INFORMATION FOR THE PATIENT
THIS LILLY HUMAN INSULIN PRODUCT DIFFERS FROM ANIMAL-SOURCE INSULINS BECAUSE IT IS STRUCTURALLY IDENTICAL TO THE INSULIN PRODUCED BY YOUR BODY' 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, LENTE, ETC), SPECIES (BEEF, PORK, BEEF-PORK, HUMAN), OR METHOD OF MANUFACTURE (rDNA VERSUS ANIMAL-SOURCE INSULIN) 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 ANIMAL-SOURCE INSULINS. IF AN ADJUSTMENT IS NEEDED, IT MAY OCCUR WITH THE FIRST DOSE OR DURING THE FIRST SEVERAL WEEKS OR MONTHS.
TO OBTAIN AN ACCURATE DOSE, CAREFULLY READ AND FOLLOW THE INSULIN DELIVERY DEVICE ("INSULIN PEN") MANUFACTURER'S INSTRUCTIONS AND THIS INFORMATION FOR THE PATIENT INSERT BEFORE USING THIS PRODUCT IN AN INSULIN PEN. ( see INSTRUCTIONS FOR USE section
Insulin is a hormone produced by the pancreas, a large gland that lies near the stomach. This hormone is necessary for the body' correct use of food, especially sugar. Diabetes occurs when the pancreas does not make enough insulin to meet your body' needs.
To control your diabetes, your doctor has prescribed injections of insulin to keep your blood glucose at a nearly normal level. Proper control of your diabetes requires close and constant cooperation with your doctor. In spite of diabetes, you can lead an active, healthy, and useful life if you eat a balanced diet daily, exercise regularly, and take your insulin injections as prescribed.
You have been instructed to test your blood and/or your urine regularly for glucose. If your blood tests consistently show above- or below-normal glucose levels or your urine tests consistently show the presence of glucose, your diabetes is not properly controlled and you must let your doctor know.
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.
Humulin is synthesized in a non-disease-producing special laboratory strain of Escherichia coli bacteria that has been genetically altered by the addition of the human gene for insulin production. Humulin® 70/30 is a mixture of 70% Human Insulin Isophane Suspension and 30% Human Insulin Injection. It is an intermediate-acting insulin combined with the more rapid onset of action of regular insulin. The duration of activity may last up to 24 hours following injection. 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 70/30 is dependent on dose, site of injection, blood supply, temperature, and physical activity. Humulin 70/30 is a sterile suspension and is for subcutaneous injection only. It should not be used intravenously or intramuscularly. The concentration of Humulin 70/30 in cartridges is 100 units/mL (U-100).
Cartridges of Humulin manufactured by Eli Lilly and Company are available in 3 formulations--Regular, NPH, and 70/30.
Your doctor has prescribed the type of insulin that he/she believes is best for you. DO NOT USE ANY OTHER INSULIN EXCEPT ON HIS/HER ADVICE AND DIRECTION.
Cartridges of Humulin 70/30, 1.5 mL, are available in boxes of 5. The cartridge containing Humulin 70/30 is not designed to allow any other insulin to be mixed in the cartridge or for the cartridge to be reused.
1.5 mL Cartridge
Humulin® 70/30 1.5 mL cartridges are for use in Becton Dickinson and Company's B-D® Pen and Novo Nordisk A/S's NovoPen®, NovolinPen®, and NovoPen® 1.5 insulin delivery devices.
Always examine the appearance of a cartridge of insulin before administering a dose. A cartridge of Humulin 70/30 contains a small glass bead to assist in mixing. A cartridge of Humulin 70/30 must be rolled between the palms 10 times and inverted 180° 10 times before each injection so that the contents are uniformly mixed ( see Figures 1 and 2). Before inserting it in the insulin pen, inspect the cartridge for uniform mixing and repeat the above steps as necessary.
Humulin 70/30 should look uniformly cloudy or milky after mixing. Do not use if the insulin substance (the white material) remains visibly separated from the liquid after mixing. Do not use a cartridge of Humulin 70/30 if there are clumps in the insulin after mixing ( see Figure 3). Do not use a cartridge of Humulin 70/30 if solid white particles stick to the walls of the cartridge, giving it a frosted appearance ( see Figure 4).
Always check the appearance of the cartridge before using, and if you note anything unusual in the appearance of your insulin or notice your insulin requirements changing markedly, consult your doctor.
Insulin cartridges should be stored in a refrigerator but not in the freezer. The insulin pen and cartridge of insulin that you are currently using should not be refrigerated but should be kept as cool as possible (below 86°F [30°C]) and away from heat and light. Do not use insulin if it has been frozen. Unrefrigerated 1.5 mL cartridges must be discarded after 1 week , even if they still contain insulin. Do not use a cartridge of Humulin 70/30 after the expiration date stamped on the label.
Pens for insulin delivery differ in their operation. It is important to read, understand, and follow the instructions for use of the particular insulin pen you are using.
NEVER SHARE INSULIN PENS, CARTRIDGES, OR NEEDLES.
Your doctor has told you which insulin to use, how much, and when and how often to inject it. Because each patient' case of diabetes is different, this schedule has been individualized for you.
Your usual insulin dose may be affected by changes in your food, activity, or work schedule. Carefully follow your doctor' instructions to allow for these changes. Other things that may affect your insulin dose are:
Illness, especially with nausea and vomiting, may cause your insulin requirements to change. Even if you are not eating, you will still require insulin. You and your doctor should establish a sick day plan for you to use in case of illness. When you are sick, test your blood glucose/urineglucose and ketones frequently and call your doctor as instructed.
Good control of diabetes is especially important for you and your unborn baby. Pregnancy may make managing your diabetes more difficult. If you are planning to have a baby, are pregnant, or are nursing a baby, consult your doctor.
Insulin requirements may be increased if you are taking other drugs with hyperglycemic activity, such as oral contraceptives, corticosteroids, or thyroid replacement therapy. Insulin requirements may be reduced in the presence of drugs with hypoglycemic activity, such as oral hypoglycemics, salicylates (for example, aspirin), sulfa antibiotics, and certain antidepressants. Always discuss any medications you are taking with your doctor.
Exercise may lower your body' need for insulin during and for some time after the activity. Exercise may also speed up the effect of an insulin dose, especially if the exercise involves the area of injection site (for example, the leg should not be used for injection just prior to running). Discuss with your doctor how you should adjust your regimen to accommodate exercise.
Persons traveling across more than 2 time zones should consult their doctor concerning adjustments in their insulin schedule.
Hypoglycemia (too little glucose in the blood) is one of the most frequent adverse events experienced by insulin users. It can be brought about by:
Symptoms of mild to moderate hypoglycemia may occur suddenly and can include:
Signs of severe hypoglycemia can include:
Therefore, it is important that assistance be obtainedimmediately.
Early warning symptoms of hypoglycemia may be different or less pronounced under certain conditions, such as long duration of diabetes, diabetic nerve disease, medications such as beta-blockers, change in insulin preparations, orintensified control (3 or more insulin injections per day)of diabetes.
A few patients who have experienced hypoglycemic reactions after transfer from animal-source insulin to human insulin have reported that the early warning symptoms of hypoglycemia were less pronounced or different from those experienced with their previous insulin.
Without recognition of early warning symptoms, you may not be able to take steps to avoid more serious hypoglycemia. Be alert for all of the various types of symptoms that may indicate hypoglycemia. Patients who experience hypoglycemia without early warning symptoms should monitor their blood glucose frequently, especially prior to activities such as driving. If the blood glucose is below your normal fasting glucose, you should consider eating or drinkingsugar-containing foods to treat your hypoglycemia.
Mild to moderate hypoglycemia may be treated by eating foods or drinks that contain sugar. Patients should always carry a quick source of sugar, such as candy mints or glucose tablets. More severe hypoglycemia may require the assistance of another person. Patients who are unable to take sugar orally or who are unconscious require an injection of glucagon or should be treated with intravenous administration of glucose at a medical facility.
You should learn to recognize your own symptoms of hypoglycemia. If you are uncertain about these symptoms, you should monitor your blood glucose frequently to help you learn to recognize the symptoms that you experience with hypoglycemia.
If you have frequent episodes of hypoglycemia or experience difficulty in recognizing the symptoms, you should consult your doctor to discuss possible changes in therapy, meal plans, and/or exercise programs to help you avoidhypoglycemia.
Hyperglycemia (too much glucose in the blood) may develop if your body has too little insulin. Hyperglycemia can be brought about by:
In patients with insulin-dependent diabetes, prolonged hyperglycemia can result in diabetic acidosis. The first symptoms of diabetic acidosis usually come on gradually, over a period of hours or days, and include a drowsy feeling, flushed face, thirst, loss of appetite, and fruity odor on the breath. With acidosis, urine tests show large amounts of glucose and acetone. Heavy breathing and a rapid pulse are more severe symptoms. If uncorrected, prolonged hyperglycemia or diabetic acidosis can lead to nausea, vomiting, dehydration, loss of consciousness or death. Therefore, it is important that you obtain medical assistance immediately.
Rarely, administration of insulin subcutaneously can result in lipoatrophy (depression in the skin) or lipohypertrophy (enlargement or thickening of tissue). If you notice either of these conditions, consult your doctor. A change in your injection technique may help alleviate the problem.
Local Allergy --Patients occasionally experience redness, swelling, and itching at the site of injection of insulin. This condition, called local allergy, usually clears up in a few days to a few weeks. In some instances, this condition may be related to factors other than insulin, such as irritants in the skin cleansing agent or poor injection technique. If you have local reactions, contact your doctor.
Systemic Allergy --Less common, but potentially more serious, is generalized allergy to insulin, which may cause rash over the whole body, shortness of breath, wheezing, reduction in blood pressure, fast pulse, or sweating. Severe cases of generalized allergy may be life threatening. If you think you are having a generalized allergic reaction to insulin, notify a doctor immediately.
Additional information about diabetes may be obtained from your diabetes educator.
DIABETES FORECAST is a national magazine designed especially for patients with diabetes and their families and is available on subscription from the American Diabetes Association, National Service Center, 1660 Duke Street, Alexandria, Virginia 22314, 1-800-DIABETES (1-800-342-2383).
Another publication, DIABETES COUNTDOWN , is available from the Juvenile Diabetes Foundation International (JDF), 120 Wall Street, 19th Floor, New York, New York 10005-4001, 1-800-JDF-CURE (1-800-533-2873).
Additional information about Humulin can be obtained by calling 1-888-88-LILLY (1-888-885-4559).
Literature revised March 26, 1999
PA 9077 FSAMP 
* B-D® is a registered trademark of Becton Dickinson and Company.
** NovolinPen® and NovoPen® are registered trademarks of Novo Nordisk A/S.