Description
Release form
Injection
5ml 3rd
packaging
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 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 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 Penfill reduces the tendency of molecules to form hexamers, which is observed in human insulin solution. In this regard, NovoRapid Penfill is much faster absorbed from subcutaneous fat and begins to act much faster than soluble human insulin. NovoRapid Penfill reduces blood glucose more strongly in the first 4 hours after a meal than soluble human insulin.
The effect of the drug NovoRapid Penfill after sc administration is shorter than 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 Penfill in patients with type I diabetes, there is a decrease in the risk of nocturnal hypoglycemia compared with soluble human insulin. There was no significant increase in the risk of daytime hypoglycemia.
NovoRapid Penfill is equipotential soluble human insulin based on molarity indices.
Indications
– type 1 diabetes mellitus (insulin-dependent)
– type 2 diabetes mellitus (non-insulin-dependent): stage of resistance to oral hypoglycemic drugs, partial resistance to these drugs (during combination therapy), intercurrent36 diabetes pf90 p40 Type 1 (insulin-dependent)
– diabetes mellitus type 2 (non-insulin-dependent): stage of resistance to oral hypoglycemic agents, partial resistance to these drugs (during combination therapy), 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 of age, because clinical studies in this age group have not been conducted.
Pregnancy and lactation
Clinical experience with NovoRapid Penfill during pregnancy is very limited. In experimental 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. The need for insulin, as a rule, 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 Penfill 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 with type I 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, with intensified insulin therapy, in patients, their typical symptoms of precursors of hypoglycemia may change, about which patients should be informed.
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 Penfill should be used in direct connection with food intake. The high rate of onset of the effect of the drug in the treatment of patients should be taken into account. having concomitant diseases or taking medications 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. When changing the concentration, type, manufacturer and species (human insulin, insulin of animal origin, human insulin analogue) insulin preparations and / or method of manufacture may require a dose change. Patients switching to NovoRapid Penfill 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 Penfill contains metacresol, which in rare cases can cause allergic reactions.
Pediatric use
Use NovoRapid Penfill instead of soluble human insulin in children only if it is necessary to quickly start the action of the drug, 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
With the development of hypoglycemia, the ability to drive a car and engage in other potentially dangerous activities that require increased attention and quick psychomotor reactions may deteriorate.
Composition
1 ml contains insulin aspart 100 units
Dosage and administration
NovoRapid Penfill is intended for SC and IV administration. NovoRapid Penfill has a faster onset and shorter duration of action than soluble human insulin. Due to the faster onset of action, NovoRapid Penfill should be administered, as a rule, immediately before meals (if necessary, you can enter soon after eating).
The dose of the drug is determined by the doctor individually in each case, based on the level of glucose in the blood. NovoRapid Penfill 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 NovoRapid Penfill 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 Penfill 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 NovoRapid Penfill 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. However, a faster onset of action compared to soluble human insulin is maintained regardless of the location of the injection site.
If necessary, NovoRapid Penfill may be administered iv, but only by qualified medical personnel.
For iv administration, infusion systems with NovoRapid 100 U / ml with a concentration of 0.05 U / ml to 1 U / ml of insulin aspart at 0 are used. 9% sodium chloride solution 5% or 10% dextrose solution containing 40 mmol / l potassium chloride, using polypropylene bags for infusion. These solutions are stable at room temperature for 24 hours. During insulin infusions, it is necessary to constantly monitor the level of blood glucose.
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 Penfill insulin pump for infusion, do not mix with other types of insulin.
Patients using FDI should be fully trained in the use of the pump, appropriate reservoir and 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 Penfill with FDI should have extra insulin in the event of a breakdown in the infusion system.
Side effects of
Side effects associated with effects on carbohydrate metabolism: hypoglycemia (increased sweating, pale skin, nervousness or tremors, anxiety or tremors, anxiety, feeling anxious, 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 with side of the gastrointestinal tract, angioedema, difficulty breathing, tachycardia, decreased blood pressure
Local reactions: allergic local reactions (redness, swelling, itching of the skin at the injection site), usually temporary and passing e further treatment infrequently – lipodystrophy
Other:. at the beginning of therapy rarely – edema, rarely – a violation of refraction. These side effects are usually temporary.
Adverse reactions observed in patients using NovoRapid Penfill are mainly dose-dependent and are due to the pharmacological effect of insulin.
Drug interactions
Hypoglycemic effect of insulin is enhanced by oral hypoglycemic drugs, MAO inhibitors, ACE inhibitors, carbonic anhydrase inhibitors, non-selective beta-adrenergic blocking agents, bromocriptine, teflonofilofilofilofenofolindofolit, anabolic sulfonyl aminofilofenofolide fenfluramine, lithium preparations, preparations containing ethanol.
Oral contraceptives, glucocorticosteroids, thyroid hormones, thiazide diuretics, heparin, tricyclic antidepressants, sympathomimetics, danazole, clonidine, calcium channel blockers, diazoxide, morphine nicken, 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, in case of loss of consciousness by the patient, 40% dextrose (glucose) solution in m / 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 otpuska from drugstore
prescription
dosage form
injection
Possible product names
NovoRapid Penfil rd in. 100ED / ml 3ml x5
NovoRapid Penfill 100ED / ml 3ml rd r / in and in. Cartridge X5 B M (R)
NOVORAPID PENFILL 100ED / ML. 3ML. RR D / V / V, SC No. 5 CARTRIDGES
NOVORAPID PENFILL 100ME / ML 3ML N5 CARTRIDGE
NovoRapid Penfill cartridges 100 IU / ml 3 ml, 5 pcs.
Novo Nordisk, Denmark
