Description
Release form
Injection
Packaging
5 syringe pens, 3 ml each.
Pharmacological action
Hypoglycemic drug, short-acting human insulin analogue, produced by recombinant DNA biotechnology using a strain of Saccharomyces cerevisiae, in which the amino acid proline at position B28 is replaced with aspartic acid.
interacts with a specific receptor on the outer cytoplasmic membrane of cells and forms an insulin-receptor complex, stimulating 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 an increase in its intracellular transport, increased uptake by tissues, stimulation of lipogenesis, glycogenogenesis, and a decrease in the rate of glucose production by the liver.
Substitution of the amino acid proline at position B28 with aspartic acid in NovoRapid Flexpen reduces the tendency of molecules to form hexamers, which is observed in a solution of ordinary insulin. In this regard, NovoRapid Flexpen is much faster absorbed from subcutaneous fat and begins to act much faster than soluble human insulin. NovoRapid Flexpen 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 with the administration of NovoRapid, compared with soluble human insulin.
The duration of action of the drug NovoRapid Flexpen after sc administration is shorter than that of soluble human insulin.
After sc administration, 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.
When using NovoRapida Flexpen in patients with type 1 diabetes mellitus, there is a decrease in the risk of nocturnal hypoglycemia compared to soluble human insulin. There was no significant increase in the risk of daytime hypoglycemia.
NovoRapid Flexpen is an equipotential soluble human insulin based on molarity indices.
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 of age, because clinical studies in this age group have not been conducted.
Pregnancy and lactation
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 the possible onset of pregnancy and throughout its entire period, it is necessary to carefully monitor the condition of patients with diabetes mellitus and monitor the level of glucose in the blood.
Insulin demand usually decreases in the first trimester and gradually increases in the second and third trimesters of pregnancy. During and immediately after birth, insulin requirements may decrease dramatically. Shortly after birth, the need for insulin quickly returns to the level that was before pregnancy.
During lactation (breastfeeding) NovoRapid Flexpen can be used without restrictions (administration of insulin to a nursing mother does not pose a threat to the baby). However, it may be necessary to adjust the dose of the drug.
Special instructions
An insufficient dose or discontinuation of treatment, especially for type 1 diabetes mellitus, can lead to the development of hyperglycemia or diabetic ketoacidosis. As a rule, 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, as well as the appearance of an acetone odor in exhaled air. Without appropriate treatment, hyperglycemia can lead to death. After compensating for carbohydrate metabolism, for example, during intensified insulin therapy, patients may experience typical symptoms of precursors of hypoglycemia, which patients should be informed about.
In patients with diabetes 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 the level of glucose in the blood.
A consequence of the pharmacodynamic characteristics of short-acting insulin analogues is that the development of hypoglycemia during their use begins earlier than with the use of soluble human insulin.
NovoRapid Flexpen should be used in direct connection with food intake. You should take into account the high speed of the 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 tends to increase. Impaired renal or hepatic function may lead to a decrease in insulin requirements.
When transferring a patient to other types of insulin, the early symptoms of precursors of hypoglycemia may change or become less pronounced compared to those using the previous type of insulin.
Transferring a patient to a new type of insulin or insulin preparation from another manufacturer must 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 the manufacturing method, a dose change may be required. Patients undergoing 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 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 with a change in diet and with increased physical exertion. Exercise right after eating can increase your risk of developing hypoglycemia. Skipping meals or unplanned exercise can lead to hypoglycemia.
A significant improvement in the state of compensation for carbohydrate metabolism can lead to a state of acute pain neuropathy, which is usually reversible.
Continued improvement in glycemic control reduces the risk of progression of diabetic retinopathy. However, the intensification of insulin therapy with a sharp 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.
Pediatric use
Use NovoRapid Flexpen instead of soluble human insulin in children only when a fast onset of action is necessary, for example, when it is difficult for a child to observe the necessary time interval between injection and food intake.
Influence on the ability to drive vehicles and control mechanisms
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 necessary (for example, when driving or working with cars 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 diminished symptoms of precursors of developing hypoglycemia or suffering from frequent episodes of hypoglycemia. In these cases, the feasibility of such work should be considered.
Composition
1 ml contains insulin aspart 100 units
other ingredients:
glycerin,
phenol,
sodium chloride srdl srdl srdl srdl srdl srd hydroxide,
hydrochloric acid,
d / i water.
Dosage and administration of
NovoRapid Flexpen is intended for SC and IV administration. NovoRapid Flexpen has a faster onset and shorter duration of action than soluble human insulin. Due to the faster onset of action, NovoRapid Flexpen should be administered, as a rule, immediately before a meal (if necessary, it can be administered shortly after a meal).
The dose of the drug is determined by the doctor individually in each case, based on the level of glucose in the blood. NovoRapid Flexpen is usually used in combination with medium-duration or long-acting insulin preparations, which are administered at least 1 time / day.
Typically, the total daily requirement for insulin is between 0.5-1 U / kg body weight. With the introduction of the drug before meals, the need for insulin can be provided by the drug NovoRapid Flexpen by 50-70%, the remaining need for insulin is provided by extended-acting insulin.
The temperature of the administered insulin should be at room temperature.
NovoRapid Flexpen is injected sc into the region of the anterior abdominal wall, thigh, shoulder or buttock. The injection sites within the same area of the body must be regularly changed.
As with any other insulin preparation, the duration of action of NovoRapid Flexpen depends on the dose, place of administration, blood flow intensity, temperature and level of physical activity.
S / c administration to the anterior abdominal wall provides faster absorption compared to administration to other places. Nevertheless, a faster onset of action compared with soluble human insulin is maintained regardless of the location of the injection site.
If necessary, NovoRapid Flexpen may 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 insulin aspart in 0.9% sodium chloride solution 5% or 10% dextrose solution containing 40 mmol / l chloride potassium using polypropylene bags for infusion. These solutions are stable at room temperature for 24 hours. During insulin infusions, blood glucose levels must be constantly monitored.
NovoRapid can also be used for continuous s / c insulin infusions (PPII) in insulin pumps designed for insulin infusions. FDI should be produced in the anterior abdominal wall. The place of infusion should be periodically changed.
When using the NovoRapid Flexpen pen insulin pump for infusion, do not mix with other types of insulin.
Patients using FDI should be fully trained in using the pump, the appropriate reservoir, and the tubing system for the pump. The infusion set (tube and catheter) should be replaced in accordance with the user manual attached to the infusion set.
Patients receiving NovoRapid Flexpen with FDI, must have extra insulin in case of breakdown of the infusion system.
Side effects
Side effects, associated with the effect on carbohydrate metabolism: hypoglycemia (increased sweating, pallor of the skin, nervousness or tremor, anxiety, unusual tiredness or weakness, impaired orientation, impaired attention, dizziness, severe hunger, temporary visual impairment, headache, nausea, tachycardia). Severe hypoglycemia can lead to loss of consciousness and / or cramps, temporary or irreversible disruption of the brain and death.
The incidence of side effects was defined as: infrequent (&> 1/1000, & 1/10000, & Allergic reactions: infrequently – urticaria, skin rash very rarely – anaphylactic reactions. Generalized allergic reactions may include skin rash, itching of the skin, increased sweating, disturbances from the gastrointestinal tract, angioedema, difficulty breathing, tachycardia, decreased blood pressure.
Local reactions: local allergic reactions (redness, swelling, itching of the skin at the injection site), usually temporary and disappearing infrequently as treatment continues, lipodystrophy.
Other: at the beginning of therapy rarely – edema, infrequently – impaired refraction. 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.
Drug interaction
The hypoglycemic effect of insulin is enhanced by oral hypoglycemic drugs, MAO inhibitors, ACE inhibitors, carbonic anhydrase inhibitors, non-selective beta-blockers, bromocriptine, octreotide, sulfanilamides, anabolic steroids, tetracyclines, clofibrate, ketoconazole, mebendazole, pyridoxine, theophylline, cyclophosphamide, phenfluramine, lithium preparations.
Oral contraceptives, corticosteroids, thyroid hormones, thiazide diuretics, heparin, tricyclic antidepressants, sympathomimetics, danazole, clonidine, calcium channel blockers, diazoxide, morphine, phenytoin weaken the hypoglycemic effect of insulin.
Under the influence of reserpine and salicylates, both weakening and enhancing the action of the drug are possible.
Pharmaceutical incompatibility
Medicines containing thiol or sulfite, when added to insulin, cause its destruction.
Overdose
Symptoms: hypoglycemia.
Treatment: the patient can eliminate mild hypoglycemia on his own by taking in glucose, sugar or carbohydrate-rich foods (patients are advised to carry sugar, sweets, cookies or sweet fruit juice on a regular basis).
In severe cases, with loss of consciousness of the patient, a 40% solution of dextrose (glucose) v / m or p / k glucagon (0.5-1 mg) is injected into / into.
After regaining consciousness, the patient is advised to eat carbohydrate-rich foods to prevent hypoglycemia from developing again.
Storage Conditions
Do not store the unused product cartridge in its packaging, in a place protected from sunlight at 2 ° to 8 ° C (in a refrigerator).
Shelf life
2 years.
Deystvuyushtee substance
Insulin aspart
Terms and conditions
prescription
Le pd form
injection
Possible product names
NovoRapid Flexpen 100ED / ml 3ml solution d / in / in and s / to enter. Syringe pen X5 B (R)
NovoRapid Flexpen 100ED / ml 3ml sp. X5
NOVORAPID FLEXPEN 100ME / ML 3ML N5 SYRINGE HANDLE
NOVORAPID FLEXPEN R-R D / IN. 100ED / ML 3ML N5
NOVORAPID FLEXPEN RR FOR I / O AND P / K INTRODUCTION. 100ME / ML 3ML SYRINGE HANDLES No.5
Novo Nordisk, Denmark
