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ProZinc (Canada)

This page contains information on ProZinc for veterinary use.
The information provided typically includes the following:
  • ProZinc Indications
  • Warnings and cautions for ProZinc
  • Direction and dosage information for ProZinc

ProZinc

This treatment applies to the following species:
Manufacturer: Boehringer

Sterile

Protamine Zinc Recombinant Human Insulin Injectable Suspension

40 IU/mL

Veterinary Use Only

DIN 02405202

Description

ProZinc is a cloudy white injectable suspension. Each mL of ProZinc contains:

Active Ingredient

40 IU recombinant human insulin, USP;

Preservative: Phenol 2.50 mg;

Non-Medicinal Ingredients: Protamine sulfate, zinc oxide, glycerin, dibasic sodium phosphate heptahydrate, hydrochloric acid, sodium hydroxide and water for injection.

ProZinc Indications

ProZinc 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 twice daily on the back of the neck or on the side of the cat.

Always provide the Cat Owner Information Sheet with each prescription.

The initial recommended ProZinc dose is 0.2 - 0.7 IU insulin/kg body weight 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 4.44 and 8.33 mmol/L (80 - 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 if there are changes in the cat’s diet, body weight, or concomitant medication, or if the cat develops concurrent infection, inflammation, neoplasia or an additional endocrine or other medical disorder.

In cats, clinical diabetic remission may be possible. It is important to monitor for signs of hypoglycemia and make dosage adjustments accordingly.

Contraindications

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.

Cautions:

FOR SUBCUTANEOUS INJECTION IN CATS ONLY.

The safety and effectiveness of ProZinc insulin in kittens or breeding, pregnant or lactating cats has not been evaluated.

Owners should be advised to observe for signs of hypoglycemia (see Cat Owner Information Sheet). 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.

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.

Progestogens, certain endocrinopathies and glucocorticoids can have an antagonistic effect on insulin activity. Progestogen and glucocorticoid use should be avoided.

Warnings

Keep out of 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.

Adverse Reactions

ProZinc insulin, like other insulin products, is not free from adverse reactions. Owners should be advised of the potential for adverse reactions and be informed of the associated clinical signs (See Cat Owner Information Sheet).

Potential adverse reactions include: hypoglycemia, insulin antagonism/resistance, rapid insulin metabolism, insulin-induced hyperglycemia (Somogyi Effect) and local or systemic reactions.

Hypoglycemia can occur at the prescribed dose or following an overdose (see Overdose section below). In mild cases; offer the animal its usual food. Signs may include: weakness, depression, behavioral changes, muscle twitching and anxiety. More serious symptoms can be treated with immediate administration of a glucose solution. Without prompt treatment, severe cases of hypoglycemia can progress to seizures, coma and death.

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 adverse reactions on a case-by-case basis to determine if an adjustment in therapy is appropriate or if alternative therapy should be considered.

Local injection site reactions were very rarely reported and resolved without cessation of therapy.

Overdose:

An overdose of insulin can result in hypoglycemia. If a cat is given an overdose of insulin (or an overdose is suspected), it should be examined by a Veterinarian immediately.

Efficacy Study Information:

45 Day Effectiveness Field Study:

A total of 187 client-owned cats were enrolled in a 45-day field study, with 176 receiving ProZinc insulin. One hundred and fifty-one (151) cats were included in the effectiveness analysis. The patients included various purebred and mixed breed cats ranging in age from 3 to 19 years and in weight from 2.1 to 9.4 kg. Of the cats included in the effectiveness analysis, 101 were castrated males, 49 were spayed females, and 1 was an intact female.

Cats were started on ProZinc insulin at a dose of 0.2 - 0.7 IU/kg twice daily. Cats were evaluated at 7, 14, 30, and 45 days after initiation of therapy and the dose was adjusted based on clinical signs and results of the glucose nadir from 9-hour blood glucose curves on Days 7, 14, and 30.

Effectiveness was based on successful control of diabetes which was defined as improvements in at least one blood glucose variable (glucose curve mean, nadir or fructosamine) and at least one clinical sign (polyuria, polydipsia or body weight). Of the 151 cats, 115 (76.2%) were considered successful. Blood glucose curve means decreased from 23.07 mmol/L (415.3 mg/dL) on Day 0 to 11.29 mmol/L (203.2 mg/dL) by Day 45 and the mean blood glucose nadir decreased from 22.66 mmol/L (407.9 mg/dL) on Day 0 to 7.91 mmol/L (142.4 mg/dL) on Day 45. Mean fructosamine values decreased from 505.9 µmol/L on Day 0 to 380.7 µmol/L on Day 45.

136 Day Extended Use Field Study

Cats that completed the effectiveness study were eligible to enroll in an extended use field study. In this study 145 cats received ProZinc insulin for up to an additional 136 days. The mean fructosamine value was 342.0 µmol/L after a total of 181 days of ProZinc therapy.

Storage

Store upright at 2-8°C. Do not freeze. Protect from light.

Presentation:

10 mL multi-dose vials.

Boehringer Ingelheim (Canada) Ltd., 5180 South Service Road, Burlington, ON L7L 5H4

Revised: 03-2013

449906-00

NAC No.: 1230137.0

BOEHRINGER INGELHEIM (CANADA) LTD.
5180 SOUTH SERVICE ROAD, BURLINGTON, ON, L7L 5H4
Customer Care No.:   800-567-1885
Technical Services No.:   1-877-565-5501
Website:   www.boehringer-ingelheim.ca
Every effort has been made to ensure the accuracy of the ProZinc information published above. However, it remains the responsibility of the readers to familiarize themselves with the product information contained on the Canadian product label or package insert.

Copyright © 2016 North American Compendiums. Updated: 2016-08-21

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