PRODUCT DESCRIPTION

This vial contains Novolin® R , commonly known as Regular, Human Insulin Injection (recombinant DNA origin). The concentration of this product is 100 units of insulin per milliliter. It is a clear, colorless solution which has a short duration of action. The effect of Novolin® R begins approximately ¹ / ₂ hour after injection. The effect is maximal between 2 ¹ / ₂ and 5 hours and ends approximately 8 hours after injection. The time course of action of any insulin may vary considerably in different individuals or at different times in the same individual. Because of this variation, the time periods listed here should be considered as general guidelines only.

This human insulin (recombinant DNA origin) is structurally identical to the insulin produced by the human pancreas. This human insulin is produced by recombinant DNA technology utilizing Saccharomyces cerevisiae (bakers' yeast) as the production organism.

STORAGE

Insulin should be stored in a cold place, preferably in a refrigerator, but not in the freezing compartment. Do not let it freeze. Keep the insulin vial in its carton so that it will stay clean and protected from light. If refrigeration is not possible, the bottle of insulin which you are currently using can be kept unrefrigerated as long as it is kept as cool as possible and away from heat and sunlight.

Never use Novolin® R if it becomes viscous (thickened) or cloudy; use it only if it is clear and colorless.

Never use insulin after the expiration date which is printed on the vial label and carton.

MIXING TWO TYPES OF INSULIN-- SEE NOVOLIN® N.

IMPORTANT NOTES

1. Due to risk of precipitation in some pump catheters, Novolin® R is not recommended for use in insulin pumps.
2. A change in the type, strength, species or purity of insulin could require a dosage adjustment. Any change in insulin should be made under medical supervision.
3. You may have learned how to test your urine or your blood for glucose. It is important to do these tests regularly and to record the results for review with your physician or nurse educator.
4. If you have an acute illness, especially with vomiting or fever, continue taking your insulin. If possible, stay on your regular diet. If you have trouble eating, drink fruit juices, regular soft drinks, or clear soups; if you can, eat small amounts of bland foods. Test your urine for glucose and ketones and, if possible, test your blood glucose. Note the results and contact your physician for possible insulin dose adjustment. If you have severe and prolonged vomiting, seek emergency medical care.
5. You should always carry identification which states that you have diabetes.
6. Always ask your physician or pharmacist before taking any drug.

Always consult your physician if you have any questions about your condition or the use of insulin.

See Novolin® 70/30 for complete package insert information on Warning: Insulin use in Diabetes: Types of Insulin: Syringes: Important: Preparing the Injection: Giving the Injection: Usage in Pregnancy: Insulin Reaction and Shock: Diabetic Ketoacidosis and Coma: Adverse Reactions.

HOW SUPPLIED

Vials, U-100, 100 units/mL, 10 mL, (List No. 183311) (1's)

Manufactured by: Novo Nordisk A/S, DK 2880 Bagsvaerd, Denmark and by Novo Nordisk Pharmaceutical Industries, Inc., 3612 Powhatan Road, Clayton, NC. 27520

Date of Issue: February 1999