Part 2
E R B I S O L
Immunomodulator,
hepatoprotector,
reparant and adaptogene
ERBISOL - Highly effective medication of new generation with original
mechanism of action.
It contains the low-molecular “signal” fragments of specialized molecules
(markers of cell physiological condition), which in case of pathological
changes, activate the evolutionally formed organism controlling systems,
responsible for the search and elimination of pathologic changes in
organs and tissues. One of the main such controlling systems is the
immune system of the organism.
Accelerates the recovery of the damaged cells and destruction
of anomalous cells and tissues.
ERBISOL influences only on the unbalanced systems, the affected
organs and tissues and remains practically indifferent for organism,
without side effects, i. e. innocuous, does not induce medicine poisoning
in overdose or long-term application.
Enhances protective and adaptation functions of the organism. It will help
you to realize your physiological potential for the valuable mode of life.
Exclusive rights on medical preparations of “Erbisol” class are patented
in 20 countries of the world on the basis of international application
PCT/UA93/00003, including European patent №0673653, and also patents
of USA № 08/397288, Russia № 2041715, Ukraine № 2164,
Byelorussia № 2039, Poland № 173321, Bulgaria № 61679…
“Biologically active substance with immunomodulating properties,
method of its production, preparation on its basis and method for the
normalization of physiological state in human and animal organisms
using the preparation”
Term of patent validity is 20 years, from 21.07.1992.

E R B I S O L
Immunomodulator,
hepatoprotector,
reparant and adaptogene
ERBISOL - Highly effective medication of new generation with original
mechanism of action.
It contains the low-molecular “signal” fragments of specialized molecules
(markers of cell physiological condition), which in case of pathological
changes, activate the evolutionally formed organism controlling systems,
responsible for the search and elimination of pathologic changes in
organs and tissues. One of the main such controlling systems is the
immune system of the organism.
Accelerates the recovery of the damaged cells and destruction
of anomalous cells and tissues.
ERBISOL influences only on the unbalanced systems, the affected
organs and tissues and remains practically indifferent for organism,
without side effects, i. e. innocuous, does not induce medicine poisoning
in overdose or long-term application.
Enhances protective and adaptation functions of the organism. It will help
you to realize your physiological potential for the valuable mode of life.
Exclusive rights on medical preparations of “Erbisol” class are patented
in 20 countries of the world on the basis of international application
PCT/UA93/00003, including European patent №0673653, and also patents
of USA № 08/397288, Russia № 2041715, Ukraine № 2164,
Byelorussia № 2039, Poland № 173321, Bulgaria № 61679…
“Biologically active substance with immunomodulating properties,
method of its production, preparation on its basis and method for the
normalization of physiological state in human and animal organisms
using the preparation”
Term of patent validity is 20 years, from 21.07.1992.

In gastroenterology:
- gastric and duodenal ulcers;
- erosive gastroduodenitis, enterocolitis;
- ulcerative colitis.
In surgery and traumatology:
- traumatic, postoperative and purulent septic wounds, it promotes their
quick healing;
- traumas and fractures, for the acceleration of consolidation
processes in the osseous breakings and the reparation of the soft
tissues;
- trophic ulcers;
- acute paraproctitis;
- decubitus.
In stomatology:
- parodontitis and paradontal disease.
In endocrinology:
- in diabetes mellitus it inhibits autoimmune process and promotes the
reparation of damaged β-cells resulting in the decrease of blood sugar;
- autoimmune thyroiditis.
In gerontology:
- in functional insufficiency of the organs and tissues related with age
disorders.
In general therapy:
- in complex therapy of unspecific lung diseases
(pneumonia, chronic bronchitis);
- tissue dystrophy;
- angiopathies, for the improvement of microcirculation, normalization
of tonus and blood filling of vessels;
- asthenic syndrome, for increase of physiological activity and life tonus
- the medication optimizes function of cardiovascular system, promotes
recovery of myocardial dystrophy at preinfarction phase and more
complete regeneration of the myocardium at postinfarction period.
In sexopathology:
- for an increase (the recovery) of the potency.
ERBISOL as the antioxidant is applied for the complex treatment of
persons, suffered as a result of radiation consequences and ecologic
contamination.

ERBISOL as the immunomodulator:
In oncology:
ERBISOL does not stimulate the unbalanced immune system of oncologic
patients, but it contributes to its correction, restoring correlation between
cellular and humoral immunity, resulting in the activation of early
depressed antitumorous functions of the immune system, in contrast to other
immunomodulators.
It activates: macrophages, Th1-helpers, N- and T-killers,
induces the synthesis of interleukins IL-1, IL-2, α-, γ-interferons and
Factor of Necrotic Tumours (FNT).
It inhibits: Th2-helpers, B-lymphocytes and synthesis of IL-4, IL-10.
In Oncology ERBISOL is the medication of
accompaniment, rehabilitation and activation of
antitumorous protection in the organism.
- in the surgical treatment ERBISOL is used as a reparant and for
prophylaxis of metastasis;
- in chemo- and radiotherapy ERBISOL is used in a complex as the
medication of accompaniment, as hepato-, immumoprotector and
reparant, in rehabilitation periods, and in period between treatment
courses ERBISOL is used as the immunocorrector and reparant for
activization of antitumorous protection in the organism.
ERBISOL is the medication of comfort in Oncology
Contributes to good of tolerance intensive chemoradiotherapy, prevents
cytopenia, lesion of mucous membranes, alopecia and dyspepsia.
in clinic of infectious diseases:
At the treatment of viral and microbic infections it mobilizes the immune
system, activates specific immunity against infectious stimulator.
In complex therapy of hazard infections it potentiates effect of antibiotics,
α-, β-, γ-interferons and reduces their side effect.
in allergology:
Allergic and autoimmune disease, including bronchial asthma,
seasonal exacerbation of allergic diseases, hepatitis, diabetes mellitus,
autoimmune thyroiditis.

APPROVED
Order of Ministry of Public
Health of Ukraine
26. 10. 1999 N 255.
INSTRUCTION
for medical application of the medication:
“ERBISOL” solution for injections
( ERBISOLUM pro injectionibus )
GENERAL CHARACTERISTIC:
International name: Erbisol.
Principal physical and chemical properties: light yellow liquid;
composition: a complex of the natural protein-free low-molecular
weight organic combinations of nonhormonal origin obtained from the
embryonic tissue of chicken or duck germs, contains glycopeptides,
peptides, nucleotides and amino acids.
FORM OF OUTPUT. Solution for injections.
PHARMACOLOGICAL GROUP. Immunomodulator, reparant,
hepatoprotector.
PHARMACOLOGICAL CHARACTERISTICS. Pharmacological
activity of the medication is determined by the content of low-molecular
weight biologically active peptides, activating the natural evolutionally
formed controlling systems, responsible for the search and elimination of
pathological changes in the organism. One of such systems is the immune
system, which is activated by Erbisol for quicker restoration of the damaged
cells, and destruction of anomalous cells and tissues. A principal
immunomodulating effect of the medication is first of all realized throughout
its effect on macrophagic link, responsible for repair of the damaged cells and
the restoration of organ and tissue functional activity, and throughout
N- and T-killers, which are responsible for the destruction of damaged cells,

incapable for the regeneration, or anomalous cells (mutant, malignant, virus
carrying cells and so on) and tissues too. Further more, Erbisol has the
immunocorrelating action and promotes the normalization of disturbed
immunologic status by activizing 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 stopping the autoimmune processes. Depending
on the immune status of the organism the medication corrects the activity of
some other factors in the humoral and cellular immunity, induces the
synthesis of interferon and factor of necrotic tumors. Erbisol potentiates the
effect of antibiotics, endogenous α-, β-, γ-interferons and decreases their toxic
side effect.
Erbisol accelerates the reparative process in patients with erosive
gastric intestinal ulcers, contributes to healing the mucosal damage in the
stomach and duodenum. The medication increases regenerative and
reparative tissue potential, resulting in healing of trophic ulcers, traumatic,
postoperative and pyoceptic wounds, traumas and also the consolidation of
osseous breakings in fractures, the treatment of parodontitis and
paradontosis.
High efficacy of Erbisol is revealed in the treatment of acute and
chronic hepatitis of various etiology including toxic, medicamentous and
viral hepatitis, when the medication activates the regenerative processes of
the liver. In viral hepatitis Erbisol activates T-killers that destroy viral
carriers and also induces the interferon synthesis contributing to the
acceleration of viral elimination additionally. At the same time, while
activating the regenerative processes of the liver the medication promotes
the substitution of dead hepatocytes by healthy ones, that allows Erbisol to
be related to the medications, decreasing the severity of infectious disease.
The medication has antiinflammatory properties, however the treatment of
chronic inflammatory processes may be without the acute phase during 2-5
days. Erbisol contributes to the normalization of the hepatocyte functions, it

manifests the clear antioxidant and membranostabilizing effects at the level
of plasma membranes, prevents the development of dystrophy, cytolysis,
cholestasis and also atherosclerosis; in the liver damages, contributes to the
normalization of the bilirubin and transaminase levels. All this leads to
quicker disappearance of asthenovegetative, dispeptic and painful
syndromes. The normalization of the liver function results in the quicker
elimination of alien toxic agents and injurious products of the organism vital
activity.
At the chronic obstructive lung diseases and bronchial asthma with
respiratory deficiency, Erbisol decreases neutrophile inflammation, which
excessive activation creates an irreversible component of bronchial
obstruction by the destruction of elastic collagen base of the lungs. The
decrease in cellular inflammation contributes to functional improvement of
external respiration, that influences on the level of tissue hypoxia, energy
supply of cells, to the decrease of toxin contents in their membranes and
immunocomplexes, potentiates katecholaminebinding function of
erythrocyte membranes, decreases the relative viscosity of erythrocyte
suspension and capacity for red blood cell aggregation, increases the
erythrocyte deformity that promotes the increase in blood dilution and the
improvement of microcirculation. Clinical effect of Erbisol is manifested by
the significant weakening of expressed cellular symptoms of disease, the
positive increase in dynamic indices of functional external respiration,
decrease in a number of inhalation bronchodilators, that are used.
In insulin dependent diabetes mellitus (type 1 diabetes mellitus)
Erbisol activates T-suppressors, decreases the intensity of autoimmune
processes, and activating macrophages, contributes to the reparation of
damaged beta-cells, that leads to a decrease in daily requirement of insulin
injections, and also to the stable compensation of carbohydrate and lipid
metabolism, to the decrease in lipid peroxidation. This contributes to the
decrease or liquidation of clinical signs and to the functional improvement
of the liver, myocardium, cardiovascular system. In complex therapy
Erbisol has the positive effect on the treatment of neuropathy, macro- and
microangiopathies in diabetes mellitus; improves the microcirculation of the
blood vessels, prevents the development of gangrene. In newly diagnosed
diabetes mellitus Erbisol contributes to the significant decrease in daily dose
of insulin, to the persistent and prolonged remission. In patients with non
insulin dependent diabetes mellitus (type 2 diabetes mellitus) Erbisol
regulates the indices of metabolic syndrome, and improves myocardial
contractility. Erbisol contributes to the improvement of life level in patients
with diabetes mellitus.
In oncologic patients, ERBISOL does not stimulate their disbalanced
immune system, but first of all promotes its correction, normalizing the
immune status by activation of T-lymphocytes, Th1-helpers and T-killers,
inhibiting B-lymphocytes, that contributes to the restoration of specific cell
immunity and first of all to the activation of T-helpers, in contrast to other
immunomodulators. The medication also activates the macrophages and
natural killers (N-killers) of unspecific immunity, induces the synthesis of
interferon and factor of necrotic tumours. This leads to inhibition of the
malignant tumor growth and metastasis, and in a case of a complex surgical
intervention or chemo- and radiotherapy contributes to their effective
destruction. As a medication of accompaniment for chemo- and
radiotherapy, Erbisol significantly increases an efficacy of the treatment in
two directions: firstly, as the reparant, hepato- and immunoprotector it
protects the healthy cells and tissues from chemical and radiation injuries,
restoring the damaged links. This allows to apply more intensive regimens
of drastic chemical preparations and radiation doses without the risk for
arising the significant negative consequences in patient status, preventing
the loss of hear, elimination or significant decrease in the manifestations of
vegetative, dyspeptic and painful syndromes. Secondly, as immunocorrector
the medication restores the antitumorous functions of the immune system
and despite a damaged effect of chemo- and radiotherapy contributes to the
normalization of immune status in patients after the treatment to the
parameters, comparable with the parameters of immune status of healthy
persons. This permits to mobilize the protective antitumorous functions of
the organism during the treatment, as well as between the periods of
treatment courses, that favour their increased role, and an improvement of
the living standard and also the possibile substitution of some chemotherapy
courses by immunotherapy and immunocorrection with Erbisol, in contrast
to the standard chemo- and radiotherapy. A decrease in a number of the
repeated intensive courses of chemo- and radiotherapy, that were needed in
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 clinical examinations in patients, who applied Erbisol.
Erbisol is a good adaptogene, increasing the protective and adjusting
functions of organism. Its use is recommended for the complex therapy in
the treatment of consequences of radiation effect and ecological
contaminations. The medication manifests the radioprotective effect,
associated with its membranostabilizing and antioxidant properties, the
activation of reparative processes at the cellular as well as genetic (activizes
DNA-polymerase-B – a reparant of genetic code) levels, the normalization
of the liver functions for effective elimination of the alien toxic agents.
Erbisol activates the immune system for inspection and restoration of
the organism, that is of great importance in gerontology, as in the process of
vital activity a great number of the anomalous cells are accumulated, many
of which are in the “drowsiness” state and are activated while the immune
system is relaxed. Erbisol contributes to the functional rehabilitation of the
immune system, when activated N- and T-killers have opportunity for the
inspection (to find and destroy the anomalous cells and to do any restoration
of macrophages), for the regeneration of organ and tissue functions
disturbed in elderly patients.
The medication is nontoxic, without the allergogenic, teratogenic,
cumulative, mutagenous and carcinogenous activities.
PHARMACOKINETICS
The immunomodulating effect begins to develop on the days 5-7 and
the maximum values are reached on the days 20 – 21, keeping at the same
level for 8-10 days after finishing the medication administration. The
reparative effect begins to develop on the days 2-3 of the treatment and the
hepatoprotective effect is manifested after 2-3 injections of the medication.
INDICATIONS:
- Gastroenterology: hepatitis of various aetiology (including virus,
toxic and also provoked by the use of “special shock” doses of antibiotics,
interferons, chemicals and other drastic medicamentous preparations
inducing side effects), hepatopathies, hepatosis, hepatic cirrhosis, stomach
and duodenum ulcers, erosive gastroduodenitis, ulcerative colitis.
- Toxicology: Erbisol, activating the liver function, promotes the
organism clearence from toxic agents and injurious products of the vital
activity.
- Endocrinology: diabetes mellitus, autoimmune thyroiditis.
- Therapy: nonspecific pulmonary diseases (pneumonia, chronic
bronchitis), dystrophic lesions of tissues, angiopathies; for the improvement
of microcirculation, the normalization of tonus and bloodfilling of the
vessels. Erbisol is applied in the complex therapy of patients, suffered as the
result of radiation consequences and ecologic contamination.
- Allergology: allergic and autoimmune diseases including bronchial
asthma, seasonal acute conditions of allergic diseases, hepatitis, diabetes
mellitus.
- Gerontology: in functional insufficiency, associated with the age
disturbances in the liver, immune, nervous and cardiovascular systems. For
the increase of the physical activity and total vital tonus, for the
potentiation of potency.
- Stomatology: parodontitis and paradontosis.
- Surgery and traumatology: traumatic, postoperative and pyoceptic
wounds, fractures (for quicker consolidation of osseous breakings), trophic
ulcers of different etiology, diabetic angiopathies, decubitus.
- Oncology: for prophylaxis of metastasis in surgical intervention (as
a reparant). Erbisol in complex with chemo- and radiotherapy is used as a
medication of accompaniment as a hepato-, immunoprotector and reparant,
but during the rehabilitation period and the periods between the treatment
courses is also applied as an immunoprotector and reparant for the
activation of antitumor protection of the organism.
DOSAGE AND ADMINISTRATION: The medication Erbisol,
solution for injections, is daily administered as intramuscular injection into
the buttocks or intravenously or intraarterialy in a dose of 2-4 ml for 20 days
and taking into account the chronorhytms of the organism, its single
administration is desirable at 20-22 o’clock before going to the bed in 2-3
hours after meals, if other time is not stipulated (a total course of the
treatment consists of 20 - 40 ampules per 2 ml).
At hepatopathies, exacerbation of inflammatory processes,
autoimmune, allergic diseases Erbisol is daily administered in a dose of 2 ml
for 20 days.
At wounds, parodontitis and paradontosis Erbisol is administered in a
dose of 4 ml for the first 10 days, and in a dose of 2 ml for the next 10 days
in a case of need. The additional gingival applications and electrophoresis
with Erbisol from the (+) are applied in generalized parodontitis.
In patients with chronic obstructive lung diseases and bronchial
asthma with respiratory deficiency of degree 1 Erbisol is administered in a
single daily dose of 2 ml intramuscularly at 21 o’clock the first 3 days then
twice daily at 17 and 21 o’clock for 5 days and then once daily at 21 o’clock
for 7 days. The medication is alternatively administered in 2-3 hours after
the meals in the both buttocks. In chronic obstructive lung diseases and
bronchial asthma with respiratory deficiency of degree 2 the medication is
daily administered intramuscularly at 21 o’clock for the first 3 days and
twice a day - the next 10 days: in a dose of 2 ml intramuscularly at 17 and
21 o’clock, then in a dose of 2 ml intramuscularly at 21 o’clock for 7 days.
The course dose consists of 30 ampules per 2 ml. The requirement of
Erbisol for the treatment course of chronic obstructive lung diseases and
bronchial asthma accompanied by great and irreversible changes in the
function of external respiration with respiratory deficiency of degree 3 is no
less than 40 ampules. The medication is twice prescribed in patients of this
group: in a dose of 2 ml intramuslularly at 17 and 21 o’clock for 20 days.
The offered method of the treatment supplements the basic schema of
therapy.
At hepatitis, hepatosis, hepatic cirrhosis, erosive ulcerous injuries of
gastrointestinal tract, ulcerative colitis, dystrophic tissue damages, traumatisms,
fractures, trophic ulcers of different aetiology, decubitus and also for
the quicker consolidation of osseous breakings, for the rehabilitation and
reducing therapy, for increasing the physical activity and total vital tonus
Erbisol is twice applied every day: in a dose of 2 ml at 7 or 21 o’clock for
20 days or in a single daily dose at 21 o’clock for the first 3 days. The next
10 days Erbisol is twice administered (in a dose of 2 ml at 7 o’clock and at
21 o’clock) and then in a dose of 2 ml at 21 o’clock for 7 days.
In diabetes mellitus Erbisol is preferably administered intravenously
twice in a daily dose of 2 ml (at 9-11 o’clock in the morning and at 20-22
o’clock in the evening) for 20 days. The course of therapy may be repeated
2-3 times a year.
At oncologic diseases, as a medication of accompaniment and
rehabilitation in chemo- and radiotherapy Erbisol is twice applied in
radiotherapy in a daily intramuscular dose of 2 ml at 6-8 o’clock in the
morning and at 20-22 o’clock in the evening for 20 days starting course with
1-2 days before the radiotherapy. In chemotherapy Erbisol is administered
in a daily intramuscular dose of 2 ml at 20-22 o’clock in the evening starting
with 2-3 days before, during the course of chemotherapy and finishing on
the 7-12 days after chemotherapy (15-25 days) and also in a intramuscular
dose of 2 ml starting with 1-2 days before, during the chemotherapy course
and finishing on the days 3-7 after the end of chemotherapy. It means that
Erbisol can be applied in a single daily dose of 2 ml at 20-22 o’clock in the
evening on the first and the last 4-7days of Erbisol course. On the days of
chemotherapy Erbisol injection is applied in a fractional dose of 4-16 ml. It
is advisable to administer Erbisol injection in a dose of 2 ml in the morning
instead of the intramuscular (depending on dosage regimen of chemical
preparations) directly before the administration of every cytostatic agents by
intravenous, intraarterial, intratumorous or intraperitoneal injections and the
additional intramuscular injection of Erbisol in a dose of 2 ml at 17 o’clock.
For example, Erbisol is firstly administered intravenously in a dose of 2 ml
before the infusion of every 200 ml chemical solution as the intravenous
drop infusion of chemical preparation. In regional chemotherapy Erbisol is
administered in a dose of 4 ml by intraarterial or intratumorous injections
before the administration of chemical solution by the same way. An
additional intramuscular administration of Erbisol in a dose of 2 ml is
prescribed in 2-3 days after the administration of acute doses of chemical
preparations which accompaniment requires 8-16 ml Erbisol.
The calculation of Erbisol amount necessary for use in the complex
with chemical preparations to prevent their side effects on patient healthy
tissues, is realized depending on a injected dose of chemical preparations.
For example, the administration of Erbisol in a dose of 2 ml is desirable
before every: 25-30 mg of doxorubitsine or 25 mg of platinum agents or
0,5-0,75 g of cyclophosphane or 1,0 g of 5-fluoruratsile or other chemical
preparations with an equivalent toxic effect.
Some examples of schemes for Erbisol use an accompaniment of
chemotherapy courses are mentioned below in Appendix.
If the patient was underwent a surgical intervention before chemo- and
radiotherapy, Erbisol is prescribed in a dose of 2 ml intramuscularly in the
evening for 7-10 days before the course of chemoradiotherapy starting from
the days 1-3 after an operation. It is advisable for the patients with
concomitant liver diseases and/or hepatitis in the anamnesis.
For improvement of patient life quality, a course of immunotherapy
with Erbisol can be performed in 3-5 weeks after a chemotherapy. The first
3 days, Erbisol is intramuscularly taken in a single daily dose of 2 ml at
20-22 o’clock in the evening. The next 5-10 days – twice a day: in a dose of
2 ml at 6-8 o’clock in the morning and at 20-22 o’clock in the evening, and
then in a dose of 2 ml at 20-22 o’clock in the evening for 7 days.
SIDE EFFECT. Erbisol has a good tolerance in patients and the side
effects are in the most cases absent. However, in some cases during the first
days of the administration, the medication can induce an exacerbation of
chronic inflammatory process that is not considered as a negative effect
because this is a stage of curative process in the majority of cases. At high
arterial pressure and during the exacerbation phase of pathological process
the medication should be used carefully in the decreasing dose.
CONTRAINDICATIONS: individual intolerance.
INTERACTION WITH OTHER MEDICINES.
Erbisol potentiates the effect of antibacterial agents. For the effective
realization of direct immunomodulating effect Erbisol is prohibited to use
together with:
а) alcohol (it neutralizes the reparative effect of the macrophages);
б) immunomodulators that can stimulate the humoral immunity
preventing the T-killer effect.
Erbisol increases the receptor sensitivity so its complex application
with the hormonal medications, biostimulators and bioinhibitors
(tranquilizers, soporific, ataraxic, psychotropic agents, depressants and so
on) requires the control of their dosage and the decrease in a case of need.