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<DOCUMENT author="perl program" datec=020199 title="leaflet" book="ABPI" edition="1996-97" section="company">
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Actrapid Pen
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<BLOCK>
Please read this carefully before you start to take your insulin . This leaflet provides a summary of the information available on your insulin. If you have any questions or are not sure about anything, ask your doctor or pharmacist.
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<DIV type=1>

<HEAD>
The name of your insulin is: Actrapid Pen (Insulin Injection BP)
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<BLOCK>
This preparation contains insulin [Human insulin (pyr)] which is identical to the insulin produced by the human pancreas. Insulin preparations supplement or replace the insulin that your own pancreas produced before you developed diabetes. They allow your body to continue converting the carbohydrates you eat into energy.
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<HEAD weight="bold" >
Things to remember about Actrapid Pen
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Take your insulinTake your  
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*
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**
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<BLOCK>
More detailed information about Actrapid Pen is given below.
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<BLOCK>
Actrapid Pen is used for the treatment of insulin-requiring diabetics. It is a disposable dial-a-dose insulin delivery device ("Pen"), able to deliver 2-78 units in increments of 2 units and containing a neutral solution of human insulin (pyr). The insulin preparation in this device (Insulin Injection) is a short-acting insulin; it is a clear liquid.
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 Taking your insulin
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Before taking your insulin, be sure you do not have hypoglycaemia, i.e. low blood sugar or 'hypo-. You must not take insulin if you have hypoglycaemia (see *Possible Problems).
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<BLOCK>
Be sure your insulin is the same as usual; changes in type of insulin without your doctors knowledge can cause problems such as hypoglycaemia.
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<BLOCK>
It is important to take your insulin at the right times. Take it as advised by your doctor. If you are unsure of anything ask your doctor.
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<BLOCK>
Before each injection make sure the injection site is clean. Injections should not be given at exactly the same place each time, as they might cause fatty lumps to develop at the injection site. This may affect your diabetic control.
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<BLOCK>
Carefully read the Instructions for Use, below, before using your Pen.
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<BLOCK>
Always perform an "air shot" prior to each injection, this will release any air which may have collected and ensures the correct functioning of the Pen.
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<BLOCK>
The insulin injection is usually given subcutaneously. Follow your doctors instructions concerning injection techniques.
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<HEAD weight="bold" >
Pregnancy
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<BLOCK>
If you are pregnant consult your doctor immediately. If you are planning to become pregnant, consult your doctor well in advance to discuss your diabetic control and insulin requirements.
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<HEAD weight="bold" >
Illness
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<BLOCK>
Illness is likely to alter (usually increase) your insulin requirements and your dose may need to be adjusted. Do not stop taking your insulin even if you are eating much less than normal.
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<BLOCK>

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Other medicines
</EMPH>
 Other medicines can affect your diabetic control. If you start on corticosteroids, oral contraceptives (the "pill") or thyroid hormone replacement therapy you may require more insulin, whereas if you start on monoamine oxidase inhibitors (MAOI; some medicines used for the treatment of depression) or beta blockers (medicines used for treating high blood pressure, heart disease and glau- <CB n=2> coma) you may require less insulin. Beta blockers may also blur the symptoms of hypoglycaemia. Always notify your doctor if you are taking any other medicines, even if obtained without a prescription.
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<HEAD weight="bold" >
Exercise
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<BLOCK>
If you take physical exercise you will probably need to lower your insulin dose. Get advice from your doctor and always have extra carbohydrate (sugar or glucose tablets) available. The effect of exercise on your blood sugar can last for many hours after you have actually stopped exercising.
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<HEAD weight="bold" >
Driving or operating machinery
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<BLOCK>
Hypoglycaemia (low blood sugar) can seriously impair your ability to drive or operate machinery. You should discuss with your doctor whether it is safe for you to drive or operate machinery, particularly if you have just started on insulin, if you have difficulty recognising the symptoms of hypoglycaemia, or if you have recently experienced changes in your diabetic control. Never drive or operate machinery for more than 2 hours without a break for a snack.
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<HEAD weight="bold" >
Alcohol
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<BLOCK>
Remember, alcohol should be taken with caution as it may lead to hypoglycaemia (low blood sugar). Never drink alcohol on an empty stomach.
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<HEAD ltag="bullet" >
*Possible problems with insulin treatment Hypoglycaemia (low blood sugar)
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<BLOCK>
It is important not to let your blood sugar levels fall too low. You should always carry some form of sugar with you .
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<BLOCK>
Low blood sugar levels or hypo's can be caused by:
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<ITEM>

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Too much insulin
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</ITEM>


<ITEM>

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Eating too little or missing a meal
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</ITEM>


<ITEM>

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Unplanned exercise
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</ITEM>


<ITEM>

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Drinking alcohol
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</ITEM>


<ITEM>

<BLOCK>
Some medicines
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<BLOCK>
Because of its strong initial effect, the injection of Actrapid Pen should be followed by a meal within approximately 30 minutes of giving it, to avoid hypoglycaemia.
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<BLOCK>
The symptoms of low blood sugar differ from one person to another and you will learn to recognise your own symptoms. Early symptoms and signs often include: sweating, shakiness, mood changes, and paleness. If blood sugar levels fall even lower, this may cause tiredness, dizziness, faintness, hunger and tingling in the hands and feet.
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<BLOCK>
If your doctor has asked you to intensify your insulin treatment in order to improve your blood sugar levels, you may at some point lose some of the warning symptoms (such as shakiness, pounding heart beat, sweating and feeling anxious) which usually occur when your blood sugar is falling too low (hypoglycaemia). In this case it is important to think carefully about the timing of your meals, to bear in mind the exercise you take, and to keep a close watch on your blood sugar by frequent blood glucose testing. This is particularly important if you are driving.
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<HEAD weight="bold" >
Treatment of hypoglycaemia
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<BLOCK>
If you feel you may be suffering a hypo you should, without delay eat food containing carbohydrate, preferably as glucose tablets or sugar. If low blood glucose is not corrected this can lead to loss of consciousness. It is, therefore, important that close friends and relatives know what to do if this occurs. It is also advisable to carry or wear something stating that you are being treated with insulin.
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<BLOCK>
If you lose consciousness due to hypoglycaemia your relatives or close friends may have been taught to give you a subcutaneous or intramuscular injection of glucagon. You should always take sugar or glucose on recovery. If you do not respond to glucagon or it is not available, your relatives and close friends should know to call a doctor immediately so that intravenous glucose can be given.
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continued
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<HEAD weight="bold" >
Hyperglycaemia (high blood sugar)
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<BLOCK>
This results from taking too little insulin in relation to your food intake or exercise. If your blood sugar is high you are likely to be very thirsty and will need to pass urine frequently. Prolonged high blood sugar may eventually lead to coma. If your blood sugar level rises to high levels check your urine for ketones. If ketones are present contact your doctor immediately.
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<HEAD weight="bold" >
Side effects
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<BLOCK>
Side effects to insulin are rare. The most common is itching or redness at the site of injection. If you experience any skin reaction at the injection side, tell your doctor as soon as possible.
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<BLOCK>
When insulin treatment is first started you may get swollen feet and blurred vision in the first week or so. These problems usually disappear with continued treatment; tell your doctor if they persist.
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<HEAD weight="bold" >
Changing to human insulin
</HEAD>


<BLOCK>
You should only change to human insulin on your doctor’s advice.
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<BLOCK>
Transfer from porcine to human insulin of the same type, does not normally require a change in dosage.
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<BLOCK>
Transfer from bovine or mixed bovine/porcine insulins to human insulin may require a dosage adjustment; follow your doctors advice on this.
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<BLOCK>
A few patients have reported that after being transferred to human insulin, the early warning symptoms for hypoglycaemia were less pronounced than they were with animal source insulins.
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<HEAD ltag="bullet" >
**Storage of disposable pen preparations
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<BLOCK>
As with all insulin preparations, store your full packs of disposable pens, and pens not in use, in a refrigerator at 2° to 8°C, but do not allow the insulin to freeze.
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<BLOCK>
Pens which are in use must not be kept in a refrigerator. Pens in use or carried as a spare can be kept at normal surrounding temperature (e.g. in the pocket or handbag) for up to one month, but should not be exposed to excessive heat or sunlight.
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<HEAD weight="bold" >
What's in your medicine
</HEAD>


<BLOCK>
Actrapid Pen contains 3 ml of a solution of human insulin (pyr) in a strength of 100 iu/ml; it is a clear, colourless liquid. Actrapid Pen also contains glycerol, and m-cresol as added preservative.
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</DIV>
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<HEAD weight="bold" >
Instructions for use
</HEAD>


<BLOCK>
Please read these instructions carefully before using your disposable Pen.
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<BLOCK>
Actrapid Pen must only be used with NovoFine needles.
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<HEAD ltag="bullet" >
Preparing the Pen
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<BLOCK>
Check that your Pen contains the correct type of insulin. Pull off the cap.
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<BLOCK>
Disinfect the rubber membrane.
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Remove the protective tab from a NovoFine needle and screw the needle onto the Pen. Pull off the outer and inner needle caps.
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<BLOCK>
"Air shot": Small amounts of air may collect in the needle and reservoir during normal use. To avoid the injection of air hold the Pen with the needle upwards and tap the reservoir gently with the finger, so any air bubbles collect in the top of the reservoir.
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<ITEM>

<BLOCK>
Keeping the Pen with the needle upwards turn the reservoir one click in the direction of the arrow.
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<ITEM>

<BLOCK>
Still with the needle upwards press the push button fully home, and see if a drop of insulin appears at the needle tip. If not, repeat the procedure until a drop of insulin is seen at the needle tip.
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</ITEM>

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<BLOCK>
Some air may remain in the insulin reservoir after this but it will not be injected.
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Setting the dose
</EMPH>
 <FIGURE></FIGURE>
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</ITEM>


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Replace the cap so that 
<EMPH weight="bold">
0
</EMPH>
 is opposite the dosage indicator.
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</ITEM>


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<FIGURE></FIGURE>
<ITEM>

<BLOCK>
Hold the Pen horizontally and turn the cap in the direction of the arrow to set the required dose.
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</LIST>



<BLOCK>
Be careful not to put your hand over the push button when dialling the dose. If the button is not allowed to rise freely, insulin will be pushed out of the needle.
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<BLOCK>
The scale on the cap shows 
<EMPH weight="bold">
0, 2, 4, 6, 8,10,12,14,16
</EMPH>
 and 
<EMPH weight="bold">
18
</EMPH>
 units. For every click you feel when you turn the cap 2 units are set.
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<BLOCK>
As the cap is turned the push button rises. The scale under the push button shows 
<EMPH weight="bold">
20, 40
</EMPH>
 and 
<EMPH weight="bold">
60
</EMPH>
 units. Every time you fully turn the cap 20 units will be set <FIGURE></FIGURE>
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<LIST type="ordered">

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<BLOCK>
To check the dose set add the figure on the cap opposite the dosage indicator to the highest figure revealed on the push button scale.
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<HEAD weight="bold" >
Dosage examples
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<BLOCK>
8 units:
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<BLOCK>
Turn the cap until 
<EMPH weight="bold">
8
</EMPH>
 is opposite the dosage indicator
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<BLOCK>
52 units:
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<BLOCK>
Turn the cap 2 full turns so 
<EMPH weight="bold">
0
</EMPH>
 is opposite the dosage indicator again. The 40 number will show on the push button scale. Continue turning until 
<EMPH weight="bold">
12
</EMPH>
 is opposite the dosage indicator (see 
<EMPH weight="bold">
F
</EMPH>
)
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<BLOCK>
If you have a set a wrong dose, simply turn the cap forwards or backwards until the right number of units has been set.
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<BLOCK>
78 units is the maximum dose. If you attempt to set a higher dose, excess insulin will be expelled from the needle and the dose will be wrong.
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<BLOCK>
If you set more than 78 units turn the cap back as far as you can until the push button is firmly home and resistance is felt. Now start again, remembering that 78 units is the maximum dose. After the dose is set, remove the cap to make the injection.
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<HEAD ltag="bullet" >
Making the injection
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<BLOCK>
Use the injection technique advised by your doctor. Deliver the dose by pressing the push button firmly home. To allow the insulin to distribute under the skin allow the needle to remain in the skin for a few seconds.
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<BLOCK>
After injection the outer needle cap is replaced, the <PB n=4> <CB n=2> needle is unscrewed and carefully discarded. The cap is replaced with 
<EMPH weight="bold">
0
</EMPH>
 opposite the dosage indicator.
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</DIV>
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<HEAD ltag="bullet" >
Subsequent injections
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<BLOCK>
Always check that the push button is fully home. If not, turn the cap until the push button is completely down then proceed as described above 1-3.
</BLOCK>


<BLOCK>
You cannot set a dose greater than the number of units remaining in the reservoir. The indicator for remaining insulin can be used to estimate the amount of insulin still to be used, but must not be used for dose selection.
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<BLOCK>
Discard the used Pen carefully, without the needle attached.
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</DIV>
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<HEAD ltag="bullet" >
Important
</HEAD>




<BLOCK>
Expel air before each injection, until a drop of insulin appears at the needle tip.
</BLOCK>


<BLOCK>
The needle must be removed after each injection. If it is not removed, temperature changes may expel liquid out of the needle and the insulin concentration may change.
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<BLOCK>
Do not use the indicator for remaining insulin to measure the amount of insulin to be injected.
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<BLOCK>
Care should be taken not to drop the Pen or subject it to impact or misuse.
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<BLOCK>
Keep out of the reach of children.
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<BLOCK>
Used Pens can be discarded in household waste, but do not leave the needle attached. Dispose of the needle carefully, as recommended by your doctor or diabetic clinic.
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</DIV>

</DIV>
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Remember
</HEAD>


<BLOCK>
These insulin Pens have been prescribed by your doctor for your use only. They must not be used by anyone else.
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<BLOCK>
Are you a member of a Diabetic Association ? If not, and you would like to have further information about it, please write to:
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<BLOCK>
The British Diabetic Association 10 Queen Anne Street London W1M 0BD
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