The overall incidence of recurrent ischemic stroke during the study was within the limits assumed for this patient population, but the incidence was slightly higher in the Actovegin group compared with the placebo group.
Peripheral blood flow disorders and their consequences. Approximately 190 patients with peripheral arterial disease were treated with Actovegin for a period of 10 to 42 days in several small, comparative randomized trials that showed a short-term advantage of Actovegin infusions over placebo. An improvement in the form of an increase in walking distance of 35–42% was demonstrated in the Actovegin group compared with the placebo group.
In an open, randomized study, 60 patients with large trophic ulcers of the lower extremities with venous insufficiency received a standard therapy regimen with or without the addition of Actovegin. The preparation Actovegin was administered in the form of daily intravenous infusions of 250 ml of 10% solution for 4 weeks. The average ulcer healing time was 31 days (in the group receiving Actovegin) and 42 days (in the group not receiving Actovegin). An improvement in the number of points on the pain intensity scale compared with the baseline level was observed in both groups, in particular in the group receiving the preparation Actovegin, there was a decrease in the number of points from 4.47 to 1.77, and in the other study group - from 4.13 up to 2.07.
Diabetic polyneuropathy. In a study involving 70 patients with diabetic polyneuropathy, statistically significant changes in walking distance, nerve impulse conduction velocity and pain sensitivity were demonstrated in patients treated with Actovegin compared with a placebo group. The difference in the therapeutic effect of placebo was about 6.5 m at walking distance, 0.9 m / s in the speed of nerve impulse conduction, and 6.8 points on the pain sensitivity scale (on a 100-point scale).
As part of a 6-month, double-blind, randomized, placebo-controlled study evaluating the safety and efficacy of 567 patients with type II diabetes mellitus and symptomatic diabetic distal polyneuropathy received 20 intravenous infusions of Actovegin (2000 mg / day) (n = 281) or placebo (n = 286) once a day for 20–36 days, after which they received 3 tablets of Actovegin (1800 mg / day) or placebo 3 times a day for 140 days. When using the preparation Actovegin, there was a better effect compared to placebo according to the endpoint assessment on the overall symptom score (TSS), including positive neuropathic pain symptoms, burning, paresthesias and numbness of the feet or legs, decreased vibration sensitivity and improved the quality of life of patients. There were no significant differences in the distribution of adverse events between the treatment group and the control group.
Pharmacokinetics. Using pharmacokinetic methods, it is impossible to study the pharmacokinetic characteristics of the preparation Actovegin (absorption, distribution and elimination of active ingredients), since it consists only of physiological components that are usually found in the body.
The results obtained in studies on animals and in the framework of clinical studies have shown that the effect of the preparation begins no later than 30 minutes after its administration. The maximum effect is achieved 3 hours after parenteral administration or oral administration of the preparation (2-6 hours).
Treatment of cerebral diseases of vascular origin, including post-stroke cognitive impairment and dementia. treatment of peripheral (arterial, venous) blood circulation disorders and their complications (arterial angiopathy, venous trophic ulcer). treatment of diabetic polyneuropathy.
Actovegin, injection solution, is in ampoules with a break point.
How to open breakpoint ampoules. Point the top of the colored dot upward. Let the solution flow down from the top of the ampoule by tapping and shaking the ampoule. Break off the top of the ampoule.
a) General recommendations. Actovegin, injection solution, is used intravenously, intravenously or intramuscularly; it can also be added to infusion solutions.
Depending on the severity of the patient's condition and the clinical picture, 10–20 ml of the preparation Actovegin, solution for injection, intravenously or intravenously, is administered daily; for further treatment, 5 ml is administered intravenously or slowly intramuscularly daily or several times a week.
For use in the form of infusions, it is necessary to add 10-50 ml of the preparation Actovegin, injection solution, to 200-300 ml of the main solution (isotonic physiological solution or 5% glucose solution). Depending on the severity of the patient's condition and the clinical picture, 1–2 infusions intravenously or intravenously are performed daily or several times a week, the total dose is 10–20 infusions. When using the preparation in the form of infusions, use infusion systems with 15 micron filters. The recommended infusion rate is about 2 ml / min.
The intramuscular solution is administered slowly, no more than 5 ml / day, because it is hypertensive.
b) Dosage depending on indications for use
In diseases of the brain of vascular origin: first, 10 ml IV daily for 2 weeks, then - 5-10 ml IV several times a week for at least 4 weeks.
For arterial angiopathy: add 20-50 ml of the preparation to the main solution, apply intravenously or intravenously daily or several times a week; the duration of treatment is about 4 weeks.
For venous trophic ulcer: 10 ml IV or 5 ml IM daily or several times a week, depending on the healing process.
For diabetic polyneuropathy: the initial dose is 50 ml (2000 mg) per day as an intravenous infusion for 3 weeks, followed by a switch to tablets - 2-3 tablets 3 times a day (up to 1800 mg) for at least 4– 5 months
Contraindications
Hypersensitivity to any components of the preparation or preparations with a similar composition. decompensated heart failure, pulmonary edema, oliguria, anuria are general contraindications to infusion therapy, therefore, administration of the preparation in the form of infusions in these conditions is contraindicated due to possible overhydration.
Side effects
The following are the side reactions that may occur in patients as a result of the use of the preparation Actovegin. anaphylactoid (allergic) reactions may occur, which may manifest themselves:
from the immune system and skin: hypersensitivity reactions are possible, 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, skin edema and / or mucous membranes, hot flashes, changes at the injection site;
from the digestive tract: dyspeptic symptoms, including pain in the epigastric region, nausea, vomiting, diarrhea;
on the part of the cardiovascular system: pain in the region of the heart, increased heart rate (tachycardia), shortness of breath, acrocyanosis, pallor of the skin, arterial hypotension or hypertension;
from the respiratory system: increased breathing, a feeling of constriction in the chest, difficulty swallowing and / or breathing, sore throat, an attack of suffocation;
from the nervous system: headache, general weakness, dizziness, loss of consciousness, agitation, tremors (tremors), paresthesia;
from the musculoskeletal system: muscle and / or joint pain, back pain.
In such cases, treatment with Actovegin should be discontinued and symptomatic therapy should be applied.
Special instructions
In / m it is desirable to inject no more than 5 ml of solution, since it is hypertensive.
The injection solution is compatible with 0.9% sodium chloride solution and 5% glucose solution. The preparation Actovegin, injection solution, should be used under sterile conditions. Since the preparation does not contain preservatives, the contents of the ampoule are intended for single use. Open ampoules and ready-made solution should be used immediately. Unused product and waste should be disposed of in accordance with local regulations.
Due to the possibility of anaphylactic reactions, it is recommended to conduct a test injection (hypersensitivity test). In case of development of violations of water and electrolyte metabolism (for example, hyperchloremia, hypernatremia), it is necessary to carry out an appropriate correction. 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 negatively affect the activity of the preparation or the sensitivity to it.
You can use only transparent solution without visible particles.
Solution contains sodium. This should be taken into account in patients on a controlled sodium diet.
Use during pregnancy and lactation. The preparation should be used during pregnancy and lactation only when the expected benefit to the mother outweighs the possible risk to the fetus or child. During the use of the preparation Actovegin with placental insufficiency, although rarely, fatal cases were observed that could be a consequence of the underlying disease. The use of the preparation Actovegin during lactation was not accompanied by negative effects for either the mother or the child.
Children. There are no data on the use of the preparation in children; therefore, the preparation is not recommended for use in this category of patients.
The ability to influence the reaction rate when driving vehicles or other mechanisms. Actovegin does not have or has very little effect on the ability to drive vehicles or other mechanisms. However, one should take into account the possible manifestations of side effects from the nervous system (see SIDE EFFECTS).
Interactions
There are no data on the interaction of Actovegin with other preparations.
Incompatibility. The preparation should not be mixed in the same container with other solutions, except for those indicated in the APPLICATION section.
Overdose
Overdose cases of Actovegin are unknown.
Storage conditions
At a temperature not exceeding 25 ° C in the original packaging.