(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 No. 050604 in Sec. 510.600(c) of this chapter.
(c) Conditions of use--(1) Amount. Administer only by deep intramuscular injection in the lumbar muscles (L3-L5).
(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. [60 FR 49340, Sept. 25, 1995, as amended at 79 FR 16191, Mar. 25, 2014]