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 to keep your blood glucose at a near-normal level. Proper control is important. Uncontrolled diabetes (hyperglycemia) over a long period of time can result in a number of serious problems such as blindness, kidney failure, poor circulation/heart attacks, strokes and/or nerve damage. These problems can be prevented or reduced by good diabetes management. This will require close and constant cooperation with your diabetes healthcare team including: yourself, your doctor and your diabetes educators (nurses, dietitians, social workers, pharmacists and other health care professionals). Thus, you can lead an active, healthy and productive life by eating a balanced daily diet, exercising regularly, and taking 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 identification to indicate that you have diabetes so that appropriate treatment can be given if complications occur away from home.

Do not use any other insulin except on your doctor's advice and direction.

When you receive your insulin from the pharmacy, always check to see that:

• You are given the proper type of insulin.
  
• The carton and cartridge or prefilled pen label is correct for your type of insulin.
  
• The expiration date on the package will allow you to use the insulin before that date.
  

Novolin®ge is stucturally identical to natural human insulin. When administered in appropriate regular doses to patients with diabetes mellitus and who follow a controlled diet and exercise program, Novolin®ge temporarily restores their ability to metabolize carbohydrates, protein and fats.

Dosage: Your doctor has told you which insulin to use, how much, and when and how often to inject it. Because each patient's 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's instructions to allow for these changes. Other things that may affect your insulin dose are:

Illness: 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/urine frequently and call your doctor as instructed.

Pregnancy: Clinical experience with insulin in pregnancy is limited but may be used in pregnancy if clinically indicated. 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.

Medication: 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, sulfa antibiotics, and certain antidepressants. Always discuss any medications you are taking with your doctor.

Exercise: Exercise may lower your body's 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. Discuss with your doctor how you should adjust your regimen to accommodate exercise.

Travel: Persons travelling across more than 2 time zones should consult their doctor concerning adjustments in their insulin schedule.

Insulin Reaction and Shock: 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:

• Missing or delaying meals
  
• Taking too much insulin
  
• Exercising or working more than usual
  
• An infection or illness (especially with diarrhea or vomiting)
  
• A change in the body's need for insulin
  
• Diseases of the adrenal, pituitary, or thyroid gland, or progression of kidney or liver disease
  
• Interactions with other drugs that lower blood glucose, such as oral hypoglycemics, salicylates, sulfa antibiotics, and certain antidepressants
  
• Consumption of alcoholic beverages
  

Dietary Implications: If a usual meal cannot be obtained at the appropriate time, then to avoid hypoglycemia, you should take the amount of carbohydrate prescribed for this meal in the form of orange juice, syrup, candy, or bread and milk, without changing your insulin dosage. If it becomes necessary to omit a meal on account of nausea and vomiting, you should test your blood sugar level and notify your doctor.

Symptoms and Treatment: Symptoms of mild to moderate hypoglycemia may occur suddenly and can include:

• sweating
  
• dizziness
  
• palpitation
  
• tremor
  
• hunger
  
• restlessness
  
• tingling in the hands, feet, lips, or tongue
  
• lightheadedness
  
• inability to concentrate
  
• headache
  
• drowsiness
  
• sleep disturbances
  
• anxiety
  
• blurred vision
  
• slurred speech
  
• depressive mood
  
• irritability
  
• abnormal behaviour
  
• unsteady movement
  
• personality changes

Signs of severe hypoglycemia can include:

• disorientation
  
• unconsciousness
  
• seizures
  
• death
  

Therefore, it is important that assistance be obtained immediately.

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, or intensified management (3 or more injections/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.

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 should be treated with intravenous administration of glucose at a medical facility or should be given an injection of glucagon (either intramuscular or subcutaneous). The patient should be given oral carbohydrates as soon as consciousness is recovered.

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 avoid hypoglycemia.

Diabetic Acidosis and Coma:

Hyperglycemia (too much glucose in the blood) may develop if your body has too little insulin. Hyperglycemia can be brought about by any of the following:

• Omitting your insulin or taking less than the doctor has prescribed
  
• Eating significantly more than your meal plan suggests
  
• Developing a fever, infection, or other significant stressful situation
  

In patients with type 1 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.

Lipodystrophy: 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.

Allergy to Insulin: Local Allergy: Patients occasionally experience redness, swelling, and itching at the site of injection. 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, notify a doctor immediately.

Preparing a Cartridge of Novolin or Prefilled Pen:

1. Wash your hands.
   
2. Roll the cartridge or prefilled pen between the palms 10 times.
   
3. Holding the cartridge or prefilled pen by one end, invert it 180° slowly 10 times to allow the glass bead to travel the full length of the cartridge with each inversion.
   
4. To load a cartridge into a reusable device and to attach the needle prior to administration of the insulin, refer to the manufacturer's instruction for the insulin delivery device.
   
5. For instruction on how to administer insulin, refer to the manufacturer's instruction for the insulin delivery device.
   

Injecting the Dose:

1. Wash your hands.
   
2. Use an alcohol swab to wipe the exposed rubber surface on the metal cap end of the cartridge or prefilled pen.
   
3. Carefully resuspend the insulin by rolling the pen in your hands 10 times and inverting it 180° 10 times. This must be performed each time before you give yourself an injection even after just loading the pen.
   
4. Follow pen manufacturer's directions for attaching needle.
   
5. Hold the pen with needle pointing straight up. If there are large bubbles, tap the side of the pen until they float to the top. Remove the bubbles and the air in the needle by setting the pen to a 2-unit dose and depressing the plunger. Repeat this step if necessary until a drop of insulin appears at the end of the needle.
   
6. To avoid tissue damage, injection sites can be rotated so that the same site is not used more than approximately once a month.
   
7. Cleanse the skin with alcohol where the injection is to be made.
   
8. With one hand, stabilize the skin by spreading it or pinching up a large area.
   
9. Insert the needle as instructed by your doctor.
   
10. To inject, follow the pen manufacturer's instructions.
    
11. Pull the needle out and apply gentle pressure over the injection site for several seconds. Do not rub the area.
    
12. Immediately after an injection, remove the needle from the pen. This will guard against contamination and prevent leakage, reentry of air, and potential needle clogs. Dispose of the needle in a responsible manner. Do not reuse needle. Needles, cartridges, and pens must not be shared.
    
13. Use the gauge on the side of the cartridge to help you judge how much insulin remains. You may continue to use the cartridge until the plunger will no longer advance. See injection instructions accompanying the pen to ensure that a complete dose is obtained.
    

Warnings: Novolin®ge Toronto should not be used if it is not water-clear and colorless. Due to the risk of precipitation in some pump catheters, Novolin®ge Toronto is not recommended for use in insulin pumps.

Novolin®ge Lente, Novolin®ge Ultralente, Novolin®ge NPH and Novolin®ge premixed insulin suspensions should not be used if the precipitate has become lumpy or granular in appearance or has formed a deposit of solid particles on the wall of the vial or cartridge. These insulin suspensions should also not be used if the contents remain clear after the vial or cartridge has been shaken carefully.

Storage: Insulin preparations including Penfill® cartridges should be stored between 2 and 10°C. They should not be exposed to heat or sunlight, and should never be frozen.

A vial in use can be kept at room temperature (max. 25°C) for 1 month. NovolinSet®ge and Novolin®ge Penfill® when used in Novo Nordisk insulin delivery systems can be in-use or carried as a spare for up to 1 month at ambient temperature (max. 37°C). When in use, Novo Nordisk insulin delivery systems and their cartridges should not be refrigerated.

Insulin should not be used after the expiry date printed on the package.