Aquaflor® (Florfenicol)

Product Type: VFD TYPE A MEDICATED ARTICLE ANIMAL DRUG LABEL
Autor Name: Schering Corporation
Code Source: 0061-1355
Route of Administration: ORAL

Aquaflor

Generic: florfenicol

Ingredients:

• florfenicol florfenicol : Active ingredient - basis of strength - 500 g in 1 kg
• Lactose Monohydrate : Inactive ingredient
• Povidone : Inactive ingredient

Package Description:

• 2 kg in 1 POUCH

Type A Medicated Article For Use in Freshwater-reared Finfish Feeds Only

Do Not Feed Undiluted

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 g (1.1 lb) of florfenicol in a palatable base.

Indications

Caution: Not for use in recirculating aquaculture systems. The effect of florfenicol on recirculating system biofilters and water quality has not been evaluated. 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.

Fish Species	Indication	Florfenicol (mg/kg body weight/day)
Freshwater-reared salmonids	For the control of mortality due to furunculosis associated with Aeromonas salmonicida .	10
For the control of mortality due to coldwater disease associated with Flavobacterium psychrophilum .
Freshwater-reared finfish	For the control of mortality due to columnaris disease associated with Flavobacterium columnare .	Warmwater: 10 -15 Others:10
Catfish	For the control of mortality due to enteric septicemia associated with Edwardsiella ictaluri .	10 - 15
Freshwater-reared warmwater finfish	For the control of mortality due to streptococcal septicemia associated with Streptococcus iniae .	15

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Feeds containing Aquaflor ^® (florfenicol) must be withdrawn 15 days prior to slaughter.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

Mixing Instructions

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.

Caution

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.

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 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 temperatures up to 25 °C with excursions permitted to 40°C.
NADA #141-246, Approved by FDA. Copyright © 2012 Intervet Inc., a subsidiary of Merck & Co. Inc. Summit, NJ 07901 USA All rights reserved. Made in Austria.
119436 R3

PRINCIPAL DISPLAY PANEL - 2.0 kg Pouch

2.0 kg (4.4 lb)
Aquaflor ^®
(Florfenicol)
Type A Medicated Article For Use in Freshwater-reared Finfish 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.
Copyright © 2012 Intervet Inc., a subsidiary of Merck & Co. Inc.
Summit, NJ 07901 USA.
All rights reserved.
Made in Austria.
MERCK
Animal Health
105304 R1

PRINCIPAL DISPLAY PANEL - 2.0 kg Pouch