Aquaflor Type A Medicated Article

Manufacturer: Schering-Plough

(florfenicol)

For Use In Catfish And Salmonid Feeds Only

Do Not Feed Undiluted

Aquaflor Type A Medicated Article 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.

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 grams (1.1 lb) of the antibiotic 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).

Table 1: Minimum inhibitory concentration (MIC) of florfenicol against Edwardsiella ictaluri isolated from channel catfish, between 1998-2001.

Organism	No. Of Isolates	Mic90 (µg/ml)	Mic90 Mic Range (ìg/ml)
Edwardsiella ictaluri	95	0.25	0.25

Aquaflor Type A Medicated Article Indications

Catfish

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

Freshwater-reared Salmonids

For the control of mortality in freshwater-reared salmonids due to coldwater disease associated with Flavobacterium psychrophilum.

Aquaflor Type A Medicated Article 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.

Warning Catfish: Feeds containing AQUAFLOR® (florfenicol) must be withdrawn 12 days prior to slaughter.

Warning Salmonids: Feeds containing AQUAFLOR® (florfenicol) must be withdrawn 15 days prior to slaughter.

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^® Type C Medicated Feed for catfish and freshwater-reared salmonids: a) AQUAFLOR^® (florfenicol) is added to other feed ingredients in the mixer prior to extrusion, 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/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^® 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.

Recommended AQUAFLOR^® (florfenicol) Inclusion Rates for Preparation of Type C Medicated Feed for Catfish and Freshwater-reared Salmonids

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 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.

Aquaflor Type A Medicated Article 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^® 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 more information or to report adverse effects, call 1-800-224-5318. For customer service, call 1-800-521-5767. For a copy of MSDS sheet, call 1-800-770-8878.

Storage Conditions: Store At 2-30°c (36-86°f).

NADA #141-246, Approved by FDA.

AQUAFLOR is a registered trademark of Schering-Plough Animal Health Corporation.

Copyright © 2005, 2007, Schering-Plough Animal Health Corporation, Summit, NJ 07901, USA. Made in Ireland.

All rights reserved.

Take Time To Observe Label Directions.

	NDC
2.0 kg (4.4 lb)	0061-1355-01	28396023 Rev. 1/07
8 x 2.0 kg - 16 kg (35.2 lb)	0061-1355-01	28395906 6/05 28396112 Rev. 8/05

Nac No.

10472501