Instruction for use: RYZODEG FlexTouch

Active substance Insulin degludec + Insulin aspart

ATX CodeA10AD06 Insulin degludec + insulin aspart

Pharmacological group

A hypoglycemic agent, a combination of insulin analogues of medium duration or long and short action [Insulins in combinations]

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 / insulin aspart 100 ED (in the ratio 70/30)

(Equivalent to 2.56 mg insulin degludec / 1.05 insulin aspart)

Auxiliary substances: glycerol - 19 mg; Phenol - 1.5 mg; Meta-cresol - 1.72 mg; Zinc - 27.4 μg (in the form of zinc acetate - 92 μg); Sodium chloride - 0.58 mg; Hydrochloric acid / sodium hydroxide (for pH correction); Water for injection - up to 1 ml

The pH of the solution is 7.4

1 syringe-pen contains 3 ml of a solution equivalent to 300 units

1 unit of insulin Rezodeg® contains 0.0256 mg of anhydrous salt-free insulin degludec and 0.0105 mg of anhydrous salt-free insulin aspart

1 unit of insulin Rezodeg® corresponds to one IU of human insulin, 1 unit of insulin glargine, 1 ED of insulin detemir or 1 unit of two-phase insulin aspart

Description of dosage form

Clear colorless solution.

pharmachologic effect

Pharmacological action - hypoglycemic.

Pharmacodynamics

Ryzodeg® FlexTouch® is a combined preparation consisting of a soluble analog of human super insulin insulin (insulin degludec) and a high-speed soluble analog of human insulin (insulin aspart), produced by the method of recombinant DNA biotechnology using the strain of Saccharomyces cerevisiae.

Mechanism of action

Insulin degludec and insulin aspart bind specifically to the human endogenous insulin receptor and, interacting with it, realize their pharmacological effect similarly to the effect of human insulin.

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

The pharmacodynamic effects of the components of the preparation Ryzodeg® FlexTach® differ distinctly (Figure 1) and the overall profile of the action of the preparation reflects the profiles of the action of the individual components: fast acting insulin aspart and insulin degludec of superlative action.

The basal component of the preparation Ryzodeg® FlexTouch®, which has a super-long-acting effect (insulin degludec), after injection injects forms soluble multiexamers in the subcutaneous depot, from which there is a continuous slow intake of insulin degludec into the circulation, providing a flat action profile and stable hypoglycemic effect of the drug. This effect is preserved in combination with insulin aspart and does not affect the rate of absorption of fast-acting insulin aspart monomers.

Ryzodeg® Flex Tach® starts to act quickly, providing a prandial insulin requirement shortly after injection, while the basal component has a flat, stable and ultra-long action profile that provides a basal insulin requirement. The duration of a single dose of Ryzodeg® FlexTouch® is more than 24 hours.

A linear relationship between the increase in the dose of Ryzodeg® FlexTouch® and its overall and maximum hypoglycemic effect was demonstrated. Css of the drug Ryzodeg® FlexTouch® is achieved after 2-3 days of drug administration.

Differences in the pharmacodynamics of Ryzodeg® FlexTach® in elderly and senile patients and younger patients have not been revealed.

Clinical efficacy and safety

Five international randomized controlled open-label clinical trials of Rezodeg® under the Treatment-to-Target regime for 26 or 52 weeks, involving 1,360 patients with diabetes mellitus (362 patients with type 1 diabetes and 998 patients with type 2 diabetes). Two comparative studies of a single administration of Ryzodeg® in combination with oral hypoglycemic drugs (PGHP) and single administration of insulin glargine in combination with PGHP in patients with type 2 diabetes were carried out. Two times a day, in combination with PGHP, the introduction of Rasodeq® was compared with the administration Two-phase insulin aspart 30 twice a day in combination with PGHP in two studies in patients with type 2 diabetes mellitus. The introduction of Raizodeq® once a day in combination with insulin aspart The same was compared with the administration of insulin detemir once or twice a day in combination with insulin aspart in patients with type 1 diabetes mellitus.

The lack of superiority of the comparative drugs over Ryzodeg® in the reduction of HbA1c was demonstrated in all studies in the treatment of patients "up to the target."

In patients with type 1 diabetes mellitus, treatment with Raizodeq® once a day in combination with insulin aspart before other meals showed similar glycemic control (HbA1c and fasting plasma glucose) with more rare cases of nocturnal hypoglycemia compared with basal bolus insulin regimen Detemir and insulin aspart with each meal.

According to the meta-analysis data of two 26-week open-label, open-label studies with patients with type 2 diabetes mellitus, Ryzodeg®, administered twice daily, showed a lower incidence of confirmed hypoglycemic episodes as a whole (Figure 2) and episodes of confirmed nocturnal hypoglycemia (Figure 3) compared with the two-phase insulin aspart 30. Results showed that Ryzodeg® reduces plasma glucose in the fasting plasma with a lower risk of hypoglycaemia To during the study and during the maintenance of the dose from the 16th week.

There was no clinically significant formation of antibodies to insulin after treatment with Ryzodeg® for an extended period

Pharmacokinetics

Absorption. After SC injection, the formation of soluble stable multigensamers insulin degludec, which create a depot of insulin in the subcutaneous fat, while not hampering the rapid release of insulin aspart monomers in the vascular bed.

Multi-hexameres gradually dissociate, releasing insulin degludec monomers, resulting in a slow continuous flow of the drug into the blood. Css of the ultra-long-acting (insulin degludec) component in blood plasma is achieved 2-3 days after the administration of Ryzodeg®.

Well-known indicators of the rapid absorption of insulin aspart are preserved in the preparation Ryzodeg®. The pharmacokinetic profile of insulin aspart appears 14 minutes after injection, Cmax is observed after 72 minutes.

Distribution. The affinity of insulin degludec to serum albumin corresponds to the binding capacity of plasma protein> 99% in human blood plasma. For insulin aspart, the binding capacity of the plasma protein is lower (<10%), as does human insulin.

Metabolism. The breakdown of insulin degludec and insulin aspart is similar to that of human insulin, all the metabolites that are formed are inactive.

Excretion. T1 / 2 of Ryzodeg® after injection is determined by the rate of its absorption from the subcutaneous tissue. T1 / 2 insulin degludec is approximately 25 hours and is dose independent.

Linearity. The total effect of Ryzodeg® is proportional to the administered dose of the basal component (insulin deglucose) and the prandial component (insulin aspart) in type 1 and type 2 diabetes mellitus.

Special patient groups. There were no differences in the pharmacokinetic properties of the preparation Ryzodeg®, 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 Ryzodeg® between elderly and young patients, patients of different ethnic groups, patients with impaired renal and hepatic function, and healthy patients.

Children and teenagers. The pharmacokinetic properties of Ryzodeg® in children (6-11 years) and adolescents (12-18 years) with type 1 diabetes mellitus are comparable to those of adult patients with a single injection. The total concentration and Cmax of insulin aspart are higher in children than in adults and are the same in adolescents and adults. The pharmacokinetic properties of insulin degludec in children and adolescents with type 1 diabetes mellitus are comparable to those of adult patients.

Against the background of a single administration to patients with type 1 diabetes mellitus insulin degludec, it was demonstrated that the total dose effect of the drug in children and adolescents is higher than that of adult patients.

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 danger to humans. The ratio of metabolic and mitogenic activity of insulin deglucose is similar to that of human insulin.

Indications

Diabetes mellitus in adults.

Contraindications

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

Period of pregnancy;

The period of breastfeeding;

Children under 18 years of age (clinical experience of the drug in children, women during pregnancy and breastfeeding is absent).

pregnancy and lactation

The use of the drug Ryzodeg® 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 Ryzodeg® FlexTouch® during the period of 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.

Fertility. In animal studies, there was no adverse effect of insulin degloodec on fertility.

Side effects

The most common side effect reported during treatment 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 the frequency is unknown (it is impossible to estimate 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: the frequency is unknown - lipodystrophy.

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

Description of individual adverse reactions

From the immune system. With the use of insulin preparations, it is possible to develop allergic reactions. Allergic reactions of immediate type to insulin or ancillary components of the drug may potentially threaten the life of the patient.

When Ryzodeg® FlexTouch® is used, hypersensitivity reactions (including swelling of the tongue or lips, diarrhea, nausea, fatigue and skin itching) and hives are rare.

Hypoglycemia. It can develop if the dose of insulin is too high in relation to the patient's need for it. 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 sweat, pale skin, increased fatigue, nervousness or tremor, anxiety, unusual fatigue or weakness, impaired orientation, decreased concentration, drowsiness, severe hunger, visual impairment, headache, nausea, palpitations.

Lipodystrophy. 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 Ryzodeg® FlexTouch® showed reactions at the injection site (hematoma, pain, local hemorrhage, erythema, connective tissue nodules, 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. Pharmacokinetic properties of the preparation Ryzodeg® FlexTach® have been studied in children and adolescents under the age of 18 (see "Pharmacokinetics"). Studies of efficacy and safety in children and adolescents have not been conducted.

Special patient groups

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

Interaction

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

The need for insulin can reduce: oral hypoglycemic drugs, glucagon-like peptide-1 receptor agonists (GLP-1), MAO inhibitors (monoamine oxidase), non-selective beta-blockers, ACE inhibitors (angiotensin converting enzyme), salicylates, anabolic steroids and sulfonamides.

The need for insulin can increase: oral hormonal contraceptives, thiazide diuretics, GCS, thyroid hormones, sympathomimetics, somatotropin and danazol. Beta-blockers can mask symptoms of hypoglycemia.

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

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

Incompatibility. Some medicinal substances, when added to the preparation of Ryzodeg® FlexTouch®, can cause the destruction of insulin degludec and / or insulin aspart.

Ryzodeg® FlexTouch® should not be added to infusion solutions. You can not mix this drug with other medications.

Dosing and Administration

P / to, 1 or 2 times a day before the main meals. If necessary, patients have the opportunity to independently change the time of administration of the drug, but it must be tied to the main meal.

The drug Raizodeq® FlexTouch® is a combination of soluble insulin analogs-an ultra long-acting basal insulin (insulin deglucose) and a rapid-acting prandial insulin (insulin aspart). In patients with type 2 diabetes mellitus, the Ryzodeg® FlexTouch® preparation can be used either as monotherapy or in combination with PGHP or bolus insulin. Patients with type 1 diabetes are prescribed Ryzodeg® FlexTouch® in combination with short / ultrasound insulin before other meals.

The dose of Ryzodeg® FlexTouch® is determined individually according to the patient's needs. To optimize the control of glycemia, it is recommended to correct the dose of the drug based on fasting plasma glucose.

As with any form of insulin, the dose adjustment may be required if the patient's physical activity is increased, his normal diet changes, or a concomitant disease.

The initial dose of Ryzodeg® FlexTouch®

Patients with type 2 diabetes mellitus. The recommended initial daily dose of Ryzodeg® FlexTouch® is 10 units with the subsequent selection of an individual dose of the drug.

Patients with type 1 diabetes mellitus. The recommended initial dose of Ryzodeg® FlexTouch® is 60-70% of the total daily insulin requirement. The drug Raizodeq® FlexTouch® is prescribed once a day during the main meal in combination with fast / short-acting insulin administered before the rest of the meals, 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 during the first weeks of the appointment of the new drug. It may be necessary to correct concomitant hypoglycemic therapy (dose and time of administration of insulin preparations of short and ultrashort action or dose of PGHP).

Patients with type 2 diabetes mellitus. When transferring patients receiving basal insulin therapy or biphasic insulin therapy once a day, the dose of Ryzodeg® Flex Tach® should be calculated on a "one-on-one" basis from the total daily insulin dose that the patient received before transferring to A new type of insulin. When transferring patients who are in more than one mode of administration of basal or biphasic insulin, the dose of Ryzodeg® FlexTouch® should be calculated on a unit-by-unit basis, with a two-fold administration of Ryzodeg® FlexTouch® in the same total daily dose of insulin, Which the patient received before the transfer to a new type of insulin. When transferring patients on a basis-bolus insulin regimen, the dose of Ryzodeg® should be calculated on the basis of the patient's individual needs. As a rule, patients start with the same dose of basal insulin.

Patients with type 1 diabetes mellitus. The recommended initial dose of Ryzodeg® FlexTouch® is 60-70% of the total daily insulin requirement in combination with short / ultrashort insulin with other meals and the subsequent selection of an individual dose of the drug.

Flexible dosing regimen. The time of administration of Ryzodeg® FlexTouch® can change if the time of the main meal changes.

If the dose of Ryzodeg® FlexTouch® is missed, the patient may enter the next dose on the same day with the next main reception, then return to his usual time of drug administration. Do not add an additional dose to compensate for the missed dose.

Special patient groups

Patients of advanced age (over 65 years). The drug Ryzodeg® FlexTouch® can be used in elderly patients. You should carefully monitor the concentration of glucose in the blood and adjust the dose of insulin individually (see "Pharmacokinetics").

Patients with kidney and liver failure. The drug Ryzodeg® FlexTouch® can be used in patients with kidney and liver failure. You should carefully monitor the concentration of glucose in the blood and adjust the dose of insulin individually (see "Pharmacokinetics").

Children and teenagers. Existing pharmacokinetics data are presented in the section "Pharmacokinetics", however, the efficacy and safety of Ryzodeg® FlexTach® in children and adolescents under 18 years of age have not been studied, and recommendations for the dose of the drug in children have not been developed.

Mode of application

The preparation of Ryzodeg® FlexTouch® is intended only for the administration of the patient. The preparation of Ryzodeg® FlexTouch® can not be administered intravenously. This can lead to the development of severe hypoglycemia. Preparation of Ryzodeg® Flex Tach® should not be given in / m (intramuscularly), because In this case, the absorption of the drug varies. The preparation Ryzodeg® FlexTouch® can not be used in insulin pumps.

The preparation Ryzodeg® FlexTouch® is injected into the thigh area, anterior abdominal wall or shoulder area. You should constantly change injection sites within the same anatomical area to reduce the risk of developing lipodystrophy.

The Flex-Tach® pen is designed for use with NovoFine® or NovoTvist® disposable needles. FlexTach ® allows you to enter doses from 1 to 80 units (unit of action) in steps of 1 unit.

Instructions for use

The pre-filled Ryzodeg® FlexSac® pen has been developed for use with NovoFine® or NovoTvist® needles up to 8 mm in length. Ryzodeg® FlexTouch® allows the administration of doses from 1 to 80 units in 1-step increments. It is necessary to follow the detailed instructions contained in the enclosed instructions for the use of the FlexShack® syringe pen. Ryzodeg® FlexTouch® and needles are for personal 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 if it has been frozen.

Dispose of the needle after each injection. Observe local requirements for disposal of used medical materials. For detailed instructions on the use of the syringe pen, see the instructions for patients on the use of Ryzodeg® FlexTouch®.

Instructions for patients on the use of the preparation Ryzodeg® Flex Tach® solution for subcutaneous administration 100 U / ml

Please read this manual carefully before using the pre-filled FlexTach® pen.

If the patient does not follow the instructions carefully, he may inject 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 only after the patient has learned how to use it under the guidance of a doctor or nurse.

Check the label on the label of the pen syringe to make sure that it contains the preparation Ryzodeg® FlexTouch®, 100 U / ml, and then carefully examine the illustrations below, which show the various parts of the syringe and needle.

If the patient is visually impaired or has serious vision problems and can not distinguish between the numbers on the dose counter, do not use a syringe pen without outside help.

A person can be helped by a person without visual impairment, trained in the correct use of the pre-filled FlexTouch® syringe pen.

Ryzodeg® FlexTouch® is a pre-filled syringe pen containing 300 units of insulin. The maximum dose that the patient can establish is 80 units in steps of 1 unit. The Ryzodeg® FlexSac® 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. For safe use of the syringe pen, special attention must be paid to information marked as important.

I. Preparation of the syringe pen for use

A. Check the name and dosage on the label of the pen syringe to make sure it contains the preparation Ryzodeg® FlexTouch®, 100 units (unit of action) / ml. This is especially important if the patient uses insulin preparations of different types. If a patient mistakenly enters another type of insulin, the blood glucose concentration may become too high or too low.

Remove the cap from the syringe handle.

B. Make sure that the insulin solution in the syringe pen is clear and colorless. Look at the scale of the scale of the insulin residue. If the insulin solution is cloudy, the syringe 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 attempts to put the inner cap back on the needle, he may accidentally prick. At the end of the needle, a drop of insulin may appear. This is normal, however, you still need to check the intake of insulin.

Important information. For each injection use a new needle. This reduces the risk of infection, infection, leakage of insulin, blockage of needles 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 every injection, check the intake of insulin, so the patient can be sure that the insulin dose is completely introduced.

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.

At the end of the needle, a small air bubble may remain, 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 the drop of insulin did not appear, change the needle and repeat the operations of IIG-II I. Do not use the syringe pen if a drop of insulin at the end of the needle has not appeared.

Important information. Before each injection, make sure that a drop of insulin appeared 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 given, even if the dose counter will move. This may indicate that the needle is clogged or damaged. Before each injection should 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 Setting the dose

J. Before starting the injection, make sure that the dose counter is set to "0". "0" should stand in front of the dose indicator.

Rotating the dose selector to set the required dose, as recommended by a doctor or nurse. If an incorrect dose is set, you can turn the dose selector forwards or backwards until the correct dose is established. The maximum dose that a patient can establish is 80 units. .

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. The maximum dose that can be set is 80 units. If the insulin residue in the syringe pen is less than 80 U, the dose counter will stop at the amount of insulin ED that remains in the syringe pen.

At 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 amount of insulin IU remaining in the syringe pen). Do not count these clicks.

Important information. Before each injection, it should be checked how much of the insulin DM was taken by the patient over the counter and the dose indicator. Do not count flicks of the syringe pen. If an incorrect dose is established and introduced, the blood glucose concentration may become too high or too 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 your doctor or nurse. 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. In this case, 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.

Important information. 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 the patient entered. Always check with the dose counter readings to know how many units of insulin the patient has injected. The dose counter will show the exact amount of ED. Do not count the number of clicks. Hold the trigger button until the dose counter after the injection 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 cap of the needle on a flat surface, insert the end of the needle into the cap, without touching it or until the needle tip.

N. When the needle enters the cap, gently put it on. Unscrew the needle. Throw it away, observing the precautionary measures.

A. After each injection, a cap must be put on the syringe pen to protect the insulin contained in it from exposure to light.

Need to throw out the needle after each injection to avoid infection, infection, leakage of insulin, blockage of needles 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, follow 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 after each injection and store the syringe pen with the needle disconnected. This will prevent infection, infection, leakage of insulin, blockage of needles 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, use the dose counter: rotate the dose selector until the dose counter stops. If the dose counter shows a figure of 80, this means that at least 80 units of insulin remains in the syringe pen. If the dose counter shows less than 80, this means that in the syringe pen there was exactly that amount of insulin ED that was displayed on the dose counter. 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. One must be very careful when calculating the remainder of the necessary dose of insulin. If there is any doubt, it is better to enter a full dose of insulin with a new syringe pen. If the patient makes a mistake in the calculations, he can introduce an insufficient or too large a dose of insulin. This can lead to the fact that the concentration of glucose in the blood will become too high or too low.

Important information. 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. Never transfer your syringe pen and needle to it to others. This can lead to cross infection. Never transfer your syringe pen to others. This can damage their health.

Persons caring for the patient should handle the used needles with extreme caution in order to avoid accidental injections and cross infection.

Care of the syringe pen

With a syringe handle, handle gently. Negligent or improper handling may cause an incorrect dosage, which can lead to too high or too low a concentration of glucose in the blood. 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 dust, contaminants and all kinds of liquids. 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 has dropped the syringe pen or doubts that it is working properly, a new needle should be attached and insulin intake checked before the injection.

Do not refill the syringe pen. Empty syringe pen must be discarded. Do not attempt to repair the syringe pen by itself or dismantle it.

Overdose

Symptoms: A certain dose required for an insulin overdose has not been established, however hypoglycemia may 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 only enter Medical worker.) It is also necessary to inject dextrose intravenously into the IV, if the patient does not regain consciousness 10-15 minutes after the introduction of glucagon. After restoring consciousness, the patient is recommended to take food rich in carbohydrates to prevent relapse of hypoglycemia.

special instructions

Hypoglycemia. Skipping meals or unplanned intensive physical activity can lead to the development of hypoglycemia. Hypoglycemia can develop if the dose of insulin is too high in relation to the patient's need (see "Side effects" and "Overdose"). 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 the use of other basal insulin preparations or preparations with a basal component, recovery from hypoglycemia with the use of Ryzodeg® FlexTouch® can be delayed.

Hyperglycemia. For the treatment of severe hyperglycemia, it is recommended that rapid insulin be administered. An insufficient dose of the drug and / or discontinuation of treatment in patients who require insulin can lead to the development of hyperglycemia and potentially to diabetic ketoacidosis. In addition, concomitant diseases, especially infectious diseases, can promote the development of hyperglycemic conditions and, thus, 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, frequent urination, nausea, vomiting, drowsiness, redness and dryness of the skin, dry mouth, loss of appetite, smell of acetone in the exhaled air. In type 1 diabetes mellitus, without appropriate treatment, hyperglycemia leads to the development of diabetic ketoacidosis, a condition that is potentially lethal.

Transfer of the patient from other insulin preparations. Transfer of the 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 developing chronic heart failure. This fact should be taken into account in the appointment of patients with combined therapy with thiazolidinediones and Rizodeg® FlexTouch® preparation.

In the appointment of such combination therapy, it is necessary to conduct medical examinations of patients to identify signs and symptoms of chronic heart failure, increase in body weight 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 each label before each injection to avoid accidental mixing of the preparation Ryzodeg® FlexTouch® with other insulin preparations.

Patients should check the dose on the injector dose counter. Therefore, only patients who can clearly distinguish the numbers on the dose counter of the syringe-pen can inject insulin themselves.

It is necessary to inform visually impaired or visually impaired people that they always need help from those who do not have vision problems and are trained to work with the injector.

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 especially needed (for example, when driving vehicles or working with 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 with 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. 3 ml in cartridges of glass 1 of hydrolytic class, sealed with stoppers with disks 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. 5 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 a temperature of 2 to 8 ° C (in the refrigerator). Use within 4 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.