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).
- 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 pre-filled pen, OptiSet. It is a clear, colourless, aqueous solution with no particles visible.
Each pen contains 3 ml solution, equivalent to 300 Units. Packs of 1, 3, 4, 5, 6, 8, 9 and 10 pre-filled pens 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 (too 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.
OPTISET INSTRUCTIONS FOR USE
OptiSet is a pre-filled pen for the injection of insulin. Doses from 2 to 40 units can be set in steps of 2 units. Each pen contains multiple doses.
Talk with your healthcare professional about proper injection technique before using OptiSet.
Read these instructions carefully before using your OptiSet. If you are not able to follow all the instructions completely on your own, use OptiSet only if you have help from a person who is able to follow the instructions. Hold the pen as shown in this leaflet. To ensure that you read the dose correctly, hold the pen horizontally, with the needle on the left and the dosage selector to the right as shown in the illustrations below.
Follow these instructions completely each time you use OptiSet to ensure that you get an accurate dose. If you do not follow these instructions completely, you may get too much or too little insulin, which may affect your blood glucose.
If you have any questions about OptiSet or about diabetes, ask your healthcare professional or call the local sanofi-aventis number on the front of this leaflet.
Keep this leaflet for future reference each time you use OptiSet.
Schematic diagram of the pen
New information for use: - Name of the insulin is printed on the pen
- Dosage selector can only be turned in one direction
Important information for use of OptiSet:
Always attach a new needle before each use. Only use needles that have been approved for use with OptiSet. Always perform the safety test before each injection see Step 3. If you are using a new OptiSet the initial safety test must be done with the 8 units preset by the manufacturer. The dosage selector can only be turned in one direction. Never turn the dosage selector i.e. never change the dose after injection button has been pulled out. This pen is only for your use. Do not share it with anyone else. If your injection is given by another person, special caution must be taken by this person to avoid accidental needle injury and transmission of infection. Never use OptiSet if it is damaged or if you are not sure that it is working properly. Always have a spare OptiSet in case your OptiSet is lost or damaged.
Step 1. Check the insulin
A. Take off the pen cap.
B. Check the label on your OptiSet and insulin reservoir to make sure you have the correct insulin.
C. Check the appearance of your insulin. Apidra is a clear insulin. Do not use this OptiSet if the insulin is cloudy, coloured or has particles.
Step 2. Attach the needle
Always use a new sterile needle for each injection. This helps prevent contamination, and potential needle blocks.
Before use of needle, carefully read the ?Instructions for use? accompanying the needles. Please note: The needles shown are for illustrative purposes only.
A. Remove the protective seal from a new needle.
B. Line up the needle with the pen, and keep it straight as you attach it (screw or push on,
depending on the needle type).
- If the needle is not kept straight while you attach it, it can damage the rubber seal and cause leakage, or damage the needle.
Step 3. Perform a safety test
Always perform the safety test before each injection. This ensures that you get an accurate dose by: - making sure that pen and needle work properly
- removing air bubbles
If you are using a new OptiSet the initial safety test must be done with the 8 units preset by the manufacturer, otherwise the pen will not function properly.
A. Make sure the injection button is pressed in.
B. Select the dose for the Safety Test. New and unused OptiSet a dose of 8 units is already preset by the manufacturer for the first safety test. In-use OptiSet select a dose of 2 units by turning the dosage selector forward till the dose arrow points to 2. The dosage selector will only turn in one direction.
C. Pull out the injection button completely in order to load the dose. Never turn the dosage selector after injection button has been pulled out.
D. Take off the outer needle cap and keep it to remove the used needle after injection. Take off the inner needle cap and discard it. keep
E. Hold the pen with the needle pointing upwards.
F. Tap the insulin reservoir so that any air bubbles rise up towards the needle.
G. Press the injection button all the way in. Check if insulin comes out of the needle tip.
You may have to perform the safety test several times before insulin is seen.
- If no insulin comes out, check for air bubbles and repeat the safety test two more times to remove them.
- If still no insulin comes out, the needle may be blocked. Change the needle and try again. - If no insulin comes out after changing the needle, your OptiSet may be damaged. Do not use this OptiSet.
Step 4. Select the dose
You can set the dose in steps of 2 units, from a minimum of 2 units to a maximum of 40 units. If you need a dose greater than 40 units, you should give it as two or more injections.
A. Check if you have enough insulin for your dose.
The residual insulin scale on the transparent insulin reservoir shows approximately how much insulin remains in the OptiSet. This scale must not be used to set the insulin dose.
If the black plunger is at the beginning of the coloured bar, then there are approximately 40 units of insulin available.
If the black plunger is at the end of the coloured bar, then there are approximately 20 units of insulin available.
B. Select your required dose by turning the dose selector forward.
If you turned past your dose,
- and you have not yet pulled the injection button, you can keep turning forward till you reach your dose again,
- and you have already pulled the injection button out, you must discard the dose that has been loaded before you turn the dosage selector again.
Step 5. Load the dose
A. Pull out the injection button completely in order to load the dose.
B. Check if the selected dose is fully loaded. Note that the injection button only goes out as far as the
amount of insulin that is left in the reservoir.
- The injection button must be held out under tension during this check.
- The last thick line visible on the injection button shows the amount of insulin loaded. When the injection button is held out only the top part of this thick line can be seen.
- In this example, 12 units are loaded.
- if you have selected 12 units you can inject your dose.
- if you have selected more than 12 units then only 12 units of your total insulin dose can be injected with this pen.
In this case what should you do:
- either you can inject what is remaining in the pen and complete your dose with a new OptiSet. - or use a new OptiSet for your full dose.
Step 6. Inject the dose
A. Use the injection method as instructed by your health care professional.
B. Insert the needle into the skin.
C. Deliver the dose by pressing the injection button in all the way. A clicking sound can be heard, which will stop when the injection button has been pressed in completely.
D. Keep the injection button pressed in and slowly count to 10 before you withdraw the needle from the skin. This ensures that the full dose will be delivered.
The pen plunger moves with each dose. The plunger will reach the end of the cartridge when the total of 300 units of insulin have been used.
Step 7. Remove and discard the needle
Always remove the needle after each injection and store OptiSet without a needle attached. This helps prevent:
- Contamination and/or infection
- Entry of air into the insulin reservoir and leakage of insulin, which can cause inaccurate dosing.
A. Put the outer needle cap back on the needle, and use it to unscrew the needle from the pen. To
reduce the risk of accidental needle injury, never replace the inner needle cap.
B. Dispose of the needle safely, as instructed by your healthcare professional.
C. Put the pen cap back on, then store the pen until your next injection.
Please check Section 5 - How to store Apidra- of the reverse (insulin) side of this leaflet for OptiSet storage instructions.
If your OptiSet is in cool storage, take it out 1 to 2 hours before you inject to allow it to warm up to room temperature. Cold insulin is more painful to inject.
Discard your used OptiSet as required by your local regulations.
Protect your Optiset from dust and dirt.
You can clean the outside of your OptiSet by wiping it with a damp cloth.
Do not soak, wash or lubricate the pen as this may damage it.
Your OptiSet is designed to work accurately and safely. It should be handled with care. Avoid situations where OptiSet might be damaged. If you are concerned that your OptiSet may be damaged, discard it and use a new one.
Questions and Answers
Wrong dose selected. Follow the instructions in Step 4 to select the correct dose. Dose has been selected and the injection button has been pulled out and pressed in again without a needle attached. 1. Attach a new needle. 2. Press the injection button completely in and discard the insulin. 3. Perform the safety test. If the safety test is successful OptiSet is ready for use. If test is not successful, the pen might be damaged. Use a new OptiSet. If in any doubt whether the pen is working correctly use a new OptiSet. The dosage selector does not turn. You are turning in the wrong direction. The dosage selector can only be turned forward. You are turning forward while the injection button is pulled out. Press the injection button in completely to discard the dose and select again. The amount indicated on the injection button is higher than the dose selected. Difference is 2 units. Discard insulin, then set your dose and check again. If the same error occurs again, OptiSet may be damaged, use a new OptiSet. Difference is more than 2 units OptiSet is damaged, use a new OptiSet. The amount indicated on the injection button is lower than the dose required There is not enough insulin in the reservoir. You can do one of the following inject the amount indicated on the injection button from this OptiSet and then inject the remaining dose using a new OptiSet, or inject the entire dose using a new OptiSet. The injection button cannot be pressed in. 1. Make sure you pulled out the injection button completely. 2. Attach a new needle. 3. Press the injection button completely in to discard the insulin. Perform the safety test. You dont hear clicking OptiSet is damaged, use a new OptiSet. while injecting.
Insulin is leaking from the pen. Needle may have been attached imprecisely e.g. at a slant. Remove needle and replace with a new needle attaching it on straight see Step 2. Perform the safety test see Step 3. Air bubbles are present in the reservoir. Small amounts of air may be present in the needle and insulin reservoir during normal use. You must remove this air by performing the safety test see Step 3. The tiny air bubbles in the insulin reservoir that do not move with tapping will not interfere with the injection and dosage. Do not force it. Do not try to repair or use tools on it. OptiSet is damaged or is not working properly. Use a new OptiSet. OptiSet has been dropped or subjected to impact. If in any doubt whether the pen is working correctly use a new OptiSet.