home→Stomach→ How is insulin Novorapid Flexpen and Penfill used? Novorapid penfill, solution for subcutaneous and intravenous administration Novorapid mn name.

How is insulin Novorapid Flexpen and Penfill used? Novorapid penfill, solution for subcutaneous and intravenous administration Novorapid mn name.

During the day, the amount of insulin in the blood is not at the same level. During meals, the peak release of the hormone occurs. To mimic this in diabetics, ultrashort insulin, such as NovoRapid, is used. It is included in the basal bolus therapy regimen for diabetes mellitus in order to better control sugar levels and avoid the development of complications of diabetes.

Description of the hormone

NovoRapid is an analogue of short human insulin. The active ingredient is insulin Aspart. The drug is synthesized by genetic engineering, replacing proline with an aspartic amino acid. This does not allow the formation of hexamers, the hormone is absorbed at a faster rate from the subcutaneous fat. It shows its effect in 10-20 minutes, the effect does not last as long as that of regular insulin, only 4 hours.

Pharmacological features

NovoRapid has the appearance of a colorless transparent solution. 1 ml contains 100 units (3.5 mg) of insulin Aspart. Biological effects are based on the interaction of the hormone with cell membrane receptors. This stimulates the formation of the main enzymes:

Hexokinase.
Pyruvate kinases.
glycogen synthase.

They are involved in the metabolism of glucose, accelerate its utilization and reduce the concentration in the blood. It is also provided by the following mechanisms:

Enhanced lipogenesis.
Stimulation of glycogenogenesis.
Accelerating the use of tissues.
Inhibition of glucose synthesis in the liver.

Using only NovoRapid is impossible, it is administered on Levemir, which ensures the maintenance of the natural amount of insulin in between meals.

Clinical studies of the action of the drug flexpene showed that in adult patients the likelihood of hypoglycemia at night is reduced in comparison with traditional insulin. The drug has proven effective in maintaining normoglycemia in elderly patients with type 2 diabetes and when administered to children.

In women diagnosed before pregnancy diabetes Type 1 does not adversely affect the fetus or gestation. The use of insulin NovoRapid Flexpen for the treatment of gestational diabetes (diagnosed for the first time during pregnancy) improves control over the amount of glycemia after meals.

It should be remembered that the action of ultrashort insulins is much stronger than that of the usual one. For example, 1 unit of NovoRapid is 1.5 times stronger than short insulin. Therefore, the dosage for a single injection should be reduced.

Novorapid begins to act in 10-20 minutes, the effect lasts 4 hours

Who is prescribed a hormone, and who is contraindicated

To prescribe NovoRapid, the patient must be diagnosed with:

Diabetes mellitus type 1.
Type 2 diabetes requiring a combination of insulin and pills.
Gestational diabetes.

This drug has proven to be safe in lowering blood sugar in pregnant women, as evidenced by clinical trials.

Treatment is contraindicated in case of individual hypersensitivity to the components of the drug, as well as in children under 2 years of age: clinical trials for young children have not been performed. During breastfeeding he does not pose a danger to the child, but the number of units needs to be adjusted.

Side effects

Undesirable effects from the NovoRapid insulin preparation in the form of a Flexpen cartridge are due to the action of insulin itself. It is able to lower glucose to the state of hypoglycemia.

When therapy is started, transient symptoms may occur. side effects, which pass over time:

Refractive errors.
Pain, hyperemia and swelling at the injection site.
Hematomas at injection sites.
Acute painful neuropathy.

Gradually, these manifestations disappear. Other effects develop infrequently:

From the side immune system- Urticaria, skin rash, anaphylactic reactions.
On the part of vision - retinopathy, refractive error.
Partial or complete disappearance of adipose tissue at injection sites.

Wrong choice and excess dosage lead to the development of a dangerous condition - hypoglycemia. Her symptoms appear suddenly. Disturbed by weakness, dizziness, pallor, nausea, drowsiness. The patient throws into sweat, concentration of attention and vision is disturbed. In severe cases, there is loss of consciousness, irreversible changes in the brain and death. Therefore, it is important to choose the right dosage, to administer the drug on time.

Dosage and administration

How many units of flexpene hormone is needed, the doctor decides on an individual basis. How much insulin is needed is calculated based on the fact that a person needs on average half or one unit per kilogram of body weight per day. Treatment is coordinated with meals. At the same time, the ultrashort hormone covers up to 70% of the need for the hormone, the remaining 30% is covered by long insulin.

Insulin NovoRapid in the form of Penfill should be taken 10-15 minutes before the start of a meal.

Insulin NovoRapid in the form of Penfill is administered 10-15 minutes before meals. If an injection was missed, it can be administered without delay after a meal. How many hours the action lasts depends on the injection site, the number of units of the hormone in the dose, physical activity and the carbohydrates taken.

According to the indications, this drug can be used intravenously. An insulin pump (pump) is also used for administration. With its help, a hormone is injected under the skin of the anterior abdominal wall for a long time, periodically changing the injection points. It is impossible to dissolve pancreatic hormone in other preparations.

For intravenous use, take a solution that contains insulin up to 100 U / ml, diluted in 0.9% sodium chloride, 5% or 10% dextrose. During the infusion period, blood glucose must be monitored.

NovoRapid is available in the form of a Flexpen syringe pen and Penfill replaceable cartridges for it. One pen contains 300 units of the hormone in 3 ml. The syringe is used only individually.

Unopened packaging is kept in the refrigerator at 2-8 degrees, but in no case is it frozen. After opening, it is stored at room temperature, protected from direct sunlight and heating above 30 degrees.

The pen is used with disposable needles and is equipped with a dispenser. To make an injection, you need to remove the cap, the sticker from the needle and screw it to the syringe. The needle needs to be changed with each injection. To release air bubbles, use the selector to collect 2 IU of the hormone. The handle is placed up with a needle, lightly tapped on it. When the bubbles move up, press the start button. A drop of solution should appear on the cut of the needle. If this does not happen, the procedure is repeated up to 6 times. The absence of a result indicates a malfunction of the syringe.

After that, set the dose prescribed by the doctor. To inject the drug, press the start button and hold until the selector takes the zero position. After injection, the needle is capped and discarded.

Analogues of ultrashort insulins and cost

NovoRapid has modern analogues that are similar to it in action and effect development. These are Apidra and Humalog. Humalog is faster: 1 U acts 2.5 times faster than the same amount of short hormone. In Apidra, the effect develops at about the same speed as in NovoRapid.

The cost of 5 Flexpen syringe pens is about 1930 rubles. A replacement Penfill cartridge costs up to 1800 rubles. The cost of analogues, which are also available in syringe pens, is approximately identical and ranges from 1,700 to 1,900 rubles in various pharmacies.

Conclusion

Therapy of diabetes mellitus is aimed at maintaining normoglycemia. To achieve the desired glucose values, the patient is prescribed basal bolus therapy. The choice of specific drugs is made by the doctor based on monitoring the concentration of glucose at different times of the day. Due to their short duration of action, ultrashort insulins are prescribed to patients who do not know exactly what time they will eat. For most, short insulins are given first.

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 during the period of use of 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. The international name is 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 component. As part of both pens and cartridges of 3 ml of insulin.

The manufacture of NovoRapid insulin occurs 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 the cells, as well as the chemical compound of the 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 rate, temperature and the degree of 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.

Novorapid is a drug with a hypoglycemic effect.

Release form and composition

Novorapid is produced in the form of a solution for subcutaneous and intravenous administration: transparent, colorless (in 3 ml glass cartridges; Novorapid Penfill - 5 cartridges in blister packs, 1 blister in a cardboard box; Novorapid Flexpen - 1 cartridge in multi-dose disposable syringe pens for multiple injections, 5 syringe pens per cardboard box).

1 ml of solution contains:

Active substance: insulin aspart - 3.5 mg (100 IU (action units));
Auxiliary components: water for injection - up to 1 ml; hydrochloric acid 2M - about 1.7 mg; sodium hydroxide 2M - about 2.2 mg; sodium hydrophosphate dihydrate - 1.25 mg; sodium chloride - 0.58 mg; zinc chloride - 0.0196 mg; metacresol - 1.72 mg; phenol - 1.5 mg; glycerol - 16 mg.

Indications for use

Novorapid is used to treat diabetes mellitus.

Contraindications

Age up to 2 years (due to the lack of necessary clinical data confirming its safety and efficacy for this age group of patients);

Method of application and dosage

The solution is administered subcutaneously, intravenously.

Medicine is a fast-acting insulin analogue. The doctor determines the dosage individually, depending on the needs of the patient.

Novorapid is usually used in combination with intermediate-acting or long-acting insulin preparations administered at least once a day.

In order to achieve optimal glycemic control, it is necessary to regularly adjust the dose of insulin and measure the concentration of glucose in the blood. In most cases, the individual daily requirement for insulin in children and adults varies between 0.5-1 IU per 1 kg of body weight. In cases of administration of Novorapid before meals, the need for insulin can be provided by 50-70%, the remaining need is provided with long-acting insulin.

The need for dose adjustment may occur with an increase in the patient's physical activity, a change in habitual nutrition, or a concomitant disease.

The drug has a rapid onset and shorter duration of action compared to soluble human insulin. Due to the faster onset of action, it is recommended to administer it immediately before meals, and also shortly after meals (if necessary). The risk of developing nocturnal hypoglycemia in patients receiving Novorapid therapy is lower than when using human insulin, which is associated with its shorter duration of action.

During the period of use of the drug, as well as other insulin-containing drugs, in patients with hepatic or kidney failure and elderly patients, more careful monitoring of blood glucose concentrations and individual dose adjustment of insulin aspart are necessary.

The use of Novorapid in children and adolescents instead of soluble human insulin is preferable in cases where a rapid onset of action of the drug is required (for example, when it is difficult for a child to observe the required interval between injection and food intake).

In cases of transferring a patient from other insulin-containing drugs, it may be necessary to adjust the dose of Novorapid and basal insulin.

The solution is injected subcutaneously into the gluteal or deltoid region, shoulder, thigh, region of the anterior abdominal wall. Within the same area of the body, injection sites should be changed regularly to reduce the risk of developing lipodystrophy. Subcutaneous administration of Novorapid, as well as other insulin-containing drugs, into the anterior abdominal wall provides faster absorption compared to administration to other sites.

The duration of action of the drug directly depends on the level of physical activity, temperature, intensity of blood flow, the site of administration and the dose used. However, the faster onset of action compared to soluble human insulin is maintained regardless of injection site location.

It is allowed to use the drug for long-term subcutaneous insulin infusions in insulin pumps designed for insulin infusions. Long-term subcutaneous insulin infusions should be made in the anterior abdominal wall and periodically change the place of their application. Novorapid must not be mixed with other types of insulin when using an insulin infusion pump.

Patients using continuous subcutaneous insulin infusions should be fully trained in the use of the pump, tubing, and appropriate reservoir.

The infusion set (catheter and tubing) must be changed in accordance with the user manual supplied with the infusion set. Patients receiving Novorapid by continuous subcutaneous insulin infusions are advised to have additional insulin available in case of breakdown of the infusion system.

The drug, if necessary, can be administered intravenously, but only by qualified medical personnel.

For intravenous administration, infusion systems are used with Novorapid 100 IU per 1 ml with a concentration ranging from 0.04-1 IU per 1 ml of insulin aspart in 0.9% sodium chloride solution, 5% dextrose solution or 10% dextrose solution containing 40 mmol per 1 liter of potassium chloride, using polypropylene infusion containers. These solutions are stable at room temperature for 24 hours. For some time, despite stability, a certain amount of insulin is initially absorbed by the material of the infusion system. When conducting insulin infusion, it is important to constantly monitor the concentration of blood glucose.

Cases when Novorapid cannot be used:

low blood glucose (onset of hypoglycemia);
Violation of the storage conditions of the solution or its freezing;
Insulin is no longer colorless and transparent;
The cartridge or insulin delivery system with the cartridge installed has been damaged;
Hypersensitivity to the components of the drug.

Before using Novorapid, you should make sure that the label indicates the correct type of insulin, there is no visible damage on the cartridge or a gap between the white strip and the piston. A new needle must be used for each injection to avoid infection. The drug and needles must be used individually. Insulin should not be administered intramuscularly. The needles should be discarded after each injection.

The drug can be used in insulin pumps. Suitable for use in pumps were considered tubes, the inner surface of which was made of polyolefin or polyethylene. In emergency cases (failure of the insulin delivery device, hospitalization), the solution can be withdrawn from the cartridge/pen using the U100 insulin syringe for administration to the patient.

When injecting, use the technique recommended by your doctor or nurse.

The needle must be held under the skin for at least 6 seconds. The start button must be kept pressed until the needle is removed from under the skin, which will ensure the introduction of a full dose of Novorapid and prevent blood from entering the insulin cartridge or needle. You cannot refill the cartridge with insulin.

Side effects

The disturbances observed in patients with the use of Novorapid are mainly due to the pharmacological effect of insulin.

Development frequency side effects may vary depending on the patient population, dosing regimen and glycemic control. On the initial stage insulin therapy may develop refractive errors, edema and reactions at the injection site of the solution (in the form of redness, pain, inflammation, urticaria, hematoma, itching and swelling at the injection site). As a rule, these symptoms are transient. Rapid improvement in glycemic control can lead to acute painful neuropathy, which is reversible in most cases.

With the intensification of insulin therapy with a sharp improvement in the control of carbohydrate metabolism, a temporary worsening of the state of diabetic retinopathy may develop, while a long-term improvement in glycemic control reduces the likelihood of progression of diabetic retinopathy.

During the use of Novorapid, the following disorders may develop (> 10% - very often; > 1% and<10% – часто; >0.1% and<1% – нечасто; >0.01% and<0,1% – редко; <0,01% – очень редко; при невозможности оценить частоту развития побочных действий – с неизвестной частотой):

Nervous system: rarely - acute pain (peripheral) neuropathy;
Immune system: infrequently - skin rash, urticaria, skin rashes; very rarely - anaphylactic reactions;
Skin and subcutaneous tissues: infrequently - lipid degeneration (at the injection site of the solution);
Organ of vision: infrequently - refractive errors, diabetic retinopathy;
Metabolism and nutrition: very often - hypoglycemia;
General disorders and disorders at the injection site: infrequently - edema, reactions at the injection site.

In very rare cases, anaphylactic reactions manifest themselves in the form of a generalized skin rash, itching, increased sweating, gastrointestinal disorders, angioedema, difficulty breathing, rapid heartbeat, lowering blood pressure. These disorders can be life threatening.

Hypoglycemia is one of the most common side effects. Its development is possible in cases of too high a dose of insulin in relation to the need for it. In severe hypoglycemia, there may be loss of consciousness and / or convulsions, temporary or irreversible impairment of brain function, up to death. As a rule, signs of hypoglycemia develop suddenly. These include: cold sweat, pallor of the skin, increased fatigue, nervousness or tremors, anxiety, decreased concentration, unusual tiredness or weakness, disorientation, severe hunger, drowsiness, visual disturbances, headache, heart palpitations and nausea.

special instructions

Before a long trip, which is associated with a change in time zones, you should consult your doctor, because in this case you should eat and administer Novorapid at a different time.

When using the drug in an insufficient dose or when therapy is stopped, especially in patients with type 1 diabetes mellitus, diabetic ketoacidosis and hyperglycemia may develop. As a rule, signs of hyperglycemia (in the form of nausea, vomiting, drowsiness, redness and dryness of the skin, dry mouth, increased urine output, thirst and loss of appetite, the smell of acetone in exhaled air) occur gradually, over several hours or days. Without appropriate therapy, hyperglycemia can lead to death.

With unplanned increased physical activity, skipping meals, or too high a dose of insulin in relation to the patient's needs, hypoglycemia may develop. After compensation for carbohydrate metabolism, patients may change their typical symptoms, precursors of hypoglycemia. With a prolonged course of diabetes mellitus, the symptoms-precursors may disappear.

The development of hypoglycemia with the use of short-acting insulin analogs may begin earlier than with soluble human insulin therapy.

It is necessary to take into account the high rate of onset of the effect of Novorapid in the treatment of patients with concomitant diseases or taking drugs that slow down the absorption of food. As a rule, concomitant diseases, especially those accompanied by fever and infectious diseases, increase the body's need for insulin. Also, correction of the dosing regimen may be required in the presence of concomitant pathologies of the liver, kidneys, functional disorders of the adrenal glands, thyroid gland or pituitary gland.

Due to the transfer of the patient to other types of insulin, it is possible to reduce the severity of early symptoms, precursors of hypoglycemia.

It is necessary to transfer the patient to a new type of insulin or insulin from another manufacturer under strict medical supervision. If the type, concentration, type (animal insulin, human insulin, human insulin analog) and the manufacturer of insulin preparations and/or the method of its manufacture change, it may be necessary to change the dosing regimen or increase the frequency of injections compared to previously used insulin preparations. If a dose adjustment is necessary, it can be made already at the first administration of the drug or during the first weeks or months of therapy.

With a regular change in the injection site in the same anatomical area, it is possible to reduce symptoms or prevent the development of reactions at the injection site (in the form of pain, redness, urticaria, inflammation, hematoma, swelling and itching). Withdrawal of Novorapid for this reason is usually required only in very rare cases.

During the use of thiazolidinediones simultaneously with insulin preparations, the development of chronic heart failure is possible, especially in the presence of risk factors. This fact should be taken into account when prescribing combination therapy. It is also necessary to conduct medical examinations of patients to identify signs of weight gain, chronic heart failure and the presence of edema. If the symptoms of heart failure worsen, the use of thiazolidinediones should be discontinued.

During hypoglycemia, the reaction rate of patients and their ability to concentrate may be impaired, which must be taken into account when driving vehicles and performing potentially hazardous work. This is especially important for patients with absent or mild symptoms, precursors of developing hypoglycemia or suffering from frequent episodes of hypoglycemia.

drug interaction

With the simultaneous use of Novorapid with certain drugs, the following effects may occur:

Oral hypoglycemic drugs, cyclophosphamide, carbonic anhydrase inhibitors, monoamine oxidase inhibitors, lithium drugs, angiotensin-converting enzyme inhibitors, non-selective beta-blockers, sulfonamides, bromocriptine, anabolic steroids, tetracyclines, fenfluramine, clofibrate, mebendazole, ketoconazole, theophylline, pyridoxine, salicine insulin;
Nicotine, sympathomimetics, oral contraceptives, thyroid hormones, glucocorticosteroids, thiazide diuretics, heparin, tricyclic antidepressants, danazol, somatropin, calcium channel blockers, clonidine, morphine, diazoxide, phenytoin: weakening the hypoglycemic action of insulin;
Beta-blockers: masking the symptoms of hypoglycemia;
Lanreotide / octreotide: increase or decrease in insulin requirements;
Alcohol: increase or decrease in the hypoglycemic effect of insulin.

Novorapid should not be mixed with other drugs. The exceptions are solutions for infusions and isophane-insulin.

Terms and conditions of storage

Store in a place protected from light (in a cardboard box) and excessive heat, out of the reach of children at a temperature of 2-8 ° C (in the refrigerator, but not near the freezer - do not freeze!). It is recommended to store the syringe-pen for protection from light with the cap on.

Shelf life - 30 months.

Opened cartridges should be stored at temperatures below 30°C (not in the refrigerator) for up to 4 weeks. The pen syringe (used or carried as a spare) should not be stored in the refrigerator.

Found a mistake in the text? Select it and press Ctrl + Enter.

Hypoglycemic drug, analogue of short-acting human insulin.
Preparation: NOVORAPID® FlexPen®
The active substance of the drug: insulin aspart
ATX encoding: A10AB05
CFG: Short-acting human insulin analog
Registration number: P No. 016171/01
Date of registration: 27.01.05
The owner of the reg. credit: NOVO NORDISK A/S (Denmark)

Novorapid flexpen release form, drug packaging and composition.

Solution for s / c and / in the introduction of a transparent, colorless.

1 ml
insulin aspart
100 units*

Excipients: glycerol, phenol, metacresol, zinc chloride, disodium phosphate dihydrate, sodium chloride, sodium hydroxide, hydrochloric acid, water for injections.

* 1 unit corresponds to 35 mcg of anhydrous insulin aspart.

3 ml - multi-dose syringe pens with a dispenser (5) - packs of cardboard.

The description of the drug is based on the officially approved instructions for use.

Pharmacological action of Novorapid flexpen

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 NovoRapid FlexPen reduces the tendency of molecules to form hexamers, which is observed in a solution of regular insulin. In this regard, NovoRapid FlexPen is much faster absorbed from the subcutaneous fat and begins to act much faster than soluble human insulin. NovoRapid FlexPen lowers blood glucose levels more strongly in the first 4 hours after a meal than 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.

When using NovoRapid FlexPen insulin in patients with type 1 diabetes mellitus, there is a reduced risk of nocturnal hypoglycemia compared with soluble human insulin. There is no significant increase in the risk of daytime hypoglycemia.

Insulin aspart is equipotential to soluble human insulin based on molarity.

Clinical studies in adults with type 1 diabetes demonstrate lower postprandial blood glucose levels with NovoRapid FlexPen compared with soluble human insulin.

The use of NovoRapid FlexPen in children has shown similar results in long-term glucose control compared to 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 pharmacokinetic/pharmacodynamic study using 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 mellitus (322 + 27 examined: 157 received insulin aspart, 165 received human insulin) did not reveal any negative effects of insulin aspart on pregnancy or health fetus/newborn. Additional clinical studies of women with gestational diabetes mellitus 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 of the drug.

Suction

After s / c 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. Insulin concentration returns to its original level 4-6 hours after drug administration. The rate of absorption is slightly lower in patients with type 2 diabetes mellitus, resulting in a lower Cmax (352±240 pmol/l) and a later Tmax (60 min). The inter-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 of the drug.

in special clinical situations

Pharmacokinetic studies have not been conducted in elderly patients and in patients with impaired renal or hepatic function.

In children 6-12 years of age and adolescents 13-17 years of age 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 the value of Cmax in the two age groups, which emphasizes the importance of individual selection of the dosage regimen of the drug.

Indications for use:

Diabetes.

Dosage and method of application of the drug.

NovoRapid FlexPen is intended for s / c and / in the introduction. 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).

The dose of the drug is determined by the doctor individually based on the level of glucose in the blood. NovoRapid FlexPen is usually used in combination with intermediate-acting or long-acting insulin preparations administered at least once a day.

Usually the total daily requirement for insulin is from 0.5-1 IU / kg of body weight. With the introduction of the drug before meals, the need for insulin can be provided by NovoRapid FlexPen by 50-70%, the remaining need for insulin is provided by long-acting insulin.

The temperature of the injected insulin should correspond to room temperature.

NovoRapid FlexPen is injected s / c into the region of the anterior abdominal wall, thigh, shoulder or buttock. Injection sites within the same area of the body should be changed regularly.

As with any other insulin preparations, the duration of action of NovoRapid FlexPen depends on the dose, site of administration, blood flow, temperature and level of physical activity.

S / c introduction into the anterior abdominal wall provides faster absorption compared to the introduction to other places. However, the faster onset of action compared to soluble human insulin is maintained regardless of injection site location.

If necessary, NovoRapid FlexPen can be administered intravenously, but only by qualified medical personnel.

For intravenous administration, infusion systems are used with the drug NovoRapid FlexPen 100 U / ml with a concentration of 0.05 U / ml to 1 U / ml insulin aspart in 0.9% sodium chloride solution; 5% or 10% dextrose solution containing 40 mmol/l potassium chloride using polypropylene infusion bags. These solutions are stable at room temperature for 24 hours. During insulin infusions, blood glucose levels must be constantly monitored.

NovoRapid FlexPen can also be used for continuous SC 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 FlexPen 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 FlexPen using CSII should have additional insulin available in the event of a breakdown in the infusion line.

NovoRapid FlexPen is a pre-filled syringe pen with a dispenser. The FlexPen pen is designed for use with the company's insulin injection systems with NovoFine short cap needles. The package with needles is marked with the symbol "S". The FlexPen syringe pen provides the ability to administer from 1 to 60 units of the drug with an accuracy of 1 unit. You must follow the exact instructions in the instructions for use supplied with the device.

FlexPen is for personal use only and cannot be refilled.

Side effects of Novorapid flexpen:

Side effects associated with the effect on carbohydrate metabolism: hypoglycemia (increased sweating, pallor of the skin, nervousness or tremor, anxiety, unusual tiredness or weakness, disorientation, impaired concentration, dizziness, severe hunger, temporary visual impairment, 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 was defined as: infrequent (>1/1000,<1/100), редкие (>1/10000, <1/1000); отдельные спонтанные случаи представлены как очень редкие и определены как <1/10000 — включая отдельные случаи.

Allergic reactions: infrequently - urticaria, skin rash; very rarely - anaphylactic reactions. Generalized allergic reactions may include skin rash, itchy skin, increased sweating, gastrointestinal disturbances, angioedema, difficulty breathing, tachycardia, decreased blood pressure.

Local reactions: allergic local reactions (redness, swelling, itching of the skin at the injection site), usually temporary and disappearing as treatment continues; infrequently - lipodystrophy.

Other: at the beginning of therapy, rarely - edema, infrequently - refractive error. These side effects are usually temporary.

Adverse reactions observed in patients using NovoRapid FlexPen are mainly dose-dependent and are due to the pharmacological effect of insulin.

Contraindications to the drug:

hypoglycemia;

Increased individual sensitivity to insulin aspart or any of the components of the drug.

Use during pregnancy and lactation.

NovoRapid (insulin apart) can be used during pregnancy. Two randomized controlled clinical trials (322+27 pregnant women examined) did not reveal any adverse effects of insulin apart on pregnancy or fetal/newborn health compared to human insulin.

During the period of a possible onset of pregnancy and throughout its entire period, it is necessary to control the level of glucose in the blood and carefully monitor the condition of patients with diabetes mellitus. 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 lactation (breastfeeding) NovoRapid FlexPen can be used without restrictions. The introduction of insulin to a nursing mother does not pose a threat to the child. However, it may be necessary to adjust the dose of the drug.

Special instructions for the use of Novorapid flexpen.

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.

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 of an infectious nature, the need for insulin, as a rule, increases. Impaired kidney or liver function may lead to a decrease in insulin requirements.

When transferring a patient 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 need to increase the frequency of injections or change the dose compared to the doses of 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.

In addition, a change in the dose of the drug may be required when changing the diet and with increased physical activity. Physical exercise performed immediately after a meal may increase the risk of hypoglycemia. Skipping meals or unplanned exercise can lead to hypoglycemia.

A significant improvement in the state of compensation of carbohydrate metabolism can lead to a state of acute painful neuropathy, which is usually reversible.

Long-term improvement in glycemic control reduces the risk of progression of diabetic retinopathy. However, the intensification of insulin therapy with a dramatic improvement in glycemic control may be accompanied by a temporary worsening of diabetic retinopathy.

NovoRapid FlexPen contains metacresol, which in rare cases may cause allergic reactions.

Influence on the ability to drive vehicles and control mechanisms

The ability of patients to concentrate and reaction speed may be impaired during hypoglycemia and hyperglycemia, which can be dangerous in situations where these abilities are especially needed (for example, when driving a car or working with machines and mechanisms). Patients should be advised to take measures to prevent the development of hypoglycemia and hyperglycemia when driving a car 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. In these cases, the feasibility of such work should be considered.

Drug overdose:

Symptoms: hypoglycemia.

Treatment: Patients can treat mild hypoglycemia by themselves by ingesting glucose, sugar, or carbohydrate-rich foods (patients are advised to carry sugar, sweets, biscuits, or sweet fruit juice with them at all times). In severe cases, when the patient loses consciousness, a 40% dextrose (glucose) solution is injected intravenously; i / m or s / c - glucagon (0.5-1 mg). After regaining consciousness, the patient is advised to eat a meal rich in carbohydrates to prevent the recurrence of hypoglycemia.

Interaction of Novorapid flexpen with other drugs.

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 destruction.

Conditions of sale in pharmacies.

The drug is dispensed by prescription.

Terms of the storage conditions of the drug Novorapid flexpen.

List B. Unused NovoRapid FlexPen should be stored at a temperature of 2 ° to 8 ° C (in the refrigerator), but not near the freezer; do not freeze. To protect from light, store NovoRapid FlexPen with the protective cap on. Shelf life - 30 months.

Depending on the type of diabetes and its course, the patient is prescribed appropriate medications. These can be tablets or insulin of varying degrees of action. The last category of medicines includes the injectable Novorapid, a new sample.

General information about the drug

Insulin Novorapid is a new generation drug that is used in medical practice to treat diabetes. The agent has a hypoglycemic effect by replenishing the deficiency of human insulin. Shows a short effect.

The drug is characterized by good tolerance and fast action. With proper use, hypoglycemia occurs less frequently than when taking human insulin.

Available as a solution for injection. The active ingredient is insulin aspart. Aspart is similar to a hormone that is produced by the human body. It is used in combination with longer-acting injections.

Available in 2 variations: Novorapid FlexPen and Novorapid Penfil. The first type is a syringe pen, the second is a cartridge. Each of them has the same composition - insulin aspart. The substance is transparent without turbidity and third-party inclusions. If stored for a long time, a fine precipitate may form.

Pharmacology and pharmacokinetics

The drug interacts with cells and activates the processes occurring there. As a result, a complex is formed - it stimulates intracellular mechanisms. The action of the drug occurs in relation to the human hormone earlier. The result can be seen in 15 minutes. The maximum action is 4 hours.

When sugar is reduced, there is a decrease in its production by the liver. There is an activation of glycogenolysis and an increase in intracellular transport, the synthesis of basic enzymes. Critical glycemic episodes are much shorter than with human insulin.

From the subcutaneous tissue, the substance is rapidly transported into the bloodstream. Studies have shown that the maximum concentration in DM 1 is reached after 40 minutes, which is 2 times shorter than with human insulin therapy. Novorapid in children (6 years of age and above) and adolescents is rapidly absorbed. The intensity of absorption in DM 2 is weaker and the maximum concentration is reached longer - only after an hour. After 5 hours, there is a return of the previous level of insulin.

Indications and contraindications

The medicine is prescribed for:

DM 1 for adults and children from 2 years;
DM 2 with resistance to tablet preparations;
intercurrent diseases.

Contraindications for use:

children under 2 years old;
drug allergy;
intolerance to the components of the drug.

Method of application and dosage

For an adequate result of therapy, the drug is combined with longer-acting insulin. In the course of treatment, constant monitoring of sugar is carried out in order to keep glycemia under control.

Novorapid can be used both subcutaneously and intravenously. Most often, patients administer the drug in the first way. Intravenous injections are given only by a health worker. The recommended area for injections is the thigh, shoulder, front of the abdomen.

Attention! To reduce the risks associated with lipodystrophy, change the injection site only within the same zone.

The agent is administered using a syringe pen. It is designed to safely and accurately introduce the solution. The medicine can be used if necessary in infusion pumps. Throughout the process, indicators are monitored. In the event of a system failure, the patient must have spare insulin. Detailed guidance can be found in the instructions for use supplied with the product.

The drug is used before or after meals. This is due to the rapid action of the drug. The dosage of Novorapid is determined for each patient individually, taking into account the personal need for the drug and the course of the disease. The daily dose is usually< 1.0 ЕД/кг.

During therapy, dose adjustments can be made in the following cases: a change in the diet, based on the course of concomitant diseases, surgery, an increase in physical activity.

Special Patients and Instructions

During pregnancy, the use of the drug is allowed. In the process of testing, the harmful effects of the substance on the fetus and the woman were not revealed. During the entire period, the dosage is adjusted. During lactation, there are also no restrictions.

The absorption of the substance in the elderly is reduced. When determining the dose, the dynamics of sugar levels is taken into account.

When Novorapid is combined with other antidiabetic drugs, sugar levels are constantly monitored to avoid cases of hypoglycemia. In case of violation of the kidneys, pituitary gland, liver, thyroid gland, it is necessary to carefully select and adjust the dose of the drug.

Untimely eating can provoke a critical condition. Incorrect use of Novorapid, sudden discontinuation of administration can provoke ketoacidosis or hyperglycemia. When changing the time zone, the patient may have to change the time of taking the drug.

Before a planned trip, you should consult with your doctor. With infectious, concomitant diseases, the patient's need for medicine changes. In these cases, a dose adjustment is made. When transferring from another hormone, it will be necessary to adjust the dose of each antidiabetic drug.

Attention! When switching to Novorapid, the harbingers of an increase in glycemia may not be as pronounced as in previous cases.

Side effects and overdose

A common side effect is hypoglycemia. Temporary adverse reactions may occur in the injection area - pain, redness, small bruises, swelling, inflammation, itching.

During the reception, the following undesirable phenomena may also be observed:

With an exaggeration of the dose, hypoglycemia of varying severity may occur. A slight overdose can be eliminated by yourself by taking 25 g of sugar. Even the recommended dosage of the drug in some cases can provoke hypoglycemia. Patients should always carry glucose with them.

In severe cases, glucagon is administered intramuscularly to the patient. If the body does not respond to the agent after 10 minutes, then glucose is administered intravenously. Within a few hours, the patient is monitored to prevent a second attack. If necessary, the patient is hospitalized.

Interaction with other drugs and analogues

The effect of Novorapid may decrease or increase under the influence of different drugs. It is not recommended to mix Aspart with other medicines. If it is impossible to cancel another non-diabetic medicine, you should inform your doctor. In such cases, the dose is adjusted and enhanced monitoring of sugar indicators is carried out.

The destruction of insulin is caused by drugs containing sulfites and thiols. Strengthen the action of Novorapid antidiabetic agents, Ketoconazole, preparations containing ethanol, male hormones, fibrates, tetracyclines, lithium preparations. Weaken the effect - nicotine, antidepressants, contraceptives, adrenaline, glucocorticosteroids, Heparin, Glucagon, antipsychotics, diuretics, Danazol.

When combined with thiazolidinediones, heart failure may develop. The risks increase if there is a predisposition to the disease. With combined therapy, the patient is under medical supervision. If the work of the heart worsens, the drug is canceled.

Alcohol can change the effect of Novorapid - increase or decrease the hypoglycemic effect of Aspart. It is necessary to refrain from alcohol during hormone treatment.

Similar products with the same active substance and principle of action include Novomix Penfil.

Drugs containing another type of insulin include Actrapid Hm, Vosulin-R, Insuvit N, Gensulin R, Insugen R, Insuman Rapid, Insular Active, Rinsulin R, Humodar R, Farmasulin, Humulin.

Medicine with animal insulin - Monodar.

Attention! The transition to another remedy is carried out only under the supervision of a physician.

Video tutorial on using a syringe pen:

Patient opinions

From the reviews of diabetics who used insulin Novorapid, we can conclude that the drug is well received and quickly reduces sugar, but there is also a high price for it.

The drug makes my life easier. Quickly reduces sugar, does not cause side effects, unplanned snacks are possible with it. Only the price is higher than that of similar drugs.

Antonina, 37 years old, Ufa

The doctor prescribed treatment with Novorapid along with "long" insulin, which keeps sugar normal throughout the day. The prescribed remedy helps to eat at an unplanned time by the diet, well reduces sugar after eating. Novorapid is a good mild fast-acting insulin. Very comfortable syringe pens, there is no binding to syringes.

Tamara Semyonovna, 56 years old, Moscow

The drug is dispensed by prescription.

The cost of Novorapid Flexpen (100 units / ml, 3 ml) is about 2270 rubles.

Insulin Novorapid is a drug that has a short hypoglycemic effect. It has advantages over other similar means. The risk of hypoglycemia is less than with the use of the human hormone. The syringe-pen as part of the medication provides convenient use.