21 CFR 522.1362 - Melarsomine powder for injection.
(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. 050604 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.