subchapter_subject: "ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS"
part_code: "522"
part_subject: "IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS"
subpart_code: "B"
subpart_subject: "Specific Administrative Rulings and Decisions"
section_number: "522.1182"
section_subject: "Iron injection."
cfr_reference: "21 CFR 522.1182"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 500 to 599"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
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(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:
(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.