NovoRapid® FlexPen® is a fast-acting insulin analogue. The dose of NovoRapid® FlexPen® is determined by the doctor individually in accordance with the patient's needs. Usually, 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.

Typically, the individual daily need for insulin in adults and children ranges from 0.5 to 1 U / kg body weight. When the drug is administered before a meal, the need for insulin can be provided by NovoRapid® FlexPen® by 50-70%, the remaining need for insulin is provided by prolonged-action insulin.

An increase in the patient's physical activity, a change in the usual 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 its faster onset of action, NovoRapid® FlexPen® should be administered, as a rule, immediately before a meal, if necessary, it can be administered shortly after a meal. Due to the shorter duration of action compared with human insulin, the risk of developing 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 levels should be more closely monitored and the dose of insulin aspart should be adjusted individually.

Children and adolescents

It is preferable to use NovoRapid® FlexPen® 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 an injection and a meal.

Transfer from other insulin preparations

When transferring a patient from other insulin preparations to NovoRapid® FlexPen®, a 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 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.

NovoRapid® can be used for continuous subcutaneous insulin infusion (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, NovoRapid® 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 NovoRapid® with PPII should have additional insulin available in case of breakdown of the infusion system.

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 U / ml with a concentration of 0.05 U / ml to 1 U / 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. Despite being stable over time, a certain amount of insulin is initially absorbed into the material of the infusion system. During insulin infusions, you must constantly monitor the concentration of blood glucose.

Side effects associated with the effect on carbohydrate metabolism: hypoglycemia (increased sweating, pallor of the skin, nervousness or tremors, 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: urticaria, skin rash, 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 local reactions (redness, swelling, itching of the skin at the injection site), usually temporary and disappearing as treatment continues, lipodystrophy. Others: edema, refractive error. These side effects are usually temporary.

Symptoms: hypoglycemia. Treatment: the patient can eliminate mild hypoglycemia on his own by ingesting glucose, sugar or carbohydrate-rich foods (patients are advised to always carry sugar, sweets, cookies or sweet fruit juice with them). In severe cases, when the patient loses consciousness, a 40% dextrose (glucose) solution is injected intravenously; i / m or s / c - glucagon (0.5-1 mg). After regaining consciousness, the patient is advised to eat food rich in carbohydrates to prevent the recurrence of hypoglycemia.

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, ketoconazolloid, drugs 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 strengthening of the action of the drug are possible. Pharmaceutical incompatibility Medicines containing thiol or sulfite, when added to insulin, cause its destruction.

An 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. After compensation of carbohydrate metabolism, for example, with intensified insulin therapy, patients may change their typical symptoms, precursors of hypoglycemia, of which patients should be informed. In diabetic patients with optimal metabolic control, late complications of diabetes develop later and progress more slowly. A consequence of the pharmacodynamic features of short-acting insulin analogues is that the development of hypoglycemia with their use begins earlier than with the use of soluble human insulin. Insulin aspart should be used in direct connection with food intake. Consideration should be given to the high rate of onset of the drug's effect when treating patients with concomitant diseases or taking medications that slow down the absorption of food. Impaired kidney or liver function can lead to decreased insulin requirements. When the patient is transferred to other types of insulin, the early warning signs of hypoglycemia may change or become less pronounced, compared with those with the previous type of insulin. Transferring a patient to a new type of insulin or insulin from another manufacturer must be carried out under strict medical supervision. Patients switching to insulin aspartom treatment may need to increase the frequency of injections or change the dose compared to the doses of previously used insulin preparations. If necessary, dose adjustment can be made already at the first administration of the drug or during the first weeks or months of treatment. In addition, a change in the dose of the drug may be required when changing the diet and with increased physical activity. Exercise 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 progression of diabetic retinopathy. Patients should be advised to take measures to prevent the development of hypoglycemia and hyperglycemia while driving and operating machinery. For more information, see the instructions for use.