Symptoms: an overdose of insulin, such as the administration of an excessive amount of insulin compared to the food consumed or energy expenditure, can lead to severe and sometimes prolonged and life-threatening hypoglycemia.
Treatment: mild episodes of hypoglycemia (the patient is conscious) can be stopped by ingesting carbohydrates. You may need to adjust your insulin dose, food intake, and physical activity.
More severe episodes of hypoglycemia with coma, convulsions or neurological disorders can be stopped by the administration of glucagon or intravenous administration of a concentrated dextrose solution.
In children, the amount of dextrose administered is set in proportion to the child's body weight. After an increase in the concentration of glucose in the blood, it may be necessary to maintain carbohydrate intake and follow-up, since after the apparent clinical elimination of the symptoms of hypoglycemia, its re-development is possible.
In cases of severe or prolonged hypoglycemia, following the injection of glucagon or the administration of dextrose, it is recommended to infuse a less concentrated solution of dextrose, in order to prevent the recurrence of hypoglycemia.
In young children, it is necessary to carefully monitor the concentration of glucose in the blood, due to the possible development of severe hyperglycemia.
Under certain conditions, it is recommended to hospitalize patients in intensive care units for more careful monitoring of their condition and monitoring of the therapy.
hypersensitivity reaction to insulin or to any of the auxiliary components of the drug, except in cases where insulin therapy is vital,
hypoglycemia.
With caution: renal insufficiency (may decrease insulin requirements due to reduced insulin metabolism), elderly patients (gradual loss of kidney function can lead to ever-increasing reduction in insulin requirements), hepatic failure (insulin requirements may be reduced due to the lower capacity for gluconeogenesis and reduced insulin metabolism), severe stenosis of the coronary and cerebral arteries (these patients hypoglycemic episodes may be of particular clinical significance, t.to. there is an increased risk of cardiac or cerebral complications of hypoglycemia), patients with proliferative retinopathy, especially those not treated with photocoagulation (laser therapy), t.to. they have a risk of transient amaurosis with hypoglycemia — complete blindness, patients with intercurrent diseases (t.to. in intercurrent diseases, the need for insulin often increases)
If the patient has one of these diseases or conditions, you should definitely consult your doctor before using the drug.
Co-administration with hypoglycemic agents for oral administration, ACE inhibitors, disopyramide, fibrates, fluoxetine, MAO inhibitors, pentoxifylline, propoxyphene, salicylates, amphetamine, anabolic steroids and male sex hormones, cibenzoline, cyclophosphamide, fenfluramine, guanetidine, ifosfamide, phenoxybenzamine, phentolamine, somatostatin and its analogues, sulfonamides, tetracyclines, tritokvalin or trophosfamide may enhance the hypoglycemic effect of insulin and increase the predisposition to hypoglycemia.
Co-administration with corticotropin, corticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, estrogens and progestogens (for example, present in combined contraceptives), phenothiazine derivatives, somatotropin, sympathomimetic agents (for example, epinephrine, salbutamol, terbutaline), thyroid hormones, barbiturates, nicotinic acid, phenolphthalein, derivatives phenytoin, doxazosin may weaken the hypoglycemic effect of insulin.
Beta-blockers, clonidine, and lithium salts can either potentiate or weaken the hypoglycemic effect of insulin.
With ethanol. Ethanol can either potentiate or weaken the hypoglycemic effect of insulin. The use of ethanol can cause hypoglycemia or reduce the already low blood glucose to dangerous levels. The tolerance of ethanol in patients receiving insulin is reduced. The permissible amounts of alcohol consumed should be determined by the doctor.
With pentamidine. With simultaneous administration, hypoglycemia may develop, which can sometimes turn into hyperglycemia. When combined with sympatholytic agents, such as beta-blockers, clonidine, guanetidine and reserpine, it is possible to weaken or completely eliminate the symptoms of reflex (in response to hypoglycemia) activation of the sympathetic nervous system.
Hypoglycemia. The most common side effect of insulin therapy, can develop if the dose of insulin administered exceeds the need for it (see "Special instructions"). Severe repeated episodes of hypoglycemia can lead to the development of neurological symptoms, including coma, convulsions (see "Overdose"). Prolonged or severe episodes of hypoglycemia can be life-threatening.
In many patients, symptoms and manifestations of neuroglycopenia may be preceded by symptoms of reflex (in response to developing hypoglycemia) activation of the sympathetic nervous system. Usually, with a more pronounced or faster decrease in the concentration of glucose in the blood, the phenomenon of reflex activation of the sympathetic nervous system and its symptoms are more pronounced.
With a sharp decrease in the concentration of glucose in the blood, hypokalemia (complications from the CCC) or the development of cerebral edema may develop.
The following are the adverse events observed in clinical trials, which are classified by system-organ classes and in order of decreasing frequency of occurrence: very frequent (≥1/10), frequent (≥1/100 and <1/10), infrequent (≥1/1000 and <1/100), rare (≥1/10000 and <1/1000), very rare (<1/10000), frequency is unknown (according to available data, it is not possible to determine the frequency of side effects).
On the part of the immune system: immediate allergic reactions to insulin or excipients (frequency unknown), may manifest as generalized skin reactions (frequency unknown), angioedema (frequency unknown), bronchospasm (frequency unknown), decreased blood pressure (frequency unknown), and anaphylactic shock (infrequent reactions) and may endanger the patient's life. Allergic reactions require the immediate adoption of appropriate emergency measures.. The use of insulin can cause the formation of antibodies to insulin (the frequency is unknown). In rare cases, the presence of such antibodies to insulin may require a change in the dose of insulin to correct the tendency to hyper-or hypoglycemia
From the side of metabolism and nutrition: insulin can cause sodium retention (frequency unknown) and edema (frequent), especially when improving previously deficient metabolic control through the use of more intensive insulin therapy.
On the part of the visual organ: significant changes in glycemic control can cause transient visual disturbances (frequency unknown) due to temporary changes in the turgor of the eye lenses and their refractive index.
Long-term improvement in glycemic control reduces the risk of progression of diabetic retinopathy. However, more intensive insulin therapy with a sharp improvement in glycemic control may be associated with a temporary deterioration in the course of diabetic retinopathy (frequency unknown). In patients with proliferative retinopathy, especially if they are not treated with photocoagulation (laser therapy), severe hypoglycemic episodes may cause transient amaurosis (complete loss of vision) (frequency unknown).
From the skin and subcutaneous tissues: as with any insulin therapy, it is possible to develop lipodystrophy at the injection site (the frequency is unknown) and slow down the local absorption of insulin.
The constant change of injection sites within the recommended area of administration may help to reduce or stop these reactions.
General disorders and disorders at the injection site: often there are moderate reactions at the injection site. These include redness at the injection site (frequency unknown), pain at the injection site (frequency unknown), itching at the injection site (frequency unknown), urticaria at the injection site (frequency unknown), swelling at the injection site (frequency unknown), or an inflammatory reaction at the injection site (frequency unknown).
The most pronounced reactions to insulin at the injection site usually disappear after a few days or weeks.
Diabetes mellitus requiring insulin treatment.
Insuman® Basal GT contains insulin, identical in structure to human insulin and obtained by genetic engineering using the strain Escherichia coli K12 135 pINT90d.
The mechanism of action of insulin:
- reduces the concentration of glucose in the blood, promotes anabolic effects and reduces catabolic effects,
- increases the transport of glucose into cells and the formation of glycogen in the muscles and liver and improves the utilization of pyruvate, inhibits glycogenolysis and glyconeogenesis,
- increases lipogenesis in the liver and adipose tissue and inhibits lipolysis,
- promotes the entry of amino acids into cells and protein synthesis,
- increases the supply of potassium to the cells.
Insuman® Basal GT is a long-acting insulin with a gradual onset of action. After p / c administration, the hypoglycemic effect occurs within 1 hour and reaches a maximum within 3-4 hours. The effect persists for 11-20 hours.
In healthy individuals, T1/2 the amount of insulin from the plasma is approximately 4-6 minutes. In patients with severe renal insufficiency, it is more prolonged. However, it should be noted that the pharmacokinetics of insulin do not reflect its metabolic action.
Biosulin N (Insulin-isophan [human biosynthetic])
Insulin-isophan [human Biosynthetic]
The target blood glucose concentration, the insulin preparations to be used, and the insulin dosage regimen (doses and time of administration) should be determined and adjusted individually to match the patient's diet, physical activity level, and lifestyle.
There are no precisely regulated rules for the dosage of insulin. However, the average daily dose of insulin is 0.5-1 IU / kg / day, and the proportion of prolonged-acting human insulin accounts for 40-60% of the required daily dose of insulin.
The doctor should give the necessary instructions on how often to determine the concentration of glucose in the blood, as well as give appropriate recommendations in case of any changes in the diet or in the mode of insulin therapy.
Switching from another type of insulin to Insuman® Basal GT
When transferring patients from one type of insulin to another, it may be necessary to adjust the insulin dosage regimen: for example, when switching from animal-derived insulin to human insulin, or when switching from one human insulin preparation to another, or when switching from a treatment regimen with soluble human insulin to a regimen that includes longer-acting insulin.
After switching from animal-derived insulin to human insulin, it may be necessary to reduce the dose of insulin, especially in patients who were previously treated at sufficiently low blood glucose concentrations, in patients who are prone to hypoglycemia, in patients who previously required high doses of insulin due to the presence of antibodies to insulin. The need to adjust (reduce) the dose may occur immediately after switching to a new type of insulin or develop gradually over several weeks.
When switching from one type of insulin to another and then in the following first weeks, careful monitoring of the concentration of glucose in the blood is recommended. In patients who required high doses of insulin due to the presence of antibodies, it is recommended to switch to another type of insulin under medical supervision in a hospital.
Additional change in the insulin dose
Improved metabolic control can lead to increased insulin sensitivity, which may reduce the body's need for insulin.
A dose change may also be required when:
- changes in the patient's body weight,
- lifestyle changes (including diet, physical activity level, etc.).),
- other circumstances that may contribute to an increased predisposition to hypo - or hyperglycemia.
Dosage regimen in special groups of patients
Elderly people. In the elderly, the need for insulin may decrease. It is recommended that the initiation of treatment, the increase in doses and the selection of maintenance doses in elderly patients with diabetes mellitus, should be carried out with caution to avoid hypoglycemic reactions.
Patients with hepatic or renal insufficiency. In patients with hepatic or renal insufficiency, the need for insulin may decrease.
Introduction of the drug Insuman® Basal GT
Insuman® Basal GT is usually administered deep p / c for 45-60 minutes before meals. The injection site within the same injection area must be changed each time. The change of injection of insulin (e.g. the abdomen to the thigh) should be made only after consultation with a doctor, since the absorption of insulin and therefore the effect of reducing the concentration of glucose in the blood can vary depending on the area of injection (such as the abdomen or the thigh).
Insuman® Basal GT is not used in various types of insulin pumps (including implanted ones).
Intravenous administration of the drug is absolutely excluded!
You can not mix Insuman® Basal GT with insulins of a different concentration, with insulins of animal origin, insulin analogues or other drugs.
Insuman® Basal GT can be mixed with all Sanofi-aventis Group human insulin preparations. Insuman® Basal GT should not be mixed with insulin intended specifically for use in insulin pumps.
It should be remembered that the concentration of insulin is 100 IU / ml (for 5 ml vials or 3 ml cartridges), so you should only use plastic syringes designed for this concentration of insulin in the case of using vials, or OptiPen Pro1 or ClickStar syringe pens in the case of using cartridges. The plastic syringe must not contain any other drug or its residual amounts.
Before the first set of insulin from the bottle, it is necessary to remove the plastic cap (the presence of a cap is evidence of an unopened bottle). Directly in front of the set, the suspension needs to be well mixed, it does not have to be formed foam. This is best done by turning the bottle, holding it at an acute angle between the palms. After mixing, the suspension should have a uniform consistency and a milky white color. The suspension can not be used if it has any other form, t.e. if it remains transparent or flakes or lumps have formed in the liquid itself, on the bottom or walls of the bottle. In such cases, you should use another bottle that meets the above conditions, and you should also inform your doctor
Before taking insulin from the vial, a volume of air equal to the prescribed dose of insulin is sucked into the syringe and injected into the vial (not into the liquid). Then the bottle together with the syringe is turned upside down with the syringe and the desired amount of insulin is collected. Before the injection, remove the air bubbles from the syringe. At the injection site, take a fold of the skin, insert a needle under the skin and slowly inject insulin. After the injection, the needle is slowly removed and the injection site is pressed with a cotton swab for a few seconds. The date of the first set of insulin from the bottle should be written on the label of the bottle.
After opening, the vials can be stored at a temperature of no more than 25 °C for 4 weeks in a place protected from light and heat.
Before installing the cartridge (100 IU/ml) in the OptiPen Pro1 and ClickStar pen, it is necessary to maintain it for 1-2 hours at room temperature (injections of chilled insulin are more painful). After that, gently turning the cartridge (up to 10 times) to achieve a homogeneous suspension. Each cartridge additionally has 3 metal balls for faster mixing of its contents. After placing the cartridge in the pen, before each injection of insulin, turn the pen several times to obtain a homogeneous suspension. After mixing, the suspension should have a uniform consistency and a milky white color. The suspension can not be used if it has any other form, t.e. if it remains transparent or flakes or lumps have formed in the liquid itself, on the bottom or walls of the cartridge. In such cases, you should use a different cartridge that meets the above conditions, and you should also inform your doctor. Remove any air bubbles from the cartridge before injection (see. Instructions for using the OptiPen Pro1 or ClickStar syringe pens)
The cartridge is not designed for mixing the drug Insuman® Basal GT with other insulins. Empty cartridges cannot be refilled. If the pen is broken, you can inject the required dose from the cartridge using a regular syringe. It should be remembered that the concentration of insulin in the cartridge is 100 IU / ml, so it is necessary to use only plastic syringes designed for this concentration of insulin. The syringe should not contain any other drug or its residual amounts.
After installing the cartridge, it can be used for 4 weeks. It is recommended to store at a temperature of no more than 25 °C in a place protected from light and heat. When using the cartridge, the pen should not be stored in the refrigerator (because injections with chilled insulin are more painful). After installing a new cartridge, you must check the correct operation of the pen before injecting the first dose (see the instructions for using the OptiPenPro1 or ClickStar pen).
Instructions for using and handling a pre-filled SoloStar syringe pen®
Before the first use, the pen must be held at room temperature for 1-2 hours.
Before use, inspect the cartridge inside the pen after thoroughly mixing the suspension in it by rotating the pen around its axis, holding it at an acute angle between the palms. It should only be used if, after mixing, the suspension has a uniform consistency and a milky white color. The pen can not be used if the suspension in it after mixing has any other appearance, i.e. if it remains transparent or flakes or lumps have formed in the liquid itself, on the bottom or walls of the cartridge. In such cases, you should use a different pen and inform your doctor.
Empty syringe pens SoloStar® must not be reused and must be destroyed.
To prevent infection, the pre-filled syringe pen should only be used by one patient and should not be passed on to another person.
Handling the SoloStar pen®
Before using the SoloStar pen® please read the usage information carefully.
Important information on using the SoloStar pen®
Before each use, it is necessary to carefully connect the new needle to the pen and perform a safety test. You should only use needles that are compatible with the Solostar®.
Special precautions should be taken to avoid accidents associated with the use of the needle and the possibility of transmission of infection.
Do not use the SoloStar pen under any circumstances® if it is damaged or if the patient is not sure that it will work properly.
It is always necessary to have a spare SoloStar pen in stock® in case of loss or damage to the working copy of the SoloStar pen®.
Storage instructions
It is necessary to study the section "Storage conditions" regarding the storage rules of the SoloStar pen®.
If the syringe-pen is SoloStar® stored in the refrigerator, it should be removed from there for 1-2 hours before the intended injection, so that the suspension takes room temperature. The introduction of chilled insulin is more painful.
Used SoloStar syringe pen® it must be destroyed.
Operation
SoloStar Pen Syringe® it must be protected from dust and dirt.
The outer side of the SoloStar syringe pen® you can clean it by wiping it with a damp cloth.
Should not be immersed in liquid, do not rinse and do not lubricate the pen Solostar®, because this can damage it.
The syringe pen Solostar® accurately dispenses insulin and is safe to use. It also requires careful handling. Avoid situations where damage to the SoloStar pen may occur.®. If the patient suspects that the working copy of the syringe pen is SoloStar® could be damaged, you should use a new syringe pen.
Stage 1. Insulin control
It is necessary to check the label on the SoloStar syringe pen®, to make sure that it contains the appropriate insulin. For Insuman® Basal GT syringe pen SoloStar® white color with a green button for injection. After removing the cap of the pen, the appearance of the insulin contained in it is controlled: the insulin suspension after mixing should have a uniform consistency and a milky white color.
Step 2. Connecting the needle
Only use needles that are compatible with the SoloStar pen.®.
For each subsequent injection, a new sterile needle is always used. After removing the cap, the needle must be carefully placed on the syringe handle.
Step 3. Performing the safety test (always performed after mixing the suspension, see above).
Before each injection is administered, a safety test should be performed to ensure that the pen and needle are working well and that the air bubbles are removed.
Measure a dose equal to 2 units.
The outer and inner needle caps must be removed.
Placing the pen needle up, gently tap the insulin cartridge with your finger so that all the air bubbles are directed towards the needle.
Fully press the injection button.
If the insulin appears on the tip of the needle, it means that the pen and needle are working correctly.
If the appearance of insulin at the tip of the needle is not observed, then stage 3 can be repeated until the insulin appears at the tip of the needle.
Step 4. Dose selection (always performed after mixing the suspension, see above)
The dose can be set with an accuracy of 1 UNIT: from the minimum dose-1 unit to the maximum dose-80 units. If you need to enter a dose exceeding 80 units, you should perform 2 or more injections.
The dosage window should show " 0 " after the safety test is completed. After that, the required dose can be set.
Stage 5. Dose administration
The patient should be informed about the injection technique by a medical professional.
The needle must be inserted under the skin. The injection button must be fully pressed. It is held in this position for another 10 seconds until the needle is removed. This ensures that the selected dose of insulin is fully administered.
Step 6. Removing and discarding the needle
In all cases, the needle should be removed and discarded after each injection. This ensures the prevention of pollution and/or make infections, the ingress of air into the container for insulin and leakage of insulin.
Special precautions must be taken when removing and discarding the needle. The recommended safety measures for removing and disposing of needles (such as the technique of putting the cap on with one hand) should be followed in order to reduce the risk of accidents associated with the use of the needle, as well as to prevent infection.
After removing the needle, close the SoloStar pen® with a cap.
A10AC Medium-acting insulins and their analogues for injectable administration
