21 CFR 522.2112 - Sometribove zinc suspension.

§ 522.2112 Sometribove zinc suspension.

(a)Specifications. Each single-dose syringe contains 500 milligrams (mg) sometribove zinc in a prolonged-release suspension.

(b)Sponsor. See No. 058198 in § 510.600(c) of this chapter.

(c)Conditions of use -

(1)Amount. Inject 500 mg every 14 days starting during the 9th or 10th week (57 to 70 days) after calving and continue until the end of lactation.

(2)Indications for use. To increase production of marketable milk in healthy lactating dairy cows.

(3)Limitations. Use in lactating dairy cows only. Safety to replacement bulls born to treated dairy cows has not been established. Inject subcutaneously. Avoid injections within 2 weeks of expected slaughter to minimize injection site blemishes on carcass. There is no milk discard or preslaughter withdrawal period. Use may reduce pregnancy rates and increase days open. Treated cows are at an increased risk for mastitis and higher milk somatic cell counts. Use care to differentiate increased body temperature due to use of this product from an increased body temperature that may occur due to illness. Cows treated with this product may have more enlarged hocks and disorders of the foot region. Use may reduce hemoglobin and hematocrit values during treatment. Human warning: Avoid prolonged or repeated contact with eyes and skin.

[ 58 FR 59947, Nov. 12, 1993, as amended at 67 FR 18085, Apr. 15, 2002; 68 FR 62006, Oct. 31, 2003; 74 FR 53164, Oct. 16, 2009; 81 FR 48702, July 26, 2016]

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

Title 21 published on 19-May-2018 03:57

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

  • 2018-04-05; vol. 83 # 66 - Thursday, April 5, 2018
    1. 83 FR 14584 - New Animal Drugs; Approval of New Animal Drug Applications; Changes of Sponsorship; Change of a Sponsor's Name and Address
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule.
      This rule is effective April 5, 2018.
      21 CFR Parts 510, 520, 522, 526, and 558