Treatment of diabetes mellitus is a long and responsible process. This disease is dangerous with complications, and the patient may die if he does not receive the necessary drug support.
General information about the drug
Actrapid is recommended to combat diabetes mellitus. His international name(MHH) – soluble.
This is a well-known hypoglycemic drug with a short-term effect. It is produced in the form of a solution used for injection. The physical state of the drug is a colorless liquid. The suitability of a solution is determined by its transparency.
The drug is used in the treatment of diabetes types 1 and 2. It is also effective in treating hyperglycemia, so is often used to help emergency care patients during attacks.
Patients with insulin-dependent diabetes It is necessary to control blood sugar levels throughout your life. This requires insulin injections. To improve the results of therapy, specialists combine varieties of the drug according to the characteristics of the patient and clinical picture diseases.
Pharmacological action
Insulin Actrapid HM is a short-acting drug. Thanks to its effects, blood sugar levels are reduced. This is possible due to the activation of its intracellular transport.
At the same time, the drug reduces the rate of glucose production by the liver, which also helps normalize sugar levels.
The medicine begins to act approximately half an hour after the injection and retains its effect for 8 hours. Maximum result observed within 1.5-3.5 hours after the injection.
Release forms and composition
Actrapid is commercially available in the form of an injection solution. There are no other forms of release. Its active substance is soluble insulin in an amount of 3.5 mg.
In addition to this, the drug contains components with auxiliary properties such as:
- glycerin – 16 mg;
- zinc chloride – 7 mcg;
- sodium hydroxide – 2.6 mg – or hydrochloric acid – 1.7 mg – (they are necessary for pH regulation);
- metacresol – 3 mg;
- water – 1 ml.
The drug is a clear, colorless liquid. Available in glass containers (volume 10 ml). The package contains 1 bottle.
Indications for use
This drug is designed to control blood sugar.
It should be used for the following diseases and disorders:
- type 1 diabetes mellitus;
- type 2 diabetes mellitus with complete or partial insensitivity to oral hypoglycemic agents;
- gestational diabetes that appeared during pregnancy (if there are no results from diet therapy);
- diabetic ketoacidosis;
- infectious diseases with high temperature in patients with diabetes;
- upcoming surgery or childbirth.
Self-medication with Actrapid is prohibited; this remedy should be prescribed by a doctor after studying the picture of the disease.
Directions for use and dosage
Instructions for using the product are necessary to ensure that the treatment is effective and the drug does not cause harm to the patient. Before using Actrapid, you should carefully study it, as well as the recommendations of a specialist.
The drug is administered intravenously or subcutaneously. Daily dose The doctor must select each patient individually. On average, it is 0.3-1 IU/kg (1 IU is 0.035 mg of anhydrous insulin). In certain categories of patients it may be increased or decreased.
The drug should be administered approximately half an hour before meals, which must contain carbohydrates. It is advisable to inject into the anterior abdominal wall subcutaneously - this way absorption occurs faster. But it is allowed to inject the medicine into the thighs and buttocks or into the deltoid brachialis muscle. To avoid lipodystrophy, you need to change the injection sites (while remaining within the recommended zone). To fully administer the dose, it is necessary to keep the needle under the skin for at least 6 seconds.
Actrapid can also be used intravenously, but a specialist must administer the drug in this way.
If the patient has concomitant diseases, the dosage will have to be changed. Due to infectious diseases with febrile manifestations, the patient's need for insulin increases.
Video instructions on insulin administration technique:
You also need to select the appropriate dose for such deviations as:
- kidney disease;
- disorders of the adrenal glands;
- liver pathologies;
- thyroid diseases.
Changes in the patient's diet or exercise level may affect the body's need for insulin, which may require adjustments to the prescribed dose.
Special patients
Treatment with Actrapid during gestation is not prohibited. Insulin does not pass through the placenta and does not harm the fetus.
But for expectant mothers, it is necessary to select the dose with caution, since improper treatment there is a risk of developing hyper- or hypoglycemia.
Both of these disorders can affect the health of the unborn child, and sometimes they provoke a miscarriage. Therefore, doctors should monitor sugar levels in pregnant women until delivery.
This drug is not dangerous for infants, so its use during lactation is also permitted. But at the same time, you need to pay attention to the diet of a nursing woman and choose the appropriate dosage.
Actrapid is not prescribed to children and adolescents, although studies have not found any particular risks to their health. Theoretically, treatment of diabetes with this drug in this age group is allowed, but the dosage should be selected individually.
Contraindications and side effects
Actrapid has few contraindications. These include increased sensitivity to the components of the drug and the presence of hypoglycemia.
Probability of appearance side effects at correct use of the drug is low. Most often, hypoglycemia occurs, which is a consequence of choosing an inappropriate dose for the patient.
It is accompanied by such phenomena as:
In severe cases, hypoglycemia can cause fainting or seizures. Some patients may die because of it.
Other side effects of Actrapid include:
These features appear rarely and are characteristic of the initial stage of treatment. If they are observed for a long period of time, and their intensity increases, it is necessary to consult with your doctor regarding the advisability of such therapy.
Interaction with other drugs
Actrapid must be properly combined with other medications, given that individual species drugs and individual substances can increase or decrease the body’s need for insulin. There are also medications, the use of which destroys the effect of Actrapid.
Table of interactions with other drugs:
Hypoglycemia is more difficult to detect when beta blockers are used because these drugs dampen the symptoms.
When a patient drinks alcohol, his body's need for insulin can either increase or decrease. Therefore, it is advisable for diabetics to give up alcohol.
Drugs with similar effects
The product has analogues that can be used if it is not possible to use Actrapid.
The main ones: 
- Gensulin R;
- Vozulim R;
- Monoinsulin PR;
- Biosulin R.
Terms and conditions of storage, price
The product should be kept out of the reach of children. To preserve the properties of the drug, it is necessary to protect it from exposure to sunlight. The optimal storage temperature is 2-8 degrees. Therefore, Actrapid can be stored in the refrigerator, but should not be placed in the freezer. After freezing, the solution becomes unusable. Shelf life – 2.5 years.
Once opened, the bottle should not be placed in the refrigerator; storage requires a temperature of about 25 degrees. It must be protected from the rays of the sun. The shelf life of an opened package of the drug is 6 weeks.
The approximate cost of the drug Actrapid is 450 rubles. Insulin Actrapid HM Penefill is more expensive (about 950 rubles). Prices may vary depending on region and type of pharmacy.
Actrapid is not suitable for self-medication, so you can only purchase the medicine with a doctor's prescription.
Diabetes mellitus - chronic disease resulting from a violation metabolic processes in the body. The disease can affect any inhabitant of our planet, regardless of gender and age. Every year the number of people with diabetes continues to increase.
In diabetes, the process of secretion of the hormone insulin by the pancreas is disrupted. To break down sugar and stabilize the patient’s condition, insulin drugs are introduced into the patient’s body, for example, actrapide, which we will talk about today.
Without constant insulin injections, sugar is not absorbed properly, which causes systemic disorders in all organs human body. In order for Actrapid NM to act properly, it is necessary to follow the rules for administering the drug and constantly monitor blood glucose levels.
Violation of the rules can lead to a sharp jump or drop in sugar and death.
According to the instructions for use, Actrapid is used to treat:
Insulin Actrapid is recommended during pregnancy and lactation, as well as the development of diseases that accompany diabetes. The drug has effective analogues, for example, Actrapid MS, Iletin Regular, Betasint and others. Please note that the transition to analogues is carried out exclusively in a hospital setting under the supervision of the attending physician and constant monitoring of blood sugar levels.
Important: since the active ingredient in Actrapid is pork insulin, some patients may experience a persistent allergic reaction. In this case, you may need to change the drug.
Technique introduction
Subcutaneous, intramuscular and intravenous administration of the drug is allowed. When administered subcutaneously, patients are advised to choose the thigh area for injection, this is where the drug is absorbed slowly and evenly.
Additionally, you can use the buttocks, forearms and front wall for injections abdominal cavity(when injected into the stomach, the effect of the drug begins as soon as possible). You should not give injections in one area more than once a month, the drug can provoke lipodystrophy.
If it is necessary to supplement short-term insulin with long-term insulin, the following algorithm is performed:
- Air is introduced into both ampoules (both short and long);
- First, insulin is drawn into the syringe short acting, then it is supplemented with a long-term drug;
- The air is removed by tapping.
Diabetics with little experience are not recommended to administer Actropid shoulder area independently, since there is a high risk of forming an insufficient skin-fat fold and injecting the drug intramuscularly. It is worth noting that when using needles up to 4-5 mm, a subcutaneous fat fold is not formed at all. 
It is prohibited to inject the drug into tissues altered by lipodystrophy, as well as into areas of hematomas, seals, scars.
Actropid can be administered using a regular insulin syringe, pen or automatic pump. In the latter case, the drug is introduced into the body independently; in the first two cases, it is worth mastering the administration technique.
Syringe pen:
- A disposable needle is installed;
- The drug is easily mixed, 2 units of the drug are selected using a dispenser, and they are released into the air;
- Using the switch, the value of the desired dose is set;
- A fat fold forms on the skin, as described in the previous technique;
- The drug is administered by pressing the piston all the way;
- After 10 seconds, the needle is removed from the skin and the fold is released.
The needle must be thrown away.
If short-acting Actrapid is used, there is no need to stir it before use.
To avoid improper absorption of the drug and the occurrence of hypoglycemia, as well as hyperglycemia, you should not inject insulin into inappropriate areas and use dosages that have not been agreed upon with your doctor. It is prohibited to use expired Actrapid, medicinal product may cause insulin overdose.
Administration intravenously or intramuscularly is carried out only under the supervision of the attending physician. Actrapid is administered into the body half an hour before a meal; the meal must contain carbohydrates. 
Advice: it is better to inject insulin at room temperature, so the pain from the injection will be less noticeable.
How Actrapid works
Insulin Actrapid belongs to a group of drugs whose main effect is aimed at lowering blood sugar levels. It is a short-acting drug.
Sugar reduction occurs due to:
The degree and speed of the drug’s effect on the body depends on several factors:
- Dosage of insulin drug;
- Method of administration (syringe, pen, insulin pump);
- The selected site for administering the drug (abdomen, forearm, thigh or buttock).
When Actrapid is administered subcutaneously, the drug begins to act after 30 minutes; it reaches its maximum concentration in the body after 1-3 hours, depending on the individual characteristics patient, the hypoglycemic effect is active for 8 hours.
Side effects
When switching to Actrapid, patients may experience swelling of the limbs and problems with vision clarity for several days (or weeks, depending on the individual characteristics of the patient).
Other adverse reactions are recorded when:
The most common side effect is hypoglycemia. If the patient's skin turns pale, excessive irritability and a feeling of hunger, confusion, tremors of the limbs and increased sweating, perhaps your blood sugar has dropped below the acceptable level.
At the first manifestation of symptoms, you need to measure your sugar and eat it easily digestible carbohydrates, if the patient loses consciousness, glucose is injected intramuscularly.
IN advanced cases hypoglycemia can result in coma and death.
In some cases, Actrapid insulin may cause allergic reactions, which appear:
If the patient does not comply with the injection rules different places, lipodystrophy develops in the tissues.
Patients who experience hypoglycemia on a regular basis need to mandatory Contact your doctor to adjust the administered doses.
Special instructions
At permanent treatment diabetes Actrapidom it is extremely important to keep track of your blood sugar levels using a glucometer. Self-control will prevent sharp jump sugar level.
Often hypoglycemia can be caused not only by an overdose of the drug, but also by a number of other reasons:
If the patient enters insufficient quantity the drug or skips administration, he develops hyperglycemia (ketoacidosis), a condition no less dangerous, which can lead to a coma.
Signs of hyperglycemia:
Use during pregnancy
Treatment with Actrapid is allowed if the patient is pregnant. Throughout the entire period, it is necessary to monitor sugar levels and change dosages. So, during the first trimester, the need for the drug decreases, during the second and third, on the contrary, it increases.
After childbirth, the need for insulin is restored to the level it was before pregnancy.
During lactation, a dosage reduction may be necessary. The patient needs to carefully monitor her blood sugar levels so as not to miss the moment when the need for the drug stabilizes. 
Purchase and storage
You can buy Actrapid at a pharmacy with a prescription from your doctor.
It is best to store the drug in the refrigerator at a temperature of 2 to 7 degrees Celsius. Do not expose the drug to direct heat or sun rays. When frozen, Actrapid loses its glucose-lowering characteristics.
Before the injection, the patient should check the expiration date of the drug; using expired insulin is not allowed. Be sure to check the ampoule or bottle with Actrapid for the presence of sediment and foreign inclusions.
Actrapid is used by patients with both type 1 and type 2 diabetes mellitus. When used correctly and following the dosages specified by the doctor, it does not cause the development of side effects in the body.
Remember that diabetes treatment must be comprehensive: in addition to daily drug administration, it is necessary to adhere to a certain diet, monitor physical activity and not expose the body to stressful situations. 
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Comments:
Actrapid NM injection solution (the instructions for use clearly prescribe this) is recommended for people suffering from diabetes. The drug is based on biosynthetically produced human insulin. Its manufacturer is pharmaceutical company Novo Nordisk A/S from Denmark, engaged in the development and production of medicines for diabetes. Actrapid is used only as prescribed by a doctor and is dispensed from pharmacies with a prescription form.
Active component and effect of the drug, indications for its use
Actrapid NM is a hypoglycemic agent with a short-term effect. Produced in the form clear liquid colorless and odorless, intended for injection under the skin and intravenously. The active component of the drug is soluble human insulin, obtained using rDNA biotechnology using the Saccharomyces cerevisiae strain. 1 ml of solution contains 100 IU of the active ingredient, which is equivalent to 0.035 anhydrous insulin. In addition to the active substance, the product additionally contains sterile water, sodium in the form of hydroxide, zinc chloride, metacresol and hydrochloric acid.
The drug is sold in 10 ml transparent glass bottles sealed with rubber stoppers. Each bottle is packed in a thick paper box and supplied with a medical note.
The hypoglycemic properties of Actrapid NM are due to the absorption of glucose by the body after binding of insulin to cell receptors and inhibition of its production by the liver. The product has a short-term effect. The effect of its use occurs half an hour after the dose is administered and lasts up to 8 hours. Maximum concentration active component Actrapida NM in the blood plasma is observed 1.5–2 hours after the injection.
Actrapid NM is used in the treatment of insulin-dependent diabetes mellitus in people of all age groups. Thanks to fast action the drug can be used in critical cases when the patient has problems with glycemic control.
Situations in which you should be careful with the medicine
People suffering from diabetes should take into account that the use of Actrapid NM is not indicated for all patients. Instructions for use prohibit prescribing this drug to persons who have:
- individual intolerance to the substances included in its composition;
- hypoglycemia.
The use of Actrapid NM in pediatric practice is not contraindicated. The solution can be used in the treatment of children and adolescents who need insulin injections to maintain normal blood sugar levels.
The insulin solution does not tend to penetrate the placental barrier, so it can be used by pregnant patients without restrictions. Women preparing for motherhood need to choose correct dosage a drug that will allow them to control their blood sugar levels. The use of the drug in an inadequate dose can lead to the occurrence of hypoglycemia or hyperglycemia - conditions that during pregnancy can lead to abnormal development and fetal death.
Expectant mothers should carefully adjust the dose of Actrapid NM. It should be taken into account that in the first trimester the need for it decreases slightly, and in later periods it increases. After the birth of a child, a woman’s need for insulin gradually returns to the level that she had before the onset of the “interesting” situation.
Actrapid NM is not dangerous for the health of infants, therefore there is no need to limit its use to breastfeeding women. Sometimes a young mother may need to adjust the dose of the drug.
In persons suffering from renal and liver failure, the body's need for insulin can be reduced. They need to monitor their blood glucose levels with particular care and calculate the amount of drug administered individually, based on the results of the examination.
The use of Actrapid NM by people over 65 years of age should be carried out against the background of regular glucose monitoring. To avoid development negative consequences From treatment, patients in this age group should try not to exceed the dosage of the solution.
The drug does not affect human fertility. Patients who use it constantly are not prohibited from producing offspring.
Features of use and undesirable consequences
Actrapid must be administered subcutaneously or intravenously. The dosage of the drug depends on the patient's body's needs for insulin. It should be installed by an endocrinologist based on the results of the diabetic’s tests. This medicine has an effect for a short time, so if necessary it can be prescribed in combination with insulin drugs long acting.
It is recommended to use the medicinal solution Actrapid NM half an hour before meals. At subcutaneous use It is advisable to inject the drug into the anterior wall of the peritoneum. You can also inject insulin into the shoulder, thigh, or buttock area. To avoid the development of fatty degeneration, the patient should regularly change the injection site of the solution. According to the doctor's decision, the patient may be prescribed Actrapid NM intravenously. This procedure is carried out in a medical institution.
The use of Actrapid NM can cause the development of adverse reactions. The most common undesirable consequence from treatment with this solution is hypoglycemia, which develops as a result of the use large quantity insulin and is diagnosed when blood sugar levels drop. At mild form This pathology causes a person to complain of lethargy, weakness, thirst, nausea, dryness skin, lack of appetite, frequent urination, acetone smell from the mouth.
Severe hypoglycemia can be recognized by seizures, fainting, and impaired brain function. In the absence of an adequate treatment approach this pathology can lead to human death. If hypoglycemia develops, the diabetic should refrain from administering insulin again and seek qualified medical help as soon as possible.
In addition to hypoglycemia, a patient receiving Actrapid NM injections may experience symptoms of hypersensitivity to the drug, which manifest themselves as a decrease in blood pressure, skin rash, shortness of breath, tachycardia, sweating, dyspepsia, Quincke's edema, clouding or loss of consciousness. A similar reaction to medicinal solution is considered life-threatening and requires immediate medical attention.
Side effects that develop in some people while using Actrapid NM also include:
- peripheral neuropathy;
- vision problems (myopia, farsightedness, astigmatism, hypermetropia, myopia);
- fatty degeneration;
- allergic reactions (itching, urticaria);
- local reactions (pain, itching, swelling, hematomas, hyperemia at the site of insulin injection).
Any undesirable symptoms that occur in a person after starting to use Actrapid should be a reason for him to contact a specialist. Ignoring adverse reactions can lead to the development of irreversible health consequences.
First aid for overdose, drug interactions and storage
The use of Actrapid NM in doses exceeding the norm leads to the development of an overdose, which manifests itself in the form of hypoglycemia. Help for the patient depends on the severity of his condition. A slight drop in sugar levels can be normalized without consulting a doctor. A diabetic can stabilize his condition on his own by eating a little sugar or other food that contains a lot of carbohydrates.
In case of severe hypoglycemia, accompanied by fainting, the patient needs emergency medical care. To eliminate the danger to life, he is administered glucagon and dextrose. To avoid a repeated drop in glucose, the patient, after being brought out of a fainting state, is given rich in carbohydrates food.
Insulin Actrapid interacts with certain groups of drugs. Persons taking beta-blockers, tetracycline antibiotics, sulfonamides, anabolic steroids, carbonic anhydrase, monoamine oxidase and ACE inhibitors, ketoconazole, theophylline, mebendazole, clofibrate, sugar-lowering drugs for oral use, should take into account that all of these drugs enhance the effect of insulin.
The hypoglycemic properties of Actrapid NM are weakened by its simultaneous administration with glucocorticosteroids, oral contraception, blockers calcium channels, thiazide diuretics, sympathomimetics, morphine, heparin, danazol, tricyclic antidepressants.
When combining an insulin solution with salicylates and reserpine, unexpected reactions may occur. When taking the drug in parallel with alcoholic beverages and ethanol-containing medications, its effect becomes stronger and prolonged.
Actrapid NM is incompatible with medications, created on the basis of sulfites and thiols. Their addition to the solution leads to its destruction.
The shelf life of Actrapid NM is limited to 30 months from the date of production. It is recommended to keep unopened bottles of the drug in the refrigerator at a temperature of 2°C to 8°C. It is important to ensure that insulin is not frozen, as this will reduce its hypoglycemic properties.
After opening, the bottle of medicine should be kept at room temperature in a place protected from bright light. Printed insulin must be used within 45 days. The use of the drug that remains after this period is strictly prohibited.
Thank you for your feedback
Comments
Megan92 () 2 weeks ago
Has anyone managed to completely cure diabetes? They say it is impossible to completely cure...
Daria () 2 weeks ago
I also thought it was impossible, but after reading this article, I had long since forgotten about this “incurable” disease.
Megan92 () 13 days ago
Daria () 12 days ago
Megan92, that’s what I wrote in my first comment) I’ll duplicate it just in case - link to article.
Sonya 10 days ago
Isn't this a scam? Why do they sell on the Internet?
Yulek26 (Tver) 10 days ago
Sonya, what country do you live in? They sell it on the Internet because stores and pharmacies charge outrageous markups. In addition, payment is only after receipt, that is, they first looked, checked and only then paid. And now they sell everything on the Internet - from clothes to TVs and furniture.
Editor's response 10 days ago
Sonya, hello. This drug for the treatment of diabetes mellitus is indeed not sold through the pharmacy chain in order to avoid inflated prices. Currently you can only order from official website. Be healthy!
Sonya 10 days ago
Catad_pgroup Insulins
Actrapid MS - official* instructions for use
*registered by the Ministry of Health of the Russian Federation (according to grls.rosminzdrav.ru)
INSTRUCTIONSBy medical use drug
Registration number:
P N014272/02Trade name: Actrapid ® NM
INN: Soluble insulin (human genetically engineered)
Dosage form:
Solution for injectionCompound:
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 of anhydrous human insulin.
excipients: zinc chloride, glycerin (glycerol), metacresol, sodium hydroxide and/or hydrochloric acid (to adjust pH), water for injection.
1 bottle contains 10 ml of the drug, which corresponds to 1000 ME.
Description
Transparent, colorless liquid.
Pharmacotherapeutic group:
Hypoglycemic agent, short-acting insulin.ATX code- A10AB01.
Pharmacological properties:
PharmacodynamicsActrapid ® NM is a short-acting insulin preparation produced by biotechnology recombinant DNA using a strain of Saccharomyces cerevisiae. Interacts with a specific receptor on the outer cytoplasmic membrane of cells and forms an insulin-receptor complex. Through activation of cAMP biosynthesis (in fat cells and liver cells) or directly penetrating the cell (muscles), the insulin receptor complex stimulates intracellular processes, including the synthesis of a number of key enzymes (hexokinase, pyruvate kinase, glycogen synthase, etc.). The decrease in glucose content 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, etc. Normalization of plasma glucose concentration (up to 4.4-6.1 mmol/l ) by using intravenous administration the drug Actrapid ® NM in patients of the department intensive care who have suffered serious 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 duration of action of insulin drugs is mainly determined by the rate of absorption, which depends on several factors (for example, dose, route, site of administration, and type of diabetes mellitus). Therefore, the insulin action profile is subject to significant fluctuations, as in different people, and for the same person. The effect of the drug Actrapid ® NM begins within half an hour after administration, and the maximum effect appears within 1.5-3.5 hours, while the total duration of action is about 7-8 hours.
Pharmacokinetics
Suction
The completeness of absorption and the onset of the effect of insulin depends on the method of administration (subcutaneous, intramuscular), injection site (abdomen, thigh, buttocks), dose (volume of insulin administered), insulin concentration in the drug, etc. The maximum concentration (Cmax) of insulin in plasma is achieved within 1.5-2.5 hours after subcutaneous administration.
Distribution
There is no pronounced binding to plasma proteins; sometimes only circulating antibodies to insulin are detected.
Metabolism
Human insulin is broken down by insulinase or insulin-digesting enzymes, and possibly by protein disulfide isomerase. It is assumed that the human insulin molecule has several sites of cleavage (hydrolysis); however, none of the metabolites resulting from cleavage are active.
Removal
The half-absorption period (T 1/2) is determined by the rate of absorption from subcutaneous tissues. Thus, T 1/2 is more likely a measure of absorption, and not actually a measure of removal of insulin from the plasma (T 1/2 of insulin from the bloodstream is only a few minutes). Studies have shown that T 1/2 is about 2-5 hours.
Children and teenagers
The pharmacokinetic profile of the drug Actrapid ® NM was studied in a small group of children with diabetes mellitus (18 people) aged 6-12 years, as well as adolescents (aged 13-17 years). Although the data obtained are considered limited, they still showed that the pharmacokinetic profile of Actrapid ® NM in children and adolescents is similar to that in adults. However, differences were identified between different age groups according to such an indicator as Cmax, which once again emphasizes the need for individual dose selection.
Preclinical safety data
In the course of clinical trials, which included toxicity studies with reintroduction dose, genotoxicity studies, carcinogenic potential and reproductive toxicity, no specific risk to humans was identified.
Indications for use:
Diabetes mellitus.Emergency conditions in patients with diabetes mellitus, accompanied by impaired glycemic control.
Contraindications:
Hypoglycemia.Hypersensitivity to human insulin or to any of its ingredients this drug.
Pregnancy and lactation
There are no restrictions on the use of insulin during pregnancy, since insulin does not penetrate the placental barrier. Moreover, if diabetes is not treated during pregnancy, it poses a risk to the fetus. Therefore, diabetes therapy must be continued during pregnancy.
Both hypoglycemia and hyperglycemia, which can develop in cases of insufficiently selected therapy, increase the risk of fetal malformations and intrauterine death fetus Pregnant women with diabetes should be monitored throughout pregnancy and enhanced control 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 childbirth, insulin requirements quickly return to pre-pregnancy levels.
There are also no restrictions on the use of the drug Actrapid NM during the period breastfeeding. Insulin therapy for nursing mothers does not pose a risk to the baby. However, the mother may need to adjust the dosage regimen of Actrapid NM and/or diet.
Directions for use 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. Typically, insulin requirements range from 0.3 to 1 IU/kg/day. Daily requirement in 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, their diabetes complications tend to appear 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 meals or light snack containing carbohydrates.
Actrapid NM is usually injected subcutaneously into the anterior abdominal wall. If convenient, injections can also be given in the thigh area, in the gluteal area or in the deltoid muscle area of the shoulder. When the drug is administered to the anterior abdominal wall, faster absorption is achieved than when administered to other areas. Injecting into a fold of skin reduces the risk of getting into the muscle.
It is necessary to change injection sites within the anatomical region to prevent the development of lipodystrophies.
Intramuscular 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 medical worker.
Dose adjustment
If the kidneys or liver are damaged, the need for insulin decreases.
Side effect:
Adverse reactions observed in patients during therapy with Actrapid ® NM were predominantly 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 trials, as well as during the use of the drug after its release on consumer market It has been found that the incidence of hypoglycemia varies in different patient populations and when using different dosage regimens, so it is not possible to indicate exact frequency values.In severe hypoglycemia, loss of consciousness and/or convulsions may occur, temporary or permanent violation brain function and even death. Clinical studies have shown that the incidence of hypoglycemia generally did not differ between patients receiving human insulin and patients receiving insulin aspart.
Below are the frequencies of adverse reactions identified during clinical studies that were assessed as associated with the use of the drug Actrapid ® NM. Frequency was determined as follows: uncommon (> 1/1000, Immune system disorders
Uncommon: urticaria, rash.
Very rarely - anaphylactic reactions. Symptoms of generalized hypersensitivity may include generalized skin rash, itching, increased sweating, organ violations gastrointestinal tract, angioedema, shortness of breath, palpitations, decreased blood pressure, fainting/loss of consciousness.
Generalized hypersensitivity reactions can be life-threatening.
Nervous system disorders
Uncommon: peripheral neuropathy.
If improvement in blood glucose control is achieved very quickly, a condition called "acute painful neuropathy" may develop, which is usually reversible.
Visual disorders
Uncommon: refractive errors.
Refractive errors are usually noted on initial stage 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 progression of diabetic retinopathy is reduced. However, 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
Uncommon: lipodystrophy.
Lipodystrophy can develop at the injection site if the permanent shift injection sites within one area of the body.
Disorders of the body as a whole, as well as reactions at the injection site
Uncommon: reactions at the injection site.
During insulin therapy, reactions may occur at the injection site (skin redness, swelling, itching, pain, hematoma formation at the injection site). However, in most cases, these reactions are transient and disappear during therapy.
Uncommon: swelling.
Swelling is usually noted at the initial stage of insulin therapy. As a rule, this symptom is transient.
Overdose:
A specific dose, when administered, could indicate an overdose of insulin, has not been established, however, in cases where patients are given too much high doses exceeding their needs, the condition may develop hypoglycemia varying degrees gravity:There are a number of medications that affect the need for insulin. The doctor must know what medicines is taken by the patient to take into account possible drug interactions. 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 steroid, tetracyclines, clofibrate, ketoconazole, mebendazole, pyridoxine, theophylline, cyclophosphamide, fenfluramine, lithium preparations, preparations 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, phenytoin, nicotine.
Under the influence of reserpine and salicylates, it is possible to both weaken and enhance the effect of the drug.
Beta blockers may mask the symptoms of hypoglycemia and make it more difficult to reverse hypoglycemia.
Octreotide/lanreotide can either decrease or increase insulin requirements. Alcohol can enhance and prolong the hypoglycemic effect of insulin.
Incompatibility
Actrapid ® NM can only be added to those compounds with which it is known to be compatible. Some drugs (for example, drugs containing thiols or sulfites) when added to an insulin solution can cause its degradation.
Special instructions
If the dose is incorrectly selected or therapy is discontinued, it may develop hyperglycemia, especially in patients with type 1 diabetes. The first symptoms of hyperglycemia usually appear gradually over several hours or days. These symptoms include nausea, vomiting, severe drowsiness, red, dry skin, dry mouth, increased urine output, thirst, loss of appetite, and the smell of acetone on the breath.If left untreated, hyperglycemia in type 1 diabetes can lead to life-threatening diabetic ketoacidosis. In cases of significant improvement in glycemic control, for example, due to intensified insulin therapy, the usual symptoms that predict hypoglycemia may also change, about which patients should be warned.
With concomitant diseases, especially with infections and feverish conditions, patients' need for insulin usually increases.
If a patient is transferred from one type of insulin to another, then early symptoms-harbingers hypoglycemia may change or become less severe than those noted with the introduction of previous insulin.
Transferring patients to another type of insulin or to insulin from another manufacturer should only be done under medical supervision. When changing biological activity, a change in the manufacturer, type, species (animal, human, analogue of human insulin) and/or manufacturing method may require a change in dosage regimen.
If dose adjustments are necessary, this can be done at the time of the first dose or during the first weeks or months of therapy.
Skipping meals or unplanned strenuous exercise can cause hypoglycemia.
If the patient is traveling across time zones, he should consult with his doctor, as he will have to change the timing of insulin administration and meals.
When adding Actrapid NM to solutions for infusion, the amount of insulin absorbed by the infusion system is unpredictable, therefore the use of Actrapid NM in CSII is not permitted.
The drug Actrapid NM contains metacresol, which can cause allergic reactions.
Impact on the ability to drive a car and operate machinery
Patients' ability to concentrate and react quickly may be impaired during hypoglycemia and hyperglycemia, which can be dangerous in situations where these abilities are especially needed (for example, when driving a car or working with machinery). Patients should be advised to take measures to prevent the development of hypoglycemia and hyperglycemia when driving a car and working with machinery. This is especially important for patients with the absence or decrease in severity of symptoms that are warning signs of developing hypoglycemia or who suffer from frequent episodes of hypoglycemia. In these cases, the advisability of driving should be considered.
Instructions for use and handling of the drug
For intravenous administration, infusion systems containing the drug Actrapid NM 100 IU/ml are used, in concentrations from 0.05 IU/ml to 1 IU/ml 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 intravenous system uses infusion bags made of polypropylene; these solutions are stable for 24 hours at room temperature.
Although these solutions remain stable for a certain period of time, some insulin is initially absorbed by the material from which the infusion bag is made. During the infusion, it is necessary to monitor blood glucose levels.
Release form:
Solution for injection 100 IU/ml.10 ml of the drug in a glass bottle of hydrolytic class 1, sealed with a bromobutyl/polyisoprene rubber stopper and a plastic cap. 1 bottle along with instructions for use in a cardboard box.
Storage conditions:
Store in the refrigerator at a temperature of 2 o C to 8 o C (not too close to the freezer) in a cardboard box. Do not freeze.For an opened bottle: store at a temperature not exceeding 25 o C for 6 weeks. It is not recommended to store in the refrigerator. Store the bottle in a cardboard box to protect from light.
The drug should be protected from heat and sunlight.
Keep out of the reach of children.
Best before date:
30 months. Do not use after expiration date.Conditions for dispensing from pharmacies:
By prescriptionManufacturer:
Novo Nordisk A/SNovo Alle, DK-2880 Bagsvaerd, Denmark Representation
Novo Nordisk A/S
119330, Moscow, Lomonosovsky prospect, 38, office 11 Instructions for the use of Actrapid ® NM that must be given to the patient. Vials with the drug Actrapid NM can only be used together with insulin syringes, which have a scale that allows you to measure the dose in action units. Vials with the drug Actrapid NM are intended only for individual use. Before using the drug Actrapid ® NM you must:
✓ Check the label to make sure the correct type of insulin is selected.
✓ Disinfect the rubber plug using a cotton swab. The drug Actrapid ® NM cannot be used in the following cases:
✓ In insulin pumps.
✓ Patients must be explained that if a new bottle just received from a pharmacy does not have a protective cap or it does not fit tightly, such insulin must be returned to the pharmacy.
✓ If the insulin was stored incorrectly or if it was frozen.
✓ If insulin is no longer transparent and colorless. Injection technique
If the patient is using only one type of insulin
1. Fill the syringe with air in an amount corresponding to the required dose of insulin.
2. Inject air into the insulin vial. To do this, pierce the rubber plug with a needle and press the piston.
3. Turn the bottle with the syringe upside down.
4. Draw the required dose of insulin into the syringe.
5. Remove the needle from the bottle.
6. Remove air from the syringe.
7. Check that the insulin dose is set correctly.
8. Inject immediately. If the patient needs to mix Actrapid ® NM with long-acting insulin
1. Roll the vial of long-acting insulin (“cloudy”) between your palms until the insulin becomes uniformly white and cloudy.
2. Fill the syringe with air in an amount corresponding to the dose of “cloudy” insulin. Inject air into the vial of cloudy insulin and remove the needle from the vial.
3. Fill the syringe with air in an amount corresponding to the dose of the drug Actrapid NM (“transparent”). Inject air into the vial containing Actrapid NM.
4. Turn the bottle with the syringe (“transparent”) upside down and draw the required dose of Actrapid NM. Remove the needle and remove air from the syringe. Check the correct dose.
5. Insert the needle into the vial of cloudy insulin.
6. Turn the bottle with the syringe upside down.
7. Draw up the required dose of cloudy insulin.
8. Remove the needle from the vial.
9. Remove air from the syringe and check that the dose is correct.
10. Immediately inject the mixture of short-acting and long-acting insulin. Always draw short- and long-acting insulins in the same order as described above. Instruct the patient how to administer insulin.
1. Using two fingers, take a fold of skin, insert the needle into the base of the fold at an angle of about 45 degrees and inject insulin under the skin.
2. After injection, the needle should remain under the skin for at least 6 seconds to ensure that the insulin is completely injected. Actrapid ® - registered trademark, owned by Novo Nordisk A/S, Denmark
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 of anhydrous human insulin.
excipients: zinc chloride about 7 mcg, glycerin (glycerol) 16 mg, metacresol 3.0 mg, sodium hydroxide about 2.6 mg and/or hydrochloric acid about 1.7 mg (to adjust pH), water for injection up to 1.0 ml .
Description
Transparent, colorless liquid.
Pharmacological action"type="checkbox">
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 the binding of insulin to insulin receptors in muscle and fat tissues 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) using intravenous administration of the drug Actrapid ® NM in intensive care unit 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%).
The effect of the drug Actrapid ® NM begins within half an hour after administration, and the maximum effect appears within 1.5-3.5 hours, while the total duration of action is about 7-8 hours.
Pharmacokinetics
The half-life of insulin from the bloodstream is only a few minutes.
The duration of action of insulin drugs is mainly determined by the rate of absorption, which depends on several factors (for example, the dose of insulin, the route and site of administration, the thickness of the subcutaneous fat layer and the type of diabetes mellitus). Therefore, the pharmacokinetic parameters of insulin are subject to significant inter- and intra-individual fluctuations.
Suction
The maximum concentration (Cmax) of insulin in plasma is achieved within 1.5-2.5 hours after subcutaneous administration.
Distribution
No pronounced binding to plasma proteins is observed, with the exception of antibodies to insulin (if present).
Metabolism
Human insulin is broken down by insulinase or insulin-degrading enzymes, and possibly by protein disulfide isomerase.
It is assumed that the human insulin molecule has several sites of cleavage (hydrolysis); however, none of the metabolites resulting from cleavage are active.
Removal
The half-absorption period (T ½) is determined by the rate of absorption from subcutaneous tissues. Thus, T ½ is a measure of absorption rather than actual removal of insulin from the plasma (T ½ of insulin from the bloodstream is only a few minutes). Studies have shown that T ½ is about 2-5 hours.Children and teenagers
The pharmacokinetic profile of the drug Actrapid ® NM was studied in a small group of children with diabetes mellitus (18 people) aged 6-12 years, as well as adolescents (aged 13-17 years). Although the data obtained are considered limited, they still showed that the pharmacokinetic profile of Actrapid ® NM in children and adolescents is similar to that in adults. At the same time, differences were identified between different age groups in such an indicator as Cmax, which once again emphasizes the need for individual dose selection.
Preclinical safety data
Preclinical studies, which included pharmacological safety studies, repeated dose toxicity studies, genotoxicity studies, carcinogenic potential and reproductive toxicity studies, did not identify any specific risk to humans.
Indications for use
Diabetes mellitus.
Contraindications
Hypersensitivity to human insulin or to any component of this drug. Hypoglycemia.
Pregnancy and lactation
There are no restrictions on the use of insulin during pregnancy, since insulin does not penetrate the placental barrier.
Both hypoglycemia and hyperglycemia, which can develop in cases of insufficiently selected therapy, increase the risk of fetal malformations and intrauterine fetal death. Pregnant women with diabetes should be monitored throughout pregnancy and have increased monitoring 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 childbirth, insulin requirements usually quickly return to pre-pregnancy levels.
There are also no restrictions on the use of Actrapid ® NM during breastfeeding. Insulin therapy for nursing mothers does not pose a risk to the baby. However, the mother may need to adjust the dosage regimen of the drug Actrapid ® NM and/or diet
Directions for use and doses
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.
Typically, insulin requirements range from 0.3 to 1 IU/kg/day. The daily insulin requirement 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 into the anterior abdominal wall. If convenient, injections can also be given in the thigh area, in the gluteal area or in the deltoid muscle area 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 into a retracted skin fold, risk of accident intramuscular injection the drug is reduced to a minimum. The needle should remain under the skin for at least 6 seconds to ensure complete delivery of the dose. It is necessary to constantly change injection sites within the anatomical region to reduce the risk of developing lipodystrophies.
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 a cartridge is permitted only as an exception in the absence of bottles. In this case, you should take the drug into insulin syringe without air intake or 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 NovoTwist ® needles. Detailed recommendations for use and administration of the drug should be followed (see. "Instructions for use of Actrapid ® NM Penfill ®, which must be given to the patient").
Dose adjustment
Concomitant diseases, especially infectious ones and those accompanied by fever, usually increase the body's need for insulin. Dose adjustment may also be necessary if the patient has concomitant diseases kidneys, liver, dysfunction of the adrenal glands, pituitary gland or thyroid gland.
The need for dose adjustment may also arise if there is 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.
Side effect"type="checkbox">
Side effect
The most common adverse event with insulin use is hypoglycemia. During clinical studies, as well as during 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 the level of glycemic control (see. "Description individual adverse reactions").
On initial stage Insulin therapy may cause refractive errors, swelling and reactions at the injection site (including pain, redness, hives, inflammation, bruising, swelling and itching at the injection site). These symptoms are usually temporary. Rapid improvement in glycemic control can lead to a condition of "acute painful neuropathy", which is usually reversible. Intensification of insulin therapy with dramatic improvement in control carbohydrate metabolism may lead to a temporary worsening of diabetic retinopathy, while long-term improvement in glycemic control reduces the risk of progression of diabetic retinopathy.
Scroll side effects presented in the table.
All side effects presented below, based on data obtained during clinical trials, are divided into groups according to the frequency of occurrence 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); нечасто (≥1/1000 до <1/100); редко (≥1/10000 до <1/1000), очень редко (<1/10000) и неизвестно (невозможно оценить на основании имеющихся данных).
|
Immune system disorders |
Uncommon: urticaria, skin rash |
|
Very rare - anaphylactic reactions* |
|
|
Metabolic and nutritional disorders |
Very common – hypoglycemia* |
|
Nervous system disorders |
Uncommon: peripheral neuropathy (“acute painful neuropathy”) |
|
Visual disorders |
Uncommon - refractive errors |
|
Very rare - diabetic retinopathy |
|
|
Skin and subcutaneous tissue disorders |
Uncommon – lipodystrophy* |
|
General and administration site disorders |
Uncommon: injection site reactions |
|
Uncommon - edema |
*Cm. "Description of selected adverse reactions"
Description of individual adverse reactions:
Anaphylactic reactions
Very rare generalized hypersensitivity reactions have been reported (including generalized skin rash, itching, sweating, gastrointestinal distress, angioedema, difficulty breathing, rapid heartbeat, decreased blood pressure, and fainting/loss of consciousness, 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 insulin requirement. Severe hypoglycemia can lead to loss of consciousness and/or seizures, temporary or permanent damage to brain function, or even death. Symptoms of hypoglycemia usually develop suddenly. These may include cold sweats, pale skin, fatigue, nervousness or tremors, anxiety, unusual tiredness or weakness, disorientation, decreased concentration, drowsiness, increased hunger, blurred vision, headache, nausea, and rapid heartbeat. .
Lipodystrophy
Rare cases of lipodystrophy have been reported. Lipodystrophy may develop at the injection site.
Overdose
There is no specific dose required for insulin overdose, but hypoglycemia can develop gradually if doses of insulin are administered that are too high in relation to the patient's needs.
The patient can eliminate mild hypoglycemia himself by ingesting glucose or sugar-containing foods. Therefore, patients with diabetes are advised to carry sugar-containing products with them at all times.
In 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 a glucose solution should be administered intravenously (can only be administered by a medical professional). It is also necessary to administer intravenous glucose if the patient does not regain consciousness 10-15 minutes after the administration of glucagon. After regaining consciousness, the patient is advised to take a carbohydrate-rich meal to prevent relapse of hypoglycemia.
Interaction with other drugs
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, luramine, 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 may mask the symptoms of hypoglycemia and impair recovery from hypoglycemia.
Octreotide/lanreotide can either increase or decrease the body's need for insulin.
Alcohol can increase or decrease the hypoglycemic effect of insulin.
Incompatibility
Actrapid ® NM can only be added to those compounds with which it is known to be compatible. Some drugs (for example, drugs containing thiols or sulfites) when added to an insulin solution can cause its degradation.
Features of application
Insufficient dosage of the drug or cessation of treatment, especially in type 1 diabetes mellitus, can lead to the development hyperglycemia.
Typically, the first symptoms of hyperglycemia appear gradually, over several hours or days. Symptoms of hyperglycemia are a feeling of thirst, increased 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 condition that is potentially fatal.
Hypoglycemia
Hypoglycemia can develop if a dose of insulin is administered that is too high in relation to the patient's needs.
Skipping meals or unplanned intense exercise can lead to hypoglycemia.
After compensation of carbohydrate metabolism, for example, with intensified insulin therapy, patients may experience changes in their typical symptoms that are precursors of hypoglycemia, of which patients should be informed. The usual warning symptoms may disappear with prolonged diabetes mellitus.
Transferring patients to another type of insulin or to insulin from another manufacturer should only be done under medical supervision. If the concentration, manufacturer, type, type (human insulin, human insulin analogue) and/or manufacturing method changes, the insulin dose may need to be changed. Patients switching to treatment with Actrapid ® NM may require a dose change or an increase in the frequency of injections compared to previously used insulin preparations. If a dose adjustment is necessary when transferring patients to treatment with Actrapid ® NM, this can be done already with the first dose or in the first weeks or months of therapy.
As with other insulin medications, injection site reactions may occur, including pain, redness, hives, inflammation, bruising, swelling and itching. Regularly changing the injection site in the same anatomical area will help reduce symptoms or prevent these reactions from developing. The reactions usually disappear within a few days to a few weeks. In rare cases, it may be necessary to discontinue Actrapid ® NM due to reactions at the injection sites.
Before traveling due to jet lag, the patient should consult with his/her physician, as jet lag means that the patient must eat and take insulin at different times.
When adding Actrapid ® NM to solutions for infusion, the amount of insulin absorbed by the infusion system is unpredictable, therefore the use of Actrapid ® NM in CSII is not permitted.
Simultaneous use of drugs of the thiazolidinedione group and insulin drugs
Cases of congestive heart failure have been reported when patients were treated with thiazolidinediones in combination with insulin drugs, especially if such patients have risk factors for congestive heart failure. This fact should be taken into account when prescribing combination therapy with thiazolidinediones and insulin drugs to patients. When prescribing such combination therapy, it is necessary to conduct medical examinations of patients to identify signs and symptoms of congestive heart failure, weight gain and the presence of edema. If patients' symptoms of heart failure worsen, treatment with thiazolidinediones should be discontinued.
Impact on the ability to drive a car and operate machinery
Patients' ability to concentrate and react quickly may be impaired during hypoglycemia, which can be dangerous in situations where these abilities are especially needed (for example, when driving a car or working with machinery). Patients should be advised to take measures to prevent the development of hypoglycemia when driving. This is especially important for patients with the absence or decrease in severity of symptoms that are warning signs of developing hypoglycemia or who suffer from frequent episodes of hypoglycemia. In these cases, the advisability of driving and performing similar work should be considered.
Precautions
For intravenous administration, infusion systems containing the drug Actrapid ® NM 100 IU/ml are used, in concentrations from 0.05 IU/ml to 1 IU/ml 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 intravenous system uses infusion bags made of polypropylene; these solutions are stable for 24 hours at room temperature.
Although these solutions remain stable for a certain period of time, some insulin is initially absorbed by the material from which the infusion bag is made. During the infusion, it is necessary to monitor blood glucose levels.
Cartridges should only be used in combination with compatible products to ensure their safety and effectiveness.
The drug Actrapid ® NM Penfill ® and needles are intended for individual use only. The cartridge must not be refilled.
Insulin preparations should not be used if they have been frozen.
Insulin should not be used if it is no longer transparent and colorless.
Actrapid ® NM cannot be used in insulin pumps for long-term subcutaneous infusion of insulin.
Inform the patient to discard the needle after each injection.
In emergency cases (hospitalization, malfunction of the insulin administration device), Actrapid ® NM for administration to the patient can be removed from the cartridge using a U100 insulin syringe.
Release form
Solution for injection 100 IU/ml.
3 ml of the drug in glass cartridges of hydrolytic class 1, sealed with rubber discs and pistons. 5 cartridges each along with instructions for use in a cardboard box.
