APPROVED
Order of Ministry of Public
Health of Ukraine
__12.12.2008__ №__741___
Registration certificate
№ ___UA/9178/01/01______
INSTRUCTION
for medical use of the medication ERBISOL®
Composition:
active substances: a complex of the natural protein-free low-molecular organic compounds of nonhormonal origin obtained from the animal embryonic tissue, 1 ml of medication contains oligopeptides, and glycopeptides (in sum 0,07 – 1,0 mg), nucleotides and amino acids;
adjuvant substances: isotonic solution of 0,9 % sodium chloride up to 1 ml.
Medicinal form. Solution for injections.
Pharmacotherapeutical group.
Cytokines and immunomodulators Code ATC L03A X;
Hepatotropic medications Code ATC A05B A;
General characteristics.
Indications:
– Gastroenterology: hepatitis of different aetiology (including viral, medicamentous hepatitis induced by the use of antibiotics, interferons, chemicals and other drastic medications provoking the side effects), reactive hepatitis, steatohepatosis, hepatic cirrhosis, gastric and duodenum ulcers, erosive gastroduodenitis, unspecific ulcerative colitis;
– Toxicology: Erbisol® intensifies the desintoxicating functions of the liver;
– Therapy: unspecific pulmonary diseases (pneumonia, chronic bronchitis), pulmonary tuberculosis, metabolic dystrophies, syndrome of chronic fatigue, angiopathies; for the improvement of microcirculation, the normalization of tonus and blood content of the vessels. Erbisol® is used in the complex therapy of patients, suffered as the result of the radiation consequences and the ecologic contamination, the medication has the pronounced adaptation-correlation characteristics increasing the compensatory and protective functions of the organism in the combination with above-mentioned pathologies;
– Endocrinology: diabetes mellitus, autoimmune thyroiditis;
– Gynecology: uterine leiomyoma, premenstrual syndrome, ovarian cyst;
– Allergology: allergic and autoimmune diseases including bronchial asthma, atopic dermatitis, atopic rhino-conjunctivitis;
– Stomatology: parodontitis;
– Surgery and traumatology: traumatic, postoperative and pyo-ceptic wounds, fractures (for the accelerating the consolidation of the osteal breakings), trophic ulcers of different etiology, diabetic angiopathies, decubitus;
– Gerontology: in 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 and potency, for the elimination of asthenic syndrome;
– Oncology: for metastasis prophylaxis and for quick healing of wounds in the surgical treatment. In chemo- and radiotherapy, Erbisol® is used in the complex as the accompanying medication in the quality of the hepato-, immunoprotector and reparant, and also as the immunoprotector and reparant for making more active the antitumor protection of the organism during the rehabilitation period and the periods between the treatment courses.
Contraindications: Individual intolerance.
Administration and Dosage. Erbisol® is administered in a dose of 2-4 ml as an every day intramuscular, intravenous, intraarterial or intratumoral injections in the adults. The treatment course consists of 20-30 days, and taking into account the organism chronorhytms, its single administration is desirable to administer in the evening at 21-24 o’clock before going to the bed in 2-3 hours after food, an additional administration is prescribed at 6-9 o’clock, 1-2 hours before food in a case of the double administration. The average course dose consists of 40 – 100 ml.
In reactive hepatitis, autoimmune and allergic diseases, Erbisol® is administered in a dose of 4 ml intramuscularly every day for 20 days in the adults.
In the wounds, parodontitis, Erbisol® is administered in a dose of 4 ml at the first 10 days, and in a dose of 2 ml at the next 10 days, in a case of need, in the adults. The additional infiltration injections are administered into the gingivas, and Erbisol® applications and electrophoresis from anode (+) to the gingiva are used in generalized paradontitis.
Erbisol® is administered in a dose of 2 ml intramuscularly once a day at 22-24 o’clock at the first three days every day then in a dose of 2 ml – twice a day at 16-18 o’clock and 22-24 o’clock for 5 days and then in a dose of 2 ml once a day at 22-24 o’clock for 7 days in the adult patients with chronic obstructive lung diseases and bronchial asthma with degree I respiratory deficiency. There is 40 ml that are required for the total course of treatment. The medication is administered in a dose of 2 ml intramuscularly at 20-22 o’clock once a day for the first 3 days and in a dose of 2 ml – twice a day at the next 10 days: at 16-18 and 22-24 o’clock, and then in a dose of 2 ml at 22-24 o’clock for 7 days in degree II respiratoty deficiency. The course dose consists of 60 ml. No less than 80 ml of Erbisol® are required for the treatment course of chronic obstructive lung diseases and bronchial asthma accompanied by the deep and irreversible changes in the function of external respiration with degree III respiratory deficiency. The medication is administered in a dose of 2 ml intramuscularly twice a day: at 16-18 and 22-24 o’clock for 20 days in patients of this group. The basic scheme of therapy is added with the offered method of treatment.
The medication is administered in a dose of 2 ml intramuscularly twice a day : at 6-8 and 22-24 o’clock for 20 days or in a dose of 2 ml ones a day at 22-24 o’clock for the first 3 days, and in a dose of 2 ml twice a day – the next 10 days: at 6-8 o’clock and at 22-24 o’clock and then in a dose of 2 ml at 22-24 o’clock for 7 days in hepatitis, steatohepatosis, hepatic cirrhosis, gastric and duodenum ulcers, unspecific ulcerative colitis, metabolic dystrophies, tissue damages, traumata, fractures (for accelerating the consolidation of the osseous breakings), trophic ulcers of different aetiology, decubitus and also for increasing the physical activity, the adaptation correlative and protective functions of the organism, for the elimination of asthenia, syndrome of chronic fatigue in the rehabilitation and recoverying therapy of the adult patients.
Erbisol® is prescribed in a dose of 2 ml intramuscularly once a day the first 2 days at 22-24 o’clock and then as 4 cycles every of which includes every day administration of medication twice a day: at 7-9 o’clock and 22-24 o’clock for 5 days with two weeks interval when the medication is aministered once a day at 22-24 o’clock in diabetes mellitus, autoimmune thyroiditis, uterine leiomyoma, premenstrual syndrome, ovarian cyst. The course dose consists of 100 ml for 30 days.
The basis therapy is added with the proposed method of treatment. In a case of diabetic therapy the 2nd course is repeated in a month, and then in 2-4 months and more depending on patients state.
As the accompanying and rehabilitation medication of radiotherapy, Erbisol® is administered in a dose of 2 ml intramuscularly every day: 2 days before and in 2 days after radiotherapy and also 1 time a day in a dose of 2 ml at 22-24 o’clock at the rest-days from it performance, and 2 time a day in a dose of 2 ml at 6-8 o’clock in the morning and at 22-24 o’clock in the evening at the days of radiotherapy.
In chemotherapy Erbisol® is administered in a dose of 2 ml intramuscularly once a day at 22-24 o’clock in the evening every day starting with 3 days before the chemotherapy course, and in a dose of 2 ml intramuscularly twice a day at 6-8 in the morning and at 22-24 in the evening 1-2 days before, and during 3-4 days after the chemical preparation injection, then 2 ml dose is administered once a day.
Erbisol® is advisable to administer in the fractional dose of 4-12 ml (depending on the dosage regimen and the dose of the chemicals) directly before the administration of every cytostatic agents and by the same way, that is intravenously or intraarterialy, or intratumoraly, or intraperitonealy instead the morning intramuscular injection and the additional intramuscular injection of the medication Erbisol® in a dose of 2 ml at 17 o’clock at the days while the chemicals are taken. For example, in a case of the intravenous drop infusion of the chemicals, Erbisol® is firstly administered in a dose of 2 ml intravenously before the infusion of every 200 ml of the chemical solution. Erbisol® is administered by the same way i. e. intraarterialy in a case of the intraarterial infusion of the chemical agent. In regional chemotherapy, Erbisol® is administered in a dose of 4 ml intraarterialy or intratumoraly before the administration of chemical solution by the same way. An additional intramuscular administration of Erbisol® is administered in a dose of 2 ml at 17 o’clock in 2-3 days after the administration of acute chemical doses.
Under carried out chemotherapy using the medications influencing on the hormomal status of patient, Erbisol® is administered no early than in 3 hours after taking such medications.
The calculation of Erbisol® amount, that is necessary to take in the complex with chemicals for preventing their side effects on the patient healthy tissues, is realized depending on the administered dose of chemicals: the medication Erbisol® is desirable to administer in a dose of 2 ml before every 25-30 mg of doxorubitsine or 25-30 mg of platinum agents or 0,5-0,75 g of cyclophosphane or 1,0 g of 5-fluorouracil or other chemicals with an equivalent toxic effect.
Some schemes of Erbisol® usage in the combination with the chemotherapy courses are listed in the information appendix.
If the patient was underwent the surgical intervention before chemo- and radiotherapy, Erbisol® is administered in a dose of 2 ml intramuscularly in the evening from the 1-3 days, for 7-10 days before starting the chemoradiotherapy course in the adults. This is also advisable to realize in the patients with concomitant hepatic diseases and/or hepatitis in the anamnesis.
The course of immunotherapy with Erbisol® usage can be possible in 3-5 weeks after the chemotherapy course for improving the physical state of patient. Erbisol® is administered in a dose of 2 ml intramuscularly once a day at 22-24 o’clock in the evening, and the next 10 days – twice a day: at 6-8 o’clock in the morning and at 22-24 o’clock in the evening, and then in a dose of 2 ml at 22-24 o’clock in the evening for 7 days or in a dose of 2 ml twice a day: at 6-8 o’clock and at 22-24 o’clock for 20 days in the adults the first 3 days.
Side effect. Erbisol® is well tolerated in patients. However, in some cases during the first 2-5 days of the therapy, the medication can induce the exacerbation of chronic inflammatory process that is a stage of treatment process in the majority of cases. No the allergic reactions were noted in the process of clinical trials and also during the medication use in clinical practice, but the risk of their manifestation as dermal eruptions is not completely excluded.
Overdosage. The short-term increased excitability can take place, without requiring specific therapy.
Administration in pregnancy and lactation. Its administration is not recommended in pregnancy and lactation.
Children. It is not recommended for the children administration.
Peculiarities of usage:
Cholecystitis It should be combined with therapy, normalizing the function of
the biliary system.
Hypertension Erbisol® is administered in a dose of 2 ml in the evening once a day,
in a dose of 2 ml once a day per 2 days – in the disease exacerbation.
Ulcerous The medication is combined with erydical anticheliobacterial therapy.
diseases Antisecretants (blockators of H2 histamine receptors and proton pumps), and the
of GIT antacid medications are needed for use in a case of the increased gastric acidity.
The blood sugar level should be controlled starting from the 2nd course of the
Diabetes medication use. In a case of its stable reduction, the insulin dose can be slightly
mellitus decreased.
The additional Erbisol® is administered in a dose of 2 ml once a day at 22-24 o’clock for 5-7 days in the presence of the autoimmune aggression for its stopping in the beginning .
The medication should be used with caution, decreasing a dose under the increased blood arterial pressure and also at the phase of the acute pathologic processes.
Ability for influence on reaction rate while driving the motor transport and operating other machinery. Erbisol® does not influence on the reaction rate while driving the motor transport and operating other machinery.
Interaction with other medications and other kinds of interaction. Erbisol® potentiates the effect of the antibacterial agents and interferons. Erbisol® increases the receptor sensitivity, so its complex usage with the hormonal medications, biostimulators and also bioinhibitors (tranquilizers, soporific, ataraxic, psychotropic agents, depressants and etc.) requires the control of their dosage and the dose decrease in a case of need.
Pharmacological characteristics.
Pharmacodynamics. Pharmacological activity of the medication is determined by the content of low-molecular biologically active peptides, making more active the natural evolutionally formed controlling systems of the organism, responsible for the search and the elimination of the pathological changes. Erbisol® makes more active the immune system for the accelerated restoration of the damaged cells, and the elimination of the anomalous cells and the tissues. The principal immunomodulating effect of the medication is first of all manifested throughout its effect on the macrophagic link, responsible for repair of the damaged cells and the restoration of functional activity in the organs and the tissues, and also throughout the NK-cells (CD3–16+56+), and T-killers (CD3+16+56+), which are responsible for the elimination of damaged cells, incapable for the regeneration, or the anomalous cells (mutant, malignant, virus carrying cells etc.) and the tissues. At that time, Erbisol has the immunocorrelating action and promotes the normalization of disturbed immunologic status by making more active T-lymphocytes, Th1-helpers and T-killers and inhibiting the activity of Th2-helpers and B-lymphocytes that is important for the balance recovery between cellular and humoral immunity in oncologic diseases, and for suppressing the autoimmune and allergic reactions. Depending on the immune status of the organism, the medication corrects the activity of some other factors of cellular and humoral immunity: induces the synthesis of α-, β-, γ-interferons, tumour necrosis factor, interleukin-2 (IL-2) and IL-12, inhibits synthesis of IL-4 and IL-10. Erbisol® potentiates the effect of antibiotics, exogenous interferons and at the same time decreases their toxic side effects.
Erbisol® accelerates the reparative processes in erosive gastric intestinal ulcers, contributing the healing of the gastric and duodenal mucosal damages. The medication increases the regenerative and reparative tissue potential, resulting in healing of the traumatic, purulent and postoperative wounds, trophic ulcers of different aetiology, the accelerated consolidation of the osseous fragments in the fractures, the effective treatment of parodontitis.
Erbisol® is effective in the treatment of acute and chronic hepatitis of different aetiology including toxic, medicamentous and virus hepatitis while the medication makes more active the hepatic regenerative processes. Beside that, Erbisol® activates the cytotoxic T-lymphocytes (CD8+) and T-killers (CD3+16+56+), responsible for eliminating the virus carrier cells and also induces the synthesis of α-, β- and γ-interferons increasing their blood level by 4-6 times that contributes to the accelerated virus elimination in virus hepatitis. At the same time, the medication promotes the substitution of dead hepatocytes by healthy ones, activating the hepatic regenerative processes, that allows to relate Erbisol® to the medications, decreasing the severity degree of infectious disease. The medication has the antiinflammatory properties, however the treatment of the chronic inflammatory processes may be passed without the phase of the acute condition during 2-5 days. Erbisol® contributes to the normalization of the hepatocyte functions, manifests the clear antioxidant and membranestabilizing effects at the level of plasma membranes, prevents the development of dystrophy, cytolysis, cholestasis and also atherosclerosis in the hepatic damages, contributes to the normalization of the bilirubin and transaminase levels. All this leads to the more quick disappearance of asthenovegetative, dispeptic and painful syndromes. The medication promotes the accelerated elimination of the foreign toxic agents from the organism and the harmful products of its vital activity, making more active the hepatic functions.
In the chronic obstructive pulmonary diseases and bronchial asthma with the pulmonary insufficiency, Erbisol® decreases the phenomena of neutrophile inflammation, which excessive activation formes an irreversible component of bronchial obstruction by the destruction of elastic collagen base of the lungs. The decrease in cellular inflammation contributes to the functional improvement of external respiration, that influences on the level of tissue hypoxia, energy supply of the cells, the decrease in loading their membranes with toxines and immunocomplexes, potentiates the catecholaminebinding function of the erythrocyte membranes, decreases the relative viscosity of the erythrocyte suspension and their capacity for the aggregation, increases the erythrocyte deformity that promotes the blood dilution and the improvement of microcirculation. The clinical effect of Erbisol® is manifested by the significant weakening of expressed cellular symptoms of disease, the positive increase in dynamic indices of external respiratory function, decrease in a number of inhalation bronchodilators, that are used.
In insulin dependent diabetes mellitus (type 1 diabetes mellitus) Erbisol® inhibiting the activity of Th2-helpers and B-lymphocytes, decreases an intensity of the autoimmune processes, and making more active macrophages, contributes to the reparation of damaged beta-cells, that leads to a decrease in the daily requirement of insulin injections, and also the stable compensation of carbohydrate and lipid metabolism, the decrease in lipid peroxidation. This contributes to the decrease or the liquidation of clinical signs and the improvement of the hepatic function, the myocardium, and the cardiovascular system. Under complex therapy Erbisol® has the positive effect on the treatment of neuropathy, diabetic macro- and microangiopathies, improves the microcirculation of the blood vessels, and prevents the development of gangrene. In newly diagnosed diabetes mellitus it contributes to the significant decrease in a daily dose of insulin, the persistent and prolonged remission. In patients with non insulin dependent diabetes mellitus (type 2 diabetes mellitus) Erbisol® regulates the indices of the metabolic syndrome, and improves the myocardial contractility. Erbisol® contributes to the improvement of the life level in patients with diabetes mellitus.
In oncologic diseases, ERBISOL® does not stimulate the disbalanced immune system of patients, but promotes its correction, normalizing the immune status by making more active T-lymphocytes, Th1-helpers and T-killers, and inhibiting the activity of Th2-helpers and B-lymphocytes, that contributes to the restoration of specific cellular immunity and first of all the activization of T-killers. The medication makes more active also macrophages and natural killers (NK-killers) of unspecific immunity, induces the synthesis of α- and γ-interferons and tumour necrosis factor. This leads to inhibition of the malignant tumour growth as well as metastasis, and in a complex with surgical intervention or chemo- and radiotherapy, contributes to their effective elimination. Erbisol® as the acompanying medication, significantly increases the treatment efficacy in two directions under chemo- and radiotherapy. Firstly, as the reparant, the hepato- and immunoprotector it protects the healthy cells and tissues from the chemical and radiation damages, restoring the damaged links. This allows to apply the more intensive regimens using the drastic chemicals and the radiation doses without the risk of arising the significant negative consequences in the patient status, preventing the hear loss, the elimination or the significant decrease in the manifestations of vegetative, dyspeptic and painful syndromes. Secondly, as the immunocorrector the medication restores the antitumoral functions of the immune system and contributes to the normalization of the patient immune status up to the parameters of the healthy persons after the therapy, despite a damaging effect of chemo- and radiotherapy. This permits to mobilize the protective antitumoral functions of the organism during the treatment, as well as between the periods of the treatment courses, that favours their subsequent increased role, and an improvement of the patient living standard and also the possibile substitution of some chemotherapy courses by the immunotherapy and immunocorrection courses with Erbisol®, in contrast to the standard chemo- and radiotherapy.
The decrease in a number of the repeated intensive courses of chemo- and radiotherapy, that were needed in the nearest period, and also the decrease in the incidence of newly diagnosed metastatic nodes in the periods between the plan courses of treatment were revealed by the clinical investigations with the participation of patients, who were used Erbisol®.
Erbisol® activates the immune system for performing the organism revision and restoration, that is of great importance in the gerontology, since a great number of the anomalous cells, many of which are in the “drowsiness” state, are accumulated and are activated while the immune system is relaxed in the process of vital activity. Erbisol® promotes the rehabilitation of the immune system function, while activated N- and T-killers have opportunity for the revision – to find and to destroy the anomalous cells and to make the macrophage restoration to some extent i. e. to regenerate the organ and tissue functions that are disturbed in the elderly.
Immunomodulating effect begins to develop at the days 5-7 and the maximal indices are reached at the days 20-21 maintaining this level after finishing the medication usage yet for 8-10 days. The reparative effect begins to develop at the days 2-3 of the therapy and the hepatoprotective effect is manifested after 2-3 injections of the medication.
The medication is nontoxic, without the cumulative toxicity, allergenic, teratogenic, mutagenic and carcinogenic characteristics.
Pharmacokinetics. It is not studied.
Pharmaceutic characteristics.
Main physical and chemical properties: the transparent or slightly opalescent colourless or light-yellow liquid.
Incompatibility. For the effective realization of the directed immuno-modulating effect, Erbisol® is prohibited to use together with:
а) alcohol (it neutralizes the reparative effect of macrophages);
б) immunomodulators that can stimulate the humoral immunity preventing the T-killer effect.
Shelf-life – 5 years. Don’t use after the expiration date indicated on packing.
Conditions of storage. Keep the medication at a temperature of +4 – 12о C, in the place out of the reach of children. An appearance of opalescence is permissible during storage.
Packing. 10 ampules per 1 ml or 2 ml.
Distribution. According to prescription.
Manufacturer. Scientific-Industry Centre “ERBIS” Ltd.
E-mail: erbis@ukr.net
Web site: www.erbisol.com.ua
Address. Ukraine, 02002, Kiev, R. Okipnaya Str., 10b
tel: +38 (044) 456-70-13 592-37-77.