FOR USE IN EXTERNAL INSULIN INFUSION PUMPS OR WITH U-100 INSULIN SYRINGES
Please read this leaflet carefully.
ANY CHANGE OF INSULIN SHOULD BE MADE CAUTIOUSLY AND ONLY UNDER MEDICAL SUPERVISION. CHANGES IN PURITY, STRENGTH (E.G., U-40, U-100), MANUFACTURER, TYPE (E.G., LENTE®, NPH, REGULAR) OR SPECIES (BEEF, PORK, BEEF/PORK, HUMAN) MAY RESULT IN THE NEED FOR A CHANGE IN DOSAGE. ADJUSTMENT MAY BE NEEDED WITH THE FIRST DOSE OR OVER A PERIOD OF SEVERAL WEEKS. BE AWARE THAT SYMPTOMS OF HYPOGLYCEMIA (LOW BLOOD GLUCOSE) OR HYPERGLYCEMIA (HIGH BLOOD GLUCOSE) MAY INDICATE THE NEED FOR DOSAGE ADJUSTMENT. PLEASE READ SECTIONS ENTITLED "INSULIN REACTION" AND "DIABETIC KETOACIDOSIS AND COMA".
VELOSULIN® BR SHOULD NOT BE MIXED WITH ANY OTHER INSULIN SINCE THE BUFFERING AGENT IN VELOSULIN® BR MAY INTERACT WITH THE OTHER INSULIN AND RESULT IN A CHANGE OF ACTIVITY.
CHANGE THE CATHETER TUBING, THE INSULIN, AND THE RESERVOIR EVERY 48 HOURS.
Your physician has explained that you have diabetes and that your treatment involves the use 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 do not make any or 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 administer 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 any questions.
Standard and purified animal insulins as well as human insulins 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. Insulins vary in time of action and in strength; see PRODUCT 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.
Velosulin® BR is a clear solution of insulin in a phosphate buffer. The concentration of this product is 100 units of insulin per milliliter. This human insulin is structurally identical to the insulin produced by the pancreas in the human body. This structural identity is obtained by recombinant-DNA technology utilizing Saccharomyces cerevisiae (bakers' yeast) as the production organism. When a U-100 insulin syringe is used to deliver the insulin, the effect of Velosulin® BR begins approximately 1 / 2 hour after the injection. The effect lasts up to approximately 8 hours with a maximal effect between the 1st and 3rd hour.
The time course of action of any insulin may vary considerably in different individuals, or at different times in the same individual, or when using an external insulin infusion pump to deliver the insulin.
Because of this variation, the time periods listed here should be considered as general guidelines only when using U-100 insulin syringes to deliver the insulin.
Insulin should be stored in a cool place, preferably in a refrigerator, but not in the freezing compartment. Do not use insulin if it has been frozen. Keep the insulin 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 (below 86°F [30°C] and away from heat and sunlight. Never use Velosulin® BR if it becomes viscous (thickened) or cloudy. Use it only if it is clear and colorless.
Never use insulin after the expiration date which is printed on the vial label and carton.Once the vial has been opened, it should be used within four weeks (28 days).
(Note: Remove the tamper-resistant cap at first use. If the cap has already been removed, do not use this product and return it to your pharmacy.)
Velosulin® BR is indicated for use with external insulin infusion pumps. Novo Nordisk has demonstrated Velosulin® BR to be compatible with MiniMed® Model 506 external insulin infusion pump, using MiniMed® catheters of Polyfin and Sofset types without Quick Release. MiniMed® Models 506, 505, and 507 external insulin infusion pumps are equivalent with regard to insulin compatibility. If you have any questions on how to operate the pump, consult with your physician or diabetes educator. It is important that you follow the instructions in your pump manual. Failure to follow the instructions may result in an inaccurate insulin dose. The pump manual will also help you in the selection, use and sterilization of the appropriate accessories specific to your pump model. Use the correct reservoir and catheter for the pump that you are using to minimize catheter blockage. Follow your external insulin infusion pump instructions for filling a new reservoir making certain that there are no large air bubbles in the syringe or the catheter. Before inserting the needle, use soap and water to clean your hands and the skin of the infusion site to avoid infection. Choose a new site for each new needle.
Follow your instructions from your physician or diabetes educator regarding basal infusion rates and mealtime insulin bolus dosages. An insulin bolus should be followed by a meal within 30 minutes.
Velosulin® BR is for infusion under the skin. It should not be mixed with any other insulin. To get the most benefit from insulin, measure your blood sugar levels regularly. This will also help in detecting any possible malfunction of your insulin pump.
Change the catheter tubing, the insulin, and the reservoir every 48 hours.
NOTE: In case of pump interruption or failure, switch back to conventional insulin therapy using U-100 syringes and consult with your physician or diabetes educator. Please see the following information:
Failure to comply with the above instructions and the antiseptic measures may lead to infections at the injection site.
Note: you should use the injection technique recommended by your physician.
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 diabetes educator.
Insulin reaction (too little sugar in the blood, also called hypoglycemia) can occur if the external infusion pump delivers too much insulin, if you take too large an insulin bolus, skip meals, exercise or work harder than normal. 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 symptoms, which usually come on suddenly, are hunger, dizziness, and sweating. 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 a 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 may develop if your body has too little insulin. The most common causes are acute illness, infection, failure to take enough insulin by injection, or catheter clogging when used with an external insulin infusion pump. 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 a physician immediately if the urine test is positive for ketones (acetone) or if you have any of these symptoms. More severe symptoms are fast, heavy breathing and rapid pulse; if these symptoms occur, you should seek medical attention right away. Severe, sustained hyperglycemia may result in diabetic coma and death.
Insulin allergy occurs very rarely, but when it does, it may cause a serious reaction including a general 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. The formation of fatty lumps at the infusion site or injection site is usually a sign of frequent needle insertion at the same site. Remember to choose new infusion sites or injection sites at which to insert each new needle and consult with your physician or diabetes educator if you develop these fatty lumps at the infusion site. The skin at the infusion site or injection site may also become red, swollen and itchy. This is a local reaction. It may occur if needle insertion is not properly made at the infusion site or injection site, or as a result of skin sensitivity to the cleansing solutions or if the patient is allergic to insulin. If you have a local reaction, consult with your physician or diabetes educator.
Patients with severe systemic allergic reactions to insulin (i.e. generalized urticaria, angioedema, anaphylaxis) should be skin tested with each new preparation to be used prior to initiation of therapy with that preparation.
Contact 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, 1160 Duke St., Alexandria, VA 22314.
Novo Nordisk, Velosulin® and Lente® are trademarks of Novo Nordisk A/S
MiniMed®, Polyfin, and Sofset are trademarks of MiniMed Inc.
© 1999 Novo Nordisk Pharmacueticals, Inc.
For information contact: Novo Nordisk Pharmaceuticals, Inc., Princeton, NJ 08540
Manufactured by: Novo Nordisk A/S, DK-2880 Bagsvaerd, Denmark
Date of issue: July 1999