Actrapid® NM, 100 me/ml 10 ml

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

By increasing the synthesis of cAMP (in fat cells and liver cells) or directly penetrating into the cell (muscles) the insulin-receptor complex stimulates intracellular processes, including the synthesis of several key enzymes (hexokinase, pyruvate kinase, glycogen synthetase and others).

The reduction of glucose concentration in blood is conditioned by the increase of its intracellular transport, increased absorption and assimilation by tissues, stimulation of lipogenesis, glycogenogenesis and protein synthesis, reduction of glucose production by liver (decrease of glycogen decay) and others.

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

Indications

Type 1 diabetes

Insulin-dependent diabetes mellitus

Composition

Active ingredient:

Human genetically engineered soluble insulin 100 IU* * 1 IU corresponds to 35 µg of anhydrous human insulin.

Associates:

Zinc chloride,

Glycerol,

Methacresol,

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

water d/i.

How to take, the dosage

The drug is intended to be administered by injection and intravenously.

The dose of the drug is adjusted individually according to the patient’s needs. Usually the requirement for insulin is 0.3 to 1 IU/kg/day. Daily insulin requirements may be higher in patients with insulin resistance (e.g., during puberty and in obese patients) and lower in patients with residual endogenous insulin production.

If optimal glycemic control is achieved in patients with diabetes mellitus, their diabetes complications tend to occur later in life. Therefore, optimize metabolic control should be sought, particularly by careful monitoring of blood glucose levels.

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

The product is injected 30 minutes before a meal or snack containing carbohydrates.

Actrapid NM is usually given p/k, in the anterior abdominal wall. If convenient, it can also be injected into the thigh, gluteal area or deltoid region of the upper arm. When injecting in the area of the anterior abdominal wall, more rapid absorption is achieved than when injecting in other areas. Performing the injection in the skin fold reduces the risk of entering the muscle.

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

Intrauterine injections are also possible, but only if prescribed by a physician.

Actrapid NM is also injectable v/v and only a healthcare professional can do this.

Dose adjustment

If there is kidney or liver damage, the insulin requirement is decreased.

Instructions for Use and Handling

Infusion systems containing Actrapid NM 100 IU/ml, in concentrations of 0.05 IU/ml to 1 IU/ml human insulin in infusion solutions such as 0.9% sodium chloride solution and 5% and 10% dextrose solutions that include 40 mmol/L potassium chloride; the IV system uses infusion bags made of polypropylene and these solutions are stable for 24 hours at room temperature.

While these solutions are stable for a period of time, initially there will be some absorption of insulin into the infusion bag material. Blood glucose levels should be monitored during the infusion.

Instructions for use of Actrapid NM to be given to the patient

Actrapid NM vials should only be used in conjunction with insulin syringes that have a scale on them to measure the dose in units of action. The vials of Actrapid NM are for individual use only.

Before using Actrapid NM, you must:

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

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

• In insulin pumps.
• Patients should be explained that if a new bottle just received from the pharmacy has a protective cap missing or does not fit tightly, such insulin must be returned to the pharmacy.
• If the insulin has not been stored correctly, or if it has been frozen.
• If the insulin is no longer clear and colorless.

Injection technique

If the patient only uses one type of insulin

1. Puff the syringe with the amount of air appropriate for the dose of insulin.
2. Push air into the bottle of insulin. To do this, pierce the rubber stopper with a needle and press the piston.
3. Turn the bottle with the syringe upside down.
4. Push the desired dose of insulin into the syringe.
5. Pick the needle out of the syringe.
6. Clear the air from the syringe.
7. Check that your dose of insulin is correct.
8. Inject immediately.

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

1. Roll the vial of long-acting insulin (“turbid”) between your palms until the insulin is uniformly white and turbid.
2. Push the amount of air into the syringe that corresponds to the dose of the “turbid” insulin. Insert air into the vial of turbid insulin and remove the needle from the vial.
3. Puff the syringe with the amount of air corresponding to the dose of Actrapid NM (“clear”). Insert the air into the bottle with the Actrapid NM.
4. Turn the bottle with the syringe (“transparent”) upside down and draw in the desired dose of Actrapid NM. Remove the needle and remove any air from the syringe. Check that the dose is correct.
5. Push the needle into the vial of turbid insulin
6. Turn the syringe vial upside down.
7. Push the correct dose of cloudy insulin
8. Push the needle out of the vial
9. Please remove the air from the syringe and check the correct dose
10. . Immediately inject the selected mixture of short- and long-acting insulin.

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Interaction

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

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

The effects of reserpine and salicylates may impair as well as enhance the effect of insulin.

Pharmaceutical interactions

Ethanol and various disinfectants may decrease the biological activity of insulin.

Special Instructions

Actrapid NM Penfill may be combined with the use of long-acting insulin drugs upon a physician’s recommendation. Patients receiving more than 100 units of insulin per day should be hospitalized when changing the drug.

In case of liver damage, the need for insulin decreases.

In case of renal damage, insulin need decreases.

Impact on ability to drive and operate machinery

After a patient is switched to biosynthetic human insulin, the ability to drive and engage in other potentially hazardous activities that require increased attention and quick psychomotor reactions may be temporarily impaired.

Contraindications

Hypersensitivity to the components of the drug, hypoglycemia.

Side effects

Adverse reactions observed in patients during therapy with Actrapid NM were mainly dose-dependent and were caused by the pharmacological action of insulin. As with other insulin preparations, the most frequent side effect is hypoglycemia. This occurs when the dose of insulin significantly exceeds the need for insulin. In clinical studies, and during the use of the drug after its release to the consumer market, it was found that the frequency of hypoglycemia varies in different patient populations and using different dosing regimens, so it is not possible to specify exact frequency values.

In severe hypoglycemia, loss of consciousness and/or seizures, temporary or permanent impairment of brain function and even death may occur. Clinical studies have shown that the incidence of hypoglycemia generally did not differ between patients who received human insulin and those who received aspart insulin.

The following are the frequencies of adverse reactions identified in the clinical studies that were considered to be related to the use of Actrapid NM. The frequency was defined as follows: infrequent ( > 1/1000,

Immune system disorders: infrequent – urticaria, rash; very rare – anaphylactic reactions. Symptoms of generalized hypersensitivity may include generalized skin rash, itching, sweating, GI disorders, angioedema, shortness of breath, palpitations, decreased BP, syncope / loss of consciousness. Generalized hypersensitivity reactions may be life threatening.

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

Visual organ disorders: infrequent – refractive disorders. Refractive disorders 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 provided for a long time, the risk of diabetic retinopathy progression is reduced. However, intensification of insulin therapy with a dramatic improvement in glycemic control may lead to a temporary increase in the severity of diabetic retinopathy.

Skin and subcutaneous tissues: infrequent – lipodystrophy. Lipodystrophy may develop at the injection site in case if there is no constant change of the injection site within one region of the body.

The body in general, as well as reactions at the injection site: infrequent reactions at the injection site. During insulin therapy, reactions may occur at the injection site (skin redness, swelling, itching, pain, bruising at the injection site). However, in most cases, these reactions are transient and disappear during the continuation of therapy. Swelling usually occurs at the initial stage of insulin therapy. As a rule, this symptom is transient.

Overdose

Symptoms: initial symptoms of hypoglycemia: sudden increase in sweating, palpitation, tremor, feeling of hunger, agitation, Paresthesias in the mouth, pallor, headache, sleep disorders. In severe cases of overdose – coma.

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