Actrapid NM Penfill, 100 me/ml cartridges, 3 ml, 5 pcs.

Composition

1 ml of the drug contains:

Active ingredient:

soluble insulin (human genetically engineered) 100IU (3.5 mg);

1IU corresponds to 0.035 mg of anhydrous human insulin;

Auxiliary substances:

zinc 7 mcg (as zinc chloride),

glycerol (glycerol) 16 mg,

metacresol 3.0 mg,

sodium hydroxide about 2.6 mg and/or hydrochloric acid about 1.7 mg (for pH adjustment),

water for injection up to 1.0 ml

. Pharmacological action

Actrapid ® NM is a short-acting insulin preparation produced by recombinant DNA biotechnology using the Saccharomyces cerevisiae strain.

A decrease in blood glucose levels occurs due to an increase in its intracellular transport after binding of insulin to insulin receptors in muscle and adipose tissue and a simultaneous decrease in the rate of glucose production by the liver.

Normalization of the plasma glucose concentration (up to 4.4-6.1 mmol / l) with intravenous administration of Actrapid ® NM in intensive care patients who underwent major surgical interventions (204 patients with diabetes mellitus and 1344 patients without diabetes mellitus), who had hyperglycemia (plasma glucose concentration > 10 mmol/L), reduced mortality by 42% (4.6% instead of 8%).

Action of Actrapid® NM begins within half an hour after administration, and the maximum effect is manifested within 1.5-3.5 hours, while the total duration of action is about 7-8 hours.

Indications

• Diabetes mellitus.
• Emergency conditions in patients with diabetes mellitus, accompanied by a violation of glycemic control.

Contraindications

• Hypersensitivity to human insulin or to any component that is part of this drug.
• Hypoglycemia.

Side effects

The most common adverse event when using insulin is hypoglycemia. During clinical studies, as well as during the use of the drug after its release to the consumer market, it was found that the frequency of hypoglycemia varies depending on the patient population, the dosage regimen of the drug and glycemic control. At the initial stage of insulin therapy, refractive errors, edema, and reactions at the injection site may occur (including pain, redness, urticaria, inflammation, hematoma, swelling, and itching at the injection site). These symptoms are usually temporary. Rapid improvement in glycemic control can lead to a state of “acute pain neuropathy, ” which is usually reversible.

The intensification of insulin therapy with a dramatic improvement in carbohydrate metabolism control may lead to a temporary worsening of diabetic retinopathy, while long-term improvement in glycemic control reduces the risk of diabetic retinopathy progression. The list of side effects is presented below.

All of the following side effects, based on data obtained from clinical trials, are grouped according to the frequency of development in accordance with MedDRA and organ systems. The frequency of side effects is defined as: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10000 to <1/1000), very rare (

Immune system disorders: infrequently – urticaria, skin rash; very rarely-anaphylactic reactions.

Metabolic and nutritional disorders: very often – hypoglycemia.

Nervous system disorders: infrequently-peripheral neuropathy (“acute pain neuropathy”).

Visual disturbances: infrequently-refractive errors; very rarely – diabetic retinopathy.

Skin and subcutaneous tissue disorders: infrequently-lipodystrophy.

General disorders and disorders at the injection site: infrequently-injection site reactions; infrequently-edema.

Description of individual adverse reactions:

Anaphylactic reactions

Very rare generalized hypersensitivity reactions have been reported (including generalized skin rash, pruritus, increased sweating, gastrointestinal disorders, angioedema, difficulty breathing, rapid heartbeat, decreased blood pressure, and fainting/ unconsciousness, which are potentially life-threatening.

Hypoglycemia

Hypoglycemia is the most common side effect. It can develop if the insulin dose is too high in relation to the need for insulin. Severe hypoglycemia can lead to loss of consciousness and/or seizures, temporary or permanent impairment of brain function, or even death. Symptoms of hypoglycemia usually develop suddenly. These may include “cold sweats, ” pallor of the skin, increased fatigue, nervousness or tremors, feelings of anxiety, unusual tiredness or weakness, disorientation, decreased concentration, drowsiness, severe hunger, visual disturbances, headache, nausea, and rapid heartbeat.

Lipodystrophy

Infrequent cases of lipodystrophy have been reported. Lipodystrophy may develop at the injection site.

Interaction

There are a number of medications that affect the need for insulin. The hypoglycemic effect of insulin is enhanced by oral hypoglycemic drugs, monoamine oxidase inhibitors, angiotensin-converting enzyme inhibitors, carbonic anhydrase inhibitors, non-selective beta-blockers, bromocriptine, sulfonamides, anabolic steroids, tetracyclines, clofibrate, ketoconazole, mebendazole, pyridoxine, theophylline, cyclophosphamide, fenfluramine, lithium preparations, salicylates.

The hypoglycemic effect of insulin is weakened by oral contraceptives, glucocorticosteroids, thyroid hormones, thiazide diuretics, heparin, tricyclic antidepressants, sympathomimetics, growth hormone (somatropin), danazol, clonidine, slow calcium channel blockers, diazoxide, morphine, phenytoin, nicotine.

Beta-blockers can mask the symptoms of hypoglycemia and make recovery from hypoglycemia more difficult. Octreotide / lanreotide can both increase and decrease the body’s need for insulin.

Alcohol may increase or decrease the hypoglycemic effect of insulin.

Incompatibility

Actrapid NM can only be added to compounds with which it is known to be compatible. Certain medications (such as those containing thiols or sulfites) can cause insulin degradation when added to the solution.

How to take, course of administration and dosage

The drug is intended for subcutaneous and intravenous administration.

The dose of the drug is selected individually, taking into account the needs of the patient.

Usually, the need for insulin is from 0.3 to 1 IU / kg / day. The daily requirement for insulin may be higher in patients with insulin resistance (for example, during puberty, as well as in obese patients), and lower in patients with residual endogenous insulin production.

The drug is administered 30 minutes before a meal or light snack containing carbohydrates.

Actrapid® NM is a short-acting insulin and can be used in combination with long-acting insulins.

Actrapid® NM is usually administered subcutaneously, in the area of the anterior abdominal wall. If it is convenient, then injections can also be made in the thigh area, in the gluteal region or in the area of the deltoid muscle of the shoulder. When the drug is administered to the anterior abdominal wall, faster absorption is achieved than when administered to other areas.

If the injection is made in a drawn-out skin fold, the risk of accidental intramuscular administration of the drug is minimized. The needle should remain under the skin for at least 6 seconds, which guarantees a complete dose. It is necessary to constantly change the injection sites within the anatomical area to reduce the risk of developing lipodystrophy.

Intramuscular injections are also possible, but only when prescribed by a doctor.

Actrapid® NM can also be administered intravenously and such procedures can only be performed by a medical professional.

Intravenous administration of Actrapid ® NM Penfill® from the cartridge is allowed only as an exception in the absence of vials. In this case, you should dial the drug Actrapid® Insert NM into an insulin syringe without drawing air, or administer the infusion using an infusion system. This procedure should only be performed by a doctor.

Actrapid ® NM Penfill® is designed for use with Novo Nordisk insulin injection systems and NovoFine® or NovoTvist®needles.

Follow the detailed recommendations for the use and administration of the drug (see “Instructions for use of Actrapid® NM Penfill® to be given to the patient”).

Dose adjustment

Concomitant diseases, especially those that are infectious and accompanied by fever, usually increase the body’s need for insulin.

Dose adjustment of the drug may also be required if the patient has concomitant diseases of the kidneys, liver, adrenal gland, pituitary gland or thyroid gland.

The need for dose adjustment may also arise if the patient’s physical activity or usual diet changes.

Dose adjustment may be necessary when transferring a patient from one type of insulin to another.

Overdose

The exact dose required for an insulin overdose has not been established, but hypoglycemia may develop gradually if too high doses of insulin are administered in relation to the patient’s needs.

• The patient can eliminate mild hypoglycemia by taking glucose or sugar-containing foods inside. Therefore, patients with diabetes are advised to carry sugar-containing products at all times.
•  In the case of severe hypoglycemia, when the patient is unconscious,0.5 mg to 1 mg of glucagon should be administered intramuscularly or subcutaneously (can be administered by a trained person), or intravenously dextrose (glucose) solution (can only be administered by a medical professional). It is also necessary to inject dextrose intravenously if the patient does not regain consciousness 10-15 minutes after the introduction of glucagon. After regaining consciousness, the patient is recommended to take a carbohydrate-rich diet to prevent the recurrence of hypoglycemia.

Special instructions

Insufficient dosage of the drug or discontinuation of treatment, especially in patients with type 1 diabetes, can lead to the development of hyperglycemia. As a rule, the first symptoms of hyperglycemia appear gradually, over several hours or days. Symptoms of hyperglycemia include a feeling of thirst, frequent urination, nausea, vomiting, drowsiness, redness and dryness of the skin, dry mouth, loss of appetite, and the appearance of the smell of acetone in the exhaled air. Without appropriate treatment, hyperglycemia in patients with type 1 diabetes can lead to diabetic ketoacidosis, a potentially fatal condition.

Hypoglycemia

Hypoglycemia can develop if the dose of insulin is too high in relation to the patient’s needs.

Skipping a meal or doing an unplanned amount of intense physical activity can lead to hypoglycemia.

After compensation of carbohydrate metabolism, for example, with intensive insulin therapy, patients may change their typical symptoms-harbingers of hypoglycemia, which patients should be informed about. The usual harbinger symptoms may disappear with a prolonged course of diabetes mellitus.

The transfer of patients to another type of insulin or to another manufacturer’s insulin should only be carried out under medical supervision. If you change the concentration, manufacturer, type, type (human insulin, analog of human insulin) and / or manufacturing method, you may need to change the dose of insulin. Patients switching to treatment with Actrapid NM may need to change the dose or increase the frequency of injections compared to previously used insulin preparations. If a dose adjustment is necessary when transferring patients to Actrapid NM treatment, this can be done already at the first dose or in the first weeks or months of therapy.

As with other insulin preparations, reactions at the injection site may develop, which is manifested by pain, redness, urticaria, inflammation, hematoma, swelling and itching. Regularly changing the injection site in the same anatomical area will help reduce symptoms or prevent the development of these reactions. Reactions usually disappear within a few days to several weeks. In rare cases, it may be necessary to cancel Actrapid NM due to reactions at the injection sites. Before traveling due to jet lag, the patient should consult with their healthcare provider, as jet lag means that the patient must eat and administer insulin at a different time.

When the drug Actrapid NM is added to infusion solutions, the amount of insulin absorbed by the infusion system is unpredictable, so the use of Actrapid NM in PPI is not allowed.

Simultaneous use of drugs of the thiazolidinedione group and insulin preparations

Cases of chronic heart failure have been reported when patients are treated with thiazolidinediones in combination with insulin preparations, especially when these patients have risk factors for developing chronic heart failure. This fact should be taken into account when prescribing combination therapy with thiazolidinediones and insulin preparations to patients. When prescribing such combination therapy, it is necessary to conduct medical examinations of patients for signs and symptoms of chronic heart failure, weight gain and the presence of edema. If heart failure symptoms worsen in patients, treatment with thiazolidinediones should be discontinued.

Influence on the ability to drive vehicles and work with mechanisms

Patients ‘ ability to concentrate and react quickly may be impaired during hypoglycemia, which can be dangerous in situations where these abilities are particularly necessary (for example, when driving vehicles or working with machines and mechanisms). Patients should be advised to take measures to prevent the development of hypoglycemia when driving vehicles. This is especially important for patients with the absence or reduction of symptoms-harbingers of developing hypoglycemia or suffering from frequent episodes of hypoglycemia. In these cases, it is necessary to consider the feasibility of driving vehicles and performing such work.

Form of production

Solution for injection.

Storage conditions

Store in a dark place, at a temperature of 2-8 °C (do not freeze)

Shelf

life 2.5 years

Active ingredient

Genetically Engineered Human Soluble Insulin

Conditions of release from pharmacies

By prescription

Dosage form

solution for injection

Purpose

For adults as prescribed by a doctor, Pregnant women as prescribed by a doctor, Nursing mothers as prescribed by a doctor, Children as prescribed by a doctor

Indications

Type 1 Diabetes

Weight

Weight: 57 gr.