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d 0.5

33

0.5 < d <1.0

149

1.0 d <1.5

59

d > 1.5

12

Total doses

253

182

71

253

At a ratio of more than 2.5:1, the majority of VETSULIN doses administered were less than 1.0 IU/kg compared to doses of 1.0 IU/kg or more.

The starting dose of insulin varies significantly from the dose that achieves acceptable control of hyperglycemia and hyperglycemia-associated clinical signs. The goal at therapy initiation is to establish significant control of diabetic signs while avoiding hypoglycemia. Although insulin treatment varies between patients and for an individual patient over time due to differences in physiological state, concurrent disease conditions, endogenous insulin production, diet, and /or exercise, review of the existing field study data and the literature cited support 0.5 IU/kg of VETSULIN as a safe and effective starting dose.

Cat

The starting dose of insulin may vary significantly from the dose that achieves acceptable control of hyperglycemia and hyperglycemia-associated clinical signs. The goal at therapy initiation is to establish significant control of diabetic signs while avoiding hypoglycemia. Initial insulin zinc suspension dose rates for cats of 1 to 2 IU per injection given every twelve hours are reported in the literature. 8, 14

Exogenous insulin is customarily classified as fast-, intermediate-, or long-acting. These characteristics are primarily dependent on the absorption rate from the injection site, which is generally varied by the addition of protamine (PZI and NPH insulin) or variation in crystal size (IZS and extended IZS insulin). VETSULIN (Insulin zinc suspension porcine) is classified as an intermediate-acting insulin. In cats, the peak activity following subcutaneous administration of VETSULIN occurs between 1.5 and 8 hours, and the duration of activity varies between 8 and 12 hours. 16

B. Substantial Evidence:

Dog

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