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NADA Number: 141-246

Proprietary Name Aquaflor® Type A Medicated Article
Sponsor Intervet, Inc.
Sponsor Address 556 Morris Ave.
Summit, NJ    07901
USA
Ingredients Florfenicol
Species (Class) FISH (Salmonids, freshwater-reared)
FISH (Warmwater finfish, freshwater-reared)
FISH (Finfish, freshwater-reared)
FISH (Catfish)
Routes of Administration Per Os
Dosage Form Medicated feed
Dispensing Status VFD
Exclusivity Added a single indication for Salmonids reared in fresh water.
Withdrawal Time

Feeds containing florfenicol must be withdrawn 15 days prior to slaughter


Dosage Amount,
Indications
& Limitations

558.261 Florfenicol

Specifications: Type A medicated article containing 500 grams florfenicol per kilogram.

Conditions of use:Amount

Catfish: 10 to 15 milligrams (mg) florfenicol per kilogram (kg) of fish
Salmonids: 10 to 15 mg florfenicol per kg of fish
Warmwater finfish: 15 mg florfenicol per kg of fish
Finfish: 10 to 15 mg florfenicol per kg of fish

Indications

Catfish: For the control of mortality due to enteric septicemia of catfish associated with Edwardsiella ictaluri
Salmonids: For the control of mortality due to coldwater disease associated with Flavobacterium psychrophilum and furunculosis associated with Aeromonas salmonicida
Finfish: For the control of mortality due to columnaris disease associated with Flavobacterium columnare
Warmwater Finfish: For the control of streptococcal septicemia associated with Streptococcus iniae.

Limitations.

Catfish: Feed containing florfenicol shall not be fed for more than10 days. Following administration, fish should be reevaluated by a licensed veterinarian before initiating a further course of therapy. A dose-related decrease in hematopoietic/lymphopoietic tissue may occur. The time required for hematopoietic/lymphopoietic tissues to regenerate was not evaluated. The effects of florfenicol on reproductive performance have not determined.
Salmonids: Following administration, fish should be reevaluated by a licensed veterinarian before initiating a further course of therapy. The effects of florfenicol on reproductive performance have not been determined.
Finfish: Feed containing florfenicol shall not be fed for more than 10 days. Following administration, fish should be reevaluated by a licensed veterinarian before initiating a further course of therapy. For catfish, a dose-related decrease in hematopoietic/ lymphopoietic tissue may occur. The time required for hematopoietic/lymphopoietic tissues to regenerate was not evaluated. The effects of florfenicol on reproductive performance have not been determined.
Warmwater finfish: Feed containing florfenicol shall not be fed for more than 10 days. Following administration, fish should be reevaluated by a licensed veterinarian before initiating a further course of therapy. For catfish, a dose-related decrease in hematopoietic/ lymphopoietic tissue may occur. The time required for hematopoietic/lymphopoietic tissues to regenerate was not evaluated. The effects of florfenicol on reproductive performance have not been determined..

Special considerations: Federal law limits this drug to use under the professional supervision of a licensed veterinarian. See Sec. 558.6 of this chapter for additional requirements. The expiration date of veterinary feed directives (VFDs) for florfenicol must not exceed 15 days from the date of issuance. VFDs for florfenicol shall not be refilled.

 

Tolerances

Florfenicol: Cattle a. Liver (the target tissue). The tolerance for florfenicol amine (the marker residue) is 3.7 parts per million (ppm). b. Muscle. The tolerance for florfenicol amine (the marker residue) is 0.3 ppm.

Swine a. Liver (the target tissue). The tolerance for parent florfenicol (the marker residue) is 2.5 ppm. b. Muscle. The tolerance for parent florfenicol (the marker residue) is 0.2 ppm.