Instructions Erbisol solution for injection ampoule 2 ml No. 10
Composition
active ingredients:
1 ml of the drug contains: a complex of natural non-protein low-molecular organic compounds of non-hormonal origin, obtained from animal embryonic tissue, contains oligopeptides and glycopeptides (total 0.07 - 1.0 mg), nucleotides, amino acids;
excipients: 0.9% isotonic sodium chloride solution.
Dosage form
Solution for injection.
Main physicochemical properties: transparent or slightly opalescent colorless or light yellow liquid with a specific odor.
Pharmacotherapeutic group
Immunostimulants. ATX code L03A X
Hepatotropic drugs. ATX code A05B A.
Pharmacological properties
Pharmacodynamics
The pharmacological activity of the drug is determined by the content of low-molecular biologically active peptides in it, which activate the natural, evolutionarily formed control systems of the body, which are responsible for the search and elimination of pathological changes. ERBISOL® activates the immune system to accelerate the recovery of damaged and destruction of abnormal cells and tissues. The main immunomodulatory effect of the drug is manifested, first of all, through the effect on the macrophage link, which is responsible for the repair of damaged cells and the restoration of the functional activity of organs and tissues, as well as through NK cells (CD3-16+56+) and T-killers (CD3+16+56+), which are responsible for the destruction of damaged cells incapable of regeneration, or abnormal cells (mutant, malignant, virus-carrying cells, etc.) and tissues. At the same time, ERBISOL® has an immunocorrective effect and, in case of immune disorders, contributes to its normalization due to the activation of T-lymphocytes, Th1-helpers and T-killers and inhibition of the activity of Th2-helpers and B-lymphocytes, which is important for restoring the balance between cellular and humoral immunity in cancer diseases and for stopping allergic reactions. Depending on the immune status of the body, the drug corrects the activity of some other factors of humoral and cellular immunity: induces the synthesis of α-, β- and γ-interferon, tumor necrosis factor, interleukin-2 (IL-2) and IL-12, inhibits the synthesis of IL-4 and IL-10. ERBISOL® potentiates the effect of antibiotics, exogenous interferons and, at the same time, weakens their toxic side effects.
ERBISOL® accelerates the regeneration and repair process in erosive-ulcerative lesions of the gastrointestinal tract, promotes healing of damage to the mucous membranes of the stomach and duodenum. The drug increases the regenerative-reparative potential of tissues, which leads to rapid healing of traumatic, purulent and postoperative wounds, trophic ulcers of various etiologies, to accelerated consolidation of bone fragments in fractures, and promotes effective treatment of periodontitis.
ERBISOL® is effective in the treatment of acute and chronic hepatitis of various etiologies, including toxic, drug-induced and viral hepatitis, in which the drug activates liver regeneration processes. In viral hepatitis, ERBISOL® also activates cytotoxic T-lymphocytes (CD8+) and T-killers (CD3+16+56+), responsible for the destruction of virus-carrying cells, and also induces the synthesis of α-, β- and γ-interferon, increasing their level in the blood by 4-6 times.
times, which helps to accelerate the elimination of the virus. At the same time, by activating the processes of liver regeneration, the drug promotes the replacement of dead hepatocytes with healthy cells, which allows ERBISOL® to be attributed to drugs that alleviate the severity of an infectious disease. The drug exhibits anti-inflammatory properties, but the treatment of chronic inflammatory processes may go through an exacerbation phase for 2-5 days. ERBISOL® contributes to the normalization of hepatocyte functions, exhibits pronounced antioxidant and membrane-stabilizing effects at the level of plasma membranes, prevents the development of dystrophy, cytolysis and cholestasis, as well as atherosclerosis in liver lesions, contributes to the normalization of bilirubin and transaminase levels. This leads to the rapid disappearance of asthenovegetative, dyspeptic and pain syndromes. By activating liver functions, the drug contributes to the acceleration of the removal of foreign toxic agents and harmful products of its vital activity from the body.
In insulin-dependent diabetes mellitus, ERBISOL®, by inhibiting the activity of Th2-helpers and B-lymphocytes, reduces the intensity of the autoimmune process, and by activating macrophages, promotes the repair of damaged beta cells, which leads to a decrease in the daily need for injectable insulin, as well as to stable compensation of carbohydrate and lipid metabolism, a decrease in lipid peroxidation. This contributes to the reduction or elimination of clinical manifestations and improvement of liver, myocardium, and cardiovascular system function. In complex therapy, ERBISOL® has a positive effect on the treatment of neuropathies, diabetic macro- and microangiopathies, improves microcirculation in blood vessels, and prevents the development of gangrene. In initially diagnosed diabetes mellitus, it contributes to a significant reduction in the daily dose of insulin, stable and long-term remission. In patients with non-insulin-dependent diabetes mellitus, ERBISOL® improves metabolic syndrome indicators and myocardial contractility. ERBISOL® contributes to improving the quality of life of patients with diabetes mellitus.
In cancer, ERBISOL® does not stimulate the unbalanced immune system of patients, but contributes to its correction, normalizing the immune status by activating T-lymphocytes, Th1-helpers and T-killers and inhibiting the activity of Th2-helpers and B-lymphocytes, which contributes to the restoration of specific cellular immunity and, above all, the activation of T-killers. The drug also activates macrophages and natural killers (N-killers) of non-specific immunity, induces the synthesis of α- and γ-interferon and tumor necrosis factor. This leads to inhibition of both the growth and metastasis of malignant tumors, and in combination with surgical intervention or with chemo- and radio-therapy, contributes to their effective destruction. ERBISOL® as a support drug for chemo- and radio-therapy significantly increases the effectiveness of treatment in two directions. Firstly, as a reparant, hepatoprotector and immunoprotector, it protects healthy cells and tissues from chemical and radiation damage, restoring damaged areas. This allows the use of more intensive schemes with the use of potent chemotherapeutic agents and radiation doses without the risk of particularly negative consequences for the condition of patients, preventing hair loss, eliminating or significantly reducing the manifestations of vegetative, dyspeptic and pain syndromes. Secondly, as an immunocorrector, the drug restores the antitumor functions of the immune system and, despite the damaging effects of chemo- and radio-radiation therapy, contributes to the normalization of the immune status of patients after treatment to the parameters of healthy people. This allows, unlike standard chemo- and radio-radiation therapy, to mobilize the protective antitumor functions of the body both during treatment and in the inter-course periods, which contributes to the further increase of their effectiveness and improvement
quality of life of patients, as well as the possible replacement of some courses of chemotherapy and radiotherapy with courses of immunotherapy and immunocorrection with ERBISOL®.
In clinical studies involving patients who used ERBISOL®, a decrease in the number of repeated intensive courses of chemo- and radiotherapy that must be performed in the near future was noted, as well as a decrease in the frequency of new metastatic nodes in the period between planned courses of treatment.
ERBISOL® is an adaptogen that increases the protective and adaptive functions of the body. ERBISOL® is recommended for use in complex therapy of the effects of radiation exposure and environmental pollution. The drug exhibits a radioprotective effect, which is associated with its membrane-stabilizing and antioxidant properties, activation of repair processes at both the cellular and genetic (activates DNA polymerase B - a reparant of the genetic code) levels, normalization of liver function for effective removal of foreign toxic agents.
ERBISOL® activates the immune system to carry out an audit and restoration of the body, which is of great importance in gerontology, because in the process of life a large number of abnormal cells accumulate, many of which are in a "hidden" state and are activated when the immune system is weakened. ERBISOL® helps restore the function of the immune system, when activated N- and T-killers are able to carry out an audit - find and destroy abnormal cells, and macrophages to some extent restore, that is, regenerate the functions of organs and tissues that are impaired in elderly people.
The immunomodulatory effect begins to develop from 5-7 days and reaches maximum values on 20-21 days, remaining at this level for another 8-10 days after the end of the course of drug therapy. The reparative effect begins to develop on 2-3 days of treatment, and the hepatoprotective effect appears after 2-3 injections of the drug.
The drug is non-toxic, does not exhibit cumulative toxicity, allergenic, teratogenic, mutagenic and carcinogenic properties.
Pharmacokinetics
Not studied.
Indication
gastroenterology: hepatitis of various etiologies (including viral, toxic and drug-induced hepatitis caused by the use of antibiotics, interferons, chemotherapy drugs and other potent drugs that cause side effects), reactive hepatitis, steatohepatitis, liver cirrhosis, gastric and duodenal ulcers, erosive gastroduodenitis, nonspecific ulcerative colitis;
toxicology: ERBISOL® enhances the detoxification functions of the liver;
endocrinology: diabetes mellitus, autoimmune thyroiditis;
therapy: nonspecific lung diseases (pneumonia, chronic bronchitis), pulmonary tuberculosis, angiopathy, to improve microcirculation, normalize vascular tone and blood supply, metabolic dystrophies. ERBISOL® is used in the complex treatment of people who have suffered from the effects of radiation exposure and environmental pollution, the drug has pronounced adaptive-corrective properties in the combination of the above pathologies, increases the compensatory and protective functions of the body;
allergology: allergic and autoimmune diseases, including bronchial asthma;
gerontology: functional insufficiency associated with age-related disorders of the liver, immune, nervous and cardiovascular systems. To increase physical activity and eliminate asthenic syndrome, to increase potency;
dentistry: periodontitis;
surgery and traumatology: traumatic, postoperative and purulent-septic wounds, fractures (to accelerate the consolidation of bone fragments), trophic ulcers of various etiologies, diabetic angiopathy, to activate reparative processes in the complex treatment of bedsores;
oncology: during surgical treatment to prevent metastasis and speed up wound healing. During chemo- and radio-radiation therapy, ERBISOL® is used in a complex as a supporting drug as a hepato-, immunoprotector and reparant, and in the rehabilitation and inter-course periods as an immunocorrector and reparant to activate the body's anti-tumor defense.
Contraindication
Individual intolerance, hypersensitivity to any component of the drug.
Interaction with other medicinal products and other types of interactions
ERBISOL® enhances the effect of antibacterial agents, exogenous interferons and at the same time reduces their toxic effect. For effective implementation of the directed immunomodulatory action, ERBISOL® is not recommended to be prescribed with immunomodulators that stimulate humoral immunity. ERBISOL® increases the sensitivity of receptors, therefore, when used together with hormonal drugs, biostimulants and bioinhibitors (tranquilizers, hypnotics, sedatives, psychotropic drugs, depressants, etc.), their dosage should be controlled, reducing the dose if necessary.
Application features
For cholecystitis, combine with therapy that normalizes the activity of the biliary system.
Combined with eradication anti-helicobacter therapy. With increased acidity of gastric juice, antisecretory and antacid drugs should be used.
In case of diabetes, starting from the 3rd day of using the drug, the blood sugar level should be monitored. In case of its decrease, starting from the 10th day, the dose of hypoglycemic drugs can be slightly reduced. If there is a tendency to decrease the sugar level, the course of treatment should be extended to 23-30 days. In the presence of autoimmune aggression, initially, in order to stop it, ERBISOL® is additionally prescribed 2 ml once a day at 9-12 pm for 5-7 days.
In case of high blood pressure, as well as in the phase of exacerbation of the pathological process, ERBISOL® should be used with caution, reducing the dose to 2 ml once a day in the evening or to 2 ml once every 2 days.
This medicinal product contains less than 1 mmol (23 mg) sodium/dose, i.e. essentially 'sodium-free'.
Use during pregnancy or breastfeeding
Studies on the effectiveness of the drug ERBISOL® during pregnancy or breastfeeding have not been conducted. ERBISOL® should not be prescribed during pregnancy or breastfeeding.
Ability to influence reaction speed when driving vehicles or other mechanisms
The effect on the reaction rate when driving vehicles or using other mechanisms has not been studied. It is unlikely that the drug ERBISOL® can affect the reaction rate when driving vehicles or working with other mechanisms.
Method of administration and doses
The dosage and course of treatment are determined by the doctor individually, depending on the nature and course of the disease (as monotherapy or as part of complex treatment).
ERBISOL® is administered intramuscularly, intravenously, intraarterially, intraperitoneally or intratumorally to adults daily in a dose of 2-4 ml. The course of treatment is 20 days and, taking into account the chronorhythms of the body, a single administration is preferably administered in the evening before bedtime at 21-24 hours 2-3 hours after a meal, and in the case of a double administration - additionally administered in the morning at 6-9 hours 1-2 hours before a meal. The average course dose is 40-80 ml.
For wounds and periodontitis, adults are prescribed 4 ml intramuscularly for the first 10 days, and 2 ml for the next 10 days if necessary. For generalized periodontitis, infiltration into the gums or applications or electrophoresis of ERBISOL® from the anode (+) to the gums is additionally prescribed.
Patients with chronic obstructive pulmonary disease and bronchial asthma with respiratory
In case of I degree insufficiency, ERBISOL® is administered intramuscularly to adults in a dose of 2 ml once a day at 9:00 PM to 12:00 PM for the first 3 days, then 2 ml twice a day at 4:00 PM to 6:00 PM and 9:00 PM to 12:00 PM for 5 days, and 2 ml once a day at 9:00 PM to 12:00 PM for 7 days. The course dose is 40 ml.
For patients with chronic obstructive pulmonary disease and bronchial asthma with respiratory failure of the 2nd degree, ERBISOL® is administered intramuscularly for the first 3 days, 2 ml once a day at 9-12 pm, and for the next 10 days, 2 ml is administered twice: at 4-6 pm and at 9-12 pm, then for 7 days - 2 ml at 9-12 pm. The course dose is 60 ml.
In chronic obstructive pulmonary diseases and bronchial asthma, which are accompanied by deep and irreversible changes in the function of external respiration with respiratory failure of the III degree, pulmonary tuberculosis, a course of treatment requires at least 80 ml of ERBISOL®. Patients in this group are prescribed the drug intramuscularly - 2 ml twice: at 16 - 18 hours and at 21 - 24 hours. The course of treatment is 20 days. The proposed method of treatment complements the stepwise scheme of basic therapy.
In case of hepatitis, steatohepatitis, cirrhosis of the liver, gastric and duodenal ulcers, erosive gastroduodenitis, nonspecific ulcerative colitis, metabolic dystrophies, tissue damage, fractures (to accelerate the consolidation of bone fragments), trophic ulcers of various etiologies, bedsores, as well as in rehabilitation and restorative therapy, to increase physical activity, adaptive-corrective and protective functions of the body, to eliminate asthenic syndrome, the drug is administered intramuscularly to adults in 2 ml daily twice a day: at 6 - 9 and 21 - 24 hours for 20 days, or for the first 3 days, 2 ml of the drug is administered once a day at 21 - 24 hours, and in the next 10 days, 2 ml is administered twice: at 6 - 9 hours and at 21 - 24 hours, then for 7 days – 2 ml at 9 pm – 12 pm.
For diabetes mellitus and autoimmune thyroiditis, ERBISOL® is prescribed 2 ml twice a day - in the morning at 6-9 am and in the evening at 9-12 pm intravenously or intramuscularly for 20 days.
In cancer, as a support and rehabilitation drug for radiotherapy, ERBISOL® is prescribed intramuscularly daily to adults, 2 ml 2 times a day in the morning at 6-9 am and in the evening at 9-12 pm for 20 days, starting 1-2 days before the course of radiotherapy.
During chemotherapy, ERBISOL® is administered to adults daily, starting 2-3 days before the chemotherapy course, once a day in the evening at 9-12 pm, 2 ml intramuscularly, during chemotherapy and ending on the 7-12th day after the chemotherapy course (total 15-25 days), as well as intramuscularly 2 ml in the morning at 6-9 am, starting 1-2 days before the chemotherapy course, during chemotherapy and ending on the 3-7th day after the chemotherapy course. That is, on the 1st day and the last 4-7 days of the course, ERBISOL® can be administered 2 ml once a day in the evening at 9-12 pm. On days of chemotherapy, instead of the morning intramuscular injection of 2 ml of ERBISOL®, it is advisable to administer 4-16 ml of ERBISOL® (depending on the administration regimen and dose of chemotherapy) in fractions, immediately before the administration of each cytostatic and by the same route, i.e. intravenously or intraarterially, or intratumorally, or intraperitoneally, and at 5 p.m. additionally administer 2 ml of ERBISOL® intramuscularly. For example, with intravenous drip infusion of chemotherapy, ERBISOL® is first administered intravenously in 2 ml before the infusion of each 200 ml of chemotherapy solution. With intraarterial infusion of chemotherapy, ERBISOL® is administered in the same way intraarterially. In regional chemotherapy, before the administration of the chemotherapy solution, 4 ml of ERBISOL® is administered intraarterially or intratumorally in the same way. Additional intramuscular administration of 2 ml of ERBISOL® at 5 pm is prescribed for another 2-3 days after the administration of significant doses of chemotherapy. When conducting chemotherapy with the use of drugs that affect the hormonal status of the patient, ERBISOL® is prescribed no earlier than 3 hours after the use of such drugs.
The calculation of the amount of ERBISOL® required for administration together with chemotherapy drugs in order to prevent their side effects on healthy tissues of patients is carried out depending on the administered dose of chemotherapy drugs: 2 ml of ERBISOL® should preferably be administered before each 25-30 mg of doxorubicin or 25-30 mg of platinum drugs, or 0.5-0.75 g of cyclophosphamide, or 1.0 g of 5-fluorouracil, or other chemotherapy drugs with equivalent toxic effects.
To improve the physical condition of patients, a course of immunotherapy using ERBISOL® may be performed 3–5 weeks after a course of chemotherapy.
For the first 3 days, adults are prescribed 2 ml of the drug intramuscularly once a day in the evening at 9:00 PM - 12:00 PM, and in the next 10 days, 2 ml is administered twice: in the morning at 6:00 AM - 9:00 AM and in the evening at 9:00 PM - 12:00 PM, then for 7 days - 2 ml in the evening at 9:00 PM - 12:00 PM or daily 2 ml twice a day: at 6:00 AM - 9:00 AM and at 9:00 PM - 12:00 PM for 20 days.
Children
The safety and efficacy of the drug have not been studied in children. The drug should not be prescribed to children.
Overdose
Short-term increased excitability or fatigue is possible, which does not require specific therapy.
Side effects
Sometimes during the first 2-5 days of taking the drug may cause exacerbation of chronic inflammation, which in most cases is a stage of the healing process. Hypersensitivity reactions are possible, including rashes, itching, increased blood pressure and body temperature.
Expiration date
5 years.
Do not use after the expiry date stated on the packaging.
Storage conditions
Store at a temperature of 4 - 12 °C out of the reach of children. Opalescence may occur during storage.
Incompatibility
For effective implementation of the directed immunomodulatory action, ERBISOL® should not be used together with:
alcohol (neutralizes the reparative effect of macrophages);
immunomodulators that can stimulate humoral immunity, which interferes with the action of T-killers.
Packaging
10 ampoules of 1 ml or 2 ml.
Vacation category
According to the recipe.
Producer
Applicant: Private Enterprise "Laboratory Erbis"
Email: erbis@ukr.net
Website: www.erbisol.com.ua
Address
Ukraine, 02002, Kyiv, Raisy Okipnoi St., 10-B, office 92
phone: +38 (044) 592-37-77, 592-17-30.
