21 CFR 522.2100 - Selenium, vitamin E injection.

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There are 3 Updates appearing in the Federal Register for 21 CFR 522. View below or at eCFR (GPOAccess)
§ 522.2100 Selenium, vitamin E injection.
(a)
(1) Specifications. The drug is an emulsion containing in each milliliter, 5.48 milligrams sodium selenite (equivalent to 2.5 milligrams selenium), 50 milligrams of vitamin E (68 I.U.) (as d-alpha tocopheryl acetate).
(2) Sponsor. See No. 000061 in § 510.600(c) of this chapter.
(3) Conditions of use.
(i) The drug is intended for use for the prevention and treatment of selenium-tocopherol deficiency syndrome in horses.
(ii) The drug is administered by intravenous or deep intramuscular injection in divided doses in 2 or more sites in the gluteal or cervical muscles at a dosage level of 1 milliliter per 100 pounds of body weight and may be repeated at 5 to 10 day intervals.
(iii) Do not use in horses intended for food.
(iv) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(b)
(1) Specifications. The drug contains in each milliliter 2.19 milligrams of sodium selenite (equivalent to 1 milligram of selenium), 50 milligrams of vitamin E (68 I.U.) (as d-alpha tocopheryl acetate).
(2) Sponsor. See No. 000061 in § 510.600(c) of this chapter.
(3) Conditions of use.
(i) The drug is intended for use as an aid in alleviating and controlling inflammation, pain and lameness associated with certain arthropathies in dogs.
(ii) The drug is administered subcutaneously or intramuscularly in divided doses in 2 or more sites at a dosage level of 1 milliliter per 20 pounds of body weight with a minimum dosage of 1/4 milliliter and a maximum dosage of 5 milliliters. The dosage is repeated at 3 day intervals until a satisfactory therapeutic response is observed. A maintenance regimen is then initiated which consists of 1 milliliter per 40 pounds of body weight with a minimum dosage of 1/4 milliliter which is repeated every 3 days or 7 days, or longer, as required to maintain continued improvement or an asymptomatic condition; or the drug may be used in capsule form for oral maintenance therapy.
(iii) Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(c)
(1) Specifications. Each milliliter contains 2.19 milligrams of selenite sodium (equivalent to 1 milligram selenium), 50 milligrams vitamin E (68 U.S.P. units).
(2) Sponsor. See No. 000061 in § 510.600(c) of this chapter.
(3) Conditions of use—
(i) Dosage. Calves: 2.5 to 3.75 milliliters per 100 pounds of body weight. Lambs 2 weeks of age or older: 1 milliliter per 40 pounds, minimum 1 milliliter. Ewes: 2.5 milliliters per 100 pounds. Sows: 1 milliliter per 40 pounds. Weanling pigs: 1 milliliter per 40 pounds, minimum 1 milliliter.
(ii) Indications for use. Calves, lambs, and ewes: prevention and treatment of white muscle disease (selenium-tocopherol deficiency syndrome). Sows and weanling pigs: an aid in the prevention and treatment of selenium-tocopherol deficiency.
(iii) Limitations. For subcutaneous or intramuscular use. Not for use in newborn pigs. Do not use in pregnant ewes. Calves: Discontinue use 30 days before treated calves are slaughtered for human consumption. Lambs, ewes, sows, or pigs: Discontinue use 14 days before treated lambs, ewes, sows, or pigs are slaughtered for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(d)
(1) Specifications. Each milliliter contains 10.95 milligrams selenite sodium (equivalent to 5 milligrams selenium), 50 milligrams vitamin E (68 U.S.P. units).
(2) Sponsor. See Nos. 000061 and 000856 in § 510.600(c) of this chapter.
(3) Conditions of use—
(i) Dosage. Breeding beef cows: 1 milliliter per 200 pounds of body weight during the middle third of gestation, and 30 days before calving. Weanling calves: 1 milliliter per 200 pounds of body weight.
(ii) Indications for use. Weanling calves and breeding beef cows: For the prevention and treatment of selenium-tocopherol deficiency syndrome.
(iii) Limitations. For subcutaneous or intramuscular use. Discontinue use 30 days before treated cattle are slaughtered for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
(e)
(1) Specifications. Each milliliter contains 0.55 milligram selenite sodium (equivalent to 0.25 milligram selenium), 50 milligrams (68 U.S.P. units) vitamin E.
(2) Sponsor. See No. 000061 in § 510.600(c) of this chapter.
(3) Conditions of use—
(i) Dosage. Newborn lambs: 1 milliliter. Lambs 2 weeks of age or older: 4 milliliters. Baby pigs: 1 milliliter (or treat the sow during the last week of pregnancy).
(ii) Indications for use. Lambs: for prevention and treatment of white muscle disease (selenium-tocopherol deficiency syndrome). Baby pigs: an aid in the prevention and treatment of selenium-tocopherol deficiency.
(iii) Limitations. For subcutaneous or intramuscular use only. Discontinue use 14 days before treated animals are slaughtered for human consumption. Federal law restricts this drug to use by or on the order of a licensed veterinarian.
[40 FR 13858, Mar. 27, 1975, as amended at 52 FR 7832, Mar. 13, 1987; 57 FR 21209, May 19, 1992; 58 FR 57556, Oct. 26, 1993; 60 FR 57833, Nov. 22, 1995; 64 FR 27916, May 24, 1999]

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.

  • 2014-07-31; vol. 79 # 147 - Thursday, July 31, 2014
    1. 79 FR 44277 - New Animal Drugs; Bacitracin Methylene Disalicylate; Dinoprost Solution; Gonadorelin Hydrochloride; Progesterone Intravaginal Inserts; Salinomycin; Ractopamine; Tylosin
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendment.
      This rule is effective July 31, 2014.
      21 CFR Parts 520, 522, 529, and 558

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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.

  • 2014-07-31; vol. 79 # 147 - Thursday, July 31, 2014
    1. 79 FR 44277 - New Animal Drugs; Bacitracin Methylene Disalicylate; Dinoprost Solution; Gonadorelin Hydrochloride; Progesterone Intravaginal Inserts; Salinomycin; Ractopamine; Tylosin
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule; technical amendment.
      This rule is effective July 31, 2014.
      21 CFR Parts 520, 522, 529, and 558