Expiration date: 03/2027

The composition and form of issue:

Solution for subcutaneous injection. 1 ml contains:

insulin glargine 100 U (3,6378 mg)

excipients: metacresol (m-cresol) of zinc chloride, glycerol (85%) sodium hydroxide hydrochloric acid water for injections 

cartridge 3 ml mounted in disposable syringe handle Solostar in a cardboard pack of 5 syringe pens.

Description pharmaceutical form:

Transparent, colorless or almost colorless liquid.

Feature:

An analogue of long-acting insulin.

Pharmacokinetics:

Comparative study of the concentrations of insulin glargine and insulin-izofan in the blood serum in healthy people and patients with diabetes, after p/to the introduction of drugs identified the slow and much longer absorption, as well as the absence of the peak concentration of insulin glargine compared with insulin-izofan.

Single during the day p/to the introduction of Lantus Solostar equilibrium concentration of insulin glargine in the blood is achieved through 2-4 days of daily administration.

When on/in a T1/2 of insulin glargine and human insulin were comparable.

In human subcutaneous adipose tissue insulin glargine is partially cleaved from the carboxyl end (C-end) &beta-chains with the formation of 21A-Gly-insulin and 21A-Gly-des-30B-Thr-insulin. Present in the plasma as unchanged insulin glargine, and its cleavage products.

Description pharmacological action:

Insulin glargine is an analogue of human insulin obtained by recombinant DNA bacteria Escherichia coli (K12 strains).

Insulin glargine was developed as an analogue of human insulin, characterized by low solubility in neutral medium. Composed of Lantus Solostar it is completely soluble, provided that acidic solution for injection (??4). After the introduction in the subcutaneous fat the acid reaction of the solution neutralizes that leads to the formation of microprecipitates, which released small amounts of insulin glargine, providing a predictable, smooth (without the peaks) profile curve "concentration—time" as well as a prolonged effect of the drug.

A bond with an insulin receptor: kinetics of binding with specific receptors of insulin of insulin glargine is very close to that of human insulin, therefore insulin glargine is capable of biological action similar to that of endogenous insulin.

The most important action of insulin and its analogues, including insulin glargine, is regulation of glucose metabolism. Insulin and its analogues reduce the amount of glucose in the blood by stimulating the uptake of glucose by peripheral tissues (especially skeletal muscle and adipose tissue) and by inhibiting the formation of glucose in the liver.

Insulin inhibits lipolysis in adipocytes and inhibits proteolysis, increasing protein synthesis at the same time.

The prolonged action of insulin glargine is directly related to a reduced rate of its absorption, allowing you to use the drug 1 time per day. After p/to the introduction is the beginning of his action comes, on average, over 1 h. the Average duration is 24 h, maximum — 29 h. the Duration of action of insulin and its analogues such as insulin glargine may vary considerably in different individuals or the same person.

Indications:

Diabetes mellitus, requiring insulin treatment, in adults, adolescents and children over 6 years.

Contraindications:

• increased sensitivity to insulin glargine or to any excipients of the drug
  
• children up to age 6 years (no clinical data on the use).
  

Caution: pregnant women (the possibility of changes in insulin requirements during pregnancy and after childbirth).

Application of pregnancy and breast-feeding:

In animal studies it was not received direct or indirect data about embryotoxic or fetotoksicheskoe action of insulin glargine.

To date, no statistical data is available regarding the use of the drug during pregnancy. There is evidence of the use of Lantus Solostar in 100 pregnant women with diabetes. The course and outcome of pregnancy in these patients did not differ from those in pregnant women with diabetes treated with other insulin preparations.

The purpose of Lantus Solostar in pregnant women should be used with caution. Required careful monitoring of glucose levels in the blood.

For patients with pre-existing or gestational diabetes is important during pregnancy to maintain glycemic control. Insulin requirements may be reduced in the first trimester of pregnancy and, in General, to increase during the II and III trimesters. Immediately after birth the need for insulin decreases rapidly (increasing the risk of hypoglycemia). In these conditions is essential careful monitoring of concentrations of glucose in the blood.

In women during lactation may require correction dosing regimen of insulin and diet.

Side effects:

Hypoglycaemia, the most frequent undesirable effect of insulin therapy, may occur if the insulin dose is too high compared to the demand for it.

The following undesirable effects are given by organ system in accordance with the following graduations of the frequency of their occurrence: very common — &ge10% often — &ge1 –<10% infrequently — &ge0,1–<1% rare — &ge0,01–<0.1% is very rare — &le0,01%

From the metabolic: often — hypoglycemia. Symptoms of hypoglycemia usually occur suddenly. Often, however, neuropsychiatric disorders on the background of neuroglycopenia (feeling tired, unusual tiredness or weakness, decreased ability to concentrate, drowsiness, visual disturbances, headache, nausea, confusion, or loss of, sudorozhny syndrome) usually preceded by symptoms of adrenergic kontrrevolyutsiei (activation of the sympatho-adrenal system in response to hypoglycemia) — the feeling of hunger, irritability, nervous agitation or tremor, anxiety, paleness, "cold" sweat, tachycardia, pronounced heartbeat (the faster developing hypoglycemia and how is it heavier, the more pronounced symptoms of adrenergic contraregulatory).

Bouts of severe hypoglycemia, particularly recurring may lead to damage to the nervous system. Episodes of prolonged and pronounced hypoglycemia could threaten patients ' lives, because with an increase of hypoglycemia may even result in death.

The immune system: rarely — allergic reactions. Allergic reactions immediate type of insulin are rare. Such reactions to insulin (including insulin glargine) or the excipients may occur development generalized skin reactions, angioedema, bronchospasm, arterial hypotension or shock and can, thus, threaten the patient's life.

The use of insulin can cause the formation of antibodies thereto. The formation of antibodies, cross reacting with human insulin and insulin glargine, is observed with similar frequency with insulin-isophane and insulin glargine. In rare cases, the presence of such antibodies to insulin may necessitate dosage adjustment for the elimination of the tendency to the development of Hypo - or hyperglycemia.

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

From the body of the vision: rarely — visual disturbances, retinopathy.

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

The long-term normalization of glucose in the blood reduces the risk of progression of diabetic retinopathy. Insulin therapy, accompanied by sharp fluctuations of glucose in the blood can be associated with temporary worsening of diabetic retinopathy. Patients with proliferative retinopathy, especially not receiving treatment with photocoagulation, episodes of severe hypoglycemia can lead to the development of transient loss of vision.

The skin and subcutaneous fat: often — lipodystrophy (1-2% patients). As with the treatment of any other insulin preparations at the site of injection may develop lipodystrophy, can slow the local absorption of insulin.

Rare — lipoatrophy. The constant change seats injection within the body areas that are recommended for subcutaneous injection of insulin, can help reduce the severity of this reaction or prevent its development.

On the part of the musculoskeletal system and connective tissue: very rarely — myalgia.

General disorders and reactions at the injection site: often — reaction at the injection site (3-4%) (redness, pain, itching, hives, swelling or inflammation). Most minor reactions at the injection insulins usually resolve in a period of time from several days to several weeks.

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

The safety profile for patients younger than 18 years of age, in General, similar to that for patients older than 18 years. In patients under the age of 18 relatively more likely to have reactions at the injection site and skin reactions (rash, hives).

The safety data in patients younger than 6 years do not exist.

Drug interactions:

Pharmacodynamic interaction

Oral hypoglycaemic agents, ACE inhibitors, disopyramide, fibrates, fluoxetine, MAO inhibitors, pentoxifylline, propoksifen, salicylates and sulfa antibiotics — may increase hypoglycemic effect of insulin and increase susceptibility to hypoglycemia. Simultaneous treatment with insulin glargine may require dose adjustment of insulin.

Corticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, oestrogens and Progestogens (e.g. hormonal contraceptives), phenothiazine derivatives, somatropin, sympathomimetic agents (e.g. epinephrine, salbutamol, terbutaline) and thyroid hormones, protease inhibitors, atypical antipsychotics (e.g. olanzapine or clozapine) — can weaken the hypoglycemic action of insulin. Simultaneous treatment with insulin glargine may require dose adjustment of insulin glargine.

Beta-adrenoblokatora, clonidine, lithium salts or alcohol — perhaps both the increase and the weakening of the hypoglycemic action of insulin.

Pentamidine — in combination with insulin may cause hypoglycemia, which sometimes gives way to hyperglycemia.

Drugs simpatoliticescoe actions such as beta-blockers, clonidine, guanetidin reserpine and a — may be reduced or absent signs of contraregulatory adrenergic (activation of sympathetic nervous system) with the development of hypoglycemia.

Pharmaceutical interaction

When mixed the Lantus Solostar with other drugs, including other insulins, as well as dilution of the drug may precipitate or modify the action of the drug in time.

Method of application and dose:

N/a. Adults and children over 6 years.

Lantus Solostar should be used only n/a 1 once a day always at the same time. Lantus® Solostar® should be injected in the subcutaneous fat belly, shoulder or thigh. Injection sites should be alternated at each new injection within the recommended areas for subcutaneous injection.

The dose of Lantus® Solostar® and the time for introduction of selected individually. In patients with diabetes mellitus type 2 Lantus Solostar can be used both as monotherapy and in combination with other hypoglycemic drugs.

The transition from treatment with other hypoglycemic drugs for Lantus Solostar

When changing regimens insulin average duration or long-acting for a treatment regimen with Lantus Solostar may require correction daily basal insulin dose and also be necessary to change in concomitant antidiabetic therapy (doses and schedule of administration are additionally used insulin short action or their analogues or the dose gipoglikemicakih oral drugs).

When transferring patients from twice during the day insulin-izofan on a single administration of Lantus Solostar order to reduce the risk of hypoglycemia during the night and early morning time should be reduced daily dose of basal insulin on 20-30% in the first week of treatment. During this period, a dose reduction at least partly be compensated by increasing doses of short-acting insulin, followed by individual correction mode.

Lantus Solostar should not be mixed with other insulin or diluted. You must ensure that the syringes did not contain residues of other drugs. When mixing or dilution may change the action profile of insulin glargine in time. Mixing with other insulinami can cause precipitation.

As the application of other analogues of human insulin, in patients receiving high insulin doses because of antibodies to human insulin, when switching to Lantus ® Solostar may notice an increase in response to insulin. In the process of switching to Lantus Solostar and in the first weeks after it requires careful monitoring of glucose in the blood and, if necessary, correction of dosing regimen of insulin.

In the case of improving metabolic regulation and the resulting increase in the sensitivity of tissues to insulin, you may need further dosage adjustment. Dose adjustment may also be required, for example, changing the body weight of the patient, his lifestyle, time of day for drug administration or at occurrence of other circumstances that contribute to increase susceptibility to Hypo - or hyperglycemia.

The drug should not be administered I/V. V/in a normal dose intended for the introduction of p/K, can cause the development of severe hypoglycemia.

The duration of action of Lantus Solostar depends on the location of his place of p/to the introduction.

Instructions for use and handling the pre-filled syringe handle Solostar

Before first use the pen must be kept at room temperature for 1-2 h.

Before using, inspect the cartridge inside the pen. It should only be used if the solution is clear, colorless, does not contain visible particles and the consistency of water.

Empty syringe-pens Solostar should not be reused and must be destroyed.

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

Handling the syringe handle Solostar

Before use syringe-pens Solostar should carefully read the information on the use.

Important information on how to use the pen Solostar

Before each use caution to connect a new needle to the syringe handle and test for security. You only need to use needles, compatible with Solostar.

It is necessary to take special precautions to avoid accidents associated with the use of needles, and the possibility of transfer infection.

In any case you should not use the pen Solostar if it is damaged or in case if there is no certainty that it will work properly.

You always need to have a spare syringe pen Solostar in case of loss or damage to the previous instance of the pen Solostar.

Storage instructions

You should review the section "storage Conditions" in respect of rules of storage of the pen Solostar.

If the syringe handle Solostar stored in the refrigerator, you should retrieve it for 1-2 hours before the alleged injection of the solution at room temperature. The introduction of cold insulin is more painful.

Used syringe pen Solostar shall be subjected to destruction.

Operation

The pen Solostar is required to protect from dust and dirt.

The outside of the pen Solostar can be cleaned by wiping it with a damp cloth.

Do not dip the pen Solostar into a liquid, premawathi to lubricate it, as this can damage the pen Solostar.

Syringe pen Solostar insulin doses accurately and safe in operation. It also requires careful handling. You should avoid situations which can cause damage to syringe-pens Solostar. If it is suspected that the instance of the pen Solostar damaged, use a new syringe pen.

Stage 1. Control of insulin

You need to check the label on the syringe handle Solostar in order to make sure that it contains the appropriate insulin. For Lantus pen Solostar gray with purple button for injection. After removing the cap of the pen control the appearance of the contained insulin: insulin solution must be transparent, colorless, does not contain visible particles and the consistency to resemble water.

Stage 2. Connecting the needle

You should only use needles that are compatible with the syringe handle Solostar.

For each subsequent injections always use a new sterile needle. After removal of the needle cap must be carefully installed on the syringe handle.

Stage 3. Performing safety tests

Before the introduction of each injection, it is necessary to test for safety and to make sure that pen and needle work well and the air bubbles removed.

Metered dose equal to 2 UNITS.

The outer and inner needle caps should be removed.

Positioning the pen needle up, gently tapped the cartridge with insulin your finger so that any air bubbles went in the direction of the needle.

Fully press the button injection.

If insulin appears at the needle tip, this means that the pen and needle are working properly.

If the appearance of insulin at the needle tip is not observed, the stage 3 can be repeated until then, until insulin appears at the needle tip.

Stage 4. The choice of dose

The dose may be set with an accuracy of 1 UNIT of the minimum dose (1 IU) to the maximum (80 UNITS). If you want to enter dose greater than 80 UNITS, you should spend 2 or more injections.

The metering window should show "0" after completion of the safety tests. After this can be set the required dose.

Stage 5. Dosing

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

The needle must be injected under the skin.

Button injection should be pressed completely. It is held in this position for a further 10 s until the extraction needle. Thus the introduction of the selected dose of insulin completely.

Stage 6. Extraction and ejection of the needle

In all cases the needle after each injection should be removed and discarded. This ensures prevention of contamination and/or introduction of an infection, the ingress of air into the container for insulin and leakage of insulin.

When removing and disposing of the needle should be performed with special precautions. You must comply with recommended safety measures for removal and disposal of needles (for example, the technique of donning the cap with one hand) in order to reduce the risk of accidents associated with the use of the needle and also of preventing infection.

After removal of the needle should close the pen Solostar cap.

Overdose:

Symptoms: overdosage of insulin can lead to severe and sometimes prolonged hypoglycemia, life-threatening patient.

Treatment: episodes of moderate hypoglycemia is usually stopped by intake of rapidly digestible carbohydrates. You may need to change the dosing of the drug, diet or physical activity.

Episodes of more severe hypoglycemia, manifested by coma, convulsions or neurological disorders, require in/m or p/to the introduction of glucagon, as well as in/with the introduction of concentrated solution of dextrose (glucose). You may need long-term use of carbohydrates and surveillance specialist, because after apparent clinical improvement possible recurrence of hypoglycemia.

Special instructions:

Lantus Solostar is not the drug of choice for the treatment of diabetic ketoacidosis. In such cases it is recommended in/with the introduction of short-acting insulin.

In view of the limited experience with the use of Lantus Solostar, it was not possible to assess its efficacy and safety in patients with liver dysfunction or patients with moderate or severe renal insufficiency.

In patients with impaired renal function, insulin requirements may decrease due to slowing its elimination. In elderly patients the progressive deterioration of renal function may lead to a permanent reduction in insulin requirements.

In patients with severe hepatic impairment, insulin requirements may be reduced in relation to reduced capacity for gluconeogenesis and the decrease of the biotransformation of insulin.

In the case of ineffective control over the glucose in the blood, and in the presence of a trend towards Hypo - or hyperglycemia, before correction mode dosing should verify the accuracy of executing the prescribed treatment regimens, adherence in respect of field of application and the correct techniques for p/to the injections, taking into account all the factors affecting it.

Hypoglycemia

The time of hypoglycemia depends on the action profile of insulins used and may, therefore, change them when changing treatment regimens. Due to the increased time of intake of long-acting insulin when using Lantus Solostar should expect a lesser likelihood of nocturnal hypoglycemia, whereas in the early morning hours this probability of hypoglycemia is higher. In the event of hypoglycemia in patients, receiving Lantus Solostar, you should consider the possibility of slowing down the exit condition of hypoglycemia due to the prolonged action of insulin glargine.

Patients who have episodes of hypoglycemia may be of particular clinical significance, such as patients with severe stenosis of coronary arteries or brain vessels (the risk of cardial and cerebral complications of hypoglycemia), as well as patients with proliferative retinopathy, especially if they do not receive treatment photocoagulation (risk of transient loss of vision after hypoglycemia), you should be particularly careful and to intensify the monitoring of glucose levels in the blood.

Patients should be warned about the conditions in which the symptoms-signs of hypoglycaemia may be reduced. In patients of certain risk groups symptoms of hypoglycemia may be changed, be less pronounced or be absent. These include:

• patients who have markedly improved the regulation of glucose in the blood
  
• patients in whom hypoglycaemia develops gradually
  
• elderly patients
  
• patients transferred from animal insulin to human insulin
  
• patients with neuropathy
  
• patients with a long history of diabetes
  
• patients suffering from mental disorders
  
• patients receiving concomitant treatment with other drugs (see "Interactions").
  

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

If there is normal or reduced performance of glycosylated hemoglobin, it is necessary to consider the possibility of repeating unrecognized hypoglycemia (especially at night).

Patient compliance dosing schedules and food regimen, correct insulin delivery and knowledge of symptoms of hypoglycemia-precursors contribute to a significant reduction in the risk of hypoglycemia.

The factors that increase the tendency to hypoglycemia, the presence of which require particularly careful monitoring and may be require dose adjustment of insulin:

• change of insulin
  
• increase insulin sensitivity (for example, elimination of stress factors)
  
• unaccustomed, increased or prolonged physical activity
  
• intercurrent disease, accompanied by vomiting, diarrhea
  
• violation of diet and nutrition
  
• skipping meals
  
• consumption of alcohol
  
• certain uncompensated endocrine disorders (e.g. hypothyroidism, insufficiency of the anterior pituitary or adrenal cortex)
  
• concomitant treatment with certain other drugs.
  

Intercurrent disease

When intercurrent diseases require more intensive control of glucose level in the blood. In many cases, shows the analysis for the presence of ketone bodies in the urine, often requires correction of dosing regimen of insulin. Insulin requirements often increase. Patients with diabetes mellitus type 1 should continue regular consumption, at least a small amount of carbohydrates, even if they are able to consume food only in small amounts or even can't eat, or if they have vomiting, etc., and they should never completely discontinue insulin.

During storage of Lantus Solostar in the fridge, you must ensure that the containers are not directly in contact with the freezer compartment or frozen packages.

Before first use the pen, Lantus Solostar should be kept at room temperature for 1-2 h.

Used disposable syringe-pens Solostar should be stored at a temperature not exceeding 25 °C protect from exposure to light.

Pre-filled syringe handle Solostar not cool.

The shelf life in disposable syringe handle Solostar after the first use — 4 weeks. It is recommended to note on the label the date the first injection of the drug.

Storage conditions:

Once opened, please store at temperature not above 25 °C in cardboard packaging (but not in the refrigerator).