AQUAFLOR TYPE A MEDICATED ARTICLE
-
florfenicol powder
Schering Corporation
----------
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.
Description
Each kg of Aquaflor® (florfenicol) contains 500 g (1.1 lb) of florfenicol in a palatable base.
Activity
Catfish
In vitro and in vivo investigations in catfish have established florfenicol's activity against Edwardsiella ictaluri (Table 1).
| Organism | No. of Isolates | MIC90 (µg/mL) | MIC Range (µg/mL) |
|---|---|---|---|
| Edwardsiella ictaluri | 95 | .025 | .025 |
Indications
Caution
The effects of Aquaflor® (florfenicol) on reproductive performance have not been determined. 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.
IMPORTANT
Must be thoroughly mixed in feeds or surface-coated (top-coated) onto the feeds before use.
Mixing Instructions
For incorporation inside pellets
For making Aquaflor® (florfenicol) Type C Medicated Feed for catfish and freshwater-reared salmonids: a) Aquaflor® (florfenicol) is added to other feed ingredients in the mixer, b) the medicated feed is mixed thoroughly to insure homogeneity, c) the mixture is extruded and pellets are dried, d) the pellets are dry-mixed or coated with a predetermined amount of fish or vegetable oil, and e) at the completion of mixing, the product is transferred to a storage tank for packaging or transport.
For surface-coating (top-coating)
For making Aquaflor® (florfenicol) Type C Medicated Feed for freshwater-reared salmonids only: a) add a known quantity of fish feed into a mixer, b) weigh out Aquaflor® (florfenicol), c) weigh out fish oil or vegetable oil into a bucket, d) mix Aquaflor® (florfenicol) and oil thoroughly in the bucket, e) add the Aquaflor® (florfenicol) and oil mixture to the feed in the mixer, slowly, while the mixer is running at low speed, f) at the completion of mixing, the product is transferred to a storage tank for packaging or transport.
| Feeding Rate | Florfenicol Concentration in Feed | Amount of Aquaflor® (florfenicol) per Ton | Biomass of Fish Medicated per Ton of Feed per 10-day Treatment Period |
|---|---|---|---|
| % Biomass | Grams/ton | lbs | lbs |
| 0.5 | 1.816 | 8.00 | 40,000 |
| 1.0 | 908 | 4.00 | 20,000 |
| 2.0 | 454 | 2.00 | 10,000 |
| 3.0 | 300 | 1.32 | 6,666 |
| 5.0 | 182 | 0.80 | 4,000 |
Feeding Directions
Catfish
Feed as the sole ration for 10 consecutive days. Aquaflor® (florfenicol) medicated feed should only be administered once disease associated with Edwardsiella ictaluri in catfish has been appropriately diagnosed. Feeding fish at a percent of biomass and corresponding florfenicol concentration included in the table above will deliver 10 mg florfenicol per kg of fish.
Freshwater-reared salmonids
Feed as the sole ration for 10 consecutive days. Aquaflor® (florfenicol) medicated feed should only be administered once disease associated with Flavobacterium psychrophilum or Aeromonas salmonicida in freshwater-reared salmonids has been appropriately diagnosed. Feeding fish at a percent of biomass and corresponding florfenicol concentration included in the table above will deliver 10 mg florfenicol per kg of fish.
Caution
Feed containing Aquaflor® (florfenicol) shall not be fed to catfish or freshwater-reared salmonids for more than 10 days. Following administration, fish should be reevaluated 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.
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 Material Safety Data Sheet (MSDS) contains more detailed occupational safety information. For a copy of MSDS sheet, call 1-800-770-8878. For more information or to report adverse effects, call 1-800-211-3573.
For customer service, call 1-800-521-5767.
NADA #141-246, Approved by FDA.
Intervet
Schering-Plough Animal Health
Copyright © 2006, 2011 Intervet International B.V. All rights reserved.
Made in Austria
000119 R1
NDC 0061-1355-01
2.0 kg (4.4 lb)
PRINCIPAL DISPLAY PANEL - 2.0 kg Pouch
2.0 kg (4.4 lb)
Aquaflor®
(florfenicol)
Type A Medicated Article
For Use in Catfish and Salmonid Feeds Only
Do Not Feed Undiluted
Active Drug Ingredient: Florfenicol 500 g per kg (227.27 g per lb)
Description: Each kg of Aquaflor® (florfenicol) contains 500 g (1.1 lb)
of florfenicol in a palatable base.
NADA #141-246, Approved by FDA.
Aquaflor is the property of Intervet International B.V. or affiliated companies or licensors and is protected by copyrights, trademark and other intellectual property laws.
Copyright © 2005, 2011 Intervet International B.V. All rights reserved.
Made in Austria
Rev. 5/11
112365 R1
Intervet
Schering-Plough Animal Health
| AQUAFLOR
TYPE A MEDICATED ARTICLE
florfenicol powder |
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| NADA | NADA141246 | 12/05/2011 | |
| Labeler - Schering Corporation (001317601) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Intervet GESMBH | 303295794 | MANUFACTURE | |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| MINSHENG GROUP SHAOXING PHARMACEUTICAL CO., LTD. | 544607919 | API MANUFACTURE | |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Shanghai Sunve Baoling Pharmaceutical Factory | 527263118 | API MANUFACTURE | |
Revised: 12/2011 Schering Corporation