Instruction for use: Tresiba FlexTech

ATX Code A10AE06 Insulin Degludec

Active substance Insulin degludec

Pharmacological group

Hypoglycemic agent - long-acting insulin analog [Insulins]

Nosological classification (ICD-10)Z31.1 Artificial insemination

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

E11 Non-insulin-dependent diabetes mellitus

Acetonuric diabetes, Decompensation of carbohydrate metabolism, Diabetes insulin-independent sugar, Diabetes sugar type 2, Type 2 Diabetes, Non-insulin-dependent diabetes, Non-insulin dependent diabetes mellitus, Non-insulin-dependent diabetes mellitus, Insulin resistance, Insulin resistant diabetes mellitus, Coma lactobacillus diabetic, Violation of carbohydrate metabolism, Type 2 diabetes mellitus, Diabetes mellitus type II, Diabetes mellitus in adulthood, Diabetes mellitus in old age, Diabetes insulin-independent, Diabetes mellitus type 2, Sugar insulin-independent diabetes type II

Composition

Solution for subcutaneous administration 1 ml

active substance:

Insulin degludec 100 ED (3.66 mg) / 200 ED (7.32 mg)

Auxiliary substances: glycerol - 19.6 / 19.6 mg; Phenol 1.5 / 1.5 mg; Meta-cresol - 1.72 / 1.72 mg; Zinc - 32.7 / 71.9 μg (in the form of zinc acetate - 109.7 / 241.4 μg); Hydrochloric acid / sodium hydroxide (for pH correction); Water for injection - up to 1/1 ml

PH of the solution is 7.6 / 7.6

1 The syringe pen contains 3/3 ml of a solution equivalent to 300/600 ED. The syringe-pen allows you to enter up to 80/160 units per injection in increments of 1/2 ED

1 unit of insulin degludec contains 0.0366 mg of anhydrous saltless insulin deglucose

1 unit of insulin degludec corresponds to 1 ME of human insulin, 1 ED of insulin detemir or insulin glargine

Description of dosage form

Clear colorless solution.

pharmachologic effect

Pharmacological action - hypoglycemic.

Pharmacodynamics

Tresiba® FlexTech® is an analogue of human super-long-acting insulin, produced by the method of biotechnology of recombinant DNA using the strain of Saccharomyces cerevisiae.

Mechanism of action. Insulin degludec specifically binds to the receptor of human endogenous insulin and interacts with it, realizes its pharmacological effect similar to the effect of human insulin.

The hypoglycemic effect of insulin degludec is due to the increased utilization of glucose by tissues after the binding of insulin to the receptors of muscle and fat cells and a simultaneous decrease in the rate of glucose production by the liver.

The drug Tresiba® FlexTach® is a basal analogue of human insulin of super-long-acting action; After SC injections, it forms soluble multi-hexamers in the subcutaneous depot, from which there is a continuous and prolonged absorption of insulin degludec into the vascular bed, providing an ultra-long, flat profile and stable hypoglycemic effect of the drug (see Figure 1).

During the 24-hour monitoring period of the hypoglycemic effect of the drug in patients who received insulin degludec once a day, Tresiba® Flex Tach®, in contrast to insulin glargine, demonstrated a uniform Vd between action in the first and second 12-hour periods (AUCGIR0 -12h.SS / AUCGIRtotal.SS = 0.5).

The duration of the drug Tresiba® FlexTech® is more than 42 hours within the therapeutic range of doses.

Css of the drug in the blood plasma is achieved 2-3 days after the administration of the drug.

Insulin degludec in the Css state demonstrates a significantly lower (by 4 times) insulin glargine variability in the daily profiles of hypoglycemic action, which is estimated from the CV value for the hypoglycemic effect of the drug during a single dosing interval (AUCGIR.t.SS) And within the time frame from 2 to 24 hours (AUCGIR2-24h.SS)

A linear relationship between an increase in the dose of the drug Tresiba® Flex Tach® and its general hypoglycemic effect is proved.

Both forms release drug Tresiba® FleksTach® - 100 and 200 U / ml demonstrate comparable between a common hypoglycemic effect when administered each of the two dosages of the drug in the same total dose.

In studies, there was no clinically significant difference in the pharmacodynamics of the drug Tresib ® between elderly patients and older patients of young age.

Clinical efficacy and safety

Held 11 international randomized, open clinical studies Treat-to-Target (strategy "treat to target") lasting 26 and 52 weeks, conducted in parallel groups, which included a total of 4275 patients (1102 patients with diabetes type 1 and 3173 patients with diabetes with Type 2 diabetes mellitus) who received the drug Tresiba®.

Efficacy Tresiba® preparation was studied in patients with type 1 diabetes who have not received before insulin, and type 2 diabetes treated with insulin therapy, in a fixed or flexible dosing regimen Tresiba® preparation. The lack of superiority of the reference drugs (insulin detemir and insulin glargine) over the Tresiba® preparation for the reduction of HbA1c from the moment of inclusion to the end of the study was proved.

The exception was the sitagliptin drug in comparison with which the drug has demonstrated its Tresiba® statistically significant superiority in reducing HbA1s index.

Results of clinical studies (strategy "treat to target") on initiating insulin therapy in patients with type 2 diabetes showed a decrease by 36% the frequency of episodes of confirmed nocturnal hypoglycemia (defined as hypoglycemia episodes occurred during the time of day between zero hours and six o'clock in the morning , Confirmed by the result of measuring the concentration of glucose in blood plasma <3,1 mmol / l or the evidence that the patient needed help from third parties for restoring the condition) against the background of daily Tresiba® administration once daily in combination with oral hypoglycemic drugs (oral agent), compared with that in the application of insulin glargine in combination with oral agents. The results of the clinical study (the "treat to the target" strategy) for assessing the basal bolus regimen of insulin therapy in patients with type 2 diabetes mellitus demonstrated a lower overall risk of hypoglycemic episodes and nocturnal hypoglycemia with Tresiba® compared with that of insulin glargine .

The results of a prospective meta-analysis of data from seven pre-clinical clinical trials involving patients with type 1 and type 2 diabetes demonstrated the benefits of treatment with Tresiba® with a lower glargine compared with insulin therapy, Frequency of development in patients of episodes of confirmed hypoglycemia and episodes of confirmed nocturnal hypoglycemia. Reduction in the frequency of episodes of hypoglycemia in the background of Tresiba® treatment was achieved with a lower average fasting plasma glucose index than with insulin glargine.

There was no clinically significant formation of antibodies to insulin after treatment with Tresib® Flex Tach® for an extended period of time. In a 104-week clinical trial, 57% of patients with type 2 diabetes mellitus treated with Tresiba in combination with metformin achieved the HbA1c target of <7%, and the remaining patients continued to participate in the 26-week open-label study and were randomized to Addition of liraglutide or the use of insulin aspart once a day (with the main meal). In the group that received a combination of insulin degludec and liraglutide, the insulin dose was reduced by 20% to minimize the risk of developing hypoglycemia.

The addition of liraglutide resulted in a statistically significantly lower HbA1c (-0.73% when using liraglutide versus -0.4% when using the reference drug, the calculated average values) and body weight (-3.03 kg versus 0, 72 kg, calculated average values). The incidence of episodes of hypoglycemia (per patient-year exposure) was statistically significantly lower with the addition of liraglutide compared with the addition of a single dose of insulin aspart (1 vs. 8.15; ratio: 0.13; 95% CI: 0.08 to 0.21).

Children and teenagers. The efficacy and safety of Tresib® were studied in a randomized (1: 1) controlled clinical trial in children and adolescents with type 1 diabetes mellitus lasting 26 weeks (n = 350) followed by a 26-week prolongation period (n = 280). The Tresiba® group included 43 children aged 1 to 5 years, 70 children aged 6 to 11 years, and 61 adolescents aged 12 to 17 years. With the use of the drug Tresiba once a day, a similar decrease in the HbA1c index for the 52nd week and a more pronounced decrease in the fasting plasma glucose (FPG) relative to baseline values were compared with the comparison drug (insulin detirim once or twice a day day). This result was achieved with the use of the drug Tresiba in a daily dose of 30% less than that of insulin detemir. The frequency (episodes of one patient-year of exposure) of episodes of severe hypoglycemia (definition of the International Society for the Study of Diabetes Mellitus in Children and Adolescents (ISPAD), 0.51 versus 0.33), confirmed hypoglycemia (57.71 vs 54 , 05) and night confirmed hypoglycemia (6.03 versus 7.6) was comparable with Tresib® and insulin detemir. In both treatment groups in children aged 6 to 11 years, the incidence of episodes of confirmed hypoglycemia was higher than in other age groups. There was a higher incidence of episodes of severe hypoglycemia in children aged 6 to 11 years in the Tresiba® group. The incidence of episodes of hyperglycemia with ketosis was significantly lower with the use of the drug Tresiba® in comparison with treatment with insulin detemir - 0.68 and 1.09, respectively. The incidence, type and severity of adverse reactions in the population of children's patients do not differ from those in the general population of patients with diabetes mellitus. The development of antibodies was rare and did not have clinical significance. Data on efficacy and safety obtained from adolescents with type 2 diabetes mellitus were extrapolated from data from adolescents and adult patients with type 1 diabetes mellitus and adult patients with type 2 diabetes mellitus. The results suggest the use of Tresiba® for treatment Adolescents with type 2 diabetes mellitus.

Pharmacokinetics

Absorption. The super-long action of insulin degludec is due to the specially created structure of its molecule. After SC injection, the formation of soluble stable multi-hexamers, which create a depot of insulin in the subcutaneous fat tissue. Multiexameres gradually dissociate, releasing insulin degludec monomers, resulting in a slow and prolonged delivery of the drug into the blood.

Css of the drug Tresiba in blood plasma is achieved 2-3 days after the administration of the drug.

The effect of insulin degludec for 24 hours with its daily administration once a day is evenly distributed between the first and second 12-hour intervals (AUCGIR0-12h.SS / AUCGIR.t.SS = 0.5).

Distribution. The relationship of insulin degludec with plasma proteins (albumin) is> 99%.

Metabolism. The breakdown of insulin degludec is similar to that of human insulin; All formed metabolites are inactive.

Excretion. T1 / 2 after the injection Tresiba® Flex Tach® is determined by the rate of its absorption from the subcutaneous tissue. T1 / 2 of the drug Tresiba® Flex Tach® is approximately 25 hours and is dose independent.

Linearity. In n / to the introduction, the total concentrations in the blood plasma were proportional to the administered dose in the range of therapeutic doses. In direct comparison of both forms of release of the Tresiba® FlexTach® preparation - 100 and 200 U / ml, data were obtained on the compliance of their bioequivalence with the established requirements (based on the data obtained by AUCIDeg.t.SS and Cmax.IDeg.SS)

Special patient groups

There was no difference in the pharmacokinetic properties of the Tresib ® Flex-Tach ® drug depending on the sex of the patients.

Patients of advanced age, patients of different ethnic groups, patients with impaired renal or hepatic function. There were no clinically significant differences in the pharmacokinetics of insulin degludec between elderly and young patients, between patients of different ethnic groups, between patients with impaired renal function, liver and healthy patients.

Children and teenagers. The pharmacokinetic properties of insulin degludec in children (1 to 11 years) and adolescents (12 to 18 years) in equilibrium were comparable to those observed in adult patients with type 1 diabetes. However, after a single application, the total exposure in children and adolescents Was higher than in adult patients with type 1 diabetes mellitus.

Pre-clinical safety data. Preclinical data based on studies of pharmacological safety, toxicity of repeated doses, carcinogenic potential, toxic effect on reproductive function, did not reveal any hazard of insulin deglucose for humans.

The ratio of metabolic and mitogenic activities of insulin deglucose is similar to that of human insulin.

Indications

Diabetes mellitus in adults, adolescents and children over 1 year old.

Contraindications

Increased individual sensitivity to the active substance or any of the auxiliary components of the drug;

The period of pregnancy, the period of breastfeeding (clinical experience of the drug in women during pregnancy and breastfeeding is absent).

Children age up to 1 year, t. Clinical studies in children younger than 1 year have not been conducted.

pregnancy and lactation

The use of the drug Tresiba® FlexTach® during pregnancy is contraindicated, because Clinical experience of its use during pregnancy is absent. Studies of reproductive function in animals have not revealed differences between insulin degludec and human insulin in terms of embryotoxicity and teratogenicity.

The use of the drug Tresiba® FlexTach® during breastfeeding is contraindicated, because Clinical experience of its use in lactating women is absent.

Animal studies have shown that in rats, insulin degloodec is excreted in breast milk, the concentration of the drug in breast milk is lower than in blood plasma.

It is not known whether insulin dehydrude is excreted in breast milk of women.

No metabolic effects are expected in newborn infants and infants breastfed.

Fertility. In animal studies, the adverse effect of insulin degludec on fertility was not detected.

Side effects

The most common side effect reported during the treatment with insulin degludec is hypoglycemia (see Description of individual adverse reactions).

All of the side effects presented below, based on data from clinical trials, are grouped according to MedDRA and organ systems. The incidence of side effects is defined as: very often (≥1 / 10); Often (≥1 / 100 to <1/10); Infrequently (≥1 / 1000 to <1/100); Rarely (≥1 / 10000 to <1/1000); Very rarely (<1/10000) and unknown (can not be estimated based on available data).

From the immune system: rarely - hypersensitivity reactions, hives.

From the side of metabolism and nutrition: very often - hypoglycemia.

From the skin and subcutaneous tissues: infrequently - lipodystrophy.

General disorders and disorders at the injection site: often - reactions at the injection site; Infrequent peripheral edema.

Description of individual adverse reactions

Impaired immune system. With the use of insulin preparations, it is possible to develop allergic reactions. Allergic reactions of the immediate type to the insulin preparation itself or the auxiliary components that make up it can potentially threaten the life of the patient.

When using the drug Tresiba® FlexTech®, hypersensitivity reactions (including swelling of the tongue or lips, diarrhea, nausea, fatigue and pruritus) and hives are rarely noted.

Hypoglycemia. It can develop if the dose of insulin is too high in relation to the patient's need for insulin. Severe hypoglycemia can lead to loss of consciousness and / or convulsions, temporary or irreversible disruption of brain function up to a lethal outcome. Symptoms of hypoglycemia tend to develop suddenly. They include: cold sweats, pale skin, increased fatigue, nervousness or tremor, anxiety, unusual fatigue or weakness, impaired orientation, decreased concentration, drowsiness, pronounced hunger, visual impairment, headache, nausea, palpitations.

Lipodystrophy (including lipohypertrophy, lipoatrophy) can develop at the injection site. Observance of the rules of changing the injection site within one anatomical area helps to reduce the risk of this side reaction.

Reactions at the site of administration. Patients treated with Tresiba® FlexTech® showed reactions at the injection site (hematoma, pain, local hemorrhage, erythema, connective tissue nodules, swelling, skin discoloration, itching, irritation and compaction at the injection site). Most reactions at the site of administration are insignificant and temporary, and usually disappear when continuing treatment.

Children and teenagers. The drug Tresiba ® was used in children and adolescents under the age of 18 years to study the pharmacokinetic properties. In a long-term study, children aged 1 to 18 years were shown to be safe and effective. The frequency of occurrence, type and severity of adverse reactions in the population of patients of childhood do not differ from those in the general population of patients with diabetes mellitus (see Pharmacodynamics.)

Special patient groups

In clinical trials, no differences in the frequency, type, or severity of adverse reactions between elderly patients and patients with impaired renal or hepatic function and the general population of patients have been identified.

Interaction

There are a number of drugs that affect the need for insulin.

The need for insulin can be reduced: oral hypoglycemic drugs, GLP-1 receptor agonists, MAO inhibitors, nonselective beta-blockers, ACE inhibitors, salicylates, anabolic steroids and sulfonamides.

The need for insulin can increase: oral hormonal contraceptives, thiazide diuretics, GCS, thyroid hormones, sympathomimetics, somatropin and danazol.

Beta-blockers can mask symptoms of hypoglycemia.

Octreotide / lanreotide can both increase and decrease the body's need for insulin.

Ethanol (alcohol) can both enhance and reduce the hypoglycemic effect of insulin.

Incompatibility. Some drugs when added to the preparation of Tresib® Flex Tach® can cause its destruction. The drug Tresiba® Flex Tach® should not be added to infusion solutions. Do not mix Tresiba® Flex Tach® with other medications.

Dosing and Administration

SC, once a day at any time of the day, but it is preferable to administer the drug at the same time every day.

The drug Tresiba® FlexTech® is an analogue of insulin super-long-acting.

In patients with type 2 diabetes mellitus, the drug Tresiba® Flex Tach® can be used either as monotherapy or in combination with PGHP, GLP-1 receptor agonists or bolus insulin (see Pharmacodynamics). Patients with type 1 diabetes mellitus are prescribed Tresiba® Flex Tach® in combination with short / ultrashort insulin to cover the need for prandial insulin.

The dose of the drug Tresiba® FlexTach® should be determined individually according to the needs of the patient. To optimize the control of glycemia, it is recommended to adjust the dose of the drug on the basis of fasting blood glucose in the blood plasma.

As with any form of insulin, the dose adjustment of Tresib® FlexTech® may also be necessary if the patient's physical activity is increased, his normal diet changes, or if he has a concomitant disease.

The initial dose of Tresiba® FlexTech®

Patients with type 2 diabetes mellitus. The recommended initial daily dose of the drug Tresiba® FlexTach® is 10 units, followed by the selection of an individual dose of the drug.

Patients with type 1 diabetes mellitus. The drug Tresiba® Flex Tach® is prescribed once a day in combination with prandial insulin, which is administered along with the food intake, followed by the selection of an individual dose of the drug.

Translation from other insulin preparations

It is recommended that the blood glucose concentration be closely monitored during the transfer and in the first weeks of the new drug administration. Perhaps, correction of concomitant hypoglycemic therapy (dose and time of administration of insulin preparations of short and ultrashort action or other simultaneously used hypoglycemic drugs) will be required.

Patients with type 2 diabetes mellitus. When transferring to Tresiba® FlexTach® preparation of patients with type 2 diabetes mellitus on basal or basal bolus insulin regimens, or the regime of treatment with insulin preparations / self-mixed insulins, the dose of Tresiba® Flex Tach® should be Calculate on the basis of the dose of basal insulin that the patient received before the transfer to a new type of insulin, according to the "unit per unit" principle, and then adjust according to the individual needs of the patient .

Patients with type 1 diabetes mellitus. In most patients with type 1 diabetes mellitus, when switching from any basal insulin to the Tresiba® FlexTech® preparation, the principle "unit per unit" is used based on the dose of basal insulin that the patient received before the transition, then the dose is adjusted to According to his individual needs. In patients with type 1 diabetes mellitus who, at the time of transfer to Tresiba® FlexTech®, were on insulin therapy with basal insulin twice daily, or in patients with a HbA1c <8%, the dose of Tresib® Flex Tach® should be set on an individual Basis. It may be necessary to reduce the dose with subsequent individual selection based on glycemia.

Use of the drug Tresiba in combination with GLP-1 receptor agonists in patients with type 2 diabetes mellitus. With the addition of the drug Tresiba to the treatment with GLP-1 receptor agonists, the recommended initial daily dose is 10 units, followed by an individual dose adjustment.

When GLP-1 receptor agonists are added to Trexib® treatment, it is recommended to reduce the dose of Tresiba® by 20% to minimize the risk of developing hypoglycemia. Subsequently, the dose should be adjusted.

Flexible dosing regimen

Based on the patient's needs, Tresiba® FlexTech® allows changing the time of its administration (see "Pharmacodynamics"). In this case, the interval between injections should be at least 8 hours. Those patients who forget to enter the dose of insulin in time, it is recommended to enter the dose as soon as they have found it, and then return to their usual time of a daily single injection of the drug.

The drug Tresiba® Flex Tach® 100 and 200 U / ml. The drug Tresiba® FlexTech® is presented in two dosages. For both dosages, the set of the required dose of the drug is carried out in units. However, the dose step differs between the two dosages of the Tresib®® FlexTech® preparation.

Tresiba® FlexTech®, 100 U / ml, allows the administration of doses ranging from 1 to 80 U in steps of 1 unit per injection. Tresiba® FlexTech®, 200 U / ml, allows the administration of doses from 2 to 160 U with a step of 2 units per injection. The insulin dose is contained in half the volume of the solution as compared with the preparations of basal insulin 100 U / ml.

The dose counter shows the number of units regardless of dosage; Do not recount the dose when transferring patients to a new dosage.

Special patient groups

Patients of advanced age (over 65 years). The drug Tresiba® Flex Tach® can be used in elderly patients. It is necessary to carefully monitor the concentration of blood glucose and adjust the dose of insulin individually (see "Pharmacokinetics").

Lack of kidney and liver function. The drug Tresiba® Flex Tach® can be used in patients with kidney and liver failure. It is necessary to carefully monitor the concentration of blood glucose and adjust the dose of insulin individually (see "Pharmacokinetics").

Children and teenagers. The drug Tresiba ® can be used to treat adolescents and children older than 1 year (see "Pharmacodynamics"). When switching from basal insulin to Tresiba®, in each individual case, the need to reduce the dose of basal and bolus insulin should be considered to minimize the risk of developing hypoglycemia (see "Special instructions").

Mode of application

The drug Tresiba® FlexTech® is intended for administration only. The drug Tresiba® Flex Tach® can not be administered iv. This can lead to the development of severe hypoglycemia. The drug Tresiba® Flex Tach® can not be administered in / m, because In this case, the absorption of the drug varies. The drug Tresiba® FlexTech® can not be used in insulin pumps.

Tresiba® Flex-Tach® is injected into the thigh, anterior abdominal wall or shoulder area. You should constantly change injection sites within the same anatomical area to reduce the risk of developing lipodystrophy. Tresiba® FlexTech® is a pre-filled syringe pen designed for use with NovoFine® or NovoTvist® disposable needles.

Instructions for use

FlexTech® - pre-filled syringe pen is designed for use with NovoFine® or NovoTvist® needles up to 8 mm in length.

Tresiba® FlexTech®, 100 U / ml, allows the administration of doses from 1 to 80 units in steps of 1 unit.

Tresiba® FlexTach® 200 ED / ml allows the administration of doses from 2 to 160 U with a step of 2 units. It is necessary to strictly follow the instructions contained in the attached Instruction for the use of the FlexShack® syringe pen.

Tresiba® Flex Tach® and needles are for individual use only. Do not refill the syringe pen cartridge. Do not use the drug if the solution has ceased to be clear and colorless. Do not use the drug if it has been frozen. Dispose of the needle after each injection.

Observe local requirements for disposal of used medical materials.

Instruction for patients on the use of the drug Tresiba® FlexTech®, a solution for subcutaneous administration 100 or 200 U / ml

Read this manual carefully before using the pre-filled Tresib® FlexTach® pen. If the patient does not comply with the instructions, he may introduce an insufficient or too large dose of insulin, which can lead to too high or too low a blood glucose concentration.

Use a syringe pen should only after the patient learns to use it under the guidance of a doctor or nurse.

Check the label on the syringe pen label to make sure it contains the Tresiba® FlexTech® preparation, and then carefully examine the illustrations below, which show the details of the syringe pen and needle.

If the patient is visually impaired or has serious vision problems, and he can not distinguish the numbers on the dose counter, do not use a syringe pen without outside help. To help such a patient can a person without visual impairment, trained in the correct use of the pre-filled FlexTach® syringe pen.

Tresiba® Flex Tach® 100 U / ml is a pre-filled syringe pen containing 300 units of insulin degludec. The maximum dose that you can set is 80 units in 1-step increments.

Tresiba® FlexTach® 200 ED / ml allows the administration of doses from 2 to 160 U with a step of 2 units.

The Tresiba® FlexTech® pen is designed for use with NovoFine® or NovoTvist® disposable needles up to 8 mm long. Needles are not included in the packaging.

Important information. Pay attention to the information marked with such icons, it is very important for the safe use of the syringe pen.

I. Preparation of the syringe pen for use

Check the name and dosage on the label of the syringe pen to make sure it contains the Tresiba® FlexTech® preparation, 100 U / ml / Tresiba® FlexTech®, 200 U / ml. This is especially important if the patient uses insulin of different types. If he mistakenly enters another type of insulin, the blood glucose concentration may be too high or low.

A. Remove the cap from the syringe handle

B. Make sure that the insulin preparation in the syringe pen is clear and colorless. Look at the scale of the scale of the insulin residue. If the drug is cloudy, a pen can not be used.

C. Take a new disposable needle and remove the protective sticker

D. Put the needle on the syringe pen and rotate it so that the needle fits tightly on the syringe pen.

E. Remove the outer cap of the needle, but do not throw it away. It will be needed after the injection is completed to safely remove the needle.

F. Remove and discard the inner needle cap. If the patient tries to put the inner cap back on the needle, he can prick.

At the end of the needle, a drop of insulin may appear. This is normal, but the patient still needs to check the intake of insulin.

Important information. For each injection, use a new needle to avoid infection, infection, leakage of insulin, blockage of the needle and the introduction of an incorrect dose of the drug. Never use the needle if it is bent or damaged.

II. Insulin intake check

G. Before each injection, check the intake of insulin. So the patient can be sure that the insulin dose is introduced completely. Type 2 units of the drug by turning the dose selector. Make sure that the dose counter shows "2".

H. Holding the needle with the needle up, tap the upper part of the syringe handle a few times with the tip of the finger, so that the air bubbles move upward.

I. Press the start button and hold it in this position until the dose counter returns to zero. "0" should stand in front of the dose indicator. At the end of the needle should appear a drop of insulin. Sometimes a small air bubble may remain at the end of the needle, but it will not be injected. If a drop of insulin at the end of the needle does not appear, repeat the operations IIG-II I, but no more than 6 times. If a drop of insulin did not appear, change the needle and repeat the operations of IIG-II I.

If a drop of insulin at the end of the needle has not appeared, do not use this syringe pen, use a new syringe pen.

Important information. Before each injection, make sure that a drop of insulin appears on the tip of the needle. This ensures the intake of insulin. If a drop of insulin does not appear, the dose will not be entered, even if the dosage counter moves. This may indicate that the needle is clogged or damaged.

Before each injection, check the intake of insulin. If the patient does not check the intake of insulin, he may inject an insulin dose or not enter it at all, which can lead to too high a concentration of glucose in the blood.

III. Dose setting

J. Before starting the injection, make sure that the dose counter is set to "0". "0" must be in front of the dosing indicator. Rotate the dose selector to set the dose assigned by the doctor. The dose selector sets the number of units. Only the dose counter and dose indicator show the number of units of insulin in the selected dose. If an incorrect dose is set, the patient can turn the dose selector forwards or backwards until the correct dose is established. The maximum dose that he can set is 80/160 units. If the insulin residue in the syringe pen is less than 80/160 U, the dose counter will stop on the number of insulin units left in the syringe pen. With each turn of the dose selector, clicks are heard, the sound of clicks depends on which way the dose selector is rotating (forward, backward or if the dialed dose exceeds the number of units of insulin remaining in the syringe pen). Do not count these clicks.

Important information. Before each injection, check how many units of insulin the patient has typed on the dose counter and the dose indicator. Do not set the dose by the number of clicks. If the patient establishes and enters the wrong dose, the blood glucose concentration may become too high or low.

The scale of the insulin residue shows the approximate amount of insulin remaining in the syringe, so it can not be used to measure the dose of insulin

IV. Introduction of insulin

C. Insert the needle under the skin using the injection technique recommended by the doctor. Make sure that the dose counter is in the patient's field of vision. Do not touch the dose counter with your fingers - this may interrupt the injection. Press the start button until it stops and hold it in this position until the dose counter shows "0". "0" must be exactly opposite the dose indicator, and the patient can hear or feel a click.

After injection, leave the needle under the skin for at least 6 seconds. This will ensure the introduction of a full dose of insulin.

L. Pull the needle out from under the skin by pulling the syringe up.

If blood appears at the injection site, gently press a cotton swab into the injection site. Do not massage the injection site.

After completion of the injection, the patient can see a drop of insulin at the end of the needle. This is normal and does not affect the dose of the drug that is introduced.

Important information. Always check with the dose counter readings to know how many units of insulin are injected. The dose counter will show the exact number of units. Do not count the number of clicks. Hold the button until the dose counter shows "0". If the dose counter stopped before it showed "0", a full dose of insulin was not injected, which could lead to a too high concentration of glucose in the blood.

V. After the injection is completed

M. After placing the outer needle cap on a flat surface, insert the end of the needle into the cap, without touching it or the needle.

N. When the needle enters the cap, gently place the cap on the needle. Unscrew the needle and discard it, observing the precautionary measures.

After each injection, put a cap on the syringe pen to protect the insulin contained in it from exposure to light. Discard the needle after each injection to avoid infection, infection, leakage of insulin, blockage of the needle and the introduction of an incorrect dose of the drug. If the needle is clogged, the patient will not be able to inject insulin. Dispose of the used syringe pen with the needle disconnected, according to the recommendations given by the doctor, nurse, pharmacist or according to local requirements.

Important information. To avoid accidental pricking with a needle, never try to put the inner cap back on the needle. Remove the needle from the syringe-pen after each injection and store the syringe-pen with the needle disconnected. This will avoid infection, infection, leakage of insulin, blockage of the needle and the introduction of an incorrect dose of the drug.

VI. How much insulin is left?

P. The scale of the insulin residue shows the approximate amount of insulin remaining in the syringe pen.

R. To find out how much insulin is left in the syringe pen, you need to use a dose counter. Rotate the dose selector until the dose counter stops. If the dose counter shows a digit of 80/160, this means that at least 80/160 units of insulin is left in the syringe pen. If the dose counter shows less than 80/160, this means that exactly the number of insulin units that was displayed on the dose counter remained in the syringe pen.

Rotate the dose selector in the opposite direction until the dose counter shows "0". If the insulin remaining in the syringe-pen is not enough to introduce the full dose, you can enter the required dose for two injections using two syringes-pens.

Important information. It is necessary to be very careful when calculating the remainder of the necessary dose of insulin. If the patient has doubts, it is better to introduce a full dose of insulin with a new syringe pen. If the patient makes a mistake in the calculations, he may inject an inadequate dose or an excessively high dose of insulin. This can lead to the fact that the concentration of glucose in the blood can become too high or low.

Always carry a syringe-pen with you. Always carry a spare syringe pen and new needles in case they are lost or damaged. Keep the syringe pen and needle out of reach of all, and especially for children, the place. Never transfer your syringe pen and needle to it to others. This can lead to cross-infection. Persons caring for the patient should handle the used needles with extreme caution in order to avoid accidental injections and infection.

Care of the syringe pen

Carefully handle the syringe pen. Negligent or improper handling can cause an incorrect dosage, which can lead to too high or too low a glucose concentration.

Do not leave a syringe pen in the car or any other place where it can be exposed to too high or too low temperatures.

Protect the syringe handle from getting dust, contaminants and all kinds of liquids on it.

Do not wash the syringe pen, do not immerse it in liquid and do not lubricate it. If necessary, the syringe handle can be cleaned with a damp cloth moistened with a mild detergent. Do not drop or hit the syringe handle on a hard surface. If the patient drops a syringe pen or doubts that it is working properly, attach a new needle and check the insulin intake before injecting.

Do not refill the syringe pen. Empty syringe pen should be thrown away immediately. Do not attempt to repair the syringe pen by yourself or dismantle it.

Overdose

Symptoms: A certain dose needed for an insulin overdose has not been established, however hypoglycemia can develop gradually if the dose of the drug has been introduced too high (see "Special instructions").

Treatment: mild hypoglycemia, the patient can eliminate himself by taking glucose or sugar-containing foods inside. Therefore, patients with diabetes are encouraged to constantly carry with them sugar-containing foods.

In case of severe hypoglycemia, when the patient is unconscious, he should enter glucagon (0.5 to 1 mg) IM or SC (can be injected by a trained person), or / in a solution of dextrose (glucose) (can enter Only a medical professional). It is also necessary in / dextrose administered if after 10-15 min after administration of glucagon patient does not regain consciousness. After recovery of consciousness the patient is advised to take food rich in carbohydrates, for the prevention of relapse of hypoglycaemia.

special instructions

Hypoglycemia. When skipping meals or unplanned intensive exertion of the patient may develop hypoglycemia. Hypoglycemia can also develop if the dose of insulin is too high in relation to the patient's need (see "Side effects" and "Overdose").

Children should be careful when choosing insulin doses (especially with basal-bolus regimen), taking into account food intake and physical activity to minimize the risk of developing hypoglycemia.

After compensating for carbohydrate metabolism (for example, with intensified insulin therapy), the symptoms typical for them, precursors of hypoglycemia, can change in patients, which patients should be informed about. Common symptoms-precursors can disappear with prolonged course of diabetes. Concomitant diseases, especially infectious and accompanied by fever, usually increase the body's need for insulin. Correction of the dose of the drug may also be required if the patient has concomitant diseases of the kidneys, liver or disorders of the adrenal, pituitary or thyroid gland function.

As with other basal insulin preparations, recovery from hypoglycemia with Tresiba® FlexTech® may be delayed.

Hyperglycemia. An insufficient dose of the drug or discontinuation of treatment can lead to the development of hyperglycemia or diabetic ketoacidosis. In addition, concomitant diseases, especially infectious diseases, can promote the development of hyperglycemic conditions and, accordingly, increase the body's need for insulin.

Typically, the first symptoms of hyperglycemia appear gradually, within a few hours or days. These symptoms include thirst, rapid urination, nausea, vomiting, drowsiness, redness and dryness of the skin, dry mouth, loss of appetite, odor of acetone in the exhaled air. With type 1 diabetes mellitus, without appropriate treatment, hyperglycemia leads to the development of diabetic ketoacidosis and can lead to death.

For the treatment of severe hyperglycemia, it is recommended that rapid insulin be administered.

Transfer of the patient from other insulin preparations. Transfer of a patient to a new type or preparation of insulin of a new brand or other manufacturer should occur under strict medical supervision. The translation may require a dose adjustment.

Simultaneous use of the preparations of the thiazolidinedione group and insulin preparations. Cases of CHF in the treatment of patients with thiazolidinediones in combination with insulin preparations have been reported, especially if such patients have risk factors for CHF. This fact should be taken into account in the appointment of patients with combined therapy with thiazolidinediones and the preparation of Tresiba® FlexTech®. In the appointment of such combination therapy, it is necessary to conduct medical examinations of patients to identify signs and symptoms of CHF, weight gain and the presence of peripheral edema. If the symptoms of heart failure worsen in patients, treatment with thiazolidinediones should be discontinued.

Disorders from the side of the organ of sight. Intensification of insulin therapy with a sharp improvement in carbohydrate metabolism control may lead to a temporary deterioration in the state of diabetic retinopathy, while a prolonged improvement in glycemic control reduces the risk of progression of diabetic retinopathy.

Prevention of accidental entanglement of insulin preparations. The patient should be instructed to check the labeling on the label before each injection to avoid accidental administration of another dose or other insulin. Before each injection, patients should check the dose counter for the number of units recruited into the syringe pen. Thus, only patients who can clearly distinguish the numbers on the dose counter can inject insulin themselves.

It is necessary to inform visually impaired or visually impaired people that they always need the help of persons who do not have vision problems and are trained to work with a syringe pen.

Antibodies to insulin. With the use of insulin, the formation of antibodies is possible. In rare cases, the formation of antibodies may require correction of the dose of insulin to prevent cases of hyperglycemia or hypoglycemia.

Influence on the ability to drive vehicles and mechanisms. The ability of patients to concentrate and respond to the reaction may be impaired during hypoglycemia, which can be dangerous in situations where this ability is particularly needed (for example, when driving vehicles or mechanisms). Patients should be advised to take measures to prevent the development of hypoglycemia in the management of vehicles. This is especially important for patients with a lack or decline in symptomatic signs of developing hypoglycemia or frequent episodes of hypoglycemia. In these cases, the desirability of driving a vehicle should be considered.

Form of issue

Solution for subcutaneous administration, 100 U / ml in pre-filled FlexTach® syringes.

Solution for subcutaneous administration, 200 U / ml in pre-filled FlexTech® syringes

3 ml in the cartridges of glass I of hydrolytic class, sealed with stoppers with discs of halobutyl rubber / polyisoprene on one side and pistons of halobutyl rubber on the other side. The cartridge is sealed in a multi-dose disposable polypropylene syringe pen for multiple injections.

For a dosage of 100 U / ml: 5 multi-dose disposable syringes are placed in a cardboard box.

For a dosage of 200 units / ml: 3 multi-dose disposable syringes are placed in a cardboard box.

Terms of leave from pharmacies

On prescription.

Storage conditions

At a temperature of 2-8 ° C (in the refrigerator). But not next to the freezer. Do not freeze. For the used or portable as a spare syringe handle with the drug: store at a temperature not higher than 30 ° C. Can be stored at 2 to 8 ° C (in the refrigerator). Use within 8 weeks. To protect from light, close the syringe handle with a cap.

Keep out of the reach of children.

Shelf life

30 months

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