Novorapid flekspen injection solution 100E for ml 3 ml N5
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Active ingredients
Insulin aspart
Release form
Solution
Composition
1 ml of solution contains: Active substance: insulin aspart 100 U (3.5 mg). Additional substances: glycerol - 16 mg, phenol - 1.5 mg, metacresol - 1.72 mg, zinc chloride - 19.6 μg, sodium chloride - 0.58 mg, sodium hydrogen phosphate dihydrate - 1.25 mg, sodium hydroxide 2M - about 2.2 mg, hydrochloric acid 2M - about 1.7 mg, water d / and - up to 1 ml.
Pharmacological effect
A hypoglycemic drug, an analogue of short-acting human insulin, produced by recombinant DNA biotechnology using the Saccharomyces cerevisiae strain, in which the amino acid proline at position B28 is replaced with aspartic acid. including synthesis of a number of key enzymes (hexokinase, pyruvate kinase, glycogen synthetase). The decrease in blood glucose is due to an increase in its intracellular transport, increased tissue absorption, stimulation of lipogenesis, glycogenogenesis, a decrease in glucose production by the liver. The substitution of the amino acid Proline in position B28 for aspartic acid in insulin aspart reduces the tendency of molecules to form hexamers, which is observed in a solution insulin. In this regard, insulin aspart is absorbed much faster from subcutaneous fat and begins to act much faster than soluble human insulin. Insulin aspart lowers blood glucose levels more than soluble human insulin in the first 4 hours after a meal. The duration of insulin aspart after subcutaneous injection is shorter than soluble human insulin. After subcutaneous administration, the effect of the preparation begins within 10-20 minutes after the introduction. The maximum effect is observed 1-3 h after injection. The duration of the drug is 3-5 hours. In clinical studies involving patients with type 1 diabetes mellitus, the risk of nocturnal hypoglycemia is reduced when insulin aspart is administered compared with soluble human insulin. The risk of daytime hypoglycemia was not significantly increased. Insulin aspart is an equipotential soluble human insulin based on molar indicators. In clinical studies involving adult patients with type 1 diabetes,that insulin aspart administration has a lower postprandial blood glucose level compared to soluble human insulin. A randomized, double-blind, cross-sectional study of the pharmacokinetics and pharmacodynamics of insulin aspart and soluble human insulin was performed in elderly patients with type 2 diabetes years, average age 70 years). The relative differences in pharmacodynamic properties between insulin aspart and soluble human insulin in elderly patients were similar to those in healthy volunteers and younger diabetes patients. When using insulin aspart in children and adolescents, similar results of long-term glucose control compared with soluble human insulin were shown . A clinical study using soluble human insulin before meals and insulin aspart after meals was conducted in children aged 2 to 6 years (26 patients); as well as a pharmacokinetic / pharmacodynamic study with a single dose was conducted in children 6–12 years old and adolescents 13–17 years old. The pharmacodynamic profile of insulin aspart in children was similar to that in adult patients. Clinical studies of the comparative safety and efficacy of insulin aspart and human insulin in the treatment of pregnant women with type 1 diabetes (322 surveyed: 157 received insulin aspart, 165 received human insulin) did not reveal any negative effects of insulin aspart on the course of pregnancy or the health of the fetus / newborn. Additional clinical studies in 27 women with gestational diabetes mellitus who received insulin aspart (14 patients) and human insulin (13 patients) showed comparability of safety profiles, along with a significant improvement in glucose control after a meal with insulin aspart treatment.
Pharmacokinetics
Absorption After insulin insulin aspart Tmax administration in plasma is on average 2 times less than after administration of soluble human insulin. Cmax in plasma is on average 492 ± 256 pmol / l and is reached 40 minutes after s / c injection at a dose of 0.15 U / kg body weight in patients with type 1 diabetes.Insulin concentration returns to baseline 4-6 h after drug administration. The absorption rate is slightly lower in patients with type 2 diabetes, which leads to lower Cmax (352 ± 240 pmol / l) and later Tmax (60 min). Intra-individual Tmax variability is significantly lower when insulin aspart is used compared to soluble human insulin, whereas this variability in Cmax value for insulin aspart is greater. Pharmacokinetics in special clinical cases (6–12 years old) and adolescents (13–17 years old) with sugar Type 1 diabetes: the absorption of insulin aspart occurs rapidly in both age groups with a Tmax similar to that in adults. However, there are Cmax differences in the two age groups, which emphasizes the importance of individual dosing of the drug. Older people: the relative differences in pharmacokinetics between insulin aspart and soluble human insulin in elderly patients (65-83 years old, average age 70 years) diabetes mellitus type 2 was similar to those in healthy volunteers and in younger patients with diabetes. In elderly patients, a decrease in the rate of absorption was observed, which led to a slowing of Tmax (82 (variability: 60-120 min)), whereas Cmax was the same as that observed in younger patients with type 2 diabetes and slightly less than in patients with sugar type 1 diabetes. Liver function insufficiency: a pharmacokinetics study was conducted when a single dose of insulin aspart was administered to 24 patients whose liver function ranged from normal to severe impairment. In persons with impaired liver function, the absorption rate of insulin aspart was reduced and more variable, resulting in a slowing of Tmax from about 50 minutes in people with normal liver function to about 85 minutes in people with impaired liver function of moderate and severe severity. AUC, Cmax and total clearance of the drug were similar in patients with reduced and normal liver function. Insufficiency of the kidney function: the pharmacokinetics of insulin aspart were studied in 18 patients whose kidney function ranged from normal to severe impairment. No apparent effect of creatinine clearance on insulin aspart AUC, Cmax, Tmax was found.The data were limited to indicators for persons with impaired renal function of moderate and severe forms. Persons with renal insufficiency requiring dialysis were not included in the study. Preclinical safety data: During preclinical studies, no danger to humans was identified based on data from generally accepted pharmacological safety studies, toxicity of repeated use, genotoxicity and reproductive toxicity In vitro tests, including binding to insulin receptors and insulin-like growth factor-1, as well as the effect on cell growth, the behavior of insulin aspart is very similar to that of human insulin. Research results also showed that dissociation of insulin aspart binding to the insulin receptor is equivalent to that of human insulin.
Indications
- Diabetes in adults, adolescents and children over 2 years.
Contraindications
- Hypersensitivity to insulin aspart and other components of the drug. It is not recommended to use NovoRapid FlexPen in children under 2 years of age, because No clinical studies have been conducted in children under 2 years of age.
Precautionary measures
NovoRapid FlexPen and needles are intended for individual use only. Do not refill the cartridge syringe pens. New Rapid FlexPen can not be used if it has ceased to be transparent and colorless, or if it was frozen. The patient should be warned about the need to throw out the needle after each injection. NovoRapid can be used in insulin pumps. Tubes, the inner surface of which is made of polyethylene or polyolefin, were checked and found to be suitable for use in pumps. In case of emergency (hospitalization, malfunction of the device for administering insulin), NovoRapid can be removed from FlexPen using an U100 insulin syringe for administration to the patient. It is necessary to warn the patient about when NovoRapid FlexPen should not be used: - in case of allergy (hypersensitivity) to insulin aspart or any other component of the drug; - if hypoglycemia begins; - if FlexPen is dropped, or it is damaged or crushed; - if the storage conditions of the drug were violated or it was frozen; - if insulin stopped l be transparent and bestsvetnym.Pered using NovoRapid FleksPen patient should: - check the label to make sure that the correct type of insulin - always use a new needle for each injection,to prevent infection; - remember that NovoRapid FlexPen and needles are intended only for individual use; - never inject insulin in / m; - change the injection site every time within the anatomical region, this will help reduce the risk of seals and ulceration - regularly measure the concentration of glucose in the blood.
Use during pregnancy and lactation
NovoRapid FlexPen can be prescribed during pregnancy. In two randomized controlled clinical trials (157 + 14 examined pregnant women) no adverse effect of insulin aspart on pregnancy or fetal / newborn health compared with human insulin was detected. Careful monitoring of blood glucose and monitoring of pregnant women with diabetes mellitus are recommended (1 type, type 2, or gestational diabetes) during the entire pregnancy, as well as during the period of possible pregnancy. The need for insulin, as a rule, decreases in the first trimester and gradually increases in the second and third trimesters of pregnancy. Shortly after birth, the need for insulin quickly returns to the level that was before pregnancy. During breastfeeding, NovoRapid FlexPen can be used without restrictions, because administering insulin to a nursing woman does not pose a threat to the baby. However, it may be necessary to adjust the dose of the drug.
Dosage and administration
NovoRapid FlexPen is a fast-acting analogue of insulin. The dose of NovoRapid FlexPen is determined by the doctor individually according to the needs of the patient. Usually, the drug is used in combination with insulin preparations of average duration or long-term action, which are administered at least 1 time / day. To achieve optimal glycemic control, it is recommended that you regularly measure your blood glucose concentration and adjust your insulin dose. Typically, individual daily insulin requirements in adults and children range from 0.5 to 1 U / kg body weight. With the introduction of the drug before a meal, the need for insulin can be provided by NovoRapid FlexPen by 50-70%, the remaining need for insulin is provided by prolonged insulin. An increase in the patient's physical activity, a change in the usual diet or associated diseases can lead to the need for dose adjustment. NovoRapid FlexPen has faster onset and shorter duration of action than soluble human insulin.Due to the faster onset of action, NovoRapid FlexPen should be administered, as a rule, immediately before a meal, if necessary, can be administered soon after a meal. Due to the shorter duration of action compared to human insulin, the risk of developing nighttime hypoglycemia in patients receiving NovoRapid FlexPen is lower. As with the use of other insulins, in elderly patients and patients with renal or hepatic insufficiency, the concentration of glucose should be more closely controlled. Exercise NovoRapid FlexPen instead of soluble human insulin in children, preferably when it is necessary to quickly start the action of the drug, for example, when it is difficult for the child to observe the required time interval between injection and food intake. When transferring a patient from other drugs of insulin on NovoRapid FlexPen, you may need a dose adjustment of NovoRapid FlexPen and basal insulin. A injection of NovoRapid FlexPen is injected s / c into the anterior abdomen. second wall, hip, shoulder deltoid or gluteal region. Injection sites within the same area of the body should be changed regularly to reduce the risk of developing lipodystrophy. As with the use of all insulin preparations, sc injection into the anterior abdominal wall provides a faster absorption compared with administration to other places. The duration of action depends on the dose, place of administration, intensity of blood flow, temperature and level of physical activity. However, a more rapid onset of action compared with soluble human insulin is maintained regardless of the location of the injection site. NovoRapid can be used for long-lasting insulin infusions (PPII) in insulin pumps designed for insulin infusions. FDII should be made in the anterior abdominal wall. Infusion sites should be periodically changed. When using an insulin pump for infusions, NovoRapid should not be mixed with other types of insulin. Patients using PPSI should be fully trained to use the pump, the appropriate reservoir and tubing system for the pump.The infusion set (tube and catheter) should be replaced in accordance with the user's manual attached to the infusion set. Patients receiving NovoRapid with the help of PPII should have additional insulin available in case of an infusion system breakdown. In / In the introduction If necessary, NovoRapid can be administered IV, but only by qualified medical personnel. For iv injection, NovoRapid 100 U / ml infusion systems with a concentration of 0.05 U / ml to 1 U / ml insulin aspart in a 0.9% sodium chloride solution are used; 5% dextrose solution or 10% dextrose solution containing 40 mmol / l potassium chloride, using polypropylene infusion containers. These solutions are stable at room temperature for 24 hours. Despite stability for some time, a certain amount of insulin is initially absorbed by the material of the infusion system. During insulin infusions, it is necessary to constantly monitor the concentration of blood glucose. Using a syringe pen New Rapid FlexPen is an insulin syringe pen with a dispenser and color-coded. The dose of insulin administered, ranging from 1 to 60 U, may vary in increments of 1 U. NovoRapid FlexPen is designed for use with Novofine and NovoTvist needles up to 8 mm long. As a precaution, you should always carry with you a spare system for administering insulin in case of loss or damage of NovoRapid FlexPen. Before using syringe-pens1. Check the label to make sure that NovoRapid FlexPen contains the required type of insulin.2. Remove the cap from the syringe handle. Remove the protective sticker from the disposable needle. Carefully and tightly screw the needle onto NovoRapid FlexPen. Remove the outer cap from the needle, but do not throw it away. Remove and discard the inner needle cap. For each injection, use a new needle to prevent infection. Do not bend or damage the needle before use. To avoid accidental injections, never put the inner cap back on the needle. Checking insulin flow Even with proper use of a syringe pen, a small amount of air can accumulate in the cartridge before each injection. To prevent the entry of a bubble of air and ensure the introduction of the correct dose of the drug should be: 1. Dial 2 U of the drug by turning the dosage selector.2.Holding NovoRapid FlexPen with the needle up, gently tap the cartridge several times with your fingertip so that the air bubbles move to the top of the cartridge.3. Hold NovoRapid FlexPen needle up, press the start button to the stop. The dosage selector will return to 0. A drop of insulin should appear at the end of the needle. If this does not happen, replace the needle and repeat the procedure, but not more than 6 times. If insulin does not come from the needle, this indicates that the pen is defective and cannot be used any further. Dose setting The dosage selector should be set to position 0. Select the number of units needed for the injection. The dose can be adjusted by rotating the dosage selector in any direction, until the correct dose is set against the dosage indicator. When rotating the dosage selector, take care not to accidentally press the start button to avoid the insulin dose being released. It is not possible to set a dose that exceeds the number of units remaining in the cartridge. You cannot use the residue scale to measure the insulin dose. Insulin administration1. Introduce needle sc. The patient should use the injection technique recommended by the doctor. To inject, press the trigger button all the way until it is 0 in front of the dosage indicator. When the drug is injected, only the trigger button should be pressed. When you turn the selector dosage dose will not occur. When removing the needle from under the skin, keep the start button fully depressed. After injection, leave the needle under the skin for at least 6 seconds. This will ensure the introduction of a full dose of insulin. To direct a needle to an outside cap of a needle, without touching a cap. When the needle goes inside, put on the cap and unscrew the needle. Throw the needle out, taking precautions, and close the pen with a cap. Remove the needle after each injection and never store NovoRapid FlexPen with the needle attached. Otherwise, liquid may leak out of NovoRapid FlexPen, which can lead to incorrect dosage. Caregivers should be careful when removing and discarding needles to avoid the risk of an accidental injection by a needle. Throw away used NovoRapid FlexPen with a disconnected needle. New Rapid FlexPen is intended for individual use only. Storage and careNew Rapid FlexPen is designed for efficient and safe use and requires careful handling.In case of a fall or strong mechanical impact, damage to the syringe handle and leakage of insulin may occur. The surface of NovoRapid FlexPen can be cleaned with a cotton swab dipped in alcohol. Do not immerse the pen in alcohol, do not wash or lubricate it, because It may damage the mechanism. It is not allowed to refill NovoRapid FlexPen.
Side effects
Adverse reactions observed in patients receiving NovoRapid FlexPen are mainly dose-dependent and are due to the pharmacological effect of insulin. The most common adverse event in the use of insulin is hypoglycemia. At the initial stage of insulin therapy, refraction disorders, edema and reactions at the injection sites (pain, redness, urticaria, inflammation, hematoma, swelling and itching at the injection site) can occur. These symptoms are usually transient. A rapid improvement in glycemic control can lead to a state of acute pain neuropathy, which is usually reversible. Intensification of insulin therapy with a dramatic improvement in the control of carbohydrate metabolism can lead to a temporary worsening of diabetic retinopathy, while at the same time, a long-term improvement in glycemic control reduces the risk of progression of diabetic retinopathy. excessive sweating, gastrointestinal disorders, angioedema, difficulty breathing, heart palpitations, decreased AD), which are potentially life-threatening. Hypoglycemia Hypoglycemia is the most frequent side effect. It may develop if the insulin dose is too high in relation to the need for insulin. Severe hypoglycemia can lead to loss of consciousness and / or convulsions, temporary or irreversible dysfunction of the brain, or even death. Symptoms of hypoglycemia, as a rule, develop suddenly. They may include cold sweat, pallor of the skin, fatigue, nervousness or tremor, anxiety, unusual tiredness or weakness, disorientation, decreased concentration, drowsiness, marked hunger, blurred vision, headache, nausea, and palpitations. Clinical studies have shown that the incidence of hypoglycemia varies depending on the patient population, dosing regimen and glycemic control.In clinical studies, no differences were found in the overall incidence of episodes of hypoglycemia between patients receiving aspart insulin therapy and patients receiving human insulin. LipodystrophyFrequently reported cases of lipodystrophy were reported. Lipodystrophy may develop at the injection site.
Overdose
A definite dose required for insulin overdose has not been established. Symptoms: hypoglycemia, which can develop gradually if too high doses are administered in relation to the patient's needs. Treatment: the patient can eliminate light hypoglycemia himself by ingesting glucose or sugar-containing foods. Therefore, patients with diabetes are advised to constantly carry with them sugar-containing products. In the case of severe hypoglycemia, when the patient is unconscious, you should enter from 500 μg to 1 mg of glucagon intramuscularly or s / c (a trained person can enter), or in / into a glucose solution (dextrose) (only a medical professional can enter) . It is also necessary to introduce dextrose in / in the case if the patient does not regain consciousness 10-15 minutes after the introduction of glucagon. After the recovery of consciousness, the patient is recommended to take carbohydrate-rich food to prevent the recurrence of hypoglycemia.
Interaction with other drugs
Hypoglycemic action The hypoglycemic effect of insulin weakens oral contraceptives, GCS, thyroid hormones, thiazide diuretics, heparin, tricyclic antidepressants, sympatomies drugs, somatropin, danazol, clonidine, slow calcium channel blockers, diazoxide, morphine, phenytoin, nicotine. Beta-adrenoblockers can mask the symptoms of hypoglycemia. Octreotide / lanreotide can both increase and decrease the need for insulin. Ethanol can both increase the need for insulin. to reduce the hypoglycemic effect of insulin. Pharmaceutical incompatibility Drugs containing thiol or sulfite groups, when added to the preparation NovoRapid FlexPen can cause the destruction of insulin aspart. The drug NovoRapid FlexPen should not be mixed with other drugs.The exceptions are insulin isophane and the solutions for infusions listed above.
special instructions
Before a long trip associated with changing time zones, the patient should consult with your doctor, because changing the time zone means that the patient has to eat and inject insulin at another time. Hyperglycemia Insufficient dose of the drug or discontinuation of treatment, especially for type 1 diabetes, may lead to the development of hyperglycemia and diabetic ketoacidosis. As a rule, the symptoms of hyperglycemia appear gradually, over several hours or days. Symptoms of hyperglycemia include nausea, vomiting, drowsiness, redness and dryness of the skin, dry mouth, increased urine, thirst and loss of appetite, and the smell of acetone in exhaled air. Without appropriate treatment, hyperglycemia can lead to death. HypoglycemiaA skip meal, unplanned increased exercise or insulin dose that is too high relative to the patient's needs can lead to hypoglycemia. symptoms are precursors of hypoglycemia, about which patients should be informed. The usual symptoms of precursors can disappear with a long course of sa diabetes. The consequence of the pharmacodynamic features of short-acting insulin analogues is that the development of hypoglycemia, when used, can begin earlier than with the use of soluble human insulin. the treatment of patients with comorbidities or taking drugs that slow down the absorption of food. Bani, especially infectious and accompanied by fever, usually increases the body's need for insulin. Dose adjustment of the drug may also be required if the patient has concomitant diseases of the kidneys, liver, dysfunction of the adrenal glands, pituitary gland or thyroid gland. When transferring a patient to other types of insulin,early symptoms, precursors of hypoglycemia, may become less pronounced compared to those of the previous type of insulin. Transferring a patient from other insulin preparations Transferring a patient to a new type of insulin or insulin from another manufacturer must be carried out under strict medical supervision. When changing the concentration, type, manufacturer and type (human insulin, animal insulin, human insulin analogue) of insulin preparations and / or method of manufacture, it may be necessary to change the dose or increase the frequency of injections compared to previously used insulin preparations. If necessary, dose adjustment, it can be made already at the first injection of the drug or during the first weeks or months of treatment. Reactions at the injection site As with other insulin preparations, reactions can develop at the injection site, which manifests as pain, redness, hives, inflammation , hematoma, swelling and itching. Regularly changing the injection site in the same anatomical area can reduce symptoms or prevent the development of reactions. In very rare cases, NovoRapid FlexPen may need to be discontinued. Simultaneous use of thiazolidinedione group drugs and insulin preparations. Cases of chronic heart failure have been reported in patients treated with thiazolidinedione in combination with insulin preparations, especially if these patients have risk factors for developing chronic heart failure. This fact should be taken into account when prescribing thiazolidinediones and insulin combination therapy to patients. When prescribing such a combination therapy, it is necessary to conduct medical examinations of patients in order to identify their signs and symptoms of chronic heart failure, weight gain and the presence of edema. If the symptoms of heart failure worsen in patients, treatment with thiazolidinediones should be stopped. Impact on ability to drive vehicles and control mechanisms Patients' ability to concentrate and reaction rate can be impaired during hypoglycemia, which can be dangerous in those situations where these abilities are especially necessary (for example , when driving or working with machines and mechanisms).Patients should be advised to take measures to prevent the development of hypoglycemia when driving and working with mechanisms. This is especially important for patients with the absence or decrease in the severity of symptoms, precursors of developing hypoglycemia or suffering from frequent episodes of hypoglycemia.