Actrapid NM solution for injection 100 IU/ml vials, 10 ml

Composition

Active ingredient:

soluble insulin (human genetically engineered) 100 IU * * 1 IU corresponds to 35 micrograms of anhydrous human insulin.

Auxiliary substances:

zinc chloride,

glycerol,

metacresol,

hydrochloric acid and / or sodium hydroxide (to maintain the pH level),

d/i water.

Pharmacological action

Actrapid NM is a short-acting insulin preparation. Interacting with a specific receptor of the outer cell membrane, it forms an insulin-receptor complex.

Increasing the synthesis of cAMP (in fat cells and liver cells) or directly penetrating the cell (muscle), the insulin-receptor complex stimulates intracellular processes, including the synthesis of a number of key enzymes (hexokinase, pyruvate kinase, glycogen synthetase, etc. ).

A decrease in the concentration of glucose in the blood is due to an increase in its intracellular transport, increased absorption and assimilation by tissues, stimulation of lipogenesis, glycogenogenesis, protein synthesis, a decrease in the rate of glucose production by the liver (a decrease in glycogen breakdown), etc.

After subcutaneous injection, the effect occurs within 20-30 minutes, reaches a maximum in 1-3 hours and lasts, depending on the dose,5-8 hours. The duration of action of the drug depends on the dose, method, place of administration and has significant individual characteristics.

Indications

Insulin-dependent diabetes mellitus

Contraindications

Hypersensitivity to the components of the drug, hypoglycemia.

Side effects

Adverse reactions observed in patients treated with Actrapid NM were mainly dose-dependent and were due to the pharmacological action of insulin. As with other insulin medications, the most common side effect is hypoglycemia. It develops in cases where the dose of insulin significantly exceeds the need for it. 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 differs in different patient populations and when using different dosage regimens, so it is not possible to specify the exact frequency values.

With severe hypoglycemia, loss of consciousness and/or convulsions may occur, temporary or permanent impairment of brain function may occur, and even death. Clinical studies have shown that the overall incidence of hypoglycemia did not differ between patients treated with human insulin and those treated with insulin aspart.

The following are the values of the frequency of adverse reactions identified during the clinical study, which were considered to be associated with the use of the drug Actrapid NM. The frequency was determined as follows: infrequently ( > 1/1000, >

From the immune system: infrequently-urticaria, rash; very rarely-anaphylactic reactions. Symptoms of generalized hypersensitivity may include generalized skin rash, pruritus, sweating, gastrointestinal disorders, angioedema, shortness of breath, palpitations, decreased blood pressure, fainting / unconsciousness. Generalized hypersensitivity reactions can be life-threatening.

Nervous system disorders: very rare – peripheral neuropathy. If improvements in blood glucose control were achieved very quickly, a condition called “acute painful neuropathy” may develop, which is usually reversible.

From the side of the organ of vision: infrequently-refractive errors. Refractive errors are usually noted at the initial stage of insulin therapy. As a rule, these symptoms are reversible; very rarely – diabetic retinopathy. If adequate glycemic control is maintained over a long period of time, the risk of diabetic retinopathy progression is reduced. However, the intensification of insulin therapy with a sharp improvement in glycemic control may lead to a temporary increase in the severity of diabetic retinopathy.

Skin and subcutaneous tissue disorders: infrequently-lipodystrophy. Lipodystrophy can develop at the injection site if the injection site is not constantly changed within one area of the body.

From the body as a whole, as well as reactions at the injection site: infrequently — reactions at the injection site. During insulin therapy, reactions may occur at the injection site (redness of the skin, swelling, itching, soreness, hematoma formation at the injection site). However, in most cases, these reactions are transient and disappear during the continuation of therapy. Swelling is usually noted at the initial stage of insulin therapy. As a rule, this symptom is transient.

Interaction

The hypoglycemic effect of insulin is enhanced by MAO inhibitors, non-selective beta-blockers, sulfonamides, anabolic steroids, tetracyclines, clofibrate, cyclophosphamide, fenfluramine; drugs containing ethanol.

The hypoglycemic effect of insulin is reduced by oral contraceptives, glucocorticoids, thyroid hormones, thiazide diuretics, heparin, lithium preparations, tricyclic antidepressants.

Under the influence of reserpine and salicylates, both a weakening and an increase in the action of insulin is possible.

Pharmaceutical interaction

Ethanol, various disinfectants can reduce the biological activity of insulin.

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.

If patients with diabetes mellitus achieve optimal glycemic control, they tend to develop diabetes complications later. In this regard, efforts should be made to optimize metabolic control, in particular by carefully monitoring blood glucose levels.

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

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

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. Performing an injection into a fold of the skin reduces the risk of getting into the muscle.

It is necessary to change the injection sites within the anatomical area to prevent the development of lipodystrophy.

Intravenous injections are also possible, but only as prescribed by a doctor.

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

Dose adjustment

If the kidneys or liver are affected, the need for insulin decreases.

Instructions for use and handling of the drug

For intravenous administration, infusion systems containing the drug Actrapid NM 100 IU/ml, in concentrations from 0.05 IU/ml to 1 IU/ml of human insulin are used in infusion solutions, such as 0.9% sodium chloride solution,5% and 10% dextrose solutions, including potassium chloride at a concentration of 40 mmol/l; the system for intravenous administration uses infusion bags made of polypropylene; these solutions remain stable for 24 hours at room temperature.

Although these solutions remain stable for a certain time, at the initial stage, some amount of insulin is absorbed by the material from which the infusion bag is made. During the infusion, it is necessary to monitor the level of glucose in the blood.

Instructions for use Actrapid NM that should be given to the patient

Vials of Actrapid NM can only be used together with insulin syringes that are marked with a scale that allows you to measure the dose in units of action. Vials of Actrapid NM are intended for individual use only.

Before using Actrapid NM, you must:

• Check the label to make sure that the correct type of insulin is selected.
• Disinfect the rubber stopper with a cotton swab.

Actrapid NM should not be used in the following cases::

• In insulin pumps.
• Patients should be told that if a new bottle just received from the pharmacy does not have a protective cap or it does not sit tight, then such insulin must be returned to the pharmacy.
• If the insulin was stored incorrectly, or if it was frozen.
• If the insulin is no longer clear and colorless.

Injection technique

If the patient uses only one type of insulin

If the patient needs to mix Actrapid NM with long-acting insulin

Overdose

Symptoms: initial symptoms of hypoglycemia: sudden increased sweating, palpitations, tremors, hunger, agitation, Paresthesia in the mouth, pallor, headache, sleep disturbances. In severe cases of overdose – coma.

Treatment: the patient can eliminate mild hypoglycemia by taking sugar or sugar-rich foods. In severe cases,1 mg of glucagon is administered subcutaneously or intramuscularly. If necessary, therapy is continued with intravenous administration of concentrated glucose solutions.

Special instructions

On the recommendation of a doctor, treatment with Actrapid NM Penfill can be combined with the use of long-acting insulin preparations. Patients receiving more than 100 units of insulin per day should be hospitalized when changing the drug.

When the liver is affected, the need for insulin decreases.

When the kidneys are affected, the need for insulin decreases.

Influence on the ability to drive motor vehicles and manage mechanisms

After transferring the patient to biosynthetic human insulin, the ability to drive a car and engage in other potentially dangerous activities that require increased attention and rapid psychomotor reactions may temporarily deteriorate.

Form of production

Solution for injection

Storage conditions

Store in the refrigerator at a temperature of 2°C to 8°C (not too close to the freezer) in a cardboard box. Do not freeze it. The product should be protected from heat and sunlight. Opened bottle-store at a temperature not higher than

Expiration date

Shelf life: 2.5 years. The opened bottle lasts for 6 weeks.

Active ingredient

Genetically Engineered Human Soluble Insulin

Conditions of release from pharmacies

By prescription

Dosage form

solution for injection

Purpose

Children as prescribed by a doctor, Nursing mothers as prescribed by a doctor, Adults as prescribed by a doctor, Pregnant women as prescribed by a doctor

Indications

Type 1 Diabetes

Weight

Weight: 24 gr.