100 IU / ml injection, suspension in a prefilled injection pen
human insulin
1. What Insuman Comb 25 is and what it is used for
Insuman Comb 25 contains the active substance insulin human which is manufactured using biotechnology and is identical to the body’s own insulin.
Insuman Comb 25 is an insulin preparation with gradual onset of action and a long duration of action. It comes in cartridges you sealed in a pen for single-use SoloStar.
Insuman Comb 25 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 you use Insuman Comb 25
Do not use Insuman Comb 25
If you are allergic to insulin or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Insuman Comb 25 in a pre-filled pen should only be injected under the skin (see also section 3). Talk to your doctor if you need to inject your insulin using another method.
Talk to your doctor, pharmacist, or nurse before using Insuman Comb 25.
Be sure to follow the dosing instructions and instructions for control (of blood and urine), eating habits, physical activities (physical work and exercise), and injection technique 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 Comb 25). 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 , needles, etc.,
- the storage of insulin during the journey,
- 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 Comb 25
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 painkillers 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 (such as birth control pills 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 first 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 Comb 25 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 Comb 25 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.
Important information about some of the ingredients of Insuman Comb 25
This medicine contains less than 1 mmol (23 mg) sodium per dose, ie essentially ‘sodium-free.
3. How to use Insuman Comb 25
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 Comb 25 per day you will need,
- 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 Comb 25
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.
Time of administration
Insuman Comb 25 is injected under the skin 30-45 minutes before a meal.
Method of administration
Insuman Comb 25 is a suspension for injection under the skin.
NEVER inject Insuman Comb 25 into a vein (blood vessel).
SoloStar can administer insulin in doses ranging from 1-80 units in increments of 1 unit. Each pen contains several doses.
Your doctor will show you in which area of the skin insulin et should be injected. Change the injection site each time in the area of the skin that you use for injection.
Management of SoloStar
SoloStar is a pre-filled disposable pen that contains human insulin. Insuman Comb 25 in a pre-filled pen should only be injected under the skin. Talk to your doctor if you need to inject your insulin using another method.
Carefully read the “SoloStar Instructions for Use” attached to this leaflet. You must use the pen as described in this manual.
Attach a new injection needle before each use. Only use injection needles that are approved for use with SoloStar.
A safety test should be performed before each injection.
Mix the insulin thoroughly and check it before first use. Insulin is then reconstituted thoroughly, immediately before each injection.
This is best done by slowly turning the pen back and forth at least 10 times. To facilitate mixing, the cartridge contains 3 small metal balls.
After mixing, the suspension must have an even milky white appearance. It must not be used if it remains clear or if, for example, lumps, flakes, particles, or the like appear in suspension one or on the sides or bottom of the cartridge one in the pen. A new pen with an even suspension after mixing must then be used.
Always use a new pen if you notice that your blood sugar control unexpectedly deteriorates. If you suspect that you have a problem with SoloStar, contact your doctor, pharmacist, or nurse.
To avoid possible transmission of disease, each pen should only be used by one patient.
Special precautions before injection
Make sure that neither alcohol nor other disinfectants or other substances contaminate the insulin.
Do not mix insulin with other medicines. Insuman Comb 25 SoloStar, a pre-filled pen, is not intended to be mixed with any other insulin in the cartridge.
Empty pens must not be refilled and must be discarded.
Do not use SoloStar if it is damaged or not working properly. It will then be discarded and a new SoloStar will be used.
If you take more Insuman Comb 25 than you should
- If you have injected too much Insuman Comb 25 , 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 Comb 25
- If you have missed a dose of Insuman Comb 25 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 Comb 25
This can lead to severe hyperglycemia (very high blood sugar) and ketoacidosis (the development of acid in the blood because the body breaks down fat instead of sugar). Do not stop taking Insuman Comb 25 without consulting 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 Comb 25 with other insulins.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most serious side effects are
Less common 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 hypoglycemia can cause a 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 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 Comb 25
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 pen label. The expiration date is the last day of the specified month.
Injection pens not in use
Store in a refrigerator (2 ° C-8 ° C). Do not freeze. Do not place the pre-filled pen near the freezer compartment or cooling lamp.
Keep the pre-filled pen in the outer carton. Sensitive to light.
In-use
pens In- use Pre-filled in-use pens or carried as a spare can be stored for a maximum of 4 weeks at a maximum of 25 ° C protected from direct heat (eg next to an element) or direct light (direct sunlight or next to a lamp). The pen during use must not be stored in the refrigerator. Thereafter, the pen should not be used.
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 Comb 25
- The active substance is human insulin. One ml solution of Insuman Comb 25 contains 100 IU (International Units) of the active substance insulin human. Insulin is 25% dissolved in water; the remaining 75% occurs in the form of very small insulin protamine crystals.
- The other ingredients are: protamine sulphate, metacresol, phenol, zinc chloride, sodium dihydrogen phosphate dihydrate, glycerol , sodium hydroxide (see section 2 under “Important information about some of the ingredients of Insuman Comb 25”), hydrochloric acid (for pH adjustment) and water for injections.
Insuman Comb 25 look and feel
After the mixture is Insuman Comb 25 is a fluid ( injection, suspension ) with a uniformly milky appearance with no visible lumps, particles, or flakes.
Insuman Comb 25 is supplied in pre-filled pens, SoloStar, containing 3 ml suspension (300 IU). Packs of 3, 4, 5, 6, 9, and 10 3 ml pens are available.
Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Sanofi-Aventis Deutschland GmbH
D-65926 Frankfurt am Main
Germany.
For any information about this medicinal product, please contact the local representative of the Market
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