ProZinc - Boehringer Ingelheim Vetmedica
Transcription
ProZinc - Boehringer Ingelheim Vetmedica
ProZinc® (protamine zinc recombinant human insulin) Description PROZINC is a protamine zinc insulin that is FDA approved for use in diabetic cats. PROZINC is a sterile injectable suspension supplied in 10-mL multidose vials. Each mL of PROZINC contains 40 IU recombinant human insulin. Advantages Features Benefits PROZINC is a protamine zinc insulin, which has a duration of effect in the cat of 10 — 14 hours1 Contains protamine and zinc Protamine and zinc serve to release insulin slowly over each treatment period to help maintain blood glucose levels throughout the day 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 cats2 Human recombinant insulin source FDA approved for cats and backed by the largest prospective study in diabetic cats3 to date Proven safe and effective for both newly diagnosed and poorly regulated diabetic cats Not subject to sourcing constraints of older, animal-source insulin products, which means a more reliable supply of product Confidence and support from Boehringer Ingelheim Vetmedica, Inc., a trusted partner in managing feline diabetes A versatile solution for a variety of clinical situations Indications PROZINC is indicated for the reduction of hyperglycemia and hyperglycemia-associated clinical signs in cats with diabetes mellitus. Dosage & Administration PROZINC insulin should be mixed by gently rolling the vial prior to withdrawing each dose from the vial. Inject subcutaneously on the back of the neck or on the side of the cat using a U-40 syringe. Use of a syringe other than a U-40 syringe will result in incorrect dosing. 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. Further adjustments in the dosage may be necessary with 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. Any adjustments should be made under a veterinarian’s supervision. Warnings For use in cats only. Keep out of the reach of children. 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. Owners should be advised to observe for signs of hypoglycemia. Use of PROZINC insulin, 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. The safety and effectiveness of PROZINC insulin in kittens and in breeding, pregnant, and lactating cats has not been evaluated. Please refer to package insert for complete product information. Storage Information: Store in an upright position under refrigeration at 36 – 46º F (2 – 8º C). Do not freeze. Protect from light. HIGHLIGHTS •FDA approved for cats •Predictable glycemic control; PROZINC has a duration of action identified by AAHA as appropriate for the majority of diabetic cats4 •Feline specific — backed by the largest prospective study in diabetic cats3 •Human recombinant technology — offers a reliable supply of product Product Information NAME ProZinc® (protamine zinc recombinant human insulin) CODE (449911000) SIZE 10-mL vial Boehringer Ingelheim Vetmedica, Inc. 2621 North Belt Highway St. Joseph, MO 64506-2002 Information 1-866-638-2226 Sales Service 1-800-325-9167 Fax 1-800-318-8366 www.ProZinc.us www.BI-Vetmedica.com PRO0211002 Nelson RW. Disorders of the endocrine pancreas. In: Nelson RW, Couto CG, eds. Small Animal Internal Medicine, 4th ed. St. Louis, MO: Mosby Elsevier; 2009:764-802. 1 Nelson RW, Henley K, Cole C, et al. Field safety and efficacy of protamine zinc recombinant human insulin for the treatment of diabetes mellitus in cats. J Vet Intern Med. 2009;23:787-793. FOI for NADA 141-297. (PROZINC) 4 Rucinsky R, Cook A, Haley S, et al. AAHA diabetes management guidelines for dogs and cats. J Am Anim Hosp Assoc. 2010;46:215-22 2 3