Actrapid HM injection 100 IU ml 10 ml
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Active ingredients
Insulin soluble [human genetically engineered]
Release form
Solution
Composition
1 bottle contains: Insulin soluble (human genetically engineered) 1000 IU * Excipients: zinc chloride, glycerol, metacresol, sodium hydroxide and / or hydrochloric acid (to maintain the pH level), water d / i. * 1 IU corresponds to 35 mcg anhydrous human insulin.
Pharmacological effect
DNA recombinant human insulin. It is an insulin of average duration of action. Regulates glucose metabolism, has an anabolic effect. In muscle and other tissues (with the exception of the brain), insulin accelerates the intracellular transport of glucose and amino acids, enhances protein anabolism. Insulin contributes to the conversion of glucose to glycogen in the liver, inhibits gluconeogenesis and stimulates the conversion of excess glucose to fat.
Pharmacokinetics
Absorption Absorption completeness and the beginning of the insulin effect depends on the route of administration (subcutaneously, intramuscularly), the site of administration (abdomen, thigh, buttocks), dose (volume of insulin injected), insulin concentration in the drug, etc. The maximum concentration (Cmax) of insulin in plasma is reached within 1.5-2.5 hours after subcutaneous administration. Distribution There is no marked binding to plasma proteins, sometimes only circulating antibodies to insulin are detected. Metabolism Human insulin is cleaved by insulinase or insulin-digesting enzymes, and possibly also by the action of protein disulfide isomerase. It is assumed that there are several cleavage sites (hydrolysis) in the human insulin molecule; however, none of the metabolites formed by cleavage is active. Withdrawal The period of semi-absorption (T1 / 2) is determined by the rate of absorption from the subcutaneous tissues. Thus, T1 / 2 is rather a measure of absorption, rather than the actual measure of insulin excretion from plasma (T1 / 2 of insulin from the bloodstream is just a few minutes). Studies have shown that T1 / 2 is about 2-5 hours. Children and adolescents The pharmacokinetic profile of Actrapid NM was studied in a small group of children with diabetes (18 people) aged 6-12 years, as well as adolescents (aged 13-17). Although the data obtained are considered limited, they still showed that the pharmacokinetic profile of the drug Actrapid NM in children and adolescents is similar to that in adults.At the same time, differences between different age groups were identified in terms of Cmax, which once again underscores the need for individual dose selection. Preclinical safety data During preclinical studies, including toxicity studies with repeated dosing, genotoxicity, carcinogenic potential and toxic Impact on the reproductive sphere, the specific risk to humans has not been identified.
Indications
- diabetes; - emergency conditions in patients with diabetes mellitus, accompanied by a violation of glycemic control.
Contraindications
- Hypoglycemia; - Hypersensitivity to human insulin or to any component that is part of this drug.
Precautionary measures
With comorbidities, especially with infections and feverish conditions, patients' need for insulin usually increases. If a patient is transferred from one type of insulin to another, the early symptoms, the forerunners of hypoglycemia, may change or become less pronounced than those that were observed with the introduction of the previous insulin.
Use during pregnancy and lactation
Restrictions on the use of insulin during pregnancy does not exist, since insulin does not penetrate the placental barrier. Moreover, if you do not treat diabetes during pregnancy, there is a danger to the fetus. Therefore, the treatment of diabetes must continue during pregnancy. Both hypoglycemia and hyperglycemia, which can develop in cases of insufficiently well-chosen therapy, increase the risk of fetal malformations and fetal death. Pregnant women with diabetes should be monitored throughout their pregnancy, they need to exercise enhanced control of blood glucose levels; The same recommendations apply to women who are planning a pregnancy. Insulin requirements usually decrease in the first trimester of pregnancy and gradually increase in the second and third trimesters. After birth, the need for insulin quickly returns to the level that was noted before pregnancy.There are also no restrictions for the use of the drug Actrapid NM during breastfeeding. Conducting insulin therapy for nursing mothers is not dangerous for the child. However, the mother may need to adjust the dosing regimen of Actrapid NM and / or diet.
Dosage and administration
The drug is intended for SC and IV administration. The dose of the drug is selected individually, taking into account the needs of the patient. Usually the need for insulin ranges from 0.3 to 1 IU / kg / day. The daily insulin requirements may be higher in patients with insulin resistance (for example, during puberty, as well as in patients with obesity), and lower in patients with residual endogenous insulin production. complications of diabetes, they usually appear later. In this regard, you should strive to optimize metabolic control, in particular, by carefully monitoring the level of glucose in the blood. Actrapid HM is short-acting insulin and can be used in combination with long-acting insulins. containing carbohydrates. Actrapid NM is usually injected s / c into the region of the anterior abdominal wall. If this is convenient, injections can also be made in the thigh, in the gluteal region or in the deltoid muscle of the shoulder. With the introduction of the drug in the anterior abdominal wall is achieved faster absorption than with the introduction in other areas. Performing an injection into the skin fold reduces the risk of getting into the muscle. It is necessary to change the injection sites within the anatomical region to prevent the development of lipodystrophy. V / m injection is also possible, but only as prescribed by a doctor.
Side effects
Immune system disorders: infrequently - urticaria, rash; very rarely - anaphylactic reactions. Symptoms of generalized hypersensitivity may include generalized skin rash, itching, sweating, disorders of the gastrointestinal tract, angioedema, shortness of breath, palpitations, decreased blood pressure, fainting / loss of consciousness. Generalized hypersensitivity reactions can pose a threat to life. Violations of the nervous system: very rarely - peripheral neuropathy.If an improvement in blood glucose control was achieved very quickly, a condition called acute painful neuropathy may develop, which is usually reversible. Violations of the organ of vision: infrequently, 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 glycemia control is provided for a long time, the risk of progression of diabetic retinopathy is reduced. However, the intensification of insulin therapy with a sharp improvement in glycemic control can lead to a temporary increase in the severity of diabetic retinopathy. Disorders of the skin and subcutaneous tissues: infrequently - lipodystrophy. Lipodystrophy may develop at the injection site in the event that they do not constantly change the injection site within one area of the body. Disorders of the body as a whole, as well as reactions at the injection site: infrequently, reactions at the injection site. During insulin therapy, reactions can occur at the injection site (redness of the skin, swelling, itching, pain, hematoma formation at the injection site). However, in most cases, these reactions are transient and disappear in the process of continuing therapy. Infrequently - puffiness. Puffiness is usually marked at the initial stage of insulin therapy. As a rule, this symptom is transient.
Overdose
There was no specific dose, with the introduction of which it would be possible to talk about insulin overdose, however, in cases when patients are given too high doses that exceed their needs, a state of hypoglycemia of varying severity may develop: The patient can eliminate slight hypoglycemia himself by ingesting sugar or carbohydrate-rich foods. Therefore, patients with diabetes are advised to constantly carry with them sugar, sweets, cookies or sweet fruit juice. In severe cases, when the patient loses consciousness, a 40% dextrose (glucose) solution is administered intravenously; intramuscularly, subcutaneously - glucagon (0.5-1 mg). After regaining consciousness, the patient is recommended to take carbohydrate-rich food to prevent the recurrence of hypoglycemia.
Interaction with other drugs
There are a number of drugs that affect the need for insulin.The physician must know which drugs the patient is taking in order to take into account possible drug interactions. Hypoglycemic effect containing ethanol. The hypoglycemic effect of insulin is weakened by oral contraceptives, glucocorticosteroids, thyroid hormones, thiazide diuretics, heparin, tricyclic antidepressants, sympathomimetics, somatropin, danazol, clonidine, slow calcium channel blockers, diazoxide, morphine, morphine, morphine, morphine, morphine, morphine, morphine, morphine, danazol, clonidine, slow calcium channel blockers, diazoxide, morphine, morphine, morphine, morphine, morphine, danazol, clonidine. Under the influence of reserpine and salicylates, both weakening and strengthening the effect of the drug are possible. Beta-blockers may mask the symptoms of hypoglycemia and make it more difficult to eliminate hypoglycemia. Octreotide / Lanreotide can both reduce and increase the need for insulin. Alcohol can enhance and prolong the hypoglycemic effect of insulin. Incompatibility Actrapid NM can be added only to those compounds with which it is known to be compatible. Some drugs (for example, drugs containing thiols or sulfites) when insulin is added to a solution, it can cause its degradation.
special instructions
When an incorrect dose is selected or when therapy is canceled, hyperglycemia may develop, especially in patients with type 1 diabetes. The first symptoms of hyperglycemia usually appear gradually, over several hours or days. Such symptoms include nausea, vomiting, severe sleepiness, reddened, dry skin, dry mouth, increased urine output, thirst, loss of appetite, and the smell of acetone from the mouth. If you do not treat hyperglycemia in type 1 diabetes, it can lead to the development of life-threatening diabetic ketoacidosis. In cases of significant improvement in glycemic control, for example, due to intensified insulin therapy, the usual symptoms of precursors of hypoglycemia can also change, which patients should be warned about. In case of concomitant diseases, especially in infections and febrile conditions, patients usually need insulin.If a patient is transferred from one type of insulin to another, the early symptoms, the forerunners of hypoglycemia, may change or become less pronounced than those that were observed with the introduction of the previous insulin. Transfer of patients to another type of insulin or to insulin of another manufacturer should only be carried out under medical supervision. If you change the biological activity, change the manufacturer, type, type (animal, human, analogue of human insulin) and / or method of manufacture, you may need to change the dosage regimen. If a dose adjustment is necessary, this can be done already with the first dose or in the first weeks or months of therapy. Skipping meals or unplanned heavy physical exertion can cause hypoglycemia. If the patient is going to travel across time zones, then he should consult with his doctor, since he will have to change the time for insulin administration and food intake. When adding the drug Aktrapid NM to solutions for infusions, the amount of insulin absorbed by the infusion system is unpredictable, therefore the use of Actrapid NM in PSII is not allowed. The composition of the drug Aktrapid NM includes metacresol, which can cause allergic reactions. Impact on ability to drive and work with mechanisms The ability of patients to concentrate and the speed of reaction may be impaired during hypoglycemia and hyperglycemia, which can be dangerous in situations where these abilities are especially necessary (for example, when driving a car or working with machines and mechanisms ). Patients should be advised to take measures to prevent the development of hypoglycemia and hyperglycemia while driving a car and working with mechanisms. This is especially important for patients with the absence or decrease in the severity of symptoms, precursors of developing hypoglycemia or suffering from frequent episodes of hypoglycemia. In these cases, you should consider the feasibility of driving. Instructions on how to use and handle the drug For intravenous administration, infusion systems are used that contain the drug Aktrapid HM 100 IU / ml,in concentrations from 0.05 IU / ml to 1 IU / ml of human insulin 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 period of time, at the initial stage some insulin is absorbed by the material from which the infusion bag is made. In the course of the infusion, it is necessary to monitor the level of glucose in the blood.