclusivity

Seven years of exclusive marketing rights. (July 6, 2015).


Withdrawal Time

Salmon, catfish, freshwater-reared salmonids, and freshwater-reared Oncorhynchus mykiss: 21 days before slaughter.

Lobsters: 30 days before slaughter.

Pacific Salmon: 7 days before slaughter.

 


Specifications

Type A medicated articles: 200 grams per pound. The amount of mono-alkyl (C8-C18) trimethylammonium oxytetracycline expressed is expressed in terms of an equivalent amount of oxytetracycline hydrochloride or the amount of oxytetracycline dihydrate base is expressed in terms of an equivalent amount of oxytetracycline hydrochloride.


Dosage Amount,
Indications
& Limitations

Pacific salmon

Amount: 250 milligrams of Oxytetracycline per kilogram of fish per day (11.35 grams per 100 pounds of fish per day) in fish feed.

Indications: For marking of skeletal tissue.

Limitations: For salmon not over 30 grams body weight. Administer as sole ration for 4 consecutive days. Fish not to be liberated for at least 7 days following the last administration of medicated feed.

Salmonids

Amount: 2.5 to 3.75 grams Oxytetracycline per 100 pounds of fish per day in fish feed.

Indications: Control of ulcer disease caused by Haemophilus piscium, furunculosis caused by Aeromonas salmonicida, bacterial hemorrhagic septicemia caused by Aeromonas liquefaciens, and pseudomonas disease.

Limitations: Administer in mixed ration for 10 days. Do not liberate fish or slaughter fish for food for 21 days following the last administration of medicated feed.

Catfish

Amount: 2.5 to 3.75 grams Oxytetracycline per 100 pounds of fish per day in fish feed.

Indications: Control of bacterial hemorrhagic septicemia caused by Aeromonas liquefaciens and pseudomonas disease.

Limitations: Administer in mixed ration for 10 days. Do not liberate fish or slaughter fish for food for 21 days following the last administration of medicated feed. Do not administer when water temperature is below 16.7 degress C (62 degrees F).

Freshwater-reared salmonids

Amount: 3.75 g oxytetracylcine per 100 lb of fish per day for 10 days.

Indications: Control of mortality due to coldwater disease associated with Flavobacterium psychrophilum.

Limitations: Administer in mixed ration for 10 days. Do not liberate fish or slaughter fish for food for 21 days following the last administration of medicated feed.

Freshwater-reared Oncorhynchus mykiss

Amount: 3.75 g oxytetracylcine per 100 lb of fish per day for 10 days.

Indications: Control of mortality due to colunmaris disease associated with Flavobacterium colmnare.

Limitations: Administer in mixed ration for 10 days. Do not liberate fish or slaughter fish for food for 21 days following the last administration of medicated feed.

Lobsters

Amount: 1 gram Oxytetracycline per pound of medicated feed in fish feed.

Indications: Control of gaffkemia caused by Aerococcus viridans.

Limitations: Administer as sole ration for 5 consecutive days.

 

 

Tolerances

Oxytetracycline Dihydrate: Beef cattle, dairy cattle, calves, swine, sheep, chickens, turkeys, finfish and lobster. Tolerances are established for the sum of residues of the tetracyclines including chlortetracycline, oxytetracycline, and tetracycline, in tissues and milk as follows: a. 2 parts per million (ppm) in muscle b. 6 ppm in liver c. 12 ppm in fat and kidney d. 0.3 ppm in milk.