Label: TERRAMYCIN 200 FOR FISH- oxytetracycline quartenary salt powder
- NDC Code(s): 66104-7938-0
- Packager: Phibro Animal Health
- Category: VFD TYPE A MEDICATED ARTICLE ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Animal Drug Application
Drug Label Information
Updated November 6, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Drug Ingredient:
-
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)
Approved by FDA under NADA #038-439
7938000
101-9090-09
-
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
WEIGHING UP TO 30 GRAMS
For marking of skeletal tissue.
Administer medicated feed as the sole ration 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 SALMONIDS WEIGHING UP TO 55 GRAMS
For marking of skeletal tissue.
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: Immediate release is permitted 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 concentration Type C Medicated 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
- INDICATIONS & USAGE
- Terramycin 200 for Fish
-
INGREDIENTS AND APPEARANCE
TERRAMYCIN 200 FOR FISH
oxytetracycline quartenary salt powderProduct 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)
