21 C.F.R. § 522.2005 Propofol injection.
Title 21 - Food and Drugs
(a) Specifications. The drug is a sterile, nonpyrogenic, oil-in-water emulsion containing 10 milligrams of propofol per milliliter. (b) Sponsor. See No. 000061 in §510.600(c) of this chapter for use as in paragraphs (c)(1) and (c)(2) of this section. See No. 000074 in §510.600(c) of this chapter for use as in paragraph (c)(1) of this section. (c) Conditions of use—(1) Dogs. (i) The drug is indicated for use as an anesthetic as follows: As a single injection to provide general anesthesia for procedures lasting up to 5 minutes; for induction and maintenance of general anesthesia using incremental doses to effect; for induction of general anesthesia where maintenance is provided by inhalant anesthetics. (ii) The drug is administered by intravenous injection as follows: For induction of general anesthesia without the use of preanesthetics the dosage is 5.5 to 7.0 milligrams per kilogram (2.5 to 3.2 milligrams per pound); for the maintenance of general anesthesia without the use of preanesthetics the dosage is 1.1 to 3.3 milligrams per kilogram (0.5 to 1.5 milligrams per pound). The use of preanesthetic medication reduces propofol dose requirements. (iii) Adequate data concerning safe use of propofol in pregnant and breeding dogs have not been obtained. Doses may need adjustment for geriatric or debilitated patients. Federal law restricts this drug to use by or on the order of a licensed veterinarian. (2) Cats. (i) The drug is indicated for use as an anesthetic as follows: As a single injection to provide general anesthesia for short procedures, for induction and maintenance of general anesthesia using incremental doses to effect, and for induction of general anesthesia where maintenance is provided by inhalant anesthetics. (ii) The drug is administered by intravenous injection as follows: For induction of general anesthesia without the use of preanesthetics the dosage is 8.0 to 13.2 milligrams per kilogram (3.6 to 6.0 milligrams per pound). For the maintenance of general anesthesia without the use of preanesthetics the dosage is 1.1 to 4.4 milligrams per kilogram (0.5 to 2.0 milligrams per pound). The use of preanesthetic medication reduces propofol dose requirements. (iii) Adequate data concerning safe use of propofol in pregnant and breeding cats have not been obtained. Doses may need adjustment for geriatric or debilitated patients. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [61 FR 66582, Dec. 18, 1996, as amended at 62 FR 61625, Nov. 19, 1997; 63 FR 24420, May 4, 1998; 64 FR 13510, Mar. 19, 1999]
Title 21: Food and Drugs
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
§ 522.2005 Propofol injection.
