The action of the drug NovoRapid FlexPen occurs earlier than with the introduction of soluble human insulin, while the level of glucose in the blood becomes lower during the first 4 hours after a meal. With s / c administration, the duration of action of NovoRapid FlexPen is shorter compared to soluble human insulin and occurs 10–20 minutes after administration. Maximum effect develops between 1 and 3 h after injection. Duration of action - 3-5 hours.
The results of clinical studies of patients diabetes Type I shows that with the introduction of the drug NovoRapid FlexPen, the level of glucose after a meal is lower than with the introduction of human insulin.
Children and teenagers. In children, when treated with NovoRapid FlexPen, the effectiveness of long-term control of blood glucose levels is the same as when treated with soluble human insulin. In a clinical study of 26 children aged 2-6 years, the effectiveness of glycemic control was compared between the administration of soluble human insulin before meals and insulin aspart administered after meals, and also determined the pharmacokinetics and pharmacodynamics in children aged 6-12 years and adolescents 13-13 years of age. 17 years. The pharmacodynamic profile of insulin aspart in children and adults was the same. results clinical research patients with type I diabetes mellitus have shown that when insulin aspart is used, the risk of developing hypoglycemia at night is lower compared to soluble human insulin; with regard to the frequency of cases of hypoglycemia during the day, no significant differences were noted. When calculating the dose (in moles), insulin aspart is equipotent to soluble human insulin. The substitution of amino acid proline at position B-28 of the insulin molecule for aspartic acid in NovoRapid FlexPen results in a decrease in the formation of hexamers, which is noted with the introduction of soluble human insulin. Consequently, NovoRapid FlexPen is more rapidly absorbed into the bloodstream from subcutaneous adipose tissue compared to soluble human insulin. The time to reach the maximum concentration of insulin in the blood is on average half that of an injection of soluble human insulin. The maximum concentration of insulin in the blood of patients with type I diabetes mellitus 492 ± 256 pmol/l is reached 30–40 minutes after the s / c administration of NovoRapid FlexPen at the rate of 0.15 U / kg of body weight. Insulin levels return to baseline 4-6 hours after administration. The intensity of absorption is somewhat lower in patients with type II diabetes mellitus. Therefore, the maximum concentration of insulin in such patients is slightly lower - 352 ± 240 pmol / l and is reached later - on average after 60 minutes (50–90) minutes. With the introduction of NovoRapid FlexPen, the variability in the time to reach the maximum concentration in the same patient is significantly less, and the variability in the level of the maximum concentration is greater than with the introduction of human soluble insulin.
In elderly patients or with impaired liver or kidney function, the pharmacokinetics of NovoRapid FlexPen have not been studied. The pharmacokinetics and pharmacodynamics of NovoRapid FlexPen were studied in children (6–12 years old) and adolescents (13–17 years old) with type 1 diabetes mellitus. Insulin aspart was rapidly absorbed in both age groups studied, while the time to reach the maximum concentration in the blood was the same as in adults. However, the level of maximum concentration is different in children. different ages, which indicates the importance of individual selection of doses of NovoRapid FlexPen.
Novorapid - indications for use
diabetes treatmentContraindications
hypoglycemia; hypersensitivity to insulin aspart or any ingredient of the drug.Usage Precautions
inadequate dosage or discontinuation of treatment (especially in type 1 diabetes mellitus) can lead to hyperglycemia and diabetic ketoacidosis, which are potentially deadly. Patients who have significantly improved blood glucose control, such as through intensive care, may note a change in the usual symptoms - precursors of hypoglycemia, about which patients should be warned in advance. A consequence of the pharmacodynamic features of high-speed insulin analogs is the possible faster development of hypoglycemia compared to soluble human insulin. NovoRapid FlexPen should be administered immediately before meals. The rapid onset of its action should be considered in the treatment of patients with concomitant diseases or taking drugs that slow down the absorption of food in the gastrointestinal tract.Concomitant diseases, especially infections and fevers, usually increase the patient's need for insulin.
The transfer of patients to a new type or type of insulin should be carried out under strict medical supervision. If the concentration, type, type, origin of the insulin preparation (animal, human, analogue of human insulin) and / or method of its production, it may be necessary to adjust the dose. Patients taking NovoRapid FlexPen may need to increase the number of injections or change the dose compared to the usual insulin. The need for dose selection may arise both at the first introduction of a new drug, and during the first few weeks or months of its use.
Skipping meals or unexpected strenuous exercise can lead to hypoglycemia. Physical exercise immediately after a meal increases the risk of hypoglycemia. NovoRapid FlexPen contains metacresol, which in rare cases may cause allergic reactions.
Use during pregnancy and lactation. Experience with the use of NovoRapid FlexPen during pregnancy is limited. The results of animal studies have shown that insulin aspart, like human insulin, does not have embryotoxic and teratogenic effects. Enhanced monitoring is recommended in the treatment of pregnant women with diabetes mellitus throughout the entire period of pregnancy, as well as when pregnancy is suspected. The need for insulin usually decreases in the first trimester of pregnancy and increases significantly in the second and third trimesters. There are no restrictions on the treatment of diabetes mellitus with NovoRapid FlexPen during breastfeeding. Treatment during pregnancy does not pose a risk to the baby. However, during this period, the mother may need to adjust the dose.
Impact on ability to drive vehicles and mechanisms. The patient's response and ability to concentrate may be impaired by hypoglycemia. This can become a risk factor in situations where increased attention is required (for example, when driving a car or operating machinery). Patients should be advised to take measures to prevent hypoglycemia before driving. This is especially important for patients who have weakened or absent symptoms - precursors of hypoglycemia or episodes of hypoglycemia occur frequently. Under such circumstances, the advisability of driving should be weighed.
Interaction with drugs
row medicinal substances affects glucose metabolism.Drugs that may reduce the need for insulin: oral hypoglycemic agents, octreotide, MAO inhibitors, non-selective β-adrenergic blockers, ACE inhibitors, salicylates, alcohol, anabolic steroids, sulfonamides.
Drugs that may increase the need for insulin: oral contraceptives, thiazides, corticosteroids, thyroid hormones, sympathomimetics, danazol.
β‑adrenergic blockers may mask the symptoms of hypoglycemia.
Alcohol can enhance and prolong the hypoglycemic effect of insulin.
Incompatibility. Adding certain drugs to insulin can cause it to become inactivated, for example medicines containing thiols or sulfites.
Novorapid - method of administration and dosage
Dosing of NovoRapid FlexPen is individual and determined by the doctor in accordance with the characteristics and needs of the patient. Usually NovoRapid FlexPen is used in combination with insulin preparations. medium duration or long-acting, which is administered at least 1 time per day.The individual insulin requirement is usually 0.5–1.0 units/kg/day. With the frequency of use in accordance with the meal, 50-70% of the need for insulin is satisfied by NovoRapid FlexPen, and the rest by insulin of medium duration or long-acting.
The mode of administration of NovoRapid FlexPen is characterized by a faster onset and a shorter duration of action compared to soluble human insulin. Due to the faster onset of action, NovoRapid FlexPen should generally be administered just before a meal. If necessary, this drug can be administered shortly after meals.
NovoRapid is injected under the skin of the anterior abdominal wall, thigh, in the area of the deltoid muscle of the shoulder or buttocks. Injection sites should be changed even within the same area of the body. With s / c injections in the region of the anterior abdominal wall, the effect of the drug begins in 10-20 minutes. The maximum effect is between 1-3 hours after injection. The duration of action is 3-5 hours. As with all insulins, s / c administration in the anterior abdominal wall provides faster absorption than when administered at other sites. Nevertheless, the faster onset of action of NovoRapid FlexPen compared to soluble human insulin is maintained regardless of the injection site. If necessary, NovoRapid FlexPen can be administered intravenously, these injections can only be performed under medical supervision. NovoRapid can be used for continuous subcutaneous administration using appropriate infusion pumps. Continuous s / c injection is carried out in the anterior abdominal wall, the injection site should be changed periodically. When used in infusion pumps, NovoRapid must not be mixed with any other insulin preparations. Patients using infusion pumps should be thoroughly instructed in the use of these systems and use the appropriate containers and tubing. The infusion set (tubes and cannulas) should be changed in accordance with the requirements of the attached instructions. Patients using NovoRapid in a pumping system should have insulin available in case of failure. Impaired liver and kidney function can reduce the patient's need for insulin. In children, instead of soluble human insulin, NovoRapid FlexPen should be administered in cases where it is desirable to receive fast action insulin, for example before meals. NovoRapid FlexPen is a pre-filled pen for use with NovoFine® short cap needles. Packaging with NovoFine® needles is marked with the symbol S. FlexPen allows you to administer from 1 to 60 units of the drug with an accuracy of 1 unit. You must follow the instructions for medical use drug that is in the package. NovoRapid FlexPen is intended for individual use only and must not be reused.
Instructions for use of NovoRapid FlexPen
NovoRapid is intended for subcutaneous injections or continuous administration using infusion pumps. NovoRapid can also be administered intravenously under the strict supervision of a physician.
Use in infusion pumps
For infusion pumps, tubes are used, the inner surface of which is made of polyethylene or polyolefin. Some insulin is initially absorbed into the inner surface infusion tank.
Use for IV administration
Infusion systems with the drug NovoRapid 100 U / ml at an insulin aspart concentration of 0.05 to 1.0 U / ml in an infusion solution containing 0.9% sodium chloride, 5 or 10% dextrose and 40 mmol / l chloride potassium, are in polypropylene infusion containers, are stable at room temperature for 24 hours. During the infusion of insulin, it is necessary to monitor the concentration of glucose in the blood.
Side effects
adverse reactions noted in patients using NovoRapid FlexPen are mainly related to the size of the administered dose of the drug and are a manifestation pharmacological action insulin. The most commonly reported side effect of insulin therapy is hypoglycemia. May develop if the dose significantly exceeds the patient's need for insulin. Severe hypoglycemia can lead to loss of consciousness and/or seizures, followed by temporary or permanent impairment of brain function and even death.According to the results of clinical studies, as well as data registered after the release of the drug on the market, the incidence of severe hypoglycemia varies in different groups of patients and with different dosing regimens; the incidence of severe hypoglycemia in patients receiving insulin aspart is the same as in those receiving human insulin. Below is the frequency adverse reactions which, according to clinical studies, may be associated with the administration of NovoRapid. According to the frequency of occurrence, these reactions are divided into those that occur sometimes (> 1/1000, 1/10,000,
From the side of the immune system
Sometimes: urticaria, itching, skin rashes.
Very rare: anaphylactic reactions. Generalized reactions hypersensitivity may include skin rashes, itching, sweating, gastrointestinal disturbances, angioedema, labored breathing, palpitations, and decreased blood pressure. These reactions are potentially life-threatening.
From the side of the nervous system
Rare: peripheral neuropathy. Rapid improvement in blood glucose control can cause acute painful neuropathy, usually transient.
visual impairment
Sometimes: refractive error. Transient refractive errors may occur at the start of insulin therapy; diabetic retinopathy.
Long-term maintenance of glycemic control reduces the risk of progression of diabetic retinopathy. However, the intensification of insulin therapy to rapidly improve glycemic control may cause a temporary exacerbation of diabetic retinopathy.
From the skin and subcutaneous tissue
Sometimes: lipodystrophy can occur at injection sites as a result of non-compliance with the recommendation to change the injection site within the same area; local hypersensitivity.
With the introduction of insulin, reactions at the injection sites are sometimes noted as manifestations of local hypersensitivity (redness, swelling and itching). Swelling of the tissues in the injection area may develop at the beginning of insulin therapy. These reactions are usually transient and stop with continued treatment.
Overdose
there is no specific definition of overdose for insulin, but hypoglycemia may develop after its administration.In case of mild hypoglycemia, oral glucose or sugary foods should be taken. Therefore, patients with diabetes are advised to always have a few pieces of sugar or sweets with them.
In severe hypoglycemia, when the patient is unconscious, it is necessary to IM or SC inject glucagon (0.5-1 mg), which can be done by persons who have received appropriate instructions. medical worker may give the patient intravenous glucose. Glucose should also be administered intravenously if the patient does not respond to glucagon administration within 10-15 minutes. After the patient regains consciousness, he should ingest carbohydrates to prevent recurrence of hypoglycemia.
Storage conditions
shelf life - 2.5 years. The used pen with NovoRapid FlexPen should not be stored in the refrigerator. The syringe pen, which is used or carried with you as a spare, should be stored for no more than 4 weeks (at a temperature not exceeding 30 ° C). An unused pen with NovoRapid FlexPen should be stored in a refrigerator at a temperature of 2-8 ° C (away from the freezer). Do not freeze. To protect from light, store the syringe pen with the cap on.NovoRapid is an anti-diabetic drug that can compensate for the lack of natural insulin. NovoRapid insulin injections lower blood sugar levels. This new drug has many advantages in comparison with analogues.
It is quickly and easily absorbed, sugar is immediately normalized. You can use it at any time, no matter before or after meals, as it belongs to the group of ultrashort insulins. The body does not get used to this medicine, at any time you can quit it or switch to another drug.
Evidence of its safety is that it is allowed even during pregnancy.
Features of the action of NovoRapid
NovoRapid is considered a direct analog of natural human insulin, but much more powerful in terms of its action. Its main component is insulin aspart, which has a short-term hypoglycemic effect. Due to the fact that the movement of glucose inside the cells increases, and its formation in the liver slows down, blood sugar levels are greatly reduced.
When the amount of sugar in the blood decreases, the following processes occur:
NovoRapid solution can be administered subcutaneously or intravenously. But introduction under the skin is recommended, then NovoRapid is absorbed more efficiently and has its effect much faster when compared with soluble insulin. But the time of action is not as long as that of soluble insulin.
NovoRapid is activated almost immediately after the injection - after 10-15 minutes, greater efficiency is noticeable after 2-3 hours, and the duration will be 4-5 hours.
Patients while using this medicinal solution note a decrease in the risk that nocturnal hypoglycemia will develop. In addition, you should not worry that NovoRapid insulin will cause the body to get used to it, you can always cancel or change the drug.
Indications for the use of NovoRapid
The drug is prescribed for the following diseases:
NovoRapid is contraindicated in the following patients:
NovoRapid insulin is approved for the management of diabetes in women throughout pregnancy and while breastfeeding.
Sometimes with NovoRapid injections, side reactions appear:
In a situation of overdose in the body there will be such reactions:
- Fainting,
- hypotension,
- Skin blanching.
Production of NovoRapid
The manufacturer of NovoRapid is Novo Nordisk, the country is Denmark. International name- insulin aspart.
NovoRapid is available in two forms:
- Replacement Penfill cartridges.
The medicine itself is the same in these types - a clear, colorless liquid, 1 ml contains 100 units active ingredient. As part of both pens and cartridges of 3 ml of insulin.
The production of NovoRapid insulin takes place according to a special technology based on the Saccharomyces cerevisiae strain, while aspartic acid is replaced by an amino acid, as a result of which a receptor complex is obtained, it is he who activates the processes occurring in cells, as well as chemical compound main components (glycogen synthetase, hexokinases, pyruvate kinases).
Between the types of NovoRapid FlexPen and NovoRapid Penfill, the difference lies solely in the form of release: the first type represents a syringe pen, the second - replaceable cartridges. But the medicine is the same. Each patient has the opportunity to choose which form of insulin is more convenient for him to use.
Both types of drugs can be bought in retail pharmacies only with a doctor's prescription.
Cost of NovoRapid
The price of NovoRapid Penfill for 5 pieces in Russia is 1600-1800 rubles, the price of FlexPen for 5 pens (one package) is 1800-2000 rubles.
Instructions for use NovoRapid
In order to combat type 1 or type 2 diabetes, it is advisable to give an injection subcutaneously in the thigh, buttock, anterior abdominal wall or shoulder before eating on an empty stomach.
To determine the dose of the drug at one time, you need to multiply your body weight by daily dose and then divide by two. Round up the result.
The average patient's need for insulin per day should be from 0.5 to 1 U / kg of body weight. It is compensated by 60-70% by administering the drug before meals, and the rest is taken up by longer-acting insulin.
NovoRapid FlexPen is a pre-filled syringe pen. For convenience, there is a dispenser and color coding. For injections with insulin, needles 8 mm long with a short protective cap from NovoFine or Novotwist are used, the symbol “S” must be on their packaging. 
This syringe can inject from 1 to 60 units of medication with a resolution of up to 1 unit. You must follow the instructions for using the device. The FlexPen pen is issued for personal use and must not be refilled or transferred to other persons.
Patients who miss a dose are required to check their blood for glucose concentration, and then return to the usual regimen once a day. In no case, after a missed dose, you can not enter a double dose in order to make up for the forgotten one!
The course of treatment is often long, so specific terms are difficult to establish. The duration of the drug is affected by the dose administered, the injection site on the body, blood flow velocity, temperature and degree physical activity.
NovoRapid Penfill is available in the form of cartridges that are used for the administration of insulin by injection.
Produced by NovoNordisk, NovoFine needles are included.
Do not use FlexPen and Penfill in the following situations:
Special instructions when using NovoRapid:
Analogues of NovoRapida
If NovoRapid is not suitable for a diabetic for any reason, then the doctor recommends using the following analogues: Apidra, Gensulin N, Humalog, Novomix, Rayzodeg. Their price is about the same.
Often patients ask their doctors the question: "Which is better - Humalog or NovoRapid?". But there can be no accurate information to answer, since for every diabetic patient different types insulin in different ways. Usually from one drug to another causes an allergy to pass.
Judging by the feedback from patients, NovoRapid acts much faster than its short-acting counterparts. And there is another important advantage of NovoRapid insulin - it is allowed to be used by women during pregnancy and lactation.
In addition, in patients with diabetes, the question arises: “Which is better - Apidra or NovoRapid?”. Of course, everyone chooses what is more convenient. Apidra is also a short-acting insulin, it begins to act 4-5 minutes after the injection, but it must be injected strictly before meals or immediately after meals, which is not always convenient for the patient.
INSTRUCTIONS
on the medical use of the drug
Registration number:
P N016171/01Tradename: NovoRapid® FlexPen®
INN: insulin aspart
Dosage form:
Solution for subcutaneous and intravenous administrationCompound:
1 ml of the drug contains:active substance: insulin aspart 100 IU (3.5 mg);
Excipients: glycerol 16 mg, phenol 1.5 mg, metacresol 1.72 mg, zinc chloride 19.6 mcg, 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 for injection up to 1 ml.
One syringe pen contains 3 ml of a solution equivalent to 300 IU.
Description
Clear, colorless solution.
Pharmacotherapeutic group:
Hypoglycemic agent, a short-acting human insulin analogue.ATX code- A10AB05.
Pharmacological properties:
Pharmacodynamics.Insulin aspart is a short-acting human insulin analog produced by recombinant DNA biotechnology using a strain of Saccharomyces cerevisiae, in which the amino acid proline at position B28 is replaced by aspartic acid.
Interacts with a specific receptor on the outer cytoplasmic membrane of cells and forms an insulin-receptor complex that stimulates intracellular processes, including the synthesis of a number of key enzymes (hexokinase, pyruvate kinase, glycogen synthase, etc.). The decrease in blood glucose is due to an increase in its intracellular transport, increased absorption by tissues, stimulation of lipogenesis, glycogenogenesis, a decrease in the rate of glucose production by the liver, etc.
The replacement of the amino acid proline at position B28 with aspartic acid in insulin aspart reduces the tendency of molecules to form hexamers, which is observed in a solution of regular insulin. In this regard, insulin aspart is much faster absorbed from the subcutaneous fat and begins to act faster than soluble human insulin. Insulin aspart lowers blood glucose more strongly in the first 4 hours after a meal than soluble human insulin. Duration of action of insulin aspart after subcutaneous injection shorter than soluble human insulin. After subcutaneous administration, the effect of the drug begins within 10-20 minutes after administration. The maximum effect is observed 1-3 hours after the injection. The duration of the drug is 3-5 hours.
Clinical studies in patients with type 1 diabetes have demonstrated a reduced risk of nocturnal hypoglycemia with insulin aspart compared with soluble human insulin. The risk of daytime hypoglycemia was not significantly increased.
Insulin aspart is equipotential to soluble human insulin based on molarity.
Adults. Clinical studies in patients with type 1 diabetes demonstrate lower postprandial blood glucose concentrations with insulin aspart compared with soluble human insulin.
Elderly: A randomized, double-blind, cross-over study of the pharmacokinetics and pharmacodynamics (PK/PD) of insulin aspart and soluble human insulin was conducted in elderly patients with type 2 diabetes mellitus (19 patients aged 65-83 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 in younger diabetics.
Children and teenagers. The use of insulin aspart in children showed similar results of long-term glycemic control when compared with soluble human insulin.
A clinical study using soluble human insulin before meals and insulin aspart after meals was conducted in young children (26 patients aged 2 to 6 years); and a PK/PD study using a single dose was conducted in children (6-12 years) and adolescents (13-17 years). The pharmacodynamic profile of insulin aspart in children was similar to that in adult patients.
Pregnancy: Clinical studies of the comparative safety and efficacy of insulin aspart and human insulin in the treatment of pregnant women with type 1 diabetes mellitus (322 examined pregnant women, of which 157 received insulin aspart, 165 - human insulin) did not reveal any negative impact of insulin aspart on the course of pregnancy or fetal health / newborn.
Additional clinical studies in 27 women with gestational diabetes receiving insulin aspart and human insulin (14 women received insulin aspart, 13 women received human insulin) show comparable safety profiles along with a significant improvement in postprandial glucose control with insulin aspart treatment.
Pharmacokinetics.
After subcutaneous administration of insulin aspart, the time to reach the maximum concentration (t max) in blood plasma is on average 2 times less than after administration of soluble human insulin. The maximum plasma concentration (Cmax) averages 492 ± 256 pmol / l and is reached 40 minutes after a subcutaneous dose of 0.15 U / kg of body weight in patients with type 1 diabetes mellitus. The concentration of insulin returns to its original level 4-6 hours after the administration of the drug. The absorption rate is slightly lower in patients with type 2 diabetes, resulting in a lower maximum concentration (352±240 pmol/l) and a later t max (60 minutes).
The intra-individual variability in t max is significantly lower with insulin aspart compared to soluble human insulin, while the indicated variability in C max for insulin aspart is greater.
Pharmacokinetics in children (6-12 years old) and adolescents (13-17 years old) with type 1 diabetes mellitus. Absorption of insulin aspart occurs rapidly in both age groups with t max similar to that in adults. However, there are differences in Cmax in the two age groups, which emphasizes the importance of individual dosing of the drug. Elderly: The relative differences in pharmacokinetics between insulin aspart and soluble human insulin in elderly patients (65-83 years old, mean age 70 years) with type 2 diabetes mellitus were similar to those in healthy volunteers and in younger patients with diabetes mellitus. In elderly patients, a decrease in the rate of absorption was observed, which led to a slowdown in t max (82 (variability: 60-120) minutes), while C max was the same as that observed in younger patients with type 2 diabetes mellitus and slightly less than in patients with type 1 diabetes mellitus. Hepatic impairment: A pharmacokinetic study was conducted with a single dose of insulin aspart in 24 patients with normal to severe hepatic impairment. In persons with impaired liver function, the rate of absorption of insulin aspart was reduced and more variable, resulting in a slowing of t max from about 50 minutes in persons with normal function liver to about 85 minutes in persons with moderate to severe hepatic impairment. The area under the concentration-time curve, maximum plasma concentration and total drug clearance (AUC, Cmax and CL/F) were similar in patients with reduced and normal liver function. Renal impairment: The pharmacokinetics of insulin aspart was studied in 18 patients whose renal function ranged from normal to severe impairment. There was no clear effect of creatinine clearance on AUC, C max , t max of insulin aspart. Data were limited to those with moderate to severe renal impairment. Persons with kidney failure requiring dialysis were not included in the study.
Preclinical safety data:
No hazard to humans has been identified in preclinical studies based on data from established studies of safety pharmacology, repeated use toxicity, genotoxicity and reproductive toxicity. In 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. The results of the studies also showed that the dissociation of the binding of insulin aspart to the insulin receptor is equivalent to that of human insulin.
Indications for use:
Diabetes mellitus in adults, adolescents and children over 2 years of age.Contraindications:
Use during pregnancy and during breastfeeding
NovoRapid® FlexPen® can be administered during pregnancy. Data from two randomized controlled clinical trials (157 + 14 pregnant women examined) did not reveal any adverse effects of insulin aspart on pregnancy or fetal / newborn health compared to human insulin (see section "
Pharmacological properties:
"). Careful monitoring of blood glucose levels and monitoring of pregnant women with diabetes mellitus (type 1 diabetes, type 2 diabetes or gestational diabetes) is recommended throughout pregnancy and during possible pregnancy. The need for insulin, as a rule, decreases in the first trimester and gradually increases in the II and III trimesters of pregnancy. Shortly after delivery, insulin requirements quickly return to pre-pregnancy levels.During breastfeeding, NovoRapid® FlexPen® can be used, because. the introduction of insulin to a woman during breastfeeding does not pose a threat to the child. However, it may be necessary to adjust the dose of the drug.
Dosage and administration:
NovoRapid® FlexPen® is a fast-acting insulin analogue. 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 medium duration or long-acting, which are administered at least 1 time per day.To achieve optimal glycemic control, it is recommended to regularly measure the concentration of glucose in the blood and adjust the dose of insulin.
Usually individual daily requirement in insulin in adults and children ranges from 0.5 to 1 U / kg of body weight. When the drug is administered before meals, the need for insulin can be provided by NovoRapid® FlexPen® by 50-70%, the remaining insulin requirement is provided by long-acting insulin.
An increase in the patient's physical activity, a change in the habitual diet, or concomitant diseases may lead to the need for dose adjustment.
NovoRapid® FlexPen® has a faster onset and shorter duration of action than soluble human insulin. Due to the faster onset of action, NovoRapid® FlexPen® should usually be administered immediately before a meal, if necessary, it can be administered shortly after a meal. Due to the shorter duration of action compared to human insulin, the risk of nocturnal hypoglycemia in patients receiving NovoRapid® FlexPen® is lower.
Special patient groups
As with the use of other insulins, in elderly patients and patients with renal or hepatic insufficiency, blood glucose concentrations should be more carefully monitored and the dose of insulin aspart adjusted individually.
Children and teenagers
Use of NovoRapid® FlexPen® instead of soluble human insulin in children is preferable when a rapid onset of action of the drug is necessary, for example, when it is difficult for a child to observe the required time interval between injection and food intake.
Transfer from other insulin preparations
When transferring a patient from other insulin preparations to NovoRapid® FlexPen®, dose adjustment of NovoRapid® FlexPen® and basal insulin may be required.
NovoRapid® FlexPen® is injected subcutaneously into the region of the anterior abdominal wall, thigh, 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 all insulin preparations, subcutaneous injection into the anterior abdominal wall provides faster absorption compared to administration at other sites. The duration of action depends on the dose, site of administration, blood flow, temperature and level of physical activity. However, the faster onset of action compared to soluble human insulin is maintained regardless of injection site location.
NovoRapid® can be used for continuous subcutaneous insulin infusions (CSII) in insulin pumps designed for insulin infusions. CSII should be made into the anterior abdominal wall. Infusion sites should be changed periodically.
When using an insulin infusion pump, NovoRapid® should not be mixed with other types of insulin.
Patients using CSII should be fully trained in the use of the pump, appropriate reservoir, and pump tubing. The infusion set (tube and catheter) should be changed in accordance with the user manual supplied with the infusion set.
Patients receiving NovoRapid® via CSII should have extra insulin available in case of a breakdown in the infusion line.
Intravenous administration
If necessary, NovoRapid® can be administered intravenously, but only by qualified medical personnel.
For intravenous administration, infusion systems are used with the drug NovoRapid® 100 U / ml with a concentration of 0.05 U / ml to 1 U / ml of insulin aspart in 0.9% sodium chloride solution; 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. Although stable 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.
Side effect:
Adverse reactions observed in patients using NovoRapid® FlexPen® are mainly due to pharmacological effect insulin.The most common adverse reaction is hypoglycemia. Frequency of occurrence side effects varies depending on the patient population, dosing regimen and glycemic control (see section below).
On the initial stage refractive errors, edema and reactions at the injection sites (pain, redness, urticaria, inflammation, hematoma, swelling and itching at the injection site) may occur during insulin therapy. These symptoms are usually transient. Rapid improvement in glycemic control can lead to a state of "acute painful neuropathy", which is usually reversible. Intensification of insulin therapy with a dramatic improvement in carbohydrate control may lead to a temporary worsening of diabetic retinopathy, while long-term improvement in glycemic control reduces the risk of progression of diabetic retinopathy.
The list of adverse reactions is presented in the table.
|
Immune System Disorders | Infrequently - Urticaria, skin rash, skin rashes |
| Very rare - Anaphylactic reactions* | |
| Metabolic and nutritional disorders | Very common - Hypoglycemia* |
| Nervous System Disorders | Rarely - peripheral neuropathy ("acute painful neuropathy") |
|
Violations of the organ of vision | Infrequently - refractive errors |
| Uncommon - diabetic retinopathy | |
| Skin and subcutaneous tissue disorders | Uncommon - lipodystrophy* |
|
General disorders and disorders at the injection site | Infrequently - reactions at the injection sites |
| Infrequently - edema |
*Cm. "Description of selected adverse reactions"
All adverse reactions presented below, based on data obtained from clinical studies, are grouped according to the frequency of development in accordance with MedDRA and organ systems. The frequency of development of adverse reactions is defined as: very often (≥ 1/10); often (≥ 1/100 to<1/10); нечасто (≥1/1,000 до <1/100); редко (≥1/10,000 до <1/1,000), очень редко (<1/10,000) и неизвестно (невозможно оценить на основании имеющихся данных).
Description of individual adverse reactions:
Anaphylactic reactions
Very rare generalized hypersensitivity reactions (including generalized skin rash, pruritus, increased sweating, gastrointestinal disturbances, angioedema, difficulty breathing, rapid heartbeat, decreased blood pressure) have been reported, which are potentially life-threatening.
hypoglycemia
Hypoglycemia is the most common side effect. It can develop if the dose of insulin is too high in relation to the need for insulin. Severe hypoglycemia can lead to loss of consciousness and / or convulsions, temporary or irreversible impairment of brain function, and even death. Symptoms of hypoglycemia usually develop suddenly. These may include cold sweats, pale skin, increased fatigue, nervousness or tremors, anxiety, unusual tiredness or weakness, confusion, decreased concentration, drowsiness, severe hunger, visual disturbances, headache, nausea, and heart palpitations. . Clinical studies have shown that the incidence of hypoglycemia varies depending on the patient population, dosing regimen and glycemic control. In clinical studies, there was no difference in the overall incidence of episodes of hypoglycemia between patients receiving insulin aspart therapy and patients using human insulin preparations.
Lipodystrophy
Infrequent cases of lipodystrophy have been reported. Lipodystrophy can develop at the injection site.
Overdose:
The specific dose required for insulin overdose has not been established, however, hypoglycemia can develop gradually if doses that are too high in relation to the patient's needs are administered.Mild hypoglycemia can be corrected by the patient himself by ingesting glucose or sugar-containing foods. Therefore, diabetic patients are advised to carry sugar-containing products with them at all times.
- In case of severe hypoglycemia, when the patient is unconscious, 0.5 mg to 1 mg of glucagon should be administered intramuscularly or subcutaneously (a trained person may administer), or an intravenous glucose (dextrose) solution (only a medical professional may administer). It is also necessary to inject dextrose intravenously if the patient does not regain consciousness 10-15 minutes after the administration of glucagon. After regaining consciousness, the patient is advised to take a carbohydrate-rich meal to prevent the recurrence of hypoglycemia.
Interaction with other drugs
There are a number of drugs that affect the need for insulin.The hypoglycemic effect of insulin is enhanced by oral hypoglycemic drugs, monoamine oxidase inhibitors, angiotensin-converting enzyme inhibitors, carbonic anhydrase inhibitors, non-selective beta-blockers, bromocriptine, sulfonamides, anabolic steroids, tetracyclines, clofibrate, ketoconazole, mebendazole, pyridoxine, theophylline, cyclophosphamide, phenthylamine, drugs .
The hypoglycemic effect of insulin is weakened by oral contraceptives, glucocorticosteroids, thyroid hormones, thiazide diuretics, heparin, tricyclic antidepressants, sympathomimetics, somatropin, danazol, clonidine, slow calcium channel blockers, diazoxide, morphine, phenytoin, nicotine. Beta-adrenergic blockers may mask the symptoms of hypoglycemia. Octreotide/lanreotide can either increase or decrease insulin requirements.
Alcohol can either increase or decrease the hypoglycemic effect of insulin.
Incompatibility
Some drugs, for example, containing thiol or sulfite groups, when added to NovoRapid® FlexPen®, can cause the destruction of insulin aspart. NovoRapid® FlexPen® should not be mixed with other medicinal products. The exceptions are isophane-insulin and solutions for infusion, described in the section "
Dosage and administration:
».special instructions
The patient should consult with their healthcare provider prior to a long jet lag trip, as jet lag means that the patient must eat and inject insulin at different times.hyperglycemia
Insufficient dose of the drug or discontinuation of treatment, especially in type 1 diabetes mellitus, can 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 are nausea, vomiting, drowsiness, redness and dryness of the skin, dry mouth, increased urine output, thirst and loss of appetite, and the smell of acetone in the exhaled air. Without proper treatment, hyperglycemia can lead to death.
hypoglycemia
Skipping meals, unplanned increased physical activity, or too high a dose of insulin in relation to the patient's need can lead to hypoglycemia.
After compensation for carbohydrate metabolism, for example, with intensified insulin therapy, patients may change their typical symptoms, precursors of hypoglycemia, about which patients should be informed.
The usual warning symptoms may disappear with a long course of diabetes mellitus.
A consequence of the pharmacodynamic characteristics of short-acting insulin analogues is that the development of hypoglycemia with their use may begin earlier than with the use of soluble human insulin.
Since NovoRapid® FlexPen® should be used in direct connection with food intake, the high rate of onset of the effect of the drug should be taken into account when treating patients with concomitant diseases or taking drugs that slow down the absorption of food.
Concomitant diseases, especially infectious and accompanied by fever, usually increase 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, the early warning symptoms of hypoglycemia may become less pronounced than when using the previous type of insulin.
Transfer of the patient from other insulin preparations
The transfer of a patient to a new type of insulin or an insulin preparation 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 it is necessary to adjust the dose, it can be made already at the first administration of the drug or during the first weeks or months of treatment.
Reactions at the injection site
As with other insulin preparations, reactions at the injection site may develop, which is manifested by pain, redness, urticaria, inflammation, hematoma, swelling and itching. Regularly changing the injection site in the same anatomical area may reduce symptoms or prevent the development of reactions. In very rare cases, it may be necessary to cancel NovoRapid® FlexPen®.
Simultaneous use of drugs of the thiazolidinedione group and insulin drugs
Cases of the development of chronic heart failure have been reported in the treatment of patients with thiazolidinediones in combination with insulin preparations, especially if such patients have risk factors for the development of chronic heart failure. This fact should be taken into account when prescribing combination therapy with thiazolidinediones and insulin preparations to patients. When prescribing such a combination therapy, it is necessary to conduct medical examinations of patients in order to identify signs and symptoms of chronic heart failure, weight gain and the presence of edema. If symptoms of heart failure worsen in patients, treatment with thiazolidinediones should be discontinued.
Influence on the ability to drive vehicles and work with mechanisms
The ability of patients to concentrate and reaction speed may be impaired during hypoglycemia, which can be dangerous in situations where these abilities are especially needed (for example, when driving vehicles or working with machines and mechanisms). Patients should be advised to take measures to prevent the development of hypoglycemia when driving vehicles and working with mechanisms. This is especially important for patients with no or reduced symptoms of developing hypoglycemia or suffering from frequent episodes of hypoglycemia.
Release form:
Solution for subcutaneous and intravenous administration 100 IU/ml.3 ml of the drug in glass cartridges of hydrolytic class 1 with bromobutyl rubber pistons, sealed with bromobutyl rubber / polyisoprene disks on one side and sealed in plastic multi-dose disposable syringe pens for multiple injections on the other.
5 plastic multi-dose disposable syringe pens for multiple injections, together with instructions for use, are placed in a cardboard box.
Storage conditions:
Store between 2°C and 8°C (refrigerator) but away from the freezer. Do not freeze.To protect from light, store the syringe pen with the cap on.
NovoRapid® FlexPen® should be protected from exposure to excessive heat and light.
Do not store in the refrigerator when used or carried as a spare pen with the drug. Store at a temperature not exceeding 30°C. Use within 4 weeks.
Keep out of the reach of children.
Shelf life:
30 months. Do not use after the expiration date indicated on the pen label and packaging.Conditions for dispensing from pharmacies:
On prescription.Manufacturer:
Novo Nordisk A/SNovo Alle
DK-2880 Bagsvaerd, Denmark
Representation
Novo Nordisk A/S
119330, Moscow, Lomonosovsky prospect, 38, office 11
Precautions for use
NovoRapid® FlexPen® and needles are for individual use only. Do not refill the pen cartridge.
NovoRapid® FlexPen® must not be used if it is no longer clear and colorless, or if it has been frozen. Inform the patient to discard the needle after each injection.
NovoRapid® can be used in insulin pumps (see "
Dosage and administration:
"). Tubing with an inner surface made of polyethylene or polyolefin has been tested and found suitable for use in pumps.In case of emergency (hospitalization, malfunction of the insulin delivery device), NovoRapid® can be removed from FlexPen® using a U100 insulin syringe for administration to a patient.
Instructions for patients on the use of NovoRapid® FlexPen®
Do not use NovoRapid® FlexPen®
Before using NovoRapid® FlexPen®
Mode of application
NovoRapid® is intended for subcutaneous injection or long-term infusion in an insulin pump system (PPII). NovoRapid® can also be used intravenously under the strict supervision of a physician. Never inject insulin intramuscularly.
Change the injection site within the anatomical region each time. This will help reduce the risk of lumps and ulceration at the insertion site. It is best to inject the drug into the anterior abdominal wall, shoulder or anterior thigh. Insulin will act faster if it is injected into the anterior abdominal wall. Check your blood glucose levels regularly.
How to use NovoRapid® FlexPen®
Please read carefully the enclosed Patient Instructions for Use of NovoRapid® FlexPen®. Use your pen in strict accordance with this instruction.
Instructions for patients on the use of NovoRapid® FlexPen®
NovoRapid® FlexPen® is a unique insulin syringe pen with a dispenser and color coding. The dose of insulin administered, ranging from 1 to 60 units, can be changed in increments of 1 unit. NovoRapid® FlexPen® is designed for use with NovoFine® and NovoTwist® disposable needles up to 8 mm in length. As a precaution, always carry a spare insulin delivery system with you in case your NovoRapid® FlexPen® is lost or damaged.
Getting Started
Check the label to make sure NovoRapid® FlexPen® contains the correct type of insulin.
Use a new needle for each injection to prevent infection.
Be careful not to bend or damage the needle before use.
To avoid accidental injections, never put the inner cap back on the needle.
Insulin Check
Even with proper use of the pen, a small amount of air may accumulate in the cartridge before each injection.
To prevent air bubbles from entering and ensure the correct dose is administered:
E. Dial 2 units of the drug by turning the dosage selector. |
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F. Holding the NovoRapid® FlexPen® with the needle pointing up, lightly tap the cartridge several times with your fingertip to move the air bubbles to the top of the cartridge. |
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G. While holding NovoRapid® FlexPen® with the needle up, press the trigger button all the way. The dosage selector will return to zero. |  |
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Dose setting
Make sure the dosage selector is set to the "O" position.
Do not use the balance scale to measure the dose of insulin.
Storage and care
NovoRapid® FlexPen® is designed for effective and safe use and must be handled with care. In the event of a fall or strong mechanical impact, the syringe pen may be damaged and insulin may leak out.
The surface of NovoRapid® FlexPen® can be cleaned with a cotton swab dipped in alcohol. Do not immerse the pen in liquid, do not wash or lubricate it, because. this may damage the mechanism.
Do not refill NovoRapid® FlexPen®.
Insulin administration
Insert the needle under the skin. Use the injection technique recommended by your doctor.
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I. To inject, press the start button all the way down until "0" appears next to the dosage indicator. Be careful: when administering the drug, you should only press the start button. |  |
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J. When removing the needle from under the skin, keep the trigger button fully depressed. |  |
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K. Guide the needle into the outer needle cap without touching the cap. When the needle enters, put on the cap and unscrew the needle. |  |
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Remove the needle after each injection and never store NovoRapid® FlexPen® with the needle attached. Otherwise, liquid may leak out of NovoRapid® FlexPen®, which may lead to incorrect dosing.
Caregivers should be careful when removing and discarding needles to avoid the risk of accidental needle stick.
Throw away the used NovoRapid® FlexPen® with the needle removed.
Needles and NovoRapid® FlexPen® are intended for individual use only.
Insulin preparations are used to correct glucose levels in patients with diabetes mellitus. NovoRapid is one of the representatives of the latest generation of hypoglycemic agents. It is used as part of diabetes therapy to compensate for insulin deficiency if its synthesis in the body is impaired.
NovoRapid is slightly different from the usual human hormone, due to which it begins to act faster, and patients can start eating. immediately after its introduction. Compared to traditional insulins, NovoRapid shows better results: in diabetics, glucose stabilizes after meals, the number and severity of nighttime decreases. The advantages include a stronger effect of the drug, which allows most people with diabetes to reduce its dosage.
Instructions for use
NovoRapid insulin is produced by the Danish pharmaceutical company Novo Nordisk, whose main goal is to improve glycemic control in patients with diabetes. The active ingredient in the preparation is aspart. Its molecule is an analogue of insulin, it repeats its structure with the exception of a single, but significant difference - one replaced amino acid. Due to this, aspart molecules do not stick together to form hexamers, as in regular insulin, but are in a free state, so they begin work to reduce sugar faster. Such a replacement has become possible thanks to modern bioengineering technologies. Comparison of aspart with human insulin did not reveal any negative effects of the modification of the molecule. On the contrary, the effect of drug administration became stronger and more stable.
NovoRapid is a ready-made solution for subcutaneous administration, it is used for all types of diabetes mellitus, if there is a serious lack of own insulin. The drug is allowed in children (from 2 years old) and the elderly, pregnant women. It can be injected with syringe pens and. For the treatment of acute hyperglycemic conditions, intravenous administration is possible.
Important information for diabetics about insulin NovoRapide from the instructions for use:
| Pharmacodynamics | The main action of NovoRapid, like any other insulin, is to lower blood sugar. It significantly improves the permeability of cell membranes, allowing glucose to pass inside, activates the breakdown of glucose, increases glycogen stores in muscles and liver, and stimulates the synthesis of fats and proteins. |
| Release form | Available in 2 forms:
According to the instructions, insulin Penfill and Flexpen are similar in composition and concentration. Penfill is more convenient to use if low doses of the drug are required. |
| Indications |
|
| Side effects | The most common side effect of insulin is. It develops when the dosage of insulin administered exceeds the needs of the body. Infrequently (0.1-1% of diabetics), allergies can occur both at the injection site and generalized. Symptoms: swelling, rash, itching, digestive problems, redness. In 0.01% of cases, anaphylactic reactions are possible. Temporarily, during a period of a sharp decrease in glycemia, diabetics may experience symptoms of neuropathy, blurred vision, and swelling. These side effects disappear on their own without treatment. |
| Dose selection | The right amount is calculated depending on the carbohydrate content of the food. The dose increases with serious physical exertion, stress, diseases with fever. |
| The influence of drugs | Some medicines may increase or decrease the need for insulin. These are mainly hormonal drugs, antidepressants, tablets for the treatment of hypertension. Beta-blockers can lessen the symptoms of hypoglycemia, making it harder to recognize. Drinking alcohol together with NovoRapid is prohibited, as it significantly impairs the compensation of diabetes mellitus. |
| Rules and storage time | According to the instructions, unused insulin is stored in a refrigerator capable of maintaining a temperature of 2-8°C. Cartridges - within 24 months, syringe pens - 30 months. The started package can be kept at room temperature for 4 weeks. Aspart is destroyed by sunlight, at temperatures below 2 and above 35 degrees. |
Due to the fact that NovoRapid is very sensitive to storage conditions, patients with diabetes should acquire special cooling devices for its transportation -. Insulin cannot be bought from advertisements, since a spoiled drug may not visually differ from normal in any way.
Average price of NovoRapid insulin:
- Cartridges: 1690 rubles. per pack, 113 rubles. for 1 ml.
- Syringe pens: 1750 rubles. per pack, 117 rubles. for 1 ml.
Let us consider in more detail how to administer NovoRapid correctly, when its action begins and ends, in which cases insulin may not work, with what drugs it should be combined.
Novorapid (Flexpen and Penfill) - the drug acts very quickly
Pharmacological group
NovoRapid is considered an ultra-short acting insulin. The hypoglycemic effect after its introduction is observed earlier than when using, and their analogues. The onset of action is between 10 and 20 minutes after the injection. The time depends on the individual characteristics of the diabetic, the thickness of the subcutaneous tissue at the injection site and its blood supply. The maximum effect occurs 1-3 hours after the injection. Inject insulin NovoRapid 10 minutes before meals. Due to the accelerated action, it immediately removes incoming sugar, preventing it from accumulating in the blood.
Typically, aspart is used in conjunction with long-acting and intermediate-acting insulins. If a diabetic has an insulin pump, only a short hormone is enough for him.
Time of action
To avoid unnecessary damage to the skin and subcutaneous tissue at injection sites, NovoRapid insulin should only be at room temperature, and the needle should be new every time. The injection site is constantly changed, the same area of skin can be reused after 3 days and only if there are no injection marks left on it. The most rapid absorption is characteristic of the anterior abdominal wall. It is in the area around the navel and lateral ridges that it is advisable to inject short insulin.
Before using new means of introduction, syringe pens or pumps, you need to study their instructions for use in detail. At first, it is worth more often than usual to measure blood sugar. To be sure of the correct dosage of the product, all consumables must be strictly disposable. Their repeated use is fraught with an increase in the risk of side effects.
Non-standard action
If the calculated dose of insulin does not work, and hyperglycemia occurs, it can be eliminated only after 4 hours. Before the introduction of the next portion of insulin, you need to establish the reason why the previous one did not work.
It could be:
- Expired product or improper storage conditions. If the medicine is forgotten in the sun, frozen, or it has been in the heat for a long time without a thermo bag, the bottle must be replaced with a new one from the refrigerator. The spoiled solution may become cloudy, with flakes inside. Possible formation of crystals on the bottom and walls.
- Incorrect injection, calculated dose. The introduction of insulin of a different type: long instead of short.
- Breakage of the syringe pen, poor-quality needle. The patency of the needle is controlled by squeezing a drop of solution out of the syringe. It is impossible to check the performance of the syringe pen, so it is replaced at the first suspicion of a breakdown. A diabetic should always carry a spare insulin delivery device with him.
- Using a pump may clog the infusion line. In this case, it must be replaced ahead of schedule. The pump usually warns of other breakdowns with an audible signal or a message on the screen.
An increase in the action of NovoRapida insulin can be observed with its overdose, alcohol intake, insufficient liver and kidney function.
Replacing NovoRapid with Levemir
NovoRapid and Levemir are drugs from the same manufacturer with fundamentally different effects. What is the difference: Levemir is a long insulin, it is administered up to 2 times a day to create the illusion of basic secretion of the hormone.
NovoRapid - ultrashort, needed to reduce sugar after eating. In no case should you replace one with the other, this will lead first to hyper-, and after a few hours to hypoglycemia.
Diabetes mellitus requires complex treatment, both a long and a short hormone are needed to normalize sugar. Insulin NovoRapid is often combined with Levemir, since their interaction is well studied.
Analogues
Currently, NovoRapid insulin is the only ultrashort drug in Russia with aspart as an active substance. In 2017, Novo Nordisk launched a new insulin, Fiasp, for sale in the US, Canada and Europe. In addition to aspart, it contains other components, making its action even faster and more stable. Such insulin will help solve the problem of high sugar after a meal containing a large amount of fast carbohydrates. It can also be used by diabetics with an unstable appetite, since this hormone can be injected immediately after a meal, counting the food eaten. It is not yet possible to buy it on the territory of Russia, and when ordering from other countries, its price is much higher than that of NovoRapid, about 8500 rubles. for packing.
Available analogues of NovoRapid are Humalog and Apidra insulins. Their profile of action is almost the same, despite the fact that the active substances are different. It is necessary to change insulin to an analogue only in case of allergic reactions to a certain brand, since the replacement requires the selection of a new dose and will inevitably lead to a temporary deterioration in glycemia.
Application during pregnancy
Clinical studies have shown that NovoRapid insulin is not toxic and does not affect the development of the fetus, so it is allowed to be used during pregnancy. According to the instructions, during the bearing of a child, patients with diabetes require repeated dose adjustments: a decrease in the 1st trimester, an increase in the 2nd and 3rd. During childbirth, much less insulin is required; after childbirth, a woman usually returns to dosages calculated before pregnancy.
Aspart does not penetrate into milk, so breastfeeding will not harm the baby.
Novo Nordisk A/S Novo Nordisk A/S Novo Nordisk A/S/ Novo Nordisk OOOCountry of origin
Denmark Denmark/RussiaProduct group
Remedies for diabetesShort-acting human insulin analog
Release forms
- 3 ml - glass cartridges - multi-dose disposable syringe pens for multiple injections 5 pieces - packs of cardboard
Description of the dosage form
- Solution for s / c and / in the introduction of a transparent, colorless.
pharmachologic effect
A hypoglycemic drug, a short-acting human insulin analogue produced by recombinant DNA biotechnology using a strain of Saccharomyces cerevisiae, in which the proline amino acid at position B28 is replaced by aspartic acid. Interacts with a specific receptor on the outer cytoplasmic membrane of cells and forms an insulin-receptor complex that stimulates intracellular processes, incl. 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 uptake by tissues, stimulation of lipogenesis, glycogenogenesis, and a decrease in the rate of glucose production by the liver. The replacement of the amino acid proline at position B28 with aspartic acid in insulin aspart reduces the tendency of molecules to form hexamers, which is observed in a solution of regular insulin. In this regard, insulin aspart is much faster absorbed from the subcutaneous fat and begins to act much faster than soluble human insulin. Insulin aspart reduces blood glucose levels more strongly in the first 4 hours after a meal than soluble human insulin. The duration of action of insulin aspart after subcutaneous administration is shorter than that of soluble human insulin. After s / c injection, the effect of the drug begins within 10-20 minutes after administration. The maximum effect is observed 1-3 hours after injection. The duration of action of the drug is 3-5 hours. In clinical studies involving patients with type 1 diabetes mellitus, a reduced risk of nocturnal hypoglycemia has been shown with the administration of insulin aspart compared with soluble human insulin. The risk of daytime hypoglycemia was not significantly increased. Insulin aspart is equipotential to soluble human insulin based on molarity. In clinical studies in adult patients with type 1 diabetes mellitus, insulin aspart has been shown to result in lower postprandial blood glucose levels compared to soluble human insulin. A randomized, double-blind, cross-over study of the pharmacokinetics and pharmacodynamics of insulin aspart and soluble human insulin was conducted in elderly patients with type 2 diabetes mellitus (19 patients aged 65-83 years, mean 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 in younger diabetics. When using insulin aspart in children and adolescents, similar results of long-term glucose control are shown compared with soluble human insulin. 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); and a single dose pharmacokinetic/pharmacodynamic study was conducted in children 6-12 years of age and adolescents 13-17 years of age. 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 mellitus (322 examined: 157 received insulin aspart, 165 received human insulin) did not reveal any negative impact of insulin aspart on pregnancy or fetal health. newborn. Additional clinical studies in 27 women with gestational diabetes treated with insulin aspart (14 patients) and human insulin (13 patients) show comparable safety profiles along with a significant improvement in postprandial glucose control when treated with insulin aspart.Pharmacokinetics
Absorption After subcutaneous administration of insulin, aspart Tmax in blood plasma is on average 2 times less than after administration of soluble human insulin. Cmax in blood plasma averages 492 ± 256 pmol / l and is achieved 40 minutes after s / c administration at a dose of 0.15 U / kg of body weight in patients with type 1 diabetes mellitus. The concentration of insulin returns to its original level 4-6 hours after the administration of the drug. The rate of absorption is somewhat lower in patients with type 2 diabetes mellitus, resulting in a lower Cmax (352±240 pmol/l) and a later Tmax (60 min). The intra-individual variability in Tmax is significantly lower with insulin aspart compared to soluble human insulin, while the reported variability in Cmax for insulin aspart is greater. Pharmacokinetics in special clinical situations Children (6-12 years) and adolescents (13-17 years) with type 1 diabetes mellitus: absorption of insulin aspart occurs rapidly in both age groups with Tmax similar to that of adults. However, there are differences in Cmax in the two age groups, which emphasizes the importance of individual dosing of the drug. Elderly: The relative differences in pharmacokinetics between insulin aspart and soluble human insulin in elderly patients (65-83 years, mean age 70 years) with type 2 diabetes mellitus were similar to those in healthy volunteers and in younger patients with diabetes mellitus. In elderly patients, a decrease in the rate of absorption was observed, which led to a slowing of Tmax (82 (variability: 60-120 min), while Cmax was the same as that observed in younger patients with type 2 diabetes mellitus and slightly less than in patients with diabetes mellitus Type 1 Hepatic impairment: A pharmacokinetic study was conducted with a single dose of insulin aspart in 24 patients with normal to severely impaired liver function.In individuals with impaired liver function, the absorption rate of insulin aspart was reduced and more variable, resulting which was a slowdown from approximately 50 minutes in subjects with normal liver function to approximately 85 minutes in subjects with moderate to severe hepatic impairment.The AUC, Cmax, and total clearance of the drug were similar in subjects with reduced and normal liver function. : a study of the pharmacokinetics of insulin aspart was conducted in 18 patients, func whose kidney function ranged from normal to severe impairment. No clear effect of creatinine clearance on AUC, Cmax, Tmax of insulin aspart was found. Data were limited to those with moderate to severe renal impairment. Individuals with renal insufficiency requiring dialysis were not included in the study. Preclinical Safety Data: No hazard to humans has been identified in preclinical studies based on data from conventional safety pharmacology studies.Special conditions
Insufficient dose of the drug or discontinuation of treatment, especially in type 1 diabetes mellitus, can lead to the development of hyperglycemia or diabetic ketoacidosis. As a rule, the symptoms of hyperglycemia appear gradually, over several hours or days. Symptoms of hyperglycemia are nausea, vomiting, drowsiness, redness and dryness of the skin, dry mouth, increased urine output, thirst and loss of appetite, and the smell of acetone in the exhaled air. Without proper treatment, hyperglycemia can lead to death. After compensation of carbohydrate metabolism, for example, with intensified insulin therapy, patients may change their typical symptoms, precursors of hypoglycemia, about which patients should be informed. In diabetic patients with optimal metabolic control, late complications of diabetes develop later and progress more slowly. In this regard, it is recommended to carry out activities aimed at optimizing metabolic control, including monitoring blood glucose levels. A consequence of the pharmacodynamic characteristics of short-acting insulin analogues is that the development of hypoglycemia with their use begins earlier than with the use of soluble human insulin. Due to the shorter duration of action compared to human insulin, the risk of nocturnal hypoglycemia in patients receiving NovoRapid® FlexPen® is lower. NovoRapid® FlexPen® should be used in direct connection with food intake. Consideration should be given to the high rate of onset of the effect of the drug in the treatment of patients with concomitant diseases or taking drugs that slow down the absorption of food. In the presence of concomitant diseases, especially infectious nature, the need for insulin, as a rule, increases. Impaired kidney or liver function may lead to a decrease in insulin requirements. Use of NovoRapid® FlexPen® instead of soluble human insulin in children is preferable when a rapid onset of action of the drug is necessary, for example, when it is difficult for a child to observe the required time interval between injection and food intake. When a patient is transferred to other types of insulin, the early warning symptoms of hypoglycemia may change or become less pronounced than when using the previous type of insulin. The transfer of a patient to a new type of insulin or an insulin preparation from another manufacturer must be carried out under strict medical supervision. If the concentration, type, manufacturer and type (human insulin, animal insulin, human insulin analog) of insulin preparations and/or method of manufacture may require a change in dose. Patients switching to treatment with NovoRapid® FlexPen® may require an increase in the frequency of injections or a dose change compared to the doses of previously used insulin preparations.Compound
- insulin aspart 100 units * Excipients: glycerol, phenol, metacresol, zinc chloride, sodium hydrogen phosphate dihydrate, sodium chloride, hydrochloric acid or sodium hydroxide, water for injections. * - 1 unit corresponds to 35 mcg of anhydrous insulin aspart.
NovoRapid FlexPen indications for use
- diabetes.
NovoRapid FlexPen contraindications
- - hypoglycemia; - hypersensitivity to insulin aspart and other components of the drug. It is not recommended to use the drug NovoRapid® FlexPen® in children under the age of 2 years, because. clinical studies in children under 2 years of age have not been conducted.
NovoRapid FlexPen dosage
- 100 U/ml
NovoRapid FlexPen side effects
- On the part of the endocrine system: adverse reactions observed in patients using NovoRapid® FlexPen® are mainly dose-dependent and are due to the pharmacological effect of insulin. The most common adverse event with insulin is hypoglycemia. Hypoglycemia develops if too high a dose of insulin is administered relative to the body's need for insulin. Symptoms of hypoglycemia usually develop suddenly. These may include cold sweats, pale skin, nervousness or tremors, anxiety, unusual tiredness or weakness, disorientation, difficulty concentrating, dizziness, severe hunger, temporary blurred vision, headache, nausea, tachycardia. Severe hypoglycemia can lead to loss of consciousness and/or seizures, temporary or permanent brain damage, and death. The incidence of side effects during the use of NovoRapid® FlexPen® is presented below. The incidence of side effects: infrequently (> 1/1000, 1/10 000,
drug interaction
The hypoglycemic effect of insulin is enhanced by oral hypoglycemic drugs, MAO inhibitors, ACE inhibitors, carbonic anhydrase inhibitors, non-selective beta-blockers, bromocriptine, octreotide, sulfonamides, anabolic steroids, tetracyclines, clofibrate, ketoconazole, mebendazole, pyridoxine, theophylline, cyclophosphamide, fenflur, preparations containing ethanol. The hypoglycemic effect of insulin is weakened by oral contraceptives, corticosteroids, thyroid hormones, thiazide diuretics, heparin, tricyclic antidepressants, sympathomimetics, danazol, clonidine, calcium channel blockers, diazoxide, morphine, phenytoin, nicotine. Under the influence of reserpine and salicylates, both a weakening and an increase in the effect of the drug are possible. Pharmaceutical incompatibility Drugs containing thiol or sulfite, when added to insulin, cause its destructionOverdose
hypoglycemiaStorage conditions
- store in a dry place
- keep away from children
- store in a place protected from light
Synonyms
- 1 unit corresponds to 35 mcg of anhydrous insulin aspart
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