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Title 21: Food and Drugs
CHAPTER I: FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED)
SUBCHAPTER E: ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS
PART 522: IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
522.1183 - Iron hydrogenated dextran injection.
(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]
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