Mixtard® 30 Pen
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.
The name of your insulin is: Human Mixtard 30 Pen (Biphasic Isophane Insulin Injection 30/70 BP)
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.
Things to remember about Human Mixtard 30
You can find these listed below**
Further details are given below***
More detailed information about Human Mixtard 30 Pen is given below.
Human Mixtard 30 Pen is used for the treatment of insulin-requiring diabetics. It is a disposable dial-a-dose insulin delivery device able to deliver 2-78 units in increments of 2 units and containing a mixture of soluble and isophane human insulin (pyr) in the ratio 30:70. The insulin preparation in this device (Biphasic Isophane Insulin Injection BP) is an intermediate-acting insulin (due to the isophane insulin component) with a strong initial effect; the ratio of soluble to isophane insulin gives a measure of the intensity of the initial effect (eg 10/90 low, 50/50 high). Human Mixtard 30 Pen is a suspension which appears white and cloudy when shaken.
* Taking your insulin
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).
Be sure your insulin is the same as usual; changes in type of insulin without your doctor’s knowledge can cause problems such as hypoglycaemia.
It is important to take your insulin at the right time. Take it as advised by your doctor. If you are unsure of anything ask your doctor.
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.
Human Mixtard 30 Pen must be resuspended before use by agitating the device up and down until the insulin appears uniformly white and cloudy. A glass ball is included in the insulin reservoir to make resuspension easier. The dose should then be immediately injected.
Carefully read the Instructions for Use, below, before using your Pen.
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.
The insulin injection is usually given subcutaneously. Follow your doctors instructions concerning injection techniques.
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.
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.
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 glaucoma) 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.
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.
Driving or operating machinery
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.
Remember, alcohol should be taken with caution as it may lead to hypoglycaemia (low blood sugar). Never drink alcohol on an empty stomach.
**Possible problems with insulin treatment
Hypoglycaemia (low blood sugar)
It is important not to let your blood sugar levels fall too low. You should always carry some form of sugar with you .
Low blood sugar levels or hypo's can be caused by:
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.
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.
Treatment of hypoglycaemia
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.
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.
Hyperglycaemia (high blood sugar)
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.
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.
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.
Changing to human insulin
You should only change to human insulin on your doctor’s advice.
Transfer from porcine to human insulin of the same type, does not normally require a change in dosage.
Transfer from bovine or mixed bovine/porcine insulins to human insulin may require a dosage adjustment; follow your doctors advice on this.
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.
***Storage of disposable pen preparations
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.
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.
What's in your medicine
Human Mixtard 30 Pen contains 3 ml of a suspension of human insulin (pyr) in a strength of 100 iu/ml. The suspension appears white and cloudy when shaken. Human Mixtard 30 Pen also contains glycerol, sodium phosphate, protamine sulphate as retarding agent and m-cresol and phenol as added preservative.
Important information for users of Human Mixtard 30 Pen
The product was formerly called PenMix 30/70.
Do not use any of the products of Human Insulatard or Human Mixtard 30/70 with dark blue or dark pink packaging respectively. This is older stock which contains Human insulin (emp); these products were discontinued in April 1995.
If you used Human Insulatard, or Human Mixtard 30/70 prior to April 1995 who should follow your doctor’s advice with regard to dosage change on transfer to Human Mixtard 30 Pen. Monitor your blood glucose more carefully for some time after transfer; diabetic care may need to be increased during this period. If you notice changes in your usual range of blood glucose requirements during this time you should discuss this with your diabetes specialist.
Instructions for use
Please read these instructions carefully before using your disposable Pen.
Human Mixtard 30 Pen must only be used with NovoFine® needles.
Check that your Pen contains the correct type of insulin. Pull off the cap.
Disinfect the rubber membrane.
Turn the Pen up and down between A and B so the glass ball is moved from one end of the reservoir to the other. Do this at least 10 times, until the liquid appears uniformly white and cloudy.
Disinfect the rubber membrane.
"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.
Some air may remain in the insulin reservoir after this but it will not be injected.
2. Setting the dose
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.
The scale on the cap shows 0, 2, 4, 6, 8,10,1 2, 14, 16 and 18 units. For every click you feel when you turn the cap 2 units are set.
As the cap is turned the push button rises. The scale under the push button shows 20, 40 and 60 units. Every time you fully turn the cap 20 units will be set.
Turn the cap until 8 is opposite the dosage indicator
Turn the cap 2 full turns so 0 is opposite the dosage indicator again. The 40 number will show on the push button scale. Continue turning until 12 is opposite the dosage indicator (see H).
If you have a set a wrong dose, simply turn the cap forwards or backwards until the right number of units has been set.
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.
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.
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.
After injection the outer needle cap is replaced, the needle is unscrewed and carefully discarded. The cap is replaced with 0 opposite the dosage indicator.
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.
You cannot set a dose greater than the n umber 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.
For any injection there must be at least 12 units left in the reservoir to give the glass ball space to move when shaking the insulin. If your dose is less than 12 units, and the reservoir is nearly empty, first dial up to 12 (to check that 12 units are left) and then set the required dose. If 12 cannot be dialled change to a new Pen. Discard the used Pen carefully, without the needle attached.
Expel air before each injection, until a drop of insulin appears at the needle tip.
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.
Do not use the indicator for remaining insulin to measure the amount of insulin to be injected.
Care should be taken not to drop the Pen or subject it to impact or misuse. Keep out of the reach of children.
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.
These insulin pens have been prescribed by your doctor for your use only. They must not be used by anyone else.
Are you a member of a Diabetic Association ? If not, and you would like to have further information about it, please write to:
The British Diabetic Association
10 Queen Anne Street
London W1M 0BD