Insuman Rapid SoloStar 100 IU/ml solution for injection in a pre-filled pen

 

What is it and how is it used?

Insuman Rapid is a solution for injection under the skin. The insulin contained in Insuman Rapid is made by a biotechnology process and is identical with the body's own insulin.

Insuman Rapid is an insulin preparation with a rapid onset and short duration of action. It comes in cartridges sealed in disposable pen injectors, SoloStar.

Insuman Rapid is used to reduce high blood sugar in patients with diabetes mellitus. Diabetes mellitus is a disease where your body does not produce enough insulin to control the level of blood sugar.

What do you have to consider before using it?

Do not use Insuman Rapid

If you are allergic (hypersensitive) to insulin or any of the other ingredients of Insuman Rapid.

Take special care with Insuman Rapid

Follow closely the instructions for dosage, monitoring (blood and urine tests), diet and physical activity (physical work andexercise), injection technique as discussed with 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.

Travel

Before travelling, consult your doctor. You may need to talk about

  • the availability of your insulin in the country you are visiting,
  • supplies of insulin, injection syringes etc.,
  • correct storage of your insulin while travelling,
  • timing of meals and insulin administration while travelling,
  • the possible effects of changing to different time zones,
  • possible new health risks in the countries to be visited,
  • what you should do in emergency situations when you feel unwell or become ill.

Illnesses and injuries

In the following situations, the management of your diabetes may require a lot of care:

  • If you are ill or have a major injury then your blood sugar level may increase (hyperglycaemia).
  • If you are not eating enough, your blood sugar level may become too low (hypoglycaemia). In most cases you will need a doctor. Make sure that you contact a doctor early.

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).

Using other medicines

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 dosage 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 or have recently taken any other medicines, including medicines obtained without a prescription. 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:

  • all other medicines to treat diabetes,
  • angiotensin converting enzyme (ACE) inhibitors (used to treat certain heart conditions or high blood pressure),
  • disopyramide (used to treat certain heart conditions),
  • fluoxetine (used to treat depression),
  • fibrates (used to lower high levels of blood lipids),
  • monoamine oxidase (MAO) inhibitors (used to treat depression),
  • pentoxifylline, propoxyphene, salicylates (such as aspirin, used to relieve pain and lower fever),
  • sulfonamide antibiotics.

Medicines that may cause your blood sugar level to rise (hyperglycaemia) include:

  • corticosteroids (such as "cortisone", used to treat inflammation),
  • danazol (medicine acting on ovulation),
  • diazoxide (used to treat high blood pressure),
  • diuretics (used to treat high blood pressure or excessive fluid retention),
  • glucagon (pancreas hormone used to treat severe hypoglycaemia),
  • isoniazid (used to treat tuberculosis),
  • oestrogens and progestogens (such as in the contraceptive pill used for birth control),
  • phenothiazine derivatives (used to treat psychiatric disorders),
  • somatropin (growth hormone),
  • sympathomimetic medicines (such as epinephrine [adrenaline] or salbutamol, terbutaline used to treat asthma),
  • thyroid hormones (used to treat the thyroid gland disorders),
  • protease inhibitors (used to treat HIV),
  • atypical antipsychotic medications (such as olanzapine and clozapine).

Your blood sugar level may either rise or fall if you take:

  • beta-blockers (used to treat high blood pressure),
  • clonidine (used to treat high blood pressure),
  • lithium salts (used to treat psychiatric disorders). 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.

Using Insuman Rapid with food and drink

Your blood sugar levels may either rise or fall if you drink alcohol.

Pregnancy and breast-feeding

Ask your doctor or pharmacist for advice before taking any medicine.

Inform your doctor if you are planning to become pregnant, or if you are already pregnant. Your insulin dosage 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 Rapid 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:

  • you have hypoglycaemia (low blood sugar levels),
  • you have hyperglycaemia (high blood sugar levels),
  • you have problems with your sight. Keep this possible problem in mind in all situations where you might put yourself and others at risk (such as driving a car or operating machines). You should contact your doctor for advice on driving if:
  • you have frequent episodes of hypoglycaemia,
  • the first warning symptoms which help you to recognise hypoglycaemia are reduced or absent.

Important information about some of the ingredients of Insuman Rapid

This medicinal product contains less than 1 mmol (23 mg) sodium per dose, i.e. it is essentially ‘sodium-free’.

How is it used?

Dosage

Based on your life-style and the results of your blood sugar (glucose) tests, your doctor will

  • determine how much Insuman Rapid per day you will need,
  • tell you when to check your blood sugar level, and whether you need to carry out urine tests,
  • tell you when you may need to inject a higher or lower dose of Insuman Rapid.

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.

Frequency of administration

Insuman Rapid is injected under the skin 15 to 20 minutes before a meal.

Method of administration

SoloStar delivers insulin in doses from 1 to 80 units in steps of 1 unit. Each pen contains multiple doses.

Your doctor will show you in which area of the skin you should inject your insulin. With each injection, change the puncture site within the particular area of skin that you are using.

How to handle SoloStar

SoloStar is a pre-filled disposable pen containing insulin human.

Read carefully the "SoloStar Instructions for Use" included in this package leaflet. You must use the pen as described in these Instructions for Use.

A new injection needle must be attached before each use. Only use needles that have been approved for use with SoloStar.

A safety test must be performed before each injection.

Look at the cartridge before you use the pen. Do not use Insuman Rapid if you notice particles in it. Only use Insuman Rapid if the solution is clear, colourless and waterlike.

Always use a new penif you notice that your blood sugar control is unexpectedly getting worse. If you think you may have a problem with SoloStar, consult your Healthcare Professional.

To prevent the possible transmission of disease, each pen must be used by one patient only.

Special care before injection

Make sure that neither alcohol nor other disinfectants or other substances contaminate the insulin.

Do not mix insulin with any other medicines. Insuman Rapid Solostar pre-filled pen, is not designed to allow any other insulin to be mixed in the cartridge.

Empty pens must not be re-filled and must be properly discarded.

Do not use SoloStar if it is damaged or not working properly, it has to be discarded and a new SoloStar has to be used.

Mistakes in dosage

If you use more Insuman Rapid than you should

  • If you have injected too much Insuman Rapid, your blood sugar level may become too low (hypoglycaemia). Check your blood sugar frequently. In general, to prevent hypoglycaemia you

must eat more food and monitor your blood sugar. For information on the treatment of hypoglycaemia, see box at the end of this leaflet.

If you forget to use Insuman Rapid

  • If you have missed a dose of Insuman Rapid or if you have not injected enough insulin, your blood sugar level may become too high (hyperglycaemia). Check your blood sugar frequently. For information on the treatment of hyperglycaemia, see box at the end of this leaflet.
  • Do not take a double dose to make up for a forgotten dose.

If you stop using Insuman Rapid
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 Rapid 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 product, ask your doctor or pharmacist.

Insulin Mix-ups

You must always check the insulin label before each injection to avoid medication mix-ups between Insuman Rapid and other insulins.

What are possible side effects?

Like all medicines, Insuman Rapid can cause side effects, although not everybody gets them.

As with all insulin therapy, the most frequent side effect is hypoglycaemia (low blood sugar). Serious hypoglycaemia may cause a heart attack or brain damage and may be life-threatening. For further information on the side effects of low blood sugar or high blood sugar, see the box at the end of this leaflet.

Severe allergic reactions to insulin may occur which may become life-threatening. Such reactions to insulin or to the excipients can cause large-scale skin reactions (rash and itching all over the body), severe swelling of skin or mucous membranes (angiooedema), shortness of breath, a fall in blood pressure with rapid heart beat and sweating.

Side effects reported commonly (Seen in less than 1 in 10 but more than 1 in 100 patients)- Oedema
Insulin treatment may cause temporary build-up of water in the body with swelling in the calves and ankles.
- Injection site reactions

Side effects reported uncommonly (Seen in less than 1 in 100 but more than 1 in 1000 patients)- Severe allergic reaction with low blood pressure (shock)
- Injection site urticaria (itchy rash)

Other side effects include
- Systemic allergic reactions
Associated symptoms may include large-scale skin reactions (rash and itching all over the body), severe swelling of skin or mucous membranes (angiooedema), shortness of breath, a fall in blood pressure with rapid heart beat and sweating.- Eye reactions
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.
- Skin changes at the injection site (lipodystrophy)

If you inject your insulin too often at the same skin site, fatty tissue under the skin at this site may either shrink or thicken. Insulin that you inject in such a site may not work very well. Changing the injection site with each injection may help to prevent such skin changes.
- Skin and allergic reactions
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 dosage.

Tell your doctor or pharmacist if you notice any of the side effects listed above or any other unwanted or unexpected effects. To prevent serious reactions, speak to a doctor immediately if a side effect is severe, occurs suddenly or gets worse rapidly.

How should it be stored?

Keep out of the reach and sight of children.

Do not use Insuman Rapid after the expiry date which is stated on the carton and on the label of the pen. The expiry date refers to the last day of that month.

Not in-use pens
Store in a refrigerator (2°C - 8°C). Do not freeze. Do not put the pre-filled pen next to the freezer compartment or a freezer pack. Keep the pre-filled pen in the outer carton in order to protect from light.

In-use pens
Pre-filled pensin-use or carried as a spare may be stored for a maximum of 4 weeks not above 25°C and away from direct heat (for example next to a heating unit) or direct light (direct sunlight or next to a lamp). The pen in-use must not be stored in a refrigerator. Do not use the pen after this time period.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

What is it?

Insuman is a range of insulin solutions and suspensions for injection. It is supplied in vials, cartridges, or pre-filled disposable pens (OptiSet and SoloStar).
Insuman contains the active substance insulin human. The Insuman range is comprised of fast-acting insulin solutions (Insuman Rapid and Insuman Infusat) that contain soluble insulin, an intermediate-acting insulin suspension (Insuman Basal) that contains isophane insulin, and combinations of fast- and intermediate-acting insulins in various proportions (Insuman Comb):

  • Insuman Comb 15: 15% soluble insulin and 85% crystalline protamine insulin;
  • Insuman Comb 25: 25% soluble insulin and 75% crystalline protamine insulin;
  • Insuman Comb 30: 30% soluble insulin and 70% crystalline protamine insulin;
  • Insuman Comb 50: 50% soluble insulin and 50% crystalline protamine insulin.

What is it used for?

Insuman is used in patients with diabetes who need treatment with insulin.
Insuman Rapid can also be used for the treatment of hyperglycaemic coma (coma caused by too much blood glucose [sugar]) and ketoacidosis (high levels of ketones [acids] in the blood), and to control blood glucose before, during or after an operation.
The medicine can only be obtained with a prescription.

How is it used?

Insuman is given by injection under the skin, generally in the abdominal wall (tummy) or the thigh, according to the doctor’s recommendations. The injection site is changed for each injection. The desired blood glucose levels, the type of Insuman to be used, and the dose and timing of injections are determined by the doctor for each patient individually, and are adjusted to suit the patient’s diet, physical activity and lifestyle. The patient’s blood glucose should be tested regularly to find the lowest effective dose. Insuman should be given before meals. See the Package Leaflet for exact timings. Insuman Rapid may also be given into a vein, but only in hospital where the patient can be closely monitored. Insuman Infusat is specially prepared ready to be used in infusion pumps.

How does it work?

Diabetes is a disease in which the body does not produce enough insulin to control the level of blood glucose. Insuman is a replacement insulin that is identical to the insulin made by the body. The active substance in Insuman, insulin human, is produced by a method known as ‘recombinant DNA technology’: it is made by a bacterium that has received a gene (DNA), which makes it able to produce insulin. Insuman contains insulin in various forms: the soluble form, which acts quickly (within 30 minutes of injection), and the isophane and crystalline-protamine forms, which are absorbed much more slowly during the day, giving them a longer duration of action. The replacement insulin acts in the same way as naturally produced insulin and helps glucose enter cells from the blood. By controlling the level of blood glucose, the symptoms and complications of diabetes are reduced.

How has it been studied?

Insuman has been studied in two trials in 611 patients with either type 1 diabetes (when the pancreas cannot produce insulin) or type 2 diabetes (when the body is unable to use insulin effectively). In one of the studies, Insuman was used in an insulin pump. In the other study, Insuman Comb 25 was compared with semi-synthetic human insulin. The studies measured the ‘fasting’ blood glucose levels (measured when the patient had not eaten for at least eight hours) or a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled. The studies also looked at the number of patients who developed hypoglycaemia (low blood glucose levels).

What benefits has it shown during the studies?

Insuman led to a decrease in the level of HbA1c, indicating that blood glucose levels had been controlled to a similar level to that seen with semi-synthetic human insulin. Insuman was effective for both type 1 and type 2 diabetes.

What is the risk associated?

Insuman may cause hypoglycaemia. For the full list of all side effects reported with Insuman, see the Package Leaflet.
Insuman should not be used in people who may be hypersensitive (allergic) to insulin human or any of the other ingredients. Insuman doses might also need to be adjusted when it is given with other medicines that may have an effect on blood glucose levels. The full list of these medicines is available in the Package Leaflet.

Why has it been approved?

The Committee for Medicinal Products for Human Use (CHMP) decided that Insuman’s benefits are greater than its risks for the treatment of diabetes mellitus. The Committee recommended that Insuman be given marketing authorisation.

Further information

The European Commission granted a marketing authorisation valid throughout the European Union for Insuman to Sanofi-Aventis Deutschland GmbH on 21 February 1997. The marketing authorisation was renewed on 21 February 2002 and on 21 February 2007.