Code of Federal Regulations (alpha)

CFR /  Title 21  /  Part 522  /  Sec. 522.2005 Propofol.

(a) Specifications. Each milliliter of emulsion contains 10 milligrams (mg) propofol.

(b) Sponsors. See sponsor numbers in Sec. 510.600(c) of this chapter.

(1) No. 000859 for use as in paragraphs (c)(1), (c)(2)(i), and (c)(3) of this section.

(2) No. 000044 for use as in paragraphs (c)(1), (c)(2)(i), and (c)(3) of this section.

(3) No. 054771 for use as in paragraphs (c)(1), (c)(2)(ii), and (c)(3) of this section.

(c) Conditions of use in dogs and cats--(1) Amount. Administer by intravenous injection according to label directions. The use of preanesthetic medication reduces propofol dose requirements.

(1) Amount. Administer by intravenous injection according to label directions. The use of preanesthetic medication reduces propofol dose requirements.

(2) Indications for use--(i) As a single injection to provide general anesthesia for short procedures; for induction and maintenance of general anesthesia using incremental doses to effect; for induction of general anesthesia where maintenance is provided by inhalant anesthetics.

(i) As a single injection to provide general anesthesia for short procedures; 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) For the induction and maintenance of anesthesia and for induction of anesthesia followed by maintenance with an inhalant anesthetic.

(3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [75 FR 20269, Apr. 19, 2010, as amended at 75 FR 38700, July 6, 2010; 78 FR 17868, Mar. 25, 2013; 79 FR 16195, Mar. 25, 2014]