AQUAFLOR TYPE A MEDICATED ARTICLE- florfenicol powder
Schering Corporation
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Aquaflor®
(Florfenicol)
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.
Description
Each kg of Aquaflor® (florfenicol) contains 500 g (1.1 lb) of florfenicol in a palatable base.
Indications
| Fish Species | Indication | Florfenicol (mg/kg body weight/day) |
|---|---|---|
| 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. | ||
| 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Feeds containing Aquaflor® (florfenicol) must be withdrawn 15 days prior to slaughter.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
For incorporation into feed pellets
For making Aquaflor® (florfenicol) Type C Medicated Feed:
- a)
- Aquaflor® (florfenicol) is added to other feed ingredients in the mixer prior to extrusion,
- b)
- the ingredients are mixed thoroughly to insure homogeneity,
- c)
- the mixture is steam pelleted or extruded and pellets are dried,
- d)
- medicated feed pellets are 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) onto feed pellets
There are two methods for making Aquaflor® (florfenicol) Type C Medicated Feed by top-coating.
Method 1:
- a)
- add a known quantity of fish feed into a mixer,
- b)
- weigh out Aquaflor® (florfenicol),
- c)
- mix Aquaflor® with feed pellets,
- d)
- medicated feed pellets are 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.
Method 2:
- a)
- weigh out fish oil or vegetable oil into a bucket,
- b)
- weigh out Aquaflor® (florfenicol) and mix thoroughly with the oil in the bucket,
- c)
- add a known quantity of fish feed into a mixer,
- d)
- add the Aquaflor® (florfenicol) and oil mixture to the feed in the mixer, slowly, while the mixer is running at low speed,
- e)
- at the completion of mixing, the product is transferred to a storage tank for packaging or transport.
| Feeding Rate | Florfenicol Concentration in Feed | Amount of Aquaflor® (florfenicol) per Ton of Feed | Biomass of Fish Medicated per Ton of Feed per 10-day Treatment Period | ||
|---|---|---|---|---|---|
| % Biomass | Grams/ton | lbs | lbs | ||
| Dose 10 mg/kg | Dose 15 mg/kg | Dose 10 mg/kg | Dose 15 mg/kg | ||
| 0.5 | 1,816 | 2,724 | 8.00 | 12.00 | 40,000 |
| 1.0 | 908 | 1,362 | 4.00 | 6.00 | 20,000 |
| 2.0 | 454 | 681 | 2.00 | 3.00 | 10,000 |
| 3.0 | 300 | 450 | 1.32 | 1.98 | 6,666 |
| 5.0 | 182 | 273 | 0.80 | 1.20 | 4,000 |
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.
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
| AQUAFLOR
TYPE A MEDICATED ARTICLE
florfenicol powder |
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| Labeler - Schering Corporation (001317601) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Intervet GESMBH | 303295794 | MANUFACTURE | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| MINSHENG GROUP SHAOXING PHARMACEUTICAL CO., LTD. | 544607919 | API MANUFACTURE | |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Shanghai Sunve Baoling Pharmaceutical Factory | 527263118 | API MANUFACTURE | |