21 CFR 522.1380 - Methocarbamol injection.

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§ 522.1380 Methocarbamol injection.
(a) Specifications. The product is a sterile, pyrogen-free solution, each milliliter containing 100 milligrams of methocarbamol, 0.5 milliliter of polyethylene glycol 300, and water for injection q.s. Its pH is 3.5 to 6.0.
(b) Sponsor. See No. 000856 in § 510.600(c) of this chapter.
(c) Conditions of use—
(1) Amount—
(i) Dogs and cats. 20 milligrams per pound of body weight for moderate conditions, 25 to 100 milligrams per pound of body weight for severe conditions (tetanus and strychnine poisoning), total cumulative dose not to exceed 150 milligrams per pound of body weight.
(ii) Horses. 2 to 10 milligrams per pound of body weight for moderate conditions, 10 to 25 milligrams per pound of body weight for severe conditions (tetanus), additional amounts may be needed to relieve residual effects and to prevent recurrence of symptoms.
(2) Indications for use. As an adjunct for treating acute inflammatory and traumatic conditions of the skeletal muscles and to reduce muscular spasms.
(3) Limitations. For intravenous use only. For dogs, administer rapidly half the estimated dose, pause until the animal starts to relax, then continue administration to effect. For horses, administer rapidly to effect. Not for horses intended for food use. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[45 FR 79758, Dec. 2, 1980, as amended at 46 FR 18964, Mar. 27, 1981; 67 FR 67521, Nov. 6, 2002]

Title 21 published on 2013-04-01

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.

  • 2014-04-15; vol. 79 # 72 - Tuesday, April 15, 2014
    1. 79 FR 21126 - New Animal Drugs; Ceftiofur Sodium; Gentamicin; Xylazine
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendment.
      This rule is effective April 15, 2014.
      21 CFR Part 522

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

Title 21 published on 2013-04-01

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

  • 2014-04-15; vol. 79 # 72 - Tuesday, April 15, 2014
    1. 79 FR 21126 - New Animal Drugs; Ceftiofur Sodium; Gentamicin; Xylazine
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendment.
      This rule is effective April 15, 2014.
      21 CFR Part 522