Composition:
Each ml contains:
- Recombinant human insulin - 40 IU
- Protamine Sulfate - 0.466 mg
- Zinc oxide - 0.088 mg
- glycerin - 16.00 mg
- Dibasic sodium phosphate, heptahydrate - 3.78 mg
- Phenol (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.
Dosage and
Administration: USE OF A SYRINGE OTHER THAN A U-40 SYRINGE WILL RESULT
IN INCORRECT DOSING.
FOR SUBCUTANEOUS INJECTION IN
CATS ONLY.
Federal law restricts this drug to use by or on the order of a licensed
veterinarian
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.
Always provide the Cat
Owner 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 loss were
improved.
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.
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.
Warnings: 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.
Animal Safety:
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.
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.
Reproductive
Safety: 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.
How Supplied:
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.
Storage
Conditions: Store in an upright position under refrigeration at 36-46°F
(2-8°C). Do not freeze. Protect from light.
Boehringer Ingelheim
