Melarsomine powder for injection.

21 C.F.R. § 522.1362
in effectEffective: 2024-07-01
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(a) Specifications. The drug consists of a vial of lyophilized powder containing 50 milligrams of melarsomine dihydrochloride which is reconstituted with the provided 2 milliliters of sterile water for injection. (b) Sponsor. See Nos. 000010 and 086073 in § 510.600(c) of this chapter. (c) Conditions of use—(1) Amount. Administer only by deep intramuscular injection in the lumbar muscles (L3-L5). (2) Indications. Treatment of stabilized, class 1, 2, and 3 heartworm disease (asymptomatic to mild, moderate, and severe, respectively) caused by immature (4 month-old, stage L5) to mature adult infections of Dirofilaria immitis in dogs. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

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