21 CFR 522.52 - Alfaxalone.

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There are 3 Updates appearing in the Federal Register for 21 CFR 522. View below or at eCFR (GPOAccess)
§ 522.52 Alfaxalone.
(a) Specifications. Each milliliter contains 10 milligrams (mg) alfaxalone.
(b) Sponsor. See No. 049480 in § 510.600(c) of this chapter.
(c) Conditions of use in cats and dogs—
(1) Amount—
(i) Cats— (A) Induction of general anesthesia. Administer by intravenous injection over approximately 60 seconds or until clinical signs show the onset of anesthesia, 2.2 to 9.7 mg/kilogram (kg) for cats that did not receive a preanesthetic or 1.0 to 10.8 mg/kg for cats that received a preanesthetic.
(B) Maintenance of general anesthesia following induction. Administer an intravenous bolus containing 1.1 to 1.3 mg/kg to provide an additional 7 to 8 minutes of anesthesia in preanesthetized cats; a dose containing 1.4 to 1.5 mg/kg provides an additional 3 to 5 minutes anesthesia in unpreanesthetized cats.
(ii) Dogs—
(A) Induction of general anesthesia. Administer by intravenous injection over approximately 60 seconds or until clinical signs show the onset of anesthesia, 1.5 to 4.5 mg/kg for dogs that did not receive a preanesthetic or 0.2 to 3.5 mg/kg for dogs that received a preanesthetic.
(B) Maintenance of general anesthesia following induction. Administer an intravenous bolus containing 1.2 to 1.4 mg/kg to provide an additional 6 to 8 minutes of anesthesia in preanesthetized dogs; a dose of 1.5 to 2.2 mg/kg provides an additional 6 to 8 minutes of anesthesia in unpreanesthetized dogs.
(2) Indications for use. For the induction and maintenance of anesthesia and for induction of anesthesia followed by maintenance with an inhalant anesthetic, in dogs and cats.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[77 FR 64717, Oct. 23, 2012]

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