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Title 21: Food and Drugs
§ 522.1055 Gleptoferron.

(a) Specifications. Each milliliter (mL) contains the equivalent of 200 milligrams of elemental iron as gleptoferron, a complex of ferric hydroxide and dextran glucoheptonic acid.

(b) Sponsors. See No. 013744 in § 510.600(c) of this chapter.

(c) Conditions of use in swine - (1) Indications for use and amounts. (i) Prevention of anemia due to iron deficiency: Administer 1 mL (200 mg iron) per pig by intramuscular injection on or before 3 days of age.

(ii) Treatment of anemia due to iron deficiency: Administer 1 mL (200 mg iron) per pig by intramuscular injection as soon as signs of deficiency appear.

(2) [Reserved]

[81 FR 59134, Aug. 29, 2016, as amended at 82 FR 11508, Feb. 24, 2017; 82 FR 21690, May 10, 2017]
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