21 CFR 522.2470 - Tiletamine and zolazepam for injection.

§ 522.2470 Tiletamine and zolazepam for injection.
(a) Specifications. The drug is a sterile powder. Each milliliter of constituted solution contains tiletamine hydrochloride equivalent to 50 milligrams (mg) of tiletamine base and zolazepam hydrochloride equivalent to 50 mg of zolazepam base.
(b) Sponsor. See No. 054771 in § 510.600(c) of this chapter.
(c) Conditions of use in dogs and cats—
(1) Amount. Expressed as milligrams of the drug combination:
(i) Healthy dogs: An initial intramuscular dosage of 3 to 4.5 mg per pound of body weight for diagnostic purposes; 4.5 to 6 mg per pound of body weight for minor procedures of short duration such as repair of lacerations and wounds, castrations, and other procedures requiring mild to moderate analgesia. Supplemental doses when required should be less than the initial dose and the total dose given should not exceed 12 mg per pound of body weight. The maximum total safe dose is 13.6 milligrams per pound of body weight.
(ii) Healthy cats: An initial intramuscular dosage of 4.4 to 5.4 mg per pound of body weight for such procedures as dentistry, treatment of abscesses, foreign body removal, and related types of surgery; 4.8 to 5.7 mg per pound of body weight for minor procedures requiring mild to moderate analgesia, such as repair of lacerations, castrations, and other procedures of short duration. Initial dosages of 6.5 to 7.2 mg per pound of body weight are recommended for ovariohysterectomy and onychectomy. When supplemental doses are required, such individual supplemental doses should be given in increments that are less than the initial dose, and the total dose given (initial dose plus supplemental doses) should not exceed the maximum allowable safe dose of 32.7 mg per pound of body weight.
(2) Indications for use. For restraint or for anesthesia combined with muscle relaxation in cats and in dogs for restraint and minor procedures of short duration (30 minutes) requiring mild to moderate analgesia.
(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[79 FR 16197, Mar. 25, 2014]
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§ 522.2470 Tiletamine and zolazepam for injection.

(a) Specifications. The drug is a sterile powder. Each milliliter of constituted solution contains tiletamine hydrochloride equivalent to 50 milligrams (mg) of tiletamine base and zolazepam hydrochloride equivalent to 50 mg of zolazepam base.

(b) Sponsors. See Nos. 026637 and 054771 in § 510.600(c) of this chapter.

(c) Conditions of use in dogs and cats -

(1) Amount. Expressed as milligrams of the drug combination:

(i) Healthy dogs: An initial intramuscular dosage of 3 to 4.5 mg per pound of body weight for diagnostic purposes; 4.5 to 6 mg per pound of body weight for minor procedures of short duration such as repair of lacerations and wounds, castrations, and other procedures requiring mild to moderate analgesia. Supplemental doses when required should be less than the initial dose and the total dose given should not exceed 12 mg per pound of body weight. The maximum total safe dose is 13.6 milligrams per pound of body weight.

(ii) Healthy cats: An initial intramuscular dosage of 4.4 to 5.4 mg per pound of body weight for such procedures as dentistry, treatment of abscesses, foreign body removal, and related types of surgery; 4.8 to 5.7 mg per pound of body weight for minor procedures requiring mild to moderate analgesia, such as repair of lacerations, castrations, and other procedures of short duration. Initial dosages of 6.5 to 7.2 mg per pound of body weight are recommended for ovariohysterectomy and onychectomy. When supplemental doses are required, such individual supplemental doses should be given in increments that are less than the initial dose, and the total dose given (initial dose plus supplemental doses) should not exceed the maximum allowable safe dose of 32.7 mg per pound of body weight.

(2) Indications for use. For restraint or for anesthesia combined with muscle relaxation in cats and in dogs for restraint and minor procedures of short duration (30 minutes) requiring mild to moderate analgesia.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[79 FR 16197, Mar. 25, 2014, as amended at 80 FR 34279, June 16, 2015]

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

Title 21 published on 2015-04-01

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

  • 2015-12-09; vol. 80 # 236 - Wednesday, December 9, 2015
    1. 80 FR 76384 - New Animal Drugs; Approval of New Animal Drug Applications; Withdrawals of Approval of New Animal Drug Applications; Changes of Sponsorship
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendments.
      This rule is effective December 9, 2015, except for the amendments to 21 CFR 520.446, 520.2043, 558.625, and 558.630, which are effective December 21, 2015.
      21 CFR Parts 510, 520, 522, 524, and 558