21 C.F.R. § 522.1183 Iron hydrogenated dextran injection.
Title 21 - Food and Drugs
(a) Specifications. Each milliliter contains 100 milligrams of elemental iron stabilized with a low molecular weight hydrogenated dextran and 0.5 percent phenol as a preservative. (b)–(c) [Reserved] (d)(1) Sponsor. See No. 000003 in §510.600(c) of this chapter. (2) Conditions of use. It is used in baby pigs as follows: (i) For the prevention of anemia due to iron deficiency, administer by intramuscular or subcutaneous injection of 100 milligrams of elemental iron to each animal at 2 to 4 days of age. (ii) For the treatment of anemia due to iron deficiency, administer by intramuscular or subcutaneous injection of 100 milligrams of elemental iron in baby pigs up to 4 weeks of age. (e)(1) Sponsors. See Nos. 000010, 058005, and 059130 in §510.600(c) of this chapter. (2) Conditions of use. It is used in baby pigs as follows: (i) For the prevention of iron deficiency anemia, administer intramuscularly 100 milligrams at 2 to 4 days of age. (ii) For the treatment of iron deficiency anemia, administer intramuscularly 100 milligrams. Treatment may be repeated in 10 days. [42 FR 53955, Oct. 4, 1977, as amended at 46 FR 39128, July 31, 1981; 50 FR 23298, June 3, 1985; 52 FR 18691, May 19, 1987; 52 FR 36023, Sept. 25, 1987; 53 FR 40728 and 40729, Oct. 18, 1988; 55 FR 8462, Mar. 8, 1990; 55 FR 33670, Aug. 17, 1990; 62 FR 35076, June 30, 1997; 63 FR 44384, Aug. 19, 1998; 65 FR 45877, July 26, 2000; 66 FR 22117, May 3, 2001; 69 FR 47361, Aug. 5, 2004]
Title 21: Food and Drugs
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
§ 522.1183 Iron hydrogenated dextran injection.
