DailyMed - HUMULIN N- insulin human injection, suspension
3 mL Vial (300 Units per vial)
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.
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.
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).
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.
Insulin human 100 [iU] in 1 mL
Zinc 0.025 mg in 1 mL
Phenol 0.65 mg in 1 mL
Sodium phosphate, dibasic 3.78 mg in 1 mL
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
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.
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.
Carefully shake or rotate the bottle of insulin several times to completely mix the insulin.
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.
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.
If you are mixing insulins, refer to the “Mixing Humulin N and Regular Human Insulin” section below.
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.
Turn the Humulin N bottle and syringe upside down. Hold the bottle and syringe firmly in one hand and shake gently.
Making sure the tip of the needle is in the Humulin N suspension, withdraw the correct dose of Humulin N into the syringe.
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.
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)
Humulin N should be mixed with Humulin R only on the advice of your doctor.
Draw an amount of air into the syringe that is equal to the amount of Humulin N you are taking. Insert the needle into the Humulin N bottle and inject the air. Withdraw the needle.
Draw an amount of air into the syringe that is equal to the amount of Humulin R you are taking. Insert the needle into the Humulin R bottle and inject the air, but do not withdraw the needle.
Turn the Humulin R bottle and syringe upside down.
Making sure the tip of the needle is in the Humulin R solution, withdraw the correct dose of Humulin R into the syringe.
Before removing the needle from the Humulin R 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.
Remove the syringe with the needle from the Humulin R bottle and insert it into the Humulin N bottle. Turn the Humulin N bottle and syringe upside down. Hold the bottle and syringe firmly in one hand and shake gently. Making sure the tip of the needle is in the Humulin N, withdraw the correct dose of Humulin N.
Follow the directions under “Injection Instructions” section below.
Follow your doctor’s instructions on whether to mix your insulins ahead of time or just before giving your injection. It is important to be consistent in your method.
the model and brand of syringe or needle that your doctor has prescribed.
Push the plunger in as far as it will go.
Pull the needle out and apply gentle pressure over the injection site for several seconds. Do not rub the area.
Place the used needle in a puncture-resistant disposable container and properly dispose of the puncture-resistant container as directed by your Health Care Professional.
Your usual dose of Humulin N may be affected by changes in your diet, activity, or work schedule. Carefully follow your doctor’s instructions to allow for these changes. Other things that may affect your Humulin N dose are:
Insulin requirements may be increased if you are taking other drugs with blood–glucose–raising activity, such as oral contraceptives, corticosteroids, or thyroid replacement therapy. Insulin requirements may be reduced in the presence of drugs that lower blood glucose or affect how your body responds to insulin, such as oral antidiabetic agents, salicylates (for example, aspirin), sulfa antibiotics, alcohol, certain antidepressants and some kidney and blood pressure medicines. Your Health Care Professional may be aware of other medications that may affect your diabetes control. Therefore, always discuss any medications you are taking with your doctor.
A change in the body’s need for insulin.
Early warning symptoms of hypoglycemia may be different or less pronounced under certain conditions, such as long duration of diabetes, diabetic nerve disease, use of medications such as beta–blockers, changing insulin preparations, or intensified 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 drinking sugar–containing foods to treat your hypoglycemia.
In patients with type 1 or insulin–dependent diabetes, prolonged hyperglycemia can result in DKA (a life-threatening emergency). The first symptoms of DKA 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 DKA, blood and urine tests show large amounts of glucose and ketones. Heavy breathing and a rapid pulse are more severe symptoms. If uncorrected, prolonged hyperglycemia or DKA can lead to nausea, vomiting, stomach pain, dehydration, loss of consciousness, or death. Therefore, it is important that you obtain medical assistance immediately.
Information about diabetes may be obtained from your diabetes educator.
Additional information about diabetes and Humulin can be obtained by calling The Lilly Answers Center at 1-800-LillyRx (1-800-545-5979) or by visiting www.LillyDiabetes.com.
Patient Information revised September 2, 2009
10 mL Vials manufactured by
3 mL Vials manufactured by
3 ML PREFILLED INSULIN DELIVERY DEVICE
HUMULIN® N Pen
(rDNA ORIGIN) ISOPHANE SUSPENSION
TO OBTAIN AN ACCURATE DOSE, CAREFULLY READ AND FOLLOW THE INSULIN DELIVERY DEVICE USER MANUAL AND THIS “INFORMATION FOR THE PATIENT” INSERT BEFORE USING THIS PRODUCT.
THE PEN MUST BE PRIMED TO A STREAM OF INSULIN (NOT JUST A FEW DROPS) BEFORE EACH INJECTION TO MAKE SURE THE PEN IS READY TO DOSE. YOU MAY NEED TO PRIME A NEW PEN UP TO SIX TIMES BEFORE A STREAM OF INSULIN APPEARS.
PRIMING THE PEN IS IMPORTANT TO CONFIRM THAT INSULIN COMES OUT WHEN YOU PUSH THE INJECTION BUTTON AND TO REMOVE AIR THAT MAY COLLECT IN THE INSULIN CARTRIDGE DURING NORMAL USE. IF YOU DO NOT PRIME, YOU MAY RECEIVE TOO MUCH OR TOO LITTLE INSULIN (see also INSTRUCTIONS FOR INSULIN PEN USE section).
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.
The Humulin N Pen is available in boxes of 5 prefilled insulin delivery devices (“insulin Pens”). The Humulin N Pen is not designed to allow any other insulin to be mixed in its cartridge, or for the cartridge to be removed.
Always check the carton and the Pen 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 Humulin N suspension in your insulin Pen before using. A cartridge of Humulin N contains a small glass bead to assist in mixing. Roll the Pen back and forth between the palms 10 times (see Figure 1). Gently turn the Pen up and down 10 times until the insulin is evenly mixed (see Figure 2).
If not evenly mixed, repeat the above steps until contents are mixed. Pens containing Humulin N suspension should be examined frequently.
if the insulin substance (the white material) remains visibly separated from the liquid after mixing or
if solid white particles stick to the walls of the cartridge, giving a frosted appearance.
If you see anything unusual in the appearance of the Humulin N suspension in your Pen or notice your insulin requirements changing, talk to your doctor.
Not in-use (unopened): Humulin N Pens not in-use should be stored in a refrigerator, but not in the freezer.
In-use (opened): Humulin N Pens in-use should NOT be refrigerated but should be kept at room temperature [below 86°F (30°C)] away from direct heat and light. The Humulin N Pen you are currently using must be discarded 2 weeks after the first use, even if it still contains Humulin N.
It is important to read, understand, and follow the instructions in the Insulin Delivery Device User Manual before using. Failure to follow instructions may result in getting too much or too little insulin. The needle must be changed and the Pen must be primed to a stream of insulin (not just a few drops) before each injection to make sure the Pen is ready to dose. You may need to prime a new Pen up to six times before a stream of insulin appears. Performing these steps before each injection is important to confirm that insulin comes out when you push the injection button, and to remove air that may collect in the insulin cartridge during normal use.
Prime to a stream of insulin (not just a few drops) to make sure the Pen is ready to dose.
Follow the instructions in your Insulin Delivery Device User Manual to prepare for injection.
After injecting the dose, pull the needle out and apply gentle pressure over the injection site for several seconds. Do not rub the area.
After the injection, remove the needle from the Humulin N Pen. Do not reuse needles.
Additional information about diabetes and Humulin can be obtained by calling The Lilly Answers Center at 1–800–LillyRx (1–800–545–5979) or by visiting www.LillyDiabetes.com.
Patient Information revised March 16, 2009
This section contains a representative sample of product package labeling. Product may be manufactured at multiple manufacturing sites. See the Additional Information section for a list of products and associated manufacturing sites.
isophane suspension
https://dailymed.nlm.nih.gov/dailymed/labelrss.cfm?setid=81f28314-31c8-4114-a4b3-336eb2094558