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21 C.F.R. § 522.1182   Iron dextran complex injection.

Title 21 - Food and Drugs

Title 21: Food and Drugs
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

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§ 522.1182   Iron dextran complex injection.

(a)(1) Specifications. Each milliliter of sterile solution contains ferric hydroxide dextran complex equivalent to 100 milligrams of elemental iron. It contains 0.5 percent phenol as a preservative.

(2) [Reserved]

(3)(i) Sponsor. See No. 000856 in §510.600(c) of this chapter.

(ii) Conditions of use. It is used in baby pigs as follows:

(a) For the prevention of anemia due to iron deficiency, administer an initial intramuscular injection of 100 milligrams of elemental iron to each animal at 2 to 4 days of age. Dosage may be repeated in 14 to 21 days.

(b) For the treatment of anemia due to iron deficiency, administer and intramuscular injection of 200 milligrams of elemental iron.

(4)(i) Sponsor. See Nos. 000061 and 062408 in §510.600(c) of this chapter.

(ii) Conditions of use. It is used in baby pigs as follows:

(a) For the prevention of iron deficiency anemia, administer intramuscularly an amount of drug containing 100 to 150 milligrams of elemental iron to animals from 1 to 3 days of age.

(b) For the treatment of iron deficiency anemia, administer intramuscularly an amount of drug containing 100 to 200 milligrams of elemental iron per animal. Dosage may be repeated in 10 days to 2 weeks.

(b)(1) Specifications. Each milliliter of sterile solution contains ferric hydroxide in complex with dextran equivalent to 200 milligrams of elemental iron. It contains 0.5 percent phenol as a preservative.

(2)(i) Sponsor. See Nos. 000010 and 059130 in §510.600(c) of this chapter.

(ii) Conditions of use. It is used in baby pigs as follows:

(a) For prevention of baby pig anemia due to iron deficiency, intramuscularly inject 200 milligrams of elemental iron (1 milliliter) at 1 to 3 days of age.

(b) For treatment of baby pig anemia due to iron deficiency, intramuscularly inject 200 milligrams of elemental iron at the first sign of anemia.

[49 FR 38938, Oct. 2, 1984, as amended 52 FR 7832, Mar. 13, 1987; 53 FR 40727, Oct. 18, 1988; 54 FR 41442, Oct. 10, 1989; 61 FR 18672, Apr. 29, 1996; 62 FR 35076, June 30, 1997; 63 FR 53578, Oct. 6, 1998]

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