ProZinc is indicated for the reduction of hyperglycemia and hyperglycemia-associated clinical signs in cats with diabetes mellitus. ProZinc is a protamine zinc insulin that is FDA approved for use in diabetic cats. Efficacy and safety studies demonstrated that ProZinc is effective in controlling hyperglycemia as either an initial treatment for newly diagnosed diabetic cats or as an alternative treatment for poorly regulated diabetic cats.
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Each mL contains:
recombinant human insulin 40 International Units IU
protamine sulfate 0.466 mg
zinc oxide 0.088 mg
glycerin 16.00 mg
dibasic sodium phosphate
heptahydrate 3.78 mg
phenol added as preservative 2.50 mg
hydrochloric acid 1.63 mg water for injection maximum 1005 mg
pH is adjusted with hydrochloric acid and/or sodium hydroxide.
ProZinc protamine zinc recombinant human insulin is indicated for the reduction of hyperglycemia and hyperglycemia-associated clinical signs in cats with diabetes mellitus.
Dosage and Administration:
USE OF A SYRINGE OTHER THAN A U-40 SYRINGE WILL RESULT IN INCORRECT DOSING. FOR SUBCUTANEOUS INJECTION IN CATS ONLY.
ProZinc insulin should be mixed by gently rolling the vial prior to withdrawing each dose from the vial.
Using a U-40 insulin syringe, the injection should be administered subcutaneously on the back of the neck or on the side of the cat.
The initial recommended ProZinc dose is 0.1 - 0.3 IU insulin/pound of body weight 0.2 - 0.7 IU/kg every 12 hours. The dose should be given concurrently with or right after a meal.
The veterinarian should re-evaluate the cat at appropriate intervals and adjust the dose based on both clinical signs and glucose nadirs until adequate glycemic control has been attained. In the effectiveness field study, glycemic control was considered adequate if the glucose nadir from a 9-hour blood glucose curve was between 80 and 150 mg/dL and clinical signs of hyperglycemia such as polyuria, polydipsia, and weight loss were improved.
Further adjustments in the dosage may be necessary with changes in the cat&rsquos diet, body weight, or concomitant medication, or if the cat develops concurrent infection, inflammation, neoplasia, or an additional endocrine or other medical disorder.
ProZinc insulin is contraindicated in cats sensitive to protamine zinc recombinant human insulin or any other ingredients in the ProZinc product. ProZinc insulin is contraindicated during episodes of hypoglycemia.
User Safety: For use in cats only. Keep out of the reach of children. Avoid contact with eyes. In case of contact, immediately flush eyes with running water for at least 15 minutes. Accidental injection may cause hypoglycemia. In case of accidental injection, seek medical attention immediately. Exposure to product may induce a local or systemic allergic reaction in sensitized individuals.
Use of this product, even at established doses, has been associated with hypoglycemia. An animal with signs of hypoglycemia should be treated immediately. Glucose should be given orally or intravenously as dictated by clinical signs. Insulin should be temporarily withheld and, if indicated, the dosage adjusted. Any change in insulin should be made cautiously and only under a veterinarian's supervision. Changes in insulin strength, manufacturer, type, species human, animal or method of manufacture rDNA versus animal-source insulin may result in the need for a change in dosage. Appropriate diagnostic tests should be performed to rule out other endocrinopathies in diabetic cats that are difficult to regulate. Precautions: Animals presenting with severe ketoacidosis, anorexia, lethargy, and/or vomiting should be stabilized with short-acting insulin and appropriate supportive therapy until their condition is stabilized. As with all insulin products, careful patient monitoring for hypoglycemia and hyperglycemia are essential to attain and maintain adequate glycemic control and to prevent associated complications.
Overdosage can result in profound hypoglycemia and death. Progestogens, certain endocrinopathies and glucocorticoids can have an antagonistic effect on insulin activity. Progestogen and glucocorticoid use should be avoided.
The safety and effectiveness of ProZinc insulin in breeding, pregnant, and lactating cats has not been evaluated. Use in Kittens: The safety and effectiveness of ProZinc insulin in kittens has not been evaluated.
Potential adverse reactions include:
hypoglycemia, insulin antagonism/resistance, rapid insulin metabolism, insulin-induced hyperglycemia Somogyi Effect, and local or systemic reactions.
The most common adverse reaction observed is hypoglycemia. Signs may include: weakness, depression, behavioral changes, muscle twitching, and anxiety. In severe cases of hypoglycemia, seizures and coma can occur. Hypoglycemia can be fatal if an affected cat does not receive prompt treatment. Appropriate veterinary monitoring of blood glucose, adjustment of insulin dose and regimen as needed, and stabilization of diet and activity help minimize the risk of hypoglycemic episodes. The attending veterinarian should evaluate other adverse reactions on a case-by-case basis to determine if an adjustment in therapy is appropriate, or if alternative therapy should be considered.
ProZinc insulin is supplied as a sterile injectable suspension in 10 mL multidose vials. Each mL of ProZinc product contains 40 IU recombinant human insulin.
Store in an upright position under refrigeration at 36-46°F 2-8°C.
Do not freeze.
Protect from light.
Manufactured for: Boehringer Ingelheim Vetmedica, Inc., St. Joseph, MO 64506 U.S.A. Manufactured by: AAIPharma Services Corp., Charleston, SC 29405 ProZinc® is a registered trademark of Boehringer Ingelheim Vetmedica, Inc. © 2010 Boehringer Ingelheim Vetmedica, Inc. All Rights Reserved. 449901L-01-1002 Revised 02/2010 Code 449911 NAC No.: 1028175.1