21 CFR 522.1125 - Hemoglobin glutamer-200 (bovine).

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There are 3 Updates appearing in the Federal Register for 21 CFR 522. View below or at eCFR (GPOAccess)
§ 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. For intravenous use only. Overdosage or an excessive rate of administration (greater than 10 milliliters per kilogram per hour) may result in circulatory overload. 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]

Title 21 published on 2014-04-01

The following are only the Rules published in the Federal Register after the published date of Title 21.

For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.

  • 2014-07-31; vol. 79 # 147 - Thursday, July 31, 2014
    1. 79 FR 44277 - New Animal Drugs; Bacitracin Methylene Disalicylate; Dinoprost Solution; Gonadorelin Hydrochloride; Progesterone Intravaginal Inserts; Salinomycin; Ractopamine; Tylosin
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendment.
      This rule is effective July 31, 2014.
      21 CFR Parts 520, 522, 529, and 558

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United States Code
U.S. Code: Title 21 - FOOD AND DRUGS

Title 21 published on 2014-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 522 after this date.

  • 2014-07-31; vol. 79 # 147 - Thursday, July 31, 2014
    1. 79 FR 44277 - New Animal Drugs; Bacitracin Methylene Disalicylate; Dinoprost Solution; Gonadorelin Hydrochloride; Progesterone Intravaginal Inserts; Salinomycin; Ractopamine; Tylosin
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendment.
      This rule is effective July 31, 2014.
      21 CFR Parts 520, 522, 529, and 558