21 CFR § 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. 016592 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.