21CFR522.2005

(a) Specifications. Each milliliter of emulsion contains 10 milligrams (mg) propofol. (b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter . (c) Conditions of use in dogs — (d) Conditions of use in cats — (1) No. 086064 for use as in paragraphs (c)(1) , (c)(2)(i) , (c)(3) , (d)(1) , (d)(2)(i) , and (d)(3) of this section. (2) No. 054771 for use as in paragraphs (c)(1) , (c)(2)(ii) , (c)(3) , (d)(1) , (d)(2)(ii) , and (d)(3) of this section. (3) Nos. 054771 and 068504 for use as in paragraphs (c)(1) , (c)(2)(iii) , and (c)(3) of this section. (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; and for induction of general anesthesia where maintenance is provided by inhalant anesthetics. (ii) For induction of general anesthesia; for maintenance of anesthesia for up to 20 minutes; and for induction of general anesthesia followed by maintenance with an inhalant anesthetic. (iii) For induction and maintenance of general anesthesia; and for induction of general 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. (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; and for induction of general anesthesia where maintenance is provided by inhalant anesthetics. (ii) For induction and maintenance of general anesthesia; and for induction of general 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.