What is AQUAFLOR?

AQUAFLOR® (florfenicol) Type A Medicated Article is a fast-acting, broad-spectrum, highly palatable, antibiotic premix specifically for aquaculture. Developed by Schering-Plough Animal Health Corporation, AQUAFLOR has been used worldwide to treat highly infectious bacterial diseases in salmon, trout and other farm-raised aquaticspecies. It was recently approved in the United States for the treatment of channel catfish. In fact, AQUAFLOR is the first antibiotic licensed for U.S. aquaculture in more than 20 years.

What is florfenicol?

Florfenicol is the active ingredient in AQUAFLOR. It has proved to be a highly effective and safe antibiotic in aquatic species, as well as in cattle, swine and poultry. The unique compound is also found in NUFLOR® (florfenicol), which has been used successfully in the United States since 1996 to treat respiratory disease in beef and non-lactating dairy cattle. Unlike sulfa drugs and tetracyclines, florfenicol is used exclusively in farm-raised fish and food animals. It is not used in human medicine.

How exactly does AQUAFLOR work and how is it different from other antibiotic treatments?

The product’s active ingredient, florfenicol, is a synthetic, broad-spectrum antibiotic that has been shown in in vitro and in vivo studies to have activity against an extensive range of aerobic and anaerobic gram-positive and gram-negative bacteria.

Florfenicol is a member of the phenicol antibiotic family. Its antibacterial activity is due to the inhibition of protein synthesis in bacteria.

How will AQUAFLOR be used in U.S. catfish?

FDA has approved AQUAFLOR for controlling mortality in catfish due to enteric septicemia (ESC) of catfish associated with Edwardsiella ictaluri. Schering-Plough Animal Health gave priority to securing a claim for ESC because of high death losses associated with the disease — more than $13 million a year, according to a USDA estimate. We are now seeking additional claims for other disease-causing pathogens in channel catfish and eventually other aquatic species.

How effective is AQUAFLOR against ESC?

Studies show that treating with AQUAFLOR® results in significantly lower ESC mortality rates. In a study at Mississippi State University, challenged fingerlings treated with AQUAFLOR had a cumulative mortality rate of only 0.8 percent, compared to 60 percent for challenged, untreated catfish (p<0.0001). In the same trial, challenged fingerlings treated with AQUAFLOR showed an infection rate of only 1.7 percent, compared to 72.3 percent for challenged, untreated fish (p<0.0001).

What is the recommended dose rate for AQUAFLOR?

AQUAFLOR should be used at a dose rate of 10 mg florfenicol per kg of fish. Feed containing AQUAFLOR should be used as the sole ration for 10 consecutive days.

 Can AQUAFLOR be used with another in-feed antibiotics or medicines?

Concomitant use of AQUAFLOR with other in-feed medications is not recommended.

How safe is AQUAFLOR?

AQUAFLOR has established an excellent safety record for fish, human food and the environment. It is also well tolerated by fingerlings and food fish, with no performance setbacks. The safety of AQUAFLOR® in brood stock has not been established.

In trials to evaluate the safety of AQUAFLOR, researchers administered the product up to 10 times the recommended dose rate over the prescribed treatment period of 10 days and up to 5 times the recommended dosage rate over 20 days — twice the prescribed treatment period. In these studies, all fish treated with AQUAFLOR had a 100 percent survival rate, with no negative effect on feed consumption or growth.

How palatable is AQUAFLOR?

AQUAFLOR has proved to be highly palatable when blended with catfish feed. Studies show that fish consume feed medicated with AQUAFLOR at the same rate as unmedicated feed — even when AQUAFLOR was used at 10 times the recommended dose rate.

Studies also show that fish stay on feed throughout the treatment period. That helps to minimize wasted feed and maximize feed conversion and antibiotic intake.

Can AQUAFLOR be used in floating feed?

Yes. AQUAFLOR Type A Medicated Article has shown excellent stability in feed following high temperature extrusion. The product’s uniform granulation also ensures optimum distribution in feed and more precise dose delivery. Using AQUAFLOR in a floating feed helps you monitor feed and antibiotic intake.

Does AQUAFLOR have a withdrawal time?

Yes, AQUAFLOR has a 12-day withdrawal time. This assigned withdrawal time should allow producers to remain flexible in harvesting and marketing their fish.

Are there age restrictions for feeding AQUAFLOR to channel catfish?

No. Feed containing AQUAFLOR® can be fed to catfish at any stage, from fingerling to food fish.

Can feed medicated with AQUAFLOR be manufactured by any feed mill?

No. AQUAFLOR is the first in-feed antibiotic in aquaculture and only second for all food-animal species to be classified by FDA as a Veterinary Feed Directive (VFD) drug. This exclusive status is assigned to all new in-feed drugs to ensure correct usage and long-term effectiveness. Only feed mills with a valid Medicated Feed Mill License are permitted by FDA to blend feeds with AQUAFLOR.

Can producers simply order feed medicated with AQUAFLOR?

No. Under FDA guidelines, catfish producers may obtain VFD drugs through normal feed distribution channels, but they will require a signed Veterinary Feed Directive from a licensed veterinarian.

How do you get a signed Veterinary Feed Directive?

Producers can get a signed VFD from a diagnosing veterinarian or veterinary laboratory, as long as there is what the FDA calls a “veterinarian-client-patient relationship”. This VFD authorizes the client to obtain the medicated feed in accordance with the directions for use approved by FDA. There is no “extra-label” or “off label” use for any VFD drug. That means AQUAFLOR can be prescribed only for the use specified on the product label.

With the VFD form in hand, producers can go to their feed mill to order and obtain the VFD-containing feed. Responsibility for compliance falls on the feed mills, veterinarians and producers. The VFD form needs to be completed by a veterinarian and everything must be legal, valid and correct before the feed mill can fill that VFD order.

What constitutes a “veterinarian-client-patient relationship”?

FDA offers the following guidelines:

1. The veterinarian has assumed responsibility for making clinical judgments regarding the health of the animals and the need for medical treatment, and the client has agreed to follow the veterinarian's instructions.

2. The veterinarian has sufficient knowledge of the animals to initiate at least a general or preliminary diagnosis of the medical condition of the animals. This means that the veterinarian has recently seen and is personally acquainted with the keeping and care of the animals by virtue of an examination of the animals or by medically appropriate and timely visits to the premises where the animals are kept.

3. The veterinarian is readily available for follow-up evaluation, or has arranged for emergency coverage, in the event of adverse reactions or failure of the treatment regime.

Why was AQUAFLOR designated a VFD drug?

VFD regulations were developed by a coalition of members in the animal health community to better control new therapeutic antimicrobial drugs. The system will help reduce antibiotic resistance and prolong effectiveness of new antimicrobials and other in-feed therapeutics through judicious use.

VFD drugs require some additional paperwork, but the pork industry, which also uses a VFD drug, has proven that it’s not a big issue. There is always a learning curve in any new product or technology, but the rewards of a new drug to treat catfish disease certainly justify the learning process.

Is AQUAFLOR used in other aquatic species?

Yes. As noted earlier, AQUAFLOR is approved in other parts of the world for use in salmon, trout and other farm-raised aquatic species. At this time, AQUAFLOR is approved only for use in channel catfish in the United States, but Schering-Plough Animal Health is pursuing additional claims for use in other farm-raised aquatic species.

AQUAFLOR also has several sister products for livestock, including NUFLOR® (florfenicol) Injectable for cattle and NUFLOR®  (florfenicol) Drinking Water Concentrate for swine, which are licensed for use in the United States.

When prescribing AQUAFLOR, can my veterinarian write a VFD order for another species of fish?

No, VFD products are not eligible for off-label use in other aquatic species.

How long can feed medicated with AQUAFLOR be stored?

In-feed stability studies were performed on AQUAFLOR Type C medicated feeds. These studies have shown that AQUAFLOR Type C Medicated feed is stable for at least 13 weeks at 25˚ C (77˚ F) and 60% relative humidity.  Medicated feed should be protected from light. Since our data support the stability of florfenicol in Type C medicated feeds for a minimum of three months, FDA’s Center for Veterinary Medicine did not assign an expiration date for AQUAFLOR Type C medicated feed.

The AQUAFLOR ad campaign says “We want to take you higher.”  What exactly does that mean?

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

Where can I get more information about AQUAFLOR?

Contact your feed company, catfish health consultant or go to
www.AQUAFLOR-USA.com. You may also contact:

Schering-Plough Animal Health
Customer Service
1.800.521.5767

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.

AQUAFLOR and NUFLOR are registered trademarks of Schering-Plough Veterinary Corporation. Copyright ©2005. Schering-Plough Animal Health Corporation. All rights reserved. SPAH-AQF-220