The current generation uses the effective drug Novorapid. Novorapid penfill, solution for subcutaneous and intravenous administration Contraindications for use

Insulin preparations are used to correct glucose levels in patients diabetes. 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. Active substance in the preparation - aspart. Its molecule is an analogue of insulin, it repeats it in structure, with the exception of a single, but significant difference - one replaced amino acid. Thanks 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 consequences molecule modifications. 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:

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 correctly administer NovoRapid, 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. Time depends on individual features 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. Repeated use is fraught with increased risk 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:

1. Drug with expired shelf life 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.
2. Incorrect injection, calculated dose. The introduction of insulin of a different type: long instead of short.
3. 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.
4. Using a pump may clog the infusion set. 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 NovoRapid 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 requires complex treatment, to normalize sugar, both a long and a short hormone are needed. 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 active substances different. It is necessary to change insulin to an analog only in case of allergic reactions to a certain trademark, 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, insulin is required much less, after childbirth, a woman usually returns to the dosages calculated before pregnancy.

Aspart does not penetrate into milk, so breastfeeding will not harm the baby.

Latin name: NovoRapid FlexPen
ATX code: A10A B05
Active substance: Aspart
Manufacturer: Novo Nordisk (France, Denmark)
Vacation from the pharmacy: On prescription
Storage conditions: t° 2-8 °C
Best before date: 30 months, after opening - 1 month.

Hypoglycemic drug based on insulin aspart. Novorapid FlexPen is intended for intravenous or s / c administration in the treatment of insulin-dependent type 1 diabetes. It can be used in type 2 pathology, if the patient has partial or complete resistance to oral hypoglycemic drugs, as well as in case of complications of diabetes due to the addition of other diseases.

Composition and forms of release

1 ml of insulin solution contains:

• Active ingredient: 100 units of aspart (identical to 3.5 mg)
• Additional substances: glycerol, phenol, metacresol, zinc chloride, sodium chloride, sodium hydroxide, hydrochloric acid, water for injections, etc.

The drug is in the form of a liquid for s / c and / in injections - an uncolored or slightly yellowish solution without suspensions. It is placed in a glass cartridge of a reusable syringe pen. In 1 product - 3 ml of aspart. In a pack of thick cardboard - 5 pens, instructions for the drug.

In addition to syringe pens, aspart also comes in the form of separate cartridges. Produced under the name Novorapid Penfill.

Medicinal properties

The drug is an analogue of human insulin fast and short acting. Compared to other soluble insulins, aspart rather lowers glucose levels: its maximum effectiveness develops during the first 4 hours after the injection, and the sugar content is at a lower level. But after injection under the skin, the duration of its action is shorter compared to human insulin.

The patient feels relief after Novorapid FlexPen already after 10-15 minutes, the effect of the drug lasts from 3 to 5 hours.

Conducted clinical studies of the effect of the drug on glycemia in type 1 diabetics showed that after aspart the threat of hypoglycemia at night is much lower compared to a similar drug of human origin. The incidence is identical for these substances.

The hypoglycemic effect of the drug is achieved due to insulin aspart - a substance that is identical in properties to human insulin. Aspart is produced by a genetic engineering method that replaces proline with aspartic acid in a strain of Saccharomyces cerevisiae. Due to this, aspart penetrates the circulatory system at a higher speed and has the desired effect.

Mode of application

The use of Novorapid FlexPen should be carried out according to the therapy scheme developed by the endocrinologist on the basis of glucose levels. As a rule, the drug is combined with intermediate or long-acting insulin, which are administered at least once a day.

At the same time, they are guided by indicators of the daily need for insulin. On average, it is ½-1 IU per 1 kg of weight. If the drug is administered before meals, then 50-70% of Novorapid FlexPen is used, and the rest is replenished with long-term insulin.

The dosage must be adjusted when the physical activity changes in any direction (increase or decrease), the daily diet.

When using the drug, it should be borne in mind that it has a fast action, so it is better to administer it a few minutes before eating or immediately after a meal.

Application features

• Needles and the drug should be used exclusively individually. It should not be allowed to be used by third parties.
• Do not refill cartridges.
• Aspart pen syringes are considered unsuitable for use if they have been exposed to sub-zero temperatures, stored in a freezer, or in heat above 30 °C.
• Children. Due to the faster action of Novorapid compared to the human counterpart, it is better to use in cases where a quick effect is needed or when it is difficult for a child to maintain the intervals between injections and meals.
• Elderly and diabetic patients with liver and / or kidney pathologies: Novorapid therapy should be carried out with more careful glycemic control and a corresponding change in the dosage of aspart.

How to administer Novorapid FlexPen

The drug can be self-administered by a diabetic. Recommended injection sites under the skin: in the abdomen (anterior part of the peritoneum), thigh, deltoid muscle, upper buttocks. To prevent lipodystrophy, you should constantly change the injection zone.

The drug can be used in CSII using insulin infusion pumps. In this case, the procedure is carried out in the anterior region of the peritoneum. HP should not be mixed with other insulin preparations.

If necessary, Novorapid can also be administered intravenously, but this procedure can only be performed by physicians with experience in handling medical equipment for insulin therapy.

During pregnancy and breastfeeding

Clinical experience with Novorapid FlexPen is extremely limited. Experiments conducted on laboratory animals did not reveal any differences between the properties of this drug and human insulin during pregnancy.

During the preparation period and throughout the gestation, patients with diabetes should be constantly monitored by doctors and regularly monitor the level of glycemia.

It is known that the body requires less insulin in the first trimester, but then its need gradually increases. During and immediately after childbirth, the demand for it drops sharply, but then again increases to the level that the woman had before pregnancy.

The drug can be used in pregnant women, since an insufficient amount of insulin in female body during gestation may adversely affect the development of the fetus / child. In addition, aspart does not cross the placenta.

Breastfeeding women are also allowed to inject aspart during lactation. If necessary, the dosage of the drug should be adjusted.

Contraindications and precautions

Novorapid FlexPen, according to the instructions for use, is forbidden to use if the patient has a high level of sensitivity or complete intolerance to the substances that make up the drug.

Features of the use of insulin

Average price: (5 pcs.) - 1852 rubles.

If a diabetic is going to travel to places with a different time zone, he should consult in advance how to take the medicine: at what time, in what quantity, and find out other aspects of taking it.

If Novorapid FlexPen is administered in insufficient quantities or for some reason the patient has stopped administering it, this can provoke hyperglycemia and diabetic ketoacidosis. Type 1 diabetics are especially susceptible to this. Symptoms develop gradually, constantly getting worse. You can judge a dysfunctional state by nausea, bouts of vomiting, drowsiness, dryness skin and mucous tissues oral cavity, increased urination, constant thirst, loss of appetite. You can also judge hyperglycemia by the characteristic smell of acetone when breathing.

If there is a suspicion of hypoglycemia, appropriate treatment should be urgently applied, otherwise the aggravation of the condition can lead to the death of a diabetic. However, it should be borne in mind that intensive insulin therapy can distort characteristic symptoms hypoglycemia.

In diabetics, with normal control of metabolic processes, the complications of the disease slow down and progress at a slower rate. Therefore, it is desirable to take appropriate measures aimed at normalizing metabolic control, including monitoring blood sugar levels.

It should be borne in mind that hypoglycemic processes are formed at a faster pace if a diabetic has concomitant diseases or is undergoing therapy with drugs that inhibit the absorption of food. With concomitant pathologies, especially if they are of infectious origin, the need for the drug increases. If a diabetic has problems with the liver and / or kidneys, then the body's need for insulin is reduced.

After the transition of a diabetic to other types of drug early signs hypoglycemia may be distorted or become less intense compared to previously used insulin.

The transition to a different type of insulin must be monitored by physicians. Changing the dosage may be required not only when changing the type of drug, but also the manufacturer, production method.

The dosage should be adjusted if the diabetic has switched to a different diet, changed diet, started or stopped exercising. The patient should remember that skipping meals or unforeseen physical activity can cause hypoglycemia.

Prolonged proper glycemic control reduces the risk of worsening diabetic retinopathy. An intensive course of insulin and a rapid improvement in glycemic levels can provoke a temporary worsening of retinopathy.

Does insulin Novorapid FlexPen affect the reaction rate

Conditions characteristic of hypo- and hyperglycemia, affect the speed of reaction and the ability to concentrate, can contribute to dangerous situations when driving vehicles or complex mechanisms. Patients should take measures in advance to prevent their development. This is especially true for those diabetics whose symptoms of pathology are lubricated, they appear weakly. In these cases, the diabetic is advised to think about giving up this kind of activity.

Cross-drug interactions

Be aware that some medications can affect blood glucose levels. Therefore, if a diabetic is forced to take other drugs, he should inform the doctor about them in advance in order to know how to inject the medication correctly.

• Drugs that reduce the body's need for insulin: oral hypoglycemic agents, MAOIs, beta-blockers, drugs from the salicylates and sulfanilamide groups, anabolics.
• Drugs that increase the need for insulin: oral contraceptives, corticosteroids, thiazide diuretics, thyroid hormones, indirect-acting adrenomimetics, growth hormone, Danazol, lithium-based preparations, morphine, nicotine.
• If it is necessary to combine insulin with beta-blockers, it must be taken into account that latest drugs may mask manifestations of hypoglycemia.
• Alcohol-containing liquids (drinks or drugs), Octreotide, Lantreotide, when combined with insulin, can unpredictably change its effect: increase or decrease.
• If a diabetic needs to take other drugs besides insulin, he should discuss the specifics of taking medications with his doctor.

Side effects

Possible adverse conditions during the course of Novorapid FlexPen are due to the characteristics of its main component - insulin rDNA. The most common side effect in diabetics, as with other types of insulin, there is a sharp decrease in glucose levels and subsequent hypoglycemia. The frequency of its occurrence varies in different groups of diabetics, is determined by the dosage and quality of control.

At the beginning of the course, refractive disorders usually occur, and at the injections - swelling, soreness, hyperemia, inflammation, itching. Local reactions are usually temporary, as the course continues, they disappear on their own. Rapid correction of glycemia, especially too intensive, can cause a transient worsening of diabetic retinopathy, and timely, well-observed control will slow down its progression.

Other undesirable effects that occur in diabetics manifest themselves in the form of various disorders in the functioning of internal systems and organs:

• Immune system: rashes, urticaria, in rare cases - anaphylactic reactions, in isolated patients - erythema
• NS: disorders of the peripheral NS (loss of sensitivity of nerve endings, muscle weakness, in rare cases, pain)
• Vision: refractive error, retinopathy
• Skin and s / c fiber: lipodystrophy, generalized reactions, swelling at the injection site

hypoglycemia

The condition develops with insufficient dosage, skipping or canceling the drug. If hypoglycemia develops in severe form, then the subsequent progression of the condition poses a threat to human life. He has disorders of the cardiovascular system, there are temporary or irreversible disorders in the functioning of the GM, which can lead to death.

Symptoms usually develop unexpectedly, manifest as cold sweat, cyanosis of the dermis, cooling of the skin, fatigue, increased irritability and nervousness, tremor, drowsiness, blurred vision, a feeling of constant hunger, nausea, heart palpitations. The intensity of the condition is affected by the mode of administration of the drug, the presence of gaps in therapy. The symptoms and frequency of hypoglycemia are generally identical to those caused by injections of human insulin.

Children, the elderly, diabetics with kidney and/or liver problems

Side effects in patients of these groups are no different from the conditions that occur in other patients.

Overdose

As such, the concept of overdose after insulin injections has not been formed. The introduction of high doses of any drug containing it can lead to the development of hypoglycemia. The degree of intensity in this case depends not only on the dosage, but also how often it was used, the particular condition of the diabetic, the presence or absence of aggravating factors.

Symptoms of hypoglycemia develop in stages, worsening in the absence of adequate glucose control.

If the pathology manifests itself in mild form, then to eliminate it, the patient is recommended to eat a carbohydrate product or sugar, drink sweet tea or juice. Patients should always have something sweet with them, so that they always have the opportunity to help themselves in a timely manner.

In a serious condition, the patient loses consciousness, and specialists or people with similar experience can help him. In order for a diabetic to regain consciousness, glucagon is injected under the skin or injected into the muscle. As a last resort, if the previous measures did not give the desired result, and the patient continues to faint, he is poured into / into a saturated dextrose solution. When the diabetic comes to his senses, to prevent a repeated sharp drop in blood glucose, he is given to eat sweets or foods high in carbohydrates.

Analogues

Only the attending endocrinologist can select analogues or substitutes for the drug, who can accurately calculate the correct dosage of insulin and select the desired injection regimen. Drugs that can be prescribed: Actrapid (MS, NM, NM-Penfill), Apidra, Biosulin R, Insuman Rapid GT, Rinsulin R, Rosinsulin R, Humalog, Humulin Regular.

Novo Nordisk PF do Brasil (Brazil)

Average cost:(5 pcs.) - 1799 rubles.

A short-acting aspart-based insulin preparation for hypoglycemic control in type 1 diabetes and, if necessary, for use in type 2 diabetics if previous use of other drugs has failed or the patient has partial or complete resistance to the substance.

Penfill is produced as a solution for s / c and / in injections. Packaged in glass cartridges. In one container - 100 units of aspart. The drug is used in Novo Nordisk systems.

The scheme of injections and the frequency of Penfill procedures is determined by the attending specialist.

Pros:

• Fast acting
• One of the best for cleaning impurities.

Minuses:

• Not suitable for everyone
• Need a long adaptation after switching from another insulin.

For the treatment of diabetes, pharmacologists have invented a large number of different drugs. Insulin is the most effective drug, in the treatment this disease. Like many medicines, it is divided into several pharmacological groups. Insulin Novorapid is especially effective. There are various analogues of Novorapida insulin: Flexpen, Aspart.

Clinical picture

What doctors say about diabetes

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The use of Novorapid according to the instructions

For the correct taking of the medicine, there is an instruction for the use of Novorapida insulin.

Composition and form of release

This type of drug is similar to the physiological analogue of insulin. Due to this, this drug is famous for its high quality. The basis of this drug is the pharmacological drug "Aspart". The medicine has two ways of application: by injection intravenously;

"Novorapid" has no color, is a clear liquid without impurities. This drug is produced in the form of cartridges, made of colorless glass.

Indications for use

It is prescribed for people suffering from diabetes of varying degrees. Approved for use from 2 years.

• Age less than 2 years.

pharmachologic effect

Novorapid interacts with cell membrane receptors, stimulating the production of a physiological hormone.

While using this drug, a decrease in blood sugar is possible, this is usually caused by:

• transportation and production of insulin in the patient's blood;
• absorption of the drug by body tissues;
• decreased production of glucose by the liver.

While taking any type of insulin, measure your blood glucose levels to avoid diabetic coma.

It is thanks to their actions that this type of insulin is highly effective.

The dose of the drug is prescribed individually for each patient. The average daily dose for aunts and adults is: 0.5-1 per kg of body weight. To make a diagnosis and prescribe a drug, you need to see a doctor. The specialist will make the correct diagnosis and prescribe drugs, taking into account your lifestyle.

be careful

According to the World Health Organization, 2 million people die every year from diabetes and its complications. In the absence of qualified body support, diabetes leads to various complications, gradually destroying the human body.

The most common complications are: diabetic gangrene, nephropathy, retinopathy, trophic ulcers, hypoglycemia, ketoacidosis. Diabetes can also lead to the development of cancerous tumors. In almost all cases, a diabetic either dies while struggling with a painful disease, or turns into a real invalid.

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Under certain factors, the doctor may change the dosage:

• increase in physical activity;
• other chronic diseases that aggravate the symptoms of diabetes;
• worsening of the patient's condition;
• taking drugs of another pharmacotherapeutic group.

The drug is injected under the skin using a special syringe. Medical staff may administer insulin intravenously.

Use with caution

Any drug has certain indications, in which it must be used carefully, or even excluded altogether:

• each cartridge is used once. It is forbidden to reuse an already opened drug. When re-injecting, use a disposable sterile syringe;
• do not use this medicine if the solution is cloudy or tinted;
• for urgent insulin administration, use the U100 syringe.

Application methods

"Novorapid" is intended for subcutaneous administration. Intravenous administration is possible, when injected by a qualified specialist. For the introduction of insulin, the following places are best suited:

• abdomen;
• shoulder;
• hip.

Inject insulin under the skin, according to the technique advised by your doctor.

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Storage

"Novorapid" is stored at a temperature of 2-8 degrees. It is better to put the medicine in the refrigerator, but avoid freezing. Exclude direct exposure to sunlight and keep track of the storage date.

Insulin Aspart

For insulin "Aspart", instructions for use are individual. By following it, you will avoid many problems associated with taking Astarte.

Composition and form of release

Insulin of this type is a two-phase liquid, consisting of 30% soluble insulin astarte and 70% crystalline astarte. "Aspart" is similar to human insulin, but has a short action. It has a high adsorption, which allows you to quickly normalize, even the critical condition of the patient.

Indications for use

• Chronic diseases that accompany diabetes.
• Diabetes mellitus of the first and second degree.

Contraindications

• Hypoglycemia.
• Individual intolerance to the components of the drug.
• The period of pregnancy and lactation.
• Children's age less than 6 years.

pharmachologic effect

Aspart interacts with cell membrane receptors, improving its performance. Adsorbed faster than physiological insulin, but has a short effect.

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Dosage and correct administration

The dosage is prescribed by the attending physician, individually for each patient. It is injected under the skin in certain areas:

• anterior abdominal wall;
• shoulder;
• outer thigh.

Overdose symptoms

• chills;
• temperature rise;
• tremor of the lower extremities;
• fainting;
• tachycardia;
• increased nervousness;
• hypoglycemia.

If one or more of these symptoms occur, you should consult a doctor or call ambulance. Untimely access to a doctor can lead to serious consequences.

Storage method

Insulin Flexpen

Before taking Insulin Flexpen, read the instructions.

Composition and form of release

Flexpen is a long-acting insulin similar to human counterparts. This gives an advantage over other types of this drug. It is quickly adsorbed, improving cell function. The body quickly gets used to the drug, during the use of "Flexpen" there is no dependence.

Given medication, is: a clear liquid with no impurities. The composition of "Flexpena" includes the following excipients:

• sodium chloride;
• zinc acetate;
• phenol;
• glycerol.

Indications for use

• Diabetes mellitus, varying degrees.
• Diseases associated with diabetes.

Contraindications

This drug has certain contraindications:

• lactation and pregnancy;
• individual intolerance to the components of the drug;
• age up to 2 years.

Dosage and method of application

The dose is prescribed by the doctor, individually for each patient. When calculating the dosage, the following factors are taken into account:

• patient's age;
• the patient's condition at the time of prescribing the drug;
• the needs and lifestyle of the patient;
• taking other medications.

Flexpen is injected under the skin with a special insulin syringe. Also, the drug can be administered intravenously, but injection should be carried out by qualified medical personnel. In no case, do not inject the drug into muscle tissue.

The introduction of the drug is made in certain places:

• gluteal cavity;
• anterior abdominal wall;
• hip;
• shoulder.

Side effect

If the dose is exceeded, the following symptoms may occur:

• feeling of fear;
• tachycardia;
• tremor of the limbs;
• headache;
• fainting.

These symptoms can occur, not only with an overdose, but also while taking other medications, because they can enhance the action of insulin. Before you start using a new drug, consult a specialist.

Storage

Insulin "Flexpen" must be stored at a temperature of 2-8 degrees. Direct sunlight is not recommended. Throw away used containers with medicine, re-use of open insulin is prohibited. Watch the expiration date.

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A short-acting human insulin analogue.

Release form, composition and packaging

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

1 ml of solution contains:

active substance: insulin aspart - 100 IU (3.5 mg);

excipients: glycerol, phenol, metacresol, zinc chloride, sodium chloride, sodium hydrogen phosphate dihydrate, sodium hydroxide 2M, hydrochloric acid 2M, water for injections.

10 ml (1000 IU) - bottle (1) - cardboard pack. 3 ml (300 units) - glass cartridges (1) - multi-dose disposable syringe pens for multiple injections (5) - cardboard packs.

Indications

Diabetes mellitus in adults, adolescents and children over 2 years of age.

Contraindications

Hypersensitivity to insulin aspart and other components of the drug.

Dosage

Novorapid is a fast-acting insulin analogue. The dose of Novorapid 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 / 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. Typically, the individual daily requirement for insulin in adults and children ranges from 0.5 to 1 U / kg of body weight. With the introduction of the drug before meals, the need for insulin can be provided by Novorapid by 50-70%, the remaining need for insulin 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 has a faster onset and shorter duration of action than soluble human insulin. Due to the faster onset of action, Novorapid should be administered, as a rule, 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 is lower.

elderly patients and patients with renal or hepatic insufficiency should more carefully monitor the concentration of glucose in the blood and adjust the dose of insulin aspart individually.

Use Novorapid instead of soluble human insulin in children preferably when a rapid onset of action of the drug is needed, for example, when it is difficult for a child to observe the required time interval between injection and food intake.

At transferring a patient from other insulin preparations on Novorapid, dose adjustment of Novorapid and basal insulin may be required.

Precautions for use

Novorapid and needles are for individual use only. Do not refill the pen cartridge.

Novorapid should not be used if it is no longer clear and colorless, or if it has been frozen. The patient should be warned to discard the needle after each injection.

Novorapid can be used in insulin pumps. Tubing with an inner surface made of polyethylene or polyolefin has been tested and found suitable for use in pumps. In emergency cases (hospitalization, malfunction of the insulin delivery device), Novorapid can be removed from Novorapid for administration to the patient using a U100 insulin syringe.

The patient should be warned about the cases in which Novorapid should not be used:

If you are allergic (hypersensitive) to insulin aspart or any other component of the drug;

If hypoglycemia begins;

If the pen has been dropped or damaged or crushed;

If the storage conditions of the drug were violated or it was frozen;

If insulin is no longer clear and colorless.

Before using Novorapid, the patient should:

Check the label to make sure it's selected correct type insulin;

Always use a new needle for each injection to prevent infection;

Remember that Novorapid and needles are for individual use only;

Never inject an IM insulin preparation;

Each time to change the injection site within the anatomical area, this will help reduce the risk of formation of seals and ulceration at the site of reference;

Regularly measure the concentration of glucose in the blood.

Rules for the administration of the drug

S / c introduction

Novorapid is injected s / c 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, s / c injection into the anterior abdominal wall provides faster absorption compared to the introduction to other places. 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 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 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 system.

In / in the introduction

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 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.

Using a pen

Novorapid is an insulin pen with a dispenser and color coding. The administered dose of insulin, ranging from 1 to 60 units, can be changed in increments of 1 unit. Novorapid is designed for use with NovoFine and NovoTwist needles up to 8 mm in length. As a precaution, you should always carry a spare insulin delivery system with you in case Novorapid is lost or damaged.

Before using the pen

1. Check the label to make sure Novorapid contains the correct type of insulin.

2. Remove the cap from the syringe pen.

3. Remove the protective sticker from the disposable needle. Carefully and tightly screw the needle onto Novorapid. Remove the outer cap from the needle, but do not discard it. Remove and discard the inner needle cap.

Use a new needle for each injection to prevent infection. Do not bend or damage the needle before use. To avoid accidental injections, never put the inner cap back on the needle.

Insulin Check

Even with proper use of the pen, a small amount of air may accumulate in the cartridge before each injection. To prevent the entry of an air bubble and ensure the correct dose of the drug should be:

1. Draw up 2 units of the drug by turning the dosage selector.

2. Holding Novorapid with the needle up, lightly tap the cartridge several times with your fingertip to move the air bubbles to the top of the cartridge.

3. Holding Novorapid with the needle up, press the start button all the way. The dosage selector will return to "0".

A drop of insulin should appear at the end of the needle. If this does not happen, replace the needle and repeat the procedure, but no more than 6 times. If insulin does not come out of the needle, this indicates that the pen is defective and cannot be used further.

Dose setting

The dosage selector must be set to position "0".

Dial the number of units required for the injection. The dose can be adjusted by turning the dose selector in any direction until the correct dose is set against the dose indicator.

Overdose

The specific dose required for an overdose of insulin has not been established.

Symptoms: hypoglycemia, which can develop gradually if too high doses are administered in relation to the patient's needs.

Treatment: 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 the case of severe hypoglycemia, when the patient is unconscious, 500 micrograms to 1 mg of glucagon should be administered intramuscularly or subcutaneously (a trained person may administer), or an intravenous glucose (dextrose) solution (can only be administered medical worker). 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.

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, sulfonamides, anabolic steroids, tetracyclines, clofibrate, ketoconazole, mebendazole, pyridoxine, theophylline, cyclophosphamide, fenfluramine, lithium preparations.

The hypoglycemic effect of insulin is weakened by oral contraceptives, corticosteroids, thyroid hormones, thiazide diuretics, heparin, tricyclic antidepressants, sympathomimetics, somatropin, danazol, clonidine, slow calcium channel blockers, diazoxide, morphine, phenytoin, nicotine.

Beta-blockers may mask the symptoms of hypoglycemia.

Octreotide/lanreotide can either increase or decrease insulin requirements.

Ethanol can either increase or decrease the hypoglycemic effect of insulin.

Pharmaceutical incompatibility

Drugs containing thiol or sulfite groups, when added to Novorapid, can cause the destruction of insulin aspart. Novorapid should not be mixed with other medicinal products. The exceptions are insulin isophane and the infusion solutions listed above.

Side effects

Adverse reactions observed in patients receiving Novorapid are mainly dose-dependent and are due to pharmacological effect insulin. Most often The most common side effect associated with the use of insulin is hypoglycemia.

A 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.

Allergic reactions: urticaria, skin rash, anaphylactic reactions.

From the side of metabolism: hypoglycemia.

From the nervous system: peripheral neuropathy ("acute painful neuropathy").

From the side of the organ of vision: refractive error, diabetic retinopathy.

From the skin and subcutaneous tissues: lipodystrophy.

Others: edema, reactions at the injection site.

Description of individual adverse reactions:

Anaphylactic reactions

Very rare reactions of generalized hypersensitivity (including generalized skin rash, itching, increased sweating, gastrointestinal disorders, angioedema, difficulty breathing, palpitations, decreased blood pressure), 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 rapid heartbeat. . 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 receiving human insulin preparations.

Lipodystrophy

Infrequent cases of lipodystrophy have been reported. Lipodystrophy can develop at the injection site.

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 appropriate treatment, hyperglycemia can lead to death.

hypoglycemia

Skipping meals, unplanned increased exercise stress or too high a dose of insulin in relation to the patient's need can lead to hypoglycemia.

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.

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 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 medicines 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 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

Transfer of the patient to new type insulin or an insulin preparation from another manufacturer must be administered 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.

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 carry out medical examinations patients for signs and symptoms of chronic heart failure, weight gain and edema. If symptoms of heart failure worsen in patients, treatment with thiazolidinediones should be discontinued.

Impaired kidney function can lead to a decrease in insulin requirements.

As with the use of other insulins in patients with renal insufficiency, the concentration of glucose in the blood should be more carefully monitored and the dose of insulin aspart adjusted individually.

Impaired liver function can lead to a decrease in insulin requirements.

As with the use of other insulins in patients with hepatic insufficiency, the concentration of glucose in the blood should be more carefully monitored and the dose of insulin aspart adjusted individually.

Influence on the ability to drive vehicles and control mechanisms

Patients' ability to concentrate and reaction speed may be impaired during hypoglycemia, which may 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 and operating machinery. This is especially important for patients with no or reduced symptoms of developing hypoglycemia or suffering from frequent episodes of hypoglycemia.

Pregnancy and lactation

Novorapid can be prescribed during pregnancy. In two randomized controlled clinical research(157+14 pregnant women surveyed), no adverse effects of insulin aspart on the course of pregnancy or the health of the fetus / newborn were found compared to human insulin.

Careful monitoring of blood glucose levels and monitoring of pregnant women with diabetes mellitus (type 1, type 2 or gestational diabetes) is recommended throughout pregnancy, as well as during a 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 the period breastfeeding Novorapid can be used without restrictions, because. the introduction of insulin to a nursing woman does not pose a threat to the child. However, it may be necessary to adjust the dose of the drug.

Application in childhood

Use in the elderly

As with other insulins, elderly patients should more carefully monitor the concentration of glucose in the blood and adjust the dose of insulin aspart individually.

Terms and conditions of storage

The drug 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 the syringe pen with the cap on. Expiration date - 30 months.

Novorapid 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 below 30°C. Use within 4 weeks.

The drug should be stored out of the reach of children.