INFORMATION FOR THE PATIENT
10 mL Vial

WARNINGS

THIS LILLY HUMAN INSULIN PRODUCT DIFFERS FROM ANIMAL–SOURCE INSULINS BECAUSE IT IS STRUCTURALLY IDENTICAL TO THE INSULIN PRODUCED BY YOUR BODY’S PANCREAS AND BECAUSE OF ITS UNIQUE MANUFACTURING PROCESS.

ANY CHANGE OF INSULIN SHOULD BE MADE CAUTIOUSLY AND ONLY UNDER MEDICAL SUPERVISION. CHANGES IN STRENGTH, MANUFACTURER, TYPE (E.G., REGULAR, NPH, ANALOG), SPECIES, OR METHOD OF MANUFACTURE MAY RESULT IN THE NEED FOR A CHANGE IN DOSAGE.

SOME PATIENTS TAKING HUMULIN® (HUMAN INSULIN, rDNA ORIGIN) MAY REQUIRE A CHANGE IN DOSAGE FROM THAT USED WITH OTHER INSULINS. IF AN ADJUSTMENT IS NEEDED, IT MAY OCCUR WITH THE FIRST DOSE OR DURING THE FIRST SEVERAL WEEKS OR MONTHS.

DIABETES

Insulin is a hormone produced by the pancreas, a large gland that lies near the stomach. This hormone is necessary for the body’s correct use of food, especially sugar. Diabetes occurs when the pancreas does not make enough insulin to meet your body’s needs.

To control your diabetes, your doctor has prescribed injections of insulin products to keep your blood glucose at a near–normal level. You have been instructed to test your blood and/or your urine regularly for glucose. Studies have shown that some chronic complications of diabetes such as eye disease, kidney disease, and nerve disease can be significantly reduced if the blood sugar is maintained as close to normal as possible. The American Diabetes Association recommends that if your pre–meal glucose levels are consistently above 130 mg/dL or your hemoglobin A1c (HbA1c) is more than 7%, you should talk to your doctor. A change in your diabetes therapy may be needed. If your blood tests consistently show below–normal glucose levels, you should also let your doctor know. Proper control of your diabetes requires close and constant cooperation with your doctor. Despite diabetes, you can lead an active and healthy life if you eat a balanced diet, exercise regularly, and take your insulin injections as prescribed by your doctor.

Always keep an extra supply of insulin as well as a spare syringe and needle on hand. Always wear diabetic identification so that appropriate treatment can be given if complications occur away from home.

NPH HUMAN INSULIN

Description

Humulin is synthesized in a special non–disease–producing laboratory strain of Escherichia coli bacteria that has been genetically altered to produce human insulin. Humulin N [Human insulin (rDNA origin) isophane suspension] is a crystalline suspension of human insulin with protamine and zinc providing an intermediate-acting insulin with a slower onset of action and a longer duration of activity (up to 24 hours) than that of Regular human insulin. The time course of action of any insulin may vary considerably in different individuals or at different times in the same individual. As with all insulin preparations, the duration of action of Humulin N is dependent on dose, site of injection, blood supply, temperature, and physical activity. Humulin N is a sterile suspension and is for subcutaneous injection only. It should not be used intravenously or intramuscularly. The concentration of Humulin N is 100 units/mL (U–100).

Identification

Human insulin from Eli Lilly and Company has the trademark Humulin. Your doctor has prescribed the type of insulin that he/she believes is best for you.

DO NOT USE ANY OTHER INSULIN EXCEPT ON YOUR DOCTOR’S ADVICE AND DIRECTION.

Always check the carton and the bottle label for the name and letter designation of the insulin you receive from your pharmacy to make sure it is the same as prescribed by your doctor.

Always check the appearance of your bottle of Humulin N before withdrawing each dose. Before each injection the Humulin N bottle must be carefully shaken or rotated several times to completely mix the insulin. Humulin N suspension should look uniformly cloudy or milky after mixing. If not, repeat the above steps until contents are mixed. Do not use Humulin N:

• if the insulin substance (the white material) remains at the bottom of the bottle after mixing or

• if there are clumps in the insulin after mixing, or

• if solid white particles stick to the bottom or wall of the bottle, giving a frosted appearance.

If you see anything unusual in the appearance of Humulin N suspension in your bottle or notice your insulin requirements changing, talk to your doctor.

Storage

Not in-use (unopened): Humulin N bottles not in-use should be stored in a refrigerator, but not in the freezer.

In-use (opened): The Humulin N bottle you are currently using can be kept unrefrigerated as long as it is kept as cool as possible [below 86°F (30°C)] away from heat and light.

Do not use Humulin N after the expiration date stamped on the label or if it has been frozen.

INSTRUCTIONS FOR INSULIN VIAL USE

NEVER SHARE NEEDLES AND SYRINGES.

Correct Syringe Type

Doses of insulin are measured in units. U–100 insulin contains 100 units/mL (1 mL=1 cc). With Humulin N, it is important to use a syringe that is marked for U–100 insulin preparations. Failure to use the proper syringe can lead to a mistake in dosage, causing serious problems for you, such as a blood glucose level that is too low or too high.

Syringe Use

To help avoid contamination and possible infection, follow these instructions exactly.

Disposable syringes and needles should be used only once and then discarded by placing the used needle in a puncture-resistant disposable container. Properly dispose of the puncture-resistant container as directed by your Health Care Professional.

Preparing the Dose

1. Wash your hands.

2. Carefully shake or rotate the bottle of insulin several times to completely mix the insulin.

3. Inspect the insulin. Humulin N suspension should look uniformly cloudy or milky. Do not use Humulin N if you notice anything unusual in its appearance.

4. If using a new Humulin N bottle, flip off the plastic protective cap, but do not remove the stopper. Wipe the top of the bottle with an alcohol swab.

5. If you are mixing insulins, refer to the “Mixing Humulin N and Regular Human Insulin” section below.

6. Draw an amount of air into the syringe that is equal to the Humulin N dose. Put the needle through rubber top of the Humulin N bottle and inject the air into the bottle.

7. Turn the Humulin N bottle and syringe upside down. Hold the bottle and syringe firmly in one hand and shake gently.

8. Making sure the tip of the needle is in the Humulin N suspension, withdraw the correct dose of Humulin N into the syringe.

9. Before removing the needle from the Humulin N bottle, check the syringe for air bubbles. If bubbles are present, hold the syringe straight up and tap its side until the bubbles float to the top. Push the bubbles out with the plunger and then withdraw the correct dose.

10. Remove the needle from the bottle and lay the syringe down so that the needle does not touch anything.

11. If you do not need to mix your Humulin N with Regular human insulin, go to the “Injection Instructions” section below and follow the directions.

Mixing Humulin N and Regular Human Insulin (Humulin R)