21 CFR 522.2610 - Trimethoprim and sulfadiazine.

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There are 5 Updates appearing in the Federal Register for 21 CFR 522. View below or at eCFR (GPOAccess)
§ 522.2610 Trimethoprim and sulfadiazine.
(a) Specifications. Each milliliter (mL) contains:
(1) 40 milligrams (mg) trimethoprim suspended in a solution containing 200 mg sulfadiazine; or
(2) 80 mg trimethoprim suspended in a solution containing 400 mg sulfadiazine (as the sodium salt).
(b) Sponsors. See Nos. 000061 and 054771 in § 510.600(c) of this chapter.
(c) Conditions of use—
(1) Dogs—(i) Amount. 1 mL of the product described in paragraph (a)(1) of this section (40 mg trimethoprim and 200 mg sulfadiazine) per 20 pounds (9 kilograms) of body weight per day by subcutaneous injection.
(ii) Indications for use. For the treatment of acute urinary tract infections, acute bacterial complications of distemper, acute respiratory tract infections, acute alimentary tract infections, and acute septicemia due to Streptococcus zooepidemicus.
(iii) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(2) Horses—
(i) Amount. 2 mL of the product described in paragraph (a)(2) of this section (160 mg trimethoprim and 800 mg sulfadiazine) per 100 pounds (45 kilograms) of body weight per day by intravenous injection as single, daily dose for 5 to 7 days. The daily dose may also be halved and given morning and evening.
(ii) Indications for use. For use where systemic antibacterial action against sensitive organisms is required during treatment of acute strangles, respiratory tract infections, acute urogenital infections, and wound infections and abscesses.
(iii) Limitations. Do not use in horses intended for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[71 FR 30803, May 31, 2006, as amended at 79 FR 16197, Mar. 25, 2014]

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