HUMAN INSULIN
NOVOLIN 70/30 PREFILLED (Novo Nordisk)

70% NPH, Human Insulin Isophane Suspension and 30% Regular,
Human Insulin Injection (recombinant DNA origin)
in a 1.5 ml Prefilled Syringe
100 units/mL

NOVOLIN N PREFILLED
NPH, Human Insulin Isophane
Suspension (recombinant DNA origin)

in a 1.5 ml Prefilled Syringe
100 units/mL

NOVOLIN R PREFILLED
Regular, Human Insulin Injection

(recombinant DNA origin)
in a 1.5 ml Prefilled Syringe
100 units/mL


Please read both sides of this leaflet carefully before using this product.

Novolin Prefilled syringe is for single person use only. See Important Notes section.

WARNING

ANY CHANGE OF INSULIN SHOULD BE MADE CAUTIOUSLY AND ONLY UNDER MEDICAL SUPERVISION. CHANGES IN PURITY, STRENGTH, BRAND (MANUFACTURER), TYPE (REGULAR, NPH, LENTE ETC.), SPECIES (BEEF, PORK, BEEF-PORK, HUMAN) AND/OR METHOD OF MANUFACTURE (RECOMBINANT DNA VERSUS ANIMAL-SOURCE INSULIN) MAY RESULT IN THE NEED FOR A CHANGE IN DOSAGE.

SPECIAL CARE SHOULD BE TAKEN WHEN THE TRANSFER IS FROM A STANDARD BEEF OR MIXED SPECIES INSULIN TO A PURIFIED PORK OR HUMAN INSULIN. IF A DOSAGE ADJUSTMENT IS NEEDED, IT WILL USUALLY BECOME APPARENT EITHER IN THE FIRST FEW DAYS OR OVER A PERIOD OF SEVERAL WEEKS, ANY CHANGE IN TREATMENT SHOULD BE CAREFULLY MONITORED.

PLEASE READ THE SECTIONS "INSULIN REACTION AND SHOCK" AND "DIABETIC KETOACIDOSIS AND COMA" FOR SYMPTOMS OF HYPOGLYCEMIA (LOW BLOOD GLUCOSE) AND HYPERGLYCEMIA (HIGH BLOOD GLUCOSE).

INSULIN USE IN DIABETES

Your physician has explained that you have diabetes and that your treatment involves injections of insulin or insulin therapy combined with an oral antidiabetic medicine. Insulin is normally produced by the pancreas, a gland that lies behind the stomach. Without insulin, glucose (a simple sugar made from digested food) is trapped in the bloodstream and cannot enter the cells of the body. Some patients who don't make enough of their own insulin, or who cannot use the insulin they do make properly, must take insulin by injection in order to control their blood glucose levels.

Each case of diabetes is different and requires direct and continued medical supervision. Your physician has told you the type, strength and amount of insulin you should use and the time(s) at which you should inject it, and has also discussed with you a diet and exercise schedule. You should contact your physician if you experience any difficulties or if you have questions.

TYPES OF INSULIN

Standard and purified animal insulin as well as human insulin are available. Standard and purified insulins differ in their degree of purification and content of noninsulin material. Standard and purified insulins also vary in species source: they may be of beef, pork, or mixed beef and pork origin. Human insulin is identical in structure to the insulin produced by the human pancreas, and thus differs from animal insulins. Insulin Products vary in time of action; see PRODUCT DESCRIPTION for additional information.

Your physician has prescribed the insulin that is right for you; be sure you have purchased the correct insulin and check it carefully before you use it.

PRODUCT DESCRIPTION

A package contains five (5) Novolin Prefilled insulin syringes.

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.

Novolin 70/30 Prefilled contains Novolin 70/30, a mixture of 70% NPH, Human Insulin Isophane Suspension (recombinant DNA origin) and 30% Regular, Human Insulin Injection (recombinant DNA origin) USP. 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 to the bottom of the insulin reservoir, therefore, the syringe must be rotated up and down so that the contents are uniformly mixed before a dose is given. Novolin 70/30 has an intermediate duration of action. The effect of Novolin 70/30 begins approximately 1 / 2 hour after injection. The effect is maximal between 2 and approximately 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 the variation, the time periods listed here should be considered as general guidelines only.

Novolin N Prefilled contains 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 to the bottom of the insulin reservoir, therefore, the syringe must be rotated up and down so that the contents are uniformly mixed before a dose is given. 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 approximately 12 hours. The full duration of action may last up to 24 hours after injection.

Novolin R Prefilled contains 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.

STORAGE

Novolin Prefilled insulin syringes should be stored in a cold place, preferably in a refrigerator, but not in the freezing compartment. Do no let it freeze. Keep Novolin Prefilled in the carton so that they will stay clean and protected from light. Novolin 70/30 Prefilled and Novolin N Prefilled can be kept unrefrigerated for one (1) week.

Novolin R Prefilled can be kept unrefrigerated for (1) month. Unrefrigerated syringes must be used within this time period or discarded. Be sure to protect syringes from sunlight and extreme heat or cold.

Never use any Novolin R Prefilled if the insulin becomes viscous (thickened) or cloudy; use it only if it is clear and colorless. Never use any Novolin 70/30 Prefilled or Novolin N Prefilled if the precipitate (the white deposit) has become lumpy or granular in appearance or has formed a deposit of solid particles on the wall of the insulin reservoir. This insulin should not be used if the liquid in the insulin reservoir remains clear after it has been mixed.

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

IMPORTANT

Failure to comply with the following antiseptic measures may lead to infections at the injection site.

  • Disposable needles are for single use; they should be used only once and discarded properly.
  • Clean your hands and the injection site with soap and water or with alcohol.
  • Wipe the rubber stopper with an alcohol swab.

PREPARING THE INJECTION

Never place a single-use needle on your insulin delivery device until you are ready to give an injection, and remove it immediately after each injection. If the needle is not removed, some liquid may be expelled from the cartridge causing a change in the insulin concentration (strength).

For Novolin N Prefilled & Novolin 70/30 Prefilled, the cloudy material in an insulin suspension will settle to the bottom of the insulin reservoir, so the contents must be mixed before injection. These syringes contain a glass ball to aid mixing.

Rotate the syringe up and down so that the contents are uniformly mixed before the dose is given.

Follow the directions for use of this syringe on the reverse side of this insert.

Insulin prefilled syringes may contain a small amount of air. To prevent an injection of air and make certain insulin is delivered, an air shot must be done before each injection. Directions for performing an air shot are provided on the reverse side of this insert.

GIVING THE INJECTION

  1. The following areas are suitable for subcutaneous insulin injection: thighs, upper arms, buttocks, abdomen. Do not change areas without consulting your physician. The actual point of injection should be changed each time; injection sites should be about an inch apart.
  2. The injection site should be clean and dry. Pinch up skin area to be injected and hold it firmly.
  3. Hold the syringe like a pencil and push the needle quickly and firmly into the pinched-up area. Release the skin and push the push-button all the way in to inject insulin beneath the skin. To ensure that all the insulin is injected keep the needle in the skin for several seconds after injection with your thumb on the push-button.
  4. Do not inject into a muscle unless your physician has advised it. You should never inject insulin into a vein.
  5. Remove the needle. If slight bleeding occurs, press lightly with a dry cotton swab for a few seconds-- do not rub.

For additional information see GIVING THE INJECTION on the reverse side of this insert.

USAGE IN PREGNANCY

It is particularly important to maintain good control of your diabetes during pregnancy and special attention must be paid to your diet, exercise and insulin regimens. If you are pregnant or nursing a baby, consult your physician or nurse educator.

INSULIN REACTION AND SHOCK

Insulin reaction (hypoglycemia) occurs when the blood glucose falls very low. This can happen if you take too much insulin, miss or delay a meal, exercise more than usual or work too hard without eating, or become ill (especially with vomiting or fever). Hypoglycemia can also happen if you combine insulin therapy and other medications that lower blood glucose, such as oral antidiabetic agents or other prescription and over-the-counter drugs. The first symptoms of an insulin reaction usually come on suddenly. They may include a cold sweat, fatigue, nervousness or shakiness, rapid heartbeat, or nausea. Personality change or confusion may also occur. If you drink or eat something right away (a glass of milk or orange juice, or several sugar candies), you can often stop the progression of symptoms. If symptoms persist, call your physician-an insulin reaction can lead to unconsciousness. If a reaction results in loss of consciousness, emergency medical care should be obtained immediately. If you have had repeated reactions or if an insulin reaction has led to a loss of consciousness, contact your physician. Severe hypoglycemia can result in temporary or permanent impairment of brain function and death.

In certain cases, the nature and intensity of the warning symptoms of hypoglycemia may change. A few patients have reported that after being transferred to human insulin, the early warning symptoms of hypoglycemia were less pronounced than they had been with animal-source insulin.

DIABETIC KETOACIDOSIS AND COMA

Diabetic ketoacidosis may develop if your body has too little insulin. The most common causes are acute illness or infection or failure to take enough insulin by injection. If you are ill you should check your urine for ketones. The symptoms of diabetic ketoacidosis usually come on gradually, over a period of hours or days, and include a drowsy feeling, flushed face, thirst and loss of appetite. Notify your physician right away if the urine test is positive for ketones (acetone) or if you have any of these symptoms. Fast, heavy breathing and rapid pulse are more severe symptoms and you should have medical attention right away. Severe, sustained hyperglycemia may result in diabetic coma and death.

Adverse Reactions

A few people with diabetes develop red, swollen and itchy skin where the insulin has been injected. This is called a "local reaction" and it may occur if the injection is not properly made, if the skin is sensitive to the cleaning solution or if you are allergic to the insulin being used. If you have a local reaction, tell your physician.

Generalized insulin allergy occurs rarely, but when it does it may cause a serious reaction, including skin rash over the body, shortness of breath, fast pulse, sweating, and a drop in blood pressure. If any of these symptoms develop, you should seek emergency medical care.

If severe allergic reactions to insulin have occurred (i.e. generalized rash, swelling or breathing difficulties) you should be skin-tested with each new insulin preparation before it is used.

IMPORTANT NOTES

  1. 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.
  2. To avoid possible transmission of disease, Novolin Prefilled syringe is for single person use only.
  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.

Helpful information for people with diabetes is published by American Diabetes Association, 1660 Duke Street, Alexandria, VA 22314.

For information contact:

Novo Nordisk Pharmaceuticals, Inc.

100 College Road West

Princeton, NJ 08540

1-800-727-6500

Manufactured by

Novo Nordisk A/S

DK-2880 Bagsvaerd, Denmark

License under U.S. Patent No. 5,462,535 and 4,973,318 restricted to use with Novo Nordisk pen needles.

Novo Nordisk, Novolin Prefilled, Novolin, NovoFine and Lente are trademarks owned by Novo Nordisk A/S

Date of Issue: Dec 1998

How Supplied

Novolin 70/30 Prefilled Syringe, U-100, 100 units/ml, 1.5 ml, (List No. 001771) (5's)

Novolin N Prefilled Syringe, U-100, 100 units/ml, 1.5 ml, (List No. 004571) (5's)

Novolin R Prefilled Syringe, U-100, 100 units/ml, 1.5 ml, (List No. 004471) (5's)

Prefilled syringe directions for use

This is a disposable dial-a-dose insulin delivery system able to deliver 2-58 units in increments of 2 units. Novolin Prefilled syringe is designed for use with NovoFine single-use needle or other products specifically recommended by Novo Nordisk. Novolin Prefilled syringe is not recommended for the blind or visually impaired without the assistance of a sighted individual trained in the proper use of this product.

Please read these instructions completely before using this device.

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1.PREPARING THE SYRINGE

Pull off the cap.

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A. Turn the syringe up and down between a and b so the glass ball is moved from one end of the insulin reservoir to the other. Do this at least 10 times, until the liquid appears uniformly white and cloudy. Wipe rubber stopper with an alcohol swab. This step is not necessary with Novolin R Prefilled.

images/757/5501501b.jpg

B. Remove the protective tab from the disposable needle and screw the needle onto the syringe. Never place a disposable needle on your syringe until you are ready to give an injection. Remove the needle immediately after use. If the needle is not removed, some liquid may be expelled from the syringe causing a change in insulin concentration (strength).

Giving the air shot prior to each injection:

Small amounts of air may collect in the needle and insulin reservoir during normal use.

To avoid the injection of air and ensure proper dosing, hold the syringe with the needle upwards and tap the syringe gently with your finger so any air bubbles collect in the top of the reservoir. Remove both the plastic outer cap and the needle cap.

images/7575/501501cd.jpg

C. Holding the syringe with the needle pointing upwards, slowly turn the insulin reservoir clockwise (in the direction of the arrow, see fig. C) to the first notch where resistance is felt ( 1 / 5 of a full rotation).

D. Still with the needle pointing upwards, press the push button as far as it will go and see if a drop of insulin appears at the needle tip (Fig. D). If not, repeat the procedure until insulin appears.

Before the first use of Novolin Prefilled you may need to perform up to 6 air shots to get a droplet of insulin at the needle tip. If you need to make more than 6 air shots do not use and return the product to Novo Nordisk.

A small air bubble may remain but it will not be injected because the operating mechanism prevents the reservoir from being completely emptied.

2.SETTING THE DOSE

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E. Replace the cap, so 0 is opposite the dosage indicator.

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F. Hold the syringe horizontally and turn the cap in the direction of the arrow to set the required dose. Do not put your hand over the push button when dialing the dose. If the button is not allowed to rise freely, insulin will be pushed out of the needle. The dosage display on the cap shows 0, 2, 4, 6 and 8 units.

images/757/5501501g.jpg

G. As the cap is turned, the push button rises. The dosage display below the push button shows 10, 20, 30, 40 and 50 units. Every time you fully turn the cap, 10 units will be set.

To check the dose set, add the figure on the cap opposite the dosage indicator to the highest number showing on the push button display.

Dosage examples

  • 8 units:
    Turn the cap until 8 is opposite the dosage indicator.
  • 36 units:
    Turn the cap 3 full turns so 0 is opposite the dosage indicator. The 30-line will show on the push button scale. Continue turning until 6 is opposite the dosage indicator (see fig. G ).

If you have set a wrong dose, simply turn the cap forward or backwards until the right number of units has been set.

58 units is the maximum dose. If you attempt to set a higher dose, insulin will be expelled from the needle and the dose will be wrong. If you set more than 58 units, turn the cap back as far as you can until resistance is felt and the push button is fully depressed. If the dosage indicator is not lined up with 0 when resistance is felt, remove the cap and replace it with 0 opposite the dosage indicator. Now start again, remembering that 58 units is the maximum dose. After the dose is set, remove the cap.

3. GIVING THE INJECTION

Use the injection technique recommended by your doctor. Check that you have set the proper dose and depress the push button as far as it will go. When depressing the push button you may hear a clicking sound. Do not rely on this clicking sound as a means of determining or confirming your dose. After making the injection, replace the plastic outer cap. Unscrew the needle and discard appropriately. Replace the cap with 0 opposite the dosing indicator.

For additional information see GIVING THE INJECTION on the reverse side of this insert.

4. SUBSEQUENT INJECTIONS

Always check that the push button is fully depressed before using the syringe again. If not, turn the cap until the push button is completely down. Then proceed as stated under steps 1-3.

The numbers on the insulin reservoir can be used to estimate the amount of insulin left in the syringe. These numbers are not used for measuring the insulin dose.

You cannot set a dose greater then the number of units remaining in the reservoir.

If you are using Novolin N Prefilled or Novolin 70/30 Prefilled there must be at least 12 units left in the reservoir to give the glass ball space to move when mixing the insulin. If your dose is less than 12 units -- and the reservoir is nearly empty -- first dial up to 12 (to check that 12 units are left) and then set the desired dose. If 12 cannot be dialed, change to a new syringe. Discard the used syringe carefully, without the needle attached.

5. Important Notes

If you need to perform more than 6 air shots before the first use of Novolin Prefilled to get a droplet of insulin at the needle tip, do not use.

  • Remember to perform an air shot before each injection. See Figs. C and D.
  • Care should be taken not to drop the syringe or subject it to impact.
  • The compact size of this prefilled syringe makes it easy to use and convenient to carry. Remember to keep it with you; don't leave it in a car or other location where extremes of temperature can occur.
  • Novolin Prefilled is designed for use with NovoFine disposable needles or other products specifically recommended by Novo Nordisk.
  • Never place a disposable needle on this syringe until you are ready to use it. Remove the needle immediately after use. If the needle is not removed, some liquid may leak from the syringe causing a change in insulin concentration (strength).
  • Always carry a spare Novolin Prefilled syringe with you in case your prefilled syringe is damaged or lost.
  • Novo Nordisk cannot be held responsible for adverse reactions occurring as a consequence of using this insulin delivery system with products that are not recommended by Novo Nordisk.
  • Keep this syringe out of the reach of children.

For information contact:

Novo Nordisk Pharmaceuticals, Inc.

100 College Road West

Princeton, NJ 08540

1-800-727-6500

Manufactured by

Novo Nordisk A/S

DK-2880 Bagsvaerd, Denmark

License under U.S. Patent No. 5,462,535 and 4,973,318 restricted to use with Novo Nordisk pen needles.

Novo Nordisk, Novolin Prefilled, Novolin, NovoFine and Lente are trademarks owned by Novo Nordisk A/S

Date of issue: December 1998

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