Prozinc

Generic name: protamine zinc recombinant human insulin injection
Dosage form: FOR ANIMAL USE ONLY

Package Insert for Cats

Prozinc®

(protamine zinc recombinant human insulin)

40 IU/mL

Caution:

Federal law restricts this drug to use by or on the order of a licensed veterinarian.

Description:

Prozinc is a sterile aqueous protamine zinc suspension of recombinant human insulin.

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.

Indication:

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 ONLY.

DO NOT SHAKE OR AGITATE THE VIAL.

Prozinc should be mixed by gently rolling the vial prior to withdrawing each dose from the vial. Once mixed, Prozinc suspension has a white, cloudy appearance. Clumps or visible white particles can form in insulin suspensions: do not use the product if clumps or visible white particles persist after gently rolling 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.

Always provide the Client Information Sheet with each prescription.

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 lo