Instructions for use ACTRAPID® HM
If the dose is incorrectly selected or therapy is discontinued, hyperglycemia may develop, 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 are precursors of hypoglycemia may also change, about which patients should be warned.
With concomitant diseases, especially infections and febrile conditions, patients' need for insulin usually increases. If a patient is transferred from one type of insulin to another, the early warning symptoms of hypoglycemia may change or become less pronounced than those noted with the introduction of the previous insulin. Transferring patients to another type of insulin or to insulin from another manufacturer should only be done under medical supervision. If the biological activity changes, the manufacturer, type, species (animal, human, analogue of human insulin) and/or manufacturing method change, a change in dosage regimen may be required. 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.
Effects on the ability to drive and operate machines 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 operating machines). ). 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 no or decreased 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 remain 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
Actrapid NM (insulin) bottle 100IU/ml 10ml
A country
Denmark
The country of production may vary depending on the batch of goods. Please check with the operator for detailed information when confirming your order.
Active substance
Soluble insulin (human genetically engineered)
Compound
Soluble insulin (human genetically engineered).
pharmachologic effect
Short-acting insulin preparation. The decrease in the concentration of glucose in the blood is due to an increase in its intracellular transport, increased absorption and assimilation by tissues, stimulation of lipogenesis, glycogenogenesis, protein synthesis, a decrease in the rate of glucose production by the liver (decreased glycogen breakdown), etc. After subcutaneous injection, the effect occurs within 20-30 minutes, reaches a maximum after 1-3 hours and continues, depending on the dose, for 5-8 hours. The duration of action of the drug depends on the dose, method, site of administration and has significant individual characteristics. The completeness of absorption depends on the method of administration (s.c., i.v. m), injection site (abdomen, thigh, buttocks), dose, concentration of insulin in the drug, etc. Distributed unevenly in tissues. Does not penetrate the placental barrier and into breast milk. Excreted by the kidneys.
Indications for use
Diabetes mellitus type 1, diabetes mellitus type 2: stage of resistance to oral hypoglycemic drugs, partial resistance to oral hypoglycemic drugs (combination therapy); diabetic ketoacidosis, ketoacidotic and hyperosmolar coma; diabetes mellitus that occurs during pregnancy (if diet therapy is ineffective); for intermittent use in patients with diabetes mellitus against the background of infections accompanied by high fever; for upcoming surgeries, injuries, childbirth, metabolic disorders, before switching to treatment with long-acting insulin preparations.
Mode of application
The dose and route of administration of the drug is determined individually in each specific case based on the glucose level in the blood before meals and 1-2 hours after meals, as well as depending on the degree of glucosuria and the characteristics of the course of the disease. The drug is administered subcutaneously, intravenously, intramuscularly, 15-30 minutes before meals. The most common route of administration is subcutaneous. For diabetic ketoacidosis, diabetic coma, during surgery - intravenously or intramuscularly. With monotherapy, the frequency of administration is usually 3 times a day (if necessary, up to 5-6 times a day), the injection site is changed each time to avoid the development of lipodystrophy (atrophy or hypertrophy of subcutaneous fat tissue). The average daily dose is 30-40 IU, in children - 8 IU, then in the average daily dose - 0.5-1 IU/kg or 30-40 IU 1-3 times a day, if necessary - 5-6 times a day. At a daily dose exceeding 0.6 U/kg, insulin must be administered in the form of 2 or more injections into different areas of the body. Can be combined with long-acting insulins. The insulin solution is drawn from the vial by piercing the rubber stopper with a sterile syringe needle, wiped with ethanol after removing the aluminum cap.
Interaction
Pharmaceutically incompatible with solutions of other drugs. The hypoglycemic effect is enhanced by sulfonamides (including oral hypoglycemic drugs, sulfonamides), MAO inhibitors (including furazolidone, procarbazine, selegiline), carbonic anhydrase inhibitors, ACE inhibitors, non-steroidal anti-inflammatory drugs (including salicylates), anabolic steroids (including stanozolol, oxandrolone, methandrostenolone), androgens, bromocriptine, tetracyclines, clofibrate, ketoconazole, mebendazole, theophylline, cyclophosphamide, fenfluramine, Li+ preparations, pyridoxine, quinidine, quinine, chloroquinine, ethanol. The hypoglycemic effect is weakened by glucagon, somatropin, glucocorticosteroids, oral contraceptives, estrogens, thiazide and loop diuretics, slow calcium channel blockers, thyroid hormones, heparin, sulfinpyrazone, sympathomimetics, danazol, tricyclic antidepressants, clonidine, calcium antagonists, diazoxide, morphine, mar. ihuana, nicotine , phenytoin, epinephrine, H1-histamine receptor blockers. Beta-blockers, reserpine, octreotide, pentamidine can both enhance and weaken the hypoglycemic effect of insulin.
Side effect
Allergic reactions (urticaria, angioedema - fever, shortness of breath, decreased blood pressure); hypoglycemia, hypoglycemic coma; hyperglycemia and diabetic acidosis (at low doses, skipping an injection, non-compliance with the diet, against the background of fever and infections); impaired consciousness (up to the development of a precomatous and comatose state); transient visual disturbances (usually at the beginning of therapy); immunological cross-reactions with human insulin; an increase in the titer of anti-insulin antibodies with a subsequent increase in glycemia; hyperemia, itching and lipodystrophy at the injection site. At the beginning of treatment, swelling and refractive error occur (they are temporary and disappear with continued treatment).
Contraindications
Hypersensitivity, hypoglycemia.
Overdose
Symptoms: hypoglycemia (weakness, “cold” sweat, pallor of the skin, palpitations, trembling, nervousness, hunger, paresthesia in the hands, legs, lips, tongue, headache), hypoglycemic coma, convulsions. Treatment: the patient can experience mild hypoglycemia eliminate it yourself by ingesting sugar or foods rich in easily digestible carbohydrates. Glucagon or a hypertonic dextrose solution is administered subcutaneously, intramuscularly or intravenously. When a hypoglycemic coma develops, 20-40 ml (up to 100 ml) of a 40% dextrose solution is injected intravenously until the patient emerges from the comatose state.
special instructions
If foreign bodies appear, cloudiness or precipitation of the substance appears on the glass of the bottle, the drug cannot be used. The temperature of the administered insulin should be at room temperature. The dose of insulin must be adjusted in cases of infectious diseases, thyroid dysfunction, Addison's disease, hypopituitarism, chronic renal failure and diabetes mellitus in people over 65 years of age. The causes of hypoglycemia can be: insulin overdose, drug replacement, skipping meals, vomiting, diarrhea, physical stress; diseases that reduce the need for insulin (advanced kidney and liver diseases, as well as hypofunction of the adrenal cortex, pituitary gland or thyroid gland), change of injection site (for example, skin on the abdomen, shoulder, thigh), as well as interaction with other drugs. It is possible to reduce the concentration of glucose in the blood when transferring a patient from animal insulin to human insulin. Transferring a patient to human insulin should always be medically justified and carried out only under the supervision of a physician. The tendency to develop hypoglycemia can impair the ability of patients to actively participate in road traffic, as well as to maintain machines and mechanisms. Patients with diabetes can relieve self-perceived mild hypoglycemia by eating sugar or eating foods high in carbohydrates (it is recommended to always have at least 20 g of sugar with you). It is necessary to inform the attending physician about hypoglycemia in order to decide whether treatment adjustments are necessary. When treated with short-acting insulin, in isolated cases there may be a decrease or increase in the volume of adipose tissue (lipodystrophy) in the injection area. These phenomena can be largely avoided by constantly changing the injection site. During pregnancy, it is necessary to take into account a decrease (I trimester) or increase (II-III trimesters) in the need for insulin. During and immediately after childbirth, the need for insulin may decrease dramatically. During lactation, daily monitoring is necessary for several months (until insulin needs stabilize). Patients receiving more than 100 units of insulin per day require hospitalization when changing the drug.
Dispensing conditions in pharmacies
On prescription
Actrapid® HM (Actrapid® NM)
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. The drug Actrapid® NM is a short-acting insulin and can be used in combination with long-acting insulins.
The drug Actrapid® NM is usually administered subcutaneously into the area of 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, the risk of accidental intramuscular injection of the drug is minimized. 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.
Intramuscular injections are also possible, but only as prescribed by a doctor.
The drug Actrapid® NM can also be administered intravenously and such procedures can only be performed by a medical professional.
The drug Actrapid® NM in vials can only be used together with insulin syringes, which have a scale that allows you to measure the dose of insulin in action units.
Intravenous administration of the drug Actrapid® NM from a cartridge or syringe pen is permitted only as an exception in the absence of vials. In this case, you should draw the drug Actrapid® NM into an insulin syringe without taking in air or carry out an infusion using an infusion system. This procedure should only be performed by a medical professional.
The FlexPen® is a pre-filled pen designed for use with NovoFine® or NovoTwist® disposable needles up to 8 mm in length. The FlexPen® syringe pen allows you to administer a dose from 1 to 60 ME in 1 ME increments.
Detailed recommendations for the use and administration of the drug should be followed (see “Actrapid® NM solution for injection in vials. Instructions for use for patients” or “Actrapid® NM solution for injection in FlexPen® syringe pens. Instructions for use for patients”) .
Dose adjustment
Concomitant diseases, especially infectious ones and those 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 when the patient's physical activity or usual diet changes. Dose adjustment may be required when transferring a patient from one type of insulin to another.
Actrapid® NM injection solution in FlexPen® syringe pens.
Instructions for use for patients
Read these instructions carefully before using Actrapid® NM FlexPen®.
If you do not follow the directions, you may give too little or too much insulin, which could cause your blood glucose levels to be too high or too low.
FlexPen® is a pre-filled insulin pen with a pump. You can select doses from 1 to 60 units in 1 unit increments. The FlexPen® syringe pen is designed for use with NovoFine® or NovoTwist® disposable needles up to 8 mm in length. As a precaution, always carry a spare insulin delivery system with you in case your Actrapid® NM FlexPen® is lost or damaged.
Caring for the wide handle
The FlexPen® syringe pen requires careful handling.
In case of a fall or severe damage to the syringe pen and insulin. This may cause incorrect dosing, which may result in glucose concentrations that are too high or too low.
The surface of the FlexPen® syringe pen can be cleaned with a cotton swab soaked in alcohol. Do not immerse the syringe pen in liquid, do not wash or lubricate it, because this may damage the mechanism. FlexPen® syringe pens must not be refilled.
Preparation of Actrapid® NM FlexPen®
Check the name and color of the pen label to make sure it contains the correct type of insulin.
This is especially important if you use different types of insulin. If you give another type of insulin by mistake, your blood glucose concentration may be too high or too low.
A
Remove the cap from the pen (see Figure A).
IN
Remove the protective sticker from the new disposable needle.
Screw the needle tightly onto the FlexPen® syringe pen.
WITH
Remove the large outer cap from the needle, but do not throw it away.
D
Remove and discard the inner needle cap.
Never try to put the inner cap back on the needle. You may inject yourself.
Use a new needle for each injection. This reduces the risk of contamination, infection, leakage of insulin, clogged needles, and injecting the wrong dose of medication.
Be careful not to bend or damage the needle before use.
Checking insulin delivery
E
Even with proper use of the pen, a small amount of air may accumulate in the cartridge before each injection. To avoid air bubbles and ensure the correct dose is administered:
Dial 2 units of the drug by turning the dose selector.
F
Holding the FlexPen® pen with the needle facing up, lightly tap the cartridge several times with your fingertip to force air bubbles to the top of the cartridge.
G
While holding the syringe pen with the needle up, press the start button all the way. The dose selector will return to zero.
A drop of insulin should appear at the end of the needle. If this does not happen, replace the needle and repeat the procedure, but no more than 6 times.
If a drop of insulin does not appear at the end of the needle, this indicates that the syringe pen is faulty. Use a new syringe pen.
Before each injection, make sure that a drop of insulin appears at the end of the needle. This ensures the supply of insulin. If no insulin drop appears, no dose will be delivered even if the dose selector moves. This may indicate that the needle is blocked or damaged.
Before each injection, check your insulin supply. If you do not check your insulin supply, you may give insufficient or no insulin, which can cause your blood glucose levels to become too high.
Setting the dose
N
Make sure the dose selector is set to position "0".
Turn the dose selector to select the number of units you need for the injection.
The dose can be adjusted by rotating the dose selector in any direction until the correct dose is set against the dose indicator. When rotating the dose selector, be careful not to accidentally press the trigger button to avoid releasing the insulin dose.
It is not possible to set a dose greater than the number of units remaining in the cartridge.
Before injecting, always check how many units of insulin you have taken using the dose selector and dose indicator.
Don't count the clicks of the syringe pen. If you set and administer the wrong dose, your blood glucose concentration may become too high or too low. The insulin remaining scale shows the approximate amount of insulin remaining in the pen, so it cannot be used to measure insulin doses.
Insulin administration
I
Insert the needle under the skin using the injection technique recommended by your doctor or nurse.
To inject, press the trigger button all the way until a “0” appears next to the dose indicator. Be careful: when administering the drug, you should only press the start button.
When turning the dose selector, insulin will not be administered.
J
After injection, leave the needle under the skin for at least 6 seconds while keeping the trigger button pressed fully. This will ensure that the full dose of insulin is administered.
Remove the needle from under the skin and release the trigger button.
Make sure the dose selector returns to zero after injection. If the dose selector stops before indicating "O", the full dose of insulin has not been delivered, which may result in blood glucose concentrations that are too high.
TO
Guide the needle into the large outer needle cap without touching the cap. When the needle goes in, put the cap on completely and unscrew the needle.
Discard the needle, taking precautions, and put the cap on the syringe pen.
Remove the needle after each injection and store Actrapid® NM FlexPei® with the needle disconnected.
This reduces the risk of contamination, infection, leakage of insulin, clogged needles, and injecting the wrong dose of medication.
Important information
Caregivers should handle used needles with extreme care to reduce the risk of accidental sticks and cross-infection.
Throw away the used FlexPey® pen with the needle removed.
Never share your syringe pen and needles with others. This may lead to cross-infection.
Never give your pen to others. Your drug may harm their health.
Keep the pen and needles out of the reach of everyone, and especially children.
Buy Actrapid HM Penfill injection solution 100 IU/ml 3ml No. 5 in pharmacies
Dosage forms injection solution 100U/ml Manufacturers Novo Nordisk A/S (Denmark)
PharmGroup Short-acting insulins
International nonproprietary name Soluble insulin (human genetically engineered)
Dispensing order Dispensed by prescription
Synonyms Actrapid HM, Biosulin R, Gansulin R, Gensulin R, Insuman Rapid GT, Insuran R, Rinsulin R, Rosinsulin R, Humodar R 100 Rec, Humulin R, Humulin Regular, Humulin Regular
Composition: Soluble insulin (human genetically engineered).
Pharmacological action Short-acting insulin preparation. The decrease in the concentration of glucose in the blood is due to an increase in its intracellular transport, increased absorption and assimilation by tissues, stimulation of lipogenesis, glycogenogenesis, protein synthesis, a decrease in the rate of glucose production by the liver (decreased glycogen breakdown), etc. After subcutaneous injection, the effect occurs within 20-30 minutes, reaches a maximum after 1-3 hours and lasts, depending on the dose, 5-8 hours. The duration of action of the drug depends on the dose, method, place of administration and has significant individual characteristics. The completeness of absorption depends on the route of administration (s.c., i.m.), injection site (abdomen, thigh, buttocks), dose, concentration of insulin in the drug, etc. It is distributed unevenly in tissues. Does not penetrate the placental barrier and into breast milk. Excreted by the kidneys.
Indications for use Diabetes mellitus type 1, diabetes mellitus type 2: stage of resistance to oral hypoglycemic drugs, partial resistance to oral hypoglycemic drugs (combination therapy); diabetic ketoacidosis, ketoacidotic and hyperosmolar coma; diabetes mellitus that occurs during pregnancy (if diet therapy is ineffective); for intermittent use in patients with diabetes mellitus against the background of infections accompanied by high fever; for upcoming surgeries, injuries, childbirth, metabolic disorders, before switching to treatment with long-acting insulin preparations.
Contraindications Hypersensitivity, hypoglycemia.
Side effects Allergic reactions (urticaria, angioedema - fever, shortness of breath, decreased blood pressure); hypoglycemia, hypoglycemic coma; hyperglycemia and diabetic acidosis (at low doses, skipping an injection, non-compliance with the diet, against the background of fever and infections); impaired consciousness (up to the development of a precomatous and comatose state); transient visual disturbances (usually at the beginning of therapy); immunological cross-reactions with human insulin; an increase in the titer of anti-insulin antibodies with a subsequent increase in glycemia; hyperemia, itching and lipodystrophy at the injection site. At the beginning of treatment, swelling and refractive error occur (they are temporary and disappear with continued treatment).
Interaction Pharmaceutically incompatible with solutions of other drugs. The hypoglycemic effect is enhanced by sulfonamides (including oral hypoglycemic drugs, sulfonamides), MAO inhibitors (including furazolidone, procarbazine, selegiline), carbonic anhydrase inhibitors, ACE inhibitors, non-steroidal anti-inflammatory drugs (including salicylates), anabolic steroids (including stanozolol, oxandrolone, methandrostenolone), androgens, bromocriptine, tetracyclines, clofibrate, ketoconazole, mebendazole, theophylline, cyclophosphamide, fenfluramine, Li+ preparations, pyridoxine, quinidine, quinine, chloroquinine, ethanol. The hypoglycemic effect is weakened by glucagon, somatropin, glucocorticosteroids, oral contraceptives, estrogens, thiazide and loop diuretics, slow calcium channel blockers, thyroid hormones, heparin, sulfinpyrazone, sympathomimetics, danazol, tricyclic antidepressants, clonidine, calcium antagonists, diazoxide, morphine, mar. ihuana, nicotine , phenytoin, epinephrine, H1-histamine receptor blockers. Beta-blockers, reserpine, octreotide, pentamidine can both enhance and weaken the hypoglycemic effect of insulin.
Overdose Symptoms: hypoglycemia (weakness, “cold” sweat, pale skin, palpitations, trembling, nervousness, hunger, paresthesia in the hands, legs, lips, tongue, headache), hypoglycemic coma, convulsions. Treatment: the patient can eliminate mild hypoglycemia on his own by ingesting sugar or foods rich in easily digestible carbohydrates. Glucagon or a hypertonic dextrose solution is administered subcutaneously, intramuscularly or intravenously. When a hypoglycemic coma develops, 20-40 ml (up to 100 ml) of a 40% dextrose solution is injected intravenously until the patient emerges from the comatose state.
Method of administration and dosage The dose and route of administration of the drug is determined individually in each specific case based on the glucose level in the blood before meals and 1-2 hours after meals, as well as depending on the degree of glucosuria and the characteristics of the course of the disease. The drug is administered subcutaneously, intravenously, intramuscularly, 15-30 minutes before meals. The most common route of administration is subcutaneous. For diabetic ketoacidosis, diabetic coma, during surgery - intravenously or intramuscularly. With monotherapy, the frequency of administration is usually 3 times a day (if necessary, up to 5-6 times a day), the injection site is changed each time to avoid the development of lipodystrophy (atrophy or hypertrophy of subcutaneous fat tissue). The average daily dose is 30-40 IU, in children - 8 IU, then in the average daily dose - 0.5-1 IU/kg or 30-40 IU 1-3 times a day, if necessary - 5-6 times a day. At a daily dose exceeding 0.6 U/kg, insulin must be administered in the form of 2 or more injections into different areas of the body. Can be combined with long-acting insulins. The insulin solution is drawn from the vial by piercing the rubber stopper with a sterile syringe needle, wiped with ethanol after removing the aluminum cap.
Special instructions If foreign bodies appear, cloudiness or precipitation of the substance appears on the glass of the bottle, the drug cannot be used. The temperature of the administered insulin should be at room temperature. The dose of insulin must be adjusted in cases of infectious diseases, thyroid dysfunction, Addison's disease, hypopituitarism, chronic renal failure and diabetes mellitus in people over 65 years of age. The causes of hypoglycemia can be: insulin overdose, drug replacement, skipping meals, vomiting, diarrhea, physical stress; diseases that reduce the need for insulin (advanced kidney and liver diseases, as well as hypofunction of the adrenal cortex, pituitary gland or thyroid gland), change of injection site (for example, skin on the abdomen, shoulder, thigh), as well as interaction with other drugs. It is possible to reduce the concentration of glucose in the blood when transferring a patient from animal insulin to human insulin. Transferring a patient to human insulin should always be medically justified and carried out only under the supervision of a physician. The tendency to develop hypoglycemia can impair the ability of patients to actively participate in road traffic, as well as to maintain machines and mechanisms. Patients with diabetes can relieve self-perceived mild hypoglycemia by eating sugar or eating foods high in carbohydrates (it is recommended to always have at least 20 g of sugar with you). It is necessary to inform the attending physician about hypoglycemia in order to decide whether treatment adjustments are necessary. When treated with short-acting insulin, in isolated cases there may be a decrease or increase in the volume of adipose tissue (lipodystrophy) in the injection area. These phenomena can be largely avoided by constantly changing the injection site. During pregnancy, it is necessary to take into account a decrease (I trimester) or increase (II-III trimesters) in the need for insulin. During and immediately after childbirth, the need for insulin may decrease dramatically. During lactation, daily monitoring is necessary for several months (until insulin needs stabilize). Patients receiving more than 100 units of insulin per day require hospitalization when changing the drug.
Storage conditions List B. Store in a cool place at a temperature of 2-8 degrees. WITH.
