21 C.F.R. § 522.1160 Insulin.
Title 21 - Food and Drugs
(a) Specifications. Each milliliter of porcine zinc insulin suspension contains 40 international units (IU) of insulin. (b) Sponsor. See No. 057926 in §510.600 of this chapter. (c) Conditions of use in dogs—(1) Amount. (i) Administer by subcutaneous injection. An initial once-daily dose, administered by subcutaneous injection concurrently with or right after a meal, is calculated as follows: (ii) Adjust the once-daily dose described in paragraph (c)(1)(i) of this section at appropriate intervals based on clinical signs, urinalysis results, and glucose curve/spot check values until adequate glycemic control has been attained. Twice-daily therapy should be initiated if the duration of insulin action is determined to be inadequate. If twice-daily treatment is initiated, the two doses should be 25 percent less than the once daily dose required to attain an acceptable nadir. (2) Indications for use. For the reduction of hyperglycemia and hyperglycemia-associated clinical signs in dogs with diabetes mellitus. (3) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian. [69 FR 25827, May 10, 2004]
Title 21: Food and Drugs
PART 522—IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
§ 522.1160 Insulin.
------------------------------------------------------------------------ Body Weight Initial Dose------------------------------------------------------------------------<10 kg\1\ (<22 lb\2\) 1 IU/kg + 1 IU------------------------------------------------------------------------10 to 11 kg (22 to 24 lb) 1 IU/kg + 2 IU------------------------------------------------------------------------12 to 20 kg (25 to 44 lb) 1 IU/kg + 3 IU------------------------------------------------------------------------>20 kg (>44 lb) 1 IU/kg + 4 IU------------------------------------------------------------------------\1\ kg means kilograms.\2\ lb means pounds.
