Electronic Code of Federal Regulations
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e-CFR data is current as of July 10, 2020 |
Title 21 → Chapter I → Subchapter E → Part 522 → §522.1125 |
Title 21: Food and Drugs
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
§522.1125 Hemoglobin glutamer-200 (bovine).
(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.
[63 FR 11598, Mar. 10, 1998, as amended at 65 FR 20732, Apr. 18, 2000; 79 FR 16189, Mar. 25, 2014]