Active ingredient
- human insulin
Legal Category
POM: Prescription only medicine
POM: Prescription only medicine
The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine. It is written for patients and gives information about taking or using a medicine. It is possible that the leaflet in your medicine pack may differ from this version because it may have been updated since your medicine was packaged.
Below is a text only representation of the Patient Information Leaflet. The original leaflet can be viewed using the link above.
The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on 0800 198 5000. The product code(s) for this leaflet is: PLGB 04425/0812.
Insuman Infusat 100 IU/ml solution for injection in a cartridge
Package leaflet: Information for the user
Insuman® Infusat 100 IU/ml solution for injection in a cartridge
insulin human
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Phone 0800 035 2525 for help.
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
What is in this leaflet
1. What Insuman Infusat is and what it is used for
2. What you need to know before you use Insuman Infusat
3. How to use Insuman Infusat
4. Possible side effects
5. How to store Insuman Infusat
6. Contents of the pack and other information
1. What Insuman Infusat is and what it is used for
Insuman Infusat contains the active substance insulin human which is made by a biotechnology process and is identical with the body's own insulin.
Insuman Infusat is an insulin preparation with a rapid onset and short duration of action. It comes in cartridges designed for use in Hoechst Infusor and H-Tron (insulin pumps).
Insuman Infusat must only be used in insulin pumps suitable for this insulin.
Insuman Infusat is used to reduce high blood sugar in patients with diabetes mellitus who need treatment with insulin. Diabetes mellitus is a disease where your body does not produce enough insulin to control the level of blood sugar.
2. What you need to know before you use Insuman Infusat
Do not use Insuman Infusat
If you are allergic to insulin or any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor, pharmacist or nurse before using Insuman Infusat.
Follow closely the instructions for dose, monitoring (blood and urine tests), diet and physical activity (physical work and exercise) as discussed with your doctor.
If you are allergic to this medicine or to animal insulins, talk to your doctor.
Special patient groups
If you have liver or kidneys problems or if you are elderly, speak to your doctor as you may need a lower dose.
Skin changes at the injection site
The injection site should be rotated to prevent skin changes such as lumps under the skin. The insulin may not work very well if you inject into a lumpy area (see How to use Insuman Infusat). Contact your doctor if you are currently injecting into a lumpy area before you start injecting in a different area. Your doctor may tell you to check your blood sugar more closely, and to adjust your insulin or your other antidiabetic medications dose.
Travel
Before travelling, consult your doctor. You may need to talk about
Illnesses and injuries.
In the following situations, the management of your diabetes may require a lot of care:
If you have type 1 diabetes (insulin dependent diabetes mellitus), do not stop your insulin and continue to get enough carbohydrates. Always tell people who are caring for you or treating you that you require insulin.
Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with pioglitazone and insulin experienced the development of heart failure. Inform your doctor as soon as possible if you experience signs of heart failure such as unusual shortness of breath or rapid increase in weight or localised swelling (oedema).
Other medicines and Insuman Infusat
Some medicines cause changes in the blood sugar level (decrease, increase or both depending on the situation). In each case, it may be necessary to adjust your insulin dose to avoid blood sugar levels that are either too low or too high. Be careful when you start or stop taking another medicine.
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Before taking a medicine ask your doctor if it can affect your blood sugar level, and what action, if any, you need to take.
Medicines that may cause your blood sugar level to fall (hypoglycaemia) include:
Medicines that may cause your blood sugar level to rise (hyperglycaemia) include:
Your blood sugar level may either rise or fall if you take:
Pentamidine (used to treat some infections caused by parasites) may cause hypoglycaemia which may sometimes be followed by hyperglycaemia.
Beta blockers like other sympatholytic medicines (such as clonidine, guanethidine, and reserpine) may weaken or suppress entirely the first warning symptoms which help you to recognise a hypoglycaemia.
If you are not sure whether you are taking one of those medicines ask your doctor or pharmacist.
Insuman Infusat with alcohol
Your blood sugar levels may either rise or fall if you drink alcohol.
Pregnancy and breast feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Inform your doctor if you are planning to become pregnant, or if you are already pregnant. Your insulin dose may need to be changed during pregnancy and after giving birth. Particularly careful control of your diabetes, and prevention of hypoglycaemia, is important for the health of your baby. However, there is no experience with the use of Insuman Infusat in pregnant women.
If you are breast feeding consult your doctor as you may require adjustments in your insulin doses and your diet.
Driving and using machines
Your ability to concentrate or react may be reduced if:
Keep this possible problem in mind in all situations where you might put yourself and others at risk (such as driving a car or using machines). You should contact your doctor for advice on driving if:
Insuman Infusat contains sodium
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.
3. How to use Insuman Infusat
Dose
Always use this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Based on your life style and the results of your blood sugar (glucose) tests, your doctor will
Many factors may influence your blood sugar level. You should know these factors so that you are able to react correctly to changes in your blood sugar level and to prevent it from becoming too high or too low. See the box at the end of this leaflet for further information.
Method of administration
Insuman Infusat is a solution to be given under the skin.
Your doctor will show you how and in which area of the skin you should infuse your insulin and how often you must change the puncture site within the particular area of skin where you are infusing the insulin. Speak to your doctor before you change the area of skin that you are infusing.
Do not use Insuman Infusat in peristaltic pumps with silicone tubing. Situations in which you must not start or continue to use insulin pumps are described in the operating manuals for these pumps.
How to handle the cartridges
Insuman Infusat comes in cartridges designed for use in Hoechst Infusor and H-Tron. It must only be used in insulin pumps suitable for this insulin. Only tetrafluoroethylene or polyethylene catheters must be used for infusion. The operating manual provided with the pump will tell you how to use it. Insuman Infusat must only be used if the solution is clear, colourless, with no solid particles visible, and has a water like consistency.
Keep the cartridge at room temperature 1 to 2 hours before inserting it in the pump so that you can see and remove any air bubbles which form during warming-up.
Special care before infusion
Before starting the infusion remove any air bubbles. Make sure that neither alcohol nor other disinfectants or other substances contaminate the insulin.
Do not mix insulin with any other medicines. Insuman Infusat must NOT be mixed with any other insulin preparations.
Do not re-fill and re-use empty cartridges.
Insulin pump faults
You should always consider the possibility of a technical problem if, in order to achieve the desired blood sugar levels,
For details on safety precautions in the use of insulin pumps see the operating manual. If the pump does not function well, you can draw the insulin from the cartridge into an injection syringe. Therefore, keep injection syringes and injection needles as well. However, use only those injection syringes which are designed for an insulin concentration of 100 IU (International Units) per ml.
If you use more Insuman Infusat than you should
If you forget to use Insuman Infusat
If you stop using Insuman Infusat
This could lead to severe hyperglycaemia (very high blood sugar) and ketoacidosis (build up of acid in the blood because the body is breaking down fat instead of sugar). Do not stop Insuman Infusat without speaking to a doctor, who will tell you what needs to be done. If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Insulin Mix-ups
You must always check the insulin label before each injection to avoid mix-ups between Insuman Infusat and other insulins.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Most serious side effects
Side effects reported uncommonly
(may affect up to 1 in 100 people)
Side effects reported with a frequency not known (cannot be estimated from the available data)
Other side effects
Side effects reported commonly (may affect up to 1 in 10 people)
Insulin treatment may cause temporary build up of water in the body with swelling in the calves and ankles.
Side effects reported uncommonly
Side effects reported with a frequency not known (cannot be estimated from the available data)
A marked change (improvement or worsening) in your blood sugar control can disturb your vision temporarily. If you have proliferative retinopathy (an eye disease related to diabetes) severe hypoglycaemic attacks may cause temporary loss of vision.
If you inject your insulin too often at the same skin site, fatty tissue under the skin at this site may either shrink (lipoatrophy) or thicken (lipohypertrophy). Lumps under the skin may also be caused by build-up of a protein called amyloid (cutaneous amyloidosis). The insulin may not work very well if you inject into a lumpy area. Change the injection site with each injection to help prevent these skin changes.
Other mild reactions at the injection site (such as injection site redness, unusually intense pain on injection site, itching, injection site swelling or injection site inflammation) may occur. They can also spread around the injection site. Most minor reactions to insulins usually resolve in a few days to a few weeks.
Insulin treatment can cause the body to produce antibodies to insulin (substances that act against insulin). However, only very rarely, this will require a change to your insulin dose.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Insuman Infusat
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and on the label of the cartridge after “EXP”. The expiry date refers to the last day of that month.
Unopened cartridges
Store in a refrigerator (2°C – 8°C). Do not freeze. Do not put Insuman Infusat next to the freezer compartment or a freezer pack. Keep the cartridge in the outer carton in order to protect from light.
Once in the pump, Insuman Infusat may be kept for up to 2 weeks.
Do not throw away any medicines via waste water or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Insuman Infusat contains
What Insuman Infusat looks like and contents of the pack
Insuman Infusat is a clear, colourless solution for injection, with no solid particles visible, and of water-like consistency.
Insuman Infusat is supplied in cartridges containing 3.15 ml solution (315 IU). Pack of 5 cartridges of 3.15 ml is available.
Marketing Authorisation Holder and Manufacturer
This leaflet does not contain all the information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist.
This leaflet was last revised in June 2021
Other source of information
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu/
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
HYPERGLYCAEMIA AND HYPOGLYCAEMIA
Always carry some sugar (at least 20 grams) with you.
Carry some information with you to show you are diabetic.
HYPERGLYCAEMIA (high blood sugar levels)
If your blood sugar is too high (hyperglycaemia), you may not have injected enough insulin.
Why does hyperglycaemia occur?
Examples include:
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?
Examples include:
Hypoglycaemia is also more likely to occur if:
Warning symptoms of hypoglycaemia
The first symptoms which alert you to hypoglycaemia (“warning symptoms”) may change, be weaker or may be missing altogether if
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 hypo glycaemia.
What should you do if you experience hypoglycaemia
1. Stop your insulin infusion (if necessary, by withdrawing the needle) at least until you feel that you are fully alert again. 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.
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