NovoRapid FlexPen solution for d / p / c and intravenous injection. 100U / ml, 3ml No. 5 syringe-pen

NovoRapidЃ FlexPenЃ is a fast-acting insulin analogue. The dose of NovoRapidЃ FlexPenЃ is determined by the doctor individually in accordance with the patient's needs. Typically, the drug is used in combination with medium-duration or long-acting insulin preparations, which are administered at least once a day.

To achieve optimal glycemic control, it is recommended that you regularly measure your blood glucose concentration and adjust your insulin dose.

Usually, the individual daily need for insulin in adults and children is from 0.5 to 1 U / kg of body weight. With the introduction of the drug before meals, the need for insulin can be provided by the drug NovoRapidЃ FlexPenЃ by 50-70%, the remaining need for insulin is provided by long-acting insulin.

Increased physical activity of the patient, changes in dietary habits or concomitant diseases may lead to the need for dose adjustment

NovoRapidЃ FlexPenЃ has a faster onset and shorter duration of action than soluble human insulin. Due to its faster onset of action, NovoRapidЃ FlexPenЃ should be administered, as a rule, immediately before a meal, if necessary, it can be administered shortly after a meal. Due to the shorter duration of action compared to human insulin, the risk of developing nocturnal hypoglycemia in patients receiving NovoRapidЃ FlexPenЃ is lower.

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

Children and adolescents
It is preferable to use NovoRapidЃ FlexPenЃ instead of soluble human insulin in children when a rapid onset of action of the drug is required, 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 NovoRapidЃ FlexPenЃ, a dose adjustment of NovoRapidЃ FlexPenЃ and basal insulin may be required.

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

NovoRapidЃ can be used for continuous subcutaneous insulin infusions (PSII) in insulin pumps designed for insulin infusions. PPII should be performed in the anterior abdominal wall. Infusion sites should be changed periodically.

When using an insulin pump for infusion, NovoRapidЃ should not be mixed with other types of insulins.

Patients using PPII should be fully trained in the use of the pump, appropriate reservoir and pump tubing. The infusion set (tube and catheter) should be replaced according to the user manual that came with the infusion set.

Patients receiving NovoRapidЃ with PPII should have additional insulin available in case of breakdown of the infusion system.

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

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

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

1 ml

insulin aspart 100 U (3.5 mg)

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

• Hypoglycemia

• children and adolescents up to 18 years old,

• hypersensitivity to insulin aspart.

pharmachologic effect

A fast-acting analogue of human insulin. In the molecular structure of this insulin, the amino acid proline in position B28 is replaced by aspartic acid, which reduces the tendency of molecules to form hexamers, which is observed in ordinary insulin solutions.

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

Side effect

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

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

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

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

Application during pregnancy and lactation

Can be used during pregnancy and during breastfeeding in the dosage forms intended for this.

Insulin requirements tend to change during pregnancy and during breastfeeding.

Application for violations of liver function

Insulin dose adjustment may be required for liver disease.

Application for impaired renal function

If you have kidney disease, you may need to adjust your insulin dose.

Application in children

Contraindicated for use in children and adolescents under the age of 18 years.

Use in elderly patients

In elderly patients, blood glucose should be carefully monitored and the dose adjusted individually. There is no experience with patients aged 75 and over.

special instructions

An insufficient dose of insulin or discontinuation of treatment can lead to the development of hyperglycemia or diabetic ketoacidosis. Typically, 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 odor of acetone in the exhaled air. Hyperglycemia can be fatal if left untreated. After compensation of carbohydrate metabolism, for example, with intensive insulin therapy, patients may change their typical symptoms, precursors of hypoglycemia.

In elderly patients, blood glucose should be carefully monitored and the dose adjusted individually. There is no experience with patients aged 75 and over.

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.

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

When a patient is switched to other types of insulin, the early precursor symptoms of hypoglycemia may change or become less pronounced, compared with those when using the previous type of insulin.

Transfer of a patient to a new type of insulin or insulin preparation from another manufacturer must be carried out under strict medical supervision. Changes in concentration, type, manufacturer and type (human insulin, animal insulin, human insulin analog) of insulin preparations and / or manufacturing method may require a change in dose.

A change in the dose of insulin may be required with a change in diet and with increased physical activity. Exercise immediately after a meal can 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 diabetic retinopathy progression. However, intensification of insulin therapy with a sharp improvement in glycemic control may be accompanied by a temporary worsening of diabetic retinopathy.

Influence on the ability to drive vehicles and mechanisms

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

Drug interactions

The hypoglycemic effect of insulin is enhanced by oral hypoglycemic drugs, MAO inhibitors, ACE inhibitors, carbonic anhydrase inhibitors, nonselective beta-blockers, bromocriptine, octreotide, sulfonamides, anabolic steroids, tetracyclines, clofibazylamide, ketoconazole preparations containing ethanol.

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

Under the influence of reserpine and salicylates, both weakening and enhancement of the action of insulin aspart are possible.