21 CFR 522.1055 - Gleptoferron injection.

Code of Federal Regulations - Title 21: Food and Drugs

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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

522.1055 - Gleptoferron injection.

(a) Specifications. Each milliliter contains the equivalent of 200 milligrams of elemental iron as gleptoferron (complex of ferric hydroxide and dextran glucoheptonic acid), and 0.5 percent phenol as a preservative.

(b) Sponsor. See 062408 in ? 510.600(c) of this chapter.

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

(1) For prevention of iron deficiency anemia, administer 200 milligrams of elemental iron intramuscularly on or before 3 days of age.

(2) For treatment of iron deficiency anemia, administer 200 milligrams of elemental iron intramuscularly.

[45 FR 61288, Sept. 16, 1980, as amended at 61 FR 18672, Apr. 29, 1996]



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