combat Aquacalm Powder Generic Name: metomidate powder Dosage Form: FOR ANIMAL USE ONLY Print this page Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here. AquacalmTM (Metomidate hydrochloride) For immersion use in ornamental finfish only. Not for use in fish intended for human or animal consumption. NOT APPROVED BY FDA Legally marketed as an FDA indexed product under MIF 900-002. Extra-label use is prohibited. Aquacalm Powder Description Each gram of Aquacalm TM powder contains 1 gm of metomidate hydrochloride. Aquacalm TM acts on the central nervous system to induce sedation or anesthesia in fish immersed in water containing the drug. INDICATIONS For the sedation and anesthesia of ornamental finfish. Aquacalm TM 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. DIRECTIONS FOR USE Aquacalm TM is packaged as a dry powder and must be mixed with water to be used. Determine the amount of Aquacalm TM powder needed to achieve the desired concentration for the intended use. Dissolve Aquacalm TM 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: Aquacalm TM has been tested on representative ornamental finfish species, but has not been tested on all fish species. The effect of Aquacalm TM 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 Aquacalm TM For example, if the desired Aquacalm TM 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 Aquacalm TM CAUTION AND WARNING CAUTION: NOT FOR USE IN FISH INTENDED FOR HUMAN OR ANIMAL CONSUMPTION. Not for use in humans. Keep out of the reach of children. Use in a well-ventilated area. Wear gloves. WARNING: 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 STORAGE AND HANDLING Store at 10 C to 30 C (50 F to 86 F) and protect from sunlight or sources of heat. Aquacalm Label AQUACALM metomidate powder Product Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:50378-013 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength metomidate (metomidate) metomidate 1000 mg in 1 g Packaging # Item Code Package Description 1 NDC:50378-013-02 1 BOTTLE, PLASTIC (BOTTLE) in 1 CARTON 1 NDC:50378-013-01 1 g in 1 BOTTLE, PLASTIC 2 NDC:50378-013-06 1 BOTTLE, PLASTIC (BOTTLE) in 1 CARTON 2 NDC:50378-013-05 5 g in 1 BOTTLE, PLASTIC 3 NDC:50378-013-11 1 BOTTLE, PLASTIC (BOTTLE) 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 06/15/2009 Labeler - Western Chemical Inc. (085803500) Registrant - Western Chemical Inc. 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to break down Aquacalm Powder commonly
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