Instruction for use: Lantus SoloStar

Active substance Insulin glargine

ATX codeA10AE04 Insulin glargine

Pharmacological group of substance Calcitonin

Hypoglycemic agent. Long-acting insulin [Insulins]

Nosological classification (ICD-10)

E10 Insulin-dependent diabetes mellitus

Decompensation of carbohydrate metabolism, Diabetes mellitus, Diabetes insulin sugar, Diabetes mellitus type 1, Diabetic ketoacidosis, Insulin-dependent diabetes, Insulin-dependent diabetes mellitus, Coma hyperosmolar non-ketoacidotic, Labile form of diabetes mellitus, Violation of carbohydrate metabolism, Type 1 diabetes mellitus, Type I diabetes mellitus, Insulin-dependent diabetes mellitus, Type 1 diabetes mellitus

Composition

Solution for subcutaneous administration 1 ml

active substance:

Insulin glargine 100 ED (3.6378 mg)

Auxiliary substances: metacresol (m-cresol) - 2.7 mg; Zinc chloride - 0.0626 mg (corresponding to 30 μg of zinc); Glycerol (85%) - 20 mg; Sodium hydroxide - up to pH 4; Hydrochloric acid - up to pH 4; Water for injection - up to 1 ml

Description of dosage form

Transparent, colorless or almost colorless liquid.

pharmachologic effect

Pharmacological action - hypoglycemic.

Pharmacodynamics

Insulin glargine is an analog of human insulin, obtained by recombination of DNA-bacteria of the species Escherichia coli (strains K12).

Insulin glargine is designed as an analog of human insulin, characterized by low solubility in a neutral medium. In the formulation Lantus ® SoloStar ®, it is completely soluble, which is provided by acid reaction of the solution for injection (pH 4). After introduction into the subcutaneous fat, the acid reaction of the solution is neutralized, which leads to the formation of micro-precipitates, from which small amounts of insulin glargine are constantly released, providing a predictable, smooth (without peaks) profile of the concentration-time curve, as well as a prolonged action of the drug.

Insulin glargine is metabolized to two active metabolites M1 and M2 (see "Pharmacokinetics").

Relationship with insulin receptors: the binding kinetics to specific insulin receptors in insulin glargine and its metabolites - M1 and M2 - is very close to that of human insulin, and therefore insulin glargine is capable of carrying out a biological action similar to that of endogenous insulin.

The most important action of insulin and its analogs, incl. And insulin glargine, is the regulation of glucose metabolism. Insulin and its analogues reduce the concentration of glucose in the blood, stimulating the absorption of glucose by peripheral tissues (especially skeletal muscle and fat tissue) and inhibiting the formation of glucose in the liver.

Insulin inhibits lipolysis in adipocytes and inhibits proteolysis, simultaneously increasing protein synthesis.

The prolonged action of insulin glargine is directly associated with a reduced rate of its absorption, which allows the drug to be applied once a day. After the sc administration, the onset of its action occurs on average after 1 hour. The average duration of action is 24 hours, the maximum is 29 hours. The duration of action of insulin and its analogues, such as insulin glargine, can vary significantly for different individuals or for one and the same The same person.

The efficacy of using Lantus® SoloStar® in children over the age of 2 with type 1 diabetes was shown. Moreover, in children aged 2-6 years, the incidence of hypoglycemia with clinical manifestations with insulin glargine was lower both during the day and so And at night compared with the use of insulin-isophane (correspondingly an average of 25.5 episodes against 33 episodes in one patient for one year). In five-year follow-up of patients with type 2 diabetes mellitus, there were no significant differences in the progression of diabetic retinopathy in the treatment of insulin with glargine compared with insulin-isophane.

Relationship with the receptors of insulin-like growth factor 1 (IGF-1): the affinity of insulin glargine to the IGF-1 receptor is approximately 5-8 times higher than in human insulin (but approximately 70-80 times lower than in IGF-1), At the same time, compared with human insulin, in the metabolites of glargine M1 and M2 insulin, the affinity for the IGF-1 receptor is somewhat less.

The total therapeutic concentration of insulin (insulin glargine and its metabolites), determined in patients with type 1 diabetes, was markedly lower than that required for half-maximal binding to IGF-1 receptors and subsequent activation of the mitogen-proliferative pathway through IGF-1 receptors. The physiological concentrations of endogenous IGF-1 can activate the mitogenic-proliferative pathway; however therapeutic insulin concentrations determined with insulin therapy including treatment with Lantus SoloSTAR® significantly below pharmacological concentrations required for activation mitogenically-proliferative path.

ORIGIN study (Outcome Reduction with Initial Glargine INtervention) was an international, multicenter, randomized, conducted in 12537 patients c high risk of developing cardiovascular disease and impaired fasting glucose (IFG), impaired glucose tolerance (IGT) or early stage diabetes mellitus type 2. study participants were randomized (1: 1), the group of patients receiving insulin glargine (n = 6264) which titrated to achieve a concentration of fasting blood glucose (FBG) <5.3 mmol, and the group of patients receiving std rtnoe treatment (n = 6273). The first end point of the study was the time to the development of cardiovascular death, the first development of non-fatal myocardial infarction or nonfatal stroke, and the second endpoint was the time before the first occurrence of any complication from the above or before the revascularization procedure (coronary, carotid or peripheral arteries) , Or before hospitalization for the development of heart failure.

Secondary endpoints were mortality for any reason and a combined measure of microvascular outcome. The ORIGIN study showed that treatment with insulin glargine compared with standard hypoglycemic therapy did not change the risk of developing cardiovascular complications or cardiovascular mortality; There was no difference in the indices of any component that made up the endpoints, mortality from all causes, combined index of microvascular outcomes.

At the beginning of the study, the median of HbA1c was 6.4%. Median values of HbA1c during treatment were in the range of 5.9-6.4% in the group of insulin glargine and 6.2-6.6% in the standard treatment group throughout the follow-up period. In the group of patients receiving insulin glargine, the incidence of severe hypoglycemia was 1.05 episodes per 100 patient-years of therapy, and in the group of patients receiving standard hypoglycemic therapy 0.3 episodes per 100 patient-years of therapy. The incidence of mild hypoglycemia was 7.71 episodes per 100 patient-years of therapy in the group receiving insulin glargine, and 2.44 episodes per 100 patient-years of therapy in the group receiving standard hypoglycemic therapy. In a 6-year study, 42% of patients in the insulin glargine group did not experience any cases of hypoglycemia.

The median change in body weight compared with the outcome at the last visit of treatment was 2.2 kg higher in the group of insulin glargine than in the standard treatment group.

Pharmacokinetics

A comparative study of the concentrations of insulin glargine and insulin-isophane in blood plasma in healthy people and patients with diabetes mellitus after the administration of drugs showed a slower and much longer absorption, as well as a lack of peak concentration in insulin glargine compared with insulin-isophane. At a single dose during the day, the administration of Lantus® SoloStar® Css insulin glargine in blood is achieved after 2-4 days with daily administration.

With IV injection of T1 / 2 insulin glargine and human insulin were comparable. When insulin glargine was administered to the abdomen, shoulder, or thigh, there were no significant differences in serum insulin concentrations. In comparison with human medium-duration insulin, insulin glargine is characterized by less variability in the pharmacokinetic profile, both in the same and in different patients. In humans, in the subcutaneous fat, insulin glargine is partially cleaved from the carboxyl terminus (C-terminus) of the beta chain (beta chain) to produce two active metabolites of M1 (21A G1y-insulin) and M2 (21A G1y-des-30B- Th-insulin). The M1 metabolite predominantly circulates in the blood plasma. Systemic exposure of M1 metabolite increases with increasing dose of the drug.

Comparison of pharmacokinetics and pharmacodynamics data showed that the effect of the drug is mainly due to the systemic exposure of the metabolite M1. The overwhelming majority of patients failed to detect insulin glargine and M2 metabolite in the systemic circulation. In cases where nevertheless it was possible to detect insulin glargine and M2 metabolite in blood, their concentrations did not depend on the administered dose of Lantus® SoloStar®.

Special patient groups

Age and sex. Information on the effect of age and sex on the pharmacokinetics of insulin glargine is absent. However, these factors did not cause differences in the safety and efficacy of the drug.

Smoking. In clinical studies, subgroup analysis did not reveal differences in the safety and efficacy of glargine insulin for this group of patients compared to the general population.

Obesity. In obese patients, there was no difference in the safety and efficacy of insulin glargine and insulin isophane compared to patients with normal body weight.

Children. In children with type 1 diabetes at the age of 2 to 6 years, the concentrations of insulin glargine and its major metabolites M1 and M2 in blood plasma before the introduction of the next dose were similar to those in adults, indicating that there was no accumulation of insulin glargine and its metabolites at Constant use of insulin glargine in children.

Indications

Diabetes mellitus, requiring insulin treatment, in adults, adolescents and children older than 2 years.

Contraindications

Increased sensitivity to insulin glargine or any of the auxiliary components of the drug;

Children under 2 years of age (lack of clinical data for use).

With caution: pregnant women (the possibility of changing the need for insulin during pregnancy and after childbirth).

pregnancy and lactation

Patients should inform the attending physician about the present or planned pregnancy.

There were no randomized controlled clinical studies on the use of insulin glargine in pregnant women.

A large number of observations (more than 1000 outcomes of pregnancies with retrospective and prospective observation) in the postmarketing use of insulin glargine showed no specific effects on the course and outcome of pregnancy or fetal status, or the health of newborns.

In addition, in order to assess the safety of insulin glargine and insulin-isophane in pregnant women with pre-existing or gestational diabetes mellitus, a meta-analysis of eight observational clinical trials involving women who had insulin glargine (n = 331) And insulin isophane (n = 371). This meta-analysis did not reveal significant differences in the safety of maternal or newborn health when using insulin glargine and insulin-isophane during pregnancy.

In animal studies, no direct or indirect data were obtained on the embryotoxic or fetotoxic effect of insulin glargine.

For patients with pre-existing or gestational diabetes mellitus, it is important during the entire pregnancy to maintain adequate regulation of metabolic processes to prevent the emergence of unwanted outcomes associated with hyperglycemia.

The preparation Lantus® SoloStar® can be used during pregnancy according to clinical indications.

The need for insulin can decrease in the first trimester of pregnancy and, in general, increase during the II and III trimesters.

Immediately after delivery, the need for insulin decreases rapidly (the risk of developing hypoglycemia increases). In these conditions, careful monitoring of the concentration of glucose in the blood is essential.

Patients in the period of breastfeeding may need to adjust the dosage regimen of insulin and diet.

Side effects

Hypoglycemia, the most common undesirable consequence of insulin therapy, can occur if the dose of insulin is too high compared to the need for it.

The following undesirable effects are given according to the systems of organs in accordance with the following gradations of the frequency of their occurrence: very often - ≥10%; Often - ≥1- <10%; Infrequently - ≥0.1- <1%; Rarely - ≥0.01 - <0.1%; Very rarely - ≤0.01%

From the side of metabolism: very often - hypoglycemia. Hypoglycemia, the most common undesirable reaction in insulin therapy, can occur if the dose of insulin is too high compared to the need for it. Symptoms of hypoglycemia usually develop suddenly. However, often neuropsychiatric disorders due to neuroglycopenia (fatigue, unusual fatigue or weakness, decreased ability to concentrate, drowsiness, visual disturbances, headache, nausea, confusion or loss of it, convulsive syndrome) are usually preceded by symptoms of adrenergic counterregulation (activation of the sympathoadrenal system In response to hypoglycemia) - a feeling of hunger, irritability, nervous excitement or tremor, anxiety, pallor of the skin, cold sweat, Tachycardia, marked palpitation (the faster the hypoglycemia develops and the more severe it is, the stronger the symptoms of adrenergic counterregulation).

Attacks of severe hypoglycemia, especially recurrent, can lead to damage to the nervous system. Episodes of prolonged and severe hypoglycemia can endanger the lives of patients, With the growth of hypoglycemia, even a fatal outcome is possible.

From the immune system: rarely - allergic reactions. Allergic reactions of an immediate type to insulin are rare. Similar reactions to insulin (including insulin glargine) or excipients may be manifested by the development of generalized skin reactions, angioedema, bronchospasm, arterial hypotension or shock and thus pose a threat to the life of the patient.

The use of insulin can cause the formation of antibodies to it. The formation of antibodies cross-reacting with human insulin and insulin glargine is observed at the same frequency with insulin-isophane and insulin glargine. In rare cases, the presence of such antibodies to insulin may cause the need for correction of the dosing regimen in order to eliminate the tendency to develop hypo- or hyperglycemia.

From the nervous system: very rarely - dysgeusia (perversion of taste).

From the side of the organ of vision: rarely - visual impairment, retinopathy.

Significant changes in the regulation of blood glucose can cause temporary visual impairment due to changes in tissue turgor and the refractive index of the lens of the eye.

Long-term normalization of blood glucose reduces the risk of progression of diabetic retinopathy. Insulin therapy, accompanied by rapid fluctuations in blood glucose, may be accompanied by a temporary deterioration in the course of diabetic retinopathy. In patients with proliferative retinopathy, especially those who do not receive photocoagulation treatment, episodes of severe hypoglycemia can lead to the development of transient visual loss.

From the skin and subcutaneous fat: often - lipodystrophy (in 1-2% of patients). As with any other insulin medication, lipodystrophy can occur at the injection site, which can slow the local absorption of insulin; Infrequently - lipoatrophy. The constant change of injection sites within the body regions recommended for insulin administration may help to reduce the severity of this reaction or prevent its development.

From the musculoskeletal system and connective tissue: very rarely - myalgia.

General disorders and reactions at the injection site: often - reactions at the injection site (3-4%) (redness, pain, itching, urticaria, edema or inflammation). Most minor reactions at the site of insulin administration are usually resolved between a few days and several weeks; Rarely - sodium retention, swelling (especially if intensified insulin therapy leads to an improvement in previously inadequate metabolic control).

The safety profile for patients under the age of 18 is generally similar to that for patients over 18 years of age. In patients younger than 18 years, reactions at the site of administration and skin reactions (rashes, urticaria) are relatively more frequent.

Safety data are not available in patients younger than 2 years.

Interaction

Pharmacodynamic interaction

Oral hypoglycemic agents, ACE inhibitors, disopyramide, fibrates, fluoxetine, MAO inhibitors, pentoxifylline, propoxyphene, salicylates and sulfonamide antimicrobials - can increase the hypoglycemic effect of insulin and increase the predisposition to the development of hypoglycemia. Simultaneous reception with insulin glargine may require correction of the dose of insulin.

GCS, danazol, diazoxide, diuretics, glucagon, isoniazid, estrogens and gestagens (eg in hormonal contraceptives), phenothiazine derivatives, somatotropin, sympathomimetics (eg epinephrine, salbutamol, terbutaline) and thyroid hormones, protease inhibitors, atypical antipsychotics (eg olanzapine or Clozapine) - can weaken the hypoglycemic action of insulin. Simultaneous reception with insulin glargine may require correction of the dose of insulin glargine.

Beta-adrenoblockers, clonidine, lithium salts or alcohol - is possible as an enhancement, and weakening of hypoglycemic action of insulin.

Pentamidine - when combined with insulin can cause hypoglycemia, which is sometimes replaced by hyperglycemia.

Sympatholytic drugs, such as beta-adrenoblockers, clonidine, guanethidine and reserpine, may have signs of adrenergic counterregulation (activation of the sympathetic nervous system) diminishing or absent in the development of hypoglycemia.

Pharmaceutical interaction

When mixing Lantus ® SoloStar ® with other medicinal substances, incl. And with other insulins, as well as the dilution of the drug, it is possible to form a precipitate or change the profile of the drug in time.

Dosing and Administration

PC. Adults and children over 2 years.

General recommendations

Lantus® SoloStar® should be administered once a day at any time of the day, but every day at the same time.

In patients with type 2 diabetes mellitus, Lantus® SoloStar® can be used both as monotherapy and in combination with other hypoglycemic drugs.

Target values of blood glucose concentration, as well as dose and time of administration or intake of hypoglycemic drugs should be determined and adjusted individually.

Dose adjustment may also be required, for example, with a change in the patient's body weight, lifestyle, changes in the time of administration of the insulin dose, or in other conditions that may increase the propensity to develop hypoglycemic or hyperglycemia (see "Special instructions"). Any changes in the dose of insulin should be conducted with caution and under medical supervision.

Lantus® SoloStar® is not an insulin of choice for the treatment of diabetic ketoacidosis. In this case, preference should be given to / in the introduction of short-acting insulin.

In treatment regimens including injections of basal and prandial insulin, 40-60% of the daily insulin dose in the form of insulin glargine is usually administered to meet the need for basal insulin.

In patients with type 2 diabetes mellitus who use hypoglycemic drugs for oral administration, the combination therapy begins with a dose of 10 mg of glargine 10 times a day, and then the treatment regimen is adjusted individually.

In all patients with diabetes it is recommended to monitor the concentration of glucose in the blood.

Transition from treatment with other hypoglycemic drugs to Lantus® SoloStar®

When transferring a patient from a treatment regimen using insulin of medium duration or prolonged action to a treatment regimen using Lantus® SoloStar®, it may be necessary to correct the amount (doses) and time of administration of short-acting insulin or an analogue thereof during the day or change the doses of oral hypoglycemic drugs .

When transferring patients from a single day during the day of insulin-isophane administration to once-daily administration of Lantus® SoloStar®, the initial doses of insulin do not usually change (that is, the amount of ED / day of Lantus® SoloStar® is equal to the amount of ME / day Insulin-isophane).

When transferring patients from twice daily insulin-isophane administration to a single administration of Lantus® SoloStar® before bedtime in order to reduce the risk of hypoglycaemia during the night and early morning hours, the initial daily dose of insulin glargine is usually reduced by 20% (compared with the daily dose Insulin-isophane), and then it is adjusted depending on the patient's reaction.

Lantus® SoloStar® should not be mixed with other insulin preparations or diluted. It is necessary to make sure that the syringes do not contain the remains of other drugs. When mixing or diluting, the profile of insulin glargine can change in time.

When switching from human insulin to Lantus® SoloStar® and during the first weeks after it, careful metabolic monitoring (monitoring of glucose concentration in the blood) is recommended under medical supervision, with correction, if necessary, of an insulin dosage regimen. As with other human insulin analogues, this is especially true for patients who, due to their antibodies to human insulin, require the use of high doses of human insulin. In such patients, with insulin glargine, a significant improvement in the response to insulin administration can be observed.

With the improvement of metabolic control and the resulting increase in the sensitivity of tissues to insulin, it may be necessary to correct the dosage regimen of insulin.

Mixing and dilution

The preparation Lantus® SoloStar® should not be mixed with other insulins. Mixing can change the time / effect ratio of the Lantus® SoloStar® preparation, as well as lead to precipitation.

Special patient groups

Children. The preparation Lantus® SoloStar® can be used in children over 2 years of age. Use in children under 2 years of age has not been studied.

Patients of advanced age. In elderly patients with diabetes mellitus, the use of moderate initial doses is recommended, their slow increase and the use of moderate maintenance doses.

Mode of application

The preparation Lantus® SoloStar® is injected in the form of SC injections. Not for intravenous administration. The long duration of the action of insulin glargine is observed only when it is introduced into the subcutaneous fat. In / in the administration of a usual subcutaneous dose can cause severe hypoglycemia. Lantus® SoloStar® should be injected into the subcutaneous fat of the abdomen, shoulders, or thighs. The injection sites should alternate with each new injection within the recommended areas for the administration of the drug.

As with other types of insulin, the degree of absorption, and hence the onset and duration of its action, can change under the influence of physical activity and other changes in the patient's condition.

Lantus® SoloStar® is a clear solution, not a suspension. Therefore, re-suspension before use is not required.

If the Lantus® SoloStar® handle is damaged, insulin glargine can be removed from the cartridge in a syringe (suitable for 100 IU / ml insulin) and injected.

Instructions for use and handling of pre-filled SoloStar® syringe pen

Before the first use, the syringe pen should be held at room temperature for 1-2 hours.

Before use, inspect the cartridge inside the syringe pen. It should only be used if the solution is clear, colorless, free of visible solids and resembles water in a consistency.

Empty SoloStar® pen need not be reused and must be destroyed.

To prevent infection, a pre-filled syringe pen should only be used by one patient and not transferred to another person.

Handling of the SoloStar® syringe handle

Before using the SoloStar® pen, you should read the usage information carefully.

Important information on using the SoloStar® pen

Before each use, it is necessary to carefully connect a new needle to the syringe pen and conduct a safety test. It is necessary to use only needles compatible with SoloStar®.

It is necessary to take special precautions to avoid accidents involving the use of the needle and the possibility of infection transmission.

In no case should you use the SoloStar® syringe handle if it is damaged or if you are not sure that it will work properly.

It is always necessary to have a spare SoloStar® pen in case of loss or damage to the former SoloStar® pen.

Storage Instruction

The "Storage conditions" section regarding the rules for storing SoloStar® syringe pens should be studied.

If the SoloStar® pen is stored in the refrigerator, you should remove it from there 1-2 hours before the proposed injection so that the solution will become room temperature. The introduction of chilled insulin is more painful.

The used SoloStar® pen must be destroyed.

Exploitation

The SoloStar® syringe handle must be protected from dust and dirt.

The outer side of the SoloStar® pen can be cleaned by wiping it with a damp cloth.

Do not immerse the SoloStar® pen in the liquid, rinse and lubricate it, as this can damage the SoloStar® syringe.

The syringe handle SoloStar® precisely doses insulin and is safe in operation. It also requires careful handling. Avoid situations in which the SoloStar® pen can be damaged. If there is a suspicion that the used copy of the SoloStar® pen is damaged, a new syringe pen should be used.

Stage 1. Insulin control

It is necessary to check the label on the SoloStar® syringe pen to ensure that it contains the appropriate insulin. For Lantus®, the SoloStar® syringe pen is gray with a purple button for injection. After removing the cap of the syringe pen, the appearance of the insulin contained in it is controlled: the insulin solution must be transparent, colorless, free of visible solid particles and resemble water in a consistency.

Stage 2. Connecting the needle

Use only needles that are compatible with the SoloStar® syringe pen.

For each subsequent injection, a new sterile needle is always used. After removing the cap, the needle should be carefully installed on the syringe pen.

Stage 3. Performance of the safety test

Before each injection, a safety test must be carried out and the syringe and needle should work well and air bubbles be removed.

Measure the dose equal to 2 units.

The outer and inner needle caps must be removed.

With the needle pen up, gently tap the cartridge with the insulin finger so that all air bubbles are directed towards the needle.

Fully press the injection injection button.

If insulin appears at the tip of the needle, it means that the pen and needle work correctly.

If no insulin appears on the tip of the needle, stage 3 can be repeated until insulin appears at the tip of the needle.

Stage 4. Dose selection

The dose can be established with an accuracy of 1, from the minimum dose (1 U) to the maximum (80 U). If it is necessary to enter a dose exceeding 80 units, two or more injections should be given.

The dosage window should indicate "0" after the safety test is completed. After that, the required dose can be set.

Stage 5. Dosing Introduction

The patient should be informed about the technique of injection by a medical professional.

The needle must be inserted under the skin.

The injection button must be pressed completely. It is held in this position for another 10 seconds until the needle is removed. Thus, the introduction of a selected dose of insulin is ensured completely.

Stage 6. Extraction and ejection of a needle

In all cases, the needle after each injection should be removed and discarded. This ensures the prevention of contamination and / or infection, air entering the insulin tank and leakage of insulin.

When removing and discarding the needle, special precautions must be taken. It is necessary to observe the recommended safety measures for removing and disposing needles (for example, the technique of putting the cap on with one hand) in order to reduce the risk of accidents involving the use of the needle and to prevent infection.

After removing the needle, close the SoloStar® syringe with the cap.

Overdose

An overdose of insulin can lead to severe and sometimes prolonged hypoglycemia, which threatens the life of the patient.

Treatment: episodes of moderate hypoglycemia are usually stopped by ingestion of rapidly digested carbohydrates. It may be necessary to change the dosage regimen of the drug, diet or physical activity.

Episodes of more severe hypoglycemia, manifested by coma, convulsions or neurological disorders, require / m or n / c administration of glucagon, as well as in / in the administration of a concentrated solution of dextrose (glucose). It may be necessary to take carbohydrates for a long time and observe the specialist, since After a visible clinical improvement, a relapse of hypoglycemia is possible.

special instructions

Lantus® SoloStar® is not a drug of choice for the treatment of diabetic ketoacidosis. In such cases, the introduction of short-acting insulin is recommended.

Due to limited experience with Lantus® SoloStar®, it was not possible to evaluate its effectiveness and safety in the treatment of patients with impaired hepatic function or with moderate or severe renal insufficiency.

In patients with impaired renal function, the need for insulin may decrease due to a slowdown in its elimination. In elderly patients, progressive deterioration of kidney function can lead to a persistent decrease in insulin requirements.

In patients with severe hepatic insufficiency, the need for insulin can be lowered due to a decrease in the ability to gluconeogenesis and slowing down the biotransformation of insulin.

In case of insufficient control of blood glucose level, as well as in the presence of a tendency to hypo- or hyperglycemia, before correcting the dosage regimen, it is necessary to check the accuracy of the prescribed treatment regimen, adherence to the directions for the injection site and the correctness of the technique / To injections taking into account all factors affecting it.

Hypoglycaemia

The time of development of hypoglycemia depends on the profile of the action of the insulin used and can thus change when the treatment regimen is changed. Due to an increase in the time of insulin administration of a prolonged action with Lantus® SoloStar®, a lower probability of developing nocturnal hypoglycemia should be expected, whereas in the early morning hours this probability of hypoglycemia is higher. If hypoglycaemia occurs in patients receiving Lantus® SoloStar®, the possibility of slowing the release from hypoglycemia due to the prolonged action of insulin glargin should be considered.

Patients who have episodes of hypoglycemia may have a particular clinical significance, such as patients with severe stenosis of the coronary arteries or cerebral vessels (risk of developing cardiac and cerebral complications of hypoglycemia), as well as patients with proliferative retinopathy, especially if they do not receive photocoagulation treatment (risk Transient loss of vision following hypoglycemia), special care should be taken and intensified monitoring of blood glucose levels.

Patients should be warned about conditions in which symptoms-precursors of hypoglycemia may diminish. In patients of certain risk groups, the symptoms of hypoglycemia may change, become less pronounced or absent. These include:

- Patients who have significantly improved the regulation of blood glucose;

- Patients who develop hypoglycemia gradually;

- patients of advanced age;

- patients transferred from insulin of animal origin to human insulin;

- patients with neuropathy;

- Patients with a long history of diabetes mellitus;

- patients suffering from mental disorders;

- patients receiving concomitant medication with other medications (see "Interaction").

Such situations can lead to the development of severe hypoglycemia (with possible loss of consciousness) before the patient realizes that he is developing hypoglycemia.

In case normal or reduced rates of glycosylated Hb are observed, it is necessary to consider the possibility of developing recurrent unrecognized episodes of hypoglycemia (especially at night).

Patient compliance with the dosing regimen and diet, proper insulin administration and knowledge of hypoglycemia precursors contribute to a significant reduction in the risk of developing hypoglycemia.

Factors that increase the tendency to hypoglycemia, in the presence of which a particularly careful observation is required and correction of the insulin dose may be necessary:

- change of place of insulin administration;

- Increased sensitivity to insulin (for example, when stress factors are eliminated);

- unusual, increased or prolonged physical activity;

- intercurrent diseases, accompanied by vomiting, diarrhea;

- violation of diet and diet;

- missed food intake;

- consumption of alcohol;

- Some uncompensated endocrine disorders (eg, hypothyroidism, adenohypophysis failure or adrenal cortex);

- concomitant treatment with some drugs (see "Interaction").

Intercurrent diseases

When intercurrent diseases require more intensive monitoring of blood glucose levels. In many cases, the analysis of the presence of ketone bodies in the urine is shown, and often a correction of the insulin dosage regimen is required. The need for insulin is often increased. Patients with type 1 diabetes should continue to regularly consume at least a small amount of carbohydrates, even if they are able to consume food only in small amounts or can not eat at all, or they have vomiting, etc., and they should never completely stop The introduction of insulin.

Recommendations for handling the drug

When storing Lantus® SoloStar® in the refrigerator, care must be taken to ensure that the containers do not directly touch the freezer compartment or frozen packages.

Before using for the first time, the Lantus® SoloStar® pen should be kept at room temperature for 1-2 hours.

The disposable SoloStar® disposable syringes should be stored at a temperature not exceeding 30 ° C, protected from light.

Do not cool the pre-filled SoloStar® pen.

Shelf life of the drug in a disposable syringe pen SoloStar® after the first use is 4 weeks. It is recommended to mark the date of the first injection of the drug on the label.

Form of issue

Solution for subcutaneous administration, 100 units / ml. For 3 ml of the drug in a cartridge of clear, colorless glass (type 1). The cartridge is sealed on one side with a bromobutyl stopper and crimped with an aluminum cap, on the other hand by a bromobutyl plunger.

The cartridge is mounted in a disposable syringe pen SoloStar®. 5 SoloStar® syringe pens are placed in a cardboard box equipped with a cardboard latch.

Terms of leave from pharmacies

On prescription.

Storage conditions

In the dark place at a temperature of 2-8 ° C (do not freeze). After the beginning of use, store at a temperature of no higher than 25 ° C in a carton (but not in the refrigerator).

Keep out of the reach of children.

shelf life

3 years.

Do not use after the expiry date printed on the package.