Actovegin 80 mg 2 ml. Actovegin - instructions for use, reviews, analogs and forms of release (tablets, injections in ampoules for injection, ointment, gel and cream) drugs for the treatment of metabolic disorders of the brain in adults, children (newborns) and with

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Varieties, names, composition and forms of release

• Gel for external use;
• Ointment for external use;
• Cream for external use;
• Solution for infusions ("droppers") on dextrose in 250 ml bottles;
• Solution for infusion in 0.9% sodium chloride (in saline) in 250 ml bottles;
• Solution for injection in ampoules of 2 ml, 5 ml and 10 ml;
• Tablets for oral administration.

All dosage forms of Actovegin as an active (active) component contain deproteinized hemoderivat derived from blood collected from healthy calves fed exclusively on milk. Deproteinized hemoderivat is a product obtained from the blood of calves by cleaning it from large protein molecules (deproteinization). As a result of deproteinization, a special set of biologically active blood molecules of calves, small in mass, is obtained, which are able to activate the metabolism in any organ and tissue. Moreover, such a combination of active substances does not contain large protein molecules that can cause allergic reactions.

Deproteinized hemoderivat from the blood of calves is standardized according to the content of certain classes of biologically active substances. This means that chemists ensure that each hemoderivate fraction contains the same amount of biologically active substances, despite the fact that they are obtained from the blood of different animals. Accordingly, all hemoderivate fractions contain the same amount of active ingredients and have the same intensity of therapeutic action.

The active component of Actovegin (deproteinized derivative) is often called in official instructions "Actovegin concentrate".

Various dosage forms of Actovegin contain different amounts of the active ingredient (deproteinized hemoderivat):

• Gel Actovegin - contains 20 ml of gemoderivate (0.8 g in dried form) in 100 ml of gel, which corresponds to 20% concentration of the active ingredient.
• Ointment and cream Actovegin - contain 5 ml of gemoderivate (0.2 g in dried form) in 100 ml of ointment or cream, which corresponds to 5% concentration of the active ingredient.
• Solution for infusion in dextrose - contains 25 ml of hemoderivat (1 g in dried form) per 250 ml of a ready-to-use solution, which corresponds to an active ingredient concentration of 4 mg / ml or 10%.
• Solution for infusion in 0.9% sodium chloride - contains 25 ml (1 g dried) or 50 ml (2 g dried) hemoderivat per 250 ml ready-to-use solution, which corresponds to an active ingredient concentration of 4 mg / ml ( 10%) or 8 mg/ml (20%).
• Solution for injection - contains 40 mg of dry hemoderivat per 1 ml (40 mg / ml). The solution is available in ampoules of 2 ml, 5 ml and 10 ml. Accordingly, ampoules with 2 ml of solution contain 80 mg of the active ingredient, with 5 ml of solution - 200 mg and with 10 ml of solution - 400 mg.
• Tablets for oral administration - contain 200 mg of dry hemoderivate.

Hemoderivative, which is part of all dosage forms of Actovegin, contains sodium chloride in the form of sodium and chlorine ions, which appeared in it, since the blood of calves contains this salt, and it is not removed during deproteinization. That is, sodium chloride is not added specifically to hemoderivative obtained from the blood of calves. Manufacturers indicate that the solution for injection contains approximately 26.8 mg of sodium chloride per 1 ml. The content of sodium chloride in other dosage forms of Actovegin is not indicated, since it is not calculated.

Solution for injection in ampoules as an auxiliary component contains only sterile distilled water. Solution for infusion on dextrose as auxiliary components contains distilled water, dextrose and sodium chloride. Solution for infusion on 0.9% sodium chloride contains only sodium chloride and water as auxiliary components.

Actovegin tablets as auxiliary components contain the following substances:

• Mountain wax glycolate;
• Titanium dioxide;
• Diethyl phthalate;
• Dried gum arabic;
• Microcrystalline cellulose;
• Povidone K90 and K30;
• Sucrose;
• magnesium stearate;
• Talc;
• Dye quinoline yellow varnish aluminum (E104);
• Hypromellose phthalate.

Solutions for infusion Actovegin based on dextrose or 0.9% sodium chloride are clear, colorless or slightly yellow liquids that do not contain impurities. The solutions are produced in 250 ml transparent glass bottles, which are closed with a cork and an aluminum cap with control of the first opening.

Actovegin injection solutions are available in 2 ml, 5 ml or 10 ml ampoules. Sealed ampoules are placed in a carton box of 5, 10, 15 or 25 pieces. The solutions themselves in ampoules are a transparent liquid of slightly yellow or colorless color with a small amount of floating particles.

Actovegin tablets are colored greenish-yellow, shiny, round biconvex. Tablets are packed in dark glass bottles of 50 pieces.

The volume of Actovegin ampoules in ml

Currently, the solution is available in ampoules of 2 ml, 5 ml and 10 ml. Moreover, ampoules of different volumes contain a solution with the same concentration of the active substance - 40 mg / ml, but the total content of the active ingredient in ampoules of different volumes is different. Thus, 2 ml ampoules contain 80 mg of the active substance, 5 ml ampoules contain 200 mg, and 10 ml ampoules contain 400 mg, respectively.

Therapeutic action

The general effect of Actovegin, which consists in improving energy metabolism and increasing resistance to hypoxia, at the level of various organs and tissues is manifested by the following therapeutic effects:

• Accelerates the healing of any tissue damage(wounds, incisions, cuts, abrasions, burns, ulcers, etc.) and the restoration of their normal structure. That is, under the action of Actovegin, any wounds heal easier and faster, and the scar is formed small and inconspicuous.
• The process of tissue respiration is activated, which leads to a more complete and rational use of oxygen delivered with blood to the cells of all organs and tissues. Due to a more complete use of oxygen, the negative consequences of insufficient blood supply to tissues are reduced.
• Stimulates the use of glucose by cells in a state of oxygen starvation or metabolic depletion. And this means that on the one hand, the concentration of glucose in the blood decreases, and on the other hand, tissue hypoxia decreases due to the active use of glucose for tissue respiration.
• Improves the synthesis of collagen fibers.
• Stimulates the process of cell division with their subsequent migration to areas where it is necessary to restore the integrity of the tissue.
• Stimulates the growth of blood vessels, which leads to improved blood supply to tissues.

In addition, improving energy metabolism and increased glucose utilization leads to a decrease in the severity of symptoms of circulatory disorders in any other tissues and organs.

Indications for use (Why is Actovegin prescribed?)

Ointment, cream and gel Actovegin - indications for use. All three dosage forms of Actovegin intended for external use (cream, gel and ointment) are indicated for use in the same following conditions:

• Acceleration of wound healing and inflammatory processes on the skin and mucous membranes (abrasions, cuts, scratches, burns, cracks);
• Improving tissue repair after burns of any origin (hot water, steam, solar, etc.);
• Treatment of weeping skin ulcers of any origin (including varicose ulcers);
• Prevention and treatment of reactions to the effects of radiation exposure (including radiation therapy of tumors) from the skin and mucous membranes;
• Prevention and treatment of bedsores (only for Actovegin ointment and cream);
• For pre-treatment of wound surfaces before skin grafting in the treatment of extensive and severe burns (only for Actovegin gel).

• Treatment of metabolic and vascular disorders of the brain (for example, ischemic stroke, the consequences of a traumatic brain injury, impaired blood flow in brain structures, as well as dementia and impaired memory, attention, ability to analyze due to vascular diseases of the central nervous system, etc.);
• Treatment of peripheral vascular disorders, as well as their consequences and complications (for example, trophic ulcers, angiopathy, endarteritis, etc.);
• Treatment of diabetic polyneuropathy;
• Healing of wounds of the skin and mucous membranes of any nature and origin (for example, abrasions, cuts, incisions, burns, bedsores, ulcers, etc.);
• Prevention and treatment of lesions of the skin and mucous membranes when exposed to radiation, including radiation therapy of malignant tumors;
• Treatment of thermal and chemical burns (only for injection solutions);

• As part of the complex therapy of metabolic and vascular diseases of the brain (for example, cerebrovascular insufficiency, traumatic brain injury, as well as dementia due to vascular and metabolic disorders);
• Treatment of peripheral vascular disorders and their complications (trophic ulcers, angiopathy);
• Diabetic polyneuropathy;
• Hypoxia of organs and tissues of any origin (this indication is approved only in the Republic of Kazakhstan).

Instructions for use

Ointment, cream and gel Actovegin - instructions for use

The choice of gel, cream or ointment Actovegin and the features of their use for various types of wounds

Actovegin gel does not contain fat, as a result of which it is easily washed off and promotes the formation of granulations (the initial stage of healing) with simultaneous drying of the wet discharge (exudate) from the wound surface. Therefore, it is advisable to use the gel for the treatment of weeping wounds with profuse discharge or at the first stage of therapy for any wet wound surfaces until they are covered with granulations and become dry.

Actovegin cream contains macrogols, which form a light film on the surface of the wound that binds the discharge from the wound. This dosage form is optimally used for the treatment of wet wounds with moderate discharge or for the treatment of dry wound surfaces with thin growing skin.

Ointment Actovegin contains paraffin in its composition, due to which the agent forms a protective film on the surface of the wound. Therefore, the ointment is best used for long-term treatment of dry wounds without detachable or already dried wound surfaces.

In general, Actovegin gel, cream and ointment are recommended to be used in combination as part of a three-stage therapy. At the first stage, when the surface of the wound is weeping and there is a copious discharge, the gel should be used. Then, when the wound dries up and the first granulations (crusts) form on it, you should switch to Actovegin cream and use it until the wound surface is covered with thin skin. Further, until the complete restoration of the integrity of the skin, Actovegin ointment should be used. In principle, after the wound stops getting wet and becomes dry, you can use either Actovegin cream or ointment until complete healing, without changing them sequentially.

• If the wound is weeping with copious discharge, then the gel should be used until the wound surface dries. When the wound dries up, it is necessary to switch to the use of a cream or ointment.
• If the wound is moderately wet, the discharge is poor or moderate, then a cream should be used, and after the wound surface has completely dried, switch to the use of an ointment.
• If the wound is dry, without discharge, then an ointment should be applied.

There are differences in the use of gel, cream and ointment for the treatment of various wounds and ulcers on the skin. Therefore, in the text below, under the term "wound" we will mean any damage to the skin, with the exception of ulcers. And, accordingly, we will separately describe the use of the gel, cream and ointment for the treatment of wounds and ulcers.

The gel is used to treat weeping wounds with profuse discharge. Actovegin gel is applied exclusively to a previously cleaned wound (except for the treatment of ulcers), from which all dead tissues, pus, exudate, etc. have been removed. It is necessary to clean the wound before applying the Actovegin gel because the drug does not contain antimicrobial components and is not able to suppress the onset of the infectious process. Therefore, in order to avoid infection of the wound, it should be washed with an antiseptic solution (for example, hydrogen peroxide, chlorhexidine, etc.) before treatment with Actovegin healing gel.

On wounds with liquid discharge (except for ulcers), the gel is applied in a thin layer 2-3 times a day. In this case, the wound may not be covered with a bandage if there is no risk of infection and additional injury during the day. If the wound can be contaminated, then it is better to cover it with a regular gauze bandage after applying Actovegin gel, and change it 2-3 times a day. The gel is applied until the wound becomes dry and granulations appear on its surface (an uneven surface at the bottom of the wound, indicating the beginning of the healing process). Moreover, if part of the wound is covered with granulations, then they begin to treat it with Actovegin cream, and the weeping areas continue to be lubricated with gel. Since granulations are most often formed from the edges of the wound, after their formation, the perimeter of the wound surface is smeared with cream, and the center with gel. Accordingly, as the granulation area increases, the area treated with the cream increases, and the area treated with the gel decreases. When the whole wound becomes dry, it is lubricated only with cream. Thus, both the gel and the cream can be applied to the surface of the same wound, but to different areas.

However, if ulcers are being treated, then their surface can not be washed with an antiseptic solution, but immediately apply Actovegin gel in a thick layer, and cover it with a gauze bandage soaked in Actovegin ointment. Such a bandage is changed once a day, but if the ulcer is too wet and the discharge is plentiful, then the treatment is carried out more often: 2-4 times a day. In the case of strongly weeping ulcers, the bandage is changed as the bandage gets wet. In this case, each time a thick layer of Actovegin gel is applied to the ulcer, and the defect is closed with a gauze bandage soaked in Actovegin cream. When the surface of the ulcer stops getting wet, they begin to treat it with Actovegin ointment 1 to 2 times a day, until the defect is completely healed.

Actovegin cream is used to treat wounds with a small amount of discharge or dry wound surfaces. The cream is applied in a thin layer on the surface of the wounds 2-3 times a day. A bandage is applied to the wound if there is a risk of lubricating Actovegin cream. The cream is usually used until the wound is covered with a layer of thick granulation (thin skin), after which they switch to the use of Actovegin ointment, which is used to treat the defect until it is completely healed. The cream should be applied at least twice a day.

Actovegin ointment is applied only to dry wounds or to wounds covered with thick granulation (thin skin), a thin layer 2-3 times a day. Before using the ointment, the wound must be washed with water and treated with an antiseptic solution, such as hydrogen peroxide or chlorhexidine. A regular gauze bandage can be applied over the ointment if there is a risk of lubricating the preparation from the skin. Actovegin ointment is used until the wound is completely healed or until a strong scar is formed. The product should be used at least twice a day.

In general, it is obvious that Actovegin gel, cream and ointment are used in stages to treat wounds at various stages of healing. At the first stage, when the wound is wet, with discharge, a gel is applied. Then, at the second stage, when the first granulations appear, a cream is used. And then, at the third stage, after the formation of a thin skin, the wound is lubricated with ointment until the integrity of the skin is completely restored. However, if for some reason it is not possible to treat wounds sequentially with gel, cream and ointment, then only one Actovegin remedy can be used, starting to use it at the appropriate stage from which it is recommended. For example, Actovegin gel can be used at any stage of wound healing. Actovegin cream begins to be applied from the moment the wound dries up, it can be used until the defect is completely healed. Actovegin ointment is used from the moment the wound is completely dry and until the skin is restored.

To prevent bedsores and skin damage from radiation, you can use either a cream or ointment Actovegin. In this case, the choice between cream and ointment is made solely on the basis of individual preferences or considerations of the convenience of using any one form.

To prevent bedsores, a cream or ointment is applied to areas of the skin in the area of ​​\u200b\u200bwhich there is a high risk of forming the latter.

To prevent damage to the skin by radiation, Actovegin cream or ointment is applied to the entire surface of the skin after radiotherapy, and once a day, once a day, in the intervals between regular sessions of radiation therapy.

If it is necessary to carry out therapy for severe trophic ulcers on the skin and soft tissues, then Actovegin gel, cream and ointment are recommended to be combined with an injection of the solution.

If, when applying Actovegin gel, cream or ointment, pain and discharge appear in the area of ​​​​a wound defect or ulcer, the skin turns red next to it, body temperature rises, then this is a sign of infection of the wound. In such a situation, you should immediately stop using Actovegin and consult a doctor.

If, against the background of the use of Actovegin, a wound or ulcer does not heal within 2 to 3 weeks, then you should also consult a doctor.

Gel, cream or ointment Actovegin for the full healing of defects should be used for at least 12 days in a row.

Actovegin tablets - instructions for use (adults, children)

However, tablets can be taken without prior parenteral administration of Actovegin, if for some reason it is impossible to give injections or the condition is not severe, for the normalization of which the effect of the tablet form of the drug is quite enough.

Tablets should be taken 15 to 30 minutes before meals, swallowing them whole, not biting, chewing, breaking or crushing in other ways, but drinking a small amount of non-carbonated pure water (half a glass is enough). As an exception, when using Actovegin tablets for children, it is allowed to divide them into halves and quarters, which are then dissolved in a small amount of water and given to babies in a diluted form.

For various conditions and diseases, adults are recommended to take tablets 1-2 pieces 3 times a day for 4-6 weeks. Actovegin tablets are given to children 1/4 - 1/2 2 - 3 times a day for 4 - 6 weeks. The indicated adult and children's dosages are average, indicative, and the specific dose and frequency of taking the tablets in each case should be determined by the doctor individually, based on the severity of the symptoms and the severity of the pathology. The minimum course of therapy should be at least 4 weeks, since the necessary therapeutic effect is not achieved with shorter periods of use.

In diabetic polyneuropathy, Actovegin is always first administered intravenously at 2000 mg per day daily for three weeks. And only after that they switch to taking the drug in tablets of 2-3 pieces 3 times a day, for 4-5 months. In this case, taking Actovegin tablets is a maintenance phase of therapy, which allows you to consolidate the positive therapeutic effect achieved by intravenous injections.

If, while taking Actovegin tablets, a person develops allergic reactions, then the drug is urgently canceled, and treatment is carried out with antihistamines or glucocorticoids.

The tablets contain dye quinoline yellow aluminum lacquer (E104), which is considered potentially harmful, and therefore Actovegin tablets are prohibited for use in children under 18 years of age in the territory of the Republic of Kazakhstan. Such a norm, which prohibits taking Actovegin tablets by children under 18 years old, is currently only available in Kazakhstan among the countries of the former USSR. In Russia, Ukraine and Belarus, the drug is approved for use in children.

Actovegin injections - instructions for use

Actovegin in ampoules of 2 ml, 5 ml and 10 ml is intended for parenteral administration - that is, for intravenous, intra-arterial or intramuscular injections. In addition, the solution from the ampoules can be added to ready-made infusion formulations ("droppers"). Solutions in ampoules are ready for use. This means that they do not need to be pre-diluted, added or otherwise prepared for use. To use the solutions, you just need to open the ampoule and draw its contents into the syringe of the required volume, and then inject.

The concentration of the active ingredient in 2 ml, 5 ml and 10 ml ampoules is the same (40 mg/ml), and the difference between them is only in the total amount of the active ingredient. It is obvious that the total dose of the active ingredient is minimal in 2 ml ampoules (80 mg), the average is in 5 ml ampoules (200 mg) and the maximum is in 10 ml ampoules (400 mg). This is done for the convenience of using the drug, when for the production of an injection you just need to choose an ampoule with such a volume of solution that contains the required dosage (amount of active substance) prescribed by the doctor. In addition to the total content of the active substance, there is no difference between the ampoules with a solution of 2 ml, 5 ml and 10 ml.

Ampoules with a solution should be stored in a dark, dark place at an air temperature of 18 - 25 o C. This means that the ampoules should be stored in the cardboard box in which they were sold, or in any other available. After opening the ampoule, the solution should be used immediately, its storage is not allowed. Do not use a solution that has been stored in an opened ampoule for some time, as microbes from the environment can get into it, which will violate the sterility of the drug and can cause negative consequences after injection.

The solution in ampoules has a yellowish tint, the intensity of which may be different in different batches of the drug, since it depends on the characteristics of the feedstock. However, the difference in the color intensity of the solution does not affect the effectiveness of the drug.

Do not use a solution containing particles or cloudy. This solution should be discarded.

Since Actovegin can cause allergic reactions, it is recommended to make a test injection before starting therapy by injecting 2 ml of the solution intramuscularly. Further, if a person does not show signs of an allergic reaction for several hours, therapy can be safely carried out. The solution is administered in the required dosage intramuscularly, intraarterially or intravenously.

Ampoules with solutions are equipped with a break point for easy opening. The breaking point is bright red applied to the tip of the ampoule. Ampoules should be opened as follows:

• Take the ampoule in your hands so that the breaking point is directed upwards (as shown in Figure 1);
• Tap the glass with your finger and gently shake the ampoule so that the solution drains from the tip to the bottom;
• With the fingers of the second hand, break off the tip of the ampoule in the area of ​​the point by moving away from you (as shown in Figure 2).

Figure 2- Correct breaking off of the tip of the ampoule for its opening.

Dosages and method of administration of Actovegin solutions are determined by the doctor. However, you need to know that in order to achieve the fastest possible effect, it is optimal to administer Actovegin solutions intravenously or intraarterially. A somewhat slower therapeutic effect is achieved with intramuscular injection. With intramuscular injections, more than 5 ml of Actovegin solution cannot be administered at a time, and with intravenous or intra-arterial injections, the drug can be administered in a much larger amount. This should be taken into account when choosing the route of administration of the drug.

Depending on the severity of the course of the disease and the severity of clinical symptoms, 10-20 ml of the solution is usually prescribed on the first day intravenously or intra-arterially. Further, from the second day until the end of therapy, 5-10 ml of the solution is administered intravenously or 5 ml intramuscularly.

If it is decided to administer Actovegin by infusion (in the form of a "dropper"), then 10 - 20 ml of the solution from the ampoules (for example, 1 - 2 ampoules of 10 ml each) is poured into 200 - 300 ml of the infusion solution (physiological saline or glucose solution 5%) . The resulting solution is then injected at a rate of 2 ml/min.

Depending on the type of disease in which Actovegin is used, the following dosages are currently recommended for injection of the solution:

• Metabolic and vascular disorders of the brain (traumatic brain injury, cerebrovascular insufficiency) - 5-25 ml of solution is administered daily for two weeks. After completing the course of injections of Actovegin, they switch to taking the drug in tablets in order to maintain and consolidate the achieved therapeutic effect. In addition, instead of switching to a maintenance pill, you can continue injecting Actovegin by injecting 5-10 ml of the solution intravenously 3-4 times a week for two weeks.
• Ischemic stroke - Actovegin is administered by infusion ("dropper"), adding 20 - 50 ml of solution from ampoules to 200 - 300 ml of saline or 5% dextrose solution. In this dosage, the drug is infused daily for a week. Then, in 200-300 ml of infusion solution (saline solution or dextrose 5%), add 10-20 ml of Actovegin solution from ampoules and inject at this dosage daily in the form of "droppers" for another two weeks. After completing the course of "droppers" with Actovegin, they switch to taking the drug in tablet form.
• Angiopathy (peripheral vascular disorders and their complications, for example, trophic ulcers) - Actovegin is administered by infusion ("dropper"), adding 20-30 ml of the solution from the ampoules to 200 ml of saline or 5% dextrose solution. In this dosage, intravenous infusion, the drug is administered daily for four weeks.
• Diabetic polyneuropathy - Actovegin is administered intravenously, 50 ml of a solution from ampoules, daily for three weeks. After completing the course of injections, they switch to taking Actovegin in the form of tablets for 4 to 5 months to maintain the achieved therapeutic effect.
• Healing of wounds, ulcers, burns and other wound damage to the skin - a solution is injected from 10 ml ampoules intravenously or 5 ml intramuscularly either daily or 3-4 times a week, depending on the rate of healing of the defect. In addition to injections, Actovegin can be used in the form of an ointment, cream or gel to accelerate wound healing.
• Prevention and treatment of radiation damage (during radiation therapy of tumors) of the skin and mucous membranes - Actovegin is injected with 5 ml of a solution from ampoules intravenously daily, in between radiation therapy sessions.
• Radiation cystitis - inject 10 ml of a solution from ampoules transurethral (through the urethra) daily. Actovegin in this case is used in combination with antibiotics.

Intramuscularly, no more than 5 ml of solutions from ampoules can be administered at a time, since in a larger amount the drug can have a strong irritating effect on tissues, which is manifested by severe pain. Therefore, for intramuscular administration, only ampoules of 2 ml or 5 ml of Actovegin solution should be used.

To produce an intramuscular injection, you first need to select a part of the body where the muscles come close to the skin. These areas are the lateral upper thigh, the lateral upper third of the shoulder, the abdomen (in non-obese people), and the buttocks. Next, the area of ​​\u200b\u200bthe body into which the injection will be made is wiped with an antiseptic (alcohol, Belasept, etc.). After that, the ampoule is opened, the solution is drawn from it into the syringe and turned upside down with the needle. Gently tap the surface of the syringe with your finger in the direction from the piston to the needle to peel off air bubbles from the walls. Then, to remove air, press the plunger of the syringe until a drop or trickle of solution appears at the tip of the needle. After that, the syringe needle is inserted perpendicular to the skin surface deep into the tissues. Then, pressing the piston, slowly release the solution into the tissue and remove the needle. The injection site is re-treated with an antiseptic.

Each time, a new place is chosen for the injection, which should be 1 cm away from the marks from previous injections on all sides. You should not prick twice in the same place, focusing on the mark left after the injection on the skin.

Since Actovegin injections are painful, it is recommended to sit quietly for 5-10 minutes after the injection and wait until the pain subsides.

Actovegin solution for infusion - instructions for use

Since Actovegin can cause allergic reactions, it is recommended to make a test injection before the "dropper", for which 2 ml of the solution is injected intramuscularly. If after a few hours an allergic reaction has not developed, then you can safely start administering the drug intravenously or intraarterially in the required amount.

If, against the background of the use of Actovegin, a person develops allergic reactions, then the use of the drug should be stopped and the necessary therapy with antihistamines should be started (Suprastin, Diphenhydramine, Telfast, Erius, Cetirizine, Cetrin, etc.). If the allergic reaction is very severe, then not only antihistamines should be used, but also glucocorticoid hormones (Prednisolone, Betamethasone, Dexamethasone, etc.).

Solutions for infusion are colored yellowish, the shade of which may be different for preparations of different batches. However, such a difference in color intensity does not affect the effectiveness of the drug, since it is due to the characteristics of the raw materials used to manufacture Actovegin. Turbid solutions or solutions containing floating particles visible to the eye should not be used.

The total duration of therapy is usually 10-20 infusions ("droppers") per course, but if necessary, the duration of treatment can be increased by the doctor. Dosages of Actovegin for intravenous infusion administration under various conditions are as follows:

• Circulatory and metabolic disorders in the brain (traumatic brain injury, lack of blood supply to the brain, etc.) - 250-500 ml (1-2 bottles) are administered once a day, daily for 2-4 weeks. Further, if necessary, in order to consolidate the obtained therapeutic effect, they switch to taking Actovegin tablets, or continue to inject the solution intravenously, 250 ml (1 bottle) 2-3 times a week for another 2 weeks.
• Acute disorders of cerebral circulation (stroke, etc.) - 250 - 500 ml (1 - 2 bottles) are administered once a day, daily, or 3 - 4 times a week for 2 - 3 weeks. Further, if necessary, they switch to taking Actovegin tablets in order to consolidate the obtained therapeutic effect.
• Angiopathy (impaired peripheral circulation and its complications, for example, trophic ulcers) - 250 ml (1 vial) is administered once a day, daily, or 3-4 times a week for 3 weeks. Simultaneously with "droppers", Actovegin can be applied externally in the form of an ointment, cream or gel.
• Diabetic polyneuropathy - 250 - 500 ml (1 - 2 bottles) are administered once a day, daily, or 3 - 4 times a week for 3 weeks. Next, be sure to switch to taking Actovegin tablets in order to consolidate the resulting therapeutic effect.
• Trophic and other ulcers, as well as long-term non-healing wounds of any origin - 250 ml (1 bottle) are administered once a day, daily, or 3-4 times a week, until the wound defect is completely healed. Simultaneously with infusion administration, Actovegin can be used topically in the form of a gel, cream or ointment to accelerate wound healing.
• Prevention and treatment of radiation damage (during radiation therapy of tumors) of the skin and mucous membranes - 250 ml (1 vial) are administered one day before the start, and then daily throughout the course of radiation therapy, and additionally for another two weeks after last irradiation session.

special instructions

Since Actovegin can cause allergic reactions, it is recommended to make a test injection before parenteral administration (intravenously, intramuscularly or intraarterially). To do this, 2 ml of solution for infusion or solution for injection of Actovegin is injected intramuscularly and wait 2 hours. If no signs of allergy appear within two hours, then Actovegin can be administered parenterally in the required quantities.

When using Actovegin tablets, gel, cream and ointment, it is not necessary to carry out a trial injection, since these dosage forms can be quickly canceled in case of an allergic reaction.

Before using Actovegin solutions, you should always carefully examine them. If the solution is cloudy or contains floating particles, then it should not be used. Only clear solutions with a yellowish color of any intensity can be used. If solutions from different batches differ greatly in the intensity of the yellowish color, but are not cloudy and do not contain particles, then they can be used without fear, since the color of the drug may vary, as it is due to the characteristics of the raw material (bovine blood). Various variations in the color of the solution do not affect its effectiveness.

Solutions of Actovegin, both in ampoules and in vials, should be used immediately after opening the packages. Do not store open solutions. It is also unacceptable to use solutions that have been stored for some time in an opened package.

For intravenous infusion administration ("droppers"), both infusion solutions in 250 ml vials and solutions in 2 ml, 5 ml and 10 ml ampoules can be used. Only solutions for infusion are ready for use and can be administered without preparation, and solutions from ampoules for installing a "dropper" must first be poured into the infusion solution in the required amount (200 - 300 ml of saline, or 200 - 300 ml of dextrose solution, or 200 - 300 ml glucose solution 5%).

Intramuscularly, a maximum of 5 ml of injection solution can be administered at a time. Intravenous and intra-arterial injections can be administered in large quantities (up to 100 ml at a time).

Overdose

An overdose of Actovegin gel, cream or ointment is not possible.

Influence on the ability to control mechanisms

Interaction with other drugs

Solutions and tablets of Actovegin also do not interact with other drugs, so they can be used as part of complex therapy with any other means. However, it must be remembered that Actovegin solutions cannot be mixed in one syringe or in one "dropper" with other drugs.

With caution, Actovegin solutions should be combined with potassium preparations, potassium-sparing diuretics (Spironolactone, Veroshpiron, etc.) and ACE inhibitors (Captopril, Lisinopril, Enalapril, etc.).

How to make an intramuscular injection (in the buttock) - video

In this article, you can read the instructions for using the drug Actovegin. Reviews of site visitors - consumers of this medicine, as well as opinions of doctors of specialists on the use of Actovegin in their practice are presented. We kindly ask you to actively add your reviews about the drug: the medicine helped or did not help get rid of the disease, what complications and side effects were observed, perhaps not declared by the manufacturer in the annotation. Analogues of Actovegin in the presence of existing structural analogues. Use for the treatment of metabolic and vascular disorders of the brain, tissue trophism, burns and bedsores, diabetic polyneuropathy in adults, children (including newborns), as well as during pregnancy and lactation.

Actovegin- antihypoxant, is a gemoderivate, which is obtained by dialysis and ultrafiltration (compounds with a molecular weight of less than 5000 daltons penetrate).

It has a positive effect on the transport and utilization of glucose, stimulates oxygen consumption (which leads to stabilization of the plasma membranes of cells during ischemia and a decrease in the formation of lactates), thus providing an antihypoxic effect.

Actovegin increases the concentrations of ATP, ADP, phosphocreatine, as well as amino acids (glutamate, aspartate) and GABA.

The effect of Actovegin on oxygen uptake and utilization, as well as insulin-like activity with stimulation of glucose transport and oxidation, are significant in the treatment of diabetic polyneuropathy.

In patients with diabetes mellitus and diabetic polyneuropathy, Actovegin significantly reduces the symptoms of polyneuropathy (stabbing pain, burning sensation, paresthesia, numbness of the lower extremities). Objectively, sensitivity disorders are reduced, the mental well-being of patients improves.

The effect of Actovegin begins to appear no later than 30 minutes (10-30 minutes) after parenteral administration and reaches a maximum, on average, after 3 hours (2-6 hours).

Compound

Deproteinized hemoderivat from calf blood (Actovegin concentrate or granulate) + excipients.

Pharmacokinetics

Using pharmacokinetic methods, it is impossible to study the pharmacokinetic characteristics (absorption, distribution, excretion) of the active components of Actovegin, since it consists only of physiological components that are usually present in the body.

To date, no decrease in the pharmacological efficacy of hemoderivatives has been found in patients with altered pharmacokinetics (including with hepatic or renal insufficiency, metabolic changes associated with advanced age, due to the peculiarities of metabolism in newborns).

Indications

• metabolic and vascular disorders of the brain (including ischemic stroke, traumatic brain injury);
• peripheral (arterial and venous) vascular disorders and their consequences (arterial angiopathy, trophic ulcers);
• diabetic polyneuropathy;
• wound healing (ulcers of various etiologies, trophic disorders /bedsores/, burns, impaired wound healing processes);
• prevention and treatment of radiation damage to the skin and mucous membranes during radiation therapy.

Release forms

Film-coated tablets 200 mg.

Solution for injections (injections) 40 mg/ml in ampoules of 5 ml and 10 ml.

Ointment for external use 5% (not supplied to Russia).

Cream for external use 5% (not supplied to Russia).

Gel for external use 20% (not supplied to Russia).

Instructions for use and dosage

Tablets

Assign inside 1-2 tablets 3 times a day before meals. The tablet is not chewed, washed down with a small amount of water. The duration of treatment is 4-6 weeks.

Ampoules

The solution for injection is administered intra-arterially, intravenously (including as an infusion or dropper) and intramuscularly. The infusion rate is about 2 ml / min. In connection with the potential for the development of anaphylactic reactions, it is recommended to test for the presence of hypersensitivity to the drug before infusion.

The duration of the course of treatment is determined individually, depending on the symptoms and severity of the disease.

Metabolic and vascular disorders of the brain: from 5 to 25 ml (200 - 1000 mg per day) intravenously daily for two weeks, followed by the transition to a tablet form.

Ischemic stroke: 20-50 ml (800-2000 mg) in 200-300 ml of 0.9% sodium chloride solution or 5% dextrose solution intravenously daily for 1 week, then 10-20 ml (400-800 mg ) intravenously drip - 2 weeks, followed by the transition to a tablet form.

Peripheral (arterial and venous) vascular disorders and their consequences: 20-30 ml (800-1000 mg) of the drug in 200 ml of 0.9% sodium chloride solution or 5% dextrose solution intra-arterially or intravenously daily; the duration of treatment is 4 weeks.

Diabetic polyneuropathy: 50 ml (2000 mg) per day intravenously for 3 weeks, followed by the transition to a tablet form - 2-3 tablets 3 times a day for at least 4-5 months.

Wound healing: 10 ml (400 mg) intravenously or 5 ml intramuscularly daily or 3-4 times a week, depending on the healing process (in addition to local treatment with Actovegin in dosage forms for external use).

Prevention and treatment of radiation damage to the skin and mucous membranes during radiation therapy: the average dose is 5 ml (200 mg) intravenously daily during breaks in radiation exposure.

Radiation cystitis: 10 ml (400 mg) daily transurethral in combination with antibiotic therapy.

Side effect

• skin rash;
• skin hyperemia;
• hyperthermia;
• hives;
• swelling;
• medicinal fever;
• anaphylactic shock.

Contraindications

• decompensated heart failure;
• pulmonary edema;
• oliguria, anuria;
• fluid retention in the body;
• hypersensitivity to the components of the drug;
• hypersensitivity to similar drugs.

Use during pregnancy and lactation

The use of the drug during pregnancy did not adversely affect the mother or fetus, however, if necessary, the use of the drug during pregnancy should take into account the potential risk to the fetus. So the use of Actovegin in these cases requires caution.

special instructions

In connection with the potential for the development of anaphylactic reactions, it is recommended to conduct a test (trial injection of 2 ml / m) before infusion.

In the case of an intramuscular route of administration, the drug should be administered slowly in an amount of not more than 5 ml.

Solutions of Actovegin have a slightly yellowish tint. The color intensity may vary from one batch to another depending on the characteristics of the starting materials used, but this does not affect the effectiveness and tolerability of the drug.

Do not use an opaque solution or a solution containing particles.

With repeated injections, the water-electrolyte balance of the blood plasma should be monitored.

After opening the ampoule or vial, the solution cannot be stored.

drug interaction

Drug interaction of the drug Actovegin has not been established.

However, in order to avoid possible pharmaceutical incompatibility, it is not recommended to add other drugs to Actovegin infusion solution.

Analogues of the drug Actovegin

The drug Actovegin has no structural analogues for the active substance.

Analogues by pharmacological group (antihypoxants and antioxidants):

• Actovegin granulate;
• Actovegin concentrate;
• Antisten;
• Astrox;
• Vixipin;
• Vitanam;
• Hypoxen;
• Glation;
• Deprenorm;
• Dihydroquercetin;
• Dimephosphone;
• Cardioxipin;
• Carditrim;
• Carnitine;
• Carnifit;
• Kudevita;
• Kudesan;
• Kudesan for children;
• Kudesan Forte;
• Levocarnitine;
• Limontar;
• Meksidant;
• Mexidol;
• Mexidol solution for injections 5%;
• Mexicor;
• Mexipridol;
• Mexiprim;
• Mexifin;
• Methylethylpyridinol;
• Metostabil;
• Sodium oxybutyrate;
• Neurox;
• Neurolipon;
• Octolipen;
• Olifen;
• Predizin;
• Preductal;
• Rexod;
• Rimecore;
• Solcoseryl;
• Thiogamma;
• Thiotriazoline;
• Trekrezan;
• Triducard;
• Trimectal;
• Trimetazidine;
• Phenosanoic acid;
• Cerecard;
• Cytochrome C;
• Eltacin;
• Emoxybel;
• Emoxipin;
• Enerlit;
• Yantavit.

In the absence of analogues of the drug for the active substance, you can follow the links below to the diseases that the corresponding drug helps with and see the available analogues for the therapeutic effect.

INN: Deproteinized hemoderivat from calf blood

Manufacturer: Takeda Austria GmbH

Anatomical-therapeutic-chemical classification:

Registration number in the Republic of Kazakhstan: No. RK-LS-5 No. 121855

Registration period: 10.12.2015 - 10.12.2020

Instruction

Tradename

Actovegin®

International non-proprietary name

Dosage form

Solution for injection 40 mg / ml - 2 ml, 5 ml

Compound

1 ml contains

active substance - deproteinized hemoderivate of calf blood (in terms of dry matter) * 40.0 mg.

Excipients: water for injections

*contains approximately 26.8 mg sodium chloride

Description

Clear, yellowish solution.

Pharmacotherapeutic group

Other hematological preparations

ATX code B06AB

Pharmacological properties

Pharmacokinetics

It is impossible to study the pharmacokinetic characteristics (absorption, distribution, excretion) of Actovegin®, since it consists only of physiological components that are usually present in the body.

Actovegin® has an antihypoxic effect, which begins to appear at the latest 30 minutes after parenteral administration and reaches a maximum after an average of 3 hours (2-6 hours).

Pharmacodynamics

Actovegin® antihypoxant. Actovegin® is a hemoderivate, which is obtained by dialysis and ultrafiltration (compounds with a molecular weight of less than 5000 daltons pass). Actovegin® causes an organ-independent intensification of energy metabolism in the cell. The activity of Actovegin® was confirmed by measuring increased absorption and increased utilization of glucose and oxygen. These two effects are interrelated, and they lead to an increase in the production of ATP, thereby providing a greater extent for the energy needs of the cell. Under conditions that limit the normal functions of energy metabolism (hypoxia, lack of substrate), and with increased energy consumption (healing, regeneration), Actovegin® stimulates the energy processes of functional metabolism and anabolism. The secondary effect is increased blood supply.

The effect of Actovegin® on oxygen uptake and utilization, as well as insulin-like activity with stimulation of glucose transport and oxidation, are significant in the treatment of diabetic polyneuropathy (DPN).

In patients with diabetes mellitus and diabetic polyneuropathy, Actovegin® significantly reduces the symptoms of polyneuropathy (stabbing pain, burning sensation, parasthesia, numbness in the lower extremities). Objectively, sensitivity disorders are reduced, the mental well-being of patients improves.

Indications for use

 metabolic and vascular disorders of the brain (including dementia);

- peripheral (arterial and venous) vascular disorders and their consequences (arterial angiopathy, venous ulcers of the lower extremities); diabetic polyneuropathy.

Dosage and administration

Actovegin®, solution for injection, is used intramuscularly, intravenously (including in the form of infusions) or intra-arterially.

Instructions for using ampoules with one break point:

take the ampoule so that the top containing the label is at the top. Gently tapping with your finger and shaking the ampoule, allow the solution to flow down from the tip of the ampoule. Break off the top of the ampoule by pressing on the mark.

Depending on the severity of the clinical picture, the initial dose is 10-20 ml intravenously or intra-arterially; further on 5 ml in / in or slowly in / m daily or several times a week.

When used as an infusion, 10-50 ml is diluted in 200-300 ml of isotonic sodium chloride solution or 5% dextrose solution (stock solutions), administration rate: about 2 ml / min.

b) Doses depending on indications:

Metabolic and vascular disorders of the brain: from 5 to 25 ml (200-1000 mg per day) intravenously daily for two weeks, followed by the transition to a tablet form of administration.

Cerebrovascular and nutritional disorders such as ischemic stroke: 20-50 ml (800 - 2000 mg) in 200-300 ml of 0.9% sodium chloride solution or 5% glucose solution, intravenously daily for 1 week, then 10 - 20 ml (400 - 800 mg) intravenously drip - 2 weeks, followed by the transition to a tablet form of administration.

Peripheral (arterial and venous) vascular disorders and their consequences: 20-30 ml (800-1000 mg) of the drug in 200 ml of 0.9% sodium chloride solution or 5% glucose solution, intra-arterially or intravenously daily; the duration of treatment is 4 weeks.

Diabetic polyneuropathy: 50 ml (2000 mg) per day intravenously for 3 weeks, followed by the transition to a tablet form of administration - 2-3 tablets 3 times a day for at least 4-5 months.

Venous ulcers of the lower extremities: 10 ml (400 mg) IV or 5 ml IM daily or 3 to 4 times a week depending on the healing process

The duration of the course of treatment is determined individually according to the symptoms and severity of the disease.

Side effects

From the side of the immune system

Rare: allergic reactions (drug fever, symptoms of anaphylactic shock).

Skin and subcutaneous tissue disorders

Rare: urticaria, redness

Contraindications

hypersensitivity to the components of the drug Actovegin®

general contraindications to infusion therapy: decompensated heart failure, pulmonary edema, oliguria, anuria, hyperhydration

Drug Interactions

Not installed

special instructions

Intramuscularly, it is desirable to inject slowly no more than 5 ml, since the solution is hypertonic.

In view of the possibility of anaphylactic reactions, a trial injection (2 ml intramuscularly) is recommended before starting therapy.

The use of Actovegin® should be carried out under medical supervision, with appropriate facilities for the treatment of allergic reactions.

For infusion use, Actovegin®, injection, can be added to isotonic sodium chloride solution or 5% glucose solution. Aseptic conditions must be observed, since Actovegin® for injection does not contain preservatives.

From a microbiological point of view, opened ampoules and prepared solutions should be used immediately. Solutions that have not been used should be discarded.

With regard to mixing Actovegin® solution with other solutions for injection or infusion, physico-chemical incompatibility, as well as interaction between active substances, cannot be excluded, even if the solution remains optically clear. For this reason, Actovegin® solution should not be mixed with other drugs, except for those mentioned in the instructions.

The solution for injection has a yellowish tint, the intensity of which depends on the batch number and starting material, but the color of the solution does not affect the efficacy and tolerability of the drug.

Do not use an opaque solution or a solution containing particles!

Use with caution in hyperchloremia, hypernatremia.

Children

There are currently no data available and use is not recommended.

Use during pregnancy

The use of the drug Actovegin® is allowed if the expected therapeutic benefit outweighs the possible risk to the fetus.

Application during lactation

When using the drug in the human body, no negative effects on the mother or child were identified. Actovegin® should be used during lactation only if the expected therapeutic benefit outweighs the possible risk to the child.

Features of the influence of the drug on the ability to drive a vehicle or potentially dangerous mechanisms

No or minor influences.

Overdose

There is no data on the possibility of overdose with Actovegin®. Based on pharmacological data, no additional undesirable effects are expected.

Release form and packaging

Solution for injections 40 mg/ml.

2 and 5 ml of the drug in colorless glass ampoules (type I, Eur.pharm.) with a break point. 5 ampoules in a plastic blister pack. 1 or 5 blister packs with instructions for use are placed in a cardboard box. Transparent protective stickers of a round shape with holographic inscriptions and control of the first opening are pasted on the pack.

active substance: 1 ml of the drug contains deproteinized hemoderivat from the blood of calves, corresponds to 40 mg of dry weight;

Excipients: sodium chloride, water for injection.

Dosage form

Injection.

Basic physical and chemical properties: yellowish solution.

Pharmacotherapeutic group

Drugs affecting the digestive system and metabolic processes. ATX code A16A X.

Pharmacological properties

Pharmacodynamics.

The drug Actovegin is a deproteinized hemoderivative from the blood of calves, it contains only physiological substances with a molecular weight of less than 5000 daltons. The action of the drug is manifested by neuroprotective and metabolic effects. Neuroprotective effects are provided by a decrease in the juvenile effect of oxidative stress and a decrease in neuronal apoptosis. Metabolic effects are non-organ specific. At the molecular level, Actovegin accelerates the processes of oxygen utilization (increases resistance to hypoxia) and glucose, thereby helping to increase energy metabolism. The overall effect of these processes is to enhance the energy state of the cell, especially under conditions of hypoxia and ischemia. The effect of Actovegin on oxygen uptake and utilization, as well as insulin-like activity with stimulation of glucose transport and oxidation, are significant in the treatment of diabetic polyneuropathy.

In patients with type 2 diabetes mellitus and diabetic polyneuropathy, Actovegin reduces the intensity of symptoms of diabetic polyneuropathy (stabbing pain, burning sensation, paresthesia, numbness in the lower extremities). Reduces violations of vibration sensitivity and improves the quality of life of patients.

Pharmacokinetics.

Using pharmacokinetic methods, it is impossible to study the pharmacokinetic characteristics of Actovegin (absorption, distribution and elimination of active ingredients), since it consists only of physiological components that are usually present in the body.

Indications

• Diseases of the brain of vascular and metabolic origin (including dementia).
• Peripheral (arterial, venous) circulation disorders and their complications (arterial angiopathy, venous trophic ulcer).
• Diabetic polyneuropathy (DPN).

Contraindications

Hypersensitivity to any components of the drug or to drugs of a similar composition. Decompensated heart failure, pulmonary edema, oliguria, anuria are common contraindications to infusion therapy, so the administration of the drug in the form of infusions in these conditions is contraindicated due to possible overhydration.

Interaction with other medicinal products and other forms of interaction

There are no data on the interaction of Actovegin with other drugs.

Application features

Intramuscularly, it is desirable to inject no more than 5 ml, since the solution is hypertonic.

Solution for injection is compatible with 0.9% sodium chloride solution and 5% glucose solution.

The drug Actovegin, solution for injection, should be used under sterile conditions. Since the drug does not contain preservatives, the contents of the ampoule are intended for single use. Opened ampoules and ready solution should be used immediately. Unused product and waste must be disposed of in accordance with local regulations.

Due to the possibility of anaphylactic reactions, a test injection (hypersensitivity test) is recommended. In case of development of violations of water and electrolyte metabolism (for example, hyperchloremia, hypernatremia), it is necessary to carry out an appropriate correction.

The solution for injection has a slightly yellowish tint. The color intensity may vary from one batch to another depending on the characteristics of the starting materials used, but this does not adversely affect the activity of the drug or sensitivity to it.

Only a clear solution without visible particles can be used.

The solution contains sodium. This should be considered in patients who are on a controlled sodium diet.

Use during pregnancy or lactation.

The drug should be used during pregnancy or lactation only when the expected benefit to the mother outweighs the possible risk to the fetus or child. During the use of the drug Actovegin in placental insufficiency, although rarely, fatal cases were observed, which could be a consequence of the underlying disease. The use of the drug Actovegin during breastfeeding was not accompanied by negative effects either for the mother or for the child.

The ability to influence the reaction rate when driving vehicles or operating other mechanisms.

Actovegin has no or very little effect on the reaction rate when driving vehicles or operating other mechanisms. However, possible manifestations of side effects from the nervous system should be taken into account (see section "Adverse reactions").

Dosage and administration

Actovegin, solution for injection, apply intravenously (stream, drip), intra-arterially, 5-20 ml per day.

Intramuscularly injected slowly, no more than 5 ml per day.

For intravenous administration, dilute the drug in 0.9% sodium chloride solution or 5% glucose solution. The final concentration of Actovegin is allowed - up to 2000 mg of dry matter per 250 ml of solution.

given the clinical symptoms, first administer 5-10 ml intravenously or intraarterially, then 5 ml intravenously or slowly intramuscularly daily or several times a week;

b) doses depending on the indications for use:

For severe conditions

Intravenously drip inject 20-50 ml / day of Actovegin for several days until a pronounced clinical effect is achieved.

Condition of moderate severity or exacerbation of chronic diseases

5-20 ml / day intravenously or intramuscularly for 14-17 days.

The course of planned treatment

2-5 ml / day intravenously or intramuscularly for 4-6 weeks.

The number of injections - from 1 to 3 times, depending on the severity.

With diabetic polyneuropathy

Treatment begins with intravenous use of the drug at a dose of 2 g per day for 3 weeks, followed by the transition to tablets - 2-3 tablets 3 times a day for at least 4-5 months.

Children. There are no data on the use of the drug in children, so the drug is not recommended for use in this category of patients.

Overdose

Cases of overdose with Actovegin are unknown.

Adverse reactions

The following describes the adverse reactions that may occur in patients as a result of the use of the drug Actovegin. Anaphylactic (allergic) reactions may occur, which can manifest themselves:

from the immune system and skin- possible hypersensitivity reactions, including allergic reactions, anaphylactic and anaphylactoid reactions up to the development of anaphylactic shock, fever, chills, angioedema, skin flushing, skin rashes, itching, urticaria, increased sweating, swelling of the skin and / or mucous membranes, hot flashes fever, changes at the injection site;

from the digestive tract- dyspeptic phenomena, including pain in the epigastric region, nausea, vomiting, diarrhea;

from the cardiovascular system- pain in the region of the heart, increased heart rate (tachycardia), shortness of breath, acrocyanosis, pale skin, arterial hypotension or hypertension;

from the respiratory system- rapid breathing, a feeling of constriction in the chest, difficulty swallowing and / or breathing, sore throat, choking attack;

from the nervous system- headache, general weakness, dizziness, loss of consciousness, agitation, trembling (tremor), paresthesia;

from the musculoskeletal system- pain in the muscles and / or joints, pain in the lower back.

In such cases, treatment with Actovegin should be discontinued and symptomatic therapy applied.

Best before date

Storage conditions

Store below 25°C in original packaging. Keep out of the reach of children!

Incompatibility

The drug should not be mixed in the same container with other solutions, with the exception of those indicated in the section "Method of application and doses".

Package

2 ml per ampoule, 25 ampoules per carton.

5 ml in an ampoule; 5 ampoules in a carton box

10 ml in an ampoule; 5 ampoules in a cardboard box.

Holiday category

On prescription.

Manufacturer

LLC "Kusum Pharm", Ukraine / LLC "Kusum Pharm", Ukraine.

(packaging from in-bulk form by Takeda Austria GmbH, Austria)/(packaging of in-bulk by Takeda Austria GmbH, Austria).

Location of the manufacturer and its address of the place of business

st. Skryabina, 54, m. Sumy, Sumy region, 40020, Ukraine/54, Skryabina str., Sumy, Sumy region, 40020, Ukraine.

Instructions for use

Actovegin instructions for use

Dosage form

Clear yellowish solution.

Compound

1 ampoule contains: active ingredient: Actovegin® concentrate (in terms of dry deproteinized calf blood hemoderivat)1) - 80.0 mg; excipient: water for injection - up to 2 ml.

1) Actovegin® concentrate contains sodium chloride in the form of sodium and chloride ions, which are components of the blood of calves. Sodium chloride is not added or removed during the production of the concentrate. The content of sodium chloride is about 53.6 mg (for 2 ml ampoules),

Pharmacodynamics

Actovegin is an antihypoxant that has three types of effects: metabolic, neuroprotective and microcirculatory. Actovegin * increases the absorption and utilization of oxygen; the phospho-oligosaccharides included in the preparation inositol have a positive effect on the transport and utilization of glucose, which leads to an improvement in the energy metabolism of cells and a decrease in the formation of lactate in conditions of ischemia.

Several ways of implementing the neuroprotective mechanism of drug action are considered.

Actovegin® prevents the development of apoptosis induced by beta-amyloid peptide (Ap25-35).

Actovegin modulates the activity of nuclear factor kappa B (NF-kB), which plays an important role in the regulation of apoptosis and inflammation in the central and peripheral nervous system.

Another mechanism of action is associated with the nuclear enzyme poly(ADP-ribose) polymerase (PARP). PARP plays an important role in the detection and repair of single-stranded DNA damage, but excessive activation of the enzyme can trigger cell death in conditions such as cerebrovascular disease and diabetic polyneuropathy. Actovegin inhibits the activity of PARP, which leads to a functional and morphological improvement in the state of the central and peripheral nervous system.

The positive effects of the drug Actovegin®, affecting the processes of microcirculation and the endothelium, are an increase in the rate of capillary blood flow, a decrease in the pericapillary zone, a decrease in the myogenic tone of precapillary arterioles and capillary sphincters, a decrease in the degree of arteriovenular shunting blood flow with predominant blood circulation in the capillary bed and stimulation of endothelial synthase function nitric oxide, affecting the microvasculature.

In the course of various studies, it was found that the effect of the drug Actovegin® occurs no later than 30 minutes after its administration. The maximum effect is observed 3 hours after parenteral and 2-6 hours after oral administration.

Pharmacokinetics

Using pharmacokinetic methods, it is impossible to study the pharmacokinetic parameters of Actovegin®, since it consists only of physiological components that are usually present in the body.

Side effects

The frequency of side effects was determined in accordance with the classification of the Council of International Medical Scientific Organizations (CIOMS): very often (> 1/10); often (> 1/100 to<1/10); нечасто (>1/1000 to<1/100); редко (>1/10000 to<1/1000); очень редко (<1/10000); не известно (не может быть оценена по имеющимся данным).

Immune System Disorders

Rare: allergic reactions (drug fever, symptoms of shock).

Skin and subcutaneous tissue disorders Rare: urticaria, sudden redness.

Musculoskeletal and connective tissue disorders:

Not known: myalgia.

Selling Features

prescription

Special conditions

Parenteral administration of the drug should be carried out under sterile conditions.

Due to the possibility of an anaphylactic reaction, a test injection (hypersensitivity test) is recommended.

In the case of electrolyte disorders (such as hyperchloremia and hypernatremia), these conditions should be adjusted accordingly.

The solution for injection has a slightly yellowish tint. The color intensity may vary from one batch to another depending on the characteristics of the starting materials used, but this does not adversely affect the activity of the drug or its tolerability.

Do not use a solution that is opaque or contains particles.

After opening the ampoule, the solution cannot be stored.

Clinical Data

In the multicenter, randomized, double-blind, placebo-controlled ARTEMIDA study (NCT01582854), which aimed to investigate the therapeutic effect of Actovegink on cognitive impairment in 503 patients with ischemic stroke, the overall incidence of serious adverse events and death was similar in both treatment groups. Although the frequency of recurrent ischemic strokes was within the expected range in this patient population, there were more cases in the group taking the drug Actovegin compared to the placebo group, but this difference was not statistically significant. An association between recurrent stroke events and study drug was not established.

Use in pediatric patients

Currently, data on the use of the drug Actovegin "1 in children are not available, so its use in this group of people is not recommended.

Influence on the ability to drive a car and other mechanisms

Not installed.

Indications

As part of complex therapy:

Symptomatic treatment of cognitive impairment, including post-stroke cognitive impairment and dementia.

Symptomatic treatment of peripheral circulatory disorders and their consequences.

Symptomatic treatment of diabetic polyneuropathy (DPN).

Contraindications

Hypersensitivity to Actovegish and similar drugs or excipients.

Decompensated heart failure, pulmonary edema, oliguria, anuria, fluid retention in the body.

Children's age up to 18 years.

Use during pregnancy and during breastfeeding

Actovegin® should be used only in cases where the therapeutic benefit outweighs the potential risk to the fetus or child.

drug interaction

Currently unknown.

Prices for Actovegin in other cities

Mode of application

Dosage

Instructions for using ampoules with a break point:

Position the tip of the ampoule point up! Gently tapping with your finger and shaking the ampoule, allow the solution to flow down from the tip of the ampoule.

Depending on the severity of the clinical picture, at first, 10-20 ml of the drug should be administered intravenously or intra-arterially daily; for further treatment, 5 ml intravenously or intramuscularly slowly, daily or several times a week. For infusion administration, from 10 to 50 ml of the drug should be added to 200-300 ml of the stock solution (isotonic sodium chloride solution or 5% glucose solution). The infusion rate is about 2 ml/min.

For intramuscular injections, no more than 5 ml of the drug is used, which should be administered slowly, since the solution is hypertonic.

Post-stroke cognitive impairment

In the acute period of ischemic stroke, starting from 5-7 days, 2000 mg per day intravenously, up to 20 infusions with the transition to a tablet form, 2 tablets 3 times a day (1200 mg / day). The total duration of treatment is 6 months.

dementia

2000 mg per day intravenously for up to 4 weeks.

Peripheral circulatory disorders and their consequences

800 - 2000 mg per day intra-arterially or intravenously drip.

The duration of treatment is up to 4 weeks.

Diabetic polyneuropathy

2000 mg per day intravenously, 20 infusions with the transition to a tablet form, 3 tablets 3 times a day (1800 mg / day) for a period of 4 to 5 months.

Overdose