Apidra® (Apidra®)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substanceInsulin GlulisinInsulin Glulisin
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  • Apidra®
    solution PC 
    Sanofi-Aventis Deutschland GmbH     Germany
  • Apidra® SoloStar®
    solution PC 
    Sanofi-Aventis Deutschland GmbH     Germany
    • Dosage form: & nbsphypodermic solution
    Composition:

    1 ml of the solution contains:

    active substance: insulin glulisine 100 ED (3.49 mg);

    Excipients: m-cresol 3.15 mg, tromethamol (tromethamine) 6.0 mg, sodium chloride 5.0 mg, polysorbate 20 0.01 mg, sodium hydroxide to pH 7.3, hydrochloric acid to pH 7.3, water for injection up to 1.0 ml.

    Description:

    Transparent colorless liquid.

    Pharmacotherapeutic group:hypoglycemic agent - short-acting insulin analog
    ATX: & nbsp

    A.10.A.B.06   Insulin Glulisin

    Pharmacodynamics:

    Insulin glulisin is a recombinant analog of human insulin, which by force of action is equal to the usual human insulin. After subcutaneous administration insulin glulisin begins to act faster and has a shorter duration of action than soluble human insulin.

    The most important action of insulin and insulin analogues, including insulin glulisin, is the regulation of glucose metabolism. Insulin reduces the concentration of glucose in the blood, stimulating the absorption of glucose by peripheral tissues, especially skeletal muscle and fat tissue, and also inhibiting the formation of glucose in the liver.Insulin inhibits lipolysis in adipocytes, suppresses proteolysis and increases protein synthesis.

    Studies conducted in healthy volunteers and patients with diabetes showed that with subcutaneous injection insulin glulisin begins to act faster and has a shorter duration of action than soluble human insulin. With subcutaneous administration, the lowering of the glucose concentration in the blood, the effect of glulisin insulin begins in 10-20 minutes. With intravenous administration, the effects of reducing blood glucose in the blood of insulin glulisin and soluble human insulin are equal in strength. One unit of glulisin insulin has the same glucose-lowering activity as one unit of soluble human insulin.

    In the Phase I study, in patients with type 1 diabetes mellitus, glucose-lowering profiles of insulin glulisin and soluble human insulin administered subcutaneously at a dose of 0.15 U / kg at different times with respect to the standard 15-minute meal were evaluated. The results of the study showed that insulin glulisin introduced 2 minutes before meals provided the same glycemic control after eating as soluble human insulin, administered 30 minutes before meals.When administered 2 min before meals insulin glulisin provided better glycemic control after eating than soluble human insulin, administered 2 minutes before meals.

    Insulin glulisine, administered 15 minutes after the start of food intake, gave the same glycemic control after meals as the soluble human insulin administered 2 minutes before meals.

    Phase I study with insulin glulisin, insulin lispro and soluble human insulin in a group of obese patients showed that in these patients insulin glulisin retains its fast-response characteristics. In this study, the time to reach 20% of the total AUC was 114 min for glulisin insulin, 121 min for insulin lispro and 150 min for soluble human insulin, a AUC(0-2H), reflecting also the early glucose-lowering activity, respectively, was 427 mg / kg for insulin glulisin, 354 mg / kg for insulin lispro, and 197 mg / kg for soluble human insulin.

    Clinical researches

    Type 1 diabetes mellitus

    In a 26-week Phase III clinical trial,in which a comparison was made between glulisin insulin and insulin lizpro, administered subcutaneously shortly before meals (0-15 min) in patients with type 1 diabetes mellitus using basal insulin insulin glargine, insulin glulisin was comparable with insulin lizpro for glycemic control, which was estimated from a change in the concentration of glycosylated hemoglobin (HBA1c) at the time of the endpoint of the study compared with the outcome. Comparable values ​​of blood glucose concentration determined by self-monitoring were observed. With the introduction of insulin glulisine, unlike the treatment with insulin lyspro, did not require an increase in the dose of basal insulin.

    A 12-week clinical phase III study conducted in patients with type 1 diabetes who received basal therapy insulin glargine, showed that the effectiveness of insulin glulisin immediately after meals was comparable to that of insulin glulisin just before meals (0-15 min) or soluble human insulin (30-45 min before meals).

    In the population of patients who completed the study protocol, in the group of patients who received food before meals insulin glulisin, a significantly greater decrease was observed HbA1C compared with the group of patients receiving soluble human insulin.

    Diabetes mellitus type 2

    A 26-week phase III clinical trial followed by a 26-week follow-up as a safety study was conducted to compare glulisin insulin (0-15 minutes before meals) with soluble human insulin (30-45 minutes before meals), which were administered subcutaneously in patients with type 2 diabetes, except for using insulin-isophane as a basal insulin. The average body mass index of patients was 34.55 kg /m2. Insulin Glulisin proved to be comparable to soluble human insulin with respect to changes in concentration HbA1C after 6 months of treatment compared to the baseline (-0.46% for glulisin insulin and -0.30% for soluble human insulin, p = 0.0029) and after 12 months of treatment compared with baseline (-0.23 % for insulin glulisin and - 0.13% for soluble human insulin, the difference is not reliable). In this study, the majority of patients (79%) mixed their short-acting insulin with insulin-isophane immediately before injection.58 patients at the time of randomisation used oral hypoglycemic drugs and received instructions to continue their admission at the same (unchanged) dose.

    For continuous subcutaneous insulin infusion with a pump device (for type 1 diabetes), 59 patients treated with Apidra® or insulin aspart in both treatment groups had a low incidence of occlusion of the catheter (0.08 occlusions per month with Apidra® and 0.15 occlusions per month with the use of insulin aspart), and a similar frequency of reactions at the site of administration (10.3% with Apidra® and 13.3% with insulin aspart).

    In children and adolescents with type 1 diabetes mellitus, who received basal insulin once a day at night insulin glargine or twice daily in the morning and evening of insulin-isophane, when comparing the efficacy and safety of insulin-treated glulisin and insulin lispro with their subcutaneous administration 15 minutes before meals, it was shown that glycemic control, the incidence of hypoglycemia requiring third-party intervention, and and the incidence of severe hypoglycemic episodes were comparable in both treatment groups.However, after 26 weeks of treatment, patients who received insulin glulisin treatment to achieve glycemic control comparable to insulin lyspro required a significantly smaller increase in daily doses of basal insulin, fast acting insulin and total insulin dose.

    Racial origin and gender

    In controlled clinical studies in adults, there was no difference in the safety and efficacy of glulisin insulin in the analysis of subgroups isolated by race.

    Pharmacokinetics:

    In insulin glulisine, the substitution of the amino acid asparagine of human insulin at position B3 for lysine and lysine at position B29 for glutamic acid promotes faster absorption.

    Absorption and bioavailability

    The pharmacokinetic concentration-time curves in healthy volunteers and patients with type 1 and type 2 diabetes demonstrated that the absorption of glulisin insulin compared to soluble human insulin was approximately 2 times faster, and the maximum plasma concentration achieved (CmOh) was approximately 2 times greater.

    In a study conducted in patients with type 1 diabetes, after subcutaneous administration of insulin glulisin at a dose of 0.15 U / kg, TmOh (the time of the maximum plasma concentration) was 55 minutes, and CmOh was 82 ± 1.3 μED / ml compared to TmOh, which is 82 minutes, and CmOh, which is 46 ± 1.3 μED / ml, for soluble human insulin. The average residence time in the systemic circulation of glulisin insulin was shorter (98 minutes) than that of soluble human insulin (161 minutes).

    In a study in patients with type 2 diabetes mellitus after subcutaneous administration of insulin glulisin at a dose of 0.2 U / kg CmOh was 91 μED / ml with interquartile latitude from 78 to 104 μDU / ml.

    With subcutaneous administration of glulisin insulin to the anterior abdominal wall, hip or shoulder region (to the deltoid muscle region), absorption was faster when injected into the anterior abdominal wall area as compared with the administration of the drug to the thigh area. The rate of absorption from the deltoid muscle region was intermediate. The absolute bioavailability of glulisin insulin after subcutaneous administration was approximately 70% (73% of the region of the anterior abdominal wall,71 of the deltoid muscle region and 68% of the hip area) and had low variability in different patients.

    Distribution and deduction

    The distribution and excretion of insulin glulisin and soluble human insulin after intravenous administration are similar, with distribution volumes of 13 liters and 21 liters and half-lives of 13 and 17 minutes, respectively.

    After subcutaneous administration insulin glulisin is excreted faster than soluble human insulin, with an apparent half-life of 42 minutes, compared to an apparent half-life of soluble human insulin of 86 minutes. In a cross-sectional analysis of studies of insulin glulisin, both in healthy individuals and in individuals with type 1 and type 2 diabetes, the apparent half-life was in the range of 37 to 75 minutes.

    Special patient groups

    - Patients with renal insufficiency

    In a clinical study conducted in individuals without diabetes mellitus with a wide range of renal functional status (creatinine clearance> 80 ml / min, 30-50 ml / min, <30 ml / min), the overall rapidity of the insulin glulisin effect persisted .However, the need for insulin in the presence of renal insufficiency can be reduced.

    - Patients with hepatic insufficiency

    In patients with impaired hepatic function, pharmacokinetic parameters were not studied.

    - Elderly people

    There are very limited data on the pharmacokinetics of insulin glulisin in patients with advanced diabetes mellitus.

    - Children and teens

    Pharmacokinetic and pharmacodynamic properties of glulisin insulin have been studied in children (7-11 years) and adolescents (12-16 years old) with type 1 diabetes mellitus. In both age groups insulin glulisin quickly absorbed with TmOh and CmOh similar to those in adults (healthy volunteers and patients with type 1 diabetes mellitus). As in adults when administered immediately before a meal test insulin glulisin provides better control of blood glucose after eating than soluble human insulin. Increased blood glucose after eating (AUC0-6 hours the area under the curve "blood glucose concentration-time" from 0 to 6 hours) was 641 mg / (h * dL) for insulin glulisin and 801 mg / (h * dl) for soluble human insulin.

    Indications:

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

    Contraindications:

    Hypersensitivity to insulin glulisin or to any of the components of the drug.

    Hypoglycemia.

    Carefully:

    During pregnancy.

    Pregnancy and lactation:

    Pregnancy

    There are no controlled clinical studies on the use of the drug Apidra® in pregnant women. A limited amount of data obtained from the use of glulisin insulin in pregnant women (reported less than 300 pregnancies) does not indicate its adverse effect on pregnancy, intrauterine fetal development, or on a newborn baby. Reproductive studies in animals have not revealed any differences between insulin glulisin and human insulin with respect to pregnancy, fetal / fetal development, childbirth and postnatal development.

    Use of the drug Apidra® SoloStar® in pregnant women should be done with caution. A careful monitoring of the concentration of glucose in the blood and the maintenance of glycemic control are mandatory.

    Patients with pre-pregnancy or gestational diabetes mellitus need to maintain glycemic control throughout their entire pregnancy. During the first trimester of pregnancy, the need for insulin can decrease, and during the second and third trimesters, it can usually increase. Immediately after delivery, the need for insulin rapidly decreases.

    Breastfeeding period

    Unknown, excreted or not insulin glulisin in breast milk. Women in the period of breastfeeding may need to adjust the dosage regimen of insulin and diet.

    Dosing and Administration:

    Apidra® should be administered shortly (0-15 minutes) before or shortly after meals.

    The drug Apidra® should be used in treatment regimens that include either medium-term insulin or long-acting insulin or a long-acting insulin analogue. In addition, the preparation of Apidra® can be used in combination with oral hypoglycemic drugs.

    Dosing regimen of the drug Apidra® is selected individually.

    Administration of the drug

    Apidra® is intended for subcutaneous injection or continuous subcutaneous insulin infusion with a pump device suitable for the administration of insulin.

    Subcutaneous injections of the drug Apidra® should be performed in the area of ​​the anterior abdominal wall, shoulder or thigh, and the administration of the drug by continuous subcutaneous infusion is performed in the area of ​​the anterior abdominal wall. The injection sites within the above-mentioned areas and the place of continuous subcutaneous infusion should alternate with each new administration of the drug. The absorption rate and, correspondingly, the beginning and duration of the action can be influenced by: the site of injection, physical stress and other changing conditions. Subcutaneous injection into the anterior abdominal wall provides for a somewhat faster absorption than administration to the other abovementioned parts of the body (see Pharmacokinetics section).

    Precautions should be taken to ensure that the preparation does not enter the blood vessels directly. After the administration of the drug, massage of the area of ​​administration can not be performed. Patients should be trained in the correct technique of injection.

    Mixing with insulin for subcutaneous injection

    The drug Apidra® can be mixed with human insulin-isophane.

    When mixing the drug Apidra® with human insulin-isophane, the Apidra® preparation must be injected into the syringe first. Subcutaneous injection should be performed immediately after mixing.

    Mixed above insulin can not be administered intravenously.

    Application of the drug Apidra® with a pump device for continuous subcutaneous insulin infusion

    The Apidra® preparation can also be administered by a pump device for continuous subcutaneous insulin infusion.

    In this case, the infusion set and the tank used with the Apidra® preparation should be replaced with aseptic rules, at least every 48 hours. These recommendations may differ from the general instructions in the manuals for the use of pump devices. It is important that patients follow the above-mentioned special instructions for the use of the drug Apidra®. Failure to comply with these special instructions for the use of the drug Apidra® can lead to the development of serious adverse events.

    When using the drug Apidra® with a pump device for continuous subcutaneous infusion of insulin. The drug Apidra® can not be mixed with other insulins or solvents.

    Patients to whom Apidra® is administered by continuous subcutaneous infusion should have alternative systems for insulin administration and should be trained to administer insulin by subcutaneous injection (in the event of a breakdown of the pump device used).

    When using the Apidra® preparation with pump devices for continuous subcutaneous insulin infusion, a malfunction of the pump device, failure of the infusion set or mistakes in handling them can quickly lead to hyperglycemia, ketosis and diabetic ketoacidosis. In the case of hyperglycemia or ketosis or diabetic ketoacidosis, rapid identification and elimination of the causes of their development is required.

    Special patient groups

    Impaired renal function

    The need for insulin in renal failure may be reduced.

    Impaired liver function

    In patients with impaired liver function, the need for insulin may decrease due to reduced ability to gluconeogenesis and slowing down the metabolism of insulin.

    Elderly patients

    The available data on the pharmacokinetics in elderly patients with diabetes mellitus are inadequate.

    Impaired renal function in the elderly can lead to a decrease in the need for insulin.

    Children and teens

    The drug Apidra ® can be used in children over 6 years and adolescents. Clinical information on the use of the drug in children younger than 6 years is limited.

    For more information on handling the drug (see section "Instructions for use and circulation").

    It is necessary to follow instructions for correctly handling pre-filled syringes (see section "Instructions for use and handling").

    Side effects:

    The undesirable reactions observed were reactions known to this pharmacological class and, therefore, are common to any insulin.

    Disorders from the metabolism and nutrition

    Hypoglycemia, the most frequent undesirable effect of insulin therapy, can occur if too high doses of insulin are used, exceeding the need for it.

    Symptoms of hypoglycemia usually develop suddenly.However, usually neuropsychiatric disorders due to neuroglycopenia (fatigue, unusual fatigue or weakness, decreased ability to concentrate, drowsiness, visual disturbances, headache, nausea, confusion or loss of it, convulsive syndrome) are preceded by symptoms of adrenergic counterregulation (sympathetic activation, adrenal system in response to hypoglycemia): hunger, irritability, nervous excitement or tremor, anxiety, pale skin, "cold" sweat, tahik ardia, marked palpitation (the faster the hypoglycemia develops and the more severe it is, the stronger the symptoms of adrenergic counterregulation).

    Episodes of severe hypoglycemia, especially recurrent, can lead to damage to the nervous system. Long and pronounced hypoglycemia can threaten the lives of patients, as with the growth of hypoglycemia, even a fatal outcome is possible.

    Immune system disorders

    Local hypersensitivity reactions to insulin

    Local hypersensitivity reactions may occur (hyperemia, swelling and itching at the injection site of insulin).These reactions usually disappear after a few days or weeks of use. In some cases, these reactions may not be associated with insulin, but are caused by skin irritation caused by antiseptic treatment before injection or incorrect subcutaneous injection (if the correct technique for subcutaneous injection is violated).

    Systemic hypersensitivity reactions to insulin

    Such reactions to insulin (including insulin glulisin) can, for example, be accompanied by the appearance of a rash all over the body (including accompanied by itching), a feeling of tightness in the chest, suffocation, a decrease in blood pressure, a rapid pulse or heavy sweating. Severe cases of generalized allergies, including anaphylactic reactions, can threaten the patient's life.

    Disturbances from the skin and subcutaneous tissue

    Lipodystrophy

    As with any other insulin, lipodystrophy can develop at the injection site, which can slow the absorption of insulin. The development of lipodystrophy can be facilitated by the violation of the alternation of places of insulin administration, since the introduction of the drug in the same place can contribute to the development of lipodystrophy.

    The constant alternation of injection sites within one of the injection areas (thigh, shoulder, front surface of the abdominal wall) can help reduce and prevent the development of this undesirable reaction.

    Other

    It was reported about the accidental administration of other insulins by mistake, in particular long-acting insulins, instead of insulin glulisin.

    Overdose:

    With an excess of insulin in relation to the need for it, determined by food intake and energy expenditure, hypoglycemia may develop.

    There are no specific data on glutamine insulin overdose. However, with its overdose, the development of hypoglycemia is possible. Episodes of mild hypoglycemia can be stopped by taking glucose or foods containing sugar. Therefore, it is recommended that patients with diabetes always have pieces of sugar, sweets, biscuits or sweet fruit juice.

    Episodes of severe hypoglycemia with coma, convulsions and neurological disorders can be stopped by intramuscular or subcutaneous injection of 0.5-1 mg of glucagon or by intravenous administration of a concentrated (20%) solution of dextrose (glucose) by a medical professional.

    After restoration of consciousness it is recommended to give the patient carbohydrates inside to prevent the recurrence of hypoglycemia, which is possible after apparent clinical improvement.

    After the introduction of glucagon, to establish the cause of this severe hypoglycemia and prevent the development of other similar episodes, the patient should be observed in the hospital.

    Interaction:

    Studies on pharmacokinetic interactions were not conducted. Based on the available empirical knowledge in relation to other similar drugs, the appearance of clinically significant pharmacokinetic interactions is unlikely. Some drugs can affect glucose metabolism, which may require correction of glulisine insulin doses and especially careful monitoring of treatment.

    To substances that can increase the hypoglycemic action of insulin and increase the predisposition to hypoglycemia include: oral hypoglycemic agents, angiotensin converting enzyme inhibitors, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, propoxyphene, salicylates and sulfonamide antimicrobial agents.

    To substances that can reduce the hypoglycemic action of insulin, include: glucocorticosteroids, danazol, diazoxide, diuretics, glucagon, isoniazid, phenothiazine derivatives, somatropin, sympathomimetics (for example, epinephrine [adrenalin], salbutamol, terbutaline), thyroid hormones, estrogens, gestagens (for example, in hormonal contraceptives), protease inhibitors and atypical antipsychotics (for example, olanzapine and clozapine).

    Beta-blockers, clonidine, lithium salts or ethanol can either potentiate or weaken the hypoglycemic action of insulin. Pentamidine may cause hypoglycemia followed by hyperglycaemia. In addition, under the influence of drugs with sympatholytic activity, such as beta-blockers, clonidine, guanethidine and reserpine, the symptoms of reflex adrenergic activation in response to hypoglycemia may be less pronounced or absent.

    Compatibility Guidelines

    Due to the lack of compatibility studies, insulin glulisin should not be mixed with any other medicines, with the exception of human insulin-isophane.

    When administered with an infusion pump device, the Apidra® preparation should not be mixed with solvents and other insulin preparations.

    Special instructions:

    Due to the short duration of the action of the Apidra® preparation, patients with diabetes mellitus require additionally either the introduction of insulin of medium duration, or the infusion of insulin with an insulin pump, to maintain adequate glycemic control.

    Any changes in insulin therapy should be done with caution and only under the supervision of a physician. Change in the concentration of insulin, the insulin producer, the type of insulin (soluble human insulin, insulin-isophane, insulin analogs), insulin species (insulin of animal origin, human insulin) or insulin production method (insulin, recombinant DNA, or animal insulin) may require a change in the dose of insulin.It may also be necessary to change the doses of simultaneously taken oral hypoglycemic agents.

    The need for insulin can change during intercurrent illness, as a result of emotional overload or stress. The use of inadequate insulin doses or discontinuation of treatment, especially in patients with type 1 diabetes, can lead to the development of hyperglycemia and diabetic ketoacidosis - conditions that are potentially life threatening.

    Hypoglycaemia

    The time through which hypoglycemia develops depends on the speed of onset of the effect of the insulin used and, in this connection, changes when the treatment regimen is changed.

    Conditions that can change or make less pronounced the precursors of hypoglycemia include: intensification of insulin therapy and significant improvement in glycemic control, gradual development of hypoglycemia, elderly patient, neuropathy of the autonomic nervous system, prolonged existence of diabetes mellitus, administration of certain medications (see. section "Interaction with other drugs").

    Such situations can lead to the development of severe hypoglycemia (and possibly to loss of consciousness) before the patient realizes that he is developing hypoglycemia.

    Correction of insulin doses may also be required if patients increase physical activity or change their usual eating patterns. Physical exercise performed immediately after a meal can increase the risk of developing hypoglycemia. Compared to soluble human insulin, hypoglycemia may develop earlier after the injection of fast acting insulin analogues.

    Uncompensated hypoglycemic or hyperglycaemic reactions can lead to loss of consciousness, coma development or death.

    Renal insufficiency

    The need for Apidra®, like all other insulins, may decrease as renal failure progresses.

    Liver failure

    In patients with hepatic insufficiency, the need for insulin is reduced due to a decrease in the ability to gluconeogenesis in the liver and slowing down the metabolism of insulin.

    Elderly patients

    Impaired renal function in the elderly can lead to a decrease in the need for insulin.

    Older patients may have difficulty recognizing signs of developing hypoglycemia.

    Children and teens

    The drug Apidra ® can be used in children over 6 years and adolescents. Clinical information on the use of the drug in children younger than 6 years is limited.

    Pharmacokinetic and pharmacodynamic properties of glulisin insulin have been studied in children (7-11 years) and adolescents (12-16 years old) with type 1 diabetes mellitus. In both age groups insulin glulisin was quickly absorbed, and the rate of its absorption did not differ from that in adults (healthy volunteers and patients with type 1 diabetes mellitus). As in adults, in both age groups of children and adolescents when administered directly before a meal test insulin glulisin provides better control of blood glucose after eating than soluble human insulin.

    After the beginning of use, the bottles, pre-filled OptiSet® syringes, cartridges or cartridge systems of OpticKlik® should be stored at a temperature not higher than + 25 ° C in a place protected from light and out of reach of children. Do not chill (the introduction of chilled insulin is more painful).To protect against exposure to light, you should store the bottle, the pre-filled OptiSet® pen, the cartridge or the OpticKlik® cartridge systems in your own carton.

    Shelf life of the drug in the vial, cartridge, OptiKlik® cartridge system or the OptSet® pen-handle after the first use is 4 weeks. It is recommended to mark the date of the first injection of the drug on the label.

    Instructions for use and circulation

    Since Apidra® is a solution, resuspension is not required before use.

    Bottles

    Vials of the drug Apidra® are intended for use with insulin syringes with a corresponding scale of units and for use with a pump insulin system.

    Inspect the bottle before use. It should only be used if the solution is clear, colorless and free of visible solids. Continuous subcutaneous infusion with a pump system The Apidra® preparation can be used to perform continuous subcutaneous insulin infusion (NPII) using a pump system,suitable for infusion of insulin with appropriate catheters and reservoirs.

    Infusion set and reservoir should be replaced every 48 hours in accordance with the rules of asepsis.

    Patients receiving Apidra® by NPII should have an alternative insulin in reserve in the event of a pump system failure.

    Pre-filled Optic syringe pens®

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

    The empty OptiSet® syringes should not be reused and must be destroyed.

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

    Handling of OptiSet® syringe-pen

    Carefully read the usage information before using the OptiSet® syringe pen.

    Important information on using OptiSet® pen syringes

    - Always use a new needle every time you use it. Use only needles that are suitable for the OptiSet® pen.

    - Before each injection, always test the ready-made syringe-pen for use (see below).

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

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

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

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

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

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

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

    Insulin testing

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

    Attaching the needle

    After removing the cap, you should carefully and tightly connect the needle to the syringe pen. Check the availability of the syringe pen for use.

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

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

    If a syringe pen is used, the dispenser should be rotated until the dose indicator stops at 2. The dispenser will rotate in only one direction. Pull out the fully-actuated button to dial the dose. Never rotate the dose selector after the start button is pulled out.

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

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

    Then press the start button all the way.

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

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

    Selecting an insulin dose

    A dose of 2 units up to 40 units can be set in increments of 2 units. If a dose exceeding 40 units is required, it must be administered in two or more injections. Make sure you have enough insulin for the right dose.

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

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

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

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

    Insulin Dose Fence

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

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

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

    Introduction of insulin

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

    The needle must be administered subcutaneously.

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

    Removing the needle

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

    After this, it is necessary to put back the cap for the syringe pen.

    Cartridges

    Cartridges should be used together with an insulin syringe pen, such as Optipen® Pro1 or ClickStar®, and as recommended in the information provided by the device manufacturer. They should not be used with other reusable syringes, as the dosing accuracy was only established with the Optipen® Pro1 and the ClickSTAR® syringes.

    The manufacturer's instructions for the use of the Optipen® Pro1 or the ClickSTART® syringe for loading the cartridge, attaching the needle and performing insulin injection should be strictly followed. Inspect the cartridge before use. It should only be used if the solution is clear, colorless, free of visible solids. Before inserting the cartridge into the reusable syringe pen, the cartridge should be at room temperature for 1-2 hours.Before carrying out the injection, the air bubbles should be able to escape from the cartridge (see the instructions for using the syringe pen). Instructions for the use of the syringe handle must be strictly followed. Empty empty cartridges can not be refilled. If the Optipen® Pro1 or the ClickStart® syringe is damaged, it can not be used.

    If the syringe pen does not work properly, the solution may be recruited from the cartridge into a plastic syringe suitable for insulin at a concentration of 100 U / ml and administered to the patient.

    To prevent infection, the reusable syringe pen should only be used by the same patient.

    OptiKlik® cartridge system

    The OptiKlik® cartridge system is a glass cartridge containing 3 ml of glulisin insulin solution, which is fixed in a transparent plastic container with an attached piston mechanism.

    The OptikKlik® cartridge system should be used together with the Optiklik® syringe handle in accordance with the recommendations in the information provided by the device manufacturer.

    The manufacturer's instructions on the use of the Optiklik® syringe for loading the cartridge system, attaching the needle and performing insulin injection should be carried out exactly.

    If the OptiKlik® syringe is damaged or does not work properly, as a result of a mechanical defect, it must be replaced with a new one.

    Before installing the cartridge system into the OptiKlik ® syringe, it should be at room temperature for 1-2 hours. Inspect the cartridge system before installation. It should only be used if the solution is clear, colorless, free of visible solids. Before carrying out the injection, the air bubbles should be removed from the cartridge system (see the instructions for using the syringe pen). Empty empty cartridges can not be refilled.

    If the syringe pen does not work correctly, the solution can be recruited from the cartridge system into a plastic syringe suitable for insulin at a concentration of 100 U / ml and administered to the patient.

    To prevent infection, the reusable syringe pen should only be used for one patient.

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

    The patient's ability to concentrate and the speed of psychomotor reactions can be compromised by hypoglycemia or hyperglycemia, as well as by visual disorders.This can present a certain risk in situations where these capabilities are important, for example, when driving vehicles or other mechanisms.

    Patients should be advised to use caution and avoid developing hypoglycemia while driving. This is especially important in patients who have reduced or no ability to recognize symptoms that indicate the development of hypoglycemia, or there are frequent episodes of hypoglycemia. Such patients should individually decide whether they can be managed by vehicles or other mechanisms.

    Form release / dosage:

    Solution for subcutaneous administration, 100 units / ml.

    Packaging:

    1) For 10 ml of the drug in a bottle of clear, colorless glass (type I). The bottle is sealed with a cork, crimped with an aluminum cap and covered with a protective cap. 1 bottle with instructions for use in a cardboard box.

    2) 3 ml of the drug in a cartridge of clear, colorless glass (type I). The cartridge is sealed on one side with a cork and crimped with an aluminum cap, on the other hand - by a plunger.

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

    b) The cartridge is mounted in the OptiSet® disposable syringe pen. 5 OptiSet® syringe pens along with instructions for use in a cardboard box equipped with a cardboard latch.

    c) The cartridge is inserted into the OptiKlik® cartridge system. On 5 cartridge systems OptiKlik® together with instructions for use in a cardboard box equipped with a cardboard lock.

    Storage conditions:

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

    Keep out of the reach of children.
    Shelf life:

    2 years.

    Do not use after expiry date.

    Terms of leave from pharmacies:On prescription
    Registration number:LS-002064
    Date of registration:03.10.2011
    The owner of the registration certificate:Sanofi-Aventis Deutschland GmbHSanofi-Aventis Deutschland GmbH Germany
    Manufacturer: & nbsp
    Representation: & nbspSanofi Russia, JSCSanofi Russia, JSCRussia
    Information update date: & nbsp24.10.2015
    Illustrated instructions
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