Compound
1 ml of the drug contains:
Active substance:
soluble insulin (human genetically engineered) 100 IU (3.5 mg);
1 IU corresponds to 0.035 mg anhydrous human insulin;
Excipients:
zinc 7 mcg (as zinc chloride)
glycerin (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.
pharmachologic effect
Actrapid® NM is a short-acting insulin preparation produced by recombinant DNA biotechnology using a strain of Saccharomyces cerevisiae.
A decrease in blood glucose levels occurs due to an increase in its intracellular transport after insulin binds to insulin receptors in muscle and adipose tissue and a simultaneous decrease in the rate of glucose production by the liver.
Normalization of plasma glucose concentration (up to 4.4-6.1 mmol / l) with intravenous administration of the drug Actrapid® NM in patients of the intensive care unit 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%).
The action of the drug 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.
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 with insulin is hypoglycemia. In clinical studies, as well as during the use of the drug after its release to the consumer market, it was found that the incidence 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 sites (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 painful neuropathy”, which is usually reversible.
Intensification of insulin therapy with a dramatic improvement in carbohydrate control may lead to a temporary worsening of diabetic retinopathy, while long-term improvement in glycemic control reduces the risk of progression of diabetic retinopathy. The list of side effects is presented below.
All side effects listed below, based on data obtained during clinical trials, are grouped according to the frequency of development in accordance with MedDRA and organ systems. The incidence of side effects is defined as: very often (≥1/10); often (≥1/100 to <1/10); infrequently (≥1/1000 to <1/100); rare (≥1/10000 to <1/1000), very rare (<1/10000) and not known (cannot be estimated from the available data).
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 painful neuropathy”).
On the part of the organ of vision: infrequently – refractive errors; very rarely – diabetic retinopathy.
Skin and subcutaneous tissue disorders: infrequently – lipodystrophy.
General disorders and disorders at the injection site: infrequently – reactions at the injection site; infrequently – edema.
Description of individual adverse reactions:
Anaphylactic reactions
Very rare generalized hypersensitivity reactions (including generalized skin rash, pruritus, increased sweating, gastrointestinal disturbances, angioedema, breathing difficulties, palpitations, decreased blood pressure, and syncope/loss of consciousness, which are potentially life-threatening, have been noted.
hypoglycemiaHypoglycemia is the most common side effect. It can develop if the dose of insulin is too high in relation to the need for insulin. Severe hypoglycemia can lead to loss of consciousness and/or convulsions, temporary or permanent impairment of brain function, or even death. Symptoms of hypoglycemia usually develop suddenly. These may include cold sweats, pale skin, increased fatigue, nervousness or tremors, anxiety, unusual tiredness or weakness, disorientation, decreased concentration, drowsiness, severe hunger, blurred vision, headache, nausea, and heartbeat.
Lipodystrophy
Infrequent cases of lipodystrophy have been reported. Lipodystrophy can develop at the injection site.
Interaction
There are a number of drugs 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, phenthylamine drugs .
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 may mask the symptoms of hypoglycemia and make it difficult to recover from hypoglycemia. Octreotide/lanreotide can either increase or decrease the body’s need for insulin.
Alcohol may increase or decrease the hypoglycemic effect of insulin.
Incompatibility
Actrapid HM may only be added to compounds with which it is known to be compatible. Some drugs (for example, drugs containing thiols or sulfites) when added to a solution of insulin can cause its degradation.
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.
The usual insulin requirement is 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 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, into the region 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. With the introduction of the drug into the region of the anterior abdominal wall, faster absorption is achieved than when administered to other areas.
If the injection is made into a retracted skin fold, the risk of accidental intramuscular injection of the drug is minimized. The needle must remain under the skin for at least 6 seconds to ensure that the dose is fully administered. It is necessary to constantly change injection sites within the anatomical region in order to reduce the risk of developing lipodystrophy.
Intramuscular injections are also possible, but only on prescription.
Actrapid® NM can also be administered intravenously and such procedures can only be performed by a medical professional.
Intravenous administration of the drug Actrapid® NM Penfill® from the cartridge is allowed only as an exception in the absence of vials. In this case, Actrapid® NM should be drawn into an insulin syringe without air intake or infused using an infusion system. This procedure should only be carried out by a doctor.
Actrapid® HM Penfill® is designed for use with Novo Nordisk insulin injection systems and NovoFine® or NovoTwist® needles.
Detailed recommendations for the use and administration of the drug should be followed (see “Instructions for the use of Actrapid® NM Penfill®, which must be given to the patient”).
Dose adjustment
Concomitant diseases, especially 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, dysfunction of the adrenal glands, pituitary gland or thyroid gland.
The need for dose adjustment may also arise with a change in physical activity or the patient’s usual diet.
Dose adjustment may be required when transferring a patient from one type of insulin to another.
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