Read the Patient Information Leaflet provided by your pharmacist before you start using this medication and each time you get a refill. If you have any questions, ask your doctor, diabetes educator, or pharmacist.

Learn all preparation and usage instructions from your health care professional and the product package.

Before using, check this product visually for particles or discoloration. If either is present, do not use the insulin. Insulin detemir should be clear and colorless.

Before injecting each dose, clean the injection site with rubbing alcohol. Change the injection site each time to lessen injury under the skin and to avoid developing problems under the skin (lipodystrophy). Insulin detemir may be injected in the stomach area, the thigh, or the back of the upper arm. Do not inject into a vein or muscle because very low blood sugar (hypoglycemia) may occur. Do not rub the area after the injection. Do not inject into skin that is red, swollen, or itchy. Do not inject cold insulin because this can be painful. The insulin container you are currently using can be kept at room temperature (see also Storage section). Do not shake the container.

Inject this medication under the skin as directed by your doctor, usually once or twice daily. Insulin detemir is usually injected with the evening meal or at bedtime. If you are using it twice a day, inject as directed by your doctor, usually your first dose in the morning and your second dose with the evening meal, at bedtime, or 12 hours after the morning dose.

This product should not be mixed with any other insulin. Do not use insulin detemir in an infusion pump.

Do not change brands or types of insulin without directions on how to do so from your doctor.

Do not share your pen device with another person, even if the needle is changed. You may give other people a serious infection, or get a serious infection from them. Learn how to store and discard medical supplies safely.

The dosage is based on your medical condition and response to treatment. Measure each dose very carefully because even small changes in the amount of insulin may have a large effect on your blood sugar.

Check your blood sugar regularly as directed by your doctor. Keep track of your results and share them with your doctor. This is very important in order to determine the correct insulin dose.

Use this medication regularly to get the most benefit from it. To help you remember, use it at the same times each day.

Tell your doctor if your condition does not improve or if it worsens (your blood sugar is too high or too low).

Injection site reactions (such as pain, redness, irritation) and swelling of the hands/feet may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: signs of low potassium level in the blood (such as muscle cramps, weakness, irregular heartbeat).

This medication can cause low blood sugar (hypoglycemia). This may occur if you do not consume enough calories from food or if you do unusually heavy exercise. Symptoms of low blood sugar include sudden sweating, shaking, fast heartbeat, hunger, blurred vision, dizziness, or tingling hands/feet. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you don't have these reliable forms of glucose, rapidly raise your blood sugar by eating a quick source of sugar such as table sugar, honey, or candy, or drink fruit juice or non-diet soda. Tell your doctor right away about the reaction and the use of this product. To help prevent low blood sugar, eat meals on a regular schedule, and do not skip meals. Check with your doctor or pharmacist to find out what you should do if you miss a meal.

Symptoms of high blood sugar (hyperglycemia) include thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, and fruity breath odor. If these symptoms occur, tell your doctor right away. Your dosage may need to be increased.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

A product that may interact with this drug is: rosiglitazone.

Beta-blocker medications (such as metoprolol, propranolol, glaucoma eye drops such as timolol) may prevent the fast/pounding heartbeat you would usually feel when your blood sugar falls too low (hypoglycemia). Other symptoms of low blood sugar, such as dizziness, hunger, or sweating, are unaffected by these drugs.

Many drugs can affect your blood sugar levels, making it more difficult to control your blood sugar. Before you start, stop, or change any medication, talk with your doctor or pharmacist about how the medication may affect your blood sugar. Check your blood sugar regularly as directed by your doctor. Tell your doctor about the results and of any symptoms of high or low blood sugar. (See also Side Effects section.) Your doctor may need to adjust your diabetes medication, exercise program, or diet.

Before using insulin detemir, tell your doctor or pharmacist if you are allergic to it; or to other types of insulins; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Do not use this medication when you have low blood sugar (hypoglycemia).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: adrenal/pituitary gland problems, kidney disease, liver disease, thyroid problems.

You may experience blurred vision, dizziness, or drowsiness due to extremely low or high blood sugar. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely.

Limit alcohol while taking this medication because it can increase the risk of developing low blood sugar.

It may be harder to control your blood sugar when your body is stressed (such as due to fever, infection, injury, or surgery). Consult your doctor because this may require a change in your treatment plan, medications, or blood sugar testing.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Check your blood sugar readings before and after exercise. You may need a snack before exercising.

If traveling across time zones, ask your doctor about how to adjust your insulinschedule. Take extra insulin and supplies with you.

Older adults may be more sensitive to the side effects of this drug, especially low blood sugar.

Children may be more sensitive to the side effects of this drug, especially low bloodsugar.

Tell your doctor right away if you are pregnant. Pregnancy may cause or worsen diabetes. Discuss a plan with your doctor for managing your blood sugar while pregnant. Your doctor may change your diabetes treatment during your pregnancy (such as diet and medications including insulin).

This medication passes into breast milk, but is unlikely to harm a nursing infant. Consult your doctor before breast-feeding. Your insulin needs may change while breast-feeding.

If you use this medicine for several days, it is important that your doctor check your progress to make sure that this medicine is working properly and to decide if you should continue to use it.

This medicine may cause drowsiness, trouble with thinking, or trouble with seeing clearly. Make sure you know how you react to this medicine before you drive, use machines, or do other jobs that require you to be alert, well-coordinated, or able to think or see well.

If you develop any unusual or strange thoughts and behavior while using scopolamine transdermal, be sure to discuss it with your doctor. Some changes that have occurred in people receiving this medicine are like those seen in people who drink too much alcohol. Other changes might be confusion, delusions, hallucinations (seeing, hearing, or feeling things that are not there), and unusual excitement, nervousness, or irritability.

Tell the doctor in charge that you are using this medicine before having a magnetic resonance imaging (MRI) scan. Skin burns may occur at the site where the patch is worn during this procedure. Ask your doctor if the patch should be removed before having an MRI scan. You might need to put on a new patch after the procedure.

Scopolamine transdermal will add to the effects of alcohol and other central nervous system (CNS) depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for allergies or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates or medicine for seizures; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your doctor before taking any of the above while you are using this medicine.

Scopolamine transdermal may cause dry mouth. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Incidence not known

• Blurred vision
• chest pain or discomfort
• difficulty with urinating
• dilation of the pupils
• dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
• eye pain
• flushing or redness of the skin
• mood or mental changes
• muscle weakness
• nausea or vomiting
• rash
• redness of the white part of the eyes
• restlessness
• seeing, hearing, or feeling things that are not there
• shortness of breath
• slow or irregular heartbeat
• sweating
• unusual tiredness
• unusually warm skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

• Anxiety
• blurred or loss of vision
• change in consciousness
• decrease in frequency of urination
• decrease in urine volume
• difficulty in passing urine (dribbling)
• disturbed color perception
• double vision
• dry mouth
• dry, flushed skin
• fast, pounding, or irregular heartbeat or pulse
• halos around lights
• headache
• hyperventilation
• irritability
• loss of consciousness
• nervousness
• night blindness
• overbright appearance of lights
• painful urination
• pounding in the ears
• seizures
• shaking
• sleepiness
• trouble with sleeping
• tunnel vision
• unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Potassium

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Bupropion
• Donepezil
• Tiotropium

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Use this medicine exactly as directed by your doctor. It will only work if applied correctly.

To use the patch:

• Wash your hands with soap and water before and after applying a patch. Do not touch your eyes until after you have washed your hands.
• Apply the patch right away after removing it from the protective pouch. Do not cut it into smaller pieces and do not touch the sticky surface of the patch.
• Apply the patch to a clean, dry, and intact skin area behind your ear. Choose an area with little or no hair and free of scars, cuts, or irritation.
• Press the patch firmly in place with your fingertips to make sure that the edges of the patch stick well.
• The patch should stay in place even during showering, bathing, or swimming. Apply a new patch behind the other ear if the first one becomes too loose or falls off.
• Remove the patch after 3 days. If treatment is to be continued for more than 3 days, remove the first patch and apply a new one behind the opposite ear.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For transdermal dosage form (skin patch):
  • For prevention of nausea and vomiting after anesthesia and surgery:
    • Adults—Apply one patch behind the ear the evening before surgery.
    • Children—Use is not recommended.
  • For prevention of nausea and vomiting from motion sickness:
    • Adults—Apply one patch behind the ear at least four hours before the effect is needed.
    • Children—Use is not recommended.

Missed Dose

If you forget to wear or change a patch, put one on as soon as you can. If it is almost time to put on your next patch, wait until then to apply a new patch and skip the one you missed. Do not apply extra patches to make up for a missed dose.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

After removing a used patch, fold the patch in half with the sticky sides together. Make sure to dispose of it out of the reach of children and pets.

Do not use VICTOZA if:

• You or a member of your family has ever had medullary thyroid cancer.
• You have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
• You are allergic to any of the ingredients in VICTOZA.
• You are pregnant or breastfeeding.

Talk about any health conditions or problems you may have, including if you:

• Or a member of your family has or has had medullary thyroid carcinoma, or if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
• Have type 1 diabetes.
• Have ever had diabetic ketoacidosis (increased ketones in the blood or urine).
• Have ever had an allergic reaction to VICTOZA.
• Have a high heart rate (fast pulse).
• Have a condition called heart block.
• Have any heart disease, such as angina, heart rhythm disturbances or congestive heart failure; or if you have ever had a myocardial infarction (heart attack).
• Have kidney problems.
• Have liver problems.
• Have gastrointestinal (digestive) problems.
• Have ever had pancreatitis.
• Are breastfeeding or plan to breastfeed.
• Are pregnant or plan to become pregnant.
• Have severe vomiting and/or diarrhea and/or dehydration.

When initiating treatment with VICTOZA, you may in some cases experience loss of fluids/dehydration, e.g. in case of vomiting, nausea and diarrhea. It is important to avoid dehydration by drinking plenty of fluids. Worsening of renal function may sometime require hemodialysis. Contact your doctor if you have any questions or concerns.

VICTOZA may increase heart rate and could cause changes known as PR prolongation, which are detected by electrocardiogram (ECG) tracings. Increased heart rate is the same as a faster pulse. Rarely, drugs with these effects can cause changes in heart rhythm that could result in dizziness, palpitations (a feeling of rapid, pounding, or irregular heart beat), fainting or death. These heart rhythm changes are more likely if you have heart disease, or if you are taking certain other drugs. It is important to follow your doctor's advice about the dose of VICTOZA or about any special tests that you may need.

VICTOZA is not recommended for use in children under 18 years of age.Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

In particular, tell your doctor, Diabetes Nurse Educator or pharmacist if you are using any of the following medicines for diabetes:

• A sulfonylurea medicine (such as glibenclamide or glimepiride). This is because using VICTOZA at the same time may cause your blood sugar to get too low (hypoglycemia).
• When you first start using these medicines together, your doctor may tell you to lower the dose of the sulfonylurea medicine.
• Insulin. You may get hypoglycemia (low blood sugar) when using VICTOZA with insulin as insulin increases the risk of hypoglycemia
• If you are not sure if the medicines you are taking contain a sulfonylurea, ask your doctor, Diabetes Nurse Educator or pharmacist.

Like all medicines, VICTOZA can cause side effects. The following side effects may happen with this medicine.

Very common (affect more than 1 in 10 people)

• Feeling sick (nausea). This usually goes away over time.
• Diarrhea.

Common (affects less than 1 in 10 people)

• Low blood sugar (hypoglycemia). This is usually mild. It is more likely if you are also taking a medicine for diabetes called a sulfonylurea. The warning signs of low blood sugar may come on suddenly. They can include: cold sweat, cool pale skin, headache, fast heart beat, feeling sick, feeling very hungry, changes in vision, feeling sleepy, feeling weak, nervous, anxious, or confused, difficulty concentrating, shaking (tremor). Your doctor will tell you how to treat low blood sugar and what to do if you notice these warning signs. If you are already taking a sulfonylurea medicine when you start using VICTOZA, your doctor may tell you to reduce the dose of the sulfonylurea. While you are driving or using tools or machines, you should avoid getting low blood sugar (hypoglycemia), because this may reduce your ability to concentrate.
• Anorexia.
• Decreased appetite.
• Headache.
• Being sick (vomiting).
• Burping.
• Indigestion.
• Inflamed stomach (gastritis). The signs include stomach pain, feeling sick (nausea) and being sick (vomiting).
• Gastro-esophageal reflux disease (GERD). The signs include heartburn.
• Painful or swollen tummy (abdomen).
• Constipation.
• Wind (flatulence).
• Infection of the upper airways.
• Injection site reactions (such as bruising, pain, irritation, itching and rash).
• Increased heart rate.

Since the market introduction of VICTOZA, cases of urticaria (a type of skin rash) have been reported.

The following list includes some, but not all, of the drugs that may increase the risk of heart rhythm problems while receiving VICTOZA. You should check with your doctor or pharmacist before taking any other medication with VICTOZA:

• Drugs to treat hypertension.
• Drugs to treat heart failure.
• Drugs to treat HIV infection.
• Drugs to treat attention deficit-hyperactivity disorder.
• Drugs to suppress appetite/cause weight loss.
• Decongestants.
• Drugs to treat asthma.

VICTOZA is an injection which is given under the skin (subcutaneously). Do not inject it into a vein or muscle. Before you use the pen for the first time, your doctor or Diabetes Nurse Educator will show you how to use it. The best places to give yourself the injection are the front of your thighs, the front of your waist (abdomen) or your upper arm. You can give yourself the injection at any time of the day Do not share your VICTOZA pen with anyone else, even if the needle is changed. Do not reuse or share needles with another person including family members. You may give another person an infection or get an infection from them.

Overdose:

If you think you have taken too much VICTOZA, contact your health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

If you use more VICTOZA than you should, talk to your doctor straight away. You may need medical treatment. If you use too much VICTOZA you may feel sick (have nausea) or become sick (vomit).

Missed Dose:

If a dose of VICTOZA is missed take your dose on the next day as usual. Do not take an extra dose or increase the dose on the following day to make up for the missed dose.

Do not stop using VICTOZA without talking to your doctor. If you stop using it, your blood sugar levels may increase.

Usual dose:

The dosage of APIDRA should be individualized and determined based on your health professional’s advice in accordance with your needs.

APIDRA should be given by subcutaneous injection within 15 minutes before a meal or within 20 minutes after starting a meal.

Many factors may affect your usual APIDRA dose, which may include changes in your diet, activity, or work schedule. Follow your health professional’s instructions carefully. Consult your health professional if you notice your insulin requirements changing markedly. Other factors that may affect your dose of insulin or your need to do additional blood/urine testing are:

Illness:

Illness, especially with nausea and vomiting, diarrhea and/or fever, may change how much insulin you need. Even if you are not eating, you will still require insulin. You and your health professional 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 health professional as instructed.

Pregnancy:

If you are planning to have a baby, are pregnant, or are nursing a baby, consult your health professional. Good control of diabetes is especially important for you and your unborn baby. Pregnancy may make managing your diabetes more difficult.

Medication:

Always discuss any medications you are taking, prescription or “over-the-counter”, with your health professional. To prevent drug interactions, volunteer the names of everything you are taking even before they ask if there have been any changes. Insulin requirements may be increased in the presence of drugs with hyperglycemic activity, such as contraceptives (for example, birth control pills, injections and patches) and hormone replacement therapies, corticosteroids, thyroid replacement therapy, and sympathomimetic agents such as decongestants and diet pills. Insulin requirements may be reduced in the presence of drugs with hypoglycemic activity, such as oral antidiabetic agents, salicylates (for example, aspirin), sulfa antibiotics, blood pressure medications including ACE inhibitors, and certain psychiatric medications including MAO inhibitors or antidepressants and anti-anxiety medications.

Substances including beta-blockers, used for conditions including blood pressure, heart arrhythmias, palpitations and headache, and alcohol may enhance or weaken the blood-glucose-lowering effect of insulins, and signs of hypoglycemia may be reduced or absent.

Exercise:

If your exercise routine changes, discuss with your health professional the possible need to adjust your insulin regimen. Exercise may lower your body's need for insulin during and for some time after the activity. As for all insulins, the rate of absorption, and consequently the onset and duration of action, may be affected by exercise and other variables.

Travel:

Consult your health professional concerning possible adjustments in your insulin schedule if you will be traveling across time zones. You may want to take along extra insulin and supplies whenever you travel.

Missed dose:

If you have missed a dose of APIDRA or if you have not injected enough insulin, your blood sugar level may become too high (hyperglycemia). Check your blood sugar frequently. Do not take a double dose to make up for a forgotten dose.

Overdose:

If you have injected too much APIDRA, your blood sugar level may become too low (hypoglycemia). Check your blood sugar frequently. In general, to prevent hypoglycemia you must eat more food and monitor your blood sugar.

Hypoglycemia may occur as a result of an excess of insulin relative to food intake, energy expenditure, or both.

In severe cases, coma, seizure and brain disorders may be seen and treated with glucagon (injected in the muscle or subcutaneous tissue) or glucose (injected in the vein).

You should continue checking your blood sugar even if you feel better because hypoglycemia may recur.

In case of drug overdose, contact a health professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Hyperglycemia (too much glucose in the blood) may develop if your body has too little insulin.

Hyperglycemia can be brought about by:

• intercurrent conditions (illness, stress, or emotional disturbances),

• not taking your insulin or taking less than recommended by your health professional,

• malfunction and/or misuse of medical devices,

• eating significantly more than your meal plan suggests,

• a new insulin type or schedule,

• some new medications, including prescriptions, over-the-counter medications, herbs, vitamins and street drugs.

Symptoms of hyperglycemia include:

• confusion or drowsiness,

• increased thirst,

• decreased appetite, nausea, or vomiting,

• rapid heart rate,

• increased urination and dehydration (too little fluid in your body),

• blurred vision,

• flushed dry skin,

• acetone odour of breath.

Hyperglycemia can be mild or severe. It can progress to high glucose levels, diabetic ketoacidosis (DKA), and result in unconsciousness and death.

Diabetic ketoacidosis (DKA):

The first symptoms of diabetic ketoacidosis usually come on over a period of hours or days. With ketoacidosis, urine tests show large amounts of glucose and acetone.

Symptoms of diabetic ketoacidosis include:

First symptoms:

• drowsiness,

• flushed face,

• thirst,

• loss of appetite,

• fruity smelling breath,

• rapid, deep breathing,

• abdominal (stomach area) pain.

Severe symptoms:

• heavy breathing,

• rapid pulse.

Prolonged hyperglycemia or diabetic ketoacidosis can lead to:

• nausea,

• vomiting,

• dehydration,

• loss of consciousness,

• death.

Severe or continuing hyperglycemia or DKA requires prompt evaluation and treatment by your health professional.

Allergic reactions:

In rare cases, a patient may be allergic to an insulin product. Severe insulin allergies may be life-threatening. If you think you are having an allergic reaction, seek medical help immediately.

Signs of insulin allergy include:

• a rash all over your body,

• shortness of breath,

• wheezing (trouble breathing),

• a fast pulse,

• sweating,

• low blood pressure.

Possible reactions on the skin at the injection site:

Injecting insulin can cause the following reactions on the skin at the injection site:

• a little depression in the skin (lipoatrophy),

• skin thickening (lipohypertrophy),

• redness, itching, swelling, or hemorrhage at injection site.

In some instances, these reactions may be related to factors other than insulin, such as irritants in the skin cleansing agent or poor injection technique. You can reduce the chance of getting an injection site reaction if you change the injection site each time. If you have local injection site reactions, contact your health professional.

This is not a complete list of side effects. For any unexpected effects while taking APIDRA, contact your health professional.

Other medicines, including non-prescription medicines, and dietary supplements (such as vitamins) can change the way insulin works. Your dose of insulin or other medications may need to be changed in consultation with your healthcare professional.

Serious Warnings and Precautions

• Hypoglycemia (low blood sugar) is the most common adverse effect of insulin, including APIDRA.
• Blood glucose (blood sugar) monitoring is recommended for all patients with diabetes.
• Uncorrected hypoglycemic (low blood sugar) or hyperglycemic (high blood sugar) reactions can cause loss of consciousness, coma, or death.
• Any change of insulin should be made cautiously and only under medical supervision. This may result in dosage adjustment.
• When used as a meal time insulin, the dose of APIDRA should be given within 15 minutes before or within 20 minutes after starting a meal.
• APIDRA given by subcutaneous injection should generally be used in regimens with an intermediate or long-acting insulin. APIDRA can also be used alone in insulin infusion pump therapy to maintain adequate glucose control.
• APIDRA can be mixed with NPH human insulin (except when administered with pump).
• Insulin products shall not be used if it is not water-clear and colourless or if it has formed a deposit of solid particles on the wall of the vial or cartridge.

In some situations, your need in insulin may change, for example if you are stress or suffering from other illnesses (e.g. infections).

Your diabetes may also be more difficult to control if you suffer from acromegaly (too much growth hormone), Cushing’s syndrome (too much cortisol hormone), hyperthyroidism (too much thyroid hormone) or have a pheochromocytoma (tumor of the adrenal glands).

If you also take other oral drugs to reduce your blood sugar, their dose may need to be adjusted.

The use of thiazolidinediones (such as rosiglitazone and pioglitazone), alone or in combination with other antidiabetic agents (including insulin), has been associated with heart failure and swelling of the lower extremities. Please contact your physician immediately if you develop symptoms of shortness of breath, fatigue, exercise intolerance, or swelling of the lower extremities while you are on these agents.

Hypokalemia (low potassium) is a possible side effect. You might be more at risk if you are on potassium lowering drugs or losing potassium (e.g. diarrhea).

Always keep an extra supply of insulin as well as the appropriate injection supplies on hand. Always wear medical alert identification and carry information about your diabetes so that appropriate treatment can be given if complications occur away from home.

Accidental mix-ups between insulin glulisine and other insulins, particularly long-acting insulins, have been reported. To avoid medication errors between insulin glulisine and other insulins, patients should be instructed to always check the insulin label before each injection.

Your needles and syringes are only for you and must not be shared to avoid disease transmission.

BEFORE you use APIDRA talk to your health professional if:

• you are planning to have a baby, are pregnant, or are nursing a baby;
• you drink alcohol;
• you are ill;
• you exercise more than usual or if you want to change your usual diet;
• you are traveling;
• you drive or use tools or machine;
• you have trouble with your kidneys or liver;
• you are taking any other medication.

Your ability to concentrate or react may be reduced if you have hypoglycemia (low blood sugar) or hyperglycemia (high blood sugar). Please keep these possible problems in mind in all situations where you might put yourself or others at risk (for example driving a car or operating machinery).

You should contact your doctor about the advisability of driving if you have:

• frequent episodes of hypoglycemia
• reduced or absent warning signs of hypoglycemia.