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NADA Number: 141-246

Proprietary Name Aquaflor® Type A Medicated Article
Sponsor Intervet, Inc.
Sponsor Address 2 Giralda Farms
Madison, NJ    07940
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

Seven years exclusive marketing rights granted for the control of mortality due to columnaris disease associated with Flavobacterium columnare in freshwater-reared finfish and for the control of mortality due to streptococcal septicemia associated with Streptococcus iniae. Columnaris disease – freshwater-reared finfish except catfish (Expires 4/4/2019); Streptococcal septicemia (Expires 4/4/2019).

Three years marketing exclusivity granted for the increase in the maximum daily dose for freshwater-reared finfish other than freshwater-reared warmwater finfish (Expires 1/29/2017).


Withdrawal Time

Feeds containing florfenicol must be withdrawn 15 days prior to slaughter


Specifications

Type A medicated article containing 500 grams florfenicol per kilogram.


Dosage Amount,
Indications
& Limitations

Catfish

Amount: 10 to 15 milligrams (mg) florfenicol per kilogram (kg) of fish

Indications: For the control of mortality due to enteric septicemia of catfish associated with Edwardsiella ictaluri.

Limitations: 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. A dose-related decrease in hematopoietic/lymphopoietic tissue may occur. The time required for hematopoietic/lymphopoietic tissues to regenerate was not evaluated. Not for use in animals intended for breeding purposes. The effects of florfenicol on reproductive performance have not been determined. Toxicity studies in dogs, rats, and mice have associated the use of florfenicol with testicular degeneration and atrophy.

Salmonids

Amount: 10 to 15 mg florfenicol per kg of fish

Indications: For the control of mortality due to coldwater disease associated with Flavobacterium psychrophilum and furunculosis associated with Aeromonas salmonicida.

Limitations: Following administration, fish should be reevaluated by a licensed veterinarian before initiating a further course of therapy. Not for use in animals intended for breeding purposes. The effects of florfenicol on reproductive performance have not been determined. Toxicity studies in dogs, rats, and mice have associated the use of florfenicol with testicular degeneration and atrophy.

Warmwater finfish

Amount: 15 mg florfenicol per kg of fish

Indications: For the control of streptococcal septicemia associated with Streptococcus iniae.

Limitations: 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. Not for use in animals intended for breeding purposes. The effects of florfenicol on reproductive performance have not been determined. Toxicity studies in dogs, rats, and mice have associated the use of florfenicol with testicular degeneration and atrophy.

Finfish

Amount: 10 to 15 mg florfenicol per kg of fish

Indications: For the control of mortality due to columnaris disease associated with Flavobacterium columnare.

Limitations: 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. Not for use in animals intended for breeding purposes. The effects of florfenicol on reproductive performance have not been determined. Toxicity studies in dogs, rats, and mice have associated the use of florfenicol with testicular degeneration and atrophy.

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 6 months from the date of issuance. VFDs for florfenicol shall not be refilled.

 

Tolerances

Florfenicol:

Cattle—(i) Liver (the target tissue). The tolerance for florfenicol amine (the marker residue) is 3.7 parts per million (ppm). (ii) Muscle. The tolerance for florfenicol amine (the marker residue) is 0.3 ppm.

(2) Swine—(i) Liver (the target tissue). The tolerance for parent florfenicol (the marker residue) is 2.5 ppm. (ii) Muscle. The tolerance for parent florfenicol (the marker residue) is 0.2 ppm.

(3) Catfish. The tolerance for florfenicol amine (the marker residue) in muscle (the target tissue) is 1 ppm.

(4) Salmonids. The tolerance for florfenicol amine (the marker residue) in muscle/skin (the target tissues) is 1 ppm.