100 IU / ml injection solution in a cartridge
human insulin
1. What Insuman Infusat is and what it is used for
Insuman Infusat contains the active substance insulin human, which is manufactured using biotechnology and is identical to the body’s own insulin.
Insuman Infusat is an insulin preparation with rapid onset of action and short duration of action. It is supplied in cartridges designed for use in Hoechst Infusor and H-Tron (insulin pumps).
Insuman Infusat should only be used in insulin pumps designed for this insulin.
Insuman Infusat is used to reduce high blood sugar in patients with diabetes mellitus who need insulin treatment. Diabetes mellitus is a disease in which the body does not produce enough insulin to control blood sugar levels.
2. What you need to know before using 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 cautions
Talk to your doctor, pharmacist, or nurse before using Insuman Infused.
Be sure to follow the dosing instructions and instructions for control (of blood and urine), diet, and physical activities (physical work and exercise) as discussed with your doctor.
Talk to your doctor if you are allergic to this medicine or to insulin of animal origin.
Special patient groups
If you have problems with your liver or kidneys or if you are older, talk to your doctor as you may need a lower insulin dose.
Skin changes at the injection site
To prevent skin changes, e.g. nodules under the skin, you should constantly change the injection site. It may be that insulin et not work as well if you inject in an area of nodules (see How to use Insuman Infusat). Contact your doctor before changing the injection site if you are currently injecting in an area with lumps. Your doctor may advise you to check your blood sugar more often and to adjust your insulin dose or the dose of other diabetes medicines.
Travel
Consult your doctor before setting out on a journey. You may need to raise questions about
- the availability of your insulin in the country you are visiting,
- the availability of insulin , syringes, etc.,
- the storage of insulin during the journey,
- who to contact if the pump does not work properly,
- times for meals and insulin use during the trip,
- possible consequences of travel to other time zones,
- any new health risks in the countries you visit,
- what to do in emergencies when you feel bad or when you get sick.
Diseases and injuries
In the following situations, the management of your diabetes may require extra care:
- If you are ill or have a serious accident, your blood sugar level may increase ( hyperglycaemia ).
- If you do not eat enough, your blood sugar level may become too low ( hypoglycaemia ).
In most cases, you will need medical attention. Contact a doctor at an early stage.
If you have type 1 diabetes (insulin-dependent diabetes mellitus ), you should not stop taking insulin and you should continue to add enough carbohydrates. Always tell those who see you or treat you that you need insulin.
Some patients with long-term type 2 diabetes mellitus and heart disease or previous stroke, treated with pioglitazone and insulin, developed heart failure. Tell your doctor as soon as possible if you get signs of heart failure such as increased shortness of breath, rapid weight gain, or local swelling ( edema ).
Other medicines and Insuman Infusat
Some medicines affect the blood sugar level (lowering, raising, or both and depending on the circumstances). In either case, it may be necessary to adjust your insulin dose to avoid blood sugar levels that are either too low or too high. Keep this in mind 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 any medicine, consult your doctor if it may affect your blood sugar level and if so, what to do next.
Drugs that can lower blood sugar (hypoglycemia) include:
- all other medicines used to treat diabetes,
- ACE inhibitors (used to treat certain heart diseases or high blood pressure ),
- disopyramide (used to treat certain heart diseases),
- fluoxetine (used to treat depression),
- fibrates (used to lower high levels of blood fats),
- MAO inhibitors (used to treat depression),
- pentoxifylline, propoxyphene, salicylates such as acetylsalicylic acid , used as analgesics and antipyretics),
- sulfonamide antibiotics.
Drugs that can increase blood sugar levels ( hyperglycemia ) include:
- corticosteroids (such as ‘cortisone’, used to treat inflammation ),
- danazol (medicines used to treat ovulation),
- diazoxide (used to treat high blood pressure ),
- diuretics (used to treat high blood pressure or if you have accumulated too much fluid),
- glucagon (pancreatic hormone used to treat severe hypoglycaemia ),
- isoniazid (used to treat tuberculosis ),
- estrogens and progestogens as in birth control pills which are used for birth control),
- phentiazine derivatives (used to treat mental illness),
- somatropin ( growth hormone ),
- sympathomimetics (such as epinephrine [adrenaline], salbutamol , terbutaline used to treat asthma ),
- thyroid hormones (used to treat hypothyroidism),
- protease inhibitors (used to treat HIV ),
- atypical antipsychotic drugs (eg olanzapine and clozapine).
Blood sugar levels can sometimes increase and sometimes decrease if you use:
- beta-blockers (used to treat high blood pressure ),
- clonidine (used to treat high blood pressure ),
- lithium salts (used to treat mental illness).
Pentamidine (used to treat certain parasitic infectious diseases) can cause hypoglycemia which can sometimes be followed by hyperglycemia.
In addition, beta-blockers as well as other sympatholytic drugs such as clonidine, guanethidine, and reserpine may weaken or completely suppress the initial warning signs that help you recognize hypoglycemia.
If you are not sure if you are taking any of these medicines, ask your doctor or pharmacist.
Insuman Infused with alcohol
Your blood sugar levels can either increase or decrease if you drink alcohol.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Tell your doctor if you intend to become pregnant or if you are already pregnant. The insulin dose may need to be adjusted during pregnancy and after delivery. For the sake of the child, it is especially important that your diabetes is monitored and that hypoglycemia is prevented. However, there is no experience with the use of Insuman Infusat in pregnant women.
If you are breastfeeding, your insulin dose and diet may need to be adjusted, so consult your doctor.
Driving and using machines
Your ability to concentrate and react may deteriorate if:
- you get hypoglycaemia (low blood sugar levels),
- you get hyperglycaemia (high blood sugar levels),
- you have vision problems.
Always remember the risk of this in all situations where you may expose yourself and others to danger (such as driving or using machines). Contact your doctor for advice on driving if:
- you often have episodes of hypoglycaemia ,
- the first warning signs that make you recognize hypoglycaemia are weakened or absent.
Insuman Infusat contains sodium
This medicine contains less than 1 mmol (23 mg) sodium per dose, ie it is essentially ‘sodium-free.
3. How to use Insuman Infusat
Dose
Always use this medicine exactly as your doctor or pharmacist has told you. Ask your doctor or pharmacist if you are unsure.
Depending on your lifestyle and the results of your blood glucose ( glucose ) test, your doctor will
- determine how much Insuman Infusat is needed daily, how much of this is to be infused continuously (base dose) and how much and when additional insulin is needed in the form of an extra dose (“bolus dose”);
- tell you when to check your blood sugar level and if you need to take a urine sample,
- tell you when you may need to increase or decrease the dose of Insuman Infusat
There are many factors that can affect blood sugar levels. You need to know these factors so that you can react correctly when your blood sugar level changes and to prevent the level from becoming too high or too low. See the box at the end of the package leaflet for further information.
Method of administration
Insuman Infusat is a liquid to be given under the skin.
Your doctor will show you how and in what area of the skin insulin et should be infused and how often the infusion site must be changed within the area where insulin et is infused. Talk to your doctor before changing the infusion site you are using.
Do not use Insuman Infusat in peristaltic pumps with silicone tubing. Situations, where you are not allowed to start or continue using insulin pumps, are specified in the operating instructions for these pumps.
Handling of the cartridge is
Insuman Infusat supplied cartridges s designed to be used in the Hoechst Infusor and H-Tron. It may only be used in insulin pumps designed for this insulin. Only tetrafluoroethylene or polyethylene catheters may be used for infusion. The operating instructions supplied with the pump inform you how to use it.
Insuman Infusat should only be used if the solution is clear, colorless, with no visible solid particles, and has a water-like consistency.
Keep the cartridge one at room temperature for 12 hours before it is inserted into the infusion system so that you can see and remove any air bubbles that develop during the heating.
Special precautions before injection
Remove all air bubbles before starting an infusion. Make sure that neither alcohol nor other disinfectants or other substances contaminate the insulin.
Do not mix insulin with other medicines. Insuman Infusat must NOT be mixed with any other insulin.
Do not refill or reuse empty cartridges.
Insulin pump failure
Always consider the possibility of a technical problem if you find that in order to reach the desired blood sugar level you must:
- take additional insulin (“bolus doses”) in larger doses or more often than usual, or,
- Take additional insulin (“bolus doses”) in smaller doses or less often than usual.
For details on precautionary measures when using insulin pumps, refer to the operating instructions.
If the pump does not work properly, insulin can be withdrawn from the cartridge with a syringe. Therefore also have syringes and needles on hand. Use only syringes designed for the insulin concentration 100 IU (International Units) per ml.
If you take more Insuman Infusat than you should
- If you have injected too much Insuman Infusat , your blood sugar level may become too low ( hypoglycaemia ). Check your blood sugar often. To avoid hypoglycaemia , you usually need to eat more food and control your blood sugar. For information on the treatment of hypoglycaemia , see the box at the end of the package leaflet.
If you forget to take Insuman Infusat
- If you have missed a dose of Insuman Infusat or have not injected enough insulin , your blood sugar level may become too high ( hyperglycaemia ). Check your blood sugar often. For information on treating hyperglycaemia , see the 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 Infusat
This can lead to severe hyperglycemia (very high blood sugar) and ketoacidosis
(development of acid in the blood because the body breaks down fat instead of sugar). Do not stop taking Insuman Infusat without talking 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, pharmacist, or nurse.
Insulin confusions
You must always check the insulin label before each injection to avoid confusing Insuman Infused with other insulins.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most serious adverse reactions are
uncommon side effects are (may affect up to 1 in 100 people)
- Severe allergic reaction with low blood pressure ( shock )
Adverse reactions reported with unknown frequency (cannot be calculated from the available data)
- The most common side effect is hypoglycaemia (low blood sugar) . Severe hypoglycaemia can cause heart attack or brain damage and can be life threatening. For more 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 and these may be life threatening.
Such reactions to insulin or to excipients can cause extensive skin reactions (rash and itching all over the body), severe swelling of the skin or mucous membranes ( angioedema ), shortness of breath, drop in blood pressure with high heart rate, and sweating.
Other side effects are
an adverse reaction is reported as normal (may affect up to 1 in 10 persons)
- Edema
insulin treatment can also cause a temporary storage of water in the body, with swelling in the calves and ankles. - Injection site reactions
Side effects are reported as uncommon
- Hives at the injection site (rash with itching )
Adverse reactions have been reported with unknown frequency
- Sodium retention
- Eye reactions
A marked change (improvement or deterioration) in blood sugar control may temporarily interfere with vision. If you have proliferative retinopathy (an eye disease associated with diabetes ), severe hypoglycaemic attacks can cause temporary loss of vision.
- Skin changes at the injection site
If you inject insulin too often in the same place in the skin, the adipose tissue in this place under the skin may shrink (lipoatrophy) or thicken (lipohypertrophy). Nodules under the skin can also be caused by the accumulation of a protein called amyloid ( cutaneous amyloidosis). It may be that insulin et not work as well if you inject in an area with nodules. Change the injection site for each injection to prevent these skin changes.
- Skin and allergic reactions
Other mild injection site reactions (such as redness, unusually intense pain at the injection site, itching, swelling, and inflammation at the injection site) may occur. These reactions may also occur around the injection site. Most less severe insulin reactions usually last from a few days to a few weeks.
- Antibody is against insulin
Insulin treatment may cause the formation of antibodies to insulin (substances that react with insulin ). However, it is very rare that it becomes necessary to change the insulin dosage.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency, By reporting side effects, you can help increase drug safety information.
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 cartridge after “EXP”.
The expiration date is the last day of the specified month.
Unopened cartridge s
Store in the refrigerator (2 ° C-8 ° C). Do not freeze. Do not place Insuman Infusat near the freezer compartment or cooling lamp. Keep the cartridge one in the outer carton. Sensitive to light.
The Insuman Infusat can be stored in the pump for up to 2 weeks.
Do not use Insuman Infusat if you notice particles in the solution. Only use Insuman Infusat if the solution is clear, colorless, and with a water-like consistency.
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.
6. Contents of the packaging and other information
Content declaration Insuman Infusat
- The active substance is human insulin. One ml solution of Insuman Infusat contains 100 IU (International Units) of the active substance insulin human.
- The other ingredients are: phenol, zinc chloride, trometamol, poloxamer 171, glycerol , sodium hydroxide, hydrochloric acid (for pH adjustment) and water for injections.
Insuman Infusat appearance and pack sizes
Insuman Infusat is a clear and colorless solution for injection without visible solid particles and with a water-like consistency.
Insuman Infused in cartridge s solution containing 3.15 ml (315 IU). Pack of 5 cartridges of 3.15 ml is available.
Marketing Authorization Holder and Manufacturer
Sanofi-Aventis Deutschland GmbH
D-65926 Frankfurt am Main
Germany.
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