Active substanceInsulin degludec + Insulin aspartInsulin degludec + Insulin aspart
Similar drugsTo uncover
  • Rhizodeq® Penphill®
    solution PC 
    Novo Nordisk A / S     Denmark
  • Rizodeq® FlexTech®
    solution PC 
    Novo Nordisk A / S     Denmark
  • Dosage form: & nbsphypodermic solution
    Composition:

    In 1 ml of the drug contains:

    active substance: 100 units of insulin degludec / insulin aspart in a ratio of 70/30 (equivalent to 2.56 mg insulin degludec / 1.05 insulin aspart);

    Excipients: glycerol 19.0 mg, phenol 1.5 mg, metacresol 1.72 mg, zinc 27.4 μg (as zinc acetate 92.0 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.

    One syringe pen contains 3 ml of a solution equivalent to 300 units.

    One unit of insulin Raizodeg® contains 0.0256 mg of anhydrous insolide deglucose and 0.0105 mg of anhydrous salt-free insulin aspart.

    One unit of insulin Raizodeg® (ED) corresponds to one international unit (ME) of human insulin, one unit of insulin glargine, one unit of insulin detemir, or one unit of two-phase insulin aspart.

    Description:

    A clear, colorless solution.

    Pharmacotherapeutic group:hypoglycemic agent - a combination of insulin analogues of medium duration or long and short action
    ATX: & nbsp

    A.10.A.D.06   Insulin degludec and insulin aspart

    Pharmacodynamics:

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

    Insulin Degloodec and insulin aspart specifically bind to the human endogenous insulin receptor and, interacting with it, realize their pharmacological effect similarly to the effect of human insulin. The hypoglycemic action 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 Rhizodeg® FlexTach® differ distinctly (Fig. 1) and the overall profile of the action of the preparation reflects the profiles of the action of the individual components: high-speed insulin aspart and insulin degludec of long-acting action.

    The basal component of the preparation Raizodeg® Flex Tach®, which has an extremely long-acting effect (insulin degluedek) After subcutaneous injection of soluble forms multigeksamery in the subcutaneous depot, from which there is a continuous slow degludek delivery of insulin into the circulation, providing a flat profile of action 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.

    Rayzodeg® FleksTach® drug takes effect quickly, providing prandial insulin needs shortly after the injection, whereas the basal component has a flat, stable and extremely long profile of action, which provides a basal insulin requirement. The duration of a single dose of Raizodeg® FlexTech® is more than 24 hours.

    See Figure 1. Average profile of glucose infusion rate - equilibrium concentration of the preparation Raizodeg® after the administration of a single dose of 0.8 U / kg for type 1 diabetes mellitus (study 3539).

    A linear relationship between an increase in the dose of Raizodeg® FlexTech® and its overall and maximum hypoglycemic effect was demonstrated.The equilibrium concentration of the preparation Raizodeg® FlexTech® is achieved after 2-3 days of the drug administration.

    Differences in the pharmacodynamics of Raizodeg® FlexTech® 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 the Raizodeg® preparation were conducted in the Treatment to Goal mode for 26 or 52 weeks with the participation of 1360 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 Raizodeg® in combination with oral hypoglycemic drugs (PGHP) and single administration of insulin glargine in combination with PGHP in patients with type 2 diabetes have been conducted. The administration of Raizodeq® twice a day in combination with PGHP was compared with the administration of biphasic insulin aspart 30 twice a day in combination with PGHP in two studies in patients with type 2 diabetes mellitus. The administration of Raizodeq® once a day in combination with insulin aspart was also compared with the administration of insulin detirim once or twice a day in combination with insulin aspart in patients with type 1 diabetes.

    The lack of superiority of the comparative drugs over the preparation Raizodeg® with respect to the decrease in the HbA1C in all studies in the treatment of patients to the goal.

    In patients with type 2 diabetes mellitus who never received insulin therapy and patients who had previously received insulin therapy, Rhizodeg® in combination with PGHP provides similar glycemic control compared to insulin glargine. Raizodeg® provides superior prandial glycemic control compared to insulin glargine with a lower incidence of nocturnal hypoglycemia (defined as episodes of hypoglycemia occurring between 0 and 6 am, confirmed by measuring plasma glucose concentrations below 3.1 mmol / L or by evidence The fact that the patient required the help of third parties).

    The introduction of Raizodeg® twice daily provides a similar glycemic control (HbA1c) in comparison with the two-phase insulin aspart 30, which was also administered twice a day. The drug Raizodeg® provides the best positive dynamics in reducing fasting plasma glucose.With the use of Raizodeg®, the target blood plasma glucose values ​​of 5 mmol / L were achieved more quickly in patients than in patients treated with biphasic insulin aspart 30. The drug Raizodeg® less often causes hypoglycemia (including nocturnal).

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

    According to the meta-analysis data of two 26-week open-label studies planned for patients with type 2 diabetes, Rizodeq®, administered twice a day, showed a lower incidence of episodes of confirmed hypoglycemia in general (Figure 2) and episodes of confirmed nocturnal hypoglycemia (Figure 3) compared with the two-phase insulin aspart 30. Results showed that the preparation Raizodeg® lowers plasma glucose concentration in the fasting plasma with less risk of hypoglue kemy both during study and in maintenance doses from 16 weeks (Table 1).

    Table 1. Results of meta-analysis of data on episodes of confirmed hypoglycemia when administered twice a day during the study and during the maintenance of the dose from week 16

    Analyzes

    Established relative frequency [95% CI] study period

    Established relative frequency [95% CI] dosing period

    The total number of confirmed hypoglycemia preparation Raizodeg® (2 times a day) / biphasic insulin aspart 30 (2 times a day)

    0,81

    0,69

    [0,67; 0,98]

    [0,55; 0,87]

    Nocturnal confirmed hypoglycemia preparation Raizodeg® (2 times a day) / biphasic insulin aspart 30 (2 times a day)

    0,43

    0,38

    [0,31; 0,59]

    [0,25; 0,58]

    See Figure 2. The confirmed episodes of hypoglycemia are Raizodeg® (2 times a day) as compared to the two-phase insulin aspart 30 (2 times a day), in terms of cumulative function for two 26-week, open-label studies designed to "treat to the target" in patients with type 2 diabetes mellitus

    See Figure 3. Nocturnal confirmed episodes of hypoglycemia Rizodeg® (2 times a day) in comparison with biphasic insulin aspart 30 (2 times a day), in the value of cumulative function during two 26-week, open-label studies designed according to the "treat to the target" principle patients with type 2 diabetes mellitus.

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

    Pharmacokinetics:

    Absorption

    After subcutaneous injection, the formation of soluble stable multi-hexamers insulin degludec, which create a depot of insulin in the subcutaneous tissue, while not hindering the rapid release of insulin aspart monomers into the bloodstream. Multiexameres gradually dissociate, releasing insulin degludec monomers, resulting in a slow continuous flow of the drug into the blood. The equilibrium concentration of the ultra-long-acting (insulin degludec) component in blood plasma is achieved 2-3 days after the administration of the Raizodeg® preparation.

    Well-known indicators of the rapid absorption of insulin aspart are preserved in the preparation Raizodeg®. The pharmacokinetic profile of insulin aspart appears 14 minutes after the injection, the maximum concentration 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.In 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 formed metabolites are inactive.

    Excretion

    The half-life of Raizodeg® after subcutaneous injection is determined by the rate of its absorption from the subcutaneous tissue. The half-life of insulin degludec is approximately 25 hours and does not depend on the dose.

    Linearity

    The total effect of the preparation Raizodeg® is proportional to the administered dose of the basal component (insulin degludec) 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 Raizodeg® in dependence from the sex of 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 Raizodeg® between elderly and young patients, between patients of different ethnic groups, between patients with impaired renal and hepatic function and healthy patients.

    Children and teens

    The pharmacokinetic properties of Raizodeg® in studies in children (6-11 years) and adolescents (12-18 years) with type 1 diabetes are comparable to those in adult patients with a single injection.

    The total concentration and maximum concentration 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 are comparable to those in adult patients. Against the background of a single administration to patients with diabetes mellitus type 1 of insulin degludec dose 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 degludec 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.

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

    Pregnancy and lactation:Pregnancy

    Application of the drug Rhizodeg® FlexTach® is contraindicated during pregnancy, since there is no clinical experience with its use during pregnancy. Studies of reproductive function in animals showed no difference between insulin degludec and human insulin in terms of embryotoxicity and teratogenicity.

    Breastfeeding period

    Application of the drug Raizodeg® FlexTach® is contraindicated during breastfeeding, as there is no clinical experience with its use in lactating women.

    Studies in animals have shown that in rats insulin degluedek 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 degluedek with breast milk of women.

    Fertility

    In studies on animals, there was no adverse effect of insulin degludec on fertility.

    Dosing and Administration:

    The preparation Rhizodeg® FlexTech® is a combination of soluble insulin analogs - basal insulin of super long-acting action (insulin degluedek) and rapid-acting prandial insulin (insulin aspart).

    The drug is administered subcutaneously 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.

    In patients with type 2 diabetes mellitus, the preparation Rhizodeg® FlexTech® can be used either as monotherapy or in combination with PGHP or bolus insulin.

    Patients with type 1 diabetes mellitus are prescribed Rhizodeg® Flex Tach® in combination with short / ultrashort insulin before other meals.

    The dose of Rhizodeg® FlexTech® 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, correction of the dose of the drug may be required with increased physical activity of the patient, a change in his usual diet or with concomitant disease.

    The initial dose of Raizodeg® FlexTech®

    Patients with type 2 diabetes mellitus

    The recommended initial daily dose of Raizodeg® FlexTech® 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 Raizodeg® FlexTech® is 60-70% of the total daily insulin requirement.

    The preparation of Rhizodeg® FlexTech® is prescribed once a day during the main meal in combination with fast / short insulin injected 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 in the first weeks of the appointment of the new drug. It may be necessary to correct the 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 who receive basal insulin therapy or biphasic insulin therapy once a day, the dose of Raizodeg® FlexTech® should be calculated on a unit-by-unit basis from the total daily insulin dose that the patient received before switching 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 Raizodeg® FlexTech® should be calculated on the basis of the "unit per unit" principle, with a two-fold introduction of Raizodeg® FlexTech® 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 baseline-bolus insulin regimen, the dose of Raizodeg® FlexTech® should be calculated based on 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 Raizodeg® FlexTech® is 60-70% of the total daily insulin requirement in combination with short / ultrashort insulinactions with other meals and the subsequent selection of an individual dose of the drug.

    Flexible dosing regimen

    The time of administration of the preparation Rhizodeg® FlexTach® can be changed if the time of the main meal changes.

    If the dose of Raizodeg® FlexTech® is missed, the patient may enter the next dose on the same day with the next main meal, and then return to his usual injection time. Do not administer an additional dose to compensate for the missed dose.

    Special patient groups

    Patients of advanced age (over 65 years)

    The drug Rhizodeg® FlexTech® can be used in elderly patients. You should carefully monitor the concentration of blood glucose and adjust the dose of insulin individually (see section "Pharmacokinetics ").

    Patients with kidney and liver failure

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

    Children and teens

    Existing pharmacokinetic data are presented in subsection Pharmacokinetics, However, the efficacy and safety of Raizodeg® FlexTech® in children and adolescents under the age of 18 have not been studied, and recommendations for the dose of the drug in children have not been developed.

    Mode of application

    The preparation Rhizodeg® FlexTech® is intended only for subcutaneous administration.

    The drug Raizodeg® FlexTech® can not be administered intravenously, as this can lead to the development of severe hypoglycemia. The preparation of Rhizodeg® FlexTech® can not be administered intramuscularly, since in this case the absorption of the drug changes.

    The preparation Rhizodeg® FlexTech® can not be used in insulin pumps.

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

    The FlexShip® pen is designed for use with Novoin® or NovoTvist® disposable needles. FlexTach ® allows you to enter doses from 1 to 80 units in steps of 1 unit.

    Side effects:

    The most common side effect reported during treatment is hypoglycemia (see below). 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 / 1,000 to <1/100); rarely (≥1 / 10,000 to <1/1000), very rarely (<1/10 000) and unknown (impossible to estimate based on available data).

    Immune system disorders

    Rarely - Hypersensitivity reactions

    Rarely - Hives

    Disorders from the metabolism and nutrition

    Often - Hypoglycaemia

    Disturbances from the skin and subcutaneous tissues

    Infrequently - Lipodystrophy

    General disorders and disorders at the site of administration

    Often - Reactions at the site of administration

    Infrequently - Peripheral edema

    Description of individual adverse reactions

    Immune system disorders

    With the use of insulin preparations, it is possible to develop allergic reactions. Allergic reactions of immediate type to insulin or ancillary components that make up the drug may potentially threaten the patient's life.

    When Rhizodeg® FlexTech® was used, hypersensitivity reactions (including edema of the tongue or lips, diarrhea, nausea, fatigue and pruritus) and hives were rarely noted.

    Hypoglycaemia

    Hypoglycemia 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 impairment of brain function up to a lethal outcome. Symptoms of hypoglycemia, as a rule, develop suddenly. They include cold sweats, paleness of the skin, increased fatigue, nervousness or tremor, anxiety, unusual fatigue or weakness, disorientation, decreased concentration, drowsiness, severe hunger, visual impairment, headache, nausea, palpitations.

    Lipodystrophy

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

    Reactions at the site of administration

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

    Children and teens

    The pharmacokinetic properties of the drug Rayzodeg® FleksTach® been studied in children and adolescents under 18 years of age (see. Subpart Pharmacokinetics). Studies of efficacy and safety in children and adolescents have not been conducted.

    Special patient groups

    In clinical trials, no difference in frequency, type, or severity of adverse reactions between patients elderly, patients with impaired renal or hepatic function and the general population of patients was not revealed.

    Overdose:

    A certain dose necessary for an insulin overdose has not been established, however hypoglycemia can develop gradually if the dose of the drug has been too high in comparison with the patient's need (see "Special instructions").

    Light 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 hypoglycemiawhen the patient is unconscious, he should enter glucagon (from 0.5 to 1 mg) intramuscularly or subcutaneously (can be administered by a trained person), or intravenously a solution of dextrose (glucose) (can be administered only by a medical professional). It is also necessary to inject dextrose intravenously in the case if the patient does not regain consciousness 10 to 15 minutes after the administration of glucagon. After restoration of consciousness, the patient is recommended to take food rich in carbohydrates, to prevent the recurrence of hypoglycemia.

    Interaction:

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

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

    The need for insulin can increase: oral hormonal contraceptives, thiazide diuretics, glucocorticosteroids, 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 can both enhance and reduce the hypoglycemic effect of insulin.

    Incompatibility

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

    Do not add Rezodega® FlexTech® to infusion solutions.

    Do not mix this drug with other medications.

    Special instructions:

    Hypoglycaemia

    If you miss a meal or an unplanned intensive physical exertion, the patient may develop hypoglycemia. Hypoglycemia can also develop if the insulin dose is too high in relation to the patient's need (see "Side effect" and "Overdose").

    After the compensation of carbohydrate metabolism (for example, with intensified insulin therapy), the symptoms typical for them-precursors of hypoglycemia may 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 drugs with a basal component, recovery from hypoglycemia with the use of Raizodeg® FlexTech® can be delayed.

    Hyperglycaemia

    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 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.

    The simultaneous use of drugs of the thiazolidinedione group and insulin preparations

    Cases of chronic heart failure 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 when appointing patients combination therapy with thiazolidinediones and Rizodeq® FlexTech® 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.

    Disturbances on the part 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 accidentally mistaking the preparation Rhizodeg® FlexTech® with other insulin preparations.

    Patients should check the dose on the injector dose counter.

    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 a dose adjustment of insulin to prevent cases of hyperglycemia or hypoglycemia.

    Instructions for use

    The pre-filled Rhizodeg® Flex-Tach® pen has been developed for use with NovoFine® or NovoTvist® needles up to 8 mm in length. Rizodeg® FlexTech® allows the administration of doses ranging from 1 to 80 units in 1-step increments. Follow the detailed instructions contained in the attached instructions for the use of the FlexShack® syringe pen.

    Rhizodeg® FlexTech® 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.

    Discard the needle after each injection.

    Instructions for patients on the use of the drug Rizodeq® FlexTech®

    Read this manual carefully before using the pre-filled Rhizodeg® FlexTech® syringe pen.

    Use a syringe pen only after you learn to use it under the guidance of a doctor or nurse. Check the label on the label of the pen syringe to make sure it contains the Rhizodeg® FlexTech® 100 U / ml preparation, and then carefully examine the illustrations below, which show the details of the syringe pen and needle.

    If you are visually impaired or you have serious vision problems and you can not distinguish the numbers on the dose counter, do not use a syringe pen without help. You can be helped by a person without visual impairment, trained in the correct use of a pre-filled Flex-Tach® pen. Rhizodeg® FlexTech® is a pre-filled syringe pen containing 300 units of insulin. The maximum dose that you can set is 80 units in 1-step increments. The Rhizodeg® 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

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

    Rhizodeg® FlexTech® and the needle (see Figure 4 for an example)

    1. Preparing the syringe pen for use

    A.

    - Check the name and dosage on the label of the syringe pen to make sure that it contains the preparation Rhizodeg® Flex Tach® 100 U / ml. This is especially important if you use insulin preparations of different types.

    - Remove the cap from the syringe pen.

    AT.

    - Make sure that the insulin solution in the syringe pen is clear and colorless. Look at the scale of the insulin balance. If the insulin solution is cloudy, the syringe pen can not be used.

    FROM.

    - 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 handle.

    - Remove the outer cap of the needle, but do not throw it away.

    You will need it after the injection is completed to safely remove the needle.

    F.

    - Remove and discard the inner needle cap. To avoid accidental pricks, do not try to put the inner cap back on the needle (see Figure 5 A-F).

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

    (!) For each injection, use a new needle to avoid clogging the needle, infecting, infecting and injecting the wrong dose of the drug.

    (!) Never use the needle if it is bent or damaged.

    2. Insulin intake check

    A.

    - Before each injection, check the intake of insulin, so you can be sure that the dose of insulin is introduced completely.

    - Dial 2 units of the drug by turning the dose selector. Make sure that the dose counter shows "2".

    AT.

    - Holding the syringe handle with the needle upwards, tap the upper part of the syringe handle several times with the tip of the finger, so that the air bubbles move upwards.

    FROM.

    - 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, a drop of insulin should appear (see Figure 6A, B, C).

    Sometimes a small air bubble may remain at the end of the needle, but it will not be injected.

    If a drop of insulin does not appear at the end of the needle, repeat steps 2A to 2C, but no more than 6 times. If a drop of insulin did not appear, change the needle and repeat operations 2A - 2C again.

    (!) Do not use a syringe pen if a drop of insulin at the end of the needle has not appeared.

    (!) Before each injection, make sure that a drop of insulin appears on the tip of the needle. If a drop of insulin does not appear, the dose will not be given, even if the dose counter moves.

    3. Setting the dose

    A.

    - Before starting the injection, make sure that the dose counter is set to "0".

    "0" should stand in front of the dose indicator.

    - Rotate the dose selector set the dose assigned by the doctor.

    If you have set the wrong dose, you can turn the dose selector forwards or backwards until the correct dose is set. The maximum dose that you can set is 80 units (see Figure 7A).

    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 you can set is 80 units. If the insulin residue in the syringe pen is less than 80 units, the dose counter will stop on the number of units of insulin 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 number of units of insulin remaining in the syringe pen). Do not count these clicks.

    (!) Before each injection, check how many units of insulin you have typed on the dose counter and dose indicator.

    Do not set the dose by the number of clicks.

    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.

    4. Introduction of insulin

    A.

    - Insert the needle under the skin using the injection technique recommended by the doctor.

    - Make sure that the dose counter is in your field of vision.

    Do not touch the dose counter with your fingers - this may interrupt the injection.

    - Press the start button all the way down and hold it in this position until the dose counter shows "0".

    "0" must be exactly opposite the dose indicator. You 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 (see Figure 8A).

    AT.

    - Remove the needle from under the skin by pulling the syringe handle upwards (see Figure 8B).

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

    After the injection is complete, you can see a drop of insulin at the end of the needle.

    This is normal and does not affect the dose of the drug you entered.

    (!) Always check with the dose counter to know how many insulin units you have entered.

    Do not count the number of clicks. The dose counter will show the exact number of units.

    5. After the injection is completed

    A.

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

    AT.

    - When the needle enters the cap, carefully put on the cap.

    - Unscrew the needle. Throw out the needle, observing the precautionary measures.

    FROM.

    - After each injection, put a cap on the syringe pen to protect the insulin contained in it from exposure to light (see Fig. 9 A, B, C).

    Discard the needle after each injection, this will ensure a comfortable injection of insulin and prevent clogging of the needle. If the needle is clogged, you can not 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.

    (!) To avoid accidental pricking with a needle, never try to put the inner cap back on the needle.

    (!) Remove the needle after each injection.

    This will prevent clogging of the needle, infection, infection, leakage of insulin from the syringe pen and incorrect dosing.

    6. How much insulin is left?

    A.

    - The scale of the insulin residue shows an approximate amount of insulin,left in the syringe-pen.

    AT.

    - To find out how much insulin remains in your syringe pen, use the dose counter (see Figure 10A, B).

    Rotate the dose selector until the dose counter stops.

    If the dose counter shows a figure of 80, this means that at least 80 insulin units remain in the syringe pen.

    If the dose counter shows less than 80, 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.

    (!) Be very careful when calculating the remainder of the insulin dose you need to prevent an error.

    If you have doubts, better enter a full dose of insulin with a new syringe pen.

    (!) 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 give your syringe pen and needle to it to others.

    - Persons caring for the patient should handle the used needles with extreme care to avoid accidental injections and infection.

    Care of the syringe pen

    - 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 on it dust, dirt 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 you drop a syringe pen or doubt its serviceability, attach a new needle and check the intake of insulin before you inject.

    - Do not refill the syringe pen. Do not reuse an empty syringe pen.

    - Do not attempt to repair the syringe pen by itself or dismantle it.

    Effect on the ability to drive transp. cf. and fur:

    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 necessary (for example, in the management of 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 absence or reduction in the severity of symptoms-harbingers of developing hypoglycemia or frequent episodes of hypoglycaemia. In these cases, the desirability of driving a vehicle should be considered.

    Form release / dosage:Solution for subcutaneous administration, 100 units / ml.
    Packaging:

    In pre-filled FlexTech® syringes.

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

    5 multi-dose disposable syringes with instructions for use in a cardboard pack.

    Storage conditions:

    Store at a temperature of 2 to 8 ° C (in the refrigerator), but not next to the freezer. Do not freeze.

    For the used or portable as a spare syringe pen with the drug: do not store in the refrigerator. Store at a temperature not youwe 30 ° C for 4 weeks. After use, cover the syringe handle with a cap to protect it from light.

    Keep out of the reach of children.

    Shelf life:

    30 months.

    Do not use after expiry date.

    Terms of leave from pharmacies:On prescription
    Registration number:LP-002315
    Date of registration:27.11.2013
    Date of cancellation:2018-11-27
    The owner of the registration certificate:Novo Nordisk A / SNovo Nordisk A / S Denmark
    Manufacturer: & nbsp
    Representation: & nbspNOVO NORDISK TOVNOVO NORDISK TOVDenmark
    Information update date: & nbsp25.10.2015
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