PRODUCT DESCRIPTION

This vial contains Novolin® N commonly known as NPH, Human Insulin Isophane Suspension (recombinant DNA origin). The concentration of this product is 100 units of insulin per milliliter. It is a cloudy or milky suspension of human insulin with protamine and zinc. The insulin substance (the cloudy material) settles at the bottom of the vial, therefore, the vial must be gently agitated or rotated so that the contents are uniformly mixed before a dose is withdrawn. Novolin® N has an intermediate duration of action. The effect of Novolin® N begins approximately 1 1 / 2 hours after injection. The effect is maximal between 4 and 12 hours. The full duration of action may last up to 24 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® N if the precipitate (the white deposit at the bottom of the vial) has become lumpy or granular in appearance or has formed a deposit of solid particles on the wall of the vial. This insulin should not be used if the liquid in the vial remains clear after the vial has been gently agitated.

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

MIXING TWO TYPES OF INSULIN

Different insulins should be mixed only under instruction from a physician. Hypodermic syringes may vary in the amount of space between the bottom line and the needle ("dead space"), so if you are mixing two types of insulin be sure to discuss any change in the model and brand of syringe you are using with your physician or pharmacist. When you are mixing two types of insulin, always draw the Regular (clear) insulin into the syringe first.

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: Important Notes.

HOW SUPPLIED

Vials, U-100, 100 units/mL, 10 mL, (List No. 183411) (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

PRODUCT PHOTO(S):

NOTE: These photos can be used only for identification by shape, color, and imprint. They do not depict actual or relative size.

The product samples shown here have been supplied by the manufacturer and reproduced in full color by PDR as a quick-reference identification aid. While every effort has been made to assure accurate reproduction, please remember that any visual identification should be considered preliminary. In cases of poisoning or suspected overdosage, the drug's identity should be verified by chemical analysis.

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