The use of insulin novorapid and its analogues with prices and reviews for diabetics. Novorapid penfill, solution for subcutaneous and intravenous administration Insulin novorapid instructions for use

Insulin Novorapid is a new generation drug that allows you to compensate for the deficiency of the hormone in the body. It has many advantages: it is easily and quickly absorbed, normalizes blood sugar levels, and can be used regardless of meals. Belongs to the category of ultra-short-acting insulins.

Compound

The diabetic drug Novorapid is a colorless liquid for injection. Available in replaceable cartridges and syringe pens of 3 ml. The active component of the drug, insulin aspart, has a powerful hypoglycemic effect and is an analogue of the human hormone. The substance is extracted using recombinant DNA biotechnology and amounts to 100 IU, or 3.5 g of the total solution.

Additional components are glycerol, phenol, metacresol, zinc chloride, sodium chloride, sodium hydrogen phosphate dihydrate, sodium hydroxide, hydrochloric acid and water.

Indications and contraindications

Novorapid is prescribed for type 1 and type 2 diabetes. In non-insulin-dependent diabetics, the drug should be administered when resistance to hypoglycemic formulations intended for oral use is diagnosed.

Can be taken by children from 2 years of age. However, this composition has not passed clinical trials, so the drug can only be administered after 6 years of age. Indications for prescription are difficulties in the child observing the intervals between injections and meals.

Contraindications include individual sensitivity to the components of the drug. Use with extreme caution in elderly people with liver or kidney failure.

Directions for use and dosage

Novorapid is intended for subcutaneous and intravenous administration. The dose of the hormone is selected individually, taking into account the characteristics of the body and the severity of the disease. The drug is recommended for use in combination with long- or medium-acting insulins, which are administered once a day. To avoid surges in glucose levels, before administering Novoropid, you should check your blood sugar and adjust the dose depending on the indicators.

The recommended daily dose of the drug for adults and children ranges from 0.5–1 IU per 1 kg of body weight. Novorapid can be administered immediately before meals. In this case, insulin will cover about 60–70% of the diabetic’s needs. The remaining amount will be compensated by long-acting insulins. It is also acceptable to administer the composition after a meal.

It is necessary to adjust the dose of the hormone:

when changing your usual diet;
for intercurrent diseases;
with unplanned or excessive physical activity;
during surgical interventions.

The dosage of short-acting insulin is usually adjusted after measuring your sugar levels for a week. Based on these indicators, the specialist will draw up an individual dosage regimen. For example, if surges in blood glucose levels are observed in the evening, Novorapid is administered once a day before dinner. If sugar rises after each snack, injections should be given before meals.

To administer insulin, you should choose the areas of the hips, shoulders, buttocks and anterior abdominal wall. To reduce the risk of lipodystrophy, injection zones must be alternated.

The duration of action of the hormone depends on many factors: dosage, injection site, blood flow, physical activity, etc. If necessary, it is possible to administer the drug using an insulin pump. However, this method should be used only if you have the necessary skills and available equipment (reservoir, catheter and tube system). Intravenous administration is permissible only under the watchful supervision of a specialist. For infusion, an insulin solution with sodium chloride or dextrose is used.

Novorapid Flexpen

Most often, the drug is administered using a syringe pen. Insulin Novorapid Flexpen is equipped with color coding and a dispenser. One syringe step contains 1 IU of the substance. Before using the hormone, you must carefully read the instructions for use. Check the manufacturing date and expiration date. Then remove the cap from the syringe and remove the sticker from the needle. Screw the needle to the handle. Remember: a sterile needle must be used for each injection.

The manufacturer warns that the pen may contain a small amount of air inside. To avoid the accumulation of oxygen bubbles and to administer the drug correctly, follow certain rules. Draw up 2 units of hormone, lift the syringe with the needle up and gently tap the cartridge with your fingertip. This will move the air bubbles up. Now press the start button and wait until the dosage selector returns to the “0” position. If the syringe is working properly, a drop of the composition will appear on the needle. If this does not happen, try again a few more times. Failure of insulin to enter the needle indicates a malfunction of the syringe.

After making sure that the device is functioning normally, set the syringe dosage selector to the “0” position. Take the required amount of the drug. Be careful when setting the dose. Accidental pressing can cause premature release of the hormone. Do not set the rate higher than prescribed by the manufacturer. Administer insulin following the technique and recommendations of your doctor. Keep your finger on the trigger button for 6 seconds after the injection to ensure the dose is fully administered.

Remove the needle and guide it into the outer cap. Once it's in there, unscrew it and dispose of it. Close the syringe with a cap and put it in a storage place. Detailed information about injections and disposal of used needles can be found in the instructions for use.

The use of Novorapid Flexpen is prohibited in certain cases.

Allergic reactions to insulin aspart or other components of the drug.
Hypoglycemia in the initial stage (always measure your sugar before administering the hormone).
The pen is damaged, crushed, or dropped on the floor.
The liquid in the syringe is cloudy, foreign particles are floating in it or sediment is visible.
The storage conditions of the medicinal product were violated or the substance was frozen.

The surface of the syringe pen can be treated with an alcohol wipe. Do not immerse Novorapid Flexpen in liquid, wash or lubricate it. Otherwise, the device mechanism may fail.

Novorapid during pregnancy

Like other insulins, Novorapid is approved for use during pregnancy and lactation. Many special studies have confirmed that the drug has no adverse effects on the fetus. However, the expectant mother should carefully monitor blood glucose levels, since hypo- and hyperglycemia are dangerous to the health of both the woman and the baby.

The dosage of short-acting insulin must be adjusted depending on the stage of pregnancy. At the beginning of the 1st trimester, the need for insulin will be much less than at the end of the 2nd and beginning of the 3rd trimester. Immediately after birth, glycemic levels return to normal, but in rare cases, minor adjustments may still be necessary.

Side effects and overdose

Most often, undesirable reactions occur to the hormone itself and manifest in the form of hypoglycemia, which is accompanied by:

excessive sweating,
pale skin
nervousness,
unreasonable feelings of anxiety,
tremor of the limbs,
weakness in the body
impaired orientation and decreased concentration.

Often, an excessive decrease in blood sugar can cause:

dizziness,
hunger,
vision problems,
nausea,
headaches,
tachycardia.

Severe glycemia can lead to loss of consciousness, convulsions, cerebrovascular accidents and death.

If the drug is used incorrectly, local and allergic reactions are possible: urticaria, itching, redness and swelling. Most often, these symptoms occur at the beginning of using the hormone and go away on their own after some time. However, some diabetics have also noted other allergic reactions, accompanied by gastrointestinal upset, angioedema, difficulty breathing, rapid heartbeat and low blood pressure.

Excessive use of Novorapid insulin can lead to an overdose, which is accompanied by hypoglycemia. Mild overdose can be easily eliminated on your own. To do this you need to eat foods containing sugar. Moderate and severe forms of glycemia, accompanied by loss of consciousness, should be treated in a hospital setting.

Analogs

If for some reason Novorapid is not suitable for the patient, the endocrinologist can select its analogues. The most common among them are Apidra, Novomix, Actrapid, Humalog, Gensulin N, Protafan and Ryzodeg. All of these drugs are short-acting insulins, suitable for the treatment of type 1 and type 2 diabetes and easy to use.

Storage rules

The drug should be stored in the refrigerator at a temperature of +2 ... +8 ° C. It is unacceptable to freeze the drug and expose it to direct sunlight. If necessary, it is possible to store the hormone at a temperature of +30 °C, but in this case its shelf life is reduced to 4 weeks.

When using the drug, certain nuances should be taken into account.

When using a pen, remember that it can get lost or damaged, so always have a spare injection system with you.
The drug is most often recommended at the beginning of diagnosing diabetes and is prescribed against the background of a course of long-acting insulin.
An analogue of the human hormone can cause a sharp drop in glucose in children, so Novorapid should be prescribed with caution at a young age.
Transfer from another insulin-containing drug to Novorapid should be carried out under medical supervision.
The hormone is used in direct connection with food intake. Therefore, it is important to consider its rapid action when treating diabetics who suffer from concomitant diseases or are taking medications that slow down the absorption of food.

Insulin Novorapid is a soft and high-quality drug that effectively reduces blood glucose levels even in type 1 diabetes. Using the drug along with long-acting insulin helps maintain sugar levels after meals and allows for snacking outside of school hours. However, an incorrectly selected dosage often causes hypoglycemia and negatively affects well-being. To avoid side effects, taking the drug should be discussed with your doctor.

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Short-acting analogue of human insulin.

Release form, composition and packaging

The solution for subcutaneous and intravenous administration is transparent, colorless.

1 ml of solution contains:

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

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

10 ml (1000 units) – 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 analogue of insulin. The dose of Novorapid is determined by the doctor individually in accordance with the needs of the patient.

Typically, the drug is used in combination with intermediate-acting or long-acting insulin preparations, which are administered at least once a day. To achieve optimal glycemic control, it is recommended to regularly measure blood glucose concentrations and adjust the insulin dose. Typically, the individual daily insulin requirement is adults and children ranges from 0.5 to 1 U/kg body weight. When the drug is administered before meals, the need for insulin can be met by Novorapid by 50-70%, the remaining need for insulin is provided by long-acting insulin.

Increased physical activity of the patient, changes in 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 soon after a meal.

Due to its 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 liver failure Blood glucose concentrations should be monitored more carefully and the dose of insulin aspart adjusted individually.

Use Novorapid instead of soluble human insulin in children it is preferable when a rapid onset of action of the drug is necessary, for example, when it is difficult for a child to maintain the required time interval between injection and meal.

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

Precautions for use

Novorapid and needles are intended for individual use only. The pen cartridge must not be refilled.

Novorapid cannot 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 internal surface made of polyethylene or polyolefin has been tested and found suitable for use in pumps. In emergency cases (hospitalization, malfunction of the insulin injection 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 (hypersensitivity) to insulin aspart or any other component of the drug;

If hypoglycemia begins;

If the pen has been dropped, damaged or crushed;

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

If insulin is no longer transparent and colorless.

Before using Novorapid, the patient should:

Check the label to make sure the correct type of insulin is selected;

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

Remember that Novorapid and needles are intended for individual use only;

Never administer insulin IM;

Change the injection site within the anatomical area each time, this will help reduce the risk of compaction and ulceration at the injection site;

Regularly measure blood glucose levels.

Rules for administering the drug

SC introduction

Novorapid is administered subcutaneously into the anterior abdominal wall, thigh, shoulder, deltoid or gluteal region. Injection sites within the same body area should be changed regularly to reduce the risk of developing lipodystrophy. As with all insulin preparations, subcutaneous injection into the anterior abdominal wall ensures faster absorption compared to administration at other sites. The duration of action depends on the dose, site of administration, intensity of blood flow, temperature and level of physical activity. However, the faster onset of action compared to soluble human insulin persists regardless of injection site location.

Novorapid can be used for continuous subcutaneous insulin infusions (CSII) in insulin pumps designed for insulin infusions. CSII should be administered into the anterior abdominal wall. Infusion sites should be changed periodically. When using an insulin pump for infusions, Novorapid should not be mixed with other types of insulin.

Patients using CSII should be fully trained in the use of the pump, associated reservoir, and pump tubing. The infusion set (tubing and catheter) should be replaced according to the user manual that came with the infusion set. Patients receiving Novorapid via CSII should have extra insulin available in case of infusion system failure.

IV administration

If necessary, Novorapid can be administered intravenously, but only by qualified medical personnel. For intravenous administration, infusion systems 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 are used; 5% dextrose solution or 10% dextrose solution containing 40 mmol/L potassium chloride, using polypropylene infusion containers. These solutions are stable at room temperature for 24 hours. Although stable for some time, a certain amount of insulin is initially absorbed by the material of the infusion set. During insulin infusions, blood glucose concentrations must be constantly monitored.

Using a pen

Novorapid is an insulin syringe 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 system with you in case your Novorapid is lost or damaged.

Before using the syringe 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 throw it away. 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 needle sticks, never put the inner cap back on the needle.

Checking insulin delivery

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 air bubbles and ensure the correct dose of the drug is administered:

1. Take 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 so that air bubbles move to the top of the cartridge.

3. While 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 faulty and cannot be used again.

Setting the dose

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

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

Overdose

There is no specific dose required for an insulin overdose.

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

Treatment: The patient can eliminate mild hypoglycemia himself by ingesting glucose or sugar-containing foods. Therefore, patients with diabetes are advised to carry sugar-containing products with them at all times. In case of severe hypoglycemia, when the patient is unconscious, 500 mcg to 1 mg of glucagon should be administered IM or SC (can be administered by a trained person), or IV glucose (dextrose) solution (can only be administered by a healthcare professional) . It is also necessary to administer 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 relapse of hypoglycemia.

Drug interactions

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, alicylates.

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

Beta blockers may mask the symptoms of hypoglycemia.

Octreotide/lanreotide can either increase or decrease insulin requirements.

Ethanol can both enhance and reduce the hypoglycemic effect of insulin.

Pharmaceutical incompatibility

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

Side effects

Adverse reactions observed in patients receiving Novorapid are mainly dose-dependent and due to the pharmacological effect of insulin. Most often A common adverse event when using insulin is hypoglycemia.

Rapid improvement in glycemic control can lead to a condition of "acute painful neuropathy", which is usually reversible. Intensification of insulin therapy with a sharp improvement in the control of carbohydrate metabolism can 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 errors, diabetic retinopathy.

For the skin and subcutaneous tissues: lipodystrophy.

Others: swelling, reactions at the injection site.

Description of individual adverse reactions:

Anaphylactic reactions

Very rare reactions of generalized hypersensitivity have been noted (including generalized skin rash, itching, increased sweating, gastrointestinal disorders, angioedema, difficulty breathing, rapid heartbeat, 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 insulin requirement. Severe hypoglycemia can lead to loss of consciousness and/or seizures, temporary or irreversible impairment of brain function, and even death. Symptoms of hypoglycemia usually develop suddenly. These may include cold sweats, pale skin, fatigue, nervousness or tremors, anxiety, unusual tiredness or weakness, disorientation, decreased concentration, drowsiness, increased hunger, blurred vision, headache, nausea, and rapid heartbeat. . Clinical studies have shown that the incidence of hypoglycemia varies depending on the patient population, dosage regimen and glycemic control. In clinical studies, there was no difference in the overall incidence of hypoglycemic episodes between patients receiving insulin aspart therapy and patients receiving human insulin preparations.

Lipodystrophy

Rare cases of lipodystrophy have been reported. Lipodystrophy may develop at the injection site.

Special instructions

Before traveling for long periods of time due to jet lag, the patient should consult with their physician, as jet lag means that the patient must eat and take insulin at different times.

Hyperglycemia

An insufficient dose of the drug or discontinuation of treatment, especially in type 1 diabetes, can lead to the development of hyperglycemia and diabetic ketoacidosis. Typically, symptoms of hyperglycemia appear gradually over several hours or days. Symptoms of hyperglycemia include nausea, vomiting, drowsiness, redness and dryness of the skin, dry mouth, increased urine output, thirst and loss of appetite, as well as the smell of acetone in the exhaled air. Without appropriate treatment, hyperglycemia can lead to death.

Hypoglycemia

Skipping meals, unplanned increased physical activity, or an insulin dose that is too high for the patient's needs can lead to hypoglycemia.

After compensation of carbohydrate metabolism, for example, with intensified insulin therapy, patients may experience changes in their typical symptoms that are precursors of hypoglycemia, of which patients should be informed.

The usual warning symptoms may disappear with prolonged diabetes mellitus.

A consequence of the pharmacodynamic properties 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 drug’s effect should be taken into account when treating patients with concomitant diseases or taking medications that slow down the absorption of food.

Concomitant diseases, especially infectious ones and those accompanied by fever, usually increase the body's need for insulin. Dose adjustment of the drug may also be required if the patient has concomitant diseases of the kidneys, liver, dysfunction of the adrenal glands, pituitary gland or thyroid gland.

When transferring a patient to other types of insulin, early symptoms that are precursors of hypoglycemia may become less pronounced compared to those when using the previous type of insulin.

Transferring the patient from other insulin preparations

Transferring 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 analogue) of insulin preparations and/or manufacturing method change, it may be necessary to change the dose or increase the frequency of injections compared to previously used insulin preparations. If dose adjustment is necessary, it can be done at the first administration of the drug or during the first weeks or months of treatment.

Reactions at the injection site

As with treatment with other insulin drugs, reactions may develop at the injection site, manifested by pain, redness, urticaria, inflammation, hematoma, swelling and itching. Regularly changing injection sites in the same anatomical area may reduce symptoms or prevent reactions. In very rare cases, it may be necessary to discontinue Novorapid.

Simultaneous use of drugs of the thiazolidinedione group and insulin drugs

Cases of the development of chronic heart failure have been reported when patients were treated 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 drugs to patients. When prescribing such combination therapy, it is necessary to conduct medical examinations of patients to identify signs and symptoms of chronic heart failure, weight gain and the presence of edema. If patients' symptoms of heart failure worsen, treatment with thiazolidinediones should be discontinued.

For impaired renal function

Impaired kidney function may result in decreased insulin requirements.

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

For liver dysfunction

Impaired liver function can lead to decreased insulin requirements.

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

Impact on the ability to drive vehicles and operate machinery

Patients' ability to concentrate and react quickly may be impaired during hypoglycemia, which can be dangerous in situations where these abilities are especially needed (for example, when driving or operating machinery). Patients should be advised to take measures to prevent the development of hypoglycemia when driving vehicles and operating machinery. This is especially important for patients with no or decreased severity of symptoms that are warning signs of developing hypoglycemia or who suffer from frequent episodes of hypoglycemia.

Pregnancy and lactation

Novorapid can be prescribed during pregnancy. Two randomized controlled clinical trials (157+14 pregnant women studied) showed no adverse effects of insulin aspart on pregnancy or fetal/newborn health compared with human insulin.

Close monitoring of blood glucose levels and monitoring in pregnant women with diabetes mellitus (type 1, type 2 or gestational diabetes) is recommended throughout pregnancy and during pregnancy. The need for insulin, as a rule, decreases in the first trimester and gradually increases in the second and third trimesters of pregnancy. Shortly after birth, insulin requirements quickly return to pre-pregnancy levels.

During breastfeeding, Novorapid can be used without restrictions, because administering insulin to a nursing woman does not pose a threat to the baby. However, it may be necessary to adjust the dose of the drug.

Use in childhood

Use in old age

As with other insulins, elderly patients Blood glucose concentrations should be monitored more carefully and the dose of insulin aspart adjusted individually.

Storage conditions and periods

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 pen with the cap on. Shelf life - 30 months.

Novorapid should be protected from exposure to excess heat and light.

When used or carried as a spare syringe pen with the drug, do not store it in the refrigerator. Store at a temperature not exceeding 30°C. Use within 4 weeks.

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

A hypoglycemic drug, an analogue of short-acting human insulin.
Drug: NOVORAPID® FlexPen®
Active substance of the drug: insulin aspart
ATX encoding: A10AB05
KFG: Short-acting analogue of human insulin
Registration number: P No. 016171/01
Registration date: 01/27/05
Owner reg. cert.: NOVO NORDISK A/S (Denmark)

Novorapid flexpen release form, drug packaging and composition.

The solution for subcutaneous and intravenous administration is 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 injection.

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

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

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

Pharmacological action Novorapid flexpen

A hypoglycemic drug, an analogue of short-acting human insulin, produced by recombinant DNA biotechnology using a strain of Saccharomyces cerevisiae, in which the amino acid proline at position B28 is replaced by aspartic acid.

It 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 levels is due to an increase in its intracellular transport, increased absorption by tissues, stimulation of lipogenesis, glycogenogenesis, and a decrease in the rate of glucose production by the liver.

Substitution 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 absorbed much more quickly from 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 subcutaneous administration, 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, there is a reduction in the risk of nocturnal hypoglycemia compared to soluble human insulin. There was no significant increase in the risk of daytime hypoglycemia.

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

Clinical studies in adult patients with type 1 diabetes mellitus demonstrate lower postprandial blood glucose levels when administered with NovoRapid FlexPen compared to soluble human insulin.

The use of NovoRapid FlexPen in children showed similar results of 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 single-dose pharmacokinetic/pharmacodynamic study was conducted in children 6–12 years of age and adolescents 13–17 years of age. The pharmacodynamic profile of insulin aspart in children was similar to that in adult patients.

Clinical studies of the comparative safety and effectiveness 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) indicate comparable safety profiles along with significant improvements in postprandial glucose control with insulin aspart treatment.

Pharmacokinetics of the drug.

Suction

After subcutaneous administration of insulin aspart, Tmax in blood plasma is on average 2 times less than after administration of soluble human insulin. Cmax in blood plasma averages 492±256 pmol/l and is achieved 40 minutes after subcutaneous administration at a dose of 0.15 U/kg body weight to patients with type 1 diabetes mellitus. Insulin concentration returns to the original level 4-6 hours after administration of the drug. 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). Interindividual variability in Tmax is significantly lower with insulin aspart compared to soluble human insulin, while the reported variability in Cmax is greater for insulin aspart.

Pharmacokinetics of the drug.

in special clinical cases

Pharmacokinetic studies have not been conducted in elderly patients or 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 a Tmax similar to that in adults. However, there are differences in the Cmax value in the two age groups, which emphasizes the importance of individual selection of the drug dosage regimen.

Indications for use:

Diabetes mellitus.

Dosage and method of administration of the drug.

NovoRapid FlexPen is intended for subcutaneous and intravenous administration. 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 be administered, as a rule, 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, which are administered at least once a day.

Typically, the total daily need for insulin ranges from 0.5-1 U/kg body weight. When the drug is administered before meals, the need for insulin can be met by NovoRapid FlexPen by 50-70%, the remaining need for insulin is provided by long-acting insulin.

The temperature of the administered insulin should be at room temperature.

NovoRapid FlexPen is injected subcutaneously into the area of the anterior abdominal wall, thigh, shoulder or buttock. Injection sites within the same area of the body must be changed regularly.

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

Subcutaneous injection into the anterior abdominal wall provides faster absorption compared to injection into other places. However, the faster onset of action compared to soluble human insulin persists regardless of injection site location.

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

For intravenous administration, infusion systems 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 are used; 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 subcutaneous insulin infusions (CSII) in insulin pumps designed for insulin infusions. CSII should be administered into the anterior abdominal wall. Infusion sites should be changed periodically.

When using an insulin pump for infusions, NovoRapid FlexPen should not be mixed with other types of insulin.

Patients receiving NovoRapid FlexPen via CSII should have additional insulin available in case of infusion system failure.

NovoRapid FlexPen is a pre-filled syringe pen with a dispenser. The FlexPen syringe pen is intended for use with injection systems for administering insulin from the company with needles with a short NovoFine cap. The package of needles is marked with the symbol “S”. The FlexPen syringe pen allows you to inject 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.

The FlexPen syringe pen is intended for individual use only and cannot be refilled.

Side effects of Novorapid Flexpen:

Side effects associated with the effect on carbohydrate metabolism: hypoglycemia (increased sweating, pale skin, nervousness or tremor, anxiety, unusual fatigue or weakness, disorientation, impaired concentration, dizziness, severe hunger, temporary blurred vision, headache , nausea, tachycardia). Severe hypoglycemia can lead to loss of consciousness and/or seizures, temporary or permanent impairment of brain function, 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: uncommon - urticaria, skin rash; very rarely - anaphylactic reactions. Generalized allergic reactions may include skin rash, itchy skin, increased sweating, gastrointestinal disorders, angioedema, difficulty breathing, tachycardia, and decreased blood pressure.

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

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

Adverse reactions observed in patients using the drug NovoRapid FlexPen are mainly dose-dependent and 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 studied) found no adverse effects of insulin apart on pregnancy or fetal/newborn health compared with human insulin.

During the period of possible pregnancy and throughout its entire duration, it is necessary to monitor blood glucose levels and carefully monitor the condition of patients with diabetes. The need for insulin, as a rule, decreases in the first trimester and gradually increases in the second and third trimesters of pregnancy. Shortly after birth, insulin requirements quickly return to pre-pregnancy levels.

During lactation (breastfeeding), NovoRapid FlexPen can be used without restrictions. Administration of insulin to a nursing mother does not pose a threat to the baby. However, it may be necessary to adjust the dose of the drug.

Special instructions for the use of Novorapid Flexpen.

Insufficient dosage of the drug or discontinuation of treatment, especially in type 1 diabetes mellitus, can lead to the development of hyperglycemia or diabetic ketoacidosis. Typically, symptoms of hyperglycemia appear gradually over several hours or days. Symptoms of hyperglycemia include nausea, vomiting, drowsiness, redness and dryness of the skin, dry mouth, increased urine output, thirst and loss of appetite, as well as the smell of acetone in the exhaled air. Without appropriate treatment, hyperglycemia can lead to death. After compensation of carbohydrate metabolism, for example, with intensified insulin therapy, patients may experience changes in their typical symptoms that are precursors of hypoglycemia, of which patients should be informed.

In patients with diabetes mellitus, with optimal metabolic control, late complications of diabetes develop later and progress more slowly. In this regard, it is recommended to carry out measures aimed at optimizing metabolic control, including monitoring blood glucose levels.

A consequence of the pharmacodynamic properties 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. The high rate of onset of the drug's effect should be taken into account when treating patients with concomitant diseases or taking medications 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 reduce insulin requirements.

When transferring a patient to other types of insulin, early symptoms that are precursors of hypoglycemia may change or become less pronounced compared to those when using the previous type of insulin.

Transferring 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 analogue) of insulin preparations and/or manufacturing method change, the dose may need to be changed. Patients switching to treatment with NovoRapid FlexPen may require an increase in the frequency of injections or a dose change compared to the doses of previously used insulin preparations. If necessary, dose adjustment 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. Exercise performed immediately after meals may increase the risk of hypoglycemia. Skipping meals or unplanned exercise can lead to hypoglycemia.

A significant improvement in carbohydrate metabolism compensation 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, intensification of insulin therapy with a sharp improvement in glycemic control may be accompanied by a temporary worsening of diabetic retinopathy.

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

Impact on the ability to drive vehicles and operate machinery

Patients' ability to concentrate and react quickly 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 machinery). Patients should be advised to take measures to prevent the development of hypoglycemia and hyperglycemia when driving a car and working with machinery. This is especially important for patients with no or decreased severity of symptoms that are warning signs of developing hypoglycemia or who suffer from frequent episodes of hypoglycemia. In these cases, the feasibility of performing such work should be considered.

Drug overdose:

Symptoms: hypoglycemia.

Treatment: the patient can eliminate mild hypoglycemia on his own by ingesting glucose, sugar or carbohydrate-rich foods (patients are advised to carry sugar, sweets, cookies or sweet fruit juice with them at all times). In severe cases, when the patient loses consciousness, a 40% dextrose (glucose) solution is administered intravenously; IM or SC - 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, lithium preparations, 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, it is possible to both weaken and enhance the effect of the drug.

Pharmaceutical incompatibility

Medicines containing thiol or sulfite, when added to insulin, cause its destruction.

Terms of sale in pharmacies.

The drug is available with a prescription.

Storage conditions for 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.

NovoRapid is a medicine against diabetes that can compensate for the lack of natural insulin. Injections using NovoRapid insulin lower blood sugar. This new drug has many advantages over its analogues.

It is quickly and easily absorbed, and sugar levels are immediately normalized. You can use it at any time, no matter before or after meals, as it belongs to the group of ultra-short insulins. The body does not get used to this medicine; you can quit it at any time or switch to another drug.

Evidence of its safety is that it is allowed even during pregnancy.

Features of NovoRapid's action

NovoRapid is considered a direct analogue of natural human insulin, but is much more powerful in its action. Its main component is insulin aspart, which has a short-term hypoglycemic effect. Due to the fact that the movement of glucose within cells increases and its formation in the liver slows down, blood sugar levels drop significantly.

After a decrease in blood sugar, the following processes occur:

NovoRapid solution can be administered subcutaneously or intravenously. But it is recommended to administer it under the skin, then NovoRapid is absorbed more efficiently and has an effect much faster when compared with soluble insulin. But the action time is not as long as that of soluble insulin.

NovoRapid is activated almost immediately after the injection - after 10-15 minutes, greater effectiveness 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 become addicted to it; you can always stop or change the drug.

Indications for use of NovoRapid

The drug is prescribed for the following diseases:

NovoRapid is contraindicated in the following patients:

NovoRapid insulin is approved for the control of diabetes mellitus in women throughout pregnancy and during breastfeeding.

Sometimes adverse reactions occur with NovoRapid injections:

In a situation of overdose, the body will have the following reactions:

Fainting,
Hypotension,
Pallor of the skin.

NovoRapid production

The manufacturer of NovoRapid is Novo Nordisk, country is Denmark. International name: insulin aspart.

NovoRapid is available in two forms:

Replacement Penfill cartridges.

The medicine itself is the same in these types - a clear, colorless liquid, 1 ml contains 100 units of the active component. Both pens and cartridges contain 3 ml of insulin.

The production of NovoRapid insulin takes place using a special technology based on the Saccharomyces cerevisiae strain, in which the amino acid is replaced with aspartic acid, as a result of which a receptor complex is obtained, which activates the processes occurring in cells, as well as the chemical combination of the main components (glycogen synthetase, hexokinases, pyruvate kinases).

The difference between the types of NovoRapid FlexPen and NovoRapid Penfill consists solely in the form of release: the first type is a syringe pen, the second is replaceable cartridges. But the medicine poured there is the same. Each patient has the opportunity to choose which form of insulin is more convenient for him to use.

Both types of medications can be purchased in retail pharmacies only with a doctor’s prescription.

NovoRapid cost

The price of NovoRapid Penfill for 5 pens in Russia is 1600-1800 rubles, the price of FlexPen for 5 pens (one package) is 1800-2000 rubles.

Instructions for use of NovoRapid

In order to combat type 1 or type 2 diabetes, it is advisable to give the injection subcutaneously in the thigh, buttock, anterior abdominal wall or shoulder before meals on an empty stomach.

To determine the dose of medication for one time, you need to multiply your body weight by the daily dose, and then divide by two. Round the resulting result.

The patient's average need for insulin per day should be from 0.5 to 1 U/kg body weight. It is compensated by 60-70% by administering the medicine before meals, and the rest is supplied 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; their packaging should have the symbol “S”.

With this syringe you can inject from 1 to 60 units of medication with a precision of up to 1 unit. You must follow the instructions for using the device. The FlexPen syringe pen is produced for personal use and cannot be refilled or transferred to others.

Patients who miss a dose are required to test their blood for glucose concentrations and then return to their normal regimen once a day. In no case should you administer a double dose after a missed dose to make up for the forgotten one!

The course of treatment is often long, so specific timing is difficult to establish. The duration of the drug is affected by the dose administered, the injection site on the body, the speed of blood flow, temperature and the degree of physical activity.

NovoRapid Penfill is available in the form of cartridges that are used to administer insulin by injection.

Manufactured by NovoNordisk, NovoFine needles are included.

Do not use FlexPen and Penfill in the following situations:

Special instructions when using NovoRapid:

NovoRapid's analogues

If NovoRapid is not suitable for a diabetic for any reason, then the doctor recommends using the following analogues: Apidra, Gensulin N, Humalog, Novomix, Ryzodeg. Their prices are approximately the same.

Patients often ask their doctors the question: “Which is better - Humalog or NovoRapid?” But there may not be precise information to answer, since different types of insulin have different effects on each diabetic patient. Usually, an emerging allergy forces you to switch from one drug to another.

Judging by patient reviews, NovoRapid acts much faster than its short-acting analogues. And there is another important advantage of NovoRapid insulin - it can be used by women during pregnancy and lactation.

In addition, patients with diabetes have a question: “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.

Insulin aspart

Composition and release form of the drug

Solution for subcutaneous and intravenous administration transparent, colorless.

Excipients: glycerol - 16 mg, phenol - 1.5 mg, metacresol - 1.72 mg, zinc chloride - 19.6 mcg, - 0.58 mg, sodium hydrogen phosphate dihydrate - 1.25 mg, sodium hydroxide 2M - about 2.2 mg, hydrochloric acid 2M - about 1.7 mg , water d/i - up to 1 ml.

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

Pharmacological action

An analogue of human insulin with an average duration of action. In the molecular structure of this insulin, the amino acid proline at position B28 is replaced by aspartic acid, which reduces the tendency of molecules to form hexamers, which is observed in a solution of regular insulin.

It 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 hypoglycemic effect is associated with an increase in intracellular transport and increased tissue uptake, stimulation of lipogenesis, glycogenogenesis, and a decrease in the rate of glucose production by the liver.

Insulin aspart and human insulin have the same activity in molar equivalent.

Insulin aspart is absorbed from subcutaneous fat tissue more quickly and has a faster onset of action than soluble human insulin.

The duration of action of insulin aspart after subcutaneous administration is shorter than that of soluble human insulin.

Indications

(insulin dependent).

Diabetes mellitus type 2 (non-insulin dependent): stage of resistance to oral hypoglycemic agents, partial resistance to these drugs (during combination therapy), intercurrent diseases.

Contraindications

Hypoglycemia, increased sensitivity to insulin aspart.

Dosage

The dose is set individually, based on blood glucose levels.

Side effects

Side effects associated with the effect on carbohydrate metabolism: hypoglycemia (increased sweating, pallor of the skin, nervousness or tremor, anxiety, unusual fatigue or weakness, disorientation, impaired concentration, dizziness, severe hunger, temporary blurred vision, nausea, tachycardia). Severe hypoglycemia can lead to loss of consciousness and/or seizures, temporary or permanent impairment of brain function, and death.

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

Local reactions: allergic reactions (redness, swelling, itching of the skin at the injection site), usually temporary and passing as treatment continues; lipodystrophy is possible.

Others: at the beginning of therapy, rarely - swelling, possible refractive error.

Drug interactions

The hypoglycemic effect of insulin is enhanced by oral hypoglycemic drugs, MAO inhibitors, ACE inhibitors, carbonic anhydrase inhibitors, non-selective, bromocriptine, octreotide, sulfonamides, anabolic steroids, tetracyclines, clofibrate, ketoconazole, mebendazole, pyridoxine, theophylline, cyclophosphamide, fenfluramine, lithium drugs, containing ethanol

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

Under the influence of reserpine and salicylates, it is possible to both weaken and enhance the effect of the drug.

Medicines containing thiol or sulfite, when added to insulin, cause its destruction.

Special instructions

Insufficient insulin dosage or discontinuation of treatment, especially in type 1 diabetes mellitus, can lead to the development of hyperglycemia or diabetic ketoacidosis. Typically, symptoms of hyperglycemia appear gradually over several hours or days. Symptoms of hyperglycemia include nausea, vomiting, drowsiness, redness and dryness of the skin, dry mouth, increased urine output, thirst and loss of appetite, as well as the smell of acetone in the exhaled air. Without appropriate treatment, hyperglycemia can lead to death. After compensation of carbohydrate metabolism, for example, with intensive insulin therapy, patients may experience changes in their typical symptoms that are precursors of hypoglycemia.

A consequence of the pharmacodynamic properties of short-acting insulin analogues is that the development of hypoglycemia with their use begins earlier than with the use of soluble human insulin.

The high rate of development of the hypoglycemic effect should be taken into account when treating patients with concomitant diseases or taking medications that slow down the absorption of food. In the presence of concomitant diseases, especially of infectious origin, the need for insulin, as a rule, increases. Impaired kidney or liver function may reduce insulin requirements.

Changing the insulin dose may be necessary with changes in diet and increased physical activity. Exercise performed immediately after eating may increase the risk of hypoglycemia. Skipping meals or unplanned exercise can lead to hypoglycemia.

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

Impact on the ability to drive vehicles and operate machinery

Pregnancy and lactation

Clinical experience with the use of insulin asprate during pregnancy is very limited.

IN experimental studies In animals, no differences were found between the embryotoxicity and teratogenicity of insulin aspart and human insulin. During the period of possible pregnancy and throughout its entire period, it is necessary to carefully monitor the condition of patients suffering from diabetes mellitus and monitor blood glucose levels. The need for insulin, as a rule, decreases in the first trimester and gradually increases in the second and third trimesters of pregnancy. During and immediately after childbirth, the need for insulin may decrease dramatically. Shortly after birth, insulin requirements quickly return to pre-pregnancy levels.

Insulin asprate can be used during lactation (breastfeeding), but insulin dosage adjustment may be required.