Order of Ministry of Public
Health of Ukraine №651
for medical use of the medication ERBISOL® Extra
Active substances : 1 ml of the medication contains a complex of the natural protein-free low-molecular organic compaunds of nonhormonal origin, obtained from the animal embryonal tissue; oligopeptides and glycopeptides (in total 0,07-0,4) nucleotides, amino acids.
Additional substances : isotonic solution of 0.9 % sodium chloride.
Dosage form. Solution for injections.
Main physical and chemical properties: transparent or slightly opalescent colorless or light yellow liquid with a specific odor.
Immunomodulators. Code ATC L03A X;
Medicines, acting on the digestive system and metabolism. Code ATC A16A X10.
Pharmacodynamics. Pharmacological activity of the medication is determined by the content of low-molecular biologically active peptides, activizing the natural evolutionally formed controlling systems, responsible for the search and the elimination of pathological changes in the organism. ERBISOL® Extra activizes the immune system for the increased recovery of damaged cells, and the destruction of the anomalous cells and tissues.
The main immunomodulating effect of the medication is first of all realized by its effect on macrophage link, responsible for repair of the damaged cells and the restoration of organ and tissue functional activity and also by NK-cells (CD3–16+56+) and T-killers (CD3+16+56+), responsible for the destruction of damaged cells, incapable for the regeneration, or the anomalous cells (mutant, malignant, virus carrying cells etc.) and tissues. At the same time, ERBISOL® Extra has the immunocorrecting effect and promotes the normalization of disturbed immune status by activating T-lymphocytes, Th1-helpers and T-killers, and inhibiting the Th2-helper activity that is important for the balance restoration between cellular and humoral immunity in oncological diseases and for stopping the allergic processes. Depending on the body immune status, the medication corrects the activity of some other factors in cellular and humoral immunity: induces the synthesis of α-, β-, γ-interferons, tumour necrosis factor (TNF), interleukin-2 (IL-2) and IL-12, inhibits the synthesis of IL-10. ERBISOL® Extra inhibits the processes of lipid peroxidation, increases an activity of the blood glutathione dependent antioxidant system without the changes in the enzyme activity of microsome oxidation and the content of cytochrome P-450, exerts the membranostabilizing effects at the level of the plasmatic membranes determining the therapeutic efficacy and the expediency of its use in the treatment of acute as well as chronic diseases caused by generalized atherosclerosis (ischemic disease of the heart, myocardial infarction, cerebral atherosclerosis, insult, obliterating atherosclerosis of the aorta and the magistral arteries etc.).
The medication potentiates the effect of antibiotics, exogenous interferons and decreases their toxic side effect at the same time.
The medication accelerates the reparative processes in patients with erosive-ulcerative lesions of the gastrointestinal tract, contributing to the healing of the mucosal damages in the stomach and the duodenum, erosions in patients with nonspecific ulcerative colitis.
The medication increases the regenerative and reparative tissue potential, resulting in the quick healing of traumatic, purulent and postoperative wounds, trophic ulcers of different etiology, the accelerated consolidation of osseous breakings in fractures, the treatment of parodontitis and paradontosis. An activization of the regenerative processes results in functional recovery of the nervous and cardiovascular systems and also the parenchymal tissue in functional insufficiency of the organs.
The high efficiency of the medication was revealed in the treatment of acute and chronic toxic and medicamentous hepatites where the medication activizes the regenerative processes of the liver, contributing to the substitution of dead hepatocytes by healthy ones that allows ERBISOL® Extra to be added to the medications, decreasing the severity degree of disease course. The medication contributes to the normalization of the hepatocyte functions, shows a clear antioxidant and membrane-stabilizing effect at the level of plasmatic membranes, prevents the development of dystrophy, cytolysis and cholestasis in the liver damages, and also normalizes the bilirubin and transaminase levels. This leads to a more rapid disappearance of asthenovegetative, dispeptic and painful syndromes. The normalization of the liver function results in the accelerated elimination of the toxic agents and the hamful products of their vital activity from the organism. The medication has antiinflammatory properties, however the treatment of chronic inflammatory processes can go through a phase of exacerbation for 2-5 days.
In insulin dependent diabetes mellitus (type 1 diabetes mellitus) ERBISOL® Extra activizing Th1-helpers, decreases an intensity of the autoimmune process, and activizing macrophages, contributes to the reparation of damaged beta-cells, that leads to the decrease in a daily requirement of the insulin injections, and also to the stable compensation of carbohydrate and lipid metabolism, to the decreased lipid peroxidation. This contributes to the decrease or the liquidation of clinical signs and to the improvement of the liver function, the myocardium, the cardiovascular system. In complex therapy the medication has the positive effect on the treatment of diabetic polyneuropathies, diabetic macro- and microangiopathies, contributes to the improvement of microcirculation decreasing the development of gangrene in the lower extremities. It predisposes the significant decrease in a daily dose of insulin, to the stable and prolonged remission in newly diagnosed diabetes mellitus. In patients with non insulin dependent diabetes mellitus (type 2 diabetes mellitus) the medication regulates the indices of metabolic syndrome, improves the myocardial contractility. The medication contributes to the improvement of well-being level in patients with diabetes mellitus.
Immunomodulating effect begins to develop at the days 5-7 and the maximum index is reached at the days 20-21 maintaining more than 8-10 days at the same level after finishing the medication administration. The repair effect begins to develop at the days 2-3 of the treatment, and the hepatoprotective effect is manifested after 2-3 injections of the medication.
The medication is nontoxic, without the allergogenic, teratogenic, cumulative, mutagenic and carcinogenic activities.
Pharmacokinetics. It was not studied.
- Cardiology: arterial hypertension, cardiomyopathies, myocardites, ischemic cardiac disease, myocardial infarction, postinfarction cardiosclerosis, diffuse cardiosclerosis;
- Neurology: cerebral atherosclerosis, insult, neurological disorders associated with disorders of cerebral circulation (after insult), polyneurites of different genesis, demyelinizating polyneuropathies, Parkinson’s disease;
- Gastroenterology: acute and chronic hepatites of different aetiology, hepatoses, hepatic cirrhoses, pancreatitis, erosive gastroduodenitis, peptic ulcer of the stomach and duodenum, unspecific ulcerative colitis;
- Therapy: unspecific pulmonary diseases (pneumonia, chronic bronchitis), metabolic dystrophies, angiopathies; for the improvement of microcirculation, for the normalization of tonus and vessel bloodfilling; in chronic renal insufficiency, rheumatism, diffuse diseases of the connective tissue, systemic vasculites, arthrites of different etiology, deforming osteoporosis, podagra. ERBISOL® Extra is used in the complex therapy of patients, exposed to the radiation consequences and ecologic contamination, the medication has pronounced adaptative-corrective characteristics increasing the body compensatory and protective functions;
- Endocrinology: diabetes mellitus, thyroidites, autoimmune insulin syndrome.
- Stomatology: parodontitis and paradontosis;
- Surgery and traumatology: obliterating diseases of the aorta and its branches of atherosclerotic genesis, obliterating endarterites, diabetic macro- and microangiopathies, traumatic, postoperative and purulent wounds, trophic ulcers of different etiology, decubitus, fractures (for accelerated consolidation of osteal breakings);
- Allergology: allergic diseases including bronchial asthma, atopic dermatitis, and atopic rhino-conjunctivitis;
- Dermatology: pustular dermal diseases, dermatites and toxidermatoses, neurodermatoses, eczema, psoriasis;
- Gerontology: the functional insufficiency, associated with the age disorders of the hepatic function, the immune, the nervous and the cardiovascular systems. For increasing the physical activity, the general vital tonus and potency.
Contraindications: Individual intolerance, hypersensitivity to any component of the medication.
Interaction with other medicines and other types of interactions. ERBISOL® Extra potentiates the effect of antibacterial remedies, exogenous interferons and reduces their toxic effect at the same time. For the effective realization of the directed immunomodulating effect, ERBISOL® Extra is not recommended to prescribe with immunomodulators which stimulate humoral immunity. ERBISOL® Extra increases the sensitivity of the receptors, so when using the drug together with hormonal drugs and biostimulators, you should monitor the dosage of the latter by lowering the dose if necessary.
Peculiarities of use
|Cholecystitis||Prescription of ERBISOL® Extra should be combined with therapy, normalizing the function of the biliary system|
|Arterial hypertension||ERBISOL® Extra is prescribed at a dose of 2 ml once a day in the evening, during exacerbations – 2 ml once in 2 days|
|Ulcerous disease||With increased acid production of the stomach should be applied
antisecretagogues and antacid preparations
|Diabetes mellitus||Starting from the 3rd day of use, it is necessary to monitor the
blood sugar level. In case of its reduction it is necessary to begin to
reduce the insulin dose. At the first 10-12 days, there can be fluctuations in the level of blood sugar, then appears a tendency to reduce it.
With increased arterial pressure, as well as in the exacerbation phase of pathological process, the medication should be used with caution, reducing the dose. In some cases, during the first 2-5 days of medication taking, an exacerbation of chronic inflammatory process, which in most cases is a stage of the medical process can be caused.
Use during pregnancy or lactation periods.
Studies of the efficacy of the medication ERBISOL® Extra during pregnancy or lactation periods have not been carried out, therefore it should not be prescribed during pregnancy or lactation.
The ability to influence on the reaction rate when driving or working with other machinery.
Influence on the reaction rate when driving or working with other mechanisms has not been studied. It is unlikely that ERBISOL® Extra is able to influence on the reaction rate when driving vehicles or working with other mechanisms.
Method of use and dosage.
The medication ERBISOL® Extra is intramuscularly administered at a dose of 4-6 ml for 20-30 days every day, considering the body chronorhythms, the preferable use of the medication is in the morning at 6-8 hours, 1-2 hours before meals (in the treatment of pancreatic diseases at 9-11 hours in 2-3 hours after meals) and in the evening, before bedtime, at 21-24 hours in 2 -3 hours after meals.
During therapy of neurological diseases (demyelinizing polyneuropathies, Parkinson’s disease) ERBISOL® Extra is used as the everyday intramuscular injection twice a day: at 6.00-8.00 o’clock, and at 21.00-24.00 o’clock at a dose of 2 ml for the first 3 days; the medication is injected twice a day: at a dose of 4 ml at 6.00-8.00 o’clock and at dose of 2 ml at 21.00-24.00 o’clock next 10-20 days and then at a dose of 2 ml for 7-17 days twice a day.
In neurological diseases associated with disorders of cerebral circulation (after insult), and in postinfarction period the ERBISOL® Extra is recommended to prescribe at a dose of 2 ml during epicrisis and then as daily intramuscular injections, twice a day at a dose of 2 ml in the morning and in the evening for 20-30 days.
In ischemic cardiac disease, disorders of peripheral circulation the medication is prescribed as the daily intramuscular injections at a dose of 2 ml for 20 days.
In obliterating endarteritis (Burger’s disease) the medication, diluted with 250 ml physiologic salt solution, is prescribed at a dose of 4 ml, for 1-2 hours as the intravenous drop-by-drop infusion. The maintenance dose is provided with the daily intramuscular injection of the medication at a dose of 2 ml twice a day in the morning and in the evening. The treatment course consists of 10-15 days.
In nonspecific ulcerative colitis ERBISOL® Extra is daily prescribed twice a day at a dose of 2 ml – in the morning and at a dose of 2 ml – in the evening for 20-30 days as the intramuscular injections and then – at the daily dose of 2 ml in the morning and in the evening for 10-20 days.
In a case of wounds, parodontitis and paradontosis, the medication is intramuscularly administered at a dose of 2 ml for 10-20 days twice a day in the morning and in the evening every day. The additional applications and electrophoresis with ERBISOL® Extra are applied from the anode (+) to the gum in generalized parodontitis.
In hepatosis, hepatitis, erosive ulcerous injuries of gastrointestinal tract, diffuse diseases of the connective tissue, traumatic injuriesof the tissues and organs, trophic ulcers of different aetiology, decubitus; for accelerate the consolidation of bone fragments, and also for the rehabilitation and reducing therapy, for improve the body protective functions, ERBISOL® Extra is prescribed at a dose of 2 ml twice a day in the morning and in the evening for 20-30 days as the daily intramuscular injections.
In therapy of pancreatitis ERBISOL® Extra is prescribed as the daily intramuscular injections at a dose of 2 ml twice a day in the morning at 9-11 o’clock and in the evening at 21-24 o’clock for 20-30 days.
In diabetes mellitus ERBISOL® Extra is intramuscularly administered at a daily dose of 2 ml twice a day at 9-11 o’clock in the morning and at 21-24 o’clock in the evening during first 20 days and then at a dose of 2 ml in the morning for the next 10 days. The course of therapy can be repeated 2-3 times a year.
The safety and effectiveness of the medication has not been studied in children, so it should not be prescribed for them.
A short-term increased excitability can take place, that does not require the specific therapy.
Hypersensitive reactions, increased arterial pressure and body temperature can be induced with medication.
Shelf life. 5 years.
Do not use after the expiration date printed on the package.
Storage conditions. Store at a temperature of 4-12 0C in a place out of children reach. When stored, opalescence may occur.
To effective realization of the directed immunomodulating effect, ERBISOL® Extra should not be used together with:
- alcohol (neutralizes the reparative effect of macrophages);
- immunomodulators which can stimulate humoral immunity, that hinders the action of T-killers.
Packaging. 10 ampoules per 1 ml or 2 ml.
Distribution. By the prescription.
MANUFACTURER. “ERBIS” Ltd.
Web site: www.erbisol.com.ua
ADDRESS. R. Okipnoy Str., 10 B., 02002 Kiev, Ukraine,
tel: +38 (044) 569-70-13, 569-70-14.