Aquaflor-CA1

Manufacturer: Schering-Plough

(florfenicol)

Type A Medicated Article

For Use In Catfish Feeds Only

Conditionally Approved By Fda Pending A Full Demonstration Of Effectiveness Under Application Number 141-259

Do Not Feed Undiluted

Aquaflor-CA1 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. Extra-label use of this drug in or on animal feed is strictly prohibited.

Active Drug Ingredient

Florfenicol 500 g per kg (227.27 g per lb)

Inert ingredients: Lactose and Povidone.

Aquaflor-CA1 Indication

For the control of mortality in catfish due to columnaris disease associated with Flavobacterium columnare.

Aquaflor-CA1 Caution

The effects of Aquaflor^®-CA1 on reproductive performance have not been determined. A dose-related decrease in hematopoietic/lymphopoietic tissue may occur. The time required for the hematopoietic/lymphopoietic tissues to regenerate was not evaluated.

Residue Warning Feeds containing Aquaflor®-CA1 must be withdrawn 12 days prior to slaughter.

Important

Must be thoroughly mixed in feeds before use.

Mixing Instructions

For making Type C Medicated Feed for catfish: a) Aquaflor^®-CA1 is added to other feed ingredients in the mixer, b) the medicated feed is mixed thoroughly to assure 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.

Recommended Aquaflor^®-ca1 Inclusion Rates For Preparation Of Type C Medicated Feed

Feeding Rate	Florfenicol Concentration In Feed	Amount Of Aquaflor®-ca1 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

Feed as the sole ration for 10 consecutive days. Aquaflor^®-CA1 medicated feed should only be administered once disease associated with Flavobacterium columnare 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-CA1 Caution

Feed containing Aquaflor^®-CA1 shall not be fed to catfish 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^®-CA1 must not exceed 15 days from the date of prescribing. VFD for Aquaflor^®-CA1 shall not be refilled.

Warning

Avoid inhalation, oral exposure, and direct contact with skin or eyes. Operators mixing and handling Aquaflor^®-CA1 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 1-800-224-5318.

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

For customer service, call 1-800-521-5767.

Aquaflor^® is a registered trademark of Schering-Plough Animal Health Corporation.

Copyright © 2007, Schering-Plough Animal Health Corporation, Summit, NJ 07901, USA.

Made in Ireland. All rights reserved.

	NDC
8 x 2.0 kg - 16 kg (35.2 lb)	0061-1355-04	31292107, 31291909 3/07

Nac No.

10472830