What Apidra contains
- The active substance is insulin glulisine. Each ml of the solution contains 100 Units of insulin glulisine (equivalent to 3.49 mg). Each vial contains 10 ml of solution for injection, equivalent to 1000 Units.
- The other ingredients are: metacresol, sodium chloride, trometamol, polysorbate 20, concentrated hydrochloric acid, sodium hydroxide, water for injections.
What Apidra looks like and contents of the pack
Apidra 100 Units/ml solution for injection in a vial is a clear, colourless, aqueous solution with no particles visible.
Each vial contains 10 ml solution (1000 Units). Packs of 1, 2, 4 and 5 vials are available. Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Sanofi-Aventis Deutschland GmbH
D-65926 Frankfurt am Main
Sanofi-Aventis Deutschland GmbH
Industriepark Höchst, D-65926 Frankfurt
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
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This leaflet was last approved in
HYPERGLYCAEMIA AND HYPOGLYCAEMIA
Always carry some sugar (at least 20 grams) with you.
Carry some information with you to show you are a person with diabetes.
HYPERGLYCAEMIA (high blood sugar levels)
If your blood sugar is too high (hyperglycaemia), you may not have injected enough insulin.
Why does hyperglycaemia occur?
- you have not injected your insulin or not injected enough, or if it has become less effective, for example through incorrect storage,
- you are doing less exercise than usual, you are under stress (emotional distress, excitement), or you have an injury, operation, infection or fever,
- you are taking or have taken certain other medicines (see section 2, "Using other medicines").
Warning symptoms of hyperglycaemia
Thirst, increased need to urinate, tiredness, dry skin, reddening of the face, loss of appetite, low blood pressure, fast heart beat, and glucose and ketone bodies in urine. Stomach pain, fast and deep breathing, sleepiness or even loss of consciousness may be signs of a serious condition (ketoacidosis) resulting from lack of insulin.
What should you do if you experience hyperglycaemia?Test your blood sugar level and your urine for ketones as soon as any of the above symptoms occur. Severe hyperglycaemia or ketoacidosis must always be treated by a doctor, normally in a hospital.
HYPOGLYCAEMIA (low blood sugar levels)
If your blood sugar level falls too much you may become unconscious. Serious hypoglycaemia may cause a heart attack or brain damage and may be life-threatening. You normally should be able to recognise when your blood sugar is falling too much so that you can take the right actions.
Why does hypoglycaemia occur?
- you inject too much insulin,
- you miss meals or delay them,
- you do not eat enough, or eat food containing less carbohydrate than normal (sugar and substances similar to sugar are called carbohydrates; however, artificial sweeteners are NOT carbohydrates),
- you lose carbohydrates due to vomiting or diarrhoea,
- you drink alcohol, particularly if you are not eating much,
- you are doing more exercise than usual or a different type of physical activity,
- you are recovering from an injury or operation or other stress,
- you are recovering from an illness or from fever,
- you are taking or have stopped taking certain other medicines (see section 2, "Using other medicines").
Hypoglycaemia is also more likely to occur if:
- you have just begun insulin treatment or changed to another insulin preparation,
- your blood sugar levels are almost normal or are unstable,
- you change the area of skin where you inject insulin (for example from the thigh to the upper arm),
- you suffer from severe kidney or liver disease, or some other disease such as hypothyroidism.
Warning symptoms of hypoglycaemia
Examples of symptoms that tell you that your blood sugar level is falling too much or too fast: sweating, clammy skin, anxiety, fast heart beat, high blood pressure, palpitations and irregular heartbeat. These symptoms often develop before the symptoms of a low sugar level in the brain.
Examples of symptoms that indicate a low sugar level in the brain: headaches, intense hunger, nausea, vomiting, tiredness, sleepiness, sleep disturbances, restlessness, aggressive behaviour, lapses in concentration, impaired reactions, depression, confusion, speech disturbances (sometimes total loss of speech), visual disorders, trembling, paralysis, tingling sensations (paraesthesia), numbness and tingling sensations in the area of the mouth, dizziness, loss of self-control, inability to look after yourself, convulsions and loss of consciousness.
The first symptoms which alert you to hypoglycaemia ("warning symptoms") may change, be weaker or may be missing altogether if:
- you are elderly,
- you have had diabetes for a long time,
- you suffer from a certain type of nervous disease (diabetic autonomic neuropathy),
- you have recently suffered hypoglycaemia (for example the day before) or if it develops slowly,
- you have almost normal or, at least, greatly improved blood sugar levels,
- you are taking or have taken certain other medicines (see section 2, "Using other medicines.)
In such a case, you may develop severe hypoglycaemia (and even faint) before you are aware of the problem. Be familiar with your warning symptoms. If necessary, more frequent blood sugar testing can help to identify mild hypoglycaemic episodes that may otherwise be overlooked. If you are not confident about recognising your warning symptoms, avoid situations (such as driving a car) in which you or others would be put at risk by hypoglycaemia.
What should you do if you experience hypoglycaemia?
1. Do not inject insulin. Immediately take about 10 to 20 g sugar, such as glucose, sugar cubes or a sugar-sweetened beverage. Caution: Artificial sweeteners and foods with artificial sweeteners (such as diet drinks) are of no help in treating hypoglycaemia.
2. Then eat something that has a long-acting effect in raising your blood sugar (such as bread or pasta). Your doctor or nurse should have discussed this with you previously.
3. If the hypoglycaemia comes back again take another 10 to 20 g sugar.
4. Speak to a doctor immediately if you are not able to control the hypoglycaemia or if it recurs.
Tell your relatives, friends and close colleagues the following:
If you are not able to swallow or if you are unconscious, you will require an injection of glucose or glucagon (a medicine which increases blood sugar). These injections are justified even if it is not certain that you have hypoglycaemia.
It is advisable to test your blood sugar immediately after taking glucose to check that you really have hypoglycaemia.
THE FOLLOWING INFORMATION IS INTENDED FOR MEDICAL OR HEALTHCARE PROFESSIONALS ONLY:
Apidra can be administered intravenously, which should be carried out by health care professionals. Instruction for intravenous administration
Apidra should be used at a concentration of 1 Unit/ml insulin glulisine in infusion systems with sodium chloride 9 mg/ml (0.9%) solution for infusion with or without 40 mmol/l potassium chloride using coextruded polyolefin/polyamide plastic infusion bags with a dedicated infusion line. Insulin glulisine for intravenous use at a concentration of 1 Unit/ml is stable at room temperature for 48 hours.
After dilution for intravenous use, the solution should be inspected visually for particulate matter prior to administration. Never use the solution if it has become cloudy or contains particles; use it only if it is clear and colourless.
Apidra was found to be incompatible with Glucose 5% solution and Ringer?s solution and, therefore, must not be used with these solution fluids. The use of other solutions has not been studied.