NOVORAPID FLEKSPEN SYRINGE PEN 100M/ML 3 ML

Injection

Composition

1 ml contains insulin aspart 100 U;
other ingredients: glycerin, phenol, metacresol, zinc chloride, sodium chloride, disodium phosphate dihydrate, sodium hydroxide, hydrochloric acid, water d / i.

Packing

5 syringe pens 3 ml.

Mechanism of action

A hypoglycemic drug, an analogue of short-acting human insulin, produced by recombinant DNA biotechnology using the Saccharomyces cerevisiae strain, in which the amino acid proline at position B28 is replaced with aspartic acid.
Interacts with a specific receptor of the external cytoplasmic cell membrane and forms an insulin-receptor complex that stimulates intracellular processes, including synthesis of a number of key enzymes (hexokinase, pyruvate kinase, glycogen synthetase). The decrease in glucose in the blood is due to the increase in its intracellular transport, increased absorption of tissues, stimulation of lipogenesis, glycogenogenesis, and a decrease in the rate of glucose production by the liver.
Substitution of the amino acid proline at position B28 with aspartic acid in the preparation NovoRapid FlexPen reduces the tendency of molecules to form hexamers, which is observed in a solution of ordinary insulin.In this regard, NovoRapid FlexPen is absorbed much more quickly from subcutaneous fat and begins to act much faster than soluble human insulin. NovoRapid FlexPen more strongly reduces the level of blood glucose 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 with the administration of NovoRapid, compared with soluble human insulin.
The duration of action of the drug NovoRapid FlexPen after s / c administration is shorter than soluble human insulin.
After s / c administration, the effect of the drug begins within 10-20 minutes after administration. The maximum effect is observed 1-3 h after injection. The duration of the drug is 3-5 hours.
When NovoRapida FlexPen is used in patients with type 1 diabetes mellitus, there is a reduction in the risk of nocturnal hypoglycemia compared with soluble human insulin. There is no significant increase in the risk of daytime hypoglycemia.
NovoRapid FlexPen is an equipotential soluble human insulin based on molarity indicators.

Indications and usage

- diabetes mellitus type 1 (insulin-dependent);
- diabetes mellitus type 2 (insulin-independent): stage of resistance to oral hypoglycemic agents, partial resistance to these drugs (when combined therapy is used), intercurrent diseases

Contraindications

- hypoglycemia;
- increased individual sensitivity to insulin aspart or any of the components of the drug.
It is not recommended to use NovoRapid Penfill in children under 6 years old, because no clinical studies have been conducted in this age group.

Pregnancy and Breastfeeding

Clinical experience with NovoRapid FlexPen during pregnancy is very limited. In experimental animal studies, no differences were found between embryotoxicity and teratogenicity of insulin aspart and human insulin. During the period of possible pregnancy and throughout its life, it is necessary to carefully monitor the condition of patients suffering from diabetes, and to monitor the level of glucose in the blood. The need for insulin, as a rule, decreases in the first trimester and gradually increases in the second and third trimesters of pregnancy. During labor and immediately after it, the need for insulin can decrease dramatically. Shortly after giving birth, the need for insulin quickly returns to the level that was before pregnancy.
During lactation (breastfeeding) NovoRapid FlexPen can be used without restrictions (the administration of insulin to a nursing mother does not pose a threat to the baby). However, it may be necessary to adjust the dose of the drug.

Dosage and administration

NovoRapid FlexPen is intended for s / c and in / in the introduction.NovoRapid FlexPen has a faster onset and shorter duration of action than soluble human insulin. Due to the faster onset of action, NovoRapid FlexPen should be administered, as a rule, immediately before a meal (if necessary, it can be administered soon 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. NovoRapid FlexPen is usually used in combination with insulin preparations of average duration or long-term action, which are administered at least 1 time / day.
Typically, the total daily need for insulin is from 0.5-1 U / kg body weight. With the introduction of the drug before a meal, the need for insulin can be provided by the drug NovoRapid FlexPen by 50-70%, the remaining need for insulin is provided by insulin with a prolonged action.
The temperature of the insulin should be at room temperature.
NovoRapid FlexPen is injected sc into the region of the anterior abdominal wall, thigh, shoulder, or buttock. Injection sites within the same body area should be changed regularly.
As with any other insulin preparations, the duration of action of NovoRapid FlexPen depends on the dose, site of administration, blood flow intensity, temperature, and level of physical activity.
P / c introduction to the anterior abdominal wall provides faster absorption compared with the introduction to other places.However, a more rapid onset of action compared with soluble human insulin is maintained regardless of the location of the injection site.
If necessary, NovoRapid FlexPen can be administered IV, but only by qualified medical personnel.
For intravenous injection, infusion systems with NovoRapid 100 U / ml with a concentration of 0.05 U / ml to 1 U / ml of insulin aspart in a 0.9% sodium chloride solution are used; 5% or 10% dextrose solution containing 40 mmol / l potassium chloride, using polypropylene infusion bags. These solutions are stable at room temperature for 24 hours. During insulin infusions, it is necessary to constantly monitor blood glucose levels.
NovoRapid can also be used for long-lasting insulin infusions (PPII) in insulin pumps designed for insulin infusions. FDII should be made in the anterior abdominal wall. Infusion sites should be periodically changed.
When using an insulin pump for infusions, NovoRapid FlexPen should not be mixed with other types of insulin.
Patients using PPII should be fully trained in the use of a pump, an appropriate reservoir and a tubing system for the pump. The infusion set (tube and catheter) should be replaced in accordance with the user manual included with the infusion set.
Patients receiving NovoRapid FlexPen using PPII should have additional insulin available in case of breakdown of the infusion system.

Adverse reactions

Side effects associated with the effect on carbohydrate metabolism: hypoglycemia (increased sweating, pallor of the skin, nervousness or tremor, anxiety, unusual tiredness or weakness, loss of orientation, impaired concentration, dizziness, marked hunger, temporary visual impairment, headache, nausea, tachycardia). Severe hypoglycemia can lead to loss of consciousness and / or seizures, temporary or irreversible disruption of the brain and death.
The incidence of side effects was defined as: infrequent (&> 1/1000, & <1/100), rare (&> 1/10000, & <1/1000); individual spontaneous cases are presented as very rare and are defined as & <1/10000 - including individual cases.
Allergic reactions: infrequently - urticaria, skin rash; very rarely - Anaphylactic reactions. Generalized allergic reactions may include a skin rash, itchy skin, increased sweating, abnormalities in the gastrointestinal tract, angioedema, difficulty breathing, tachycardia, a decrease in blood pressure.
Local reactions: allergic local reactions (redness, swelling, itching of the skin at the injection site), usually temporary and taking place as the treatment continues; infrequently - lipodystrophy.
Other: at the beginning of therapy it is rare - edema, infrequently - a refractive error. These side effects are usually temporary.
Adverse reactions observed in patients using the drug NovoRapid FlexPen are mainly dose-dependent and are due to the pharmacological effect of insulin.

An inadequate dose or discontinuation of treatment, especially for type 1 diabetes mellitus, can lead to the development of hyperglycemia or diabetic ketoacidosis. As a rule, the symptoms of hyperglycemia appear gradually, over several hours or days. Symptoms of hyperglycemia include nausea, vomiting, drowsiness, redness and dryness of the skin, dry mouth, increased urine, thirst and loss of appetite, and the smell of acetone in exhaled air. Without appropriate treatment, hyperglycemia can lead to death. After compensation of carbohydrate metabolism, for example, in case of intensified insulin therapy, the typical symptoms of hypoglycemia, which are typical for them, may change in patients, about which patients should be informed.
In patients with diabetes mellitus with optimal metabolic control, late complications of diabetes develop later and progress more slowly. In this regard, it is recommended to carry out activities aimed at optimizing metabolic control, including monitoring of blood glucose levels.
The consequence of the pharmacodynamic features of the short-acting insulin analogues is that the development of hypoglycemia in their use begins earlier than with the use of soluble human insulin.
NovoRapid FlexPen should be used in direct connection with food intake. It is necessary to take into account 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 infectious nature, the need for insulin, as a rule, increases. Impaired renal or hepatic function may reduce insulin requirements.
When a patient is transferred to other types of insulin, the early symptoms of precursors of hypoglycemia may change or become less pronounced compared to those of the previous type of insulin.
Transferring a patient to a new type of insulin or another manufacturer’s insulin should be carried out under strict medical supervision. If you change the concentration, type, manufacturer and type (human insulin, animal insulin, human insulin analogue) of insulin preparations and / or method of manufacture, you may need to change the dose. Patients who switch to treatment with NovoRapid FlexPen may need to increase the frequency of injections or change the dose compared to doses of previously used insulin preparations. If necessary, dose adjustment, it can be made already at the first injection 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 exertion. 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 carbohydrate metabolism compensation can lead to a state of acute pain neuropathy, which is usually reversible.
Long-term improvement in glycemic control reduces the risk of progression of diabetic retinopathy. However, the intensification of insulin therapy with a dramatic improvement in glycemic control may be accompanied by a temporary deterioration of diabetic retinopathy.
NovoRapid FlexPen contains metacresol, which in rare cases can cause allergic reactions.
Use in pediatrics
NovoRapid FlexPen should be used instead of soluble human insulin in children only when a rapid onset of action of the drug is necessary, for example, when it is difficult for the child to observe the necessary time interval between injection and food intake.
Influence on ability to drive motor transport and control mechanisms
The ability of patients to concentrate and the speed of reaction may be impaired during hypoglycemia and hyperglycemia, which can be dangerous in situations where these abilities are especially necessary (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 a car and working with mechanisms. This is especially important for patients with the absence or decrease in the severity of symptoms, precursors of developinghypoglycemia or suffering from frequent episodes of hypoglycemia. In these cases, the feasibility of performing such work should be considered.

Hypoglycemic effect of the body preparations containing ethanol.
The hypoglycemic effect of insulin weakens 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 the effect of the drug are possible.
Pharmaceutical incompatibility
Drugs containing thiol or sulfite, when added to insulin, cause its destruction.

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

An unused cartridge with the drug should be stored in a package, protected from sunlight at a temperature of 2 ° to 8 ° C (in the refrigerator); do not freeze.