Animal NDC 0061-1355-01 Aquaflor Type A Medicated Article

Florfenicol

Animal NDC Product Code 0061-1355-01

Field Name Field Value
Animal NDC Code 0061-1355-01
Proprietary Name Aquaflor Type A Medicated Article What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Florfenicol What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Merck Sharp & Dohme Corp.
Product Type Vfd Type A Medicated Article Animal Drug
Active Ingredient(s)
  • Florfenicol
Inactive Ingredient(s)
  • LACTOSE MONOHYDRATE (EWQ57Q8I5X)
  • POVIDONES (FZ989GH94E)
  • LACTOSE MONOHYDRATE (EWQ57Q8I5X)
  • POVIDONES (FZ989GH94E)
Marketing Category NADA - NEW ANIMAL DRUG APPLICATION What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
FDA Application Number NADA141246 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Aquaflor Type A Medicated Article Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

Type A Medicated ArticleFor Use in Freshwater-reared Finfish Feeds OnlyDo Not Feed Undiluted

NADA #141-246, Approved by FDA.Copyright © 2012 Intervet Inc., a subsidiary of Merck & Co. Inc.Madison, NJ 07940 USAAll rights reserved.Made in Austria.Rev. 09/15131846 R3

Caution

Federal law limits this drug to use under the professional supervision of a licensed veterinarian. Animal feed bearing or containing this veterinary feed directive drug shall be fed to animals only by or upon a lawful veterinary feed directive (VFD) issued by a licensed veterinarian in the course of the veterinarian's professional practice.

Feed containing Aquaflor® (florfenicol) shall not be fed to finfish for more than 10 days. Following administration, fish should be re-evaluated by a licensed veterinarian before initiating a further course of therapy. The expiration date for VFD for Aquaflor® (florfenicol) must not exceed 15 days from the date of issuance. VFD for Aquaflor® (florfenicol) shall not be refilled.Sunburn, skin lesions, and skin sloughing have been reported in salmonids treated with florfenicol. Not all adverse drug events are reported to FDA CVM. It is not always possible to reliably estimate the adverse event incidence or to establish a causal relationship to product exposure using this data alone.Before using this drug for the first time, you must inform the appropriate National Pollutant Discharge Elimination System (NPDES) permitting authority of your intentions and of the following information. Acute and chronic water quality benchmarks for the protection of freshwater aquatic life have been derived by FDA for florfenicol following EPA guidance for calculating Tier II water quality criteria for the Great Lakes System (40 CFR 132, App. A). The acute benchmark value (Secondary Maximum Concentration) is 20.6 mg/L (equivalent to one-half of the Secondary Acute Value). The chronic benchmark value (Secondary Continuous Concentration) is 0.23 mg/L (equivalent to the Final Plant Value). The NPDES authority may require an NPDES permit before you can discharge Aquaflor®. The water quality benchmark concentrations are not discharge limits, but may be used by the NPDES authority to derive such limits for the permit. Additional environmental information on Aquaflor® and the benchmark values are available in an environmental assessment posted at http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/EnvironmentalAssessments/ucm300656.htm.

Active Drug Ingredient

Florfenicol 500 g per kg (227.27 g per lb)

Inert Ingredients

Lactose and Povidone.

Description

Each kg of Aquaflor® (florfenicol) contains 500 g (1.1 lb) of florfenicol in a palatable base.

Indications

Fish SpeciesIndicationFlorfenicol(mg/kg bodyweight/day)Florfenicol(grams/ton)Caution: 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. For catfish, a dose related decrease in hematopoietic/lymphopoietic tissue may occur. The time required for the hematopoietic/lymphopoietic tissues to regenerate was not evaluated.Freshwater-reared salmonidsFor the control of mortality due to furunculosis associated with Aeromonas salmonicida.10 - 15182-2,724For the control of mortality due to coldwater disease associated with Flavobacterium psychrophilum.Freshwater-reared finfishFor the control of mortality due to columnarisdisease associated with Flavobacterium columnare.10 - 15182-2,724CatfishFor the control of mortality due to enteric septicemia associated with Edwardsiella ictaluri.10 - 15182-2,724Freshwater-reared warmwater finfish For the control of mortality due to streptococcal septicemia associated with Streptococcus iniae.15273- 2,724

Residue Warning

Feeds containing Aquaflor® (florfenicol) must be withdrawn 15 days prior to slaughter.

Important

This product has been evaluated in salmonid and catfish feeds and should be used in feeds nutritionally similar to these evaluated feeds. Refer to the Freedom of Information Summary for details. Must be thoroughly mixed in feeds or surface-coated (top-coated) onto the feeds before use.

For Incorporation Into Feed Pellets

  • For making Aquaflor® (florfenicol) Type C Medicated Feed:a)Aquaflor® (florfenicol) is added to other feed ingredients in the mixer prior to extrusion,b)the ingredients are mixed thoroughly to insure homogeneity,c)the mixture is steam pelleted or extruded and pellets are dried,d)medicated feed pellets are mixed/coated with a predetermined amount of fish or vegetable oil, ande)at the completion of mixing, the product is transferred to a storage tank for packaging or transport.

For Surface-Coating (Top-Coating) Onto Feed Pellets

  • There are two methods for making Aquaflor® (florfenicol) Type C Medicated Feed by top-coating.Method 1:a) add a known quantity of fish feed into a mixer,b)weigh out Aquaflor® (florfenicol),c)mix Aquaflor® with feed pellets,d)medicated feed pellets are mixed/coated with a predetermined amount of fish or vegetable oil, ande)at the completion of mixing, the product is transferred to a storage tank for packaging or transport.Method 2:a) weigh out fish oil or vegetable oil into a bucket,b)weigh out Aquaflor® (florfenicol) and mix thoroughly with the oil in the bucket,c)add a known quantity of fish feed into a mixer,d)add the Aquaflor® (florfenicol) and oil mixture to the feed in the mixer, slowly, while the mixer is running at low speed,e)at the completion of mixing, the product is transferred to a storage tank for packaging or transport.

Feeding Directions

Feed as the sole ration for 10 consecutive days. Aquaflor® (florfenicol) medicated feed should only be administered once disease has been appropriately diagnosed. Feeding fish at a percent of biomass and corresponding florfenicol concentration included in the table above will deliver the appropriate florfenicol dose.

Warning

Avoid inhalation, oral exposure, and direct contact with skin or eyes. Operators mixing and handling Aquaflor® (florfenicol) should use protective clothing, gloves, goggles and NIOSH-approved dust mask. Wash thoroughly with soap and water after handling. If accidental eye contact occurs, immediately rinse thoroughly with water. If irritation persists, seek medical attention. Not for human consumption. Keep out of reach of children. The Safety Data Sheet (SDS) contains more detailed occupational safety information. For more information or to report adverse effects, call 1-800-224-5318. For customer service, call 1-800-521-5767. For a copy of SDS sheet, call 1-800-770-8878.

Storage Conditions

Store at temperatures up to 25°C with excursions permitted to 40°C.

* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.

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