Insulin NovoRapid: instructions, dosage, use during pregnancy. The current generation uses the effective drug Novorapid What kind of long-term insulin is Novorapid used

INSTRUCTIONS
on the medical use of the drug

Registration number:

Tradename: NovoRapid® FlexPen®

INN: insulin aspart

Dosage form:

Composition:

Description
Clear, colorless solution.

Pharmacotherapeutic group:

ATX code- A10AB05.

Pharmacological properties:

Interacts with a specific receptor on the outer cytoplasmic membrane of cells and forms an insulin-receptor complex that stimulates intracellular processes, including the synthesis of a number of key enzymes (hexokinase, pyruvate kinase, glycogen synthase, etc.). The decrease in blood glucose is due to an increase in its intracellular transport, increased absorption by tissues, stimulation of lipogenesis, glycogenogenesis, a decrease in the rate of glucose production by the liver, etc.

The replacement of the amino acid proline at position B28 with aspartic acid in insulin aspart reduces the tendency of molecules to form hexamers, which is observed in a solution of regular insulin. In this regard, insulin aspart is much faster absorbed from the subcutaneous fat and begins to act faster than soluble human insulin. Insulin aspart lowers blood glucose more strongly in the first 4 hours after a meal than soluble human insulin. Duration of action of insulin aspart after subcutaneous injection shorter than soluble human insulin. After subcutaneous administration, the effect of the drug begins within 10-20 minutes after administration. The maximum effect is observed 1-3 hours after the injection. The duration of the drug is 3-5 hours.

Clinical studies involving patients with diabetes Type 1 insulin has been shown to reduce the risk of nocturnal hypoglycemia with insulin aspart compared with soluble human insulin. The risk of daytime hypoglycemia was not significantly increased.

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

Adults. Clinical studies in patients with type 1 diabetes demonstrate lower postprandial blood glucose concentrations with insulin aspart compared with soluble human insulin.

Elderly: A randomized, double-blind, cross-over study of the pharmacokinetics and pharmacodynamics (PK/PD) of insulin aspart and soluble human insulin was conducted in elderly patients with type 2 diabetes mellitus (19 patients aged 65-83 years, mean age 70 years). The relative differences in pharmacodynamic properties between insulin aspart and soluble human insulin in elderly patients were similar to those in healthy volunteers and in younger diabetics.

Children and teenagers. The use of insulin aspart in children showed similar results of long-term glycemic control when compared with soluble human insulin.
A clinical study using soluble human insulin before meals and insulin aspart after meals was conducted in young children (26 patients aged 2 to 6 years); and a PK/PD study using a single dose was conducted in children (6-12 years) and adolescents (13-17 years). The pharmacodynamic profile of insulin aspart in children was similar to that in adult patients.

Pregnancy: Clinical studies of the comparative safety and efficacy of insulin aspart and human insulin in the treatment of pregnant women with type 1 diabetes mellitus (322 examined pregnant women, of which 157 received insulin aspart, 165 - human insulin) did not reveal any negative impact of insulin aspart on the course of pregnancy or fetal health / newborn.
Additional clinical studies in 27 women with gestational diabetes receiving insulin aspart and human insulin (14 women received insulin aspart, 13 women received human insulin) show comparable safety profiles along with a significant improvement in postprandial glucose control with insulin aspart treatment.

Pharmacokinetics.
After subcutaneous injection of insulin aspart, the time to reach the maximum concentration (t max) in blood plasma is on average 2 times less than after administration of soluble human insulin. The maximum plasma concentration (Cmax) averages 492 ± 256 pmol / l and is reached 40 minutes after a subcutaneous dose of 0.15 U / kg of body weight in patients with type 1 diabetes mellitus. The concentration of insulin returns to its original level 4-6 hours after the administration of the drug. The absorption rate is slightly lower in patients with type 2 diabetes, resulting in a lower maximum concentration (352±240 pmol/l) and a later t max (60 minutes).

The intra-individual variability in t max is significantly lower with insulin aspart compared to soluble human insulin, while the indicated variability in C max for insulin aspart is greater.

Pharmacokinetics in children (6-12 years old) and adolescents (13-17 years old) with type 1 diabetes mellitus. Absorption of insulin aspart occurs rapidly in both age groups with t max similar to that of adults. However, there are differences in Cmax in the two age groups, which emphasizes the importance of individual dosing of the drug. Elderly: The relative differences in pharmacokinetics between insulin aspart and soluble human insulin in elderly patients (65-83 years old, mean age 70 years) with type 2 diabetes mellitus were similar to those in healthy volunteers and in younger patients with diabetes mellitus. In elderly patients, a decrease in the rate of absorption was observed, which led to a slowdown in t max (82 (variability: 60-120) minutes), while C max was the same as that observed in younger patients with type 2 diabetes mellitus and slightly less than in patients with type 1 diabetes mellitus. Hepatic impairment: A single dose pharmacokinetic study of insulin aspart was conducted in 24 patients with normal to severe hepatic impairment. In persons with impaired liver function, the rate of absorption of insulin aspart was reduced and more variable, resulting in a slowdown in t max from about 50 minutes in people with normal liver function to about 85 minutes in people with moderate to severe hepatic impairment. The area under the concentration-time curve, the maximum plasma concentration and the total clearance of the drug (AUC, C max and CL / F) were similar in the streets with reduced and normal liver function. Renal impairment: The pharmacokinetics of insulin aspart was studied in 18 patients whose renal function ranged from normal to severe impairment. There was no clear effect of creatinine clearance on AUC, C max , t max of insulin aspart. Data were limited to those with moderate to severe renal impairment. Persons with kidney failure requiring dialysis were not included in the study.

Preclinical safety data:
In the course to clinical research no hazard to humans has been identified based on data from established studies of safety pharmacology, repeated use toxicity, genotoxicity and reproductive toxicity. In in vitro tests, including binding to insulin receptors and insulin-like growth factor-1, as well as the effect on cell growth, the behavior of insulin aspart is very similar to that of human insulin. The results of the studies also showed that the dissociation of the binding of insulin aspart to the insulin receptor is equivalent to that of human insulin.

Indications for use:

Contraindications:

Use during pregnancy and during breastfeeding
NovoRapid® FlexPen® can be administered during pregnancy. Data from two randomized controlled clinical trials (157 + 14 pregnant women examined) did not reveal any adverse effects of insulin aspart on pregnancy or fetal / newborn health compared to human insulin (see section "

Pharmacological properties:

During breastfeeding, NovoRapid® FlexPen® can be used, because. the introduction of insulin to a woman during breastfeeding does not pose a threat to the child. However, it may be necessary to adjust the dose of the drug.

Dosage and administration:

To achieve optimal glycemic control, it is recommended to regularly measure the concentration of glucose in the blood and adjust the dose of insulin.

Usually, the individual daily requirement for insulin in adults and children is from 0.5 to 1 U / kg of body weight. When the drug is administered before meals, the need for insulin can be provided by NovoRapid® FlexPen® by 50-70%, the remaining insulin requirement is provided by long-acting insulin.

An increase in the patient's physical activity, a change in the habitual diet, or concomitant diseases may lead to the need for dose adjustment.

NovoRapid® FlexPen® has a faster onset and shorter duration of action than soluble human insulin. Due to the faster onset of action, NovoRapid® FlexPen® should usually be administered immediately before a meal, if necessary, it can be administered shortly after a meal. Due to the shorter duration of action compared to human insulin, the risk of nocturnal hypoglycemia in patients receiving NovoRapid® FlexPen® is lower.

Special patient groups
As with the use of other insulins, in elderly patients and patients with renal or hepatic insufficiency, blood glucose concentrations should be more carefully monitored and the dose of insulin aspart adjusted individually.

Children and teenagers
Use of NovoRapid® FlexPen® instead of soluble human insulin in children is preferable when a rapid onset of action of the drug is necessary, for example, when it is difficult for a child to observe the required time interval between injection and food intake.

Transfer from other insulin preparations
When transferring a patient from other insulin preparations to NovoRapid® FlexPen®, dose adjustment of NovoRapid® FlexPen® and basal insulin may be required.

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

NovoRapid® can be used for continuous subcutaneous insulin infusions (CSII) in insulin pumps designed for insulin infusions. CSII should be made into the anterior abdominal wall. Infusion sites should be changed periodically.

When using an insulin infusion pump, NovoRapid® should not be mixed with other types of insulin.

Patients using CSII should be fully trained in the use of the pump, appropriate reservoir, and pump tubing. The infusion set (tube and catheter) should be changed in accordance with the user manual supplied with the infusion set.

Patients receiving NovoRapid® via CSII should have extra insulin available in case the infusion line breaks down.

Intravenous administration
If necessary, NovoRapid® can be administered intravenously, but only by qualified medical personnel.

For intravenous administration, infusion systems are used with NovoRapid® 100 IU / ml with a concentration of 0.05 IU / ml to 1 IU / ml of insulin aspart in 0.9% sodium chloride solution; 5% dextrose solution or 10% dextrose solution containing 40 mmol/l potassium chloride using polypropylene infusion containers. These solutions are stable at room temperature for 24 hours. Although stable for some time, a certain amount of insulin is initially absorbed by the infusion system material. During insulin infusions, it is necessary to constantly monitor the concentration of blood glucose.

Side effect:

The most common adverse reaction is hypoglycemia. Frequency of occurrence side effects varies depending on the patient population, dosing regimen and glycemic control (see section below).

On the initial stage refractive errors, edema and reactions at the injection sites (pain, redness, urticaria, inflammation, hematoma, swelling and itching at the injection site) may occur during insulin therapy. These symptoms are usually transient. Rapid improvement in glycemic control can lead to a state of "acute painful neuropathy", which is usually reversible. Intensification of insulin therapy with a dramatic improvement in carbohydrate control may lead to a temporary worsening of diabetic retinopathy, while long-term improvement in glycemic control reduces the risk of progression of diabetic retinopathy.

The list of adverse reactions is presented in the table.

*Cm. "Description of selected adverse reactions"

All adverse reactions presented below, based on data obtained from clinical studies, are divided into groups according to the frequency of development in accordance with MedDRA and organ systems. The frequency of development of adverse reactions is defined as: very often (≥ 1/10); often (≥ 1/100 to<1/10); нечасто (≥1/1,000 до <1/100); редко (≥1/10,000 до <1/1,000), очень редко (<1/10,000) и неизвестно (невозможно оценить на основании имеющихся данных).

Description of individual adverse reactions:
Anaphylactic reactions
Very rare generalized hypersensitivity reactions (including generalized skin rash, pruritus, increased sweating, gastrointestinal disturbances, angioedema, difficulty breathing, rapid heart rate, decreased blood pressure) have been reported, which are potentially life-threatening.

hypoglycemia
Hypoglycemia is the most common side effect. It can develop if the dose of insulin is too high in relation to the need for insulin. Severe hypoglycemia can lead to loss of consciousness and / or convulsions, temporary or irreversible impairment of brain function, and even death. Symptoms of hypoglycemia usually develop suddenly. These may include cold sweats, pale skin, increased fatigue, nervousness or tremors, anxiety, unusual tiredness or weakness, confusion, decreased concentration, drowsiness, severe hunger, visual disturbances, headache, nausea, and heart palpitations. . Clinical studies have shown that the incidence of hypoglycemia varies depending on the patient population, dosing regimen and glycemic control. In clinical studies, there was no difference in the overall incidence of episodes of hypoglycemia between patients receiving insulin aspart therapy and patients using human insulin preparations.

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

Overdose:

Mild hypoglycemia can be corrected by the patient himself by ingesting glucose or sugar-containing foods. Therefore, diabetic patients are advised to carry sugar-containing products with them at all times.
- In case of severe hypoglycemia, when the patient is unconscious, 0.5 mg to 1 mg of glucagon should be administered intramuscularly or subcutaneously (a trained person may administer), or an intravenous glucose (dextrose) solution (only a medical professional may administer). It is also necessary to inject dextrose intravenously if the patient does not regain consciousness 10-15 minutes after the administration of glucagon. After regaining consciousness, the patient is advised to take a carbohydrate-rich meal to prevent the recurrence of hypoglycemia.

Interaction with other drugs

The hypoglycemic action of insulin is enhanced by oral hypoglycemic drugs, monoamine oxidase inhibitors, angiotensin-converting enzyme inhibitors, carbonic anhydrase inhibitors, non-selective beta-blockers, bromocriptine, sulfonamides, anabolic steroids, tetracyclines, clofibrate, ketoconazole, mebendazole, pyridoxine, theophylline, cyclophosphamide, phenamide, .

The hypoglycemic effect of insulin is weakened by oral contraceptives, glucocorticosteroids, thyroid hormones, thiazide diuretics, heparin, tricyclic antidepressants, sympathomimetics, somatropin, danazol, clonidine, slow calcium channel blockers, diazoxide, morphine, phenytoin, nicotine. Beta-adrenergic blockers may mask the symptoms of hypoglycemia. Octreotide/lanreotide can either increase or decrease insulin requirements.

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

Incompatibility
Some drugs, such as those containing thiol or sulfite groups, when added to NovoRapid® FlexPen®, can cause the destruction of insulin aspart. NovoRapid® FlexPen® should not be mixed with other medicinal products. The exceptions are isophane-insulin and solutions for infusion, described in the section "

Dosage and administration:

special instructions

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 physical activity, 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® FlexPen® should be used in direct connection with food intake, the high rate of onset of the effect of the drug should be taken into account when treating patients with concomitant diseases or taking drugs that slow down the absorption of food.

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

When transferring a patient to other types of insulin, the early warning symptoms of hypoglycemia may become less pronounced than when using the previous type of insulin.

Transfer of the patient from other insulin preparations
The transfer of a patient to a new type of insulin or an insulin preparation from another manufacturer must be carried out under strict medical supervision. When changing the concentration, type, manufacturer and type (human insulin, animal insulin, human insulin analogue) of insulin preparations and / or method of manufacture, it may be necessary to change the dose or increase the frequency of injections compared to previously used insulin preparations. If it is necessary to adjust the dose, it can be made already at the first administration of the drug or during the first weeks or months of treatment.

Reactions at the injection site
As with other insulin preparations, reactions at the injection site may develop, which is manifested by pain, redness, urticaria, inflammation, hematoma, swelling and itching. Regularly changing the injection site in the same anatomical area may reduce symptoms or prevent the development of reactions. In very rare cases, it may be necessary to cancel NovoRapid® FlexPen®.

Simultaneous use of drugs of the thiazolidinedione group and insulin drugs
Cases of the development of chronic heart failure have been reported in the treatment of patients with thiazolidinediones in combination with insulin preparations, especially if such patients have risk factors for the development of chronic heart failure. This fact should be taken into account when prescribing combination therapy with thiazolidinediones and insulin preparations to patients. When prescribing such a combination therapy, it is necessary to conduct medical examinations of patients in order to identify signs and symptoms of chronic heart failure, weight gain and the presence of edema. If symptoms of heart failure worsen in patients, treatment with thiazolidinediones should be discontinued.

Influence on the ability to drive vehicles and work with mechanisms
The ability of patients to concentrate and reaction speed may be impaired during hypoglycemia, which can be dangerous in situations where these abilities are especially needed (for example, when driving vehicles or working with machines and mechanisms). Patients should be advised to take measures to prevent the development of hypoglycemia when driving and operating machinery. This is especially important for patients with no or reduced symptoms of developing hypoglycemia or suffering from frequent episodes of hypoglycemia.

Release form:

Storage conditions:

Best before date:

Conditions for dispensing from pharmacies:

Manufacturer:

Representation
Novo Nordisk A/S
119330, Moscow, Lomonosovsky prospect, 38, office 11

Precautions for use
NovoRapid® FlexPen® and needles are for individual use only. Do not refill the pen cartridge.

NovoRapid® FlexPen® must not be used if it is no longer clear and colorless, or if it has been frozen. Inform the patient to discard the needle after each injection.

NovoRapid® can be used in insulin pumps (see "

Dosage and administration:

In case of emergency (hospitalization, malfunction of the insulin delivery device), NovoRapid® can be removed from FlexPen® using a U100 insulin syringe for administration to a patient.

Instructions for patients on the use of NovoRapid® FlexPen®

Do not use NovoRapid® FlexPen®

Before using NovoRapid® FlexPen®

Mode of application
NovoRapid® is intended for subcutaneous injection or long-term infusion in an insulin pump system (PPII). NovoRapid® can also be used intravenously under the strict supervision of a physician. Never inject insulin intramuscularly.

Change the injection site within the anatomical region each time. This will help reduce the risk of lumps and ulceration at the insertion site. It is best to inject the drug into the anterior abdominal wall, shoulder or anterior thigh. Insulin will act faster if it is injected into the anterior abdominal wall. Check your blood glucose levels regularly.

How to use NovoRapid® FlexPen®
Please read carefully the enclosed Patient Instructions for Use of NovoRapid® FlexPen®. Use your pen in strict accordance with this instruction.

Instructions for patients on the use of NovoRapid® FlexPen®

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

Getting Started
Check the label to make sure NovoRapid® FlexPen® contains the correct type of insulin.

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

Insulin Check
Even with proper use of the pen, a small amount of air may accumulate in the cartridge before each injection.
To prevent air bubbles from entering and ensure the correct dose is administered:

E. Dial 2 units of the drug by turning the dosage selector.
F. Holding the NovoRapid® FlexPen® with the needle pointing up, lightly tap the cartridge several times with your fingertip to move the air bubbles to the top of the cartridge.
G. While holding NovoRapid® FlexPen® with the needle up, press the trigger button all the way. The dosage selector will return to zero. 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
Make sure the dosage selector is set to the "O" position.

Do not use the balance scale to measure the dose of insulin.

Storage and care
NovoRapid® FlexPen® is designed for effective and safe use and must be handled with care. In the event of a fall or strong mechanical impact, the syringe pen may be damaged and insulin may leak out.
The surface of NovoRapid® FlexPen® can be cleaned with a cotton swab dipped in alcohol. Do not immerse the pen in liquid, do not wash or lubricate it, because. this may damage the mechanism.
Do not refill NovoRapid® FlexPen®.

Insulin administration
Insert the needle under the skin. Use the injection technique recommended by your doctor.

I. To inject, press the start button all the way down until "0" appears next to the dosage indicator. Be careful: when administering the drug, you should only press the start button. Turning the dose selector will not deliver a dose.
J. When removing the needle from under the skin, keep the trigger button fully depressed. After injection, leave the needle under the skin for at least 6 seconds. This will ensure that the full dose of insulin is delivered.
K. Guide the needle into the outer needle cap without touching the cap. When the needle enters, put on the cap and unscrew the needle. Throw away the needle, taking precautions, and close the pen with a cap.

Remove the needle after each injection and never store NovoRapid® FlexPen® with the needle attached. Otherwise, liquid may leak out of NovoRapid® FlexPen®, which may lead to incorrect dosing.
Caregivers should be careful when removing and discarding needles to avoid the risk of accidental needle stick.
Throw away the used NovoRapid® FlexPen® with the needle removed.
Needles and NovoRapid® FlexPen® are intended for individual use only.

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 sh.-pens, instructions for the preparation.

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 diabetics with liver and / or kidney pathologies: Novorapid therapy should be carried out with more careful control of glycemia 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 the female body during gestation can 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 the unfavorable condition by nausea, bouts of vomiting, drowsiness, dry skin and mucous tissues of the oral cavity, increased urination, constant thirst, and decreased 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. It should be borne in mind that intensive insulin therapy can distort the characteristic symptoms of 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 diabetic switches to other types of the drug, early signs of 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

The conditions characteristic of hypo- and hyperglycemia affect the speed of reaction and the ability to concentrate, and may 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 adrenomimetics, growth hormone, Danazol, lithium-based drugs, morphine, nicotine.
• If it is necessary to combine insulin with beta-blockers, it should be taken into account that the latter drugs can hide the 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, is a sharp drop 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 a 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.

Instructions for medical use

medicinal product

NovoRapid® Penfill®

Tradename

NovoRapid® Penfill®

International non-proprietary name

insulin aspart

Dosage form

Solution for subcutaneous and intravenous administration, 100 units/ml

Composition

1 ml of the drug contains

active substance - insulin aspart 100 IU (600 nmol or 3.5 mg);

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

One cartridge contains 3 ml of a solution equivalent to 300 IU .

Description

Clear, colorless liquid.

Pharmacotherapeutic group

Medicines for the treatment of diabetes. Insulins.

Insulins and analogues of rapid action. insulin aspart.

ATX code A10AB05

Pharmacological properties

Pharmacokinetics

After subcutaneous injection of insulin aspart, the time to reach the maximum concentration (t max) in blood plasma is on average 2 times less than after administration of soluble human insulin. The maximum plasma concentration (Cmax) averages 492 ± 256 pmol / l and is reached 40 minutes after a subcutaneous dose of 0.15 U / kg of body weight in patients with type 1 diabetes mellitus. The insulin concentration returns to its original level after 4 -6 hours after drug administration. The rate of absorption is slightly lower in patients with type 2 diabetes, resulting in a lower maximum concentration (352±240 pmol/l) and a later t max (60 minutes). The inter-individual variability in t max is significantly lower with insulin aspart compared to soluble human insulin, while the indicated variability in C max for insulin aspart is greater.

Pharmacokinetics in children (6-12 years) and adolescents (13-17 years) with type 1 diabetes mellitus. Absorption of insulin aspart occurs rapidly in both age groups, with t max similar to that in adults. However, there are differences in C max in the two age groups, which emphasizes the importance of individual dosage of the drug.

Elderly patients(≥65 years old)

NovoRapid® Penfill® can be used in elderly patients.

As with other insulins, in elderly patients, blood glucose concentrations should be more closely monitored and the dose of insulin asprat should be adjusted individually.

Patients with renal and hepatic insufficiency

In patients with renal or hepatic insufficiency, the need for insulin may be reduced.

As with other insulins, in patients with renal or hepatic insufficiency, blood glucose concentrations should be more closely monitored and the dose of insulin asprat should be adjusted individually.

Pharmacodynamics

NovoRapid® Penfill® is a short-acting human insulin analog produced by recombinant DNA biotechnology using a strain of Saccharomyces cerevisiae, in which the proline amino acid at position B28 is replaced by aspartic acid.

Interacts with a specific receptor on the outer cytoplasmic membrane of cells and forms an insulin-receptor complex that stimulates intracellular processes, incl. synthesis of a number of key enzymes (hexokinase, pyruvate kinase, glycogen synthetase, etc.). The decrease in blood glucose is due to an increase in its intracellular transport, increased absorption by tissues, stimulation of lipogenesis, glycogenogenesis, a decrease in the rate of glucose production by the liver, etc.

The replacement of the amino acid proline at position B28 with aspartic acid in NovoRapid® Penfill® reduces the tendency of molecules to form hexamers, which is observed in a solution of regular insulin. In this regard, NovoRapid® Penfill® is much faster absorbed from the subcutaneous fat and begins to act much faster than soluble human insulin. NovoRapid® Penfill® reduces blood glucose levels more strongly in the first 4 hours after a meal than soluble human insulin. In patients with type 1 diabetes mellitus, a lower postprandial blood glucose level is detected when NovoRapid® Penfill® is administered, compared with soluble human insulin.

The duration of action of NovoRapid® Penfill® after subcutaneous administration is shorter than that of soluble human insulin.

After subcutaneous administration, the effect of the drug begins within 10-20 minutes after administration. The maximum effect is observed 1-3 hours after the injection. The duration of the drug is 3-5 hours.

Clinical studies in patients with type 1 diabetes have demonstrated a reduced risk of nocturnal hypoglycemia with insulin aspart compared with soluble human insulin. The risk of daytime hypoglycemia was not significantly increased.

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

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

Children and teenagers The use of NovoRapid® Penfill® in children has shown similar long-term glucose control results when compared to soluble human insulin.

A clinical study using soluble human insulin before meals and insulin aspart after meals was conducted in young children (26 patients aged 2 to 6 years); and a PK/PD study using a single dose was conducted in children (6-12 years) and adolescents (13-17 years). The pharmacodynamic profile of insulin aspart in children was similar to that in adult patients.

Pregnancy: Clinical studies of the comparative safety and efficacy of insulin aspart and human insulin in the treatment of pregnant women with type 1 diabetes mellitus (322 examined pregnant women, of which insulin aspart: 157; human insulin: 165) did not reveal any negative effects of insulin aspart on pregnancy or health fetus/newborn.

Additional clinical studies of 27 women with gestational diabetes receiving insulin aspart and human insulin (14 women received insulin aspart, 13 women received human insulin) show comparable safety profiles along with a significant improvement in postprandial glucose control with insulin aspart treatment.

Indications for use

Treatment of diabetes mellitus in adults, adolescents and children 2 years of age and older

Dosage and administration

NovoRapid® Penfill® is intended for subcutaneous and intravenous administration. NovoRapid® Penfill® is a fast-acting insulin analogue.

Due to the faster onset of action, NovoRapid® Penfill® should usually be administered immediately before a meal, if necessary, it can be administered shortly after a meal.

The dose of the drug is determined by the doctor individually in each case, based on the level of glucose in the blood. Usually NovoRapid® Penfill® is used in combination with intermediate or long-acting insulin preparations, which are administered at least once a day.

Individual daily insulin requirement in adults and children from 2 years is usually from 0.5 to 1.0 U / kg of body weight. With the introduction of the drug before meals, the need for insulin can be provided by NovoRapid® Penfill® by 50-70%, the remaining insulin requirement is provided by long-acting insulin. The temperature of the injected insulin should correspond to room temperature. NovoRapid® Penfill® is injected subcutaneously into the anterior abdominal wall, thigh, upper arm or buttock. Injection sites within the same area of ​​the body should be changed regularly to reduce the risk of developing lipodystrophy. As with any other insulin preparation, the duration of action of NovoRapid® Penfill® depends on the dose, site of administration, blood flow, temperature and level of physical activity.

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

If necessary, NovoRapid® Penfill® may be administered intravenously, but only by qualified medical personnel.

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

Special patient groups

As with other insulins, in elderly patients and patients with renal or hepatic insufficiency, blood glucose concentrations should be more closely monitored and the dose of insulin aspart adjusted individually.

Children and teenagers

Use of NovoRapid® Penfill® instead of soluble human insulin in children is preferable when a rapid onset of action of the drug is necessary, for example, when it is difficult for a child to observe the required interval between injection and food intake.

Transfer from other insulin preparations

When transferring a patient from other insulin preparations to NovoRapid® Penfill®, dose adjustment of NovoRapid® Penfill® may be required

and basal insulin.

Instructions for patients on the use of NovoRapid® Penfill®

Before using NovoRapid® Penfill®

• Check the label to make sure the correct type of insulin is selected.
• Always check the cartridge, including the rubber piston. Do not use a cartridge if it is visibly damaged, or if there is a visible gap between the piston and the white line on the cartridge. For further instructions, refer to the instructions for use of the insulin delivery system.
• Disinfect the rubber membrane with a cotton swab dipped in rubbing alcohol.
• Always use a new needle for every injection to prevent infection.

Do not use NovoRapid®Penfill® if

• the insulin cartridge or system has been dropped, or the cartridge is damaged or crushed, as there is a risk of insulin leakage;
• storage conditions of insulin did not correspond to those specified, or the drug was frozen;
• insulin ceased to be transparent and colorless.

NovoRapid® Penfill® is intended for subcutaneous injection or long-term infusion in an insulin pump system (PPII). NovoRapid® Penfill® can also be used intravenously under the strict supervision of a physician.

Injection sites should always be changed to avoid the formation of lipodystrophy. The best injection sites are: the anterior abdominal wall, buttocks, anterior thigh or upper arm. Insulin will act faster if it is injected into the anterior abdominal wall. Infusion sites should be changed periodically.

NovoRapid® Penfill® is designed for use with Novo Nordisk insulin injection systems and NovoFine® and NovoTwist® needles.

If NovoRapid® Penfill® and other insulin in a Penfill® cartridge are used at the same time, two separate insulin injection systems must be used, one for each type of insulin.

NovoRapid® Penfill® cannot be refilled.

How to make an injection

• Insulin should be injected under the skin. Use the injection technique recommended by your doctor or nurse, or follow the instructions for administering insulin in the instructions for your insulin device.
• Hold the needle under the skin for at least 6 seconds to be sure that you have injected the full dose of the drug.
• Be sure to discard the needle after each injection. Otherwise, liquid may leak out of the cartridge, which may result in incorrect insulin dosing.

For use in an insulin pump system for long-terminfusions

When used in a NovoRapid® pumping system, Penfill® should never be mixed with other types of insulin.

Follow your doctor's instructions and recommendations for using NovoRapid® Penfill® in a pumping system. Before using NovoRapid® Penfill® in a pumping system, you should carefully read the complete instructions for use of this system and information about any actions to be taken in case of illness, too high or too low blood sugar, or if the CSII system malfunctions.

ü Before inserting the needle, wash your hands and skin at the insertion site with soap and water to avoid any infection at the infusion site.

ü When filling a new reservoir, check that there are no large air bubbles in the syringe or tubing.

ü Replacement of the infusion set (tube and catheter) must be carried out in accordance with the user manual supplied with the infusion set.

To ensure optimal compensation of carbohydrate metabolism disorders and timely detection of a possible malfunction of the insulin pump, it is recommended to regularly monitor blood glucose levels.

What to do if the insulin pump system is not working

As a precaution, always carry a spare insulin delivery system with you in case your NovoRapid® Penfill® is lost or damaged.

Precautions for use and disposal

NovoRapid® Penfill® should only be used with products that are compatible with it and ensure its safe and effective operation.

NovoRapid® Penfill® is intended for individual use only.

Do not refill Penfill®.

Penfill® cartridges are designed for use with Novo Nordisk insulin injection systems and NovoFine® and NovoTwist® needles.

NovoRapid® Penfill® 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.

Solutions for infusion in polypropylene containers prepared from NovoRapid® Penfill® 100 IU / ml with a concentration of 0.05 to 1.0 U / ml insulin aspart in 0.9% sodium chloride solution, 5% dextrose solution or 10% dextrose solution containing 40 mmol/l potassium chloride 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 the infusion of insulin, it is necessary to constantly monitor the level of glucose in the blood.

NovoRapid® Penfill® cannot be used if it is no longer clear and colorless.

Unused drug and other materials should be disposed of in accordance with local regulations.

Side effects

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

Often (>1/100,<1/10)

The most common adverse effect during treatment is hypoglycemia. The incidence of hypoglycemia depends on the patient population, the dose of the drug and the level of glycemic control.

At the beginning of insulin treatment, refractive errors, swelling and reactions at the injection sites (pain, redness, rash, inflammation, bruising, swelling and itching at the injection site) can be observed. These reactions are usually transient. Rapid improvement in glycemic control may be associated with acute painful neuropathy, which is usually reversible. Intensification of isulin therapy with a dramatic improvement in glycemic control may be associated with temporary worsening of diabetic retinopathy, while long-term improved glycemic control reduces the risk of progression of diabetic retinopathy.

- hypoglycemia(hypoglycemia is usually the most common side effect; symptoms of hypoglycemia (“cold sweat”, pale skin, increased fatigue, nervousness or tremors, anxiety, unusual tiredness or weakness, disorientation, decreased concentration, drowsiness, pronounced feeling hunger, blurred vision, headache, nausea, palpitations) develop

sudden, severe hypoglycemia may lead to loss of consciousness and/or convulsions, temporary or permanent impairment of brain function or death)

Rare (>1/1000,<1/100)

- lipodystrophy(including lipohypertrophy, lipoatrophy) may occur at the injection site. Alternating injection sites within the same area may reduce the risk of these reactions.

- edema(swelling may occur during the initial phase of insulin therapy. These symptoms are usually temporary)

- allergic reactions, urticaria, skin rash(symptoms of generalized hypersensitivity: (itching, sweating, gastrointestinal disturbances, angioedema, difficulty breathing, palpitations, low blood pressure, anaphylactic reactions) are potentially life-threatening)

- refractive error(refractive errors may occur during the initial phase of insulin therapy, these symptoms are usually temporary)

- diabetic retinopathy(long-term improvement in glycemic control reduces the risk of progression of diabetic retinopathy, however, intensification of insulin therapy with a dramatic improvement in carbohydrate metabolism control may lead to a temporary worsening of diabetic retinopathy)

- reactions at injection sites

redness, inflammation, bruising, swelling and itching at the injection site (may develop during insulin treatment, injection site reactions may occur more often with Levemir® Penfill® than with human insulin; most injection site reactions are minor and are temporary nature, i.e. disappear with continued treatment for a few days to a few weeks)

Very rare (>1/10000,<1/1000)

- peripheral neuropathy(rapid improvement in glycemic control can lead to a state of "acute painful neuropathy" that is usually reversible)

Tabular list of adverse reactions

Data on the frequency of unwanted side effects during clinical trials are classified according to the frequency recommended by MedDRA and according to the system of organ classes. The frequency of reactions is defined as: very often (≥ 1/10), often (≥ 1/100,<1/10), нечасто (≥1/1000, < 1/100), редко (≥ 1/100000, < 1/1000), очень редко (< 1/10000), неизвестно (не может быть оценено по доступным данным).

Description of individual adverse reactions

Anaphylactic reactions

Symptoms of generalized hypersensitivity may include generalized skin rash, itching, sweating, gastrointestinal upset, angioedema, difficulty breathing, rapid heart rate, and a drop in blood pressure. Generalized hypersensitivity reactions are a potential threat to life.

Children's population

Based on data from post-marketing sources and clinical trials, the frequency, type, and severity of adverse reactions observed in the pediatric population do not indicate any difference compared to the general population.

Other special populations

Based on data from post-marketing sources and clinical trials, the frequency, type and severity of adverse reactions observed in elderly patients and in patients with impaired renal and hepatic function do not indicate any differences compared with the general population.

Contraindications

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

hypoglycemia

Children's age up to 2 years (clinical studies on this group of patients have not been conducted).

Drug Interactions

There are a number of drugs that affect the need for insulin.

The hypoglycemic effect of insulin is increased oral hypoglycemic drugs, monoamine oxidase inhibitors, angiotensin-converting enzyme inhibitors, carbonic anhydrase inhibitors, non-selective beta-blockers, bromocriptine, sulfonamides, anabolic steroids, tetracyclines, clofibrate, ketoconazole, mebendazole, pyridoxine, theophylline, cyclophosphamide, fenfluramine, drugs, lithium preparations, preparations, lithium preparations,

The hypoglycemic effect of insulin is reduced oral contraceptives, glucocorticosteroids, thyroid hormones, thiazide diuretics, heparin, tricyclic antidepressants, sympathomimetics, danazol, clonidine, calcium channel blockers, diazoxide, morphine, phenytoin, nicotine.

Beta-blockers may mask the symptoms of hypoglycemia. Octreotide/lanreotide can either increase or decrease insulin requirements.

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

Simultaneous use of drugs of the thiazolidinedione group and insulin drugs

Cases of congestive heart failure have been reported in the treatment of patients thiazolidinediones in combination with insulin preparations, especially if such patients have risk factors for congestive heart failure. This fact should be taken into account when prescribing combination therapy to patients. thiazolidinediones and insulin preparations . When prescribing such a combination therapy, it is necessary to conduct medical examinations of patients to identify signs and symptoms of congestive heart failure, weight gain and edema. If symptoms of heart failure worsen in patients, treatment thiazolidinediones needs to be stopped.

Incompatibility

Drugs containing thiol or sulfite groups, when added to NovoRapid® Penfill®, may cause the destruction of insulin aspart.

NovoRapid® Penfill® should not be mixed with other medicinal products. The exception is NPH insulin (Neutral Hagedorn protamine) and infusion solutions described in the section "Method of administration and dosage".

special instructions

Hypoglycemia develops if too high a dose of insulin is administered relative to the body's need for insulin.

NovoRapid® Penfill® should not be administered in case of hypoglycemia or suspected hypoglycemia. A decision should be made to adjust the dose after stabilization of the patient's blood glucose level.

Insufficient dose of the drug or discontinuation of treatment, especially in type 1 diabetes mellitus, can lead to the development of hyperglycemia or diabetic ketoacidosis.

Typically, symptoms of hyperglycemia develop gradually over several hours or days. Symptoms include thirst, increased frequency of urination, nausea, vomiting, drowsiness, redness and dryness of the skin, dry mouth, loss of appetite, and the smell of acetone on the breath. In type 1 diabetes, untreated hyperglycemic events can eventually lead to diabetic ketoacidosis, which is a potentially fatal condition.

After compensation of carbohydrate metabolism, for example, with intensified insulin therapy, patients may change their typical symptoms, precursors of hypoglycemia, about which patients should be informed. In diabetic patients with optimal metabolic control, late complications of diabetes develop later and progress more slowly. In this regard, it is recommended to carry out activities aimed at optimizing metabolic control, including monitoring blood glucose levels.

NovoRapid® Penfill® should be used in direct connection with food intake. Consideration should be given to the high rate of onset of the effect of the drug in the treatment of patients with concomitant diseases or taking drugs that slow down the absorption of food. In the presence of concomitant diseases, especially of an infectious nature, the need for insulin, as a rule, increases.

Concomitant diseases of the kidneys, liver, or affecting the function of the adrenal glands, pituitary gland or thyroid gland may require a change in the dose of insulin.

Impaired kidney or liver function may lead to a decrease in insulin requirements. NovoRapid® Penfill® should be used instead of soluble human insulin in children only when a rapid onset of action is required, for example, when it is difficult for the child to observe the required time interval between injection and food intake.

When transferring a patient to other types of insulin, the early warning symptoms of hypoglycemia may change or become less pronounced than when using the previous type of insulin.

The transfer of a patient to a new type of insulin or an insulin preparation from another manufacturer must be carried out under strict medical supervision. If the concentration, type, manufacturer and type (human insulin, animal insulin, human insulin analog) of insulin preparations and/or method of manufacture may require a change in dose. Patients transitioning to treatment with NovoRapid® Penfill® may require an increase in the frequency of injections or a dose change compared to the doses of previously used insulin preparations. If it is necessary to adjust the dose, it can be made already at the first administration of the drug or during the first weeks or months of treatment. In addition, a change in the dose of the drug may be required when changing the diet and with increased physical activity. Physical exercise performed immediately after a meal may increase the risk of hypoglycemia. Skipping meals or unplanned exercise can lead to hypoglycemia.

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

Long-term improvement in glycemic control reduces the risk of progression of diabetic retinopathy. However, intensification of insulin therapy with a dramatic improvement in glycemic control may be accompanied by a temporary worsening of diabetic retinopathy. NovoRapid contains metacresol, which in rare cases may cause allergic reactions.

insulin antibodies

Taking insulin can lead to the formation of insulin antibodies. In rare cases, the presence of such insulin antibodies may require adjustment of insulin doses to correct for a tendency to hyper or hypoglycemia.

As with other types of insulin, injection site reactions may occur, including pain, redness, itching, rash, swelling, and inflammation. The continuous alternation of injection sites within a certain area helps to reduce or prevent the occurrence of these reactions. Reactions usually disappear within a few days or weeks. In rare cases, injection site reactions may require discontinuation of infusion

NovoRapid® Penfill®.

Combined applicationNovoRapid® Penfill ® with pioglitazone.

Cases of congestive heart failure have been reported in the treatment of patients with pioglitazone in combination with insulin preparations, especially if such patients have risk factors for congestive heart failure. This fact should be taken into account when prescribing combination therapy with pioglitazone and NovoRapid® Penfill® to patients. When prescribing such combination therapy, it is necessary to conduct a medical examination of patients to identify signs and symptoms of congestive heart failure, weight gain and edema. If symptoms of heart failure worsen in patients, treatment with pioglitazone should be discontinued.

Bpregnancy and lactation

NovoRapid® Penfill® (insulin aspart) may be used during pregnancy. Data from two randomized controlled clinical trials (322 + 27 examined pregnant women) did not reveal any adverse effects of insulin aspart on the course of pregnancy or the health of the fetus / newborn compared to human insulin (see section "Pharmacological properties").

Careful monitoring of blood glucose levels and monitoring of pregnant women with diabetes (type 1 diabetes, type 2 diabetes or gestational diabetes) is recommended throughout pregnancy and during the period of 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.

There are no contraindications to the use of NovoRapid® Penfill® during breastfeeding. Insulin therapy for nursing mothers does not pose a risk to the health of the child. However, dose adjustment of NovoRapid® Penfill® may be required.

Features of influence medicinal product on the ability to drive a vehicle or potentially dangerous machinery.

The ability of patients to concentrate and reaction speed may be impaired during hypoglycemia and hyperglycemia, which can be dangerous in situations where these abilities are especially needed (for example, when driving a car or working with machines and mechanisms). Patients should be advised to take measures to prevent the development of hypoglycemia and hyperglycemia when driving a car and working with mechanisms. This is especially important for patients with no or reduced symptoms of developing hypoglycemia or suffering from frequent episodes of hypoglycemia. In these cases, the feasibility of such work should be considered.

Overdose

In case of an overdose, hypoglycemia may develop.

Treatment:

- Mild hypoglycemia can be corrected by the patient himself by ingesting glucose, sugar, or carbohydrate-rich foods. Therefore, diabetic patients are advised to carry sugar, sweets, biscuits or drinks containing sugar with them at all times.

In severe cases, when the patient loses consciousness, glucagon should be administered from 0.5 to 1 mg mg intramuscularly or subcutaneously (only a medical professional can enter). It is also necessary to intravenously inject glucose if after 10-15 minutes. after the introduction of glucagon, the patient does not regain consciousness. After recovery of consciousness, the patient is recommended to take a meal rich in carbohydrates to prevent the recurrence of hypoglycemia.

With the development of severe hypoglycemia, emergency hospitalization of the patient is required.

Release form and packaging

Solution for subcutaneous and intravenous administration 100 IU/ml.

3 ml of the drug in a glass cartridge of hydrolytic class I, sealed with a rubber disc and closed with a plastic cap on one side, and on the other side with a rubber piston.

5 cartridges in a blister pack together with instructions for use are placed in a cardboard box.

Novorapid is a new generation drug that allows you to compensate for the lack of human insulin. It is characterized by a whole list of advantages over similar compounds, it quickly normalizes blood sugar levels. Novorapid is produced by recombinant DNA biotechnology using a specific strain. It is recommended to consult with your doctor before use in diabetes mellitus.

Description of insulin Novorapid Flexpen and Penfill

NovoRapid is produced in two types: ready-made FlexPen pens and replaceable Penfill cartridges. The composition of the drug in both cases is the same - it is a clear liquid for injection. One ml includes 100 IU of the active ingredient. Novorapid Flexpen and Novorapid Penfill include three ml of the hormonal component.

The main active ingredient is insulin Aspart. It is highly recommended to pay attention to the following:

• it is characterized by a powerful hypoglycemic effect;
• insulin Novorapid Flexpen and insulin Novorapid Penfill are analogs of short insulin produced in the human body;
• the substance is obtained through the use of recombinant DNA technology.

The hormonal component enters into contact with the outer cytoplasmic membranes of amino acids and forms a whole complex of insulin endings. Due to this, the processes that occur inside the cells are launched. After a decrease in blood sugar indicators, optimization of intracellular transport and an increase in the degree of digestibility of tissue structures are noted. In addition, activation of lipogenesis and glycogenesis is ensured.

Additionally, a decrease in the rate of glucose production by the liver is provided. In order to determine the difference and how much this drug costs, it is recommended to consult a diabetologist. It should be borne in mind that this is acceptable for any type of diabetes.

The list of insulin components contains some auxiliary items, for example, glycerol and phenol, as well as metacresol, zinc chloride and other components.

Indications for the use of the drug

Both compositions (Novorapid Flexpen and Novorapid Penfill) have certain indications for use. Of course, this is an insulin-dependent and non-insulin-dependent form of the disease. With type 2 diabetes, there are certain limitations that must be remembered. This is primarily about the stage of resistance to oral hypoglycemic names.

In addition, partial resistance to these drugs (during the combined course) and intercurrent pathologies (diseases that developed during the course of diabetes) are taken into account.

Method of application and dosage

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Novorapid Flexpen and Penfill are characterized by subcutaneous and intravenous routes of administration.

This hormonal component begins to act more rapidly and is characterized by a shorter duration of effect than soluble forms of human insulin.

Talking about how to use and how to inject this name, pay attention to the following features:

• it is recommended to administer it immediately before a meal or immediately after consumption (due to the rapid onset of action);
• for each patient, the diabetologist selects the dosage of the composition on an individual basis, based on the ratio of sugar in the blood;
• Novorapid Flexpen is usually combined with other types of insulin (long-acting or intermediate-acting) that are used at least once every 24 hours.

Typically, a person's need for insulin during the day is from 0.5 to 1 U / kg of body weight. This need is met by 50–70% by the introduction of Novorapid Flexpen before eating, while the remaining amount is supplemented with a prolonged action component. When administered, the temperature indicators of Novorapid Penfill and Flexpen should correspond to the ambient temperature.

In some cases, diabetics are recommended to carry out long-term infusions of the subcutaneous type. They can be provided with a special pump. The introduction of the hormonal component is recommended to be carried out in the region of the anterior abdominal wall, however, it is desirable to change specific points. This will avoid the occurrence of hematomas and other skin problems.

Using an insulin pump, it is not recommended to mix the hormonal component with other similar items. Patients receiving medication using such a system should have a spare dosage of the drug with them in case the device breaks down.

Novorapid Flexpen and Penfill are suitable for insertion into a vein, however, such an injection should only be given by a specialist.

Insufficient amounts of a hormonal component or completion of treatment, especially in type 1 diabetes, can lead to the formation of hyperglycemia or diabetic ketoacidosis. In the vast majority of cases, signs of hyperglycemia develop gradually, over several hours or days. Symptoms of hyperglycemia should be considered:

• nausea and vomiting;
• drowsiness;
• redness and dryness of the skin, as well as dryness in the oral cavity;
• increase in the ratio of excreted urine.

Other symptoms of the condition should be considered thirst and loss of appetite, the appearance of the smell of acetone in the exhaled air. If left untreated, hyperglycemia can lead to the death of a diabetic. That is why Novorapid and other types of insulin should be used in a timely manner and in full.

Can children and pregnant women use insulin?

During the period of the probable onset of pregnancy and throughout its entire period, it is desirable to constantly monitor the condition of patients with diabetes mellitus and ensure control of glucose levels. There are no specific data on the use of the drug in each of the trimesters, however, it should be borne in mind that during childbirth and immediately after them, the need for a hormonal component may decrease. After childbirth, the need for insulin returns to the level that it was before pregnancy. It must be remembered that:

• insulin Novorapid Flexpen and Novorapid Penfill can be used during lactation (breastfeeding);
• may need to adjust the amount of insulin;
• not recommended for use in children under the age of six.

Storage conditions of the drug

Closed packages are recommended to be kept in the refrigerator at a temperature of two to eight degrees. It is undesirable to store insulin in close proximity to the freezer, and even more so to freeze the composition. It is important to always use a special cap to protect Novorapid insulin from exposure to light rays. The shelf life of the hormonal component is two years.

It is not recommended to keep already started syringe pens in the refrigerator. They are suitable for use within one month from the moment of opening and if stored at a temperature of no more than 30 degrees.

Interaction with other drugs

The hypoglycemic effect of the hormonal component is enhanced by a number of drugs. Speaking of this, they mean oral hypoglycemic names, as well as MAO, ACE and carbonic anhydrase inhibitors. Non-selective beta-blockers, bromocriptine, sulfonamides and anabolic steroids take their place in this list. We should not forget about the increased exposure due to the use of Tetracycline, Ketoconazole, lithium preparations and items containing ethanol. Depending on the characteristics of the body, similar reactions to other medicinal formulations can be identified.

The hypoglycemic effect of insulin Novorapid is weakened by oral contraceptives, corticosteroids, and thyroid hormones. Also on the list are:

• thiazide diuretics;
• heparin;
• tricyclic antidepressants;
• sympathomimetics;
• danazol and clonidine.

Under the influence of Reserpine and salicylates, not only a weakening, but also an increase in the influence of the hormonal component is likely. Pharmaceutical incompatibility is determined with such drugs that contain thiol or sulfite. This is due to the fact that when added to the hormonal component, they provoke its destruction.

Insulin analogs Novorapid

Novorapid has a number of analogues, which are usually used if the hormonal component for some reason did not suit the patient. The most popular are such tools as Apidra, Gensulin N, Humalog, as well as Novomiks and Rayzodeg. All of them belong to approximately the same price range.

Before using any insulin component, it is important to consult a diabetologist and obtain a prescription from him.

NovoRapid (insulin) is a completely new medicine. Compensates for the lack of human insulin and has a number of advantages over the rest. It is quickly absorbed and reduces sugar in an instant. Can be used with or without food. It is considered ultrashort insulin.

The composition of the diabetic

Means for diabetics "NovoRapid" (insulin) is produced in two forms - these are replaceable cartridges "Penfill" and ready-made pens "FlexPen".

The composition of the cartridge and pen is the same - it is a clear liquid for injection, where 1 ml contains the active ingredient insulin aspart in the amount of 100 IU. One replaceable cartridge, like one pen, contains about 3 ml of solution, which is 300 IU.

Cartridges are made from class I hydrolytic glass. They are closed on one side with disks made of polyisoprene and bromobutyl rubber, on the opposite side - with special rubber pistons. There are five replaceable cartridges in an aluminum blister, and one blister is enclosed in a cardboard box. FlexPen syringe pens are made in a similar way. They are disposable and are designed for multiple doses. There are five of them in a carton box.

The drug is stored in a cold place at a temperature of 2-8 °C. It can not be placed next to the freezer, as well as frozen. Also, replaceable cartridges and syringe pens should be protected from the heat of sunlight. If NovoRapid insulin (cartridge) is opened, it should not be stored in the refrigerator, but should be used within four weeks. The storage temperature should not exceed 30 °C. The shelf life of unopened insulin is 30 months.

Pharmacology

The drug "NovoRapid" (insulin) has a hypoglycemic effect, and the active ingredient - insulin aspart - is an analogue of a short-acting hormone produced by humans. This substance is obtained by using special recombinant DNA biotechnologies. Here, a strain of Saccharomyces cerevisiae is added, and an amino acid called "proline" is temporarily replaced with aspartic acid.

The drug enters into contact with the receptors of the outer cytoplasmic membrane of cells, where it forms a whole complex of insulin endings, activates all the processes occurring inside the cells. After a decrease in the amount of glucose in plasma, there is an increase in intracellular transport, an increase in the digestibility of various tissues, and activation of glycogenogenesis and lipogenesis. The rate of glucose production by the liver decreases.

The replacement of the amino acid proline by aspartic under the influence of insulin aspart reduces the ability of molecules to create hexamers. This type of hormone is better absorbed by subcutaneous fat, affects the body faster than the effect of soluble standard human insulin.

In the first four hours after a meal, insulin aspart lowers plasma sugar levels faster than soluble human hormone. But the effect of NovoRapid when administered subcutaneously is shorter than that of soluble human.

How long does NovoRapid last? This question worries most people with diabetes. So, the effect of the drug occurs after 10-20 minutes after the injection. The highest concentration of the hormone in the blood is observed 1-3 hours after the use of the drug. The agent acts on the body for 3-5 hours.

Studies of individuals with type I diabetes have shown a several-fold reduction in the risk of nocturnal hypoglycemia with the use of NovoRapid, especially when compared with the administration of soluble human insulin. In addition, there was a significant decrease in postprandial plasma glucose with insulin aspart injections.

Indications and contraindications

The drug "NovoRapid" (insulin) is intended for people with type 1 diabetes mellitus, which is insulin dependent, and for patients with type 2 diabetes - non-insulin dependent (stage of resistance to hypoglycemic drugs taken orally, as well as intercurrent pathologies) .

A contraindication to the use of the drug is hypoglycemia and excessive sensitivity of the body to insulin aspart, excipients of the drug.

Do not use NovoRapid for children under the age of six due to the lack of necessary clinical studies.

Medicine "NovoRapid": instructions for use

NovoRapid is an analogue of insulin. Begins to act immediately after the injection. The dosage for each patient is individual and is selected by the doctor. For best results, this hormone is combined with long-acting or intermediate-acting insulin.

In order to control glycemia, the amount of glucose in the blood is constantly measured and the dose of insulin is carefully selected. As a rule, the daily dose for adults and children ranges from 0.5-1 U / kg.

With injections of NovoRapid medicine (instruction for use describes in detail the procedure for administering the drug), a person's need for insulin is provided by 50-70%. The rest is satisfied by the introduction of long-acting (prolonged) insulin. An increase in the patient's physical activity and a change in diet, as well as existing comorbidities, often necessitate a change in the administered dose.

Hormone "NovoRapid", unlike soluble human, begins to act quickly, but not for a long time. Slow administration of insulin is indicated. The injection algorithm involves the use of the drug immediately before the meal, and if there is an urgent need, the drug is used immediately after the meal.

Due to the fact that NovoRapid acts on the body for a short time, the risk of hypoglycemia at night in patients with diabetes is significantly reduced.

In elderly patients, as well as in people with renal or hepatic insufficiency, control of blood glucose concentration should occur more often, and the amount of insulin aspart is selected individually.

Subcutaneous insulin administration (the algorithm for using hormonal injections is described in detail in the instructions for use) involves injecting an injection into the anterior abdomen, thigh, shoulder and deltoid muscles, as well as into the buttocks. The injection site should be changed to prevent lipodystrophy.

With the introduction of the hormone into the anterior region of the peritoneum, the drug is absorbed faster than injections into other parts of the body. The duration of the effect of the hormone is affected by the dose, the injection site, the degree of blood flow, body temperature, and the level of physical activity of the patient.

NovoRapid is also used for long-term subcutaneous infusions, which are carried out with a special pump. The drug is injected into the anterior peritoneum, but the places are periodically changed. If an insulin pump is used, then NovoRapid should not be mixed with other types of insulin in it. Patients receiving the hormone through an infusion system should have a supply of medication in case the device breaks down.

NovoRapid can be used for intravenous administration, but the procedure must be carried out by a qualified healthcare professional. For this type of administration, infusion complexes are sometimes used, where insulin is contained in an amount of 100 U / ml, and its concentration is 0.05-1 U / ml. The drug is diluted in 0.9% sodium chloride, 5- and 10% dextrose solution, which contains potassium chloride up to 40 mmol / l. These funds are stored at room temperature for no more than a day. With insulin infusions, you need to regularly donate blood for the content of glucose in it.

How to calculate the dose of insulin?

To calculate the dosage, you need to know that insulin is combined, long (extended), medium, short and ultrashort. The first brings blood sugar back to normal. It is entered on an empty stomach. Indicated for people with type 1 and type 2 diabetes. There are people who use only one type of insulin - prolonged. Some people use only NovoRapid to avoid sudden spikes in glucose. Short, long insulins can be used simultaneously in the treatment of diabetes, but they are administered at different times. For some patients, only the combined use of drugs helps to achieve the desired effect.

When choosing extended insulin, some nuances should be taken into account. For example, it is necessary that without injections of a short hormone and main meals, sugar remains at the same level throughout the day only due to the action of long insulin.

The selection of the dose of prolonged insulin is as follows:

• In the morning, without breakfast, measure the level of sugar.
• The second breakfast is eaten, and after three hours the plasma glucose level is determined. Further measurements are carried out every hour before going to bed. On the first day of dose selection, lunch is skipped, but dinner is eaten.
• On the second day, breakfast and lunch are allowed, but dinner is not allowed. Sugar, as well as on the first day, must be controlled every hour, including at night.
• On the third day, they continue to take measurements, eat normally, but do not inject short insulin.

Ideal morning indicators are:

• on the 1st day - 5 mmol/l;
• on the 2nd day - 8 mmol/l;
• on the 3rd day - 12 mmol / l.

Such indicators of glucose should be obtained without a short-acting hormone. For example, if in the morning blood sugar is 7 mmol / l, and in the evening - 4 mmol / l, then this indicates the need to lower the dose of the long hormone by 1 or 2 units.

Often, patients use the Forsham formula to determine the daily dose. If glycemia fluctuates between 150-216 mg /%, then 150 is subtracted from the measured blood sugar level and the resulting number is divided by 5. As a result, a single dose of a long hormone is obtained. If glycemia exceeds 216 mg /%, then 200 is subtracted from the measured sugar, and the result is divided by 10.

To determine the dose of short insulin, you need to measure your sugar level for a week. If all daily indicators are normal, except for the evening, then short insulin is administered only before dinner. If the sugar level jumps after each meal, then injections are made immediately before meals.

To determine the time for which the hormone should be administered, you need to measure glucose first 45 minutes before meals. Further, sugar should be monitored every five minutes until its level reaches 0.3 mmol / l, only after that you should eat. This approach will prevent the onset of hypoglycemia. If after 45 minutes the sugar does not decrease, you must wait with food until the glucose drops to the desired level.

To determine the dose of ultrashort insulin, people with type 1 and type 2 diabetes are advised to follow a diet for a week. Keep track of how much and what foods they eat. It is necessary not to exceed the allowed amount of food. You should also take into account the patient's physical activity, medication, the presence of chronic diseases.

Enter 5-15 minutes before a meal. How to calculate the dose of NovoRapid insulin in this case? It should be remembered that this drug reduces glucose levels 1.5 times more than its short substitutes. Therefore, the amount of "NovoRapid" is 0.4 of the dose of a short hormone. It is possible to determine more precisely the norm only by experiment.

When choosing an insulin dose, one should take into account the degree of the disease, as well as the fact that the need for any diabetic in the hormone does not exceed 1 U / kg. Otherwise, an overdose may occur, which will cause a number of complications.

Basic rules for determining the dose for diabetes mellitus:

• In the early stage of type 1 diabetes mellitus, the dose of the hormone should be no more than 0.5 units / kg.
• In type 1 diabetes, which has been observed in a patient for a year or more, a single dose of insulin administered is 0.6 U / kg.
• If type 1 diabetes mellitus is accompanied by a number of serious diseases and has unstable blood glucose levels, then the amount of the hormone is 0.7 U / kg.
• In decompensated diabetes mellitus, the amount of insulin is 0.8 U / kg.
• If diabetes is with ketoacidosis, then about 0.9 U / kg of the hormone is required.
• During pregnancy, a woman in the third trimester needs 1.0 U / kg.

To calculate a single dose of insulin, multiply the daily dose by body weight and divide by two, and round the final figure.

The use of the drug "NovoRapid FlexPen"

The introduction of the hormone can be carried out using a NovoRapid FlexPen pen. It has color coding and dispenser. The dose of insulin administered can be from 1 to 60 U, one step of the syringe is 1 U. In the drug "NovoRapid" needles are used TM "Novotvist" or "Novofine" 8 mm long. If you use a pen, remember to always have a spare injection system with you in case the syringe gets damaged or lost.

Before the introduction of the hormone with a syringe pen, you need to:

• Read the label and make sure NovoRapid is the insulin you need.
• Remove the cap from the syringe.
• Remove the sticker that is on the disposable needle.
• Screw the needle onto the handle. Each injection requires a new needle to prevent bacterial growth. The needle must not be bent or damaged.
• In order to avoid accidental injections, the needle is not capped after the administration of insulin.

The NovoRapid syringe pen may contain a small amount of air inside. So that oxygen bubbles do not accumulate, and the dose is correctly administered, certain rules should be followed:

• Draw up 2 units of hormone by turning the dosage selector.
• Position the pen with the needle up and tap the cartridge with your fingertip. This will move the air bubbles to the upper area.
• Holding the FlexPen syringe with the needle up, press the start button all the way. The dosage selector will return to position "0" at this time. One drop of the hormone will appear on the needle. If this does not happen, the procedure can be repeated six times. If no insulin is delivered, then the syringe is defective.

Before setting the dose, make sure that the dose selector is in the "0" position. Next, you should dial the required number of units, the volume of the drug is regulated by the selector in both directions. When setting the dose, you need to be careful and try not to accidentally touch the start button, otherwise the hormone will be prematurely released. You can not set the rate more than the one in the preparation "NovoRapid". Also, do not use the balance scale to determine the dose of the hormone.

During the introduction of insulin subcutaneously follow the technique recommended by the attending physician. To perform the injection, press the start button. Hold it until the dosage selector reaches the "0" position. During the injection, only the start button is held. Turning the dosing dial normally does not deliver insulin.

After injection, the needle under the skin should be held for another six seconds without releasing the start button. So the dose of insulin will be administered completely. After the injection, the needle is directed into the outer cap, and when it enters it, it is unscrewed and thrown away, taking all precautions. The syringe is then capped. The needle is removed after each injection and should not be stored with a pen. Otherwise, fluid will leak out, which may lead to the introduction of an incorrect dose. Instructions for use will tell you more about how to inject NovoRapid insulin.

Side effects

The drug "NovoRapid" can cause a number of side effects. This is hypoglycemia, which manifests itself in the form of excessive sweating, pallor of the skin, nervousness, unreasonable feelings of anxiety, tremors of the limbs, weakness in the body, impaired orientation and reduced concentration. Also there are dizziness, hunger, malfunction of the visual apparatus, nausea, pain in the head, tachycardia. Glycemia can lead to loss of consciousness, convulsions, impaired brain activity and death.

Infrequently, patients talk about such allergic manifestations as urticaria, rashes. Possible disruption of the stomach and intestines, the appearance of angioedema, tachycardia, difficulty breathing. Patients experienced a decrease in blood pressure.

Local reactions included itching in the injection area, redness, and swelling of the skin. Infrequently, symptoms of lipodystrophy have occurred. The medicine can cause edema at the initial stage of treatment, as well as a violation of refraction.

Doctors say that all manifestations are temporary and are observed mainly in dose-dependent patients and are caused by the drug action of insulin.

Analogues

If the hormone does not fit, then you can always replace the NovoRapid FlexPen. Analogues, of course, should be selected by a doctor. The most popular include:

• Novomix.
• "Apidra".
• "Humalog".
• "Actrapid".
• "Rayzodeg".
• "Protafan".
• "Gensulin N".

Hormone cost

The drug "NovoRapid" is released strictly according to the doctor's prescription. The price of five Penfill cartridges fluctuates around 1800 rubles. The cost of the FlexPen hormone is 2000 rubles. One package contains five Novorapid insulin syringe pens. The price may fluctuate slightly depending on the distribution network.