Aquaflor - For Catfish and Freshwater-Reared Salmonids

Aquaflor (florfenicol) for ColdWater Disease

This year even more fish farmers will scale new heights in performance.

AQUAFLOR® — the first antibiotic licensed for US aquaculture in more than 20 years — has been approved for use in trout and other freshwater-reared salmonids.

With early diagnostics and proactive management, AQUAFLOR will help you reach new highs for fish survival and profitability.

Contact your veterinarian, feed supplier or extension agent today and say you want to bring your fish health program to a new high.

THE SKY’S YOUR LIMIT FROM HERE .

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First and only antibiotic approved in the US for controlling mortality in freshwater-reared salmonids associated with Flavobacterium psychrophilum (coldwater disease)

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Field-proven worldwide against major fish pathogens

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New-generation, broad-spectrum antibiotic with unique molecular structure

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Goes to work quickly for rapid decline in mortality

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Well distributed in fish tissue and fluids

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Optimal bioavailability — maximizes delivery of active ingredient to fish,
minimizes waste

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Keeps fish healthy so they stay on feed for optimum survival and growth — lets you reduce stocking rates, lower costs of production

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Exclusive Veterinary Feed Directive status ensures correct usage

IN RAINBOW TROUT :
73.9% bioavailable at 10°C
66.3% bioavailable at 16°C

Studies show US field isolates of disease-causing bacteria are more sensitive to AQUAFLOR than other antibiotics that have developed resistance.

INVITRO ACTIVITY AGAINST US FIELD ISOLATES — AQUAFLOR VS . OTHERS *
Antibiotic	Flavobacterium psychrophilum** ^{n = 51}			Aeromonas salmonicida*** ^{n = 51}
	S	I	R	S	I	R
AQUAFLOR (florfenicol)	100%	0%	0%	100%	0%	0%
Oxytetracycline	86%	5.9%	7.8%	20.4%	0%	79.6%
Ormetoprim / Sulfa	N/A	N/A	N/A	98%	0%	2%
S = Sensitive I = Intermediate R = Resistant

* Susceptibility based on published zones of inhibition for non-aquatic pathogens, Performance standards for antimicrobial disk and dilution susceptibility tests for bacteria isolated from animals - information supplement, M31-S1,
Vol 24, No. 17.
** Fish pathogens on label have demonstrated in vivo susceptibility to florfenicol which correlates to clinical efficacy.
*** The correlation between in vitro susceptibility data and clinical efficacy has not been determined. Refer to product for specific instructions.
Source: Olympia Fish Health Center, USFWS, Olympia Washington 2001-2005.

SALMONID FEEDS CONTAINING AQUAFLOR (FLORFENICOL) MUST BE WITHDRAWN 15 DAYS PRIOR TO SLAUGHTER. THE EFFECTS OF
AQUAFLOR ON REPRODUCTIVE PERFORMANCE HAVE NOT BEEN DETERMINED. SEE ACCOMPANYING PACKAGE INSERT FOR MORE PRODUCT INFORMATION.

•	Excellent safety profile for fish, human food, environment
•	Well tolerated by fry, fingerlings and food fish — with no performance setbacks
•	Developed specifically for use in fish and food animal species — market your product with added confidence
•	Friendly to environment — no significant risk to aquatic ecosystems

Safety and palatability trial in Atlantic salmon parr (11 g) and freshwater-reared rainbow trout (45-75 g)
Trial Design		Results
•	Salmon parr were fed up to 10 times the recommended dose rate for the recommended treatment period (10 days)	No Negative Effect On: • FEED CONSUMPTION • BODY WEIGHT • FISH BEHAVIOR • TISSUES (histopathology) • MORTALITY
•	Trout were fed to up to 5 times the recommended dose rate over 20 days or twice the prescribed treatment period

Studies show AQUAFLOR has no negative impact on mortality, behavior, histopathology or feed consumption — even when fed at 10 times the recommended dose rate.

AQUAFLOR SAFETY TRIALS — EFFECT OF DOSE RATE ON MORTALITY, HISTOPATHOLOGY AND FEED CONSUMPTION
	10 Days Recommended treatment period				20 Days 2x recommended treatment period.
Times recommended dose of 10 mg/kg x 10 days	1x	2x	4x	10x	2x	6x	10x
Mortality, %	0	0	0	0	0	0	0
Significant change in fish behavior	0	0	0	0	0	0	0
Significant lesions from treatment, %	0	0	0	0	0	0	0
Reductions in feed consumption and fish growth	0	0	0	0	0	0	0

* 2X = 10 mg/kg for 20 days / 6X = 30 mg/kg for 20 days / 10X = 50 mg/kg for 20 days:
A wide safety margin with Aquaflor

•	Fish readily consume feed with AQUAFLOR — palatability comparable to unmedicated feed
•	Studies show fish stay on feed and continue to gain weight throughout treatment period
•	Well accepted — no adverse effects on fish behavior or performance, even at 5x and 10x dose rates
•	Minimize feed wastage, maximize antibiotic uptake

PALATABI LITY TRIAL , RAINBOW TROUT — AQUAFLOR V S . UNMEDICATED FEED
Treatment groups 10-day treatment period	99.5 99.0 99.6
Untreated	99.8 99.6 99.4
AQUAFLOR 1X*	99.2 99.2 99.7
AQUAFLOR 3X	99.3 99.6 99.6
AQUAFLOR 5X

* Recommended dose rate for AQUAFLOR (10 mg/kg for 10 days).
** Total percentage of unconsumed feed adjusted for a recovery efficiency of 97.75%.:

2006 User Survey, US Fish Farms

In a recent survey, US fish farmers were asked to rate their experience with Aquaflor

Experience with Aquaflor	Satisfaction Rating
Controls Bacterial Disease	100%
Reduces Mortality Quickly	100%
Keeps Fish on Feed during treatment	97.2%
Overall Experience with Aquaflor	100%

Veterinary Feed Directive Checklist

AQUAFLOR is the first product for aquaculture classified by FDA as a
Veterinary Feed Directive (VFD) drug.

FDA established this new category for new in-feed therapeutics to
ensure judicious use and long-term effectiveness.

•	A veterinarian-client-patient-relationship, as defined by FDA,must be in place to obtain a VFD drug.
•	VFD orders must be signed by the producer’s veterinarian and issued in triplicate, with one copy being retained by each party: • Feed supplier (white) • Producer (yellow) • Veterinarian (pink)
•	Producers should provide an original copy of the VFD order to their feed supplier if the veterinarian has not already done so.
•	VFD orders that have been faxed to the feed supplier must be followed by the original VFD order within 5 days.
•	Producers, feed suppliers and veterinarians must retain signed VFD orders for a minimum of 2 years and make them available for review and copying during FDA inspections. For

* Recommended dose rate for AQUAFLOR (10 mg/kg for 10 days). ** Total percentage of unconsumed feed adjusted for a recovery efficiency of 97.75%.:

Veterinary Feed Directive Checklist

AQUAFLOR is the first product for aquaculture classified by FDA as a Veterinary Feed Directive (VFD) drug. FDA established this new category for new in-feed therapeutics to ensure judicious use and long-term effectiveness.

* Recommended dose rate for AQUAFLOR (10 mg/kg for 10 days).
** Total percentage of unconsumed feed adjusted for a recovery efficiency of 97.75%.:

AQUAFLOR is the first product for aquaculture classified by FDA as a
Veterinary Feed Directive (VFD) drug.

FDA established this new category for new in-feed therapeutics to
ensure judicious use and long-term effectiveness.