21 CFR 522.1125

§ 522.1125 Hemoglobin glutamer-200 (bovine).

United States · 21 CFR — Food and Drugs · Status: effective

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Citation: 21 CFR 522.1125, § 522.1125 Hemoglobin glutamer-200 (bovine), United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/87461
Permanent ID: ys:prov:87461@1
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Full text

(a) Specifications. Each 125 milliliter bag contains 13 grams per deciliter of polymerized hemoglobin of bovine origin in modified Lactated Ringer's Solution. It is a sterile, clear, dark purple solution. (b) Sponsor. See No. 063075 in § 510.600(c) of this chapter. (c) [Reserved] (d) Conditions of use—(1) Amount. One-time dose of 10 to 30 milliliters per kilogram of body weight administered intravenously at a rate of up to 10 milliliters per kilogram per hour. (2) Indications for use. For the treatment of anemia in dogs by increasing systemic oxygen content (plasma hemoglobin concentration) and improving the clinical signs associated with anemia, regardless of the cause of anemia (hemolysis, blood loss, or ineffective erythropoiesis). (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.