Insulin glargine - instructions for use, dose, side effects, contraindications

Excipients: metacresol (m-cresol) 2.7 mg, zinc chloride 0.0626 mg [corresponding to 30 μg zinc], glycerol (85%) 20 mg, sodium hydroxide to pH 4.0, hydrochloric acid to pH 4.0, water for injections up to 1.0 ml.

Description:

Transparent, colorless or almost colorless liquid.

Pharmacotherapeutic group:hypoglycemic agent - long-acting insulin analog

ATX: & nbsp

A.10.A.E.04 Insulin Glargine

Pharmacodynamics:

Insulin glargine is an analog of human insulin, obtained by recombinant DNA of bacteria of the species Escherichia coli (strains K12), and differing low solubility in a neutral medium.

In the formulation Insulin Glargine insulin glargine completely soluble, which is ensured by the acid reaction of the solution for injection (pH 4).After administration subcutaneous fat acidic reaction solution was neutralized, leading to the formation mikropretsipitatov of which is constantly released small amounts of insulin glargine, providing predictable, smooth (without peaks) profile curve "concentration-time", as well as a prolonged action drug.

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

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

The most important action of insulin and its analogues, including 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 related to the reduced rate of its absorption, which allows the drug to be used once a day. After subcutaneous administration, the onset of its action occurs on average after 1 hour. The average duration of action is 24 hours, the maximum - 29 hours.

The duration of action of insulin and its analogues, such as insulin glargine, can vary significantly between patients or from the same patient.

The effectiveness of the drug was shown Insulin Glargine in children over the age of 2 years with type 1 diabetes mellitus. In children in the age group 2-6 years, the incidence of hypoglycemia with clinical manifestations with insulin glargine was numerically lower, both during the day and at night, compared with the use of insulin isophane (respectively, an average of 25.5 episodes against 33.0 episodes in one patient for one year).

In the 5-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 glargine compared to 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 that of human insulin (but approximately 70-80 times lower than in IGF-1), while at the same time, in comparison with human insulin, metabolites insulin glargine M1 and M2, 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 mellitus, was significantly lower than that required for half-maximal binding to IGF-1 receptors and subsequent activation of the mitogenically proliferative pathway through IGF-1 receptors.

The physiological concentrations of endogenous IGF-1 can activate the mitogenically proliferative pathway, however, therapeutic insulin concentrations determined by insulin therapy, including drug treatment Insulin glargine, much lower than the pharmacological concentrations required to activate the mitogenically proliferative pathway.

The ORIGIN study was an international, multicenter, randomized trial,conducted in 12537 patients with a high risk of developing cardiovascular diseases and with impaired fasting glycemia (NGH), impaired glucose tolerance (HTG) or early stage 2 diabetes mellitus. Participants in the study were randomized to groups (1: 1): a group of patients receiving insulin glargine (n= 6264), which was titrated to achieve a fasting blood glucose (GHC) ≤ 5.3 mmol, and a group of patients receiving standard treatment (n=6273).

The first end point of the study was the time to the development of cardiovascular death, the first development of nonfatal 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 standardhypoglycemic therapy did not change the risk of developing cardiovascular complications or cardiovascular mortality; there was no difference in the indices of any component that makes up the endpoints, mortality from all causes, combined index of microvascular outcomes.

At the beginning of the study, the median of HbAlc values was 6.4%. The median of HbAlc values during treatment was 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 who received insulin glargine, the incidence of severe hypoglycemia was 1.05 episodes per 100 patient-years of therapy, and in the group receiving standard hypoglycemic therapy, 0.30 episodes per 100 patient-years of therapy. The rate of development of mild hypoglycemia was in the group of patients who received insulin glargine, 7.71 episodes per 100 patient-years of therapy, and in the group of patients receiving standard hypoglycemic therapy - 2.44 episodes per 100 patient-years of therapy. In a 6-year study, 42% of the patients in the group who received insulin glargine, no cases of hypoglycemia were noted. The median change in body weight compared to 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 serum in healthy people and patients with diabetes mellitus, after subcutaneous administration of drugs, revealed a slower and much longer absorption, as well as a lack of peak concentration in insulin glargine compared to insulin-isophane.

When administered once per day, subcutaneous administration of the drug Insulin Glargine the equilibrium concentration of insulin glargine in the blood is reached after 2-4 days with daily administration.

With intravenous administration, the half-lives of insulin glargine and human insulin were comparable.

When insulin glargine was injected into the abdomen, shoulder, or thigh, no significant differences in insulin concentrations in serum were found.

Compared with human insulin of average duration of action insulin glargine is characterized by less variability pharmacokinetic profile, both in the same and in different patients.

In humans, subcutaneous fat insulin glargine partially cleaved from the carboxyl end (C-terminus) of the 13-chain (beta chain) to form two active metabolites M1 (21^A-Gly-insulin) and M2 (21^A-Gly-des-30^B-Thr- insulin). Predominantly, the metabolite Ml circulates in the blood plasma. Systemic exposure of M1 metabolite increases with increasing dose of the drug. Comparison of pharmacokinetics and pharmacodynamics showed that the effect of the drug is mainly due to systemic exposure of the metabolite M1. The overwhelming majority of patients failed to detect insulin glargine and a metabolite of M2 in the systemic circulation. In cases where it was still possible to detect in the blood insulin glargine and metabolite M2, their concentrations did not depend on the administered dose of the drug Insulin Glargine.

Pharmacokinetics in specific 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 patients with obesity, there were no differences in the safety and efficacy of insulin glargine and insulin-isophane compared to patients with normal body weight.

Indicators of pharmacokinetics in children:

In children with type 1 diabetes mellitus aged 2 to 6 years, the concentration 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 is no accumulation of insulin glargine and its metabolites with the constant use of insulin glargine in children.

Indications:

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

Contraindications:

Hypersensitivity to insulin glargine or to any of the excipients of the drug.

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

Carefully:

Pregnant women (the possibility of changing the need for insulin during pregnancy and after childbirth).

Breastfeeding period.

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 in retrospective and prospective observation) with post-marketing use of insulin glargine showed no specific effects on the course and outcome of pregnancy or the state of the fetus or the health of newborns. In addition, in order to assess the safety of the use 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 used 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, there was no direct or indirect evidence of embryotoxic or fetotoxic effects of insulin glargine.

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

A drug Insulin Glargine 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 second and third trimesters. Immediately after delivery, the need for insulin decreases rapidly (the risk of 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.

Dosing and Administration:

A drug Insulin Glargine should be administered only subcutaneously once a day at any time of the day, but every day at the same time. A drug Insulin Glargine must 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 subcutaneous administration of the drug.

In patients with type 2 diabetes mellitus Insulin Glargine can be used, both in 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. Correction of the dose 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 predisposition to hypo- or hyperglycaemia (see section "Specific guidance"). Any changes in the dose of insulin should be conducted with caution and under medical supervision. A drug Insulin Glargine is not an insulin of choice for the treatment of diabetic ketoacidosis. In this case, preference should be given to intravenous administration of short-acting insulin.

In treatment regimens that include 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 taking oral hypoglycemic drugs,Combination therapy begins with a dose of insulin glargine 10 ED once 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 the drug Insulin Glargine

When transferring a patient from a treatment regimen using insulin with an average duration of action or a prolonged effect on a treatment regimen using a drug Insulin Glargine it may be necessary to correct the amount (doses) and time of administration of insulin short-acting or its analog during the day or change the doses of oral hypoglycemic drugs.

When transferring patients from a single dose of insulin-isophane to the unitary during the day, the administration of the drug Insulin Glargine the initial doses of insulin do not usually change (that is, the amount of ED of the drug is used Insulin Glargine per day equal to the number ME insulin-isophane per day).

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

A drug Insulin Glargine Do not mix with other insulin preparations or dilute. It must be ensured that syringes do not contain residues of other drugs. When mixed with other drugs or diluted, the profile of insulin glargine may change in time.

When switching from human insulin to a drug Insulin Glargine and in the first weeks after the transition, careful metabolic monitoring (monitoring of blood glucose concentration) 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

A drug Insulin Glargine can not be mixed with other insulins. Mixing can change the time / effect ratio of the drug Insulin Glargine, as well as lead to precipitation.

Special patient groups

Children

A drug Insulin Glargine can be used in children over 2 years of age. Use in children under 2 years of age has not been studied.

Elderly patients

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

A drug Insulin Glargine is administered as a subcutaneous injection.

A drug Insulin Glargine not intended for intravenous administration.

The long duration of action of Insulin glargine is observed only when it is introduced into the subcutaneous fat. Intravenous administration of a usual subcutaneous dose can cause severe hypoglycemia.

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

Insulin glargine is a clear solution, not a suspension. Therefore, no resuspension is required before use.

Side effects:

The following undesirable reactions (HP) are presented according to the organ systems (according to the classification of the Medical Dictionary of Regulatory Activities (MedDRA)) in accordance with the following grades of their occurrence frequency: very often (≥ 10%); often (≥ 1%; <10%); infrequently (≥ 0.1%, <1%); rarely (≥ 0.01%; <0.1%); very rarely (<0.01%), the frequency is unknown (it is not possible to determine the frequency of occurrence of HP from the available data).

Disorders from the metabolism and nutrition

Often: hypoglycemia.

Hypoglycemia, the most common undesirable reaction with 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 disturbances against neuroglycopenia (fatigue, unusual fatigue or weakness,loss of ability to concentrate attention, drowsiness, visual disturbances, headache, nausea, confusion or loss of it, convulsive syndrome) are usually preceded by symptoms of adrenergic counterregulation (activation of the sympathetic adrenal system in response to hypoglycemia): hunger, irritability, nervous arousal or tremor, anxiety, pale skin, "cold" sweat, tachycardia, marked palpitation (the faster the hypoglycemia develops and the more severe it is, the more pronounced the symptoms of the address nervous counter-regulation). 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, since with the growth of hypoglycemia, even a fatal outcome is possible.

Immune system disorders

Rarely: allergic reactions.

Allergic reactions of an immediate type to insulin are rare. Similar reactions to insulin (including insulin glargine) or excipients can be manifested by the development of generalized skin reactions, angioedema, bronchospasm,decrease in blood pressure or shock and may 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 can cause the need for correction of the dosing regimen in order to eliminate the tendency to develop hypo- or hyperglycemia.

Disturbances from the nervous system

Rarely: dysgeusia (violation or perversion of taste sensations).

Disturbances on the part of the organ of sight

Rarely: impaired vision (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); retinopathy (long-term normalization of blood glucose reduces the risk of progression of diabetic retinopathy, but insulin therapy, accompanied by rapid fluctuations in blood glucose concentrations, 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 loss of vision.

Disturbances from the skin and subcutaneous tissues

Often: lipodystrophy (in 1-2% patients). As with any other insulin medication, in place of injection can develop lipodystrophy, which can slow the local absorption of insulin.

Infrequently: lipoatrophy. The constant change of injection sites within the areas of the body, recommended for subcutaneous administration of insulin, may to reduce the severity of this reaction or prevent its development.

Disturbances from musculoskeletal and connective tissue

Rarely: myalgia.

General disorders and disorders at the site of administration

Often: reactions at the injection site (3-4%) (redness, pain, itching, hives, swelling, or inflammation). Most minor reactions at the site of insulin administration are usually resolved between a few days and several weeks.

Rarely: sodium retention, edema (especially if intensified insulin therapy leads to an improvement in previously inadequate metabolic control).

Safety profile for patients under 18 years of age: in general, is similar to the safety profile for patients over 18 years of age. In patients younger than 18 years, reactions at the site of administration and skin reactions (rash, urticaria) are relatively more frequent.

Safety data for patients younger than 2 years are absent.

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 intramuscular or subcutaneous administration of glucagon, as well as intravenous administration of a 40% solution of dextrose (glucose). It may be necessary to take carbohydrates for a long time and observe a specialist, since after a visible clinical improvement, a relapse of hypoglycemia is possible.

Interaction:

Pharmacodynamic interaction

- Oral hypoglycemic agents, angiotensin-converting enzyme inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, dextropropoxyphene, salicylates and sulfonamide antimicrobial agents - can increase the hypoglycemic action of insulin and increase the predisposition to the development of hypoglycemia. Simultaneous reception with insulin glargine may require correction of the dose of insulin.

- Glucocorticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, estrogens, gestagens, phenothiazine derivatives, somatotropin, sympathomimetics (for example, epinephrine [adrenalin], salbutamol, terbutaline) and thyroid hormones, protease inhibitors, some neuroleptics (for example, 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-blockers, clonidine, lithium salts or alcohol - is possible as strengthening, 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-blockers, clonidine, guanfacine and reserpine - signs of adrenergic counterregulation (activation of the sympathetic nervous system) may be reduced or absent in the development of hypoglycemia.

Pharmaceutical interaction:

When mixed Insulin Glargine with other medicinal substances, including other insulins, as well as dilution of the drug, it is possible to form a precipitate or change the profile of the drug in time.

Special instructions:

Insulin glargine is not a drug of choice for the treatment of diabetic ketoacidosis. In such cases, intravenous insulin administration is recommended.

Due to limited experience with the drug Insulin Glargine it was not possible to evaluate its efficacy and safety in the treatment of patients with impaired liver function or patients with moderate to severe 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 ineffective control of blood glucose level, as well as in the presence of a tendency to develop hypo- or hyperglycemia, before proceeding with correction of the dosing 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 Subcutaneous injection taking into account all the factors affecting it.

Hypoglycaemia

The time of development of hypoglycemia depends on the profile of the insulin used and can, therefore, change with a change in the treatment regimen. Due to the increased time of insulin administration to the body of long-term action when using the drug Insulin Glargine, we should expect a lower probability of developing nocturnal hypoglycemia, whereas in the early morning hours this probability of hypoglycemia is higher. When hypoglycemia occurs in patients receiving Insulin Glargine, should consider the possibility of slowing the output from the state of hypoglycemia in connection with the prolonged action of insulin glargine.

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 a 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 decrease. In patients of certain risk groups, the symptoms of hypoglycemia may change, become less pronounced or absent. These include:

- patients who have significantly improved blood glucose regulation;

- 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 treatment with other medications (see "Interaction with other drugs").

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 the event that normal or decreased glycosylated hemoglobin levels are noted, the possibility of developing recurrent unrecognized episodes of hypoglycemia (especially at night) should be considered.

Patient compliance with the dosing regimen and diet, proper insulin administration and knowledge of hypoglycaemic 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 the 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;

- alcohol consumption;

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

- concomitant medication with some other medicines.

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 often increases. Patients with type 1 diabetes should continue to regularly consume at least a small amount of carbohydrates, even if they are able to consume only small amounts of food or can not eat at all or if they have vomiting, etc., and they should never completely stop the introduction of insulin.

Instruction for use and circulation

Pre-filled syringe handles OptiSet

Before use, inspect the cartridge inside the syringe pen. It should only be used if the solution is clear, colorless, contains no visible solid particles and resembles water in a consistency.

Empty Optic syringes should 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 syringe-handle OptiSet

Before using the OptiSet pen, carefully read the usage information.

Important information on the use of the OptiSet syringe pen

- Always use a new needle every time you use it. Use only needles that are suitable for the Optix syringe.

- Always give a safety test before each injection.

- If a new OptiSet pen is used, the readiness check should be performed using 8 units preset by the manufacturer.

- The dose selector can only be rotated in one direction.

- Never turn the dose selector (dose change) after pressing the injection pushbutton.

- This insulin syringe pen is intended only for patients. You can not betray her to another person.

- If another person injects the patient, he needs to take extra care to avoid accidentally injuring the needle and infecting the infectious disease.

- Never use a damaged OptiSet pen, or if you are not sure of its serviceability.

- Always have a spare OptiSet pen in case your OptiSet syringe is damaged or lost.

Insulin testing

After removing the cap from the syringe pen, the labeling on the insulin tank must be checked to make sure it contains the proper insulin. You should also check the appearance of insulin: the insulin solution should be clear, colorless, free of visible solids and have a consistency similar to water. You can not use the OptiSet syringe if the insulin solution is cloudy, has a color or foreign particles.

Attaching the needle

After removing the cap, you should carefully and tightly connect the needle to the syringe pen.

Checking the availability of the syringe pen for use

Before each injection, it is necessary to check the readiness of the syringe pen for use.

For a new and unused syringe pen, the dose indicator should stand on the figure 8, as was previously set by the manufacturer.

If a syringe pen is used, the dispenser should be rotated until the dose indicator stops at 2. The dispenser will rotate in only one direction.

Pull out the fully-actuated button to dial the dose. Never rotate the dose selector after the start button is pulled out.

The outer and inner needle caps must be removed. Save the outer cap to remove the used needle.

Holding the syringe handle with the needle pointing upwards, gently tap with your finger on the insulin reservoir so that the air bubbles rise up towards the needle.

Then press the start button all the way.

If a drop of insulin is released from the tip of the needle, the syringe-pen and the needle function correctly.

If a drop of insulin is not displayed at the tip of the needle, repeat the readiness check of the syringe pen until the insulin appears on the tip of the needle.

Selecting an insulin dose

A dose of 2 units up to 40 units can be set in increments of 2 units. If a dose exceeding 40 units is required, it must be administered in two or more injections.

Make sure you have enough insulin for the right dose.

The scale of the residual insulin on a transparent container for insulin shows how much, approximately, of the insulin remains in the syringe-handle OptiSet. This scale can not be used to take a dose of insulin.

If the black piston is at the beginning of a colored strip, then there are approximately 40 units of insulin.

If the black piston is at the end of a colored strip, then there are about 20 units of insulin.

The dose selector should be rotated until the arrow-dose indicator indicates the desired dose.

Insulin Dose Fence

The injection button must be pulled to the limit to fill the insulin pen.

Check to see if the correct dose has been dialed. Note that the button is shifted according to the amount of insulin left in the insulin container.

The start button allows you to check which dose is dialed. During the test, the start button must be kept under tension.The last visible wide line on the start button shows the amount of insulin taken. When the start button is held, only the upper part of this wide line is visible.

Introduction of insulin

Specially trained personnel should explain the technique of injecting to the patient.

The needle must be administered subcutaneously.

Press the injection button to the limit. The click will stop when the injection pushbutton is depressed. Then press the injection button for 10 seconds before pulling the needle out of the skin. This will ensure the introduction of the entire dose of insulin.

Removing the needle

After each injection, the needle should be removed from the syringe-pen and discarded. This will prevent infection, as well as leakage of insulin, air intake and possible blockage of the needle. Needles should not be reused.

Then you need to put the cap back on the syringe pen.

Cartridges

Cartridges should be used together with the Optipen Pro1 syringe pen, and in accordance with the recommendations given by the device manufacturer.

Instructions for using the OptiPen Pro1 syringe for installing the cartridge, connecting the needle and performing insulin injection should be carried out exactly. Inspect the cartridge before use.It should only be used if the solution is clear, colorless, and contains no visible solid particles. Before installing the cartridge in the syringe pen, the cartridge should be at room temperature for 1-2 hours. Before carrying out the injection, remove air bubbles from the cartridge. It is necessary to strictly follow the instructions. Empty cartridges are not used again. If the OptiPen Pro1 syringe pen is damaged, you can not use it.

If the syringe pen is faulty, if necessary, insulin can be injected into the patient by typing the solution from the cartridge into a plastic syringe (suitable for insulin at a concentration of 100 IU / ml).

To prevent infection with a reusable pen, only one person should use it.

OptiKlik cartridge system

The Optiklik cartridge system is a glass cartridge containing 3 ml of the glargine insulin solution, which is placed in a transparent plastic container with an attached piston mechanism.

The Optiklik cartridge system should be used together with the Optiklik syringe handle in accordance with the instruction manual attached to it.

All the recommendations contained in the instruction for installing the cartridge system in the OpticClip needle pen, connecting the needle and performing the injection must be exactly followed.

If the OpticClip syringe is damaged, replace it with a new one.

Before installing the cartridge system into the OptiKlik syringe, it should be at room temperature for 1-2 hours. Inspect the cartridge system before installation. It should only be used if the solution is clear, colorless, and contains no visible solid particles. Before carrying out the injection, remove air bubbles from the cartridge system (see the instructions for using the syringe pen). Empty cartridge systems are not reused.

If the syringe pen is defective, then, if necessary, insulin can be administered to the patient by typing the solution from the cartridge into a plastic syringe (suitable for insulin at a concentration of 100 IU / ml).

To prevent infection with a reusable pen, only one person should use it.

Form release / dosage:

Solution for subcutaneous administration, 100 units / ml.

Packaging:

3 ml of the drug in a cartridge of clear, colorless glass (type I).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.

1) 5 cartridges per contour cell box made of PVC film and aluminum foil. 1 contour pack together with instructions for use in a cardboard box.

2) The cartridge is mounted in a disposable syringe-pen OptiSet. Five Optic syringe pens along with instructions for use in a cardboard box equipped with a cardboard latch.

3) The cartridge is inserted into the OptiKlik cartridge system. For 5 cartridge systems, OptikKlik together with instructions for use in a cardboard box, equipped with a cardboard lock.

Storage conditions:

Before use:

Store at a temperature of 2 to +8 ° C in a dark place. Do not freeze.

After the start of use:

The used cartridges are pre-filled OptiSet syringes and the OpticClock cartridge systems should be stored at a temperature not higher than + 25 ° C, protected from light (protect Optical, pre-filled syringes, optical cartridges and cartridge systems in their own cardboard packages).

Keep out of the reach of children.

Pre-filled syringe-handle OptiSet does not cool.

Shelf life:

3 years.

After the expiration date, the drug can not be used.

Note: the expiration date of the drug in cartridges, OptiSet syringes and OptiKlik cartridge systems after the first use is 4 weeks. It is recommended to mark the date of the first intake of the drug on the label.

Terms of leave from pharmacies:On prescription

Registration number:П N014855 / 01

Date of registration:15.01.2009

The owner of the registration certificate:Sanofi-Aventis Deutschland GmbHSanofi-Aventis Deutschland GmbH Germany

Manufacturer: & nbsp

SANOFI-AVENTIS Deutschland, GmbH Germany

SANOFI-AVENTIS VOSTOK, ZAO Russia

Representation: & nbspSanofi Aventis GroupSanofi Aventis Group

Information update date: & nbsp24.10.2015

Illustrated instructions

Instructions

Insulin Glargine (Insulin glargine)