TERRAMYCIN 200 FOR FISH- oxytetracycline quartenary salt powder

Terramycin 200 for Fish by

Drug Labeling and Warnings

Terramycin 200 for Fish by is a Animal medication manufactured, distributed, or labeled by Phibro Animal Health, Phibro Animal Heatlh. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Drug Ingredient:

Oxytetracycline (from oxytetracycline dihydrate) equivalent to

oxytetracycline hydrochloride (Terramycin®) . . . . . . . . . . . . . . . . . . . . . 200 g/lb

CAUTION:

CAUTION: Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian.

CAUTION: For use in manufacturing medicated fish and lobster feeds only. For use in dry feeds only. Not for use in liquid feed supplements.

CAUTION: Certain components of animal feeds, including medicated premixes, possess properties that may be a potential health hazard or a source of personal discomfort to certain individuals who are exposed to them. Human exposure should, therefore, be minimized by observing the general industry standards for occupational health and safety.

Precautions such as the following should be considered: dust masks or respirators and protective clothing should be worn; dust-arresting equipment and adequate ventilation should be utilized; personal hygiene should be observed; wash before eating or leaving a work site; be alert for signs of allergic reactions—seek prompt medical treatment if such reactions are suspected.

STORE AT ROOM TEMPERATURE

SEE BACK PANEL FOR COMPLETE MIXING AND USE DIRECTIONS, AND WARNINGS

Terramycin is a registered trademark of Pfizer, Inc.,

licensed to Phibro Animal Health Corporation, for Oxytetracycline.

PHIBRO and PHIBRO logo design are trademarks owned by

Phibro Animal Health Corporation or its affiliates

Phibro Animal Health Corporation, Teaneck, NJ 07666

Net Weight 50 lb (22.6 kg)

NADA #038-439, Approved by FDA

7938000

101-9090-07

DOSAGE & ADMINISTRATION

SPECIES	INDICATIONS FOR USE	FEEDING DIRECTIONS
SALMONIDS	For control of ulcer disease caused by Hemophilus piscium, furunculosis caused by Aeromonas salmonicida, bacterial hemorrhagic septicemia caused by Aeromonas liquefaciens and pseudomonas disease.	Administer medicated feed to provide a dosage of 2.5 - 3.75 g of oxytetracycline per 100 lb of fish daily for 10 days (see finfish mixing directions below). If mortality is not reduced by the fifth day of treatment, the diagnosis should be reexamined.
	Warning: Do not liberate or slaughter salmonids for food during treatment or for 21 days following last feeding of medicated feed.
PACIFIC SALMON	For marking of skeletal tissue.	Administer medicated feed as the sole ration to salmon not over 30 g body weight to provide a dosage of 11.35 g of oxytetracycline per 100 lb of fish (250 mg per kg of fish) daily for 4 consecutive days.
	Warning: Do not liberate for at least 7 days following last feeding of medicated feed.
FRESHWATER-REARED SALMONIDS	For the control of mortality in freshwater-reared salmonids due to coldwater disease associated with Flavobacterium psychrophilum.	Administer medicated feed to provide a dosage of 3.75 g of oxytetracycline per 100 lb of fish daily for 10 days (see finfish mixing directions below).
	Warning: Do not liberate or slaughter freshwater-reared salmonids for food during treatment or for 21 days following last feeding of medicated feed.
FRESHWATER-REARED Oncorhynchus mykiss	For the control of mortality in freshwater-reared Oncorhynchus mykiss due to columnaris disease associated with Flavobacterium columnare.	Administer medicated feed to provide a dosage of 3.75 g of oxytetracycline per 100 lb of fish daily for 10 days (see finfish mixing directions below).
	Warning: Do not liberate or slaughter Oncorhynchus mykissfor food during treatment or for 21 days following last feeding of medicated feed.
CATFISH	For control of bacterial hemorrhagic septicemia caused by Aeromonas liquefaciens and pseudomonas disease.	Administer medicated feed to provide a dosage of 2.5 - 3.75 g of oxytetracycline per 100 lb of fish daily for 10 days (see finfish mixing directions below). If mortality is not reduced by the fifth day of treatment, the diagnosis should be reexamined.
	Warning: Do not liberate or slaughter catfish for food during treatment or for 21 days following last feeding of medicated feed. Do not use when water temperature is below 62°F (16.7°C).
LOBSTER	For control of gaffkemia caused by Aerococcus viridans.	Administer 1 g/lb of medicated feed as sole ration for 5 consecutive days (see lobster mixing directions below).
	Warning: Withdraw medicated feed 30 days before harvesting lobsters.

MIXING DIRECTIONS—Finfish

Note that feeding rates may vary depending on the size and health of the fish. Feeding rates should be chosen to ensure that all fish in the rearing unit are adequately medicated.

Use the table below to calculate the amount of Terramycin 200 for Fish to use at your feeding rate.

Feeding Rate*	To achieve a dose rate of 2.5 – 3.75 g/100 pounds of fish
pounds/100 pounds (%)	Terramycin in Finished Feed	Terramycin 200 for Fish per ton of feed	Total biomass that one ton of medicated feed will treat**
1 2 3 4 5 6 7 8 9 10 15	(g/ton) 5,000 – 7,500 2,500 – 3,750 1,667 – 2,500 1,250 – 1,875 1,000 – 1,500 833 – 1,250 714 – 1071 625 – 938 556 – 833 500 – 750 333 – 500	(pounds) 25.00 – 37.50 12.50 – 18.75 8.33 – 12.50 6.25 – 9.38 5.00 – 7.50 4.17 – 6.25 3.57 – 5.36 3.13 – 4.69 2.78 – 4.17 2.50 – 3.75 1.67 – 2.50	(pounds) 200,000 100,000 66,667 50,000 40,000 33,333 28,571 25,000 22,222 20,000 13,333

* To calculate g Terramycin per ton finished feed at other feeding rates: (desired dose rate/feeding rate) x 2000

To calculate Terramycin 200 for Fish per ton at other feeding rates: g Terramycin per ton finished feed/200

Example: at a feeding rate of 2.5% (2.5 pounds per 100 pounds), with a desired dose of 3.75 g/100 pounds: 3.75 g per 100 lb/2.5 lb per 100 lb = 1.5 g per lb x 2000 lb = 3000 g Terramycin/ton

3000 g Terramycin per ton/200 g Terramycin per lb of Terramycin 200 for Fish = 15 pounds Terramycin per ton of feed

** To calculate total required medicated feed for the 10 day treatment period, multiply total estimated rearing unit biomass by 10 and divide by the pounds of medicated feed needed at your feeding rate

Example: at a feeding rate of 2% in a unit containing 5,000 pounds of fish biomass:

5,000 lb x 10 = 50,000 lb/100,000 lb per ton = 0.5 tons

MIXING DIRECTIONS—Lobsters

Mix 10 pounds of Terramycin 200 for Fish per ton of feed to achieve the dose rate of 1 g/lb.

INDICATIONS & USAGE

NOT FOR HUMAN USE

RESTRICTED DRUG (CALIFORNIA) – USE ONLY AS DIRECTED

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TERRAMYCIN 200 FOR FISH 
oxytetracycline quartenary salt powder

Product Information
Product Type	VFD TYPE A MEDICATED ARTICLE ANIMAL DRUG	Item Code (Source)	NDC: 66104-7938
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OXYTETRACYCLINE HYDROCHLORIDE (UNII: 4U7K4N52ZM) (OXYTETRACYCLINE ANHYDROUS - UNII:SLF0D9077S)	OXYTETRACYCLINE HYDROCHLORIDE	200 g  in 0.45 kg

Inactive Ingredients
Ingredient Name	Strength
SOYBEAN OIL (UNII: 241ATL177A)
RICE BRAN (UNII: R60QEP13IC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66104-7938-0	22.6 kg in 1 BAG

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA038439	03/31/2010

Labeler - Phibro Animal Health (006989008)

Registrant - Phibro Animal Heatlh (006989008)