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Electronic Code of Federal Regulations

e-CFR data is current as of December 11, 2019

Title 21Chapter ISubchapter EPart 522 → §522.1182


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


§522.1182   Iron injection.

(a) Specifications. See §510.440 of this chapter. Each milliliter (mL) of solution contains the equivalent of:

(1) 100 milligrams (mg) of elemental iron derived from:

(i) Ferric hydroxide;

(ii) Ferric oxide; or

(iii) Elemental iron.

(2) 200 mg of elemental iron derived from ferric hydroxide.

(b) Sponsors and conditions of use. It is used in young piglets by sponsors in §510.600(c) of this chapter as follows:

(1) Nos. 000859 and 042552 for use of product described in paragraph (a)(1)(i) of this section as follows:

(i) For prevention of iron deficiency anemia, inject 100 mg (1 mL) by intramuscular injection at 2 to 4 days of age.

(ii) For treatment of iron deficiency anemia, inject 100 mg (1 mL) by intramuscular injection. Dosage may be repeated in approximately 10 days.

(2) No. 054771 for use of product described in paragraph (a)(1)(i) of this section as follows:

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

(ii) For the treatment of anemia due to iron deficiency, administer an intramuscular injection of 200 mg.

(3) Nos. 000061 and 013744 for use of product described in paragraph (a)(1)(i) of this section as follows:

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

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

(4) No. 054771 for use of product described in paragraph (a)(1)(ii) of this section as follows:

(i) For prevention of iron deficiency anemia, administer 1 mL by intramuscular injection at 2 to 5 days of age. Dosage may be repeated at 2 weeks of age.

(ii) For treatment of iron deficiency anemia, administer 1 to 2 mL by intramuscular injection at 5 to 28 days of age.

(5) No. 054771 for use of product described in paragraph (a)(1)(iii) of this section as follows:

(i) For prevention of anemia due to iron deficiency, administer 100 mg by intramuscular or subcutaneous injection at 2 to 4 days of age.

(ii) For treatment of anemia due to iron deficiency, administer 100 mg by intramuscular or subcutaneous injection up to 4 weeks of age.

(6) Nos. 016592 and 058005 for use of product described in paragraph (a)(1)(iii) of this section as follows:

(i) For prevention of anemia due to iron deficiency, administer 100 mg by intramuscular injection at 2 to 4 days of age.

(ii) For treatment of anemia due to iron deficiency, administer 100 mg by intramuscular injection. Treatment may be repeated in 10 days.

(7) Nos. 016592 and 042552 for use of product described in paragraph (a)(2) of this section as follows:

(i) For prevention of anemia due to iron deficiency, intramuscularly inject 200 mg of elemental iron (1 mL) at 1 to 3 days of age.

(ii) For treatment of anemia due to iron deficiency, intramuscularly inject 200 mg of elemental iron at the first sign of anemia.

[73 FR 12635, Mar. 10, 2008, as amended at 73 FR 14385, Mar. 18, 2008; 78 FR 17597, Mar. 22, 2013; 78 FR 44433, July 24, 2013; 79 FR 16190, Mar. 25, 2014; 81 FR 22524, Apr. 18, 2016; 81 FR 59134, Aug. 29, 2016; 82 FR 11508, Feb. 24, 2017; 83 FR 48946, Sept. 28, 2018]

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