AQUACALM- metomidate powder

Aquacalm by

Drug Labeling and Warnings

Aquacalm by is a Animal medication manufactured, distributed, or labeled by Western Chemical Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

NET CONTENTS: 1, 5, 10 or 50 grams

DESCRIPTION:  Each gram of AquacalmTM powder contains 1 gm of metomidate hydrochloride. AquacalmTM acts on the central nervous system to induce sedation or anesthesia in fish immersed in water containing the drug.

INDICATIONS & USAGE

INDICATION:  For the sedation and anesthesia of ornamental finfish. AquacalmTM is not for use in fish intended for human or animal consumption. Sedation may be necessary in
situations such as strip spawning for hatchery rearing, transporting fish from supplier to wholesaler or retailer, photographing fish as part of a strategic marketing approach, or removal of fish from exhibit tanks prior to cleaning. Anesthesia may be necessary in situations where detailed fish examination or minor surgical procedures are to be conducted.

WARNINGS AND PRECAUTIONS

CAUTION:
FOR USE IN ORNAMANTAL FINFISH ONLY.
NOT FOR USE IN FISH INTENDED FOR HUMAN OR ANIMAL CONSUMPTION.

WARNING:
Not for use in humans. Keep out of the reach of children. Use in a well-ventilated area. Wear gloves.

INHALATION: May be harmful. Remove immediately from danger zone and provide fresh air. In case of respiratory problems or respiratory arrest, administer artificial respiration. Keep the affected individual warm and still. Contact emergency medical help.

INGESTION: May be harmful. If the person is conscious, wash out mouth with copious amounts of water. Contact emergency medical help.

EYE CONTACT: May be harmful. In case of contact, flush with copious amounts of water for at least 15 minutes. Assure
adequate flushing by separating eyelids with fingers. Contact emergency medical help.

SKIN CONTACT: May be harmful. In case of contact, flush with copious amounts of water for at least 15 minutes. Remove
contaminated clothing and wash before re-using. Contact emergency medical help.

OTHER HEALTH INFORMATION: The toxicological properties of metomidate hydrochloride have not been thoroughly investigated. It is thought to act on the central nervous system as an imidazole based non-barbiturate hypnotic.

To obtain a Material Safety Data Sheet, call WESTERN CHEMICAL INC. at (360) 384-5898, or visit www.wchemical.com

DOSAGE & ADMINISTRATION

DIRECTIONS FOR USE:
AquacalmTM is packaged as a dry powder and must be mixed with water to be used. Determine the amount of AquacalmTM powder needed to achieve the desired concentration for the intended use. Dissolve AquacalmTM in a known volume of water, mix well, and aerate water during sedation or anesthesia. Lightly sedated fish may lose their ability to maintain upright position or position in a stream flow. Deeply sedated or anesthetized fish will experience total loss of equilibrium. Before beginning sedation or anesthesia, ensure that AquacalmTM-free water is available for recovery. Always test the dosage on a small group of fish first to make sure no unintended or adverse effects occur.

SPECIES:
AquacalmTM has been tested on representative ornamental finfish species, but has not been tested on all fish species. The effect of AquacalmTM may vary between (and within) species, depending upon age and physical condition of fish, and under different water conditions. Sedate or anesthetize fish in water with temperature and pH close to the temperature and pH of the rearing water.
Caution should be taken when using this product on/for:
1. Larval fish species, which may be more sensitive to sedation than older fish of the same species
2. Fish species such as knifefish and gouramis
3. Any fish species for extended periods (e.g.> 24 hr) used during transportation

DOSAGE:
Dose for sedation: 0.1 to 1.0 mg/L
Dose for anesthesia: 1.0 to 10.0 mg/L

The dose should be individualized, depending upon the fish species and the degree of anesthesia required. Consideration should be taken when sedating or anesthetizing fish at water temperatures substantially different from the species preferred water temperature or at very low pH.

DURATION OF TREATMENT:
At doses suitable for total loss of equilibrium or anesthesia, do not expose fish for more than 60 min. At doses suitable to sedate fish for transportation, do not expose fish for more than 24 hr. To facilitate recovery upon removal from a solution of AquacalmTM, place fish in well oxygenated, high quality water free of AquacalmTM. Fish should recover in 20 to 90 min.

CONTRAINDICATIONS:
Use of AquacalmTM is contraindicated in species of fish that rely upon accessory air breathing organs for oxygen consumption. Sedation or anesthesia of such species may result in unacceptable rates of mortality.

DOSE CALCULATION:
The dose is based on the volume of water in which fish will be placed or held.
For example, if the desired AquacalmTM concentration is 2.0 mg/L and the tank holding the fish contains 10 L of water, use the following calculation:
                            2 mg/L X 10L = 20 mg = 0.02 g AquacalmTM
For example, if the desired AquacalmTM concentration is 2.0 mg/L and the tank holding the fish contains 5 gal of water, use the following calculation (note that the correction factor is used when volume is reported in gallons):
                            2 mg/L X 5 gal X 0.00378 = 0.038 g AquacalmTM

STORAGE AND HANDLING

STORAGE and HANDLING:
Store at 10°C to 30°C (50°F to 86°F) and protect from sunlight and sources of heat.

DISPOSAL:
Contact your State Environmental Control Agency, or the Hazardous Waste Representative at the nearest EPA Regional Office for guidance pertaining to disposal of unused product.

QUESTIONS/COMMENTS?  For technical assistance, call Western Chemical Inc. at (360) 384-5898.  To report an adverse event, call WESTERN CHEMICAL INC. at (360) 384-5898, or FDA at 1-888-FDA-VETS.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

AQUACALM 
metomidate powder

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 50378-013
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
metomidate (UNII: Z18ZYL8Y51) (metomidate - UNII:Z18ZYL8Y51)	metomidate	1000 mg  in 1 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50378-013-02	1 in 1 CARTON
1	NDC: 50378-013-01	1 g in 1 BOTTLE, PLASTIC
2	NDC: 50378-013-06	1 in 1 CARTON
2	NDC: 50378-013-05	5 g in 1 BOTTLE, PLASTIC
3	NDC: 50378-013-11	1 in 1 CARTON
3	NDC: 50378-013-10	10 g in 1 BOTTLE, PLASTIC
4	NDC: 50378-013-50	50 g in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Legally Marketed Unapproved New Animal Drugs for Minor Species	MIF900002	06/15/2009

Labeler - Western Chemical Inc. (085803500)

Registrant - Western Chemical Inc. (085803500)