21 CFR 522.1222b - Ketamine hydrochloride with promazine hydrochloride and aminopentamide hydrogen sulfate injection.

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§ 522.1222b Ketamine hydrochloride with promazine hydrochloride and aminopentamide hydrogen sulfate injection.
(a) Chemical name. Ketamine hydrochloride, (±),-2-(o-chlorophenyl)-2-(methylamino) cyclohexanone hydrochloride, with promazine hydrochloride, 10-[3-(dimethylamino) propyl] phenothiazine monohydrochloride, and aminopentamide hydrogen sulfate.
(b) Specifications. The drug is a sterile aqueous solution and each milliliter contains: Ketamine hydrochloride equivalent to 100 milligrams ketamine base activity, 7.5 milligrams of promazine hydrochloride, and 0.0625 milligram of aminopentamide hydrogen sulfate, with 1:10,000 benzethonium chloride.
(c) Sponsor. See Code No. 000856 in § 510.600(c) of this chapter.
(d) Special considerations. Store in a cool place. Protect from light. Do not use if precipitate appears.
(e) Conditions of use.
(1) It is used in cats as the sole anesthetic agent for ovariohysterectomy and general surgery.
(2) It is administered intramuscularly at a recommended dose from 15 to 20 milligrams ketamine base per pound of body weight, depending on the effect desired.
(3) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[40 FR 59342, Dec. 23, 1975, as amended at 42 FR 3838, Jan. 21, 1977; 53 FR 27851, July 25, 1988]

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.

  • 2014-10-28; vol. 79 # 208 - Tuesday, October 28, 2014
    1. 79 FR 64114 - New Animal Drugs; Alfaxalone; Dinoprost; Ivermectin and Clorsulon; Nitrofurazone; Trenbolone and Estradiol Benzoate; Trimethoprim and Sulfadiazine; Tylosin; Change of Sponsor
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule, technical amendment.
      This rule is effective October 28, 2014.
      21 CFR Parts 510, 520, 522, 524, and 556

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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.

  • 2014-10-28; vol. 79 # 208 - Tuesday, October 28, 2014
    1. 79 FR 64114 - New Animal Drugs; Alfaxalone; Dinoprost; Ivermectin and Clorsulon; Nitrofurazone; Trenbolone and Estradiol Benzoate; Trimethoprim and Sulfadiazine; Tylosin; Change of Sponsor
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule, technical amendment.
      This rule is effective October 28, 2014.
      21 CFR Parts 510, 520, 522, 524, and 556